1972 Amendments of Tilly METZ
Amendment 2 #
2023/2081(INI)
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
– having regard to Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act)1a , _________________ 1a OJ L 277, 27.10.2022, p. 1.
Amendment 7 #
2023/2081(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
– having regard to the EFSA scientific opinion regarding Tolerable upper intake level for dietary sugars,
Amendment 13 #
2023/2081(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas claims referring to children development and health in the labelling of foods may be authorised in accordance with the procedure laid down in Articles 15, 16, 17 and 19 of Regulation (EC) No 1924/2006, provided that they satisfy the requirements set out, inter alia, in Articles 3, 5, and 6 of that Regulation;
Amendment 14 #
2023/2081(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas, as explained in Recital 10 of Regulation (EC) No 1924/2006, foods promoted with claims may be perceived by consumers as having a nutritional, physiological or other health advantage over similar or other products to which such nutrients and other substances are not added, and this may encourage consumers to make choices which directly influence their total intake of individual nutrients or other substances in a way which would run counter to scientific advice;
Amendment 15 #
2023/2081(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the presence of nutrition or health claims affects consumers’ food choices, along with other characteristics such as price, brand, colour and packaging shape; whereas health claims, especially risk reduction claims, have more of an impact on consumers’ attitudes than nutrition claims10 ; whereas consumer understanding of nutrition and health claims is influenced by various factors, including nutritional knowledge and education levels so as to facilitate the shift to healthier diets and to stimulate food reformulation; _________________ 10 Pichierri M, Pino G, Peluso AM, Guido G., ‘The interplay between health claim type and individual regulatory focus in determining consumers’ intentions toward extra-virgin olive oil’, Food Research International. Vol. 136, Elsevier, October 2020, pp. 109467.
Amendment 17 #
2023/2081(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the EFSA panel could not set “a safe level of intake” of free and added sugars because “the risk of adverse health effects (responses) increased across the whole range of observed intake levels (doses) in a constant (linear) manner, i.e. the higher the intake, the greater the risk of adverse effects”; whereas the World Health Organization's Cancer Research Agency (IARC) has classified the sweetener aspartame as "possibly carcinogenic to humans"; whereas a systematic review by the WHO suggests that non-sugar sweeteners could be linked to an increased risk of type 2 diabetes, cardiovascular disease, all-cause mortality, and increased body weight;
Amendment 38 #
2023/2081(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Amendment 41 #
2023/2081(INI)
Motion for a resolution
Recital H b (new)
Recital H b (new)
Hb. whereas generally accepted scientific evidence shows that DHA in breast milk contributes to the visual development of infants, the synthesised DHA added to formula milks and other foods intended for infants is, however, in a different biological environment to breast milk, which is a species-specific, living substance with co-enzymes and co- factors which allow the fats to work optimally;
Amendment 42 #
2023/2081(INI)
Motion for a resolution
Recital H c (new)
Recital H c (new)
Hc. whereas in its resolution of 16 February 20221a, the European Parliament stressed the role of healthy diets in preventing and limiting the incidence of cancer; _________________ 1a OJ C 342, 6.9.2022, p. 109.
Amendment 46 #
2023/2081(INI)
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas however, information provision, education and awareness campaigns alone are insufficient to achieve the required change towards more sustainable and healthy consumer choices as these can be influenced by other key elements of food environments such as affordability, marketing and availability;
Amendment 49 #
2023/2081(INI)
Motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas according to an impact assessment analysis of the NHCR1a, the overall cost of submitting an Article 13.5 or Article 14 health claim application is likely to be in the region of €0.26 million to €1 million per application, notably due to the high cost of human intervention studies; whereas this cost constitutes a considerable barrier for applications regarding health claims on botanicals; _________________ 1a Economic Impact Assessment of the European Union (EU)’s Nutrition & Health Claims Regulation on the EU food supplement sector and market, Graham Brookes GBC Ltd, UK, September 2010.
Amendment 86 #
2023/2081(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Highlights that consumers tend to overconsume food products bearing claims to promote better health, which is known as the ‘halo-effect’; advocates for the inclusion of both minimum and maximum usage thresholds on product labels of all foods and food supplements bearing health claims, along with a recommendation to consult a healthcare professional before consuming food supplements, in particular in order to avoid potential adverse interactions with specific treatments;
Amendment 91 #
2023/2081(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Stresses that information provision, education and awareness campaigns alone are insufficient to achieve the required change towards more sustainable and healthy consumer choices and need to be accompanied by policies and legislation which improve the food environments;
Amendment 99 #
2023/2081(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Notes that many of the claims used on the EU market are for nutrients that very few European consumers lack in their diets; calls on the Commission to examine the legislative potential for extending EFSA’s remit to include assessing the relevance of the use of such claims, in addition to examining the scientific basis for such claims;
Amendment 100 #
2023/2081(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Highlights that, even when the claims for infant formula have strong scientific support, for instance the health claim "DHA intake contributes to the normal visual development of infants up to 12 months of age", their use may be inappropriate since they still risk undermining breastfeeding and limit access to improvements in these important nutritional products to those able to pay a premium price;
Amendment 103 #
2023/2081(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Commission to evaluate the possibility to restrict the use of the permitted nutrition claim ‘no added sugar’ for products containining sweeteners or high levels of free sugars;
Amendment 124 #
2023/2081(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls for the Commission and the Member States to set up a knowledge network aimed at achieving harmonisation in the enforcement of the NHCRsupporting the Working Group on Nutrition and Health claims - Regulation (EC) No 1924/2006; points out that this network should help facilitate the exchange of best practices, bridge interpretation gaps among Member States and address enforcement disparities;
Amendment 128 #
2023/2081(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Is concerned about the presence of unauthorized and misleading nutrition and health claims online; points to the responsabilites of Member States and online platform providers as established by the Digital Services Act, namely to act against the dissemintation of illegal content and to ensure transparency for consumers as regards online advertising; highlights in particular the online advertising transparency obligations of providers of very large online platforms and very large online search engines;
Amendment 136 #
2023/2081(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission and the Member States to create a platform to share best practices of online enforcement of the NHCR and encourage collaboration among the Member States’ competent authorities;
Amendment 50 #
2023/2015(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the EU imports substantial amounts of protein feed, (17 million tonnes of crude protein feed in 2022-2023 or 23.6% of the EU’s total crude protein feed use, according to the Commission’s Feed Protein Balance Sheet1a), much of which is soy-based imports, notably from Brazil, Argentina and the USA; _________________ 1a https://agriculture.ec.europa.eu/data- and-analysis/markets/overviews/balance- sheets-sector/oilseeds-and-protein- crops_en
Amendment 78 #
2023/2015(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas a shift toward extensive, sustainable and pasture-based animal farming systems, coupled with a substantial reduction in animal proteins consumption, is part of the transition to more sustainable food systems;
Amendment 90 #
2023/2015(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Amendment 94 #
2023/2015(INI)
Motion for a resolution
Recital F
Recital F
F. whereas the processing of protein crops and grasslands generates by-products that can contribute to a circular economymust be dealt with in a circular economy; whereas the waste hierarchy prioritises prevention of waste, which should be done early in the supply chain and ideally including at primary production level;
Amendment 106 #
2023/2015(INI)
Motion for a resolution
Recital G
Recital G
G. whereas the market for plant-based and alternative sources of protein is steadily increasing due to consumer demand; whereas plant-based proteins already enjoy high consumer acceptance and technological maturity;
Amendment 123 #
2023/2015(INI)
Motion for a resolution
Recital H
Recital H
H. whereas sustainable organic aquaculture has a crucial role in global food security and nutrition; whereas EU consumption of marine protein is unsustainably high;
Amendment 131 #
2023/2015(INI)
Motion for a resolution
Recital I
Recital I
I. whereas cell-based agriculture and seafood farming are promising and innovative solutionsthe development of novel proteins may propose innovative solutions to environmental and animal welfare impacts, but has as-of-yet uncertain impacts in terms of energy, water, land use, and the development of rural areas, as well as requiring new feedstocks and inputs itself;
Amendment 153 #
2023/2015(INI)
Motion for a resolution
Recital J
Recital J
J. whereas interest in insects for human and animal consumption is growing, despite a lack of scientific knowledge surrounding all aspects of insect farming, including behavioural and welfare needs of insects;
Amendment 168 #
2023/2015(INI)
Motion for a resolution
Recital K
Recital K
K. whereas research and innovation on, inclusive of farmers, on sustainable plant proteins needs to be scaled up;
Amendment 189 #
2023/2015(INI)
Motion for a resolution
Recital L a (new)
Recital L a (new)
La. whereas although the 1992 Blair House Agreement on proteins is still in force, it is de facto obsolete as it no longer reflects present-day realities; whereas WTO exemption clauses exist for socially and environmentally beneficial support measures;
Amendment 199 #
2023/2015(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Calls on the Commission to urgently present a comprehensive and ambitious EU protein strategy introducing effective measures to increase the EU’s production of plant protein in the short, medium and long term, with the primary aim of ensuring a sustainable EU production of plant proteins for EU consumption;
Amendment 214 #
2023/2015(INI)
Motion for a resolution
Paragraph 2 – point 1
Paragraph 2 – point 1
1. A vision for increasedan EU protein production that fits the needs and demands of the EU population, within the boundaries of our ecosystems;
Amendment 226 #
2023/2015(INI)
Motion for a resolution
Paragraph 2 – point 2
Paragraph 2 – point 2
2. Better supply chains conditions for protein production in the EU and coherent incentives within the CAP and promotional policy;
Amendment 240 #
2023/2015(INI)
Motion for a resolution
Paragraph 2 – point 3
Paragraph 2 – point 3
3. The development of plant-based and sustainable alternative protein for food and feed;
Amendment 247 #
2023/2015(INI)
Motion for a resolution
Paragraph 2 – point 3 a (new)
Paragraph 2 – point 3 a (new)
3a. A shift away from intensive animal protein production systems towards extensive, sustainable and pasture-based animal farming systems with high animal welfare standards;
Amendment 273 #
2023/2015(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Underlines that, from a geopolitical and strategic perspective, as well as to ensure food security dependencies on a single or few suppliers must be reduced and concentration of markets to few key players must be avoided;
Amendment 312 #
2023/2015(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Highlights that protein production must be recognised as a crucial aspect of the EU food system, while acknowledging that a single focus on protein production is detrimental to the holistic approach needed for sustainable and resilient food systems;
Amendment 318 #
2023/2015(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Considers that developing the sustainable production of plant and alternative sources of protein in the EU is an effective way of addressing many of the environmental and climate challenges that the EU faces; notes in particular the importance of supporting the relocalisation of the production of plant protein in the EU with a view to climate change mitigation, as this would shorten transport distances and limit deforestation;
Amendment 337 #
2023/2015(INI)
6a. Recalls that reducing EU production and consumption of farmed animals, particularly those farmed in intensive feed-based systems, would reduce the heavy dependence on plant proteins for feed; notes that increased job creation and comparable profitability with reduced herds can be achieved for herbivore animal farming by switching to pasture based grazing, allowing to cut input costs;
Amendment 354 #
2023/2015(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
Amendment 364 #
2023/2015(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights that a competitive agriculturen effective protein production sector is dependent on sustainable inputs such as feed additives, goodappropriate plant material, fertilisers and healthy soils;
Amendment 372 #
2023/2015(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Recognises the importance ofrole some feed additives formay play in reducing emissions, for improving protein consumption and for ensuring correct feeding strategies ; warns that the negative consequences of methane-reducing feed additives on animal welfare are understudied and risk leading to poor animal welfare, while still falling short on the needed methande reformulation of feedduction targets;
Amendment 374 #
2023/2015(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Recalls that it will be impossible to increase the production of plant-based protein without good-quality plant materials; underlines the importance of seed security and diversity, to deliver locally-sourced food and feed with high nutritional value; notes the urgent need to provide farmers with access to quality seeds for protein plant varieties adapted to the pressures of climate change and low- input farming systems, including traditional and locally-adapted varieties, genetically heterogeneous and locally adapted heirloom seeds; recalls that plant protein content is influenced by environmental factors and therefore resilience to climate change will be key;
Amendment 379 #
2023/2015(INI)
11a. Points out that gene-edited plants are patented and should therefore be avoided as they would further contribute to market concentration in seed and plant production, and the increase of input costs;
Amendment 389 #
2023/2015(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls on the Commission to propose medium- and long-term policy measures to close the nutrient loop, such as enabling the use of recovered nitrogen from manure (RENURE) products within the current framework of the Nitrate Directive and Water Directive;
Amendment 400 #
2023/2015(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Recalls that thewaste-based production of biomethane, biogas, biofuels or other bio- based chemicals that use biowaste streams is a source of important revenue to enhance and capture the value of protein- rich crops and strengthen their business case for farmers; underlines that cultivating crops for the sole purpose of bioenergy production is a threat to EU food security;
Amendment 435 #
2023/2015(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Highlights the big potential of plant-based protein and the fact that the environmentally and socially sustainable development of the sector will benefit European farmers, soil quality, biodiversity, the climate and human health;
Amendment 442 #
2023/2015(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Considers that the next protein strategy should put a special focus on leguminous crops, which can provide home-grown food and feed, replace or reduce fertiliser use by fixing nitrogen, and decrease pressure on animal feed and production costs; emphasises that the introduction of more leguminous plants in farmers’ production systems should go hand in hand with the development of new fair value chains for these crops;
Amendment 444 #
2023/2015(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Stresses the importance of grasslands as a protein source; highlights the relevance of projects that extract high- quality protein points out that extensive permanent grassland-based animal farming provides diets adapted to the animals’ natural needs, and that especially in contrast well as biomethanol from grasslands through biorefiningith intensive animal agriculture, they can have positive effects on the environment and against climate change, and contribute to a circular economy;
Amendment 458 #
2023/2015(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Is of the opinion that aquaculture is an important protein producer and that the use of algae as a feed additiv, though its production in the EU remains reliant on imported inputs such as fishmeal and fish oil; calls for shifting aquaculture towards farming of species at lower trophic level, non-carniverous and extensively reared; notes the interest in algae ias a promising way of reducing emissions from livestock; food, but recalls that the impact of cultivating and harvesting on biodiversity must be minimised; considers that the use of algae as a feed additive could be a way of reducing emissions from livestock, but remains geared towards intensive systems;
Amendment 464 #
2023/2015(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Considers it essential to halt the industrialisation of cephalopod production, given the need to counter the intensification of animal production not only for animal welfare reasons, but also to ensure that the Union’s food system is aligning itself with the agreed environmental goals; highlights that, as alerted by the scientific community, particularly in response to recent plans to open the first octopus farm, these animals are extremely intelligent and sensitive creatures whose welfare would be severely harmed by such keeping conditions;
Amendment 487 #
2023/2015(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Considers that innovative cell- based food can help increase protein production and support agriculture;
Amendment 494 #
2023/2015(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 509 #
2023/2015(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Highlights that insects farmed to feed other animals introduce an extra trophic level to the food system whose added sustainability value is, as yet, unproven;
Amendment 511 #
2023/2015(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Is of the opinion that authorisations made solely through novel food legislation should be based on the safety of the product, but that the impact of the process on human health and the environment must be considered, in line with the precautionary principle; highlights that a One Health approach must be followed with regard to the development and licensing of novel protein production, which integrates not only food safety but animal welfare, pathogen risk and environmental impact;
Amendment 530 #
2023/2015(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Underlines that policies must create a level playing field between all stakeholders and products and that protein consumption and production must be more sustainable;
Amendment 535 #
2023/2015(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls for more research and development into plant-based and alternative proteins and their impact based on a One Health approach;
Amendment 554 #
2023/2015(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Underlines that improved coordination and collaboration between the supply chain’s stakeholders is needed to bridge the current gaps between farmers, processors and retailers; notes that further legal requirements on buyers, processors and retailers might be needed to foster the development of new sustainable protein value chains;
Amendment 570 #
2023/2015(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Reiterates the farm to fork strategy’s target of reducing food waste by 50 %, which could be partly reached through a more circular agriculture sector and the promotion of short food supply chains;
Amendment 573 #
2023/2015(INI)
Motion for a resolution
Paragraph 25 b (new)
Paragraph 25 b (new)
25b. Stresses that animal welfare, including for insects and in aquaculture, must be considered within the scope of the European Protein Strategy.
Amendment 579 #
2023/2015(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Highlights that protein production in the EU will not increase if there is no market-driven demand for it, as well as public support;
Amendment 585 #
2023/2015(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Recognises that the production of renewable energy is currently linked to the production of protein; underlines however that crop-based biofuels are competing with the uses as food or feed of these same crops, including for protein plants;
Amendment 592 #
2023/2015(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Believes that public procurement and promotion policies should be used in a better way to incentivise more sustainable protein production and consumption;
Amendment 601 #
2023/2015(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Stresses that action at all levels is needed in order to increase sustainable EU protein production;
Amendment 609 #
2023/2015(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Recalls the need to promote effective agricultural knowledge and innovation systems as well as knowledge sharing and training;
Amendment 616 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point i
Paragraph 32 – point i
i. A feed additive regulation that promotes stability and innovation in the production of feed additives, while not allowing their use until the impacts on animal welfare have been thoroughly studied;
Amendment 631 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point ii
Paragraph 32 – point ii
ii. Novel food legislation that simplifies and speeds up authorisation processestreamlines authorisation processes, while fully respecting the precautionary principle;
Amendment 636 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point iii a (new)
Paragraph 32 – point iii a (new)
iiia. Improved monitoring of food waste across the EU, in particular waste generated at farm level;
Amendment 637 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point iii b (new)
Paragraph 32 – point iii b (new)
iiib. Priority to the reduction of food waste in the upcoming initiatives on marketing standards;
Amendment 642 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point iv
Paragraph 32 – point iv
iv. A renewable energy directive that allows for the long-term and stable regulation of biofuel production and removes incentives to take land out of food production;
Amendment 646 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point v
Paragraph 32 – point v
v. An energy taxation directive that provides clear and long-term rules for all bio-based fuels; , temporary suspension measures for the production and blending of crop-based biofuels, bioliquids and biomass fuels in order to secure additional food supplies, stabilise global food commodity markets and phase out crop-based biofuels, not including advanced biofuels, by 2030;
Amendment 652 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point vi
Paragraph 32 – point vi
vi. A regulation on new genomic techniques that allows new breeding techniques to be adoptedrespects the precautionary principle and the need to ensure transparency and freedom of choice to farmers, processors and consumers, including risk assessments, comprehensive requirements concerning traceability and labelling with a view to providing consumers with relevant information;
Amendment 682 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point ix
Paragraph 32 – point ix
ix. A front-of-pack label regulation that compares the carbon footprint of food and similar requirements for feed;
Amendment 688 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point xii a (new)
Paragraph 32 – point xii a (new)
xiia. A revision of public procurement legislation with a view to introducing or reinforcing minimum mandatory criteria for kindergartens and schools, other public institutions and private companies delivering public services so as to encourage notably a higher consumption of sustainably produced plant proteins, as well as the reduction of food waste in line with the principles of the circular economy;
Amendment 689 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point xii b (new)
Paragraph 32 – point xii b (new)
Amendment 690 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point xii c (new)
Paragraph 32 – point xii c (new)
xiic. Guidelines to Member States on the use of reduced VAT rates to incentivise the uptake of foods with a lower carbon footprint and fewer externalised costs, including plant protein;
Amendment 702 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point xiii a (new)
Paragraph 32 – point xiii a (new)
xiiia. An EU-wide transformation plan for the animal protein production sector, providing clear and ambitious measures to shift away from intensive animal farming systems and fostering the development of extensive, sustainable and pasture-based animal farming systems, backed by a trade policy geared towards collectively raising standards in this respect, to ensure a level-playing field with imported animal products;
Amendment 44 #
2023/0311(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Persons with disabilities moving for longer periods to other Member States for employment, study or other purposes, except where otherwise provided by law or agreed among Member States, may have their disability status reassessed and formally recognised by the competent authorities in the other Member State and may receive a disability certificate, a disability card or any other formal document recognising their disability status in accordance with applicable rules of that Member State. Nevertheless, persons with disabilities staying for a fixed period of time in the context of a mobility programme, should not need to have their disability status assessed in the new member state. Those could be mobility projects for vocational and educational training (VET), school pupils, adult education, youth exchanges, youth workers, youth participation activities, Discover EU Inclusion action, projects for higher education students and staff or partnerships for cooperation.
Amendment 65 #
2023/0311(COD)
Proposal for a directive
Recital 20
Recital 20
(20) In order to facilitate the access by persons with disabilities to special conditions or preferential treatment related to services, activities and facilities, including when provided not for remuneration, in other Member States, remaining barriers and difficulties in travelling to or visi, visiting or relocating to another Member State due to the lack of recognition of their disability status and of formal documents recognising this status issued in other Member States and parking rights should be removed.
Amendment 67 #
2023/0311(COD)
Proposal for a directive
Recital 21
Recital 21
(21) Therefore, in view of facilitating the exercise by persons with disabilities when travelling to or visiting another Member State for a short period, of the rights to access special conditions or preferential treatment offered by private operators or public authorities without discrimination on grounds of nationality on the same basis as persons with disabilities in that Member State, and in view of facilitating the use of transport and benefiting from parking conditions and facilities reserved for persons with disabilities on the same basis as in that Member State, it is necessary to establish the framework, rules and common conditions, including a common standardised model, for a European Disability Card as proof of recognised disability status and for a European Parking Card for persons with disabilities, as proof of their recognised right to parking conditions and facilities reserved for persons with disabilities.
Amendment 75 #
2023/0311(COD)
Proposal for a directive
Recital 24
Recital 24
(24) Examples of special conditions or preferential treatment include free access, reduced tariffs, reduced fees or user charges for toll roads/bridges/tunnels, priority access, designated seats in parks and other public areas, accessible seating in cultural or public events, personal assistance, assistance animals, assistance on the beach to enter the water, support (such as access to braille, audio guides, sign language interpretation), provisions of aids or assistance, loan of a wheelchair, loan of a floating wheelchair, obtaining tourist information in accessible formats, using a mobility scooter on roads or a wheelchair in bike lanes without a fine, etc. Parking conditions and facilities include extended parking or reserved parking spaces. With respect to passenger transport services, in addition to the special conditions or preferential treatment offered to persons with disabilities, in accordance with national legislation or practices, assistance animals, personal assistants or other persons accompanying or assisting persons with disabilities (or reduced mobility) may travel free of charge or be seated, where practicable next towith the person with disabilities.
Amendment 77 #
2023/0311(COD)
Proposal for a directive
Recital 25 a (new)
Recital 25 a (new)
(25 a) Member States should ensure that the European Disability Card and the European Parking Card for persons with disabilities contain all information also in braille.
Amendment 87 #
2023/0311(COD)
Proposal for a directive
Recital 30
Recital 30
(30) The envisaged framework for mutual recognition of the European Disability Card and the European Parking Card for persons with disabilities does not impinge on the competences of a Member State to assess and recognise the disability status and to grant special conditions, such as free access, reduced tariffs or preferential treatment for persons with disabilities and/or person(s) accompanying or assisting them including personal assistant(s). It does not cover social security benefits, social protection or social assistance covered by Article 24(2) of Directive 2004/38/EC of the European Parliament and of the Council56 . To ensure freedom of movement and equal opportunities for persons with disabilities, reasonable exceptions to this exclusion shall be made to allow for temporary recognition of the disability status of the holder of a European Disability Card when relocating to another Member State for employment or studies, until the new Member State has completed the reassessment of the disability status. _________________ 56 Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC, OJ L 158, 30.4.2004, p. 77.
Amendment 90 #
2023/0311(COD)
Proposal for a directive
Recital 31
Recital 31
(31) In order to raise awareness and facilitate access to special conditions or preferential treatment, while travelling to or visiting another Member State, all relevant information with respect to the conditions, rules, practices, and procedures applicable to obtain the European Disability Card and/or the European Parking Card for persons with disabilities and its subsequent use should be made publicly available on an EU digital Portal in a clear, comprehensive, user-friendly manner and accessible formats for persons with disabilities respecting the relevant accessibility requirements for services established in Annex I to Directive (EU) 2019/882 including by making all information available in the national sign language(s). Private operators or public authorities granting special conditions or preferential treatment to persons with disabilities should make such information publicly available in a clear, comprehensive, user-friendly manner and accessible formats, for persons with disabilities respecting the relevant accessibility requirements for services established in Annex I to Directive (EU) 2019/882.
Amendment 96 #
2023/0311(COD)
Proposal for a directive
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) the rules governing the issuance of the European Disability Card and the European Parking Card for persons with disabilities as proof respectively of a disability status or of a right to parking conditions and facilities reserved for persons with disabilities, in view of facilitating short staysfree movement of persons with disabilities in a Member State other than that of which they are a resident, by granting them access to any special conditions or preferential treatment with respect to services, activities or facilities, including when provided not for remuneration, or parking conditions and facilities offered to or reserved for persons with disabilities or person(s) accompanying or assisting them including their personal assistant(s);
Amendment 108 #
2023/0311(COD)
Proposal for a directive
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2 a. Exceptions to paragraph 2 shall be made by Member States to ensure equal opportunities and the freedom of movement of persons with disabilities, where: a) a holder of a European Disability Card moves to a different Member State with an employment contract or enrolment in an educational institution, until the reassessment of the disability status in the national system of this Member State is completed. b) a holder of a European Disability Card participates in an EU mobility programme, for the duration of the programme.
Amendment 123 #
2023/0311(COD)
Proposal for a directive
Article 3 – paragraph 1 – point f a (new)
Article 3 – paragraph 1 – point f a (new)
(f a) “EU mobility programme” means any programme that is temporary, lasts for a fixed period of time, and takes place in another Member State other than the person's state of residence, in the field of education, training, or for work related purposes.
Amendment 131 #
2023/0311(COD)
Proposal for a directive
Article 4 – paragraph 1 – point b a (new)
Article 4 – paragraph 1 – point b a (new)
(b a) All persons with disabilities participating in a mobility program within the EU that has a fixed period of time. In that case, the use of the Disability Card and the Parking Card shall be extended for the entire duration of the programme
Amendment 143 #
2023/0311(COD)
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Competent authorities in the Member States shall issue, renew or withdraw the European Disability Card in accordance with their national rules, procedures and practices. Such procedures shall be free of charge for the card holder. Without prejudice to Regulation (EU) 2016/679, Member States shall ensure the security, integrity, authenticity and confidentiality of the data collected and stored for the purpose of this Directive. The competent authority responsible for issuing the European Disability Card shall be considered as the controller referred to in Article 4(7) of Regulation (EU) 2016/679 and shall have responsibility for the processing of personal data. Cooperation with external service providers shall not exclude any liability on the part of a Member State which may arise under Union or national law in respect of breaches of obligations with regard to personal data.
Amendment 153 #
2023/0311(COD)
Proposal for a directive
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4 a. Member States shall use the back of the card to display information on the kind of assistance that the card holder needs.
Amendment 168 #
2023/0311(COD)
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Competent authorities in the Member States shall issue, renew, or withdraw the European Parking Card for persons with disabilities in accordance with their national rules, procedures and practices. Such procedures shall be free of charge for the card holder. Without prejudice to Regulation (EU) 2016/679, Member States shall ensure the security, authenticity and confidentiality of the personal data collected and stored for the purpose of this Directive. The competent authority responsible for issuing the European parking Card for persons with disabilities shall be considered as the controller referred to in Article 4(7) of Regulation (EU) 2016/679 and shall have responsibility for the processing of personal data. Cooperation with external service providers shall not exclude any liability on the part of a Member State which may arise under Union or national law in respect of breaches of obligations with regard to personal data.
Amendment 173 #
2023/0311(COD)
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. The European Parking Card for persons with disabilities shall be issued or renewed by the Member State of residence upon application by the person with disabilities. It shall be issued or renewed within a reasonable period from the date of the application which shall not exceed 630 days.
Amendment 181 #
2023/0311(COD)
Proposal for a directive
Article 7 a (new)
Article 7 a (new)
Article7a Provisions for card holders when changing residence 1. Member States shall ensure the beneficiaries who have changed their member state of residence and are pending the issuance of a national disability card by the competent authorities, are guaranteed their rights and benefits provided by their disability status as recognised by the Member State of origin. The European Disability Card and the European Parking Card shall be valid until the new national card has been issued. 2. Member States shall ensure that the process of re-assessment of the disability and the issuing of the new national card and therefore the new European Disabilities and Parking Card does not exceed 6 months.
Amendment 189 #
2023/0311(COD)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall make the conditions and rules, practices, and procedures to issue, renew or withdraw a European Disability Card and a European Parking Card for persons with disabilities publicly available in accessible formats, including in digital and easy to read formats, and upon request in assistive formats requested by persons with disabilities.
Amendment 191 #
2023/0311(COD)
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall take appropriate measures to raise awareness among the public andincluding to public authorities and private operators having the potential to offer preferential treatment pursuant to Article 5 and the European Commission shall coordinate a campaign to inform persons with disabilities, including in accessible ways, about the existence and conditions to obtain, use, or renew the European Disability Card and the European Parking Card for persons with disabilities.
Amendment 205 #
2023/0311(COD)
Proposal for a directive
Article 11 – paragraph 4
Article 11 – paragraph 4
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, as well as persons with disabilities and their representative organisations.
Amendment 209 #
2023/0311(COD)
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 and shall meaningfully involve representative organisations of persons with disabilities.
Amendment 224 #
2023/0311(COD)
Proposal for a directive
Article 15 – paragraph 3
Article 15 – paragraph 3
3. The information referred to in paragraph 1 of this article shall be made available free of charge in a clear, comprehensive, user-friendly and easily accessible way, including through the private operators or public authorities’ official website where available, or by other suitable means, in accordance with the relevant accessibility requirements for services set in Annex I of Directive (EU) 2019/882. The Commission shall create a digital portal containing all the information which regards the benefits of holding the European Disability Card and the European Parking Card in all Member States including information on the different procedures in each Member States. Such information shall be sent by the Member States to the Commission and updated according to the reporting requirements in Article 16 of this Directive.
Amendment 227 #
2023/0311(COD)
Proposal for a directive
Article 16 – paragraph 4 a (new)
Article 16 – paragraph 4 a (new)
4 a. The report shall include an impact assessment of the use of the card as the tool for improving the portability of benefits in the area of social security under Regulations (EC) No 883/2004 and (EC) No 987/2009 and social assistance covered by Article 24(2) of Directive 2004/38/EC.
Amendment 229 #
2023/0311(COD)
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
1. Member States shall adopt and publish, by dd/mm/yy [within 182 months after the entry into force of this Directive] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
Amendment 234 #
2023/0311(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. They shall apply those provisions from dd/mm/yy [3024 months from the date of entry into force of this Directive].
Amendment 241 #
2023/0311(COD)
Proposal for a directive
Annex II – point 3 – point b – indent 1
Annex II – point 3 – point b – indent 1
– in capital letters, the words ‘European Parking Card for persons with disabilities’ in the language(s) of the Member State issuing the card and in braille; after a suitable space, it shall appear in small type in the other languages of the European Union;
Amendment 175 #
2023/0271(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) Tackling the multi-modal competitive aspect between different transport modes is important to facilitate a substantial modal shift and reach the targets set in the Sustainable and Smart Mobility Strategy. In order to guarantee a fair level playing field between modes, framework conditions need to be levelled out and external costs should be internalised in pricing. In this regard, taxation and fees across the different modes, such as a tax on kerosene and lower track access charges, should reflect the priorities and contribute to the targets set in the Sustainable and Smart Mobility Strategy. This would incentivise people and companies to make transport choices in line with the EU’s sustainable transport vision. With an increased demand for rail capacity by both passenger and freight services, investments will also be needed to realise the capacity enhancing measures described above.
Amendment 178 #
2023/0271(COD)
Proposal for a regulation
Recital 2 b (new)
Recital 2 b (new)
(2b) A reverse progress is noted in the railway network of EU-27 in use which shrank by over 12,000 km between 1990 and 20211a __________________ 1a European Commission, Directorate- General for Mobility and Transport, (2023). EU transport in figures: statistical pocketbook 2023, Publications Office of the European Union. https://data.europa.eu/doi/10.2832/319371
Amendment 182 #
2023/0271(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) Rail infrastructure capacity and traffic management are crucial to the well- functioning of the rail sector. The operation of rail transport services needs to be carefully planned and coordinated to allow trains with very different characteristics, such as speed and braking distance, to share safely the same tracks. Optimal management of capacity creates more opportunities for, and increases reliability of, rail services, which is a particularly important requirement for the increasing market of night trains as well as the ambitions to shift goods to rail freight. Regulation should provide infrastructure managers with sufficient flexibility for effective management of capacity while making sure that all railway undertakings are treated without discrimination in their access to the network.
Amendment 185 #
2023/0271(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The rules and procedures on the management of rail infrastructure capacity should reflect betterconsider and satisfy the needs of all rail market segments in a proportionate and non-discriminatory way. They should in particular take into account the necessity of long- term stability of available capacity for passenger services and of short-term flexibility for freight traffic to respond to market demand. Therefore, the process of managing capacity should no longer have a predominantly annual focus, but be arranged in three subsequent phases of strategic capacity planning; rail service scheduling and capacity allocation; and adaptation and rescheduling of capacity. The introduction of better defined and structured phases that provide for the possibility of long-term planning and short- term adaptation in capacity management, would particularly benefit services that are less easy to plan in advance or are more complex to arrange, such as freight trains and cross-border passenger trains, including night trains.
Amendment 187 #
2023/0271(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) An increasing portion of the Union rail network is either congested or close to congested and cannot accommodate the needs for rail infrastructure capacity of all applicants and support further growth in the volume of rail transport. Infrastructure development and digitalisation, in compliance with the technical specification for interoperability developed under Directive (EU) 2016/797 of the European Parliament and of the Council, in particular the European Rail Traffic Management System (‘ERTMS’), is expected to result in an increase of available capacity in the medium to long term. Nevertheless, infrastructure managers will be required to assign priorities for the use of congested sections. Without prejudice to general principles on priority set out by Member States in the framework for the allocation of infrastructure capacity, infrastructure managers should take decisions on priorities using transparent and harmonised methodologies which clarify how social, economic and environmental factors have been taken into account and affect their decision. These socio-economic and environmental criteria need to be studied in more detail and must be based on accepted methods and best available knowledge. The Commission should set criteria and standardised methodologies for the calculation in a delegated act, involving ENIM and ERICA in its work. ENIM should then, in consultation with operational stakeholders, prepare and adopt the relevant procedures.
Amendment 191 #
2023/0271(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The strategic planning of capacity should improve the utilisation of rail infrastructure by anticipating demand for rail services and taking into account planned infrastructure development, renewal and maintenance. It should ensure that rail infrastructure capacity is allocated in a way that maximises the value of rail services for society taking into account socio-economic and environmental benefits. Infrastructure managers should ensure that strategic planning provides progressively increasing level of details about available capacity and that it is the basis for the capacity allocation.
Amendment 192 #
2023/0271(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) Integrated, clock-face timetables can improve rail connectivity by offering regular passenger services and seamless multimodal connections in urban nodes. Infrastructure managers can support the introduction of such timetables by taking the concept into account in strategic capacity planning. For this purpose, capacity can be pre-planned in the form of appropriate capacity planning objects, such as systematic train paths, while leaving sufficient flexibility to enable an optimum use of infrastructure capacity.
Amendment 198 #
2023/0271(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) A significant share of rail freight transport is long-distance and requires cross-border coordination of infrastructure managers. The policy goal of increasing rail traffic also relies on growing cross- border passenger services. To facilitate and promote an increasing cross-border traffic in the single European railway area, it is necessary to ensure greater consistency and harmonisation of the rules and procedures on the management of rail infrastructure capacity. Accordingly, the role of the European Network of Infrastructure Manager should be strengthened with a view to entrusting it with the development of guidelines for the harmonised implementation of this Regulation on procedures and methodologies for the management of rail infrastructure capacity and with the active coordination of cross- border capacity and traffic. In particular, the European Network of Infrastructure Managers should develop European frameworks for capacity management, for the coordination of cross-border traffic management, disruption management and crisis management, and fo. Railway Undertakings, applicants and other operformance reviewational stakeholders should also be consulted in the development of these European Frameworks.
Amendment 203 #
2023/0271(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) The European frameworks developed by the European Network of Infrastructure Manager ENIM and the European Rail Infrastructure Coordination body for capacity Allocation ERICA should provide guidelines that infrastructure manager should make the utmost efforts to follow, while retaining responsibility for their operational decisions. Infrastructure managers should motivatejustify any deviation from the frameworks developed by European Network of Infrastructure Manager and ERICA, which should only be allowed in exceptional cases and be subject to approval by the national rail regulatory body. This approach is considered to strike the balance between the needs of coordination and application of harmonised approaches in the single European railway area, and the need for adapting procedures and methodologies to the specific circumstances of given geographical areas. After five years of application of this Regulation, the Commission should assess whether the state of convergence of procedures and methodologies and the effectiveness of the coordination process between infrastructure managers, as well as the general progress towards the establishment of the single European railway area, warrant the introduction of secondary legislation to replace elements the European frameworks developed by the European Network of Infrastructure Manager.
Amendment 204 #
2023/0271(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) To ensure a seamless European rail network and to enhance cross-border and multi-network rail traffic for both freight and passenger transport, a new European Rail Infrastructure Coordination body for capacity Allocation (ERICA) should be established. It should be supported in an advisory role by the network coordinator. ERICA should contribute to the preparation of the European framework for capacity management, contribute to the operational coordination between infrastructure managers and provide support to the regulatory bodies regarding rules, procedures and tools. Furthermore, it should act as an additional point of contact for stakeholders outside the rail sector interested in using rail services and as a contact point for applicants and other operational stakeholders on behalf of ENIM for matters not explicitly covered under this regulation. It should also facilitate the development and implementation of digital tools and services for capacity management and traffic management processes. As a basis for future infrastructure development and funding within TEN-T, ERICA should also identify European cross-border infrastructure enhancement needs .
Amendment 206 #
2023/0271(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The operation of railway infrastructure not only requires close cooperation between infrastructure managers, but also a strong interaction with railway undertakings and other stakeholders directly involved in rail and multimodal transport and logistic operations. Therefore, it is necessary to provide for structured coordination between infrastructure managers and other stakeholders. To strengthen the role of Railway Undertakings, applicants and other operational stakeholders, ENIM should set up a consultative body to ENIM, the European Operational Stakeholder Platform (EOSP) consisting of operational stakeholders as well as service facilities, terminals and ports. As well as providing ENIM with a closer view on market developments, it can also issue own initiative opinions on any proposals or decisions by ENIM as well as ERICA.
Amendment 207 #
2023/0271(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Reliability of rail services is one of the aspects most valued by railway customers, and not least a critical requirement of the re-emerging night train market, where rail customers and applicants need to know well in advance how their services can run. Reliability of schedules is also a critical aspect for the smooth functioning of the rail system, where there are strong interactions between services and network externalities. For that reason, deviations from the schedule should be kept to the minimum. Additionally, a system of adequate incentives should be introduced to promote the fulfilment of commitments by infrastructure managers, railway undertakings and other relevant stakeholders. Those incentives should be both of economic and non-economic nature.
Amendment 213 #
2023/0271(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) To improve the performance of rail infrastructure services in the single European railway area, the infrastructure managers, in close cooperation with the Commission, ERICA, the Performance Review Body and relevant stakeholders, should set up and implement a common framework for the review of performance. This framework should ensure that all EU infrastructure managers use common principles and methodologies for measuring performance through agreed indicators. The framework should allow for identifying performance deficiencies on the EU railway network. It should ensure that infrastructure managers set performance objectives in a way that takes into account the specificities of the network they manage, but at the same time ensures coherency in identifying the most relevant performance deficiencies. The framework should allow infrastructure managers to cooperate at EU level, including within ERICA in identifying measures to address performance deficiencies and to keep track of their impact. Infrastructure managers, working together in the European Network for Infrastructure Managers and taking into account the opinion of the Performance Review Body and the Commission, should review this framework regularly to ensure that it is fit for purpose.
Amendment 216 #
2023/0271(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The rail regulatory bodies should cooperate at Union level to ensure coherent application of the regulatory framework and consistent treatment of applicants across the single European railway area. They should do so through the European Network of Rail Regulatory Bodies, with a view to develop common practices for making the decisions for which they are empowered under this Regulation. For that purpose, the European Network of Rail Regulatory Bodies should perform coordination tasks and adopt non-binding recommendations and opinions, which should not affect the competences of the rail regulatory bodies or those of the infrastructure managers. ENRRB should check the compatibility of the European Frameworks, proposed by ERICA, with the regulatory objectives of the Regulation. Regulatory supervision should be designed in a way that national decisions cannot underline the harmonised procedures described in the frameworks, unless exemptions of this Regulation apply.
Amendment 217 #
2023/0271(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) Workers are crucial for the efficient functioning of the railway sector. For services to become more efficient and to increase their quality, digitalisation will be essential. This digitalisation and /automatisation of rail capacity and traffic management will have to be accompanied by digital skill development for the sector’s employees. Additional training and investment in the extension of digital competencies with respect to new digital requirements will enable workers to adapt and positively contribute to the well- functioning of the sector through enhanced communication and capacity to deal with unexpected events. Workers' rights cannot be neglected in the shift towards increased digitalisation, but should form a central part around which to restructure the functioning of the sector.
Amendment 220 #
2023/0271(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) The ex-post evaluation of Regulation (EU) No 913/201020 concluded that the Regulation’s impact was too limited to contribute to a modal shift from road to rail. Moreover, the cooperation between Member States and infrastructure managers in the management of the rail infrastructure was still ineffective from a cross-border perspective. The evaluation has also shown that managing separately the capacity on the rail freight corridors and on the rest of the network is not efficient. A single regulatory framework should apply to the operation of rail network capacity, consolidating the related provisions in Directive 2012/34/EU and of Regulation (EU) No 913/2010. Therefore, Regulation (EU) No 913/2010 and the provisions in Directive 2012/34/EU on capacity allocation should be repealed and replaced by this Regulation. Relevant Articles of Regulation 2021/0420 on Union Guidelines for the development of the trans-European transport network should be amended accordingly. __________________ 20 SWD(2021) 134 final of 2 June 2021
Amendment 221 #
2023/0271(COD)
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29a) Similarly, alignment should be ensured with the following implementing regulations, for the allocation rules in service facilities (implementing regulation 2017/2177) and for procedures and criteria concerning framework agreements (implementing regulation 2016/545).
Amendment 228 #
2023/0271(COD)
Proposal for a regulation
Article 2 – paragraph 3 – point d
Article 2 – paragraph 3 – point d
(d) enable seamless and punctual rail traffic across more than one network by striving to eliminate bottlenecks and operational obstacles and including service facilities that are directly involved in a railway service;
Amendment 238 #
2023/0271(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point 1 a (new)
Article 4 – paragraph 2 – point 1 a (new)
(1a) ‘rail infrastructure capacity’ means the maximum number of trains that can be operated in a defined period of time on a geographically defined part of the railway network (with specific traffic and infrastructure characteristics) under required or desired level of service; this constitutes an upper limit for the ‘planned capacity’, which represents the volume of the available capacity requested by and allocated to rail operators. Big differences between available capacity (excluding also closures for planned infrastructure maintenance) and demanded capacity would lead either to under-utilized infrastructures or to unsatisfied requests.
Amendment 240 #
2023/0271(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point 1 b (new)
Article 4 – paragraph 2 – point 1 b (new)
(1b) ‘Used capacity’ refers to the actual traffic volume over the network, usually lower than the planned capacity, as some planned train paths might not be used (e.g. for unplanned disturbances or for late cancellation by operators, leading to some inefficiencies). Mechanisms should be provided for assurance that the planned timetable with its respective train capacity is actually respected in execution. If, due to inappropriate incentives, path requests are not honoured by the requestors, this may actually lead to a reduction of used capacity.
Amendment 241 #
2023/0271(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point 1 c (new)
Article 4 – paragraph 2 – point 1 c (new)
(1c) ‘Transport capacity’ is the amount of goods and/or passengers that can be transported by the trains operated on the infrastructure in the defined period of time. This is impacted also by other parameters, such as train length or axle load, influencing the maximum amount of passenger or goods that can be carried on each train; given the same number of trains on the same infrastructure, an increase in the maximum load/carrying capacity of the trains leads to an increase in the transport capacity.
Amendment 243 #
2023/0271(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point 3
Article 4 – paragraph 2 – point 3
(3) ‘operational stakeholder’ means an applicant, railway undertaking, infrastructure manager, rail service facility operator, provider of rail-related services and any other entity directly involved in operating a rail transport service as defined in Article 3(19) of Directive 2012/34/EU;
Amendment 252 #
2023/0271(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point 17 a (new)
Article 4 – paragraph 2 – point 17 a (new)
(17a) ‘systematic train paths’ are train paths pre-constructed by the infrastructure manager based on different sources such as past timetables, needs submitted by customers, market forecasts and politically driven capacity concepts. They are allocated to market segments, occur in a patterned manner in a regular schedule and are formed to further optimise the utilisation of infrastructure and to optimise interchange connections between passenger services in node stations.
Amendment 254 #
2023/0271(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point 17 b (new)
Article 4 – paragraph 2 – point 17 b (new)
(17b) 'Compensation for changes to capacity rights' means an incentive fee due to be paid in the case of the amendment and/or cancellation of an allocated train path. It shall be implemented according to the process in Article 40 and shall be published in the network statement of the respective infrastructure manager.
Amendment 256 #
2023/0271(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Infrastructure managers shall strive to follow common principles and procedures for the management of rail infrastructure capacity. For this purpose, ENIM shall develop and adopt, consult with European Operational Stakeholder Platform (EOSP) prior to the adoption and adopt under the lead of the European Rail Infrastructure Coordination body for capacity Allocation ERICA, a ‘European framework for capacity management’ in accordance with the provisions of Chapter II by [12 months of the entry into force of this Regulation]. ENIM shall publish the principles and procedures that govern this consultation.
Amendment 263 #
2023/0271(COD)
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. Infrastructure managers shall take the utmost account of the European framework for capacity management when preparing the network statement referred to in Article 27 of Directive 2012/34/EU, in particular the contents specified in Annex IV of this Regulation. They shall explain in the network statement the reason for any deviation from the common principles and procedures established in the European framework for capacity management. Deviations shall only be allowed in exceptional cases with sufficient justifications and subject to approval by the national rail regulatory body.
Amendment 276 #
2023/0271(COD)
Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 2 – introductory part
Article 8 – paragraph 4 – subparagraph 2 – introductory part
Those procedures shall assess alternative options for the use of infrastructure capacity, based on the following socioeconomic and environmental criteria, subject to the availability of data to be provided by applicants to the infrastructure manager. The criteria should include but not be limited to:
Amendment 280 #
2023/0271(COD)
Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 2 a (new)
Article 8 – paragraph 4 – subparagraph 2 a (new)
The Commission shall set out criteria and standardised methodologies for the calculation as well as standardised and representative data sources in a delegated act. These criteria and models must be based on accepted methods and best available knowledge. The Commission shall set out criteria and standardised methodologies for the calculation as well as standardised and representative data sources in a delegated act, following a consultation with ENIM and ERICA. These criteria and models must be based on accepted methods and best available knowledge.
Amendment 305 #
2023/0271(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c a (new)
Article 12 – paragraph 2 – subparagraph 1 – point c a (new)
(ca) cross-border freight and passenger services.
Amendment 312 #
2023/0271(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point c
Article 12 – paragraph 4 – point c
(c) capacity needs by operational stakeholders and the input from their consultation of current and potential applicants in accordance with Article 13;
Amendment 313 #
2023/0271(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point f a (new)
Article 12 – paragraph 4 – point f a (new)
(fa) Strategic capacity planning shall take account as far as possible of the socio-economic and environmental criteria listed in Article 8 (4) subject to the availability of data to be provided by applications to the infrastructure manager.
Amendment 315 #
2023/0271(COD)
Proposal for a regulation
Article 12 – paragraph 6 – subparagraph 1
Article 12 – paragraph 6 – subparagraph 1
Strategic capacity planning shall cover the linesentire network, but in particular those lines that are part of the TEN-T core and extended core network referred to in Article 6 of and Annex I to [new TEN-T Regulation]. Infrastructure managers may include other lines and nodes of the network they manage.
Amendment 317 #
2023/0271(COD)
Proposal for a regulation
Article 12 – paragraph 8 – point b
Article 12 – paragraph 8 – point b
(b) changes in market demand for rail transport and infrastructure capacity taking into account input by applicants for new or modified services;
Amendment 320 #
2023/0271(COD)
Proposal for a regulation
Article 12 – paragraph 9
Article 12 – paragraph 9
9. ENIM, after consulting ERICA, shall develop guidelines setting out common principles, procedures and methodologies for strategic capacity planning. It shall include those guidelines in the European framework for capacity management referred to in Article 6 of this Regulation. Those guidelines should contain at least the elements listed in Annex III to this Regulation. The infrastructure managers shall take the utmost account of those guidelines in the network statement referred to in Article 27 of Directive 2012/34/EU. They shall explain in the network statement the reason for any deviation from the common principles, procedures and methodologies established in the guidelines.
Amendment 322 #
2023/0271(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Infrastructure managers shall consult all operational stakeholders, including also operators of service facilities on strategic capacity planning in accordance with Article 7e of Directive 2012/34/EU.
Amendment 326 #
2023/0271(COD)
Proposal for a regulation
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. Throughout the capacity management process, applicants shall be given the possibility to announce their capacity needs in a structured, common way and according to suitable timelines specified by ENIM. Infrastructure managers shall take the utmost efforts to incorporate the announced needs into the strategic capacity planning referred to in Article 11(2). Where infrastructure managers cannot consider these needs, they shall consult the concerned applicant and together investigate commercially viable alternatives, including via different itineraries or feasible changes on the infrastructure.
Amendment 327 #
2023/0271(COD)
Proposal for a regulation
Article 13 – paragraph 2 b (new)
Article 13 – paragraph 2 b (new)
2b. The regulatory body shall monitor the activities of the infrastructure manager in strategic capacity planning in accordance with Article 63 of this Regulation.
Amendment 333 #
2023/0271(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Infrastructure managENRRB, in consultations with the stakeholders and ENIMdvisory groups, shall regularly monitor and analyse transport markets in order to informand relevant multimodal aspects in order to inform the work of ENIM and infrastructure managers on their overall business strategy, capacity and contingency management and investment decisions. Infrastructure managers shall communicate the results of this analysis to other stakeholders for similar purposes, including the European Coordinators.
Amendment 339 #
2023/0271(COD)
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. ENIM shall consult applicants, the new consultative bodies established in Article 55 a new, prospective applicants, customers of rail transport services and their associations, national and EU public authorities on the terms of reference for the study, in particular as regards the purpose of the study and the process for stakeholder involvement. The stakeholder involvement shall include the possibility for operational stakeholders to give input to the study and to make an independent comment on the result.
Amendment 344 #
2023/0271(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The capacity strategy shall contain information about the future development of rail infrastructure and service facilities as mentioned in Article 29 (1), an outlook on the development of the demand for different rail transport services and any other relevant information about the availability and utilisation of railway infrastructure.
Amendment 346 #
2023/0271(COD)
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
4. The infrastructure manager shall prepare, publish and regularly updateupdate when needed the capacity strategy in accordance with the schedule and the contents set out in section 2 of Annex I.
Amendment 349 #
2023/0271(COD)
Proposal for a regulation
Article 16 – paragraph 5
Article 16 – paragraph 5
5. Infrastructure managers shall consult applicants and service facilities on the capacity strategy in accordance with Article 13 and coordinate capacities strategies with other concerned infrastructure managers in accordance with Article 14.
Amendment 352 #
2023/0271(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. The capacity model shall at least provide information about the total volume of capacity available by network section, the shares of capacity reserved for different segments of rail transport services and for capacity restrictions resulting from infrastructure works. It shall also contain information on the capacity of the respective service facilities referred to in Article 29 (1). Infrastructure managers shall prepare and publish the capacity model for each working timetable period and regularly update the capacity model when needed in accordance with the contents and schedule set out in sections 1 and 2 of Annex I.
Amendment 357 #
2023/0271(COD)
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Infrastructure managers shall document and, where relevant, justify any divergence between the capacity model and the capacity strategy concerning the same working timetable period. Where needed, tThe capacity strategy shall be revised in the light of developments since the adoption or the latest update of the capacity strategydoes not have to be updated in case the capacity model was already published.
Amendment 358 #
2023/0271(COD)
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
4. Infrastructure managers shall consult applicants and the regulatory body on the capacity model in accordance with Article 13 and coordinate capacities strategies with other concerned infrastructure managers in accordance with Article 14.
Amendment 361 #
2023/0271(COD)
Proposal for a regulation
Article 17 – paragraph 4 a (new)
Article 17 – paragraph 4 a (new)
4a. The infrastructure manager shall submit the capacity model to the regulatory body for scrutiny. The regulatory body may take a decision requiring the infrastructure manager to amend the capacity model before publication. With a view to ensure the cross-border consistency of capacity models, the decision of the regulatory body shall take into account, where relevant, any opinion or recommendation by ENIM, ERICA or by other regulatory bodies.
Amendment 362 #
2023/0271(COD)
Proposal for a regulation
Article 18 – paragraph 1 – subparagraph 1 – point a
Article 18 – paragraph 1 – subparagraph 1 – point a
(a) infrastructure capacity available for allocation to applicants in the working timetable and safeguarded for later requests according to Article 33, including service facilities;
Amendment 363 #
2023/0271(COD)
Proposal for a regulation
Article 18 – paragraph 4
Article 18 – paragraph 4
4. In the capacity supply plan, infrastructure managers may indicate infrastructure capacity and capacity in service facilities as referred to in article 29 (1) as pre-planned. Pre- planned capacity means capacity for which the infrastructure manager defines characteristics and volumes of the capacity available for requests by applicants, sets out rules for the allocation of such capacity and defines the process through which such capacity can be requested, in accordance with Article 20. The specified characteristics, rules and allocation processes shall be taken into account when allocating pre-planned capacity.
Amendment 364 #
2023/0271(COD)
Proposal for a regulation
Article 18 – paragraph 7 – subparagraph 2
Article 18 – paragraph 7 – subparagraph 2
Infrastructure managers shall include in the capacity supply plan all elements listed in paragraph 6 and in coherence with the capacity strategy, and particularly for all lines and nodes included in the TEN-T core and extended core network as defined in [new TEN-T Regulation].
Amendment 365 #
2023/0271(COD)
Proposal for a regulation
Article 18 – paragraph 9
Article 18 – paragraph 9
9. The regulatory body shall analyse the capacity supply plan and may take a decision requiring the infrastructure manager to amend the capacity supply plan. The decision of the regulatory body shall take into account any opinion of or recommendation by ENIM, where such has been providedinfrastructure manager shall submit the draft capacity supply plan to the regulatory body for scrutiny. The regulatory body may take a decision requiring the infrastructure manager to amend the capacity model before publication.
Amendment 366 #
2023/0271(COD)
Proposal for a regulation
Article 18 – paragraph 9 a (new)
Article 18 – paragraph 9 a (new)
9a. With a view to ensure the cross- border consistency of capacity plans, the decision of the regulatory body shall take into account, where relevant, any opinion or recommendation by ENIM, ERICA or by other regulatory bodies.
Amendment 389 #
2023/0271(COD)
Proposal for a regulation
Article 22 – paragraph 4 – subparagraph 1
Article 22 – paragraph 4 – subparagraph 1
Infrastructure managers shall take into account the results of any capacity analysis carried out, including in other concerned networks pursuant to this Article in strategic capacity planning, in particular in the capacity strategy, in the capacity model and in the capacity supply plan.
Amendment 406 #
2023/0271(COD)
Proposal for a regulation
Article 27 – paragraph 4 – subparagraph 2
Article 27 – paragraph 4 – subparagraph 2
For multi-network capacity rights, ENIM shall establish, following ERICA approval, a single interface or a common system in accordance with Article 62, in order to manage capacity allocation in a single place and operation.
Amendment 411 #
2023/0271(COD)
Proposal for a regulation
Article 27 – paragraph 7 a (new)
Article 27 – paragraph 7 a (new)
7a. The infrastructure manager shall be allowed to use, where relevant, specific timetabling approaches including systematic train paths. When the infrastructure manager decides to use this approach, systematic train paths with cross-border relevance shall be, where possible, aligned with neighbouring and other concerned infrastructure managers across borders.
Amendment 413 #
2023/0271(COD)
Proposal for a regulation
Article 27 – paragraph 7 b (new)
Article 27 – paragraph 7 b (new)
7b. Infrastructure managers shall inform the regulatory body of all capacity requests received that did not fit the parameters of the available capacity as defined in the capacity supply plan, regardless of whether they were accepted or refused. On the basis of this information the regulatory body shall issue an opinion at least every two years, which may recommend to the infrastructure manager to amend the capacity model.
Amendment 417 #
2023/0271(COD)
Proposal for a regulation
Article 28 – paragraph 4
Article 28 – paragraph 4
4. As regards the compensation for changes to capacity rights referred to in Article 40, a multi-network capacity right shall be considered as a single capacity right. In particular, a cancellation due to unforce majeure on one network shall be considered as a cancellation due to force majeure for the capacity right along the entire route covered by iteseeable, unavoidable, exceptional and unprovoked events outside the control of one infrastructure manager or the railway undertaking or applicant, shall apply to the capacity right along the entire route covered by it only if no alternative routing, including across borders, is available.
Amendment 430 #
2023/0271(COD)
Proposal for a regulation
Article 31 – paragraph 1 – subparagraph 3
Article 31 – paragraph 1 – subparagraph 3
Amendment 437 #
2023/0271(COD)
Proposal for a regulation
Article 31 – paragraph 4
Article 31 – paragraph 4
4. Framework agreements shall not be such as to preclude the use of the relevant infrastructure by other applicants or services. For this purpose, infrastructure managers shall set the maximum shares of total capacity that can be allocated through framework agreements and include these in the network statement. Infrastructure managers of the concerned countries who have cross-border framework agreements shall align these thresholds and make them as consistent as possible.
Amendment 446 #
2023/0271(COD)
Proposal for a regulation
Article 32 – paragraph 5 – subparagraph 1
Article 32 – paragraph 5 – subparagraph 1
In accordance with Article 18 and Article 20, the infrastructure manager shall give priority to requests that are consistent with the pre-planned capacity defined in the capacity supply plan. As a result, the infrastructure manager may ei, provided operational stakeholders had been duly consulted and their accept or refuse requests that are not consistent with the capacity supply plannnouncements of capacity had been taken into account to the utmost extent.
Amendment 447 #
2023/0271(COD)
Proposal for a regulation
Article 32 – paragraph 5 – subparagraph 2
Article 32 – paragraph 5 – subparagraph 2
When accepting requests not consistent with the capacity supply plan, the infrastructure manager shall aim to maintain the overall balance between the elements of the capacity supply plan listed in Article 18(6). These applications are to be taken into account if there is enough free capacity available without restricting the needs for subsequent applications.
Amendment 452 #
2023/0271(COD)
Proposal for a regulation
Article 32 – paragraph 5 – subparagraph 3
Article 32 – paragraph 5 – subparagraph 3
When refuprocessing requests not consistent with the capacity supply plan, the infrastructure manager should offer an alternative and where time-wise possible preceded by consultation with concerned applicants. If no alternative offer is possible, the infrastructure manager shall, without delay, inform the applicant concerned of its intention to refuse a request. The latter shall have the right to lodge a complaint with the regulatory body.
Amendment 459 #
2023/0271(COD)
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. In accordance with the rules and procedures set out in Article 20, infrastructure managers may refuse to allocatshall try their utmost to offer alternative capacity for rolling planning requests if requests are inconsistent with the capacity supply plan adopted in accordance with Article 18. A refusal shall be communicated to thIf it is not possible to offer an alternative, the infrastructure manager may refuse to allocate capplicant without delayacity to such inconsistent request. The applicant shall have the right to lodge a complaint with the regulatory body.
Amendment 463 #
2023/0271(COD)
Proposal for a regulation
Article 34 – paragraph 2 a (new)
Article 34 – paragraph 2 a (new)
2a. Infrastructure managers shall inform annually the regulatory body of all ad hoc capacity requests received that were refused. On the basis of this information the regulatory body shall issue an opinion, which may require the infrastructure manager to amend the capacity model in the following year by reserving an adequate capacity dedicated to accommodate ad hoc requests, particularly for rail freight services.
Amendment 464 #
2023/0271(COD)
Proposal for a regulation
Article 36 – paragraph 2
Article 36 – paragraph 2
2. Where a situation requiring coordination arises, the infrastructure manager shall have the right, within reasonable limits, to propose infrastructure capacity that differs from that which was requested. The infrastructure manager shall define the applicable limits in its network statement. ERICA with the support of ENIM shall provide guidelines on the definition of such limits and include them in the European framework for capacity management referred to in Article 6.
Amendment 469 #
2023/0271(COD)
Proposal for a regulation
Article 36 – paragraph 8
Article 36 – paragraph 8
8. ERICA with the support of ENIM shall prepare guidelines for the consensual conflict resolution mechanism for multi- network capacity requests and include them in the European framework for capacity management referred to in Article 6.
Amendment 476 #
2023/0271(COD)
Proposal for a regulation
Article 39 – paragraph 4 a (new)
Article 39 – paragraph 4 a (new)
4a. In cases of capacity is reserved but not used, a compensation payment shall apply in accordance to Article 40.
Amendment 479 #
2023/0271(COD)
Proposal for a regulation
Article 40 – paragraph 2
Article 40 – paragraph 2
2. The compensation referred to in paragraph 1 shall not be due in cases of force majeurewhere the infrastructure manager changes an allocated capacity right because of an unforeseeable, unavoidable, exceptional and unprovoked event outside the control of the infrastructure manager, railway undertaking or applicant, and no alternative, including across borders, can be offered.
Amendment 480 #
2023/0271(COD)
Proposal for a regulation
Article 40 – paragraph 2 a (new)
Article 40 – paragraph 2 a (new)
2a. The compensation referred to in paragraph 1 shall not be due in cases where an applicant requests a change to an allocated capacity right because of an unforeseeable, exception and unprovoked event outside the applicant’s control.
Amendment 485 #
2023/0271(COD)
Proposal for a regulation
Article 40 – paragraph 3
Article 40 – paragraph 3
3. Following a consultation of the ENRRB, ENIM and EOSP, ERICA shall define harmonised conditions giving rise to compensation. Those conditions shall take into account the rules set out in Article 39(4) and (8). ENIM shall include these conditions in the European framework for capacity management referred to in Article 6. The ENRRB shall publish an opinion on the conditions defined by ENIMRICA.
Amendment 486 #
2023/0271(COD)
Proposal for a regulation
Article 40 – paragraph 5
Article 40 – paragraph 5
5. In the case of multi-network capacity rights, the obligation to pay the compensation to the applicant shall apply to the infrastructure manager or managers which is or are responsible for the change to the capacity right, taking into account the capacity right in its entirety and, where more than one infrastructure manager is responsible, the ratio of the length of their networks in the capacity right. The compensation for the entirety of the capacity right shall not exceed the compensation due for the capacity right allocated by the infrastructure manager multiplied by three. Compensation claims shall remain unaffected by this. The basic fee is centred on the compensation for the capacity right before any possible deductions from the track access charges by the member states.
Amendment 489 #
2023/0271(COD)
Proposal for a regulation
Article 41 – paragraph 2 – subparagraph 1
Article 41 – paragraph 2 – subparagraph 1
ERICA, with the support of ENIM shall develop and adopt guidelines for managing and allocating infrastructure capacity in the event of a network disruption in a transparent and non- discriminatory way. In particular, ENIMRICA shall provide guidelines on the application of the simultaneous capacity allocation process and the first come, first served principle.
Amendment 490 #
2023/0271(COD)
Proposal for a regulation
Article 41 – paragraph 2 – subparagraph 2
Article 41 – paragraph 2 – subparagraph 2
Where the simultaneous allocation process applies, ENIMRICA shall provide guidelines on the procedures to applied, involving as appropriate the application of the consensual conflict resolution process referred to in Article 36 and of the formal conflict resolution process referred to in Article 37. ENIM shall include those guidelines in the European framework for capacity management referred to in Article 6 after final approval by ERICA.
Amendment 496 #
2023/0271(COD)
Proposal for a regulation
Article 43 – paragraph 4 a (new)
Article 43 – paragraph 4 a (new)
4a. Deviations should only be allowed in reasonable cases and should be approved by the national regulatory body.
Amendment 501 #
2023/0271(COD)
Proposal for a regulation
Article 44 – paragraph 1 – subparagraph 1
Article 44 – paragraph 1 – subparagraph 1
ENIM shall develop and adopt a European framework for the coordination of cross border traffic, traffic disruption and crisis management in accordance with Article 42 at the latest by [12 months after the entry into force of this Regulation] following approval by ERICA.
Amendment 502 #
2023/0271(COD)
Proposal for a regulation
Article 44 – paragraph 1 – subparagraph 2
Article 44 – paragraph 1 – subparagraph 2
ENIM shall develop the European framework for the coordination of cross- border traffic management, disruption management and crisis management in cooperation with operational stakeholders and interested parties through the consultation process referred to in Article 54, taking into account the work of the Europe’s Rail Joint Undertaking established in Title IV of Regulation (EU 2012/2085) following approval by ERICA.
Amendment 503 #
2023/0271(COD)
Proposal for a regulation
Article 44 – paragraph 3 a (new)
Article 44 – paragraph 3 a (new)
3a. The Commission shall adopt an implementing act setting out the European framework for the coordination of cross-border traffic management, disruption management and crisis management by [36 months of the entry into force of this Regulation], taking into account the framework adopted by ENIM in accordance with paragraph 1 and following consultation of ENIM, EOSP, ERICA, ENRRB, PRB, the European Union Agency for Railways and the Europe’s Rail Joint Undertaking. This implementing act shall be adopted in accordance with the examination procedure referred to in Article 72(3).
Amendment 509 #
2023/0271(COD)
Proposal for a regulation
Article 49 – paragraph 1
Article 49 – paragraph 1
1. In accordance with Article 7f, point (d) of Directive 2012/34/EU, ENIM under the supervision of ERICA shall monitor and benchmark performance of rail infrastructure services taking into account the general objectives set out in Article 2 of this Regulation. Rail infrastructure managers shall also monitor the performance of rail transport services.
Amendment 510 #
2023/0271(COD)
Proposal for a regulation
Article 49 – paragraph 2
Article 49 – paragraph 2
2. For this purpose, infrastructure managers shall set outpropose their own performance targets in the plan referred to in Article 8(3) of Directive 2012/34/EU, taking into account any objectives set out in the contractual agreements referred to in Article 30 of that Directive. The infrastructure managers shall consult regulators, as well as their national ministries and the Commission in order to assure that the targets set are consensually accepted as consistent with EU level policies and ambitions. They shall put in place and perform procedures to monitor and report on progress towards the achievement of the targets, to identify the causes of performance deficiencies with operational stakeholders and to design and implement remedial measures to improve performance. These procedures shall take into account the European framework for performance review referred to in Article 50 of this Regulation. Infrastructure managers shall explain in the network statement the reason for any deviation from the common procedures established in the European framework for performance review. Deviations should only be allowed in reasonable cases and should be approved by the regulator.
Amendment 512 #
2023/0271(COD)
Proposal for a regulation
Article 50 – paragraph 1
Article 50 – paragraph 1
1. ERICA with the support of ENIM shall set up and implement by [12 months after the entry into force of this Regulation] a European framework for the review of performance. This framework shall take into account in particular the principles defined in Article 2(3), Article 8(4), Article 42(3) and the operational requirements, the performance objectives and target values set out in [Article 18 of the new TEN-T Regulation].
Amendment 514 #
2023/0271(COD)
Proposal for a regulation
Article 50 – paragraph 5
Article 50 – paragraph 5
5. The Commission mayshall adopt an implementing acts, setting out detailed rules on the elements in paragraph 2, points (b) to (d), in accordance with the advisory procedure referred to in Article 72(2). In doing so, the Commission shallthe European framework for performance review by [36 months of the entry into force of this Regulation], takeing into account the framework adonepted by ENIM in accordance with paragraph 31 and any recommendfollowing consultations of the performance review bodyENIM, EOSP, ERICA, ENRRB, PRB, the European Union Agency for Railways and the Europe’s Rail Joint Undertaking. This implementing act shall be adopted in accordance with the examination procedure referred to in Article 72(3).
Amendment 517 #
2023/0271(COD)
Proposal for a regulation
Article 51 – paragraph 1
Article 51 – paragraph 1
1. Without prejudice to Article 15 of Directive 2012/34/EU and Article 3 of Commission Implementing Regulation (EU) 2015/110023 , ENIMRICA shall prepare and publish by [24 months after the entry into force of this Regulation] a European performance review report on the basis of the European framework for performance review referred to in Article 50 of this Regulation and publish it every year. __________________ 23 Commission Implementing Regulation (EU) 2015/1100 of 7 July 2015 on the reporting obligations of the Member States in the framework of rail market monitoring (OJ L 181, 9.7.2015, p. 1).
Amendment 522 #
2023/0271(COD)
Proposal for a regulation
Article 51 – paragraph 4 a (new)
Article 51 – paragraph 4 a (new)
4a. The performance review report shall contain a separate section about the implementation of the processes introduced by ENIM. It shall also contain an analysis of the progress in implementation in various EU member states, including reports about national exemptions and recommendations for further harmonisation.
Amendment 524 #
2023/0271(COD)
Proposal for a regulation
Article 52 – paragraph 1
Article 52 – paragraph 1
1. In accordance with the procedure referred to in Article 732(3), the Commission mayshall set up or designate an impartial and competent body to act as a Performance Review Body. It shall be composed in equal parts of experienced experts from applicants, infrastructure managers and regulators.
Amendment 527 #
2023/0271(COD)
Proposal for a regulation
Article 52 – paragraph 3 – point a
Article 52 – paragraph 3 – point a
(a) providing recommendations to ENIM and ERICA as regards the establishment and review of the European framework for performance review referred to in Article 50, including on performance areas, performance issues to be addressed under each of the performance areas, harmonisation of methodologies, processes, criteria and definitions for the collection and analysis of data related to performance and performance indicators;
Amendment 528 #
2023/0271(COD)
Proposal for a regulation
Article 52 – paragraph 3 – point b
Article 52 – paragraph 3 – point b
(b) providing recommendations to ENIM, ERICA, the ENRRB, infrastructure managers, applicants, regulatory bodies, Member State authorities, and, where relevant, other stakeholders for corrective measures, on capacity management, traffic management, disruption management and crisis management;
Amendment 531 #
2023/0271(COD)
Proposal for a regulation
Article 52 – paragraph 5
Article 52 – paragraph 5
5. ENIM, the Network Coordinator, infrastructure managers, regulatory bodies, the ENRRB, ERICA and, where relevant, other stakeholders shall cooperate with the performance review body, in particular by providing information related to performance on their own initiative or upon the body’s request and make the utmost effort to take into account its recommendations in their work on rail performance management.
Amendment 532 #
2023/0271(COD)
Proposal for a regulation
Article 53 – paragraph 2 – subparagraph 2 – point e
Article 53 – paragraph 2 – subparagraph 2 – point e
(e) appoint a leading entity, whenever coordination activities involve multiple actors, which shall report to ENIM and ERICA and shall be responsible for organising consultation activities in accordance with Article 54;
Amendment 533 #
2023/0271(COD)
Proposal for a regulation
Article 53 – paragraph 3 – subparagraph 1
Article 53 – paragraph 3 – subparagraph 1
Coordination shall cover allparticularly be reinforced for those TEN-T lines and nodes which are part of the European Transport Corridors set out in Article 7 of and Annex III to [new TEN-T Regulation].
Amendment 537 #
2023/0271(COD)
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. ERICA with the support of ENIM shall prepare, adopt and implement guidelines to ensure appropriate and regular consultation of interested parties, including representatives from ERA, Member States as well as the representative bodies as listed by the Commission within the requirements of Article 38, paragraph 4 in regulation (EU) 2016/796 and include them in the European framework for capacity management referred to in Article 6, the European framework for the cross-border coordination of traffic management, disruption management and crisis management referred to in Article 44 and the European framework for performance review referred to in Article 50. The process shall be developed and implemented with the support of the Network Coordinator and with the involvement of the designated focal points of infrastructure managers referred to in Article 60.
Amendment 540 #
2023/0271(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Where ENIMRICA adopts an opinion or a recommendation likely to have an impact on railway undertakings, other applicants, advisory groups as established in Article 55 a new, other operational stakeholders and interested parties, including representatives from the EU Agency for Railways, Member States as well as the representative bodies as defined by Article 38, paragraph 4 in regulation (EU) 2016/796, it shall publish a draft for the consultation of concerned parties. The concerned parties shall be given an appropriate amount of time to provide feedback on the draft decision. Member State authorities shall be involved when required.
Amendment 542 #
2023/0271(COD)
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
3. ENIMRICA shall take account of the feedback provided by concerned parties in accordance with paragraph 2 when adopting the final opinion or recommendation. Where ENIMRICA fails to take into account significant elements of the feedback provided, it shall provide thejustified reasons for doing so.
Amendment 544 #
2023/0271(COD)
Proposal for a regulation
Article 54 – paragraph 3 a (new)
Article 54 – paragraph 3 a (new)
3a. In the case of diverging views between ENIM and the consultative bodies, the latter shall inform the ENRRB. The ENRRB shall take account of such divergent views in its European performance review report as referred to in Article 51.
Amendment 546 #
2023/0271(COD)
Proposal for a regulation
Article 55 – paragraph 5
Article 55 – paragraph 5
5. ENIM shall take its decisions by a simple majority, unless otherwise provided for in the rules of procedure. All members from one Member State shall together have one vote. In the absence of a member, the alternate shall be entitled to exercise the right to vote.
Amendment 549 #
2023/0271(COD)
Proposal for a regulation
Article 55 – paragraph 7
Article 55 – paragraph 7
7. The Commission and ERICA shall be a non- voting member of ENIM. It shall support the work of ENIM and facilitate coordination.
Amendment 554 #
2023/0271(COD)
Proposal for a regulation
Article 55 a (new)
Article 55 a (new)
Article 55a Consultative body to ENIM 1. ENIM shall establish a European Operational Stakeholder Platform (EOSP) made of representatives of operational stakeholders, as defined in Article 4 [definition from Directive 2012/34 (includes also ports and terminals)] as well as maritime and inland port authorities, freight terminals and operators of rail service facilities. The Commission and ERICA shall also be appointed as observers within EOSP. 2. Following the consultation of and the approval by the Commission, ENIM shall adopt and publish the rules of procedure of EOSP outlining interalia the frequency of meetings, the forms of consultation and the selection process of representatives of operational stakeholders. These shall be selected ensuring a balanced representation of stakeholders between stakeholder types and geography of the Union. ENIM may organise the activities of EOSP in subgroups grouping stakeholder types and regional clusters of Member States. 3. ENIM shall consult EOSP in the development of the European Frameworks for Capacity Management, Traffic Management and Performance Management. EOSP may issue an opinion on any proposal by ENIM and ERICA which has consequences for stakeholders. EOSP may also issue own initiative opinions addressed to ENIM, ERICA or to the Commission. 4. ENIM, following approval of EOSP representatives, shall address to ERICA and to the Commission an annual report of EOSP activities. This report shall be published.
Amendment 555 #
2023/0271(COD)
Proposal for a regulation
Article 56 – paragraph 1 – introductory part
Article 56 – paragraph 1 – introductory part
1. In addition to the tasks laid down in Article 7f of Directive 2012/34/EU, ENIM shall be responsible for all tasks assigned to it in this Regulation. It shall, where applicable under the lead of ERICA, in particular:
Amendment 557 #
2023/0271(COD)
Proposal for a regulation
Article 57 – paragraph 2
Article 57 – paragraph 2
2. ENIM shall invite the Commission, including the European Coordinators, ERICA and, where relevant, representatives of the Member States, representatives from the EU Agency for Railways, ERA as well as the representative bodies as defined by Article 38, paragraph 4 in regulation (EU) 2016/796 to its meetings with a view to discuss issues related to the development of rail infrastructure and to ensure cooperation with the European Coordinators, as outlined in [new TEN-T Regulation]. ENIM shall provide the information required under [Article 53, third subparagraph of the new TEN-T Regulation].
Amendment 560 #
2023/0271(COD)
Proposal for a regulation
Article 57 a (new)
Article 57 a (new)
Article 57a European Rail Infrastructure Coordinator for the Allocation of capacity (ERICA) 1. ERICA will fulfil the following tasks: (a) contribute to the preparation of the European framework for capacity management referred to in Article 6 with the support of the Network coordinator referred to in Article 58 and 59, the European framework for the prioritisation criteria referred to in Article 31 3 a new, coordination of cross-border traffic management, disruption management and crisis management referred to in Article 44 and the European framework for performance review referred to in Article 50; (b) contribute to the operational coordination between infrastructure managers with the support of the Network coordinator referred to in Article 58 and 59, in accordance with Article 53; (c) provide support to the regulatory bodies in identifying rules, procedures and tools within the scope of this Regulation and adopted at national or infrastructure manager level which create obstacles for multi-network rail services, as set out in this Regulation, with the support of the Network coordinator referred to in Article 58 and 59 and including for framework agreements as referred to in Article 31; (d) act as an additional point of contact for stakeholders outside the rail sector interested in using rail services, providing contacts to relevant actors at infrastructure managers and other operational stakeholders; (e) act as a contact point on behalf of ENIM for applicants and other operational stakeholders on issues not explicitly covered by this Regulation, in particular the launch or change of cross- border rail transport services or organising support for ad hoc activities, in particular to address the crisis situations referred to in Article 47; (f) be closely involved in the development and implementation of digital tools and services as foreseen in Article 62 and closely cooperate with the European system authority for telematics applications (EU Agency for Railways); (g) provide recommendations on infrastructure enhancement needs on a multi-network level also on the basis of the European Performance review report as per Art. 51, as a basis for future infrastructure development and funding within TEN-T. 2. ERICA shall be established as a structure within the European Union Agency for Railways. The Management Board of the European Union Agency for Railways shall lay down special rules applicable to ERICA in order to guarantee that ERICA and its staff are independent in the performance of their duties. The budgeting of the ERICA structure shall be defined in an Implementing Act by the Commission and may include fees applicable to infrastructure managers and operational stakeholders within the scope of Article 64 and Article 80 of Regulation (EU) 2016/796. 3. ERICA shall be supported by ENIM and by the Network Coordinator in its work by as referred to in Article 58 and 59.
Amendment 564 #
2023/0271(COD)
Proposal for a regulation
Article 58 – paragraph 1 – subparagraph 1
Article 58 – paragraph 1 – subparagraph 1
The infrastructure managers shall provide ENIM with the necessary resources to perform its tasks. For this purpose, they shall appoint by [12 months after the entry into force of this Regulation] an impartial and competent entity to fulfil the functions referred to in Article 59. Such entity will be designated as a Network Coordinator.
Amendment 566 #
2023/0271(COD)
Proposal for a regulation
Article 58 – paragraph 1 – subparagraph 1 a (new)
Article 58 – paragraph 1 – subparagraph 1 a (new)
The Commission shall appoint by [12 months after the entry into force of this Regulation] an impartial and competent entity to fulfil the functions referred to in Article 59. Such entity will be designated as the Network Coordinator appointed by the European Commission.
Amendment 567 #
2023/0271(COD)
Proposal for a regulation
Article 58 – paragraph 1 – subparagraph 2 – introductory part
Article 58 – paragraph 1 – subparagraph 2 – introductory part
Prior to the appointment of the Network Coordinator, infrastructure managers shall seek the consent of the Commission regarding the designated entity and the following aspectsthe Commission shall consult the Member States and ENIM on:
Amendment 568 #
2023/0271(COD)
Proposal for a regulation
Article 58 – paragraph 2
Article 58 – paragraph 2
2. The Network Coordinator shall execute its tasks in an impartial and cost- effective manner and shall act on behalf of ENIM and the Commission. For this purpose, it shall submit to ENIM and the Commission its annual work programme with respect to the tasks set out in this Regulation as well as an annual report on the implementation of the work programme.
Amendment 571 #
2023/0271(COD)
Proposal for a regulation
Article 61 – paragraph 1
Article 61 – paragraph 1
1. ERICA with the support of ENIM, shall prepare and adopt a common structure for the network statement referred to in Article 27 of Directive 2012/34/EU, which shall take into consideration the information listed in Annex IV to that Directive, Annex IV to this Regulation, and a common schedule for the consultation of interested parties on the draft network statement. Infrastructure managers shall take the utmost account of this structure and schedule when preparing the network statement.
Amendment 572 #
2023/0271(COD)
Proposal for a regulation
Article 61 – paragraph 3
Article 61 – paragraph 3
3. Where the infrastructure manager does not comply with paragraph 1 or 2, it shall provide a justification in the network statement and inform the competent regulatory body and ENIMRICA.
Amendment 576 #
2023/0271(COD)
Proposal for a regulation
Article 62 – paragraph 2 – point c a (new)
Article 62 – paragraph 2 – point c a (new)
(ca) where applicable be synchronised with existing register for infrastructure (referred to in Article 49 of the Directive EU 2016/797).
Amendment 585 #
2023/0271(COD)
Proposal for a regulation
Article 63 – paragraph 1
Article 63 – paragraph 1
1. The functions and the powers laid down in Article 56 of Directive 2012/34/EU shall also be exercised with respect to the matters covered by this Regulation. In particular, the regulatory body shall monitor the activities of infrastructure managers and the European network coordinator, as set out in Chapters II to V and shall verify compliance with this Regulation on its own initiative and with a view to preventing discrimination against applicants.
Amendment 591 #
2023/0271(COD)
Proposal for a regulation
Article 65 – paragraph 3
Article 65 – paragraph 3
3. Based on requests by applicants, infrastructure managers, and other interested parties, the ENRRB shall provide opinions or recommendations on pending or adopted decisions on complaints submitted to the rail regulatory bodies. This shall include the tasks and responsibilities given to the network coordinator within the scope of this regulation.
Amendment 592 #
2023/0271(COD)
Proposal for a regulation
Article 65 – paragraph 4 – subparagraph 1
Article 65 – paragraph 4 – subparagraph 1
Interested parties, railway undertakings and applicants may lodge a complaint with the ENRRB on matters within the scope of this Regulation or affecting the access to or the use of rail infrastructure in more than one Member State. Where the ENRRB receives such a complaint, it shall transfer it to the competent regulatory body or bodies without delay.
Amendment 594 #
2023/0271(COD)
Proposal for a regulation
Article 65 – paragraph 6 a (new)
Article 65 – paragraph 6 a (new)
6a. ENRRB shall assess the European Frameworks for capacity managements, traffic management and performance review as well as the network statement common structure and issue an opinion. Regulatory bodies shall take utmost account of the opinion of ENRRB in checking network statements.
Amendment 595 #
2023/0271(COD)
Proposal for a regulation
Article 66 – paragraph 2 a (new)
Article 66 – paragraph 2 a (new)
ENRRB shall ensure that its methods of operation and all relevant information about its work are made publicly available on a common website. It shall include contact details for complaints, contact information for dedicated working groups, and information about procedures.
Amendment 596 #
2023/0271(COD)
Proposal for a regulation
Article 66 – paragraph 2 b (new)
Article 66 – paragraph 2 b (new)
ENRRB shall publish its opinions and recommendations on a common website.
Amendment 597 #
2023/0271(COD)
Proposal for a regulation
Article 68 – paragraph 2 – point a a (new)
Article 68 – paragraph 2 – point a a (new)
(aa) adopt opinions and recommendations on decisions taken by ENIM and ERICA working in cooperation with the network coordinator within the scope of this regulation
Amendment 598 #
2023/0271(COD)
Proposal for a regulation
Article 68 – paragraph 2 – point a b (new)
Article 68 – paragraph 2 – point a b (new)
(ab) following complaints from railway undertakings, operators of service facilities and other interested parties, adopt recommendations and opinions of the ENRRB in relation to the consultations referred to in Article 55 a new, was well as to the decisions taken by ENIM as well as by ERICA working in cooperation with the network coordinator.
Amendment 602 #
2023/0271(COD)
Proposal for a regulation
Article 69 – paragraph 4
Article 69 – paragraph 4
4. The Board shall take decisions by a simple majority of its members, unless otherwise provided for in the rules of procedure.
Amendment 607 #
2023/0271(COD)
Proposal for a regulation
Article 74 – paragraph 1 – point c a (new)
Article 74 – paragraph 1 – point c a (new)
(ca) Articles 11, 11a (2), 38 (4) and in Article 11a (1) the words “without prejudice to Article 11 (5)”, in Article 12 (1) the words “without prejudice to Article 11 (2)” , and in Article 62 (3) the words “Article 11(4)” are deleted;
Amendment 608 #
2023/0271(COD)
Proposal for a regulation
Article 74 a (new)
Article 74 a (new)
Article 74a Amendments to Directive (EU) 2016/797 1. Directive (EU) 2016/797 is amended as follows: (a) In Annex II, point 2 the following point is added: 2.9 Use of railway infrastructure capacity: the structures, bodies and procedures referred to in Regulation (XXX this new Reg.)
Amendment 614 #
2023/0271(COD)
Proposal for a regulation
Article 77 – paragraph 2 – subparagraph 1 – point d a (new)
Article 77 – paragraph 2 – subparagraph 1 – point d a (new)
(da) Article 57a shall apply from 1 January 2029;
Amendment 618 #
2023/0271(COD)
Proposal for a regulation
Annex I – point 2 – point 1 – paragraph 3 – table
Annex I – point 2 – point 1 – paragraph 3 – table
Deliverable Milestone Deadline (at latest) Capacity strategy Publication of the first elements of the Capacity strategy elaboration phase including X–60 (Article 16) capaconsultation wityh strategyakeholders First consultation of stakeholders X–58 Publication of the draft strategy and second X–348 consultation of stakeholders Publication of final capacity strategy following X–36 final coordination between infrastructure managers Publication of capacity model X-18 Publication of final capacity supply plan X-11 follwoing IM and EOSP consultation Capacity model Start of preparation X–36 (Article 17) Consultation of applicants and operational X–24 stakeholders Publication of draft capacity model X–21 Coordination with applicants and operational X–19 stakeholders Publication of final capacity model following X–18 final coordination between infrastructure managers Capacity supply plan Start of preparation X–18 (Article 18) Consultation of applicants and operational X–14 stakeholders Publication of capacity restrictions referred to X–12 in point (1) of section (3) of this Annex Publication of final capacity supply plan X–11 following final coordination between infrastructure managers Publication of capacity restrictions referred to X–4 in point (5) of section (3) of this Annex Re-purposing of capacity reserved for X–2 allocation through the working timetable for other allocation processes Update of capacity supply plan to reflect any Until X+12 without changes to pre-planned or allocated capacity delay Note: (1) ‘X–m’ means ‘m’ months before the date of entry into force of the working timetable (‘X’), in accordance with section 4.
Amendment 620 #
2023/0271(COD)
Proposal for a regulation
Annex I – point 3 – point 1
Annex I – point 3 – point 1
1. As regards temporary restrictions of the capacity of railway lines, for reasons such as infrastructure works, including associated speed restrictions, axle load, train length, traction, or structure gauge (‘capacity restrictions’), of a duration of more than 7 consecutive days and for which more than 30 % of the estimated traffic volume on a railway line per day is cancelled, re-routed or replaced by other modes of transport, the infrastructure managers concerned shall publish all capacity restrictions, as far as they are known, and the preliminary results of a consultation with the applicants for a first time at least 24 months and, in an updated form, for a second time at least 12 months before the change of the working timetable concerned. These infrastructure restrictions shall be included in the capacity supply plan referred to in Article 18.
Amendment 621 #
2023/0271(COD)
Proposal for a regulation
Annex I – point 3 – point 7
Annex I – point 3 – point 7
7. Without prejudice to Article 40, the infrastructure manager may decide not to apply the periods laid down in points (1) to (5), if the capacity restriction is necessary to re-establish safe train operations, the timing of the restrictions is beyond the control of the infrastructure manager, the application of those periods would be cost ineffective or unnecessarily damaging in respect of asset life or condition, or if all concerned applicants agree. In those cases and in case of any other capacity restrictions that are not subject to consultation in accordance with other provisions of this Annex, the infrastructure manager shall consult the applicants and the main operators of service facilities concerned forthwith.
Amendment 623 #
2023/0271(COD)
Proposal for a regulation
Annex I – point 4 – point 1 – table
Annex I – point 4 – point 1 – table
Milestone or time period Deadline or duration(1) Period of validity of the working timetable One year (‘working timetable period’) Entry into force of the working timetable Midnight on the second Saturday in December Publication of capacity supply plan In accordance with section 2 of this Annex Publication of capacity restrictions In accordance with sections 2 and 3 of resulting from infrastructure works this Annex Deadline for applicants to submit requests X–8.5 for capacity rights Preparation of draft working timetable X–6.5 Deadline for infrastructure manager(s) to submit draft capacity offer to applicants Finalisation of coordination with X–6 applicants, ensuring that all prerequisists are met before this 2 week finalisation of ‘observation phase’ Deadline for infrastructure manager(s) to X–5.5 submit final capacity offer to applicants Publication of final working timetable X–5.25 Deadline for infrastructure manager to allocate capacity rights to applicants Conversion of capacity specifications in To be specified in the European train paths framework for capacity management referred to in Article 6 Note: (1) ‘X–m’ means ‘m’ months before the date of entry into force of the working timetable (‘X’)
Amendment 624 #
2023/0271(COD)
Proposal for a regulation
Annex I – point 7 – paragraph 1 – table
Annex I – point 7 – paragraph 1 – table
Time period Duration Maximum period for infrastructure 1 day24 hours managers to prepare an offer of capacity rights concerning a single network if the ad hoc request is placed after the publication date of the final working timetable Maximum period for infrastructure 5 days managers to prepare an offer of multi- network capacity rights
Amendment 627 #
2023/0271(COD)
Proposal for a regulation
Annex II – point 1 – point 1 – introductory part
Annex II – point 1 – point 1 – introductory part
Utilisation Classification Capacity utilisation Reference period Heterogenous Highly utilised > 65% of theoretical More than 4 hours for more than traffic capacity [value to be 200 days per year determined by ENIM] Heterogenous Congested > 95% of theoretical More than 4 hours for more than traffic capacity [value to be 250 days per year determined by ENIM] Homogeneous Highly utilised > 80% of theoretical More than 4 hours for more than traffic capacity [value to be 200 days per year determined by ENIM] Homogenous Congested > 95% of theoretical More than 4 hours for more than traffic capacity [value to be 250 days per year determined by ENIM]
Amendment 628 #
2023/0271(COD)
Proposal for a regulation
Annex IV – paragraph 1 – point 2 – point a
Annex IV – paragraph 1 – point 2 – point a
(a) the procedures according to which applicants are consulted (see Article 55 a new on EOSP) on strategic capacity planning;
Amendment 629 #
2023/0271(COD)
Proposal for a regulation
Annex VII – table 1
Annex VII – table 1
Performance areas subject to performance Performance areas subject to performance review review referred to in Article 50 referred to in Article 50 Performance area Relevant issues (indicative) Infrastructure and equipment – Capacity and capabilities of the physical infrastructure and its equipment, including deployment of TEN-T standards – Reductions in infrastructure capacity or capability due to deferred infrastructure renewal, maintenance or repair Infrastructure capacity – Capacity offer in terms of quantity and quality, including consistency across network borders – Capacity utilisation, spare capacity to accommodate traffic growth – Consistency between available capacity (planned or unplanned) and market needs – Stability of the capacity offer, in particular in connection with infrastructure works – Congested infrastructure – Planned dwelling times of trains at border stations Traffic management – Punctuality / delays of different types of rail services, at origin, intermediate stops and destination and at operationally important locations – Train cancellations – Actual dwelling times of trains at border stations Disruption management and crisis – Share of traffic that could be re- management routed or re-scheduled during the disruption or crisis – Impact of disruptions on rail traffic in terms of delays and cancellations – Impact of disruptions on operators of rail services and their customers – Specific issues encountered (qualitative) Deployment and performance of digital – Support of the processes related to services, tools and interfaces capacity management, traffic management and disruption management – Completeness and quality of of the information and data provided as well as ease of access for operational stakeholders – Alignment with European architecture developed in ERJU and with the relevant technical specifications in accordance with Directive (EU) 2016/797 Compliance with regulation; regulatory – Process indicators monitoring oversight compliance with rules and procedures – Complaints lodged with regulatory bodies and ENRRB
Amendment 28 #
Amendment 409 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 10 – point a
Article 1 – paragraph 10 – point a
Amendment 203 #
2023/0131(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) This Regulation contributes to the implementation of the One Health Approach, stressing the well-established interconnectedness between human, animal, and ecosystem health and the need to include those three dimensions when addressing public health threats. The loss of biodiversity, changes in land use, deforestation, urbanisation, agricultural expansion and intensification, poor air quality, wildlife trafficking and consumption patterns and transmissions of diseases between humans and animals are all factors that have contributed to the increasing disease burden. In addition, pollution from active pharmaceutical ingredients negatively affects the quality of waters and ecosystems, posing risks to public health globally.
