1054 Amendments of Tomislav SOKOL
Amendment 18 #
2023/2081(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas there are several voluntary front-of-pack nutrition labelling schemes present currently within the EU single market which cause its fragmentation and may confuse consumers;
Amendment 33 #
2023/2081(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. Whereas it has been estimated that in the EU in 2017 over 950,000 deaths (one out of five) and over 16 million lost healthy life years were attributable to unhealthy diets, mainly cardiovascular diseases and cancers;
Amendment 92 #
2023/2081(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the European Commission to present as soon as possible a science based legislative proposal on harmonized and mandatory front-of-pack nutrition labeling which will respect the specificities of certain food products such as olive oil;
Amendment 113 #
2023/2081(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
Amendment 115 #
2023/2081(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Considers it essential to promptly review, in line with the provisions of Regulation (EC) No 1924/2006, the yet-to- be-assessed health claims related to botanicals in foods, especially for claims currently on the 'on hold list', ensuring the rejection of any previously negatively assessed claims to guarantee consumer protection;
Amendment 116 #
2023/2081(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 11 #
2023/2075(INI)
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
Amendment 16 #
2023/2075(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
– having regard to the European Parliament resolution of 12 July 2023 on the COVID-19 pandemic: lessons learned and recommendations for the future’ (2022/2076(INI))
Amendment 49 #
2023/2075(INI)
Motion for a resolution
Recital A
Recital A
A. whereas non-communicable diseases (NCDs) are diseases that are not passed from person to person; whereas non-communicable diseases (NCD’s) cause 90 % of all deaths in the EU4 , and their prevalence continues to grow across the EU; whereas NCDs cause a great burden on people living with NCDs and their families, healthcare systems and national budgets; _________________ 4 World Health Organization, ‘Monitoring noncommunicable disease commitments in Europe 2021’, 8 December 2021.
Amendment 59 #
2023/2075(INI)
Motion for a resolution
Recital B
Recital B
B. whereas premature deaths as a result of cardiovascular diseases (CVDs), cancers, diabetes and chronic respiratory diseases account for 68 % of all premature deaths in Europe; whereas other NCDs include mental and neurological disorders, kidney diseases, oral diseases, osteoporosis, osteoarthritisliver and gastrointestinal diseases, oral diseases, rheumatic and musculoskeletal diseases (RMDs), and endometriosis among other conditions;
Amendment 76 #
2023/2075(INI)
Motion for a resolution
Recital C
Recital C
C. whereas NCDs account for the largest share of countries’ healthcare expenditures, costing EU economies EUR 115 billion, or 0.8 % of GDP annually as well as entailing other societal costs such as loss of productivity and workforce; all of which could be reduced through the implementation of measures aimed at increasing the early detection and optimal management of NCDs; whereas in 2018, no more than 2.8 % of total health expenditure in the EU was spent on prevention, whereas the costs of treating NCDs remains high5 ; _________________ 5 European Commission, ‘Healthier together – EU non-communicable diseases initiative’, p. 15, June 2022.
Amendment 83 #
2023/2075(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the increasing burden of NCDs on individuals and societies and the health needs of ageing populations represent challenges to the health systems of the Member States, which require the development of specific NCD prevention, detection and treatment policies contributing to healthy ageing;
Amendment 97 #
2023/2075(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas, according to Article 168 TFEU, the European Union can play primarily a cooperative and complimentary role with regard to healthcare, while health at its core constitutes a national competence;
Amendment 108 #
2023/2075(INI)
Motion for a resolution
Recital E
Recital E
E. whereas most NCDs are impacted by fourthe interplay of several preventable risk factors, including: tobacco use, unhealthy diet, lack of physical activity and harmful use of alcohol; whereas behavioural risk factors lead to biological risk factors, the most common being overweight and obesity, high blood pressure, high blood glucose and high blood cholesterol6 ; _________________ 6 World Health Organization, ‘Monitoring noncommunicable disease commitments in Europe 2021’, p. 13, 8 December 2021.
Amendment 143 #
2023/2075(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas chronic inflammation plays a role in contributing to the development and progression of NCDs, including CVDs, RMDs, diabetes, cancer, and neurodegenerative disorders among others;
Amendment 160 #
2023/2075(INI)
Motion for a resolution
Recital G
Recital G
G. whereas improved evidence-based health promotion and disease preventionprimary and secondary disease prevention, including targeted early detection, can reduce the prevalence of NCDs by as much as 70 %7 ; _________________ 7 European Commission, ‘Healthier together – EU non-communicable diseases initiative’, p. 15, June 2022.
Amendment 179 #
2023/2075(INI)
Motion for a resolution
Recital H
Recital H
H. whereas innovation with regard to development of technologies, medicines and healthcare practises is crucial to ensure the elimination or reduction of harm caused by preventable risk factors, early detection, integration of care, improved disease management, and new and better treatments for NCDs;
Amendment 207 #
2023/2075(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Highlights that NCDs account for 90 % of all deaths in the EU8 , most of which are preventable and which leads to high levels of productivity loss and makes NCDs account for the largest share of countries’ healthcare expenditures; stresses that it is important to reduce the prevalence of NCDs andthrough early diagnosis and screening, including through the implementation of integrated health checks, especially for at-risk individuals, at the primary care level and through better disease management; believes that enhanced health promotion and disease prevention can reduce the prevalence of NCDs by 70 %9 in conjunction with investment in health innovation and technologies; _________________ 8 European Commission, ‘Non- communicable diseases : overview’. 9 European Commission, ‘The EU ‘Healthier Together’ Non-Communicable Diseases Initiative’, 2022
Amendment 224 #
2023/2075(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the Healthier together – EU non-communicable diseases (NCD) initiative, Europe’s Beating Cancer Plan, EU4Health work programme and the Commission Communication entitled ‘A comprehensive approach to mental health’; calls on the Commission to strengthen the ‘Healthier together – EU NCD’ initiative by introducing a holistic EU strategy on NCDs complemented by action plans for specific NCDs; welcomes national plans and actions already taken against NCDs by Member States, and calls on the European Commission to facilitate knowledge sharing and the scale up of good practices introduced by existing national plans across other Member States;
Amendment 225 #
2023/2075(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the Healthier together – EU non-communicable diseases (NCD) initiative, Europe’s Beating Cancer Plan, EU4Health work programme and the Commission Communication entitled ‘A comprehensive approach to mental health’; calls on the Commission to strengthen the ‘Healthier together – EU NCD’ initiative by introducing a holistic EU strategy on NCDs complemented by action plans for specific NCDs; welcomes national plans and actions already taken against NCDs by Member States; believes however that a special cardiovascular strategy is needed in the light of cardiovascular disease being the number one cause of death in the Union;
Amendment 235 #
2023/2075(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Acknowledges that social, economic, cultural, and commercial determinants of health, and health inequities increase the risk of NCDs and underlines the need to create favourable conditions that address these factors; emphasizes the importance of a more robust implementation of the Health in All Policies principle, in dialogue with the public health community, and with thorough consideration of the health impacts of sectoral policies;
Amendment 265 #
2023/2075(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Acknowledges the complex and multifactorial causes of NCDs and that NCDs cannot always be prevented, and that even among preventable NCDs, there are many cases that cannot be explained by preventable risk factors and that many NCDs display a high degree of hereditary risk;
Amendment 295 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point a
Paragraph 5 – point a
a. implement measures to help tobacco users quit, reduce the rate of new tobacco users, and prevent tobacco use among minors;
Amendment 318 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point b a (new)
Paragraph 5 – point b a (new)
Amendment 393 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – introductory part
Paragraph 8 – introductory part
8. Notes that an unhealthy diet is one of the major risk factors for NCDs, including obesity, cardiovascular diseases, cancer, diabetes and other conditions linked to obesity15, chronic kidney disease, liver, pancreas and other gastrointestinal diseases ; acknowledges that obesity is considered a risk factor for several NCDs; calls on the Commission and the Member States to: _________________ 15 World Health Organization Regional Office for the Eastern Mediterranean, ‘Noncommunicable diseases’.
Amendment 399 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point a
Paragraph 8 – point a
a. encourage and help consumers to make informed and healthy choices about food products; promote behavioural changes via communication and mass media campaigns for healthy diets; encourage public food procurement and service policies for healthy and sustainable diets; notes that the Mediterranean diet is known as a healthy, balanced diet that plays a protective role in the primary and secondary prevention of the main chronic degenerative diseases;
Amendment 402 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point a
Paragraph 8 – point a
a. encourage and help consumers to make informed and healthy choices about food products; promote behavioural changes via communication and mass media campaigns for healthy diets; encourage public food procurement and service policies for healthy and sustainable diets; mainstream physical activities such as walking, cycling, and the practice of sports in urban planning, and put an increased emphasis on physical activity in schools;
Amendment 428 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b
Paragraph 8 – point b
b. propose a Nnew Action Plan for child obesitycomprehensive and integrated Action Plan for child obesity, with clear biding targets, benchmarks, indicators and mechanisms to monitor and ensure advancements;
Amendment 434 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b a (new)
Paragraph 8 – point b a (new)
ba. recommends the EU Member States to adopt the WHO guidelines on healthy diet by all European countries, as part of a shared commitment to address the burden of Non-Communicable Disease;
Amendment 438 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b b (new)
Paragraph 8 – point b b (new)
Amendment 442 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b c (new)
Paragraph 8 – point b c (new)
bc. promote behavioural changes via communication, and media campaigns for healthy diets and encourage public food procurement and service policies for healthy and sustainable diets;
Amendment 448 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b d (new)
Paragraph 8 – point b d (new)
bd. propose the implementation of taxation on unhealthy foods and sugary beverages, while subsidizing affordable access to minimally processed nutritious foods for socioeconomically disadvantaged populations;
Amendment 459 #
2023/2075(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the role of physical activity in NCD prevention and welcomes Commission’s HealthLifestyle4All initiative; calls on the Commission and Member States to promote physical activity and awareness campaigns to prevent NCDs; recognizes that improving population lifestyle choices is not enough to tackle the burden of NCDs, and while primary prevention plays a crucial role in reducing the incidence of many types of NCDs, secondary prevention is key for the optimal management of chronic diseases and contributes to reduce the risk of complications, comorbidities and death; stresses that a holistic approach to NCDs care pathways should be reflected in national NCDs plans and strategies, which include clear implementation roadmaps;
Amendment 463 #
2023/2075(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls on the European Commission to develop a holistic action plan on cardiovascular health, including rare cardiovascular diseases and setting forth targets and recommendations to improve the prevention and management of cardiovascular disease and encompassing all different aspects and stages of the disease;
Amendment 467 #
2023/2075(INI)
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Calls on the European Commission to develop a holistic action plan on diabetes;
Amendment 471 #
2023/2075(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Considers the European Green Deal to be instrumental in preventing NCDs in the EU by reducing air, food, water and soil pollution and chemical exposure; highlights that prevention of chronic respiratory diseases besides tobacco cessation also includes the prevention of exposure to dust and other indoor pollutant, dangerous chemicals hazard materials including asbestos and other indoor pollutants; calls the Commission and Member States to adopt an EU asbestos elimination plan, which include mandatory screening of asbestos in buildings and the establishment and maintenance of national asbestos registers and calls Member States to develop and publish their national asbestos removal strategies;
Amendment 503 #
2023/2075(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that per- and polyfluorinated alkyl substances (PFAS) can lead to health problems such as diabetes, obesity and cancer16 ; calls on the Commission to implement the PFAS restriction proposal submitted to European Chemicals Agency on 13 January 202317 ; _________________ 16 European Environment Agency, ‘What are PFAS and how are they dangerous for my health?’. 17 European Chemicals Agency, ‘ECHA publishes PFAS restriction proposal’, 2023.
Amendment 511 #
2023/2075(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Regrets the slowCalls on the Commission to continuously implementation of the Chemicals Strategy for Sustainability, and, in particular, expects the REACH Regulation18 to be revised, including in line with the Better Regulation principles, in order to be able to identify all substances of concern manufactured or imported in the EU; _________________ 18 Regulation (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), Regulation (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), OJ L 396, 30.12.2006, p. 1.
Amendment 548 #
2023/2075(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on Member States to develop tailored national plans to address the specificities of different subcategories of NCDs, including specific plans for highly prevalent diseases, with high mortality and morbidity rates, such as cardiovascular diseases, diabetes and obesity;
Amendment 556 #
2023/2075(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the importance of identifying people with a high risk of developing NCDs and diagnosing people as early as possible to improve disease management, prevent complications and save downstream costs for healthcare systems; calls for the systematic exchange at the European level of best practice regarding screening for and early detection of NCDs, such as prostate and cervical cancer; welcomes the updated Council recommendation on cancer screening and calls on Member States to implement it diligently;
Amendment 566 #
2023/2075(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the importance of identifying people with a high risk of developing NCDs, such as the elderly population, and diagnosing people as early as possible to improve disease management, prevent complications and save downstream costs for healthcare systems;
Amendment 571 #
2023/2075(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Welcomes the approval of the 2022 Council Recommendations on Cancer Screening Recommendations in Europe which include comprehensive strategies for earlier detection of breast, cervical, colorectal cancer and extend recommended screenings in Europe for lung, prostate and gastric cancers;
Amendment 582 #
2023/2075(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Encourages Member States to reduce undiagnosed NCDs by introducing targeted health checks for high-risk individuals addressing the main shared metabolic risk factors, ensuring timely access to high quality care and support NCD patients’ self- management; highlights that digital health technologies and telemedicine are beneficial in the management and disease follow-up of many NCDs;
Amendment 592 #
2023/2075(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Notes that some NCDs are closely linked such as diabetes and, cardiovascular diseases and obesity are highly interconnected conditions and the interlinks between these conditions exacerbate their respective morbidity and mortality, and that important synergies can be achieved by improving diagnosis and integrated care19 ; _________________ 19 European Commission, ‘Healthier together – EU non-communicable diseases initiative’, p. 30, June 2022.
Amendment 602 #
2023/2075(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Recommends EU funding support for pan-European public health literacy initiatives, such as the suggestion of creating a European Atlas of Early Warning Signs for Cancer, building on the model for cancer prevention created by the European Code Against Cancer;
Amendment 603 #
2023/2075(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Highlights the link between oral health, including pariodental disease and caries, and some NCDs, such as diabetes and cardiovascular diseases, and the potential positive effects on NCDs of improved oral health;
Amendment 621 #
2023/2075(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Stresses that nurses, doctors, general practitioners and other primary care professionals have a significant role in referring patients for diagnostic tests and treating NCDs; encourages the Member States to empower workforce with appropriate diagnostic tools and to offer training to healthcare professionals to better identify high-risk individuals and treat NCDs;
Amendment 634 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Stresses the importance of cost- effective healthcare, so that limited resources are put to the best use and to the use of patients in most need;
Amendment 650 #
2023/2075(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Believes that every patient is different and no NCD is the same; notes that for some NCDs, such as obesity, stigma in healthcare settings remains one of the biggest barriers to diagnose early and provide timely care and management services; calls for NCDs to be prevented and treated as effectively as possible, with a personalised and evidence-based approach tailored to the patient and the disease;
Amendment 655 #
2023/2075(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Believes that every patient is different and no NCD is the same; calls for NCDs to be prevented and treated as effectively as possible, with a personalised approach tailored to the patient and the disease, while taking Member States' need for an efficient organisation of healthcare into account;
Amendment 662 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Notes that NCDs can have a significant negative effect on mental health, and stresses the need for integrated healthcare for concerned patients; stresses that negative stereotypes related to certain NCDs, notably obesity, can be counterproductive in healthcare and prevention while recalling individual responsibility for certain risk factors;
Amendment 670 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Recommends urgent actions, including a Commission level study on the current status and impacts of the EU’s health workforce shortage and increased investment in its availability measuring and mapping exercises at the EU level;
Amendment 683 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Notes that improving disease management, notably through therapeutic adherence, and reducing complications of NCDs plays a key role in improving health systems’ resilience and preparing for future health crises;
Amendment 691 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 c (new)
Paragraph 19 c (new)
19c. Stresses the urgent need to tackle regional disparities in healthcare access, striving for equitable availability of quality NCD management across diverse geographical areas within Member States;
Amendment 694 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 d (new)
Paragraph 19 d (new)
19d. Takes note of Europe’s increasing healthcare workforce shortages and inadequate skill mix as a threat to the provision of good quality integrated care for NCDs; calls on the Commission and Member States to address the imbalance between the demand and supply of specialised NCD health professionals;
Amendment 699 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 e (new)
Paragraph 19 e (new)
19e. Expresses support for the creation of an EU Network of Comprehensive Cancer Centres, as a good case study for pan European action to improve access to high quality care and to deliver next level cooperation across borders in combating inequalities in access and improved research cooperation;
Amendment 701 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 f (new)
Paragraph 19 f (new)
19f. Calls on Member States to continue investing in innovation in NCDs care, in order to reduce overall morbidity, mortality and the quality of life of patients; calls on the European Union to support these investments through EU funding mechanisms, such as the EU4Health and Horizon Europe programmes;
Amendment 702 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 g (new)
Paragraph 19 g (new)
19g. Calls on Member States to modernise diabetes care, through early diagnosis and timely treatment intensification as per the latest treatment guidelines, avoiding therapeutic inertia and contributing to achieve better health outcome targets, and reducing the risk of costly complications;
Amendment 703 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 h (new)
Paragraph 19 h (new)
19h. Welcomes the "patient-centricity" approach of the Europe's Beating Cancer Plan, and in particular the flagship initiative under the EU4Health 2021-2027 programme to develop a smart card for cancer survivors - in the form of a mobile app - to improve the health and well-being of cancer survivors across Europe;
Amendment 704 #
2023/2075(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Recalls that patient empowerment and, health literacy, and treatment adherence are crucial for an EU NCD strategy and that treatment and care should be patient- centred; encourages the promotion of well- informed patients who are actively involved in their own treatment and calls for the therapeutic training of caregivers and patients and their empowerment in the care programmes; underlines the importance of therapeutic adherence, in order to lower hospitalisation and mortality rates as well as optimise the impact of medical investments; encourages Member States to provide healthcare professionals with training regarding patient therapeutic education;
Amendment 710 #
2023/2075(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Highlights that patient stigma should be counteracted and mitigated at the national level;
Amendment 736 #
2023/2075(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Welcomes the pharmaceutical package and calls for the strengthening of the European medicines market to ensure access to medicines and alleviate medicine shortages, reduce barriers to cross-border business, while strengthening incentives for investment in innovation; underlines that upheld regulatory data protection and intellectual property rights are crucial to ensure competitiveness in the EU by incentivising innovators to develop new products and further ongoing research efforts;
Amendment 756 #
2023/2075(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Highlights the potential of the private sector with respect to disease control and healthcare; Welcomes public- private partnerships as a way of strengthening innovation in healthcare; highlights the European Health Innovation Collaborative, which promotes entrepreneurship and innovation in the healthcare sector and brings together academia, research, and industry to foster collaboration and investment in health technologies; encourages the Commission and the Member States to foster and accelerate public-private partnerships;
Amendment 759 #
2023/2075(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Stresses the importance of innovations to improve the detection, diagnosis, management and treatment of NCDs; for instance, the development of high-quality medical technologies has improved clinical and procedural outcomes and quality of life of people living with cardiovascular diseases;
Amendment 771 #
2023/2075(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls on the Commission to strengthen support and investment in the development and uptake of new innovative medical devicediagnostic and therapeutic medical devices and medicinal products; believes that new technologies can lead to new and better treatments for NCDs, as well as quality of life for patients living with NCDs;
Amendment 791 #
2023/2075(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Believes that improving knowledge and sharing of evidence-based best practices among Member States is needed to accelerate effective prevention measures, such as supporting treatment adherence, and innovative practices;
Amendment 796 #
2023/2075(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Believes that further economic data collection at national level is needed in order to achieve a better understanding of the associated costs and burden in the Member States;
Amendment 799 #
2023/2075(INI)
Motion for a resolution
Paragraph 25 b (new)
Paragraph 25 b (new)
25b. Calls on the Commission to support treatment adherence and to recognise innovation in the form and dosage of medications, such as fixed- dose-combinations, as an innovative solution that can support patients adhere to their treatments in the long-term;
Amendment 808 #
2023/2075(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Acknowledges that many chronic diseases can lead to organ failure for which transplantation is the best therapy; notes that the EU action plan on organ donation and transplantation (2009-2015) resulted in a considerable increase in organ donation and transplantation in the EU over its period of implementation; calls on the Commission to establish a second EU action plan on organ donation and transplantation during the 2024-2029 mandate;
Amendment 813 #
2023/2075(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Commission to create a European NCD Health Knowledge Centre to improve data collection and research on NCDs; stresses the need for further research in NCD co-morbidities and managementencourages Member States to exchange best practices on prevention, management and care of NCDs in relevant forums; stresses the need for further research in NCD co-morbidities and management, including treatment adherence; recognises that data collection efforts must target every NCD through a wide range of indicators, such as prevalence, incidence, mortality, health burden and health economics; recognises the potential of interoperable and flexible diabetes data registries in improving quality of care and health outcomes; calls on Member States to put in place NCD- specific data registries;
Amendment 825 #
2023/2075(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Believes that good quality data and evidence are important and that strengthening the equity elements of existing health monitoring systems, such as European Health Data Space, will support development of evidence-based and targeted policies and interventions for improved health equity;
Amendment 829 #
2023/2075(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Welcomes the Commission Expert Group on Public Health and the sub-group on NCDs; calls on the Commission to extend the group to patient experts; calls on the Commission to establish a European expert network for prevention and control of NCD co- morbidities and complications, including patient experts ;
Amendment 833 #
2023/2075(INI)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Recognises that the EU has a role in supporting global health, including in respect to the international rise of NCDs; urges that the EU’s global health strategy therefore include objectives such as supporting the WHO goal of global elimination of cervical cancer, in line with the EU goal of eliminating HPV cancers; additionally recommends that there be a health component to EU Neighbourhood policy, including supporting the inclusion of partner countries within the framework of EU health policy, such as Europe’s Beating Cancer Plan;
Amendment 149 #
2023/2074(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Highlights that, at any point in their life, any person can become more susceptible to poorer mental health and thus become part of a vulnerable group in society; stresses that addressing mental health conditions requires a thorough understanding of the different determinants of mental health and that an intersectional approach is necessary to prevent and mitigate the impacts on individuals, communities and societies; Underlines the importance of considering biological factors, past traumas, and early childhood experiences in mental health assessments;
Amendment 205 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Recognises that mental health disorders, and associated chronic physical conditions, including chronic pain or inflammation, frequently co-occur; Highlights the pervasive inadequacy and general scarcity of scientific knowledge on how these conditions can be prevented and calls for research into the factors that lead to severe mental health conditions as well as factors that offer resilience to these conditions;
Amendment 207 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Stresses that people living with chronic non communicable diseases (NCDs), often characterised by permanent pain or disability, are particularly vulnerable in developing mental health disorders; Calls on the European Commission and Member States to adequately address the effects of NCDs or other chronic diseases and disabilities in all mental health prevention policies;
Amendment 214 #
2023/2074(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the importance of bio- psychosocial approach to mental health and the importance of social policies that tackle social exclusion, poverty, homelessness, substance-related disorders, unemployment and economic vulnerabilities in order to prevent mental health conditions and address their root causes; underlines the need to provide better instruments to help people to cope with problems;
Amendment 247 #
2023/2074(INI)
4. Considers mental health information systems an important tool to collect data and measure the effectiveness of mental health interventions, and calls for them to be systematically improved and updated; Emphasizes the importance of data privacy and the need to ensure that the data collected is used ethically;
Amendment 270 #
2023/2074(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Is deeply concerned that, despite progress in some countries, people with mental health conditions frequently experience discrimination and stigma and often do not have access to adequate healthcare, which can lead to severe human rights violations, increased risk of complications and poorer health conditions; Calls on the European Commission to support cultural change in all Member States, to reduce stigma, through awareness campaigns targeted at healthcare professionals, caregivers, educators, patients and the general public;
Amendment 287 #
2023/2074(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls for the EU and the Member States to raise awareness of the importance of promoting good mental health in a coordinated and timely manner, through a mental-health-in- all-policies approach;
Amendment 290 #
2023/2074(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the European Commission and Member States to invest in mental health literacy and include mental health in school curricula and the curricula of teaching staff; Stresses the importance of providing training for educators and psychoeducation for families to enable early intervention for children and adolescents facing mental health challenges and to better integrate them in the school environment; Recommends Member States to ensure that students have direct access to psychological help when they seek it;
Amendment 317 #
2023/2074(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Recognises that harnessing digital health or telehealth services can cater to a broader population, including population in remote arears, and reduce waiting times;
Amendment 321 #
2023/2074(INI)
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Recognises that self-management can help develop essential skills to take care and cope with long-term mental health conditions;
Amendment 352 #
2023/2074(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Calls for better collaboration and exchange of information between private and public mental healthcare services in the Member States;
Amendment 409 #
2023/2074(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Member States to improve access to treatment and support for mental health and associated chronic conditions by implementing multidisciplinary care;
Amendment 430 #
2023/2074(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Training for healthcare professionals Stresses the need for better trained professionals in the EU; Calls for the European Commission and the Member States to promote best practices of cross- speciality training to better understand the connection between physical and mental health, and to increase the awareness and expertise in detecting and coordinating psychosocial support; and particularly in children and young adolescents;
Amendment 436 #
2023/2074(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Supports that harnessing of digital technologies for mental health has the potential to contribute substantially to the Member States' efforts to achieve European mental health coverage; Calls on the European Commission and the Member States to promote best practices for digital mental health, driven by ethical principles, privacy, safety and accountability;
Amendment 443 #
2023/2074(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Urges the Member States to ensure that people on medical leave because of mental health and associated chronic conditions do not face discrimination; urges the Member States to implement national plans that promote the integration of people with mental health conditions into the labour market, in order to reduce inequities and tackle social determinants;
Amendment 450 #
2023/2074(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Advocates for policies that support good mental health in the workplace, and promote a balanced lifestyle and a culture of acceptance.