Amendment 211 #
2023/0131(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Addressing unequal patient access of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe as has been highlighted by the Council and the European Parliament. Member States have called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring patient access and availabilityconditionalities related to transparency, affodability and availability are in place to ensure patient access of medicinal products in all Member States.
Amendment 213 #
2023/0131(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) Previous amendments to the Union pharmaceutical legislation have addressed access to medicinal products by providing for accelerated assessment for marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies in some areas, and there still exist many unaddressed public health priorities, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicines, for instance due to their high prices, inadequate infrastructures in Member States or the industry’s business strategy.
Amendment 215 #
2023/0131(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The COVID-19 pandemic has spotlightfurther underlined critical issues which require a reform of the Union pharmaceuticals framework to improve medicines availablity, to strengthen its resilience and to ensure that it corresponds to public health needs and serves the people under all circumstances.
Amendment 220 #
2023/0131(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) For the sake of clarity, it isIt is therefore necessary to replace Regulation (EC) No 726/2004 of the European Parliament and of the Council38 with a new Regulation. _________________ 38 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
Amendment 222 #
2023/0131(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The structure and operation of the various bodies making up the Agency should be designed in such a way as to take into account the need to constantly renew scientific expertise, the need for cooperation between Union and national bodies, the need for adequate involvement of civil society, and the future enlargement of the Union. The various bodies of the Agency should establish and develop appropriate contacts with the parties concerned, in particular with representatives of patients, consumers and healthcare professionals.
Amendment 224 #
2023/0131(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The chief task of the Agency should be to provide Union institutions and Member States with the best possible scientific opinions to enable them to exercise the powers of authorisation and supervision of medicinal products conferred on them by Union legal acts in the field of medicinal products. Marketing authorisation should be granted by the Commission only after a single scientific evaluation procedure addressing the quality, safety and, efficacy of high- technologyand environmetal risk of medicinal products has been conducted by the Agency, applying the highest possible standards.
Amendment 225 #
2023/0131(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) The Agency's budget should be transparent composed of fees and charges paid by the private sector and contributions from the Union budget to implement Union policies and contributions paid from third countries. Although the majority of its funding comes from fees, the Agency is a public authority and it is of utmost importance to safeguard its integrity and independence in order to ensure public trust in the Union regulatory framework.
Amendment 226 #
2023/0131(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
Amendment 228 #
2023/0131(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Scientific advice for future applicants seeking a marketing authorisation should be provided more generally and in greater depth. Similarly, structures allowing the development of advice for companies, in particular small and medium-sized enterprises (‘SMEs’), and non-for-profit entities should be put in place.
Amendment 233 #
2023/0131(COD)
(20 a) Despite the evolution of science and technology at a rapid pace and the regulatory incentives currently in place, there are many diseases without or only with suboptimal treatments. This Regulation should contribute to the development of treatments to tackle these unmet medical needs. These are in particular life threatening or severely debilitating diseases where no treatment alternative exists or where the disease still causes high morbidity or mortality, despite available therapeutic options. Products receiving regulatory incentives should result in a meaningful reduction in disease morbidity or mortality for the relevant patient population and a significant increase in patient’s quality of life.
Amendment 237 #
2023/0131(COD)
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) Based on the Ombudsman’s decision in the strategic inquiry on how the European Medicines Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the EU1a, the Agency should enhance transparency of scientific advice. In addition, staff and experts from national competent authorities providing scientific advice should not be involved in a subsequent evaluation of marketing authorisation application for the same products. _________________ 1a European Ombudsman’s Decision in strategic inquiry OI/7/2017/KR on how the European Medicines Agency engages with medicine developers in the period leading up to applications for authorizations to market new medicines in the EU, July 2019.
Amendment 240 #
2023/0131(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) Legal entities that are not engaged in an economic activity such as universities, public bodies, research centres or not-for-profit organisations, represent an important source of research in unmet medical needs, research in different subpopulations, repurposing, optimisation and innovation and should also benefit from this support scheme. Whereas it should be possible to take account of the particular situation of these entities on an individual basis, such support can best be achieved by means of a dedicated support scheme, including administrative support and through the reduction, deferral and waiver of fees.
Amendment 246 #
2023/0131(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) The Agency should be empowered to give scientific recommendations on whether a product under development, which could potentially fall under the mandatory scope of the centralised procedure, meets the scientific criteria to be a medicinal product. Such an advisory mechanism would address, as early as possible, questions related to borderline cases with other areas such as substances of human origin, cosmetics or medical devices, which may arise as science develops. To ensure that recommendations given by the Agency take into account the views of equivalent advisory mechanisms in other legal frameworks, the Agency should consult the relevant advisory or regulatory bodies. Where opinions differ between the Agency and other advisory bodies, the diverging opinions and their reasoning shall be included in the recommendations of the Agency.
Amendment 250 #
2023/0131(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) The Agency has an important role in sharing of information with the general public in order to ensure trust in its work and to support health literacy of patient and consumers. In addition, it is key to share up to date information with healthcare professionals, including pharmacists, and the scientific community. To increase transparency of scientific assessments and all other activities, a user-friendly European medicines web- portal should be created and maintained by the Agency. The portal should serve an information hub for all centrally authorised medicinal products and include information about safety, efficacy, environmental risk, patient populations, antimicrobial resistance, shortages, pending obligations for marketing authorisation holders and status on intellectual property, regulatory and market protection periods. Sufficient budget should be allocated to the Agency to ensure appropriate implementation of its transparency obligations and commitments.
Amendment 256 #
2023/0131(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) The Agency’s scientific committees should be able to delegate some ofsupported for their evaluation duties toby working parties which should be open to experts from the scientific world and appointed for this purpose, and by additional experts drawn from the pool of accredited experts, whilst retaining complete responsibility for the scientific opinions issued by them.
Amendment 258 #
2023/0131(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. Their evaluation will continue to encompass all the necessary expertise for each product as part of the rapporteur teams, with the possibility for CHMP and PRAC to call upon additional scientific experts to provide specific input and advice on specific aspects raised during the evaluation. In addition, patients and healthcare professionals will be part of the pool of experts and will also be brought into EMA’s work according to their expertise in a certain disease area. The CHMP and PRAC consists of experts from all Member States while working parties and expert groups consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.
Amendment 266 #
2023/0131(COD)
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37 a) To ensure the adequate expertise and evaluation of the environmental risk assessments of pharmaceutical substances, the Agency establishes a new Environmental Risk Assessment working party which will have the scientific knowledge to characterise and assess the risks and hazards related to the development, production, use and disposal of medicines and their impact on the environment, animals, humans and public health. The working party will ensure the One Health Approach in medicines evaluation and closing the gap between pharmaceutical and environmental assessment. The working party ensures, based on cross-sectorial scientific knowledge, that substance is adequately assessed and the risk minimisation and containment strategies proposed by the applicants are sufficient in order to place the product on the market.
Amendment 275 #
2023/0131(COD)
Proposal for a regulation
Recital 41 a (new)
Recital 41 a (new)
(41 a) Protecting global health is one of the priorities of the EU and under Article 178 of the Treaty, the Union should take into account the development policy aspects in any measure and promote the creation of conditions fit for human beings worldwide. To this end, this Regulation should particularly allow for the development of efficacious, safe, accessible, and affordable innovations to address global public health needs, including antimicrobial resistance, poverty-related and neglected diseases, widespread tropical disease and ensure high quality standards for medicinal products that are exported.
Amendment 279 #
2023/0131(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) The quality, safety and, efficacy and environmental risk criteria of [revised Directive 2001/83/EC] should apply to medicinal products authorised by the Union under the centralised procedure. The benefit-risk balance of all medicinal products will be assessed when they are placed on the market, five years after approval and at any other time the competent authority deems appropriate.
Amendment 281 #
2023/0131(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) Marketing authorisation applications, like any other application submitted to the Agency, should follow the digital by default principle and hence be sent to the Agency in electronic form. Applications should be assessed based on the file submitted by the applicant in accordance with the different legal basis provided by [revised Directive 2001/83/EC]. At the same time, the Agency and the relevant committees may take into account any information that is in its possession. Applicants shall be requested to generally submit raw data, in particular with regard to the clinical trials performed by the applicant in order to ensure a full assessment of the quality, safety and, efficacy and environmental risk of the medicinal product.
Amendment 282 #
2023/0131(COD)
Proposal for a regulation
Recital 45 a (new)
Recital 45 a (new)
(45 a) Particular attention should be given to the gender balance of clinical trials so that women can fully and safely benefit from medicines throughout their life-course.
Amendment 283 #
2023/0131(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes49 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Ultimately, efforts should be made to fully replace procedures on live animals for scientific purposes. Any study involving the use of live animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available Agency and the International Committee for Harmonisation (ICH) guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use of new approach methodologies (NAMs) in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D) cell culture models, organoids and human stem cells- based models; in silico tools grouping or read-across models. _________________ 49 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33), aquatic egg models as well as invertebrate species.
Amendment 288 #
2023/0131(COD)
Proposal for a regulation
Recital 49
Recital 49
Amendment 291 #
2023/0131(COD)
Proposal for a regulation
Recital 51
Recital 51
(51) As a general rule a marketing authorisation should be granted for an unlimited time; however,for products other than generics should be granted for a period of five years in order to allow for the integration of real world evidence and re- assessment of the risk-benefit balance and in case of orphan medicines, also the related criteria related to population size and generated profit; once renewal may be decided only on justified grounds related to the safety of the medicinal producted, the marketing authorisation shall be valid for an unlimited period, unless the Agency decides on justified grounds related to the safety of the medicinal product to proceed with an additional five-year renewal period or revocation of the marketing authorisation.
Amendment 293 #
2023/0131(COD)
Proposal for a regulation
Recital 51 a (new)
Recital 51 a (new)
(51 a) As a general rule, marketing authorisation should be granted based on comparative clinical trials on patients who are representative of the population to be treated with the product. To this end, placebo controlled trials should only be accepted where duly justified, necessary and ethical. In addition, patient-reported outcome measures (PROMs) and patient- reported experience measures (PREMs) should be an integral part of clinical data submitted with the marketing authorisation application in order to assess the quality of care and the impact of the treatments on patients.
Amendment 298 #
2023/0131(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) [revised Directive 2001/83/EC] permits Member States to temporarily allow the use and supply of unauthorised medicinal products for public health reasons or individual patient needs and that includes medicinal products to be authorised under this Regulation. It is also necessary, that Member States are allowed under this Regulation to make a medicinal product available for compassionate use prior to its marketing authorisation. In those exceptional and urgent situations, where there is a lack of a suitable authorised medicinal product, the need to protect public health or the health of individual patients must prevail over other considerations, in particular the need to obtain a marketing authorisation and consequently, to have available complete information about the risks posed by the medicinal product, including any risks to the environment from medicinal products containing or consisting of genetically modified organisms (GMOs). To avoid delays in making these products available or uncertainties as regards their status in certain Member States, it is appropriate, in those exceptional and urgent situations, that for a medicinal product containing or consisting of GMOs, an environmental risk assessment or consent in accordance with Directive 2001/18/EC or Directive 2009/41/EC of the European Parliament and of the Council52 should not be a prerequisite. Nevertheless, in these cases, Member States should implement appropriate measures to minimiseprevent foreseeable negative environmental impacts resulting from the intended or unintended release of the medicinal products containing or consisting of GMOs into the environment and agree on an appropriate timeline for the delivery of the environmental risk data. _________________ 52 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (OJ L 125, 21.5.2009, p. 75).
Amendment 304 #
2023/0131(COD)
Proposal for a regulation
Recital 58
Recital 58
(58) There is the possibility under certain duly justified circumstances for marketing authorisations to be granted, subject to specific obligations or conditions, on a conditional basis or under exceptional circumstances. The legislation should allow under similar circumstances for medicinal products with a standard marketing authorisation for new indications to be authorised on a conditional basis or under exceptional circumstances. The medicinal products authorised on a conditional basis or under exceptional circumstances should in principle satisfy the requirements for a standard marketing authorisation with the exception of the specific derogations or conditions outlined in the relevant conditional or exceptional marketing authorisation and shall be subject to specific review of the fulfilment of the imposed specific conditions or obligations. It is also understood that the grounds for refusal of a marketing authorisation shall apply mutatis mutandis for such cases.
Amendment 308 #
2023/0131(COD)
Proposal for a regulation
Recital 65
Recital 65
(65) In the preparation of scientific advice and in duly justified cases, the Agency should alsopromote an open discussion about latest scientific developments and the update of scientific guidelines and should be able to consult authorities established in other relevant Union legal acts or other public bodies established in the Union, as applicable. These may include experts in clinical trials, medical devices, substances of human origin or any other as required for the provision of the scientific advice in question.
Amendment 311 #
2023/0131(COD)
Proposal for a regulation
Recital 67
Recital 67
(67) The Agency, in consultation with the Member States and the Commission, should set the scientific selection criteria for medicinal products that receive pre- authorisation support with priority to be given to public health need and the most promising developments in therapies. In the case of medicinal products for unmet medical needs, based on the scientific selection criteria set by the Agency, any interested developer can submit preliminary evidence to demonstrate that the medicinal product has the potential to provide a major therapeutic advancement with respect to the identified unmet medical need.
Amendment 323 #
2023/0131(COD)
Proposal for a regulation
Recital 76
Recital 76
(76) It is considered appropriate to also have the possibility for the Commission to grant temporary emergency marketing authorisations to address public health emergencies. Temporary emergency marketing authorisations may be granted provided that, having regard to the circumstances of the public health emergency, the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent to the fact that additional comprehensive quality, non-clinical, clinical data may still be required. The decision of the Commission should be based on the opinion issued by the Agency, detailing how the medicinal product could be effective in treating, preventing or diagnosing the disease or condition directly related to the public health emergency and how the benefits of using the product outweigh the risks. In that effect, and given the limited knowledge of both the benefits and risks, the Agency should only take into account plausible expectations of benefits which should be grounded on the data available at the time of the opinion. A temporary emergency marketing authorisation should be valid only during the public health emergency. The Commission should be given the possibility to vary, suspend or revoke such marketing authorisations in order to protect public health or when the marketing authorisation holder has not complied with the conditions and obligations set out in the temporary emergency marketing authorisation.
Amendment 331 #
2023/0131(COD)
Proposal for a regulation
Recital 77
Recital 77
(77) The development of antimicrobial resistance is a growing concern and the pipeline of effective antimicrobials is obstructed due to a market failure; it is therefore necessary to consider new measures to promote the development of priority antimicrobials that are effective against antimicrobial resistance and to support undertakings, often SMEs and non-for-profit entities, which choose to invest in this area.
Amendment 332 #
2023/0131(COD)
Proposal for a regulation
Recital 78
Recital 78
(78) To be considered a ‘priority antimicrobial’, a medicinal product should represent a real advancement against antimicrobial resistance and should therefore bring forward non-clinical and clinical data that underpin a significant clinical benefit with respect to antimicrobial resistance. When assessing the conditions for antibiotics, the Agency shall take into account the prioritisation of pathogens as regards the risk of antimicrobial resistance provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high) or in case there is an equivalent list of priority pathogens adopted at Union level, the Agency should take such Union list into account as a priority. In order to address market failures for the development of antimicrobials, the priority focus should be on the research and development and subsequent production and fair distribution of new antimicrobials. However, addressing AMR will not be solved by R&D alone. To ensure prudent use of existing antibiotics, the Authority should also support the development and procurement of rapid diagnostic tools to ensure appropriate prescriptions.
Amendment 333 #
2023/0131(COD)
Proposal for a regulation
Recital 78 a (new)
Recital 78 a (new)
(78 a) To seriously tackle major ongoing public health challenges, the antimicrobial resistance in particular, while also building on existing resources, the Health Emergency Preparedness and Response Authority (HERA) should be established as a separate structure under the legal personality of the European Centre for Disease Prevention and Control (ECDC) to boost EU’s capability to address health emergencies. The Authority should be responsible for creating, coordinating and implementing the long-term European portfolio of biomedical research and development agenda for medical countermeasures against current and emerging public health threats, as well as providing tools to ensure EU-wide access to these products, including those to support production, procurement, stockpiling and distribution capacity of medical countermeasures and other priority medical products in the EU. The Authority will play a crucial role in addressing health threats globally. The Authority should primarily focus on the fight against antimicrobial resistance and the development of new antimicrobials and medical countermeasures linked to public health emergencies. However, in the future with increasing capacity, the Authority should expand the scope of its agenda, specifically to tackle other areas of unmet medical need such as rare and neglected diseases. The Authority should have adequate resources to fulfil its mandate.
Amendment 338 #
2023/0131(COD)
Proposal for a regulation
Recital 78 b (new)
Recital 78 b (new)
Amendment 343 #
2023/0131(COD)
Proposal for a regulation
Recital 78 c (new)
Recital 78 c (new)
(78 c) The principle of open science is pivotal to ensure rapid progress in the field of scientific research for priority antimicrobials. Over the past 30 years, the lack of sharing of results, failed trials and ongoing research has created bottlenecks for scientific development and contributes to the current market failure for the placing on the market of new antimicrobials. It is therefore of the utmost importance to have a paradigm shift towards open science, particularly in the area of publicly-funded research, to reduce duplication of research, allow for peer-verification of results and building further evidence based on most recent findings, as to making research and development funding efforts more efficient. Indeed, it would also allow HERA to avoid funding research projects that would lead to similar mistakes being repeated over and over. Open science should serve as the basis for the coordinated research effort.
Amendment 344 #
2023/0131(COD)
Proposal for a regulation
Recital 78 d (new)
Recital 78 d (new)
(78 d) In order to ensure sufficient investment to address AMR, the European Antimicrobial Innovation Fund should be established. The Fund should generate and invest at least 1 billion EUR per year to address antimicrobial resistance. Since the manufacturing, use and disposal of antibiotics and other pharmaceutical substances in humans and animals and their prevalent occurance in the environment is the main cause of AMR and only a handful of developers are actively addressing this emergency, the collective effort, under the One Health Approach, of the industry and public authorities must be in place to solve the crisis. As per the polluter pays principle, companies selling medicines on the EU market, therefore contributing to the growing problem of environmental pollution including antimicrobial resistance, which do not wish to invest in R&D of antimicrobials should financially support, through annual penalty payments, the collective efforts to solving this public health emergency to the European Antimicrobial Innovation Fund. Other EU funding as well as voluntary contributions from philanthropic organisations, international schemes or Member States should represent complementary sources allocated to this Fund.
Amendment 351 #
2023/0131(COD)
Proposal for a regulation
Recital 79
Recital 79
Amendment 358 #
2023/0131(COD)
Proposal for a regulation
Recital 80
Recital 80
Amendment 365 #
2023/0131(COD)
Proposal for a regulation
Recital 81
Recital 81
Amendment 368 #
2023/0131(COD)
Proposal for a regulation
Recital 82
Recital 82
Amendment 372 #
2023/0131(COD)
Proposal for a regulation
Recital 83
Recital 83
Amendment 378 #
2023/0131(COD)
Proposal for a regulation
Recital 84
Recital 84
Amendment 381 #
2023/0131(COD)
Proposal for a regulation
Recital 86
Recital 86
(86) Medicinal products for rare diseases and for children should be subject to the same provisions as any other medicinal product concerning their quality, safety, and efficacy and environmental risk, for example for what concerns the marketing authorisation procedures, the pharmacovigilance and quality requirements. However, specific requirements also apply to them. Such requirements, which are currently defined in separate legislations, should be integrated in this Regulation in order to ensure clarity and coherency of all the measures applicable to these medicinal products.
Amendment 382 #
2023/0131(COD)
Proposal for a regulation
Recital 87
Recital 87
(87) Some orphan conditions occur so infrequently that the cost of developing and bringing to the market a medicinal product to diagnose, prevent or treat the condition cannot be recovered by the expected sales of the medicinal product. However, patients suffering from rare conditions should be entitled to the same quality of treatment as other patients; it is therefore necessary to stimulate the research, development and placing on the market of appropriate medications by the pharmaceutical industry.
Amendment 391 #
2023/0131(COD)
Proposal for a regulation
Recital 88
Recital 88
(88) Regulation (EC) No 141/2000 of the European Parliament and of the Council55 has proved to be successful in boosting developments of orphan medicinal products in the Union; for certain conditions; nevertheless, 95% of rare diseases are still without authorised treatment and the treatments available for the 5% are not necessarily transformative or curative1a, therefore an action at Union level remains preferable to uncoordinated measures by the Member States which may result in distortions of competition and barriers to intra-Union trade. _________________ 1a https://research-and- innovation.ec.europa.eu/system/files/2022 -02/ec_rtd_he-partnerships-rare- diseases.pdf 55 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
Amendment 392 #
2023/0131(COD)
Proposal for a regulation
Recital 90
Recital 90
(90) Objective criteria for the orphan designation based on the prevalence of the life-threatening or chronically debilitating condition for which diagnosis, prevention or treatment is sought and the existence of no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Union should be maintained; a prevalence of not more than five affected persons per 10 000 is generally regarded as the appropriate threshold. The orphan designation criterion on the basis of return on investment has been abolished, since it has never been used. nevertheless, products may still lose the orphan status in cases where the population criterion is no longer met or when sufficient profit was generated after five years on the market.
Amendment 393 #
2023/0131(COD)
Proposal for a regulation
Recital 90 a (new)
Recital 90 a (new)
(90 a) The aim of intellectual property and regulatory incentives is to benefit society and promote innovation in areas of public health and unmet medical needs, such as rare diseases. It is of utmost importance that such incentives are not misused or abused, nor pose threats to affordability and patient access to treatments. In particular, the practice of artificially subdividing diseases to create subgroups of patients in order to fall under the orphan medicine prevalence criterion should be prohibited.
Amendment 394 #
2023/0131(COD)
Proposal for a regulation
Recital 91
Recital 91
Amendment 396 #
2023/0131(COD)
Proposal for a regulation
Recital 92
Recital 92
Amendment 408 #
2023/0131(COD)
Proposal for a regulation
Recital 93
Recital 93
(93) If a satisfactory method of diagnosis, prevention or treatment of the condition in question has already been authorised in the Union, the orphan medicinal product will have to be of significant benefit to those affected by that condition. In this context, a medicinal product authorised in one Member State is generally deemed as being authorised in the Union. It is not necessary for it to have Union authorisation or to be authorised in all Member States to be considered as a satisfactory method. In addition, commonly used methods of diagnosis, prevention or treatment that are not subject to a marketing authorisation may be considered satisfactory if there is scientific evidence of their efficacy and safety. In certain cases, medicinal products prepared for an individual patient in a pharmacy according to a medical prescription, or according to the prescriptions of a pharmacopoeia and intended to be supplied directly to patients served by the pharmacy, mayshould also be considered as satisfactory treatment if they are well known and safe and this is a general practice for the relevant patient population in the Union.
Amendment 412 #
2023/0131(COD)
Proposal for a regulation
Recital 99
Recital 99
(99) A vast percentage of rare diseases remains without treatment with research and development clustered in the areas where profit is better assured. Therefore, there is a need to target those areas where research is mostly needed and where investments are most riskylacking.
Amendment 414 #
2023/0131(COD)
Proposal for a regulation
Recital 100
Recital 100
(100) Orphan medicinal products addressing a high unmet medical need prevent, diagnose or treat conditions where either no other method of prevention, diagnosis or treatment exists or, if such method already exists, they would bring exceptional therapeutic advancement. In both cases, the criterion of meaningfusubstantial reduction in disease morbidity or mortality for the relevant patient population should ensure that only most effective medicinal products are covered. The Agency should draw up scientific guidelines on the category of ‘orphan medicinal products addressing a high unmet medical need’.
Amendment 418 #
2023/0131(COD)
Proposal for a regulation
Recital 102
Recital 102
(102) In order to incentivise research and development of orphan medicinal products addressing high unmet needs, to ensure market predictability and to ensure a fair distribution of incentives, a modulation of market exclusivity has been introduced; orphan medicinal products addressing high unmet medical needs benefit from the longest market exclusivity, while market exclusivity for well-established use orphan medicinal products, requiring less investment, is the shortest. In order to ensure increased predictability for developers, the possibility to review the eligibility criteria for market exclusivity after six years after the marketing authorisation has been abolished.
Amendment 422 #
2023/0131(COD)
Proposal for a regulation
Recital 103
Recital 103
(103) In order to encourage faster and wider access also to orphan medicinal products, an additional period of one yearsix months of market exclusivity is granted to orphan medicinal products for a Union market launch, with the exception of well- established use medicinal products.
Amendment 427 #
2023/0131(COD)
Proposal for a regulation
Recital 104
Recital 104
Amendment 441 #
2023/0131(COD)
Proposal for a regulation
Recital 132
Recital 132
(132) The Union and Member States have developed a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing medicinal products. This process focuses specifically on the added value of a medicinal product in comparison with other new or existing health technologies However, this evaluation should not be conducted in the context of the marketing authorisation, for which it is agreed that the fundamental criteria should be retained. It is useful in this respect to allow for the possibility of gathering information on the methods used by the Member States to determine the therapeutic benefit obtained by each new medicinal product. To ensure that medicine developers generate the right type of data for regulators throughout the market access pathway, the marketing authorisation applicants should submit, unless where duly justified and ethical, data from active-control clinical trials. This is important to avoid the unnecessary repetition of clinical studies, and to uphold high scientific standards and ethical principles at the point of marketing authorisation.
Amendment 448 #
2023/0131(COD)
Proposal for a regulation
Recital 133
Recital 133
Amendment 456 #
2023/0131(COD)
Proposal for a regulation
Recital 134
Recital 134
Amendment 462 #
2023/0131(COD)
Proposal for a regulation
Recital 135
Recital 135
Amendment 481 #
2023/0131(COD)
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to communicate the necessary information to patients, consumers and healthcare professionals, including on estimated duration and available alternatives, and manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation and register such information in the European Shortages Monitoring Platform. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patientimporters, manufacturers, suppliers, patient and consumer organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 487 #
2023/0131(COD)
Proposal for a regulation
Recital 138 a (new)
Recital 138 a (new)
(138 a)To facilitate appropriate communication between patients and consumers, on the one hand, and competent authorities on the other, Member States should collect data on the impact of shortages of medicinal products on patients and consumers, and share relevant information through the MSSG, in order to inform approaches to management of shortages of medicinal products. Marketing authorisation holders should set up and maintain a minimum safety stock of critical medicinal products which shall be sufficient to cover two months demand of all Member States where the product has been placed on the market. Delegated acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. The setting up of safety stocks of critical medicinal products should not hamper the availability and affordability of these products or harm the environment by inappropriate disposals at both European and global level. Given the global nature of pharmaceutical supply chains, the safety stocks should be proportionate and take into account the potential impacts on shortages in other Member States and third countries. In order to avoid any interruption of access to critical medicinal products, national competent authorities may, in duly justified cases, grant an exemption from stockpiling obligations to the marketing authorisation holder, upon request, or adopt other complementary measures on the safety of stocks
Amendment 500 #
2023/0131(COD)
Proposal for a regulation
Recital 140
Recital 140
(140) It is recognised that improved access to information contributes to public awareness, gives the public the opportunity to express its observations and enables authorities to take due account of those observations. The general public should therefore have access to information in the Union Register of medicinal products, the Eudravigilance database and the manufacturing and wholesale distribution database, after the deletion of any commercially confidential information by the competent authority and have full access to the data on environmental risks. Regulation (EC) No 1049/2001 of the European Parliament and of the Council57 gives the fullest possible effect to the right of public access to documents and lays down the general principles and limits on such access. The Agency should therefore give the widest possible access to the documents while carefully balancing the right for information with existing data protection requirements. Certain public and private interests, such as personal data and commercially confidential information, should be protected by way of exception in accordance with Regulation (EC) No 1049/2001. _________________ 57 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
Amendment 501 #
2023/0131(COD)
Proposal for a regulation
Recital 141
Recital 141
(141) To ensure the enforcement of certain obligations relating to the marketing authorisation for medicinal products for human use granted in accordance with this Regulation, the Commission should be able to impose financial penalties. When assessing the responsibility for failures to comply with those obligations and imposing such penalties, it is important that means exist to address the fact that marketing authorisation holders could be part of a wider economic entity. Otherwise, there is a clear and identifiable risk that the responsibility for a failure to comply with those obligations could be evaded, which might have an impact on the ability to impose effective, proportional and dissuasive penalties. The penalties imposed should be effective, proportionate and dissuasive, having regard to the circumstances of the specific case. For the purposes of ensuring legal certainty in the conduct of the infringement procedure, it is necessary to set maximum amounts for penalties. Those maximum amounts should not be linked to the turnover of a particular medicinal producthe non-compliance of an entity with any requirements or obligations under this Regulation, including the supply of incorrect, incomplete or misleading information to competent authorities, should be subject to penalties of up to 20 000 000 EUR, or in the case of an undertaking, up to 5% of its total worldwide annual turnover for the preceding financial year, whichever is higher. In case of ongoing non- compliance, the competent baut the economic entity involvedhority should be able to fine the entity with fines for each day of delay, which shall be transparent and proportionate.
Amendment 504 #
2023/0131(COD)
Proposal for a regulation
Recital 143
Recital 143
(143) To ensure uniform conditions for the implementation of this Regulation in relation to marketing authorisations for medicinal products for human use, implementing powers should be conferred on the Commission. The implementing powers related to the granting of centralised marketing authorisations and for suspending, revoking or withdrawing those authorisations, for granting vouchers, establishing and modifying regulatory sandboxes and decisions on the regulatory status of medicinal products should be exercised in accordance with Regulation (EU) 182/2011.
Amendment 511 #
2023/0131(COD)
Proposal for a regulation
Recital 149
Recital 149
(149) It is therefore appropriate to envisage a centralised assessment of the ERA involving experts from the national competent authorities and the Environmental Risk Assessment working party.
Amendment 514 #
2023/0131(COD)
Proposal for a regulation
Recital 155
Recital 155
(155) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, the integrity of the person, the rights of the child, respect for private and family life, the protection of personal data and the freedom of art and science. Similarly, this Regulation respects the Aarhus Convention which protects every person’s right to live in a healthy environment.
Amendment 518 #
2023/0131(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use at Union level, establishes rules and procedures at Union and at Member State level relating to the security of supply of medicinal products and lays down the governance provisions of the European Medicines Agency (‘the Agency’) established by Regulation (EC) No 726/2004 which shall carry out the tasks relating to medicinal products for human use that are laid down in this Regulation, Regulation (EU) No 2019/6, Regulation No 2022/123, Regulation No 536/2014 and other relevant Union legal acts.
Amendment 535 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 8 – point a
Article 2 – paragraph 2 – point 8 – point a
(a) greater efficacy than an authorised medicinal orphan medicinal product in a substantial part of the target population, as assessed by effect on a clinically meaningful endpoint in adequate and well controlled clinical trial showing a comparative efficacy claim for two different medicinal product;
Amendment 536 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 8 – point b
Article 2 – paragraph 2 – point 8 – point b
(b) greater safety than an authorised medicinal product in a substantial part of the target population based on direct comparative trial;
Amendment 541 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 10
Article 2 – paragraph 2 – point 10
Amendment 562 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State does not meet the demand for that medicinal product in that Member State, whatever the cause.
Amendment 592 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
The documentation shall include a substantiated declaration to the effect that clinical trials carried out outside the Union meet the ethical requirements of Regulation (EU) No 536/2014. Those particulars and documentation shall take account of the unique, Union nature of the authorisation requested and, otherwise than in exceptional cases relating to the application of the law on trademarks pursuant to Regulation (EU) 2017/1001 of the European Parliament and of the Council66 , shall include the use of a single name for the medicinal product. The use of a single name does not exclude the use of additional qualifiers where necessary to identify different presentations of the medicinal product concerned. _________________ 66 Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ L 154, 16.6.2017, p. 1).
Amendment 593 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2 – point 1 (new)
Article 6 – paragraph 1 – subparagraph 2 – point 1 (new)
(1) Applications for market authorisation shall provide evidence from comparative studies with a standard-of- care active comparator, including, but not limited to, randomised controlled trials. In exceptional curcumstances, where such studies cannot be provided for scientifically substantiated reasons, the applicant shall submit such duly justified reasoning to the Agency as part of the application for marketing authorisation. The Agency shall set the scientific guidelines on criteria for proposing a comparator for a clinical trial, taking into account the results of the consultation of the Commission and the authorities or bodies involved in the mechanism of consultation referred to in Article 162 of this Regulation.
Amendment 594 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2 a (new)
Article 6 – paragraph 1 – subparagraph 2 a (new)
Applications for marketing authorisation shall include patient experience data (PROMs/PREMs) in the marketing application dossier. Where such data cannot be provided, the applicant should provide a justification to the Agency.
Amendment 598 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Unions with no authorised alternatives, particularly in the Union during a public health emergency or other major event, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 609 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 2
Article 6 – paragraph 5 – subparagraph 2
The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory New Approach Methodologies (NAMs), particularly non- animal testing methods are available. The Agency shall in its annual report highlight key observations and best practices in the replacement, reduction and refinement of animal testing submitted by applicants.
Amendment 615 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 7 – subparagraph 1
Article 6 – paragraph 7 – subparagraph 1
When an application is submitted for a marketing authorisation in respect of medicinal products for human use which are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovationunmet medical need, the applicant may request an accelerated assessment procedure. The same shall apply for products referred to in Article 60. The request shall be duly substantiated.
Amendment 624 #
2023/0131(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Without prejudice to Article 22 of [revised Directive 2001/83/EC], the marketing authorisation application of a medicinal product for human use containing or consisting of genetically modified organisms as defined in Article 2(2) of Directive 2001/18/EC shall be accompanied by an environmental risk assessment identifying and evaluating potential adverse effects of the genetically modified organisms on human health, animals and the environment.
Amendment 630 #
2023/0131(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) identification and characterisation of hazards for the environment, animals and for human and public health;
Amendment 633 #
2023/0131(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2
Article 9 – paragraph 1 – subparagraph 2
The Committee for Medicinal Products for Human Use shall establish an Environmental Risk Assessment Working Party and assess the environmental risk assessment.
Amendment 645 #
2023/0131(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point i
Article 12 – paragraph 4 – point i
(i) in case of medicinal products for which there is substantial, on duly justified ground submitted to the Agency, there is uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, a post- authorisation obligation to substantiate the clinical benefit;
Amendment 647 #
2023/0131(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point i a (new)
Article 12 – paragraph 4 – point i a (new)
(i a) justification in case marketing authorisation was granted where no comparative data with a standard-of-care active comparator were submitted;
Amendment 648 #
2023/0131(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point j a (new)
Article 12 – paragraph 4 – point j a (new)
(j a) where appropriate any justified reasoning for granting marketing authorisation pursuant to Article 18, 19 and 30 of this Regulation;
Amendment 649 #
2023/0131(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point m
Article 12 – paragraph 4 – point m
(m) where appropriate, to carry out medicinal product- specific validation studies to replace animal-based control methods with non- animal-based control methods.
Amendment 650 #
2023/0131(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point m a (new)
Article 12 – paragraph 4 – point m a (new)
(m a) for antimicrobials, the stewardship plan referred to in Article 17 and information materials referred to in Article 69 of [revised Directive 2001/83/EC] as well as any related obligations imposed on the marketing authorisation holder.
Amendment 657 #
2023/0131(COD)
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 1 (new)
Article 14 – paragraph 1 – subparagraph 1 (new)
Amendment 679 #
2023/0131(COD)
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 2
Article 16 – paragraph 3 – subparagraph 2 – indent 2
– a summary of environmental risk assessment studies and their results as submitted by the marketing authorisation holder and the assessment of the environmental risk assessment and the information referred to in Article 22(5) of [revised Directive 2001/83/EC] by the Agency.;
Amendment 680 #
2023/0131(COD)
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
– for antimicrobials, the stewardship plan referred to in Article 17 and information materials referred to in Article 69 of [revised Directive 2001/83/EC], as well as any related obligations imposed on the marketing authorisation holder.
Amendment 686 #
2023/0131(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Without prejudice to paragraph 2, a mMarketing authorisation for a medicinal product shall be valid for an unlimited periodfive years.
Amendment 690 #
2023/0131(COD)
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 1
Article 17 – paragraph 2 – subparagraph 1
By way of derogation from paragraph 1, the Commission may decide when granmarketing an authorisation, on the basis of a scientific opinion by the Agency concerning the safety of the medicinal product, to limit the validity of the marketing authorisation to five years for products referred to in Article 9 of [revised Directive 2001/83/EC] shall be valid for an unlimited period.
Amendment 692 #
2023/0131(COD)
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 2
Article 17 – paragraph 2 – subparagraph 2
Where the validity of the marketing authorisation is limited to five years, as laid down in paragraph 1, the marketing authorisation holder shall apply to the Agency for a renewal of the marketing authorisation at least nine months before the marketing authorisation ceases to be valid.
Amendment 694 #
2023/0131(COD)
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 3
Article 17 – paragraph 2 – subparagraph 3
Where a renewal application has been submitted in accordance with the secondfirst subparagraph, the marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 13.
Amendment 695 #
2023/0131(COD)
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 4
Article 17 – paragraph 2 – subparagraph 4
The marketing authorisation may be renewed on the basis of a re-evaluation by the Agency of the benefit-risk balance. Once renewed, the marketing authorisation shall be valid for an unlimited period unless the Agency decides, on justified grounds, to proceed with one additional five-year renewal.
Amendment 696 #
2023/0131(COD)
Proposal for a regulation
Article 17 – paragraph 2 a (new)
Article 17 – paragraph 2 a (new)
2 a. By way of derogation from paragraphs 1 and 2, marketing authorisation for a medicinal product shall be withdrawn if the review of the post-authorisation studies referred to in paragraph 1 of Article 20 result in a negative risk-benefit assessment.
Amendment 697 #
2023/0131(COD)
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. In exceptional circumstances where, in an application under Article 6 of [revised Directive 2001/83/EC] for a marketing authorisation of a medicinal product or a new therapeutic indication of an existing marketing authorisation under this Regulation, an applicant is unable to provide comprehensive data on the efficacy and safety, and, where missing, on the environmental risk of the medicinal product under normal conditions of use, the Commission may, by derogation to Article 6, grant an authorisation under Article 13, subject to specific conditions, where the following requirements are met:
Amendment 702 #
2023/0131(COD)
Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 2
Article 18 – paragraph 2 – subparagraph 2
This reassessment shall be conducted on the basis of an application by the marketing authorisation holder to maintain the authorised new therapeutic indication or, renew the marketing authorisation under exceptional circumstances or issue a negative marketing authorisation opinion and withdraw the product from the market.
Amendment 704 #
2023/0131(COD)
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2 a. Before granting an authorisation pursuant to paragraph 1, the Agency shall publish in the product’s assessment report a justification for granting marketing authorisation under this Article and explain why an authorisation pursuant to Article 19 is deemed unsuitable.
Amendment 711 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Conditional marketing authorisations or a new conditional therapeutic indication referred to in paragraph 1 may be granted only if the benefit-risk balance of the medicinal product is favourable and the applicant is likely to be ablecommits to provide comprehensive data within the agreed time-frame .
Amendment 720 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.
Amendment 723 #
2023/0131(COD)
4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the benefit- risk balance is favourable. Information on concrete commitments, timelines, status and, where applicable, justifications for any delays, for the product-specific obligations shall be made publicly available and easily accessible on EMA’s website.
Amendment 729 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 7 a (new)
Article 19 – paragraph 7 a (new)
Amendment 730 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 8 – point b
Article 19 – paragraph 8 – point b
(b) the procedures and requirements for granting a conditional marketing authorisation, for its renewal, and for adding a new conditional therapeutic indication to an existing marketing authorisation , and for product withdrawal.
Amendment 734 #
2023/0131(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point c a (new)
Article 20 – paragraph 1 – subparagraph 1 – point c a (new)
(c a) conducts a post-authorisation treatment optimisation study when the optimal usage of medicinal product was not previously established.
Amendment 738 #
2023/0131(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 3
Article 20 – paragraph 1 – subparagraph 3
Where the Agency considers that any of the post-authorisations studies referred to in points (a) to (ca) is necessary, it shall inform the marketing authorisation holder thereof in writing, stating the grounds for its assessment and shall include the objectives and timeframe for submission and conduct of the study.
Amendment 739 #
2023/0131(COD)
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Where the opinion of the Agency confirms the need for any of the post- authorisation studies referred to in paragraph 1, points (a) to (ca), to be carried out, the Commission shall vary the marketing authorisation, by means of implementing acts, adopted pursuant to Article 13 to include the obligation as a condition of the marketing authorisation unless the Commission returns the opinion to the Agency for further consideration. For obligations under paragraph 1, points (a) and (b), the marketing authorisation holder shall update the risk management system accordingly.
Amendment 747 #
2023/0131(COD)
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
(f a) commercial reasons.
Amendment 751 #
2023/0131(COD)
Proposal for a regulation
Article 24 – paragraph 3 a (new)
Article 24 – paragraph 3 a (new)
3 a. In the cases referred to in paragraph 1 point (f), the competent authorities shall forward the information to drinking water and wastewater operators.
Amendment 755 #
2023/0131(COD)
Proposal for a regulation
Article 24 – paragraph 4 a (new)
Article 24 – paragraph 4 a (new)
4 a. The national competent authority of the Member State may decide to extend obligations set in paragraph 4 to a specific non-critical medicinal product on a case by case basis.
Amendment 791 #
2023/0131(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point b
Article 31 – paragraph 1 – point b
(b) based on the scientific evidence available, the Agency issues an opinion concluding that the medicinal product could be effective in treating, preventing or diagnosing the disease or condition directly related to the public health emergency, and the known and potential benefits of the product outweigh the known and potential risks of the product, taking into consideration the threat posed by the public health emergency.
Amendment 797 #
2023/0131(COD)
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation. The scientific opinion and information on the application on the use of temporary emergency marketing authorisation shall be made publicly available by the Agency.
Amendment 802 #
2023/0131(COD)
Proposal for a regulation
Article 33 – paragraph 3
Article 33 – paragraph 3
3. Specific conditions mayshall be set to require the completion of ongoing studies or to conduct new studies to ensure the safe and effective use of the medicinal product or minimise its impact on the environment. A time limit for the submission of those studies shall be set.
Amendment 815 #
2023/0131(COD)
Proposal for a regulation
Article 36 – paragraph 1
Article 36 – paragraph 1
The marketing authorisation holder of an authorisation in accordance with Article 33 mayshall submit an application in accordance with Articles 5 and 6 in order to obtain an authorisation in accordance with Articles 13, 16 or 19 based on the pre-agreed timelines established with the Agency.
Amendment 820 #
2023/0131(COD)
Proposal for a regulation
Chapter III – title
Chapter III – title
III INCENTIVES FOR THE DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’deleted
Amendment 827 #
2023/0131(COD)
Proposal for a regulation
Article 40
Article 40
Amendment 901 #
2023/0131(COD)
Proposal for a regulation
Article 41
Article 41
Amendment 927 #
2023/0131(COD)
Proposal for a regulation
Article 42
Article 42
Amendment 941 #
2023/0131(COD)
Proposal for a regulation
Article 43
Article 43
Amendment 958 #
2023/0131(COD)
Proposal for a regulation
Article 45 – paragraph 4 – subparagraph 1
Article 45 – paragraph 4 – subparagraph 1
The Agency may at any time request the marketing authorisation holder to submit data demonstrating that the benefit-risk balance remains favourable. The marketing authorisation holder shall answer fully and promptlywithin the time limit set to any such request. The marketing authorisation holder shall also respond fully and within the time limit set to any such request of a competent authority regarding the implementation of any measures previously imposed, including risk minimisation measures.
Amendment 960 #
2023/0131(COD)
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 1
Article 48 – paragraph 1 – subparagraph 1
An entity not engaged in an economic activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive non- clinical or clinical evidence for a new therapeutic indication that is expected to fulfil an unmet medical need.
Amendment 969 #
2023/0131(COD)
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 2
Article 48 – paragraph 1 – subparagraph 2
The Agency may, at the request of a Member State, the Commission, or on its own initiative and on the basis of all available evidence make a scientific evaluation of the benefit-risk of the use of a medicinal product with a new therapeutic indication that concerns an unmet medical need.
Amendment 972 #
2023/0131(COD)
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 3
Article 48 – paragraph 1 – subparagraph 3
The opinion of the Agency shall be made publicly available and the competent authorities of the Member States and the marketing authorisation holder shall be informed.
Amendment 974 #
2023/0131(COD)
Proposal for a regulation
Article 48 – paragraph 3
Article 48 – paragraph 3
Amendment 976 #
2023/0131(COD)
Proposal for a regulation
Article 51 – paragraph 3 a (new)
Article 51 – paragraph 3 a (new)
3 a. Competent authorities and the Agency shall have procedures in place to ensure independence, impartiality, transparency and that personnel performing supervisory activities are free from any conflict of interest.
Amendment 978 #
2023/0131(COD)
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. In cooperation with the Agency, the Commission mayshall adopt detailed guidelines laying down the principles applicable to those international inspection programmes. The guidelines shall include rules on impartially, independence and conflict of interest of inspectors.
Amendment 981 #
2023/0131(COD)
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
Where the Agency concludes that a holder of a marketing authorisation granted in accordance with Article 19, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, or with post-authorisation studies laid down in Article 20, the Agency shall inform the Commission accordingly.
Amendment 987 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 2
Article 58 – paragraph 2
2. In the preparation of the scientific advice referred to in paragraph 1 and upon request by undertakings or, as relevant, not-for-profit entities that requested the scientific advice, the Agency mayshall promote an open discussion about latest scientific developments and the update of scientific guidelines, and where relevant, shall consult experts of the Member States with clinical trial or medical device expertise or the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745.
Amendment 989 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
3. In the preparation of the scientific advice referred to in paragraph 1 and in duly justified cases, the Agency may consult authorities established in other Union legal acts as relevant for the provision of the scientific advice in question or other public bodies established in the Union, as applicablein particular those listed in Article 162 of this Regulation.
Amendment 994 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 4
Article 58 – paragraph 4
4. The Agency shall include in the European public assessment report the key areas of thea detailed log of pre-submission activities, including scientific advice once the corresponding marketing authorisation decision has been taken in relation to the medicinal product, after deletion of any information of a commercially confidential nature.
Amendment 998 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 4 a (new)
Article 58 – paragraph 4 a (new)
4 a. The Agency shall make publicly available and update on a monthly basis the list of products undergoing scientific advise, including the information on the active substance, therapeutic indication, stage of development, type of applicant and date, as well as names and affiliations of staff, rapporteurs and experts involved in the scientific advise. A summary of such information, including statistics per type of developer, indication, affiliations of rapporteurs and experts, shall be published in the Agency’s annual report.
Amendment 1001 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 4 b (new)
Article 58 – paragraph 4 b (new)
4 b. The Agency staff and experts from national competent authorities providing the scientific advice shall not be involved in a subsequent evaluation of marketing authorisation application for the same products. In cases where such situation is unavoidable due to specific expertise, it shall be stated and duly justified in the products’ European Public Assessment Report.
Amendment 1028 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – point c
Article 60 – paragraph 1 – point c
(c) are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or antimicrobials with any of the characteristics mentioned in Article 40(3)provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level.
Amendment 1045 #
2023/0131(COD)
Proposal for a regulation
Article 61 – paragraph 2 – subparagraph 3
Article 61 – paragraph 2 – subparagraph 3
The Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, including substantiated opinions received from other advisory bodies, after deletion of all information of a commercially confidential nature.
Amendment 1046 #
2023/0131(COD)
Proposal for a regulation
Article 62 – paragraph 1 – subparagraph 1
Article 62 – paragraph 1 – subparagraph 1
In the case of duly substantiated disagreement with the Agency’s recommendation, raised by other advisory bodies, in accordance with Article 61(2), a Member State may request the Commission to decide whether the product is a product referred to in Article 61(1).
Amendment 1049 #
2023/0131(COD)
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. The Commission may ask the Agency and other advisory bodies for clarifications or refer the recommendation back to the Agency for further consideration where a Member State's substantiated request raises new questions of a scientific or technical nature or on its own initiative.
Amendment 1050 #
2023/0131(COD)
Proposal for a regulation
Article 62 – paragraph 3
Article 62 – paragraph 3
3. The decision of the Commission referred to in paragraph 1 shall be adopted by means of implementing acts, in accordance with the examination procedure referred to in Article 173(2), taking into account the scientific recommendation of the Agency and other advisory bodies.
Amendment 1053 #
2023/0131(COD)
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
Amendment 1060 #
2023/0131(COD)
Proposal for a regulation
Article 63 – paragraph 3
Article 63 – paragraph 3
3. The Commission shall adopt the necessary provisions for implementing this Article by means of implementingdelegated acts in accordance with the procedure laid down in Article 173(2)5 in order to further specify the requirements referred to in paragraph 1.
Amendment 1065 #
2023/0131(COD)
Proposal for a regulation
Article 64 – paragraph 2 – subparagraph 1 – point d
Article 64 – paragraph 2 – subparagraph 1 – point d
(d) justification that the criteria laid down in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) are fulfilled and a description of the stage of development, including the expected therapeutic indication.
Amendment 1070 #
2023/0131(COD)
Proposal for a regulation
Article 64 – paragraph 4 – subparagraph 1
Article 64 – paragraph 4 – subparagraph 1
The Agency shall adopt a decision granting or refusing the orphan designation based on the criteria referred to in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) within 90 days of the receipt of a valid application. The application is considered valid if it includes all the particulars and documentation referred to in paragraph 2.
Amendment 1074 #
2023/0131(COD)
Proposal for a regulation
Article 64 – paragraph 5
Article 64 – paragraph 5
5. Decisions of the Agency and a summary of consultation referred to in paragraph 4 on granting or refusing the orphan designation shall be made public after deletion of any information of a commercially confidential nature.
Amendment 1096 #
2023/0131(COD)
Proposal for a regulation
Article 67 – paragraph 3 – point c a (new)
Article 67 – paragraph 3 – point c a (new)
(c a) the stage of development;
Amendment 1103 #
2023/0131(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point a
Article 68 – paragraph 1 – point a
(a) the conduct of the various tests and trials necessary to demonstrate the quality, safety and, efficacy and environmental impact of the medicinal product, as referred to Article 138(1), second subparagraph, point (p);
Amendment 1106 #
2023/0131(COD)
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings and entities not engaged in economic activity provided for in framework programmes for research and technological development.
Amendment 1112 #
2023/0131(COD)
Proposal for a regulation
Article 69 – paragraph 2 – subparagraph 1
Article 69 – paragraph 2 – subparagraph 1
In addition, the applicant shall demonstrate that the medicinal product has been granted an orphan designation and that the criteria set out in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) are fulfilled for the therapeutic indication sought.
Amendment 1114 #
2023/0131(COD)
Proposal for a regulation
Article 69 – paragraph 3 – subparagraph 1
Article 69 – paragraph 3 – subparagraph 1
The Committee for Medicinal Products for Human Use shall assess whether the medicinal product fulfils the requirements set out in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2). In the situation referred in paragraph 2, subparagraph 2, that Committee shall also assess whether the medicinal product addresses a high unmet medical need as specified in Article 70(1).
Amendment 1116 #
2023/0131(COD)
Proposal for a regulation
Article 69 – paragraph 4
Article 69 – paragraph 4
4. The orphan marketing authorisation shall cover only those therapeutic indications, which fulfil the requirements set out in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) at the time when the orphan marketing authorisation is granted.
Amendment 1117 #
2023/0131(COD)
Proposal for a regulation
Article 69 – paragraph 6
Article 69 – paragraph 6
6. An applicant may submit an application for a separate marketing authorisation for other indications which do not fulfil the requirements set out in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2).
Amendment 1118 #
2023/0131(COD)
Proposal for a regulation
Article 69 – paragraph 6 a (new)
Article 69 – paragraph 6 a (new)
6 a. As laid down in Article 17, authorised products shall be subject to re- evaluation after 5 years. In cases of orphan medicinal products, the Committee for Medicinal Products for Human use shall in addition to the product’s safety, efficacy and environmental impact also review the criteria in set in Article 63 and assess the profitability of the product, taking into account all authorised indications, as laid down in Article 72.
Amendment 1134 #
2023/0131(COD)
Proposal for a regulation
Article 70 – paragraph 1 – point a
Article 70 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such condition or where, despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will bring exceptional therapeutic advancement; and
Amendment 1142 #
2023/0131(COD)
Proposal for a regulation
Article 70 – paragraph 1 – point b
Article 70 – paragraph 1 – point b
(b) the use of the orphan medicinal product results in a meaningfusubstantial reduction in disease morbidity or mortality for the relevant patient population.
Amendment 1166 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineseven years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1186 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) teneight years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;
Amendment 1197 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
Amendment 1214 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 4 – point c a (new)
Article 71 – paragraph 4 – point c a (new)
(c a) a compulsory license has been granted in accordance with [Regulation on compulsory licensing for crisis management and amending Regulation (EC) 816/2006].
Amendment 1219 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 7
Article 71 – paragraph 7
7. Where tThe Agency shall adopts scientific guidelines for the application of paragraphs 1 and 4, it shall consult the Commission.
Amendment 1221 #
2023/0131(COD)
Proposal for a regulation
Article 72 – title
Article 72 – title
Prolongation and reduction of market exclusivity period
Amendment 1223 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 1
Article 72 – paragraph 1
Amendment 1250 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 126 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.
Amendment 1273 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 4
Article 72 – paragraph 4
Amendment 1276 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 4 a (new)
Article 72 – paragraph 4 a (new)
4 a. The market exclusivity period shall be reduced to five years if, at the end of the fifth year, it is established, in respect of the medicinal product concerned, that the criteria laid down in Article 63 are no longer met or where it is shown on the basis of available evidence that the product is sufficiently profitable not to justify maintenance of market exclusivity. The sponsor shall provide the Agency with the information necessary to re- assess the criteria laid down in Article 63 and the externally audited product-related profit margins for all authorised indications at least nine months before end of the fifth year.
Amendment 1357 #
2023/0131(COD)
Proposal for a regulation
Article 91 – paragraph 3
Article 91 – paragraph 3
3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly, including regarding information on dosage accuracy.
Amendment 1371 #
2023/0131(COD)
Proposal for a regulation
Article 101 – paragraph 1 – subparagraph 3
Article 101 – paragraph 1 – subparagraph 3
The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation and medication errors, and on those occurring in the course of post- authorisation studies with the medicinal product or associated with occupational exposure.
Amendment 1376 #
2023/0131(COD)
Proposal for a regulation
Article 103 – paragraph 3 a (new)
Article 103 – paragraph 3 a (new)
The periodic safety update reports shall, in addition, be made publicly available in the web-portal referred to in Article 135(1)(n).
Amendment 1378 #
2023/0131(COD)
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point h
Article 104 – paragraph 1 – subparagraph 1 – point h
(h) the initiation of the procedure provided for in Article 41(2), and Articles 114, 115 and 116 of [revised Directive 2001/83/EC], the active substances or medicinal products concerned and the issue being addressed, any public hearings pursuant to that procedure and information on how to submit information and to participate in public hearings;
Amendment 1379 #
2023/0131(COD)
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point i
Article 104 – paragraph 1 – subparagraph 1 – point i
(i) conclusions of assessments, obligations for post-marketing studies, recommendations, opinions, approvals and decisions taken by the Agency and its Committees under this Regulation and [revised Directive 2001/83/EC], unless it is required that this information is made public by the Agency by other means;.
Amendment 1382 #
2023/0131(COD)
Proposal for a regulation
Article 104 – paragraph 2
Article 104 – paragraph 2
2. In the development and review of the web portal, the Agency shall consult relevant stakeholders, including patient and consumer groups, healthcare professionals, non-profit research entities and industry representatives.
Amendment 1383 #
2023/0131(COD)
Proposal for a regulation
Article 104 – paragraph 3 – subparagraph 1
Article 104 – paragraph 3 – subparagraph 1
The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a register of environmental risk assessment studies conducted for the purpose of supporting an environmental risk assessment for medicinal products authorised in the Union, unless such information is made public in the Union by different means.
Amendment 1385 #
2023/0131(COD)
Proposal for a regulation
Article 104 – paragraph 3 – subparagraph 2
Article 104 – paragraph 3 – subparagraph 2
Information in suchthe register shall be publicly available, unless restrictions are necessary to protect commercially confidential information . For the purpose of setting up such register, the Agency mayshall request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation].
Amendment 1386 #
2023/0131(COD)
Proposal for a regulation
Article 109 – paragraph 2
Article 109 – paragraph 2
2. The Agency and the European Monitoring Centre for Drugs and Drug AddictionDrugs Agency shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs.
Amendment 1396 #
Amendment 1397 #
Amendment 1449 #
2023/0131(COD)
Proposal for a regulation
Article 114
Article 114
Amendment 1456 #
2023/0131(COD)
Proposal for a regulation
Article 115
Article 115
Amendment 1486 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder and public authorities, where available, no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1504 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 1 a (new)
Article 117 – paragraph 1 a (new)
1 a. Shortage prevention plans shall be without delay submitted to the competent authority concerned defined in Article 116(1) and be made publicly available, upon request.
Amendment 1518 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned mayshall set a deadline for the submission of the information requested.
Amendment 1534 #
2023/0131(COD)
Proposal for a regulation
Article 120 – paragraph 2
Article 120 – paragraph 2
2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner.
Amendment 1535 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point -a (new)
Article 121 – paragraph 1 – point -a (new)
(-a) collect and assess the information on potential and actual shortages provided by marketing authorisation holders, importers, manufacturers and suppliers of medicinal products or active substances, wholesale distributors, healthcare professionals, patients and consumers and other persons or legal entities that are authorised or entitled to supply medicinal products to the public;
Amendment 1536 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish and regularly update information on actual shortages of medicinal products, including date when the shortage occurred, expected duration, the reasons as per Article 24(1) and mitigation measures, in cases in which that competent authority has assessed the shortage, on a publicly available website based on information reported by different stakeholders, on a publicly available website or database interoperable with the European Shortages Monitoring Platform (‘ESMP’), established by Regulation (EU) 2022/123, and ensure such information, including regarding available alternatives, has been proactively communicated to representatives of healthcare professionals and patients;
Amendment 1564 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 6
Article 121 – paragraph 6
6. The Member States may request that the MSSG provide further recommendations, referred to in Article 123(4). Where Member States that take an alternative course of action not in line with the recommendations of the MSSG at national level, they shall share the reasons for doing so with the MSSG in a timely manner.
Amendment 1588 #
2023/0131(COD)
Proposal for a regulation
Article 122 – paragraph 6
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP and include, among others, information on the duration, reasons and mitigation measures of medicine shortages. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without duplication of reporting.
Amendment 1599 #
2023/0131(COD)
Proposal for a regulation
Article 123 – paragraph 4
Article 123 – paragraph 4
4. The MSSG mayshall provide recommendations on measures to resolve or to mitigate the critical shortage, in accordance with the methods referred to in Article 122(4), point (d), an information regarding available alternatives, to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.
Amendment 1609 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 2 – subparagraph 2
Article 124 – paragraph 2 – subparagraph 2
For the purposes of this paragraph, the Agency mayshall set a deadline for the submission of the information requested.
Amendment 1618 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the listdatabases of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and the ESMP.
Amendment 1620 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 3 a (new)
Article 124 – paragraph 3 a (new)
3 a. The web portal referred to in paragraph 3 shall include at least the following information: (a) the name and common name of the medicinal product on critical shortage; (b) the therapeutic indications for the medicinal product on critical shortage; (c) the reason for the critical shortage of the medicinal product; (d) the start and expected duration of the critical shortage of the medicinal product; (e) the Member States affected by the critical shortage of the medicinal product; (f) mitigation measures taken to address the critical shortage of the medicinal product; (g) other relevant information for healthcare professionals and patients, including information on whether alternative medicinal products are available.
Amendment 1644 #
2023/0131(COD)
Proposal for a regulation
Article 128 – paragraph 2 a (new)
Article 128 – paragraph 2 a (new)
2 a. The marketing authorisation holder shall set up and maintain a minimum safety stock of critical medicinal products which shall be sufficient to cover two months demand of all Member States where the product has been placed on the market.
Amendment 1645 #
2023/0131(COD)
Proposal for a regulation
Article 128 – paragraph 2 b (new)
Article 128 – paragraph 2 b (new)
2 b. By derogation from paragraph 2a, national competent authorities may, in duly justified cases, grant an exemption from stockpiling obligations to the marketing authorisation holder, upon request, or adopt other complementary measures on the safety of stocks.
Amendment 1648 #
2023/0131(COD)
Proposal for a regulation
Article 129 – paragraph 1
Article 129 – paragraph 1
For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timelby the deadline set by the Agency mannerd provide updates whenever necessary.
Amendment 1658 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders in particular patients, consumers and healthcare professionals;
Amendment 1667 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 2
Article 130 – paragraph 1 – subparagraph 2
The Agency shall publish the information referred to in points (b), (c) and (d)aragraph 1 on a dedicated webpage on its web-portal.
Amendment 1668 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 2 – subparagraph 1 – point b
Article 130 – paragraph 2 – subparagraph 1 – point b
(b) the marketing authorisation holder of the medicinal product, including the shortage prevention and mitigation plan, referred to in Article 117 and 119(2);
Amendment 1677 #
2023/0131(COD)
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c) as well as representatives of patients, consumers and healthcare professionals. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).
Amendment 1699 #
2023/0131(COD)
Proposal for a regulation
Article 134 – paragraph 1 – point -a (new)
Article 134 – paragraph 1 – point -a (new)
(-a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating critical shortages of medicinal products;
Amendment 13 #
2023/0038M(NLE)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the elimination of tariffs on EU agri-food exports, including key products such as pigmeat (current tariff: 5 %) and wine and sparkling wine (current tariff: 5 %), thereby opening up new business opportunitiesCalls on the Committee on International Trade, as the committee responsible, to propose rejection of the Free Trade Agreement between the European Union and New Zealand;
Amendment 1 #
2022/2140(INI)
Draft opinion
Citation 7 a (new)
Citation 7 a (new)
— having regard to its Resolution of 29 November 2018 on the situation of women with disabilities (2018/2685(RSP))
Amendment 2 #
2022/2140(INI)
Draft opinion
Citation 7 b (new)
Citation 7 b (new)
— having regard to the EU Strategy for the Rights of Persons with Disabilities 2021-2030,
Amendment 3 #
2022/2140(INI)
Draft opinion
Recital -A (new)
Recital -A (new)
-A. whereas according to available data, women tend to travel with public transport and walk to a greater extent than men who are more likely to travel by car; whereas women tend to often take multiple, non-direct journeys in one day (trip-chaining), while men’s travel pattern is more linear; whereas women more often travel during off-peak hours while men are more likely to travel during peak hours;
Amendment 4 #
2022/2140(INI)
Draft opinion
Recital -A a (new)
Recital -A a (new)
-Aa. whereas although women are motivated to travel actively for health reasons, concerns about lack of time, travelling with family members and trip- chaining, as well as concerns about their personal safety and harassment are barriers preventing them from cycling and walking1a; _________________ 1a Sustrans, 2018. "Are We Nearly There Yet? Exploring Gender and Active Travel", https://www.sustrans.org.uk/media/2879/2 879.pdf
Amendment 5 #
2022/2140(INI)
Draft opinion
Recital -A b (new)
Recital -A b (new)
Amendment 6 #
2022/2140(INI)
Draft opinion
Recital -A c (new)
Recital -A c (new)
-Ac. whereas women face a greater risk of violence and harassment in public transit than men, which negatively affects women’s transport choices, employment, education and social opportunities;
Amendment 19 #
2022/2140(INI)
Draft opinion
Recital B
Recital B
B. whereas there is a lack of the reliable gender-disaggregated data needed to underpin policy initiatives toin order to overcome the gender gap in EU transportation and make the EU transport sector more inclusive ands well as to ensure its accessibility to all user groups;
Amendment 25 #
2022/2140(INI)
Draft opinion
Recital C
Recital C
C. whereas too little attention is still being paid to women’s needs in public transport, urban mobility or infrastructure planning, including security and safety issues;
Amendment 27 #
2022/2140(INI)
Draft opinion
Recital C a (new)
Recital C a (new)
Amendment 29 #
2022/2140(INI)
Draft opinion
Recital C b (new)
Recital C b (new)
Cb. whereas eradicating mobility poverty across the Union is an essential part of the EU Green Deal’s objective of ensuring a just transition where no one is left behind; whereas women are more likely to suffer from mobility poverty, in particular single mothers, who represent 85% of single parent families, women minority groups, women with low income, as well as single women, women with disabilities, or elderly women;
Amendment 34 #
2022/2140(INI)
Draft opinion
Recital D a (new)
Recital D a (new)
Amendment 39 #
2022/2140(INI)
Draft opinion
Recital D b (new)
Recital D b (new)
Amendment 43 #
2022/2140(INI)
Draft opinion
Recital D c (new)
Recital D c (new)
D c. whereas cars, seat belts, and car seats have been designed using mainly crash test dummies based on an average male human body; whereas a prototype for a crash test dummy based on the average female human body has been developed but is not yet legally required in crash tests standards;
Amendment 62 #
2022/2140(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Considers thatalls on the Commission, Member States and regional and local authorities shouldto improve data collect dataion and establish key indicators, such as gender-sensitive statistics, and age-gender differentiated mobility data on usage, requirements, attitudes, modes of transport and risk exposure, as well as age-and disability related data, in order to identify and overcome barriers for women in transport, to improve road safety and to contribute to public transport design and policy initiatives related to transport workers; recalls that EU policy-making in the field of transport should be based on reliable, accessible and detailed data, together with impact assessments, so as to help design better EU policiestherefore calls on the Commission to ensure that a gender impact assessment is carried out for all transport related proposals, so as to ensure that a gender-responsive approach is mainstreamed in all EU transport strategies, actions and legislation;
Amendment 66 #
2022/2140(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Welcomes the recently adopted General Product Safety Regulation (GPSR), which ensures that in order to consider a product safe, manufacturers will have to assess the impact of gender differences on health and safety; calls on the Commission and Member States to tackle the gender safety gap by ensuring that national standards bodies and standards developing organisations include a plan for gender responsive standards and standards development in their gender action plan, in line with the actions outlined in the Gender Responsive Standards Declaration;
Amendment 71 #
Amendment 72 #
2022/2140(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Underlines that measures enhancing the further modal shift to public transport and active mobility, including measures reducing the centrality of private cars, would not only contribute to achieving the goal of climate neutrality but also be an appropriate answer to women’s needs; highlights that prioritising women’s need in transport supports the green transition;
Amendment 73 #
2022/2140(INI)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
Amendment 75 #
2022/2140(INI)
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Recognizes that a well-designed public transport network should address accessibility, availability and affordability for women and it should take into account women’s needs in terms of mobility pattern, proximity to services as well as security and safety; points out that preventive measures such as bus stops located in places with high visibility, increased lighting, security cameras and buttons, available staff on-board and drop-offs at requested locations during the night can increase safety; underlines furthermore that better infrastructure design such as bus stations within short walking distance, more availability during off-peak hours, increased availability of service for women living in rural areas and stroller-friendly infrastructure can increase usability for women and encourage women to use public transport;
Amendment 76 #
2022/2140(INI)
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Encourages Member States to adopt measures to reduce motor vehicle traffic around schools and childcare facilities and develop safe routes to schools1a; _________________ 1a Reducing Child Deaths on European Rods, ETSC report; 2022, https://etsc.eu/reducing-child-deaths-on- european-roads-pin-flash-43/
Amendment 77 #
2022/2140(INI)
Draft opinion
Paragraph 1 f (new)
Paragraph 1 f (new)
Amendment 78 #
2022/2140(INI)
Draft opinion
Paragraph 1 g (new)
Paragraph 1 g (new)
1g. Points out that women with disabilities encounter specific barriers and discrimination in transportation and as transport workers, which often remain invisible and unaddressed; calls on Member States and the Commission to mainstream accessibility into all policies and legislation; encourages furthermore Member States to develop public transport policies that facilitate mobility for women with disabilities and promote training for public transport professionals in accessibility;
Amendment 79 #
2022/2140(INI)
Draft opinion
Paragraph 1 h (new)
Paragraph 1 h (new)
1h. Recalls that a wide range of EU funding instruments, are available for Member States to invest in women’s mobility needs and female employment in the transport sector, as well as to address mobility poverty, including the European Regional Development Fund (ERDF), the Recovery and Resilience Facility (RRF), European Social Fund+ (ESF+), the Social Climate Fund (SCF) and the Cohesion Fund; calls on the Commission and Member States to ensure that measures and investments supported by those funds respect the principle of gender equality and that particular attention is given to ensure that women benefit from the implementation of those funding instruments;
Amendment 80 #
2022/2140(INI)
Draft opinion
Paragraph 1 i (new)
Paragraph 1 i (new)
1i. Regrets that despite the fact that about one third of Recovery and Resilience Fund under the green transition pillar is allocated to sustainable mobility, not enough funding is dedicated to promote gender equality in the transport sector; calls on the Commission and Member States to propose and implement gender equality projects in the transport sector under the Recovery and Resilience Fund;
Amendment 81 #
2022/2140(INI)
Draft opinion
Paragraph 1 j (new)
Paragraph 1 j (new)
1j. Calls on the Commission to develop crash test dummy standards that include requirements for testing with dummies that are based on the average female body, including dummies representing a variety of aspects such as age, gender, size and stature for users both within and outside vehicles;
Amendment 82 #
Amendment 87 #
2022/2140(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to consider gender-related provisions in all relevant legislation, in order to ensure a saffair, safe and secure working environment for women in all transport modes, as well as any necessary preventive and dissuasive measures (e.g. safe and secure parking areas); calls, furthermore, on the Commission to promote measures for emergency situations, such as camera surveillance systems and emergency call buttons in places where they are needed, such as unattended charging stations, enabling an immediate connection to local emergency services, as recently envisaged in the proposal for a new Alternative Fuels Infrastructure Regulation3 ; _________________ 3 Proposal for a Regulation of the European Parliament and of the Council on the deployment of alternative fuels infrastructure, and repealing Directive 2014/94/EU of the European Parliament and of the Council (COM(2021)0559).
Amendment 97 #
2022/2140(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Council and all Member States to promote initiatives to prevent all kinds of discrimination, as well as to promote measures ensuring safe and secure workplaces, and training, and protocols with clear legal procedures aimed at preventing violence and harassment in all transport-related workplaces., while making sure that staff working in the transportation sector is trained to react in case of harassment, both in their place of work and among the transit users;
Amendment 106 #
2022/2140(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the Member States to raise awareness, including via information campaigns, on measures to prevent and fight harassment of women in public transport network and in the public sphere;
Amendment 108 #
2022/2140(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Calls on the Member States and the Commission to implement policies and legislation to counter the gender pay gap and improve working conditions for women in the transport sector, including measures or initiatives that may improve the work-life balance, which would benefit all workers; in this regard, calls on the Member States for a swift transposition of the Pay Transparency Directive and calls on the Commission and the Member States to better enforce the Work-Life Balance Directive;
Amendment 116 #
2022/2140(INI)
Draft opinion
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Calls on the Member States and on social partners to take initiatives, where necessary, to strengthen the social dialogue, ensure collective bargaining and collective agreements, and to promote gender parity in workers’ representative bodies as a basis for improving women’s working conditions in the transport sector;
Amendment 18 #
2022/2051(INL)
Draft opinion
Recital C
Recital C
C. whereas the Conference puts forward proposals and measures impacting agriculture and rural areas towards more climate and environmental sustainability as well as high animal welfare standards;
Amendment 24 #
2022/2051(INL)
Draft opinion
Recital C a (new)
Recital C a (new)
C a. Whereas the Conference brought forward proposals to improve the protection of animals, including through high and common animal welfare norms;
Amendment 51 #
2022/2051(INL)
Draft opinion
Paragraph 2 – indent 1 – paragraph 1 – point a
Paragraph 2 – indent 1 – paragraph 1 – point a
(a) to ensure long-term agricultural self- sufficiency, by promoting technical progress and ensuring the rational development of agricultural production and the sustainable utilisation of the factors of production;
Amendment 55 #
2022/2051(INL)
Draft opinion
Paragraph 2 – indent 1 – paragraph 1 – point a a (new)
Paragraph 2 – indent 1 – paragraph 1 – point a a (new)
(a a) to contribute to global food security within planetary boundaries;
Amendment 61 #
2022/2051(INL)
Draft opinion
Paragraph 2 – indent 1 – paragraph 1 – subparagraph 1 a (new)
Paragraph 2 – indent 1 – paragraph 1 – subparagraph 1 a (new)
Proposes that point (d) shall be amended as follows: (d) to assure the availability 'and quality' of supplies;
Amendment 83 #
2022/2051(INL)
Draft opinion
Paragraph 2 – indent 1 – paragraph 1 – point e a (new)
Paragraph 2 – indent 1 – paragraph 1 – point e a (new)
(e a) To ensure the protection of the environment and the climate;
Amendment 86 #
2022/2051(INL)
Draft opinion
Paragraph 2 – indent 1 – paragraph 1 – point e b (new)
Paragraph 2 – indent 1 – paragraph 1 – point e b (new)
(e b) To maintain the long-term fertility of soils;
Amendment 88 #
2022/2051(INL)
Draft opinion
Paragraph 2 – indent 1 – paragraph 1 – point e c (new)
Paragraph 2 – indent 1 – paragraph 1 – point e c (new)
(e c) To contribute to a high level of biodiversity;
Amendment 90 #
2022/2051(INL)
Draft opinion
Paragraph 2 – indent 1 – paragraph 1 – point e d (new)
Paragraph 2 – indent 1 – paragraph 1 – point e d (new)
(e d) To ensure high animal welfare standards;
Amendment 108 #
2022/2051(INL)
Draft opinion
Paragraph 2 – indent 1 – paragraph 2 a (new)
Paragraph 2 – indent 1 – paragraph 2 a (new)
Proposes that Article 13 be amended as follows: In formulating and implementing the Union's agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions, customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage', taking into consideration changing public sentiments and evolving scientific knowledge'.
Amendment 37 #
2022/2023(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas the current energy crisis is also impacting mobility in urban areas; whereas rising energy prices means that public transport operators face higher operational costs; whereas on the other hand it is essential to further decrease public transport ticket prices, without excluding free transport in certain cases, in order to foster an increased uptake thereof and avoid mobility poverty;
Amendment 49 #
2022/2023(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas a modal shift to more cycling and walking must be seen as a crucial tool to overcome the problems that are associated with urban areas, having a proven ability to improve air quality, reduce congestion, cut greenhouse gas emissions, improve individual health and make roads safer, where good walking and cycling infrastructure exists;
Amendment 55 #
2022/2023(INI)
Motion for a resolution
Recital E d (new)
Recital E d (new)
Amendment 56 #
2022/2023(INI)
Motion for a resolution
Recital F
Recital F
F. whereas every year around 22 700 people still lose their lives on the EU’s roads and around 120 000 are seriously injured; whereas 38 % of road fatalities in the EU occur in urban areas, and vulnerable road users such as pedestrians and cyclists account for 70 % of deaths; whereas progress in reducing these figures has stagnated in recent years and the EU’s target of halving the number of road deaths between 2010 and 2020 was not met;
Amendment 68 #
2022/2023(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas an increase in the number of lightweight powered vehicles and Suburban Utility Vehicles (SUVs) of increased mass and size gives rise to conflict in the sharing of limited road- space, and increased danger posed to vulnerable road users; recognises the need for speed limitations for vehicles and dedicated training for drivers in line with a Vizion Zero approach to ensure the safety of vulnerable road users, and notes that heavy vehicles cause accidents of greater severity and more fatalities;
Amendment 87 #
2022/2023(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Points out that in order to meet its ambitious economic, environmental, digital, health and societal objectives, urban mobility in the EU needs to be guided by smart, competitive, more sustainable and multimodal transport solutionssustainable, active and multimodal transport solutions that prioritise the public good; strongly believes that a modal shift to public transport, active mobility, and shared mobility solutions, such as public bicycles, must be the first priority in any urban mobility transport framework in order to ensure safe, affordable, accessible and sustainable mobility for all; stresses that such an approach is the most cost- effective approach for society given the massive negative externalities of the current transport system;
Amendment 135 #
2022/2023(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Highlights the success of measures to significantly lower ticket prices taken in different EU cities and Member States, either temporarily as a response to the energy crisis or permanently; points to the increase in demand for these mobility schemes which offer free or partially free public transport and suggests the Commission to elaborate a study on the different experiences and their impact on mobility patterns;
Amendment 170 #
2022/2023(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Notes that raised pedestrian and cycling crossings at crossroads improve safety by slowing down cars; highlights that this also improves accessibility for people with reduced mobility, by reducing the necessity to change levels using a stes or ramped surface when crossing carriageways at junctions; calls for targeted plans to make cycling more accessible to people with reduced mobility;
Amendment 192 #
2022/2023(INI)
Motion for a resolution
Paragraph 8 c (new)
Paragraph 8 c (new)
8c. Acknowledges the gender-cycling- gap, indicating that in many EU countries the share of female participation in cycling is considerably lower than that of men; calls for targeted plans to increase the female cycling uptake, given women currently experience a higher barrier of entry to cycling; notes the higher risk aversion of female cyclists1a and highlights that segregated cycling lanes and increased safety standards, including signalling, not only increase ridership overall but also support the closing of the gender-cycling-gap; calls for secure cycle parking, as well as minimum requirements of shower and hygiene facilities in offices and public buildings, ensuring that they fit particularly the needs of female cyclists; _________________ 1a https://www.sciencedirect.com/science/arti cle/pii/S0967070X20300809
Amendment 208 #
2022/2023(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Stresses the importance of traffic circulation plans, including low traffic neighbourhoods, as they offer significant potential to reduce emissions, increase safety and avoid congestion; suggest adopting modal priority policies based on increased efficiency, safety, and affordability and emphasises that vulnerable road users, particularly pedestrians and cyclists, have to be at the top of the hierarchy, followed by public transport; calls for the use of zoning that restrict direct routes for personal motorised vehicles, while granting direct access for active mobility like cycling, thus providing a comparative modal advantage; suggests a revaluation of priority traffic lights at crossroads, including the introduction of advanced stop lines, toucan crossings, right turn on red among other features that safely make the cycling journeys safer and smoother, such as bi-directionality for bicycles in most of the streets, while exploring also the possibility of rain sensor traffic lights giving quicker priority to bicycles on rainy days; notes that older traffic light systems do not detect the presence of cyclists and should be upgraded;
Amendment 211 #
2022/2023(INI)
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Stresses the importance of safe bicycle parking and storage facilities in proximity to start and end destinations; calls for the development and support of projects offering secure bicycle storage for citizens without access to private storage; recognises that the emergence of electric bicycles demands higher safety standards with regards to storage; notes the increased number of thefts of electric bikes;
Amendment 213 #
2022/2023(INI)
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
10c. Notes that speeding is a key factor in around 30 % of fatal road crashes and an aggravating factor in most crashes; considers that lower speed limits, such as 30km/h in residential areas, generate a positive synergy between economies in terms of energy savings, safety and sustainability, also in urban areas; recalls the “Vision Zero” targets and urges the Commission and the Member States to prioritise investing in speed enforcement; requests also the Commission to better integrate the EU road safety targets and actions into the guidelines on the sustainable urban mobility plans by monitoring and promoting best practices, including establishing an indicator on using EU funding for improve urban road safety effectively;
Amendment 220 #
2022/2023(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Welcomes the Commission’s proposal for a reinforced approach to TEN- T urban nodes as being necessary to address missing links and poor connections that remain a major challenge; highlights, in particular, the need to reinforce seamless connectivity between rural, peri-urban and urban areas, allowing effective and accessible commuting without the need of a private car, with an interoperable infrastructure backbone of sustainable modes of transport, such as rail, public transport and inland waterways, in combination with active mobility; considers in this regard that the EuroVelo network should be better integrated into the TEN-T in order so as not to obstruct the connectivity of the cycling network;
Amendment 235 #
2022/2023(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Welcomes the Commission for the Revision Proposal of the Energy Performance of Buildings Directive, which include minimum requirements for bicycle parking in all new and renovated residential and non-residential buildings in the EU; suggests however to rethink the approach of linking bicycle parking requirements with car parking space requirements and believes that Member States and the local level should update building codes where possible to set maximum car parking space requires, as opposed to minimum requirements in order to progressively reduce the number of car parking spaces in cities particularly where is an oversupply or sufficient number of car parking spaces, or the area is well-served by public transport and other sustainable transport mode infrastructure;
Amendment 241 #
2022/2023(INI)
Motion for a resolution
Paragraph 13 c (new)
Paragraph 13 c (new)
13c. Advocates for including minimum requirements for e-bike charging facilities in the sustainable urban mobility plans, as well as minimum number of parking spaces adequate for bicycles with larger dimensions, such as three-wheeled bikes for people with limited mobility and cargo bikes, both in public and private spaces;
Amendment 267 #
2022/2023(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Points out that commercially-used cargo bikes are in many instances more efficient and sustainable than light commercial vehicles in urban mobility settings; calls on the Commission to analyse data from cycle logistics hubs of companies using cargo bikes in their supply chain;
Amendment 166 #
2022/0216(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and the means of achieving that aim are appropriate and necessary. In that regard, when selecting SoHO donors, Member States should use individual risk-based questions.
Amendment 176 #
2022/0216(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, pProgrammes promoting the donation of SoHOs should be founded on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient. Donor recruitment campaigns should never refer to compensation to avoid risk of incentivising donations. Voluntary and unpaid SoHO donation is also a factor which can contribute to high safety standards for SoHOs and therefore to the protection of human health. It is also recognised, including by the Council of Europe Committee on Bioethics24, that while financial gain should be avoided, it may also be necessaryacceptableto ensure that donors are not financially disadvantaged by their donation. Thus, compensation to remove any such risk is acceptable but should never constitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate more frequently than is allowed, posing risks to their own health and to that of prospective recipients. Such compensation should, therefore, be based on quantifiable and transparent criteriaset by national authorities, at a level appropriate in their Member State to reach such objectivesthe principle of financial neutrality. Any compensation regime should not serve as an inducement to donate nor lead to inappropriate financially-driven competition, including cross-border competition, between SoHO establishments and entities over donor recruitment. _________________ 24 Council of Europe Committee on Bioethics (DH-BIO). Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors (March 2018). Available at https://rm.coe.int/guide-financial- gain/16807bfc9a.
Amendment 190 #
2022/0216(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Competent authorities should be designated by the Member States for all the areas that fall within the scope of this Regulation. While Member States are best placed to identify the competent authority or authorities for each area, for example by geography, topic or substance, they should also be required to designate a single national authority that ensures appropriately coordinated communication with other Member States’ competent authorities and with the Commission. The SoHO National Authority should be considered the same as the designated competent authority in Member States where only one competent authority is designated. The list of all SoHO competent national authorities should be made publicly available.
Amendment 209 #
2022/0216(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) Applicants requesting an authorisation of SoHO preparation should use the Euro GTP II methodologies or equivalent tools to assess the risk level of their SoHO preparation. Applicants should share the results of the risk assessments with competent authorities when requesting authorisation. With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. The most up-to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. In case of high risk, these should include a comparison with standard treatments, ideally in a study with subjects allocated to test and control groups in a randomised manner. The competent authority should approve the plans before they are implemented and should assess the outcome data as part of a SoHO preparation authorisation.
Amendment 232 #
2022/0216(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) The EDQM is a structural part of the Council of Europe working under the European Pharmacopoeia Partial Agreement. The text of the Convention on the elaboration of a European Pharmacopoeia (ETS No. 050), accepted by Council Decision 94/358/EC26, is considered to be the text of the European Pharmacopoeia Partial Agreement. Member States of the Council of Europe that have signed and ratified the European Pharmacopoeia Convention are the member States of the European Pharmacopoeia Partial Agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement, including among others: the European Pharmacopoeia Commission, the European Committee on Organ Transplantation (CD-P-TO), the European Committee on Blood Transfusion (CD-P- TS) and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The European Pharmacopoeia Convention has been signed and ratified by the European Union and all its Member States, all of whom are represented in their intergovernmental bodies. In this context, the work of the EDQM on developing and updating guidelines on safety and quality of blood, tissues and cells, should be considered an important contribution to the field of SoHOs in the Union and should be reflected in this Regulation. The guidelines address issues of quality and safety beyond the risks of communicable disease transmission, such as donor eligibility criteria for the prevention of the transmission of cancer and other non- communicable diseases and the assurance of safety and quality during collection, processing, storage and distribution. It should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this Regulation. In order to ensure impartiality and independence, and safeguard public interest, the Commission should establish a memorandum of understanding with the EDQM related to transparency of membership and outputs and conflict of interest rules for experts and stakeholders involved in drafting EDQM guidelines. _________________ 26 Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).
Amendment 240 #
2022/0216(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) It is necessary to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to help European citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. To ensure long-term sustainability, the campaigns should primarily focus on increasing the donor base for low-frequency donations. As there is a need to ensure the availability of SoHOs for medical treatments, Member States should support the establishment of public donation facilities and promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing the collection capacity and self- sufficiency in the Union. Member States are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 259 #
2022/0216(COD)
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37 a) As recommended by the World Health Organisation (WHO), Member States should additionally support optimal clinical use of SoHOs, particularly where there are alternatives which can reduce the demand for SoHOs. In such fashion, Member States should ensure efficient implementation of the Patient Blood Management (PBM), which improves patients’ safety by minimising the risks associated with transfusion and improve patient outcomes, while at the same time ensuring sufficiency of blood supplies and reducing financial pressure on health system.
Amendment 263 #
2022/0216(COD)
Proposal for a regulation
Recital 37 b (new)
Recital 37 b (new)
(37 b) In order to ensure self-sufficiency and sustainability of supply of SoHOs, Member States should establish national SoHO emergency plans setting out measures when the supply situation for critical SoHOs presents or is likely to present a serious risk to human health. Such plans shall include measures, including optimisation of use, that impact demand of critical SoHOs, targets to ensure self-sufficiency of supply of critical SoHOs, donor recruitment and retainment strategy and ways of cooperation between competent authorities, experts and relevant stakeholders. National emergency plans should be further supplemented by the EU Strategy for critical SoHO supply sufficiency, primarily focusing on supply monitoring, reporting obligations and sharing of best practices within the EU.
Amendment 269 #
2022/0216(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to promote a coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission should participate in its activities and chair it. The SCB should contribute to a coordinating the application of this Regulation throughout the Union, including by helping Member States to conduct SoHO supervisory activities. The SCB should be composed of persons designated by the Member States based on their role and expertise in their competent authorities, and should also involve experts that are not working for competent authorities, for specific tasks where access to necessary in-depth technical expertise in the field of SoHOs is required. In the latter case, appropriate consideration should be given to the possibility of involving European expert bodies such as the ECDC and the EDQM and existing professional, scientific and donor and patient representative groups at Union level in the field of SoHOs. The SCB should adhere to high degree of transparency of its outputs and all it members, observers and experts should act independently, in the public interest and be free from any external influence that might affect the impartiality of their professional conduct.
Amendment 280 #
2022/0216(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) In order to limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (the ‘EU SoHO Platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. The EU SoHO Platform should also serve as a reliable source of information for the general public regarding the work of the SoHO Coordination Board, national competent authorities and other expert bodies, including the EDQM, and SoHO entities and establishments.
Amendment 290 #
2022/0216(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection laid down in Article 5 of Regulation (EU) 2016/679. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform should be limited to the extent necessary to carry out supervisory activities provided for in this Regulation.
Amendment 291 #
2022/0216(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the integrity of the person, the protection of and the prohibition of making the human body and its parts as such a source of financial gain the protection of natural persons with regard to the processing of their personal data, the freedom of art and science and to conduct business, non-discrimination, the right to health protection and access to health care, and the rights of the child. To achieve these aims, all supervisory and SoHO activities should always be carried out in a manner that fully respects those rights and principles. The right for dignity and integrity of donors, recipients and of offspring born from medically assisted reproduction should always be taken into account, amongst others, by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material, that donor eligibility criteria are based on scientific evidence, that the use of SoHOs in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices, that activities are conducted in a transparent manner that prioritises the safety of donors and recipients, and that allocation and equitable access to SoHOs are defined in a transparent manner, on the basis of an objective evaluation of medical needs. This Regulation should therefore be applied accordingly.
Amendment 296 #
2022/0216(COD)
Proposal for a regulation
Recital 44 a (new)
Recital 44 a (new)
(44 a) Due to the high sensitivity of donor anonymity and taking into account the rights of offspring born from medically assisted reproduction with third party donation, SoHO entities should ensure donors of reproductive cells are duly informed about the possibility of ID release and the implication hereof, pursuant to provisions laid down in national legislation;
Amendment 299 #
2022/0216(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) SoHOs, by definition, relate to natural persons, and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this Regulation, especially provisions relating to vigilance and communication between competent authorities. This Regulation should provide a legal basis under Article 6 and, where relevant, fulfil the conditions under Article 9(2), point (i), of Regulation (EU) 2016/679 for processing of such personal data. With respect to personal data processed by the Commission, this Regulation should provide a legal basis under Article 5 and, where relevant, fulfil the conditions under Article 10(2), point (i), of Regulation (EU) 2018/1725. Data on safety and efficacy of new SoHO preparations in recipients should also be shared, with appropriate protective measures, to allow aggregation at Union level for more robust evidence gathering on the clinical efficacy of SoHO preparations. For all data processing, such processing should be necessary and appropriate with a view to ensuring compliance with this Regulation in order to protect human health. Data on donors, recipients and offspring should hence be limited to the minimum necessary and pseudonymised. dDonors, recipients and offspring should be informed of the processing of their personal data in line with the requirements of Regulations (EU) 2016/679 and (EU) 2018/1725, and in particular as provided for under this Regulation, including the possibility of exceptional cases where circumstances require such processing.
Amendment 306 #
2022/0216(COD)
Proposal for a regulation
Recital 47 a (new)
Recital 47 a (new)
(47 a) In order to successfully implement this Regulation and ensure high quality and safety standards of SoHOs in the long-term, Member States should enhance education and provide appropriate training for medical personnel regarding SoHO collection, processing, storage, application, transfusion and procurement.
Amendment 332 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
4 a. This Regulations further establishes provisions on: (a) national emergency plans and the EU Strategy for critical SoHO supply sufficiency; (b) SoHo Coordination Board; (c) EU SoHO Platform.
Amendment 344 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘SoHO donor’ means any person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs, whether that donation is successful or living SoHO donor or a deceased SoHO donotr;
Amendment 347 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8 a) ‘living SoHO donor’ means a living person who has presented themselves to a SoHO entity, or been presented by a person granting consent on their behalf, in accordance with national legislation, with a view to making a donation of SoHOs, whether that donation is successful or not, for the purpose of application to a person other than themselves, and other than situations of within couple use as defined in point (63);
Amendment 351 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)
Article 3 – paragraph 1 – point 8 b (new)
(8 b) ‘deceased SoHO donor’ means a person who has been referred to a SoHO entity and for whom consent or authorisation, or absence of expressed refusal to donation is in place, in accordance with national legislation;
Amendment 354 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Article 3 – paragraph 1 – point 9
(9) ‘SoHO recipient’ means the person to whom SoHOs are applied or such an application is envisaged;
Amendment 360 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 11
Article 3 – paragraph 1 – point 11
(11) ‘offspring from medically assisted reproduction’ means fetuses and children that are born following medically assisted reproduction;
Amendment 425 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 47 – introductory part
Article 3 – paragraph 1 – point 47 – introductory part
(47) ‘traceability’ means the ability to locate and identify SoHOs during any step from collection through processing and storage to distribuhuman application or disposal, including the ability to:
Amendment 426 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 51
Article 3 – paragraph 1 – point 51
(51) ‘imputability’ means the likelihood that a serious adverse occurrence, in a SoHO donor, is related to the donation process or, in a recipient or an offspring born from medically assisted reproduction , to the application of the SoHOs;
Amendment 435 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 62 a (new)
Article 3 – paragraph 1 – point 62 a (new)
(62 a) ‘ID release’ means disclosure of personal identifying information about reproductive cells donor to donor- conceived offspring;
Amendment 437 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 63
Article 3 – paragraph 1 – point 63
(63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction from two persons with an intimate physical relationship (‘partners’) , where one person supplies their own oocytes and the other person supplies their own sperm;
Amendment 439 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘compensation’ means making good of anyquantifiable losses associated with donation; such compensation shall respect the principle of financial neutrality and not be intended as an incentive to donate;
Amendment 451 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64 a (new)
Article 3 – paragraph 1 – point 64 a (new)
(64 a) 'financial neutrality' means that no financial gain or loss will be incurred by compensated donors as a result of the donation;
Amendment 485 #
2022/0216(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Each Member State shall designate a single SoHO National Authority, in conformity with Member States’ constitutional requirements, responsible for coordinating exchanges with the Commission and with other Member States’ SoHO National Authorities. The Commission shall make publicly available the list of SoHO National Authorities on the EU SoHO Platform.
Amendment 488 #
2022/0216(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Competent authorities shall ensure that their personnel have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. All relevant personnel shall make an annual declaration of their interests, which shall be published on the authorities’ web-portal.
Amendment 503 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 2
Article 14 – paragraph 2 – subparagraph 2
The competent authorities may also indicate that they consider there is a need that the SCBSCB shall consults, in accordance with Article 68(1), point (b), with the equivalent advisory bodies established in other relevant Union legislation referred to in Article 2(3).
Amendment 506 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
Amendment 507 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1
Article 14 – paragraph 4 – subparagraph 1
The Commission may, upon a duly substantiated request of a Member State following the consultation referred to in paragraphs 1 and 2, or on its own initiative after a consultation with the SCB and relevant advisory bodies established under Union legislation referred to in Article 2(3), by means of implementing acts, determine the regulatory status of a substance, product or activity under this Regulation, in case questions arise in that respect, notably when these questions cannot be resolved at the Member State level, or in discussions between the SCB and the advisory bodies established in other relevant Union legislation, in accordance with Article 68(1), point (b).
Amendment 516 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 1
Article 14 – paragraph 7 – subparagraph 1
The Commission may, by means of implementingdelegated acts, lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant Union legislation referred to in Article 2(3).
Amendment 517 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 2
Article 14 – paragraph 7 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred toprocedure laid down in Article 79(2)7.
Amendment 518 #
2022/0216(COD)
Proposal for a regulation
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
(a) have, or have access to, a sufficient number of personnel so that SoHO supervisory activities can be performed efficiently and effectively; the declarations shall be made publicly available on the authorities’ web-portal;
Amendment 547 #
2022/0216(COD)
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 1 – point a
Article 27 – paragraph 3 – subparagraph 1 – point a
(a) does not comply with the conditions of its authorisation or the provisions of this Regulation; and
Amendment 548 #
2022/0216(COD)
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 1 – point a a (new)
Article 27 – paragraph 3 – subparagraph 1 – point a a (new)
(a a) does not follow up on corrective or preventive action following an inspection by national authorities pursuant to Article 29(14); and
Amendment 554 #
2022/0216(COD)
Proposal for a regulation
Article 28 – paragraph 5 – point b
Article 28 – paragraph 5 – point b
(b) that this non-compliance, or suspected non-compliance, implies a risk to the safety of SoHO donors, recipients or offspring from medically assisted reproduction.
Amendment 566 #
2022/0216(COD)
Proposal for a regulation
Article 32 – paragraph 1 a (new)
Article 32 – paragraph 1 a (new)
1 a. All inspectors shall act in an impartial manner and be independent of any direct or indirect conflicts of interest. Inspectors shall declare such impartiality in writing; such declarations shall be made available on the authorities’ web- portal.
Amendment 569 #
2022/0216(COD)
Proposal for a regulation
Article 32 – paragraph 3 – point a
Article 32 – paragraph 3 – point a
(a) the inspection techniques and procedures to be followed, including practical exercises and conflict of interest rules;
Amendment 588 #
2022/0216(COD)
Proposal for a regulation
Article 44 – paragraph 4
Article 44 – paragraph 4
4. SoHO entities shall submit to the EU SoHO Platform an annual summary of the data collected pursuant to this Article. In cases where national or international registries collect activity data meeting the criteria defined in the SoHO platform and such registries have been verified by competent authorities as having in place data quality management procedures that ensure accuracy and completeness of data, SoHO entities may delegate the submission of the activity data referred to in this Article to such registries. National competent authorities shall ensure all data from national registries are submitted to the EU SoHO Platform in accordance with Article 18(4). The Commission shall aggregate the annual summaries of the SoHO entities, prepare and publish an Annual SoHO Activity Report.
Amendment 589 #
2022/0216(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point c
Article 45 – paragraph 2 – point c
(c) does not directly reveal the identity of the donor;
Amendment 594 #
2022/0216(COD)
Proposal for a regulation
Article 47 – paragraph 3 a (new)
Article 47 – paragraph 3 a (new)
3 a. Where SAO notification concerns public health matters, competent authorities shall communicate essential information to the general public and the SCB without delay.
Amendment 601 #
2022/0216(COD)
Proposal for a regulation
Article 51 – paragraph 2 – point b
Article 51 – paragraph 2 – point b
(b) investigation of suspected adverse occurrences in SoHO donors and recipients, recipients and, where relevant, offspring from medically assisted reproduction;
Amendment 602 #
2022/0216(COD)
Proposal for a regulation
Article 51 – paragraph 3
Article 51 – paragraph 3
3. By derogation from paragraph 2, in the case of SoHO entities that are authorised as SoHO establishments in accordance with Article 25(3), the physician shall be responsible for those tasks that are relevant to the SoHO activities performed by the SoHO entities and that have a direct influence on the health of SoHO donors and recipients, recipients, and, where relevant, offspring from medically assisted reproduction.
Amendment 606 #
2022/0216(COD)
Proposal for a regulation
Article 52 – paragraph 2 a (new)
Article 52 – paragraph 2 a (new)
2 a. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation.
Amendment 629 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. SoHO entities that collect SoHOs from donors that are subjected to a surgical procedure in order to donate, that are treated with hormones to facilitate donation, or that donate SoHOs that can be donated on a frequent and repeated basis, shall register such donors and the results of their donor health evaluations in a cross-entity registry that allows interconnection with other such registries, as referred to in paragraph 1, point (j). SoHO entities that manage such registries shall ensure interconnectivity between them.
Amendment 635 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for losses related to their participation in donations through fixed rate allowances. In such case, Member States shall establish the conditions for such allowances in national legislation, including the setting of an upper limit and transparent criteria based on quantifiable elements that ensures that allowances are financially neutral and consistent with the standards laid down in this Article. They may delegate the setting of conditions for such allowances to independent bodies that are established in accordance with national legislation.
Amendment 646 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 2 a (new)
Article 54 – paragraph 2 a (new)
2 a. Any compensation regime shall not lead to inappropriate financially- driven competition, including cross- border competition, between SoHO establishments and entities over donor recruitment.
Amendment 649 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
3. SoHO entities may compensate or reimburse donors as provided for by their competent authorities pursuant to paragraph 2. Any compensation or reimbursement must never serve as an inducement to donate.
Amendment 652 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 3 a (new)
Article 54 – paragraph 3 a (new)
3 a. Member States shall submit to the Commission and the SCB national provisions setting up the rules for compensation based on financial neutrality and consistent with standards set in this Article.
Amendment 656 #
2022/0216(COD)
Proposal for a regulation
Article 55 – title
Article 55 – title
55 Standards concerning information to be provided prior to consent or authorisation to donate SoHOs
Amendment 660 #
2022/0216(COD)
Proposal for a regulation
Article 56 – paragraph 1 – subparagraph 1
Article 56 – paragraph 1 – subparagraph 1
When the Commission deems it necessary to provide binding rules on the implementation of a particular standard or element of a standard referred to in Articles 53, 54 or 55, in order to ensure convergent and high levels of donor safety, the Commission may adopt implementingdelegated acts describing particular procedures to be followed and applied to meet such standard, or element thereof.
Amendment 661 #
2022/0216(COD)
Proposal for a regulation
Article 56 – paragraph 1 – subparagraph 2
Article 56 – paragraph 1 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 79(2)7.
Amendment 662 #
2022/0216(COD)
Proposal for a regulation
Article 56 – paragraph 3
Article 56 – paragraph 3
3. In order to apply the standards concerning donor protection or elements thereof, referred to in Articles 53, 54 and 55, SoHO entities shall follow the procedures laid down in any delegated and implementing act adopted in accordance with paragraphs 1 and 2 of this Article.
Amendment 677 #
2022/0216(COD)
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
SoHO entities shall protect the health of SoHO recipients and offspring from medically assisted reproduction from risks posed by SoHO preparations and their application. They shall do so by identifying, minimising or eliminating those risks.
Amendment 683 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 1
Article 58 – paragraph 1
1. SoHO entities shall, based on latest technical guidelines from the EDQM and the ECDC, establish procedures with measures, and, where necessary, combinations of measures, that ensure high levels of safety and quality and demonstrate benefits for SoHO recipients and offspring from medically assisted reproduction that outweigh any risks. They shall, in particular, achieve a high level of assurance that pathogens, toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction.
Amendment 694 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – point b
Article 58 – paragraph 2 – point b
(b) testing of donors for communicable diseases using certified and validated testing methods or other methods deemed adequate by EDQM and ECDC guidelines;
Amendment 697 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – point c
Article 58 – paragraph 2 – point c
(c) when feasible and deemed appropriate by the relevant technical guidelines, using processing technologies that reduce or eliminate any potential communicable pathogens.
Amendment 734 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 14 – subparagraph 2 – point a a (new)
Article 58 – paragraph 14 – subparagraph 2 – point a a (new)
(a a) donor anonymity and the possibility of ID release and the implication hereof for medically assisted reproduction with third party donation of reproductive cells, pursuant to provisions laid down in national legislation;
Amendment 746 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 1 a (new)
Article 62 – paragraph 1 a (new)
1 a. The Commission and the SCB shall provide guidance and support to the Member States when establishing national emergency plans and promote best-practice sharing within the Union.
Amendment 748 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. Member States shall make all reasonable efforts, in line with voluntary unpaid principle established in this Regulation, to promote public participation in SoHO donation activities, in particular for critical SoHOs, with a view to ensuring a resilient supply and responsive increases in donation rates when risks of shortage are detected. In so doing, they shall encourage the collection of SoHO with a strong public and non- profit sector involvement.
Amendment 766 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 3 – point a a (new)
Article 62 – paragraph 3 – point a a (new)
(a a) evidence-based measures that impact demand of critical SoHOs;
Amendment 767 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 3 – point a b (new)
Article 62 – paragraph 3 – point a b (new)
(a b) quantitative targets to ensure self- sufficiency of supply of critical SoHOs;
Amendment 768 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 3 – point a c (new)
Article 62 – paragraph 3 – point a c (new)
(a c) strategy on optimisation of use of critical SoHOs;
Amendment 769 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 3 – point a d (new)
Article 62 – paragraph 3 – point a d (new)
(a d) critical SoHO donor recruitment and retainment strategy, including communication campaigns and education programmes;
Amendment 770 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 3 – point c a (new)
Article 62 – paragraph 3 – point c a (new)
(c a) stakeholder engagement;
Amendment 774 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 3 a (new)
Article 62 – paragraph 3 a (new)
3 a. Member States shall submit their emergency plans to the Commission and the SCB within 2 years after entry into force of this Regulation.
Amendment 775 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 6
Article 62 – paragraph 6
6. Member States shall review regularly their national SoHO emergency plans to take into account changes in the organisation of competent authorities and experience gained from implementing the plans and simulation exercises. Member States shall inform without delay the Commission and the SCB of any substantial revision of the national plans.
Amendment 778 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 7 – subparagraph 1 – introductory part
Article 62 – paragraph 7 – subparagraph 1 – introductory part
The Commission may adopt implementingdelegated acts describing:
Amendment 779 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 7 – subparagraph 1 – point b
Article 62 – paragraph 7 – subparagraph 1 – point b
(b) the role of stakeholders and the supportive role of the ECDC and the EDQM in the establishment and operation of national SoHO emergency plans.
Amendment 780 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 7 – subparagraph 2
Article 62 – paragraph 7 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 79(2)7.
Amendment 783 #
2022/0216(COD)
Proposal for a regulation
Article 62 a (new)
Article 62 a (new)
Amendment 789 #
2022/0216(COD)
Proposal for a regulation
Article 63 – paragraph 3
Article 63 – paragraph 3
3. The SoHO National Authorities mshall without undue delay submit to the EU SoHO Platform the SoHO supply alert received in cases where the supply interruption might affect other Member States or where such interruption might be addressed through cooperation between Member States pursuant to Article 62(3), point (d).
Amendment 795 #
2022/0216(COD)
Proposal for a regulation
Article 65 – paragraph 1
Article 65 – paragraph 1
Member States may take additional measures to the ones set out in their national SoHO emergency plans to ensure critical SoHOs supply in case of shortages on their territory, on a case-by-case basis. Member States taking such measures shall inform the other Member States, the SCB and the Commission without undue delay and give reasons for the measures taken.
Amendment 808 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 2 a (new)
Article 67 – paragraph 2 a (new)
2 a. Permanent and alternate members of the SCB shall act independently, in the public interest and free from any external influence. SCB permanent and alternate members shall have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. Permanent and alternate members of the SCB shall make an annual declaration of their interests, which shall be available in the EU SoHO Platform.
Amendment 810 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 3
Article 67 – paragraph 3
3. Member States shall submit the names and affiliation of their nominated members to the Commission, who shall publishmake the membership list publicly available in the EU SoHO Platform.
Amendment 811 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 3 a (new)
Article 67 – paragraph 3 a (new)
3 a. The Commission shall make publicly available SCB agendas, minutes and guidance documents on the EU SoHO Platform.
Amendment 813 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 6 – point j
Article 67 – paragraph 6 – point j
(j) the rules for declarations regarding conflict of interests of SCB members, alternates, observers and invited experts;
Amendment 815 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 7 – subparagraph 1
Article 67 – paragraph 7 – subparagraph 1
The Commission shall, by means of implementingdelegated acts, adopt the necessary measures for the establishment, management and functioning of the SCB.
Amendment 816 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 7 – subparagraph 2
Article 67 – paragraph 7 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 79(2)7.
Amendment 824 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point f a (new)
Article 68 – paragraph 1 – point f a (new)
(f a) ensuring coordination regarding supply continuity and sufficiency of critical SoHOs;
Amendment 831 #
2022/0216(COD)
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
The Commission shall establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM. In order to ensure impartiality and independence and safeguard public interest, the Commission shall establish a memorandum of understanding with the EDQM related to high standards of transparency of membership and outputs and conflict of interest rules for experts and stakeholders involved in drafting of EDQM guidelines. The Commission shall make publicly available in the EU SoHO Platform a list of all members, experts and stakeholders involved in EDQM committees and their conflict of interest declarations.
Amendment 841 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1
Article 73 – paragraph 1
1. The Commission shall establish, manage and maintain the EU SoHO Platform to facilitate effective and efficient exchange of information concerning SoHO activities and supply of critical SoHOs in the Union, as provided for in this Regulation.
Amendment 857 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 3 – subparagraph 1
Article 74 – paragraph 3 – subparagraph 1
The Commission shall adopt implementingdelegated acts laying down technical specifications for the EU SoHO Platform, including its functions, the roles and responsibilities of each of the parties listed in paragraph 1, the retention periods for personal data and the technical and organisational measures to ensure the safety and security of personal data processed.
Amendment 858 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 3 – subparagraph 2
Article 74 – paragraph 3 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 79(2)7.
Amendment 859 #
2022/0216(COD)
Proposal for a regulation
Article 75 – paragraph 1 – introductory part
Article 75 – paragraph 1 – introductory part
1. Unless otherwise provided for in this Regulation or in national legislation on confidentiality, and without prejudice to Regulation (EC) No 1049/2001 of the European Parliament and of the Council33, each party involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: _________________ 33 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
Amendment 860 #
2022/0216(COD)
Proposal for a regulation
Article 75 – paragraph 1 – point a
Article 75 – paragraph 1 – point a
(a) natural persons with regard to the processing of personal data in accordance with Article 76;
Amendment 861 #
2022/0216(COD)
Proposal for a regulation
Article 75 – paragraph 3
Article 75 – paragraph 3
3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and competent authorities with regard to the exchange of information and the dissemination of alerts, nor the obligations of persons to provide information under national criminal law or other applicable law, including on access to information.
Amendment 862 #
2022/0216(COD)
Proposal for a regulation
Article 75 – paragraph 5 – introductory part
Article 75 – paragraph 5 – introductory part
5. Competent authorities mayshall publish or make otherwise available to the public the outcome of SoHO supervisory activities regarding individual SoHO entities provided that the following conditions are met:
Amendment 863 #
2022/0216(COD)
Proposal for a regulation
Article 75 – paragraph 6 – point b
Article 75 – paragraph 6 – point b
(b) the information or data made available to the public does not unnecessaridisproportionately undermine the protection of commercial interests of a SoHO entity or any other natural or legal person;
Amendment 864 #
2022/0216(COD)
Proposal for a regulation
Article 76 – paragraph 3
Article 76 – paragraph 3
3. Personal data, including data concerning health, required for the application of Articles 35, 36, 41 and 47, Article 53(1), points (f) and (g), Article 53(3), and Article 58(11), (13) and (14), shall only be processed for the purpose of ensuring safety and quality of SoHOs and protecting the concerned SoHO donors, SoHO recipients and offspring from medically assisted reproduction. Those data shall be directly related to the performance of the supervisory activities and SoHO activities concerned and be limited to the extent necessary and proportionate for that purpose. The Commission shall adopt implementing acts laying down categories of personal data necessary to fulfilling the above listed obligations. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Amendment 865 #
2022/0216(COD)
Proposal for a regulation
Article 76 – paragraph 3 a (new)
Article 76 – paragraph 3 a (new)
3 a. Any re-use of personal data of SoHO donors, recipients and offspring born from medically assisted reproduction shall be provided in an anonymised format. Where, in duly justified cases, the purpose of the data processing cannot be achieved with anonymised data, pseudonymised data format may be used.
Amendment 866 #
2022/0216(COD)
Proposal for a regulation
Article 76 – paragraph 6
Article 76 – paragraph 6
6. In relation to their responsibilities to process personal data to comply with the obligations of this Regulation, the SoHO entities and competent authorities of the Member States shall be regarded as controllers as defined in Article 4, point (7), of Regulation (EU) 2016/679 and they are bound by the rules of that Regulation. The same provisions shall apply to any third party contracted by a SoHO entity for the processing of personal data, who shall be considered a processor as defined in Article 4, point (8) of the GDPR.
Amendment 867 #
2022/0216(COD)
Proposal for a regulation
Article 77 – paragraph 2
Article 77 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 14(7), 28(10), 42(3), 53(6), 56(1), 58(15), 62(7), 62a(4), 67(7), 69(6), 73(4), 74(3) and 76(8) shall be conferred on the Commission for an indeterminate period of time from … [OP please insert the date = date of entry into force of this Regulation].
Amendment 869 #
2022/0216(COD)
Proposal for a regulation
Article 77 – paragraph 3
Article 77 – paragraph 3
3. The delegation of power referred to in Articles 14(7), 28(10), 42(3), 53(6), 56(1), 58(15), 62(7), 62a(4), 67(7), 69(6), 73(4), 74(3)and 76(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 870 #
2022/0216(COD)
Proposal for a regulation
Article 80 – paragraph 1
Article 80 – paragraph 1
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by … [OP please insert the date = 32 years after the date of entry into force of this Regulation], notify the Commission and the SCB of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them. The Commissions shall make those provisions on penalties and their use publicly available on the EU SoHO Platform.
Amendment 871 #
2022/0216(COD)
Proposal for a regulation
Article 84 – paragraph 1
Article 84 – paragraph 1
Without prejudice to the dates of application referred to in Article 87 and the transitional provisions provided for in this Chapter, the Commission is empowered to adopt the delegated acts referred to in Articles 42(3), 67(7) and 73(4) and the implementing acts referred to in Articles 26(4), 43(6), 44(3), 46(3), 67(7) and 74(3) as from … [OP please insert the date = one day after the date of entry into force of this Regulation]. Such acts shall apply from the date of application in accordance with Article 87(1), second subparagraph, without prejudice to any transitional rules provided for in this Chapter.
Amendment 167 #
2022/0140(COD)
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16, 114 and 11468 thereof,
Amendment 186 #
2022/0140(COD)
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3 a) Given the extreme sensitivity of information regarding person’s physical and mental health, this Regulation seeks to provide sufficient safeguards on both EU and national level to ensure a high degree of data privacy, security, confidentiality and ethical use. Such safeguards are necessary to promote trust in safe handling of natural person’s health data for primary and secondary use. To achieve these objectives, pursuant to Article 9(4) of Regulation (EU) 2016/679, Member States may impose additional restrictions to the rights and obligations laid down in Chapters II and IV of this Regulation.
Amendment 187 #
2022/0140(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The processing of personal electronic health data is subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council43and, for Union institutions and bodies, Regulation (EU) 2018/1725 of the European Parliament and of the Council44and Regulation (EU)2022/868 of the European Parliament and Council44a. References to the provisions of Regulation (EU) 2016/679 should be understood also as references to the corresponding provisions of Regulation (EU) 2018/1725 for Union institutions and bodies, where relevant. _________________ 43 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). 44 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 44a Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act) (OJ L 152,3.6.2022, p.1)
Amendment 197 #
2022/0140(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5 a) Improving digital health literacy for both natural persons and their healthcare professionals is key in order to achieve trust, safety and appropriate use of health data and hence achieving a successful implementation of this Regulation. Improving digital health literacy is fundamental in order to empower natural persons to have true control over their health data and actively manage their health and care, and understand the implications of disclosing such data for both primary and secondary use. Particular attention should be given to vulnerable populations, including migrants, the elderly and persons with disabilities. Healthcare professionals and IT operators should have sufficient training in working with new digital infrastructures to ensure cybersecurity and ethical management of health data.
Amendment 205 #
2022/0140(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically containsist of an electronic collection of a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed in both an electronic or analogue format, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in a cross-border context, Union action is needed in order to ensure individuals have improved access to their own personal electronic health data and are empowered to share it.
Amendment 210 #
2022/0140(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The right of access to data by a natural person, established by Article 15 of Regulation (EU) 2016/679, should be further developed in the health sector. Under Regulation (EU) 2016/679, controllers do not have to provide access immediately. While patient portals, mobile applications and other personal health data access services exist in many places, including national solutions in some Member States, the right of access to health data is still commonly implemented in many places through the provision of the requested health data in paper format or as scanned documents, which is time- consuming. This may severely impair timely access to health data by natural persons, and may have a negative impact on natural persons who need such access immediately due to urgent circumstances pertaining to their health condition.
Amendment 216 #
2022/0140(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional datavalidated by a registered healthcare professional of relevant specialisation responsible for the natural person’s treatment. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural persons should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on a case by case basis, if necessary involving health professionals responsible for the natural person’s treatment.
Amendment 224 #
2022/0140(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Natural persons should be able to exercise control over the transmission of personal electronic health data to other healthcare providers and be informed of the patient safety risks associated with limiting access to health data. Healthcare providers and other organisations providing EHRs should facilitate the exercise of this right. Stakeholders such as healthcare providers, digital health service providers, manufacturers of EHR systems or medical devices should not limit or block the exercise of the right of portability because of the use of proprietary standards or other measures taken to limit the portability. For these reasons, the framework laid down by this Regulation builds on the right to data portability established in Regulation (EU) 2016/679 by ensuring that natural persons as data subjects can transmit their electronic health data, including inferred data, irrespective of the legal basis for processing the electronic health data. This right should apply to electronic health data processed by public or private controllers, irrespective of the legal basis for processing the data under in accordance with the Regulation (EU) 2016/679. This right should apply to all electronic health data. For this purpose, providers of electronic health records shall keep a record of who has accessed which data in the last 24 months.
Amendment 228 #
2022/0140(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Natural persons may not want to allow access to some parts of their personal electronic health data while enabling access to other parts. Such selective sharing, or they may want to wholly refuse access to their personal electronic health data by electronic health data access services and health professional access services. Such selective and patient-centric control of personal electronic health data should be supported. However, such restrictions may have life threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. According to Regulation (EU) 2016/679, vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law, together with patient- centric guidance to natural persons in relation to the use of electronic health records and primary use of their personal electronic health data. Guidance should be tailored to the patient’s level of digital health literacy, with specific care for vulnerable groups, such as migrants, the elderly, and persons with disabilities. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider cannot take the data into account when providing health services.
Amendment 236 #
2022/0140(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) In the context of the EHDS, natural persons should be able to exercise their rights as they are enshrined inwithout prejudice to Regulation (EU) 2016/679. The supervisory authorities established pursuant to Article 51 of Regulation (EU) 2016/679 should remain competent, in particular to monitor the processing of personal electronic health data and to address any complaints lodged by the natural persons. In order to carry out their tasks in the health sector and uphold the natural persons’ rights, digital health authorities should cooperate with the supervisory authorities under Regulation (EU) 2016/679.
Amendment 240 #
2022/0140(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and avoiding duplications and errors. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format via commonly accepted open standards and open data formats, which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as health professional portals, to use personal electronic health data for the exercise of their duties. Moreover, t on a need to know basis in regards to the person under their treatment, irrespective of the Member State of affiliation and treatment. Moreover, the Commission and the Member States should agree on time- based targets to implement improved health data interoperability across the Union. The access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format.
Amendment 243 #
2022/0140(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, hospital discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded. The Commission should be empowered to extend the list of priority categories, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general.
Amendment 250 #
2022/0140(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, a as well as to give them better control over accessing and sharing their personal electronic health data. To this end, Member States should retain the right to require user consent, or at least provide the possibility for natural persons, to refuse the registration of their electronic health file by all or selected healthcare professionals in an EHR system. Such mechanisms areferred to in the Policy Programme “Path to the Digital Decade” key trust safeguards in the system that secure greater decentralization and user- centricity over their data. In order to make electronic health data accesible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format based on commonly accepted open standards and open data formats, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider or a pharmacy by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and portability of electronic health data. _________________ 45 Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (OJ L 39, 11.2.2019, p. 18). 46 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 258 #
2022/0140(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) While EHR systems are widely spread, the level of digitalisation of health data varies in Member States depending on data categories and on the coverage of healthcare providerfessionals that register health data in electronic format. In order to support the implementation of data subjects’ rights of access to and exchange of electronic health data, Union action is needed to avoid further fragmentation. In order to contribute to a high quality and continuity of healthcare, certain categories of health data should be registered in electronic format systematically and according to specific data quality requirements. The European electronic health record exchange format should form the basis for specifications related to the registration and exchange of electronic health data. The Commission should be empowered to adopt implementingdelegated acts for determining additional aspects related to the registration of electronic health data, such as categories of healthcare providerfessionals that are to register health data electronically, categories of data to be registered electronically, or data quality requirements.
Amendment 260 #
2022/0140(COD)
Proposal for a regulation
Recital 21
Recital 21
Amendment 266 #
2022/0140(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Regulation (EU) No 910/2014 of the European Parliament and of the Council47lays down the conditions under which Members States perform identification of natural persons in cross- border situations using identification means issued by another Member State, establishing rules for the mutual recognition of such electronic identification means. The EHDS requires a secure access to electronic health data, including in cross-border scenarios where the health professional and the natural person are from different Member States, to avoid cases of unauthorised access. At the same time, the existence of different means of electronic identification should not be a barrier for exercising the rights of natural persons and health professionals.Digital Health Authorities, including at regional and local level, should also support digital health literacy and public awareness, while ensuring that the implementation of this Regulation contributes to reducing inequalities and does not discriminate against vulnerable populations. The rollout of interoperable, cross-border identification and authentication mechanisms for natural persons and health professionals across the EHDS requires strengthening cooperation at Union level in the European Health Data Space Board (‘EHDS Board’).As the rights of the natural persons in relation to the access and transmission of personal electronic health data should be implemented uniformly across the Union, a strong governance and coordination is necessary at both Union and Member State level. Member States should establish relevant digital health authorities for the planning and implementation of standards for electronic health data access, transmission and enforcement of rights of natural persons and health professionals. In addition, governance elements are needed in Member States to facilitate the participation of national actors in the cooperation at Union level, channelling expertise and advising the design of solutions necessary to achieve the goals of the EHDS. Digital health authorities exist in most of the Member States and they deal with EHRs, interoperability, security or standardisation. Digital health authorities should be established in all Member States, as separate organisations or as part of the currently existing authorities. The EHDS Board, digital health authorities and health data access bodies should establish transparent methods for stakeholder engagement, particularly with representatives of patients, consumers and healthcare professionals.The EHDS Board, digital health authorities and health data access bodies should adhere to a high degree of transparency of its outputs and all its members, observers and experts should act independently, in the public interest and be free from any external influence that might affect the impartiality of their professional conduct. _________________ 47 Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73).
Amendment 282 #
2022/0140(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) In the context of MyHealth@EU, a central platformopen source platform licensed under an open source licence should provide a common infrastructure for the Member States to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities among the Member States, as joint controllers, and prescribe its own obligations, as processor. Furthermore, to ensure the technological sovereignty of the Union and ensure the highest security standards, the platform should be licenced under an open source licence in line with the Open Source Strategy 2020-2023 (C(2020) 7149 final) and Commission decision 2021/C 495 I/01. This would increase transparency and ensure consumer trust and confidence in the platform.
Amendment 296 #
2022/0140(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory ex-ante self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self- certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48. _________________ 48 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).
Amendment 308 #
2022/0140(COD)
Proposal for a regulation
Recital 35
Recital 35
Amendment 314 #
2022/0140(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) The distribution of information on certified EHR systems and labelled wellness applications is necessary to enable procurers and users of such products to find interoperable solutions for their specific needs. A database of interoperable EHR systems and wellness applications, which are not falling within the scope of Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final] should therefore be established at Union level, similar to the European database on medical devices (Eudamed) established by Regulation (EU) 2017/745. The objectives of the EU database of interoperable EHR systems and wellness applications should be to enhance overall transparency, to avoid multiple reporting requirements and to streamline and facilitate the flow of information. For medical devices and AI systems, the registration should be maintained under the existing databases established respectively under Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final], but the compliance with interoperability requirements should be indicated when claimed by manufacturers, to provide information to procurers.
Amendment 318 #
2022/0140(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) For the secondary use of the clinicalpersonal electronic health data for research, innovation and development, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered byrequirements provided for in Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. T. For processing of personal electronic health data for secondary use, a legal basis set out in points (a), (c), (e) of Article 6(1) combined with a further legal basis set out in Article 9(2) of Regulation (EU) 2016/679 is required. The most relevant processing grounds listed in Article 9(2) of Regulation (EU) 2016/679 in this context concern the consent of the data subject (point (a)), substantial public interest (point (g)), the provision of health or social care (point (h)), public interest in the area of public health (point (i)), and research (point (j)). Hence, this Regulation provides the specific legal basis for such processing in accordance with Articles 9(2) (a), (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 in combination with Articles 9(2) (a), (g), (h), (i) and (j) of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense ofIf the user relies upon a legal basis offered by Article 6(1), point (c) of Regulation (EU) 2016/679 for disclosing the data by the data e), it shoulder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regul make reference to another EU or nation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (runn law, different from this Regulation, mandating the usecure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation),r to process personal health data for the compliance of its tasks. For processing of electronic health data held by the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides the safeguards. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the dataer pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. The data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data, in accordance with Regulation (EU) 2016/679 and this Regulation.
Amendment 328 #
2022/0140(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In the context of the EHDS, the electronic health data already exists and is being collected by healthcare providers, professional associations, public institutions, regulators, researchers, insurers etc. in the course of their activities. Some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records, aggregated genetic data, claims data, etc.), others are collected also for other purposes such as research, statistics, patient safety, regulatory activities or policy making (e.g. disease registries, policy making registries, registries concerning the side effects of medicinal products or medical devices, etc.). For instance, European databases that facilitate data (re)use are available in some areas, such as cancer (European Cancer Information System) or rare diseases (European Platform on Rare Disease Registration, ERN registries, etc.). These data should also be made available for secondary use. However, much of the existing health-related data is not made available for purposes other than that for which they were collected. This limits the ability of researchers, innovators, policy- makers, regulators and doctorhealthcare professionals to use those data for different purposes, including research, innovationdevelopment, policy-making, regulatory purposes, and patient safety or personalised medicine. In order to fully unleash the benefits of the secondary use of electronic health data, all data holders, except for micro enterprises and small enterprises in the context of healthcare professionals’ practices and pharmacies, should contribute to this effort in making different categories of electronic health data they are holding available for secondary use. Likewise, beneficiaries should respect the principle of open science and provide open access to research or processing results.
Amendment 341 #
2022/0140(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) The categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of data users, while remaining limited to data related to health or known to influence health. It can also include relevant data from the health system (electronic health records, claims data, disease registries, genomic data etc.), as well as non- personal data with an impact on health (for example consumption of different substances, homelessness, health insurance, minimum income, professional status, behaviour, including environmental factors (for example, pollution, radiation, use of certain chemical substances). They can also include person- generated data, such as data from medical devices, wellness applications or other wearables and digital health applications. The data user who benefits from access to datasets provided under this Regulation pursuant to a data permit could enrich the data with various corrections, annotations and other improvements, for instance by supplementing missing or incomplete data, thus improving the accuracy, completeness or quality of data in the dataset. To support the improvement of the original database and further use of the enriched dataset, the dataset with such improvements and a description of the changes should be made available free of charge to the original data holder. The data holder should make available the new dataset, unless it provides a justified notification against it to the health data access body, for instance in cases of low quality of the enrichment. Secondary use of non-personal electronic data should also be ensured. In particular, pathogen genomic data hold significant value for human health, as proven during the COVID-19 pandemic. Timely access to and sharing of such data has proven to be essential for the rapid development of detection tools, medical countermeasures and responses to public health threats. The greatest benefit from pathogen genomics effort will be achieved when public health and research processes share datasets and work mutually to inform and improve each other.
Amendment 347 #
2022/0140(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) The data holders can be public, non for profit or private health or care providers, public, non for profit and private organisations, associations or other entities, public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. As such, they are controllers in the meaning of Regulation (EU) 2016/679 in the health or care sector since they process personal electronic health data. In order to avoid a disproportionate burden on small entities, micro-enterprises and small enterprises in healthcare professional setting are excluded from the obligation to make their data available for secondary use in the framework of EHDS. The public or private entities often receive public funding, from national or Union funds to collect and process electronic health data for research, statistics (official or not) or other similar purposes, including in area where the collection of such data is fragmented of difficult, such as rare diseases, cancer etc. Such data, collected and processed by data holders with the support of Union or national public funding,It should be noted that making anonymised data available for secondary use will require additional resources for healthcare systems, including often understaffed public hospitals. This additional burden for public entities should be made available by data holdersdressed and minimised to thealth data access bodies, in order to maximise the impact of the public investment and support r greatest possible extent during the implementation phase of the EHDS and, where necesesarch, innovation, patient safety or policy making benefitting the society. In some Member States, private entities, including private healthcare providers and professional associaty, allocation of additional resources should be ensured. To safeguard the long-term sustainability and durability of European healthcare systems and the provision of public goods across the Unions, play a pivotal role in the health sector. The health data held by such providers should also be made available for secondary use. At the same time, data benefiting from specific legal protection such as intellectual property from medical device companies or pharmaceutical companies often enjoy copyright protection or similar types of protection. However, public authorities and regulators should have access to such data, for instance in the event of pandemics, to verify defective devices and protect human health. In times of severe public health concerns (for example, PIP breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. The COVID-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. Such data should be made available for public and regulatory activities, supporting public bodies to carry out their legal mandate, while complying with, where relevant and possible, the protection enjoyed by commercial data. Specific rules in relation to the secondary use of health data should be provided. Data altruism activities may be carried out by different entities, in the context of Regulation […] [Data Governance Act COM/2020/767 final] and taking into account the specificities of the health sectorsufficient and adequate return to public investment in the field of health must be ensured via adequate societal access to access products and services developed via the EHDS framework on a just, fair, transparent, and redistributive basis that can contribute to greater social justice. The public good nature of European healthcare systems and equality of access need to be safeguarded by demonstrating the public value stemming from private investments via the EHDS framework and by enhancing the role of public institutions in the field. Likewise, when electronic health data is made available for secondary use, research and processing results should be made publicly available based on the principles of open science so that society at large can access relevant results in the field, enhance transparency, and further contribute to new innovative products and services that can benefit society at large. Data generated by individuals and shared through the EHDS must be considered a public investment. Uses that are detrimental to individuals, in particular to vulnerable groups, should be prohibited and subject to aggravated penalties. In light of possible future risks, a moratorium on certain uses and users should be made possible.
Amendment 352 #
2022/0140(COD)
Proposal for a regulation
Recital 40 a (new)
Recital 40 a (new)
Amendment 354 #
2022/0140(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The secondary use of health data under EHDS should enable the public, private, not for profit entities, as well as individual researchers to have access to health data for research, innovation and development, policy making, educational activities, patient safety, or regulatory activities or personalised medicine, in line with the purposes set out in this Regulation. Access to data for secondary use should contribute to the general interest of the societybe based on the data subject's explicit consent in the case of personal data and contribute to the general interest of the society as well as to high quality, accessibility and affordability of medical products. Without the data subject’s consent, any health data may only be made accessible after it has been fully and irreversibly anonymised by the data holder, where necessary by aggregating the health data of several persons. Real world evidence collected through the EHDS should in no way substitute data generated in clinical trials, which remain a gold standard in terms of data generation for regulatory purposes. Activities for which access in the context of this Regulation is lawful may include using the electronic health data for tasks carried out by public bodies which are necessary to meet a substantial public interest, such as exercise of public duty, including public health surveillance, planning and reporting duties, health policy making, ensuring patient safety, quality of care, and the sustainability of health care systems. Public bodies and Union institutions, bodies, offices and agencies may require to have regular access to electronic health data for an extended period of time, including in order to fulfil their mandate, which is provided by this Regulation. Public sector bodies may carry out such research activities by using third parties, including sub-contractors, as long as the public sector body remains at all time the supervisor of these activities. The provision of the data should also support activities related to scientific research (including private research), development and innovation, producing goods and services for therelated to health or care sectors for the prevention, early detection, diagnosis, treatment, rehabilitation, supportive care or health or care sectors, such as innovation activities or training of AI algorithms that could protectmanagement. It should also contribute to development activities aimed at producing goods and services for the health or care of natural personsectors. In some cases, the information of some natural persons (such as genomic information of natural persons with a certain disease) could support the diagnosis or treatment of other natural persons. There is a need for public bodies to go beyond the emergency scope of Chapter V of Regulation […] [Data Act COM/2022/68 final]. However, the public sector bodies may request the support of health data access bodies for processing or linking data. This Regulation provides a channel for public sector bodies to obtain access to information that they require for fulfilling their tasks assigned to them by law, but does not extend the mandate of such public sector bodies. Any attempt to use the data for any measures detrimental to the natural person, to increase insurance premiums, to advertise products or treatments, to profile and discriminate against individuals, or develop harmful products should be prohibited.
Amendment 368 #
2022/0140(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) The establishment of one or more health data access bodies, supporting access to electronic health data in Member States, is an essential component for promoting the secondary use of health- related data. Member States should therefore establish one or more health data access body, for instance to reflect their constitutional, organisational and administrative structure. However, one of these health data access bodies should be designated as a coordinator in case there are more than one data access body. Likewise, despite Member States’ constitutional, organisational and administrative specificities, health data access bodies should at least consist of authorization bodies to decide on the validity of data access applications and data requests, and of trust bodies that receive the electronic health data from data holders and disclose it to authorisation bodies. Where a Member State establishes several bodies, it should lay down rules at national level to ensure the coordinated participation of those bodies in the EHDS Board. That Member State should in particular designate one health data access body to function as a single contact point for the effective participation of those bodies, and ensure swift and smooth cooperation with other health data access bodies, the EHDS Board and the Commission. Health data access bodies may vary in terms of organisation and size (spanning from a dedicated full- fledged organization to a unit or department in an existing organization) but should have the same functions, responsibilities and capabilities. Health data access bodies should not be influenced in their decisions on access to electronic data for secondary use and their staff should not have any conflict of interest that is prejudicial to their independence and impartial conduct. However, their independence should not mean that the health data access body cannot be subject to control or monitoring mechanisms regarding its financial expenditure or to judicial review. Each health data access body should be provided with the financial and human resources, legal and technical expertise, including ethical boards and committees premises and infrastructure necessary for the effective performance of its tasks, including those related to cooperation with other health data access bodies throughout the Union. Each health data access body should have a separate, public annual budget, which may be part of the overall state or national budget. In order to enable better access to health data and complementing Article 7(3) of Regulation […] of the European Parliament and of the Council [Data Governance Act COM/2020/767 final], Member States should entrust health data access bodies with powers to take decisions on access to and secondary use of health data. This could consist in allocating new tasks to the competent bodies designated by Member States under Article 7(1) of Regulation […] [Data Governance Act COM/2020/767 final] or in designating existing or new sectoral bodies responsible for such tasks in relation to access to health data.
Amendment 373 #
2022/0140(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) The health data access bodies should monitor the application of Chapter IV of this Regulation and contribute to its consistent application throughout the Union. For that purpose, the health data access bodies should cooperate with each other and with the Commission, without the need for any agreement between Member States on the provision of mutual assistance or on such cooperation. The health data access bodies should also cooperate with stakeholders, including patient organisations. The selection procedure for health stakeholders should be transparent, public, and free of any conflict of interest. Since the secondary use of health data involves the processing of personal data concerning health, the relevant provisions of Regulation (EU) 2016/679 apply and the supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 should be tasked with enforcing these rules. Moreover, given that health data are sensitive data and in a duty of loyal cooperation, the health data access bodies should duly and expeditiously inform the data protection authorities of any issues related to the data processing for secondary use, including penalties. In addition to the tasks necessary to ensure effective secondary use of health data, the health data access body should strive to expand the availability of additional health datasets, support the development of AI in health and promote the development of common standards. They should apply tested techniques that ensure electronic health data is processed in a manner that preserves the privacy of the information contained in the data for which secondary use is allowed, including techniques for pseudonymisation, anonymisation, generalisation, suppression and randomisation of personal data. Health data access bodies can prepare datasets to the data user requirement linked to the issued data permit. This includes rules for anonymization of microdata sets.
Amendment 378 #
2022/0140(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) Considering the administrative burden for health data access bodies to inform the natural persons whose data are used in data projects within a secure processing environment, the exceptions provided for in Article 14(5) of Regulation (EU) 2016/679 should apply. Therefore, health data access bodies should provide general information concerning the conditions for the secondary use of their health data containing the information items listed in Article 14(1) and, where necessary to ensure fair and transparent processing, Article 14(2) of Regulation (EU) 2016/679, e.g. information on the purpose and the data categories processed. Exceptions from this rule should be made when the results of the research could assist in the treatment of the natural person concerned, while fully respecting the principles of medical confidentiality and professional secrecy. In this case, the data user should inform the health data access body, which should inform the data subject or his health professional. Natural persons should be able to access the results of different research projects on the website of the health data access body, ideally in an easily searchable manner. The list of the data permits should also be made public. In order to promote transparency in their operation, each health data access body should publish an annual activity report providing an overview of its activities.
Amendment 384 #
2022/0140(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) Health data access bodies and single data holders should be allowed to charge fees based on the provisions of Regulation […] [Data Governance Act COM/2020/767 final] in relation to their tasks. Such fees may take into account the situation and interest of SMEs, individual researchers or public bodies. Data holders should be allowed to also charge fees for making data available. Such fees should reflect the costs for providing such services. Private data holders may also charge fees for the collection of data. In order to ensure a harmonised approach concerning fee policies and structure, the Commission may adopt implementingdelegated acts. Provisions in Article 10 of the Regulation [Data Act COM/2022/68 final] should apply for fees charged under this Regulation.
Amendment 386 #
2022/0140(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) In order to strengthen the enforcement of the rules on the secondary use of electronic health data, appropriate measures that can lead to penalties or temporary or definitive exclusions from the EHDS framework of the data users or data holders that do not comply with their obligations. The health data access body should be empowered to verify compliance and give data users and holders the opportunity to reply to any findings and to remedy any infringement. TWhe imposition of penalties should be subject to appropriate procedural safeguardsn deciding on the amount of the penalty for each individual case, Member States should take into accordance with the general principles of law of the relevant Member State, including effective judicial protection and due processunt the margins and criteria set out in this Regulation.
Amendment 390 #
2022/0140(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) Given the sensitivity of electronic health data, it is necessary to reduce risks on the privacy of natural persons by applying the data minimisation principle as set out in Article 5 (1), point (c) of Regulation (EU) 2016/679. Therefore, the use of anonymised electronic health data which is devoid of any personal data should be made available when possible and if the data user asks itthe purpose of processing by the data user can be achieved with such data and the data subject has not given explicit consent for the secondary use of his/her personal data. If the data user needs to use personal electronic health data, it should clearly indicate in its request the justification for the use of this type of data for the planned data processing activity. The personal electronic health data should only be made available in pseudonymised format and the encryption key can only be held by the health data access body. Data users should not attempt to re-identify natural persons from the dataset provided under this Regulation, subject to administrative or possible criminal penalties, where the national laws foresee this. To this end, the Commission can adopt implementing acts to identify the procedures and requirements for a unified and irreversible procedure for anonymising and pseudonymising electronic health data. However, this should not prevent, in cases where the results of a project carried out based on a data permit has a health benefit or impact to a concerned natural person (for instance, discovering treatments or risk factors to develop a certain disease), the data users would inform the health data access body, which in turn would inform the concerned natural person(s). Moreover, the applicant can request the health data access bodies to provide the answer to a data request, including in statistical form. In this case, the data users would not process health data and the health data access body would remain sole controller for the data necessary to provide the answer to the data request.
Amendment 402 #
2022/0140(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) In order to ensure that all health data access bodies issue permits in a similar way, it is necessary to establish a standard common process for the issuance of data permits, with similar requests in different Member States. The applicant should provide health data access bodies with several information elements that would help the body evaluate the request and decide if the applicant may receive a data permit for secondary use of data, also ensuring coherence between different health data access bodies. Such information include: a description of the applicant’s identity, professional function, and operation, the legal basis under Regulation (EU) 2016/679 to request access to data (exercise of a task in the public interest assigned by law or legitimate interest), purposes for which the data would be used, description of the needed data and possible data sources, a description of the tools needed to process the data, as well as characteristics of the secfree and open source environment that are neededtools and computing resources that are needed for the secure environment. Where data is requested in pseudonymised format, the data applicant should explain why this is necessary and why anonymous data would not suffice. An ethical assessment may be requested based on national law. The health data access bodies and, where relevant data holders, should assist data users in the selection of the suitable datasets or data sources for the intended purpose of secondary use. Where the applicant needs anonymised statistical data, it should submit a data request application, requiring the health data access body to provide directly the result. In order to ensure a harmonised approach between health data access bodies, the Commission should support the harmonisation of data application, as well as data request.
Amendment 406 #
2022/0140(COD)
Proposal for a regulation
Recital 51
Recital 51
(51) As the resources of health data access bodies are limited, they can apply prioritisation rules, for instance prioritising public institutions before private entities, but they should not make any discrimination between the national or from organisations from other Member States within the same category of priorities. The data user should be able to extend the duration of the data permit by a maximum period of two additional months in order, for example, to allow access to the datasets to reviewers of scientific publication or to enable additional analysis of the dataset based on the initial findings. This would require an amendment of the data permit and may be subject to an additonal fee. However, in all the cases, the data permit should reflect theses additionals uses of the dataset. Preferably, the data user should mention them in their initial request for the issuance of the data permit. In order to ensure a harmonised approach between health data access bodies, the Commission should support the harmonisation of data permit.
Amendment 410 #
2022/0140(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) As the COVID-19 crisis has shown, the Union institutions, bodies, offices and agencies, especially the Commission, need access to health data for a longer period and on a recurring basis. This is may be the case not only infor specific circumstances stipulated by Union or Member States law in times of crisis but alsoand to provide scientific evidence and technical support for Union policies on a regular basis. Access to such data may be required in specific Member States or throughout the whole territory of the Union.
Amendment 417 #
2022/0140(COD)
Proposal for a regulation
Recital 53
Recital 53
Amendment 421 #
2022/0140(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) Given the sensitivity of electronic health data, data users should not have an unrestricted access to such data. All secondary use access to the requested electronic health data should be done through a secure processing environment based on free and open-source software. In order to ensure strong technical and security safeguards for the electronic health data, the health data access body or, where relevant, single data holder should provide access to such data in a secure processing environment, complying with the high technical and security standards set out pursuant to this Regulation. Some Member States took measures to locate such secure environments in Europe. The processing of personal data in such a secure environment should comply with Regulation (EU) 2016/679, including, where the secure environment is managed by a third party, the requirements of Article 28 and, where applicable, Chapter V. Such secure processing environment should reduce the privacy risks related to such processing activities and prevent the electronic health data from being transmitted directly to the data users. The health data access body or the data holder providing this service should remain at all time in control of the access to the electronic health data with access granted to the data users determined by the conditions of the issued data permit. Only non-personal electronic health data which do not contain any electronic health data should be extracted by the data users from such secure processing environment. Thus, it is an essential safeguard to preserve the rights and freedoms of natural persons in relation to the processing of their electronic health data for secondary use. The Commission should assist the Member State in developing common security standards in order to promote the security and interoperability of the various secure environments.
Amendment 427 #
2022/0140(COD)
Proposal for a regulation
Recital 55
Recital 55
(55) For the processing of electronic health data in the scope of a granted permit, the health data access bodies and the data users should be joint controllers in the sense of Article 26 of Regulation (EU) 2016/679, meaning that the obligations of joint controllers under that Regulation will apply. To support health data access bodies and data users, the Commission should, by means of an implementing act, provide a template for the joint controller arrangements health data access bodies and data users will have to enter into. However, the use of such a template shall not relieve health data access bodies or the data users from any of their duties and responsibilities. In order to achieve an inclusive and sustainable framework for multi-country secondary use of electronic health data, a cross-border infrastructure should be established. HealthData@EU should accelerate the secondary use of electronic health data while increasing legal certainty, respecting the privacy of natural persons and being interoperable. Due to the sensitivity of health data, principles such as “privacy by design” and “bring questions to data instead of moving data” should be respected whenever possible. Authorised participants in HealthData@EU could be health data access bodies, research infrastructures established as an European Research Infrastructure Consortium (‘ERIC’) under Council Regulation (EC) No 723/200950or similar structures established under another Union legislation, as well as other types of entities, including infrastructures under the European Strategy Forum on Research Infrastructures (ESFRI), infrastructures federated under the European Open Science Cloud (EOSC). Other authorised participants should obtain the approval of the joint controllership group for joining HealthData@EU. On the other hand, HealthData@EU should enable the secondary use of different categories of electronic health data, including linking of the health data with data from other data spaces such as environment, agriculture, social etc. The Commission could provide a number of services within HealthData@EU, including supporting the exchange of information amongst health data access bodies and authorised participants for the handling of cross- border access requests, maintaining catalogues of electronic health data available through the infrastructure, network discoverability and metadata queries, connectivity and compliance services. The Commission may also set up a secure environment, allowing data from different national infrastructures to be transmitted and analysed, at the request of the controllers. The Commission digital strategy promote the linking of the various common European data spaces. For the health sector, interoperability with the sectors such as the environmental, social, agricultural sectors may be relevant for additional insights on health determinants. For the sake of IT efficiency, rationalisation and interoperability of data exchanges, existing systems for data sharing should be reused as much as possible, like those being built for the exchange of evidences under the once only technical system of Regulation (EU) 2018/1724 of the European Parliament and of the Council51. _________________ 50 Council Regulation (EC) No 723/2009 of 25 June 2009 on the Community legal framework for a European Research Infrastructure Consortium (ERIC) (OJ L 206, 8.8.2009, p. 1). 51 Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1).
Amendment 438 #
2022/0140(COD)
Proposal for a regulation
Recital 63
Recital 63
(63) The use of funds should also contribute to attaining the objectives of the EHDS. Public procurers, national competent authorities in the Member States, including digital health authorities and health data access bodies, as well as the Commission should make references to applicable technical specifications, standards and profiles on interoperability, security and data quality, as well as other requirements developed under this Regulation when defining the conditions for public procurement, calls for proposals and allocation of Union funds, including structural and cohesion funds. To procure or fund services provided by controllers and processors established in the Union that process personal electronic health data, they are required to demonstrate that they will store the data in the Union and that they are not subject to third country legislation that conflicts with Union data protection rules.
Amendment 446 #
2022/0140(COD)
Proposal for a regulation
Recital 64
Recital 64
(64) Certain categories of electronic health data can remain particularly sensitive even when they are in anonymised format and thus non-personal, as already specifically foreseen in the Data Governance Act. Even in situations of the use of state of the art anonymization techniques, there remains a residual risk that the capacity to re-identify could be or become available, beyond the means reasonably likely to be used. Such residual risk is present in relation to rare diseases (a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Union), where the limited numbers of case reduce the possibility to fully aggregate the published data in order to preserve the privacy of natural persons while also maintaining an appropriate level of granularity in order to remain meaningful. It can affect different types of health data depending on the level of granularity and description of the characteristics of data subjects, the number of people affected or and for instance in cases of data included in electronic health records, disease registries, biobanks, person generated data etc. where the identification characteristics are broader and where, in combination with other information (e.g. in very small geographical areas) or through the technological evolution of methods which had not been available at the moment of anonymisation, can lead to the re- identification of the data subjects using means that are beyond those reasonably likely to be used. The realisation of such risk of re-identification of natural persons would present a major concern and is likely to put the acceptance of the policy and rules on secondary use provided for in this Regulation at risk. Furthermore, aggregation techniques are less tested for non-personal data containing for example trade secrets, as in the reporting on clinical trials, and enforcement of breaches of trade secrets outside the Union is more difficult in the absence of a sufficient international protection standard. Therefore, for these types of health data, there remains a risk for re-identification after the anonymisation or aggregation, which could not be reasonably mitigated initially. This falls within the criteria indicated in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final]. These types of health data would thus fall within the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final] for transfer to third countries. The protective measures, proportional to the risk of re-identification, would need to take into account the specificities of different data categories or of different anonymization or aggregation techniques and will be detailed in the context of the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final]. In case of mixed datasets, where personal and non- personal data are inextricably linked, the protections in EU data protection legislation and in this Regulation concerning personal electronic health data shall be fully applicable.
Amendment 458 #
2022/0140(COD)
Proposal for a regulation
Recital 65
Recital 65
(65) In order to promote the consistent application of this Regulation, a European Health Data Space Board (EHDS Board) should be set up. The Commission should participate in its activities and chair it. It should contribute to the consistent application of this Regulation throughout the Union, including by helping Member State to coordinate the use of electronic health data for healthcare, certification, but also concerning the secondary use of electronic health data. Given that, at national level, digital health authorities dealing with the primary use of electronic health data may be different to the health data access bodies dealing with the secondary use of electronic health data, the functions are different and there is a need for distinct cooperation in each of these areas, the EHDS Board should be able to set up subgroups dealing with these two functions, as well as other subgroups, as needed. For an efficient, independent, and public interest driven working method, the digital health authorities and health data access bodies should create networks and links at national level with different other bodies and authorities, but also at Union level. Such bodies could comprise data protection authorities, cybersecurity, eID and standardisation bodies, as well as bodies and expert groups under Regulations […], […], […] and […] [Data Governance Act, Data Act, AI Act and Cybersecurity Act].
Amendment 461 #
2022/0140(COD)
Proposal for a regulation
Recital 70
Recital 70
(70) Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement. For certain specific infringementsWhen deciding on the amount of the penalty for each individual case, Member States should take into account the margins and criteria set out in this Regulation.
Amendment 473 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) strengthenpecifies the rights of natural persons in relation to the availability and control of their electronic health data;
Amendment 482 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 3 – point a
Article 1 – paragraph 3 – point a
(a) manufacturers and suppliers of EHR systems and wellness applicationof medical devices placed on the market and put into service in the Union and the users of such products;
Amendment 493 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 4
Article 1 – paragraph 4
4. This Regulation shall be without prejudice to other Union legal acts regarding access to, sharing of or secondary use of electronic health data, or requirements related to the processing of data in relation to electronic health data, in particular Regulations (EU) 2016/679, (EU) 2018/1725, […] [Data Governance Act COM/2020/767 final] and […] [Data Act COM/2022/68 final].(EU) 2022/868 and […] [Data Act COM/2022/68 final]. (This amendment applies throughout the text)
Amendment 495 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 4 a (new)
Article 1 – paragraph 4 a (new)
4 a. Pursuant to Article 9(4) of Regulation (EU) 2016/679, Member States may impose further restrictions on the processing of personal health data laid down in Chapters II and IV of this Regulation.
Amendment 511 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) ‘personal electronic health data’ means data concerning physical or mental health, and genetic data as defined in Regulation (EU) 2016/679, as well as data referring to determinants of health, or data processed in relation to the provision of healthcare services,that are processed in an electronic form;
Amendment 514 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) ‘non-personal electronic health data’ means data concerning health and aggregated genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;
Amendment 532 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
(e) ‘secondary use of electronic health data’ means the further processing of electronic health data for purposes set out in Chapter IV of this Regulation. The data used may include personal electronic health data initially collected in the context of primary use, but also electronic health data collected for other purpose of the secondary uses;
Amendment 535 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals using commonly accepted open standards and open data formats, involving the exchange of information and knowledge without changing the content of the data between these organisations, software applications or devices, through the processes they support;
Amendment 542 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point k
Article 2 – paragraph 2 – point k
Amendment 545 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point l
Article 2 – paragraph 2 – point l
Amendment 566 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point q – point i
Article 2 – paragraph 2 – point q – point i
(i) the death of a natural person or serious damage to a natural person’s health or rights;
Amendment 575 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point y
Article 2 – paragraph 2 – point y
(y) ‘data holder’ means any natural or legal person, which is an entity or a body controller in the meaning of Regulation (EU) 2016/679 in the health or care or social security sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies whoich are a controller in the meaning of Regulation (EU) 2018/1725, which has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, to process personal health data, or in the case of non-personal health data, through control of the technical design of a product and related services, the lawful ability to make available, including to register, provide, restrict access or exchange certain data;
Amendment 584 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point z
Article 2 – paragraph 2 – point z
(z) ‘data user’ means a natural or legal person, including public authorities and EU institutions, bodies or agencies, who has lawful access to personal or non- personal electronic health data for secondary use, pursuant to a data permit in accordance with this Regulation;
Amendment 592 #
2022/0140(COD)
(aa) ‘data permit’ means an administrative decision issued to a data user by a health data access body or data holder to process the electronic health data specified in the data permit for the secondary use purposes specified in the data permit based on conditions laid down in this Regulation;
Amendment 600 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae a (new)
Article 2 – paragraph 2 – point ae a (new)
(ae a) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to an EHR system.
Amendment 619 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Natural persons shall have the right to access their personal electronic health data processed in the context of primary use of electronic health data, and any available information as to their origin, immediately, free of charge and in an easily readable, consolidated and accessible form, in accordance with Article 14 of Regulation (EU) 2016/679.
Amendment 624 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Natural persons shall have the right to receive an electronic copy, in the European electronic health record exchange format referred to in Article 6, of at least their electronic health data in the priority categories referred to in Article 5, or a printed copy thereof, in accordance with paragraph 3 of Article 15 of Regulation (EU) 2016/679.
Amendment 626 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2 a. Paragraphs 1 and 2 shall be without prejudice to Article 15 of Regulation (EU) 2016/679 and Article 17 of Regulation (EU) 2018/1725.
Amendment 630 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. In accordance with paragraph 1, point (i) of Article 23 of Regulation (EU) 2016/679, Member States may by law restrict the scope of this right whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on this or her healthperson.
Amendment 637 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. Where the personal health data have not been registered electronically prior to the application of this Regulation, Member States may require that such data is made available in electronic format pursuant to this Article. This shall not affect the obligation to make personal electronic health data registered after the application of this Regulation available in electronic format pursuant to this Article, where the data subject consents to such electronic processing.
Amendment 648 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 5 – subparagraph 1 – point b
Article 3 – paragraph 5 – subparagraph 1 – point b
(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf and on their request.
Amendment 653 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. Natural persons may, in accordance with the rules of the respective healthcare provider, insert their electronic health data in their own EHR or in that of natural persons whose health information they can access because they are proxies pursuant to paragraph 5, through electronic health data access services or applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative, shall not be available for secondary use, and shall only be considered as a clinical fact and made available for secondary use if validated by a registered healthcare professional of relevant specialisation responsible for the natural person’s treatment.
Amendment 660 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 7
Article 3 – paragraph 7
7. Member States shall ensure that, when exercising the right to rectification under Article 16 of Regulation (EU) 2016/679, natural persons can easily request rectification online through the electronic health data access services referred to in paragraph 5, point (a), of this Article. In accordance with Article 16 of Regulation (EU) 2016/679, natural persons shall not have the possibility to directly change data inserted by healthcare professionals. Such rectifications of clinical facts shall be validated by a registered healthcare professional of relevant specialisation responsible for the natural person’s treatment. The original data holder shall be responsible for the rectification.
Amendment 665 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 1
Article 3 – paragraph 8 – subparagraph 1
Amendment 672 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 3
Article 3 – paragraph 8 – subparagraph 3
Amendment 678 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 4 a (new)
Article 3 – paragraph 8 – subparagraph 4 a (new)
This paragraph is without prejudice to limitations for the processing of personal health or genetic data under Member State law, pursuant to paragraph 4 of Article 9 of Regulation (EU) 2016/679.
Amendment 681 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 9
Article 3 – paragraph 9
9. NotwithstandingWithout prejudice to Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of certain health professionals to all or part of their electronic health data. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms, which may also include the possibility of restrictions related to a specific category of health professionals. Natural persons shall be informed of the patient safety risks associated with limiting access to health data.
Amendment 688 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 9 a (new)
Article 3 – paragraph 9 a (new)
Amendment 689 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. Natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare, including access to restricted data pursuant to paragraph 9. The information shall be provided immediately and free of charge through electronic health data access services, whenever such access has taken place. For this purpose, providers of electronic health records shall keep a record of who has accessed which data in the previous 24 months. Member States may provide for restrictions to this right in exceptional circumstances, where there are factual indications that disclosure would endanger the vital interests or rights of the health professional.
Amendment 702 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 11
Article 3 – paragraph 11
11. The supervisory authority or authorities responsible for monitoring the application of Regulation (EU) 2016/679 shall also be responsible for monitoring the application of this Article, in accordance with the relevant provisions in Chapters VI, VII and VIII of Regulation (EU) 2016/679. They shall be competent to impose administrative fines up to the amount referred to in Article 83(5) of that Regulation. Those supervisory authorities and the digital health authorities referred to in Article 10 of this Regulation shall, where relevant, cooperate in the enforcement of this Regulation, within the remit of their respective competences.
Amendment 709 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 12 a (new)
Article 3 – paragraph 12 a (new)
12 a. Member States, including regional and local authorities, shall provide guidance to natural persons in relation to the use of the electronic health records and primary use of their personal electronic health data laid down in this Article. Such guidance shall take into account digital health literacy of vulnerable groups, including migrants, the elderly and persons with disabilities.
Amendment 712 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) have access to the electronic health data of natural persons under their treatment, where, and to the extent that, this is necessary for the purposes spelled out in point (h) of paragraph 2 of Article 9 of Regulation (EU) 2016/679, irrespective of the Member State of affiliation and the Member State of treatment, with the exceptions provided for in paragraphs 9 and 9a of Article 3;
Amendment 723 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. In line with the data minimisation principle provided for in Regulation (EU) 2016/679, Member States mayshall establish rules providing for the categories of personal electronic health data required by different categories of health professions. Such rules shall not be based on the source of electronic health data.
Amendment 729 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Member States and, where appropriate, local or regional authorities shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services, where, and to the extent to, this is necessary for the purposes spelled out in point (h) of paragraph 2 of Regulation (EU) 2016/679, and with the exceptions provided for in paragraphs 9 and 9a of Article 3. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services regarding the electronic health data of natural persons under their treatment, irrespective of the Member State of affiliation and treatment, free of charge.
Amendment 747 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Where access to electronic health data has been restricted by the natural person, the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisationexplicit consent by the natural person, including where the provider or professional is informed of the existence and nature of the restricted electronic health data. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.
Amendment 768 #
2022/0140(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 771 #
2022/0140(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 783 #
2022/0140(COD)
Proposal for a regulation
Article 6 – paragraph 1 – introductory part
Article 6 – paragraph 1 – introductory part
1. The Commission shall, by means of implementing acts, lay down the open technical specifications for the priority categories of personal electronic health data referred to in Article 5, setting out the European electronic health record exchange format pursuant to the FAIR principle (findability, accessibility, interoperability, re-use). The format shall include the following elements:
Amendment 798 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Member States shall ensure that, where data is processed in electronic format, health professionals systematically register the relevant health data falling under at least the priority categories referred to in Article 5 concerning the health services provided by them to natural persons, in the electronic format in an EHR system.
Amendment 800 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
Amendment 804 #
2022/0140(COD)
The Commission shall, by means of implementingdelegated acts, determine the requirements for the registration of electronic health data by healthcare providerfessionals and natural persons, as relevant. Those implementingdelegated acts shall establish the following:
Amendment 809 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 – subparagraph 1 – point a
Article 7 – paragraph 3 – subparagraph 1 – point a
(a) categories of healthcare providers fessionals that are to register health data electronically;
Amendment 812 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 – subparagraph 1 – point b
Article 7 – paragraph 3 – subparagraph 1 – point b
(b) categories of health data that are to be registered systematically in electronic format by healthcare providerfessionals referred to in point (a);
Amendment 815 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 – subparagraph 2
Article 7 – paragraph 3 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2)7.
Amendment 823 #
2022/0140(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Amendment 829 #
2022/0140(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Where a natural person uses telemedicine services or personal health data access services referred to in Article 3(5), point (a), that natural person shall have the right to identify electronically using any electronic identification means which is recognised pursuant to Article 6 of Regulation (EU) No 910/2014.
Amendment 833 #
2022/0140(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission shall, by means of implementingdelegated acts, determine the requirements for the interoperable, cross- border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final]. The mechanism shall facilitate the secure transferability of electronic health data in a cross-border context. Those implementingdelegated acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2)7.
Amendment 837 #
2022/0140(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The Commission and Member States shall implement services required by the interoperable, cross-border identification and authentication mechanism referred to in paragraph 2 of this Article at Union level, as part of the cross-border digital health infrastructure referred to in Article 12(3).
Amendment 838 #
2022/0140(COD)
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. The digital health authoritiMember States and the Commission shall implement the cross- border identification and authentication mechanism at Union and Member States’ level, respectively, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final].
Amendment 840 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Each digital health authority shall be entrusted with the following tasks and powers:
Amendment 845 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point g
Article 10 – paragraph 2 – point g
(g) ensure the implementation, at national level, of the European electronic health record exchange format, in cooperation with national authorities and stakeholders, including representatives of patients, consumers and healthcare professionals;
Amendment 849 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point h
Article 10 – paragraph 2 – point h
(h) contribute, at Union level, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing quality, interoperability, security, safety, ease of use, accessibility, non-discrimination or fundamental right concerns in accordance with Article 23 and of the specifications of the EU database for EHR systems and wellness applications referred to in Article 32;
Amendment 851 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point h a (new)
Article 10 – paragraph 2 – point h a (new)
(h a) support digital health literacy and promote awareness and understanding about the benefits, risks, rules and rights in relation to the use of EHR systems;
Amendment 852 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point k
Article 10 – paragraph 2 – point k
Amendment 858 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point m
Article 10 – paragraph 2 – point m
(m) cooperate with other relevant entities and bodies at local, regional, national or Union level, to ensure interoperability, data portability and security of electronic health data, as well as with stakeholders representatives, including patients’ and consumers’ representatives, healthcare providers, health professionals, industry associations;
Amendment 862 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point n
Article 10 – paragraph 2 – point n
(n) cooperate in the enforcement of this Regulation, within the remit of their respective competences, with supervisory authorities in accordance with Regulation (EU) 910/2014, Regulation (EU) 2016/679 and Directive (EU) 2016/1148 of the European Parliament and of the Council56with other relevant authorities, including those competent for cybersecurity, electronic identification, the European Artificial Intelligence Board, the Medical Device Coordination Group, the European Data Innovation Board and the competent authorities under Regulation […] [Data Act COM/2022/68 final]; _________________ 56 Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1).
Amendment 864 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point o – introductory part
Article 10 – paragraph 2 – point o – introductory part
(o) draw up, in collaboration where relevant with market surveillance authorities, an annual activity report, which shall contain a comprehensive overview of its activities. The report shall be transmitted to the Commission and shall be published. The annual activity report shall follow a structure that is agreed at Union level within EHDS Board, to support benchmarking pursuant to Article 59. The report shall contain at least information concerning:
Amendment 865 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point o – point vi a (new)
Article 10 – paragraph 2 – point o – point vi a (new)
(vi a) amount of persons who have restricted or refused access to their data pursuant to paragraphs 9 and 9a of Article 3, and information about the scope of such restrictions by type of health professional or health data;
Amendment 867 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point o a (new)
Article 10 – paragraph 2 – point o a (new)
(o a) enforce the compliance with this Regulation, including by: (i) conducting on-site and remote inspections, including unannounced ones; (ii) issuing of administrative fines; (iii) imposing on providers of EHRs or on other healthcare providers and professionals and other data holders and data users a ban on certain activities that are in violation of this Regulation.
Amendment 871 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point o b (new)
Article 10 – paragraph 2 – point o b (new)
(o b) promote public awareness and understanding of the benefits, risks, rules, safeguards and rights in relation to the EHDS system.
Amendment 875 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
Amendment 880 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Each Member State shall ensure that each digital health authority is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and exercise of its powers. Each Member State shall by law provide for the details of the enforcement powers pursuant to point (p) of paragraph 2. (Linked to point (p) of paragraph 2)
Amendment 883 #
2022/0140(COD)
5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients, consumers and healthcare professionals’ representatives. Members of the digital health authority shall havoid any conflictse no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly ofr interesdirectly, affect the impartiality of their professional conduct.
Amendment 897 #
2022/0140(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the digital health authority. Where the complaint concerns the rights of natural persons pursuant to Article 3 of this Regulation, the digital health authority shall informsend a copy of the complaint to and consult with the supervisory authorities under Regulation (EU) 2016/679. Those supervisory authorities shall be competent to treat the complaint in a separate proceeding, pursuant to their tasks and powers under that Regulation.
Amendment 908 #
2022/0140(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between national contact points for digital health of the Member States. The central platform shall be licenced under an open- source licence and published in the Open Source code repository of the EU institutions.
Amendment 916 #
2022/0140(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. The Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The European Union Agency for Cyber Security shall be consulted and closely involved in all steps of the procedure. Any measures adopted shall meet the highest technical standards in terms of security, confidentiality and protection of electronic health data.
Amendment 941 #
2022/0140(COD)
Proposal for a regulation
Article 13 – paragraph 3 – subparagraph 1
Article 13 – paragraph 3 – subparagraph 1
Member States and the Commission shall seek to ensure interoperability of MyHealth@EU with technological systems established at international level for the exchange of electronic health data. The Commission may adopt an implementing act establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of MyHealth@EU for the purposes of the electronic health data exchange. Before adopting such an implementing act, a compliance check of the national contact point of the third country or of the system established at an international level, as well as a compliance check with the requirements of Chapter V of Regulation (EU) 2016/679, shall be performed under the control of the Commission.
Amendment 947 #
2022/0140(COD)
Proposal for a regulation
Chapter III – title
Chapter III – title
III EHR systems and wellness applications
Amendment 949 #
2022/0140(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Manufacturers of medical devices as defined in Article 2(1) of Regulation (EU) 2017/745 that claim interoperability of those medical devices with EHR systems shall prove compliance with the essential requirements on quality and interoperability laid down in Section 2 of Annex II of this Regulation. Article 23 of this Chapter shall be applicable to those medical devices.
Amendment 950 #
2022/0140(COD)
4. PNotwithstanding the obligations laid down in Regulation [AI act COM/2021/206 final], providers of high- risk AI systems as defined in Article 6 of Regulation […] [AI act COM/2021/206 final], which does not fall within the scope of Regulation (EU) 2017/745, that claim interoperability of those AI systems with EHR systems will need to prove compliance with the essential requirements on quality and interoperability laid down in Section 2 of Annex II of this Regulation. Article 23 of this Chapter shall be applicable to those high-risk AI systems. .
Amendment 956 #
2022/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter and in Annex II of this Regulation.
Amendment 963 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) draw up and keep up to date the technical documentation of their EHR systems in accordance with Article 24;
Amendment 964 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point c
Article 17 – paragraph 1 – point c
(c) ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet provided for in Article 25 and by clear and complete instructions for use, including in accessible formats for vulnerable populations, including migrants, the elderly and persons with disabilities;
Amendment 968 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point g
Article 17 – paragraph 1 – point g
(g) take without undue dimmediatelay any necessary corrective action in respect of their EHR systems whichen manufacturers consider or have reasons to believe that such systems are not in conformity with the essential requirements laid down in Annex II, or recall or withdraw such systems;
Amendment 970 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point h
Article 17 – paragraph 1 – point h
(h) immediately inform the distributors of their EHR systems and, where applicable, the authorised representative and importers of any corrective action, recall or withdrawal;
Amendment 972 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point i
Article 17 – paragraph 1 – point i
(i) immediately inform the market surveillance authorities of the Member States in which they made their EHR systems available or put them into service of the non- conformity and of any corrective action taken;
Amendment 973 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point i a (new)
Article 17 – paragraph 1 – point i a (new)
(i a) immediately inform the market surveillance authorities of the Member States in which they made their EHR systems available, where manufacturers consider or have reasons to believe that such systems present a risk to the health or safety of natural persons or to other aspects of public interest protection;
Amendment 974 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point j
Article 17 – paragraph 1 – point j
(j) upon request of a market surveillance authority, provide itat least 6 months before placing on the market or putting into service their EHR systems, provide market surveillance authorities in the Member States concerned with all the information and documentation necessary to demonstrate the conformity of their EHR system with the essential requirements laid down in Annex II.
Amendment 978 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
Amendment 981 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Manufacturers of EHR systems shall keep the technical documentation and the EU declaration of conformity for at least 10 years after the last EHR system covered by the EU declaration of conformity has been placed on the market.
Amendment 983 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 3 a (new)
Article 17 – paragraph 3 a (new)
3 a. A manufacturer of EHR systems established outside of the Union shall ensure that its authorised representative has the necessary documentation permanently available in order to fulfil the tasks referred to in Article 18(2).
Amendment 985 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 3 b (new)
Article 17 – paragraph 3 b (new)
3 b. Natural or legal persons may claim compensation for damage caused by a defective EHR system in accordance with applicable Union and national law. Manufacturers shall have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.
Amendment 986 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 3 c (new)
Article 17 – paragraph 3 c (new)
3 c. Manufacturers shall make publicly available communication channels such as a telephone number, electronic address or dedicated section of their website, taking into account accessibility needs for vulnerable populations, including migrants, the elderly and persons with disabilities, allowing consumers and professional users to file complaints and to inform them of risks related to their health and safety or to other aspects of public interest protection and of any serious incident involving an EHR system;
Amendment 987 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 3 d (new)
Article 17 – paragraph 3 d (new)
3 d. Manufacturers shall investigate complaints and information on incidents involving an EHR system they made available on the market without undue delay and shall keep an internal register of those complaints as well as of systems recalls and any corrective measures taken to bring the EHR system into conformity;
Amendment 988 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 3 e (new)
Article 17 – paragraph 3 e (new)
3 e. Personal data stored in the internal register of complaints shall only be those personal data that are necessary for the manufacturer to investigate the complaint. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than five years after they have been encoded.
Amendment 989 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 – introductory part
Article 18 – paragraph 2 – introductory part
2. An authorised representative shall perform the tasks specified in the mandate received fromagreed with the manufacturer. The mandate shall allow the authorised representative to do at least the following:
Amendment 991 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point b
Article 18 – paragraph 2 – point b
(b) further to a reasoned request from a market surveillance authority, provide that authorityat least 6 months before an EHR system is placed on the market or putting into service provide market surveillance authorities of the Member States concerned a copy of the mandate with all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II in an official language of the authority;
Amendment 992 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point b a (new)
Article 18 – paragraph 2 – point b a (new)
(b a) immediately inform the manufacturer if the authorised representative has a reason to believe that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection or if it is aware of any serious incident involving an EHR system;
Amendment 993 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point b b (new)
Article 18 – paragraph 2 – point b b (new)
(b b) immediately inform the manufacturer about complaints received by consumers and professional users;
Amendment 995 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point c a (new)
Article 18 – paragraph 2 – point c a (new)
(c a) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation and immediately inform the market surveillance authority of the Member State in which is established.
Amendment 996 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2 a. Where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 17, the authorised representative shall be legally liable for non-compliance with this Regulation on the same basis as, and jointly and severally with, the manufacturer.
Amendment 997 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 c (new)
Article 18 – paragraph 2 c (new)
2 c. In case of change of the authorised representative, the detailed arrangements for the change shall be clearly defined in an agreement between the manufacturer, or where practicable the outgoing authorised representative, and the incoming authorised representative.That agreement shall address at least the following aspects: (a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative; (b) the transfer of documents, including confidentiality aspects and property rights.
Amendment 998 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point a
Article 19 – paragraph 2 – point a
(a) the manufacturer has drawn up the technical documentation and the EU declaration of conformity and ensure that it is made available to market surveillance authorities at least 6 months before an EHR system is placed on the market or put into service;
Amendment 1001 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point a a (new)
Article 19 – paragraph 2 – point a a (new)
(a a) the manufacturer is identified and an authorised representative in accordance with Article 18 has been appointed;
Amendment 1003 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point c
Article 19 – paragraph 2 – point c
(c) the EHR system is accompanied by the information sheet referred to in Article 25 and appropriaclear and complete instructions for use in accessible formats, including for persons with disabilities.
Amendment 1004 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. Importers shall indicate their name, registered trade name or registered trade mark and the addresspostal and electronic address and a telephone number at which they can be contacted in a document accompanying the EHR system. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
Amendment 1006 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. Where an importer considers or has reason to believe that an EHR system is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. The importer shall inform without undue delaymmediately inform the manufacturer of such EHR system and the market surveillance authorities of the Member State in which it made the EHR system available, to that effect. Where an importer considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately inform the market surveillance authority of the Member State in which the importer is established, as well as the manufacturer and where applicable, the authorised representative.
Amendment 1008 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 7
Article 19 – paragraph 7
7. Importers shall, further to a reasoned request from a market surveillance authority, provide itat least 6 months before placing on the market or putting into service an EHR system, provide market surveillance authorities of Member States concerned with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the market surveillance authority is located. They shall cooperate with that authority, at its request, and with the manufacturer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II, or to ensure that their EHR systems are withdrawn or recalled.
Amendment 1011 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 7 a (new)
Article 19 – paragraph 7 a (new)
7 a. Importers shall verify whether the communication channels referred to in Article 17(3c), are publicly available to consumers and professional users allowing them to submit complaints and communicate any risk related to their health and safety or to other aspects of public interest protection and of any serious incident involving an EHR system. If such channels are not available, the importer shall provide for them, taking into account accessibility needs of vulnerable populations including migrants, the elderly and persons with disabilities.
Amendment 1012 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 7 b (new)
Article 19 – paragraph 7 b (new)
7 b. If the importer fails to cooperate with market surveillance authorities or if the information and documentation provided is incomplete or incorrect, market surveillance authorities shall take all appropriate measures to prohibit or restrict its EHR system from being available on the market, to withdraw it from the market or to recall it until the importer cooperates or provides complete and correct information.
Amendment 1013 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 7 c (new)
Article 19 – paragraph 7 c (new)
7 c. Importers shall investigate complaints and information on incidents involving an EHR system they made available on the market and file those complaints, as well as of systems recalls and any corrective measures taken to bring the EHR system into conformity, in the register referred to in Article 17(3e) or in their own internal register. Importers shall keep the manufacturer, distributors and, where relevant, authorised representatives informed in a timely manner of the investigation performed and of the results of the investigation.
Amendment 1014 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 7 d (new)
Article 19 – paragraph 7 d (new)
7 d. Personal data stored in the internal register of complaints shall only be those personal data that are necessary for the importer to investigate the complaint. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than five years after they have been encoded.
Amendment 1017 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 1 – point c
Article 20 – paragraph 1 – point c
(c) the EHR system is accompanied by the information sheet referred to in Article 25 and appropriaby clear and complete instructions for use in accessible formats, including for persons with disabilities;
Amendment 1019 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. Where a distributor considers or has reason to believe that an EHR system is not in conformity with the essential requirements laid down in Annex II, it shall not make the EHR system available on the market until it has been brought into conformity. Furthermore, the distributor shall inform without undue delaymmediately inform the manufacturer or the importer, as well as the market surveillance authorities of the Member states where the EHR system has been made available on the market, to that effect. Where a distributor considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately inform the market surveillance authority of the Member State in which the distributor is established, as well as the manufacturer, the importer and where applicable, the authorised representative.
Amendment 1020 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Distributors shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, and with the manufacturer, the importer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II or to ensure that their EHR systems are withdrawn or recalled.
Amendment 1023 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 4 a (new)
Article 20 – paragraph 4 a (new)
4 a. Distributors that have received complaints from consumers or professional users about suspected incidents involving an EHR system they made available on the market, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. They shall keep a register of complaints, of non-conforming EHR systems and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.
Amendment 1025 #
2022/0140(COD)
Proposal for a regulation
Article 21 – title
Article 21 – title
Cases in which obligations of manufacturers of an EHR system apply to importers and distribuother economic operators
Amendment 1026 #
2022/0140(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
An importer or distributoeconomic operator other than the manufacturer shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 17, where they made an EHR system available on the market under their own name or trademark or modify an EHR system already placed on the market in such a way that conformity with the applicable requirements may be affected.
Amendment 1034 #
2022/0140(COD)
Proposal for a regulation
Article 23 – paragraph 5
Article 23 – paragraph 5
5. Where common specifications covering interoperability and security requirements of EHR systems affect medical devices or high-risk AI systems falling under other acts, such as Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], the adoption of those common specifications mayshall be preceded by a consultation with the Medical Devices Coordination Group (MDCG) referred to in Article 103 of Regulation (EU) 2017/745 or the European Artificial Intelligence Board referred to in Article 56 of Regulation […] [AI Act COM/2021/206 final], as applicable, as well as the European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679.
Amendment 1035 #
2022/0140(COD)
Proposal for a regulation
Article 23 – paragraph 6
Article 23 – paragraph 6
6. Where common specifications covering interoperability and security requirements of medical devices or high- risk AI systems falling under other acts such as Regulation (EU) 2017/745 or Regulation […] [AI Act COM/2021/206 final], impact EHR systems, the adoption of those common specifications shall be preceded by a consultation with the EHDS Board, especially its subgroup for Chapters II and III of this Regulation and, where applicable, the European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679.
Amendment 1036 #
2022/0140(COD)
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. TheManufacturers shall draw up technical documentation shall be drawn up before the EHR system is placed on the market or put into service and shall be kept up-to-date. The technical documentation shall be submitted to the market surveillance authorities of the Member States concerned at least 6 months before an EHR system is placed on the market or put into service.
Amendment 1037 #
2022/0140(COD)
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The technical documentation shall be drawn up in such a way as to demonstrate that the EHR system complies with the essential requirements laid down in Annex II and provide market surveillance authorities with all the necessary information to assess the conformity of the EHR system with those requirements. It shall contain, at a minimum, the elements set out in Annex III. In case the system or any part of it complies with European standards or common specifications, the list of the relevant European standards and common specifications shall also be indicated.
Amendment 1040 #
2022/0140(COD)
Proposal for a regulation
Article 25 – paragraph 2 – point a
Article 25 – paragraph 2 – point a
(a) the identity, registered trade name or registered trademark, and the contact details of the manufacturer including the postal and electronic address and the telephone number and, where applicable, of its authorised representative;
Amendment 1041 #
2022/0140(COD)
Proposal for a regulation
Article 25 – paragraph 3
Article 25 – paragraph 3
3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems and wellness applications referred to in Article 32, as an alternative to supplying the information sheet referred to in paragraph 1 with the EHR system.
Amendment 1045 #
2022/0140(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled. The manufacturer shall continuously update the EU declaration of conformity.
Amendment 1048 #
2022/0140(COD)
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the conformity of thecompliance with the requirements of this Regulation and all Union acts applicable to EHR systems.
Amendment 1050 #
2022/0140(COD)
Proposal for a regulation
Article 26 – paragraph 4 a (new)
Article 26 – paragraph 4 a (new)
4 a. The Commission is empowered to adopt delegated acts in accordance with Article 67 amending the minimum content of the EU declaration of conformity set out in Annex IV.
Amendment 1054 #
2022/0140(COD)
Proposal for a regulation
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1 a. The CE marking shall be affixed before making the EHR system available on the market.
Amendment 1055 #
2022/0140(COD)
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Article 27 – paragraph 2 a (new)
2 a. Where EHR systems are subject to other Union legislation in respect of aspects not covered by this Regulation, which also requires the affixing of the CE marking, the CE marking shall indicate that the systems also fulfil the requirements of that other legislation.
Amendment 1076 #
2022/0140(COD)
Proposal for a regulation
Article 28 – paragraph 2
Article 28 – paragraph 2
2. Member States shall designate the market surveillance authority or authorities responsible for the implementation of this Chapter. They shall entrust their market surveillance authorities with the powers, resources, equipmentnecessary powers, financial resources, equipment, technical expertise, adequate staffing, and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. Member States shall communicate the identity of the market surveillance authorities to the Commission which shall publish a list of those authorities.
Amendment 1077 #
2022/0140(COD)
Proposal for a regulation
Article 28 – paragraph 2 a (new)
Article 28 – paragraph 2 a (new)
2 a. Staff of market surveillance authorities shall have no direct or indirect economic, financial or personal conflicts of interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct.
Amendment 1078 #
2022/0140(COD)
Proposal for a regulation
Article 28 – paragraph 2 b (new)
Article 28 – paragraph 2 b (new)
2 b. Pursuant to paragraph 2 of this article, Member States shall determine and publish the selection procedure for market surveillance authorities. They shall ensure that the procedure is transparent and does not allow for conflicts of interest.
Amendment 1082 #
2022/0140(COD)
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
1 a. Where a market surveillance authority, on the basis of the information and documentation demonstrating the conformity of an EHR system provided by the relevant economic operator, considers or has reason to believe that the EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, including before the EHR system is placed on the market or put into service, it shall perform all the necessary checks to ensure that the system is compliant with this Regulation.
Amendment 1084 #
2022/0140(COD)
Proposal for a regulation
Article 29 – paragraph 1 b (new)
Article 29 – paragraph 1 b (new)
1 b. Where a market surveillance authority considers or has reason to believe that an EHR system has caused damage to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately provide information and documentation, as applicable, to the affected person or user and, as appropriate, other third parties affected by the damage caused to the person or user, without prejudice to data protection rules.