Amendment 452 #
2023/2074(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Supports deinstitutionalisation and independent living of disabled persons and recognises the importance of psychological support for disable persons to better integrate in the society;
Amendment 454 #
2023/2074(INI)
Motion for a resolution
Paragraph 16 c (new)
Paragraph 16 c (new)
16c. Recognises that disabled people or people living with chronic diseases are more likely to present mental health issues and experience higher rates of workplace exclusion; Recommends that Member States introduce measures to provide flexible work practices and support to employees who suffer from a disease, physical pain, stress or other health crisis;
Amendment 477 #
2023/2074(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Invites the Commission and the Member States to invest in further research on digital technologies and mental health and to share best practices used in digital mental health;
Amendment 492 #
2023/2074(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Supports the adaptation of training programs on cultural sensitivity for professionals dealing with diverse populations;
Amendment 495 #
2023/2074(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Invites the European Commission to dedicate a European Year of Brain Health, to address the challenges deriving from mental and neurological conditions.
Amendment 500 #
2023/2074(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Invites the Commission to further develop its Mental Health Strategy and draw up concrete targets and goals for the future, including more in-depth initiatives, from a bottom-up perspective, such as national mental health action plans;
Amendment 524 #
2023/2074(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Calls on the European Commission to convert the flagship initiatives, introduced in the comprehensive approach, into concrete actions with adequate financial support for vulnerable groups, people living with chronic diseases, existing health conditions, rare diseases and disabilities; further calls for the development of policies and programmes that enhance the wellbeing of their families and caregivers;
Amendment 161 #
2023/0132(COD)
Proposal for a directive
Recital 9
Recital 9
(9) Medicinal products for rare diseases and for children, should be subject to the same conditions as any other medicinal product concerning their quality, safety and efficacy, for example for what concerns the marketing authorisation procedures, quality and the pharmacovigilance requirements. However, specific requirements also apply to them considering their unique characteristics, and encountered problems such as failure to timely accomplish the paediatric clinical studies and obtain data required for marketing authorization, which results in significant delay of approval in children compared to adults. Such requirements, which are currently defined in separate legislations, should be integrated in general pharmaceutical legal framework in order to ensure clarity and coherency of all the measures applicable to these medicinal products. Furthermore, as some medicinal products authorised for use in children are authorised by the Member States, specific provisions should be integrated in this Directive.
Amendment 168 #
2023/0132(COD)
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11 a) This Directive should be in line with the EU’s industrial, digital and trade aspirations. The European life sciences sector, and the pharmaceutical industry in particular, are essential in ensuring EU’s competitiveness. Maintaining and strengthening robust R&D sectors are key pillars of the shared European sovereignty in an increasingly competitive geopolitical context.
Amendment 170 #
2023/0132(COD)
Proposal for a directive
Recital 11 b (new)
Recital 11 b (new)
(11 b) This Directive should recognize that there is no trade-off between maintaining a competitive pharmaceutical industry in the EU and ensuring the affordability, accessibility, and availability of medicinal products in the EU.
Amendment 238 #
2023/0132(COD)
Proposal for a directive
Recital 50
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’, quality of life and long-term health and developmental consequences relevant for paediatric patients following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.
Amendment 241 #
2023/0132(COD)
Proposal for a directive
Recital 50 a (new)
Recital 50 a (new)
(50 a) The development of medical products in underserved therapeutic areas can greatly increase the quality of life for patients. In that regard, elements such as acute or chronic side effects, in particular in relation to the toxicity of a product, as well as the ability of patients to perform regular life activities, the presence of pain and the management of co-morbidities should be considered in the assessment of improving quality of life. The importance of the long-term age appropriate development and maturation of paediatric patients, and of retaining their normal daily activities, can not be overemphasized.
Amendment 244 #
2023/0132(COD)
Proposal for a directive
Recital 51 a (new)
Recital 51 a (new)
(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients.
Amendment 264 #
2023/0132(COD)
Proposal for a directive
Recital 58 a (new)
Recital 58 a (new)
(58 a) Small patient populations, especially paediatric or rare disease ones, are often the most disadvantaged when it comes to access to medicines. In this regard, Directive 2011/24/EU should be considered as an alternative pathway of making available medicinal products to patients, who need paediatric, orphan medicinal products or advanced therapy medicinal products. The medicines can be administered via a center of excellence, early access or compassionate use programs, or other cross-border healthcare services.
Amendment 279 #
2023/0132(COD)
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and ithe objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rel, on day one a reference medicinal productfter loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies and, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ands, obtaining pricing and reimbursement request, and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC of the reference medicinal product, there can be no commercial usrelevant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 281 #
2023/0132(COD)
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the, without this being considered patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of thinfringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is limited exemption is however fragmented across the Union and iportant in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular of generic, biosimilar, hybrid and bio- hybrid medicinal products that relon day one a reference medicinal productfter after the loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies and, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment and pricing reimbursement requests, pricing and reimbursement, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member Stat of the patent or SPC ofor the reference medicinal product, there can be no commercial uslevant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 294 #
2023/0132(COD)
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studactivities to support pricing and reimbursementregulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing toaforementioned purpose, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.
Amendment 303 #
2023/0132(COD)
Proposal for a directive
Recital 65
Recital 65
(65) Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions1a and a resolution of the European Parliament2a. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC. _________________ 1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU 2a European Parliament resolution of 2 March 2017 on EU options for improving access to medicine
Amendment 340 #
2023/0132(COD)
Proposal for a directive
Recital 76
Recital 76
(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to placmake the product available for ordering for paediatric patients in the same markets within two years of the date of approval of the indication.
Amendment 511 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)
Article 4 – paragraph 1 – point 30 a (new)
Amendment 515 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 30 b (new)
Article 4 – paragraph 1 – point 30 b (new)
(30 b) ‘platform technology master file’ means a document that contains a detailed description of a platform technology for which the underlying scientific principles under which the platform technology is established. This can encompass quality, pre-clinical and/or clinical data in relation to the medicinal products and/or components the platform technology refers to.
Amendment 704 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. TBased on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to enterrecognise the procedure and shall informwithin 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 706 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2
Article 34 – paragraph 4 – subparagraph 2
The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawnrefused.
Amendment 715 #
2023/0132(COD)
Proposal for a directive
Article 36 – paragraph 4 a (new)
Article 36 – paragraph 4 a (new)
4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 30 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 797 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its contractual responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure Marketing authorisation holders comply with their supply obligations.
Amendment 810 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 9
Article 56 – paragraph 9
9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product, in the Union or Member State. The Marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub- paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product and any data in its possession relating to the volume of prescriptions.
Amendment 1214 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationa new therapeutic option, including new therapeutic indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:
Amendment 1226 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 1234 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has notdoes not fall in the same global marketing authorization as a medicinal product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 1239 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product shall be designated as a value added medicinal product.
Amendment 1248 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is usstudies, trials and other activities are conducted for the purposes of:
Amendment 1256 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a
Article 85 – paragraph 1 – point a
Amendment 1271 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and forand subsequent variations;
Amendment 1282 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 1292 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement. approval;
Amendment 1302 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;
Amendment 1311 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere;
Amendment 1313 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii c (new)
Article 85 – paragraph 1 – point a – point iii c (new)
(iii c) and the subsequent practical requirements associated with such activities.
Amendment 1320 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) tThe activities conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation andfalling within the first subparagraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
Amendment 1334 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activitiin a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products manufactured for the aforementioned purposes.
Amendment 1346 #
2023/0132(COD)
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article85a 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of generics, biosimilars, hibryds and biohibrids or to determine their inclusion within the scope of public health insurance system of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of generics, biosimilars, hibryds and biohibrids or its inclusion within the public health insurance system. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.
Amendment 1355 #
2023/0132(COD)
Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point b a (new)
Article 87 – paragraph 1 – subparagraph 1 – point b a (new)
(b a) to conduct a post-authorisation safety and efficacy long-term study in children receiving the drug “of the label” because the paediatric investigation plan could not be accomplished due to failure to timely complete paediatric clinical studies.
Amendment 1368 #
2023/0132(COD)
Member States shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in the Union pharmacovigilance activities including the pharmacovigilance over the post- authorization safety and efficacy long- term studies in children using the drug off label, because of the failed marketing authorization for reasons such as failure to timely complete paediatric clinical studies.
Amendment 1454 #
2023/0132(COD)
Proposal for a directive
Article 167 – paragraph 2
Article 167 – paragraph 2
2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure wholesale distributors comply with their supply obligations.
Amendment 219 #
2023/0131(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5 a) The pharmaceutical framework should be consistent with overarching EU industrial policy, including the Council Conclusions from 23 March 2023 which stress the importance of strengthening incentives for investment in innovation and the 2016 Council Conclusions which stress any revision, including to the incentive framework, should not discourage the development of medicinal products needed for the treatment of rare diseases; increased innovation will further support patient outcomes and public health.
Amendment 249 #
2023/0131(COD)
Proposal for a regulation
Recital 30 a (new)
Recital 30 a (new)
(30 a) To support evidence-based policy making, the Agency should continue to be empowered to undertake pilot programmes to ensure a future-proof regulatory ecosystem. Initiatives such as the pilot programme launched in 2022 offering enhanced support to academic and non-profit developers of advanced therapy medicinal products should guide policy-making and update regulatory support.
Amendment 254 #
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 257 #
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 267 #
2023/0131(COD)
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38 a) 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 Union, with a view to enabling earlier availability for patients, the Agency should be able to perform a ‘phased review’ of data packages concerning finalised tests and trials before a formal application for marketing authorisation is submitted, to allow a more efficient assessment of medicinal products, while guaranteeing a high level of human health protection.
Amendment 290 #
2023/0131(COD)
Proposal for a regulation
Recital 51
Recital 51
(51) AGiven that the marketing authorisation holder has to forthwith submit any new data that might impact the benefit-risk balance of its products and given that the Agency has several tools available to continuously monitor the benefits and risks of authorised medicines, such as assessment of PSURs, signal detection and referrals, regulatory action will be taken as needed throughout the lifecycle of the product. Therefore, as a general rule a marketing authorisation should be granted for an unlimited time; however, one renewal may be decided only on justified grounds related to the safety of the medicinal product.
Amendment 325 #
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. 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, or when a standard or conditional marketing authorisation has been granted for the relevant indication.
Amendment 380 #
2023/0131(COD)
(84 a) The Transferable Exclusivity Vouchers (TEV) could be complemented by a procurement mechanism, as outlined in the Council Recommendation on “Stepping up actions to combat AMR in a One Health approach”, providing coordinated financial commitment across the EU and Member States. This would provide the predictability that will encourage comprehensive commercialisation of new priority antimicrobials.
Amendment 386 #
2023/0131(COD)
Proposal for a regulation
Recital 87 a (new)
Recital 87 a (new)
(87 a) The European Parliament resolution of 10 July 2020 on the EU’s public health strategy post-COVID-19, called for an EU Action plan for rare diseases.
Amendment 388 #
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; 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. The Union should not neglect or disregard the success of the Regulation since its entry into force in 2000, and build on its success driving and ensuring a similar degree of innovation under this Regulation. _________________ 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 413 #
2023/0131(COD)
Proposal for a regulation
Recital 100
Recital 100
Amendment 420 #
2023/0131(COD)
Proposal for a regulation
Recital 102
Recital 102
(102) In order to incentivise research, innovation 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 unmetdesignated as a breakthrough orphan medicinal needproducts 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 439 #
2023/0131(COD)
Proposal for a regulation
Recital 129
Recital 129
(129) Scientific and technological progresses in data analytics and data infrastructure are essential for the development, authorisation and supervision of medicinal products. The digital transformation has affected regulatory decision-making, making it more data- driven and multiplying the possibilities to access evidence, across the life cycle of a medicinal product. This Regulation recognises the Agency’s experience and capacity to access and analyse data submitted independently from the marketing authorisation applicant or marketing authorisation holder. On thise basis of the totality of evidence made available to the Agency, the Agency should take initiative tobe able to propose updates to the summary of product characteristics in case new efficacy or safety datavidence has an impact on the benefit- risk balance of a medicinal product. In such case, the Agency and the marketing authorisation holder should collaborate to determine the particulars of any such update.
Amendment 442 #
2023/0131(COD)
Proposal for a regulation
Recital 132 a (new)
Recital 132 a (new)
(132 a)To ensure patients’ access to innovative medicines, it is appropriate to establish common rules for the testing and authorisation of innovative medicinal products and innovative technologies related to such products that, due to their exceptional nature or characteristics, are expected to not completely fit the EU medicines regulatory framework.
Amendment 445 #
2023/0131(COD)
Proposal for a regulation
Recital 132 b (new)
Recital 132 b (new)
(132 b)Regulatory sandboxes may be set up when it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product, and those characteristics or methods positively and distinctively contribute to the quality, safety or efficacy of the medicinal product or category of products or provide a major advantage contribution to patient access to treatment.
Amendment 446 #
2023/0131(COD)
Proposal for a regulation
Recital 132 c (new)
Recital 132 c (new)
(132 c) The objectives of the regulatory sandboxes should be: for the Agency and national competent authorities to increase their understanding of technical and scientific developments, to allow developers in a controlled environment to test and develop innovative medicinal products and related technologies that are not fitting the current regulatory framework, as agreed with the competent authorities, and to identify possible future adaptations of the legal framework.
Amendment 449 #
2023/0131(COD)
Proposal for a regulation
Recital 133
Recital 133
(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly importsignificant in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxesIt is important to ensure that SMEs and startups can easily access sandboxes in order to be able to contribute with their knowhow and experience. Regulatory sandboxes are controlled frameworks which, by provideing a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment especialparticularly in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. They allow the authorities tasked with implementing and enforcing the legislation to exercise on a case-by-case basis and in exceptional circumstances a degree of flexibility in relation to testing innovative technologies, for the benefit of bringing these products to patients without compromising the standards of quality, safety and efficacy. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.
Amendment 459 #
2023/0131(COD)
Proposal for a regulation
Recital 134
Recital 134
(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, as well as legal certainty, a level playing field and fair competition always need to be ensured and existingcurrent levels of protection need to be respected.
Amendment 463 #
2023/0131(COD)
Proposal for a regulation
Recital 135
Recital 135
(135) The establishment of a regulatory sandbox should be based on a Commission Decision following a recommendation of the Agency. Such decision should be based on a detailed and comprehensive plan outlining the particularspecificities of the sandbox as well as describing the products to be covered. A regulatory sandbox should be limited in duration and may be terminated at any time based on public health considerations. The learning stemming from a regulatory sandbox should inform future changes to the legal framework to fully integrate the particular innovative aspects into the medicinal product regulation. Where appropriatsuitable, adapted frameworks may be developed by the Commission on the basis of the results of a regulatory sandbox.
Amendment 523 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘orphan medicineal product sponsor’ means any legal or natural person, established in the Union, who submitted an application for or has been granted an orphan designation by a decision referred to in Article 64(4);
Amendment 529 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 7
Article 2 – paragraph 2 – point 7
(7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product if such an advantage or contribution benefits a substantialrelevant part of the target population;
Amendment 545 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 10
Article 2 – paragraph 2 – point 10
(10) ‘regulatory sandbox’ means a regulatory framework during which it is possible to develop, validate and test in a controlled environment innovative or adapted regulatory solutions that facilitate the development and authorisation of innovative products which are likely to fall in the scope of this Regulation,might be regulated as medicinal products or other categories of products pursuant to a specific plan and for a limited time under regulatory supervision.
Amendment 555 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) ‘demand’ means the request for a medicinal product by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product is acquired in appropriate time and in sufficient quantity to allow continuity of the best care of patients.
Amendment 567 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12 a (new)
Article 2 – paragraph 2 – point 12 a (new)
(12 a) ‘supply’ means the total volume of stock of a given medicinal product that is placed on the market by a marketing authorization holder or a manufacturer.
Amendment 596 #
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 Union or expected to be of major interest from the point of view of public health, 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 606 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. Where appropriate, the application may include an active substance master file certificate or an application for an active substance master file or any other quality master file certificate or application as referred to in Article 25 and Article 26 of [revised Directive 2001/83/EC].
Amendment 613 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 2
Article 6 – paragraph 6 – subparagraph 2
On the basis of a duly reasoned request, the Committee for Medicinal Products for Human Use may call for the duration of the analysis of the scientific data in the file concerning the application for marketing authorisation to be extended, once for an additional period of 30 days.
Amendment 614 #
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 whichor new therapeutic indications when grouped with an extension of the marketing authorisation, which provide an exceptional therapeutic advancement or are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation, the applicant may request an accelerated assessment procedure. The same shall apply for pProducts referred to in Article 60(2) and article 60 shall qualify for this process by default. The request shall be duly substantiated.
Amendment 617 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 1520 days.
Amendment 620 #
2023/0131(COD)
Proposal for a regulation
Article 6 a (new)
Article 6 a (new)
Article6a Parallel application (1) During the scientific assessment of an initial marketing authorisation application of a medicinal product by the Agency, the applicant may submit to the Agency a separate parallel application for one or more new indications concerning the same medicinal product. (2) The parallel application shall be assessed by the Agency as a marketing authorisation application in accordance with this Regulation, subject to the following: a) to the extent the Committee for Medicinal Products for Human Use can assess the parallel application within the timeframe applicable to the initial marketing authorisation application, leading to the same outcome for both applications it shall group the applications and issue a single opinion. b) to the extent the said Committee cannot issue an opinion on the parallel application within the timeframe applicable to the initial marketing authorisation application, the parallel application shall be converted to a Type II variation application. c) if the initial marketing authorisation application is withdrawn or receives a negative opinion from the Committee for Medicinal Products for Human Use, the Committee will pursue the assessment of the parallel application as a standalone marketing authorisation application.
Amendment 637 #
2023/0131(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Where within 960 days of the validation of the marketing authorisation application and during the assessment the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient quality or maturity to complete the assessment, the assessment can be terminated. The Committee for Medicinal Products for Human Use shall summarise the deficiencies in writing. On this basis, the Agency shall inform the applicant accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the Agency, the application shall be considered as withdrawn.
Amendment 652 #
2023/0131(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1
Article 13 – paragraph 1 – subparagraph 1
Within 126 days of receipt of the opinion of the Committee for Medicinal products for Human Use the Commission shall submit to the Standing Committee on Medicinal Products for Human Use referred to in Article 173(1) a draft of the decision on the application.
Amendment 654 #
2023/0131(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The Commission shall, by means of implementing acts, take a final decision within 126 days after obtaining the opinion of the Standing Committee on Medicinal Products for Human Use. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173, paragraphs 2 and 3.
Amendment 659 #
2023/0131(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
Amendment 669 #
2023/0131(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point d a (new)
Article 15 – paragraph 1 – point d a (new)
(d a) the content or timelines of post- authorisation studies to further clarify environmental risk assessment, as required in Article 20(c), cannot be agreed.
Amendment 674 #
2023/0131(COD)
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 1
Article 16 – paragraph 3 – subparagraph 1
The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature. Before the publishment of the assessment report, the Agency shall firstly notify patients´ organisations about the outcomes of the report.
Amendment 698 #
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, including when grouped with an extension of an existing marketing authorisation under this Regulation, an applicant is unable to provide comprehensive data on the efficacy and safety 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 700 #
2023/0131(COD)
Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 1
Article 18 – paragraph 2 – subparagraph 1
The maintenance of the authorised new therapeutic indication, including when grouped with an extension of the marketing authorisation, and the validity of the marketing authorisation granted in accordance with paragraph 1 shall be linked to the reassessment by the Agency of the conditions referred to in paragraph 1 after two years from the date when the new therapeutic indication, including when grouped with an extension of the marketing authorisation, was authorised or the marketing authorisation was granted, and thereafter at a risk-based frequency to be determined by the Agency and specified by the Commission in the marketing authorisation.
Amendment 703 #
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, including when grouped with an extension of the marketing authorisation, or renew the marketing authorisation under exceptional circumstances.
Amendment 705 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 1
Article 19 – paragraph 1 – subparagraph 1
In duly justified cases, to meet an unmet medical need of patients, as referred to in Article 83(1), point (a) and (2), of [revised Directive 2001/83/EC], a conditional marketing authorisation or a new conditional therapeutic indication to an, including when grouped with an extension of existing marketing authorisation authorised under this Regulation may be granted by the Commission to a medicinal product that is likely to address the unmet medical need in accordance with Article 83(1), point (b), of [revised Directive 2001/83/EC], prior to the submission of comprehensive clinical data provided that the benefit of the immediate availability on the market of that medicinal product outweighs the risk inherent in the fact that additional data are still required.
Amendment 706 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
In emergency situations, a conditional marketing authorisation or a new conditional therapeutic indication, including when grouped with an extension of the marketing authorisation, referred to in the first subparagraph may be granted also where comprehensive non- clinical or pharmaceutical data have not been supplied.
Amendment 709 #
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, including when grouped with an extension of the marketing authorisation, 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 able to provide comprehensive data.
Amendment 716 #
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, including when grouped with an extension of the marketing authorisation, 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 727 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 5 a (new)
Article 19 – paragraph 5 a (new)
5 a. The Agency shall lay down criteria for the fulfilment of these conditions and make them publicly available.
Amendment 731 #
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, or extension to an existing marketing authorisation.
Amendment 760 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3, paragraphs 1 and 2 available for compassionate reasons to a group of patients or a single patient with a chronically or seriously debilitating disease or whose disease is considered to be life- threatening, and who cannot be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 or the submission of such application is imminent, or it must be undergoing clinical trials in the same indication.
Amendment 761 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. When applying paragraph 1, the Member State shall notify the Agency, which shall make the notification publicly available.
Amendment 768 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. The Agency shall keep an up-to- date list of the opinions adopted in accordance with paragraph 4 and shall publish it in a central repository for compassionate use on its website.
Amendment 781 #
2023/0131(COD)
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
During a public health emergency, the Commission may, following an application by a developer grant a temporary emergency marketing authorisation (‘TEMA’) or a new temporary emergency therapeutic indication, including when grouped with an extension of an existing marketing authorisation under this Regulation, for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non- clinical, clinical data and environmental data and information.
Amendment 783 #
2023/0131(COD)
Proposal for a regulation
Article 30 – paragraph 3
Article 30 – paragraph 3
Amendment 784 #
2023/0131(COD)
Proposal for a regulation
Article 30 – paragraph 3 – subparagraph 1 (new)
Article 30 – paragraph 3 – subparagraph 1 (new)
Derogations to Articles 5 and 6 of this Regulation may apply in the context of submission of an application for a temporary emergency marketing authorisation.
Amendment 785 #
2023/0131(COD)
Proposal for a regulation
Article 31 – paragraph 1 – introductory part
Article 31 – paragraph 1 – introductory part
A temporary emergency marketing authorisation or a temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, may be granted only after the recognition of a public health emergency at Union level in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council67 and where the following requirements are met: _________________ 67 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26).