Amendment 1090 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 – introductory part
Article 30 – paragraph 1 – introductory part
1. Where a market surveillance authority makes one, inter alia, of the following findings, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to put an end to the non-compliance concernedbring the EHR system into conformity:
Amendment 1091 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) the EHR system is not in conformity with essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;
Amendment 1092 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point b
Article 30 – paragraph 1 – point b
(b) the technical documentation is either not available or not complete; or not in accordance with Article 24;
Amendment 1093 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point b a (new)
Article 30 – paragraph 1 – point b a (new)
(b a) the EHR systems is not accompanied by the information sheet provided for in Article 25, free of charge by the user, and by clear and complete instructions for use in accessible formats for persons with disabilities;
Amendment 1094 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the EU declaration of conformity has not been drawn up or has not been drawn up correctly as referred to in Article 26;
Amendment 1095 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point d a (new)
Article 30 – paragraph 1 – point d a (new)
(d a) the registration obligations of Article 32 has not been fulfilled.
Amendment 1103 #
2022/0140(COD)
Proposal for a regulation
Article 31
Article 31
Amendment 1112 #
2022/0140(COD)
Proposal for a regulation
Article 32 – title
Article 32 – title
Registration of EHR systems and wellness applications
Amendment 1113 #
2022/0140(COD)
Proposal for a regulation
Article 32 – title
Article 32 – title
Registration of EHR systems and wellness applications
Amendment 1116 #
2022/0140(COD)
Proposal for a regulation
Article 32 – paragraph 1
Article 32 – paragraph 1
1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26 and wellness applications for which a label has been issued pursuant to Article 31.
Amendment 1120 #
2022/0140(COD)
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. Before placing on the market or putting into service an EHR system referred to in Article 14 or a wellness application referred to in Article 31, the manufacturer of such EHR system or wellness application or, where applicable, its authorised representative shall register the required data into the EU database referred to in paragraph 1.
Amendment 1123 #
2022/0140(COD)
Proposal for a regulation
Article 32 – paragraph 4
Article 32 – paragraph 4
4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to determine the list of required data to be registered by the manufacturers of EHR systems and wellness applications pursuant to paragraph 2.
Amendment 1129 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Article 33 – paragraph 1 – introductory part
1. Data holders shall make the following categories of electronic data available for secondary use upon request and only with consent from the data subject in the case of personal data, and with the option to give or refuse consent for individual data categories and purposes, in accordance with the provisions of this Chapter:
Amendment 1149 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point b
Article 33 – paragraph 1 – point b
(b) datanon-personal data about determinants impacting on health, including social, environmental and behavioural determinants of health;
Amendment 1165 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point e
Article 33 – paragraph 1 – point e
(e) human genetic, genomic and proteomic data. This data shall only be used for the purposes in points (a), (b) or (c) of paragraph 1 of Article 34;
Amendment 1167 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point f
Article 33 – paragraph 1 – point f
Amendment 1177 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point g
Article 33 – paragraph 1 – point g
Amendment 1196 #
2022/0140(COD)
(l) data from research cohorts, questionnaires and surveys related to health;
Amendment 1206 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point n
Article 33 – paragraph 1 – point n
Amendment 1219 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises and small enterprises in the context of healthcare professionals’ practices and pharmacies as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59. _________________ 59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
Amendment 1228 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 3 a (new)
Article 33 – paragraph 3 a (new)
3 a. When electronic health data is made available for secondary use through health data access bodies, the beneficiary shall respect the principle of open science, and provide open access to research or processing results, following the principle ‘as open as possible, as closed as necessary’, in full respect of this Regulation and other applicable laws. Derogations from the open access requirements and open access practices shall be duly justified. The Commission shall closely monitor this, and any derogations shall be made public on the Commission’s web-portal.
Amendment 1254 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5
Article 33 – paragraph 5
5. Where the explicit consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data. Member State law pursuant to paragraph 4 of Article 9 of Regulation (EU) 2016/679, health data access bodies shall ensure the related obligations are met prior to providing access to electronic health data pursuant to Chapter IV of this Regulation. Where Member State law, pursuant to the same provision, excludes the giving of consent for certain data categories or processing purposes, the data must not be processed under the provisions of this Chapter.
Amendment 1270 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 6
Article 33 – paragraph 6
6. Where a public sector body obtains data in emergency situations as defined in Article 15, point (a) or (b) of the Regulation […] [Data Act COM/2022/68 final], in accordance with the rules laid down in that Regulation, it may be supported by a health data access body to provide technical support to process the data or combining it with other data for joint analysis.
Amendment 1275 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 7
Article 33 – paragraph 7
Amendment 1282 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 8
Article 33 – paragraph 8
8. Health data access bodies may provide access to additional categories of electronic health data that they have been entrusted with pursuant to national law or based on voluntary cooperation with the relevant data holders at national level, in particular to electronic health data held by private entities in the health sector, in accordance with the relevant security and data protection provisions.
Amendment 1286 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – introductory part
Article 34 – paragraph 1 – introductory part
1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 to a health data user only with the explicit consent from the data subject in the case of personal data. Without such consent, any health data may only be made accessible after it has been fully and irreversibly anonymised, where necessary by aggregating the health data of several groups of persons. In addition, any data may only be made accessible where the intended purpose of processing pursued by the applicant complies with:
Amendment 1301 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates, where this is necessary to meet a substantial public interest;
Amendment 1308 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point d
Article 34 – paragraph 1 – point d
Amendment 1312 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point e
Article 34 – paragraph 1 – point e
(e) scientific research and development related to health or care sectors for the prevention, early detection, diagnosis, treatment, rehabilitation, supportive care or healthcare management, including behavioural, fundamental, exploratory or applied health research;
Amendment 1318 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point f
Article 34 – paragraph 1 – point f
Amendment 1331 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point g
Article 34 – paragraph 1 – point g
Amendment 1345 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point h
Article 34 – paragraph 1 – point h
Amendment 1361 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 4
Article 34 – paragraph 4
4. Public sector bodies or Union institutions, agencies and bodies that obtain access to non-personal electronic health data entailing IP rights and trade secrets in the exercise of the tasks conferred to them by Union law or national law, shall take all specific measures necessary to preserve the confidentiality of such data.
Amendment 1365 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – introductory part
Article 35 – paragraph 1 – introductory part
Seeking access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for the following purposes shall be prohibited: or gaining access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for any purposes not listed in Article 34 shall be prohibited and subject to penalties laid down in Articles 43 and 69. Seeking or gaining access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for the following purposes shall constitute an aggravated case of breaching the rules of this Regulation, and shall be subject to higher penalties, in accordance with point (i) of paragraph 2a of Article 69: (Linked to article 69)
Amendment 1384 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point c
Article 35 – paragraph 1 – point c
(c) advertising or marketing activities towards health professionals, organisations in health or natural persons;
Amendment 1391 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point c a (new)
Article 35 – paragraph 1 – point c a (new)
(c a) developing or conducting any activity aimed at profiling of or discriminating against individuals;
Amendment 1392 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e
Article 35 – paragraph 1 – point e
(e) developing products or services that may harm individuals and societies at large, including, but not limited to illicit drugs, alcoholic beverages, tobacco and nicotine products, or goods or services which are designed or modified in such a way that they contravene public order or moralityincite addiction, harm public health and environment or contravene public order or morality or result in behavioural changes that reduce the freedom of choice or security of the natural persons.
Amendment 1426 #
2022/0140(COD)
Proposal for a regulation
Article 36 – paragraph 1 a (new)
Article 36 – paragraph 1 a (new)
1 a. Health data access bodies shall consist of two distinct parts, which shall be legally and organisationally separate from each other: (a) Authorisation bodies, which decide about data access applications pursuant to Article 37(1) and make the data accessible to authorised data users in a secure processing environment; (b) Trust bodies, which receive the electronic health data from data holders pursuant to Article 37(1a) and are responsible for disclosing the data to the authorisation bodies.
Amendment 1433 #
2022/0140(COD)
Proposal for a regulation
Article 36 – paragraph 2
Article 36 – paragraph 2
2. Member States shall ensure that each health data access body is provided with the humhuman resources with necessary legal an,d technical expertise, including ethical boards and committees, and financial resources, premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers.
Amendment 1442 #
2022/0140(COD)
Proposal for a regulation
Article 36 – paragraph 3
Article 36 – paragraph 3
3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients and consumers, data holders and data users. Staff, and with data protection experts. Health data access bodies shall actively cooperate with the authorities responsible for the application of EU and national data protection legislation. Staff members of health data access bodies shall havoid any conflicts of interese no direct or indirect economic, financial or personal conflicts of interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. Health data access bodies shall not be bound by any instructions, when making their decisions.
Amendment 1452 #
2022/0140(COD)
Proposal for a regulation
Article 36 – paragraph 3 a (new)
Article 36 – paragraph 3 a (new)
3 a. Member States shall determine and publish the selection procedure for health stakeholders referred to in paragraph 3. They shall ensure that the procedure is transparent and does not allow for conflicts of interest.
Amendment 1456 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – introductory part
Article 37 – paragraph 1 – introductory part
1. HThe authorisation bodies within the health data access bodies shall carry out the following tasks:
Amendment 1458 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point a
Article 37 – paragraph 1 – point a
(a) decide on data access applications pursuant to Article 45, authorise and issue data permits pursuant to Article 46 to access electronic health data falling within their national remit for secondary use and decide on data requests in accordance with Chapter II of Regulation […] [Data Governance Act COM/2020/767 final] and this Chapter. This includes deciding on whether the data shall be made accessible in anonymised or pseudonymised form, based on its own thorough assessment of any reasons provided by the data applicant pursuant to paragraph (d) of paragraph 2 of Article 45;
Amendment 1464 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point c
Article 37 – paragraph 1 – point c
(c) support Union institutions, bodies, offices and agencies in carrying out the tasks enshrined in their mandate of Union institutions, bodies, offices and agencies, based on national or, based on Union law;
Amendment 1466 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point d
Article 37 – paragraph 1 – point d
Amendment 1471 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point e
Article 37 – paragraph 1 – point e
Amendment 1473 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point f
Article 37 – paragraph 1 – point f
Amendment 1478 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point g
Article 37 – paragraph 1 – point g
Amendment 1482 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point h
Article 37 – paragraph 1 – point h
Amendment 1486 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point i
Article 37 – paragraph 1 – point i
Amendment 1489 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point j
Article 37 – paragraph 1 – point j
Amendment 1504 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point o
Article 37 – paragraph 1 – point o
Amendment 1513 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point q – point iii
Article 37 – paragraph 1 – point q – point iii
(iii) penalties applied pursuant to Article 43;69; (Due to alignment of art. 43 with art. 69)
Amendment 1521 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 a (new)
Article 37 – paragraph 1 a (new)
1 a. The trust bodies within the health data access bodies shall carry out the following tasks: (a) process electronic health data for the purposes set out in Article 34, including the collection, combination, preparation and disclosure of those data for secondary use on the basis of a data permit; (b) process electronic health data from other relevant data holders based on a data permit or a data request for a purpose laid down in Article 34; (c) take all measures necessary to preserve the confidentiality of IP rights and of trade secrets; (d) gather and compile or provide access to the necessary electronic health data from the various data holders whose electronic health data fall within the scope of this Regulation and put those data at the disposal of data users in a secure processing environment in accordance with the requirements laid down in Article 50; (e) contribute to data altruism activities in accordance with Article 40; (f) support the development of AI systems, the training, testing and validating of AI systems and the development of harmonised standards and guidelines under Regulation […] [AI Act COM/2021/206 final] for the training, testing and validation of AI systems in health; (g) cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;assist data holders to ensure they fully respect any refusals or restrictions for access for primary use pursuant to paragraphs 9 and 9a of Article 3; (h) facilitate cross-border access to anonymised electronic health data for secondary use hosted in other Member States through HealthData@EU and cooperate closely with each other and with the Commission.
Amendment 1523 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 2 – point a
Article 37 – paragraph 2 – point a
(a) cooperate with supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 in relation to personal electronic health data and the EHDS Board;
Amendment 1526 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 2 – point b
Article 37 – paragraph 2 – point b
(b) inform the relevant supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 where a health data access body has imposed penalties or other measures pursuant to Article 4369 in relation to processing personal electronic health data and, or where such processing refers to an attempt to re-identify an individual or unlawful processing of personal electronic health data; (Due to alignment between art. 43 and art. 69)
Amendment 1529 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 2 – point c
Article 37 – paragraph 2 – point c
(c) cooperate with stakeholders, including patient and consumer organisations, representatives from natural persons, health professionals, researchers, and ethical committees, where applicable in accordance with Union and national law;
Amendment 1534 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 4
Article 37 – paragraph 4
Amendment 1546 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 1 – point c
Article 38 – paragraph 1 – point c
(c) the applicable rights of natural persons in relation to secondary use of electronic health data, including the rights pursuant to Regulation (EU) 2016/679;
Amendment 1563 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. Health data access bodies shall not be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46.
Amendment 1565 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 3
Article 38 – paragraph 3
3. Where a health data access body is informed by a data user of a finding that may impact on the health of a natural person, the health data access body mayshall inform the natural person and his or her treating health professional about that finding, while respecting the principles of medical confidentiality and professional secrecy. In accordance with Article 23(1), point (i), of Regulation (EU) 2016/679, Member States may by law restrict the scope of the obligation to inform the natural person whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their information for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have an impact on them.
Amendment 1575 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 4
Article 38 – paragraph 4
4. Member States shall regularly inform the public at large about the role and benefits of health data access bodiesof the health data access bodies and the benefits and risk of sharing health data for research and decision-making.
Amendment 1583 #
2022/0140(COD)
Proposal for a regulation
Article 38 a (new)
Article 38 a (new)
Article 38 a Right to lodge a complaint with a health data access body 1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the health data access body, where their rights laid down in this Regulation are affected. Where the complaint concerns the rights of natural persons pursuant to Article 38(1), point (d), of this Regulation, the health data access body shall inform and send a copy of the complaint to the supervisory authorities under Regulation (EU) 2016/679. 2. The health data access body with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken.
Amendment 1584 #
2022/0140(COD)
Proposal for a regulation
Article 38 b (new)
Article 38 b (new)
Article 38 b Right to an effective remedy against a health data access body 1. Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to an effective judicial remedy against a legally binding decision of a health data access body concerning them. 2. Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to an effective judicial remedy where the health data access body which is competent pursuant to Article 37 does not handle a complaint or does not inform the natural or legal person within three months on the progress or outcome of the complaint lodged pursuant to Article 38a. 3. Proceedings against a health data access body shall be brought before the courts of the Member State where the health data access body is established.
Amendment 1587 #
2022/0140(COD)
Proposal for a regulation
Article 38 c (new)
Article 38 c (new)
Article 38 c Right to compensation 1. Any person who has suffered material or non-material damage as a result of an infringement of this Regulation shall have the right to receive compensation from the entity responsible for the infringement. 2. Any entity processing electronic health data shall be liable for the damage caused by infringing this Regulation.
Amendment 1600 #
2022/0140(COD)
Proposal for a regulation
Article 39 – paragraph 2
Article 39 – paragraph 2
2. The report shall be transmitted to the Commission, which shall make it publicly available on its website.
Amendment 1615 #
2022/0140(COD)
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
1. Where a data holder is obliged to make electronic health data available under Article 33 or under other Union law or national legislation implementing Union lawto a health data access body under Article 33, it shall cooperate in good faith with the health data access bodies, where relevant.
Amendment 1619 #
2022/0140(COD)
Proposal for a regulation
Article 41 – paragraph 2 a (new)
Article 41 – paragraph 2 a (new)
2 a. Paragraph 1 constitutes a legal obligation in the sense of Article 6(1)(c) of Regulation 2016/679 for the data holder to disclose personal electronic health data to the health data access body, in combination with Article 9(2), points (h), (i) and (j), of Regulation 2016/679.
Amendment 1622 #
2022/0140(COD)
Proposal for a regulation
Article 41 – paragraph 3 a (new)
Article 41 – paragraph 3 a (new)
Amendment 1623 #
2022/0140(COD)
Proposal for a regulation
Article 41 – paragraph 3 b (new)
Article 41 – paragraph 3 b (new)
3 b. By derogation from paragraph 3a, where the anonymisation can be done in an automated procedure that does not require an unreasonable effort, the data holder shall anonymise the data following the procedures and requirements pursuant to Article 44(3a), before putting it at the disposal of the health data access body.
Amendment 1634 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 1
Article 42 – paragraph 1
1. Health data access bodies and single data holders may charge fees for making electronic health data available for secondary use. Any fees shall include and be derived from the costs related to conducting the procedure for requests, including for assessing a data application or a data request, granting, refusing or amending a data permit pursuant to Articles 45 and 46 or providing an answer to a data request pursuant to Article 47, in accordance with Article 6 of Regulation […] [Data Governance Act COM/2020/767 final], as well as the technical and operational costs to prepare the data sets, including anonymization and pseudonymization, and to make them available.
Amendment 1643 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 3
Article 42 – paragraph 3
3. The electronic health data referred to in Article 33(1), point (o), shall be made available to a new user free of charge or against a fee matching the compensation for the costs of the human and technical resources used to enrich the electronic health data. That fee shall be paid to the entity that enriched the electronic health data.
Amendment 1650 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 4
Article 42 – paragraph 4
4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update that dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducaligning those fees proportionately towith their size or budget.
Amendment 1656 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 6
Article 42 – paragraph 6
6. The Commission mayshall, by means of implementingdelegated acts, lay down principles and rules for the fee policies and fee structures. Those implementingdelegated acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2)7.
Amendment 1658 #
2022/0140(COD)
Proposal for a regulation
Article 43 – title
Article 43 – title
Amendment 1663 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 4
Article 43 – paragraph 4
4. Health data access bodies shall have the power to revoke the data permit issued pursuant to Article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non- compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, the health data access bodies shall be able, where appropriate, to fine up to 10% of the data user's annual turnover for the previous financial year or revoke the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years. Where an EU institution, body or agency is the data user, the power to impose such penalties shall rest with the European Data Protection Supervisor, after notification from the health data access body.
Amendment 1675 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 5
Article 43 – paragraph 5
5. Where data holders withhold the electronic health data from health data access bodies with the manifest intention of obstructing the use of electronic health data, or do not respect the deadlines set out in Article 41, the health data access body shall have the power to fine the data holder with fines for each day of delay, which shall be transparent and proportionate. The amount of the fines shall be established by the health data access body. In case of repeated breaches by the data holder of the obligation of loyal cooperation with the health data access body, that body can exclude the data holder from participation in the EHDS for a period of up to 5 years. Where a data holder has been excluded from the participation in the EHDS pursuant to this Article, following manifest intention of obstructing the secondary use of electronic health data, it shall not have the right to provide access to health data in accordance withsubmitting data access applications pursuant to Chapter IV for a period of up to 5 years, while still being obliged to make data accessible pursuant to Chapter IV, where applicable. (Deletion of last sentence linked to the proposed deletion of Article 49.)
Amendment 1679 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 7
Article 43 – paragraph 7
7. Any penalties and measures imposed pursuant to paragraph 4 shall be made available to other health data access bodies and publicly available on the Commission’s website.
Amendment 1682 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 9
Article 43 – paragraph 9
Amendment 1683 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 10
Article 43 – paragraph 10
10. The Commission mayshall issues guidelines on penalties to be applied by the health data access bodies, in line with the principles set out in Article 69.
Amendment 1692 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 1
Article 44 – paragraph 1
1. The health data access body shall ensure that access is only provided to requested electronic health data relevantnecessary and relevant and as long as needed for the purpose of processing indicated in the data access application by the data user and in line with the data permit granted.
Amendment 1699 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
2. The health data access bodies shall provide the electronic health data in an anonymised format, where the purpose of processing by the data user can be achieved with such data, taking into account the information provided by the data user.:
Amendment 1702 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 2 – point a (new)
Article 44 – paragraph 2 – point a (new)
(a) where the purpose of processing by the data user can be achieved with such data, taking into account the information provided by the data user, or
Amendment 1703 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 2 – point b (new)
Article 44 – paragraph 2 – point b (new)
(b) where the data subject has not given explicit consent for the secondary use of their personal data.
Amendment 1710 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format where the data subject has given their explicit consent. The information necessary to reverse the pseudonymisation shall be available only to the health data access bodydata holder. Data users shall not re- identify the electronic health data provided to them in anonymised or pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring anonymisation or pseudonymisation shall be subject to appropriate penalties.
Amendment 1720 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 3 a (new)
Article 44 – paragraph 3 a (new)
3 a. The Commission shall, by means of implementing acts, set out the procedures and requirements, and provide technical tools, for a unified and irreversible procedure for anonymising and pseudonymising the electronic health data. Those implementing act sshall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 1725 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 1
Article 45 – paragraph 1
1. Any natural or legal personentity active in the area of health care, public health, or scientific or medical research may submit a data access application for the purposes referred to in Article 34.
Amendment 1731 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point a
Article 45 – paragraph 2 – point a
(a) a detailed explanation of the intended use of the electronic health data, including for which of the purposes referred to in Article 9(2) of Regulation (EU) 2016/679, in combination with Article 34(1), access is soughtnecessary;
Amendment 1737 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point a a (new)
Article 45 – paragraph 2 – point a a (new)
(a a) a description of the applicant’s identity, professional function and operation, including the identity of who will have access to the electronic health data;
Amendment 1753 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point h
Article 45 – paragraph 2 – point h
(h) a description of the free and open- source tools and computing resources needed for a secure environment.
Amendment 1774 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 4 – point a
Article 45 – paragraph 4 – point a
(a) a description of how the processing would comply with Article 6(1) of Regulation (EU) 2016/679;
Amendment 1791 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 1
Article 46 – paragraph 1
1. Health data access bodies shall assess if the application fulfils one of the purposes listed in Article 34(1) of this Regulation, if the requested data is necessary for the purpose listed in the application and if the requirements in this Chapter are fulfilled by the applicant. If that is the case, the health data access body shall issue a data permit.all of the following criteria:
Amendment 1796 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 1 – point a (new)
Article 46 – paragraph 1 – point a (new)
(a) the purposes described in the application match one of the purposes listed in Article 9(2) of Regulation (EU) 2016/679 in combination with Article 34(1) of this Regulation;
Amendment 1797 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 1 – point b (new)
Article 46 – paragraph 1 – point b (new)
Amendment 1798 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 1 – point c (new)
Article 46 – paragraph 1 – point c (new)
(c) the processing complies with applicable Union and national data protection law. The health data access bodies shall seek the advice from the competent data protection authorities for this matter;
Amendment 1799 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 1 – point d (new)
Article 46 – paragraph 1 – point d (new)
(d) the information provided in the application demonstrates sufficient safeguards planned to protect the rights and interests of the health data holder and of the natural persons concerned and to prevent any misuse;
Amendment 1800 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 1 – point e (new)
Article 46 – paragraph 1 – point e (new)
(e) the information on the assessment of ethical aspects of the processing, where applicable, is in line with national law;
Amendment 1801 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 1 – point f (new)
Article 46 – paragraph 1 – point f (new)
(f) other requirements in this Chapter.
Amendment 1807 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 2
Article 46 – paragraph 2
2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35 or, applications where the necessity of processing for the intended purpose has not been sufficiently demonstrated, applications that do not sufficiently provide safeguards on re-identification, and applications where requirements in this Chapter are not met.
Amendment 1816 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 3
Article 46 – paragraph 3
3. A health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where a health data access body fails to provide a decision within the time limit, the data permit shall be issued.
Amendment 1824 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 4
Article 46 – paragraph 4
4. Following the issuance of the data permit, the health data access body shall immediately request the electronic health data from the data holder and inform them whether the data shall be made accessible in anonymised or pseudonymised form. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless the health data access body specifies that it will provide the data within a longer specified timeframe due to circumstances beyond its control.
Amendment 1837 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 7
Article 46 – paragraph 7
7. Data users shall have the right to access and process the electronic health data in accordance with the data permit delivered to them on the basis of this Regulation, after they have demonstrated that the security measures pursuant to in Article 52, points (e) and (f), are effectively implemented.
Amendment 1859 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 14 a (new)
Article 46 – paragraph 14 a (new)
14 a. The authorities competent pursuant to applicable data protection legislation shall have the possibility to scrutinise and, if necessary, overturn the assessment of the data processing legal basis of data permit requests made to the health data access bodies.
Amendment 1864 #
2022/0140(COD)
Proposal for a regulation
Article 47 – paragraph 1
Article 47 – paragraph 1
1. Any natural or legal personentity active in the area of health care, public health, or scientific or medical research may submit a data request for the purposes referred to in Article 34. A health data access body shall only provide an answer to a data request in an anonymised statistical format and the data user shall have no access to the electronic health data used to provide this answer.
Amendment 1879 #
2022/0140(COD)
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
The requirement for a data permit shall be without prejudice to the right to access the electronic health data of public sector bodies and Union institutions, bodies, offices and agencies that carry out relevant activities within their mandate pursuant to Union or Member State law, where this mandate provides for such data access under this Regulation. By derogation from Article 46 of this Regulation, athe data permit shall not be required to access the electronic health data under this Articlefor public authorities may allow for data access for unlimited periods and for the possibility for periodic updates of data under a single data access application. When carrying out those tasks under Article 37 (1), points (b) and (c), the health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […] [Data Governance Act COM/2020/767 final]. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final ], the health data access body may extend the period by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless it specifies that it will provide the data within a longer specified timeframe. that shall not be longer than 2 additional months. Accelerated timelines shall be established in exceptional circumstances, including public health emergencies.
Amendment 1892 #
2022/0140(COD)
Proposal for a regulation
Article 49
Article 49
Access to electronic health data from a 1. access to electronic health data only from a single data holder in a single Member State, by way of derogation from Article 45(1), that applicant may file a data access application or a data request directly to the data holder. The data access application shall comply with the requirements set out in Article 45 and the data request shall comply with requirements in Article 47. Multi-country requests and requests requiring a combination of datasets from several data holders shall be addressed to health data access bodies. 2. issue a data permit in accordance with Article 46 or provide an answer to a data request in accordance with Article 47. The data holder shall then provide access to the electronic health data in a secure processing environment in compliance with Article 50 and may charge fees in accordance with Article 42. 3. 51, the single data provider and the data user shall be deemed joint controllers. 4. shall inform the relevant health data access body by electronic means of all data access applications filed and all the data permits issued and the data requests fulfilled under this Article in order to enable the health data access body to fulfil its obligations under Article 37(1) and Article 39.rticle 49 deleted single data holder Where an applicant requests In such case, the data holder may By way of derogation from Article Within 3 months the data holder
Amendment 1902 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 1 – point b
Article 50 – paragraph 1 – point b
(b) minimise the risk of the unauthorised reading, copying, modification or removal of electronic health data hosted in the secure processing environment through state-of-the-art technologicical and organisational meansures;
Amendment 1904 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 1 – point e
Article 50 – paragraph 1 – point e
(e) keep identifiable logs of access to the secure processing environment for the period of time necessary to verify and audit all processing operations in that environment and not shorter than one year;
Amendment 1909 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 2
Article 50 – paragraph 2
2. The health data access bodies shall ensure that electronic health data can be uploaded by data holders and can be accessed by the data user in a secure processing environment. The data users shall only be able to download or copy non- personal electronic health data from the secure processing environment.
Amendment 1912 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 3 a (new)
Article 50 – paragraph 3 a (new)
3a. The tools and computing resources provided in the secure processing environment shall be based on free and open-source software.
Amendment 1915 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 4
Article 50 – paragraph 4
4. The Commission shall, by means of implementing acts, provide for the technical, organisational, information security and interoperability requirements for the secure processing environments. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 1922 #
2022/0140(COD)
Proposal for a regulation
Article 51 – paragraph 2
Article 51 – paragraph 2
2. The Commission shall, by means of implementing acts, establish a template for the joint controllers’ arrangement that meets the requirements laid down in Article 28(3) of Regulation (EU) 2016/679. Those implementing acts shall be adopted in accordance with the advisory procedure set out in Article 68(2). The use of that template shall not relieve the health data access bodies or the data users from any of their duties and responsibilities.
Amendment 1935 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 5
Article 52 – paragraph 5
5. Third countries or international organisations may become authorised participants where they comply with the rules of Chapter IV of this Regulation and provide access to data users located in the Union, on equivalent terms and conditions, to the electronic health data available to their health data access bodies. The Commission may adopt implementing acts establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of HealthData@EU for the purposes of secondary use of health data, is compliant with the Chapter IV of this Regulation and provides access to data users located in the Union to the electronic health data it has access to on equivalent terms and conditions. The compliance with these legal, organisational, technical and security requirements, including with the standards for secure processing environments pursuant to Article 50 shall be checked under the control of the Commission. These implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68 (2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available. This paragraph is without prejudice to the requirements and safeguards for international transfer of personal data pursuant to Chapter V of Regulation (EU) 2016/679.
Amendment 1941 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 9
Article 52 – paragraph 9
9. The Commission shall develop, deploy and operate a core platform for HealthData@EU by providing information technology services needed to facilitate the connection between health data access bodies as part of the cross-border infrastructure for the secondary use of electronic health data. The Commission shall only process electronic health data on behalf of the joint controllers as a processor.
Amendment 1942 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 10
Article 52 – paragraph 10
Amendment 1943 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 11
Article 52 – paragraph 11
Amendment 1944 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 12
Article 52 – paragraph 12
Amendment 1946 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – introductory part
Article 52 – paragraph 13 – subparagraph 1 – introductory part
The Commission may, by means of implementingdelegated acts, set out:
Amendment 1950 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – point a
Article 52 – paragraph 13 – subparagraph 1 – point a
(a) requirements, technical specifications, the IT architecture of HealthData@EU, conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EUwhich shall guarantee a high level of data security, confidentiality and protection of electronic data pursuant to the state-of-the-art;
Amendment 1951 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – point a a (new)
Article 52 – paragraph 13 – subparagraph 1 – point a a (new)
(aa) conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EU;
Amendment 1954 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – point c
Article 52 – paragraph 13 – subparagraph 1 – point c
Amendment 1956 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – point d
Article 52 – paragraph 13 – subparagraph 1 – point d
Amendment 1958 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – point e
Article 52 – paragraph 13 – subparagraph 1 – point e
Amendment 1964 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 2
Article 52 – paragraph 13 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2)7.
Amendment 1970 #
2022/0140(COD)
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. The Commission may, by means of implementingdelegated acts, adopt the necessary rules for facilitating the handling of data access applications for HealthData@EU, including a common application form, a common data permit template, standard forms for common electronic health data access contractual arrangements, and common procedures for handling cross- border requests, pursuant to Articles 45, 46, 47 and 48. Those implementingdelegated acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2)7.
Amendment 1979 #
2022/0140(COD)
Proposal for a regulation
Article 55 – paragraph 2
Article 55 – paragraph 2
2. The Commission shall, by means of implementingdelegated acts, set out the minimum information elements data holders are to provide for datasets and their characteristics. Those implementingdelegated acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2)7.
Amendment 1985 #
2022/0140(COD)
Proposal for a regulation
Article 59 – paragraph 1
Article 59 – paragraph 1
The Commission shall support sharing of best practices and expertise, aimed to build the capacity of Member States to strengthen digital health literacy and systems for primary and secondary use of electronic health data. To support capacity building, the Commission shall draw up benchmarking guidelines for the primary and secondary use of electronic health data.
Amendment 1987 #
2022/0140(COD)
Proposal for a regulation
Article 60 – paragraph 2 a (new)
Article 60 – paragraph 2 a (new)
2a. Public procurers, national, regional and local competent authorities, including digital health authorities and health data access bodies, and the Commission shall require, as a condition to procure or fund services provided by controllers and processors established in the Union processing personal electronic health data, that such controllers and processors: (a) will store this data in the Union, in accordance with Article 60a of this Chapter, and (b) have duly demonstrated that they are not subject to third country legislation conflicting with Union data protection rules.
Amendment 1991 #
2022/0140(COD)
Proposal for a regulation
Article 60 a (new)
Article 60 a (new)
Article 60a Storage of electronic health data For the purposes of primary and secondary use of electronic health data, Member States shall ensure that the storage, processing and analysis of electronic health data shall be carried out exclusively within a secure location or locations within the territory of the Union, without prejudice to the possibility to transfer personal electronic health data in compliance with Chapter V of Regulation (EU) 2016/679.
Amendment 1996 #
2022/0140(COD)
Proposal for a regulation
Article 61 – paragraph 1
Article 61 – paragraph 1
1. Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (e), (f), (i), (j), (k), (m)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final], provided that their transfer to third countries presents a risk of re-identification through means going beyond those likely reasonably to be used, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future.
Amendment 2005 #
2022/0140(COD)
Proposal for a regulation
Article 61 – paragraph 2
Article 61 – paragraph 2
2. TheAdditional protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization techniques and shall be detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].
Amendment 2028 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States. Other national authorities, including market surveillance authori, and high-level representatives referred to in Article 28,of the European Data Protection Board and the European Data Protection Supervisor may be invited to the meetings, where the issues discussed are of relevance for them. Other national authorities, including market surveillance authorities referred to in Article 28, shall be invited to the meetings as permanent observers. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an ad hoc observer role where the issues discussed are of relevance for them.
Amendment 2031 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 1 a (new)
Article 64 – paragraph 1 a (new)
1a. Permanent and alternate members of the EHDS Board shall act independently, in the public interest and free from any external influence. EHDS Board permanent and alternate members shall have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. Permanent and alternate members of the EHDS Board shall make an annual declaration of their interests, which shall be available on the Commission’s web-portal.
Amendment 2032 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The composition, organisation, functioning and cooperation of the sub- groups shall be set out in the rules of procedure put forward by the Commission. The Commission shall make publicly available the membership and observers of the EHDS Board and its outputs, including rules of procedure, guidance, minutes, and meeting agendas.
Amendment 2035 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 4
Article 64 – paragraph 4
4. Stakeholders and relevant third parties, including patients’, consumers’ and healthcare professionals’ representatives, shall be invited to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity. All invited stakeholders shall provide a declaration of all direct and indirect economic, financial or personal interests ahead of the meeting to the EHDS Board.
Amendment 2048 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 1 – point b – point iii
Article 65 – paragraph 1 – point b – point iii
(iii) other aspects of the primary use of electronic health data, with the exception of aspects concerning the protection of natural persons when processing their personal data.
Amendment 2052 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 1 – point d
Article 65 – paragraph 1 – point d
(d) to share information concerning risks posed by EHR systems and serious incidents as well as their handling, without prejudice to the obligation to inform competent supervisory authorities pursuant to Regulation (EU) 2016/679;
Amendment 2053 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 1 – point e
Article 65 – paragraph 1 – point e
(e) to facilitate the exchange of views on the primary use of electronic health data with the relevant stakeholders, including representatives of patients, consumers, health professionals, researchers, regulators and policy makers in the health sector.
Amendment 2059 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 2 – point b – point vi
Article 65 – paragraph 2 – point b – point vi
(vi) other aspects of the secondary use of electronic health data, with the exception of aspects concerning the protection of natural persons when processing their personal data.
Amendment 2062 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 2 – point c
Article 65 – paragraph 2 – point c
(c) to facilitate cooperation and exchange of best practices between health data access bodies through capacity- building, establishing the structure for annual activity reporting, peer-review of annual activity reports and exchange of information pursuant to the obligations laid down in Article 37(1), point (q);
Amendment 2071 #
2022/0140(COD)
Proposal for a regulation
Article 66 – paragraph 3
Article 66 – paragraph 3
3. Stakeholders and relevant third parties, including patients’ representative, consumers’ and healthcare professionals’ representatives and data protection experts, may be invited to attend meetings of the groups and to participate in their work.
Amendment 2074 #
2022/0140(COD)
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 5(2), 10(3), 25(3), 32(4), 33(7), 377(3), 9(2), 25(3), 26(4a) 32(4), 39(3), 41(7), 42(6) 45(7), 46(8), 52(7), 52(13), 53(3), 55(2), 56(4) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
Amendment 2078 #
2022/0140(COD)
Proposal for a regulation
Article 67 – paragraph 3
Article 67 – paragraph 3
3. The power to adopt delegated acts referred to in Articles 5(2), 10(37(3), 9(2), 25(3), 326(4a), 33(7), 372(4), 39(3), 41(7), 42(6), 45(7), 46(8), 52(7), 52(13), 53(3), 55(2), 56(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 2084 #
2022/0140(COD)
Proposal for a regulation
Article 67 – paragraph 6
Article 67 – paragraph 6
6. A delegated act adopted pursuant to Articles 5(2), 10(37(3), 9(2), 25(3), 326(4a), 33(7), 372(4), 39(3), 41(7), 42(6), 45(7), 46(8), 52(7), 52(13), 53(3), 55(2), 56(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 3 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or of the Council.
Amendment 2089 #
2022/0140(COD)
Proposal for a regulation
Article 69 – paragraph 1
Article 69 – paragraph 1
Member States shall lay down the rules on penalties applicable to infringements of this Regulation, for all public and private stakeholders, in particular for the non- respect of data access and usage provisions with intent or by negligence, and shall take all measures necessary to ensure that they are properly and effectively implemented. The penalties shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them. Penalties shall cover infringements not addressed by Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) No 536/2014 and Regulation (EU) 2016/679.
Amendment 2092 #
2022/0140(COD)
Proposal for a regulation
Article 69 – paragraph 1 a (new)
Article 69 – paragraph 1 a (new)
Amendment 2093 #
2022/0140(COD)
Proposal for a regulation
Article 69 – paragraph 1 b (new)
Article 69 – paragraph 1 b (new)
The non-compliance of an entity with any requirements or obligations under this Regulation, including the supply of incorrect, incomplete or misleading information to national competent authorities, shall be subject to penalties of up to 20 million EUR or, or in the case of an undertaking, up to 10% of its total worldwide annual turnover for the preceding financial year, whichever is higher. In case the non-compliance is still going on, the health data access body shall have the power to fine the entity with fines for each day of delay, which shall be transparent and proportionate. The amount of the fines shall be established by the health data access body pursuant to paragraph 1a.
Amendment 2099 #
2022/0140(COD)
Proposal for a regulation
Article 70 – paragraph 1
Article 70 – paragraph 1
1. After 5 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III and IV, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. The evaluation shall include an assessment of the self- certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies, as well as the need to designate a public testing facility of a Member State as a Union testing facility, pursuant to Article 21 of Regulation (EU) 2019/1020. The evaluation shall also assess the added value, associated risks and feasibility of adding wellness applications and other digital health applications in the scope of primary and secondary use of the EHDS.
Amendment 2110 #
2022/0140(COD)
Proposal for a regulation
Article 71 a (new)
Article 71 a (new)
Article 71a Amendment to Directive (EU) 2020/1828 In the Annex of Directive (EU) 2020/1828, the following point is added:“(XX) Regulation (EU) XXX of the European Parliament and of the Council on the European Health Data Space”
Amendment 2127 #
2022/0140(COD)
Proposal for a regulation
Annex II – point 2 – point 2.3
Annex II – point 2 – point 2.3
2.3. An EHR system that includes a functionality for entering structured personal electronic health data shall enable the entry of data structured in a structured way that supports the data sharing in a structured, commonly used, open and machine- readable format, enabling system to system communication.
Amendment 2128 #
2022/0140(COD)
Proposal for a regulation
Annex II – point 2 – point 2.4
Annex II – point 2 – point 2.4
2.4. An EHR system shall not include features that prohibit, restrict or place undue burden on authorised access, personal electronic health data sharing, or use of personal electronic health data for permitted purposes, in particular on the basis of commercial considerations and beyond security and legal safeguards requirements.
Amendment 12 #
2022/0031(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) As a result, it cannot be excluded that Member States continue to require Union citizens exercising their right to free movement to present proof of COVID-19 vaccination, test or recovery beyond 30 June 2022, the date when Regulation (EU) 2021/953 is set to expire. It is thus important to avoid that, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022, Union citizens and their family members are deprived of the possibility to make use of their EU Digital COVID Certificates, which are an effective, secure and privacy-preserving way of proving one’s COVID-19 status. At the same time, given that any restrictions to the free movement of persons within the Union put in place to limit the spread of SARS-CoV- 2, including the requirement to present EU Digital COVID Certificates, should be lifted as soon as the epidemiological situation allows, the extension of the application of Regulation (EU) 2021/953 should be limited to 126 months. In addition, the extension of that Regulation should not be understood as requiring Member States, in particular those that lift domestic public health measures, to maintain or impose free movement restrictions. The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union delegated to the Commission pursuant to Regulation (EU) 2021/953 should be equally extended. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to scientific progress in containing the COVID-19 pandemic.
Amendment 14 #
2022/0031(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Several Member States have used the EU Digital COVID Certificate for domestic purposes by implementing national measures to allow or ban access to bars, restaurants, hotels, concert halls and other venues, despite the fact that the initial aim of the EU Digital COVID Certificate was not to be used for these purposes and that non-discrimination to access to essential services should have been preserved. Therefore, without prejudice to Member States’ competence to impose national restrictions on grounds of public health and taking into account the current phase of the pandemic, the EU Digital COVID Certificate should serve its original and primary objective, namely to be used as a tool to facilitate free of movement and EU level coordination. The EU Digital COVID Certificate should not be understood as a measure for Member States to impose unjustified and disproportionate restrictions for domestic purposes.
Amendment 30 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5 d (new)
Article 1 – paragraph 1 – point 5 d (new)
Regulation (EU) 2021/953
Article 11 – paragraph 4 a (new)
Article 11 – paragraph 4 a (new)
(5d) In Article 11, the following paragraph is added: "4a. Member States shall refrain from using the EU Digital COVID Certificate to introduce further restrictions for domestic purposes. "
Amendment 31 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EU) 2021/953
Article 12 – paragraph 2
Article 12 – paragraph 2
2. The power to adopt delegated acts referred to in Article 5(2), Article 6(2) and Article 7(1) and (2) shall be conferred on the Commission for a period of 2418 months from 1 July 2021.;
Amendment 33 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EU) 2021/953
Article 17 – paragraph 2
Article 17 – paragraph 2
It shall apply from 1 July 2021 to 30 June1 December 20232.
Amendment 2 #
2022/0030(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The application of Regulation (EU) 2021/953 is to be prolonged by 126 months. Since the objective of Regulation (EU) 2021/954 is to extend the application of Regulation (EU) 2021/953 to certain categories of third country nationals lawfully residing or staying in the Union, the duration of its application should be directly linked to that of Regulation (EU) 2021/953. Regulation (EU) 2021/954 should therefore be amended accordingly.
Amendment 1 #
2021/2075(INI)
Draft opinion
Paragraph -1 (new)
Paragraph -1 (new)
-1. Considers that the main challenges that urban areas face are related to high levels of congestion, CO2 emissions, noise and air pollution as well as road safety; stresses that congestion has huge socioeconomic costs, particularly in terms of lost productivity; notes that urban mobility is responsible for 40% of all CO2 emissions of road transport and up to 70% of other pollutants from transport; recognises that air and noise pollution has a negative impact on both physical and mental health; notes that 38% of road deaths take place on urban roads and 70% of these are pedestrians, cyclists and powered two wheelers;
Amendment 3 #
2021/2075(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses that lockdownthe Covid-19 pandemic has had a considerable impact on mobility demand and the choice of transport mode, particularly towards cycling, especially in urban areas; notes that the social distancing introduced as part of sanitary measures in the EU has led citizens to take up mobility options other than public transport in order to avoid gatherings of people; is concerned that the temporary increase in the use of private car in this particular context can have long-standing detrimental impacts in terms of emissions and congestion, unless proactive policies are put in place to foster the return and further uptake of public transport and active mobility means;
Amendment 13 #
2021/2075(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Is concerned that despite the Covid-19 pandemic which improved air quality in many regions due to a sudden drop in mainly road transport, most EU countries broke at least one EU air pollution limit in 2020; notes that the new WHO Global Air Quality Guidelines (AQGs) presented on 22nd September 2021 provide clear evidence of the damage air pollution cause on human health, including at lower concentrations than previously known and welcomes the fact that they recommend new air quality levels to protect the health of human populations; reminds that EU limits are in general far above the WHO maximum thresholds and calls therefore on the Commission to align its air quality directives with these new WHO AQGs;
Amendment 14 #
2021/2075(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Welcomes the Special Report 06/2020 on Sustainable Urban Mobility in the EU1a by the European Court of Auditors; takes good note of its conclusions that EU cities are not sufficiently moving towards more sustainable and environmentally friendly modes of transport and that the EU funds dedicated to sustainable mobility are not yet effectively used so as to fulfil their objectives; recalls that in the report the ECA has estimated that congestion is costing the EU around €270bn a year, and also that achieving fluid movement of people in urban areas could spur economic growth and boost workers’ productivity by up to 30%; _________________ 1aECA Special Report 06/2020 on Sustainable Urban Mobility in the EU: No substantial improvement is possible without Member States’ commitment https://www.eca.europa.eu/Lists/ECADoc uments/SR20_06/SR_Sustainable_Urban _Mobility_EN.pdf
Amendment 19 #
2021/2075(INI)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1 c. Considers that a more optimal allocation of scarce urban road space remains one of the core levers for a mobility transformation, fostering that cities shift away from car-centric strategies towards people and place-based resources, through improved movement of people rather than vehicles; underlines that the pandemic has favoured the rediscovery of proximity shops and activities, as theorised by the 15-minute city concept, with increased flexibility and where walking is predominant;
Amendment 21 #
2021/2075(INI)
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1 d. Notes that the increased teleworking during the lockdown period had a huge impact on mobility demand and resulted in global reductions of CO2 emissions between 8% to 75% depending on the city; believes that teleworking will remain an attractive option for many workers, at least part time, and this will have an impact on the planning of future urban mobility;
Amendment 22 #
2021/2075(INI)
Draft opinion
Paragraph 1 e (new)
Paragraph 1 e (new)
1 e. Points out that, according to the Commission's Handbook on external costs of transport1a, private vehicles are by far the largest contributor to negative externalities within passenger transport modes and that besides generating congestion and emissions related to their traffic, also when parked cars occupy a large part of the urban space, which is already increasingly scarce due to the growing trends of urbanisation; considers that reduction in emissions and other externalities requires discouraging individual road transport and the mass transition of users from private transport to collective public transport; calls to the respective competent authorities to direct public investment at public services, instead of promoting individual mobility, in order to accelerate the decarbonisation of road transport; _________________ 1a Handbook on external costs of transport - Version 2019 https://op.europa.eu/en/publication- detail/-/publication/9781f65f-8448-11ea- bf12-01aa75ed71a1
Amendment 23 #
2021/2075(INI)
Draft opinion
Paragraph 1 f (new)
Paragraph 1 f (new)
1 f. Points out that restrictive measures imposed during the lockdown have shown that more space can be made available for walking and cycling, as well as for the hospitality sector and commerces, and it is up to local authorities to keep up with it also in the long term; salutes that cities are reducing parking spaces and creating mobility hubs where it is possible to access a variety of shared services like electric car, bike and e-scooter sharing, welcomes in this regard measures such as park and ride inter- modal facilities for commuters from outside urban areas to reach the city by rail and/or public transport; considers it a positive trend that, together with the remarkable increase of car-free city centres across Europe and the establishment of ultra-low emission zones, contributes to prevent congestion and reduce emissions;
Amendment 24 #
2021/2075(INI)
Draft opinion
Paragraph 1 g (new)
Paragraph 1 g (new)
1 g. Notes that during the COVID pandemic access to public transport stations dropped by almost -70% in Europe; urges public authorities to put in place strategies and campaigns to promote the retake of public transport, tackling any safety concerns passengers might still have; considers that a level of occupancy allowing for social distancing must be ensured, which requires an adequate frequency of service;
Amendment 25 #
2021/2075(INI)
Draft opinion
Paragraph 1 h (new)
Paragraph 1 h (new)
1 h. Stresses the importance of the socioeconomic dimension of guaranteeing an adequate public transport network and quality of service, also in the urban periphery, particularly in terms of reducing existing inequalities and preventing further disadvantages exacerbated in the absence of proper public transport for the least favoured people; reminds that the high total costs of ownership of private cars, among other aspects, are an important barrier for many as well as the growing trend under the Mobility as a Service logic of individuals and families not owing a car; emphasises therefore that mobility policies must be designed under the premise that citizens need to be fully mobile without a car, including people with disabilities;
Amendment 27 #
2021/2075(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. SRecognises that public transport is the backbone of sustainable urban mobility; therefore stresses the need for local authorities to reengineercontinuously support actions within public transport in order to ensure safe, healthy and environmentally sustainable commuting options and to complement public transport with on-demand and shared transport services; making it an efficient, accessible and affordable alternative to private car use; calls furthermore on Member States and local authorities to firstly increase the outreach and frequency of public transport and equip it with additional integrated digital infrastructure, making it more compatible with on-demand management such as e-bikes and e-scooters as well as shared transport services and collaborative innovation platforms;
Amendment 37 #
2021/2075(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Calls on the Commission to ensure that Urban Mobility Framework places at its forefront the provision of the necessary tools to support the expansion of affordable, attractive, accessible and green public transport, including securing adequate funding in order to enable it achieving its maximum potential to deliver these objectives;
Amendment 39 #
2021/2075(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2 b. Suggests the Commission and Member States who have not implemented it to respectively assess the feasibility and consider establishing free public transport;
Amendment 41 #
2021/2075(INI)
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2 c. Notes that people with disabilities and reduced mobility face additional barriers that often hinder the accessibility to public transport services which is often not enough adapted to their needs and time requirements; stresses the need of making public transport accessible for everybody, also for people with disabilities and reduced mobility; and points out that the increased demand for these services due to the aging population can provide a boost to the systematic consideration of these users; urges public authorities to actively involve people with disabilities and reduced mobility in the identification of needs and in the design of solutions, and in particular duly ensure their participation in the SUMPs procedure;
Amendment 43 #
2021/2075(INI)
Draft opinion
Paragraph 2 d (new)
Paragraph 2 d (new)
2 d. Underlines that people with disabilities are vulnerable users at risk of social exclusion; stresses that beyond infrastructure and service flexibility, inclusion often depends on the behaviour and awareness of other users and points out that according to research one in four disabled people do not use public transport due to negative attitudes from other passenger; regrets that although a stated SUMP objective is to “ensure that all citizens are offered transport options that enable access to key destinations and services”, people with disabilities are only mentioned twice in the guidelines, and that a dedicated topic guide does not exist;
Amendment 46 #
2021/2075(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Calls for a revision of the Commission guidelines on developing and implementing sustainable urban mobility plans (SUMPs) to include a new objective to improve the resilience of mobility systems in case of rapid fluctuations in mobility demand; notes that demand management and land-use planning can lower traffic volumes; stresses that facilitating active mobility and guaranteeing protection of active road users should become an integral part of urban mobility and infrastructure design, which should be included within SUMPs, where the Commission already recommends including road safety as a horizontal objective;
Amendment 55 #
2021/2075(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Considers that future SUMPs should be the basis of mobility transition, going beyond traffic management and instead focus on creating an affordable, accessible and efficient green public transport offer and incentivising active mobility, particularly through adequate investment in cycling infrastructure;
Amendment 63 #
2021/2075(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Recognises that urban logistics are an essential public service; calls on local authorities to develop dedicated sustainable urban logistics plans that integrate freight into the planning of more dynamic and flexible uses of curb spacnotes the increased demand in home deliveries, also by cars, vans and powered two-wheeled vehicles such as mopeds, as a consequence of the Covid-19 pandemic, adding to congestion, increased emissions and pollution; calls on local authorities to develop dedicated sustainable urban logistics plans that integrate freight into the planning of more dynamic and flexible uses of curb space; underlines that cargo bikes have huge potential for transporting goods in urban areas including last-mile logistics, and can play an important role in reducing congestion, emissions and pollution; hence, urges EU support fore- bikes and cargo bikes; considers it crucial to establish regular safety assessments in order to improve the standards of these bikes and the cycling infrastructure;
Amendment 71 #
2021/2075(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Calls on the Commission to come up with a recommendation on the safety of delivery personnel, also within the gig economy, including requirements for employers and companies to ensure the provision and use of safety equipment and safe vehicles, as well as training in the digital tools they might have to use, such as applications and interactive platforms; calls also on the Commission and Member States to ensure that professional van drivers undergo appropriate training and to address the issue of van drivers’ fatigue and speeding, particularly as a result of the large increase in the number of home deliveries;
Amendment 75 #
2021/2075(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Calls on the Member States and local authorities to reassessprioritise and increase their investments in sustainable urban mobility and to give priority to investments in safe and active mobility infrastructure in order to accelerate the rethinking of space and transport modes, to invest in zero-emission vehicle procurement for public transport, maintain and upgrade its infrastructure including sufficient quick charging stations for electric vehicles and light means of transport, as well as ensuring multimodal integration; reminds the importance of a robust digital infrastructure that will improve the general experience of all passengers and be adapted to the post- COVID-19 needs of transport workers; calls furthermore on the Commission to lead the transition by proposing tools, such as single integrated ticketing, which can increase the uptake of public transport; stresses that coordination between different key stakeholders and accessibility for all are considerable challenges in the digital era;
Amendment 80 #
2021/2075(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Notes that bike sales have experienced a boom almost everywhere as cycling has increased as a response to the Covid-19 pandemic; calls on Member States and local authorities to dedicate adequate investments in active mobility infrastructure and to do their utmost to ensure that active mobility infrastructure that have been put in place during the pandemic become permanent and are further expanded in order to promote safe, sustainable and active mobility, which has also significant health benefits and reduce congestion; in this regard, calls on the Commission to publish a strategy on active mobility to capitalise on these changes as well as mobilise funding;
Amendment 86 #
2021/2075(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Stresses the importance of improving liveability and life quality in urban areas and welcomes plans for supporting the creation of climate-neutral cities; underlines in this regard the importance of reducing the centrality of private motorised vehicles in the public realm in order to reallocate more public space to citizens and children in particular; welcomes the European-wide annual car-free Sunday initiative given its widespread popularity and positive impact on road safety and other negative externalities, and suggests to increase its frequency to at least once a month;
Amendment 90 #
2021/2075(INI)
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5 c. Underlines that gender-related differences, such as physical and social characteristics, result in inequalities in mobility opportunities; takes note of the recent study2a highlighting that although women are motivated to travel actively for health reasons, concerns about their personal safety and harassment vulnerability, convenience and appearance are barriers preventing them from cycling and walking; underlines that a further modal shift into sustainable public transport and active mobility would require ensuring accessibility for everyone, especially taking into account the needs of women in terms of scheduling, destination and mobility patterns, accessibility of buses and wagons, security and safety as women tend anyway to use public transport and walk more than men; calls on the Commission and Member States to put forward recommendations to encourage the participation of women in the planning of urban mobility solutions and in decision-making processes; _________________ 2aSustrans, 2018. "Are We Nearly There Yet? Exploring Gender and Active Travel"
Amendment 92 #
2021/2075(INI)
Draft opinion
Paragraph 5 d (new)
Paragraph 5 d (new)
5 d. Considers that reducing the centrality of private cars, including with measures such as car-free city centres would not only contribute to the climate neutrality of urban mobility but also be an appropriate answer to women’s needs, as they tend to travel with public transport to a greater extent than men;
Amendment 94 #
2021/2075(INI)
Draft opinion
Paragraph 5 e (new)
Paragraph 5 e (new)
5 e. Insists that regional and local authorities have a key role to play in all stages: planning, preparation and implementation; strongly supports the "partnership principle" and the inclusion of NGOs and other stakeholders, as well as regional and local authorities, in the consultation process; encourages enabling more direct EU funding for local and regional authorities in order to improve efficiency, ensure consistency and reduce administrative burden; recalls that transparency and proactive communication on available funds is also an important requirement to ensure their most effective use;
Amendment 96 #
2021/2075(INI)
Draft opinion
Paragraph 5 f (new)
Paragraph 5 f (new)
5 f. Reminds that 18,844 people lost their lives in road traffic in the EU in 2020 and emphasises that 38% of road deaths occur on urban roads, with 70% of the victims being pedestrians, cyclists and powered two wheelers; emphasises that as the EU becomes more urban, road safety is becoming more and more an urban issue;
Amendment 97 #
2021/2075(INI)
Draft opinion
Paragraph 5 g (new)
Paragraph 5 g (new)
5 g. Reminds that speeding is a key factor in around 30 % of fatal road crashes and an aggravating factor in most crashes; notes that lower speed limit zones have also been introduced in some urban areas as a result of altered mobility patterns of Covid-19; calls on the Commission in its expected recommendation on speed, to make 30km/h the default speed on urban roads, as well as encouraging lower speeds of 15 km/h for residential areas predominantly for pedestrians and cyclists and around schools as a tool for improving road safety and encourage active mobility, such cycling and walking;
Amendment 99 #
2021/2075(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Believes that the Commission should ensure that access to EU funding programmes for urban mobility, such as the European Regional Development Fund, the Cohesion Fund and the Connecting Europe Facility, is conditional on existing or prospective sustainable urban mobility plans (SUMPs) which among others also ensure the highest standards of road safety and particularly protecting vulnerable road users; calls on the Commission to consider ways of supporting cities in preparing their SUMPs according to the highest standards; calls furthermore on the Commission to establish an indicator on the use of EU funds towards effectively improving urban road safety, and particularly ensuring the highest design standards to protect vulnerable road users and foster active mobility;
Amendment 103 #
2021/2075(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Considers that the volume of such funding should be enlarged in order for more urban areas to benefit from it; believes that in order to be fully eligible and have priority access to these EU funds, in the field of both urban and inter-urban mobility, programmes, plans and strategies should support particularly rail and cycling infrastructure, including multimodality enablers; requests moreover the Commission to closely monitor that allocated money is actually spent on public transport and active mobility, and to what extent its fragmented budget is delivering;
Amendment 110 #
2021/2075(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Stresses that the Union should strongly support the development of financing schemes for the purchase and procurement of the still more expensive zero-emission vehicles, particularly for public transport fleets, as requested under the Clean Vehicles directive; believes moreover that EU funding instruments such as InvestEU and CEF could steer investments into zero-emission vehicles and the deployment of related charging infrastructure;
Amendment 113 #
2021/2075(INI)
Draft opinion
Paragraph 6 c (new)
Paragraph 6 c (new)
6 c. Urges all ‘urban nodes’ in the TEN-T network and all other medium and large cities to have a Sustainable Urb an Mobility Plan (SUMP) by 2030 with road safety targets and measures, as foreseen within the Sustainable and Smart Mobility Plan;
Amendment 116 #
2021/2075(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Reiterates that sustainable development and the management of urban tourism need to be fully integrated into the wider urban agenda. ; notes that especially overtourism can have negative environmental and economic impacts such as increased pollution, loss of biodiversity, congestion, infrastructure maintenance costs and rising prices, particularly in housing, as documented in the TRAN study ‘Overtourism: impact and possible policy responses’1a; therefore calls on the Member States to invest in funding to support the shift towards more sustainable, innovative, resilient and high-quality tourism products and services and further contribute to sustainability, out-of-season travel and the geographical dispersion of tourism flows; _________________ 1a https://www.europarl.europa.eu/RegData/ etudes/STUD/2018/629184/IPOL_STU(20 18)629184_EN.pdf
Amendment 2 #
2021/2014(INI)
Motion for a resolution
Citation 10 a (new)
Citation 10 a (new)
— having regard to the Council “Declaration on Cycling as a climate friendly Transport Mode” signed by EU ministers for Transport at the Informal meeting in Luxembourg, October 7th, 2015;
Amendment 11 #
2021/2014(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the share of road deaths of vulnerable road users is increasing, as car users have been the main beneficiaries of improved vehicle safety and other road safety measures; whereas the safety of cyclists and pedestrians must be urgently addressed; whereas a modal shift towards sustainable public transport modes and active mobility is an important tool to reduce road deaths and serious injuries;
Amendment 15 #
2021/2014(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas speed and speeding are key factors in around 30 % of fatal road crashes and an aggravating factor in most crashes; whereas both the risk of fatal accidents and the severity of consequences in terms of serious injuries drastically increase at speeds above 30 km/h; whereas reducing the number of fatal accidents and serious injuries towards Vision Zero will require the setting up of 30 km/h speed limits in residential areas;
Amendment 18 #
2021/2014(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
C b. whereas some big cities across the Union have introduced 30 km/h measures in whole urban areas or large andrelevant parts of it, as well as other pioneering measures to reduce the traffic and speed within those areas, such as “superblocks” and “peaceful neighbourhoods”, moreover freeing up public space for active mobility, green spaces and terraces;
Amendment 20 #
2021/2014(INI)
Motion for a resolution
Recital C c (new)
Recital C c (new)
C c. whereas the weight, power and top speed of new cars sold in the EU are increasing and it is becoming more common with vehicles with a square front; whereas the growing trend in sales of bigger and heavier cars such as Sport Utility Vehicles has increased road safety risks, in particular for vulnerable road users but also eventually for smaller vehicle occupants in case of a collision, given the disparities in mass of the vehicles; whereas these trends are having a negative impact on air pollutants and CO2 emissions;
Amendment 21 #
2021/2014(INI)
Motion for a resolution
Recital C d (new)
Recital C d (new)
C d. whereas the LISA Car concept promotes the choice of cars whose weight, power, top speed and front design are optimised to limit the safety risk they present and CO2 emissions;
Amendment 24 #
2021/2014(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
E a. whereas the main causes of road traffic collisions include speed, drink and drug driving and, especially whilst driving for work, higher levels of fatigue and distraction;
Amendment 31 #
2021/2014(INI)
1. Welcomes the fact that the EU has reaffirmed in the 2021-2030 EU road safety policy framework its long-term vision to get close to zero deaths by 2050, known as Vision Zero, and its medium- term goal to reduce deaths and serious injuries by 50 % by 2030; highlights that these EU goals and targets relating to road safety should be underpinned by a coordinated, well-planned, systematic and well-financed road safety approach at EU, national and local level; stresses however that deaths and injuries on our roads are unacceptable and preventable and that therefore the EU should aim to increase its level of ambition and aim to reduce deaths and serious injuries by at least 60% by 2030;
Amendment 35 #
2021/2014(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes in this regard the adoption of the safe system approach at EU level, based on a performance framework and timed targets for the reduction of casualties and serious injuries; welcomes the setting up of key performance indicators (KPIs) established in cooperation with Member States to enable a more focused and targeted analysis of the Member States’ performances and to identify shortcomings; calls on the Commission to set outcome targets by 2023; underlines the importance of the ongoing cooperation between the EU and the Members States in this regard and urges all Members States to fully commit to this exercise and agree on a harmonised methodology for KPIs that will allow Member States to be compared; believes however that there is room for improvement in these KPIs and urges the Commission to improve and consider extending these indicators as soon as possible and updating them in its Road Safety Action Plan; believes the KPI for protective equipment should be complemented by a KPI that collects exposure data according to the modal share travelling distance and time for all road users (pedestrians, cyclists, powered two-wheelers, cars, vans, heavy duty vehicles) and by road types, in order to better understand the different related risk ratios and dangers;
Amendment 47 #
2021/2014(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Member States and the Commission to prioritise investments with the greatest benefit in terms of road safety, including investments in maintaining existing infrastructure and in the construction of new infrastructure; welcomes, in this regard, the launch of the Safer Transport Platform initiativeupgrading it in view of adequately protecting vulnerable road users; acknowledges the importance of a modal shift towards active and sustainable public transport modes to improve road safety; welcomes, in this regard, the launch of the Safer Transport Platform initiative, which explicitly calls for projects with good impacts on accident mitigation, including traffic calming measures and better and safer facilities for cyclists and pedestrians and calls on all interested parties to consider its use;
Amendment 57 #
2021/2014(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Highlights that a proactive assessment of the EU road network will be a useful tool to assess the in-built safety of roads and to target investment; welcomes, in this regard, the risk mapping and safety rating of motorways and primary roads introduced in the recently revised EU infrastructure safety rules4 and calls on the Member States to designate as many primary roads in their territory as possible to increase the road safety potential of the new directive; calls on the Commission and the Member States to agree as soon as possible on a methodology to carry out systematic network-wide road assessments, including elements of roads relevant for the safety of vulnerable road users as mandated in the revision of the above- mentioned act; calls on the Commission and the Member States to speed up the work on the specifications at EU level for the performance of road signs and markings in order to prepare the way for a higher level of automation in vehicles; and on the quality requirements for walking and cycling infrastructure so as to tackle the unsatisfactory level of safety for active road users; _________________ 4Directive (EU) 2019/1936 of the European Parliament and of the Council of 23 October 2019 amending Directive 2008/96/EC on road infrastructure safety management, OJ L 305, 26.11.2019, p. 1.
Amendment 61 #
2021/2014(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Notes that road users with reduced mobility and other disabilities have special needs that should be taken into account when planning and constructing new road infrastructure; calls on Member States to underpin investments in projects aimed at making road infrastructure inclusive and accessible for everyone; calls on the Commission to develop guidelines for standardised training at EU level of road safety auditors and inspectors with specific training on the needs of people with disabilities;
Amendment 65 #
2021/2014(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls for measures to further strengthen road safety in urban nodes and improve operational safety throughout the life cycle of critical infrastructure in the forthcoming revision of the TEN-T Regulation; calls furthermore for the integration of a European cycle route network into the TEN-T, on the basis of EuroVelo, so as to make cycling infrastructure safer and better connected; stresses the importance of ensuring continuous walking and cycling paths systematically within TEN-T projects and calls on the Commission to guarantee that existing and new TEN-T infrastructure does not create barriers for active mobility; calls on the Commission to set out therein the bases for future investment decisions relating to road safety;
Amendment 71 #
2021/2014(INI)
Motion for a resolution
Paragraph 6 d (new)
Paragraph 6 d (new)
Amendment 72 #
2021/2014(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Calls on Member States to apply the tools of the Road Infrastructure Safety Management Directive to all roads and to adopt self-explaining and self-enforcing road infrastructure to prevent collisions as well as ensuring a forgiving road infrastructure in case of a collision, with an additional focus on protecting vulnerable road users;
Amendment 75 #
2021/2014(INI)
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Calls on Member States to support priority measures to improve road safety in urban areas, including infrastructure for the introduction of 30 km/h zones, speed enforcement systems and investments in high-risk roads carrying a high percentage of traffic; calls to further develop and implement minimum safety criteria for supporting infrastructure in urban areas for vulnerable road users;
Amendment 76 #
2021/2014(INI)
Motion for a resolution
Paragraph 6 c (new)
Paragraph 6 c (new)
6 c. Believes the Commission should do its utmost to ensure the cycling and walking infrastructure put in place in Member States as a response to the Covid- 19 pandemic remains in place and is expanded in order to further promote safe active travel;
Amendment 78 #
2021/2014(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Welcomes the recent revision of the General Safety Regulation, which will make new advanced safety features in vehicles such as intelligent speed assistance and emergency lane keeping systems mandatory in the EU as from 2022, with the potential to save around 7 300 lives and avoid 38 900 serious injuries by 2030; calls on the Commission to adopt ambitious and timely secondary legislation, to evaluate future developments and to review the regulation where appropriate in order to keep pace with technical developmentincluding requiring a high level of performance of Intelligent Speed Assistance (ISA) systems to be fitted in all new vehicles; finally calls on the Commission to evaluate future developments and to review the regulation where appropriate in order to keep pace with technical developments, including the consideration of requiring overridable ISA systems on motorcycles and non- overridable ISA systems for cars, vans, trucks and buses;
Amendment 81 #
2021/2014(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Calls on the Commission and Member States to support cities in setting up speed limit databases in order to the support the deployment of Intelligent Speed Assistance technology as required under the General Safety Regulation;
Amendment 83 #
2021/2014(INI)
Motion for a resolution
Paragraph 7 g (new)
Paragraph 7 g (new)
7 g. Calls on the Commission to develop crash test dummies representative of more aspects of variability such as age, gender, size and stature for users inside and outside of the vehicle;
Amendment 85 #
2021/2014(INI)
Motion for a resolution
Paragraph 7 e (new)
Paragraph 7 e (new)
7 e. Calls on Member States to provide tax incentives, and private insurers to offer beneficial motor insurance schemes, to drivers purchasing the safest available vehicles to be based on safety rating assessment such as Euro NCAP; calls on the Commission to revise the legislation on car CO2 labelling in order to include additional information at the point of sale and digitally on the safety rating of new vehicles such as the information that is offered through the Euro NCAP test results when available;
Amendment 86 #
2021/2014(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Recognises the requirement for seatbelt reminders for all seats to be made mandatory under the revised General Safety Regulation; calls on Member States to continue raising awareness of the need to use seat belts, including in the back seats, considering the safety risks posed to vehicle occupants in the many vehicles that are currently in use, and will remain to be in use for years to come, that do not have such seat belt reminder technology in place;
Amendment 88 #
2021/2014(INI)
Motion for a resolution
Paragraph 7 c (new)
Paragraph 7 c (new)
7 c. Calls on the Commission to impose a minimum mandatory surcharge on heavy private vehicles such as SUVs at the point of sale based on tonnage due to the greater threat to road safety posed by such vehicles as well as their increased emissions and use of materials during production; calls on local authorities to similarly consider higher charges on such vehicles for entry into urban areas coupled with low speed zones therein as a way to further reduce their dangerousness; emphasizes that congestion charges have also been found to reduce the number of accidents in urban areas;
Amendment 89 #
2021/2014(INI)
Motion for a resolution
Paragraph 7 d (new)
Paragraph 7 d (new)
7 d. Notes the rising trend in vehicle design over recent years towards heavier and larger light duty vehicles, such as Sports Utility Vehicles (SUVs), and the negative relationship that such characteristics can have for not only road safety but also the environment; calls upon the Commission to consider the compatibility issue within future vehicle design to improve further the safety of pedestrians, cyclists and vehicle occupants as well as powered two wheelers and to explore regulatory measures that could better incentivise a shift towards lighter, smaller and safer vehicles by for instance limiting their weight and power and ensure less aggressive front side designs; notes that the increased size and weight of these vehicles increases the likelihood of serious injury and death on EU roads, in particular for vulnerable road users;
Amendment 90 #
2021/2014(INI)
Motion for a resolution
Paragraph 7 f (new)
Paragraph 7 f (new)
7 f. Invites the Commission to further develop the vehicle type-approval crashworthiness requirements and include them into future legislative revisions, integrating also the latest criteria of Euro NCAP crash tests that monitor the impact of a collision on other vehicles, with the aim of achieving an harmonisation of minimum standards and equalising passengers’ safety independently of their socioeconomic situation;
Amendment 91 #
2021/2014(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Urges the Commission, in line with the TRAN implementation report on the road safety aspects of the Roadworthiness Package, to take due account of the technical progress in vehicle safety features provided for in new General Safety Regulation and to include advanced safety systems in the scope of the next revision of the Roadworthiness Package to ensure they are checked during periodical technical inspections; Calls for higher requirements in terms of self-diagnosis of the vehicle, to prevent that a malfunctioning of a advance driving assistance system intended for enhanced safety eventually becomes a hazard;
Amendment 97 #
2021/2014(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission to propose a new harmonised regulatory framework for automated cars in order to ensure, by means of comprehensive tests, including real driving conditions, that automated cars will operate in an absolutely safe manner for their drivers and other road users, in particular concerning their interaction with conventional vehicles and vulnerable road users; calls on the Commission to place the role of the driver, as well as interaction between the driver and the automated driving systems, in a central place when preparing technical requirements;
Amendment 100 #
2021/2014(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Calls on the Commission to mandate independent investigation of crashes involving vehicles equipped with assisted and automated driving systems, before more advanced systems are put on the market;
Amendment 101 #
2021/2014(INI)
9 b. Notes the risks to road safety, such as driver overreliance, distraction, concentration drop and mode confusion, posed by currently available assisted driving systems aiming to improve primarily the comfort of the driver; urges the Commission to review their technical requirements based on the latest data from crashes and research, in order to address these systems’ risks;
Amendment 102 #
2021/2014(INI)
Motion for a resolution
Paragraph 9 c (new)
Paragraph 9 c (new)
9 c. Draws attention to the specific requirements of vehicles dedicated to animal transport, necessary to preserve their health, welfare and sanitary conditions, including during their loading, securing and unloading; calls as a matter also of road safety to ensure, besides the necessary specific training and related qualification for the personnel performing these operations and transport;
Amendment 106 #
2021/2014(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Notes that new personal mobility devices also raise a number of serious concerns related not only to the safety of the devices themselves, but also to their safe use in traffic; regrets that only a few Member States have introduced legislation on this issue and that the lack of harmonisation in the EU can create confusion and make it difficult for visitors to abide by local rules; calls on the Commission to consider a type approvalcoherent and appropriate regulatory framework for these new mobility devices and to issue guidelines for Members States on traffic rules for the use of such devices;
Amendment 116 #
2021/2014(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Notes that according to a Commission study, alcohol is estimated to be involved in around 25 % of all road fatalities, while drugs are involved in 15 % of road fatalities5 ; notes that the EU recommendation on permitted blood alcohol content dates from 2001; calls the Commission to include a zero-tolerance drink-driving limit in its recommendations, and to introduce an EU recommendation for zero tolerance regardingnotes that young people in general have a lower tolerance level for alcohol and drug s compared to older drivers, while they are more likely to have taken multiple drug combinations or alcohol with drugs; calls the Commission to propose a Directive on a zero tolerance level for all road users regarding alcohol and illicit psychoactive drugs, ands well as standards on roadside drug-driving enforcement; calls on the Commission to also include in the revised recommendations guidance on the fitting of alcohol interlock devices, with a special focus on repeat offenders, high-level first- time offenders and all professional drivers; _________________ 5Commission study of 18 February 2014 on the prevention of drink-driving by the use of alcohol interlock devices.
Amendment 119 #
2021/2014(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Notes that licit medicines can have a negative impact on driving; calls on the Commission to mandate Member States to apply the system of classification and labelling of medicines that affect driving ability and support awareness information campaigns of medical professionals; calls on the Commission to include, in the Driving Licence Directive revision, evidence-based guidelines for family doctors and other medical professionals involved in assessing the functional capabilities of persons presumably being an unfit driver and on medicine use which may affect driving;
Amendment 122 #
2021/2014(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Notes that speeding is a key factor in around 30 % of fatal road crashes and an aggravating factor in most crashes; calls on the Commission to come up withbring forward again a proposal for a direcommendation to apply safe speed limittive on speed limits1a, conducting an up-to-date impact assessment envisaging the widespread inclusion of measures in line with the safe system approach for all road types, such as maximum default speeds of 30 km/h in residentialurban areas, and areas where there are high numbers of cyclists and pedestrians, or where there could be potential to increase cycling and walking levels, and to assess the feasibility ofs well as encouraging lower speeds of 15 km/h for residential areas predominantly for pedestrians and cyclists and around schools, of maximum 70 km/h on undivided rural roads and a dynamic top speed of maximum 120 km/h or less on motorways and TEN-T, with significantly lower speeds when climatic conditions or other atmospheric reasons affect visibility; calls on the Commission to come up as well with a new legislative proposal limiting the maximum top speed of all new vehicles as an effective way of reducing road casualties, as well as air pollution and carbon dioxide emissions;CO2 emissions and air pollutants; _________________ 1aOJ No C 33, 9.2.1989 - Proposal for a Council Directive on speed limits for certain categories of motor vehicles in the Community (COM(88)706 final of 11 January 1989
Amendment 125 #
2021/2014(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls on Member States to prioritise investing in speed enforcement and high quality communication on the centrality of speed and speed management as a major cause of fatalities and severe injuries at all levels of government; calls on Member States to apply strong penalties which will deter speeding including penalty point systems and consider the introduction of speed awareness courses to rehabilitate offenders; calls on Member States to dedicate all speed camera revenue and other speeding-related fines directly back into road safety;
Amendment 135 #
2021/2014(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Recalls that the Driving Licence Directive established a harmonised EU licence model and introduced minimum requirements for obtaining licences; notes that the directive will need to be kept up- to-date regarding new technological developments in vehicle and infrastructure technology and vehicle automation; calls on the Commission to consider introducing a graduated licencing system that encourages novice drivers to gain more experience while limiting certain high-risk activities such as driving at night and with passengers; calls furthermore on the Commission to consider making theoretical and practical training as well as practical test mandatory for obtaining a driving licence for mopeds; notes with concern that cases of irregular issuing of driving licences have been reported in several Member States and calls on the Commission to monitor this issue;
Amendment 150 #
2021/2014(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Notes that the COVID-19 pandemic has led to the expansion of the home delivery sector and specifically the use of vans, powered two-wheelers and bicycles; calls on the Commission to consider introducing a requirement for van drivers to undergo professional driver training and proposing a regulation on working hours and rest periods for van drivers; calls on the Commission to assess the introduction ofcome up with a recommendation on the safety of delivery personnel, including requirements for employers and companies to ensure the provision and use of safety equipment and safe vehicles;
Amendment 151 #
2021/2014(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Expresses deep concern over driver fatigue in commercial freight and passenger transport as a cause for road accidents; considers that this needs to be consequently managed within the Work Related Road Safety logic; stresses the importance of using mandatory speed limiters and tachographs and calls on the Member States in cooperation with the Commission for full-fledged enforcement of Regulation (EU) 2020/1054 and the driving times and rest periods which have been applicable since 20 August 2020; calls on the Commission to introduce a KPI for driver fatigue in commercial freight and passenger transport;
Amendment 158 #
2021/2014(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Highlights the importance of fast and effective post-crash carresponse in significantly reducing the consequences of injury through timely and high-quality first-aid, medical care and rehabilitation and mental, social and legal support for victims, survivors and families; calls on the Member States, in this context, to establish closer collaboration between their road safety authorities and the health sector, to make it mandatory to build emergency lanes and to enforce their correct use to speed up rescue operations; calls on the Commission to consider making first aid training compulsory in the future revision of the Driving Licence Directive; calls on the Commission to consider making thorough crash analysis compulsory to identify causes and measures to prevent recurrence;
Amendment 170 #
2021/2014(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Underlines the negative effect commercials and advertisements can have on driving behaviour; calls on the Commission to explore regulatory measures to ban advertisements promoting fast and dangerous driving considering the influence that such commercials can have on motorists;
Amendment 175 #
2021/2014(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Highlights that external factors and emerging societal trends present unprecedented challenges to road safety under the EU strategy to 2030 and beyond; notes that the EU should pave the way for connected and automated vehicles to be rolled out in due timeclosely assess the consequences for safety, the environment, and consumer rights with the deployment of connected and automated vehicles and should assess the possible risks of combining such vehicles with traditional vehicles in mixed traffic and vulnerable road users;
Amendment 183 #
2021/2014(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Points out that data will play a key role in improving road safety; recalls that in-vehicle data are extremely valuable for traffic management, roadworthiness tests and the investigation of crashecrash analysis; calls on the Commission to set up a framework to access in-vehicle data beyond the repair market in compliance with the General Data Protection Regulation, solely for the purpose of accident research, prevention of repeated offences regarding speeding behaviour and roadworthiness tests;
Amendment 184 #
2021/2014(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Stresses the importance of the digital data contained in Event Data Recorders (EDR) for thorough crash analysis in order to ensure justice to victims and to improve road safety; underlines that stored data must be made readily available for crash analysis; calls on the Commission to revise the delegated act for the Event Data Recorder (EDR) under the General Safety Regulation to include data on date, time and place;
Amendment 188 #
2021/2014(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19 b. Calls on the Commission to prioritise modal shift towards sustainable collective passenger and freight transport modes thereby reducing the overall number of private motorised vehicles on EU roads, which is an important way to improve road safety while also reducing negative externalities;
Amendment 189 #
2021/2014(INI)
Motion for a resolution
Paragraph 19 c (new)
Paragraph 19 c (new)
19 c. Stresses the importance of reducing the centrality of private motorised vehicles in the public realm in order to reallocate more public space to citizens and children in particular; urges the Commission to propose a European- wide annual car-free Sunday given its positive impact on road safety as well as wider benefits;
Amendment 190 #
2021/2014(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on the Commission, in view of the upcoming revision of the Urban Mobility Package, to promote synergies between safety and sustainability measures in urban areas; calls, in this regard, for the reprioritisation of transport infrastructure in dense urban areas away from individual motorised transport towards public transport and sustainable, safer and healthier transport modes such as walking and cycling; notes that demand management and land-use planning can lower traffic volumes; stresses that facilitating walking and cycling should become an integral part of urban mobility and infrastructure design, which should be included within Sustainable Urban Mobility Plans (SUMPs), where the Commission already recommends including road safety as a horizontal objective; calls furthermore on the Commission to establish an indicator on the use of EU funds towards effectively improving urban road safety, and particularly ensuring the highest design standards to protect vulnerable road users and foster active mobility, not only for reporting purposes but also in view of making SUMPs a condition to receive EU funding for urban road infrastructure; finally, calls on the Commission to better integrate the EU road safety targets and actions within the Guidelines of the SUMPs by monitoring and promoting of best practise;
Amendment 200 #
2021/2014(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Stresses the importance of engaging civil society in achieving Vision Zero; in this regard, stresses the importance of involving children in the preparation of plans and strategies relating to road safety and the use of public spaces; welcomes the launch of the EU Urban Road Safety award, as part of European Mobility Week and the revamping of the European Road Safety Charter, the largest civil society platform on road safety; calls on the Commission to organise a ‘European Year of Road Safety’ initiative in the coming years, as part of the 2021- 2030 EU Road Safety Policy Framework; advocates furthermore, in the context of 2022 as the European Year of Greener Cities, for the launching, the funding and monitoring of a Safer City Label, based on the criteria of the highest standards of road safety for all users, lower speed limits and more liveable public spaces, including better air quality and reduced CO2 emissions;
Amendment 201 #
2021/2014(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Acknowledges World Day of Remembrance for Road Traffic Victims, that is held each third Sunday of November to remember the many millions who have been killed and seriously injured on the world’s roads and as a day to thank the emergency services and reflect on the tremendous burden and cost of this daily continuing disaster to families, communities and countries; calls on the European Parliament, European Council and European Commission to formally recognise the day by way of holding an annual event supported by the three institutions;
Amendment 205 #
2021/2014(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Is of the view that in order to properly implement the next steps in the EU road safety policy under the overarching Sustainable and Smart Mobility Strategy, some new capacities are needed in the field of road safety, in particular with respect to the coordination, monitoring and evaluation functions and technical support for the overall strategy; calls on the Commission in this regard to explore options to further support safe road transport under an existing agency or another bodyfurther support safe road transport by setting up an EU agency for road safety with the responsibility to coordinate and speed up EU’s actions in road safety by for instance collecting and analysing accident data and exposure data for all roads and users, labelling unsafe roads, road equipment and vehicles, identifying unsafe behaviours, encouraging best practice, including by information campaigns across the Union and developing new safety standards for vehicles as well as overseeing and coordinating EU’s input to the UNECE process;
Amendment 13 #
2021/2013(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
— having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,
Amendment 15 #
2021/2013(INI)
Motion for a resolution
Citation 12 b (new)
Citation 12 b (new)
— having regard to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products,
Amendment 17 #
2021/2013(INI)
Motion for a resolution
Citation 12 c (new)
Citation 12 c (new)
— having regard to Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use,
Amendment 19 #
2021/2013(INI)
Motion for a resolution
Citation 12 d (new)
Citation 12 d (new)
— having regard to the Joint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products,
Amendment 20 #
2021/2013(INI)
Motion for a resolution
Citation 12 e (new)
Citation 12 e (new)
— having regard to the proposal for a Regulation of the European Parliament and of the Council on health technology assessment and the work of EUNetHTA Joint Actions,
Amendment 21 #
2021/2013(INI)
Motion for a resolution
Citation 12 f (new)
Citation 12 f (new)
— having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use,
Amendment 22 #
2021/2013(INI)
Motion for a resolution
Citation 12 g (new)
Citation 12 g (new)
— having regard to Directive 2010/63/EU of the European Parliament and of the Council of22 September 2010 on the protection of animals used in scientific procedures,
Amendment 23 #
2021/2013(INI)
— having regard to its resolution of 2 March 2017 on EU options for improving access to medicines (2016/2057(INI)),
Amendment 24 #
2021/2013(INI)
Motion for a resolution
Citation 12 i (new)
Citation 12 i (new)
— having regard to the Council conclusions of 17 June2016 on strengthening the balance in the pharmaceutical systems in the EU and its Member States,
Amendment 25 #
2021/2013(INI)
Motion for a resolution
Citation 12 j (new)
Citation 12 j (new)
— having regard to Articles 101 and 102 TFEU laying down rules on competition,
Amendment 26 #
2021/2013(INI)
— having regard to the Doha Declaration on the Agreement on Trade- Related Aspects of Intellectual Property Rights and Public Health (WTO/MIN(01/DEC/2) and to the implementation of Paragraph 6 of the Doha Declaration of 1 September 2003(WTO/L/540),
Amendment 27 #
2021/2013(INI)
Motion for a resolution
Citation 12 l (new)
Citation 12 l (new)
— having regard to the 72nd World Health Assembly Resolution of May 2019 on Improving the transparency of markets for medicines, vaccines, and other health products,
Amendment 28 #
2021/2013(INI)
Motion for a resolution
Citation 12 m (new)
Citation 12 m (new)
— having regard to its resolution of 17 September 2020 on a strategic approach to pharmaceuticals in the environment,
Amendment 29 #
2021/2013(INI)
Motion for a resolution
Citation 12 n (new)
Citation 12 n (new)
— having regard to Article 35 of the Charter of Fundamental Rights in the EU and Article 6(1) TEU on right to health protection for European citizens,
Amendment 30 #
2021/2013(INI)
Motion for a resolution
Recital A
Recital A
A. whereas thealth is fundamental to the well-being of Europeans and Charter of Fundamental Rights of the European Union recognises the fundamental right of citizens to health, quality of life and medical treatment and public health systems are crucial to guaranteeing equitable access to health care is a pillar of the EU; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health poand safe, effective and affordable medicines; whereas patients should be at the centre of all health policies and involved throughout the medicines regulatory pathway; whereas access inequalities exist between and within Member States and special regard should be paid to people in vulnerable situation with specific health risks, including women, children, the elderly, pregnant women, persons with disabilicties, alongside investment and researchpatients with chronic conditions and comorbidities, patients in intensive care units (ICU) and persons on long-term medication;
Amendment 41 #
2021/2013(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas the increasing burden of chronic diseases and health needs of aging populations combined with high and rising prices of medicinal products and an increase in the societal cost of providing care cause budgetary and affordability constraints and serious threats to the sustainability of European health systems; whereas the adoption of integrated models of care for chronic and other long term conditions, underpinned by a person-centred and multi- disciplinary approach to health care is essential to deliver high quality health services;
Amendment 52 #
2021/2013(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas the increasing levels of medicine shortages across Europe pose severe threats to patient safety and adversely impact patient outcomes and the patient care continuum; whereas the COVID-19 pandemic further highlighted the fragility of supply chains of medicinal products; whereas the understanding of root causes of medicine shortages are crucial for constructing an appropriate European response to this long-standing challenge;
Amendment 57 #
2021/2013(INI)
Motion for a resolution
Recital B b (new)
Recital B b (new)
B b. whereas there exists a large duplication in medical research which predominantly focuses on limited therapeutic areas; whereas public investment should be driven by public health and unmet medical needs; whereas a high degree of transparency should apply in publicly funded medical research from decision-making, investment to open science;
Amendment 58 #
2021/2013(INI)
Motion for a resolution
Recital B c (new)
Recital B c (new)
B c. whereas pharmaceutical companies receive public financial support at both national and EU level for the development and production of medicines; whereas these grants and subsidies are currently not conditioned by obligations to supply the market with subsidised products for affordable prices;
Amendment 60 #
2021/2013(INI)
Motion for a resolution
Recital B d (new)
Recital B d (new)
B d. whereas gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring benefits in relation to the prevention, diagnosis, treatment and care of all diseases, provided they are effective, safe, affordable and accessible to all patients who need them;
Amendment 61 #
2021/2013(INI)
Motion for a resolution
Recital B e (new)
Recital B e (new)
B e. whereas accelerated approvals of medicinal products granted by the European Medicines Agency (EMA) should not compromise safety and efficacy of new treatments coming the EU market, not even in the times of public health crises; whereas all new treatments should demonstrate added clinical benefit and cost-effectiveness compared to existing products;
Amendment 62 #
2021/2013(INI)
Motion for a resolution
Recital B f (new)
Recital B f (new)
B f. whereas access to generics and biosimilars can generate substantial savings that can be reinvested in improved healthcare provision, as the EU annually spends 274billion USD (224 billion EUR) on pharmaceuticals, of which 76% (or 170 billion EUR)on patented medicinal products, compared to an annual expenditure of 24% (54billion EUR) on generic products; whereas robust competition rules and scrutiny is needed to enable entry of generics onto the market, reducing prices and ensuring the sustainability of healthcare systems and improving timely access for patients to affordable medicines;
Amendment 63 #
2021/2013(INI)
Motion for a resolution
Recital B g (new)
Recital B g (new)
B g. whereas supplementary protection certificate (SPC) extends patent protection up to 5additional years, after the 20 years of patent expiry, with no proven direct link to innovation, by which it delays access to more affordable generic and biosimilar products, placing an unnecessary financial burden on national healthcare systems and hampering patients access to needed medicines;
Amendment 64 #
2021/2013(INI)
Motion for a resolution
Recital B h (new)
Recital B h (new)
B h. whereas the aim of intellectual property and regulatory incentives to benefit society and promote innovation in areas of public health and unmet medical needs should not be misused/abused nor pose threats to affordability and patient access to pharmaceuticals; whereas awarding such incentives and public funds should be conditioned by transparency of public funding, research data, R&D and other associated costs, and product prices, to ensure affordability and fair return on public investment;
Amendment 65 #
2021/2013(INI)
Motion for a resolution
Recital B i (new)
Recital B i (new)
B i. whereas, during a health emergency, the EU should support the introduction of waivers of patents, data and market exclusivity to enable global access to crucial health products to swiftly overcome the crisis;
Amendment 66 #
2021/2013(INI)
Motion for a resolution
Recital B j (new)
Recital B j (new)
B j. whereas rising prices of medicines and growing uncertainty on their real-life effectiveness pose challenges to health decision-making; whereas collaboration on horizon scanning, health technology assessment (HTA), joint price negotiations and joint procurement is crucial to achieve high quality evaluation, affordability and equal access to medicines throughout the EU;
Amendment 67 #
2021/2013(INI)
Motion for a resolution
Recital B k (new)
Recital B k (new)
Amendment 68 #
2021/2013(INI)
Motion for a resolution
Recital B l (new)
Recital B l (new)
B l. whereas action is required throughout the lifecycle of medicines to reduce resource use, emissions and levels of pharmaceutical waste and residues in the environment;
Amendment 70 #
2021/2013(INI)
Motion for a resolution
Recital C
Recital C
C. whereas, in the spirit of the ‘One Health’ approach, the pharmaceutical strategy covers the full cycle of medicines, including research, testing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality; whereas animal welfare should be ensured by meeting the goal of Directive 2010/63/EU for full replacement of all animals that are used for scientific purposes;
Amendment 124 #
2021/2013(INI)
Motion for a resolution
Subheading 1
Subheading 1
Putting patients at the centre of all health policiesnd public health at the centre of pharmaceutical research and decision-making
Amendment 127 #
2021/2013(INI)
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1. Calls for national and European measures to guarantee the rights of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies; calls on Member States to guarantee the sustainability of public healthcare systems; stresses that patient access to medicines is a shared responsibility of all actors in the healthcare system;
Amendment 132 #
2021/2013(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that public and private investment in research, into andcluding the development of innovative medicines and treatments, as well astreatments, shall be driven by public health and unmet medical needs, defined with the involvement of regulators, academia, healthcare professionals, patients and payers at early stages of R&D, to ensure research priorities respond to societal needs and enable access to safe, effective and, high-quality medicines, are essential for making progress in the prevention and treatment of diseasand affordable medicines, while ensuring collaboration and minimum duplication in ongoing studies;
Amendment 159 #
2021/2013(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that investment in research has not been sufficient in relation to quality of life and late effects of treatments, to meet the specific therapeutic needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR); calls for gender equality and additional research inpatient populations regularly excluded from clinical studies, such as children, pregnant women and the elderly;
Amendment 170 #
2021/2013(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
Amendment 181 #
2021/2013(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Considers it imperative that a common EU therapeutic guide for antimicrobials be introduced and that communication campaigns on AMR be coordinated through a single calendar at EU level; the ‘One Health’ approach guides reduction and use optimisation for antimicrobials, as well as the development of new medicines, including antimicrobial agents; stresses the importance of investment into the development of new non-animal methodologies, such as in silico and organoids, to shorten pre-clinical observation periods, increase efficiency in research and reduce unnecessary and often less reliable experiments on animals;
Amendment 199 #
2021/2013(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to incWelcomes the intention to revise pharmaceutical legislation forp orate new criteria into the systephan and paediatric medicines and addressing AMR, with the aim of fincentives for research into and the development of new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systemsding more affordable therapeutic options and meeting the needs of patients and health systems; calls on the Commission to provide public research funding to investigate the use of repurposed, off-label and off-patent products that can be used safely and effectively in patients; stresses that medicines resulting from publicly funded research must be equally available across the Union for a fair and affordable price; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;
Amendment 215 #
2021/2013(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Calls on the Member States and the Commission to support research, development and innovation in the field of pharmaceuticals that are equally effective for patients and intrinsically less harmful for the environment, given that ‘greener pharmaceuticals’ are not toxic for the environment, do not bioaccumulate, and degrade more readily, into harmless substances, in wastewater treatment plants and the environment;
Amendment 237 #
2021/2013(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promotfacilitate and enable dialogue withamong the Member States and stakeholders to assess new criteria for national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefitto steer cooperation in horizon scanning, pricing and reimbursement, including best practice and information exchange related to national pricing strategies, taking into account levels of public investment, cost of R&D, added therapeutic benefit and cost-effectiveness; such dialogue should further encourage cooperation in pricing negotiations and joint procurement and guidance on principles and costing methods for establishing R&D costs of medicines and their use at the national level; calls ofn the medicine, and the primary and broader needs of the populCommission to promote information sharing among Member States on medicine net prices through the EURIPID collaboration;
Amendment 250 #
2021/2013(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the Commission to implement the World Health Assembly Resolution of May 2019on Improving the transparency of markets for medicines, vaccines, and other health products, by requiring companies to publicly disclose the costs of R&D and manufacturing, public funding contributions, regulatory dossiers containing clinical trial data, active pharmaceutical ingredient (API) sources and supply chains, number and status of patents and patent applications; calls for the revision of Directive 89/105/EEC to enhance the transparency of medicine pricing and reimbursement decisions;
Amendment 262 #
2021/2013(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to periodically evaluate and review the incentive system and its criteria, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition; on and off-patent competition and the timely entry to market of generics and biosimilars; stresses the right balance between awarding incentives in medicines development, particularly where there exist no treatment alternatives, and preventing competition distortion and unintended effects on affordability and availability of medicinal products;
Amendment 282 #
2021/2013(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Calls on the Commission to evaluate the added value and if appropriate remove the supplementary protection certificate (SPC) mechanism in order to prevent delays in access to generic medicines and improve financial sustainability of healthcare systems;
Amendment 304 #
2021/2013(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that timely access to generic and biosimilar medicines ais key to ensure accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;
Amendment 322 #
2021/2013(INI)
8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EUwelcomes and supports Commission action against abuses of dominant positions in the pharmaceutical sector;
Amendment 334 #
2021/2013(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the benefitsrole of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines; stresses that such collaboration must guarantee that research priorities are driven by patient and public health needs and public funds are invested in a transparent manner, ensuring availability and affordability of products resulting from these partnerships and other public funds; calls on the Commission to ensure that the European Partnership for Health Innovation is driven by public interest considerations and to maximise public return on public investment; calls on the Commission to adopt and implement a general policy on such conditionalities under Horizon Europe;
Amendment 342 #
2021/2013(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA incubator initiative commit to sharing of intellectual property and know-how to scale-up the production and availability of COVID-19 products; supports the Commission’s plan to set up a Health Emergency Preparedness and Response Authority (HERA); calls for ensuring that HERA is public-interest driven and contributes effectively to the development, availability and affordability of safe and effective medical countermeasures;
Amendment 348 #
2021/2013(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for,but not limited to, emergency medicines and unmet therapeutic needs; calls for exploration of such practices in areas of high priced medicines, including for rare diseases and cancer with a clear outline of milestones, objectives and commitments undertaken by all parties involved; highlights the need to ensure high levels of transparency in these initiatives and apply lessons learned from the joint procurement of COVID-19 products;
Amendment 381 #
2021/2013(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is concerned that the affordability of medicines remains a systemic challenge for national health systems, a key access barrier for patients and that innovative medicines are expensive; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug prith often uncertain added clinical benefit; stresses the need for solid evidence, based on well- designed comparative randomised clinical trials to meet health needs with meaningful endpoints and to evaluate medicine; stresses that the regulatory framework must facilitate the best possible outcomes for patients and public ing systemsterest;
Amendment 408 #
2021/2013(INI)
Motion for a resolution
Subheading 2
Subheading 2
Supporting a transparent competitive and innovative EU pharmaceutical industry to respond to public health needs
Amendment 414 #
2021/2013(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agi and predictable regulatory environment; bwelievcomes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiativee initiative to support real world evidence generation and to build interoperable digital infrastructure forwithin the European Health Data Space, while ensuring privacy and security of health data;
Amendment 490 #
2021/2013(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 505 #
2021/2013(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of recognition and creating quality jobs in the EU along the entire pharmaceutical value chain and the medical field, including the health workforce, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutmedical sector, facilitating talent retention and mobility at EU level;
Amendment 508 #
2021/2013(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 530 #
2021/2013(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation, including for blood, tissues and cells products; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse-purposing of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; stresses the need for more comparative and collaborative, multi-centre platform trials; stresses that comparative randomised double-blind well-designed clinical trials with relevant endpoints are necessary to meet the health needs and respond to questions or regulators, health technology assessment and health payers; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.
Amendment 552 #
2021/2013(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU; stresses that electronic product information should complement, but not replace, the package information leaflet as a primary source of information for patients;
Amendment 575 #
2021/2013(INI)
Motion for a resolution
Subheading 3
Subheading 3
Increasing resilience: prevention of medicine shortages, secure supply chains, sustainable medicines, crisis preparedness and response mechanisms
Amendment 577 #
2021/2013(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficientCalls on the Commission to heed the recommendations of the European Parliament stated in resolution of 17 September 2020 on the shortage of medicines; Recalls that the EU’s open strategic autonomy, particularly focused on production of critical products, contributes to the availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on atransparency of medicines' stocks and on a centralised European information network on supply problemmedicine shortages, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability and stocks of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains and impose dissuasive sanctions in the event of emergencies; non-compliance;
Amendment 606 #
2021/2013(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Calls on the Commission to ensure that the revision of the general pharmaceutical legislation builds on a good understanding of the root causes of medicine shortages;
Amendment 607 #
2021/2013(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19 b. Stresses the need for the publication of concrete and legally binding shortage management and prevention plans as part of the medicine supply obligations of marketing authorisation holders based on an analysis of the manufacturing and distribution risks, including minimum stock levels, measures allowing for the diversification of raw materials supply sources, and the development of other manufacturing sites when necessary;
Amendment 609 #
2021/2013(INI)
Motion for a resolution
Paragraph 19 c (new)
Paragraph 19 c (new)
19 c. Urges the Commission to address medicine shortages specifically aimed at women such as female hormonal medicines used for contraception and hormone replacement therapy (HRT); stresses the importance to take into account the threats posed by such shortages to women’s and girls’ sexual and reproductive health and rights, particularly among those most vulnerable such as older women or transgender women; highlights the importance of enhancing the control and management of the manufacturing, stockpiling and marketing of those medicines to ensure continuity in supply chains, fair pricing and availability;
Amendment 613 #
2021/2013(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. SConsiders it essential to improve early communication with healthcare professionals and patients on the availability of medicines; supports the Commission in its efforts to conduct a transparent and inclusive structured dialogue with players in the pharmaceutical value chain, public authorities, healthcare professionals, non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; calls on the Commission to ensure a balanced representation of stakeholders;
Amendment 658 #
2021/2013(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to heed the calls of the European Parliament in its resolution of 17September 2020 on a strategic approach to pharmaceuticals in the environment, in particular to revise the pharmaceutical legislation to strengthen the environmental risk assessment requirements and conditions of approval and use for medicines by including the environmental impacts of pharmaceuticals in the benefit-risk assessment of human medicines; calls on the Commission to strengthen inspection and auditing throughout the production chain; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs;
Amendment 696 #
2021/2013(INI)
Motion for a resolution
Subheading 4
Subheading 4
Amendment 704 #
2021/2013(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU; calls on the Commission to ensure that trade agreements contribute to improved access to safe, affective and affordable medicines in the EU and in third countries;
Amendment 711 #
2021/2013(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Urges the Commission to issue a proposal in the framework of paragraph 9 of Article218 TFEU to update the EU position regarding ongoing WTO TRIPS flexibilities so as in times of health emergency, to allow for use of TRIPS waiver, as well as lifting data and market exclusivity, to enable use of compulsory licensing by the Member States and third countries as an important public health safeguard, and to evaluate the TRIPS+ commitments in EU trade agreements;
Amendment 714 #
2021/2013(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23 b. Calls on the Commission to ensure due diligence, transparency, ethical and responsible behaviour throughout the pharmaceutical sector to promote trust in health decision-making and protect the environment and societal welfare;
Amendment 716 #
2021/2013(INI)
Motion for a resolution
Paragraph 23 c (new)
Paragraph 23 c (new)
23 c. Calls on the Commission to ensure adequate consultation with stakeholders, in particular consumer, patient and healthcare professionals and non-profit research organisations throughout the implementation of the Pharmaceutical Strategy;
Amendment 717 #
2021/2013(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Reiterates its commitment to continue working with the Commission and the World Health Organization to standardise effective, safe and sustainable regulatory frameworks for medicinal productimprove access to safe, effective and affordable medicines;
Amendment 124 #
2021/0422(COD)
Proposal for a directive
Recital 1
Recital 1
(1) According to Article 3(3) of the Treaty on European Union (TEU) and Article 191 of the Treaty on the Functioning of the European Union (TFEU), the Union is committed to ensuring a high level of protection and improvement of the quality of the environment, a prudent and rational utilisation of natural resources, promoting measures at international level to deal with regional or worldwide environmental problems, and in particular combating climate change. According to Article 191 of the Treaty on the Functioning of the European Union (TFEU), Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.
Amendment 126 #
2021/0422(COD)
Proposal for a directive
Recital 1 a (new)
Recital 1 a (new)
(1a) According to the Charter of Fundamental Rights of the European Union, the Union must ensure the protection of fundamental rights, and in particular the level of protection of the environment and the improvement of its quality (Article 37), the right to life (Article 2) and the right to personal integrity (Article 3). Considering that the impact of environmental crime not only affects biodiversity, climate and planetary boundaries, but also human rights and human and environmental health, the fight against environmental crime should be a priority at EU level in order to ensure the protection of these rights and prevent environmental damage.
Amendment 128 #
2021/0422(COD)
Proposal for a directive
Recital 2
Recital 2
(2) The Union continues to be concerned with the rise in environmental criminal offences and their effects, which undermine the effectiveness of Union environmental legislation. These offences are moreover increasingly extending beyond the borders of the Member States in which the offences are committed. In just a few decades, environmental crime has become the fourth largest criminal sector in the world, growing two to three times faster than the global economy1a,1b and is now as lucrative as drug trafficking2a. Such offences pose a threat to the environment, to the climate and the safety of the planet and therefore call for an appropriate and effective response. The Union should encourage and enable more efficient and swifter cross-border cooperation between competent authorities at EU and national level. _________________ 1a INTERPOL-UN Environment (2016), Strategic Report: Environment, Peace and Security, A Convergence of Threats. 1b UNEP (2018), The State of knowledge of crimes that have serious impacts on the environment. 2a Eurojust (2021), Rapport sur le travail d'Eurojust sur les crimes environnementaux.
Amendment 133 #
2021/0422(COD)
Proposal for a directive
Recital 3
Recital 3
(3) The existing systems of penalties under Directive 2008/99/EC of the European Parliament and of the Council20 and environmental sectoral law have not been sufficient in all environmental policy area to achieve compliance with Union law for the protection of the environment. Compliance should be strengthened by the availability of criminal penalties, which demonstrate social disapproval of a qualitatively different nature compared to administrative penalties. Criminal law, as the guardian of essential social values to be protected, must evolve in order to address current issues, in particular environmental and climate challenges. Environmental criminal law must emancipate itself from administrative regulations and thus become a complementary tool to prevent, dissuade and repair behaviour that damages the environment. _________________ 20 Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law (OJ L 328, 6.12.2008, p. 28).
Amendment 137 #
2021/0422(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) Despite the growing number of environmental crimes, a harmonised and accepted definition of environmental crimes does not yet exist at European and national level. This Directive aims to provide a general framework by defining autonomous environmental crime, in addition to the EU-wide common set of definitions of specific environmental offences1a. _________________ 1a See Rome, IAI e AMBITUS, May 2022, p. 19.
Amendment 139 #
2021/0422(COD)
Proposal for a directive
Recital 4
Recital 4
(4) The effective investigation, prosecution and adjudication of environmental criminal offences should be improved. The list of environmental criminal offences which were set out in Directive 2008/99/EC should be revised and additional categories of offences based on the most serious breaches of Union environmental law should be added. A procedure should also be established to update automatically the list of criminal offences in this Directive as environmental legislation develops. Provisions on sanctions should be strengthened in order to enhance their deterrent effect as well as the enforcement chain in charge of detecting, investigating, prosecuting and adjudicating environmental criminal offences.
Amendment 140 #
2021/0422(COD)
Proposal for a directive
Recital 5
Recital 5
(5) Member States should criminalise offence categories and provide for greater precision on the definitions of the offence categories, and harmonisation concerning sanction types and levels. The Commission should develop sentencing guidelines that will assist the Member States in the harmonisation of sanction types and levels as per the provisions of this Directive, and help ensure that sanctions for the offences are effective, dissuasive and proportionate, and where appropriate identical among the Member States, and that perpetrators who are convicted and subjected to sanctions do not profit from their illegal activities.
Amendment 151 #
2021/0422(COD)
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8a) In order to cover all forms of environmental crimes, and in line with existing legislation in different national criminal law systems, Member States should criminalise autonomous categories of environmental offences by creating an offence of endangering the environment when a conduct directly or indirectly exposes the environment to an immediate risk of substantial damage or when, knowingly, a conduct causes a substantial damage to the environment. Criminal law has its own characteristics which make it more dissuasive than administrative law, especially in terms of applicable sanctions.
Amendment 152 #
2021/0422(COD)
Proposal for a directive
Recital 8 b (new)
Recital 8 b (new)
Amendment 153 #
2021/0422(COD)
Proposal for a directive
Recital 9
Recital 9
(9) The environment shouldis threatened daily by destruction and deterioration, seriously endangering natural and human systems around the world but also increasingly in the EU. The environment should thus be protected in a wide sense, as set out under Article 3 (3) TEU and Article 191 TFEU, covering all natural resources - air, water, soil, wild fauna and flora including habitats - as well as services provided by natural resourc, ecosystems and species population- as well as functions and services provided by natural resources, and their interactions as well as respect for planetary boundaries.
Amendment 157 #
2021/0422(COD)
Proposal for a directive
Recital 10
Recital 10
(10) The acceleration of climate change, biodiversity loss and environmental degradation, as exemplified by exceedance of six of the nine planetary boundaries, paired with tangible examples of their devastating effects, have led to the recognition of the green transition as the defining objective of our time and a matter of intergenerational equity and justice. Therefore, when Union legislation covered by this Directive evolves, this Directive should also automatically cover any updated or amended Union legislation falling within the scope of criminal offences defined under this Directive, when the obligations under Union law remain unchanged in substance. However, when new legal instruments prohibit new conduct harmful to the environment, this Directive should be amended in order to add to the categories of criminal offences also the new serious breaches of Union environmental law. In such cases, the amendment of the Directive should be limited to the incorporation of new criminal offences, and only concern Article 3 and related provisions of the Directive, in order to reflect this incorporation only.
Amendment 164 #
2021/0422(COD)
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11a) Environmental crimes can be perpetrated by a range of actors, from individuals, small groups, companies and corporations, corrupt government individuals, organised criminal networks, and often a combination of all these1a. Large multinational corporations may exploit and damage the environment in order to generate more profit or reduce their costs, including through natural resource exploitation, pollution crimes and hazardous waste disposal. _________________ 1a UNEP (2018), The State of Knowledge of Crimes that have Serious Impacts on the Environment, p. IX.
Amendment 169 #
2021/0422(COD)
Proposal for a directive
Recital 13
Recital 13
(13) Inciting, and aiding and abetting the criminal offences committed intentionally should also be punishable. An attempt to commit a criminal offence that causes death or serious injury of a person, substantial damage to the environment or is likely to cause substantial damage to the environment or is otherwise considered particularly harmful should also constitute a criminal offence when committed intentionally. When such conduct is observed within public administration, it is essential to be able to bring the matter before the courts and apply criminal sanctions.
Amendment 172 #
2021/0422(COD)
Proposal for a directive
Recital 14
Recital 14
(14) Sanctions for the offences should be effective, dissuasive and proportionate. To this end, minimum levels for the maximum term of imprisonment should be set for natural persons. Accessory sanctions are often seen as being more effective than financial sanctions especially for legal persons. Additional sanctions or measures should be therefore available in criminal proceedings. These should include the obligation to reinstate the environment, exclusion from access to public funding, including tender procedures, grants and concessions and, withdrawal of permits and authorisations and making sentences public. The Commission should present, within one year after entry into force of this Directive, guidance classifying sanctions for national competent authorities, prosecutors and judges. This is without prejudice to the discretion of judges or courts in criminal proceedings to impose appropriate sanctions in the individual cases.
Amendment 175 #
2021/0422(COD)
Proposal for a directive
Recital 15
Recital 15
(15) Where national law provides for it, lLegal persons should also be held criminally liable for environmental criminal offences according to this Directive. Like natural persons, legal persons who are perpetrators, instigators or accomplices in offences must be held responsible and subject to criminal proceedings. Member States whose national law does not provide for the criminal liability of legal persons should ensure that their administrative sanctioning systems provide for effective, dissuasive and, proportionate and where possible identical sanctions types and levels as laid down in this Directive in order to achieve its objectives. Financial situation of legal persons should be taken into account to ensure the dissuasiveness of the sanction imposed, the direct and indirect environmental consequences in the short, medium and long term as well as, if applicable, the irreversible nature of the environmental damage should be taken into account to ensure the dissuasiveness of the sanction imposed. Finally, the level of criminal sanctions applicable to legal persons for other categories of offences should be taken into account.
Amendment 180 #
2021/0422(COD)
Proposal for a directive
Recital 16 a (new)
Recital 16 a (new)
(16a) While the recognition of the crime of ecocide is currently being discussed in several national parliaments around the world and in the EU, the EU should seize this issue to remain a world leader in environmental protection legislation and to ensure harmonised definition and sanctions ex ante, and not ex post. Member States shall therefore adopt a crime of ecocide, which shall be considered a criminal offence for the purposes of this Directive and be defined as unlawful or wanton acts committed with knowledge that there is a substantial likelihood of severe and either widespread or long-term damage to the environment being caused. This specific crime makes it possible to identify the most serious damage to the environment and thus to provide for a graduation of sanctions according to the gravity of the harm to the environment.
Amendment 182 #
2021/0422(COD)
Proposal for a directive
Recital 17
Recital 17
(17) Where the crimes are of a continuing nature, they should be brought to an end as soon as possible. Where offenders have made financial gains, such gains should be confiscated and could have substantial or even irreversible consequences on the environment, they should be brought to an end as soon as possible on the basis of the precautionary and preventive principles enshrined in Article 191(2) TFEU. Therefore the Commission encourages Member States to establish a mechanism at national level to deal with cases in an accelerated procedure where there is a risk of irreversible or substantial damage to the environment. Where offenders have made financial gains, such gains should be confiscated. These financial gains should be used to repair damages caused to the environment, to compensate victims and to finance measures aimed at combating similar crimes.
Amendment 186 #
2021/0422(COD)
Proposal for a directive
Recital 19
Recital 19
(19) Member States should lay down rules concerning limitation periods necessary and adapted to the specificities of environmental damage, the occurrence of which is often spread over time, in order to enable them to counter environmental criminal offences effectively, without prejudice to national rules that do not set limitation periods for investigation, prosecution and enforcement. Member States shall also ensure that special measures of limitation may be applied in the case of concealment of an offence, i.e. where the offender has prevented its discovery. In this case, the time limit shall run only from the day when the offence could be established under conditions that allow prosecution.
Amendment 190 #
2021/0422(COD)
Proposal for a directive
Recital 21
Recital 21
(21) Member States should define the scope of administrative and criminal law enforcement clearly with regard to environmental offences according to their national law. Criminal proceedings and related sanctions should be fully separate and independent from administrative proceedings and sanctions. In the application of national law transposing this Directive, Member States should ensure that the imposition of criminal sanctions and of administrative sanctions respects the principles of the Charter of Fundamental Rights of the European Union, including the prohibition of ne bis in idem.
Amendment 192 #
2021/0422(COD)
Proposal for a directive
Recital 22
Recital 22
(22) Furthermore, judicial and administrative authorities in the Member States should have at their disposal a range of criminal sanctions and other measures to address different types of criminal behaviour in a tailored and effective manner. With regard to financial sanctions, these authorities must take into account the financial situation of legal persons and in particular the turnover but also the illegal gains resulting from the realisation of the damage.
Amendment 194 #
2021/0422(COD)
Proposal for a directive
Recital 22 a (new)
Recital 22 a (new)
Amendment 196 #
2021/0422(COD)
Proposal for a directive
Recital 23
Recital 23
(23) Given, in particular, the mobility of perpetrators of illegal conduct covered by this Directive, together with the cross- border nature of offences and the possibility of cross-border investigations, Member States should establish jurisdiction in order to counter such conduct effectively. Member States should thus extend their jurisdiction where an offence creates a risk for the environment on its territory or where it is committed against its residents. Considering the limits of the territoriality principle in applying criminal law to environmental crimes of a transboundary nature and the significant number of cases where EU actors are involved in environmental crimes taking place outside of Europe, Member States should introduce so-called universal jurisdiction for serious environmental crimes, in particular when it comes to ecocide.
Amendment 201 #
2021/0422(COD)
Proposal for a directive
Recital 24
Recital 24
(24) Environmental criminal offences harm nature and society. By reporting breaches of Union environmental law, people and civil society organisations perform a service of public interest and play a key role in exposing and preventing such breaches, and thus safeguarding the environment and the welfare of society. Individuals in contact with an organisation in the context of their work-related activities are often the first to know about threats or harm to the public interest and the environment. Persons who report irregularities are known as whistleblowers. Potential whistleblowers are often discouraged from reporting their concerns or suspicions for fear of retaliation. Such persons should benefit from balanced and effective whistleblowers protection set out under Directive (EU) 2019/1937of the European Parliament and of the Council25 . _________________ 25 Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305/17).
Amendment 205 #
2021/0422(COD)
Proposal for a directive
Recital 24 a (new)
Recital 24 a (new)
Amendment 206 #
2021/0422(COD)
Proposal for a directive
Recital 24 b (new)
Recital 24 b (new)
(24b) By monitoring, raising awareness and educating on the issues and consequences of environmental crime, non-governmental organisations play a key role in effectively combating environmental crime and better preventing criminal behaviour.
Amendment 207 #
2021/0422(COD)
Proposal for a directive
Recital 24 c (new)
Recital 24 c (new)
(24c) Environmental defenders may also be subject to abusive lawsuits and threats, and should be protected from such abusive practices, also known as "Strategic lawsuits against public participation"1a. [Add a reference of the Directive of the European Parliament and of the Council on protecting persons who engage in public participation from manifestly unfounded or abusive court proceedings ("Strategic lawsuits against public participation", once it is adopted] _________________ 1a European Parliament resolution of 11 November 2021 on strengthening democracy and media freedom and pluralism in the EU: the undue use of actions under civil and criminal law to silence journalists, NGOs and civil society (2021/2036(INI)).
Amendment 208 #
2021/0422(COD)
Proposal for a directive
Recital 25
Recital 25
(25) Other natural or legal persons may also possess valuable information concerning potential environmental criminal offences. They may be members of the community affected, non- governmental organisations or members of society at large taking an active part in protecting the environment. Such persons who report environmental crimes as well as persons who cooperate with the enforcement of such offences should be provided the necessary support and assistance in the context of criminal proceedings, so that they are not disadvantaged for their cooperation but supported and assisted. notably financially. These persons should also be protected from being harassed or unduly prosecuted for reporting such offences or their cooperation in the criminal proceedings.
Amendment 210 #
2021/0422(COD)
Proposal for a directive
Recital 25 a (new)
Recital 25 a (new)
(25a) In order to further strengthen the role of civil society in the criminal justice system, the European Commission should encourage the European Ombudsperson to work closely with EU agencies, in particular Eurojust and Europol, as well as with EU bodies, including the European Public Prosecutor's Office and the European Anti-Fraud Office (OLAF), in their respective areas of competence.
Amendment 211 #
2021/0422(COD)
Proposal for a directive
Recital 26
Recital 26
(26) SConsidering the intrinsic value of nature and since nature cannot represent itself as a victim in criminal proceedings, for the purpose of effective enforcement members of the public concerned, as defined in this Directive taking into account Articles 2(5) and 9(3) of the Aarhus Convention26 , should have the possibility to act on behalf of the environment as a public goodnatural common, within the scope of the Member States’ legal framework and subject to the relevant procedural rules. In order to ensure respect for the right to an effective remedy enshrined in Article 47 of the Charter of Fundamental Rights and Article 9(3) of the Aarhus Convention, obstacles to access to justice should be limited by reducing the length and cost of proceedings for victims of environmental damage, increasing the powers of the courts to order effective compensation, and extending the possibility for members of the public to participate in proceedings as civil parties. _________________ 26 United Nations Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters.
Amendment 212 #
2021/0422(COD)
Proposal for a directive
Recital 26 a (new)
Recital 26 a (new)
(26a) The role of environmental non- governmental organisations in representing the interests of victims and bringing legal actions should also be recognised and therefore their role in criminal proceedings should be enhanced. Because they act in defence of the environment, because they are spokespersons for potential victims of environmental offences, these organisations should be able to act as civil parties in the event of prosecution of environmental offences. In the absence of identifiable victims, their role is all the more important to defend the direct voice of ecosystems and to seek redress for environmental damage.
Amendment 213 #
2021/0422(COD)
Proposal for a directive
Recital 26 b (new)
Recital 26 b (new)
(26b) The European Commission should also commit to developing guidelines under this Directive to specify the procedural framework for the participation of members of the public in the criminal prosecution of environmental offences, including the definition of easily accessible admissibility criteria. The Commission could draw, for example, inspiration from legislation already in place in certain Member States, such as Spain, where criminal proceedings are public and can be brought by any citizen, thus becoming an accusatory party in the criminal proceedings.
Amendment 214 #
2021/0422(COD)
Proposal for a directive
Recital 26 c (new)
Recital 26 c (new)
(26c) The Commission should encourage Member States to take any initiative facilitating access to justice for members of the public, including the establishment of local centres specialised in access to justice and environmental issues.
Amendment 215 #
2021/0422(COD)
Proposal for a directive
Recital 26 d (new)
Recital 26 d (new)
(26d) Member States should establish at national level a High Authority for Planetary Boundaries. This independent administrative authority should be a body for information, exchange and expertise on strategic issues related to the protection and respect of planetary boundaries. To this end, the High Authorities should organise regular consultations with other consultation and reflection bodies whose missions are related to environmental protection as well as establishing a platform for alerting the State or to the organs of justice in the event of a proven or future danger.
Amendment 216 #
2021/0422(COD)
Proposal for a directive
Recital 28
Recital 28
(28) The effective functioning of the enforcement chain depends on a range of specialist skills. As the complexity of the challenges posed by environmental offences and the technical nature of such crime require a multidisciplinary approach, a high level of legal knowledge, technical expertise and financial support as well as a high level of training and specialisation within all relevant competent authorities are necessary. Member States should provide training appropriate to the function of those who detect, investigate, prosecute or adjudicate environmental crime. To maximise the professionalism and effectiveness of enforcement chain, Member States should also consider assigning specialised investigation units, prosecutors and criminal judges to deal with environmental criminal cases. General criminal courts could provide for specialised chambers of judges. Technical expertise and financial support should be made available to all relevant enforcement authorities.
Amendment 219 #
2021/0422(COD)
Proposal for a directive
Recital 30 a (new)
Recital 30 a (new)
(30a) The Commission, Europol and Eurojust should support and develop a more institutionalised structure for existing networks of practitioners such as the European Environmental Prosecutors' Network (EEPN) and the European Union Forum of Judges for the Environment (EUFJE) with the participation of all stakeholders and work to strengthen the work of the informal environmental crime network ("EnviCrimeNet").
Amendment 220 #
2021/0422(COD)
Proposal for a directive
Recital 30 b (new)
Recital 30 b (new)
(30b) With a view to closer cooperation between Member States on environmental crime, the EU should consider extending the mandate of the European Public Prosecutor's Office (EPPO) to the criminal offences defined in this Directive. The EPPO, which has its own powers and authority to coordinate investigations and prosecutions in cross- border cases, is currently the European body best placed to deal with the most serious environmental crimes with a cross-border dimension. An extension of the mandate of the EPPO to cover serious environmental crime with across-border dimension, via the European Council in accordance with Article 86(4) TFEU, is therefore necessary. The EPPO would thus be able to deal with crimes with a cross-border dimension for which the strengthening of the criminal response is unlikely to be achieved through the traditional channels of judicial cooperation.
Amendment 221 #
2021/0422(COD)
Proposal for a directive
Recital 31 a (new)
Recital 31 a (new)
(31a) Due to its global impact and cross- border nature, the EU and its Member States should make the fight against environmental crime a strategic political priority in international judicial cooperation and within the institutions and the Conference of the Parties to the United Nations Framework Convention on Climate Change, in particular by promoting compliance with multilateral environmental agreements through the adoption of criminal sanctions and the exchange of best practices and data on environmental crime. This international approach to environmental crime should also include extending the scope of the International Criminal Court to the crime of ecocide, and the EU and its Member States have a key role and responsibility in this regard.
Amendment 222 #
2021/0422(COD)
Proposal for a directive
Recital 32
Recital 32
(32) To effectively tackle the criminal offences referred to in this Directive, it is necessary that competent authorities in the Member States collect accurate, consistent and comparable data on the scale of and trends in environmental offences and the efforts to combat them and their results. These data should be used for preparing statistics to serve the operational and strategic planning of enforcement activities as well as for providing information to citizens. Member States should collect and report to the Commission and make available online to the public relevant statistical data on environmental offences. T, in particular specifying the sanctions imposed on the authors of offences. In order to facilitate the work of civil society actors, and in particular environmental non-governmental organisations, Member States should set up a public platform at national level to collect data on environmental crime. At European level, the Commission should regularly assess and publish the results based on the data transmitted by the Member States.
Amendment 225 #
2021/0422(COD)
Proposal for a directive
Recital 33
Recital 33
(33) The statistical data collected under this Directive on environmental offences should be comparable between the Member States and collected on the basis of common minimum standards. In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission to define the standard format for statistical data transmission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council27 . These data aggregated at European level shall be available on a country-by-country basis according to the categories of information referred to in paragraph 2 of Article 21 of this Directive, under the supervision of Eurostat. _________________ 27 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 229 #
2021/0422(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
This Directive establishes minimum rules concerning the definition of environmental criminal offences and sanctions in orderas well as means and resources in order to combat environmental crime and to protect the environment more effectively.
Amendment 246 #
2021/0422(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
(3) ‘legal person’ means any legal entity having such status under the applicable national law, except for States or public bodies exercising State authority and for public international organisations;
Amendment 252 #
2021/0422(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) ‘public concerned’ means the persons affected or likely to be affected by the offences referred to in Articles 3, 3a or 4. For the purposes of this definition, persons having a sufficient interest or maintaining the impairment of a right as well as non- governmental organisations promoting the protection of the environment and meeting any proportionate requirements under national law shall be deemed to have an interest;
Amendment 259 #
2021/0422(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 5 a (new)
Article 2 – paragraph 1 – point 5 a (new)
(5a) ‘wanton’ means with reckless disregard for damage which would be clearly excessive in relation to the social and economic benefits anticipated;
Amendment 262 #
2021/0422(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 5 b (new)
Article 2 – paragraph 1 – point 5 b (new)
(5b) ‘severe’ means damage which involves very serious adverse changes, disruption or harm to any element of the environment, including grave impacts on human life, or natural, cultural or economic resources;
Amendment 268 #
2021/0422(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 5 c (new)
Article 2 – paragraph 1 – point 5 c (new)
(5c) ‘widespread’ means damage which extends beyond a limited geographic area, crosses state boundaries, or is suffered by an entire ecosystem or species or a large number of human beings ;
Amendment 271 #
2021/0422(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 5 d (new)
Article 2 – paragraph 1 – point 5 d (new)
Amendment 273 #
2021/0422(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 5 e (new)
Article 2 – paragraph 1 – point 5 e (new)
(5e) ‘environment’ means the earth, its biosphere, cryosphere, lithosphere, hydrosphere and atmosphere, as well as outer space, including the integrity of all the biotic and abiotic elements of an ecosystem, their functions, services and mutual interactions and the planetary boundaries.
Amendment 274 #
2021/0422(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 5 f (new)
Article 2 – paragraph 1 – point 5 f (new)
(5f) ‘planetary boundaries’, means the nine planetary life-support systems identified as part of the planetary boundaries framework: climate change, biosphere integrity (covering functional and genetic diversity), land system changes, freshwater use, biogeochemical flows (nitrogen and phosphorus), ocean acidification, atmospheric aerosol pollution, stratospheric ozone depletion and novel entities1a. _________________ 1a EEA report. file:///C:/Users/jsprackett/Downloads/TH- AL-20-006-EN- N%20Is%20Europe%20living%20within. pdf
Amendment 275 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph -1 (new)
Article 3 – paragraph -1 (new)
Amendment 276 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph -1 a (new)
Article 3 – paragraph -1 a (new)
-1a. Member States shall ensure that conduct which knowingly causes substantial damage to the environment constitutes a criminal offence.
Amendment 280 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) the discharge, emission or introduction of a quantity of materials or substances or ionising radiation into air, soil or water which causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to biodiversity, ecosystems services and functions, animals or plants;
Amendment 283 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) the placing on the market of a product which, in breach of a prohibition or another requirement, causes or is likely to cause death or serious injury to any person or substantial damage to air, water or soil quality, or to biodiversity, ecosystems services and functions, animals or plants as a result of the product's use on a larger scale;
Amendment 287 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c – introductory part
Article 3 – paragraph 1 – point c – introductory part
(c) the manufacture, placing on the market or, export from the Union market, use of substances, whether on their own, in mixtures or in articles, including their incorporation into articles, when:
Amendment 290 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c – point vi a (new)
Article 3 – paragraph 1 – point c – point vi a (new)
(via) this activity is not in compliance with Directive 2009/128/EC of the European Parliament and of the Council1a. _________________ 1a Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides.
Amendment 291 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c – paragraph 1
Article 3 – paragraph 1 – point c – paragraph 1
and it causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to biodiversity, ecosystems services and functions, animals or plants;
Amendment 295 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c a (new)
Article 3 – paragraph 1 – point c a (new)
(ca) any conduct in breach of the Regulation (EU) 2017/852 of the European Parliament and of the Council1a. _________________ 1a Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008.
Amendment 296 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c b (new)
Article 3 – paragraph 1 – point c b (new)
Amendment 303 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point e – introductory part
Article 3 – paragraph 1 – point e – introductory part
(e) the collection, transport, treatment, recovery or disposal of waste, the supervision of such operations and the after-care of disposal sites, including action taken as a dealer or a broker (waste management), when an unlawful conduct:
Amendment 308 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point e – point ii
Article 3 – paragraph 1 – point e – point ii
(ii) concerns other waste than referred to in point (i) and causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to biodiversity, ecosystems services and functions, animals or plants;
Amendment 317 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point h
Article 3 – paragraph 1 – point h
(h) the ship-source discharges of polluting substances defined by Article 3(2) of the Directive 2008/56/EC or referred to in Article 4(1) of Directive 2005/35/EC of the European Parliament and of the Council42 on ship-source pollution and on the introduction of penalties, including criminal penalties, into any of the areas referred to in Article 3(1) of that Directive, provided that the ship- source discharges do not satisfy the exceptions set in Article 5 of that Directive; this provision shall not apply to individual cases, where the ship- source discharge does not cause deterioration in the quality of water and the marine environment, unless repeated cases by the same offender in conjunction result in deterioration in the quality of water; _________________ 42 Directive 2005/35/EC of the European Parliament and of the Council of 7 September 2005 on ship-source pollution and on the introduction of penalties for infringements (OJ L 255, 30.9.2005, p. 11– 21).
Amendment 318 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point i
Article 3 – paragraph 1 – point i
(i) the installation, operation or dismantling of an installation in which a dangerous activity is carried out or in which dangerous substances, preparations or pollutants are stored or used falling within the scope of Directive 2012/18/EU of the European Parliament and of the Council43 , Directive 2010/75/EU of the European Parliament and of the Council44 or Directive 2013/30/EU of the European Parliament and of the Council45 and which causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to biodiversity, ecosystems services and functions, animals or plants; _________________ 43 Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC Text with EEA relevance (OJ L 197, 24.7.2012, p. 1– 37). 44 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17– 119). 45 Directive 2013/30/EU of the European Parliament and of the Council of 12 June 2013 on safety of offshore oil and gas operations and amending Directive 2004/35/EC (OJ L 178, 28.6.2013, p. 66– 106).
Amendment 321 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point j
Article 3 – paragraph 1 – point j
(j) the manufacture, production, processing, handling, use, holding, storage, transport, import, export or disposal of radioactive material falling within the scope of Council Directive 2013/59/Euratom46 , Council Directive 2014/87/Euratom47 or Council Directive 2013/51/Euratom48 , which causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to biodiversity, ecosystems services and functions, animals or plants; _________________ 46 Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1–73). 47 Council Directive 2014/87/Euratom of 8 July 2014 amending Directive 2009/71/Euratom establishing a Community framework for the nuclear safety of nuclear installations (OJ L 219, 25.7.2014, p. 42–52). 48 Council Directive 2013/51/Euratom of 22 October 2013 laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption (OJ L 296, 7.11.2013, p. 12– 21).
Amendment 325 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point k
Article 3 – paragraph 1 – point k
(k) the abstraction of surface water or groundwater which causes or is likely to cause substantial damage to the ecological status or potential of surface water bodies or to the quantitative status of groundwater bodies. The abstraction should, for example, not lead to a deterioration of the Status of the Water Bodies as defined in the last River Basin Management Plans, in accordance with the statements of Annex V of the Directive 2000/60/EC, and should not compromise the achievement of good status/potential by 2027 in any of the water bodies in the same river basin district;
Amendment 327 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point k a (new)
Article 3 – paragraph 1 – point k a (new)
(ka) the committing of a serious infringement within the meaning of Article 90 of Regulation (EC) No 1224/2009 of the European Parliament and of the Council.
Amendment 349 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point o
Article 3 – paragraph 1 – point o
(o) any conduct which causes the deterioration of a habitat within a protected site or the significant disturbance of a species, within the meaning of Article 6(2) of the Directive 92/43/EEC, when this deterioration is significant;
Amendment 352 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point p – point ii
Article 3 – paragraph 1 – point p – point ii
(ii) the conduct breaches a condition of permit issued under Article 8 or of authorisation granted under Article 9 of Regulation (EU) No 1143/2014 and causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to biodiversity, ecosystems services and functions, animals or plants;
Amendment 368 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall ensure that the conduct referred to in paragraph 1, points (a), (b), (c), (d), (e), (f), (h), (i), (j), (k), (l), (m), (n), (o), (p) (ii), (q), (r) also constitutes a criminal offence, when committed with at least serious negligence.
Amendment 383 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 3 – point e a (new)
Article 3 – paragraph 3 – point e a (new)
(ea) the conservation status of the species affected and the habitat affected.
Amendment 386 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 3 – point e b (new)
Article 3 – paragraph 3 – point e b (new)
(eb) the financial benefits gained by committing the offence;
Amendment 392 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 4 – point c a (new)
Article 3 – paragraph 4 – point c a (new)
(ca) the consequences on human health and human rights;
Amendment 393 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 4 – point c b (new)
Article 3 – paragraph 4 – point c b (new)
(cb) the act constitutes a violation or negligence of the due diligence.
Amendment 397 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 5 – point b
Article 3 – paragraph 5 – point b
(b) the extent to which the regulatory threshold, value or another mandatory parameter or hazardousness and toxicity threshold is exceeded;
Amendment 403 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 5 – point d a (new)
Article 3 – paragraph 5 – point d a (new)
(da) for offences referred to in paragraph 1 (m), the conservation status of the species;
Amendment 408 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 5 – point d b (new)
Article 3 – paragraph 5 – point d b (new)
(db) the scale of the financial benefits gained by committing the offence;
Amendment 409 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 5 – point d c (new)
Article 3 – paragraph 5 – point d c (new)
(dc) whether or not the offence was committed by an organised criminal group.
Amendment 411 #
2021/0422(COD)
Proposal for a directive
Article 3 a (new)
Article 3 a (new)
Article 3 a Ecocide Member States shall adopt a crime of ecocide, which shall be considered a criminal offence for the purposes of this Directive and shall be defined as unlawful or wanton acts committed with knowledge that there is a substantial likelihood of severe and either widespread or long-term damage to the environment being caused.
Amendment 416 #
2021/0422(COD)
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall ensure that inciting, and aiding and abetting the commission of any of the criminal offences referred to in Articles 3(1) and 3a are punishable as criminal offences.
Amendment 420 #
2021/0422(COD)
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall take the necessary measures to ensure that an attempt to commit any of the criminal offences referred to in Article 3 (1) points (a), (b), (c), (d), (e), (f), (g), (h), (i), (j), (k), (m), (n), (p) (ii), (q), (r) when committed intentionally is punishable as a criminal offence.
Amendment 422 #
2021/0422(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Member States shall take the necessary measures to ensure that the offences referred to in Articles 3, 3a and 4 are punishable by effective, proportionate and dissuasive criminal penalties.
Amendment 424 #
2021/0422(COD)
Proposal for a directive
Article 5 – paragraph 1 a (new)
Article 5 – paragraph 1 a (new)
1a. Member States shall ensure that the CEO of undertakings can be prosecuted independently as a natural person if they have committed the offences referred to in Articles 3, 3a and 4, irrespective of whether the undertaking as a legal person is also being prosecuted.
Amendment 426 #
2021/0422(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Member States shall take the necessary measures to ensure that offences referred to in Articles 3 and 3a are punishable by a maximum term of imprisonment of at least ten years if they cause or are likely to cause death or serious injury to any person.
Amendment 437 #
2021/0422(COD)
Proposal for a directive
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
4a. Member States shall take the necessary measures to develop alternative measures to imprisonment in order to contribute to the restoration of the environment.
Amendment 438 #
2021/0422(COD)
Proposal for a directive
Article 5 – paragraph 4 b (new)
Article 5 – paragraph 4 b (new)
4b. Member States shall take the necessary measures to ensure that natural persons who have committed the offences referred to in Articles 3, 3a and 4 are liable to a proportionate fine.
Amendment 439 #
2021/0422(COD)
Proposal for a directive
Article 5 – paragraph 5 – introductory part
Article 5 – paragraph 5 – introductory part
5. Member States shall take the necessary measures to ensure that natural persons who have committed the offences referred to in Articles 3, 3a and 4 may be subject to additional sanctions or measures which shall include:
Amendment 442 #
2021/0422(COD)
Proposal for a directive
Article 5 – paragraph 5 – point a
Article 5 – paragraph 5 – point a
(a) obligation to reinstate the environment within a given time period and to compensate for the damage caused;
Amendment 446 #
2021/0422(COD)
Proposal for a directive
Article 5 – paragraph 5 – point b
Article 5 – paragraph 5 – point b
(b) fines proportionate to the gravity and duration of the damage caused to the environment as well as to the financial benefits accrued by committing the offence;
Amendment 461 #
2021/0422(COD)
Proposal for a directive
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5a. Natural persons who have committed the offences referred to in Article 3a shall be subject to fines which shall be at least EUR XX or X times higher
Amendment 464 #
2021/0422(COD)
Proposal for a directive
Article 6 – paragraph 1 – introductory part
Article 6 – paragraph 1 – introductory part
1. Member States shall ensure that legal persons can be held liable for offences referred to in Articles 3, 3a and 4 where such offences have been committed for their benefit by any person who has a leading position within the legal person, acting either individually or as part of an organ of the legal person, based on:
Amendment 468 #
2021/0422(COD)
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Member States shall also ensure that legal persons can be held liable where the lack of supervision or control by a person referred to in paragraph 1 has made possible the commission of an offence referred to in Articles 3, 3a and 4 for the benefit of the legal person by a person under its authority.
Amendment 469 #
2021/0422(COD)
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Liability of legal persons under paragraphs 1 and 2 shall not exclude criminal proceedings against natural persons who are perpetrators, inciters or accessories in the offences referred to in Articles 3, 3a and 4.
Amendment 470 #
2021/0422(COD)
Proposal for a directive
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Member States shall take the necessary measures to ensure that a legal person held liable pursuant to Article 6(1) is punishable by effective, proportionate and dissuasive sanctions. Where possible, these sanctions shall be identical across Member States. The level of sanctions shall be graduated, reflecting the degree of severity and duration of the environmental consequences.
Amendment 472 #
2021/0422(COD)
Proposal for a directive
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
1a. Member States shall take the necessary measures to ensure that precautionary measures pending the judgment allow for the immediate cessation of the criminal activity or the obligation to reinstate the environment where there is a risk of substantial or irreversible damage to the environment.
Amendment 474 #
2021/0422(COD)
Proposal for a directive
Article 7 – paragraph 2 – introductory part
Article 7 – paragraph 2 – introductory part
2. Member States shall take the necessary measures to ensure that sanctions or measures for legal persons liable pursuant to Article 6(1) for the offences referred to in Articles 3, 3a and 4 shall include:
Amendment 489 #
2021/0422(COD)
Proposal for a directive
Article 7 – paragraph 2 – point k a (new)
Article 7 – paragraph 2 – point k a (new)
(ka) the removal from the European Transparency Register.
Amendment 498 #
2021/0422(COD)
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Member States shall take the necessary measures to ensure that offences referred to in Article 3(1) points (a) to (j), (n), (q), (r) are punishable by fines, the maximum limit of which shall be not less than 15% of the total worldwide turnover of the legal person [/undertaking] in the business year preceding the fining decision.
Amendment 500 #
2021/0422(COD)
Proposal for a directive
Article 7 – paragraph 5
Article 7 – paragraph 5
Amendment 506 #
2021/0422(COD)
Proposal for a directive
Article 7 – paragraph 5 a (new)
Article 7 – paragraph 5 a (new)
5 a. Member States shall take the necessary measures to ensure that offences referred to in Article 3a are punishable by fines, paid by the legal person committing the environmental offences, the maximum limit of which shall be comprised between 15 and 30% of the total worldwide turnover of the legal person[/undertaking] in the business year preceding the fining decision.
Amendment 510 #
2021/0422(COD)
Proposal for a directive
Article 7 – paragraph 6 a (new)
Article 7 – paragraph 6 a (new)
6a. Member States shall provide for the creation of a national fund dedicated to the financing of environmental decontamination, remediation or restoration, which should be financed by administrative and criminal fines paid by the author of environmental offences.
Amendment 512 #
2021/0422(COD)
Proposal for a directive
Article 8 – paragraph 1 – introductory part
Article 8 – paragraph 1 – introductory part
In so far as the following circumstances do not already form part of the constituent elements of the criminal offences referred to in Article 3, Member States shall take the necessary measures to ensure that, in relation to the relevant offences referred to in Articles 3, 3a and 4, the following circumstances may be regarded as aggravating circumstances:
Amendment 516 #
2021/0422(COD)
Proposal for a directive
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) the offence caused destruction or irreversible or long-lasting substantial damage to an ecosystem or to the conservation of populations of wild animal or plant species covered by Council Regulation (EC) No 338/97, Council Directive 92/43/EC and Directive 2009/147/EC of the European Parliament and of the Council;
Amendment 536 #
2021/0422(COD)
(ja) the offender committed an offence under Article 3 while subject to a derogation under article 15(4) of Directive 2010/75/EC.
Amendment 538 #
2021/0422(COD)
Proposal for a directive
Article 8 – paragraph 1 – point j b (new)
Article 8 – paragraph 1 – point j b (new)
(jb) the offence was committed within a Member State’s protected site, including a Natura 2000 area, or in an area where the offence is likely to have a significant effect in view of a protected site's conservation objectives;
Amendment 539 #
2021/0422(COD)
Proposal for a directive
Article 8 – paragraph 1 – point j c (new)
Article 8 – paragraph 1 – point j c (new)
(j c) the offence was committed together with other criminal offences;
Amendment 540 #
2021/0422(COD)
Proposal for a directive
Article 8 – paragraph 1 – point j d (new)
Article 8 – paragraph 1 – point j d (new)
(jd) the offence caused the unnecessary and avoidable suffering of animals.
Amendment 541 #
2021/0422(COD)
Proposal for a directive
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
Member States shall take the necessary measures to ensure that, in relation to the relevant offences referred to in Articles 3, 3a and 4, the following circumstances may be regarded as mitigating circumstances:
Amendment 543 #
2021/0422(COD)
Proposal for a directive
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) the offender restores nature to its previous condition except for offences under Article 3(1) points (a), (b), (c), (e), (i), (h), (j), (q), (r) and Article 3a;
Amendment 551 #
2021/0422(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall take the necessary measures to provide for a limitation period that enables the investigation, prosecution, trial and judicial adjudication of criminal offences referred to in Articles 3, 3a and 4 for a sufficient period of time starting after the commission of those criminal offences or from the discovery of the offence if it was concealed, in order for those criminal offences to be tackled effectively.
Amendment 553 #
2021/0422(COD)
Proposal for a directive
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
1a. Member States shall ensure that special measures of limitation may be applied in the case of concealment of an offence, i.e. where the offender has prevented its discovery. In this case, the time limit shall run only from the day when the offence could be established under conditions that allow prosecution.
Amendment 556 #
2021/0422(COD)
Proposal for a directive
Article 11 – paragraph 2 – point a
Article 11 – paragraph 2 – point a
(a) of offences referred to in Articles 3 and 4 which are punishable by a maximum sanction of at least ten years of imprisonment, for a period of at least ten years from the time when the offence was committed or from the discovery of the offence if it was concealed, when offences are punishable;
Amendment 559 #
2021/0422(COD)
Proposal for a directive
Article 11 – paragraph 2 – point b
Article 11 – paragraph 2 – point b
(b) of offences referred to in Articles 3 and 4 which are punishable by a maximum sanction of at least six years of imprisonment, for a period of at least six years from the time when the offence was committed or from the discovery of the offence if it was concealed, when offences are punishable;
Amendment 563 #
2021/0422(COD)
Proposal for a directive
Article 11 – paragraph 2 – point c
Article 11 – paragraph 2 – point c
(c) of offences referred to in Articles 3 and 4 which are punishable by a maximum sanction of at least four years of imprisonment, for a period of at least four years from the time when the offence was committed or from the discovery of the offence if it was concealed, when offences are punishable.
Amendment 570 #
2021/0422(COD)
Proposal for a directive
Article 11 – paragraph 3 a (new)
Article 11 – paragraph 3 a (new)
3 a. By way of derogation from paragraph 2 and for the offence referred to in Article 3a, Member States may provide for a limitation period longer than ten years, provided that this period may be interrupted or suspended by certain specific acts.
Amendment 573 #
2021/0422(COD)
Proposal for a directive
Article 11 – paragraph 4 – point a
Article 11 – paragraph 4 – point a
(a) a penalty of imprisonment in the case of a criminal offence which is punishable by a maximum sanction of at least ten years of imprisonment, imposed following a final conviction for a criminal offence referred to in Articles 3, 3a and 4, for at least ten years from the date of the final conviction;
Amendment 580 #
2021/0422(COD)
Proposal for a directive
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
1. Each Member State shall take the necessary measures to establish its jurisdiction over the offences referred to in Articles 3, 3a and 4 where:
Amendment 585 #
2021/0422(COD)
Proposal for a directive
Article 12 – paragraph 1 – point d a (new)
Article 12 – paragraph 1 – point d a (new)
(da) the offence is committed for the benefit of a legal person established on its territory;
Amendment 589 #
2021/0422(COD)
Proposal for a directive
Article 12 – paragraph 2 – introductory part
Article 12 – paragraph 2 – introductory part
2. A Member State shall inform the Commission where it decidtake the necessary measures to extend its jurisdiction to offences referred to in Articles 3, 3a and 4 which have been committed outside its territory, where:
Amendment 594 #
2021/0422(COD)
Proposal for a directive
Article 12 – paragraph 2 – point c
Article 12 – paragraph 2 – point c
(c) the offence has created a severe risk for the environment or for the biodiversity on its territory.
Amendment 595 #
2021/0422(COD)
Proposal for a directive
Article 12 – paragraph 2 a (new)
Article 12 – paragraph 2 a (new)
2a. Member States shall introduce universal jurisdiction of their courts for the prosecution and judgment of an offence referred to in Article 3a, in order to avoid the externalisation of environmental damage, where it was not committed on its territory, was committed by a foreign person, against a foreign victim, and without that State being the victim of the offence.
Amendment 597 #
2021/0422(COD)
Proposal for a directive
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3a. Member States shall take the necessary measures to establish on their territory either specialised environmental courts or environmental units within existing courts to prosecute, investigate and judge the offences defined in Article 3 and 3a of this Directive.
Amendment 599 #
2021/0422(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Member States shall take the necessary measures to ensure that protection granted under Directive (EU) 2019/1937, is applicable to legal and natural persons reporting criminal offences referred to in Articles 3, 3a and 4 of this Directive.
Amendment 602 #
2021/0422(COD)
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Member States shall take the necessary measures to ensure that natural and legal persons reporting offences referred to in Articles 3, 3a and 4 of this Directive and providing evidence or otherwise cooperating with the investigation, prosecution or adjudication of such offences are provided the necessary support and assistance in the context of criminal proceedings.
Amendment 604 #
2021/0422(COD)
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2 a. Member States shall take the necessary measures to ensure that legal and natural persons reporting criminal offences referred to in Articles 3, 3a and 4 of this Directive are protected against strategic lawsuits against public participation.
Amendment 606 #
2021/0422(COD)
Proposal for a directive
Article 14 – title
Article 14 – title
Rights for the public concerned to participate in proceedingsto information, participation and access to justice for the public
Amendment 607 #
2021/0422(COD)
Proposal for a directive
Article 14 – paragraph -1 (new)
Article 14 – paragraph -1 (new)
-1 Member States shall ensure that the following information is considered to be in the public interest and is made public to and easily accessible by the public concerned: (a) the state of all cases prosecuted under this Directive, the final judgments, and the level of sanctions imposed by the judge; (b) the state of all cases prosecuted under this Directive, the final judgments, and the level of sanctions imposed by the judge; (c) complaints submitted under this Directive; (d) information enabling the public concerned to know the progress of the proceedings, unless, in exceptional cases, the proper handling of the case may be jeopardised by such sharing of information; (e) the arrangements for intervention in proceedings for the offences referred to in Articles 3, 3a and 4.
Amendment 608 #
2021/0422(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
Member States shall ensure that, in accordance with their national legal system, members of the public concerned have appropriate rights to participate in proceedings concerning offences referred to in Articles 3, 3a and 4, for instance as a civil party. Member States shall encourage any initiative facilitating access to justice for members of the public, including in the establishment of local centres specialising in access to justice and environmental issues.
Amendment 612 #
2021/0422(COD)
Proposal for a directive
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
Member States shall provide for the possibility for individuals and non- governmental organisations working for the protection of the environment to bring civil actions, particularly in the absence of identifiable victims, to defend the direct voice of ecosystems.
Amendment 613 #
2021/0422(COD)
Proposal for a directive
Article 14 – paragraph 1 b (new)
Article 14 – paragraph 1 b (new)
Member States shall provide for measures to reduce obstacles to the right to an effective remedy, in particular the reduction of the length and cost of proceedings, thereby facilitating access to justice for members of the public concerned. Member States shall ensure a fair, equitable and timely procedure, non- prohibitive costs and the right to be defended or represented in court. Member States shall establish networks of environmental lawyers who can assist members of the public, including non- governmental organisations, to participate in such proceedings.
Amendment 614 #
2021/0422(COD)
Proposal for a directive
Article 14 – paragraph 1 c (new)
Article 14 – paragraph 1 c (new)
Member States shall ensure that all complaints concerning violations of the provisions of this Directive are dealt with in a prompt and effective manner. Member States shall establish a mechanism at national level to deal with complaints in an accelerated procedure where there is a risk of irreversible or serious damage to the environment.
Amendment 616 #
2021/0422(COD)
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Member States shall take appropriate action, such as proactive law enforcement tools, information and awareness- raising campaigns targeting all relevant stakeholders both from the public and private sector, anti-corruption programmes, and research and education programmes, to reduce overall environmental criminal offences, raise public awareness and reduce the risk of population of becoming a victim of an environmental criminal offence. Where appropriate, Member States shall act in cooperation with theall relevant stakeholders, in particular civil society organisations.
Amendment 627 #
2021/0422(COD)
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
Member States shall take the necessary measures to ensure that effective investigative tools, such as those which are used in organised crime or other serious crime cases, are also available for investigating or prosecuting offences referred to in Articles 3, 3a and 4.
Amendment 628 #
2021/0422(COD)
Proposal for a directive
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
Member States shall provide sufficient resources and training in order to ensure that judicial and enforcement personnel, including judges, prosecutors, police, judicial staff and competent authorities’ staff involved in criminal proceedings and investigations, have the appropriate expertise, including qualifications, in environmental crime and environmental issues.
Amendment 634 #
2021/0422(COD)
Proposal for a directive
Article 19 a (new)
Article 19 a (new)
Amendment 637 #
2021/0422(COD)
Proposal for a directive
Article 20 – paragraph 1 – point a
Article 20 – paragraph 1 – point a
(a) the short, medium, long-term and time-bound objectives and priorities of national policy in this area of offence;
Amendment 639 #
2021/0422(COD)
Proposal for a directive
Article 20 – paragraph 1 – point c
Article 20 – paragraph 1 – point c
(c) the modes of coordination and cooperation between the competent authorities, including with competent authorities of other Member States;
Amendment 640 #
2021/0422(COD)
Proposal for a directive
Article 20 – paragraph 1 – point d a (new)
Article 20 – paragraph 1 – point d a (new)
(da) guidelines for the use of the proceeds of administrative and criminal sanctions for environmental restoration actions.
Amendment 643 #
2021/0422(COD)
Proposal for a directive
Article 20 – paragraph 2
Article 20 – paragraph 2
2. Member States shall ensure that the strategy is reviewed and updated at regular intervals no longer than 53 years, on a risk- analysis-based-approach, in order to take account of relevant developments and trends and related threats regarding environmental crime.
Amendment 648 #
2021/0422(COD)
Proposal for a directive
Article 21 – paragraph 3
Article 21 – paragraph 3
3. Member States shall ensure that a consolidated review of their statistics is regularly publishedpublish annually the statistical data referred to in paragraph 2 in a standard, accessible and comparable format established in accordance with Article 22 and in a raw version.
Amendment 651 #
2021/0422(COD)
Proposal for a directive
Article 21 – paragraph 4
Article 21 – paragraph 4
4. Member States shall annually transmit to the Commission the statistical data referred to in paragraph 2 in a standard accessible and comparable format established in accordance with Article 22. These data aggregated at European level shall be available on a country-by-country basis according to the categories of information referred to in paragraph 2, under the supervision of Eurostat.
Amendment 660 #
2021/0422(COD)
Proposal for a directive
Article 22 – paragraph 2 – point a
Article 22 – paragraph 2 – point a
(a) a common classification of environmental crimes as well as sanctions that are effective, dissuasive and proportionate to the offence committed ;
Amendment 662 #
Amendment 663 #
2021/0422(COD)
Proposal for a directive
Article 25 – paragraph 1
Article 25 – paragraph 1
1. The Commission shall by [OP – please insert the date - two years after the transposition period is over], and every two years thereafter, submit a report to the European Parliament and to the Council assessing the extent to which the Member States have taken the necessary measures to comply with this Directive as well as providing recommendations to Member States. Member States shall provide the Commission with the necessary information for the preparation of that report.
Amendment 665 #
2021/0422(COD)
Proposal for a directive
Article 25 – paragraph 2
Article 25 – paragraph 2
2. Every two years as of [OP – please insert the date one year after the transposition period is over], Member States shall send the Commission a report within three months which includes a summary about implementation of and actions taken in accordance with Articles 153 to 17, 19 and 20.
Amendment 667 #
2021/0422(COD)
Proposal for a directive
Article 25 – paragraph 3 a (new)
Article 25 – paragraph 3 a (new)
3a. Within one year after the entry into force of this Directive, the Commission shall present a homogeneous and harmonised classification of environmental crimes prepared with the Member States and a regulatory classification of sanctions adapted to provide guidance to national competent authorities, prosecutors and judges in the application of the sanctions provided for in this Directive.
Amendment 669 #
2021/0422(COD)
Proposal for a directive
Article 25 – paragraph 3 b (new)
Article 25 – paragraph 3 b (new)
3b. Within one year after the entry into force of this Directive, notwithstanding Article 119 of Regulation 2017/1939, the Commission shall produce a report on the possibility of extending the powers of the European Public Prosecutor's Office provided for in Article 86 of the Treaty on the Functioning of the European Union to include serious environmental crime that are detrimental to the interests of the Union. The European Public Prosecutor's Office would thus be empowered to request independent investigations and to initiate legal proceedings in respect of environmental damage and environmental crime on a European scale.
Amendment 670 #
2021/0422(COD)
Proposal for a directive
Article 25 – paragraph 3 c (new)
Article 25 – paragraph 3 c (new)
3c. Within one year after the entry into force of this Directive, the Commission shall present guidelines to clarify the procedural framework for the participation of members of the public in the criminal prosecution of environmental offences, including the definition of easily accessible admissibility criteria.
Amendment 671 #
2021/0422(COD)
Proposal for a directive
Article 25 – paragraph 3 d (new)
Article 25 – paragraph 3 d (new)
3d. Within two years after the entry into force of this Directive, the Commission shall, and where appropriate with the assistance of inter alia the European Environment Agency, present a report on how environmental crime contributes to the exceedance of planetary boundaries as well as how the scope of this Directive could be expanded to cover actions/offences which result in the exceedance of planetary boundaries.
Amendment 20 #
2021/0414(COD)
Proposal for a directive
Recital 2
Recital 2
(2) This Directive respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union (‘the Charter’). In particular, Article 31 of the Charter provides for the right of every worker to working conditions which respect his or her health, safety and dignity. Article 27 of the Charter protects the workers’ right to information and consultation within the undertaking. Article 8 of the Charter provides that everyone has the right to the protection of personal data concerning him or her. Article 216 of the Charter recognises the freedomprovides for the right to cnonduct a business- discrimination.
Amendment 23 #
2021/0414(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Digitalisation is changing the world of work, improving productivity and enhancing flexibility, while also carrying some risks for employment and working conditions and has led to employment opportunities, in particular in the transport and tourism sectors, while also carrying some risks for employment and working conditions, putting at risk the solidarity based social protection system by denying workers their fundamental social rights, social protection and access to social dialogue. Algorithm-based technologies, including automated monitoring and decision-making systems, have enabled the emergence and growth of digital labour platforms, in particular in the transport and tourism sectors, while these systems carry risks for working conditions, health and safety and fundamental rights.
Amendment 26 #
2021/0414(COD)
Proposal for a directive
Recital 4 a (new)
Recital 4 a (new)
(4a) Precarious self-employment is a field of increasing concern in the digital labour platform industry, not least since the COVID-19 pandemic, which further expanded it and brought it to the forefront, as driving and delivery services in particular faced an unprecedented boom. It demonstrated the lack of social protection for these workers, many of them at the front-line of COVID risk exposure, with no availability of risk compensation, often not eligible for income support measures, whilst faced with loss of income. Therefore, platform workers need to be guaranteed access to social security, including protection for unemployment and sickness.
Amendment 30 #
2021/0414(COD)
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
Amendment 33 #
2021/0414(COD)
Proposal for a directive
Recital 5 b (new)
Recital 5 b (new)
(5b) Individuals performing on- location platform work, such as in driving and delivery services are, besides the typical risk of fatigue and exhaustion, also exposed to psychosocial risks like stress and anxiety related to algorithmic management and performance monitoring of work activities, which can put excessive pressure on workers with implications for their own health and safety as well as on road safety. The algorithmic management entails more personal risk-taking attitudes on the road, which contributes to the high amount of occupational incidents, and it also affects significantly the mental health of people working through digital platforms1a. _________________ 1a Approximately 50% of people working through online platforms suffer from clinical levels of social anxiety, well above the 7-8% found in the general population, according to a study led by Bérastégui P.2021) in “Exposure to psychosocial risk factors in the gig economy: a systematic review” (https://www.etui.org/publications/exposu re-psychosocial-risk-factors-gig-economy ).
Amendment 38 #
2021/0414(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Platform work can provide opportunities for accessing the labour market more easily, or for gaining additional income through a secondary activity or enjoying some flexibility in the organisation of working time. At the same time, platform work brings challenges, as it can blur the boundaries between employment relationship and self- employed activity, and the responsibilities of employers and workers. Misclassification of the employment status has consequences for the persons affected, as it is likely to restrict access to existing labour and social rights. It also leads to unfair competition and an uneven playing field with respect to businesses that classify their workers correctly, and it has implications for Member States’ industrial relations systems, their tax base and the coverage and sustainability of their social protection systems as platform companies avoid paying due taxes and social contributions. While such challenges are broader than platform work, they are particularly acute and pressing in the platform economy, especially in the driving and delivery services.
Amendment 42 #
2021/0414(COD)
Proposal for a directive
Recital 7
Recital 7
Amendment 45 #
2021/0414(COD)
Proposal for a directive
Recital 8
Recital 8
(8) Automated monitoring and decision-making systems powered by algorithms increasingly replace functions that managers usually perform in businesses, such as allocating tasks, giving instructions, evaluating the work performed, providing incentives or imposing sanctions. Digital labour platforms use such algorithmic systems as a standard way of organising and managing platform work through their infrastructure. Persons performing platform work subject to such algorithmic management often lackdo not have access to information on how the algorithms work, which personal data are being used and how their behaviour affects decisions taken by automated systems. Workers’ representatives and labour inspectorates do not have access to this information either. The lack of transparency allows digital labour platforms to set working conditions and terms of employment unilaterally. Moreover, persons performing platform work often do not know the reasons for decisions taken or supported by automated systems and lack the possibility to obtain an explanation for these decisions, to discuss those decisions with a contact person or to contest them and seek redress. This creates severe power imbalances between workers and the platforms, which this Directive should counterbalance and address with strong rights for workers.
Amendment 53 #
2021/0414(COD)
Proposal for a directive
Recital 13
Recital 13
(13) While existing or proposed Union legal acts provide for certain general safeguards, challenges in platform work require some further specific measures. In order to adequately frame the development of platform work in a sustainable manner, it is necessary for the Union to set new minimum standards in working conditions to address the challenges arising from platform work. Persons performing platform work in the Union should be provided with a number of minimum rights aiming at ensuring correct determination of their employment status, at promoting transparency, fairness and accountability in algorithmic management, and at improving transparency in platform work, including in cross-border situations. This should be done with a view to improving legal certainty, creating a level playing field between different digital labour platforms and towards offline providers of services and supporting the sustainable growth of digital labour platformsdevelopment of platform in a sustainable manner in the Union.
Amendment 55 #
2021/0414(COD)
Proposal for a directive
Recital 16
Recital 16
(16) This Directive should apply to all persons performing platform work in the Union who have, or who based on an assessment of facts may be deemed to have, an employment contract or employment relationship as defined by the law, collective agreements or practice in force in the Member States, with consideration to the case-law of the Court of Justice of the European Union. This should include situations where the employment status of the person performing platform work is not clear, so as to allow correct determination of that status. The provisions on algorithmic management which are related to the processing of personal data should also apply to genuine self-employed and othershould also apply to all persons performing platform work in the Union including those who do not have an employment relationship.
Amendment 60 #
2021/0414(COD)
Proposal for a directive
Recital 22
Recital 22
(22) Where the existence of an employment relationship is established based on facts, the party acting as employer should be clearly identified and that party should fulfil all the obligations resulting from its role as employer, and abide by all applicable labour, social security, tax and health and safety legislation, as well as collective agreements in the relevant sector of activity.
Amendment 61 #
2021/0414(COD)
Proposal for a directive
Recital 22 a (new)
Recital 22 a (new)
(22a) The risk of undeclared work and consequently labour exploitation has been detected in digital labour platforms in many Member States, particularly through the rental of accounts to undocumented migrants in delivery platforms. To prevent such practices that further put access to labour and social protection at risk, Member States should introduce legal provisions on subcontracting that provide for joint and several liability and effective access to redress across subcontracting chains. Furthermore, Member States should take all necessary measures to ensure effective access to redress for undocumented migrants without fear of retaliation by immigration enforcement authorities.
Amendment 63 #
2021/0414(COD)
Proposal for a directive
Recital 23
Recital 23
(23) Ensuring correct determination of the employment status should not prevent the improvement of working conditions of genuine self-employed persons performing platform work. Where a digital labour platform decides – on a purely voluntary basis or in agreement with the persons concerned – to pay for social protection, accident insurance or other forms of insurance, training measures or similar benefits to self-employed persons working through that platform, those benefits as such should not be regarded as determining elements indicating the existence of an employment relationship.
Amendment 71 #
2021/0414(COD)
Proposal for a directive
Recital 26
Recital 26
(26) Effective implementation of the legal presumption through appropriate measures, such as disseminating information to the public, developing guidance and strengthening controls and field inspections is essential to ensure legal certainty and transparency for all parties involved. These measures should take into account the specific situation of start-ups to support the entrepreneurial potential and the conditions for the sustainable growth of digital labour platforms in the Union.
Amendment 76 #
2021/0414(COD)
Proposal for a directive
Recital 31 a (new)
Recital 31 a (new)
(31a) Before each deployment of automated monitoring systems and systems to take or assist in decision- making, undertakings should perform a fundamental rights impact assessment of the systems’ impact in the context of use throughout the entire lifecycle and include measures to mitigate any impact on fundamental rights, health and safety, including mental health. Where the possible impacts on fundamental rights, health and safety, including mental health, cannot be mitigated, the systems should not be put into use.
Amendment 77 #
2021/0414(COD)
Proposal for a directive
Recital 32 a (new)
Recital 32 a (new)
(32a) Certain decisions, such as dismissal or any other disciplinary measures should always be taken by humans, not by automated systems. Considering the impact for workers of such decisions, including their livelihood and fundamental rights, including social rights, there should always be a human responsible for these decisions. Humans should be fully responsible for these decisions and be able to explain and justify these decisions. These decisions should at no times be taken by automated systems, due to the risks to the rights of individuals, the exacerbation of power imbalances inherent to automated decision-making.
Amendment 78 #
2021/0414(COD)
Proposal for a directive
Recital 33
Recital 33
(33) Digital labour platforms should not be required to disclose the detailed functioning of their automated monitoring and decision-making systems, including algorithms, or other detailed data that contains cCommercial secrets or is protected by intellectual property rights. However, the result of those considerations should not bejustify a refusal to provide all the information required by this Directive.
Amendment 81 #
2021/0414(COD)
Proposal for a directive
Recital 48 a (new)
Recital 48 a (new)
(48a) As the rights and freedoms of individuals can be seriously undermined by automated monitoring or decision- making systems, it is essential that affected individuals should have meaningful access to reporting and redress mechanisms with the relevant national authority, be it the data protection authority or the labour inspectorate. They should be able to report infringements of this directive to their national supervisory authority and have the right to be heard and to be informed about the outcome of their complaint and the right to a timely decision. In addition, they should have the right to an effective remedy against competent authorities who fail to enforce these rights and the right to redress.
Amendment 82 #
2021/0414(COD)
Proposal for a directive
Recital 51
Recital 51
Amendment 84 #
2021/0414(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
1. The purpose of this Directive is to improve the working conditions of persons performing platform work by ensuring correct determination of their employment status, by ensuring their health and safety, by promoting transparency, fairness and accountability in algorithmic management in platform work and by improving transparency in platform work, including in cross-border situations, while supporting the conditions for the sustainable growth of digital labour platforms in the Union.
Amendment 89 #
2021/0414(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) ‘platform work’ means any work organised or enabled through a digital labour platform and performed in the Union by an individual on the basis of a contractual relationship between the digital labour platform and the individual, irrespective of whether a contractual relationship exists between the individual and the recipient of the service;
Amendment 91 #
2021/0414(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
(3) ‘person performing platform work’ means any individual performing platform work, irrespective of the contractual designation of the relationship between that individual and the digital labour platform by the parties involved;
Amendment 94 #
2021/0414(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 5
Article 2 – paragraph 1 – point 5
(5) ‘representatives’ meansand 'workers' representative' mean representatives of recognised trade unions or other persons who are freely elected or who are designated by the workers’ in an organisations or to representatives provided for by national law or practices, or both; them in accordance with national law and practice. The exclusive prerogatives and rights of trade unions, such as the right of trade unions to participate in collective bargaining, and to conclude collective agreements, and workers' right to organise themselves in trade unions, shall be preserved.
Amendment 95 #
2021/0414(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
Amendment 97 #
2021/0414(COD)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The determination of the existence of an employment relationship shall be guided primarily by the facts relating to the actual performance of work, taking into account the use of algorithms in the organisation of platform work, irrespective of how the relationship is classified in any contractual arrangement that may have been agreed between the parties involved. Where the existence of an employment relationship is established based on facts, the party or parties assuming the obligations of the employer in relation to labour law including sectorial obligations established by collective agreements, tax payment and financing of social protection and insurances, including health and safety obligations, shall be clearly identified in accordance with national legal systems.
Amendment 101 #
2021/0414(COD)
Proposal for a directive
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2a. Digital labour platforms exerting the prerogatives of employers are undertakings and shall comply with the corresponding employers’ obligations under national law and collective agreements applicable in the sector of activity. Platform workers shall fully enjoy the status of worker in line with national law and sectorial collective agreements, including the right to join a trade union, to organise, and bargain collectively.
Amendment 106 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
1. The contractual relationship between a digital labour platform that controls, within the meaning of paragraph 2, the performance of work and a person performing platform work through that platform shall be legally presumed to be an employment relationship and the digital labour platform shall be presumed to be the employer. To that effect, Member States shall establish a framework of measures, in accordance with their national legal and judicial systems.
Amendment 109 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 1 – subparagraph 1
Article 4 – paragraph 1 – subparagraph 1
The legal presumption shall apply in all relevant administrative procedures and administrative and legal proceedings. Competent authorities and administrative bodies responsible for verifying compliance with or enforcing relevant legislation shall be able to rely onapply that presumption.
Amendment 111 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
Amendment 133 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 3 – introductory part
Article 4 – paragraph 3 – introductory part
3. Member States shall take supportingall necessary measures to ensure the effective implementation of the legal presumption referred to in paragraph 1 while taking into account the impact on start-ups, avoiding capturing the genuine self-employed and supportin order to ensure the effective protection for workers performing platform work ing the sustainable growth of digital labour platformscontext of an employment relationship. In particular they shall:
Amendment 137 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
(c) develop guidance forand establish procedures for national competent and enforcement authorities to proactively identify, target and pursue digital labour platforms in order to ensure effective compliance with the provisions established in this directive, including by imposing dissuasive sanctions against non-compliant digital labour platforms;
Amendment 140 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 3 – point c a (new)
Article 4 – paragraph 3 – point c a (new)
(ca) develop guidance and establish procedures for competent administrative authorities and institutions to proactively apply the legal presumption in the administrative procedures and to share data with other relevant authorities in order to apply the legal presumption in the processing and registration of contractual relations and social security related data;
Amendment 141 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 3 – point d
Article 4 – paragraph 3 – point d
(d) strengthen the controls and field inspections conducted by labour inspectorates or the bodies responsible for the enforcement of labour law, while ensuring that such controls and inspections are proportionate and non- discriminatory.. Member States shall be encouraged to determine every year a national target for the number of inspections to be carried out in respect of the sectors of activity in which digital labour platforms operate in order to determine the correct classification of workers;
Amendment 142 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 3 – point d a (new)
Article 4 – paragraph 3 – point d a (new)
(da) provide for an automatic and immediate inspection by labour inspectorates or the bodies responsible for the enforcement of labour law every time there is a detected case of misclassification or reclassification a person performing platform work is newly recognised as platform worker, in order to verify the status of all the other persons performing platform work for the same digital labour platform;
Amendment 144 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 3 – point d b (new)
Article 4 – paragraph 3 – point d b (new)
(db) provide for sufficient resources and trainings for labour inspectorates or the bodies responsible for the enforcement of labour law in order to strengthen their capacities, especially in the technological field, in order to enable them to effectively comply with points (ca) and (da), also by carrying out routine and announced visits;
Amendment 145 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 3 – point d c (new)
Article 4 – paragraph 3 – point d c (new)
(dc) ensuring that duly qualified technical experts and specialists, particularly with respect to algorithmic management, assist the labour inspectorates in their work when necessary.
Amendment 147 #
2021/0414(COD)
Proposal for a directive
Article 4 – paragraph 4
Article 4 – paragraph 4
4. With regard to contractual relationships entered into before and still ongoing on the date set out in Article 21(1), the legal presumption referred to in paragraph 1 shall only apply to the period starting from that date without prejudice to other applicable national and Union law, in particular Directive (EU) 2019/1152.
Amendment 149 #
2021/0414(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
Where the digital labour platform argues that the contractual relationship in question is not an employment relationship as defined by the law, collective agreements or practice in force in the Member State in question, with consideration to the case-law of the Court of Justice, the burden of proof shall be on the digital labour platform. Such proceedings shall not have suspensive effect on the application of the legal presumption.
Amendment 153 #
2021/0414(COD)
Proposal for a directive
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
Amendment 155 #
2021/0414(COD)
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 164 #
2021/0414(COD)
Proposal for a directive
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) automated decision-making systems which are used to take or support decisions that significantly affect those platform workers’ working conditions, in particular their access to work assignments and organization of their work, pricing of individual assignments, their earnings, their occupational safety and health, their working time, or are used to support decisions affecting their promotion and their contractual status, including the restriction, suspension or termination of their account.
Amendment 165 #
2021/0414(COD)
Proposal for a directive
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
1a. Member States shall equally require digital labour platforms that the above-mentioned monitoring and decision-making systems laid down in (a) and (b) are subject to information and consultation of trade unions and collective bargaining. In accordance to Regulation (EU) 2016/679, a “data controller” (the employer) should seek the views of data subjects or their representatives when undertaking an impact assessment regarding access and process of personal data.
Amendment 166 #
2021/0414(COD)
Proposal for a directive
Article 6 – paragraph 2 – point b – point iv
Article 6 – paragraph 2 – point b – point iv
(iv) the grounds for decisions to restrict, suspend or terminate the platform worker’s account, to refuse the remuneration for work performed by the platform worker, on the platform worker’s contractual status or any decision with similar effectsr any decision with similar effects, the grounds for promotion of work related relationships, for task allocation and, where decision-making is supported or based on monitoring and evaluating performance, how behaviour has been evaluated and the justification for the evaluation.
Amendment 167 #
2021/0414(COD)
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Digital labour platforms shall provide the information referred to in paragraph 2 in the form of a document which may be in electronic format. They shall provide that information at the latest on the first working day, as well as in the event of substantial changes and at any time upon the platform workers’ request. The information shall be presented in a concismplete, transparent, intelligible and easily accessible form, using clear and plain language.
Amendment 168 #
2021/0414(COD)
Proposal for a directive
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4a. Digital labour platforms shall enter into collective bargaining in good faith with representative trade unions prior to putting into use automated monitoring and decision-making systems and prior to any substantial modification that may have an impact on terms of employment and working conditions.
Amendment 169 #
2021/0414(COD)
Proposal for a directive
Article 6 – paragraph 5 a (new)
Article 6 – paragraph 5 a (new)
Amendment 170 #
2021/0414(COD)
Proposal for a directive
Article 6 a (new)
Article 6 a (new)
Article 6 a Fundamental rights impact assessments for digital labour platforms 1. Digital labour platforms must before deployment of an automated monitoring or automated decision-making publish a fundamental rights impact assessment of the systems’ impact in the context of use throughout the entire lifecycle. This assessment shall be submitted to the competent labour authorities, the competent data protection authority and officially appointed duly qualified technical experts and specialists, particularly with respect to algorithmic management. This assessment shall include at least: a. the intended purpose for which the system will be used; b. the intended geographic and temporal scope of the system; c. the potential risks of the use to any rights and freedoms of workers, including any indirect impacts or consequences of the systems; d. the categories of natural persons and groups likely or foreseen to be affected; e. the proportionality and necessity of the system’s use; f. verification of the legality of the use of the system in accordance with Union and national law; g. any specific risk of harm likely to impact marginalised, vulnerable persons or groups at risk of discrimination, and risk of increasing existing societal inequalities; j. the governance system the deployer will put in place, including human oversight, complaint-handling and redress. 2. If adequate steps to mitigate the risks outlined in the course of the assessment in paragraph 1 cannot be identified, the system shall not be put into use.
Amendment 172 #
2021/0414(COD)
Proposal for a directive
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Member States shall ensure that digital labour platforms regulartogether with workers' representatives regularly, and at least annually monitor and evaluate the impact of individual decisions taken or supported by automated monitoring and decision-making systems, as referred to in Article 6(1), on working conditions, including workers’ rights and health and safety, including mental health. This assessment shall be submitted to the competent labour inspectorates and the competent data protection authority. It shall also be made publicly available and shared with trade unions and workers’ representatives.
Amendment 173 #
2021/0414(COD)
Proposal for a directive
Article 7 – paragraph 2 – point a
Article 7 – paragraph 2 – point a
(a) evaluate the risks of automated monitoring and decision-making systems to non-discrimination and data protection and the safety and health of platform workers, in particular as regards possible risks of work-related accidents, psychosocial and ergonomic risks;
Amendment 174 #
2021/0414(COD)
Proposal for a directive
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
2a. If the assessment under paragraph 2 finds risks to health and safety and fundamental rights that cannot be mitigated, the digital labour platform shall immediately cease the use of the system to assist decision-making or automate decision-making.
Amendment 175 #
2021/0414(COD)
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Member States shall require digital labour platforms to ensure sufficient human resources for monitoring the impact of individual decisions taken or supported by automated monitoring and decision- making systems in accordance with this Article. The persons charged by the digital labour platform with the function of monitoring, decision-making assisted by automated monitoring or automated decision-making systems or review of decisions shall have the necessary competence, training and authority to exercise that function. They shall enjoy protection from dismissal, disciplinary measures or other adverse treatment for overriding automated decisions or suggestions for decisions.
Amendment 176 #
2021/0414(COD)
Proposal for a directive
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3a. Where an assessment of automated systems is found to be non- compliant or manifestly incorrect, the relevant data protection authorities, national labour authorities and social authorities shall take coordinated measures to enforce this requirement.
Amendment 177 #
2021/0414(COD)
Proposal for a directive
Article 8 – paragraph 3 a (new)
Article 8 – paragraph 3 a (new)
3a. Certain automated decisions including dismissal or equivalent detriment, such as no longer being assigned work, or any preparations for a possible dismissal, for disciplinary measures and including any disciplinary measures shall always be taken by humans and not be taken by automated decision-making systems
Amendment 180 #
2021/0414(COD)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Without prejudice to the rights and obligations under Directive 2002/14/EC, Member States shall ensure information and consultation of platform workers’ representatives or, where there are no such representatives, of the platform workers concerned by digital labour platforms, on decisions likely to lead to the introduction of or substantial changes in the use of automated monitoring and decision-making systems referred to in Article 6(1), or changes in the allocation or organisation of work in accordance with this Article.
Amendment 184 #
2021/0414(COD)
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Article 6, Article 7(1) and (3)6a, Article 7, Article 8, Article 9, Article 13 and Article 18 shall also apply to persons performing platform work who do not have an employment contract or employment relationship.
Amendment 186 #
2021/0414(COD)
Proposal for a directive
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
1. Where labour, health and safety, social protection and other relevant authorities exercise their functions in ensuring compliance with legal obligations applicable to the employment status of persons performing platform work and where the representatives of persons performing platform work exercise their representative functions, Member States shall ensure that digital labour platforms make the following information available to them:
Amendment 187 #
2021/0414(COD)
Proposal for a directive
Article 12 – paragraph 1 – point b a (new)
Article 12 – paragraph 1 – point b a (new)
(ba) the measures taken to ensure the health and safety of the persons performing on-location platform work in the driving and delivery services, including the number of persons who have received a training on the national Highway Code.
Amendment 188 #
2021/0414(COD)
Proposal for a directive
Article 12 – paragraph 1 – point b b (new)
Article 12 – paragraph 1 – point b b (new)
(bb) the number of accidents and collisions that have occurred involving persons providing on-location platform work in the driving and delivery sectors while performing work tasks.
Amendment 189 #
2021/0414(COD)
Proposal for a directive
Article 12 – paragraph 3
Article 12 – paragraph 3
3. Labour, social protection, health and safety and other relevant authorities and representatives of persons performing platform work shall have the right to ask digital labour platforms for additional clarifications and details regarding any of the data provided. The digital labour platforms shall respond to such request within a reasonable period of time by providing a substantiated reply.
Amendment 190 #
2021/0414(COD)
Proposal for a directive
Article 12 – paragraph 4
Article 12 – paragraph 4
Amendment 192 #
2021/0414(COD)
Proposal for a directive
Article 13 – paragraph 1 a (new)
Article 13 – paragraph 1 a (new)
Member States shall ensure that in subcontracting chains, the digital labour platform of which the employer is a subcontractor can, in addition to or in place of the employer, beheld liable in legal and administrative proceedings where the person performing platform work is seeking redress for the infringement of the rights arising from this Directive.
Amendment 193 #
2021/0414(COD)
Proposal for a directive
Article 13 – paragraph 1 b (new)
Article 13 – paragraph 1 b (new)
Member States shall ensure that undocumented third country nationals performing platform work can access justice and lodge complaints to ensure the respect of the rights arising from this Directive without fearing retaliation or risk for detention and/or deportation.
Amendment 195 #
2021/0414(COD)
Proposal for a directive
Article 15 a (new)
Article 15 a (new)
Article 15 a Promotion of the right to collective bargaining in platform work With a view to improve the working conditions of persons performing platform work, Member States shall promote the right to collective bargaining by: (a) prohibiting and taking measures to prevent all acts which undermine the right of persons performing platform work to join a trade union or to obstruct them from doing so, or which discriminate against workers and trade union representatives who participate or wish to participate in collective bargaining; (b) ensuring that employers provide trade union representatives with appropriate information and facilities, in order to enable them to carry out their functions; (c) ensure that trade unions have the right to access the workplace and the workers, including through digital access, to meet and contact workers individually or collectively for the purpose of organising and representing workers in collective bargaining.
Amendment 196 #
2021/0414(COD)
Proposal for a directive
Article 15 b (new)
Article 15 b (new)
Amendment 53 #
2021/0277(BUD)
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Emphasises, furthermore, that appropriate resources should be secured in the 2022 EU budget for the implementation of the Health Union proposals, as amended during the legislative process; calls, therefore, on the Commission to revise the Financial Statements for the extended mandates of the European Medicines Agency and the European Centre for Disease Prevention and Control to take into account the additional tasks set out in the revised proposals;
Amendment 57 #
2021/0277(BUD)
Draft opinion
Paragraph 7 f (new)
Paragraph 7 f (new)
7f. Stresses the need to significantly increase the budget of the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) to provide sufficient financial and staff resources to enable full implementation of their new mandates related to emergency preparedness; such additional funding of existing health agencies as well as the future European Health Emergency Response Authority (HERA) should primarily come from other sources than the EU4Health Programme;
Amendment 46 #
2021/0206(COD)
Proposal for a regulation
Recital 8
Recital 8
Amendment 51 #
2021/0206(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8 a) The depth and acute nature of the ongoing climate and environmental emergency has a more disproportionate effect on the most vulnerable groups, including the economically disadvantaged, low-income households, women, discriminated groups, people with disabilities, elderly people or children, even though these groups often have the least responsibility for causing the emissions responsible for climate change. Eradicating mobility poverty across the Union is an essential part of the EU Green Deal’s objective of ensuring a just transition where no one is left behind. A wide range of EU funding instruments, including the Cohesion Funds, the Recovery and Resilience Facility, and revenues currently generated by the EU ETS, are available for Member States to invest in the decarbonisation of the transport sector and in greater access to public, shared soft mobility. A particular attention is required for the most disadvantaged groups as well as the households and people in situation of mobility poverty to ensure that they actually benefit from the implementation of those funding instruments.
Amendment 52 #
2021/0206(COD)
Proposal for a regulation
Recital 9
Recital 9
Amendment 58 #
2021/0206(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The increase in the price for fossil fuels may disproportionally affect vulnerable households, vulnerable micro-EU Toolbox on Energy Prices1a already provides the EU and its Member States with immediate emergency measures to support and protect households and people against the current increase of entergy prisces and vulnerable transport users who spend a larger part of their incomes on energy and transport, who, in certain regions, do not have access to alternative, affordable mobility and transport solutions awhich is primarily due to a spike in fossil gas prices, including emergency income support, state aid for companies and targeted tax reductions. Ambitious climate action would allow the Union to cut its dependence on fossil fuels and to protect Union citizens from dependence on imported fossil fuels and the impact of fluctuating energy prices. The Social Climate Fund wsho may lack the financial capacity to invest into the reduction of fossil fuel consumptuld come as a complement to those measures to support Member States and aim at providing structural long-lasting solutions to eradicate energy and mobility poverty across the Union.