Amendment 790 #
2023/0131(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point a
Article 31 – paragraph 1 – point a
(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation of the medicinal productr temporary emergency therapeutic indication of the medicinal product, including when grouped with an extension of the marketing authorisation, will contribute to address the public health emergency;
Amendment 794 #
2023/0131(COD)
Proposal for a regulation
Article 32 – paragraph 1
Article 32 – paragraph 1
1. The Agency shall ensure that the scientific opinion of the Committee for Medicinal Products for Human Use is given to the applicant without undue delay, taking into account, the recommendation of the Emergency Task Force referred to in Article 38(1), second subparagraph. For the purpose of issuing its opinion, the Agency may consider any relevant data on the medicinal product concerned. in addition to the evidence submitted in the applicant’s dossier.
Amendment 795 #
2023/0131(COD)
Proposal for a regulation
Article 32 – paragraph 2 – subparagraph 1
Article 32 – paragraph 2 – subparagraph 1
The Agency shall review any new evidence provided by the developerapplicant, the Member States or the Commission, or any other evidence of sufficient quality that comes to its attention in addition to and in the context of evidence submitted by the applicant, in particular evidence that might influence the benefit-risk balance of the medicinal product concerned.
Amendment 796 #
2023/0131(COD)
Proposal for a regulation
Article 32 – paragraph 2 – subparagraph 2
Article 32 – paragraph 2 – subparagraph 2
Amendment 800 #
2023/0131(COD)
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. On the basis of the scientific opinion of the Agency referred to in paragraph 1, the Commission shall set specific conditions with respect to the temporary emergency marketing authorisation, in particular the conditions for manufacturing, use, supply and safety monitoring and the compliance with related good manufacturing, and pharmacovigilance practices. If necessary, the conditions may specify the batches of the medicinal product concerned by the temporary emergency marketing authorisation, in consultation with the with the applicant or marketing authorisation holder.
Amendment 804 #
2023/0131(COD)
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Those specific conditions and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation and shall be reviewed annually by the Agency, in consultation with the marketing authorisation holder.
Amendment 806 #
2023/0131(COD)
Proposal for a regulation
Article 34 – paragraph 1
Article 34 – paragraph 1
The temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, shall cease to be valid when the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) and (4) of Regulation (EU) 2022/2371.
Amendment 808 #
2023/0131(COD)
Proposal for a regulation
Article 34 – paragraph 1 a (new)
Article 34 – paragraph 1 a (new)
1a. When the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, ceases to be valid in accordance with first subparagraph of this Article, a transitional period shall be set by the Agency in agreement with the marketing authorisation holder in order to avoid any disruption in supply of the medicinal product concerned.
Amendment 813 #
2023/0131(COD)
Proposal for a regulation
Article 35 – paragraph 2 a (new)
Article 35 – paragraph 2 a (new)
2a. Where the Commission adopts any such implementing act, the provisions of Article 34, paragraph 1a shall apply.
Amendment 818 #
2023/0131(COD)
Proposal for a regulation
Article 36 – paragraph 2
Article 36 – paragraph 2
For the purpose of regulatory data protection, the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, and any subsequent marketing authorisation, as referred to in subparagraph 1, shall be considered as part of the same global marketing authorisation.
Amendment 819 #
2023/0131(COD)
Proposal for a regulation
Article 37 – paragraph 1
Article 37 – paragraph 1
Amendment 836 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Following a request by the applicant when applying for afor a marketing authorisation, made before that marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency.
Amendment 914 #
2023/0131(COD)
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 2
Article 41 – paragraph 1 – subparagraph 2
A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first fourhas at least two years of regulatory data protection remaining.
Amendment 934 #
2023/0131(COD)
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if ain normal circumstances, a reasonable request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled, where such request is consistent with the expected needs of the Union market and the non-fulfilment is not due to circumstances beyond the control of the marketing authorisation holder .
Amendment 950 #
2023/0131(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
This Chapter shall apply until [Note to OP: insert the date offrom the entry into force of this Regulation. 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest, the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.
Amendment 965 #
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, including any additional evidence that may be submitted by the marketing authorisation holders of the medicinal products concerned, 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. The evaluation shall consider the position of the marketing authorisation holders on the totality of evidence submitted.
Amendment 971 #
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 holders shall be informed.
Amendment 980 #
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, or a new therapeutic indication, including when grouped with an extension of the marketing authorisation, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, the Agency shall inform the Commission accordingly.
Amendment 985 #
2023/0131(COD)
Proposal for a regulation
Article 58 – paragraph 1 – subparagraph 2
Article 58 – paragraph 1 – subparagraph 2
Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC] and for medicinal products used with an in vitro diagnostic medical device.
Amendment 988 #
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 may 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 990 #
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 Unionbodies, as applicable.
Amendment 1003 #
2023/0131(COD)
Proposal for a regulation
Article 59 – paragraph 2
Article 59 – paragraph 2
2. In case of medicinal products involving aused with a medical device or an in vitro diagnostic medical device, undertakings or, as relevant, not-for-profit entities may request scientific advice as referred to in Article 58(1) in parallel with the consultation of the expert panels referred to in Article 61(2)Regulation (EU) 2017/745 ofr Regulation (EU) 2017/7456.
Amendment 1004 #
2023/0131(COD)
1. The Agency mayshall offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products and new indications, including when grouped with an extension of the marketing authorization, that, based on preliminary evidence submitted by the developer fulfil one of the following conditions:
Amendment 1023 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – point b
Article 60 – paragraph 1 – point b
(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);
Amendment 1031 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – point c
Article 60 – paragraph 1 – point c
(c) provide an exceptional therapeutic advancement or 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).
Amendment 1040 #
2023/0131(COD)
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1
Article 61 – paragraph 1 – subparagraph 1
For products under development which may fall within the categories of medicinal products to be authorised by the Union listed in Annex I, a developer or a competent authority of the Member States may submit a duly substantiated request to the Agency for a scientific recommendation with a view to determining on scientific grounds whether the concerned product is potentially a ‘medicinal product’, including an ‘advanced therapy medicinal product’ as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council71 . The Agency may rely on the relevant expertise of working parties and pools of experts, including on advanced therapy medicinal products, when making its recommendation. _________________ 71 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
Amendment 1051 #
2023/0131(COD)
Proposal for a regulation
Article 63 – paragraph 1 – point a
Article 63 – paragraph 1 – point a
(a) the condition affects not more than five5 in 10 000 persons in the Union when the application for an orphan designation is submitted;
Amendment 1061 #
2023/0131(COD)
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. The orphan medicineal product sponsor shall submit an application for the designation of the orphan medicinal product to the Agency at any stage of the development of the medicinal product before the application for marketing authorisation referred to in Articles 5 and 6 is submitted.
Amendment 1064 #
2023/0131(COD)
Proposal for a regulation
Article 64 – paragraph 2 – subparagraph 1 – introductory part
Article 64 – paragraph 2 – subparagraph 1 – introductory part
The application for the designation of the orphan medicine sponsoral product shall be accompanied by the following particulars and documentation:
Amendment 1067 #
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. Within the timelines for adoption of a decision foreseen in paragraph 3, the Agency shall transmit its scientific conclusions to the applicant. Within 30 days of receipt of the scientific conclusions, the sponsor may submit to the Agency a written request, citing detailed grounds, for a re-examination. Within 30 days following receipt of a request for re-examination, the Agency shall confirm or revise its previous scientific conclusions.Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions. If, within the 30-day period referred to in subparagraph 3, the applicant does not request re-examination, the scientific conclusions shall become definitive. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive. The application is considered valid if it includes all the particulars and documentation referred to in paragraph 2.
Amendment 1081 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
1. An orphan designation shall be valid for seven yearsrom the day of the adoption of the decision granting the orphan designation by the Agency. During this period, the orphan medicine sponsor shall be eligible for incentives referred to in Article 68.
Amendment 1085 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
Amendment 1095 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 5
Article 66 – paragraph 5
5. At any time, an orphan designation may be withdrawn at the request of the orphan medicine sponsor. The orphan medicine sponsor may provide a reasoned justification for the withdrawal request which shall be made publicly available.
Amendment 1111 #
2023/0131(COD)
Proposal for a regulation
Article 68 – paragraph 2 – subparagraph 1 (new)
Article 68 – paragraph 2 – subparagraph 1 (new)
For the purpose of paragraph 2, the definitions set out in Article 58a paragraph 1 of [revised Directive 2001/83/EC] shall apply.
Amendment 1113 #
2023/0131(COD)
Proposal for a regulation
Article 69 – paragraph 2 – subparagraph 2
Article 69 – paragraph 2 – subparagraph 2
Where appropriate, the applicant shall provide relevant evidence to demonstrate that the medicinal product addresses a high unmetconstitutes a breakthrough orphan medicinal need as specifiedproduct in accordance with in Article 70(1).
Amendment 1115 #
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 unmetconstitutes a breakthrough orphan medicinal need as specifiedproduct in accordance with in Article 70(1).
Amendment 1126 #
2023/0131(COD)
Proposal for a regulation
Article 70 – title
Article 70 – title
Breakthrough Designated Orphan medicinal products addressing a high unmet medical need
Amendment 1129 #
2023/0131(COD)
Proposal for a regulation
Article 70 – paragraph 1 – introductory part
Article 70 – paragraph 1 – introductory part
1. An orphan medicinal product shall be considered as addressing a high unmetdesignated as a breakthrough orphan medicinal needproduct where it fulfilscan be demonstrated at the moment of designation that the one of the following requirements are met:
Amendment 1131 #
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 orwhere, 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 advancementexists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Union, or;
Amendment 1138 #
2023/0131(COD)
Proposal for a regulation
Article 70 – paragraph 1 – point b
Article 70 – paragraph 1 – point b
(b) twhere, despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product uses a new and unique mechanism of action and the use of the orphan medicinal product results in a meaningful prevention of or reduction in disease morbidity or mortality or a major contribution to patient care for the relevant patient population.
Amendment 1145 #
2023/0131(COD)
Proposal for a regulation
Article 70 – paragraph 2
Article 70 – paragraph 2
Amendment 1149 #
2023/0131(COD)
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article, it shall consult the Commission and the authorities or bodies, as well as the stakeholders such as representatives of patients' organisations in the relevant disease areas, healthcare professionals, orphan medicinal product sponsors, representatives of pharmaceutical industry and other relevant stakeholders referred to in Article 162.
Amendment 1168 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineten years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1188 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) twelven years for breakthrough orphan medicinal products addressing a high unmet medical need as referred to in Article 70;
Amendment 1204 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fivesix years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].
Amendment 1206 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point c a (new)
Article 71 – paragraph 2 – point c a (new)
(c a) twelve years for orphan medicinal products addressing requirements set in Article 70, paragraph 1 point (a) and (b) in the paediatric population.
Amendment 1212 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 3
Article 71 – paragraph 3
3. Where a marketing authorisation holder holds more than one orphan marketing authorisations for the same active substance, those authorisations shall not benefit from separate market exclusivity periods. The duration of the market exclusivity shall start from the date when the first orphan, provided that a market exclusivity period was still in force when the application for marketing authorisation was granted in the Unionsubmitted.
Amendment 1227 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 1249 #
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 124 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 1257 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2
Article 72 – paragraph 2 – subparagraph 2
Such a prolongation may be granted twice, if the new therapeutic indications are each time for different orphan conditions.
Amendment 1269 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 3
Article 72 – paragraph 3
3. The orphan medicinal products which benefit from the prolongatUpon request from the applicant, the periond of market exclusivity referred to in the paragraph 2 shall not benefit from the additional period of data protection referred to in Article 81(2), point (d), of [revised Directive 2001/83/EC]for orphan medicinal products referred to in Article 71(2), points (a) and (b) shall be prolonged by an additional 24 months where an application for orphan marketing authorisation is submitted in respect of a designated orphan medicinal product and that application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan.
Amendment 1277 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 4 a (new)
Article 72 – paragraph 4 a (new)
4 a. An orphan medicinal product which benefits from the prolongation of market exclusivity as referred to in paragraph 3, shall not benefit from the rewards referred to in Article 86 [of revised Directive 2001/83/EC].
Amendment 1278 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 4 b (new)
Article 72 – paragraph 4 b (new)
4 b. The holder of an orphan marketing authorisation shall be entitled to a total maximum period of 14 years of orphan marketing exclusivity from the time the orphan medicinal product in question first obtains an authorization as defined in Article 69.
Amendment 1289 #
2023/0131(COD)
Proposal for a regulation
Article 75 – paragraph 1 – point b
Article 75 – paragraph 1 – point b
(b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless wheon the product is directed at a molecular targetbasis of existing scientific data, there is medical plausibility that on the basis of existing scientific data, is responsible forproduct, due to its mechanism of action, could address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population;
Amendment 1290 #
2023/0131(COD)
Proposal for a regulation
Article 75 – paragraph 1 – point c
Article 75 – paragraph 1 – point c
(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patientsmethods of diagnosis, prevention or treatments for paediatric patients, including when clinical studies are not feasible.
Amendment 1298 #
2023/0131(COD)
Proposal for a regulation
Article 75 – paragraph 3 a (new)
Article 75 – paragraph 3 a (new)
3 a. In consultation with the Commission and with interested parties, the Agency shall draw up guidelines for the application of this Article.
Amendment 1300 #
2023/0131(COD)
Proposal for a regulation
Article 76 – paragraph 1
Article 76 – paragraph 1
1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation confirmatory of safety and efficacy clinical studies in adults or children so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.
Amendment 1305 #
2023/0131(COD)
Proposal for a regulation
Article 77 – paragraph 1
Article 77 – paragraph 1
1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 980 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.
Amendment 1322 #
2023/0131(COD)
Proposal for a regulation
Article 81 – paragraph 3
Article 81 – paragraph 3
3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five yearsbe justified on scientific and technical grounds or on grounds relating to public health.
Amendment 1325 #
2023/0131(COD)
Proposal for a regulation
Article 82 – paragraph 1 – subparagraph 1
Article 82 – paragraph 1 – subparagraph 1
In duly justified cases, a request for a prolongation of the deferral, may be submitted, at least 612 months before the expiry of the deferral period. A prolongation of the derogation shall not exceed the duration of the deferral period given under Article 81(3).
Amendment 1333 #
2023/0131(COD)
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 2
Article 84 – paragraph 2 – subparagraph 2
The applicant shall submit the changes requested within 690 days.
Amendment 1343 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 2 a (new)
Article 87 – paragraph 2 a (new)
2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant.
Amendment 1345 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 2 b (new)
Article 87 – paragraph 2 b (new)
2 b. Within 30 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re- examination.
Amendment 1348 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 2 c (new)
Article 87 – paragraph 2 c (new)
Amendment 1350 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 2 d (new)
Article 87 – paragraph 2 d (new)
2 d. If, within the 30-day period referred to in paragraph 4, the applicant does not request re-examination, the scientific conclusions shall become definitive.
Amendment 1351 #
2023/0131(COD)
Proposal for a regulation
Article 87 – paragraph 2 e (new)
Article 87 – paragraph 2 e (new)
2 e. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive. This decision shall be communicated to the applicant in writing and shall annex the final scientific conclusions.
Amendment 1355 #
2023/0131(COD)
Proposal for a regulation
Article 88 – paragraph 1 a (new)
Article 88 – paragraph 1 a (new)
Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4 could not be completed due to failure of timely completion of pediatric studies, for the product that has already been authorized for use in adults in accordance with the provision of this Regulation, the Agency should consider evidence from the pediatric studies as specified in Article 138, paragraph 1, subparagraph 2, point za a(new)
Amendment 1361 #
2023/0131(COD)
Proposal for a regulation
Article 91 – paragraph 3 a (new)
Article 91 – paragraph 3 a (new)
3 a. Where a medicinal product is covered by a marketing authorization for adults, and the paediatric authorisation could not be completed due to the inability to timely complete the pediatric clinical studies, instead of granting deferrals, the Agency should consider evidence from the pediatric studies defined in Article 138, paragraph 1, subparagraph 2, point za a(new)
Amendment 1364 #
2023/0131(COD)
Proposal for a regulation
Article 95 – paragraph 2 a (new)
Article 95 – paragraph 2 a (new)
2 a. Within the European network, the Agency shall, together with the proposed members of the network, develop a platform study concept for paediatric patients. The objectives of the platform study concept are to create active paediatric patients’ master files open for future authorizations of the same molecules or molecules with the same mechanism of action, and/or to share the same pool of patients for joined clinical trials of industry and academia within the same administrative process.
Amendment 1400 #
2023/0131(COD)
(a) it is not possible to adequately develop the medicinal product or category of products in compliance with the requirements applicable to such medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;
Amendment 1409 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 2 – subparagraph 1
Article 113 – paragraph 2 – subparagraph 1
The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 and other applicable Union legislation under the conditions set out in Article 114.
Amendment 1412 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 3
Article 113 – paragraph 3
3. The Agency shall monitor the field of emerging medicinal products and mayshall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and mayshall engage with them in preliminary discussions, where relevant by invoking the mechanism of consultation of Article 162. The Agency may set up consultation mechanism with other Union and non- Union regulatory agencies to facilitate its monitoring. The Agency shall draw up and regularly update a list of emerging medicinal or health products for which a regulatory sandbox may be established.
Amendment 1421 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 4 – subparagraph 1
Article 113 – paragraph 4 – subparagraph 1
Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commissionproducts which might be regulated as medicinal products (including advanced therapy medicinal products), medical devices, in- vitro diagnostics, substances of human origin, it shall provide a recommendation to the Commission, where relevant after invoking the mechanism of consultation of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.
Amendment 1434 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 5
Article 113 – paragraph 5
5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and, Regulation (EC) 1394/2007 and other applicable Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.
Amendment 1437 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 7 – point c
Article 113 – paragraph 7 – point c
(c) include as part of the sandbox plan the requirements of this Regulation and of, [revised Directive 2001/83/EC], of Regulation (EC) 1394/2007 and of other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment.
Amendment 1445 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 9
Article 113 – paragraph 9
9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoaption of supplementary conditionsng the applicable requirements and conditions laid down in paragraphs 6 and 7, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).
Amendment 1452 #
2023/0131(COD)
Proposal for a regulation
Article 114 – paragraph 3
Article 114 – paragraph 3
3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and ,[revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and of other applicable Union legislation. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.
Amendment 1458 #
2023/0131(COD)
Proposal for a regulation
Article 115 – paragraph 1 – subparagraph 1
Article 115 – paragraph 1 – subparagraph 1
The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspendtop or restrict their use and inform the Commission in accordance with Article 113(2).
Amendment 1461 #
2023/0131(COD)
Proposal for a regulation
Article 115 – paragraph 1 – subparagraph 2
Article 115 – paragraph 1 – subparagraph 2
Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without any delay until an effective mitigation takes place.
Amendment 1481 #
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 no less than sixthree 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 1491 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the marketUnion list of critical medicinal products referred to in Article 131. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by determining medicinal products for which a shortage prevention plan shall be maintained and kept up to date, including due to the lack of availability of alternatives. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 1506 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 2
Article 117 – paragraph 2
2. The Agency, in collaboration with the working party referred to in Article 121(1), point (c), patients´ organisations and healthcare professionals and other interested parties shall draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.
Amendment 1523 #
2023/0131(COD)
Proposal for a regulation
Article 119 – paragraph 1 a (new)
Article 119 – paragraph 1 a (new)
1 a. To comply with their obligations, marketing authorisation holders shall have access to all relevant information contained in the repositories system referred to Article 67, paragraph 2, second subparagraph, point (e) for the purpose of fulfilling any obligation arising under [Revised] Directive (…) or this Regulation, including notifying shortages and assessing whether a product was supplied to another Member State than the one where it was placed.
Amendment 1528 #
2023/0131(COD)
Proposal for a regulation
Article 120 – paragraph 1 a (new)
Article 120 – paragraph 1 a (new)
1 a. When a marketing authorisation holder notifies a temporary disruption in supply of a medicinal product, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products shall provide information requested in a timely manner to the Agency, the competent authority in a Member State, and the relevant marketing authorisation holder to confirm that the temporary disruption in supply of the product in a Member State was not caused by parallel distribution to another Member State.
Amendment 1545 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point b a (new)
Article 121 – paragraph 1 – point b a (new)
(b a) establish an accessible and easily understandable system for patient organisations to report shortages of medicinal products;
Amendment 1583 #
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. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT regulatory and shortages reporting systems and other relevant IT systems and databases, without duplication of reportingincluding the repositories system containing information on safety features referred to in Article 67, paragraph 2, second subparagraph, point (e) of Directive [revised Directive 2001/83/EC], without duplication of reporting for marketing authorisation holders and national competent authorities. The ESMP shall be fully digitalised and automated.
Amendment 1608 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 1 a (new)
Article 124 – paragraph 1 a (new)
1 a. The Commission shall be entitled to restrict parallel distribution of medicinal products following their additions to the list of critical shortages of medicinal products in accordance with Article 123, paragraphs 1 and 2.
Amendment 1616 #
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 lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and include, to the extent possible, information from other relevant sources and databases identified by the Agency.
Amendment 1650 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
Article 130 – paragraph 1 – subparagraph 1 – introductory part
The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), patients’ organisations, healthcare professionals and marketing authorisation holders ensure the following:
Amendment 1659 #
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 and availability of alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;
Amendment 1675 #
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) in addition to marketing authorisation holders, patients´ organisations and other relevant stakeholders. 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 1682 #
2023/0131(COD)
Proposal for a regulation
Article 132 – paragraph 1
Article 132 – paragraph 1
1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c) in addition to marketing authorisation holders, patients’ organisations and other relevant stakeholders, the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may includeor recommendations on should be justified and risk-based, targeted and proportionate to the identified, underlying root causes of the supply security risk and patient impact and may include diversification of suppliers and inventory management.
Amendment 46 #
2023/0105(COD)
Proposal for a directive
Recital 3
Recital 3
(3) In light of the close link between the quality of honey and its origin and the need for the consumer not to be misled regarding the quality of the product, Directive 2001/110/EC lays down rules on the labelling of the origin where the honey has been harvested. In particular, Article 2(4) of that Directive requires the country or countries of origin where the honey has been harvested to be indicated on the label and provides that, if honey originates in more than one Member State or third country, the mandatory indication of the countries of origin may be replaced by one of the following, as appropriate: ‘blend of EU honeys’, ‘blend of non-EU honeys’, ‘blend of EU and non-EU honeys’. The different rules adopted on this basis by Member States may have misled consumers and may have hindered the functioning of the internal market. In the light of the Farm to Fork Strategy’s objective of strengthening consumers in making informed choices, including on the origin of their food, and in the interest to preserve the efficient functioning of the internal market throughout the Union through a harmonisation of the labelling rules, it is appropriate to revise the rules for honey origin labelling and provide that the country or each countriesy of origin should be mentioned on the packaging. In light of the reduced size of the packs containing only a single portion of honey (breakfast packs) and the resulting technical difficulties, it is therefore appropriate to exempt those packs from the obligation of listing all individual countries of origin, where the honey originates in more than one countr, in descending order and according to the mass percent composition of honey.
Amendment 123 #
2023/0105(COD)
Proposal for a directive
Recital 23
Recital 23
(23) In order to allow Member States to adopt national laws, regulations and administrative provisions necessary to comply with this Directive, a transposition period of 18six months should be established. In order to allow operators to sufficient time to adjust to the new requirements, those national provisions transposing this Directive should only apply from 24nine months after the date of entry into force of this Directive.
Amendment 157 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Directive 2001/110/EC
Article 2 – paragraph 4 – point a
Article 2 – paragraph 4 – point a
(a) The country of origin where the honey has been harvested shall be indicated on the label. If the honey originates in more than one country, theeach countriesy of origin where the honey has been harvested shall be indicated on the label of packs containing more than 25 gin descending order according to each country of origin’s share in weight of the honey contained in the pack, specifying the exact percentage for each country;
Amendment 253 #
2023/0105(COD)
Member States shall adopt and publish, by [OP please insert the date = 18six months after the date of 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 257 #
2023/0105(COD)
Proposal for a directive
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
They shall apply those provisions from [OP please insert the date = 24nine months after the date of entry into force of this Directive].
Amendment 260 #
2023/0105(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
Products which are placed on the market or labelled before [OP please insert the date = 2418 months after the date of entry into force of this Directive], in accordance with Directives 2001/110/EC, 2001/112/EC, 2001/113/EC and 2001/114/EC, may continue to be marketed until the exhaustion of stocks.
Amendment 263 #
2023/0105(COD)
Proposal for a directive
Article 6 a (new)
Article 6 a (new)
Article6a Penalties Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.
Amendment 71 #
2023/0083(COD)
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2a) For this reason, this Directive seeks the highest possible level of harmonization. Only full harmonization will ensure that consumers in the EU will have the same rights everywhere concerning warranties and their rights to repair. Harmonized rules will ensure effective consumer protection through clearer information and enforcement at a European level, regardless of the place of residence.
Amendment 97 #
2023/0083(COD)
Proposal for a directive
Recital 12
Recital 12
(12) Since the obligation to repair imposed on producers under this Directive covers defects that are not due to the non- conformity of the goods with a sales contract, producers may provide repair against a price paid by the consumer, against another kind of consideration, or for free. The charging of a price should encourage producers to develop sustainable business models, including the provision of repair services. Such a price may take into account, for instance, labour costs, costs for spare parts, costs for operating the repair facility and a customary margin. The price for and the conditions of repair should be agreed in a contract between the consumer and the producer and the consumer should remain free to decide whether that price and those conditions are acceptable. The need for such a contract and the competitive pressure from other repairers should encourage producers who are obliged to repair to keep the price acceptable for the consumer. The repair obligation may also be performed for free when the defect is covered by a commercial guarantee, for instance, in relation to guaranteed durability of goods. To incentivise consumers to have their product repaired outside of the legal guarantee, a producer may offer a loan of a replacement or refurbished good for the duration of the repair, which is expected to be returned once the consumer receives the repaired good.
Amendment 115 #
2023/0083(COD)
Proposal for a directive
Recital 15 a (new)
Recital 15 a (new)
(15a) To ensure consumer protection and trust in repair, repairers should be liable for any repair they carry out, be it within or beyond the liability period.
Amendment 151 #
2023/0083(COD)
Proposal for a directive
Recital 27
Recital 27
(27) The Commission should enable the development of a voluntary European quality standard for repair services, for instance by encouraging and facilitating voluntary cooperation on a standard between businesses, public authorities and other stakeholders or by issuing a standardisation request to the European standardisation organisations and SME Standardisation organisations. A European standard for repair services could boost consumer trust in repair services across the Union. Such standard could include aspects influencing consumer decisions on repair, such as the time to complete repair, the availability of temporary replacement goods, quality assurances such as a commercial guarantee on repair, and the availability of ancillary services such as removal, installation and transportation offered by repairers, and the special conditions and challenges for SMEs.
Amendment 173 #
2023/0083(COD)
Proposal for a directive
Recital 33 a (new)
Recital 33 a (new)
(33a) Fostering reparability at EU level requires a smart mix of measures not exclusively rule-based. This Directive should be accompanied by other national initiatives to counter the skills shortage to ensure that reparability services within the European Union can be provided in the future.
Amendment 174 #
2023/0083(COD)
Proposal for a directive
Recital 33 b (new)
Recital 33 b (new)
(33b) Additional incentives may be considered necessary, therefore Member States should explore measures such as lower VAT rates or reduced taxes on services and labour in order to further incentive customers to opt for a good being repaired instead of replaced. In addition, Member States should pay particular attention to micro, small and medium sized enterprises as their businesses are a vital part of the repair chain.
Amendment 175 #
2023/0083(COD)
Proposal for a directive
Recital 33 c (new)
Recital 33 c (new)
(33c) Consumer behaviour is shaped by a wide variety of aspects. When choosing between repair and new purchase, decision criteria such as economic efficiency, durability, proximity of a repair service, and the time required play an important role. Besides the provisions laid out in this Directive, awareness- raising measures for a culture of repair, improving consumers’ knowledge about proper cleaning and care of products, and improving consumers’ knowledge about the existing rights in terms of legal guarantee should be strengthened to boost the demand for reparability services.
Amendment 176 #
2023/0083(COD)
Proposal for a directive
Recital 33 d (new)
Recital 33 d (new)
(33d) This Directive should focus on the business to consumer dimension of the repairs, within the Union legal acts as listed in Annex II.
Amendment 177 #
2023/0083(COD)
Proposal for a directive
Recital 33 e (new)
Recital 33 e (new)
(33e) Where the producer’s business has been terminated, the seller or distributor must not be made subsidiarily responsible for a repair obligation
Amendment 182 #
2023/0083(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
2. ‘repairer’ means any natural or legal person who, related to that person’s trade, business, craft or profession, provides a repair service, including producers and sellers that provide repair services and repair service providers whether independent repairers, professional repairers or affiliated with such producers or sellers;
Amendment 184 #
2023/0083(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
4. ‘producer’ means a manufacturer as defined in Article 2, point (42) of Regulation [on the Ecodesign for Sustainable Products]ny natural or legal person who manufactures a product or who has a product designed or manufactured, and markets that product under its name or trademark;
Amendment 188 #
2023/0083(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 10 a (new)
Article 2 – paragraph 1 – point 10 a (new)
10a. ‘professional repairer’ means a natural or legal person who provides repair or maintenance services for a product, irrespective of whether that person acts within the manufacturer’s distribution system or independently;
Amendment 212 #
2023/0083(COD)
Proposal for a directive
Article 4 – paragraph 4 – point d a (new)
Article 4 – paragraph 4 – point d a (new)
(da) if possible, an estimation of the remaining lifespan of the product after the repair;
Amendment 236 #
2023/0083(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Member States shall ensure that upon the consumer’s request, the producer shall repair, for free or against a reasonable price or another kind of consideration, goods for which and to the extent that reparability requirements are provided for by Union legal acts as listed in Annex II. The producer shall not be obliged to repair such goods where repair is impossible. The producer may sub- contract repair in order to fulfil its obligation to repair. For the duration of the repair, the producer may provide the consumer with a replacement or a refurbished good.
Amendment 254 #
2023/0083(COD)
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Producers shall ensureallow that independent repairers have access to spare parts , notwithstanding any other product specific obligations, and repair-related information and tools in accordance with the Union legal acts listed in Annex II., without prejudice to the protection sensitive information and business secrets foreseen in Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016;
Amendment 257 #
2023/0083(COD)
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Producers shall ensure that independent repairers have access to spare parts and repair-related information and tools in accordance with the Union legal acts listed in Annex II. Producers shall ensure, that the software of their products does not restrict or impose barriers in the application of the product in the case of repair by independent repairers.
Amendment 260 #
2023/0083(COD)
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Producers shall ensure that independent repairers and consumers have access to spare parts for a reasonable and non-disproportionate price and repair- related information and tools in accordance with the Union legal acts listed in Annex II.
Amendment 266 #
2023/0083(COD)
Proposal for a directive
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3a. Consumers shall be able to seek quality and affordable repair from a repairer of their choice using either original, compatible or second-hand parts that comply with relevant EU standards and regulations.
Amendment 275 #
2023/0083(COD)
Proposal for a directive
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The Commission is empowered to adopt delegated acts, following an impact assessment and consultation with relevant stakeholders, in accordance with Article 15 to amend Annex II by updating the list of Union legal acts laying down reparability requirements in the light of legislative developments.
Amendment 283 #
2023/0083(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
Member States shall ensure that producers inform consumers of their obligation to repair pursuant to Article 5 and provide information on the repair services in an easily accessible, clear and comprehensible manner free of charge, for example through the online platform referred to in Article 7.
Amendment 305 #
2023/0083(COD)
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Registration on the online platform for repairers, as well as for sellers of goods subject to refurbishment and for purchasers of defective goods for refurbishment, shall be voluntary. Member States shall determine the access to the platform in accordance with Union law. The use of the online platform shall be free of charge for consumers.
Amendment 309 #
2023/0083(COD)
Proposal for a directive
Article 7 a (new)
Article 7 a (new)
Article 7a Measures to inform about consumers rights Member States shall take measures to ensure that consumers are informed about their consumer rights with regard to this Directive and may take measures that enable consumers to find relevant repairers, which can be done through, for example, the creation of an online platform, a dedicated information campaign, or any other means that the Member State deems appropriate. The creation of an online platform shall not impede the functioning of existing private repair platforms.
Amendment 311 #
2023/0083(COD)
Proposal for a directive
Article 7 a (new)
Article 7 a (new)
Article 7a Financial incentives Member States shall ensure that appropriate measures promoting repair in a form of financial incentives for repair exist for their territory. Such measures may among others include repair vouchers, repair funds or other financial incentives.
Amendment 316 #
2023/0083(COD)
Proposal for a directive
Article 8 a (new)
Article 8 a (new)
Article 8a Micro, small and medium sized enterprises Member States shall take appropriate measures to help small and medium sized enterprises within the meaning of the Commission recommendation 2003/361/EC apply the requirements set out in this Directive. Those measures shall at least include: guidelines on how to demonstrate compliance with the requirements set out in this Directive.
Amendment 342 #
2023/0083(COD)
Proposal for a directive
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
Amendment 345 #
2023/0083(COD)
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
Amendment 365 #
2023/0083(COD)
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Article 12 of this Directive shall not apply to sales contracts concluded before [2436 months after the entry into force]
Amendment 294 #
2022/2051(INL)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Demands the strengthening of the Union’s capacity to act by considerably increasing the number of areas where actions are decided by qualified d majority voting (QMV) and through the ordinary legislative procedure (OLP);
Amendment 304 #
2022/2051(INL)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls for the reversal of the roles of Council and Parliament in the nomination and confirmation of the President of the Commission to more accurately reflect the results of European elections; proposes to enable the Commission President to choose its members based on political preferences, whilst ensuring geographic and demographic balance; calls for the re naming of the European Commission as the Europe an Executive;
Amendment 324 #
2022/2051(INL)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Proposes to establishxamine which areas of the environment and biodiversity should be established as the exclusive Union competence for the environment and biodiversity as well as negotiations on climate changeof the EU while noting that the exclusive competence of the EU in climate change negotiations would be beneficial in terms of the effectiveness of the negotiations.;
Amendment 346 #
2022/2051(INL)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 356 #
2022/2051(INL)
Motion for a resolution
Paragraph 22
Paragraph 22
Amendment 366 #
2022/2051(INL)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Calls for the Union to develop common objectives and standards for an education that promotes democratic values and the rule of law, as well as digital and economic literacy; calls further for the Union to promoteNotes that education, including the creation of teaching content, is the primary coomperation and coherence between educational establishments systems while guaranteeing the cultural traditions and regional diversitytence of the Member States;
Amendment 377 #
2022/2051(INL)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Underline s that the equality between women and men is one of the objectives of the Europe an Union; Proposes to expand non- discrimination protections to gender, social origin, language, political opinion and membership of a national minority and introduces OLP for non-discrimination legislation; propose s to re place ‘thee quality of men and women’ by ‘gender equality’ throughout the Treaties; underlines that the Union’s institutions and their governing and consultative bodies must be composed in a non-discriminatory manner and reflect gender equality and diversity of society;
Amendment 386 #
2022/2051(INL)
Motion for a resolution
Paragraph 34
Paragraph 34
Amendment 493 #
2022/2051(INL)
Annex to the motion for a resolution Treaty on the Functioning of the European Union – Article 48 – Paragraph 2
Amendment 544 #
2022/2051(INL)
Annex to the motion for a resolution Treaty on the Functioning of the European Union – Article 253 – Paragraph 1
The Judges and Advocates-General of the Court of Justice shall be chosen from persons whose independence is beyond doubt and who possess the qualifications required for appointment to the highest judicial offices in their respective countries or who are jurisconsults of recognise d competence; they shall be appointed by common accord of the governments of the Member States for a non-renewable term of sixnine years, after consultation of the panel provided for in Article 255.
Amendment 61 #
2022/0432(COD)
Proposal for a regulation
Recital 2
Recital 2
Amendment 138 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Regulation (EC) No 1272/2008
Article 2 – paragraph 7a
Article 2 – paragraph 7a
Amendment 607 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point f
Article 3 – paragraph 1 – point 1 – point f
(f) permeable tea or coffee bagsingle- serve units necessary to contain a tea or coffee product and intended to be used and disposed of together with the product;
Amendment 612 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point g
Article 3 – paragraph 1 – point 1 – point g
(g) protective coffee or tea system single-serve unit necessary to contain a coffee or tea product and intended to be used and disposed of together with the productused in dedicated machinery;
Amendment 645 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 19
Article 3 – paragraph 1 – point 19
(19) ‘composite packaging’ means a unit of packaging made of two or more different materials, excluding materials used for labels, closures and sealing and lacquers, which cannot be separated manually and therefore form a single integral unit;
Amendment 704 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32 a (new)
Article 3 – paragraph 1 – point 32 a (new)
(32a) ‘high quality recycling’ means any processes by which materials are sufficiently and effectively collected, sorted and recycled, and are able to withstand multiple recycling loops without any change to their main material properties. The generated secondary raw materials are of sufficient quality to substitute the primary raw materials for packaging applications or any other application of similar quality.
Amendment 920 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 2 a (new)
Article 6 – paragraph 2 – subparagraph 2 a (new)
Packaging shall be considered highly recyclable where it complies with the point (a) to (e) above and, additionally, is suitable for high quality recycling.
Amendment 962 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1
Article 6 – paragraph 4 – subparagraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 58 to supplement this Regulation in order to establish design for recycling criteria and recycling performance grades based on the criteria and parameters listed in Table 2 of Annex II for packaging categories listed in Table 1 of that Annex, as well as rules concerning the modulation of financial contributions to be paid by producers to comply with their extended producer responsibility obligations set out in Article 40(1), based on the packaging recycling performance grade, and for plastic packaging, the percentage of recycled content. Design-for-recycling criteria shall consider state of the art collection, sorting and recycling processes and shall cover all packaging components.
Amendment 1078 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 11
Article 6 – paragraph 11
11. The financial contributions to be paid by producers to comply with their extended producer responsibility obligations as referred to in Article 40 shall be modulated on the basis of the recyclability performance grade, as determined in accordance with the delegated acts referred to in paragraphs 4 and 6 of this Article and, as regards plastic packaging, also in accordance with the Article 7(6).
Amendment 1200 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 3 – point c a (new)
Article 7 – paragraph 3 – point c a (new)
(ca) refill containers as defined in Article 2, point (17) of Directive 2014/40/EU where the refill containers are manufactured to ISO standard 15378.
Amendment 1360 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. By [OP: please insert the date = 24 months from the entry into force of this Regulation], packaging referred to in Article 3(1), points (f) and (g), sticky labels attached to fruit and vegetables and very lightweight plastic carrier bags shall be compostable in industrially controlled conditions in bio-waste treatment facilities.
Amendment 1945 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 7 – introductory part
Article 26 – paragraph 7 – introductory part
7. Economic operators using transport packaging in the form of pallets, plastic crates, foldable plastic boxes, pails and drums for the conveyance or packaging of products in conditions other than provided for under paragraphs 12 and 13 shall ensure that:
Amendment 2047 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 12 – subparagraph 2
Article 26 – paragraph 12 – subparagraph 2
This obligation applies to pallets, boxes, excluding cardboard, trays, plastic crates, intermediate bulk containers, drums and canisters, of all sizes and materials, including flexible formats.
Amendment 2080 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 13 – subparagraph 2
Article 26 – paragraph 13 – subparagraph 2
This obligation applies to pallets, boxes, excluding cardboard, plastic crates intermediate bulk containers, and drums, of all sizes and materials, including flexible formats.
Amendment 61 #
2022/0219(COD)
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
1 a. Third countries that are candidates for accession to the European Union may also be associated to the eligible actions under paragraph 1 of this article, provided that the Member States participating in the common procurement unanimously agree to it.
Amendment 67 #
2022/0219(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Member States or associated third countries shall appoint a procurement agent to act on their behalf for the purpose of the common procurement. The procurement agent shall carry out the procurement procedures and conclude the resulting agreements with contractors on behalf of the countries participating Member Statesin the common procurement.
Amendment 70 #
2022/0219(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The procurement procedures referred to in paragraph 1 shall be based on an agreement to be signed by the participating Member States with the procurement agent under the conditions set out in the work programme referred to in Article 11. The member states participating in the agreement may unanimously authorise the procurement agent to invite and enter into an agreement with third countries that are candidates for accession to the European Union to procure additional quantities of the procured product.
Amendment 129 #
2022/0219(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 4
Article 10 – paragraph 1 – point 4
4. the number of Member States or associated countries or third countries that are candidates for accession to the European Union participating in the common procurement;
Amendment 138 #
2022/0219(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 7 a (new)
Article 10 – paragraph 1 – point 7 a (new)
7 a. the participation of SMEs as contractors or subcontractors;
Amendment 183 #
2022/0216(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, programmes 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. 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 necessary to 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 set by national authorities, at a level appropriate in their Member State to reach such objectives. _________________ 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 222 #
2022/0216(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) With regards to standards concerning donor, recipient and offspring protection, this Regulation should provide for a hierarchy of rules for their implementation. As risks and technologies change, this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this Regulation. As part of that hierarchy, in the absence of Union legislation describing particular procedures to be applied and followed to meet the standards set out in this Regulation, following the guidelines of the European Centre for Disease Prevention and Control (ECDC) and the EDQM should be considered as a means to demonstrate compliance with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines achieve the same level of quality, safety and efficacy. In cases of detailed technical issues for which neither Union legislation nor the ECDC and the EDQM have defined a technical guideline or rule, operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified. When assesing scientific guidlines, it is important that the Commission, the ECDC, and the EDQM involve existing scientific, donor, and patient representative groups.
Amendment 286 #
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. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform, once established, should be granted within the framework of the European Health Data Space (EHDS) and otherwise should be limited to the extent necessary to carry out supervisory activities provided for in this Regulation.
Amendment 326 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 1
Article 2 – paragraph 3 – subparagraph 1
For SoHOs that are used to manufacture products in accordance with Union legislation on medical devices, regulated by Regulation (EU) 2017/745, on medicinal products, regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, on investigational medicinal products regulated by Regulation 536/2014, or on food, regulated by Regulation (EC) No 1925/2006, or as the starting and raw material thereof, the provisions of this Regulation applicable to the activities of SoHO donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, and collection of SoHOs from donors or patients shall apply. Insofar as the activities of SoHO release, distribution, import and export relate to SoHOs prior to their distribution to an operator regulated by the other Union legislation referred to in this subparagraph, the provisions of this Regulation shall also apply.
Amendment 329 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 2
Article 2 – paragraph 3 – subparagraph 2
By way of derogation from the first subparagraph, in cases where SoHOs, SoHO preparations, or products manufactured from SoHO, as referred to in that subparagraph, are exclusively for autologous use, only those provisions of this Regulation that concern the collection and testing of SoHOs from patients shall apply.
Amendment 402 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 28 – point b
Article 3 – paragraph 1 – point 28 – point b
(b) life-threatening, dirreversablinge or incapacitating condition, including transmission of a pathogen that might cause such condition;
Amendment 443 #
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 any lossexpenses and inconveniences associated with donation;
Amendment 498 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. In all cases where questions arise as to the regulatory status of a substance, product or activity, competent authorities shall consult with authorities established in other relevant Union legislation referred to in Article 2(3), as relevantsuch as the European Medicine Agency (EMA). In such cases, competent authorities shall also consult the compendium referred to Article 3 point (33). The EMA and the SoHO Coordination Board (SCB) shall have close collaboration and establish a permanent panel for reviewing such questions, while consulting other authorities, such as the Medical Devices Coordination Group.
Amendment 561 #
2022/0216(COD)
Proposal for a regulation
Article 29 – paragraph 11
Article 29 – paragraph 11
11. The interval between two on-site inspectionsinspections should be decided based on the necessary frequency to mitigate any identified risks and shall not exceed 4 years.
Amendment 631 #
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 lossexpenses and inconveniences related to their participation in donations through, for example, fixed rate allowances, days off, or tax reduction. In such case, Member States shall establish the conditions for such allowances in national legislation, including the setting of an upper limit 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. The compensation shall be limited to travel expenses, loss of earnings, or medical costs related to the medical procedure and possible side effects.
Amendment 750 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. Member States shall make all reasonable efforts 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 strongly encourage the collection of SoHO with a strong public and non- profit sector involvementthe involvement of all relevant stakeholders.
Amendment 519 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
(c) ‘electronic health data’ means personal or non-personal electronic health data; processed by providers in the context of healthcare. Such data may include actionable health data, which is collected and processed by providers in the context of healthcare which provides clinical measurements/values that are usable by patients, healthcare professionals and researchers.
Amendment 601 #
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) “real-world data” means routinely collected data relating to patient health status or the delivery of health care from a variety of sources other than traditional clinical trials.
Amendment 608 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae b (new)
Article 2 – paragraph 2 – point ae b (new)
(ae b) 'real-world evidence' means information derived from analysis of real- world data.
Amendment 609 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae c (new)
Article 2 – paragraph 2 – point ae c (new)
(ae c) ‘online pharmacy’ means a pharmacy legally established as such in a Member State for which a pharmacist within the meaning of Directive 2005/36/EC is responsible, which, by means of information society services directed to the public dispenses prescriptions, offers medicinal products for sale or provides other pharmaceutical services.
Amendment 613 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae d (new)
Article 2 – paragraph 2 – point ae d (new)
(ae d) ‘Derived data’ means the improved, corrected, or enriched dataset provided to the data holder in accordance with Article 37(1)(p) of this Regulation, as well as any new or different form of the original electronic health data created by the data user(s), including any alternative or different representation or abstraction of the original data or any new form which would enable the original data to be identified or reverse engineered.
Amendment 735 #
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, including for cross- border care, through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.
Amendment 739 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 3 a (new)
Article 4 – paragraph 3 a (new)
3 a. Member States shall establish policies aimed at providing health professionals with the digital skills, competences, infrastructures and tools required to fulfill the obligations set out in paragraph 1 of this Article.
Amendment 847 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point h
Article 10 – paragraph 2 – point h
(h) contribute, at Union level, and in cooperation with the local and regional level within the Member States, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing interoperability, security, safety 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 861 #
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’ representatives, healthcare providers, health professionals, industry associations;
Amendment 1186 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point j
Article 33 – paragraph 1 – point j
(j) electronic health data from clinical trialsfully completed clinical trials in accordance with definitions in Article 2(2) and Article 2(26) of Regulation (EU) No 536/2014;
Amendment 1234 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Electronic health data entailingWithout prejudice to the law relating to the protectedion of intellectual property and trade secreindustrial property (including of trade secrets)(“IP rights”) and commercial property, and subject to other provisions of this Regulation, electronic health data entailing protected IP rights from private enterprises shall be made available for secondary use. Where such data is made available for secondary use, all measures necessary to preserve the confidentiality of IP rights and(including trade secrets) shall be taken. Data sharing for secondary use shall be based on a data sharing agreement pursuant to Articles 46.6(g) and 46a.
Amendment 1253 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5
Article 33 – paragraph 5
5. Where the 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. Natural persons persons that are subjects to secondary use of health data shall have the right to decline the processing of their health data. Health data access bodies shall provide for an accessible and easily understandable opt-out mechanism, whereby natural persons must be offered the possibility to explicitly express their wish not to have all or part of their personal electronic health data processed for some or all secondary use purposes. In situation where natural persons explicitly express their wish to use opt-out mechanism to data holders, data holders shall direct natural persons to the health data access bodies. The exercise of this right to opt-out shall not affect the lawfulness of the processing that took place under this Chapter IV before the individual opted-out.
Amendment 1381 #
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 with the exception of communication in line with approved regulatory information or to provide up-to date, verifiable and complete scientific information to health care professionals for educational purpose in line with Directive 2001/83/EC;
Amendment 1407 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(e a) unfair commercial use or other unfair competition, in accordance with Article 39 of TRIPS Agreement;
Amendment 1410 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e b (new)
Article 35 – paragraph 1 – point e b (new)
(e b) using data from private enterprises in regulatory or reimbursement submissions for any generic or biosimilar product without an agreement from the private sector data holder while the data holder’s referenced product is under patent or regulatory data protection (including such use of data outside of the EU), or equivalent protected data of non- medicinal products such as medical devices and software medical devices.
Amendment 1788 #
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 permitand only after any data sharing agreement(s) on mutually agreed terms required by this Regulation, such as set out in Article 46a, are signed, the health data access body shall issue a data permit. However, any assessments by health data access bodies of an application concerning any data under Article 33(4) shall require the health data access bodies to consult the data holder(s).