Amendment 64 #
2021/0206(COD)
Proposal for a regulation
Recital 11
Recital 11
Amendment 70 #
2021/0206(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) This is even more relevant in view of the existing levels of energy poverty. Energy poverty is a situation in which households are unable to access essential energy services such as cooling, as temperatures rise, and heating. About 34 million Europeans reported an inability to keep their homes adequately warm in 2018, and 6.9% of the Union population have said that they cannot afford to heat their home sufficiently in a 2019 EU-wide survey32 . Overall, the Energy Poverty Observatory estimates that more than 50 million households in the European Union experience energy poverty. Energy poverty is therefore a major challenge for the Union. Similarly, there are large groups of people facing mobility poverty in the Union and the Commission is called on to ensure systematic and comparable data surveys. Mobility poverty is a situation in which households and people have limited access to available and affordable mobility services and are unable to afford the necessary transport required to meet essential services as well as essential cultural and socio-economic needs, in particular quality employment and education and training, in a given context. While social tariffs or direct income support can provide immediate relief to households and people facing energy poverty, only targeted structural measureand mobility poverty, they are not a long-term solution to lift households and people out of energy and mobility poverty. Only targeted structural measures and investments aimed at ending the reliance on fossil fuels, in particular energy sustainable renovations, can provide lasting solutions. the implementation of sustainable and smart mobility solutions that are affordable, safe and accessible for people with disabilities and have the comfort and ease-of-use for users as their central focus, including through community-lead projects and integrative planning like SUMPs (sustainable urban mobility plans) or their extensions to rural areas (as piloted by the SMARTA platform), as well as information and awareness-raising measures targeted at the households, ultimately aiming at developing a mobility guarantee for citizens, can provide lasting solutions and effectively help combating mobility poverty. _________________ 32 Data from 2018. Eurostat, SILC [ilc_mdes01]).
Amendment 79 #
2021/0206(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) A Social Climate (‘the Fund’) should therefore be established to provide funds to the Member States to support their policies to address the social impacts of the emissions trading for buildings and road transport on vulnerable households, vulnerable micro-enterprises and vulnerable transport usersThe Union and its Member States will not be able to meet their climate and environmental objectives without properly addressing energy and mobility poverty. Yet there is currently no standard Union- level definitions of either energy nor mobility poverty across the Union. As a result, no transparent and comparable data on energy and mobility poverty in the Union is currently available, hindering the possibility to effectively monitor progress at national level to eradicate energy and mobility poverty. A Social Climate Fund (‘the Fund’) should therefore be established to support Member States in their efforts to eradicate energy and mobility poverty. This should be achieved notably through temporary income support anadaptive and targeted measures and investments with lasting impact intended to reduce reliance on fossil fuels through increased energy efficiency of buildings, decarbonisation of heating and cooling of buildings, including the integration of energy from renewable soincreased access to renewable energies for heating and cooling of buildings, as well as measurces, and granting improved access to zero- and low-emission mobility and transport to the benefit of vulnerable active mobility, zero-emission sustainable shared mobility, public transport and other combined multi-modal mobility services in particular for thouseholds, vulnerable micro-enterp living in rural, insular and less accessible areas for the less developed regions and territorises and vulnerable transport user, including less developed peri-urban areas.
Amendment 91 #
2021/0206(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) For that purpose, each Member State should submit to the Commission a Social Climate Plan (‘the Plan’). Those Plans should pursue two objectives. Firstly, they should provide vulnerable households, vulnerable micro-enterprises and vulnerable transport users the necessary resources to finance and carry out investments in energy efficiency, decarbonisation of heating and cooling, in zero- and low-emission vehicles and mobility. Secondly, they should mitigate the impact of the increase in the cost of fossil fuels on the most vulnerable and therebidentify and map households and people in situation of mobility poverty, and provide a detailed analysis, conducted together with the local and regional authorities, social partners and civil society, on the main causes of mobility poverty in their respective territories. The Plans should also set targets for the progressive and effective eradication of mobility poverty, with the aim of developing and implementing a population-wide mobility guarantee. Secondly, they should provide households and people facing mobility poverty with the necessary prevent energy and transport poverty during the transition period until such investments have been implemented. The Plans should havesources to finance and carry out investments for the transition to climate neutral mobility, ensuring that no one is left behind. The Plans should mainly consist of targeted policy reforms and an investment component promoting the long-term solutions of reducephasing out fossil fuels reliance and could envisage other measures, including temporary, increase energy efficiency, combined with improved access to zero-emission sustainable mobility solutions and integrated mobility services. Other measures such as direct income support to mitigate adverse income effects in the shorter termcan be envisaged but should be limited in time and conditioned to long-term investments with long lasting impacts to be demonstrated by the Member States.
Amendment 95 #
2021/0206(COD)
(14 a) To achieve a socially just transition, the Plan should include wider policy reforms and measures aiming at eradicate mobility poverty. These may include reforms and measures targeted at addressing information deficit and administrative barriers, such as information campaigns and energy and mobility consultations, as well as reforms to include the notion of mobility poverty in existing legislation, like for example inclusion of beneficial accessibility and inclusion criteria for public tendering procedures and the inclusion of mobility poverty in SUMPs (sustainable urban mobility plans) and SMARTA(sustainable mobility for rural transport areas). It is also highly important that Member States implement the Council recommendation from December 20211a and apply the decision to reduce or even scrap VAT on services that serve to meet mobility poverty and inclusion. _________________ 1a Council decision to reduce VAT on tickets, bikes and bike repairs: https://www.consilium.europa.eu/en/press /press-releases/2021/12/07/council- reaches-agreement-on-updated-rules-for- vat-rates/
Amendment 97 #
2021/0206(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Member States, in consultation with regional, local, urban and other public authorities, civil society, economic and social partners level authorities, are best placed to design and to implement Plans that are adapted and targeted to their local, regional and national circumstances as their existing policies in the relevant areas and planned use of other relevant EU funds. In that manner, the broad diversity of situations, the specific knowledge of local and regional governments, research and innovation and industrial relations and social dialogue structures, as well as national traditions, can best be respected and contribute to the effectiveness and efficiency of the overall support to the vulnerable.
Amendment 100 #
2021/0206(COD)
Proposal for a regulation
Recital 16
Recital 16
Amendment 106 #
2021/0206(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Pending the impact of those investments on reducing costs and emissionsAs an immediate relief, well targeted, temporary direct income support for the most vulnerable would help the just transition. Such support should be understood to be a temporary measure accompanying the decarbonisation of the housing and transport sectors. It would not be permanent as it does not address the root causes of energy and transport poverty. Such support should only concern direct impacts of the inclusion of building and road transport into the scope of Directive 2003/87/EC, not electricity or heating costs related to the inclusion of power and heat production in the scope of that Directive. Eligibility for such direct income support should be limited in timose in energy and mobility poverty may contribute to reduce energy and mobility costs while waiting for more structural investments to take place. Such support should nevertheless be limited in time and understood to be an adaptive and targeted measure accompanying structural investments, such as affordable access to zero-emission mobility solutions as well as sustainable and well-coordinated multi- modal mobility services, as part of a holistic and long-term strategy to effectively eradicate energy and mobility poverty to be demonstrated by the Member States. Eligibility for such direct support should be targeted to people facing energy and mobility poverty, with special attention to elderly and younger people, including women, such as single- mothers, women with disabilities and elderly women with low income, who are disproportionately affected by energy poverty and mobility poverty, due to different energy needs and mobility patterns. Such support should be given without too much administrative burden for the households or people receiving the support. The support should be in line with the principle of additionality and should not replace national schemes already in place.
Amendment 111 #
2021/0206(COD)
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17 a) Respect for fundamental rights and compliance with the Charter of Fundamental Rights of the European Union, should be ensured throughout the preparation, evaluation, implementation and monitoring of eligible projects under the Fund. The Fund should contribute to eliminating inequalities, promoting gender equality and integrating the gender perspective, as well as combating discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation as set out in Article 2 of the Treaty on European Union (TEU), Article 10 TFEU and Article 21 of the Charter of Fundamental Rights of the European Union. All stakeholders involved at all stages of implementation of the Facility should commit to promote equality, and in particular, ensure that the impact on women is taken into account, given that women are disproportionately impacted by the transition process.
Amendment 112 #
2021/0206(COD)
Proposal for a regulation
Recital 17 b (new)
Recital 17 b (new)
(17 b) The Fund should be consistent with the Union's obligation under the UN Convention on the Rights of Persons with Disabilities and should not support any measure or investment that contributes to segregation or to social exclusion.
Amendment 113 #
2021/0206(COD)
Proposal for a regulation
Recital 17 c (new)
Recital 17 c (new)
(17 c) The aim of the Fund should be aligned with the UN 2030 Agenda as well as the principles of the European Pillar of Social Rights in order to ensure a just transition, towards a greener, fairer and more inclusive Europe.
Amendment 117 #
2021/0206(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Taking into account the importance of tacklinghe climate changeand environmental emergency in line with Paris Agreement commitments, and the commitment to the United Nations Sustainable Development Goals, the actions under this Regulation should contribute to the achievement of the target that 30% of all expenditure under the 2021- 2027 multiannual financial framework should be spent on mainstreaming climate objectives and should contribute to the ambition of providing 10% of annual spending to biodiversity objectives in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals. For this purpose, the methodology set out in Annex II of Regulation (EU) 2021/1060 of the European Parliament and of the Council33 should be used to tag the expenditures of the Fund. The Fund should support activities that fully respect the climate and environmental standards and priorities of the Union and comply with the principle of ‘do no significant harm’ within the meaning of Article 17 of Regulation (EU) 2020/852 of the European Parliament and of the Council34 . Only such measures and investments should be included in the Plans. Direct income support measures should as a rule be considered as having an insignificant foreseeable impact on environmental objectives, and as such be considered compliant with the principle of ‘do no significant harm’. The Commission intends to issue technical guidance to the Member States well ahead of the preparation of the Plans. The guidance will explain how the measures and investments must comply with the principle of ‘do no significant harm’ within the meaning of Article 17 of Regulation (EU) 2020/852. The Commission intends to present in 2021 a proposal for a Council Recommendation on how to address the social aspects of the greenecological transition. _________________ 33Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159). 34 Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13).
Amendment 119 #
2021/0206(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Women are particularly affected by carbon pricing as they represent 85% of single parent familiesdisproportionately affected by energy and mobility poverty, in particular single mothers, who represent 85% of single parent families, as well as single women, women with disabilities, or elderly women living alone. Single parent families with dependent child have a particularly high risk of childenergy and mobility poverty. Gender equality and equal opportunities for all, and the mainstreaming of those objectives, as well as questions of accessibility for persons with disabilities should be taken into accountensured and promoted throughout the design, preparation and implementation of Plans to ensure no one is left behind.
Amendment 128 #
2021/0206(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) The financial envelope of the Fund should, in principle, be commensurate to amounts corresponding to 25% of the expectedannual revenues from the inclusion of buildings and road transport into the scope of Directive 2003/87/EC in the period 2026-2032. Pursuant to Council Decision (EU, Euratom) 2020/205341 , Member States should make those revenues available to the Union budget as own resources. Member States are to finance 50% of the total costs of their Plan themselves. For this purpose, as well as for investment and measures to accelerate and alleviate the required transition for citizens negatively affected, Member States should inter alia useauctioning of allowances from Chapter II and III of Directive 2003/87/EC as of the entry into force of this Regulation. Member States are to finance 50% of the total costs of their Plan themselves. The financing of the Fund should not come at their expected revenues from emissions trading for buildings and road transport under Directive 2003/87/EC for that purpose. _________________ 41Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, p. 1)nse of other Union programmes and policies.
Amendment 133 #
2021/0206(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) The Fund should support measures that respect the principle of additionality of Union funding. The Fund should not be a substitute for recurring national expenditures, except in duly justified cases.
Amendment 135 #
2021/0206(COD)
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25 a) To ensure that support under the Plans can be effectively implemented from the initial years starting from the entry into force of the Social Climate Fund, it should be possible for an amount of up to 13 % of the financial contribution of Member States to be paid in the form of pre-financing by the Commission.
Amendment 146 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
The measures and investments supported by the Fund shall directly benefit households, micro- in enterprises and transport users, which are vulnerable and particularly affected by the inclusion of greenhouse gas emissions from buildings and road transport into the scope of Directive 2003/87/EC, especially households in energy poverty and citizens without public transport alternative to individual cars (in remote and rural areas)gy poverty and people facing mobility poverty, in particular people living in rural, insular, mountainous, and remote areas, including peri-urban areas, with low or no access to basic services or public transport as well as well coordinated multi-modal mobility services.
Amendment 153 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 4
Article 1 – paragraph 4
The general objective of the Fund is to contribute to a just, equitable and inclusive the transition towards climate neutrality by addressing the social impacts of the inclusion of greenhouse gas emissions from buildings and road transport into the scope of Directive 2003/87/EC. The specific objective of the Fund is to support vulnerable households, vulnerable micro-, in line with the Union’s commitments under the Paris agreement, by addressing the social impacts of this ecological transition. The specific objective of the Fund is to contribute to eradicate enterprises and vulnerable transport usersgy and mobility poverty across the Union, through temporary direct income support and through measures and investments intended to increase energy efficiency of buildings, decarbonisation of heating and cooling of buildings, including the integration of energy from renewable sources, and grantingprimarily through targeted policy reforms and investments intended to phase out the reliance on fossil fuels, increase energy efficiency combined with improved access to zero- and low-emission mobility and transportsustainable mobility solutions and integrated mobility services.
Amendment 154 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 4 a (new)
Article 1 – paragraph 4 a (new)
In line with these objectives, the investments and policy reforms within the Plans should not provide any support which could prolong the use of fossil fuel or lead to carbon lock-in, while hampering or delaying the deployment of renewable energy sources.
Amendment 164 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 a (new)
Article 2 – paragraph 1 – point 2 a (new)
(2 a) ‘mobility poverty' means a household with limited access to available and affordable mobility services and unable to afford the necessary transport required to meet essential services as well as essential cultural and socio-economic needs, in particular quality employment and education and training, in a given context and which can be caused by one or the combination of the following factors: low-level incomes, high fuel expenditures and/or high costs of public transport, lack of availability of adequate, affordable public transport or alternative services and their accessibility and location, travelled distances and transport practices, particularly in rural, insular, mountainous and remote areas, including peri-urban areas;
Amendment 166 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 b (new)
Article 2 – paragraph 1 – point 2 b (new)
(2 b) 'mobility guarantee' means a reliable and sufficient mobility provision, worked out by national, regional or local authorities for a specific area and in collaboration with civil society, to achieve the best quality of life within the given global constraints. It provides the planning to provide a guarantee to all citizens within that area to be able to reach their home, workplace, school as well as other essential errands and culture within a specified timeframe of e.g. 15 minutes in metropolitan areas and 30 minutes in rural areas. The mobility guarantee requires that reliable public transport service options are in place during weekdays, evening and holidays in order to provide a clear incentive for people to switch from environmentally and socially harmful transport patterns to a truly sustainable mobility;
Amendment 167 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
Amendment 170 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10
Article 2 – paragraph 1 – point 10
Amendment 173 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 11
Article 2 – paragraph 1 – point 11
Amendment 178 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 12
Article 2 – paragraph 1 – point 12
Amendment 187 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 13
Article 2 – paragraph 1 – point 13
Amendment 192 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. EWithin 6 months upon the entry into force of this Regulation, each Member State shall submit to the Commission a Social Climate Plan (‘the Plan’) together with the update to. The Plan shall be coherent and maximise synergies with the integrated national energy and climate plan of that Member State referred to in Article 14(2) of Regulation (EU) 2018/1999 in accordance with the procedure and timeline laid down in that Articl. The Plan shall contain detailed mapping of households and people in situation of mobility poverty, and an gender-sensitive analysis of the main causes of mobility poverty in that Member State. The Plan shall also contain a coherent set of measures and investments to address the impact of carbon pricing on vulnerable households, vulnerable micro- enterprises and vulnerable transport users in order to ensure affordablshort- and medium- term targets to eradicate mobility poverty, and a coherent set of measures and investments at national, regional or local level with the ultimate aim of developing a population-wide mobility guarantee. In order to facilitate theating, cooling and mobility while accompanying and accelerating necessary measures to meet the climate targets of the Union preparation of the Plan, the Commission shall publish guidance, including a template.
Amendment 198 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. TIn case Member States provide sufficient evidence that households and people in energy and/or mobility poverty may not enjoy the benefits of the measures and investments referred to in paragraph 3 within a maximum of three years after the adoption of the Plan, they may include national or subnational measures providing temporary direct income support to vulnerable households and households that are vulnerable transport users to reduce the imdirect support to households and people, provided that they demonstrate that such support is proportional and limited in time, and is pacrt of the increase in the price of fossil fuels resulting from the inclusion of buildings and road transport into the scope of Directive 2003/87/ECa holistic strategy to lift those households and people out of energy and mobility poverty, with special attention to elderly and younger people, including women and people living in remote and less accessible areas, including peri-urban areas, to help reducing immediate energy and mobility costs, by providing facilitated access to green energy efficient solutions and shared and integrated mobility services.
Amendment 203 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – introductory part
Article 3 – paragraph 3 – introductory part
3. The Plan shall include national, regional and local projects to:
Amendment 206 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point b
Article 3 – paragraph 3 – point b
(b) finance measures and investments to increase the uptake of zero- and low- emission mobility and transportaccessibility, affordability and interconnectivity of public transport as well as infrastructure that supports active mobility, such as bike lanes and fast cycling routes.
Amendment 210 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point b a (new)
Article 3 – paragraph 3 – point b a (new)
(b a) finance measures and investments with a lasting impact and with priority to the development and provision of affordable demand sensitive mobility services, in particular in rural and less accessible areas including peri-urban, starting with measures and investments leading to a modal shift from privately owned to public, shared and active mobility.
Amendment 212 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point b b (new)
Article 3 – paragraph 3 – point b b (new)
(b b) provide financial and technical support to self-organising communities in urban, peri-urban and rural areas and to the facilitation of all facets of shared mobility services, such as: - self-organised mobility initiatives; - shared and ‘pooling’ services:collective taxis, car-pooling, car-sharing (peer-to- peer, station-based, free-floating;round- trip) - benches for co-passengers; - demand-led services:book-a-bus, regio- taxi; - biking and electric bicycle promotions; - kombi-bus, e.g. linking cargo and passenger services to enhance the use of regular interval timetables.
Amendment 213 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point b c (new)
Article 3 – paragraph 3 – point b c (new)
(b c) plans and a step-wise national implementation plan to develop and introduce a mobility guarantee for all citizens.
Amendment 214 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 a (new)
Article 3 – paragraph 3 a (new)
3 a. The Plan shall include policy reforms and measures addressing non- monetary barriers to improvements in mobility to facilitate and accelerate the socially fair decarbonisation of mobility aimed at the eradication of mobility poverty. These may include reforms and measures targeted at addressing information deficit and administrative barriers, such as information campaigns and energy and mobility consultations, as well as reforms to include the notion of mobility poverty in existing legislation, like for example the inclusion of beneficial accessibility and inclusion criteria for public tendering procedures and the inclusion of mobility poverty in SUMPs (sustainable urban mobility plans) and SMARTA (sustainable mobility for rural transport areas). The cost of these measures shall not exceed 2% of the national envelope.
Amendment 216 #
2021/0206(COD)
Proposal for a regulation
Article 3 a (new)
Article 3 a (new)
Amendment 217 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) concrete measures and investments in accordance with Article 3 to reduce the effects referred to in point (c) of this paragraphand 6 to combat energy poverty and mobility poverty together with an explanation of how they would contribute effectively to the achievement of the objectives set out in Article 1 within the overall setting of a Member State’s relevant policies, including an overview of both the investments needed and the non-financial barriers to ultimately provide citizens with a mobility guarantee, as well as a detailed description of measures as well as a timeline to attain this goal;
Amendment 218 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a a (new)
Article 4 – paragraph 1 – point a a (new)
(a a) detailed quantitative information on the number of households and people facing mobility poverty identified on the basis of the definitions in Article 2;
Amendment 219 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a b (new)
Article 4 – paragraph 1 – point a b (new)
(a b) national targets and objectives to reduce the number of households and people facing mobility poverty over the duration of the Plan, including through measures and investments that are financed by other sources of funding beyond the Fund’s financial envelope;
Amendment 220 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a c (new)
Article 4 – paragraph 1 – point a c (new)
(a c) quantitative and qualitative information on the choice to spend a certain share of the Plan on direct support and another share on other measures, investments and policy reforms and on how these shares are expected to develop over time;
Amendment 222 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) concrete accompanying measures and policy reforms needed to accomplish the measures and investments of the Plan and reduce the effects referred to in point (c) as well as information on existing or planned financing of measures and investments from other Union, international, public or private sources;
Amendment 228 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) an estimate of the likely effects of that increase in prices on households, and in particular on inThese impacts are to be analysed with a sufficidence of t gendergy poverty, on micro-enterprises and on transport users, comprising in particular an estimate and the identification of vulnerable households, vulnerable micro- enterprises and vulnerable transport users; these impacts are to be analysed with a sufficient level of regional disaggregation, taking into account elements such as access to public transport and basic service disaggregated data and gender-sensitive information, a sufficient level of regional disaggregation, taking into account elements such as access to adequate, safe, accessible and affordable public mobility services that meet cultural and socio-economic needs and identifying the areas mostly affected, particularly territories which are remote, insular and rural or less accessible, including peri-urban areas;
Amendment 230 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point c a (new)
Article 4 – paragraph 1 – point c a (new)
(c a) a gender impact assessment and an explanation of how the measures and investments contained in the Plan take into account the objectives to contribute to gender equality and equal opportunities for all and the mainstreaming of those objectives, in line with principles of the UN Convention on the Rights of Persons with Disabilities (CRPD) and the associated EU CRPD framework and, where relevant, with the national gender equality strategy;
Amendment 232 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point d
Article 4 – paragraph 1 – point d
(d) where the Plan provides for measures referred to in Article 3(2), the criteria for the identification of eligible final recipients, the indication of the envisaged time limit for the measures in question and their justification on the basis of a quantitative estimate and a qualitative explanation of how the measures in the Plan are expected to reduceprovide a necessary and proportionate immediate relief for households and people in energy and transportmobility poverty and the vulnerability of households, micro-enterprises and transport users to an increase of road transport and heating fuel prices; s part of a holistic strategy to effectively lift those households out of mobility poverty through more structural investments on the short to medium term, in particular the phase out of the reliance on fossil fuel dependence as well as the development and introduction of a mobility guarantee;
Amendment 237 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point e
Article 4 – paragraph 1 – point e
(e) envisaged milestones, and targets to eradicate mobility poverty, and an indicative timetable for the implementation of the measures and investments to be completed by 31 July 2032each biennial integrated national energy and climate progress report pursuant to Article 23, and at the end of each multiannual financial framework, that is, by 31 December 2027 and by 31 July 2035 respectively;
Amendment 243 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point i
Article 4 – paragraph 1 – point i
(i) the arrangements for the effective monitoring and implementation of the Plan by the Member State concernedand regional and local authorities concerned, including the involvement of economic and social partners and civil society in the process, in particular of the proposed milestones and targets, including indicators for the implementation of measures and investments, which, where relevant, shall be those available with the Statistical office of the European Union European Statistical Office and the European Energy Poverty Observatory as identified by Commission Recommendation 2020/156354 on energy poverty; the Commission shall, by 31 July 2023, develop indicators to monitor mobility poverty in accordance with its promise in the Council Recommendation on ensuring a fair transition towards climate neutrality; _________________ 54 OJ L 357, 27.10.2020, p. 35.
Amendment 248 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point k a (new)
Article 4 – paragraph 1 – point k a (new)
(k a) the proportion of the fund set aside for community-led local mobility development to encourage and deliver an integrated place-based transition and community-led local development as defined and detailed under chapter 2 of the common provisions regulation.
Amendment 249 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1 a. By 31 July 2023, the Commission shall provide guidance to Member States on how to comply with the provisions of this Article.
Amendment 251 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. WThen preparing their Plans, Member States may request the Commission to organis Commission shall set up a platform to actively promote the exchange of good practices among all stakeholders and communities concerned by the implementation of the Fund as well as to provide guidance to enable and exchancourage the capacity buildinge of good practices. Member Statestakeholders to participate in the development and implementation of the Fund. Member States and the stakeholders involved in the preparation of the Plans may also request technical support under the ELENA facility, established by an Agreement of the Commission with the European Investment Bank in 2009, or under the Technical Support Instrument established by Regulation (EU) 2021/240 of the European Parliament and of the Council58 . _________________ 58Regulation (EU) 2021/240 of the European Parliament and of the Council of 10 February 2021 establishing a Technical Support Instrument (OJ L 57, 18.2.2021, p. 1).
Amendment 252 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph -1 (new)
Article 5 – paragraph -1 (new)
Amendment 258 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point c
Article 5 – paragraph 2 – point c
(c) zero- and low-emission emission integrated mobility services, active mobility and public transport;
Amendment 259 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point c a (new)
Article 5 – paragraph 2 – point c a (new)
(c a) mobility-on- demand services;
Amendment 264 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point e
Article 5 – paragraph 2 – point e
(e) reductions in the number of vulnerable households, especially households in energy poverty, of vulnerable micro-households and people faced with energy and mobility poverty, disaggregated per gentderprises and of vulnerable transport users, including in rural and remote areas., with a view to eradicating mobility poverty within a decade;
Amendment 266 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point e a (new)
Article 5 – paragraph 2 – point e a (new)
(e a) improvements in the ability of people facing energy and mobility poverty to participate in and adapt to the transition at a similar pace as high income households are able to do without financial support;
Amendment 271 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3 a. The Social Climate Fund shall not support measures and investments excluded under Article 9 of Regulation (EU) 2021/1056.
Amendment 272 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
Amendment 280 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – introductory part
Article 6 – paragraph 2 – introductory part
2. Member States may include the costs of the following measures and investmenstructural investments with lasting impacts in the estimated total costs of the Plans, provided they principally benefit vulnerable households, vulnerable micro-households or people facing enterprises or vulnerable transport usersgy poverty and mobility poverty and intend to:
Amendment 287 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point b a (new)
Article 6 – paragraph 2 – point b a (new)
(b a) provide households and people with tailored advice and information about sustainable and affordable mobility alternatives, including via tailored mobility management services, tailored energy consultations or other types of personalised support aimed at addressing mobility poverty;
Amendment 290 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point d
Article 6 – paragraph 2 – point d
(d) provide access to zero- and low- emission vehicles and bikinvestments aimed at accelerating the modal shift from private individual vehicles towards fostering sustainable multi-modal mobility solutions that serve the specific community best, including financial support for fiscal incentivesthe creation and development of cycling routes and of integrated mobility services, and for their purchase of bicycles, as well as for appropriate public and private infrastructure, including for recharging and refuelling; for support concerning low-emission vehicles, a timetable for gradually reducing the support shall be providedthe provision of digital applications and non-digital initiatives that connect users to facilitate shared mobility; in case Member States include measures to support access to zero-emission vehicles such as bicycles; in the case of electric cars, they shall demonstrate that the beneficiaries of such support cannot have access to other means of transport or mobility services and should promote shared use;
Amendment 303 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point f
Article 6 – paragraph 2 – point f
(f) support public and private entities in developing and providing affordable zero- and low-emission, accessible and inter-modal mobility and public transport services and the uptake of attractive and safe active mobility options for rural, insular, mountainous, remote and less accessible areas or for less developed regions or territories, including less developed peri-urban areas.;
Amendment 305 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point f a (new)
Article 6 – paragraph 2 – point f a (new)
(f a) support capacity building and training of people affected by mobility poverty in order to engage in peer-to-peer and community work initiatives aimed at combatting mobility poverty, such as car- sharing enabled either by digital applications that link users together, or, in case of digital divide, by non-digital initiatives set up at local level to connect mobility supply and demand.
Amendment 309 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. By 31 July 2025 and every two years thereafter, the Commission shall evaluate the cost-effectiveness, social fairness and progressiveness of the measures, and investments and policy reforms implemented by the Member States as part of their Plans. The Commission shall report on best-practices and shall adjust both the overall and Member States specific guidance accordingly. The Commission shall also report on the extent to which Member States take the Commission’s best- practices and recommendations to improve into account.
Amendment 312 #
2021/0206(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. The Fund shall not support, and the estimated total costs of Plans shall not includreplace measures in the form of direct income support pursuant to Article 3(2) of this Regulation for households already benefiting:
Amendment 315 #
2021/0206(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 319 #
2021/0206(COD)
Proposal for a regulation
Article 8 – title
Article 8 – title
Pass-on of benefits to households, micro- enterprises and transport users and people
Amendment 322 #
2021/0206(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Member States may include in to the estimated total costs financial support provided to public or private entities other than vulnerable households, vulnerable micro-enterprises and vulnerable transport uses, if those entities carry out measures and investments ultimately benefitting vulnerable households, vulnerable micro-enterprises and vulnerable transport usershouseholds or people facing energy or mobility poverty, if those entities carry out measures and investments on their behalf and which ultimately direct benefit households or people facing energy or mobility poverty.
Amendment 324 #
2021/0206(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
Member States shall provide for the necessary statutory and contractual safeguards to ensure that the entire benefit is passed on to the households, micro- enterprises and transport users and people.
Amendment 329 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The financial envelope for the implementation of the Fund for the period 2025-2027 shall be EUR 23 7at least EUR 48 500 000 000 in current prices.
Amendment 333 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The financial envelope for the implementation of the Fund for the period 2028-2032 shall be EUR 48 500 000 000 in current prices, subject to the availability of the amounts under the annual ceilings of the applicable multiannual financial framework referred to in Article 312 TFEUas of 2028 shall be determined during the negotiations of the next multiannual financial framework, but shall not be set at a level lower than EUR 48 500 000 000.
Amendment 339 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The amounts referred to in paragraphs 1 and 2 may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities which are required for the management of the Fund and the achievement of its objectives, in particular studies, meetings of experts, consultation of stakeholders, information and communication actions, including inclusive outreach actions, and corporate communication of the political priorities of the Union, insoin so far as they are related to the objectives of this Regulation, expenses linked to IT networks focusing on information processing and exchange, corporate information technology tools, and all other technical and administrative assistance expenses incurred by the Commission for the management of the Fund. Expenses may also cover the costs of other supporting activities such as quality control and monitoring of projects on the ground and the costs of peer counselling and experts for the assessment and implementation of the eligible actions.
Amendment 342 #
2021/0206(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Amendment 356 #
2021/0206(COD)
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Article 13 a Pre-financing 1. Subject to the adoption by the Commission of the implementing act referred to in Article 16(1), when a Member State requests pre-financing together with the submission of the Plan, the Commission shall make a pre- financing payment of an amount of up to 13 % of the financial contribution. By derogation from Article 116(1) of Regulation (EU, Euratom) 2018/1046, the Commission shall make the corresponding payment within, to the extent possible, two months after the adoption by the Commission of the legal commitment referred to in Article 18. 2. In cases of pre-financing under paragraph 1, the financial contributions shall be adjusted proportionally.
Amendment 363 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a – point i
Article 15 – paragraph 2 – point a – point i
(i) whether the Plan represents an adequate and effective response to the social impact on and challenges faced by vulnerable households, vulnerable micro-enterprises and vulnerable transport users in the Member State concerned from establishing the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/87/EChouseholds and people facing energy poverty and mobility poverty in the Member State, especially households in energy poverty, duly taking into account the challenges identified in the assessments of the Commission of the update of the concerned Member State’s integrated national energy and climate plan and of its progress pursuant to Article 9(3), and Articles 13 and 29 of Regulation (EU) 2018/1999, as well as in the Commission recommendations to Member States issued pursuant to Article 34 of Regulation (EU) 2018/1999 in view of the Union’s 2030 climate and energy targets and the long- term objective of climate neutrality in the Union by 2050. This shall take into account the specific challenges and the financial allocation of the Member State concerned;
Amendment 370 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a – point iii a (new)
Article 15 – paragraph 2 – point a – point iii a (new)
(iii a) whether the Plan has been prepared and developed through the meaningful and inclusive participation of all relevant stakeholders in compliance with Article 10 of Regulation (EU) 2018/1999 and Article 8 of Regulation (EU) 2021/1060;
Amendment 374 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a – point iii b (new)
Article 15 – paragraph 2 – point a – point iii b (new)
(iii b) whether the Plan contains a gender impact analysis and an explanation of the measures and investments contained in the Plan are expected to address the gender dimension of energy poverty and mobility poverty and ensure a gender-balanced impact, while contributing to the mainstreaming of gender equality, in line with the national gender equality strategy, the European Pillar of Social Rights and the UN Sustainable Development Goals; in case of measures providing direct support to women, whether those measures account for an amount which represents at least 60 % of the total national allocation for direct support.
Amendment 376 #
2021/0206(COD)
(i) whether the Plan is expected to have a lasting impact on the challenges addressed by that Plan and in particular on vulnerable households, vulnerable micro-households and people facing enterprises and vulnerable transport users, especially households in energgy and mobility poverty, in the Member State concerned;
Amendment 380 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point c – point iii a (new)
Article 15 – paragraph 2 – point c – point iii a (new)
(iii a) whether the measures and investments included in the Plan deliver adequately on the potential synergies between climate, environment and social targets to meet the EU's 2030 and 2050 targets and commitments to achieve the UN sustainable development goals as well as the objectives of the European Pillar of Social Rights;
Amendment 381 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point c – point iii b (new)
Article 15 – paragraph 2 – point c – point iii b (new)
(iii b) whether the measures and investments are accompanied by complementary measures required to effectively address energy poverty and mobility poverty.
Amendment 382 #
2021/0206(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Where a Social Climate Plan, including relevant milestones and targets, is no longer achievable, either in whole or in part, by the Member State concerned because of objective circumstances, in particular because of the actual direct effects of the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/87/EC, the Member State concerned may submit to the Commission an amendment of its Plan to include the necessary and duly justified changes. Member States may request technical support for the preparation of such request.
Amendment 388 #
2021/0206(COD)
Proposal for a regulation
Article 17 – paragraph 5
Article 17 – paragraph 5
5. By 15 March 2027 each Member State concerned shall assess the appropriateness of its Plans in view of the actual direct effects of the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/087/ECobjective to eradicate energy poverty and mobility poverty, while meeting the Union energy and climate targets. Those assessments shall be submitted to the Commission as part of the biennial progress reporting pursuant to Article 17 of Regulation (EU) 2018/1999.
Amendment 389 #
2021/0206(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. After the Commission has adopted a decision as referred to in Article 16, it shall in due time conclude an agreement with the Member State concerned constituting an individual legal commitment within the meaning of Regulation (EU, Euratom) 2018/1046 covering the period 20254-2027. That agreement may be concluded at the earliest one year before the year of the start of the auctions under Chapter IVa of Directive 2003/87/EC.
Amendment 397 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
(a) detailed quantitative information as well as disaggregated data on the number of households and people in energy poverty and mobility poverty and changes compared to the last report using the definition proposed in their plan;
Amendment 399 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) when applicable, detailed information on progress towards the national indicative objective to reduce the number of households and people facing energy poverty and mobility poverty;
Amendment 401 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point c
Article 23 – paragraph 1 – point c
(c) detailed information on the results of the measures and investments, included in its Plan, in particular as regards the emission reduction achieved and the number of people benefitting from the measures by gender and age group;
Amendment 402 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point f
Article 23 – paragraph 1 – point f
(f) in 2027, an assessment of the Plan referred to in Article 17(5) in view of the actual direct effects of the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/087/EC;
Amendment 406 #
2021/0206(COD)
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. By 31 July 20286, the Commission shall provide the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions with an evaluation report on the implementation and functioning of the Fund.
Amendment 410 #
2021/0206(COD)
Proposal for a regulation
Article 24 – paragraph 3
Article 24 – paragraph 3
3. The evaluation report shall, in particular, assess to which extent the objectives of the Fund laid down in Article 1 have been achieved, the efficiency of the use of the resources and the Union added value. It shall consider the continued relevance of all objectives and actions set out in Article 6 in light of the impact on greenhouse gas emissions from the emission trading system for buildings and road transport pursuant to Chapter IVa of Directive 2003/87/EC and from the national measures taken to meet the binding annual greenhouse gas emission reductions by Member States pursuant to Regulation (EU) 2018/842 of the European Parliament and of the Council63 . It shall also consider the continued relevance of the financial envelope of the Fund in relation to possible developments concerning the auctioning of allowances under the emission trading system for buildings and road transport pursuant to Chapter IVa of Directive 2003/87/EC and other relevant considerations. _________________ 63Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (OJ L 156, 19.6.2018, p. 26-42)by Member States pursuant to Article 4a, the updated integrated national energy and climate plans submitted in accordance with Article 14 of Regulation (EU) 2018/1999and progress towards the implementation of the objectives of the European Pillar of Social Rights. It shall also consider the continued relevance of the financial envelope of the Fund in relation to those developments.
Amendment 416 #
2021/0206(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
It shall apply from the date by which the Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Directive (EU) [yyyy/nnn] of the European Parliament and the Council64 amending Directive 2003/87/EC as regards Chapter IVa of Directive 2003/87/EC. _________________ 64[Directive (EU) yyyy/nnn of the European Parliament and of the Council…. (OJ …..).] [Directive amending Directive 2003/87/EC]2024.
Amendment 289 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Insists that hunting should be prohibited in marine and terrestrial protected areas
Amendment 7 #
2020/2260(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regard to Article 13 TFEU that states that when formulating and implementing the Union's policies, in particular concerning its internal market, full regard should be paid to the welfare requirements of animals, since animals are sentient beings,
Amendment 8 #
2020/2260(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regard to the United Nations Declaration on the Rights of Peasants and Other People Working in Rural Areas of 2018,
Amendment 16 #
2020/2260(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regard to its resolution of 18 December 2019 on the EU Pollinators Initiative1a, __________________ 1a P9_TA(2019)0104.
Amendment 20 #
2020/2260(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regard to the International Treaty on Plant Genetic Resources for Food and Agriculture of 2009,
Amendment 26 #
2020/2260(INI)
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
- having regard to the European Pillar of Social Rights,
Amendment 30 #
2020/2260(INI)
Motion for a resolution
Citation 5 b (new)
Citation 5 b (new)
- having regard to the Charter of Fundamental Rights of the European Union,
Amendment 34 #
2020/2260(INI)
Motion for a resolution
Citation 5 c (new)
Citation 5 c (new)
- having regard to its resolution on European protection of cross-border and seasonal workers in the context of the COVID-19 crisis adopted on 19 June,
Amendment 37 #
2020/2260(INI)
Motion for a resolution
Citation 5 d (new)
Citation 5 d (new)
- having regard to the European Commission Guidelines on Seasonal workers issued on 16 July,
Amendment 50 #
2020/2260(INI)
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
- having regard to the Court of Justice of the European Union Judgment in Case C-528/16, published on 25 July 2018,
Amendment 63 #
2020/2260(INI)
Motion for a resolution
Citation 10 a (new)
Citation 10 a (new)
- having regard to Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations1a, __________________ 1a OJ L 3, 5.1.2005, p. 1–44
Amendment 65 #
2020/2260(INI)
Motion for a resolution
Citation 10 b (new)
Citation 10 b (new)
- having regard to Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing1a, __________________ 1a OJ L 303, 18.11.2009, p. 1–30
Amendment 67 #
2020/2260(INI)
Motion for a resolution
Citation 10 b (new)
Citation 10 b (new)
- having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’)1a, __________________ 1a OJ L 84, 31.3.2016, p. 1.
Amendment 70 #
2020/2260(INI)
Motion for a resolution
Citation 10 d (new)
Citation 10 d (new)
- having regard to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products1a, __________________ 1a OJ L 4, 7.1.2019, p. 43–167
Amendment 79 #
2020/2260(INI)
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
- having regard to Council Directive of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources1a, __________________ 1a OJ L 375, 31.12.1991, p. 1.
Amendment 83 #
2020/2260(INI)
Motion for a resolution
Citation 11 b (new)
Citation 11 b (new)
- having regard to Regulation (EU) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides1a, __________________ 1a OJ L 324, 10.12.2009, p. 1–22
Amendment 86 #
2020/2260(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
- having regard to Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain1a, __________________ 1a OJ L 231, 6.9.2019, p. 1–28
Amendment 88 #
2020/2260(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
- having regards to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms,
Amendment 90 #
2020/2260(INI)
Motion for a resolution
Citation 12 b (new)
Citation 12 b (new)
- having regard to Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy1a, __________________ 1a OJ L 327, 22.12.2000, p. 1–73
Amendment 91 #
2020/2260(INI)
Motion for a resolution
Citation 12 c (new)
Citation 12 c (new)
- having regard to Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration1a, __________________ 1a OJ L 372, 27.12.2006, p. 19–31
Amendment 95 #
2020/2260(INI)
Motion for a resolution
Citation 18 a (new)
Citation 18 a (new)
- having regard to its resolution of 11 February 2015 on country of origin labelling for meat in processed food1a, __________________ 1a OJ C 310, 25.8.2016, p. 15–18
Amendment 98 #
2020/2260(INI)
Motion for a resolution
Citation 18 b (new)
Citation 18 b (new)
- having regard to its legislative resolution of 8 September 2015 on the proposal for a directive of the European Parliament and of the Council on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes1a, __________________ 1a P8_TA(2015)0285
Amendment 99 #
2020/2260(INI)
Motion for a resolution
Citation 18 c (new)
Citation 18 c (new)
- having regard to its resolution of 12 May 2016 on mandatory indication of the country of origin or place of provenance for certain foods1a, __________________ 1a OJ C 76, 28.2.2018, p. 49–53
Amendment 106 #
2020/2260(INI)
Motion for a resolution
Citation 21 a (new)
Citation 21 a (new)
- having regard to its resolution of 4 April 2017 on women and their roles in rural areas,
Amendment 109 #
2020/2260(INI)
Motion for a resolution
Citation 21 b (new)
Citation 21 b (new)
- having regard to its resolution of 16 January 2018 on Women, gender equality and climate justice,
Amendment 110 #
2020/2260(INI)
Motion for a resolution
Citation 22 a (new)
Citation 22 a (new)
- having regard to its resolution of 17 April 2018 on the implementation of the 7th Environment Action Programme1a, __________________ 1a OJ C 390, 18.11.2019, p. 10–18
Amendment 130 #
2020/2260(INI)
Motion for a resolution
Citation 25 a (new)
Citation 25 a (new)
- having regard to the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES) 2019 Global Assessment Report on Biodiversity and Ecosystem Services1a, and its 2020 Workshop Report on Biodiversity and pandemics1b, __________________ 1a https://ipbes.net/global-assessment 1b https://www.ipbes.net/pandemics
Amendment 135 #
2020/2260(INI)
Motion for a resolution
Citation 25 b (new)
Citation 25 b (new)
- having regard to the Implementation Report on the Sustainable Use of Pesticides Directive (COM(2020)204),
Amendment 146 #
2020/2260(INI)
Motion for a resolution
Citation 36 a (new)
Citation 36 a (new)
- having regard to the 2020 report commissioned by the European Parliament’s Committee on Petitions, entitled “Ending the Cage Age: Looking for Alternatives”,
Amendment 152 #
2020/2260(INI)
Motion for a resolution
Citation 37 a (new)
Citation 37 a (new)
- having regard to the opinion of the Committee of the Regions, "From Farm to Fork – the local and regional dimension",
Amendment 161 #
2020/2260(INI)
Motion for a resolution
Citation 40 a (new)
Citation 40 a (new)
- having regard to the WTO Agreement on Agriculture of 1994,
Amendment 163 #
2020/2260(INI)
Motion for a resolution
Citation 40 b (new)
Citation 40 b (new)
- having regard to the report of the Agricultural Markets Task Force entitled “Improving market outcomes: enhancing the position of farmers in the supply chain” of November 2016,
Amendment 165 #
2020/2260(INI)
Motion for a resolution
Citation 40 c (new)
Citation 40 c (new)
- having regard to the report on the state of play of farmland concentration in the EU: how to facilitate the access to land for farmers (2016/2141(INI)),
Amendment 172 #
2020/2260(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the Commission communication on a Farm to Fork Strategy sets out a holistic approach of the European food system, with agriculture, as a provider of food, fibre and fuelenvironmental amenities, at the centre, while recognising the interconnectedness of all actors throughout the whole supply chain;
Amendment 181 #
2020/2260(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas infinite economic growth on a planet with finite resources is impossible; whereas the pursuit of economic growth is a deeply problematic paradigm that needs to give way to a more sensible pursuit of enhancing quality of life and wellbeing, meaning that our economic models need to be adapted to the planetary boundaries to ensure a sustainable future;
Amendment 193 #
2020/2260(INI)
Motion for a resolution
Recital B
Recital B
B. whereas Europe’s food system should deliver food and nutrition security in a way that contributes to social well- being and maintains and restores ecosystem health; whereas currently, the food system is responsible for a range of negative impacts on human and animal health and on the environment, the climate and biodiversity; whereas it is undeniable, based on a vast body of scientific evidence, that certain contemporary farming practices also contribute highly significantly to habitat loss, including of agro-ecosystems and local species extinctions, including of species beneficial to farming; whereas the way in which we produce and consume food needs to transform in order to ensure coherence with the SDGs, the Paris Agreement, the Convention on Biological Diversity and EU policies, the International Treaty on Plant Genetic Resources for Food and Agriculture, particularly in the areas of sustainability, the environment, climate, public health, animal welfare, working conditions, food and economic sustainability for farmers;
Amendment 245 #
2020/2260(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas European citizens are increasingly concerned about the welfare of animals in the agricultural sector and expect the EU to transition away from intensive farming practices, like caged farming; whereas the European Citizens’ Initiative (ECI) “End the Cage Age”, which calls on the EU to phase-out the use of cages in animal farming, has collected nearly 1.4 million certified signatures, qualifying as one of the few successful ECIs; whereas the European Committee of the Regions committed to the objective of ending caged farming and many EU member states already adopted national legislation which goes beyond the minimum EU standards, increasing the urgency for legislative action, at the EU level, to end this inhumane practice and ensuring a level-playing field for farmers across the EU;
Amendment 263 #
2020/2260(INI)
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas animals are recognised under Article 13 TFEU as sentient beings and full regard must be paid to animal welfare requirements in EU policymaking as they deserve due consideration and respect, especially because the welfare of animals kept for food production is a key issue of concern for EU citizens; whereas significant developments in animal welfare science have taken place since the existing EU farm animal welfare legislation was adopted and it is thus vital to revise and augment the existing body of animal welfare legislation to bring it into line with the latest scientific advancements and to respond to societal demands for improvement of the welfare of animals and the elimination of outdated livestock housing systems and other production practices that negatively impact their welfare;
Amendment 279 #
2020/2260(INI)
Motion for a resolution
Recital B e (new)
Recital B e (new)
Be. whereas a diet rich in plant-based foods and with fewer animal source foods confers both improved health and environmental benefits, and transformation to healthy diets by 2050 will require substantial dietary shifts, whereas global consumption of fruits, vegetables, nuts and legumes will have to double, and consumption of foods such as red meat and sugar will have to be reduced by more than 50% in order to achieve dietary shifts towards less resource-intensive products (more plant based, less refined), with more effective distribution chains, and food waste prevention to easily compensate for the yield shortfalls that are often associated with more sustainable production methods;
Amendment 285 #
2020/2260(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the European model of a multifunctional agricultural sector, driven byre is a necessity to support the transition of the European farming model towards more localised supply chains, better agricultural practices, achieving high environmental standards and supporting and re-creating vibrant rural areas throughout the EU, while still being based on family farms, models and continuesing to ensure quality food production, local supply chains, good agriculture practices, high environmental standards and vibrant rural areas throughout the EU; whereas in just over a decade several million farms have ceased to exist, representing over a third of all farms in Europe, and the vast majority of lost farms are small family businesses;
Amendment 289 #
2020/2260(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the European model of a multifunctional agricultural sector, driven by family farms, continues to ensure quality food production, local supply chains, good agriculture practices, high environmental standards and vibrant rural areas throughout the EU; whereas this agricultural model is endangered by the ongoing takeover of production capacities by industrial and multinational companies that rely on large-scale, automated and cage-based production methods;
Amendment 360 #
2020/2260(INI)
Motion for a resolution
Recital D
Recital D
D. whereas it is important that consumers are informed and enabled to take responsibility for the consequences of their choice of food stuffs on the whole food system, from proempowered to make informed food choices, including as regards the impact on the whole food system, from production to processing and distribution; whereas consumer choices are constrained by norms and conventions, price, convenience, habit and the ways in which food choice is presented; whereas information provision, education to processing and distribution; whereas this requi, and awareness campaigns are on their own insufficient to achieve the required behavioural change towards sustainable consumer choices; whereas a healthy and sound food environment is needed, which ensures that the healthy and sustainable choice is also the easy and affordable choice, and fosters and encourages consumption patterns that support human health while ensuring the sustainable use of natural and human resources and animal welfare;
Amendment 389 #
2020/2260(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the COVID-19 pandemic has shown us how vulnerable we are for emerging zoonotic diseases; taking into account that around half of the zoonotic diseases that have emerged in humans since 1940 resulted from changes in land use, especially clearing land for crop and livestock production that bring people and livestock close to forests and increase contact between wildlife, livestock, pathogens and people; whereas the expansion and intensification of agriculture, the breeding of billions of farm animals kept in close proximity to each other and to humans and the lack of genetic diversity in kept animals coupled with the high use of veterinary medicine which reduce the natural resistance in animals, unsustainable international trade and wildlife hunting and trade create ideal conditions for outbreaks of infectious and zoonotic diseases, which, just as the novel coronavirus, have the potential to become pandemics with dramatic consequences for our health and our societies;
Amendment 390 #
2020/2260(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas genome editing methods have a high technical potential to make the whole genome available for genetic changes, very often resulting in complex patterns of genetic change (genotypes) and profound intended changes in the biological characteristics (phenotypes), even if no additional genes are inserted; whereas organisms derived from genome editing are covered by the Cartagena Biosafety Protocol of the Convention on Biological Diversity;
Amendment 403 #
2020/2260(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the European food system has played a crucial role during the COVID-19 pandemic, demonstrating its resilience with farmers, processors and retailers working together under difficult conditions, including lockdowns, to ensure that European consumers continue to have access to safe, affordable, and high quality products without impediment; whereas the COVID-19 crisis, nevertheless, has highlighted the limits and weaknesses of globalised and intricate food supply chains, and has shown that over- specialisation of agricultural production leaves countries more vulnerable to trade restrictions and sudden shifts in consumer demand;
Amendment 412 #
2020/2260(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the European food system has played a crucial role during the COVID-19 pandemic, demonstrating its resilience with farmers and their cooperatives or producers organisations, workers employed along the food value chain, processors and retailers working together under difficult conditions and sanitary risks, including lockdowns, to ensure that European consumers continue to have access to safe, affordable, and high quality products without impediment;
Amendment 548 #
2020/2260(INI)
Motion for a resolution
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Urges the Commission to integrate food aid issues in the farm to fork strategy since 33 millions of Europeans suffer from lack of food, especially single parent families and students, and the social and economic consequences of the pandemic will increase that figure; recognises the unique role of the food aid associations across the European Union that need to be more supported because of the growing number of people who need help; considers that the resilience of our food system need to increase the connections between food policies and agricultural policies at every level from the local to the European level;
Amendment 583 #
2020/2260(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the announcement of an impact-assessed proposal for a legislative framework for sustainable food systems; invites the Commission to use this proposal to set out a holistic, integrated, common food policy aimed at reducing the environmental and climate footprint of the EU food system in order to make Europe the first climate- neutral continent by 2050, taking into account also emissions that are linked to European food production and consumption but generated outside Europe, and strengthen its resilience to ensure food security in the face of climate change and biodiversity loss, leading a global transition towards sustainability from farm to fork, based on the principle of a multifunctional agricultural sector while ensuring consistency between policies by taking into account the existing legislation in order to enable all actors in the European food system to develop long-term plans based on realistic and transparent objectives through enhanced policy coherence, in order to enable all actors in the European food system to develop long-term plans based on realistic and transparent objectives; recalls that the ecological transition in food production could be a win-win-win situation for primary producers, the environment, and society as a whole; suggests that the respective base lines and progress achieved in each Member State be taken into account, while promoting the exchange of know-how and best practices between Member States; stresses the need to include the entire food and beverage chains including processing, marketing, distribution and retail;
Amendment 620 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Points out to the Commission that a governance reform towards a true and equal participation of all stakeholders, including citizens, is the basis for a successful implementation; asks for the introduction of mechanisms for systematic coordination, policy implementation, monitoring and enforcement of the new framework for sustainable food systems, emphasising therein practice sharing and learning at EU level on local and territorial food initiatives, including urban and regional food policies; insists on the importance of Member States and the European Parliament fully embracing the farm to fork strategy;
Amendment 629 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Urges the Commission to ensure a level playing field across the EU by completing the process of external convergence, as committed in 2013, so that farmers and rural communities in all EU Member States have an equal opportunity to contribute to the strategy; citizens of the Member States should have equal access to the benefits of the objectives of the strategy;
Amendment 633 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Acknowledges that the first mid- term review of the farm to fork strategy is planned by mid-2023; stresses the need for any evaluation of the strategy to consider the cumulative impact of all actions foreseen therein in a holistic and systemic manner rather than to focus on individual targets taken in isolation; insists on the need for any assessment of the strategy to cover all dimensions of sustainability, including environmental, economic and social, including health;
Amendment 666 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Recalls that the social dimension must be fully integrated in all future initiatives of the farm to fork strategy along with the economic and environmental dimensions to achieve a much-needed policy coherence for sustainable development; insists that improvement of working conditions, in line with the 8 ILO core Convention, collective bargaining, social protection, investment in public services, inclusive governance and fair taxation should be included as sustainability criteria;
Amendment 667 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Highlights the need to achieve a holistic, more localised, low input, nature- based food production in order to achieve the aims of the European Green Deal, and in particular the farm to fork strategy; notes that this will notably require to re-balance animal and crop productions in a way that fits the natural boundaries of our territories, as well as to support the widespread use of agro- ecological practices, organic farming and sustainable agro-forestry;
Amendment 668 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Recalls that for the FAO, agroecology is a fundamental part of the global response to climate change and for the creation of sustainable food and agricultural systems, the new legislative framework for sustainable food systems, to be proposed until 2023, must be based on the principles and elements defined by the FAO as agroecology in order to trigger a true agroecological transition;
Amendment 690 #
2020/2260(INI)
Motion for a resolution
Subheading 2
Subheading 2
Building the food chain that works for consumers, producers, workers, climate and the environment
Amendment 691 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 g (new)
Paragraph 2 g (new)
2g. Regrets that the Commission missed the opportunity to use the farm to fork strategy as a compass for a revised CAP; highlights that none of the objectives and the targets set by the farm to fork strategy will be reached without being matched by corresponding targets and measures in the national and regional strategic plans; calls on the Commission to ensure that these strategic plans are suited to the farm to fork objective when assessing them; insists that the CAP monitoring system must be set up in a way allowing to follow the contribution of the CAP to the objectives and targets of the farm to fork strategy;
Amendment 695 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 g (new)
Paragraph 2 g (new)
2g. Welcomes the Commission setting a target for the development of land under certified organic farming by 2030, but calls for this target to be set at 30%, notably in order to match the Commission’s ambitions for a global reduction in pesticide use and risk; Highlights the need for a parallel development of the entire organic food chain in order to allow for a local processing and distribution of the Union organic production; notes that Member states will contribute differently to this Union-wide target depending on the level of development of their organic sector and therefore calls for the definition of national targets; highlights that these targets will not be met without a strong financial support, a solid training program and advisory services; calls on member states to shape their CAP strategic plans in consequence and the Commission to make sure these strategic plans are up to the task;
Amendment 733 #
2020/2260(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Welcomes the decision to revise the directive on the sustainable use of pesticides and the reduction targets for pesticides, fertilisers, and antibiotics; emphasises the importance of pursuing these targets through holistic and circular approaches, such as agroecological practices; reiterates that the revised Directive should include EU-wide mandatory pesticide reduction targets , with a view to achieving a complete phase-out of synthetic pesticides by 2035; insists that each Member State should establish robust quantitative reduction targets, accompanied by well- defined support measures ensuring accountability at all levels to help reach these targets; reiterates its call for the translation into legislation of the above targets and objectives and calls on the Commission to clarify how it will deal withassign individual Member States’ their fair contributions to Union-wide targets whereby each Member State’s 2030 target is the end point of a linear reduction trajectory defining annual reductions for the years 2021-2030, and to clarify the baselines for these targets;
Amendment 787 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Points out that re-localisation requires a decrease in input dependency of the food farming sector, notably by supporting a -50% pesticide use target in 2025 (-80% by 2030 and phasing out chemical pesticide use by 2035); notes that a farmer's "toolbox" should be based on preventive measures, agronomic practices as well as chemical substances and alternatives to those, such as biological control; stresses however that the implementation of IPM practices is patchy, and to achieve its maximum benefits it should be made compulsory, highlights the contribution that the authorisation of low-risk natural PPPs based on natural products can make to a sustainable EU farming sector;
Amendment 830 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Urges the Commission to develop a clear and comprehensive system to rate the risk of pesticides in order to be able to fulfil the goal of the farm to fork strategy to reduce risk by 50 % until 2030. This system should at least take into account quantity, toxicity to all trophic levels, half- life in water, sediment and soil, bioaccumulation potential, use and include further scientifically based criteria, if relevant;
Amendment 845 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Calls on the Commission and the Member States to strictly apply Article 4 of Regulation No 1107/2009 concerning the placing of plant protection products on the market and to adopt clear scientifically based criteria for what constitutes unacceptable effects on the environment, taking into account real-life exposure (acute and chronic) to multiple plant protection products, including cumulative and synergistic effects; insists that prophylactic uses of pesticides, including seed treatment with synthetic pesticides, should be prohibited;
Amendment 862 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 d (new)
Paragraph 3 d (new)
3d. Notes that some Member States have a tax on pesticide production and usage to cover costs currently externalised to public health and environmental budgets and so carried by the ordinary citizens, the workers and farmers who apply them and the public purse and therefore invites Member States and the Commission to exchange best practices and look seriously to mainstreaming this tax approach to enforce the Polluter Pays Principle;
Amendment 872 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 e (new)
Paragraph 3 e (new)
3e. Emphasises the need to improve policy coordination between agricultural legislation, particularly legislation on plant protection products, biocides and fertilisers, and, inter alia, water legislation, in order to ensure the protection of our water resources, particularly those used for drinking water supply , from overexploitation and agricultural pollution;
Amendment 874 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 e (new)
Paragraph 3 e (new)
3e. Calls on the Commission and Member States to ensure that the revision of the EFSA bee guidance, and the future implementing acts, do not lead to a level of protection for bees below that laid down in the EFSA bee guidance from 2013;
Amendment 876 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 f (new)
Paragraph 3 f (new)
3f. Welcomes the Commission’s commitment to act to reduce nutrient losses by at least 50%, while ensuring that there is no deterioration in soil fertility; thus reduce the use of fertilisers by at least 20% by 2030; insists that legally binding legislative initiatives are needed to that end; points out that the reduction of excessive fertilisation needs to be accompanied by the reduction in the presence of heavy metals therein; by the enhancement of soil fertility through the closure of nutrient cycles where possible, by feeding plants preferably through the soil ecosystem, by encouraging and rewarding farmers to plant leguminous crops as part of a diverse crop rotation; recalls that reversing biodiversity loss is of key importance to reach these targets; highlights that nutrient recovery and reuse especially of nitrogen and phosphorous from waste streams should become a bigger priority; points to the importance of ensuring the development of mandatory nutrients management plans under the CAP national strategic plans;
Amendment 879 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 g (new)
Paragraph 3 g (new)
3g. With a view to the One Health approach, welcomes the Commission’s goal to halve sales of antimicrobials for farmed animals and in aquaculture by 2030; points to the fact that intermediate targets and clear actions and measures, including sanctions, are necessary to achieve this goal; furthermore recalls that to achieve this goal, improved animal husbandry practices are key as better animal welfare improves animal health, thus reducing the need for medication; calls on the Commission to meticulously scrutinise the implementation and enforcement by Member States of Regulation (EU) 2019/6 on Veterinary Medicinal Products and Regulation (EU) 2019/4 on Medicated Feed once they enter into force in 2022;
Amendment 884 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 k (new)
Paragraph 3 k (new)
3k. Welcomes EFSA's encouragement of the use of in vitro methods in assessing the safety of feed additives for food handlers and its tiered approach to toxicological testing for pesticides; believes, however, that more must be done to promote the development and use of New Approach Methodologies (NAMs) in this regard to significantly reduce tests on animals and ensure better health and environmental protection;
Amendment 885 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 l (new)
Paragraph 3 l (new)
3l. Calls for measures to facilitate the incorporation of New Approach Methodologies (NAMs) in chemical food and feed risk assessments, contributing to European (PARC) and international (OECD, APCRA) initiatives and complementing the farm to fork strategy, reducing the need for tests using animals and ultimately contributing to the complete phase-out of animal testing;
Amendment 935 #
2020/2260(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Emphasises the importance of recognising the significant impact of agriculture and especially animal production on greenhouse gas (GHG) emissions and land use; stresses the need to enhance natural carbon sinks and reduce agricultural emissions of carbon dioxide, methane and nitrous oxide, in particular in the feed and livestock sectors, as well as the mineral fertiliser sector, without further compromising animal welfare and notably by reversing intensification of animal production; calls for regulatory measures and targets to ensure progressive reductions in all GHG emissions in these sectors;
Amendment 984 #
2020/2260(INI)
Motion for a resolution
Paragraph 4 d (new)
Paragraph 4 d (new)
Amendment 987 #
2020/2260(INI)
Motion for a resolution
Paragraph 4 e (new)
Paragraph 4 e (new)
4e. Urges the revision of Council Directive 1999/74/EC laying down minimum standards for the protection of laying hens in order to rapidly phase-out and prohibit enriched battery cages and require cage-free systems for all laying hens, to create a level-playing field and improve the welfare of animals kept in the EU at the same time;
Amendment 989 #
2020/2260(INI)
Motion for a resolution
Paragraph 4 f (new)
Paragraph 4 f (new)
4f. Calls for Council Directive 2008/120/EC laying down minimum standards for the protection of pigs to be revised to inter alia remove the 28 day exemption for confining sows in individual stalls and to ensure that the animals are kept in group housing throughout the entire gestation period and farrowing;
Amendment 992 #
2020/2260(INI)
Motion for a resolution
Paragraph 4 h (new)
Paragraph 4 h (new)
4h. Emphasises that the transport of live animals does not only pose severe risks to the welfare and health of the animals transported, but also to public health due to the possible spread of diseases, and underlines in this regard the importance of reducing, refining and replacing live transport and to make sure that the revision of the Council Directive 1/2005/EC of 22 December 2004 on the protection of animals during transport contains comprehensive species- and category-specific requirements, especially regarding the maximum duration of a transport, and a more strict and transparent monitoring and reporting system to ensure that systematic violations will be effectively identified and prevented, and that this revision is in full alignment with the objectives of the farm to fork strategy;
Amendment 993 #
2020/2260(INI)
Motion for a resolution
Paragraph 4 i (new)
Paragraph 4 i (new)
4i. Stresses that, in the context of food safety, environmental protection, climate action, animal welfare and equality between Member States, the Commission must at all times ensure strict enforcement of European legislation; calls on the Commission to make more and better use of infringement procedures in this regard, including strong sanctions, and reminds the Commission of the routine docking of piglets' tails which has not been allowed in the EU since 1991 but is still common practice in many Member States and stresses the need for action to end this;
Amendment 994 #
2020/2260(INI)
Motion for a resolution
Paragraph 4 j (new)
Paragraph 4 j (new)
4j. Calls on the Commission to draw up a roadmap to ensure better welfare for broilers, that includes a timetable for phasing out the farming of chicken breeds associated with health and welfare problems, lower stocking densities without exceptions, adequate distraction facilities, sufficient natural light and space and stricter air quality parameters and calls on the Commission to revise Council Directive 2007/43/EC in order to realise a ban on the rearing of extremely fast- growing hens;
Amendment 1009 #
2020/2260(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Points out that extensive and permanent grassland-based orand organic animal husbandry imodels are features of the European food system and a defining elements of many traditional rural communities, and that it has, especially in contrast with intensive animal agriculture, they can have multiple positive effects foron the environment and against climate change, and can contributes to a circular economy; insists that public policy and funds need to support a transition to land-based animal agriculture, with diets adapted to the animals’ natural needs, and a re- balancing of animal and crop productions; further insists that stocking densities should not be allowed to exceed the carrying capacity of the land; stresses that, in consequence, current levels of meat and dairy production and consumption need to be significantly reduced;
Amendment 1039 #
2020/2260(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Recalls that each years, in the EU alone, over 300 million farmed animals spend all, or a significant part, of their lives imprisoned in cages; stresses that this practice causes tremendous suffering, as these sentient beings cannot perform most of their natural behaviours, resulting in physical and psychological illness; calls on the Commission to put forward, without delay, a legislative proposal to phase-out the use of cages for all farmed animals, while ensuring, together with Member States, appropriate measures to assist farmers in this transition;
Amendment 1043 #
2020/2260(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
Amendment 1056 #
2020/2260(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Invites the Commission to fully take into account the findings of the upcoming report of the European Parliament’s Inquiry Committee on the Protection of Animals during Transport, especially in the context of the revision of Regulation 1/2005; urges Member States and the Commission to properly enforce the CJEU ruling C- 424/13 and stop exporting live animals to third countries, regardless of the journey duration, purpose and conditions, if EU applicable animal welfare conditions and standards are not met or verifiable in the respective countries of destination; calls on the Commission to propose a phase out of the export of live animals for slaughter, regardless of the journey duration and conditions, and to promote as much as possible alternatives to live animal transport, such as meat-and-carcass and genetic material transport for exports and intra-EU trade;
Amendment 1061 #
2020/2260(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Stresses that, unless animal production standards in third countries are aligned with those of the EU, imports of animal products from third countries should be forbidden;
Amendment 1085 #
2020/2260(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Welcomes the notion of rewarding carbon sequestration in soilpromoting carbon sequestration in soils; reminds of the importance of nature-based solutions, such as agroecology or ecosystem restoration, especially peatland restoration, for increasing natural carbon sinks; stresses, however, that intensive and industrial agriculture and farming models with negative impacts on biodiversity or animal welfare should not receive climate funding or be incentivised; calls for the proposals to be in line with the environmental objectives and the ‘do no harm’ principle of the Green Deal;
Amendment 1152 #
2020/2260(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Underlines the importance of seed security and diversity, notably of promoting EU-grown plant proteins to deliver locally sourced food and feed stuffs with high nutritional value while granting farmers access to quality seeds for plant varieties adapted to the pressures of climate change and low input farming systems, including traditional and locally- adapted varieties, while ensuring access to innovative plant breedingsustainable plant and animal breeding, such as participatory plant and animal breeding in cooperation between farmers and scientists and breeding of genetically heterogeneous and locally adapted heirloom seeds, in order to contribute to healthy seeds and animals, and protect plants against harmful pests and diseases; raises awareness of the potential negative effects of concentration and monopolisation in the seed sector driven by patents on seeds, among other factors;
Amendment 1164 #
2020/2260(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Underlines the importance of seed security and diversity, notably of promoting EU-grown plant proteins to deliver locally sourced food and feed stuffs with high nutritional value while granting farmers access to quality seeds for plant varieties adapted to the pressures of climate change, including traditional and locally-adapted varieties, while ensuring access to innovative plant breeding in order to contribute to healthy seeds and protect plants against harmful pests and diseases; raises awareness of the potential negative effects of concentration and monopolisation in the seed sector;
Amendment 1189 #
2020/2260(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Recalls that the precautionary principle in regard to GMOs has to be applied in accordance with the judgment of the Court of Justice of the European Union of 25 July 2018 in Case C-528/16, which includes the need for companies to provide methods to identify the relevant organisms as well as mandatory approval process, including risk assessment and labelling.
Amendment 1194 #
2020/2260(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Highlights its opposition to the use of GMOs in agriculture, as patenting of transgenic genetically modified crops has led to the monopolisation of the commercial seed sector by a handful of companies;
Amendment 1198 #
2020/2260(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Points out that gene-edited plants and animals are being patented and would therefore further contribute to market concentration in seed, plant and animal production to the detriment of small farmers and breeders; furthermore calls, with a view to protecting consumers, for full enforcement of the judgment of the CJEU in case C-528/16 which found that the products of genome-editing techniques fall within the scope of EU GMO law and are therefore subject to the legal requirements, including risk assessment, labelling and traceability; calls for full and swift implementation of EU GMO law, as required by the ECJ ruling;
Amendment 1203 #
2020/2260(INI)
Motion for a resolution
Paragraph 7 c (new)
Paragraph 7 c (new)
7c. Notes that the use of herbicide- tolerant transgenic crops have led to an increase in the use of the herbicides, especially glyphosate, with negative impacts on different plant and insect species, as well as aquatic organisms and the composition of soil bacteria, and that herbicide-tolerant genome-edited crops will inevitably pose the same risks; calls therefore on the Commission to no longer authorise genetically modified crops that are herbicide tolerant, neither for cultivation in the EU nor for use in food and feed;
Amendment 1204 #
2020/2260(INI)
Motion for a resolution
Paragraph 7 d (new)
Paragraph 7 d (new)
7d. Highlights that genetically modifying farmed animals can have serious consequences for animal welfare as well as aiding intensive agricultural systems in pushing animals even further beyond their physiological limits; notes that this often involves cloning, which leads to birth defects, spontaneous abortions and early postnatal death; for this reason, calls on the Commission to ban genetic engineering of animals, as well as import into the EU of genetically engineered animals and all related products;
Amendment 1205 #
2020/2260(INI)
Motion for a resolution
Paragraph 7 e (new)
Paragraph 7 e (new)
7e. Reiterates its call to the Commission to present a new legislative proposal on the issue of cloning and “clone food” as a matter of urgency; insists that this proposal should include a ban on cloning, a ban on placing on the market and importing of cloned animals, their reproductive material and their descendants and a ban on placing on the market and importing of food from cloned animals and their descendants;
Amendment 1228 #
2020/2260(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls for CAP National Strategic Plans to ensure adequate financial support and incentives to promote new ecological ‘green’ business models for agriculture and artisanal food production, notably through fostering short supply chains and quality food production; calls for the Commission to check the adequation between the targets of the European Green deal strategies, including the farm to fork strategy, and the draft strategic plans in the framework of their assessment;
Amendment 1281 #
2020/2260(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Welcomes the explicit recognition of a safeguard of the social rights of workers in the food chain; recalls that this has been endorsed by the European Parliament with the introduction of the social conditionality for the CAP basic payment in its position on the national strategic plans Regulation;
Amendment 1289 #
2020/2260(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Recalls that the European food system should delivers a sufficient and varied supply of safe, nutritious, affordable and sustainable food to people at all times and underlines that increasing the economic, environmental and social sustainability of food producers will ultimately increase their resilience; highlights that the re-localisation of a diverse food system can contribute to all these objectives, as well as contributing to food security and food sovereignty, as was shown by the challenges created by the COVID-19 pandemic; notes in particular the importance of supporting the relocalisation of the production of plant protein in the EU with a view to climate change mitigation, as this would shorten transport distances and limit deforestation; highlights the need to support the development of sustainable food SMEs in rural areas; encourages the Commission to consider the food supply chain and its workers as a strategic asset for the safety and well-being of all Europeans;
Amendment 1290 #
2020/2260(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Recalls that the European food system generally delivers a sufficient and varied supply of safe, nutritious, affordable and sustainable food to people at all times and and affordable food to people at all times but emphasises that the healthfulness and sustainability of European food must still improve; points out that an estimated 11% of the population (49 million people, EU-27) are unable to afford a quality meal every second day and that COVID-19 is likely to exacerbate financial difficulties for many European households; stresses that food poverty requires appropriate policy response; underlines that increasing the economic, environmental and social sustainability of food producers will ultimately increase their resilience; encourages the Commission and the Member States to consider the food supply chain and its workers as a strategic asset for the safety and well-being of all Europeans, and to ensure that working and social protection conditions throughout the EU food supply chain meet national, EU and international standards for all workers;
Amendment 1324 #
2020/2260(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Highlights the importance of traditional craftsmanship in regional and local food production and the rich cultural diversity that results from it; reminds that maintaining and passing on knowledge of craftsmanship in food production should also be supported as a horizontal part of the farm to fork strategy, for example by better including it in participatory research and development programmes;
Amendment 1336 #
2020/2260(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Underlines that robust and reliable legal frameworks for the fisheries and aquaculture sector should provide the basis for better protection measures with subsequent increases in fish populations and more clarity regarding the use of space and licenses in aquaculture, allowing for greater predictability for investments; stresses that good traceability mechanismsfor all anthropogenic uses including aquaculture, as well as marine protected areas, allowing for greater predictability for investments without undermining environmental legislation; stresses that good traceability mechanisms, including origin and method of production labelling, and high sustainability and fish welfare standards for all products sold on EU markets are essential to ensure transparency for consumers, the sector and the different administrations, and to achieve the targets of the Green Deal and the SDGs;
Amendment 1349 #
2020/2260(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Underlines that industrial fish farming has severe impacts on the health and welfare of the fish as well as on the environment; recalls that Illegal, Unreported and Unregulated (IUU) fishing undermines existing frameworks to the detriment of biodiversity and consumers; notes that allowing fish populations to grow should be for the sake of restoring biodiversity, not of increasing human consumption of fish;
Amendment 1355 #
2020/2260(INI)
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Stresses that fish are sentient beings and should be spared unnecessary suffering; calls on the Commission and the Member States to take steps to develop and implement gentler methods of capture, landing, transport and slaughter of fish in order to reduce stress and improve fish quality;
Amendment 1356 #
2020/2260(INI)
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
10c. Notes that EU animal welfare legislation is currently not applicable to marine invertebrates, while several third countries have included these animals in their animal welfare legislation; calls on the Commission and the Member States to take steps to improve the welfare of marine invertebrates, like crabs and lobsters, by including these animals in their animal welfare legislation;
Amendment 1363 #
2020/2260(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Expresses its deep concern about the emergence of zoonotic diseases that are transferred from animals to humans (anthropozoonoses), such as Q fever, avian influenza, COVID-19 and the new strain of influenza A (H1N1), which is exacerbated by anthropogenic climate change, the destruction of biodiversity, environmental degradation and our current food production systemsenvironmental degradation, land use changes and the destruction of biodiversity and natural habitats and recognises that current industrial modes of food production and especially industrial livestock production, with large numbers of genetically similar animals kept in confined spaces and conditions which cause high stress levels and poor welfare and render the animals more susceptible to pathogens and viral spillover, contribute to this exacerbation;
Amendment 1402 #
2020/2260(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Commission and the Member States to stop supporting policies that favour practices and processes such as land grabbing and land concentration, which are widespread all across Europe and which were identified as a main obstacle for young farmers to enter into farming; asks in this context to set up a Land Observatory to strengthen soil protection and preservation and to monitor land transactions, in particular “share-deals” acquisitions, recording land prices and market behaviour, changes in land use and loss of farmland and trends in soil fertility and land erosion; asks the Commission to monitor all relevant policy areas, such as agriculture, energy, environment, regional development, mobility, finance and investment with a view to examining whether they encourage or counteract the preservation of agricultural land and effects on concentration processes;
Amendment 1410 #
2020/2260(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
Amendment 1411 #
2020/2260(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Is deeply worried about the potential of intensive livestock farms to facilitate the spread of pests and epidemic diseases, especially in areas with a high concentration of intensive farms; urges the Commission, Member States and regional authorities to use all means to their disposal to protect public and animal health, including notably spatial zoning policy ensuring a sufficiently large buffer strip between industrial farms and populated areas, and to regulate a maximum stocking density;
Amendment 1415 #
2020/2260(INI)
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Underlines that the ecological transition of our food system is an opportunity to contribute to a vibrant countryside; recalls that sustainable farming practices could create many sustainable jobs and that reversing the current demographic trend in rural areas caused mainly by the industrialisation of agriculture is necessary; recalls that the current surface-based CAP subsidies system plays a role in the concentration of farmland, creating difficulties for young farmers and new entrants;
Amendment 1417 #
2020/2260(INI)
Motion for a resolution
Paragraph 11 e (new)
Paragraph 11 e (new)
11e. Calls for an EU wide ban on fur production as the COVID-19 pandemic has shown that this sector is highly susceptible for infectious disease and is responsible for intolerable animal suffering;
Amendment 1418 #
2020/2260(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. CStresses that securing a stable and fair income for primary producers is a crucial step to enable the transition of the food system, to enhance the uptake of environmentally friendly practices and to ensure food sovereignty; calls for primary producers to be supported in making the transition to greater sustainability through the encouragement of cooperation and collective actions as well as through competition rules and the enhancement of possibilities for cooperation within the common market organisations for agricultural, fishery and aquaculture products, and thus for farmers’ and fishers’ position in the supply chain to be strengthened in order to enable them to capture a fair share of the added value of sustainable production; calls on the Commission to take active steps against corporate concentration processes and monopolisation tendencies in the retail sector and vertical integration along the whole food chain; underlines that contractualisation taking in account production costs is a demonstrated way to strengthen the bargaining position of farmers in line with the EU agricultural policy objective to protect farmers’ livelihood, notes that the liberalisation of agricultural markets and the export- oriented economic model have delivered little economic benefits to farmers thus jeopardizing the ecological transition; therefore calls the Commission to investigate the means to better regulate agricultural markets for example through supply regulation and to support contractualisation;
Amendment 1440 #
2020/2260(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls for primary producers to be supported in making the transition to greater sustainability, including cage-free animal farming, through the encouragement of cooperation and collective actions as well as through competition rules and the enhancement of possibilities for cooperation within the common market organisations for agricultural, fishery and aquaculture products, and thus for farmers’ and fishers’ position in the supply chain to be strengthened in order to enable them to capture a fair share of the added value of sustainable production;
Amendment 1446 #
2020/2260(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Highlights that the overall trend characterising the meat processing industry across the Union is an increasing concentration in large companies and mass production; notes that this concentration has been characterised by food safety and animal welfare concerns1a, de-skilling and harder working conditions with more repetitive and dangerous work task for workers, difficulties for farmers in accessing local slaughterhouses responding to their specific demands, notably for organic farmers, and ever longer transportation for live farm animals; calls on the Commission to enable and financially support local and collective equipment initiatives, local slaughterhouses and processing units, and solutions suitable for small farms such as mobile slaughterhouses; _________________ 1aEFSA, 2020, Welfare of cattle at slaughter
Amendment 1468 #
2020/2260(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Urges the Commission to follow up onthoroughly enforce Directive (EU) 2019/633 on unfair trading practices22 and the EU code of conduct on responsible business and marketing practices by producing a monitoring framework for the food and retail sectors and providing for legal action if progress in integrating economic, environmental and social sustainability into corporate strategies is insufficient, and in so doing promoting and rewarding the efforts of sustainable agricultural producers while increasing the availability and affordability of healthy, sustainable food options and reducing the overall environmental footprint of the food system; stresses the importance of halting and addressing consolidation and concentration in the grocery retail sector in order to ensure fair prices for farmersparticularly its transposition into national law and the enforcement at national level; _________________ 22 OJ L 111, 25.4.2019, p. 59.