Amendment 1834 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 6 – point f a (new)
Article 46 – paragraph 6 – point f a (new)
(f a) When required, signed data sharing agreements, as set out in Article 46a;
Amendment 1846 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 11
Article 46 – paragraph 11
11. Data users shall make public the results or output (in accordance with the definition of results/outputs under Article 2) of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47 and in compliance with minimum requirements of what needs to be published, but such that this will not prejudice the IP rights in the secondary use results/outputs, particularly if the secondary use is for development or innovation as referred to in Article 34(f) , no later than 18 months after the completion of the electronic health data processing with a possible extension to 24 months if requested by data users due to sensitivity of health data in relation to IP rights. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.
Amendment 1861 #
2022/0140(COD)
Proposal for a regulation
Article 46 a (new)
Article 46 a (new)
Article 46 a 1. In order for electronic health data entailing IP rights, including trade secrets, and commercial property from private enterprises to be made available for secondary use, the data user must sign a data sharing agreement with each private enterprise data holder. Such electronic health data shall not be made available to any data user for the purposes of secondary use unless and until the data user has signed the data sharing agreement. 2. The data sharing agreement shall set out all necessary measures to protect all IP rights, including trade secrets, and commercial property entailed in the electronic health data and additional conditions of access requested by the data holder. In particular, without limitations, it may include any or all of: a. a restriction on any use of the electronic health data outside the scope of the secondary use purposes specified in the data permit, including for any prohibited secondary use as set out in this Regulation, including Article 35; b. an undertaking by the data user to preserve and not infringe or misappropriate the IP rights, including trade secrets, of the data holder, including to (i) preserve the confidentiality of the data holder’s confidential information, including trade secrets, and (ii) not perform or enable any reverse engineering or other activity to identify the confidential information, including trade secrets, of the data holder; c. provisions to ensure the confidentiality of the electronic health data and confidential information, including trade secrets, of the data holder. For example, (i) a right of prior review by the data holder of any public disclosures or applications for registerable IP rights, including patent applications, intended by or on behalf of the data user(s), including under this Regulation, that relates to or arises from the use of the electronic health data,(including the results or outputs, including the right to delay or prohibit the publication, and (ii) data security requirements reasonably required by the data holder; d. a requirement for the data user to notify the data holder of the creation of any new IP from its use of the electronic health data and for granting the data holder non-exclusive, fully-paid up and royalty-free licence rights enabling the data holder and its affiliates to use any new IP, results and outputs for its own business purposes. Such licence shall only be sub-licensable to third parties working in collaboration with, or on behalf of, the data holder or one of its affiliates for the aforesaid purposes. Such a licence shall be non-transferable, except where needed in order to commercialise an existing product of the data holder or any of its affiliates; e. audit rights for the data holder to ensure compliance of the processing with the data sharing agreement; f. the data holder to own all and any derived data created by the data user(s), a requirement for the data user to assign to and notify the data holder of any derived data and to enable the data holder to obtain a copy of it, and the rights, obligations and undertakings of, and the restrictions on, the data user as it relates to the electronic health data and confidential information, including trade secrets, of the data holder to apply mutatis mutandis to any and all derived data.
Amendment 2047 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 1 – point b – introductory part
Article 65 – paragraph 1 – point b – introductory part
(b) to issue written contributions and to exchange best practices on matters related to the coordination of the implementation at Member State level of this Regulation and of the delegated and implementing acts adopted pursuant to it, taking into account the regional and local level, in particular as regards:
Amendment 122 #
2022/0115(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Where applicable, the information included in the single document shall be made available through the Digital Product Passport as set out by the Regulation establishing a framework for ecodesign requirements for sustainable products and repealing Directive 2009/125/ECMicro and small and medium sized companies often struggle with administrative tasks, therefore the competent authorities should draw up the single document for them on the basis of their product specifications and send it for their approval.
Amendment 143 #
2022/0115(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) As it is the first time that an Union- wide geographical indication protection system for craft and industrial product is implemented, it is importantthe Commission, Member States and relevant stakeholders are encouraged to raise awareness among consumers, producers, especially MSMEs and public authorities at national, regional and local level about the initiative.
Amendment 172 #
2022/0115(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) ‘industrial products’ means products produced in a standardised way, typically on mass scale and through the use of machines;
Amendment 173 #
2022/0115(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point b a (new)
Article 3 – paragraph 1 – point b a (new)
(ba) “geographical indications” means an indication consisting of or containing the name of a geographical area, or another indication known as referring to such area, which identifies a good as originating in that geographical area, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin;
Amendment 239 #
2022/0115(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Where a Member State charges a fee, the level of the fees shall be reasonable, foster the competitiveness of the producers of the geographical indications and shall take into account the situation offoresee reductions for micro, small and medium- sized enterprises.
Amendment 244 #
2022/0115(COD)
Proposal for a regulation
Article 11 – paragraph 3 – point a a (new)
Article 11 – paragraph 3 – point a a (new)
(aa) The competent authority shall ensure that applicants can submit their applications electronically via the digital system of the Office according to Article 18 paragraph 1 and Article 64.
Amendment 247 #
2022/0115(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
The competent authority shall examine the application and shall check within six months from the submission of the application that the product complies with the requirements for geographical indications referred to in Article 5 and provides the necessary information for registration referred to in Articles 7, 8 and 9. Where the examination period exceeds or is likely to exceed 6 months, the competent authority shall inform the applicant of the reasons for the delay in writing.
Amendment 253 #
2022/0115(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The competent authority shall establish the detailed arrangements of the opposition procedure. Those detailed arrangements may include criteria for the admissibility of an opposition, a period of consultation between the applicant and each national opponent, and submission of a report from the applicant on the outcome of the consultations including any changes the applicant has made to the applicationcheck the admissibility of the opposition. If it considers that the opposition is admissible, it shall, within 30 days after the receipt of that opposition, invite the opponent and the applicant to engage in consultations for a reasonable period not exceeding 3 months. At any time during that period, the competent authority may, at the request of either party, extend the time limit for the consultations by a maximum of 3 months.
Amendment 256 #
2022/0115(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. If the competent authority, after the examination of the application and the assessment of the results of any oppositions received, and any changes to the application agreed with the applicant, finds that the requirements of this Regulation are met, within two months it shall take a favourable decision and within two months from the favourable decision lodge a Union application for registration in accordance with Article 17.
Amendment 297 #
2022/0115(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. A publicly and easily accessible electronic Union register of geographical indications for craft and industrial products shall be developed, kept and maintained by the Office for the management of geographical indications for craft and industrial products.
Amendment 301 #
2022/0115(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. The Office shall ensure that any person is able to easily download an official extract from the Union register of geographical indications for craft and industrial products that provides proof of registration of the geographical indication, and the relevant data including the date of application for the registration of the geographical indication or other priority date. The official extract may be used as an authentic certificate in legal proceedings, in a court of law, in a court of arbitration or similar body.
Amendment 324 #
2022/0115(COD)
Proposal for a regulation
Article 33 – paragraph 5
Article 33 – paragraph 5
5. The Advisory Board shall be composed of one representative of each Member State and, one representatives of the Commission and, their respective alternates and experts in the field of the concerned product category, including of academia.
Amendment 382 #
2022/0115(COD)
Proposal for a regulation
Article 48 – paragraph 2
Article 48 – paragraph 2
2. The enforcement authority shall regularly carry out controls, based on a risk analysis and on notifications of interested producers of products designated by geographical indications, to ensure conformity with the product specification or the single document or an equivalent to the latter.
Amendment 394 #
2022/0115(COD)
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. The Office shall make public the names and addresses of the competent authorities and product certification bodies referred to in Article 46(4) and update that information periodicallywhen changes occur.
Amendment 395 #
2022/0115(COD)
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. The Office mayshall establish a digital portal where the names and addresses of the competent authorities and delegated product certification bodies including natural persons referred to in paragraphs 1 and 2 are made public.
Amendment 397 #
2022/0115(COD)
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
The digital system referred to in Article 18(1) and the Union register of geographical indications for craft and industrial products referred to in Article 26 shall be developed, kept and maintained by the Office. The Office shall make that digital system easy accessible and design in such a way, that it can be used by the Member States for their national procedure according to Articles 11 (3 a new) and 18 (1).
Amendment 1 #
2021/2245(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
— having regard to the first meeting of the EU-BiH Stabilization and Association Parliamentary Committee (SAPC) held on 5-6 November 2015, the third meeting of the EU-BiH Stabilization and Association Council held on 13 July 2018 and the fourth meeting of the EU- BiH Stabilization and Association Committee held on 7 November 2019,
Amendment 7 #
2021/2245(INI)
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
— having regard to the Joint Statement of 21 December 2020 by High Representative Josep Borrell and Commissioner Oliver Varhelyi on the holding of local elections in Mostar,
Amendment 8 #
2021/2245(INI)
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
— having regard to the Strategic Compass for Security and Defence approved by the Council on 21 March 2022,
Amendment 11 #
2021/2245(INI)
— having regard to the Council conclusions of 24 and 25 March 2022 on the prolonged political crisis in Bosnia and Herzegovina and the need for leaders in the country to demonstrate a strong commitment to finalise swiftly the constitutional and electoral reform,
Amendment 14 #
2021/2245(INI)
Motion for a resolution
Citation 15 a (new)
Citation 15 a (new)
— having regard to the EU-Western Balkans summit, held in Zagreb on 6 May 2020, and its declaration,
Amendment 18 #
2021/2245(INI)
Motion for a resolution
Citation 24 a (new)
Citation 24 a (new)
— having regard to the Convention on Environmental Impact Assessment in a Transboundary Context, adopted on 25 February 1991,
Amendment 19 #
2021/2245(INI)
Motion for a resolution
Citation 24 b (new)
Citation 24 b (new)
Amendment 20 #
2021/2245(INI)
Motion for a resolution
Citation 24 c (new)
Citation 24 c (new)
— having regard to the "Mostar Agreement" ensuring the holding of elections in Mostar, that included changes to the BiH election law in the part of election rules for the City of Mostar, signed between leaders of majority parties in Federation of Bosnia and Herzegovina on 17 June 2020,
Amendment 21 #
2021/2245(INI)
Motion for a resolution
Citation 24 d (new)
Citation 24 d (new)
— having regard the Exit Strategy of the International Crisis Group (ICG) from Bosnia and Herzegovina of 7 August 2014,
Amendment 37 #
2021/2245(INI)
C a. whereas the credibility of the enlargement process is based on unequivocal results in key areas of rule of law and judicial reform, the fight against corruption and organized crime, security, fundamental rights, democratic institutions, public administration reform, as well as economic development and competitiveness;
Amendment 40 #
2021/2245(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the Office of the High Representative (OHR) and EUFOR Althea are integral in preserving peace in accordance with their mandates based in political neutrality and full respect for the Constitution of Bosnia and Herzegovina;
Amendment 45 #
2021/2245(INI)
Motion for a resolution
Recital E
Recital E
E. whereas all BiHconstituent peoples and all citizens of BiH should enjoy equal individual and collective rights and obligations throughout BiH territory, also according to the Annex 4 of The General Framework Agreement for Peace in Bosnia and Herzegovina (Dayton-Paris Peace Agreement); whereas the country has committed to international and domestic obligations to end systematic ethnicity and residence-based discrimination and ensure citizens’ equalitydiscrimination and ensure equal rights and representation of the constituent peoples and all of its citizens before the law;
Amendment 57 #
2021/2245(INI)
Motion for a resolution
Recital F
Recital F
F. whereas glorification of convicted war criminals, ethnic or religious segregation and discrimination go against the very essence of the European project; whereas there is an urgent need to effectively outlaw denial of the Holocaust, genocide, war crimes, political persecutions and crimes against humanity regardless of the perpetrator;
Amendment 61 #
2021/2245(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
F a. whereas the Council expressed in the Strategic Compass for Security and Defence its strong support for the sovereignty, unity and territorial integrity of Bosnia and Herzegovina, based on the principles of equality and non- discrimination of all citizens and constituent peoples as enshrined in the Bosnia and Herzegovina constitution, as well as the reform process on its European path;
Amendment 66 #
2021/2245(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Underscores that the pace of EU accession is determined by the due functioning of democratic institutions, grounded in the rule of law, good governance and fundamental rights and full implementation of Dayton Peace Agreement;
Amendment 69 #
2021/2245(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Urges BiH and its political leaders to advance on the 14 key priorities by restoring the independence of the judiciary, strengthening the rule of law, intensifying the fight against corruption and organised crime, securing media freedom and an enabling environment for civil society, and protecting vulnerable groups; welcomes the progress achieved by the agreement on the rules of procedure for the EU-BiH Stabilisation and Association Parliamentary Committee and elections in Mostar held on 20 December 2020;
Amendment 75 #
2021/2245(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Reiterates its clear support for BiH’s democratic transformation through European integration, based on sovereignty, federalism, constitutionality and territorial integrity, grounded in the principles of equality and non- discrimination of all citizens and constituent peoples as enshrined in the constitution;
Amendment 77 #
2021/2245(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Reiterates its clear support for BiH’s democratic transformation through European integration, based on sovereignty and territorial integrity, grounded in the principles of equality and non- discrimination of all citizens and constituent peoples, including political representation, as enshrined in the constitution;
Amendment 80 #
2021/2245(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that enforcement of the Dayton Peace Agreement includes the obligation to adhere to the constitutional architecture of Bosnia and Herzegovina with respect for rights of all constituent peoples and citizens and obligation to implement OHR decisions;
Amendment 81 #
2021/2245(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that enforcement of the Dayton Peace Agreement includes the obligation to implement OHR decisions; recalls that the European Parliament strongly advocates the position of individual approach, full fulfilment of the set criteria and consistent and credible conditionality;
Amendment 90 #
2021/2245(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Regrets the impasse in negotiations on electoral law reform in BiH and the lack of political will to overcome it; calls on all actors to promptly reach a balanced agreement, to fulfil the constitutional duty of democratic governancefter several attempts and facilitating interventions from the European Union and United States and the lack of political will to overcome it; calls on all actors to promptly reach a compromise with a balanced agreement to avoid electoral engineering, to implement the decisions of the European Court of Human rights and the Constitutional Court of Bosnia and Herzegovina in order to fulfil the constitutional duty of democratic governance based on legitimate representation of all constituent peoples and citizens and undisputed electoral legitimacy for all legislative and executive bodies regardless of their specific features defined by the Constitution, and to ensure the transparency, legitimacy and integrity of the electoral process; before the next general elections; urges the European Union, United States and the international community to intensify their efforts in facilitation of a political agreement;
Amendment 91 #
2021/2245(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Regrets the impasse in negotiations on electoral law reform in BiH and the lack of political will to overcome it; calls on all actors to promptly reach a balanced agreement, to fulfil the constitutional duty of democratic governance and to ensure the transparency and integrity of the electoral process; stresses that the reform of the electoral law, which will guarantee the representation of the three constituent peoples, is a step towards establishing a functioning society and institutions;
Amendment 99 #
2021/2245(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Regrets the non-implementation of the binding Constitutional Court decision in the case Ljubić, that has resulted in the denial of the right of Croats to elect their own legitimate political representatives in the 2018 general elections, especially regarding the election of Croatian members of the Presidency of Bosnia and Herzegovina; calls on all stakeholders to reach an agreement on the reform of the Election Law to assure that in the 2022 general elections all constituent peoples and citizens have the right to elect their own legitimate political representatives;
Amendment 100 #
2021/2245(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Deeply regrets that BiH still remains in breach of the European Convention on Human Rights by not implementing the rulings of the European Court of Human Rights (ECtHR) in Sejdić-Finci, Zornić, Pilav and Šlaku cases; deeply regrets that BiH still has not implemented the ruling of Constitutional Court of Bosnia and Herzegovina in the case Ljubić;
Amendment 103 #
2021/2245(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Strongly denounces the disregard for international and national court decisions, norms and obligations, all hate rhetoric and disruptive action, including withdrawal from institutions, by the leadership of Bosniak and Serb parties in the House of Peoples of the Parliamentary Assembly of Bosnia and Herzegovina, and particularly by the leadership of the Republika Srpska entity, which destabilises the country, undermines its statehood in violation of the Dayton Peace Agreement and systematically hampers decisions on key laws and reforms; rejects all attempts to form parallel parastatal institutions, which undermine state institutions, legal order, judicial independence and sovereignty; calls for a full, non-selective and unconditional return to all state institutions, which should function in full accordance with the Constitution and with full electoral legitimacy and procedural legality, including the Central Electoral Commission;
Amendment 121 #
2021/2245(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls for the EU and the international community to use all available tools, including targeted sanctions, against destabilising actors in the country, including those hindering collective and individual political rights as per the Constitution;
Amendment 123 #
2021/2245(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Warns that the international community should also contribute to finding a comprehensive solution to the current complex situation in Bosnia and Herzegovina, through strong cooperation with national authorities;
Amendment 129 #
2021/2245(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Underlines that the EU future of BiH depends on sustainable peace and genuine reconciliation, and the political representation of the three constituent peoples, warranting its democratic, inclusive and multi-ethnic character; urges BiH to expedite effective and impartial prosecution of war crimes under the revised national war crimes processing strategy; calls on all regional political leaders to set up the relevant commission (RECOM);
Amendment 130 #
2021/2245(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Underlines that the EU future of BiH depends on sustainable peace and genuine reconciliation, warranting its democratic, inclusive, multi-national and multi-ethnic character according to the Dayton Peace Agreement; urges BiH to expedite effective and impartial prosecution of war crimes regardless of the perpetrator, under the revised national war crimes processing strategy; calls on all regional political leaders to set up the relevant commission (RECOM);
Amendment 148 #
2021/2245(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Notes that genuine reconciliation, cooperation and peaceful coexistence is possible only by mutual recognition and respect of the rights and needs of the all constituent peoples and citizens of Bosnia and Herzegovina, including the right of legitimate representation in all levels of government; notes that the principles of federalism would suit the functioning of this state as it would establish equality in all spheres between the constituent communities and citizens;
Amendment 154 #
2021/2245(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Urges BiH’s political actors to make progress on judicial, electoral, administrative and economic reforms that are needed to bring the country closer to the EU; denounces all attempts to stall these reforms, thus endangering access to EU funding under IPA III, which must be based on strict conditionality and depends on the cooperation of different authorities;
Amendment 157 #
2021/2245(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Deplores the damage and loss of live caused by a strong earthquake that hit Bosnia and Herzegovina near Stolac on 22 April 2022; calls on the European Union and all its Member States to show solidarity and provide appropriate financial and material assistance to the country through all possible mechanisms, including the distribution of funds from the IPA III pre-accession fund;
Amendment 163 #
2021/2245(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses the importance of holding elections this year as planned; calls for the necessary implementation of electoral reform in the run-up to the elections, in order to protect the guaranteed rights of the constituent peoples, enshrined in the Dayton Peace Agreement;
Amendment 164 #
2021/2245(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses the importance of holding elections this year as plannedgeneral elections this year as planned, based on fulfilment of necessary formal and legal preconditions in order to ensure unequivocal integrity and legitimacy of the election and election process in line with the Constitution of Bosnia and Herzegovina and rulings of domestic and international courts;
Amendment 176 #
2021/2245(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Supports transparent and inclusive limited constitutional and electoral reforms to ensure equality and non-discrimination of all constituent peoples and citizens, enhance accountability and transform BiH into a fully functional and inclusive pluralistic state by immediately implementing rulings,elevant rulings of domestic and international courts, and opinions and recommendations of competent courts and international bodies; supports transatlantic and European facilitation efforts to this end and condemns all obstructions and inactivity of political actors in that regard;
Amendment 182 #
2021/2245(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13 a. Notes that for the last twenty years, the reserved seats for minorities in democratic institutions have not been properly filled with representatives of these minorities; calls on political actors in Bosnia and Herzegovina to follow the example of the ruling of Supreme Court of Kosovo that acknowledged the decision of Election Complaints and Appeals Panel (ECAP) to annul the election of representative of Roma, Ashkali, and Egyptian communities as she was elected illegitimately in breach of the principle of legitimate representation;
Amendment 183 #
2021/2245(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls for the implementation of consistent country-wide merit-based civil service standards, enabling a streamlined, depoliticised and accountable public administration; calls for equal representation of all constituent peoples and citizens in the public service, companies and media outlets;
Amendment 190 #
2021/2245(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Underlines the need to enhance internal and regional economic harmonisation and connectivity; calls for country-wide sector strategies, improvements to strategic planning, financial management, monitoring and evaluation, and the creation of control and audit structures; welcomes the European investments in road and rail infrastructure in Bosnia and Herzegovina, namely the development of Corridor Vc linking Central Europe to port of Ploče on the Adriatic coast;
Amendment 194 #
2021/2245(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Welcomes the efforts of the EU and its Member States, as well as neighbouring countries in the region, in assisting the country in vaccination campaigns and mitigating the consequences of the COVID pandemic;
Amendment 203 #
2021/2245(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Recalls the need for improved laws on gas and electricity, renewables, energy efficiency and climate, and to step up environmental and nature protectionnotes that progress in the areas of environmental and climate protection as well as alignment with EU standards has remained low; therefore urges BiH’s authorities to ensure greater alignment with EU standards and policy objectives on climate protection and energy;
Amendment 210 #
2021/2245(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16 a. Calls on the BiH authorities to reduce transboundary air pollution, especially in case of Bosanski Brod oil refinery that affects the quality of life and health of people living in Slavonski Brod in Republic of Croatia; reminds that Bosnia and Herzegovina is a signatory party of the Convention on Environmental Impact Assessment in a Transboundary Context (Espoo, 1991) and is bound by its obligations;
Amendment 225 #
2021/2245(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Calls for the implementation of rulings of the Constitutional Court of Bosnia and Herzegovina, reminding that the rule of law is integral to the country's progress in Euro-Atlantic integration;
Amendment 238 #
2021/2245(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Deplores the continuing failure to safeguard media freedom and pluralism; insists on eliminating political interference and protecting journalists from intimidation with systematic judicial follow-up; expresses its concern over the lack of a variety of traditional media channels, including television broadcasting; draws attention to the inadmissible practices of reducing the presence of certain constituent peoples in those same media and to the problem of biased and negatively toned reporting;
Amendment 246 #
2021/2245(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Reiterates the need for equal representation of all constituent peoples in public media outlets and calls for media pluralism to be ensured in media programmes as well as content in the languages of all constituent peoples; stresses the need to ensure public broadcasting outlets in official languages which would protect cultural diversity of all constituent peoples;
Amendment 259 #
2021/2245(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to refocus IPA III support to in-country democratic forces, institutions and procedures and to enable local and regional administrations to a better absorption of funds; calls to eliminate the lack of equal distribution of IPA III funds at local and regional level in the Federation of Bosnia and Herzegovina;
Amendment 294 #
2021/2245(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Reiterates its call to urgently end segregation and discrimination inaddress the different rulings regarding the individual cases of ‘two schools under one roof’ that allow the right to education, including by implementing court rulings to end the discriminatory illegal practice of ‘two schools under one roof’ the official language of one's choice, as introduced by the OSCE; stresses that all citizens have the right of access to education in all official languages, as guaranteed by the UNESCO conventions;
Amendment 299 #
2021/2245(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25 a. Notes that the adoption of programmes and curriculum should take in account the cultural and language diversity while respecting the constitutional architecture and competences; calls on the improved coordination and standardisation of educational curricula between the different cantons in the Federation, that have the constitutional competence over education;
Amendment 310 #
2021/2245(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Deplores the failure of authorities to address the severe migration-related humanitarian crisis; recalls the need for solidarity-based solutions on migration and asylum, asylum and border management in coordination and cooperation with affected Member States on the European external border, ensuring adequate humanitarian assistance and appropriate reception capacities across the country; welcomes the opening of the EU-funded centre in Lipa;
Amendment 313 #
2021/2245(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
Amendment 319 #
2021/2245(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Urges BiH to reverse the trend of regression on alignment with the EU’s common foreign and security policy, particularly with regard to implementing sanctions against Russia and Belarus following the invasion of Ukraine; calls on BiH to strengthen good neighbourly relations and to work on resolving ongoing bilateral issues;
Amendment 336 #
2021/2245(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Welcomes EU-funded efforts tothe mobilization of European Peace Facility funds worth €10 million that will finance 150 metal detectors and 68 special vehicles in order to build capacities, boost demining and the disposal of weapons, ammunition and explosives;
Amendment 345 #
2021/2245(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Welcomes the recent reinforcement of EUFOR Althea and the support under the European Peace Facility to strengthen the armed forces of BiH; recognizes the added value that BiH's membership in NATO would have for democratic and institutional progress, as well as peacekeeping;
Amendment 13 #
2021/2101(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the digital transformation must be fair and inclusive, create opportunities and promote equality, quality of life, regional competitiveness and the modernisation of the economy;
Amendment 22 #
2021/2101(INI)
Motion for a resolution
Recital D
Recital D
D. whereas there is still a digital divide in the EU in terms of geography, age, gendersex, educational attainment, socio- economic status and income, which prevents some individuals and businesses from reaping the benefits of the digital transformation;
Amendment 48 #
2021/2101(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Highlights the role that the new cohesion policy can play in advancing the twin digital and green transitions; underlines that the digital and innovation components of the new cohesion policy will be key in enabling a sustainable transformation of society and thtowards a more competitive economy and reaching the goals of the European Green Deal;
Amendment 67 #
2021/2101(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Stresses that the digital divide has two sides: infrastructure, and capacity, that their origins are different, and that, therefore, the policies applied to them must be different and tailored to their respective features;
Amendment 69 #
2021/2101(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Notes that there is a critical digital skills divide between adults in rural areas and those living in cities, which especially affects those with low incomes, women and the elderly; notes that this divide is particularly marked in certain Member States and exacerbates the existing difficulty of finding a job in rural areas; highlights that these gaps are directly linked to a lack of access to high-capacity networks, among other causes;
Amendment 86 #
2021/2101(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Urges the Member States to use the financial resources available through both the ERDF-CF and the NextGenerationEU recovery instrument to the fullest extent and most efficient manner possible to give regions that are lagging behind the targeted support that they need to overcome the digital divide;
Amendment 90 #
2021/2101(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Urges the Member States to take account of the need for digitalisation investments to have a growth objective, be aligned with economic development strategies and incorporate all EU financing, avoiding duplication;
Amendment 93 #
2021/2101(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses the need for a socially fair and inclusive digitalisation process that lcreavtes no one behind; underlines that suopport under the ERDF-CF should contribute to an inclusive digital societyities for ordinary people while leaving no one behind;
Amendment 108 #
2021/2101(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Asks the Commission and the Member States to develop a global strategy, that integrates a gender perspective across all levels in order to tackle social inequalities associated with digitalisation, with a view to enhancing its positive effects;
Amendment 112 #
2021/2101(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls for a follow-up to the eGovernment action plan that will ensure the efficient digital transformation of public administrations andand cut red tape, with processes that improve public access to services in all Member States and boost transparency, and establish measures to increase digital skills for public sector workers;
Amendment 127 #
2021/2101(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Underlines the crucial role of entrepreneurs and small and medium- sized enterprises (SMEs) in creating decent jobs, sustainable growth and rural development and believes that public investments through cohesion policy and other instruments will contribute to better social, economic and territorial cohesion in all EU regions; highlights that different types of SMEs require different types of support and incentives at the EU, national, regional and local levels, depending on their circumstances and level of technology adoption;
Amendment 143 #
2021/2101(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
Amendment 150 #
2021/2101(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Underlines that e-skills play an essential role in fostering technological diversification and creating employment opportunities, especially in less- developed regions;
Amendment 8 #
2021/2100(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
— having regard to the 2021 study on cross-border cooperation in healthcare commissioned by the Committee on Regional Development9a, _________________ 9a https://www.europarl.europa.eu/RegData/ etudes/STUD/2021/690904/IPOL_STU(20 21)690904_EN.pdf
Amendment 68 #
2021/2100(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Recalls the substantial contribution of cohesion policy to health sector planned investments in the last programming period (2014-2020) through the ESF and the ERDF, to the tune of around EUR 5624 billion so far, aimed at improving access to services, as well as developing specialised health infrastructure and capacities in order to reduce health inequalities;
Amendment 138 #
2021/2100(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
Amendment 150 #
2021/2100(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Acknowledges the importance of health investments in cross-border cooperation programmes which respond to the needs and challenges identified in the border regions as a cross-border governance that is important in emergency situations, as well as health and emergency services covering regions on both sides of the border;
Amendment 153 #
2021/2100(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Recalls that Interreg programmes have become an important instrument to resolve problems typical to border areas, to promote cooperation between partners across borders and develop the potential of European border territories;
Amendment 154 #
2021/2100(INI)
Motion for a resolution
Paragraph 18 c (new)
Paragraph 18 c (new)
Amendment 173 #
2021/2100(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Stresses that the lack of a coordinated cross-border health insurance system discourages patients to look for treatment across the border in case they cannot afford paying the cost of care in advance before their insurance reimburses them;
Amendment 1706 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 18/23
Annex 1 – part 18/23
Add the following to the extended core network: - Zagreb (HR) - Maribor (SI) - Graz (AT) railfreight / passenger (conventional/new construction
Amendment 1707 #
2021/0420(COD)
Proposal for a regulation
Annex 1 - Part 18/23 and Part 19/23
Annex 1 - Part 18/23 and Part 19/23
Add the following to the extended core network: - Zagreb (HR) - Maribor (SI) - Graz (AT) rail freight/passenger line (conventional/new construction)
Amendment 1708 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 18/23
Annex 1 – part 18/23
Add the following to the comprehensive network: - Pula - Buzet (HR) - Divača (SI) - Trieste (IT) rail freight/passenger line Lupoglav – Buzet - state border (SI) - Prešnica (SI)
Amendment 1709 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 18/23
Annex 1 – part 18/23
Add the following to the comprehensive network: - Čakovec - Varaždin - Lepoglava - Zabok Zagreb rail freight/passenger line
Amendment 1722 #
2021/0420(COD)
Add the following to the extended core network: Postojna (SI) - Rijeka - Žuta Lokva road (HR) Add the following to the core network: Zagreb (HR) - Maribor (SI) - Graz (AT) road
Amendment 1723 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 19/23
Annex 1 – part 19/23
Add the following to the comprehensive network: Rijeka - Divača (SI) - Trieste (IT) road connection Kanfanar – Umag – State border - (SI) road connection
Amendment 1758 #
2021/0420(COD)
Proposal for a regulation
Annex 2 - table - section HR
Annex 2 - table - section HR
Node name: Ploče Maritime port: Comprehensivre
Amendment 1759 #
2021/0420(COD)
Proposal for a regulation
Annex 2 - table - section HR
Annex 2 - table - section HR
Node name: Ploče Maritime port: Comprehensivre
Amendment 1801 #
2021/0420(COD)
Proposal for a regulation
Annex 3 - part 7/14 and part 8/14
Annex 3 - part 7/14 and part 8/14
Add the following to the corridor Baltic Sea - Adriatic Sea: - Rijeka - Zagreb motorway - port of Rijeka (“core”) -Rijeka - Zagreb rail freight/passenger line
Amendment 1811 #
2021/0420(COD)
Proposal for a regulation
Annex 3 - part 10/14
Annex 3 - part 10/14
Amendment 1814 #
2021/0420(COD)
Proposal for a regulation
Annex 3 - part 12/14
Annex 3 - part 12/14
Add the following to the corridor Western Balkans : - Port of Ploče The above port shall be included in the core network as specified in Annex 1.
Amendment 153 #
2021/0366(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Another important action announced in the Communication is the establishment of the EU Observatory on deforestation, forest degradation, changes in the world’s forest cover and associated drivers (“EU Observatory”) launched by the Commission in order to better monitor changes in the world’s forest cover and related drivers. Moreover, building on already existing monitoring tools, including Copernicus products and other publicly or privately available sources, the EU Observatory will facilitate access to information on supply chains for public entities, consumers and business, providing easy-to-understand data and information linking deforestation, forest degradation, and changes in the world’s forest cover to EU demand/trade for commodities and products. The EU Observatory will thus directly support the implementation of this Regulation by providing scientific evidence in regard to global deforestation and forest degradation and related trade. The Commission should also examine how land rights can be integrated into monitoring under the EU Observatory. The EU Observatory will cooperate closely with relevant international organisations, research institutes, non-governmental organisations, operators and third countries.
Amendment 183 #
2021/0366(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) On the basis of a systemic approach, operators should take the appropriate steps in order to ascertain that the relevant commodities and products that they intend to place on the Union market comply with the deforestation-free and legality requirements of this Regulation. To that end, operators should establish and implement due diligence procedures. The due diligence procedure required by this Regulation should include three elements: information requirements, risk assessment and risk mitigation measures. The due diligence procedures should be designed to provide access to information about the sources and suppliers of the commodities and products being placed on the Union market, including information demonstrating that the absence of deforestation and forest degradation and legality requirements are fulfilled, inter alia by identifying the country and area of production, including geo-location coordinates of relevant plots of landroduction areas. These geo-location coordinates that rely on timing, positioning and/or Earth observation of relevant production areas could make use of space data and services delivered under the Union’s Space programme (EGNOS/Galileo and Copernicus) or from other publicly or privately available sources. On the basis of this information, operators should carry out a risk assessment. Where a risk is identified, operators should mitigate such risk to achieve no or negligible risk. Only after completing the required steps of the due diligence procedure and concluding that no or negligible risk exists that the relevant commodity or product is not compliant with this Regulation, should the operator be allowed to place the relevant commodity or product on the Union market or to export it.
Amendment 200 #
2021/0366(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The effective and efficient implementation and enforcement of this Regulation are essential to achieving its goals. To this end, the Commission should set up and manage an information system to support the operators and the competent authorities in presenting and accessing the necessary information on relevant commodities and products placed on the market. The operators should submit the due diligence statements and an annual audit report by an independent third-party auditor accredited with an international accreditation body such as ISEAL to the information system. The information system should be accessible to competent authorities and customs authorities to facilitate fulfilling their obligations under this Regulation. The information systemnon-commercially sensitive data should also be accessible for a wider public, with the anonymised data provided in an open and machine-readable format in line with the Union’s Open Data Policy.
Amendment 271 #
2021/0366(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
(1) ‘deforestation’ means thehuman- induced conversion of forest to agricultural use, whether human-induced or notprimary forests or other wooded land to agricultural use or to plantation forest according to FAO`s definition;
Amendment 404 #
2021/0366(COD)
Proposal for a regulation
Article 4 – paragraph 7
Article 4 – paragraph 7
7. The due diligence system of operators placing products for the first time on the market or exporting them shall be verified by an independent external auditor that is accredited with an international accreditation body on an annual basis. Operators shall also offer all assistance necessary to competent authorities to facilitate the performance of the checks under Article 15, including as regards access to premises and the presentation of documentation or records.
Amendment 427 #
2021/0366(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
In case a natural or legal person established outside the Union places on the Union market relevant commodities and products, the first natural or legal person established in the Union who buys or takes possession of such relevant commodities and products shall be considered operator within the meaning of this Regulation, regardless of its size.
Amendment 507 #
2021/0366(COD)
Proposal for a regulation
Article 10 – paragraph 6 – point a
Article 10 – paragraph 6 – point a
(a) model risk management practices, including certification or other third- party-verified schemes, reporting, record- keeping, internal control and compliance management, including for operators that are not SMEs, the appointment of a compliance officer at management level;
Amendment 605 #
2021/0366(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point g
Article 15 – paragraph 1 – point g
(g) any technical and scientific means adequate to determine whether the relevant commodity or product are deforestation- free, including Earth observation data such as from Copernicus programme and tools, or from other publicly and privately available sources, and
Amendment 714 #
2021/0366(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. This Regulation establishes a three-tier system for the assessment of countries or parts thereof. Unless identified in accordance with this Article as presenting a low or high risk, countries shall be considered as presenting a standard risk. The Commission maye Commission shall identify countries or partregions thereof that present a low or high risk of producing relevant commodities or products that are not compliant with Article 3, point (a). The list of the countries or partregions thereof that present a low or high risk shall be published by means of implementing act(s) to be adopted in accordance with the examination procedure referred to in Article 34(2) within 6 months after entry into force of this Regulation. That list shall be updated as necessary in light of new evidence.
Amendment 884 #
2021/0366(COD)
Amendment 898 #
2021/0366(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3
Annex II – paragraph 1 – point 3
3. Country of production and all plots region thereof land ofall production areas, including geo- localisation coordinates, latitude and longitude. Where a product or commodity contains materials, ingredients or components produced in different plots of landroduction areas, the geo-location coordinates of all different plots of landroduction areas shall be included;
Amendment 124 #
2021/0171(COD)
Proposal for a directive
Recital 15
Recital 15
(15) A number of Member States have applied Directive 2008/48/EC to areas not covered by its scope to enhance the level of consumer protection. In fact, several of the credit agreements not falling within the scope of that Directive can be detrimental for consumers, including short-term high cost loans whose amount is typically lower than the minimum threshold of EUR 200 set out in Directive 2008/48/EC. In this context, and with the aim to ensure a high level of consumer protection and to facilitate the cross-border consumer credit market, the scope of this Directive should cover some agreements that were excluded from the scope of Directive 2008/48/EC, such as consumer credit agreements below the amount of EUR 200. Likewise, other potentially detrimental products, because of the high costs they entail or high fees in case of missed payments, should be covered by this Directive, to ensure increased transparency and better consumer protection, resulting in higher consumer confidence. To this extent, leasing agreements, credit agreements in the form of an overdraft facility and where the credit has to be repaid within one month, and credit agreements where the credit is granted free of interest and without any other charges, including Buy Now Pay Later schemes, i.e. new digital financial tools that let consumers make purchases and pay them off over time, andwhere an obligation to purchase the object of the agreement is laid down either by the agreement itself or by any separate agreement, credit agreements in the form of an overdraft facility or overrunning and where the credit has to be repaid within one month but also credit agreements under the terms of which the credit has to be repaid within three months and only insignificant charges are payable should not be excluded from the scope of application of this Directive. Moreover, all credit agreement up until EUR 100 000 should be included in the scope of application of this Directive. The upper threshold of credit agreements under this Directive should be increased to take into account indexation to adjust for the effects of inflation since 2008 and in coming years.
Amendment 126 #
2021/0171(COD)
(15 a) Member States economic contexts vary substantially, within and without the euro area, so national authorities should be allowed to include credit agreements involving a total amount of credit of up to EUR 150 000 in the scope of this Directive if necessary to achieve the objectives of this Directive, including consumer protection.
Amendment 133 #
2021/0171(COD)
Proposal for a directive
Recital 26
Recital 26
(26) Consumers who are legally resident in the Union should not be discriminated against on ground of their nationality or place of residence, or on any ground as referred to in Article 21 of the Charter when requesting, concluding or holding a credit agreement or an agreement for the provision of crowdfunding credit services within the Union. However, nothing in this Directive should be construed to oblige a creditor, credit intermediary or provider of crowdfunding credit services to provide services in Member States in which they do not conduct the business.
Amendment 135 #
2021/0171(COD)
Proposal for a directive
Recital 26 a (new)
Recital 26 a (new)
(26 a) As there are limited financial products available on the market that encourage digital and green transition, this Directive should create an incentive to develop and offer such financial products on the market.
Amendment 136 #
2021/0171(COD)
Proposal for a directive
Recital 28
Recital 28
Amendment 148 #
2021/0171(COD)
Proposal for a directive
Recital 30
Recital 30
(30) In order to be able to make their decisions in full knowledge of the facts, consumers should receive adequate information, for careful consideration at their own leisure and convenience, at least one daywithin a reasonable time prior to the conclusion of the credit agreement or of the agreement for the provision of crowdfunding credit services, including information on the conditions and cost of the credit and on their obligations, as well as adequate explanations thereof. These rules should be without prejudice to Council Directive 93/13/EEC29 . _________________ 29 Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29).
Amendment 156 #
2021/0171(COD)
Proposal for a directive
Recital 31
Recital 31
(31) Pre-contractual information should be provided through the Standard European Consumer Credit Information form. To help consumers understand and compare offers, a Standard European Consumer Credit Overview form summarising the key element of the creditrelevant information should be provided in addition toat the beginning of the Standard European Consumer Credit Information form, through which consumers should see all essential information at a glance, even on the screen of a mobile telephone. ISuch information should be separated from the rest of pre-contractual information provided on the same form. Furthermore, all information should be clear, clearly legible and adapted to the technical constraints of certain media such as mobile telephone screens. It should be displayed in an adequate and suitable way on the different channels, to ensure that every consumer can access information on an equal basis and in line with Directive (EU) 2019/882 of the European Parliament and of the Council30 . _________________ 30 Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70).
Amendment 159 #
2021/0171(COD)
Proposal for a directive
Recital 32
Recital 32
(32) To ensure the fullest possible transparency and comparability of offers, pre-contractual information should, in particular, include the annual percentage rate of charge applicable to the credit, determined in the same way throughout the Union. As the annual percentage rate of charge can at this stage be indicated only through an example, such example should be representative. Therefore, it should correspond, for instance, to the average duration and total amount of credit granted for the type of credit agreement or crowdfunding credit services under consideration and, if applicable, to the goods purchased. When determining the representative example, the frequency of certain types of credit agreement or crowdfunding credit services in a specific market should also be taken into account. As regards the borrowing rate, the frequency of instalments and the capitalisation of interest, creditors should use their usual method of calculation for the consumer credit concerned. In case pre-contractual information is provided less than one day before the consumer is bound by any credit agreement or agreement for the provision of crowdfunding credit services, the creditor and, where applicable, the credit intermediary or providers of crowdfunding credit services should remind consumers, one day after conclusion of the contract, of the possibility to withdraw from the credit agreement.
Amendment 164 #
2021/0171(COD)
Proposal for a directive
Recital 40
Recital 40
(40) As highlighted in the Commission Proposal for a Regulation laying down harmonised rules on artificial intelligence (Artificial Intelligence Act)31 , artificial intelligence (AI) systems can be easily deployed in multiple sectors of the economy and society, including cross border, and can circulate throughout the Union. In this context, creditors, credit intermediaries and providers of crowdfunding credit services should be allowed to personalise the price of their offers for specific consumers or specific categories of consumer based on automated decision-making and profiling of consumer behaviour allowing them to assess the consumer’s purchasing power. Consumers should therefore be clearly informed wheninform consumers in clear and unambiguous manner if the price presented to them is personalised on the basis of automated processing, so that they can take into account the potential risks in their purchasing decision. Furthermore, taking into account the most vulnerable groups of consumers, personalized advertisement that encourage over- indebtedness should not be allowed. _________________ 31 COM/2021/206 final.
Amendment 168 #
2021/0171(COD)
Proposal for a directive
Recital 44
Recital 44
(44) Credit sales that have not been solicited by the consumers may in some cases be associated with practices that are harmful to the consumer. In this regard, harmful unsolicited sale of credit, including non- requested pre-approved credit cards sent to the consumers, or the unilateral increase of a consumers’ overdraft, overrunning or credit card limit, should be prohibited.
Amendment 171 #
2021/0171(COD)
Proposal for a directive
Recital 45
Recital 45
(45) Member States should take appropriate measures to promote responsible practices during all phases of the credit relationship, taking into account the specific features of their credit market. Those measures mayshould include, for instance, the provision of information to, and the education of, consumers, including warnings about the risks attaching to default on payment and to over- indebtedness. In the expanding credit market, in particular, it is important that creditors should not engage in irresponsible lending or give out credit without prior assessment of creditworthiness. Member States should carry out the necessary supervision to avoid such behaviour of creditors and should determine the necessary means to sanction such behaviour. Without prejudice to the provisions on credit risk of Directive 2013/36/EU of the European Parliament and of the Council32 , creditors or providers of crowdfunding credit services should bear the responsibility of checking individually the creditworthiness of the consumer. To that end, creditors or providers of crowdfunding credit services should be allowed to use information provided by the consumer not only during the preparation of the credit agreement or of the agreement for the provision of crowdfunding credit services in question, but also during a long standing commercial relationship. Consumers should also act with prudence and respect their contractual obligations. _________________ 32 Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).
Amendment 180 #
2021/0171(COD)
Proposal for a directive
Recital 47
Recital 47
(47) The assessment of creditworthiness should be based on information on the financial and economic situation, including income and expenses, of the consumer. The European Banking Authority Guidelines on loan origination and monitoring (EBA/GL/2020/06) provide guidelines on what categories of data may be used for the processing of personal data for creditworthiness purposes, which include evidence of income or other sources of repayment, information on financial assets and liabilities, or information on other financial commitments. Personal data, such as personal data found on social media platforms or health data, including cancer data, should not be used when conducting a creditworthiness assessment. Consumers should provide information about their financial and economic situation in order to facilitate the creditworthiness assessment. In principle, credit should only made available to the consumer where the result of the creditworthiness assessment indicates that the obligations resulting from the credit agreement or the agreement for the provision of crowdfunding credit services are likely to be met in the manner required under that agreement. However, should such assessment be negative, the creditor or the provider of crowdfunding credit services can exceptionally make credit available in specific and justified circumstances such as when they have a long-standing relationship with the consumer, or in case of loans to fund exceptional healthcare expenses, students loans or loans for consumers with disabilities. In such case, the creditor or the provider of crowdfunding credit services should be obliged to warn the consumer that due to a negative assessment of creditworthiness the consumer may be exposed to difficulties with repayment of the credit, which can lead to over-indebtedness. Furthermore when deciding on whether or not to make the credit available to the consumer, the creditor or the provider of crowdfunding credit services should take into account the amount and the purpose of the credit, and the likelihood that the obligations resulting from the agreement will be met.
Amendment 183 #
2021/0171(COD)
Proposal for a directive
Recital 47 a (new)
Recital 47 a (new)
(47 a) Taking into account the principle of proportionality, this Directive should lay down special rules for assessing the creditworthiness of consumers for ‘small value credit’ as defined in the definition norms. In this regard, data other than those specified in the Directive should not be consulted when assessing creditworthiness.
Amendment 184 #
2021/0171(COD)
Proposal for a directive
Recital 47 b (new)
Recital 47 b (new)
(47 b) As a result of their illness, cancer survivors often suffer from obstacles to their access to financial services, such as credits, owing to the frequent obligation to disclose full medical history when applying to them. This financial discrimination worsens the socioeconomic burden placed on cancer survivors and hampers their reintegration into society. Therefore, this Directive should recognise fully the right for cancer survivors not to inform the creditor or the provider of crowdfunding credit services of their past diagnosis and treatment (The Right to Be Forgotten).
Amendment 189 #
2021/0171(COD)
Proposal for a directive
Recital 48
Recital 48
(48) The Proposal for a Regulation laying down harmonised rules on artificial intelligence (Artificial Intelligence Act), establishes that AI systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk AI systems, since they determine those persons’ access to financial resources or essential services such as housing, electricity, and telecommunication services. In view of those high stakes, whenever the creditworthiness assessment involves automated processing, the consumer should have a right to obtain human intervention on the part of the creditor or providers of crowdfunding credit services. The consumer should also have the right to obtain a meaningful explanation of the assessment made and of the functiondata and data sources used and weighting ofin the automated processing used, including among others the main variables, the logic and risks involved, as well as a right to express his or her point of view and to contest the assessment of the creditworthiness and theof personal data. Furthermore, the consumer should have the right to request a review of such a decision.
Amendment 192 #
2021/0171(COD)
Proposal for a directive
Recital 49
Recital 49
(49) To assess the credit status of a consumer, the creditor or the provider of crowdfunding credit services should also consult credit databases. The legal and actual circumstances may require that such consultations vary in scope. To prevent any distortion of competition among creditors or providers of crowdfunding credit services, they should have access to private or public credit databases concerning consumers in a Member State where they are not established under non- discriminatory conditions compared with creditors or providers of crowdfunding credit services established in that Member State. Member States should facilitatensure the cross-border access to private or public databases, inbut only to those who fully compliancey with the Regulation (EU) 2016/679 of the European Parliament and of the Council33 . To enhance reciprocity, credit databases should as a minimum hold information on consumers’ arrears in payment, in accordance with Union and national law. _________________ 33 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).
Amendment 196 #
2021/0171(COD)
Proposal for a directive
Recital 54 a (new)
Recital 54 a (new)
(54 a) Overdraft facilities and overrunning are increasingly common forms of consumer credit. Therefore, there is a need to regulate these financial products in order to increase the level of consumer protection and avoid their over- indebtedness. There is a danger that consumers will be put in an extremely difficult position if the creditor decides to request an immediate refund. Therefore, consumer rights in respect of overdraft facilities and overrunning should be laid down in this Directive.
Amendment 199 #
2021/0171(COD)
Proposal for a directive
Recital 55 a (new)
Recital 55 a (new)
(55 a) In implementing this Directive, and for the purposes of Article 25 of this Directive, each Member State should determine the amount of the significant overrunning.
Amendment 200 #
2021/0171(COD)
Proposal for a directive
Recital 56
Recital 56
(56) Consumers should have a right of withdrawal without penalty and with no obligation to provide justification. However, the right of withdrawal should not be used in bad faith that is why this Directive also sets an objective deadline for exercising the right of withdrawal.