Amendment 1505 #
2020/2260(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Asks the Commission to set up an EU code of conduct on responsible business and marketing practices , to create a monitoring framework for the food and retail sectors, and to set up a legislative framework providing for legal action if progress in integrating economic, environmental and social sustainability as well as animal welfare into corporate strategies remains insufficient; this framework should promote and reward the efforts of sustainable companies while increasing the availability and affordability of healthy, sustainable, socially responsible, and higher animal welfare food options and reducing the overall environmental footprint of the food system; stresses the importance of halting and addressing consolidation and concentration in the grocery retail sector in order to ensure fair prices for farmers and market economy functionality;
Amendment 1513 #
2020/2260(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Calls on the Commission to bring forward proposals for better cooperation between farmers, already allowed under competition rules, and to support investment in improving production and marketing structures to make them more robust, stable, secure and profitable for farmers as means of helping strengthen their position in the chain;
Amendment 1518 #
2020/2260(INI)
13b. Highlights that the COVID-19 pandemic shed new light on the challenging working and living conditions of millions of workers in the agricultural sector in Europe, notably those working in slaughterhouses, and calls for the recognition of the importance of protecting workers’ individual and collective labour and social rights, thereby reinforcing the ‘social dimension’ of EU agriculture, and calls on the Commission to strengthen measures focusing on the rights, working and employment conditions and social protection of farm labourers including migrants and other mobile workers, and to ensure coherence between policy areas on this issue;
Amendment 1520 #
2020/2260(INI)
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Stresses that the EU code of conduct cannot substitute ambitious, binding rules to make the EU’s food system sustainable and fair; urges the Commission to promote alternative business models rooted in the social and solidarity economy, such as consumer- friendly cooperative schemes and community supported agriculture;
Amendment 1531 #
2020/2260(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Urges the review of the EU promotion programme for agricultural and food products, including the EU school scheme, with a view to bringing it into coherence with the objectives of the Green Deal and farm to fork strategy and to enhancing its contribution to sustainable production and consumption, notably by focusing on educational messages about the importance of healthy nutrition and promoting greater consumption of fruit and vegetables with the aim of reducing obesity rates; considers it essential to stop stimulating the production and consumption of meat and fish, as well as dairy from non-extensive respectively non-organic production;
Amendment 1588 #
2020/2260(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Welcomes the Strategy’s recognition that marketing campaigns advertising meat at very low prices should be avoided, but regrets that the Strategy made no commitment to cease stimulating the production and consumption of meat through promotional programmes for agricultural products;
Amendment 1618 #
2020/2260(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Emphasises that agricultural digitalization is not an end in itself and that public support to it should aim at tackling global challenges such as climate change and biodiversity loss; highlights that digitalization of farms should not add to farmers’ already high level of indebtedness and dependency on large corporations; notes that big data platforms in the agricultural sector are owned by a few large corporations, which enables them to have control over the market and competitive advantages; is concerned that small farmers need to buy from these large corporations data that concerns their own farms if they want access to it, which poses risks to the privacy, profitability and independence of farmers;
Amendment 1629 #
2020/2260(INI)
15b. Stresses that data on agriculture and farmland is of public interest, for food security and for environmental protection, and that this data needs to be made available to the public; highlights that complete, standardised and interoperable data is in particular necessary to steer appropriately the future performance-driven CAP; notes that EU data is particularly needed on forests and in particular the mapping of old-growth forests, soil quality and fertility, biodiversity and farmland, pollinators, as well as on pesticide, fertiliser and veterinary products’ use; calls on the Commission to ensure that data collected or created with help of public funds stay public and are not appropriated by private companies;
Amendment 1633 #
2020/2260(INI)
Motion for a resolution
Paragraph 15 c (new)
Paragraph 15 c (new)
15c. Highlights that the right to repair also needs to apply to all kinds of agricultural machinery and technologies;
Amendment 1652 #
2020/2260(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls for measures to reduce the burden that highly processed foods with high salt, sugar and fat content place on public health; regrets that the introduction of nutrient profiles is greatly delayed andcalls that nutrient profiles, which are long overdue, remain pertinent and necessary to meet the objectives of Regulation (EC) No 1924/2006 on Nutrition and Health Claims; welcomes the announcement of a legislative proposal to establish nutrient profiles; points out that many food products, including some marketed towards children, continue to use health and nutrition claims despite them having high levels of nutrients of concern; stresses that a robust set of nutrient profiles must be developed to restrict or prohibit the use of false nutritional and health claims on foods high in fats, sugars and/or salt; calls for a mandatory EU-wide front-of-pack nutrition labelling system based on independent science;
Amendment 1689 #
2020/2260(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Highlights that 1 in 2 adults is overweight or obese in the EU, demonstrating the need for stronger action to help stem this public health crisis; recognises that front-of-pack nutritional labels have been identified by international public health bodies such as the World Health Organisation as a key tool to help consumers make more informed and healthier food choices; calls on the Commission to ensure that the mandatory EU front-of-pack nutritional label is developed based on robust, independent scientific evidence and demonstrated consumer understanding; emphasises that to facilitate comparison across products, it should include an interpretive element and be based on uniform reference amounts such as per 100g/100ml;
Amendment 1709 #
2020/2260(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Points to the negative effects of ultra-processed foods on diet quality and on health, especially on the gut microbiome, therefore suggests that such a front-of-pack nutrition label should also clearly indicate the degree of processing a product has undergone or be linked to a label indicating the degree of processing; for this purpose suggests to establish a food classification and labelling system of food analogous to the NOVA1a system or similar concepts in order to enable informed choices for consumers; _________________ 1aFAO, 2019, Ultra-processed foods, diet quality, and health using the NOVA classification system
Amendment 1723 #
2020/2260(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Welcomes the Commission’s commitment to revise the EU legislation on food contact materials (FCM); reiterates its call to revise the legislation on FCM in line with the regulation on the registration, evaluation, authorisation and restriction of chemicals (REACH), as well as classification, labelling and packaging regulations, and to insert, without further delay, specific provisions to substitute endocrine disrupting chemicals; (EDCs); urges the Commission to bring forward the date of publication of a revised proposal; insists on the need for a comprehensive, harmonised regulation of all FCMs, which should be based on the precautionary principle, the principle of ‘no data, no market’, comprehensive safety assessments that address all the relevant safety and health endpoints and are based on the latest scientific data for all chemicals used in FCMs, effective enforcement and improved information to consumers;
Amendment 1795 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Underlines that the affordability of healthy and sustainable food choices is the main obstacle to the adoption by consumers of healthy and sustainable diets and that food prices must send the right signal to consumers; invites therefore the Commission to launch a study to quantify in economic terms the environmental and societal, including health-related, costs associated with the production and consumption of the most consumed food products on the EU market, as a first step towards moving towards true cost accounting for food;
Amendment 1800 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Calls on the Commission to further assess how taxation policy could incentivise the uptake of foods with a lower carbon footprint and fewer externalised costs; highlights the fact that 8 Member States already apply 0-5% VAT taxes on vegetables and fruits1a; recalls that the World Health Organisation advises countries to introduce dietary taxes on unhealthy food products of minimum 20%; asserts that any additional tax revenue should be redirected to low income groups and to food producers who privilege climate friendly practices, biodiversity and animal welfare, in order to help lower the production costs of sustainable foodstuffs with a view to making them more accessible to all citizens; _________________ 1a VAT rates applied in the Member States of the European Union - Situation at 1st January 2020 https://ec.europa.eu/taxation_customs/site s/taxation/files/resources/documents/taxat ion/vat/how_vat_works/rates/vat_rates_en .pdf
Amendment 1806 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 c (new)
Paragraph 18 c (new)
18c. Highlights consumers’ increasingly broad interest about food, which also expand to animal welfare as well as environmental and social sustainability; welcomes the Commission’s intention to develop a new framework for sustainable food labelling; calls on the Commission to define the methodology and specify which dimensions of sustainability would be covered while ensuring that the new scheme does not conflict with existing environmental frameworks such as the EU ecolabel or the organic logo;
Amendment 1809 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 d (new)
Paragraph 18 d (new)
18d. Insists that labelling related to animal welfare should be based on identifying the method of production as well as including a selection of animal welfare indicators, and should be extended to processed products; asks the Commission to finally propose harmonised requirements with regard to the labelling of vegetarian and vegan food products; calls for the extension of GMO- labelling to products coming from GMO- fed animals;
Amendment 1812 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 e (new)
Paragraph 18 e (new)
18e. Welcomes the Commission’s intention to extend the requirement for a mandatory origin or provenance indications to additional products; calls on the Commission to extend the mandatory rules of origin especially to all fresh, frozen and processed meat, seafood and aquaculture products proposed to consumers in every condition, including in restaurants and canteens and indicating the place where the animal was born, raised and slaughtered, or caught and slaughtered;
Amendment 1815 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 f (new)
Paragraph 18 f (new)
18f. Highlights that too many unsubstantiated and even misleading environmental claims are being used on food, creating confusion among consumers and making it difficult for them to identify the products that are more environmentally friendly; calls on the Commission to introduce a new regulatory framework establishing a clear, swift and efficient pre-approval procedure for all green claims and labels, taking into account the experience gained in the application of the system already in place for health and nutrition claims; stresses that such a framework would protect consumers from untruthful green claims while ensuring that businesses that genuinely strive for more environmentally friendly operations are duly rewarded for their efforts;
Amendment 1818 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 h (new)
Paragraph 18 h (new)
18h. Stresses the need that labelling and marketing rules favour the much needed transition towards sustainable diets, especially sustainable proteins, and stresses that the transition towards more plant based proteins should be promoted, not hindered; calls furthermore for the long overdue rules for clear labelling for vegetarian and vegan suitable foods to be put forward without further undue delay;
Amendment 1831 #
2020/2260(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Reaffirms its belief that policy measures that are dependent solely on consumer choice unduly shift the responsibility to purchase sustainable products to consumers; notes that third- party certification and labelling alone are not effective in ensuring sustainable production and consumption; therefore stresses the importance of binding legislation along the entire food supply chain;
Amendment 1891 #
2020/2260(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Highlights the recognition in the strategy that Europeans’ diets are not in line with recommendations for healthy eating, and that a population-wide shift in consumption patterns is needed towards more healthy and plant-based foods and less red and processed meat, fresh and sustainable, local plant-based foods and less meat, highly- processed products, food additives, sugars, salt, and fats, which will also benefit the environment; emphasises that EU-wide targets and guidelines for sustainable and healthy diets would bring clarity to consumers on what constitutes a healthy and sustainable diet and inform Member States’ own efforts to integrate sustainability elements in national dietary advice; calls on the Commission to develop such guidelines and specific actions to effectively promote healthy plant-based diets;
Amendment 1930 #
2020/2260(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Considers that the further development of sustainable plant protein production and, including for direct human consumption, and sustainable alternative sources of protein in the EU is a way of effectively addressing many of the environmental and climate challenges that EU agriculture is facing, as well as preventing deforestation in countries outside the EU; recalls that reducing production and consumption of farmed animals would reduce the heavy dependence on plant proteins for feed;
Amendment 1967 #
2020/2260(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls for a revision of public procurement legislation, including minimum mandatory criteria in schools and other public institutions to encourage organic and local food producas well as less and better meat, dairy and eggs production and consumption and to promote more healthy and sustainable diets by creating a food environment that enables consumers to make the healthy choice and to have ready access to plant-based proteins; calls on the Commission to set mandatory targets for sustainable food procurement and to develop monitoring and reporting tools to collect data on these procurements;
Amendment 1969 #
2020/2260(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Considers that public canteens should play an important role in education on sustainable and healthy diets; calls for a revision of public procurement legislation, including minimuma mandatory criteriainclusion of a minimum of 30% organic ingredients in meals served in schools and other public institutions; insists that public procurement should to encourage organic, seasonal and local food production and to promote more healthyier diets by creating a food environment that enables consumers to make the healthy choice;
Amendment 2012 #
2020/2260(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Reiterates its call to take the measures required to achieve a Union food waste reduction target of 30 % by 2025 and 50 % by 2030 compared to the 2014 baseline; underlines that binding targets are needed to achieve thithese targets need to be binding at Member State level and calls on all Member States that have not yet done so to establish and implement food waste prevention programmes; emphasises that food waste reduction targets should apply to the whole of the food supply chain, requiring further targeted actions to tackle food loss and waste at primary production and pre-retail stages; welcomes the Commission’s intention to integrate food loss and waste prevention in other EU policies, including requirements for date marking; asks the Commission to likewise integrate it into public procurement policies; welcomes the Commission’s implementation of EU- wide monitoring of food waste levels;
Amendment 2043 #
2020/2260(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Calls for the comprehensive measurement of unharvested food and food ploughed back into the field, and for the identification of the trading practices and policy changes needed to prevent such food waste; stresses that CAP Strategic Plans should include Food Loss and Waste prevention actions at farm level, including support for the development of Short Food Supply Chains, which lower the risks of generating food waste;
Amendment 2070 #
2020/2260(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Invites to delete rules in relevant EU-legislation that are detrimental to the welfare of animals such as the requirement of minimum liver weights for foie gras production in Commission Regulation 543/2008 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 as regards the marketing standards for poultry meat;
Amendment 2071 #
2020/2260(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Recalls that food traceability is crucial to prevent contaminated products from reaching consumers and enable targeted withdrawal of products if necessary; therefore calls on Member States to stringently and consistently enforce product traceability provisions enshrined in Article 18 of the General Food Law (GFL) throughout the food chain to ensure that any contaminated food products can be identified and removed quickly from the market; highlights that in cases of contamination which involve risks for public health and safety, public authorities should fully and immediately inform the public about the potential risks posed by the concerned food products;
Amendment 2079 #
2020/2260(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Expresses its concern on the dynamics resulting from the process of concentration and the increasing dominant power of financial investors in the food supply chain, which lead to lower food quality and worsening of working conditions;
Amendment 2086 #
2020/2260(INI)
Motion for a resolution
Paragraph 24 b (new)
Paragraph 24 b (new)
24b. Is concerned about the dramatic decline in food controls and lack of resources allocated to them by Member States; urges the Commission to enforce the allocation of adequate resources for food controls;
Amendment 2123 #
2020/2260(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Underlines the importance of EU funding for research and innovation as a key driver in, including participatory research, as a key driver in triggering a systemic change and accelerating the transition to a more sustainable, healthy, and inclusive European food system while facilitating investments needed to encourage agro- ecological practices in both social and technological innovation, and the crucial role of farm advisory services in ensuring the transfer of knowledge to the farming community, drawing on the existing specialised training systems for farmers in Member States; calls for 30 % of the budget for research and innovation in agriculture to be ringfenced for organic and agro-ecological approaches, both in national research and innovation programmes and European frameworks (e.g. Horizon Europe);
Amendment 2153 #
2020/2260(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Highlights the crucial role of independent farm advisory services; stresses that Member States should allocate at least the minimum share of 30 % of allocations related to farm advisory services to services and technical assistance for agroecology, agro-forestry and organic farming systems contributing to objectives in line with the targets defined in the farm to fork strategy;
Amendment 2174 #
2020/2260(INI)
Motion for a resolution
Paragraph 25 b (new)
Paragraph 25 b (new)
25b. Notes the unbalanced participation of some Member States in science and research programs and stresses that this threatens to increase their technological lag; calls on the Commission to take action to ensure more equal progress in all Member States;
Amendment 2216 #
2020/2260(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Recalls the global responsibility of European food systems and their key role in setting global standards for food safety, environmental protection, working conditions, and animal welfare; calls on the Commission and the Member States to ensure that all food and feed products imported to the EU fully meet relevant EU regulations and standards and to provide development assistance to support primary producers from developing countries in meeting those standards; welcomes the Commission’s intention to take the environmental impacts ofaspects into account when assessing requesteds for import tolerances into accountfor pesticide substances no longer approved in the EU;
Amendment 2259 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Expresses its concern that non-EU producers exporting to the EU often produce at significantly lower health and environmental standards; believes that this undermines fair competition and the level playing field for EU and non-EU producers and jeopardises the achievement of global Sustainable Development Goals;
Amendment 2277 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 b (new)
Paragraph 26 b (new)
26b. Insists on the necessity of legislation for mandatory EU-level horizontal due diligence throughout the supply chain for EU and foreign companies operating within the single market, in order to achieve the SDGs, to promote good governance, to increase traceability and accountability in global supply chains;
Amendment 2283 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 c (new)
Paragraph 26 c (new)
26c. Welcomes the announcement of a legislative proposal from the Commission on 'Measures to avoid or minimise the placing of products associated with deforestation or forest degradation on the EU market' due by June 2021; insists that strong legislation needs to be developed in particular with regard to imports of food products such as soy, palm oil, maize, beef and cocoa, to ensure that those are free from deforestation and human rights violations; in the meantime, given the urgency of stopping the accelerating deforestation in Brazil and Argentina, reiterates its call to suspend the import of GM soybeans from these countries until a sustainable production can be guaranteed;
Amendment 2286 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 c (new)
Paragraph 26 c (new)
26c. Calls to integrate Policy Coherence for Sustainable Development in trade and investment policies, and to monitor negative impacts of EU food exports on small-scale food and agricultural producers in third countries;
Amendment 2287 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 d (new)
Paragraph 26 d (new)
26d. Reminds the Commission that environmental impacts inside and outside of the EU should be considered in the authorization process of GMOs for use as food and feed; welcomes the Commission’s commitment to promote the global phase-out of pesticides no longer approved in the EU and its announcement to ensure that hazardous chemicals banned in the European Union are not produced for export1a, including by amending relevant legislation if and as needed; urges the Commission to implement this promise as soon as possible, especially with regard to pesticides; urges the Commission to present a legislative proposal to that end as soon as possible; welcomes the Commission’s announcement to review import tolerances for substances meeting the „cut-off-criteria“, and urges the Commission to implement a zero- tolerance policy towards residues of those substances; _________________ 1aCommission’s Communication of 14 October 2020 on a Chemicals Strategy for Sustainability (COM/2020/667 final)
Amendment 2291 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 e (new)
Paragraph 26 e (new)
26e. Regrets that the farm to fork strategy does not address the inconsistencies between the goals outlined in this strategy and the trade agreements currently negotiated by the EU; calls for a reorientation of trade agreements enabling rather than hindering the transition to more sustainable food systems; asks the Commission to use trade policy in favour of wellbeing of both people and the natural environment;
Amendment 2293 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 f (new)
Paragraph 26 f (new)
Amendment 1 #
2020/2170(DEC)
Draft opinion
Paragraph 1
Paragraph 1
1. Recalls that the European Chemicals Agency ('ECHA') is the driving force among regulatory authorities in implementing the Union's chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness; notes that it provides information on chemicals, helps companies comply with legislation and advances the safe use of chemicals; underlines that Regulation (EC) No 1907/20061a (REACH Regulation) specifies that this should be done in a way that ensures that animal testing is only ever a last resort and that the use of non- animal methods is promoted; __________________ 1aRegulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
Amendment 6 #
2020/2170(DEC)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Regrets the lack of resources in the ECHA budget dedicated specifically to ensuring knowledge and promotion of non-animal testing methods; reiterates its call to provide resources for staff within ECHA exclusively dedicated to animal protection and the promotion of non- animal methods across all ECHA activities1a; __________________ 1aEuropean Parliament resolution of 10 July 2020 on the Chemicals Strategy for Sustainability, P9 TA(2020)0201
Amendment 1 #
2020/2163(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Reiterates its concern that only 89 % of management board members and 81 % of advisory forum members submitted the required annual declarations of interest in 2019; notes that these figures are respectively 7 and 8 percentage points lower than in 2018; recalls that independence and transparency are crucial given the important work of the Centre; calls for a mechanism to ensure that all outstanding and future declarations of interest are submitted without delay, and calls on the Centre to consider not allowing members to take up their roles before this crucial information is provided and checked;
Amendment 2 #
2020/2162(DEC)
Draft opinion
Paragraph 2
Paragraph 2
2. Notes that EFSA's final budget of for 2019 was EUR 79 986 785, representing an increase of 1 % compared to 2018; notes that the entire sum derives from the Union budget; notes with satisfaction that the budget monitoring efforts during 2019 resulted in an implementation rate of 100 % for commitment appropriations and 91 % for payment appropriations; notes with concern that EFSA, as one of the Union regulatory agencies responsible for risk assessment of regulated products, does not receive sufficient resources to carry out its responsibilities effectively; insists that EFSA is granted sufficient resources to carry out its tasks;
Amendment 5 #
2020/2162(DEC)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Notes with satisfaction that EFSA is actively moving towards cutting edge technologies, incorporating new approach methodologies (NAMs) and artificial intelligence to avoid animal testing methods; welcomes, in particular, the use of in vitro battery testing regarding neurodevelopment disorders in children;
Amendment 6 #
2020/2162(DEC)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Welcomes EFSA's efforts to increase the use of new approach methodologies (NAMs) in the agency's human health risk assessment to reduce and replace the need for animal-based verification studies, so that by 2027 the large majority of EFSA requests for additional data will be based on NAMs;
Amendment 7 #
2020/2162(DEC)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Highlights that, in 2019, the Parliament adopted 16 objectionsto the import of genetically modified (GM) crops for food and feed; highlights that one reason for these objections are gaps in the risk assessment undertaken by EFSA's Panel on Genetically Modified Organisms; urges EFSA to address and close these gaps as a matter of urgency; whereas these gaps include, inter alia, lack of testing of cocktail effects stemming from herbicide residues, Bacillus thuringiensis ('Bt') toxins and plant constituents, the impact of increased rate of sprayings of the complementary herbicides on the overall safety of the GM plant as well as a lack of adequate toxicity testing of Bt proteins;
Amendment 9 #
2020/2162(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Believes that EFSA should pay special attention to public opinion and commit itself to openness and transparency; regrets that EFSA, in relation to the two-year cooling off period, still includes in its independence policy the obligation to screen experts' interests only in relation to the mandate of the scientific group to which the expert is applying; disagrees with the agency’s claims that the current policy is a "robust and sophisticated way to avoid potential conflicts"; calls again for the policy to be updated without delay in order to ensure that experts' interests are viewed within the context of EFSA's overall remit, as repeatedly called for by Parliament; reminds EFSA that, in order to maintain the independence of the EFSA panels, the agency can access any expertise it needs by inviting experts to participate in hearings without giving them the right to participate in the panel’s deliberations and drafting conclusions;
Amendment 10 #
2020/2162(DEC)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Regrets that the research funding from companies in EFSA's remit is not considered relevant to the cooling off period as long as amounts at stake do not rise above 25 % of the total research budget managed by the expert and/or their research team, and that the threshold is applied to individual sources as opposed to all private sources combined; calls again for the funding threshold to be removed from EFSA's independence policy, in line with the Parliament's repeated requests on the matter; stresses that EFSA’s outright dismissal1a of the European Parliament’s concerns regarding this weakness in EFSA's independence policy is not acceptable; _________________ 1aEFSA Follow-up report on European Parliament’s recommendations concerning 2018 EFSA Discharge - 28 August 2020
Amendment 2 #
2020/2157(DEC)
Draft opinion
Paragraph 9
Paragraph 9
9. Takes note that the EMA received 20 reports of improprieties from an external source in 2019 and that 13 of the cases received in 2019 and 11 cases received in previous years were closed; calls on the EMA to analyse the causes of those improprieties;
Amendment 3 #
2020/2157(DEC)
Draft opinion
Paragraph 10
Paragraph 10
10. NWelcomes the efforts of EMA to strengthen its policies on transparency in relation to drugs and vaccines against COVID-19; notes that the authorisation process for a vaccine against COVID-19 will require a speedy and transparent process within the EMA; notes that specific attention should be paid to the transparency of data from clinical trials as regards such vaccines; welcomes the EMA decision to publish the clinical study reports of drugs and vaccines against COVID-19 within three days after marketing authorisation; encourages the EMA to publish data from clinical trials before marketing authorisation and failing that, in a timely manner; calls on the EMA to request that the sponsors of clinical trials make their clinical trials protocols public before marketing authorisation;
Amendment 4 #
2020/2157(DEC)
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Welcomes the efforts of EMA to increase transparency around its activities, in particular the efforts made in favour of significantly simplified clinical trials reporting for universities and hospitals and other improvements that have led to more clinical trials resultsbeing reported;
Amendment 5 #
2020/2157(DEC)
Draft opinion
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Calls on the EMA to continue increasing the level of transparency around its activities; in particular calls on the EMA to resume as soon as possible its policy on the publication of clinical data for medicinal products for human use (‘Policy 0070’) which was suspended in December 2018 and has still not been reinstated today;
Amendment 6 #
2020/2157(DEC)
Draft opinion
Paragraph 10 c (new)
Paragraph 10 c (new)
10c. Notes with concern that the EMA still does not authorise requests for access to documents via email and regrets that long delays of more than a year are the norm in terms of answering those requests; calls on the EMA to publicly set, and comply with, clear timeframes for responding to such requests from now on;
Amendment 7 #
2020/2157(DEC)
Draft opinion
Paragraph 10 d (new)
Paragraph 10 d (new)
Amendment 4 #
2020/2071(INI)
Draft opinion
Recital A
Recital A
A. whereas the problem of medicine shortages in the Member States was highlighted during the COVID-19 crisis, demonstrating that the problem is getting ever more severe on account of the lack of production capacity in the EU and the relocation of our industries in the sector to other marketsduring epidemics considering our dependency on production in third countries;
Amendment 6 #
2020/2071(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas climate change is one of the factors behind the multiplication of epidemics, both in terms of geographic spread and severity, that are linked to globalisation and the intensification of travel, and whereas the destruction of biodiverse habitats and industrial farming creates favourable conditions for the spread of 'zoonoses' by allowing pathogens and animal origin to reach humans and spread rapidly;
Amendment 27 #
2020/2071(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Calls on the Member States to enhance their cooperation in orderat EU level, to put patient's interests at the heart of EU policies, including strong considerations of the security of supply and affordability, and to improve the medicine distribution chains through better visibility and efficient monitoring, particularly on cross- border routes, and to establish dedicated rail or low emission corridors where medical supplies but also raw materials, intermediates, APIs, substances of human origin like plasma, related materials and also packaging have priority of delivery;
Amendment 36 #
2020/2071(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. notes with concern that climate change being one of the factors behind the multiplication of epidemics, their number will grow in future; underlines that globalisation and the intensification of travel also results in the aggravation of epidemics and their geographical spread;
Amendment 37 #
2020/2071(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Notes that in times of epidemics, the few countries responsible for most of the production of active substances for medicines can become unable to meet demand; remarks that long supply chains for medicines can therefore pose a risk to human life;
Amendment 38 #
2020/2071(INI)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1 c. Notes that the security of supply is central to fight against medicine shortages and that problems with cross border transport and controls make it even more important to uphold the Schengen agreement;
Amendment 39 #
2020/2071(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. SCalls for the shortening of supply chains and relocation of European pharmaceutical companies production; stresses that boosting the industrial production ofin the Member States through favourable economic conditions in the context of national fiscal policies would lead to a more efficient and sustainable logistics networkUnion through proper regulation and part-mandatory production within the Union would lead to securing supplies; emphasises the need for more efficient and sustainable transport and logistics options and a shift to rail and more sustainable transport modes, while reducing the length of transport routes, thereby reducingat would lead to a reduction of emissions, mitigating the impact on the environment, and improving the functioning of the internal market;
Amendment 43 #
2020/2071(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Member StCommission to coordinates tohe adoption of strategic plans to upgrade theirMember States' existing infrastructure for an efficient supply of medicines; deems it necessary to remove bottlenecks, boost intermodality (while favouring the shift to rail), finance the main hubs (ports, airports andincluding intermodal platforms), and enhance thetake special account of delivery chains that rely on frequent and timely delivery of variobecause types of goods, including dangerous goods crucial forhe impossibility of stockpiling, for instance for radioisotopes; believes that the pintroduction of the chemical and pharmaceutical industryunconventional distribution and delivery plans should be considered, e.g. the combination of time-sensitive medicine deliveries via scheduled mixed traffic;
Amendment 51 #
2020/2071(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Highlights the importance of IT systems in facilitating the trackability, supervision and timely delivery of transported medicines as well as the exchange of information between the various actors involved in the transport logistics chain, including the customs authorities, with a view to optimising the distribution of medicines in the Member States and planning supply times more efficiently; in this regard, deems it important to ensure a better overview of transport and stockpiling of medicines in the Union; considers that the Commission should designate a European agency as responsible to ensuring the supply and smooth transportation of medicines in the Union;
Amendment 68 #
2020/2071(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Stresses the importance of catering to specific transport needs at local and regional levels, particularly in peripheral, rural, mountain and insular areas that are more difficult to access and involve higher delivery costs; notes that there are new automated delivery tools, such as via drones, available on the market that could help operators to access these areacould play a beneficial part in accessing these areas, institutions as well as patients;
Amendment 1 #
2020/2015(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the ambitions affirmed by the Commission in its communications of 19 February 20201 in the area of AI artificial intelligence (AI) and data; notes, however, that the issue of the protection of intellectual property rights in the context of the development of AI technologies has not been addressed by the Commission; _________________ 1(COM(2020)0064, COM(2020)0065, COM(2020)0066 and COM(2020)0067).
Amendment 6 #
2020/2015(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Highlights the fact that the development of AI technologies in the transport sector , while taking into account the impact on the natural environment and human health, has the potential to bring considerable economic, societal, environmental and safety benefitsadvantages, to the benefit of all citizens and society, by improving the quality of life, creating new employment opportunities and more sustainable business models and needs to be designed to be widely affordable;
Amendment 11 #
2020/2015(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Affirms that defining the appropriate legal framework for intellectual property rights for AI and connectivity innovations, as well as for access to and security of data will be key in the development and smooth, safe and wide dissemination of AI technologies in transport; highlights the need to ensure that EU rules on intellectual property do not hinder data accessibility, and thus the development of AI;
Amendment 18 #
2020/2015(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Considers that IP protection strategies will constantlywill evolve over time as AI evolves, and that it will be necessary to take account of issues such as flexibleadapt to this changing environment with copyright, patent protection or even trade secrets rules, and to take this into account to consider what route will provide innovators with the broadest and most robust means of IP protection, fostering creativity and innovation;
Amendment 24 #
2020/2015(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Notes that the current fragmented legal framework of IP rights and the legal uncertainty regarding them, represents an obstacle for the development of AI technologies in transport; calls on the Commission, therefore, to evaluate the fitness of its intellectual property regime for the development of AI technologies and to put forward the legislative proposals it finds necessary;
Amendment 27 #
2020/2015(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Notes that although AI makes it possible to process a large quantity of data relating to IPRs, it cannot be a substitute for human verification in relation to the granting of IPRs and the determination of liability for infringements of IPRs;
Amendment 28 #
2020/2015(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Notes, with regard to the use of data by AI, that the use of copyrighted data needs to be assessed in the light of the text and data mining exceptions provided for by the Directive on copyright and related rights in the Digital Single Market, and in the light of all uses covered by limitations and exceptions to IPR protection;
Amendment 30 #
2020/2015(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to evaluate the possibility and relevance for companies of obtaining patents based on software or algorithms with a view to ensuring both the protection of innovation and the need for transparency required for trustworthy AI;
Amendment 35 #
2020/2015(INI)
Draft opinion
Paragraph 8
Paragraph 8
8. Is fully aware that progress in AI will have to be paired with major improvements in connectivity and interoperability in order to come to full fruition; takes note of the intensive patenting activity taking place in the transport sector when it comes to AI; expresses its concern that this may result in massive litigation that will be detrimental to the industry as a wholeis concerned about the effects on the already high safety risks pertaining from mixed traffic (featuring both traditional and autonomous vehicles);
Amendment 37 #
2020/2015(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Points out that standard essential patents (SEPs) play a key role in the development and dissemination of new AI technologies and ensuring interoperability; calls on the Commission to encourage the emergence of cross-industry standards and formal standardisation; recalls in this regard the Commission’s communication of 29 November 2017 on SEP licensing and the key principles it set out for transparency in SEPs, namely fair, reasonable and non-discriminatory (FRAND) licensing and enforcement; draws particular attention to SEPs that can improve security, safety and accessibility for transport users;
Amendment 40 #
2020/2015(INI)
Draft opinion
Paragraph 10
Paragraph 10
10. Welcomes the Commission’s willingness to ensure that data will be collected and used and in full compliance with the EU’s strict data protection rules;
Amendment 47 #
2020/2015(INI)
Draft opinion
Paragraph 13
Paragraph 13
13. Welcomes the future establishment of an enabling and flexible legislative framework for the governance of common European data spaces, as well as the Commission’s willingness to foster business-to- government and business-to- business data sharing and to limit mandatory access to data under FRAND conditions to the cases where specific circumstances so dictate;
Amendment 4 #
2020/2014(INL)
Draft opinion
Recital B
Recital B
B. whereas AI in transport is driving the evolution of the next generation of IT systems and its application involves using many types of technologies such as autonomous vehicles and traffic management solutions, particular attention also needs to be paid to interoperability;
Amendment 25 #
2020/2014(INL)
Draft opinion
Paragraph 2
Paragraph 2
2. Underlines that automated functionalities can bring significant safety improvements in the medium and long term; notes that AI could also be used for planning and guiding logistics and block chains, and for increasing efficiency, resilience, reliability and flexibility;
Amendment 26 #
2020/2014(INL)
2 a. Underlines the risks pertaining from mixed traffic (featuring both traditional and autonomous vehicles) that has shown to bear the highest accident risk, thus calling for more research and development by both public and private means and more testing, to enhance product safety and as a result road safety, but not least to also provide concrete data helping further development and also to adapt civil liability rules;
Amendment 29 #
2020/2014(INL)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2 b. Underlines that a possible solution to address the existing gaps and shortcomings of rules could be the setting up of a framework for no-fault insurance for damage resulting from autonomous vehicles or the eventual reassessment of the Motor insurance Directive;
Amendment 30 #
2020/2014(INL)
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses the importance of defining a clear division of responsibilities between software developers, manufacturers of various components, service providers and operators and end users; , operators and end users in order to i.a. ensure best possible product safety, the appropriate allocation of risks, responsibility and liability relating also to operating software failures, network failures and risks and externalities relating to programming choices that are currently not adequately covered;
Amendment 40 #
2020/2014(INL)
Draft opinion
Paragraph 4
Paragraph 4
4. Underlines that for AI-related applications with a specific high-risk profile, there is a need for a risk-based approach depending on the levels of automation; risks relating to hacking and cybercrime need to be adequately addressed
Amendment 46 #
2020/2014(INL)
Draft opinion
Paragraph 6
Paragraph 6
6. Emphasises the need to guarantee at least the same level of product safety as that currently existing ones, also taking account of the EU vision zero target, to ease the remedy to victims of accidents, to avoid increasing current litigation costs; and to avoid legal uncertainty, especially for businesses that are marketing their products in the EU and globally; and in this respect insists that there should be no limitation of liability regarding the nature and extent of the damage to be compensated in order to guarantee adequate victim protection
Amendment 66 #
2020/2014(INL)
Draft opinion
Paragraph 12
Paragraph 12
12. ACalls on the Commission to explore the possibility of establishing a EU body, made up of the various member state regulators to ensure oversight on European level in order to recommend actions to the Commission when liability rules are unclear or need to be adjusted or when AI systems used in transport violate fundamental rights; also asks the Commission to present guidelines to avoid fragmented regulatory approaches at national level, taking into consideration the Product Liability Directive and national liability regimes.
Amendment 7 #
2020/2013(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Underlines that the EU should act as a global AI norm-setter in the areas of civil and military use and of state authority, with an effective strategy aimed at strengthening its influence on shaping global standards; calls on the Commission and the Member States to advocate for broader cooperation within the UN, OECD, G7, G20 and other international fora in order to promote the EU approach to AI, emphasising the fundamental rights, freedoms and values that are enshrined in the EU Treaties, the Charter of Fundamental Rights of the European Union and international human rights law and taking into account ethical standards and liability issues;
Amendment 11 #
2020/2013(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Believes that AI has changed and has helped the development of the transport sector through increasing automation and greater integration and connectivity of transport networks; underlines that automation and the integration of AI vary between transport modes; stresses that when further developing AI technologies in the transport sector, there is a need to increase energy efficiency by promoting the use of renewable technologies and to consider the impact on the natural environment and human health;
Amendment 29 #
2020/2013(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission and the Member States to participate in the international regulatory activities and discussions on autonomous vehicles, especially in the area of safety and liability, while ensuring cooperation among regulators and, vehicle manufacturers and road safety organisations relevant to the deployment of automated vehicles in road traffic in the EU; calls for standardised and interoperable geographic input data and stresses the need for accuracy of such data and a secure and anonymised transmission of the data in accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council; underlines the importance of an ethical and regulatory framework which needs to include provisions on the quality of data sets used in algorithmic systems, on the de-biasing of datasets, as well as on the algorithms themselves and on data and aggregation standards;
Amendment 42 #
2020/2013(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Stresses how intelligent transport systems can mitigate traffic congestion, increase safety and accessibility and contribute to improving efficiency and mobility solutions; draws attention to the increased exposure of traditional transport networks to cyber threats and underlines in that regard that the security risks of intelligent transport systems and autonomous vehicles need to be addressed;
Amendment 46 #
2020/2013(INI)
Draft opinion
Paragraph 10
Paragraph 10
10. Welcomes the efforts to introduce AI systems in the public sector and will support further discussions on AI deployment in transport; underlines that transport modes for which traffic control is already well established, such as public transport, should be prioritised when developing autonomous driving; calls on the Commission to carry out an evaluation of the transport sector and to compile a non- exhaustive list of high-risk segments in the context of AI systems replacing public decisions in this area;
Amendment 49 #
2020/2013(INI)
Draft opinion
Paragraph 11
Paragraph 11
11. Underlines that the European Defence Fund and Permanent Structured Cooperation should stimulate cooperation between Member States and European defence industries to develop new European defence capabilities in the field of AI and ensure security of supply, taking ethical considerations into accouse of AI for military purposes should not remove the responsibility and accountability from a human and in that sense is of the strong opinion that the decision to harm or kill a human being should only be made by a well-trained human operator; welcomes in this respect the agreement of Council and Parliament to exclude lethal autonomous weapons ‘without the possibility for meaningful human control over the selection and engagement decisions when carrying out strikes’ from actions funded under the European Defence Funtd; recalls, moreover, that the next Connecting Europe Facility, which also encourages smart infrastructure, will provide for a fund for the development of civilian/military dual-use transport infrastructure with a view to improving military mobility within the Union, stresses finally that the deployments of robots and AI should be in accordance with international humanitarian law and laws concerning armed conflicts.
Amendment 1 #
2020/2012(INL)
Draft opinion
Recital A
Recital A
A. whereas Artificial Intelligence (AI) is a strategic technology for the transport sector and is expectthat needs to benefit all citizens and society, by improving the quality of life, creating new employment opportunities and more sustainable business models and needs to be designed to be widely affordable;
Amendment 12 #
2020/2012(INL)
Draft opinion
Recital D a (new)
Recital D a (new)
D a. Whereas the importance of an ethical and regulatory framework is recognised as crucial, it also needs to include provisions on the quality of data sets used in algorithmic systems, on the de-biasing of data sets, as well as on the algorithms themselves, and on data and aggregation standards;
Amendment 28 #
2020/2012(INL)
Draft opinion
Paragraph 2 – introductory part
Paragraph 2 – introductory part
2. Stresses that the EU transport sector needs a clear framework for achieving trustworthy AI, including safety, security and liability aspects, which will be key to boosting investments in research and innovation, development of skills and the uptake of AI by public services, SMEs, start-ups and businesses and at the same time ensuring data protection as well as interoperability; and in this regard:
Amendment 34 #
2020/2012(INL)
Draft opinion
Paragraph 2 – point b a (new)
Paragraph 2 – point b a (new)
b a) calls on the Commission to establish a European market surveillance structure for algorithmic systems, including their associated data protection provisions, issuing guidance, opinions and expertise to Member States’ authorities, including on interoperability;
Amendment 39 #
2020/2012(INL)
Draft opinion
Paragraph 3
Paragraph 3
3. Considers the development of trustworthy, ethically responsible and technically robust AI an important enabler for sustainable, safe, accessible and smart mobility; in this regard, calls on the Commission to promotcontinue promoting the uptake of AI in the transport sector and to propose, if necessary in order to uphold EU fundamental rights,, to ensure that EU fundamental rights are upheld and to propose corresponding changes to EU legislation without delay and in close cooperation with all stakeholders in the transport sector;
Amendment 43 #
2020/2012(INL)
Draft opinion
Paragraph 4
Paragraph 4
4. Recommends the development of an EU-wide trustworthy AI labelstandards for the automotive industry, which should provide for common and harmonised standards on safety, interoperability, technical robustness - including concerns of resource efficient use, reparability and recyclability, privacy and transparency and for testing of AI-enabled vehicles and related products and services;
Amendment 49 #
2020/2012(INL)
Draft opinion
Paragraph 5
Paragraph 5
5. Calls on the Commission to explore the possibility of entrusting a relevant existing EU agency with enforcement and sanction mechanisms, so that actions can be takestablishing a EU body, made up of the various member state regulators to ensure oversight on European level in order to enable Commission to take action if an AI system used in transport violates fundamental rights or the European ethical and security framework;
Amendment 52 #
2020/2012(INL)
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to further support the development of trustworthy AI systems in order to render transport more efficient, accessible, affordable and inclusive, including for persons with reduced mobility and other disabilities, taking particular account of Directive (EU) 2019/882 on the accessibility requirements for products and services and of European legislation on passenger rights.
Amendment 113 #
2020/0321(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) The COVID-19 pandemic has highlighted risks to human health posed by over-exploitation of wildlife and other natural resources and accelerated loss of biodiversity. As health of humans, animals and the environment are inextricably linked and similar medicines and medical devices are used for humans and animals, it is crucial to take the ‘One Health’ approach to address current and emerging crises. This is paramount as the majority (72%) of emerging diseases of humans, including COVID-19, influenza and HIV/AIDS, are caused by zoonotic pathogens.
Amendment 121 #
2020/0321(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, insufficient mandates of its health agencies and also by the limited degree of Union and Member States preparedness in case of a public health emergency impacting a majority of Member States.
Amendment 134 #
2020/0321(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) Dealing with the issue of shortages of medicinal products has been a long- standing prioritybut unresolved problem for the Member States and European Parliament as illustrated by several reports from the European Parliament11 as well as discussions under recent Presidencies of the Council of the European Union. _________________ 11European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI))
Amendment 138 #
2020/0321(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The COVID-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic, and has highlighted the structural limitations in the Union’s and Member States' ability to rapidly and effectively react to such challenges during public health crises. Effective communication among Member States about both anticipated and actual shortages and available stocks is essential. To ensure such information exchange, the Single Point of Contact Network (SPOC) should become an established monitoring system.
Amendment 149 #
2020/0321(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators, surgical masks, and COVID-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices, led to a negative impact on supply. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of over-priced, non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency.
Amendment 155 #
2020/0321(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions amongst Member States and other national protective measures, which can seriously impact the functioning of the internal market. Furthermore, shortages of medicinal products can result in serious risks to the health of patients in the Union due to their lack of availability, which can cause fatalities, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits. It is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices.
Amendment 157 #
2020/0321(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Experience with clinical trials during the Covid-19 pandemic revealed a tremendous amount of duplication of investigations on the same interventions, many small trials, under-representation of important population subgroups, based on gender, age, ethnicity or medical comorbidities, and a lack of collaboration, posing a risk of research waste. To improve the clinical research agenda, international regulators pointed out the need for robust evidence on quality, efficacy and safety of medicinal products. The main way to obtain reliable evidence is through co-ordinated, well-designed, well-powered large randomised controlled trials. Clinical trial results and data should be made public.
Amendment 159 #
2020/0321(COD)
Proposal for a regulation
Recital 8 b (new)
Recital 8 b (new)
(8b) To accelerate, facilitate and coordinate the launch and development of clinical trials in Europe, the Agency should make full use of existing networks, including the Heads of Medicines Agencies (HMA), the Clinical Trials Facilitation and Coordination Group (CTFG), and the European Clinical Research Infrastructure Network (ECRIN).
Amendment 176 #
2020/0321(COD)
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) This Regulation establishes a framework to address the problem of shortages during public health emergencies and major events. However, shortages of medicinal products and medical devices are a persistent problem that has been increasingly affecting health and lives of EU citizens for decades. Therefore, this Regulation should be a first step towards improving the EU response to this long-lasting issue. The Commission should subsequently propose the expansion of this framework to ensure that the issue of shortages is broadly and permanently tackled in the upcoming revision of Regulation (EC) 726/2004 and Directive 2001/83/EC.
Amendment 183 #
2020/0321(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) A harmonised system of monitoring of shortages of medicinal products and medical devices should be established, which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events, which may have a serious impact on public health. That system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to addressmitigate public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices, the Agency should be able to ask and obtain information and data from the concerned marketing authorisation holders, manufacturers, wholesalers and Member States through designated points of contact. The Agency should also establish a system for the exchange of information on the availability of medicines and medical devices with healthcare professionals, in particular medical doctors and community and hospital pharmacists, consumers and patients facilitated through national medicines agencies.
Amendment 202 #
2020/0321(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The work of the Emergency Task Force should be separate from the work of the scientific committees of the Agency and should be carried out without prejudice to the scientific assessments of those committees. The Emergency Task Force should provide recommendations with regard to the use of medicinal products in the fight against the disease that is responsible forto overcome the public health crisis. The Committee for Medicinal Products for Human Use should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation.
Amendment 205 #
2020/0321(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Individual research entities may agree together, or with another party, to act as a sponsor in order to prepare one harmonised Union-wide clinical trial protocol, yet experience during the COVID-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the Union, while interacting with multiple Member States. It is therefore appropriate for the Agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, where applicable, to define respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) 536/2014 and coordinate the development of clinical trial protocols. The Emergency Task Force should define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials, so that they can meet the criteria for effective public health interventions. Such an approach would strengthen the research environment in the Union, and promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development, application, submission, and running of the trial. This may be particularly valuable for trials established by Union or international public health or research organisations.
Amendment 209 #
2020/0321(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Given the Agency’s long-standing and proven record of expertise in the field of medicinal products and considering the Agency’s experience from working with a multitude of groups of experts, it is appropriate to establish the appropriate structures within the Agency to monitor potential shortages of medical devices in the context of a public health emergency and to provide the Agency with a mandate to host the expert panels on medical devices. In this regard, all national and, eventually, Union entities engaged in stockpiling of medical devices, should report their stocks to the Agency. This would allow for long-term sustainability for the functioning of the panels and provide clear synergies with related crisis preparedness work for medicinal products. Those structures would in no way change the regulatory system or the decision- making procedures in the area of medical devices already in place in the Union, which should remain clearly distinct from the one for medicinal products.
Amendment 216 #
2020/0321(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) Due to the sensitive nature of health data, the Agency should safeguard and guarantee its processing operations respect the data protection principles of lawfulness, fairness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality. The Agency should strictly respect the principles of data protection as defined in Article 27 of Regulation (EU)2018/1725 EUDPR, while also determining appropriate technical and organisational security measures in accordance with Article 33 EUDPR.
Amendment 219 #
2020/0321(COD)
Proposal for a regulation
Recital 26 b (new)
Recital 26 b (new)
(26b) Where processing of personal data is not necessary to perform the activities of the Agency, measures should be put in place to ensure use of anonymous data in line with the principle of data minimisation. Where anonymisation would not allow to achieve the specific purpose of the processing, the data should be pseudonymised. Where it is necessary for the purposes of this Regulation to process personal data, this should be carried out in accordance with Union law on the protection of personal data. Any processing of personal data based on this Regulation shall take place in accordance with Regulation 2018/1725 (EUDPR).
Amendment 220 #
2020/0321(COD)
Proposal for a regulation
Recital 26 c (new)
Recital 26 c (new)
Amendment 221 #
2020/0321(COD)
Proposal for a regulation
Recital 26 d (new)
Recital 26 d (new)
(26d) Credibility of the Agency and public trust in its decisions relies on a high degree of transparency. Therefore, proactive engagement of adequate communication tools with the general public should be foreseen. In addition, strengthened and accelerated transparency standards and measures regarding the Agency’s working bodies and clinical data assessed for the evaluation and surveillance of medicinal products and medical devices are paramount to gain and upheld public trust. This Regulation establishes a framework for these strengthened transparency standards and measures, based on the EMA’s efforts, standards and measures put in place during the Covid-19 pandemic.
Amendment 253 #
2020/0321(COD)
(b) prevent, monitor and report on shortages of medicinal products for human use and medical devices;
Amendment 274 #
2020/0321(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet the anticipated demand for that medicinal product or medical device, no matter the cause;
Amendment 295 #
2020/0321(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
(fa) ‘demand’ relates to the request for a medicinal product or a medical device by a healthcare professional or patient in response to a clinical need. For demand to be satisfactorily met, the medical product will need to be acquired in time and sufficient quantity to allow continuity of best care of patients.
Amendment 298 #
2020/0321(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f b (new)
Article 2 – paragraph 1 – point f b (new)
(fb) ‘supply’ refers to the total volume of stock of an individual medicinal product or a medical device that is placed on the market by the Marketing Authorisation Holder or the producer, including situations in which a product is withdrawn from the market for commercial reasons.
Amendment 312 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission and, one senior representative per Member State, a representative of the Patients' and Consumers' Working Party (PCWP) and a representative of the Healthcare Professionals' Working Party (HCPWP). Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The list of members of the Steering Group shall be made public on the EMA web-portal.
Amendment 318 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2 a. Members of the Medicines Steering Group must have no financial or other interests that could affect their impartiality. They shall act in the public interest and in an independent manner and make an annual declaration of their financial interests. All indirect interests which could relate to the industry shall be entered in a register held by the Agency and be accessible to the public, upon request.
Amendment 322 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. The Chair mayAll members of the Medicines Steering Group may propose to the Chair to invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings, in particular healthcare professionals, patients, consumers and marketing authorisation holders to attend its meetings when their contribution may inform the discussions of the Steering Group.
Amendment 333 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. The Medicines Steering Group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. Agendas and minutes of the Steering Group as well as the rules of procedure and recommendations shall be made available to the public via the EMA web-portal.
Amendment 346 #
2020/0321(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall continuously monitor any event that is likelyhas the potential to lead to a major event or a public health emergency. In this regard, the Agency shall cooperate closely with the European Centre for Disease Prevention and Control (ECDC) and other Union agencies, where relevant.
Amendment 359 #
2020/0321(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. To facilitate the monitoring task referred to in paragraph 1, the national competent authorities, through the single points of contact referred to in Article 3(5), shall, based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), report to the Agency on any event, including a shortage of a medicinal product in a given Member State, that is likelyhas the potential to lead to a major event or a public health emergency. Where a national competent authority informs the Agency of a shortage of a medicinal product in a given Member State, it shall provide the Agency with any information received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC. Based on a report of an event from a national competent authority and in order to understand the impact of the event in other Member States, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(5).
Amendment 362 #
2020/0321(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Where the Agency considers that an actual or imminent major event needs to be addressed, it shall inform the Commission and the Member States thereof. The Commission, on its own initiative or following a request from one or more Member States, or the Executive Director of the Agency may shall then request the assistance of the Medicines Steering Group to address the major event.
Amendment 383 #
2020/0321(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Medicines Steering Group shall adopt a set of information necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof. Union or national entities that are engaged in stockpiling of medicinal products shall be informed accordingly.
Amendment 390 #
2020/0321(COD)
Proposal for a regulation
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
Amendment 407 #
2020/0321(COD)
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
The Single Point of Contact Network (SPOC) shall be extended to become a reliable monitoring system for shortages of medicines and other medical counter.
Amendment 408 #
2020/0321(COD)
Proposal for a regulation
Article 7 – paragraph 1 b (new)
Article 7 – paragraph 1 b (new)
As shortage of medicines outside of the critical lists established in a public health emergency or a major event are outside of the scope of this Regulation and yet pose a persistent challenge that has been increasingly affecting health and well- being of EU citizens for the past decades, this Regulation should be a first step towards improving the EU response to this long-lasting issue. The Commission shall subsequently propose the expansion of this framework to ensure that the issue of shortages is broadly and permanently tackled in the upcoming revision of Regulation (EC) 726/2004 and Directive 2001/83/EC.
Amendment 417 #
2020/0321(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Where requested by the Commission or the sub-network referred to in Article 9(2), the Medicines Steering Group shall provide aggregated data and forecasts of demand to substantiate its findings. In that regard, the Medicines Steering Group shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medicinal product needs, and with the Executive Steering Group on Shortages of Medical Devices referred to in Article 19 where medicinal products included on the critical medicines lists are administered with a medical device. It shall share its findings and conclusions with Union and national entities engaged with stockpiling of medicinal products and medical devices.
Amendment 421 #
2020/0321(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals, consumers and patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.
Amendment 428 #
2020/0321(COD)
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The Medicines Steering Group may, on its own initiative or upon request from the Commission, provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals, to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events.
Amendment 443 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) specify the procedures for establishing the critical medicines lists, , ensuring adequate consultation with healthcare professionals, consumers, patients a high level of transparency in decision-making;
Amendment 464 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point f a (new)
Article 9 – paragraph 1 – point f a (new)
(fa) publish information referred to in paragraph (1) (a), (b) and (f) on its web- portal.
Amendment 474 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point d
Article 9 – paragraph 3 – point d
(d) details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause as well as information on potential bottlenecks in the supply chain;
Amendment 475 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point d a (new)
Article 9 – paragraph 3 – point d a (new)
(da) information on active substance manufacturing sites, where relevant;
Amendment 479 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) prevention and mitigation plans including production and supply capacitybut not limited to information on production and supply capacity, production sites of finished pharmaceutical products and active pharmaceutical ingredients and raw materials, potential alternative production sites, minimum stock levels;[PA1] such plans shall contain preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains;
Amendment 496 #
2020/0321(COD)
Proposal for a regulation
Article 10 – title
Article 10 – title
Obligations on marketing authorisation holders and other actors in the supply chain
Amendment 505 #
2020/0321(COD)
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the Agency. Marketing authorisation holders failing to comply with their reporting obligations shall be subject to proportionate sanctions set by the Commission in a delegated act.
Amendment 516 #
2020/0321(COD)
Proposal for a regulation
Article 10 – paragraph 6 a (new)
Article 10 – paragraph 6 a (new)
6 a. In order to supplement the shortage prevention and mitigation plans of critical products, the Agency and national competent authorities may request additional information from wholesale distributors and other relevant actors regarding any logistical challenges incurred by the wholesale supply chain.
Amendment 519 #
2020/0321(COD)
Proposal for a regulation
Article 10 – paragraph 6 b (new)
Article 10 – paragraph 6 b (new)
6 b. The Commission shall exercise its power to lay down rules on sanctions for non-compliance with the obligations established under this Article in a delegated act.
Amendment 534 #
2020/0321(COD)
Proposal for a regulation
Article 11 – paragraph 4 a (new)
Article 11 – paragraph 4 a (new)
4 a. National medicines agencies in Member States shall facilitate patient and consumer reporting of medicine shortages through the provision of alternative reporting formats in addition to web- based formats. Aggregated data from these reports shall be shared by the sub- network of single points of contact from national competent authorities referred to in Article 3 (5) with the Medicines Steering Group to inform recommendations on medicine shortage impact and management.
Amendment 538 #
2020/0321(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals, to support them in their work and in the communication with patients;
Amendment 554 #
2020/0321(COD)
Proposal for a regulation
Article 13 – paragraph -1 (new)
Article 13 – paragraph -1 (new)
-1 The Agency shall establish an early warning system to inform relevant stakeholders, including doctors and community and hospital pharmacists of any supply problems and potential or actual shortages of medicines included on the critical medicines list.
Amendment 555 #
2020/0321(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform the public and interest groups in a timely manner with regard to the work of the Medicines Steering Group, and ensure adequate consultation with the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP). The list of the members of the Medicines Steering Group, the rules of procedure, agendas and minutes of the meetings and recommendations shall be published on the Agency’s web-portal.
Amendment 563 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened in preparation for and during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.
Amendment 567 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) reviewing clinical trial protocols and providing advice to developers on clinical trials to be conducted in the Union, in particular on large multi-centre trials, for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency, in accordance with Article 15;
Amendment 576 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The Emergency Task Force shall be composed of representatives of the scientific committees, working parties, namely representatives of the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party, and staff members of the Agency, the coordination group established in accordance with Article 27 of Directive 2001/83/EC, and the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) 536/2014.21 External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency. _________________ 21Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1
Amendment 580 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, independent clinical trials experts and researchers, and interest groups representing patients and healthcare professionals to attend its meetings.
Amendment 584 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The Emergency Task Force shall establish its rules of procedure including rules on the adoption of recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The rules of procedure including rules on the adoption of recommendations, as well as the opinions meeting minutes and agendas should be made public on the Agency web-portal.
Amendment 595 #
2020/0321(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. In preparation of the review, the Emergency Task Force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability. The Emergency Task Force shall liaise with medicine agencies of third countries for additional information and data exchange.
Amendment 604 #
2020/0321(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Emergency Task Force, and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party. The list of the members of the Emergency Task Force, the rules of procedure, agendas and minutes of the meetings and recommendations shall be published on the Agency’s web-portal.
Amendment 620 #
2020/0321(COD)
Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
Article 18 – paragraph 1 – point d a (new)
(da) take urgent and appropriate measures to ensure the protection of health data from attacks against information systems. These measures should be built on combination of regular penetration testing, decentralised solutions and security by design principles.
Amendment 631 #
2020/0321(COD)
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. The Medical Devices Steering Group shall be composed of a representative of the Agency, a representative of the Commission and, one senior representative per Member State, a representative of the Patients' and Consumers' Working Party (PCWP) and a representative of the Healthcare Professionals' Working Party (HCPWP). Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The list of members of the Steering Group shall be made public on the Agency web-portal.
Amendment 635 #
2020/0321(COD)
Proposal for a regulation
Article 19 – paragraph 2 a (new)
Article 19 – paragraph 2 a (new)
2 a. Members of the Medical Devices Steering Group must have no financial or other interests that could affect their impartiality. They shall act in the public interest and in an independent manner and make an annual declaration of their financial interests. All indirect interests which could relate to the industry shall be entered in a register held by the Agency and be accessible to the public, upon request.
Amendment 638 #
2020/0321(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair mayAll members of the Medicines Steering Group may propose to the Chair to invite third parties, including representatives of medical device interest groups to attend its meetings, in particular healthcare professionals, consumers and patients, to attend its meetings when their contribution may inform the discussions of the Steering Group.
Amendment 643 #
2020/0321(COD)
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. The Medical Devices Steering Group shall establish its rules of procedure including procedures relating to the working party referred to in paragraph 5, and on the adoption of lists, sets of information and recommendations. The rules of procedures shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. Agendas and minutes of the Steering Group as well as the rules of procedure and recommendations should be made available to the public via the Agency web-portal.
Amendment 655 #
2020/0321(COD)
Proposal for a regulation
Article 20 – paragraph 3 a (new)
Article 20 – paragraph 3 a (new)
3 a. The Agency shall report about the shortage of public health emergency critical devices through the database referred to in Article 6 (4a).
Amendment 668 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
(a) specify the procedures for establishing the public health emergency critical devices list, ensuring adequate consultation with healthcare professionals, consumers, patients and a high level of transparency indecision- making;
Amendment 675 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point d
Article 23 – paragraph 1 – point d
Amendment 676 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 2 – point a
Article 23 – paragraph 2 – point a
(a) establish and maintain for the duration of the public health emergency, a sub-network of single points of contact from medical device manufacturers and notified bodies based on the medical devices included on the public health emergency critical devices list based on single points of contact to be included for all medical device manufacturers in the database referred to in Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746;
Amendment 680 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) prevention and mitigation plans including production and supply capacity; such plans shall contain preventative measures that help ensure the continued supply of critical medical devices;
Amendment 691 #
2020/0321(COD)
Proposal for a regulation
Article 24 – paragraph 6 a (new)
Article 24 – paragraph 6 a (new)
6 a. The Commission shall exercise its power to lay down rules on sanctions for non-compliance with the obligations established under this Article in a delegated act.
Amendment 697 #
2020/0321(COD)
Proposal for a regulation
Article 25 – paragraph 4 – point a
Article 25 – paragraph 4 – point a
(a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, while at the same time ensuring both patient and product safety;
Amendment 705 #
2020/0321(COD)
Proposal for a regulation
Article 27 – paragraph -1 (new)
Article 27 – paragraph -1 (new)
-1 The Agency shall establish an early warning system to inform relevant stakeholders, including healthcare professionals of any supply problems and potential or actual shortages of medicinal products included on the critical products list.
Amendment 706 #
2020/0321(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Medical Devices Steering Group, and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party. The list of the members of the Medical Devices Steering Group, the rules of procedure, agendas and minutes of the meetings and recommendations shall be published on the Agency’s web-portal.
Amendment 711 #
2020/0321(COD)
Proposal for a regulation
Article 28 – paragraph 1 – introductory part
Article 28 – paragraph 1 – introductory part
The Agency shall, on behalf of the Commission, from 1 March 2022 onwards, provide the secretariat of the expert panels designated in accordance with Implementing Decision (EU) 2019/1396 and provide the support necessary to ensure that those panels can efficiently perform their tasks as set out in Article 106(9) and (10) of Regulation (EU) 2017/745. The Agency shall:
Amendment 713 #
2020/0321(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point a
Article 28 – paragraph 1 – point a
(a) provide administrative, scientific and technical support to the expert panels for the provision of scientific opinions, views and advice;
Amendment 717 #
2020/0321(COD)
Proposal for a regulation
Article 29 a (new)
Article 29 a (new)
Article 29 a Transparency and publication of clinical data 1. For the duration of a public health emergency, the sponsors of clinical trials related to products linked to the disease in question, shall: (a) publish the study protocol at the start of the trial through the EU clinical trials register; (b) publish the summary of the results through the EU clinical trials register within two months after marketing authorisation. 2. The Agency shall implement exceptional measures with regard to medicinal products, including vaccines, and medical devices falling under the scope of this Regulation, strengthening transparency measures and speeding up standard publication timelines and providing more information. These measures include: (a) Publication of the product information with details of the conditions of use at the time of marketing authorisation; (b) Expedited publication of the full European Public Assessment Reports (EPAR), within 7days after marketing authorisation. The EPARs should include a description of received scientific advice; (c) Expedited publication, within a period of 2 months after marketing authorisation, of clinical data submitted to the Agency in support of the applications for medicines, after personal data have been anonymised and any commercially confidential information redacted. Access shall be provided to all independent individual participant level data along with protocols and analytic codes; (d) Publication of the full risk management plan for authorised medicines; (e) Publication of news announcements within 1 day of the start of initial rolling reviews or the evaluation of new evidence or applications for extension of indication. 3. The Agency shall make agendas and minutes of all meetings public, as well as the recommendations, opinions and decisions from the Steering Groups and the Emergency Task Force on its web- portal. 4. The membership of the Emergency Task Force, Steering Groups and Working Parties shall be made public. Members of the Emergency Task Force, Steering Groups and experts shall not have financial or other interests in the pharmaceutical or medical device industry which could affect their impartiality. They shall act in the public interest in an independent manner and shall make an annual declaration of their financial interests. All indirect interests which could relate to the industry shall be entered in a register held by the Agency, which is accessible to the public, upon request. Members of the Emergency Task Force, Steering Groups and Working Parties, and experts who participate in meetings or working groups of the Agency shall declare, at each meeting, any specific interests which could be considered to be prejudicial to their independence with respect to the items on the agenda. These declarations shall be made available to the public.
Amendment 719 #
Amendment 720 #
2020/0321(COD)
Proposal for a regulation
Article 30 – paragraph 1 – introductory part
Article 30 – paragraph 1 – introductory part
1. Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/200124 and on the legal protection of persons who report breaches of Union law, and existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: _________________ 24Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.05.2001, p. 43
Amendment 722 #
2020/0321(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) personal data in accordance with Article 32the definitions contained in Article 4(1) of Regulation (EU) 2016/679 (GDPR) and Article3(1) of Regulation (EU) 2018/1725 (EUDPR);
Amendment 724 #
2020/0321(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point b
Article 30 – paragraph 1 – point b
(b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights accordance with Directive 2016/943 and without prejudice to Directive 2019/1937, as well as intellectual property rights, unless there is an overriding public interest in disclosure;
Amendment 728 #
2020/0321(COD)
Proposal for a regulation
Article 30 – paragraph 5
Article 30 – paragraph 5
5. The Commission, the Agency, and Member States may, in compliance with Chapter V of the EUDPR, exchange commercially confidential information and, where necessary to protect public health, personal data, with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Amendment 730 #
2020/0321(COD)
Proposal for a regulation
Article 30 – paragraph 5 a (new)
Article 30 – paragraph 5 a (new)
5 a. All parties involved in the application of this Regulation shall ensure that the concept of commercially confidential information is interpreted narrowly, and information of public interest is, to the extent possible, proactively disclosed.
Amendment 733 #
2020/0321(COD)
Proposal for a regulation
Article 30 – paragraph 5 b (new)
Article 30 – paragraph 5 b (new)
5 b. This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Regulation (EU) No 2016/679 and Directive 2002/58/EC on privacy and electronic communications, or the obligations of the Agency and the Commission relating to their processing of personal data under Regulation (EU) No 2018/1725, when fulfilling their responsibilities.
Amendment 735 #
Amendment 737 #
2020/0321(COD)
Proposal for a regulation
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
Chapters I, II and III shall apply from [date of entry into force]. Chapter IV shall apply from [date of entry into force + 3 months].
Amendment 70 #
2020/0262(COD)
Proposal for a directive
Article 1 – point -1 f (new)
Article 1 – point -1 f (new)
Directive 2004/37/EC
Article 3 – paragraph 2 – subparagraph 1
Article 3 – paragraph 2 – subparagraph 1
(-1f) In Article 3(2), the first subparagraph is replaced by the following: "In the case of any activity likely to involve a risk of exposure to carcinogens or mutagens, or reprotoxic substances; the nature, degree and duration of workers' exposure shall be determined by way of a systematic risk assessment, in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken. The assessment shall be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to carcinogens or mutagen, mutagens or reprotoxic substances. The employer shall supply the authorities responsible at their request with the information used for making the assessment. " Or. en (02004L0037)
Amendment 83 #
2020/0262(COD)
Proposal for a directive
Article 1 – point -1 s (new)
Article 1 – point -1 s (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point i a (new)
Article 5 – paragraph 5 – point i a (new)
(-1s) In Article 5(5), the following point is inserted: "(ia) ensure that personal protective equipment is provided;"
Amendment 85 #
2020/0262(COD)
Proposal for a directive
Article 1 – point -1 u (new)
Article 1 – point -1 u (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point m a (new)
Article 5 – paragraph 5 – point m a (new)
(-1u) In Article 5(5), the following point is added: "(ma) in accordance with Directive 92/85/EC, take the necessary measures to ensure that pregnant workers, workers who have recently given birth and workers who are breastfeeding are duly protected and are in no circumstances required to carry out activities which could jeopardise their safety or health."
Amendment 91 #
2020/0262(COD)
Proposal for a directive
Article 1 – point -1 aa (new)
Article 1 – point -1 aa (new)
Directive 2004/37/EC
Article 11 – paragraph 1 – subparagraph 2 – indents 1 and 2
Article 11 – paragraph 1 – subparagraph 2 – indents 1 and 2
Amendment 57 #
2020/0104(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14 a) The third sector employs nearly 13% of the European workforce (with over 23 million full-time equivalent workers), and generates a set of distinctive socio-economic impacts on society. As such, third sector organisations represent a unique resource for social and economic problem-solving and civic engagement in Europe. At the time of social and economic distress and enormous pressures on governmental budgets, this resource is needed more than ever. The Facility should therefore be used to provide financial support to third sector organisations in an effort to help mitigate the societal impact caused by the present COVID-19 crisis.
Amendment 122 #
2020/0104(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
The scope of application of the Recovery and Resilience Facility established by this Regulation shall refer to policy areas related to economic, social and territorial cohesion, the green and digital transitions, health, competitiveness, resilience, productivity, education and skills, research and innovation, smart, sustainable and inclusive growth, jobs and investment, including support for the third sector, and the stability of the financial systems.
Amendment 554 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 a (new)
Article 4 – paragraph 1 – point 5 a (new)
(5a) Support actions to ensure the collection of safe blood, and blood components that facilitate a wide range of essential, often live-saving treatments; support actions to raise awareness on the importance of non-remunerated blood donation to this end,
Amendment 780 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point viii
Annex I – point f – point viii
(viii) Actions to support investigation, risk assessment and risk management work on the link between animal health, wildlife trade, environmental factors, and human diseases, including during health crises, also through the development of ambitious EU coordinated actions to improve animal welfare.
Amendment 781 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point viii
Annex I – point f – point viii
(viii) Actions to support investigation, risk assessment and risk management work on the link between animal health, animal welfare, wildlife trade, pet trade, intensive farming, environmental factors, and human diseases, including during health crises.
Amendment 79 #
2020/0036(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) A fixed long-term objective is crucial to contribute to economic and societal transformation, jobs, de-growth, and the achievement of the United Nations Sustainable Development Goals, as well as to movereach in a fair and cost-effective manner towards the temperature goal of the 2015 Paris Agreement on climate change following the 21st Conference of the Parties to the United Nations Framework Convention on Climate Change (the ‘Paris Agreement’).
Amendment 83 #
2020/0036(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The Union’s and the Member States’ climate action aims to protect people and the planet, welfare, prosperity, health, food systems, the integrity of eco- systems and biodiversity against the threat of climate change, in the context of the 2030 agenda for sustainable development and in pursuit of the objectives of the Paris Agreement, and to maximize prosperity within the planetary boundaries and, to increase resilience and regeneration of ecosystems and to reduce vulnerability of society to climate change.
Amendment 102 #
2020/0036(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The Union is a global leader in the transition towards climate neutrality, and is determined to help raise global ambition and to strengthen the global response to climate change, using all tools at its disposal, including climate diplomacy. Considering international solidarity and the historical emissions of European countries, the Union has a particular responsibility to urgently reduce its emissions and a responsibility for loss and damage caused by climate change impacts.
Amendment 117 #
2020/0036(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The Union should aimgive priority to the reduction of anthropogenic emissions while aiming to achieve a balance between anthropogenic economy- wide emissions and removals, through natural and technological solutions, of greenhouse gases domestically within the Union and at individual Member State level by 20540. The Union-wide 20540 climate-neutrality objective should be pursued by all Member States collectively, and the Member States, the European Parliament, the Council and the Commission should take the necessary measures to enable its achievement. Measures at Union level wiland Member State level constitute anequally important parts of the measures needed to achieve the objective.
Amendment 132 #
2020/0036(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Adaptation is a key component of the long-term global response to climate change. Therefore, Member States and the Union should enhance their adaptive capacity, strengthen resilience and regeneration of ecosystems and reduce vulnerability to climate change, as provided for in Article 7 of the Paris Agreement, as well as maximise the co- benefits with other environmental policies and legislation. Member States should adopt comprehensive national adaptation strategies and plans.
Amendment 136 #
2020/0036(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) In taking the relevant measures at Union and national level to achieve the climate-neutrality objective, Member States and the European Parliament, the Council and the Commission should take into account the contribution of the transition to climate neutrality to the well- being of citizens, the prosperity of society and the competitivenesslong-term sustainability of the economy; energy and, food security, food sovereignty and affordability; fairness and solidarity across and within Member States considering their economic capability, national circumstances and the need for convergence over time; the need to make the transition just and socially fair; best available scientific evidence, in particular the findings reported by the IPCC, IPBES and the EPCC; the need to integrate climate change related risks into investment and planning decisions; cost- effectiveness and technological neutrality in achieving greenhouse gas emissions reductions and removals and increasing resilience; progression over time in environmental integrity and level of ambition.
Amendment 160 #
2020/0036(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) To ensure the Union and the Member States remain on track to achieve the climate-neutrality objective and progress on adaptation, the Commission should regularly assess progress. Should the collective progress made by Member States towards the achievement of the climate-neutrality objective or on adaptation be insufficient or Union measures inconsistent with the climate- neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience and regeneration of ecosystems or reduce vulnerability, the Commission should take the necessary measures in accordance with the Treaties. The Commission should also regularly assess relevant national measures, and issue recommendations where it finds that a Member State’s measures are inconsistent with the climate-neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience and regeneration of ecosystems and reduce vulnerability to climate change.
Amendment 192 #
2020/0036(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23 a) Due to the particularly high amount of greenhouse gas emissions emitted by airplanes, cruise ships and fossil fuel cars, a warning message covering 20 % of the advertisements for these transport modes should be included in the advertisements, as misleading and aggressive advertisements are prohibited by Directive 2005/29/EC on unfair commercial practices.
Amendment 299 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point b
Article 3 – paragraph 3 – point b
(b) competiveness and the long-term sustainability of the Union’s economy;
Amendment 873 #
2020/0036(COD)
Proposal for a regulation
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
4a. In order to ensure continuous progress towards the achievement of climate neutrality set out in articles 1and 2, the Commission and the Member States shall fully take into account the obligations set out in the Article 3(b) of Directive 2011/92/EU on the assessment of the effects of certain public and private projects on the environment and in Article 3, paragraph 1 and Article 4 of Directive 2001/42/EC on the assessment of the effects of certain plans and programmes on the environment as with a view to address the greenhouse gas emissions of public and private projects during their whole life cycle, such as those occurring in the construction and operational phase and including indirect emissions in a project’s value chain. In addition, any energy and transport infrastructure projects must, upon independent assessment, be deemed consistent with the 2030, 2050 and possibly 2040 climate objectives and coherent with the Union objective of building a fully renewables- based, highly resource and energy- efficient, climate-neutral and circular economy.
Amendment 6 #
2019/2186(INI)
Draft opinion
Recital A
Recital A
A. whereas the platform economy has become an integral and rapidly growing part of the European transport sector posing both challenges and opportunities for the sector;
Amendment 24 #
2019/2186(INI)
Draft opinion
Recital B
Recital B
B. whereas precarious self- employment in the platform sector is increasing, particularly for low-skilled platform-determined on-location work1 , including driving and delivery and whereas there is no EU framework that regulates the working conditions, rights and access to social protection of platform workers; _________________ 1Eurofound (2018), Employment and working conditions of selected types of platform work, Publications Office of the European Union, Luxembourg.
Amendment 34 #
2019/2186(INI)
Draft opinion
Recital B a (new)
Recital B a (new)
B a. whereas most platforms are active in different EU countries and are often not based in the country where the activities performed by their workers take place;
Amendment 39 #
2019/2186(INI)
Draft opinion
Recital B b (new)
Recital B b (new)
B b. whereas the European Court of Justice has ruled in case C-434/15 that Uber is not merely an information society service, but a transportation service and thus has to comply with the EU transport acquis;
Amendment 42 #
2019/2186(INI)
Draft opinion
Recital B c (new)
Recital B c (new)
B c. whereas four drivers have filed a case against Uber in the Amsterdam District Court for having been automatically fired by the algorithm without human oversight, claiming they were wrongly accused of fraudulent activity and that the company has not shared any of its evidence against them to justify dismissing them from the platform;
Amendment 46 #
2019/2186(INI)
Draft opinion
Recital B d (new)
Recital B d (new)
B d. whereas algorithmic management can create power imbalances and obscurity about decision-making and must be fully transparent in order for workers to effectively challenge these decisions and ascertain their rights;
Amendment 48 #
2019/2186(INI)
B e. whereas the workers have the right not to be subject to a decision based solely on automated processing enshrined in Article 22(1) of Regulation (EU) 2016/679(GDPR), which means there must be human oversight;
Amendment 50 #
2019/2186(INI)
Draft opinion
Recital B f (new)
Recital B f (new)
Amendment 51 #
2019/2186(INI)
Draft opinion
Recital B g (new)
Recital B g (new)
B g. whereas platform workers in the transport and tourism sector are exposed to particular health and safety risks due to the characteristics of work they are performing and have an increased risk of contracting Covid-19 or other transmittable diseases and therefore need to be equipped with adequate protective equipment and guaranteed accident insurances, technical checks and repairs of their vehicles;
Amendment 52 #
2019/2186(INI)
Draft opinion
Recital B h (new)
Recital B h (new)
B h. whereas cyclists, that are widely used for food or high-speed urban deliveries, need particular protection as vulnerable road users that are often employed in unfavourable and difficult weather conditions and therefore should be equipped with protective equipment and accident insurances;
Amendment 53 #
2019/2186(INI)
Draft opinion
Recital B i (new)
Recital B i (new)
B i. whereas several studies1a show that transportation network companies adds to an increase in road traffic, congestion and emission levels and reduce the use of public transport and active mobility in cities where they are operating, thereby causing an increase in air pollution and CO2 emissions; _________________ 1a https://www.transportenvironment.org/ne ws/uber-and-lyft-increase-pollution-and- undermine-public-transport-study-shows
Amendment 54 #
2019/2186(INI)
Draft opinion
Recital B j (new)
Recital B j (new)
B j. whereas platform companies lack legal requirements to address environmental and health concerns, nor requirements to avoid empty runs and maximise mobility efficiency;
Amendment 56 #
2019/2186(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses that the unfair competitive advantages of the platform economy over the traditional economy, based on social dumping and tax avoidance and evasion, are unacceptable and the unclear interface between business and private equipment ownership, are unacceptable; underlines that labour-intensive platforms exerting the prerogatives of employers should abide to all the legal obligations that this entails in terms of payment of income tax, financing of social protection and insurances, responsibility for health and safety, due diligence and corporate social responsibility;
Amendment 64 #
2019/2186(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to come up with a strategypropose a directive on decent working conditions and rights in the digital economy, covering all workers, including non-standard workers on atypical contracts, workers in platform companies and the self-employed to align the working conditions of platformthose workers with those of regular employees, with full respect for the diversity of national labour market models and the autonomy of social partners; underlines that platform workers should have the right to social protection, including protection for unemployment and sickness, annual leave and special leave; furthermore, stresses that the platforms should be responsible for providing the workers with adequate protective equipment, accident insurances and technical checks and repairs of the vehicles;
Amendment 84 #
2019/2186(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Member States to consider the need for national definitions of self-employed workers, withCommission to propose a European definition of a worker, with consideration to the criteria established by the Court of Justice of the European Union that has ruled that “worker” means “a natural person who for a certain period of time performs services for and under the direction of another person in return for remuneration” and to put in place a rebuttable legal presumption that places the burden of proof on platforms to prove that their workers are not in fact employees;
Amendment 99 #
2019/2186(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Calls on the Commission to support Member States in finding policyUnderlines that the solutions to determine the status of work for platform workers; remains sceptical of the is not an addition of a third category;
Amendment 105 #
2019/2186(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Emphasises the need for transparency and non-discrimination in transport and tourism platforms, specifically regarding algorithms that affect service, allocation of tasks, pricing, and advertisingthe percentage of the fare kept by the platform, rating and rewarding systems, and advertising; underlines the need for protection for platform workers against pre-existing societal biases embedded in algorithms, for example based on gender, religion or ethnicity; furthermore, stresses that platform workers should have the right of co-determination regarding the algorithms; calls on the Commission to ensure mandatory human oversight for managerial decisions, such as hiring and or firing employees and appraisals, underlining that the workers must have the right to appeal these decisions;
Amendment 112 #
2019/2186(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the Commission and Member States to ensure appropriate protection of workers’ rights and well- being, such as non-discrimination, privacy, human dignity and protection against exploitation by platforms using AI in the workplace; stresses that algorithmic management and performance monitoring of work activities can put excessive pressure on workers with implications for both their own health and safety and the safety of those in contact with them - i.a. in road traffic;
Amendment 117 #
2019/2186(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Emphasises the importance to workers of the right to portability of data between platforms, including their consumer-sourced ratings;
Amendment 124 #
2019/2186(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. WelcomesCalls on the Commission’s intention to modify EU competo take initiation rulves to ensure that platform workers andhave the bogus self-employedright to get organised, to be represented by trade unions and to gain access to real collective bargaining;
Amendment 134 #
2019/2186(INI)
Draft opinion
Paragraph 8
Paragraph 8
8. Encourages platform companies to develop training and professional development pathways in order to broaden their workers’ professional options.;
Amendment 138 #
2019/2186(INI)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Calls on the Commission and the Member States to monitor the impact transportation network companies have on traffic congestion, CO2 emissions, air pollution and public health and to propose if necessary, after an impact assessment, additional measures to achieve the objectives enshrined in the Green Deal;
Amendment 1 #
2019/2078(DEC)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Notes with concern that the Authority, as one of the Union regulatory agencies responsible for risk assessment of regulated products, does not receive sufficient resources to carry out effectively its responsibilities; insists that the Authority is granted sufficient resources to carry out its tasks;
Amendment 5 #
2019/2078(DEC)
Draft opinion
Paragraph 7
Paragraph 7
7. Welcomes that, following adoption of its new policy on independence in 2017, the Authority has in 2018 for the first time included a new annex to its consolidated annual report, dedicated to implementation of the Authority’s policy on independence; notes with satisfaction that the two-year cooling off periods requested by the European Parliament was enforced for the first time during the 2018 scientific panel selection process;
Amendment 6 #
2019/2078(DEC)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Regrets that, in relation to the two- year cooling-off period, the 2017 independence policy includes the obligation to screen experts' interests only in relation to the mandate of the scientific group to which the expert is applying; calls for the policy to be updated without delay in order to ensure that experts' interests are viewed within the context of the overall remit of the Authority, as repeatedly called for by Parliament;
Amendment 7 #
2019/2078(DEC)
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Regrets that the research funding from companies in the Authority's remit is not considered relevant to the cooling-off period as long as amounts at stake do not rise above 25 % of the total research budget managed by the expert and/or their research team, and that the threshold is applied to individual sources as opposed to all private sources combined; calls for the funding threshold to be removed from the Authority's independence policy, in line with Parliament's repeated requests on the matter;
Amendment 8 #
2019/2078(DEC)
Draft opinion
Paragraph 7 c (new)
Paragraph 7 c (new)
7 c. Recalls that the Authority already has the possibility to organise expert hearings to which they can invite any expert, regardless of any conflict of interest, to answer questions posed by a scientific panel without the expert having the right to participate in the panel's deliberations and drafting of the opinion;
Amendment 9 #
2019/2078(DEC)
Draft opinion
Paragraph 7 d (new)
Paragraph 7 d (new)
7 d. Recalls that the revised Regulation (EC) No 178/20021a will require the Authority to pro-actively make regulatory data, that has been submitted by applicants, available to be downloaded, printed and searched through in an electronic format; whereas this will allow the Authority to benefit from extended peer review of the scientific community; recalls that this transparency requirement is indispensable for industry-sponsored research but it cannot be used as an argument to refuse academic data using data kept confidential for legitimate reasons, such as patients' personal medical records; _________________ 1aRegulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002, p. 1).
Amendment 135 #
2018/2110(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Calls on the Parliament to set up a Committee of Inquiry to investigate alleged contraventions and maladministration in the application of Union law in relation to animal welfare during transport within and outside the EU, given the numerous and systematic violations of the Regulation 1/2005 by Member States, and considering the insufficient resources that the Commission invests in undertaking official audits on animal welfare during transport.
Amendment 262 #
2018/2110(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Calls to limit journeys of unweaned animals to both a maximum distance of 50km and a maximum duration of 1.5 hours, given the difficulty of ensuring their welfare during transport;
Amendment 268 #
2018/2110(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls for the reduction of animal journey times, in particular long and very long journey times, by employing alternative strategies, such as economically viable local slaughter facilities, replacing the transport of breeding animals by using semen or embryos, and transportation of carcasses and meat products, as well as by means of legislative initiatives in Member States to facilitate on-farm slaughter, whilst ensuring the highest possible animal welfare standards;
Amendment 359 #
2018/2110(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls for the upcoming CAP reform to maintain and reinforce the link between increased CAP payments and improved animal welfare conditions which fully respect or go beyond the standards set out in Regulation 1/2005; Calls for coupled support likewise to be conditional upon improved animal welfare standards, to be assured by the Commission within their assessment of the CAP Strategic Plans
Amendment 380 #
2018/2110(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Considers that export-oriented agricultural policy gives rise to unnecessary suffering in live animal transport; Considers that both animal welfare and rural economies are better served by shorter supply chains focused on more local or regional consumption and breeding.
Amendment 382 #
2018/2110(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23b. Calls for the prohibition of live animal exports to third countries, with limited exceptions for breeding purposes, provided that the breeds are suited to the relevant climatic and environmental context.
Amendment 28 #
2018/2108(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
E a. whereas EU citizens have the right to access specialised care in their own Member State, where it is available;
Amendment 40 #
2018/2108(INI)
Motion for a resolution
Recital H
Recital H
H. whereas patient mobility in the EU remains relatively low under the scope of the Directive and has not had a significant budgetary impact on the sustainability of the national health systems;
Amendment 59 #
2018/2108(INI)
Motion for a resolution
Recital M
Recital M
M. whereas the directivcross-border healthcare will only be effective if patients, healthcare professionals and other stakeholders are well informed about it;
Amendment 68 #
2018/2108(INI)
Motion for a resolution
Recital Q a (new)
Recital Q a (new)
Q a. whereas authorisation systems are intended to allow for Member State planning and protect patients from treatments raising serious and specific concerns relating to the quality or safety of the care;
Amendment 75 #
2018/2108(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Invites the Commission to establish guidelines for implementation, especially where Regulation 883/2004 on the coordination of social security systems and the Directive 2011/24/EU on the application of patient's rights in cross- border healthcare interact, and to ensure better coordination amongst all relevant stakeholders within the institutions;
Amendment 155 #
2018/2108(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Encourages the Commission to guarantee access to information, medicines and medical treatment for rare disease patients throughtout the EU, to promote better coordination and learning across Member States and to strive for an improved access to early and accurate diagnosis;
Amendment 159 #
2018/2108(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Urges the Commission to implement an action plan for the further development and sustainable financing of the ERNs and patient's networks supporting them, via the European Joint Programme on Rare Diseases;
Amendment 167 #
2018/2108(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Acknowledges that eHealth can help to ensure that health systems are sustainable and can be an important part of the EU’s response to the healthcare challenges of today; supports healthcare information exchange amongst Member States through inclusive digitalisation, whilst guaranteeing patients privacy; considers that special attention should be paid to allowing easy access to care for all patients; believes that exclusion through digitalisation shall by all means be avoided;
Amendment 175 #
2018/2108(INI)
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29 a. Encourages the Commission to support the set-up of specialised centres for rare diseases in the EU, fully integrated in the ERNs;
Amendment 176 #
2018/2108(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. UrgInvites the Member States to take swift action to connect their health systems to the eHDSI through a dedicated NCP for eHealth following their own risk assessment, and asks the Commission to facilitate this process;
Amendment 11 #
2018/2090(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Welcomes the Commission communication of 17 January 2018 on the Digital Education Action Plan (COM(2018)0022) and recalls the importance of completing the digital single market; points out that digitalisation has a twofold impact on education systems: firstly, citizens should be prepared for lifelong learning in a world that is becoming increasingly digitalised, and secondly, digital transformation should also be applied to education systems themselves, following a differentiated and tailor-made approach adapted to the age, characteristics and needs of the targeted audience while preserving the human dimension necessary to achieve an efficient and healthy learning process and personal development;
Amendment 20 #
2018/2090(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Underlines that the transformations brought by the digitalisation of industry and of many of the activities undergone in the society need to be accompanied by educational and cultural support for the workforce, enabling them to transition to new positions or find new roles in the society.
Amendment 27 #
2018/2090(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Underlines that sufficient infrastructure offering high-quality and accessible connectivity is of great importance and its rollout should be accompanied by proper training ensuring healthy and efficient usage ; highlights the need to close the digital divide by creating an investment- friendly environment and fostering digital infrastructure such as high-capacity broadband networks;
Amendment 31 #
2018/2090(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Recalls that the digital divide is created by lack of network access but also by uneven speeds between regions and lack of knowledge about the way the network can be used to improve citizens’ life. Calls for a comprehensive approach to increase coverage, achieve similar levels of connectivity and equal knowledge for all.
Amendment 53 #
2018/2090(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Underlines that digital competencies are more than design and management of networks, software and ICT equipment, but also the possibility to interact with administrations and participate in the political life, exercise of the freedom of speech and other fundamental rights. Calls for measure meant to empower the citizens to properly function in a connected world and avoid pitfalls like fake news and online disinformation.
Amendment 59 #
2018/2090(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Stresses that the advance in technology also brings the need for societal evolution and all citizens, especially the young digital natives, need to have in their learning curricula privacy, security and basic safeguards that will empower them and protect from malicious activity.
Amendment 61 #
2018/2090(INI)
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Stresses that digital transformation in the education sector should contribute to gender equality, empowering equally girls and boys, women and men, to feel secure to use new technologies, and engage into ICT studies.
Amendment 53 #
2018/0231(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The internal market is a cornerstone of the Union. Since its inception, it has proved a major contributor to growtheconomic development, prosperity, competitiveness and employment. It has generated new opportunities and economies of scale for European businesses, notably micro, small and medium sized enterprises (SMEs), and strengthened their industrial competitiveness. The internal market contributed to the creation of jobs and offered greater choice at lower prices for consumersdiversification for consumers in terms of products and services offered. It continues to be an engine for building a sustainable, stronger, more balanced and transparent, inclusive and fairer economy. It is one of the Union’s major achievements and its best asset in an increasingly global world and a core element in succeeding in the transformation into a net-zero carbon emission, resource- and energy efficient sustainable economy.
Amendment 58 #
2018/0231(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The internal market has to continuously adapt to a rapidly changing environment of digital revolution and, globalisation and the increasing pressures of climate change. A new era of digital and eco-innovation and new collaborative business models continues to provide opportunities for businesses and individuals, creates new productsustainable, more resource and energy efficient products, services and business models but equally constitutes a challenge to regulation and enforcement.
Amendment 60 #
2018/0231(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The substantial body of Union legislation underpins the functioning of the internal market. This concerns, in particular, competitiveness, standardisation, consumer protecand environmental protection, energy transition, market surveillance and food chain regulation but also rules concerning business, trade and financial transactions and the promotion of fair competition providing for a level playing field including social and environmental factors essential for the functioning of the internal market.
Amendment 61 #
2018/0231(COD)
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) Subsequent to the Paris Agreement, EU climate-related spending under the MFF should be significantly increased in comparison with the current MFF and reach at least 30 %. Measures covered by this Regulation should contribute to achieving a net-zero GHG- emission economy and society by 2050 at the latest. It is important to ensure that climate change mitigation and adaptation as well as risk prevention is integrated ex- ante in the preparation, design and implementation of the Single Market Programme rather than simply reported ex-post.
Amendment 65 #
2018/0231(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) Several programmes for Union action exist currently in the fields of competitiveness and sustainability of enterprises including SMEs, consumer protection, customers and end-users in financial services, policy making in financial services and food chain. Some additional activities are financed directly under the internal market budget lines. It is necessary to streamline and exploit synergies between various actions and provide for a more flexible and agile framework to finance activities aiming to achieve a well-functioning internal market in the most cost-efficient mannerand sustainable internal market that in is efficient, affordable, and consumer friendly and takes into consideration environmental, social and governance factors. It is therefore necessary to establish a new programme bringing together activities financed previously under those other programmes and other relevant budget lines. The programme should also include new initiatives which aim to improve the functioning of the internal market.
Amendment 69 #
2018/0231(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) It is therefore appropriate to establish a Programme for the internal market, competitiveness of enterprises, includingand sustainability of enterprises, with particular attention to micro, small and medium-sized enterprises, and European statistics (the ‘Programme’). The Programme should be established for the duration of seven years from 2021 to 2027.
Amendment 70 #
2018/0231(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The Programme should support the design, implementation and enforcement of Union legislation underpinning the proper functioning of the internal market. The Programme should support the creation of the right conditions to empower all actors of the internal market: businesses, citizens including consumers, civil society and public authorities. To that end, the Programme should aim to ensure both the competitiveness and sustainability of businesses, notably SMEs, but also a high- level of consumer protection, with a focus on certain consumers who are more vulnerable than other, by supporting the enforcement of consumer protection, and safety rules as well as environmental standards and by raising the awareness of businesses and individuals by providing them with the right tools, knowledgeinformation, tools, training and competence to make informed decisions and strengthen their participation in Union’s policy- making. Furthermore, the Programme should aim to enhance regulatory and administrative cooperation, notably through exchange of best practices, building of knowledge and competence bases, including the use of strategic public procurement. The Programme should also aim to support the development of high- quality international standards that underpin the implementation of Union legislation. This also includes standard setting in the field of financial reporting and audit, thereby contributing to the transparency and well-functioning of the Union’s capital markets and to enhancing investor protection. The Programme should support rulemaking and standard setting also by ensuring the broadest possible stakeholder involvement. The objective of the Programme should also be to support the implementation and enforcement of Union legislation providing for a high level of health for humans, animals and plants along the food chain and the improvement of the welfare of animals.
Amendment 76 #
2018/0231(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) A modern internal market promotes competition andpromote highly qualitative services for the benefits of consumers, businesses and employees and society as a whole, preserves employment and working conditions of employees, and ensures a better functioning of high-quality services of general economic interest. . Making better use of the ever evolving internal market in services should help European businesses create jobs and grow across borders, offer wider choice of services at better prices, and maintain high standards for consumers and workers. To achieve this, the Programme should contribute to the removal of remaining barriers, and to ensure a regulatory framework that can accommodate new innovative business models whilst ensuring a high level of social protection.
Amendment 81 #
2018/0231(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) New regulatory and enforcement challenges relate to a rapidly changing environment of the digital revolution, concerning issues such as cybersecurity, internet of things or artificial intelligence. and related ethical standards. Should damage occur, stringent rules on product safety and liability are essential to ensure a policy response that allows European citizens, including consumers and businesses, to access and to benefit from such rules. The Programme should therefore contribute to the rapid adaptation and enforcement of a Union product liability regime which fosters innovation.
Amendment 84 #
2018/0231(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Public procurement is used by public authorities to ensure value for public money spent and to contribute to a more innovative, sustainable, inclusive and competitive internal market. Directive 2014/23/EU of the European Parliament and of the Council49 , Directive 2014/24/EU of the European Parliament and of the Council50 and Directive 2014/25/EU of the European Parliament and of the Council51 provide the legal framework for the integration and effective functioning of the public procurement markets representing 14% of Union’s gross domestic product, to the benefit of public authorities, businesses as well as citizens, including consumers. Public authorities, through their procurement policy, can establish and support markets for innovative goods and services. The Programme should therefore support measures to ensure a wider uptake of strategic public procurement, a more systematic use of environmental, social and fair trade criteria in awarding contracts, the professionalisation of public buyers, improved access to procurement markets for SMEs, particularly to further tap into the potential of green markets, increase of transparency, integrity and better data, boosting the digital transformation of procurement and promotion of joint procurement, through strengthening a partnership approach with the Member States, improving data gathering and data analysis including through development of dedicated IT tools, supporting exchange of experiences and good practices, providing guidance, pursuing beneficial trade agreements, strengthening cooperation among national authorities and launching pilot projects. __________________ 49 Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (OJ L 94, 28.3.2014, p. 1). 50 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 51 Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243).
Amendment 89 #
2018/0231(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The Programme should support the development of the Union regulatory framework in the area of company law and corporate governance, as well as contract law, with a view to make business more efficient and competitive while providing protection for stakeholders affected by company operations, and to react to emerging policy challenges. It should also ensure appropriate evaluation, implementation and enforcement of the relevant acquis, inform and assist stakeholders and promote information exchange in the area. The Programme should further support the Commission’s initiatives in favour of a clear and adapted legal framework for the data economy and innovation. Those initiatives are necessary to enhance legal certainty with regard to contractual and extra contractual law, in particular with regard to liability and ethics in the context of emerging technologies, such as internet of things, artificial intelligence, robotics, 3D Printing. The Programme should aim at stimulating the development of data-driven business whilst ensuring a high level of privacy protection, as it will be decisive for the position of the Union economy in a global competition.
Amendment 94 #
2018/0231(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) The Programme in particular needs to tackle the radical implications for competition and the functioning of the internal market resulting from the ongoing transformation of the economy and business environment, in particular through the exponential growth and use of data, taking account of the increasing recourse to artificial intelligence and other IT tools and expertise by companies and their advisors. It is also essential that the Programme supports networks and cooperation with Member State authorities and courts, considering that undistorted competition and the functioning of the internal market depend critically on action by those entities. In view of the particular role of competition policy in preventing harm to the internal market resulting from anticompetitive conduct beyond the Union’s border, the Programme should also support cooperation with third country authorities, as appropriate. Finally, widening outreach activities is necessary in order to allow more citizens and businesses to reap the full benefits of fair competition in the internal market. Given that a number of initiatives in the Programme are new and that the competition part of the Programme is particularly affected by dynamic developments in the conditions of competition in the internal market, notably relating to Artificial Intelligence, algorithms, big data, cybersecurity and forensic technology, the pace and magnitude of which are difficult to estimate, it is anticipated that flexibility will be required to face the evolving needs under this part of the Programme.
Amendment 96 #
2018/0231(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Strengthening the competitiveness and sustainability of European enterprises while reassuring an effective level playing field and an open and competitive internal market is of outmost importance. SMEs are the engine of the European economy making up 99% of all businesses in Europe, providing two thirds of jobs, and contributing substantially to the creation of new jobs with a regional and local dimension. European enterprises need to distinguish themselves on the global market by providing high quality products and services that are smarter, customised and adhere to highest environmental and sustainability standards creating less waste and pollution. Improved productivity, in particular through increased resource efficiency, energy savings and the implementation of the ‘energy efficiency first’ principle are the primary source of sustainable income and competitiveness. SMEs are the engine of the European economy making up 99% of all businesses in Europe, providing two thirds of jobs, and contributing substantially to the creation of new jobs with a regional and local dimension, and hence social cohesion. SMEs are key drivers in the context of the energy transition, the fight against climate change, the EU’s competitiveness on green tech and a major source of innovation in the EU. Bearing this in mind, specific actions under this Programme should include promoting the development of sustainable products, services, technologies, non-technical solutions and processes, as well as enhanced resource- and energy-efficiency and corporate social responsibility.
Amendment 99 #
2018/0231(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) SMEs share common challenges that do not affect larger firms to the same extent to obtain finance, to find skilled work force, to alleviate administrative burden, to take-up creativity and innovation, to access markets and foster internationalisation activities. The Programme should address such market failures proportionally, while not unduly distorting competition in the internal market, and enhance SME’s role in achieving a net-zero carbon emission economy by 2050 at the latest. Particular attention should be paid to micro enterprises, enterprises engaged in craft activities, the self-employed, the liberal professions and social enterprises. Attention should also be paid to potential, new, young and female entrepreneurs, as well as to other specific target groups, such as older people, migrants and entrepreneurs belonging to socially disadvantaged or vulnerable groups such as persons with disabilities.
Amendment 101 #
2018/0231(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Many of the Union’s competitiveness problems involve SMEs’ difficulties in obtaining access to finance because they lack information, struggle to demonstrate their credit-worthiness and, have insufficient collateral or simply due to low awareness of existing mechanisms to support their activities at EU, national or local level. Additional financing challenges arise from SMEs’ need to stay competitive by engaging e.g. in digitization, internationalization and innovation activities and skilling up their workforce. Limited access to finance has a negative effect on businesses creation, growth and survival rates, as well as on the readiness of new entrepreneurs to take over viable companies in the context of a business succession.
Amendment 103 #
2018/0231(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) To overcome these market failures and to ensure that SMEs continue to play their role as the foundation for the Union economy´s competitiveness, and driver for a sustainable economy, small and medium sized enterprises need extra support through debt and equity instruments to be established under the SME window of the InvestEU Fund established by Regulation […] of the European Parliament and of the Council52 . The loan guarantee facility put in place under Regulation (EU) No 1287/2013 of the European Parliament and of the Council53 has a proven added value and is expected to bring a positive contribution to at least 500 000 SMEs; a successor will be established under the SME window of the InvestEU Fund. __________________ 52 COM(2018) 439 final 53 Regulation (EU) No 1287/2013 of the European Parliament and of the Council of 11 December 2013 establishing a Programme for the Competitiveness of Enterprises and small and medium-sized enterprises (COSME) (2014 - 2020) and repealing Decision No 1639/2006/EC (OJ L 347 of 20.12.2013, p. 33).
Amendment 107 #
2018/0231(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) Besides access to finance also access to skills is crucial, including managerial skills and knowledge are critical factors for SMEs to access existing funds, innovate, compete and grow. The delivery of financial instruments as envisaged under EUInvest should therefore be accompanied by the development of appropriate mentoring, coaching schemes and delivery of knowledge-based business services.
Amendment 108 #
2018/0231(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The Programme should provide effective support for SMEs throughout their life-cycle. It should build on the unique knowledge and expertise developed with regard to SMEs and industrial sectors and on a long experience in working with European, national and regional stakeholders. This support should build on the successful experience of the Enterprise Europe Network as a one-stop-shop to improve SMEs competitiveness and develop their business in the Single Market and beyond. The Network plans to continue delivering services on behalf of other Union programmes, notably for the Horizon2020 programme, using the financial resources of these programmes. It shall also support enhanced participation of SMEs representatives organisations in development of Single Market Policy initiatives, such as public procurement, standardisation processes and intellectual property regimes. Also the mentoring scheme for new entrepreneurs should remain the tool to enable new or aspiring entrepreneurs to gain business experience by matching with an experienced entrepreneur from another country and thus allow strengthening entrepreneurial talents. The Programme should further strive to grow and extend its geographical coverage ensuring a balanced geographical distribution while enhancing its effectiveness in particular as regards the uptake of SMEs of the services provided and thus offer wider range of matching possibilities to entrepreneurs in complementarity with other Union initiatives where relevant.