Amendment 207 #
2021/0171(COD)
Proposal for a directive
Recital 62
Recital 62
(62) The consumer should have the right to discharge his or her obligations before the date agreed in the credit agreement. As provided by the Court of Justice of the EU Lexitor ruling,34 the right of the consumer to a reduction in the total cost of the credit in the event of early repayment of the credit includes all the costs imposed on the consumer. In the case of early repayment the creditor should be entitled to a fair and objectively justified compensation for the costs directly linked to the early repayment, taking into account also any savings thereby made by the creditor. However, in order to determine the method of calculating the compensation, it is important to respect several principles. The calculation of the compensation due to the creditor should be transparent and comprehensible to consumers already at the pre-contractual stage and in any case during the performance of the credit agreement. In addition, the calculation method should be easy for creditors to apply, and supervisory control of the compensation by the competent authorities should be facilitated. Therefore, and due to the fact that consumer credit is, given its duration and volume, not financed by long- term funding mechanisms, the ceiling for the compensation should be fixed in terms of a flat-rate amount. This approach reflects the specific nature of consumer credits and should not prejudice the approach in respect of other products which are financed by long-term funding mechanisms, such as fixed-rate mortgage loans. _________________ 34 Judgment of the Court of Justice of 11 September 2019, Lexitor, C-383/18, ECLI:EU:C:2019:702.
Amendment 213 #
2021/0171(COD)
Proposal for a directive
Recital 65 a (new)
Recital 65 a (new)
(65 a) To off-set the impact on economic operator of lack of harmonization of legal regimes across the Union, the Commission should make available, in a concise and clear form, the legal frameworks of Member States, including fixed caps.
Amendment 216 #
2021/0171(COD)
(70) Given the significant consequences for creditors, consumers and potentially financial stability of enforcement proceedings, it is appropriate to encourage creditors to deal proactively with emerging credit risk at an early stage and to put in place necessary measures to ensure that creditors exercise reasonable forbearance and make reasonable attempts to resolve the situation through other means before enforcement proceedings are initiated. Where possible, solutions should be found which take account, among other elements, of the individual circumstances of the consumer, the consumer’s interests and rights, his or her ability to repay the credit and reasonable need for living expenses, and limit costs for consumers in case of default. Member States should not prevent the parties to a credit agreement from expressly agreeing that the transfer to the creditor of goods covered by a linked credit agreement or proceeds from the sale of such goods is sufficient to repay the credit. In order to exchange best practices, it is therefore necessary to provide that the European Commission should monitor and report on the implementation of debt advisory services in the Member States.
Amendment 217 #
2021/0171(COD)
Proposal for a directive
Recital 71
Recital 71
(71) Forbearance measures may include a total or partial refinancing of a credit agreement or a modification of the previous terms and conditions of a credit agreement. Such modification may include, among others: extending the term of the credit agreement; changing the type of the credit agreement; deferring payment of all or part of the instalment repayment for a period; changreducing the interest rate; offering a payment holiday; partial repayments; currency conversion; and partial forgiveness and debt consolidation.
Amendment 221 #
2021/0171(COD)
Proposal for a directive
Recital 78
Recital 78
(78) Consumers should have access to adequate, promptly and effective alternative dispute resolution procedures for the settlement of disputes arising out of rights and obligations established under this Directive, using existing entities where appropriate. Such access is already ensured by Directive 2013/11/EU of the European Parliament and of the Council35 in so far as relevant contractual disputes are concerned. However, consumers should also have access to alternative dispute resolution procedures in the event of pre- contractual disputes concerning rights and obligations established by this Directive, for example, in relation to pre-contractual information requirements, advisory services and creditworthiness assessment and also in relation to the information given by credit intermediaries which are remunerated by creditors and therefore have no direct contractual relationship with consumers. Such alternative dispute resolution procedures and the entities offering them should comply with the quality requirements established by Directive 2013/11/EU. _________________ 35 Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (OJ L 165, 18.6.2013, p. 63).
Amendment 223 #
2021/0171(COD)
Proposal for a directive
Recital 80
Recital 80
(80) Member States should lay down rules on penalties to address infringements of the national provisions adopted pursuant to this Directive and ensure that they are implemented. While the choice of penalties remains within the discretion of the Member States, the penalties provided for should be effective, proportionate and dissuasive in order to achieve its full purpose. However, in addition to behavioral sanctions, the possibility of imposing systematic sanctions as an ultima ratio measure should be envisaged if repeated non-compliance would disruptively affect the consumer credit market, creating unfair business conditions in the market.
Amendment 226 #
2021/0171(COD)
Proposal for a directive
Recital 81
Recital 81
(81) Current national rules on penalties differ significantly across the Union. In particular, not all Member States ensure that effective, proportionate and dissuasive fines can be imposed on traders responsible for widespread infringements or widespread infringements with a Union dimension. To ensure that Member States’ authorities can impose effective, proportionate and dissuasive penalties in relation to widespread infringements and to widespread infringements with a Union dimension that are subject to coordinated investigation and enforcement measures in accordance with Regulation (EU) 2017/2394 of the European Parliament and of the Council36 , fines should be introduced as an element of penalties for such infringements. In order to ensure that the fines have a deterrent effect, Member States should set in their national law the maximum fine for such infringements at a level that is at least 46 % of the creditor, credit intermediary or provider of crowdfunding credit services’ annual turnover in the Member State or Member States concerned. In certain cases, those traders can also be a group of companies. _________________ 36 Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (OJ L 345, 27.12.2017, p. 1).
Amendment 228 #
2021/0171(COD)
Proposal for a directive
Recital 86 a (new)
Recital 86 a (new)
(86 a) When transposing the Directive, Member States should ensure that the cost of implementing this Directive is neither borne by consumers nor passed on to them.
Amendment 229 #
2021/0171(COD)
Proposal for a directive
Recital 86 b (new)
Recital 86 b (new)
(86 b) Due to the ubiquitous trend of digitalisation and the emergence of new service providers in the consumer credit market, the European Commission should actively monitor the situation on the market and propose review of the Directive if new forms of actors appear whose business is not currently covered by this Directive.
Amendment 235 #
2021/0171(COD)
Proposal for a directive
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) credit agreements which are secured either by a mortgage, or by another comparable security commonly used in a Member State on residential immovable property such as lien or secured by a right related to residential immovable property;
Amendment 236 #
2021/0171(COD)
Proposal for a directive
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) credit agreements the purpose of which is to acquire or retain property rights in land or in an existing or projected building if such credit agreements are secured either by a mortgage, or by another comparable security commonly used in a Member State on residential immovable property such as lien or secured by a right related to residential immovable property ;
Amendment 240 #
2021/0171(COD)
Proposal for a directive
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
(f) credit agreements which are the outcome of a settlement reached in court or before another statutory authority or which are the outcome of alternative dispute resolution;;
Amendment 241 #
2021/0171(COD)
Proposal for a directive
Article 2 – paragraph 2 – point f a (new)
Article 2 – paragraph 2 – point f a (new)
(f a) credit agreements where the credit is granted free of interest and without any other charges other than late payment fees;
Amendment 243 #
2021/0171(COD)
Proposal for a directive
Article 2 – paragraph 2 – point f b (new)
Article 2 – paragraph 2 – point f b (new)
(f b) leasing agreements where an obligation to purchase the object of the agreement is not laid down either by the agreement itself or by any separate agreement;
Amendment 244 #
2021/0171(COD)
Proposal for a directive
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
(g) credit agreements which relate to the deferred payment, free of interests and without any other charges, of an existing debt;
Amendment 247 #
2021/0171(COD)
Proposal for a directive
Article 2 – paragraph 2 – point i
Article 2 – paragraph 2 – point i
(i) credit agreements which relate to loans granted to a restricted public under a statutory or legal provision with a general interest purpose, and at lower interest rates than those prevailing on the market or free of interest or on other terms which are more favourable to the consumer than those prevailing on the market.
Amendment 262 #
2021/0171(COD)
Proposal for a directive
Article 2 – paragraph 3 a (new)
Article 2 – paragraph 3 a (new)
3 a. Notwithstanding paragraph 2, point (c), Member States may provide that the provisions of this Directive also apply to credit agreements involving a total amount of credit of up to EUR 150 000.
Amendment 264 #
2021/0171(COD)
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. In the case of credit agreements in the form of overrunning, only Articles 1, 2 and 3, Article 25, 3, 25, 29, 35, 36, 39, 40, and Articles 41 to 50 shall apply.
Amendment 272 #
2021/0171(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) ‘consumer’ means a natural person who acts for purposes which are outside his or her professional activity, trade, or business or profession;
Amendment 273 #
2021/0171(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) ‘creditor’ means a natural or legal person who grants or promises to grant credit in the course of his or her professional activity, trade, or business or profession;
Amendment 279 #
2021/0171(COD)
(3 a) 'small value credit’ means a credit agreement involving a total amount of credit of up to EUR 200;
Amendment 281 #
2021/0171(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 3 b (new)
Article 3 – paragraph 1 – point 3 b (new)
(3 b) ‘ancillary service’ means a service offered to the consumer in conjunction with the credit agreement;
Amendment 288 #
2021/0171(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 11
Article 3 – paragraph 1 – point 11
(11) ‘durable medium’ means any interoperable instrument which enables the consumer to store information addressed personally to him or her in a way accessible for future reference for a period of time adequate for the purposes of the information and which allows the unchanged reproduction of the information stored;
Amendment 291 #
2021/0171(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
(13) ‘pre-contractual information’ means the information that the consumer needs to be able to compare different credit offers, understand them and take an informed decision on whether to conclude the credit agreement or the agreement for the provision of crowdfunding credit services;
Amendment 295 #
2021/0171(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 22
Article 3 – paragraph 1 – point 22
(22) ‘early repayment’ means the full or partial discharge of the consumer’s obligations under a credit agreement or crowdfunding credit services, before the date for the final payment agreed in the credit agreement;
Amendment 309 #
2021/0171(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
Member States shall require that, when information is provided to consumers in accordance with this Directive, such information is provided timely and without charge to the consumer.
Amendment 310 #
2021/0171(COD)
Proposal for a directive
Article 5 – paragraph 1 a (new)
Article 5 – paragraph 1 a (new)
Exceptionally, if the information cannot be provided to the consumer electronically or involves the sending of information by post, Member States may provide that creditors or, where applicable, credit intermediaries or providers of crowdfunding credit services, may require the consumer to reimburse the actual cost of sending the requested information.
Amendment 314 #
2021/0171(COD)
Proposal for a directive
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
Refusal to provide services in a Member State where the creditor or, where applicable, credit intermediaries or providers of crowdfunding credit services do not conduct business shall not be considered discrimination.
Amendment 316 #
2021/0171(COD)
Proposal for a directive
Article 6 a (new)
Article 6 a (new)
Article 6 a Digital, green and sustainable financial products Member States shall encourage creditors or, where applicable, credit intermediaries or providers of crowdfunding credit services to develop and offer financial products that support digital, green and sustainable transition.
Amendment 319 #
2021/0171(COD)
Proposal for a directive
Article 7 – paragraph 1
Article 7 – paragraph 1
Without prejudice to Directive 2005/29/EC, Member States shall require that any advertising and marketing communications concerning credit agreements or crowdfunding credit services are fair, clear and not misleading. Wording in such advertising and marketing communications that may create false expectations for a consumer regarding the availability or the cost of a credit or where applicable, the total amount payable by the consumer shall be prohibited.
Amendment 326 #
2021/0171(COD)
Proposal for a directive
Article 8 – paragraph 1 – introductory part
Article 8 – paragraph 1 – introductory part
1. Member States shall require that advertising concerning credit agreements or crowdfunding credit services which indicates an interest rate or any figures relating to the cost of the credit to the consumer include standard information in accordance with this Article.
Amendment 328 #
2021/0171(COD)
Proposal for a directive
Article 8 – paragraph 1 – subparagraph 1
Article 8 – paragraph 1 – subparagraph 1
Amendment 332 #
2021/0171(COD)
Proposal for a directive
Article 8 – paragraph 2 – point f a (new)
Article 8 – paragraph 2 – point f a (new)
(f a) a general warning concerning possible consequences of non-compliance with the commitments linked to the credit agreement or crowdfunding credit services.
Amendment 334 #
2021/0171(COD)
Proposal for a directive
Article 8 – paragraph 2 – point f b (new)
Article 8 – paragraph 2 – point f b (new)
(f b) After consulting the European Central Bank, the European Commission is empowered to adopt a delegated act concerning further specification of the content of the warning contained in point (fa) of the first subparagraph.
Amendment 340 #
2021/0171(COD)
Proposal for a directive
Article 8 – paragraph 3 a (new)
Article 8 – paragraph 3 a (new)
3 a. Without prejudice to (Digital Services Act Regulation) and Regulation 2016/679 (GDPR), if online advertisement concerning credit agreements covered by this regulation are based on personalized data they must clearly and unambiguously inform the consumer of this.
Amendment 343 #
2021/0171(COD)
Proposal for a directive
Article 8 – paragraph 3 b (new)
Article 8 – paragraph 3 b (new)
3 b. Member States shall ensure that consumer is provided with the possibility to exclude personalized credit offers. The possibility to be excluded from such personalized credit offers must be clearly identified in the advertisement.
Amendment 344 #
2021/0171(COD)
Proposal for a directive
Article 8 – paragraph 3 c (new)
Article 8 – paragraph 3 c (new)
3 c. In any case, Member States shall prohibit advertisements based on personalized data for consumer credit products which incites over-indebted consumers to seek credit.
Amendment 345 #
2021/0171(COD)
Amendment 359 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 1 – introductory part
Article 10 – paragraph 1 – introductory part
1. Member States shall require that the creditor and, where applicable, the credit intermediary or the provider of crowdfunding credit services provide the consumer with the pre-contractual information needed to compare different offers in order to take an informed decision on whether to conclude a credit agreement or crowdfunding credit services on the basis of the credit terms and conditions offered by the creditor or by the provider of crowdfunding credit services and, where applicable, the preferences expressed and information supplied by the consumer. Such pre-contractual information shall be provided to the consumer at least one day within a reasonable time before he or she is bound by any credit agreement or offer, or by any agreement or offer for the provision of crowdfunding credit services.
Amendment 364 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1
Article 10 – paragraph 1 – subparagraph 1
Amendment 374 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. The pre-contractual information referred to in paragraph 1 shall be provided on paper, electronically or on another durable medium by means of the Standard European Consumer Credit Information form set out in Annex I. All the information provided in the form shall be equally prominent. The creditor shall be deemed to have fulfilled the information requirements in this paragraph and in Article 3, paragraphs (1) and (2) of Directive 2002/65/EC if he or she has supplied the Standard European Consumer Credit Information.
Amendment 399 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 3 – point n
Article 10 – paragraph 3 – point n
(n) a warning regarding the consequences of missing or late paymentslegal and financial consequences that non- compliance with specific contractual obligations may lead to;
Amendment 423 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 4 – introductory part
Article 10 – paragraph 4 – introductory part
4. At the same time as the Standard European Consumer Credit Information form ishall provided to the consumer, the creditor and, where applicable, the credit intermediary or the provider of crowdfunding credit services, shall provide the consumer with the Standard European Consumer Credit Overview form set out in Annex II, containing the following with the following pre- contractual information at the beginning of the form, which information will be noticeably separated from the rest of the pre-contractual information provided on the same form:
Amendment 432 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 4 – point f
Article 10 – paragraph 4 – point f
(f) a warning regarding the consequences of missing or late payments including costs in the case of late payments;
Amendment 435 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 4 – point f a (new)
Article 10 – paragraph 4 – point f a (new)
(f a) information about early repayment in accordance to Article 29;
Amendment 437 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 4 – point f b (new)
Article 10 – paragraph 4 – point f b (new)
(f b) the existence of a right of withdrawal.
Amendment 444 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 5 – introductory part
Article 10 – paragraph 5 – introductory part
5. Information displayed in the Standard European Consumer Credit Information form and in the Standard European Consumer Credit Overview form shall be consistent. It shall be clearly legible and take into account the technical constraints of the medium on which it is displayed. Information shall be displayed in an adequate and suitable way on the different channels taking into account interoperability.
Amendment 450 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 5 – subparagraph 1
Article 10 – paragraph 5 – subparagraph 1
Any additional information which the creditor may provide to the consumer shall be given in a separate document which may be annexed to the Standard European Consumer Credit Information form or the Standard European Consumer Credit Overview form.
Amendment 453 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 6
Article 10 – paragraph 6
Amendment 459 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 7
Article 10 – paragraph 7
7. If the agreement has been concluded at the consumer's request using a means of distance communication which does not enable the information to be provided in accordance with this article, the creditor and, where applicable, the credit intermediary or the provider of crowdfunding credit services shall provide the consumer with the Standard European Consumer Credit Information form and the Standard European Consumer Credit Overview form immediately after the conclusion of the credit agreement or of the agreement for the provision of crowdfunding credit services.
Amendment 461 #
2021/0171(COD)
Proposal for a directive
Article 10 – paragraph 8
Article 10 – paragraph 8
8. Upon request from the consumer, the creditor and, where applicable, the credit intermediary or the provider of crowdfunding credit services shall, in addition to the Standard European Consumer Credit Information form and the Standard European Consumer Credit Overview form, provide the consumer free of charge with a copy of the draft credit agreement, or of the draft agreement for the provision of crowdfunding credit services, provided that the creditor at the time of the request is willing to proceed to the conclusion of the credit agreement or of the agreement for the provision of crowdfunding credit services with the consumer. If not regulated otherwise by national law, the provision of the credit offer shall oblige the creditor to maintain its terms and conditions for a minimum of 14 days from the date of receipt by the consumer.
Amendment 470 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. For credit agreements referred to in Article 2(5) or (6), the pre-contractual information referred to in Article 10(1) shall, by way of derogation from paragraph 2 of that Article, be provided on paper, electronically or on another durable medium by means of the European Consumer Credit Information form set out in Annex III. All information provided in that form shall be equally prominent. The creditor shall be deemed to have fulfilled the information requirements in this paragraph and in Article 3, paragraphs (1) and (2) of Directive 2002/65/EC if he or she has supplied the European Consumer Credit Information.
Amendment 472 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 2 – point c
Article 11 – paragraph 2 – point c
Amendment 473 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 2 – point d
Article 11 – paragraph 2 – point d
Amendment 474 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 2 – point e
Article 11 – paragraph 2 – point e
Amendment 475 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 2 – point i
Article 11 – paragraph 2 – point i
Amendment 476 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 2 – point o a (new)
Article 11 – paragraph 2 – point o a (new)
(o a) a warning regarding the legal and financial consequences that non- compliance with specific contractual obligations may lead to;
Amendment 478 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 480 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 3 – subparagraph 1 (new)
Article 11 – paragraph 3 – subparagraph 1 (new)
Standard European Consumer Credit Information form shall provide the consumer with the following pre- contractual information at the beginning of the form, which information will be noticeably separated from the rest of the pre-contractual information provided on the same form: (a) the total amount of credit; (b) the duration of the credit agreement; (c) the borrowing rate, or all borrowing rates if different borrowing rates apply in different circumstances; (d) the annual percentage rate of charge and the total amount payable by the consumer; (e) in the case of a credit in the form of deferred payment for specific goods or services and in the case of linked credit agreements, the specific goods or services and their cash price; (f) a warning regarding the consequences of missing or late payments including costs in the case of late payments; (g) the right of early repayment, and, where applicable, information concerning the creditor's right to compensation and the way in which that compensation will be determined.
Amendment 483 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 4
Article 11 – paragraph 4
4. Information displayed in the European Consumer Credit Information form and in the Standard Consumer Credit Overview form shall be consistent. It shall be clearly legible and take into account the technical constraints of the medium on which it is displayed. Information shall be displayed in an adequate and suitable way on the different channels taking into account interoperability.
Amendment 484 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 6
Article 11 – paragraph 6
6. Upon request from the consumer, the creditor and, where applicable, the credit intermediary shall, in addition to the European Consumer Credit Information and the Standard European Consumer Credit Overview form, provide the consumer free of charge with a copy of the draft credit agreement, provided that the creditor at the time of the request is willing to proceed to the conclusion of the credit agreement with the consumer.
Amendment 489 #
2021/0171(COD)
Proposal for a directive
Article 11 – paragraph 7
Article 11 – paragraph 7
7. If the agreement has been concluded at the consumer's request using a means of distance communication which does not enable the information to be provided in accordance with this Article, the creditor shall immediately after the conclusion of the credit agreement provide the consumer with the European Consumer Credit Information form and the Standard European Consumer Credit Overview form immediately after the conclusion of the credit agreement.
Amendment 495 #
2021/0171(COD)
Proposal for a directive
Article 12 – paragraph 1 – point a
Article 12 – paragraph 1 – point a
(a) the information referred to in Article 10, 11 and 38 with particular emphasis on explaining the legal and financial consequences that may result from improper performance of contractual obligations;
Amendment 496 #
2021/0171(COD)
Proposal for a directive
Article 12 – paragraph 1 – subparagraph 1 (new)
Article 12 – paragraph 1 – subparagraph 1 (new)
Creditors and, where applicable, credit intermediaries and providers of crowdfunding credit services are required to provide, free of charge, adequate explanations before conclusion of contract with consumer.
Amendment 503 #
2021/0171(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
Member States shall require that creditors, credit intermediaries and providers of crowdfunding credit services inform consumers in clear and unambiguous manner when they are presented with a personalised offer that is based on profiling or other types of automated processing of personal data.
Amendment 522 #
2021/0171(COD)
Proposal for a directive
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The agreement of the consumer to the purchase of ancillary services presented through boxes shall be given by aunambiguous and clear affirmative act establishing a freely given, specific, informed and unambiguous indication of his or her approval to the content and substance associated to the boxes.
Amendment 523 #
2021/0171(COD)
Proposal for a directive
Article 15 – paragraph 2 – subparagraph 1 (new)
Article 15 – paragraph 2 – subparagraph 1 (new)
Silence or inactivity in no case imply consent to constitute agreement within meaning of this Article.
Amendment 525 #
2021/0171(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
Amendment 526 #
2021/0171(COD)
Proposal for a directive
Article 16 – paragraph 2 – introductory part
Article 16 – paragraph 2 – introductory part
2. Member States shall requiensure that the creditor, and where applicable the credit intermediary and the provider of crowdfunding credit services, before the provision of advisory services or the conclusion of a contract for the provision of such services, provide the consumer with the following information on paper or another durable medium:
Amendment 538 #
2021/0171(COD)
Proposal for a directive
Article 16 – paragraph 6 – subparagraph 1 – point c
Article 16 – paragraph 6 – subparagraph 1 – point c
(c) the advisory services are provided in the context of management of existing debt by public or voluntary debt advisory services providers which do not operate on a commercial basis but which meet the professional criteria to provide advisory services set by the Member State;
Amendment 545 #
2021/0171(COD)
Proposal for a directive
Article 17 – paragraph 1 – subparagraph 1 (new)
Article 17 – paragraph 1 – subparagraph 1 (new)
This provision shall not apply to credit agreements concluded at point of sale to finance the purchase of a good or a service.
Amendment 546 #
2021/0171(COD)
Proposal for a directive
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
In particular, Member States shall prohibit the introduction of a new overdraft facility or overrunning agreement or the raising of the limit of an existing overdraft facility or overrunning agreement, without the consumer’s prior request or explicit agreement.
Amendment 554 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
1. Member States shall require that, before concluding a credit agreement, or an agreement for the provision of crowdfunding credit services, the creditor or, where applicable, the provider of crowdfunding credit services makes a thoroughcomprehensive assessment of the consumer’s creditworthiness. That assessment shall be done in the interest of the consumer, to prevent irresponsible lending practices and over-indebtedness, and shall take appropriate account of factors relevant to verifying the prospect of the consumer to meet his or her obligations under the credit agreement or the agreement for the provision of crowdfunding credit services.
Amendment 560 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 2 – introductory part
Article 18 – paragraph 2 – introductory part
2. The assessment of creditworthiness shall be carried out on the basis of relevant and accurate information on the consumer’s income and expenses and other financial and economic circumstances which is necessary and proportionate such as evidence of income or other sources of repayment, information on financial assets and liabilities, or information on other financial commitments. The information shall be obtained from relevant internal or external sources, including the consumer and, where necessary, on the basis of a consultation of a database referred to in Article 19.