Amendment 115 #
2018/0231(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) Clusters are a strategic tool for supporting the competitiveness and scaling-up of SMEs as they offer favourable business environments. Joint Cluster Initiatives should achieve critical mass to accelerate the growth of SMEs. By connecting specialised eco-systems, clusters create new business opportunities for SMEs and integrate them better in European and global strategic value chains. Support should be provided for the development of transnational partnership strategies and the implementation of joint activities, supported by the European Cluster Collaboration Platform. Sustainable partnering should be encouraged with continuation funding if performance and participation milestones are reached. Direct support to SMEs should be channelled through cluster organisations for the following: uptake of advanced technologies, new business models, low- including non-technical solutions and social innovation, zero-carbon and resource- and energy-efficient solutions, creativity and design, skills upgrading, talent attraction, entrepreneurship acceleration, and internationalisation. Other specialised SME support actors should be associated to facilitate industrial transformation and implementations of smart specialisation strategies. The Programme should thus contribute to growthsustainable economic development and build linkages with the Union’s (digital) innovation hubs and investments made under Cohesion Policy and Horizon Europe. Synergies with the Erasmus programme can also be explored.
Amendment 118 #
2018/0231(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) CBesides creativity and innovation, enhanced sustainability in terms of production processes, in particular enhanced resource and energy efficiency, are crucial for the competitiveness of the Union’s industrial value chains. They represent catalysts for industrial modernisation and contribute to smart, inclusive sustainable growtheconomy. However, uptake by SMEs is still lagging behind. The Programme should therefore support targeted actions, networks and partnerships for creativity- and sustainability driven innovation throughout the industrial value chain.
Amendment 122 #
2018/0231(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) European standards play an important role in the internal market. They are of vital interest for the competitiveness of undertakings, and especially SMEs. They are also a crucial tool to support Union legislation and policiey goals in a number of key areas such as energy, climate changeaccelerating the energy transition, tackling climate change, environmental protection, improved air quality, information and communication technology, sustainable use and recycling of resources, innovation, product safety, consumer protection, worker’s safety and working conditions and ageing population, thus positively contributing to the society as a whole.
Amendment 124 #
2018/0231(COD)
Proposal for a regulation
Recital 30 a (new)
Recital 30 a (new)
(30a) The principles of transparency and equal gender opportunity should be taken into account in all relevant initiatives and actions covered by the programme. Respect for human rights and fundamental freedoms for all citizens should be also considered in those initiatives and actions.
Amendment 135 #
2018/0231(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) The general objective of Union law in the food chain area is to contribute to a high level of health for humans, animals and plants along the food chain, to support the improvement ofguarantee the welfare of animals, to contribute to a high level of protection and information for consumers and a high level of protection of the environment, including the preservation of biodiversity, while improving the sustainability of European food and feed productions, increasing quality standards across the Union, enhancing the competitiveness of the Union food and feed industry and favouring the creation of jobs.
Amendment 136 #
2018/0231(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) Considering the specific nature of the actions concerning a high level of health for humans, animals and plants along the food chain special eligibility criteria concerning provision of grants and use of public procurement need to be provided in this Regulation. In particular, by way of derogation from Regulation (EU, Euratom) of the European Parliament and of the Council61 (the ‘Financial Regulation’), as an exception to the principle of non-retroactivity, the costs for the emergency measures, due to their urgent and unforeseeable nature, should be eligible and include also costs incurred as a result of a suspected occurrence of a disease or pest provided that that occurrence is subsequently confirmed and notified to the Commission. The corresponding budgetary commitments and the payment of eligible expenditure should be made by the Commission, after signature of the legal commitments and after assessment of the payment applications submitted by the Member States. Where emergencies in the area of human, animal and plant health in the food chain can be traced back to specific union practices, measures should be taken to revise these practices. Costs should also be eligible for protection measures taken in the case of a direct threat to the status of health in the Union as a result of the occurrence or development, in the territory of a third country, a Member State or overseas countries and territories, of certain animal diseases and zoonoses as well as in respect of protection measures, or other relevant activities, taken in support of the health status of plants in the Union. __________________ 61 [to add]
Amendment 137 #
2018/0231(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) Official controls carried out by the Member States are an essential tool for verifying and monitoring that relevant Union requirements are being implemented, complied with and enforced. The effectiveness and efficiency of official control systems is vital for maintaining a high level of safety for humans, animals and plants along the food chain whilst ensuring a high level of protection of the environment and of animal welfare. Union financial support should be made available for such control measures, especially where compliance with Union law as concerns the health and safety of humans, animals and plants is still deficient, such as live animal transport. In particular, a financial contribution should be available to Union reference laboratories in order to help them bear the costs arising from the implementation of work programmes approved by the Commission. Moreover, since the effectiveness of official controls also depends on the availability to the control authorities of well trained staff with an appropriate knowledge of Union law, the Union should be able to contribute to their training and relevant exchange programmes organised by competent authorities.
Amendment 139 #
2018/0231(COD)
Proposal for a regulation
Recital 53
Recital 53
(53) Reflecting tThe importance of tackling climate change in line with the Union’s commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals should be reflected in the next Multiannual Financial Framework and therefore, this Programme should contribute to mainstream climate actions and to the achievement of an overall target of 25 30% of the Union budget expenditures supporting climate objectives and achieving a net- zero carbon society by 2050 at the latest. Relevant actions will be identified during the Programme’s preparation and implementation, and reassessed in the context of the relevant evaluations and review processes.
Amendment 144 #
2018/0231(COD)
Proposal for a regulation
Recital 74
Recital 74
(74) To ensure regular monitoring and reporting, a proper framework for monitoring the actions and results of the Programme should be put in place from the very beginning. Such monitoring and reporting should be based on indicators, measuring the effects of the actions under the Programme against pre-defined baselines. A yearly report on its implementation should be made presenting progress achieved and planned activities. The report should be presented to the European Parliament.
Amendment 145 #
2018/0231(COD)
Proposal for a regulation
Recital 83
Recital 83
(83) The Programme should also be to ensure greater visibility and coherence of the Union’s internal market, competitiveness and sustainability of enterprises including SMEs and European statistics actions towards European citizens, businesses and administrations.
Amendment 146 #
2018/0231(COD)
Proposal for a regulation
Recital 85
Recital 85
(85) It is appropriate to ensure a smooth transition without interruption between the programmes in the fields of competitiveness and sustainability of enterprises and SMEs, consumer protection, customers and end- users in financial services, policy making in financial services, food chain and European statistics, established by Regulation (EU) No 1287/2013, Regulation (EU) No 254/2014, Regulation (EU) 2017/826, Regulation (EU) No 258/2014, Regulation (EU) No 652/2014, Regulation (EU) No 99/2013 and this Programme, in particular regarding the continuation of multiannual measures and the evaluation of the previous programmes successes,
Amendment 148 #
2018/0231(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation establishes the programme for improving the functioning of the internal market and the competitiveness of enterprises, includingand sustainability of enterprises, paying particular attention to the needs of micro, small and medium-sized enterprises and the framework for financing of development, production and dissemination of European statistics within the meaning of Article 13 of Regulation (EC) No 223/2009 (the ‘Programme’).
Amendment 151 #
2018/0231(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) to improve the functioning of the internal market through a reinforcement of its legal social and environmental framework in line with EU’s long-term climate objectives and a net-zero carbon economy, and especially to protect and empower citizens, consumers and businesses, in particular micro, small and medium-sized enterprises (SMEs), by enforcement of Union law, facilitation of market access and improved access to finance, standard setting, and by promoting human, animal and plant health and animal welfare; as well as to enhance cooperation between the competent authorities of Member States and between the competent authorities of Member States and the Commission and the decentralised Union agencies;
Amendment 156 #
2018/0231(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point a
Article 3 – paragraph 2 – point a
(a) making the internal market more effective, promoting local economic development and local sustainable value chains, facilitating the prevention and removal of obstacles, supporting the development, implementation and enforcement of the Union law, including social and environmental standards, in the areas of the internal market for goods and services, public procurement, market surveillance as well as in the areas of company law and contract and extra- contractual law, anti-money laundering, free movement of capital, financial services and competition, including the development of governance tools;
Amendment 159 #
2018/0231(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
(b) improvingstrengthening both the competitiveness and sustainability of enterprises with special emphasis on SMEs, paying particular attention to their specific needs, promoting their creation, and achieving additionality through the provision of measures that provide various forms of support to SMEs, access to markets including the internationalisation of SMEs, favourable business environment for SMEs, the competitiveness of sectors, the modernisation of industrreduced administrative burden, improved access to finance for SMEs in their start-up and growth phase, access to markets including the internationalisation of SMEs, favourable business environment for SMEs and ,improved framework conditions for enhancing the competitiveness and sustainability of sectors, the accelerating the modernisation of industry and enterprises, in order to be compatible with a net-zero carbon, climate-resilient, energy and resource efficient economy and the promotion of entrepreneurship;
Amendment 174 #
2018/0231(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The financial envelope for the implementation of the Programme for the period 2021 to 2027 shall be EUR 45 088 580 000 in curreonstant prices.
Amendment 177 #
2018/0231(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point a
Article 4 – paragraph 2 – point a
(a) EUR 12 000 000 000 to the objective referred to in Article 3(2)(b);
Amendment 190 #
2018/0231(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation. The Commission shall publish work programmes adopted for each of the specific objectives referred to in Article 2(2) specifying the amount of grants to be allocated.
Amendment 192 #
2018/0231(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point a
Article 8 – paragraph 2 – point a
(a) creation of the right conditions to empower all actors of the internal market, including businesses, and in particular SMEs, citizens and consumers, civil society and public authorities through transparent information and awareness raising campaigns, best practice exchange, promotion of good practices, exchange and dissemination of expertise and knowledge and organization of trainings;
Amendment 195 #
2018/0231(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point c
Article 8 – paragraph 2 – point c
(c) capacity building, training, facilitation and coordination of joint actions between Member States and between the competent authorities of Member States and between the competent authorities of Member States and the Commission, the decentralised Union agencies and third country authorities;
Amendment 196 #
2018/0231(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point d
Article 8 – paragraph 2 – point d
(d) support for the effective enforcement and modernisation of the Union legal framework and its rapid adaptation to the ever-changing environment, including through data gathering and analyses; studies, evaluations and policy recommendations; organization of demonstration activities and pilot projects; communication activities; development of dedicated IT tools and contact points ensuring transparent and efficient functioning of the internal market.
Amendment 198 #
2018/0231(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point b
Article 8 – paragraph 3 – point b
(b) facilitating SMEs’ access to markets, supporting them in addressing global and societal challenges and business internationalisationfinance and markets, providing information and raising awareness in relation to, among others, Union programmes, law and standards, supporting them in addressing global and societal challenges, in particular as embodied by the SDGs and the Paris Agreement, and business internationalisation, support service in terms of data protection and intellectual property rights in third countries, and strengthening Union industrial leadership and sustainability in global value chains, including the Enterprise Europe Network;
Amendment 202 #
2018/0231(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point c
Article 8 – paragraph 3 – point c
(c) addressing market barriers, reducing administrative burden and creating a favourable business environment to empower SMEs to benefit from the internal marketaccess to finance and the internal market; providing appropriate guidance, mentoring and coaching schemes delivery of knowledge-based business services, that may be crucial for ensuring access to funds and up scaling;
Amendment 204 #
2018/0231(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point d
Article 8 – paragraph 3 – point d
(d) facilitating the growth of businesses, including skills development, anddevelopment and growth of sustainable businesses, raising SMEs’ awareness of environmental and energy-related issues and to assist them implementing legislation, assessing their environmental and energy performance, including upgrading their skills and qualifications development, and to develop new sustainable business models and resource-efficient value-chains fostering sustainable industrial transformation across manufacturing and service sectors;
Amendment 207 #
2018/0231(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point e
Article 8 – paragraph 3 – point e
(e) supporttrengthening the competiveness and sustainability of enterprises and whole sectors of economy, and supporting SMEs’ uptake of innovation, creating champions in eco-innovation and energy and resource efficient production and manufacturing processes as well as non- technical solutions and services, enhancing corporate social responsibility and value chain collaboration through strategically connecting ecosystems and clusters, including the joint cluster initiative;
Amendment 209 #
2018/0231(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point f
Article 8 – paragraph 3 – point f
(f) fostering an entrepreneurial business environment and entrepreneurial culture, includenlarging the mentoring scheme for new entrepreneurs and supporting start- ups, business sustainability and scale-ups with particular attention to young entrepreneurs, new and potential entrepreneurs and female entrepreneurs, as well as specific target groups, such as migrants, socially disadvantaged or vulnerable groups such as people with disabilities.
Amendment 210 #
2018/0231(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point f a (new)
Article 8 – paragraph 3 – point f a (new)
(fa) The Commission may take actions such as mobility programmes for new entrepreneurs to improve their ability to develop their entrepreneurial know-how, skills and attitudes and to improve their technological capacity and enterprise management.
Amendment 213 #
2018/0231(COD)
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 1
Article 14 – paragraph 2 – subparagraph 1
may receive on a voluntary basis, support from the European Regional Development Fund, the Cohesion Fund, the European Social Fund Plus or the European Agricultural Fund for Rural Development, in accordance with paragraph 5 of Article [67] of Regulation (EU) XX [Common Provisions Regulation] and Article [8] or Regulation (EU) XX [Financing, management and monitoring of the Common Agricultural Policy], provided that such actions are consistent with the objectives of the programme concernedand in line with the Cohesion Policy objectives. The rules of the Fund providing support shall apply.
Amendment 217 #
2018/0231(COD)
Proposal for a regulation
Article 16 – paragraph 2 a (new)
Article 16 – paragraph 2 a (new)
2a. The work programme covering the COSME actions and giving effect to the specific objective referred to in Article3(2)(b) shall include: (i) an indication of the amount allocated to each action to be financed, including the expected amount contributing to climate-related expenditure; (ii) an indicative implementation timetable; (iii) appropriate indicators for monitoring the effectiveness vis- à -vis the objectives, evaluation and award criteria and the maximum rate of co-financing; and (iv) references to other actions at Union level that are being implemented and that could be of interest to SME and the networking the framework of other Union programmes or actions. The work programme and the actions shall also be published, on the websites of each of the contact points of the Network, where such websites are available. This is particularly important for actions addressed to SMEs.
Amendment 218 #
2018/0231(COD)
Proposal for a regulation
Article 17 – paragraph -1 (new)
Article 17 – paragraph -1 (new)
-1. The Commission shall draw up an annual monitoring report examining the efficiency and effectiveness of supported actions in terms of financial implementation, results and where possible impact. The report shall include information on the amount of climate related expenditure and the impact of support to climate change objectives. The annual report shall be presented to the European Parliament and made available to the public.
Amendment 228 #
2018/0231(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point 2.1 – introductory part
Annex I – paragraph 1 – point 2 – point 2.1 – introductory part
2.1. Annual and multiannual veterinary and phytosanitary programmes for the prevention, eradication, control and surveillance of animal diseases and zoonoses listed in Annex III and of plant pests have to be implemented in compliance with the provisions laid down in the relevant Union law.
Amendment 230 #
2018/0231(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 3
Annex I – paragraph 1 – point 3
3. Activities to support the improvement of the welfare of animals, including measures to ensure compliance with animal welfare standards during animal transport, and at Union and MS borders.
Amendment 239 #
2018/0231(COD)
Proposal for a regulation
Annex IV – column INDICATOR – box 2
Annex IV – column INDICATOR – box 2
1 - Number of SMEs receiving support 2 - Number of companies supported having concluded business partnerships. 1 Green products and services are those with a predominant function of reducing environmental risk and minimising pollution and resources. Products with environmental features (eco-designed, eco-labelled, organically produced, and with an important recycled content) are also included. Source: Flash Eurobarometer 456, "SMEs, R1. Marked reduction in number of days to set-up a new SME 2. Marked reduction in the average start-up costs in the Union compared to baseline 3. Marked increase in the number of Member States where the time needed to get licences and permits (including environmental permits) to take up and perform the specific activity of an enterprise is one month 4. Marked increase in the number of Member States with a one-stop shop for business start-ups 5. Number of SMEs receiving support services 6. Increase of SME output (value added) and employees compared to baseline 7. Increase in the proportion of SMEs exporting and increase in the proportion of SMEs exporting outside the Union compared to baseline 8. Increase in the proportion of SMEs exporting and increase in the proportion of SMEs exporting outside the Union compared to baseline. 9. Increase in the proportion of Union citizens that would like to be self- employed compared to baseline 10. Marked increase in number of Member States implementing entrepreneurship solutions targeting potential, young, new and female entrepreneurs, as well as other specific target groups compared to baseline 11. Performance of SMEs as regards sustainability to be measured by the increase in the proportion of Union SME producing green, i.e. environmentally friendly, products1 compared to baseline, for example by means of Eurobarometer survey 12. Increase in the proportion of Union SMEs that are taking at least one action to be more resource efficient (which may include energy, materials or water, recycling, etc.) compared to baseline, for example by means of Eurobarometer survey 13. Increase in the proportion of Union SMEs that are planning to implement additional resource Eefficiency and Green Markets".ctions (which may include energy, materials or water, recycling, etc.) every two years compared to baseline, for example by means of Eurobarometer survey
Amendment 47 #
2018/0229(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) With 1.8% of EU GDP, down from 2.2% in 2009, infrastructure investment activities in the Union in 2016 were about 20% below investment rates before the global financial crisis. Thus, while a recovery in investment-to-GDP ratios in the Union can be observed, it remains below what might be expected in a strong recovery period and is insufficient to compensate years of underinvestment. More importantly, the current investment levels and forecasts do not cover the Union’s structural investment needs in the face of technological change and global competitiveness, including for innovation, skills, infrastructure, small and medium- sized enterprises ('SMEs') and the need to address key societal challenges such as sustainability or population ageing. Consequently, continued support is necessary to address market failures and sub-optimal investment situations to reduce the investment gap in targeted sectors to achieve the Union's policy objectives. In that regard, the primary aim of the InvestEU Programme should be to support otherwise difficult to fund projects that provide European citizen with long-term environmental and societal benefits such as high quality long-term jobs and public infrastructure. It is therefore much more important to identify and support projects that provide this genuine additionality and quality rather than being driven by technical aspects such as leverage factors or project speed and volumes.
Amendment 58 #
2018/0229(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The InvestEU Fund should contribute to improving the competitiveness of the Union, including in the field of innovation and digitisation, the sustainability of the Union's economic growth, the social resilience and inclusiveness and the integration of the Union capital markets, including solutions addressing their fragmentation and diversifying sources of financing for the Union enterprises. To that end, it should support projects that are technically and economically viable by providing a framework for the use of debt, risk sharing and equity instruments underpinned by a guarantee from the Union's budget and by contributions from implementing partners. It should be demand-driven while support under the InvestEU Fund should at the same time focus on providing strategic, long-term societal and environmental benefits in key areas of EU policy which would otherwise not be funded, thus contributing to meeting policy objectives of the Union.
Amendment 69 #
2018/0229(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The InvestEU Fund should support investments in tangible and intangible assets to foster growth, investment and employment, that are also resilient to climate change, and thereby contributing to an improved environment, well-being and fairer income distribution in the Union. Intervention through the InvestEU Fund should complement Union support delivered through grants.
Amendment 71 #
2018/0229(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The Union endorsed the objectives set out in the United Nations Agenda 2030 and its Sustainable Development Goals and the Paris Agreement in 2015 as well as the Sendai Framework for Disaster Risk Reduction 2015-2030. To achieve the agreed objectives, including those embedded in the environmental policies of the Union, action pursuing sustainable development is to be stepped up significantly. Therefore, the principles of sustainable development, safety and climate-proofing should feature prominently in the design of the InvestEU Fund, which means that fossil fuel infrastructure and nuclear installations in the power sector should not be funded.
Amendment 73 #
2018/0229(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) Reflecting the importance of tackling climate change in line with the Union’s climate related long-term objective and remaining carbon budget, the Union's commitments to implement the Paris Agreement 1a and the United Nations Sustainable Development Goals, the InvestEU Programme will contribute to mainstream climate actions and to the achievement of an overall target of 25 50% of the Union budget expenditures supporting climate objectives. Actions under the InvestEU Programme are expected to contribute 30 at least 60% of the overall financial envelope of the InvestEU Programme to climate objectives. Relevant actions will be identified during the InvestEU Programme's preparation and implementation and reassessed in the context of the relevant evaluations and review processes. Climate mainstreaming and climate proofing mechanisms should be unified by reforming, expanding and centralising the Rio Marker system, in order to differentiate between sectors, as well as between mitigation and adaptation. Additionally, infrastructure investment planning shall fully consider the ‘Energy Efficiency first’ assessments, as set out in the [Regulation on the Governance of the Energy Union]. _________________ 1a In particular Article 2.1c on Alignment of financial flows with a climate resilient development
Amendment 77 #
2018/0229(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) With regard to cost of capital of renewable energy projects, the InvestEU Fund should allow for the use of an innovative guarantee instrument to reduce regulatory risk and associated high cost of capital in some Member States. This possibility should be open on a voluntary basis. To achieve this objective, the InvestEU Fund should contribute where appropriate to the enabling framework for investment into renewable energy as set out in Art 3.5 of the [revised Renewables Directive], including the financing mechanism established by Article 27bis of the [Governance Regulation].
Amendment 80 #
2018/0229(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The contribution of the InvestEU Fund to the achievement of the climate target will be tracked through an EU climate tracking system developed by the Commission in cooperation with implementing partners and using in an appropriate way the criteria established by [Regulation on the establishment of a framework to facilitate sustainable investment14 ] for determining whether an economic activity is environmentally sustainable. The InvestEU Fund will also contribute to implementing the Sustainable Development Goals (SDGs) into EU policies and initiatives, with sustainable development as an essential guiding principle. _________________ 14 COM(2018)353.
Amendment 84 #
2018/0229(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) According to the 2018 Global Risks Report issued by the World Economic Forum, half of the ten most critical risks threatening the global economy relate to the environment. Such risks include air, soil and water pollution, extreme weather events, biodiversity losses and failures of climate-change mitigation and adaptation. Environmental principles are strongly embedded in the Treaties and many of the Union's policies. Therefore, the mainstreaming of environmental objectives should be promoted in the InvestEU Fund related operations. Environmental protection and related risk prevention and management should be integrated in the preparation and implementation of investments. The EU should also track its biodiversity-related and air pollution control-related expenditure in order to fulfil the reporting obligations under the Convention on Biological Diversity and Directive (EU) 2016/2284 of the European Parliament and of the Council. 15 Investment allocated to environmentally sustainability objectives should therefore be tracked using common methodologies coherent with that developed under other Union programmes applying to climate, biodiversity and air pollution management in order to allow assessing the individual and combined impact of investments on the key components of the natural capital, including air, water, land, soil and biodiversity. _________________ 15 Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1).
Amendment 85 #
2018/0229(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) The InvestEU Programme should also integrate the gender perspective in all its working and decision making processes, make sure that committees and projects teams are gender balanced and ensure that the implementation of this fund contributes to the promotion of gender equality in compliance with EU gender mainstreaming obligations (article 8 TFEU).
Amendment 90 #
2018/0229(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Low infrastructure investment rates in the Union during the financial crisis undermined the Union's ability to boost sustainable growth, competitiveness and convergence. Sizeable iInvestments in the European infrastructure, notably interconnection and energy efficiency are fundamental to meet the Union's sustainability targets, including the Union’s commitments towards the SDGs, and the 2030 energy and climate targets. Accordingly, support from the InvestEU Fund should target investments into sustainable development- compatible projects on transport, energy, including energy efficiency and renewable energy, environmental, climate action, maritime and digital infrastructure. InvestEU shall prioritise the most significantly under-invested areas that require the most additional investment to meet the Union’s sustainability targets, such as energy efficiency. To maximise the impact and the value added of Union financing support, it is appropriate to promote a streamlined, climate-proof investment process enabling visibility of the project pipeline and consistency across relevant Union programmes. Bearing in mind security threats, investment projects receiving Union support should take into account principles for the protection of citizens in public spaces. This should be complementary to the efforts made by other Union funds such as the European Regional Development Fund providing support for security components of investments in public spaces, transport, energy and other critical infrastructure.
Amendment 96 #
2018/0229(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Whereas the level of overall investment in the Union is increasing, investment in higher-risk activities such as research and innovation is still inadequate. The resulting underinvestment in research and innovation is damaging to the industrial and economic competitiveness of the Union and the quality of life of its citizens. The InvestEU Fund should provide the appropriate financial products to cover different stages in the innovation cycle and a wide range of stakeholders, in p. Particular to allow the upscaling of and deployment of solutions at a commercial scale in the Union, in order to make such solutions competitive on world marketsimportance should be given to promoting EU excellence in green technologies at global level.
Amendment 99 #
2018/0229(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) A significant effort is urgently needed to invest in digital transformation and to distribute the benefits of it to all Union citizens and businesses. The strong policy framework of the Digital Single Market Strategy should now be matched by investment of a similar ambition, including in ethical artificial intelligence. (AI). The latter shall be subject to an ex-ante ethical impact assessment. This review must extend beyond the narrow confines of privacy and data protection and take into account the broader societal impacts of the underlying AI agenda. Projects that raise substantial ethical and/or societal impact concerns must be subject to enhanced scrutiny and control and to ethical review.
Amendment 102 #
2018/0229(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) As the single market is negatively impacted by the digital divide, created by lack of network access, uneven speeds between regions and lack of knowledge, the digital transformation of the society should empower citizens, especially the young digital natives, to feel secure to use new technologies, learning about privacy, security and basic safeguards that will protect them from malicious activity and increase their potential for the economy. Therefore a comprehensive approach to increase coverage, achieve similar levels of connectivity and equal knowledge for all is needed.
Amendment 103 #
2018/0229(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Small and medium-sized enterprises (SMEs) play a crucial role in the Unionrepresent over 99% of businesses in the Union and their economic value is significant and crucial. However, they face challenges when accessing finance because of their perceived high risk and lack of sufficient collateral. Gender disparities also need to be addressed, as female creativity and entrepreneurial potential are an under- exploited source of growth and jobs that should be further developed. Whereas women constitute 52% of the total European population, they represent only 34.4% of the EU self-employed and 30% of start-up entrepreneurs. Additional challenges arise from SMEs' need to stay competitive by engaging in digitisation, internationalisation and innovation activities and skilling up their workforce. Moreover, compared to larger enterprises, they have access to a more limited set of financing sources: they typically do not issue bonds, have only limited access to stock exchanges or large institutional investors. The challenge in accessing finance is even greater for those SMEs whose activities focus on intangible assets. SMEs in the Union rely heavily on banks and debt financing in the form of bank overdrafts, bank loans or leasing. Supporting SMEs that face the above challenges and providing more diversified sources of funding is necessary for increasing the ability of SMEs to finance their creation, growth and development, withstand economic downturns, and for making the economy and the financial system more resilient during economic downturn or shocks. This is also complementary to the initiatives already undertaken in the context of the Capital Markets Union. The InvestEU Fund should provide an opportunity to focus on specific, more targeted financial products. (Numbers from EC retrieved at https://ec.europa.eu/growth/smes/promotin g-entrepreneurship/we-work- for/women_en)
Amendment 111 #
2018/0229(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) As set out in the reflection paper on the social dimension of Europe16 and the European Pillar of Social Rights17 , building a more inclusive and fairer Union is a key priority for the Union to tackle inequality and foster social inclusion policies in Europe. Inequality of opportunities affects in particular access to education, training and health. Investment in the social, skills and human capital- related economy, as well as in the integration of vulnerable populations in the society, can enhance economic opportunities, especially if coordinated at Union level. TGiven the significant need for investment into social infrastructure and projects in the fields of social services, healthcare services, education, care and social housing, the InvestEU Fund should be used to support investment in education and training, help increase employment, in particular among the unskilled and long- term unemployed, and improve the situation with regard to gender equality, equal opportunities, intergenerational solidarity, the health sector, homelessness, digital inclusiveness, community development, the role and place of young people in society as well as vulnerable people, including third country nationals. The InvestEU Programme should also contribute to the support of European culture and creativity. To counter the profound transformations of societies in the Union and of the labour market in the coming decade, it is necessary to invest in human capital, microfinance, social enterprise finance and new social economy business models, including social impact investment and social outcomes contracting and forms of employment that support work-life balance and better distribution of care responsibilities. The InvestEU Programme should strengthen nascent social market eco-system, increasing the supply of and access to finance to micro- and social enterprises, to meet the demand of those who need it the most. The report of the High-Level Task- Force on Investing in Social Infrastructure in Europe18 has identified investment gaps in social infrastructure and services, including for education, training, health and housing, which call for support, including at the Union level. Therefore, the collective power of public, commercial and philanthropic capital, as well as support from foundations, should be harnessed to support the social market value chain development and a more resilient Union. _________________ 16 17COM(2017) 206. COM(2017) 206. 17 COM(2017) 250. COM(2017) 250. 18 Published as European Economy Discussion Paper 074 in January 2018.
Amendment 115 #
2018/0229(COD)
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) The projects funded under InvestEU should promote equality between women and men, in particular in research and innovation, by addressing the underlying causes of gender imbalance, by exploiting the full potential of both female and male researchers, and by integrating the gender dimension into the research and innovation content; as well as by paying particular attention to ensuring gender balance in evaluation panels and in other relevant advisory and expert bodies. Activities should also aim at implementation of principles relating to equality between women and men as laid down in Articles 2 and 3 of the Treaty on European Union and in Article 8 TFEU and Directive 2006/54/EC on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation.
Amendment 123 #
2018/0229(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Each policy window should be composed of two compartments, that is to say an EU compartment and a Member State compartment. The EU compartment should address Union-wide market failures or sub-optimal investment situations in a proportionate manner; supported actions should have a clear European added value. The Member State compartment should give Member States the possibility to contribute a share of their resources of Funds under shared management to the provisioning of the EU guarantee to use the EU guarantee for financing or investment operations to address specific market failures or sub- optimal investment situations in their own territory, including in vulnerable and remote areas such as the outermost regions of the Union, to deliver objectives of the Fund under shared management. Actions supported from the InvestEU Fund through either EU or Member State compartments should not duplicate or crowd out private financing or distort competition in the internal market.
Amendment 127 #
2018/0229(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) The Member State compartment should be specifically designed to allow the use of funds under shared managementnational funds to provision a guarantee issued by the Union. That combination aims at mobilising the high credit rating of the Union to promote national and regional investments while ensuring a consistent risk management of the contingent liabilities by implementing the guarantee given by the Commission under indirect management. The Union should guarantee the financing and investment operations foreseen by the guarantee agreements concluded between the Commission and implementing partners under the Member State compartment, the Funds under shared managementnational funds should provide the provisioning of the guarantee, following a provisioning rate determined by the Commission based on the nature of the operations and the resulting expected losses, and the Member State would assume losses above the expected losses by issuing a back-to-back guarantee in favour of the Union. Such arrangements should be concluded in a single contribution agreement with each Member State that voluntarily chooses such option. The contribution agreement should encompass the one or more specific guarantee agreements to be implemented within the Member State concerned. The setting out of the provisioning rate on a case by case basis requires a derogation from [Article 211(1)] of Regulation (EU, Euratom) No XXXX19 (the 'Financial Regulation'). This design provides also a single set of rules for budgetary guarantees supported by funds managed centrally or by funds under shared management, which would facilitate their combination. _________________ 19
Amendment 128 #
2018/0229(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) The InvestEU Fund should be open to contributions from third countries that are members of the European Free Trade Association, acceding countries, candidates and potential candidates, countries covered by the Neighbourhood policy and other countries, in accordance with the conditions laid down between the Union and those countries. Cooperation and support should be provided to decrease dependence on fossil fuels and increase access to affordable renewable energy, as well as to support access to science, technology and innovation in line with the SDGs. This should allow continuing cooperating with the relevant countries, where appropriate, in particular in the fields of research and innovation as well as SMEs.
Amendment 145 #
2018/0229(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) An Investment Committee composed of independent experts should conclude on the granting of the support from the EU guarantee to financing and investment operations fulfilling the eligibility criteria, thereby providing external expertise in investment assessments in relation to projects. The Investment Committee should have different configurations to best cover different policy areas and sectors, but always include also experts from climate, environmental and civil society organisations.
Amendment 160 #
2018/0229(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) The InvestEU Advisory Hub should support the development of a robust pipeline of investment projects in each policy window providing for effective implementation of geographic diversification with a view to contributing to the Union objective of economic, social, and territorial cohesion and reducing regional disparities. The Advisory Hub should pay particular attention to the necessity of aggregating small projects and bundle them into larger portfolios. In addition, a cross- sectoral component under the InvestEU Programme should be foreseen to ensure a single-entry point and cross-policy project development assistance for centrally managed Union programmes.
Amendment 163 #
2018/0229(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) In order to ensure a wide geographic outreach of the advisory services across the Union and to successfully leverage local knowledge about the InvestEU Fund, a local presence of the InvestEU Advisory Hub should be ensured, where needed in every Member State, taking into account existing support schemes, with a view to provide tangible, proactive, tailor- made assistance on the ground.
Amendment 165 #
2018/0229(COD)
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) Given the positive track record of national promotional banks in generating, bundling and financing projects, for example on small scale energy efficiency and renewable energy projects on a local and regional level, their expertise should be pooled into advisory hubs and their role as implementing partners should continue to be valued.
Amendment 170 #
2018/0229(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
(1) 'blending operations' means operations supported by the Union budget combining non-repayable forms of support or repayable support or both from the Union budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors; for the purposes of this definition, Union programmes financed from sources other than the Union budget, such as the EU Emissions Trading System (ETS) Innovation Fund, can be assimilated to Union programmes financed by the Union budget;‘additionality’ means additionality as defined in Article 8a (new).
Amendment 172 #
2018/0229(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1 a (new)
Article 2 – paragraph 1 – point 1 a (new)
(1a) 'blending operations' means operations supported by the Union budget combining selected non-repayable forms of support or repayable support or both from the Union budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors;
Amendment 173 #
2018/0229(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1 b (new)
Article 2 – paragraph 1 – point 1 b (new)
Amendment 187 #
2018/0229(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point d a (new)
Article 3 – paragraph 1 – point d a (new)
(da) contribute to achieving the climate objectives, as well as delivering long-term environmental and societal benefits.
Amendment 190 #
2018/0229(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
(b) to support financing and investment operations in researchinclusive and ethical research, product development, innovation and digitisation;
Amendment 195 #
2018/0229(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point c
Article 3 – paragraph 2 – point c
(c) to increase the access to and the availability of finance for SMEs and, in duly justified cases, for small mid-cap companies;
Amendment 200 #
2018/0229(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point d a (new)
Article 3 – paragraph 2 – point d a (new)
(da) to increase investment in climate mitigation and adaptation and to make sure that the InvestEU Fund is contributing at least 60% to climate objectives.
Amendment 207 #
2018/0229(COD)
Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 2
Article 4 – paragraph 1 – subparagraph 2
An additional amount of the EU guarantee may be provided for the purposes of the Member State compartment referred to in point (b) of Article 8(1), subject to the allocation by Member States, pursuant to [Article 10(1)] of Regulation [[CPR] number]28 and Article [75(1)] of Regulation [[CAP plan] number]29 , of the corresponding amounts. _________________ 28 29.
Amendment 211 #
2018/0229(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. The financial envelope for the implementation of the measures provided in Chapters V and VI shall be at least EUR 5725 000 000 (current prices).
Amendment 218 #
2018/0229(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) sustainable infrastructure policy window: comprises sustainable investment in the areas of transport, energy, digital connectivity, supply and processing of raw materials, space, oceans and water, waste - in particular the increased deployment of renewable energy and energy efficiency investments - digital connectivity, climate adaptation and mitigation, recycling and processing of raw materials, space, water, waste avoidance, recycling and reduction and the circular economy, nature and other environment infrastructure, equipment, mobile assets and deployment of innovative technologies that contribute to the environmental or social sustainability objectives of the Union, or to both, or meet the environmental or social sustainability standards of the Union;.
Amendment 223 #
2018/0229(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point b
Article 7 – paragraph 1 – point b
(b) research, innovation and digitisation policy window: comprises research, product development and innovation activities, transfer of technologies and research results to the market, supporting market enablers and cooperation between enterprises, including regulatory systems demonstration and deployment of innovative solutions and support to scaling up of innovative companies other than SMEs on the net-zero carbon economy, resilience and adaptation to climate change, on the circular economy, as well as digitisation of Union industry;.
Amendment 229 #
2018/0229(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point c
Article 7 – paragraph 1 – point c
(c) SMEs policy window: access to and availability of finance for SMEs and, in duly justified cases, for small mid-cap companiesparticular to environmentally-friendly production processes, resource and energy efficiency in SMEs and other climate relevant projects, and female entrepreneurship;
Amendment 242 #
2018/0229(COD)
Proposal for a regulation
Article 7 – paragraph 3 – subparagraph 1
Article 7 – paragraph 3 – subparagraph 1
Financing and investment operations under the sustainable infrastructin all foure policy windows referred to in point (a), (b), (c), (d) of paragraph (1) shall be subject to climate, environmental and social sustainability proofing and tracking, with a view to minimise detrimental impacts and maximise benefits on climate, environment and the social dimension. For that purpose, promoters requesting financing shall provide adequate information based on guidance to be developed by the Commission. Projects below a certain size defin in form of a delegated act that the latter is empowered to adopt in accordance with article 26, taking fully into account the criteria established inby the guidance shall be excluded from the proofing. [Regulation on the establishment of a framework to facilitate sustainable investment] for determining whether an economic activity is environmentally sustainable, and in line with EU climate objectives.
Amendment 251 #
2018/0229(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Implementing partners shall provide the information necessary to allow the tracking of investment that contributes to meeting the Union objectives on climate and environment, based on guidance to be provided by the Commission. and using in an appropriate way the criteria established by [Regulation on the establishment of a framework to facilitate sustainable investment] for determining whether an economic activity is environmentally sustainable and being complementary to the role of the Platform on sustainable finance who shall monitor and report regularly to the Commission on capital flows towards sustainable investment.
Amendment 257 #
2018/0229(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. Implementing partners shall target that at least 50 % of thell investment under the sustainable infrastructure policy window contribute to meeting the Union objectives on climate and environment in line with the EU commitments made under the Paris Agreement.
Amendment 259 #
2018/0229(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) the Member State compartment shall address specific market failures or sub-optimal investment situations in one or several Member States to deliver objectives of the contributing Funds under shared management.
Amendment 262 #
2018/0229(COD)
Proposal for a regulation
Article 8 a (new)
Article 8 a (new)
Article 8a Additionality For the purposes of this Regulation, ‘additionality’ means the support by the InvestEU Fund of operations which address market failures or sub-optimal investment situations, such as long-term return on investments or higher risk financing needs for projects delivering longer-term environment and societal benefits, and which could not have been carried out during the period in which the EU guarantee can be used, or not to the same extent, by implementing partners without InvestEU Fund support. Projects supported by the InvestEU Fund shall support the objectives laid down in Article 3, shall strive to create long-term employment, public infrastructure, sustainable growth and contribute to achieving the climate objectives of the EU.
Amendment 265 #
2018/0229(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
Amendment 269 #
2018/0229(COD)
Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2
Article 9 – paragraph 2 – subparagraph 2
Amendment 272 #
2018/0229(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point a
Article 9 – paragraph 3 – point a
(a) the overall amount of the part of the EU guarantee under the Member State compartment pertaining to the Member State, its provisioning rate, the amount of the contribution from Funds under shared managementnational funds, the constitution phase of the provisioning in accordance with an annual financial plan and the amount of the resulting contingent liability to be covered by a back-to-back guarantee provided by the Member State concerned;
Amendment 275 #
2018/0229(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point d
Article 9 – paragraph 3 – point d
(d) the possible contribution from Ffunds under shared management to the InvestEU Advisory Hub;
Amendment 278 #
2018/0229(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 2
Article 9 – paragraph 4 – subparagraph 2
Where, within nine months from the signature of the contribution agreement, no guarantee agreement has been concluded or the amount of a contribution agreement is not fully committed through one or more guarantee agreements, the contribution agreement shall be terminated in the first case or amended accordingly in the second case and the unused amount of provisioning re-used pursuant to [Article 10(5)] of Regulation [[CPR] number] and Article [75(5)] of Regulation [[CAP plan] number].
Amendment 279 #
2018/0229(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 3
Article 9 – paragraph 4 – subparagraph 3
Amendment 280 #
2018/0229(COD)
(a) after the constitution phase referred to in point (a) of paragraph 3 of this Article, any annual surplus of provisions, calculated by comparing the amount of provisions required by the provisioning rate and the actual provisions, shall be re- used pursuant to [Article 10(6)] of the [CPR] and to Article [75(6)] of the [[CAP plan] number];
Amendment 292 #
2018/0229(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) comply with the conditions set out in [points (a) to (e) of Article 209(2)] of [the Financial Regulation], in particular with the additionality requirement set out in [point (b) of Article 209(2)] of [the Financial Regulation] and contribute to social, climate and environmental policy objectives of the European Union, where appropriate, maximising private investment in accordance with [point (d) of Article 209(2)] of the [Financial Regulation];
Amendment 293 #
2018/0229(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
(b) contribute, complement and are consistent to the Union policy objectives and fall under the scope of the areas eligible for financing and investment operations under the appropriate window in accordance with Annex II to this Regulation; and
Amendment 294 #
2018/0229(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point c
Article 11 – paragraph 1 – point c
(c) are econsistent with the investment guidelines.omically and financially viable, while taking into account the specific operating environment;
Amendment 295 #
2018/0229(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point c a (new)
Article 11 – paragraph 1 – point c a (new)
(ca) are technically viable and are sustainable from an environmental and social point of view, in accordance with Annex III to this Regulation.
Amendment 297 #
2018/0229(COD)
Proposal for a regulation
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
1a. The Invest EU Fund shall not support activities related to production, processing, distribution, storage or combustion of fossil fuels or CO2 transport infrastructure.
Amendment 310 #
2018/0229(COD)
(fa) Achieves additionality as laid out in Article 8a (new);
Amendment 350 #
2018/0229(COD)
Proposal for a regulation
Chapter 4 a (new)
Chapter 4 a (new)
All bodies participating in the decision- making and selection of projects shall act according to the principles of transparency, accountability and guaranteed stakeholder participation, including from civil society organisations. They should be composed of independent experts from various technical backgrounds, including climate experts, and aim for gender balance. Information on projects, selection procedure and decision-making shall be published, while respecting commercially sensitive information. (This amendment shall serve as introduction to the chapter and apply thus to Articles 17-19. It shall appear before Article 17 in the text.)
Amendment 352 #
2018/0229(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 a (new)
Article 20 – paragraph 1 – subparagraph 1 a (new)
The InvestEU Advisory Hub shall provide advisory support at regional and local level to promote projects with a climate, environmental and social impact and in line with the ‘Energy Efficiency First’ principle. Such support should also include a communication and a project development assistance component to continue building more capacity to develop sustainable projects and to aggregate smaller projects into larger ones.
Amendment 360 #
2018/0229(COD)
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. FCommensurate fees may be charged for the services referred to in paragraph 2 to cover part of the costs for providing those services.
Amendment 366 #
2018/0229(COD)
Proposal for a regulation
Article 20 – paragraph 6
Article 20 – paragraph 6
6. The InvestEU Advisory Hub shall have locala presence, where necessary. It shall be established in particular in Member States or in each Member State, with a particular focus on ensuring a presence in regions that face difficulties in developing projects under the InvestEU Fund. The InvestEU Advisory Hub shall assist in the transfer of knowledge to the regional and local level with a view to building up regional and local capacity and expertise for support referred to in paragraph 1.
Amendment 371 #
2018/0229(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The Commission shall report on the implementation of InvestEU Programme in accordance with [Articles 241 and 250] of the [Financial Regulation]. For that purpose, the implementing partners shall provide annually the information necessary to allow the Commission to comply with its reporting obligations. As part of the annual reporting, the Commission shall carry out annually, a robust, multi-annual consolidation exercise to identify whether climate expenditure is on track to achieve the 60% target. The Commission shall provide information on the scale and results of support to climate change objectives differentiating between mitigation and adaptation as well as information on the climate contribution of relevant financial instruments, and make this publicly available.
Amendment 373 #
2018/0229(COD)
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
5. In addition, each implementing partner shall submit every six months a report to the Commission on the financing and investment operations covered by this Regulation, broken down by the EU compartment and the Member State compartment by Member State, as appropriate. The report shall include an assessment of compliance with the requirements on the use of the EU guarantee and with the key performance indicators laid down in Annex III to this Regulation. The report shall also include operational, statistical, financial and accounting data on each financing and investment operation and at the compartment, policy window and the InvestEU Fund level. One of those reports shall contain the information the implementing partners shall provide in accordance with [Article 155(1)(a)] of the [Financial Regulation]. The Commission shall compile, and assess implementing partners’ reports and submit a summary in the form of public annual reports, providing information on the level of implementation of the programme against its objectives and performance indicators, indicating risks and opportunities for the financing and investment operations supported by the InvestEU programme.
Amendment 374 #
2018/0229(COD)
Proposal for a regulation
Article 22 – paragraph 5 a (new)
Article 22 – paragraph 5 a (new)
5a. The Commission, shall publish on their web-portal information on financing and investment operations, including information on expected impacts and benefits of the projects, taking into account the protection of confidential and commercially sensitive information. The web-portal shall also provide public access to a registry of eligible counterparts. In accordance with relevant transparency policies and Union rules on data protection and on access to documents and information, the implementing partners and other recipients of Union funds shall proactively and systematically make publicly available on their websites information relating to all financing and investment operations covered by this programme, relating in particular to the manner in which those projects contribute to the achievement of the objectives and requirements of this Regulation. Such information shall always take into account the protection of confidential and commercially sensitive information. Implementing partners shall make public Union support in all information, which they publish on financing and investment operations covered by this programme in accordance with this Regulation.
Amendment 383 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – introductory part
Annex II – paragraph 1 – introductory part
The financing and investment operations may fall under one or more of the following areas but shall not support activities related to production, processing, distribution, storage or combustion of fossil fuels, or CO2 transport infrastructure:
Amendment 389 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point a
Annex II – paragraph 1 – point 1 – point a
(a) expansion of theand accelerating the deployment of generation, supply or use of clean and sustainable renewable energy;
Amendment 394 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point d
Annex II – paragraph 1 – point 1 – point d
(d) production and supply of synthetic fuels from renewable/carbon-neutral sources; alternative fuels sources under the condition of a positive lifecycle impact and efficiency assessment;
Amendment 398 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point e
Annex II – paragraph 1 – point 1 – point e
Amendment 404 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 2 – point a
Annex II – paragraph 1 – point 2 – point a
(a) projects supporting the sustainable development of the TEN-T infrastructure and small scale projects, including its urban nodes, when targeted to multimodality and zero-emission technologies, sustainable maritime and inland ports, multimodal terminals and their connection to the main networks, as well as cross sectorial projects at those ports and terminals such as waste and water recycling and integrated electricity charging stations for ships when at berth;
Amendment 407 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 2 – point b
Annex II – paragraph 1 – point 2 – point b
(b) smart and sustainable urban mobility projects (targeting lowzero-emission urban transport modes, accessibility, air pollution and noise, energy consumption and accidents);
Amendment 408 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 2 – point c
Annex II – paragraph 1 – point 2 – point c
(c) supporting the renewal and retrofitting of transport mobile assets with the view of deploying lowzero-emission mobility solutions;
Amendment 409 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 2 – point d
Annex II – paragraph 1 – point 2 – point d
(d) railway infrastructure, other rail projects, andincluding regional cross-border missing links that were dismantled or abandoned in the past and sustainable maritime ports;
Amendment 414 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 2 – point e
Annex II – paragraph 1 – point 2 – point e
(e) alternative fuels infrastructure, including electric charging infrastructure.
Amendment 415 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3 – point c
Annex II – paragraph 1 – point 3 – point c
(c) projects and enterprises in the fields of environmental resource management and cleansustainable technologies;
Amendment 416 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3 – point f
Annex II – paragraph 1 – point 3 – point f
(f) climate change actions, including natural hazard disaster risk reduction, climate adaptation and mitigation;
Amendment 417 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3 – point g
Annex II – paragraph 1 – point 3 – point g
(g) projects and enterprises that implement circular economy by integrating resource and energy efficiency aspects in the production and product life-cycle, including the sustainable supplyrecycling of primary and secondary raw materials;
Amendment 419 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3 – point h
Annex II – paragraph 1 – point 3 – point h
(h) decarbonisation of and substantial reduction of emissions of energy-intensive industries, including large-scale demonstration of CCU and innovative lowzero-emission technologies and their deployment.
Amendment 426 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point a
Annex II – paragraph 1 – point 5 – point a
(a) research, including research infrastructure, regulatory frameworks and support to academia, and product development and innovation projects contributing to the objectives of [Horizon Europe];
Amendment 429 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point d
Annex II – paragraph 1 – point 5 – point d
(d) collaboration projects between academia and industry, public-private partnerships, and civil society, including patient and end-user organisations;
Amendment 433 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point f
Annex II – paragraph 1 – point 5 – point f
(f) new effectivand improved effective, accessible and affordable healthcare products, including pharmaceuticals, vaccines, medical devices, diagnostics and advanced therapy medicinal products, new antimicrobials and innovative development processes that avoid using animal testing.
Amendment 439 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point a
Annex II – paragraph 1 – point 6 – point a
(a) ethical artificial intelligence subject to prior assessment;
Amendment 441 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point d
Annex II – paragraph 1 – point 6 – point d
(d) blockchain and other distributed ledger technologies;
Amendment 442 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point e
Annex II – paragraph 1 – point 6 – point e
(e) advanceding digital skills;
Amendment 446 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 7 – introductory part
Annex II – paragraph 1 – point 7 – introductory part
7. Financial support to entities employing up to 3 000 employees, with a particular focus on SMEs and small mid- cap companieSMEs, in particular through:
Amendment 450 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 7 – point b a (new)
Annex II – paragraph 1 – point 7 – point b a (new)
(ba) Female entrepreneurship
Amendment 454 #
Amendment 456 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 11 – point c a (new)
Annex II – paragraph 1 – point 11 – point c a (new)
(ca) promotion of gender equality
Amendment 461 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 11 – point h
Annex II – paragraph 1 – point 11 – point h
(h) innovative health solutions, including e-health, health services and new care models;
Amendment 464 #
2018/0229(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 12
Annex II – paragraph 1 – point 12
Amendment 481 #
2018/0229(COD)
Proposal for a regulation
Annex III – point 3 – point 3.2
Annex III – point 3 – point 3.2
3.2 Investment supporting climate objectives, detailed per policy window and category, as well as share of climate relevance;
Amendment 485 #
2018/0229(COD)
Proposal for a regulation
Annex III – point 4 – point 4.2
Annex III – point 4 – point 4.2
4.2 Energy: Number of households with improved energy consumption classification, number of households renovated to NZEB and passive house standard;
Amendment 487 #
2018/0229(COD)
Proposal for a regulation
Annex III – point 4 – point 4.4
Annex III – point 4 – point 4.4
4.4 Transport: Investment mobilised in TEN-T of which: TEN-T core, small scale projects, other
Amendment 492 #
2018/0229(COD)
Proposal for a regulation
Annex III – point 5 – point 5.2 a (new)
Annex III – point 5 – point 5.2 a (new)
5.2a Contribution to tackling Global Societal Challenges within Horizon Europe: 'Health and well-being', 'Inclusive society’, ‘Resilient society’, ‘Sustainable food', 'Natural resources and the Environment’.
Amendment 494 #
2018/0229(COD)
Proposal for a regulation
Annex III – point 6 – introductory part
Annex III – point 6 – introductory part
6. Gender disaggregated data on SMEs
Amendment 496 #
2018/0229(COD)
Proposal for a regulation
Annex III – point 6 – point 6.1
Annex III – point 6 – point 6.1
6.1 Number of enterprises supported by size (micro, small, medium sized and small mid-caps)
Amendment 499 #
2018/0229(COD)
Proposal for a regulation
Annex III – point 7 – introductory part
Annex III – point 7 – introductory part
7. Gender disaggregated data on Social Investment and Skills
Amendment 78 #
2018/0227(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) A central role in the implementation of the Programme should be attributed to Digital Innovation Hubs, which should stimulate the broad adoption of advanced digital technologies by industry, by public organisations and academia. A network of Digital Innovation Hubs should ensure the widest geographical coverage across Europe59 . A first set of Digital Innovation Hubs will be selected based on Member States’ proposals and then the network will be enlarged through an open, transparent and competitive process. The Digital Innovation Hubs will serve as access points to latest digital capacities including high performance computing (HPC), artificial intelligence, cybersecurity, as well as other existing innovative technologies such as Key Enabling Technologies, available also in fablabs or citylabs. They shall act as single-entry points in accessing tested and validated technologies and promote open innovation. They will also provide support in the area of advanced digital skills. The network of Digital Innovation Hubs should also contribute to the participation of the outermost regions in the Digital Single Market. _________________ 59 As indicated in the Communication on Digitising European Industry (COM(2016) 180 final)
Amendment 95 #
2018/0227(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The advanced digital technologies supported by this Programme, such as high performance computing, cybersecurity, data protection and artificial intelligence are now sufficiently mature to move beyond the research arena and be deployed, implemented and scaled- up at Union level. Just as the deployment of these technologies require a Union response so does the skills dimension. Training opportunities in advanced digital skills need to be scaled up, increased and made accessible throughout the EU. Failing this could impede the smooth deployment of advanced digital technologies and hamper the overall competitiveness of Union’s economy. The actions supported by this programme are complementary to those supported by the ESF, ERDF and Horizon Europe programmes.
Amendment 100 #
2018/0227(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point e
Article 2 – paragraph 1 – point e
(e) ‘Digital Innovation Hub’ means legal entity designated or selected in an open and competitive procedure in order to fulfil the tasks under the Programme, in particular providing access to technological expertise and experimentation facilities, such as equipment and software tools to enable the digital transformation of the industry. The detailed conditions to be fulfilled in order to be designated as ‘Digital Innovation Hub’ and the tasks to be executed, shall be harmonised and announced in due time in order to allow for proper preparation and implementation of the actions.
Amendment 108 #
2018/0227(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point b a (new)
Article 3 – paragraph 1 – point b a (new)
(ba) support the uptake of advanced digital skills for the European citizens, giving proper consideration to social and economic transformations brought by the digitalisation and the gender perspective;
Amendment 109 #
2018/0227(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) deploy, coordinate at the Union level and operate an integrated world-class exascale77 supercomputing and data infrastructure in the Union that shall be accessible on a non-commercial basis to public and private users and for publicly funded research purposes; _________________ 77 Billions of billions of floating operations per second
Amendment 111 #
2018/0227(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) deploy and operate a post- exascale78 infrastructure, encourage the development of European hardware and software necessary for such deployment, including the integration with quantum computing technologies and develop new research infrastructures for computing science. _________________ 78 A thousand times faster than exascale A thousand times faster than exascale
Amendment 112 #
2018/0227(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) build up and strengthen core artificial intelligence capacities in the Union, including data resources and libraries of algorithms in compliance with data protection legislation and the principles of security and privacy by design and by default;
Amendment 116 #
2018/0227(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) make those capacities accessible to all businesses and public administrations;
Amendment 118 #
2018/0227(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) reinforce and network existing ethical artificial intelligence testing and experimentation facilities in Member States;
Amendment 123 #
2018/0227(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) support, together with Member States, the procurement of advanced cybersecurity equipment, tools and data infrastructures in order to achieve a common high level of cybersecurity at the European level, in full compliance with data protection legislation and fundamental rights;
Amendment 127 #
2018/0227(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) support the best use and the increase of European knowledge, capacity and skills related to cybersecurity;
Amendment 135 #
2018/0227(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
The financial intervention by the Union under Specific Objective 4. Advanced Digital skills shall support the development of advanced digital skills in areas supported by this programme, thus contributing to increase Europe’s talent pool, reducing the digital divide amongst European regions, eliminating the gender specific issues, fostering greater professionalism, especially with regard to high performance computing, big data analytics, data protection competencies, cybersecurity, distributed ledger technologies, robotics and artificial intelligence. The financial intervention shall pursue the following operational objectives:
Amendment 140 #
2018/0227(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) support the design and delivery of more long-term and requalification trainings and courses for students, the workforce, IT professionals and the workforce, researchers and academics;
Amendment 146 #
2018/0227(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point b
Article 7 – paragraph 1 – point b
(b) support the design and delivery of short-term trainings and courses for the workforce and entrepreneurs, including small business leaders and the workforceinnovators;
Amendment 149 #
2018/0227(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point c
Article 7 – paragraph 1 – point c
(c) support on-the-job trainings and traineeships for students, young entrepreneurs and graduateworkforce and entrepreneurs.
Amendment 155 #
2018/0227(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) deploy, operate and maintain trans- European interoperable state of the art Digital Service Infrastructures (including related services) in complementarity with national and regional actions;
Amendment 157 #
2018/0227(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point c
Article 8 – paragraph 1 – point c
(c) facilitate the development, update and use of solutions and frameworks by European public administrations, businesses and citizens, including open source and the re- use of interoperability solutions and frameworks;
Amendment 166 #
2018/0227(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point h
Article 8 – paragraph 1 – point h
(h) support cooperation towards achieving a European ecosystem for trusted infrastructures using distributed ledger services and applications, including support for interoperability and standardisation and fostering the deployment of EU cross- border applications;
Amendment 176 #
2018/0227(COD)
Proposal for a regulation
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
1a. Planning, development and procurement in the programme shall be done with a view to enhancing European Union competitiveness in the medium and long term. Priority shall be given to actions that increase the strategic potential and limit the dependence on suppliers and products from outside the European Union.
Amendment 180 #
2018/0227(COD)
Proposal for a regulation
Article 12 – paragraph 5 a (new)
Article 12 – paragraph 5 a (new)
5a. Actions that limit technology transfers outside the European Union shall be given priority. With a view to ensuring long-term strategic security objectives, an opportunity evaluation shall be done for the participation of entities not having their main establishment in the European Union.
Amendment 185 #
2018/0227(COD)
Proposal for a regulation
Article 16 – paragraph 2 – introductory part
Article 16 – paragraph 2 – introductory part
2. For the purpose of the establishment of the network mentioned in paragraph 1, each Member State shall designate candidate entities based on harmonised rules, through an open, transparent and competitive process, on the basis of the following criteria:
Amendment 201 #
2018/0227(COD)
Proposal for a regulation
Article 20 – paragraph 1 – point e
Article 20 – paragraph 1 – point e
(e) where applicable, the economic, social, climate and environmental impact, gender balance opportunities and accessibility;
Amendment 1158 #
2018/0224(COD)
Proposal for a regulation
Article 15 – paragraph 1 – subparagraph 2
Article 15 – paragraph 1 – subparagraph 2
Particular attention shall be paid to the principle of proportionality, the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity of a person, the right to non-discrimination and the need to ensure high levels of human health protection. Particular attention shall also be paid to the intrinsic value of animals and their right to be treated as sentient creatures.
Amendment 1161 #
2018/0224(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point d
Article 15 – paragraph 2 – point d
(d) for activities making use of human embryonic stem cells or animals, as appropriate, details of licensing and control measures that shall be taken by the competent authorities of the Member States concerned as well as details of the ethics approvals that shall be obtained before the activities concerned start.
Amendment 1163 #
2018/0224(COD)
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
3. Proposals shall be systematically screened to identify those actions raising complex or serious ethics issues and submit them to an ethics assessment. The ethics assessment shall be carried out by the Commission unless it is delegated to the funding body. For actions involving the use of animals, human embryonic stem cells or human embryos, an ethics assessment shall be mandatory. Ethics screenings and assessments shall be carried out with the support of ethics experts. The Commission and the funding bodies shall ensure the transparency of the ethics procedures as much as possible.
Amendment 1467 #
2018/0224(COD)
Proposal for a regulation
Article 45 – paragraph 3 a (new)
Article 45 – paragraph 3 a (new)
3a. Adopted scientific methods and approaches that can provide scientific evidence and technical support to Union policies shall be reported by the recipients of Union funds to the Commission or funding body. The Commission shall clarify information requirements, paying particular attention to actions raising ethical issues according to Article 15. Such information shall not compromise protection of intellectual property.
Amendment 135 #
2018/0217(COD)
Proposal for a regulation
Recital 25 c (new)
Recital 25 c (new)
(25 c) Following the principle of budgetary efficiency, concentrated feeding operations should not be financed under the CAP.
Amendment 219 #
2018/0217(COD)
Proposal for a regulation
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3 a. The EAGF shall not finance concentrated feeding operations, following the principle of budgetary efficiency.
Amendment 221 #
2018/0217(COD)
Proposal for a regulation
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
Following the principle of budgetary efficiency, interventions that lead support concentrated feeding operations shall not be financed under the EAFRD.
Amendment 137 #
2018/0216(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Member States should set farm advisory services for the purpose of improving the sustainable management and overall performance of agricultural holdings and rural businesses, covering economic, environmental and social dimensions, and to identify the necessary improvements as regards all measures at farm level provided for in the CAP Strategic Plans. These farm advisory services should help farmers and other beneficiaries of CAP support to become more aware of the relationship between farm management and land management on the one hand, and certain standards, requirements and information, including animal welfare, environmental and climate ones, on the other hand. The list of the latter includes standards applying to or necessary for farmers and other CAP beneficiaries and set in the CAP Strategic Plan, as well as those stemming from the legislation on water, on the sustainable use of pesticides, as well as the initiatives to combat antimicrobial resistance and the management of risks. In order to enhance the quality and effectiveness of the advice, Member States should integrate advisors within the Agricultural Knowledge and Innovation Systems (AKIS), in order to be able to deliver up-to-date technological and scientific information developed by research and innovation.
Amendment 167 #
2018/0216(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) Member States should be allowed to use part of their financial ceiling available for direct payments for coupled income support in order to improve competitiveness, sustainability, and/or quality in certain sectors and productions that are particularly important for social, economic or environmental reasons and undergo certain difficulties. Support should be conditional on the respect of strict sustainability criteria, including on animal welfare, and animal health. Furthermore, Member States should also be allowed to use an additional part of their financial ceiling available for direct payments to grant coupled income support specifically for the support of protein crop production in order to reduce the Union's deficit in this regard.
Amendment 209 #
2018/0216(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) EAFRD should not provide support to investments that would harm the environment, endanger human or animal health or are unable to meet animal welfare requirements. Hence it is necessary to provide in this Regulation a number of exclusion rules, as well as the possibility to further develop these guarantees in delegated acts. Notably, the EAFRD should not finance investments in irrigation which do not contribute towards the achievement, or the preservation, of good status of the associated water body or bodies and investments in afforestation which are not consistent with climate and environmental objectives in line with sustainable forest management principles.
Amendment 221 #
2018/0216(COD)
Proposal for a regulation
Recital 52 a (new)
Recital 52 a (new)
(52a) In order to improve animal health and animal welfare in accordance with best available scientific knowledge and societal demands, Member States should reserve at least 5% of the total EAFRD contribution to their Strategic Plan for measures supporting practices exceeding standards in the existing Union legislation on animal welfare.
Amendment 245 #
2018/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point b a (new)
Article 3 – paragraph 1 – point b a (new)
(ba) 'stocking density' means the total weight of animals which are present in a house at the same time per square metre of useable area.
Amendment 433 #
2018/0216(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point i a (new)
Article 6 – paragraph 1 – point i a (new)
(ia) improve animal welfare in line with Treaty provisions, best available scientific knowledge, and societal demands.
Amendment 454 #
2018/0216(COD)
Proposal for a regulation
Article 9 – paragraph 1 a (new)
Article 9 – paragraph 1 a (new)
Member States shall ensure the integration of a gender perspective throughout the preparation, implementation and evaluation of the interventions, with the aim to promote gender equality and combat gender discrimination.
Amendment 611 #
2018/0216(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1 – point b
Article 15 – paragraph 2 – subparagraph 1 – point b
Amendment 673 #
2018/0216(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Member States should set farm advisory services for the purpose of improving the sustainable management and overall performance of agricultural holdings and rural businesses, covering economic, environmental and social dimensions, and to identify the necessary improvements as regards all measures at farm level provided for in the CAP Strategic Plans. These farm advisory services should help farmers and other beneficiaries of CAP support to become more aware of the relationship between farm management and land management on the one hand, and certain standards, requirements and information, including animal welfare, environmental and climate ones, on the other hand. The list of the latter includes standards applying to or necessary for farmers and other CAP beneficiaries and set in the CAP Strategic Plan, as well as those stemming from the legislation on water, on the sustainable use of pesticides, as well as the initiatives to combat antimicrobial resistance and the management of risks. In order to enhance the quality and effectiveness of the advice, Member States should integrate advisors within the Agricultural Knowledge and Innovation Systems (AKIS), in order to be able to deliver up-to-date technological and scientific information developed by research and innovation.
Amendment 696 #
2018/0216(COD)
Proposal for a regulation
Title 3 – chapter 2 – section 2 – subsection 4 – title
Title 3 – chapter 2 – section 2 – subsection 4 – title
Schemes for the climate and, the environment and animal welfare
Amendment 698 #
2018/0216(COD)
Proposal for a regulation
Title 3 – chapter 2 – section 2 – subsection 4 – title
Title 3 – chapter 2 – section 2 – subsection 4 – title
schemes for the climate and, the environment and animal welfare
Amendment 701 #
2018/0216(COD)
Proposal for a regulation
Article 28 – title
Article 28 – title
Amendment 708 #
2018/0216(COD)
Proposal for a regulation
Article 28 – paragraph 1
Article 28 – paragraph 1
1. Member States shall provide support for voluntary schemes for the climate and, the environment and animal welfare ('eco- schemes') under the conditions set out in this Article and as further specified in their CAP Strategic Plans.
Amendment 739 #
2018/0216(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Member States shall establish the list of agricultural practices beneficial for the climate and, the environment and the wellbeing of farmed animals.
Amendment 754 #
2018/0216(COD)
Proposal for a regulation
Article 28 – paragraph 4
Article 28 – paragraph 4
4. Those practices shall be designed to meet one or more of the specific environmental-, climate-related and clanimatl welfare-related objectives laid down in points (d), (e), (f) and (fia) of Article 6(1).
Amendment 772 #
2018/0216(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) Member States should be allowed to use part of their financial ceiling available for direct payments for coupled income support in order to improve competitiveness, sustainability, and/or quality in certain sectors and productions that are particularly important for social, economic or environmental reasons and undergo certain difficulties. Support should be conditional to the respect of strict sustainability criteria, including on animal welfare and animal health. Furthermore, Member States should also be allowed to use an additional part of their financial ceiling available for direct payments to grant coupled income support specifically for the support of protein crop production in order to reduce the Union's deficit in this regard.
Amendment 826 #
2018/0216(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. Where the coupled income support concerns bovine animals or sheep and goats, Member States shall define as eligibility conditions for the support the requirements to identify and register the animals in compliance with Regulation (EC) No 1760/2000 of the European Parliament and of the Council32 or Council Regulation (EC) No 21/200433 respectively. However, without prejudice to other applicable eligibility conditions, bovine animals or sheep and goats shall be considered as eligible for support as long as the identification and registration requirements are met by a certain date in the claim year concerned to be fixed by the Member States. __________________ 32 __________________ 32 Regulation (EC) No 1760/2000 of the Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 (OJ L 204, 11.8.2000, p. 1). 33 Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC (OJ L 5, 9.1.2004, p. 8).
Amendment 830 #
2018/0216(COD)
Proposal for a regulation
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
2a. Where the coupled income support concerns livestock productions, only methods of production that go beyond the minimum national and Union standards for animal welfare and animal health shall be considered as eligible for support.
Amendment 936 #
2018/0216(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) EAFRD should not provide support to investments that would harm the environment, endanger human or animal health, or are unable to meet animal welfare requirements. Hence it is necessary to provide in this Regulation a number of exclusion rules, as well as the possibility to further develop these guarantees in delegated acts. Notably, the EAFRD should not finance investments in irrigation which do not contribute towards the achievement, or the preservation, of good status of the associated water body or bodies and investments in afforestation which are not consistent with climate and environmental objectives in line with sustainable forest management principles.
Amendment 952 #
2018/0216(COD)
Proposal for a regulation
Recital 52 a (new)
Recital 52 a (new)
(52 a) In order to improve animal health and animal welfare in accordance with best available scientific knowledge and societal demands, Member States should reserve at least 5% of the total EAFRD contribution to their Strategic Plan for measures supporting practices exceeding standards in the existing Union legislation on animal welfare.
Amendment 1098 #
2018/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point b a (new)
Article 3 – paragraph 1 – point b a (new)
(b a) 'stocking density' means the total live weight of animals which are present in a house at the same time per square metre of useable area;
Amendment 1170 #
2018/0216(COD)
Proposal for a regulation
Article 68 – paragraph 3 – subparagraph 1 – point h a (new)
Article 68 – paragraph 3 – subparagraph 1 – point h a (new)
(ha) investments in infrastructures which are not consistent with recommendations to support good animal health and animal welfare, and the principles laid down in Council Directive 98/58/EC concerning the protection of animals kept for farming purposes, in particular the provision of housing, food, water and care appropriate to the physiological and ethological needs of the animals, in accordance with established experience and best available scientific knowledge.
Amendment 1201 #
2018/0216(COD)
Proposal for a regulation
Article 69 – paragraph 2 a (new)
Article 69 – paragraph 2 a (new)
2a. Member States shall make sure that interventions referred to in this article are distributed in a way that contributes to achieving gender equality in rural areas.
Amendment 1290 #
2018/0216(COD)
Proposal for a regulation
Article 86 – paragraph 2 a (new)
Article 86 – paragraph 2 a (new)
2a. At least 30% of the total EAFRD contribution to the CAP Strategic Plan as set out in Annex IX shall be reserved for interventions addressing the specific environmental-, climate- and animal welfare-related objectives set out in points (d), (e), (f), and (ia) of Article 6(1) of this Regulation, excluding interventions based on Article 66.
Amendment 1292 #
2018/0216(COD)
Proposal for a regulation
Article 86 – paragraph 3 a (new)
Article 86 – paragraph 3 a (new)
3a. At least 5% of the total EAFRD contribution to the CAP Strategic Plan as set out in Annex IX shall be reserved for interventions addressing the specific animal welfare-related objective set out in point (ia) of Article 6(1), excluding interventions based on Article 66.
Amendment 1360 #
2018/0216(COD)
Proposal for a regulation
Article 92 – paragraph 1
Article 92 – paragraph 1
1. Member States shall aim to make, through their CAP Strategic Plans and in particular through the elements of the intervention strategy referred to in point (a) of Article 97(2), a greater overall contribution to the achievement of the specific environmental- and, climate- and animal welfare-related objectives set out in points (d), (e), (f) and (fia) of Article 6(1) in comparison to the overall contribution made to the achievement of the objective laid down in point (b) of the first subparagraph of Article 110(2) of Regulation (EU) No 1306/2013 through support under the EAGF and the EAFRD in the period 2014 to 2020.
Amendment 1423 #
2018/0216(COD)
Proposal for a regulation
Article 97 – paragraph 2 – point e a (new)
Article 97 – paragraph 2 – point e a (new)
(ea) an explanation of how the CAP Strategic Plan ensures gender mainstreaming and contributes to the objective to achieve gender equality;
Amendment 1491 #
2018/0216(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point i a (new)
Article 6 – paragraph 1 – point i a (new)
(i a) improve animal welfare in line with Treaty provisions, best available scientific knowledge and societal demands.
Amendment 1623 #
2018/0216(COD)
Proposal for a regulation
Annex I –Impact indicators – I.25 a (new)
Annex I –Impact indicators – I.25 a (new)
I.25a Attracting women farmers: Evolution of number of women farmers
Amendment 1624 #
2018/0216(COD)
Proposal for a regulation
Annex I –Impact indicators – I.25 b (new)
Annex I –Impact indicators – I.25 b (new)
I.25b Contributing to increase women’s employment rate in rural areas: Evolution of women’s employment rate in rural areas
Amendment 1625 #
2018/0216(COD)
Proposal for a regulation
Annex I –Impact indicators – I.25 d (new)
Annex I –Impact indicators – I.25 d (new)
I.25d Promoting rural inclusion: Evolution of income of women in rural areas, evolution of poverty index among women in rural areas
Amendment 1629 #
2018/0216(COD)
Proposal for a regulation
Annex I –Result indicators – R.35 a (new)
Annex I –Result indicators – R.35 a (new)
R.35a Improving gender balance: Number of women farmers setting up a farm with support from the CAP
Amendment 1631 #
2018/0216(COD)
Proposal for a regulation
Annex I – Result indicators – R.35 b (new)
Annex I – Result indicators – R.35 b (new)
R.35b Growth and jobs in rural areas: New jobs for women in supported projects
Amendment 1632 #
2018/0216(COD)
Proposal for a regulation
Annex I – Result indicators – R.35 c (new)
Annex I – Result indicators – R.35 c (new)
R.35c Promoting social inclusion: Number of women from minority and/or vulnerable groups benefitting from supported social inclusion projects number of small farmers according to Eurostat definitions
Amendment 2282 #
2018/0216(COD)
Proposal for a regulation
Title 3 – chapter 2 – section 2 – subsection 4 – title
Title 3 – chapter 2 – section 2 – subsection 4 – title
Amendment 2285 #
2018/0216(COD)
Proposal for a regulation
Article 28 – title
Article 28 – title
Schemes for the climate and, the environment and animal welfare
Amendment 2291 #
2018/0216(COD)
Proposal for a regulation
Article 28 – paragraph 1
Article 28 – paragraph 1
1. Member States shall provide support for voluntary schemes for the climate and, the environment and animal welfare (‘eco- schemes’) under the conditions set out in this Article and as further specified in their CAP Strategic Plans.
Amendment 2347 #
2018/0216(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Member States shall establish the list of agricultural practices beneficial for the climate and, the environment and the wellbeing of farmed animals.
Amendment 2365 #
2018/0216(COD)
Proposal for a regulation
Article 28 – paragraph 4
Article 28 – paragraph 4
4. Those practices shall be designed to meet one or more of the specific environmental-, climate- and clanimatl welfare-related objectives laid down in points (d), (e), (f) and (fia) of Article 6(1).
Amendment 2499 #
2018/0216(COD)
Proposal for a regulation
Article 29 – paragraph 3 a (new)
Article 29 – paragraph 3 a (new)
3a. The Commission shall ensure in line with chapter III of title V that coupled support for livestock shall only be granted to farms that stay within a defined maximum livestock stocking density for a given river basin 1a. _________________ 1a As defined in Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for the Community action in the field of water policy
Amendment 2541 #
2018/0216(COD)
Proposal for a regulation
Article 31 – paragraph 1 a (new)
Article 31 – paragraph 1 a (new)
1a. Beneficiaries shall only be eligible for coupled payments if their standards of production are higher than the relevant minimum environmental and animal welfare standards in force
Amendment 2544 #
2018/0216(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. Where the coupled income support concerns bovine animals or sheep and goats, Member States shall define as part of the eligibility conditions for the support the requirements to identify and register the animals in compliance with Regulation (EC) No 1760/2000 of the European Parliament and of the Council32 or Council Regulation (EC) No 21/200433 respectively. However, without prejudice to other applicable eligibility conditions, bovine animals or sheep and goats shall be considered as eligible for support as long as the identification and registration requirements are met by a certain date in the claim year concerned to be fixed by the Member States.
Amendment 2550 #
2018/0216(COD)
Proposal for a regulation
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
2a. When the coupled income support concerns bovine animals or sheeps and goats, Member States may only support animals raised in a grass-fed, pasture- based grazing system and with significantly higher environmental or animal welfare results.
Amendment 2551 #
2018/0216(COD)
Proposal for a regulation
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
2a. Where the coupled income support concerns livestock productions, only methods of production that go beyond the minimum national and Union standards for animal welfare and animal health shall be considered as eligible for support.
Amendment 2554 #
2018/0216(COD)
Proposal for a regulation
Article 31 – paragraph 2 b (new)
Article 31 – paragraph 2 b (new)
2b. The Commission and Member States shall ensure though the procedure outlined in title V of this regulation, that the CAP strategic plans contain provisions to ensure that by the end of the strategic plan programming period, the total livestock stocking density per Member State shall not exceed 0.7 livestock units per hectare.
Amendment 2555 #
2018/0216(COD)
Proposal for a regulation
Article 31 – paragraph 2 c (new)
Article 31 – paragraph 2 c (new)
2c. Concentrated animal feeding operations shall not be eligible for coupled support.
Amendment 3538 #
2018/0216(COD)
Proposal for a regulation
Article 68 – paragraph 3 – subparagraph 1 – point h a (new)
Article 68 – paragraph 3 – subparagraph 1 – point h a (new)
(ha) investments in infrastructures which are not consistent with recommendations to support good animal health and animal welfare, and the principles laid down in Council Directive 98/58/EC concerning the protection of animals kept for farming purposes, in particular the provision of housing, food, water and care appropriate to the physiological and ethological needs of the animals, in accordance with established experience and best available scientific knowledge.
Amendment 4009 #
2018/0216(COD)
Proposal for a regulation
Article 86 – paragraph 2 – subparagraph 1
Article 86 – paragraph 2 – subparagraph 1
At least 30% of the total EAFRD contribution to the CAP Strategic Plan as set out in Annex IX shall be reserved for interventions addressing the specific environmental-, climate- and clanimatl welfare-related objectives set out in points (d), (e), (f) and (fia) of Article 6(1) of this Regulation, excluding interventions based on Article 66.
Amendment 4050 #
2018/0216(COD)
Proposal for a regulation
Article 86 – paragraph 3 a (new)
Article 86 – paragraph 3 a (new)
3a. At least 5% of the total EAFRD contribution to the CAP Strategic Plan as set out in Annex IX shall be reserved for interventions addressing the specific animal welfare-related objective set out in point (ia) of Article 6(1), excluding interventions based on Article 66.
Amendment 4243 #
2018/0216(COD)
Proposal for a regulation
Article 92 – paragraph 1
Article 92 – paragraph 1
1. Member States shall aim to make, through their CAP Strategic Plans and in particular through the elements of the intervention strategy referred to in point (a) of Article 97(2), a greater overall contribution to the achievement of the specific environmental- and, climate- and animal welfare-related objectives set out in points (d), (e), (f) and (fia) of Article 6(1) in comparison to the overall contribution made to the achievement of the objective laid down in point (b) of the first subparagraph of Article 110(2) of Regulation (EU) No 1306/2013 through support under the EAGF and the EAFRD in the period 2014 to 2020.
Amendment 5087 #
2018/0216(COD)
Proposal for a regulation
Annex I – Impact indicators – I.28 a (new)
Annex I – Impact indicators – I.28 a (new)
I.28a Decrease of non-compliance rate, per animal welfare SMR
Amendment 5088 #
2018/0216(COD)
Proposal for a regulation
Annex I – Impact indicators – I.28 b (new)
Annex I – Impact indicators – I.28 b (new)
I.28b Evolution of stocking density rate, per species
Amendment 5091 #
2018/0216(COD)
Proposal for a regulation
Annex I – EU Specific objectives – point 9 a (new)
Annex I – EU Specific objectives – point 9 a (new)
Improve animal welfare in line with Treaty provisions, best available scientific knowledge and societal demands
Amendment 5134 #
2018/0216(COD)
Proposal for a regulation
Annex III – Climate and environment – GAEC 5 a (new)
Annex III – Climate and environment – GAEC 5 a (new)
Requirements and standards: Maximum livestock densities within the carrying capacity of the river basin, linked to area of fodder or pasture grazing for ruminants Main objective of the standard Closed loop nutrient cycling, minimising excess nutrient losses and water pollution
Amendment 5140 #
2018/0216(COD)
Proposal for a regulation
Annex III – GAEC 6 – Requirements and standards
Annex III – GAEC 6 – Requirements and standards
Amendment 5159 #
2018/0216(COD)
Proposal for a regulation
Annex III – GAEC 8
Annex III – GAEC 8
Amendment 5234 #
2018/0216(COD)
Proposal for a regulation
Annex III – SMR 15 a (new)
Annex III – SMR 15 a (new)
Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens (OJ L 203, 3.8.1999, p. 53): Articles 3 to 6
Amendment 5235 #
2018/0216(COD)
Proposal for a regulation
Annex III – SMR 15 b (new)
Annex III – SMR 15 b (new)
Council Directive 2007/43/EC of 28 June 2007 laying down minimum rules for the protection of chickens kept for meat production (OJ L 182, 12.7.2007, p. 19) Article 3
Amendment 5236 #
2018/0216(COD)
Proposal for a regulation
Annex III – SMR 15 c (new)
Annex III – SMR 15 c (new)
Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1) Article 3
Amendment 5237 #
2018/0216(COD)
Proposal for a regulation
Annex III – SMR 15 d (new)
Annex III – SMR 15 d (new)
Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, p. 1) Articles 3 and 4
Amendment 5241 #
2018/0216(COD)
Proposal for a regulation
Annex III – SMR 16 a (new)
Annex III – SMR 16 a (new)
Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (when animals are slaughtered in the farm): Articles 3 to 9
Amendment 5242 #
2018/0216(COD)
Proposal for a regulation
Annex III – SMR 16 b (new)
Annex III – SMR 16 b (new)
Council Directive 2007/43/EC of 28 June 2007 laying down minimum rules for the protection of chickens kept for meat production (‘Broiler Directive’): Article 3
Amendment 5243 #
2018/0216(COD)
Proposal for a regulation
Annex III – SMR 16 c (new)
Annex III – SMR 16 c (new)
Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens: Articles 3 and 4
Amendment 70 #
2018/0205(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point 2 – point a
Article 6 – paragraph 1 – point 2 – point a
Directive 2010/63/EU
Article 54 – paragraph 1 – subparagraph 3
Article 54 – paragraph 1 – subparagraph 3
Amendment 71 #
2018/0205(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point 2 – point a
Article 6 – paragraph 1 – point 2 – point a
Directive 2010/63/EU
Article 54 – paragraph 1 a (new)
Article 54 – paragraph 1 a (new)
1a. The Commission shall, no later than 10 November 2020 and at least every five years thereafter, carry out an evaluation of this Directive and of its implementation, based in particular on the information received from the Member States pursuant to Article 54(1), and taking into account advancements in the development of alternative methods not entailing the use of animals. The Commission shall report to the European Parliament and to the Council on the results of this evaluation and accompany such reports, if necessary, by appropriate legislative proposals.
Amendment 51 #
2018/0172(COD)
Proposal for a directive
Recital 1
Recital 1
(1) The high functionality and relatively low cost of plastic means that this material is increasingly ubiquitous in everyday life. ItPlastic's growing use in short- lived applications, which are not designed for re- use or cost-effective recycling means that related production and consumption patterns have become increasingly inefficient and linear. Therefore, in the context of the Circular Economy Action Plan32 , the Commission concluded in the European Strategy for Plastics33 that the steady increase in plastic waste generation and its leakage into our environment, in particular into the marine environment but also into terrestrial and aquatic environments, must be tackled in order to achieve a truly circular lifecycle for plastics. __________________ 32 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions "Closing the loop – An EU action plan for the Circular Economy" (COM(2015)0614 final). 33 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions "A European Strategy for Plastics in a Circular Economy" (COM(2018)28 final).
Amendment 69 #
2018/0172(COD)
Proposal for a directive
Recital 5
Recital 5
(5) In the Union, 80 to 85 % of marine litter, measured as beach litter counts, is plastic, with single-use plastic items representing 50 % and fishing-related items representing 27 %. Single-use plastics products include a diverse range of commonly used fast-moving consumer products that are discarded after having been used once for the purpose for which they were provided, are rarely recycled, and are prone to littering. A significant proportion of the fishing gear placed on the market is not collected for treatment. Single-use plastic products and fishing gear containing plastic are therefore a particularly serious problem in the context of marine litter and pose a severe risk to marine ecosystems, biodiversity and, potentially, to humans well as to human and animal health, and are damaging activities such as tourism, fisheries and shipping.
Amendment 72 #
2018/0172(COD)
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5 a) The Union should adopt a comprehensive approach to the problem of microplastics and should encourage all producers to eliminate microplastic ingredients from their formulations and prevent loss of microplastics to the environment. The REACH Regulation restriction procedure should target the widest restriction scope for intentionally added microplastics, while the Union should also urgently adopt measures to tackle the largest direct sources of unintentionally formed microplastics which end up in the aquatic and terrestrial environment, with particular attention to textile and tyre manufacturers and prevention of pre-production pellet loss.
Amendment 91 #
2018/0172(COD)
Proposal for a directive
Recital 7 a (new)
Recital 7 a (new)
(7 a) In addition, terrestrial plastic pollution can potentially be an even more significant threat to the environment, pose a threat to animal health and be of an even larger quantity than marine plastic pollution.
Amendment 197 #
2018/0172(COD)
Proposal for a directive
Recital 20
Recital 20
(20) Beverage bottles that are single-use plastic products are one of the most found marine litter items on the beaches in the Union. This is due to ineffective separate collection systems and low participation in those systems by the consumers. It is necessary to promote more efficient separate collection systems and therefore,the physical and chemical qualities of plastics, which make them resistant to degradation and therefore persistent in the environment for decades or centuries after fulfilling their purpose. It is necessary to promote the reduction in consumption of these products, to increase their production from recycled content, as well as to promote more efficient separate collection systems and therefore, a Union-wide consumption reduction target and a recycled content target should be established, and a minimum separate collection target should be established for beverage bottles that are single-use plastic products. Member States should be able to achieve that minimum separate collection target by setting separate collection targets for beverage bottles that are single-use plastic products in the framework of the extended producer responsibility schemes or by establishing deposit refund schemes or by any other measure that they find appropriate. This will have a direct, positive impact on the collectionoverall quantity of bottle waste generated, the collection and recycling rate, the quality of the collected material and the quality of the recyclates, offering opportunities for the recycling business and the market for the recyclate. In accordance with the Drinking Water Directive, Member States should be required to take the necessary measures to achieve a significant reduction of single- use plastic beverage bottles, by ensuring that equipment to freely access tap water is available in all cities. Additionally, multi-use bottles should be encouraged as a sustainable alternative.
Amendment 223 #
2018/0172(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
The objective of this Directive is to prevent and reduce the impact of certain plastic products on the environment, in particular in the aquatic and in the terrestrial environment, and on human health as well as to promote the transition to a non-toxic circular economy withby reducing the consumption of single-use products, and by promoting sustainable, innovative business models, and non-toxic re-usable products and materials, thus also contributing to the efficient functioning of the internal market.
Amendment 293 #
2018/0172(COD)
Proposal for a directive
Article 4 – paragraph 1 – subparagraph 1 a (new)
Article 4 – paragraph 1 – subparagraph 1 a (new)
Member States shall also take the necessary measures to achieve a 30% reduction by 2025 and a 50% reduction by 2030 in the consumption of indent 2a and 2b of Part A of the Annex.
Amendment 447 #
2018/0172(COD)
Proposal for a directive
Article 9 – paragraph 1 – point b a (new)
Article 9 – paragraph 1 – point b a (new)
(b a) Member States shall ensure that plastic bottles are made with at least 60% recycled content by 2025 and at least 70% recycled content by 2030.
Amendment 462 #
2018/0172(COD)
Proposal for a directive
Article 10 – paragraph 1 – point b
Article 10 – paragraph 1 – point b
(b) the impact of littering and other inappropriate waste disposal of those products and fishing gear containing plastic on the environment, and in particular on the marine environmentthose plastic products and fishing gear and its chemical composition, on the environment, and in particular on the aquatic and terrestrial environment as well as on human health, in particular the impact of littering and other inappropriate disposal of those products.
Amendment 544 #
Amendment 606 #
2018/0172(COD)
Proposal for a directive
Annex I – part B – indent 6 c (new)
Annex I – part B – indent 6 c (new)
- Tea bags made wholly or partly from plastic
Amendment 609 #
2018/0172(COD)
Proposal for a directive
Annex I – part B – indent 6 d (new)
Annex I – part B – indent 6 d (new)
- Coffee pods made wholly or partly from plastic
Amendment 670 #
2018/0172(COD)
Proposal for a directive
Annex I – part E – indent 8 a (new)
Annex I – part E – indent 8 a (new)
- Agricultural plastics, including mulch film
Amendment 1 #
2017/0237(COD)
Council position
Recital 37
Recital 37
Amendment 2 #
2017/0237(COD)
Council position
Article 9 – paragraph 3 a (new)
Article 9 – paragraph 3 a (new)
3 a. Railway undertakings in cooperation with station managers and infrastructure managers shall indicate in timetables information about accessible train connections and stations.
Amendment 3 #
2017/0237(COD)
Council position
Article 12 – paragraph 1 – subparagraph 1
Article 12 – paragraph 1 – subparagraph 1
For the purpose of the first subparagraph the term ‘sole railway undertaking’ shall also include all railway undertakings which are eieither have at least half of their whollyshares owned by the same owner or which are wholly-owned subsidiary undertakings of one of the railway undertakings involved.
Amendment 4 #
2017/0237(COD)
Council position
Article 18 – paragraph 3 – subparagraph 1
Article 18 – paragraph 3 – subparagraph 1
Where the available re-routing options are not communicated to the passenger within 1060 minutes from the scheduled departure time of the delayed or cancelled service or the missed connection, the passenger shall be entitled to conclude such a contract with other providers of public transport services by rail, coach or bus. The railway undertaking shall reimburse the passenger for the necessary, appropriate and reasonable costs that he or she incurs.
Amendment 5 #
2017/0237(COD)
Council position
Article 19 – paragraph 1 – point a
Article 19 – paragraph 1 – point a
(a) 250 % of the ticket price for a delay of 60 to 1190 minutes;
Amendment 6 #
2017/0237(COD)
Council position
Article 19 – paragraph 1 – point b
Article 19 – paragraph 1 – point b
(b) 750 % of the ticket price for a delay of 9120 minutes or more.
Amendment 7 #
2017/0237(COD)
Council position
Article 19 – paragraph 10
Article 19 – paragraph 10
Amendment 8 #
2017/0237(COD)
Council position
Article 24 – paragraph 1 – point a – introductory part
Article 24 – paragraph 1 – point a – introductory part
(a) assistance in stations shall be provided during times rail services operate on condition that the railway undertaking, the station manager, the ticket vendor or the tour operator with which the ticket was purchased, or the Single Point of Contact referred to in point (f), where applicable, is notified of the passenger’s need for such assistance at least 124 hours before the assistance is needed. A single notification per journey shall be sufficientIn stations where daily traffic exceeds 10 000 passengers per day, no pre-notification is needed, however, the person in need of assistance shall be at the respective station at least 30 minutes before the departure of the train. In stations where daily traffic is between 2 000 and 10 000 passengers per day, the notification shall be reduced to maximum three hours. Such notifications shall be forwarded to all other railway undertakings and station managers involved in the person’s journey.;
Amendment 9 #
2017/0237(COD)
Council position
Article 24 – paragraph 1 – point a – paragraph 2
Article 24 – paragraph 1 – point a – paragraph 2
Where a ticket or season ticket permits multiple journeys, one notification shall be sufficient provided that adequate information on the timing of subsequent journeys is provided, and in any case at least 24 hours before the first time the assistance is needed. The passenger or his/her representative shall make all reasonable efforts to inform of any annulation of such subsequent journeys at least 12 hours in advance.
Amendment 10 #
2017/0237(COD)
Council position
Article 24 – paragraph 1 – point a – paragraph 3
Article 24 – paragraph 1 – point a – paragraph 3