Amendment 569 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 2 – subparagraph 1
Article 18 – paragraph 2 – subparagraph 1
The information obtained in accordance with this paragraph, where possible and necessary, shall be appropriately verified, where necessary through reference to independently verifiable documentation.
Amendment 571 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2 a. Personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation and data collected from social networks shall not be processed or used to perform creditworthiness assessments.
Amendment 575 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 2 b (new)
Article 18 – paragraph 2 b (new)
2 b. Member States shall ensure that the implementation of this Directive guarantees the ‘Right to Be Forgotten’.
Amendment 577 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 2 c (new)
Article 18 – paragraph 2 c (new)
2 c. Member States shall ensure that creditors or providers of crowdfunding services are held liable and are subject to appropriate sanctions in case of a breach of the above-mentioned provision.
Amendment 578 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 2 d (new)
Article 18 – paragraph 2 d (new)
2 d. The creditor or, where applicable, the provider of crowdfunding credit services may perform assessment of creditworthiness for 'small value credits' consulting only: (a) recent payment account data; (b) income and benefit data; (c) information on financial assets and liabilities. Without prejudice to paragraph 2 a, only in exceptional cases where the creditor or, where applicable, the provider of crowdfunding credit services considers that the information contained in this paragraph are insufficient to assess creditworthiness, the assessment may also be made on the basis of other information.
Amendment 584 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 3 a (new)
Article 18 – paragraph 3 a (new)
3 a. If the credit application is submitted jointly by more than one consumer, the creditor or, where applicable, the provider of crowdfunding credit services shall perform the creditworthiness assessment on the basis of the joint repayment capacity of the consumers.
Amendment 589 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 4 – introductory part
Article 18 – paragraph 4 – introductory part
4. Member States shall ensure that the creditor or the provider of crowdfunding credit services only makes the credit available to the consumer where the result of the creditworthiness assessment indicates that the obligations resulting from the credit agreement or the agreement for the provision of crowdfunding credit services are likely towill be met in the manner required under that agreement.
Amendment 595 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 4 – subparagraph 1
Article 18 – paragraph 4 – subparagraph 1
Notwithstanding the first subparagraphs, where the result of the creditworthiness assessment indicates that the obligations resulting from the credit agreement or the agreement for the provision of crowdfunding credit services arewill not likely to be meet in the manner required under that agreement, the creditor or the provider of crowdfunding credit services may exceptionally make credit available to the consumer in specific and well justified circumstances that include cases of loans that fund exceptional healthcare expenses, students loans or loans for consumers with disabilities.
Amendment 596 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 4 – subparagraph 1 a (new)
Article 18 – paragraph 4 – subparagraph 1 a (new)
If the creditor or the provider of crowdfunding credit services make credit available to the consumer in accordance with subparagraph 1, the creditor or the provider of crowdfunding credit services shall warn the consumer in writing, on paper or on another durable medium, of a negative credit assessment that may lead to over-indebtedness. Such information must be communicated to the consumer before the conclusion of the credit agreement.
Amendment 599 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 5
Article 18 – paragraph 5
5. Member States shall ensure that where a creditor or a provider of crowdfunding credit services concludes a credit agreement or an agreement for the provision of crowdfunding credit services with a consumer, the creditor or provider of crowdfunding credit services shall not subsequently cancel or alter the credit agreement or the agreement for the provision of crowdfunding credit services to the detriment of the consumer on the grounds that the assessment of creditworthiness was incorrectly conducted. This paragraph shall not apply where it is demonstrated that the consumer has not acted in good faith and especially if the consumer knowingly withheld or falsified the information provided to the creditor or the provider of crowdfunding credit services referred to in paragraph 2.
Amendment 606 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 6 – point a
Article 18 – paragraph 6 – point a
(a) request and obtain human intervention on the part of the creditor or the provider of crowdfunding credit services to review the decision, in case of a negative decision;
Amendment 612 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 6 – point b
Article 18 – paragraph 6 – point b
(b) request and obtain from the creditor or the provider of crowdfunding credit services a clear explanation of the assessment of creditworthiness, including on the logic and risks involveddata and data sources used and the weighing in the automated processing of personal data as well as its significance and effects on the decision;
Amendment 616 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 6 – point c
Article 18 – paragraph 6 – point c
(c) express his or her point of view and contest the assessment of the creditworthiness and the decisionrequest a review and new decision on the granting of the credit by the creditor or the provider of crowdfunding credit services.
Amendment 622 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 7
Article 18 – paragraph 7
7. Member States shall ensure that where the credit application is rejected the creditor or the provider of crowdfunding credit services is required to inform the consumer without delay of the rejection and, where applicable, of the fact that the assessment of creditworthiness is based on automated or semi-automated processing of data.
Amendment 624 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 8
Article 18 – paragraph 8
8. Where the parties agree to change the total amount of credit after the conclusion of the credit agreement, or the agreement for the provision of crowdfunding credit services, Member States shall ensure that the creditor or the provider of crowdfunding credit services is required to reassess the consumer’s creditworthiness on the basis of updated information before any significant increase in the total amount of credit is granted.
Amendment 631 #
2021/0171(COD)
Proposal for a directive
Article 18 – paragraph 9 a (new)
Article 18 – paragraph 9 a (new)
9 a. This article shall apply without prejudice to Regulation (EU) n°2016/679 (GDPR).
Amendment 633 #
2021/0171(COD)
Proposal for a directive
Article 19 – paragraph 1
Article 19 – paragraph 1
1. Each Member State shall in the case of cross-border credit ensure access for creditors and providers of crowdfunding credit services from other Member States to accurate and up-to-date databases used in that Member State for assessing the creditworthiness of consumers. The conditions for access to such databases shall be non-discriminatory.
Amendment 634 #
2021/0171(COD)
Proposal for a directive
Article 19 – paragraph 1 – subparagraph 1 (new)
Article 19 – paragraph 1 – subparagraph 1 (new)
Member States shall ensure that only those creditors and providers of crowdfunding credit services who are under the supervision of the competent national authority and who fully comply with Regulation (EU) n°2016/679 (GDPR) have access to the database.
Amendment 637 #
2021/0171(COD)
Proposal for a directive
Article 19 – paragraph 3
Article 19 – paragraph 3
3. ThState or private databases referred to in paragraph 1 shall hold at least information on consumers’ arrears in payment and shall not hold personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation nor data collected from digital social networks.
Amendment 639 #
2021/0171(COD)
Proposal for a directive
Article 19 – paragraph 4 – subparagraph 1 (new)
Article 19 – paragraph 4 – subparagraph 1 (new)
Member States shall ensure that consumers are notified within thirty days of the registration of any negative credit data in a database, informing them of the possibility of exercising their right of access, rectification, erasure and opposition, in line with Regulation (EU) n°2016/679 (GDPR).
Amendment 645 #
2021/0171(COD)
Proposal for a directive
Article 20 – paragraph 1 – subparagraph 1 (new)
Article 20 – paragraph 1 – subparagraph 1 (new)
Any modification of credit agreements or agreements for the provision of crowdfunding credit services shall be done only in writing on paper or on another durable medium.
Amendment 647 #
2021/0171(COD)
Proposal for a directive
Article 20 – paragraph 2 a (new)
Article 20 – paragraph 2 a (new)
2 a. Member States may introduce more lenient rules on agreements of 'small value credit'.
Amendment 650 #
2021/0171(COD)
Proposal for a directive
Article 21 – paragraph 1 – subparagraph 1 a (new)
Article 21 – paragraph 1 – subparagraph 1 a (new)
The legal effects of the absence in the credit agreement or the agreement for the provision of crowdfunding credit services of information referred to in the first subparagraph shall be assessed in accordance with the national general rules on the law of obligations.
Amendment 652 #
2021/0171(COD)
Proposal for a directive
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
Without prejudice to other obligations foreseen in this Directive, Member States shall ensure that prior to modifying the terms and conditions of the credit agreement, or of the agreement for the provision of crowdfunding credit services, the creditor or the provider of crowdfunding credit services communicate in writing on paper or on another durable medium the following information to the consumer:
Amendment 655 #
2021/0171(COD)
Proposal for a directive
Article 23 – paragraph 2 – point c
Article 23 – paragraph 2 – point c
(c) the new reference rate is made publicly available in a timely manner and by appropriate means;
Amendment 658 #
2021/0171(COD)
Proposal for a directive
Article 23 – paragraph 2 – point d
Article 23 – paragraph 2 – point d
(d) the information concerning the new reference rate is also available at the premises of the creditor or of the provider of crowdfunding credit services and online.
Amendment 660 #
2021/0171(COD)
Proposal for a directive
Article 24 – paragraph 1 – introductory part
Article 24 – paragraph 1 – introductory part
1. Where a credit has been granted in the form of an overdraft facility, Member States shall require that the creditor, throughout the duration of the credit agreement, keeps the consumer regularly informedinformed at least once per month by means of statements of account, on paper or on another durable medium, containing the following elements:
Amendment 663 #
2021/0171(COD)
Proposal for a directive
Article 24 – paragraph 2 – introductory part
Article 24 – paragraph 2 – introductory part
2. Where a credit has been granted in the form of an overdraft facility, Member States shall require that the creditor informs the consumer, on paper or another durable medium, of increases in the borrowing rate or in any charges payable, at least 15 days before the change in question enters into force.
Amendment 666 #
2021/0171(COD)
Proposal for a directive
Article 24 – paragraph 2 a (new)
Article 24 – paragraph 2 a (new)
2 a. Member States shall require the creditor or where applicable credit intermediaries or the provider of crowdfunding credit services to notify the consumer in an agreed manner of each reduction or cancellation of the current account overdraft facility at the least 30 days prior to the day when the actual reduction or cancellation of the overdraft facility takes effect.
Amendment 667 #
2021/0171(COD)
Proposal for a directive
Article 24 – paragraph 2 b (new)
Article 24 – paragraph 2 b (new)
2 b. The creditor or where applicable credit intermediaries or the provider of crowdfunding credit services shall enable the consumer, against whom no forced collection proceedings have been initiated by the creditor or where applicable by credit intermediaries or the provider of crowdfunding credit services, without obligation of previous request on the part of the consumer and with no additional costs, to repay the amount by which the previous overdraft facility was reduced or the amount of the cancelled previous overdraft facility, in 12 equal monthly instalments at the interest rate applicable to the current account overdraft facility. If the consumer has not been offered to repay the amount by which the overdraft facility has been reduced or the amount of the cancelled previous overdraft facility, he shall not be obligated to accept the reduction or the cancellation of the current account overdraft facility.
Amendment 672 #
2021/0171(COD)
Proposal for a directive
Article 25 – paragraph 3 a (new)
Article 25 – paragraph 3 a (new)
Amendment 673 #
2021/0171(COD)
Proposal for a directive
Article 25 – paragraph 3 b (new)
Article 25 – paragraph 3 b (new)
3 b. The creditor or where applicable credit intermediaries or the provider of crowdfunding credit services shall enable the consumer, against whom no forced collection proceedings have been initiated by the creditor or where applicable by credit intermediaries or the provider of crowdfunding credit services, without obligation of previous request on the part of the consumer and with no additional costs, to repay the amount by which the previous overrunning was reduced or the amount of the cancelled previous overrunning, in 12 equal monthly instalments at the interest rate applicable to the current account overrunning. If the consumer has not been offered to repay the amount by which the overrunning has been reduced or the amount of the cancelled previous overrunning, he shall not be obligated to accept the reduction or the cancellation of the current account overrunning.
Amendment 676 #
2021/0171(COD)
Proposal for a directive
Article 26 – paragraph 1 – subparagraph 1 a (new)
Article 26 – paragraph 1 – subparagraph 1 a (new)
Amendment 687 #
2021/0171(COD)
Proposal for a directive
Article 28 – paragraph 1 – subparagraph 1
Article 28 – paragraph 1 – subparagraph 1
Member States shall ensure that the creditor or the provider of crowdfunding credit services, where agreed in the credit agreement or in the agreement for the provision of crowdfunding credit services, may effect standard termination of an open-end credit agreement or agreement for the provision of crowdfunding credit services by giving the consumer at least twohree months' notice on paper or on another durable medium.
Amendment 694 #
2021/0171(COD)
Proposal for a directive
Article 29 – paragraph 2 a (new)
Article 29 – paragraph 2 a (new)
2 a. The calculation of the compensation due to the creditor shall be transparent and comprehensible to consumers already at the pre-contractual stage and in any case during the performance of the credit agreement
Amendment 695 #
2021/0171(COD)
(b) the credit is granted in the form of an overdraft facility or overrunning;
Amendment 701 #
2021/0171(COD)
Proposal for a directive
Article 29 – paragraph 4 – point b
Article 29 – paragraph 4 – point b
(b) the creditor may exceptionally claim higher compensation if the creditor can prove that the loss suffered due to early repayment exceeds the amount determined in accordance with paragraph 2. However, this compensation should not exceed the amount of interest that the consumer would have paid during the period between the early repayment and the agreed date of termination of the credit agreement.
Amendment 723 #
2021/0171(COD)
Proposal for a directive
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
2 a. The European Commission shall make publicly available the caps introduced by Member States.
Amendment 727 #
2021/0171(COD)
Proposal for a directive
Article 32 – paragraph 1 – point e a (new)
Article 32 – paragraph 1 – point e a (new)
(e a) advertising credit products.
Amendment 735 #
2021/0171(COD)
Proposal for a directive
Article 33 – paragraph 1
Article 33 – paragraph 1
1. Member States shall ensure that creditors, credit intermediaries and providers of crowdfunding credit services require their staff to possess and keep up- to-date an appropriate level of knowledge and competence in relation to the manufacturing, the offering, the advertising and the granting of credit agreements or crowdfunding credit services, the carrying out of credit intermediation activities, the provision of advisory services or crowdfunding credit services. Where the conclusion of a credit agreement or an agreement for the provision of crowdfunding credit services includes an ancillary service, appropriate knowledge and competence in relation to that ancillary service shall be required.
Amendment 740 #
2021/0171(COD)
Proposal for a directive
Article 34 – paragraph 1 – introductory part
Article 34 – paragraph 1 – introductory part
1. Member States shall promote measures that support the education of consumers in relation to responsible borrowing and debt management, in particular in relation to consumer credit agreements. Clear and general information on the credit granting process shall be provided to consumers in order to guide them, in particular those who take out a consumer credit for the first time, and especially on digital tools. In creating and promoting these measures, Member States closely cooperate with consumer organisations.
Amendment 748 #
2021/0171(COD)
Proposal for a directive
Article 35 – paragraph 1 – point b – point iv
Article 35 – paragraph 1 – point b – point iv
(iv) changreducing the interest rate;
Amendment 751 #
2021/0171(COD)
Proposal for a directive
Article 35 – paragraph 4
Article 35 – paragraph 4
Amendment 755 #
2021/0171(COD)
Proposal for a directive
Article 36 – paragraph 1
Article 36 – paragraph 1
Member States shall ensure that debt advisory services are made available to consumers free of charge.
Amendment 756 #
2021/0171(COD)
Proposal for a directive
Article 36 – paragraph 1 a (new)
Article 36 – paragraph 1 a (new)
The European Commission shall within two years of implementation of this Directive, present a report providing an overview of the availability of debt-advice services across Member States and identify best practices for the further developments of such services.
Amendment 758 #
2021/0171(COD)
Proposal for a directive
Article 36 a (new)
Article 36 a (new)
Article 36 a Debt collection Member States shall determine the practices which are in any case considered impermissible in the collection of debts. Such practices shall include, in particular, intimidation of consumers, the presentation of false legal information and the making of excessive calls or messages.
Amendment 763 #
2021/0171(COD)
Proposal for a directive
Article 37 – paragraph 1
Article 37 – paragraph 1
Member States shall ensure that any creditors, credit intermediaries and providers of crowdfunding credit services that are not credit institutions as defined in Article 4(1), point (1), of Regulation (EU) No 575/2013 are subject to an adequate admission process and to registration and supervision arrangements set up by an independent competent authority.
Amendment 774 #
2021/0171(COD)
Proposal for a directive
Article 39 – paragraph 2
Article 39 – paragraph 2
2. Member States shall require that the original creditor or the provider of crowdfunding credit services inform the consumer of the assignment referred to in paragraph 1, except where the original creditor or the provider of crowdfunding credit services, by agreement with the assignee, continues to service the credit vis-à-vis the consumer.
Amendment 775 #
2021/0171(COD)
Proposal for a directive
Article 39 – paragraph 2 a (new)
Article 39 – paragraph 2 a (new)
2 a. The European Commission is empowered to adopt and, where necessary amend, regulatory technical standards to stipulate the format of the notification that creditor or the provider of crowdfunding credit services is obliged to provide to consumer in case of assignment of rights to a third party.
Amendment 777 #
2021/0171(COD)
Proposal for a directive
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Member States shall ensure that consumers have access to adequate, promptly and effective out-of-court dispute resolution procedures for the settlement of disputes between consumers and creditors, credit intermediaries or providers of crowdfunding credit services concerning rights and obligations established under this Directive, using existing entities where appropriate. Such out-of-court dispute resolution procedures and the entities offering them shall comply with the quality requirements laid down by Directive 2013/11/EU.
Amendment 782 #
2021/0171(COD)
2. Where a Member State makes use of the regulatory choices provided for in Article 2(3), 2(5) and 2(6), Article 8(12)(c), Article 820(2)(c, Article 26(2), Article 20(29(4), Article 26(243(3a) and Article 29(444(2), it shall inform the Commission thereof as well as of any subsequent changes. Member States shall also take the appropriate measures to diffuse that information amongst national creditors, credit intermediaries, providers of crowdfunding credit services and consumers.
Amendment 783 #
2021/0171(COD)
Proposal for a directive
Article 43 – paragraph 3 a (new)
Article 43 – paragraph 3 a (new)
3 a. Nothing in this Directive shall prevent Member States from providing in their national law higher level of consumer protection regarding Article 24 and Article 25 of this Directive.
Amendment 784 #
Amendment 789 #
2021/0171(COD)
Proposal for a directive
Article 44 – paragraph 2
Article 44 – paragraph 2
2. Member States shall ensure that when penalties are to be imposed in accordance with Article 21 of Regulation (EU) 2017/2394, they include the possibility either to impose fines through administrative procedures or to initiate legal proceedings for the imposition of fines, or both, the maximum amount of such fines being at least 46% of the creditor, the credit intermediary or the provider of crowdfunding credit services’ annual turnover in all Member States concerned by the coordinated enforcement action.
Amendment 790 #
2021/0171(COD)
Proposal for a directive
Article 44 – paragraph 2 a (new)
Article 44 – paragraph 2 a (new)
2 a. In the case of systematic and repeated infringements of the provisions of this Directive by the creditor, the credit intermediary or the provider of crowdfunding credit services, where it is clear that the imposition of penalties in accordance to paragraf (2) of this Article cannot ensure the purpose of the penalty, and breaches of the provisions have a disruptive effect on the market, Member States may, as a last resort, provide for the imposition of structural remedies.
Amendment 794 #
2021/0171(COD)
Proposal for a directive
Article 46 – paragraph 1 – subparagraph 1 (new)
Article 46 – paragraph 1 – subparagraph 1 (new)
In the evaluation referred to in the paragraph (1), the European Commission will include an assessment of new forms of service providers participating in the consumer credit market with a special focus on digital trends and will propose the necessary amendment to the Directive accordingly.
Amendment 803 #
2021/0171(COD)
Proposal for a directive
Annex II
Annex II
Amendment 2291 #
2021/0106(COD)
Proposal for a regulation
Article 53 – paragraph 1
Article 53 – paragraph 1
1. AI regulatory sandboxes established by SMEs, start-ups, enterprises and other innovators, one or more Member States competent authorities or the European Data Protection Supervisor shall provide a controlled environment that facilitates the safe development, testing and validation of innovative AI systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. TFor Member States competent authorities or the European Data Protection Supervisor, this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this Regulation and, where relevant, other Union and Member States legislation supervised within the sandbox. For SMEs, start-ups, enterprises and other innovators, this shall take place independently from supervising authorities, while following rules and regulations (e.g. a Code of conduct) established in cooperation with Member State competent authorities.
Amendment 2304 #
2021/0106(COD)
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. Member States shall ensure that to the extent the innovative AI systems involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the national data protection authorities and those other national authorities are associated to the operation of the AI regulatory sandbox established by one or more Member States competent authorities or the European Data Protection Supervisor. Without prejudice to the Regulation (EU) 2016/679, start- ups, SMEs, enterprises and other innovators may request access to personal data from relevant national authorities to be used in their AI sandbox under the guidelines defined through Member State rules and regulations (e.g. Code of conduct).
Amendment 2319 #
2021/0106(COD)
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. The AI regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. Any significant risks to health and safety and fundamental rights identified during the development and testing of suchAI systems shall result in immediate mitigation and, failing that, in the suspension of the development and testing process until such mitigation takes place.
Amendment 2326 #
2021/0106(COD)
Proposal for a regulation
Article 53 – paragraph 5
Article 53 – paragraph 5
5. Member States’ competent authorities that have established AI regulatory sandboxes shall coordinate their activities and cooperate within the framework of the European Artificial Intelligence Board. They shall submit annual reports to the Board and the Commission on the results from the implementation of those scheme, including good practices, lessons learnt and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legislation supervised within the sandbox. SMEs, start-ups, enterprises and other innovators are invited to share their good practices, lessons learnt and recommendations on their AI sandboxes with Member State competent authorities.
Amendment 5 #
2020/2262(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Recalls the importance, for a properlywell- functioning and competitive internal market, of effective better law- making tools that take subsidiarity and proportionality fully into account when drawing up scientifically based and balanced legislation, particularly for consumers and SMEs;
Amendment 44 #
2020/2262(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Reminds that digital innovation develops fast and that entrepreneurs are driving the digital agenda; therefore it is of key importance to provide future proof rules that are digital by default and that keep the pace of digital innovation; calls on the Commission to always take into account futureproof digital elements when assessing subsidiarity and proportionality in internal market legislation and in the related impact assessments;
Amendment 51 #
2020/2262(INI)
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
Amendment 52 #
2020/2262(INI)
Draft opinion
Paragraph 5 d (new)
Paragraph 5 d (new)
5d. Underlines that according to the three Commission’s reports 2017, 2018 and 2019 on the application of the principle of subsidiarity and proportionality, there is the need to improve the quality of the impact assessments when it comes to both elements; subsidiarity and proportionality are important preconditions for an effective and balanced EU legislation that can be beneficial for a well-functioning internal market;
Amendment 55 #
2020/2262(INI)
Draft opinion
Paragraph 5 e (new)
Paragraph 5 e (new)
5e. Points out that all EU regulatory measures should always be accompanied by universal impact assessments that take into account in an effective and thorough way the principles of subsidiarity and proportionality; stresses that only regulatory measures that are based on improved impact assessments can be beneficial for both consumers and businesses within the internal market and can trigger innovation, encourage investments, reinforcing European competitiveness and ultimately being instrumental in strengthening consumer protection; stresses furthermore that improved impact assessments should clearly strengthen the SMEs fitness check element;
Amendment 56 #
2020/2262(INI)
Draft opinion
Paragraph 5 f (new)
Paragraph 5 f (new)
5f. Stresses that all impact assessments, evaluations and fitness checks should carry out an analysis on subsidiarity and proportionality; on subsidiarity it is crucial to assess whether action at national, regional or local level would be sufficient to achieve the objectives pursued and whether action at EU level would provide added value compared to action at national level; on proportionality that the content and form of EU action must not exceed what is necessary to meet the pursued objectives ensuring that the approach chosen and the intensity of the regulatory action are necessary to achieve its objectives; calls on the Commission to take further steps in the direction of proper independent impact assessments and of improving the quality of the above analysis in order to make the EU internal market legislation more effective;
Amendment 7 #
2020/2260(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the fact that the aim of the Farm to Fork Strategy is to establish a sustainable, healthy and resilient food system which benefits consumers in the EU and includes the production, transport, distribution, marketing and consumption of food;
Amendment 18 #
2020/2260(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Considers that promoting healthy and sustainable food consumption calls for changes to diets, and production systems and internal trade, which should be supported by harmonised front-of-pack nutritional labelling framework in order to avoid market fragmentation and better enforcement of internal market rules; considers, however, that the 'Farm to Fork' Strategy should be based primarily on a scientific approach, and therefore calls on the European Commission to make a further impact assessment of the effects of the objectives set out in the Strategy;
Amendment 31 #
2020/2260(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Notes that the 'Farm to Fork' Strategy is specific in relation to the objectives it seeks to achieve but lacks in relation to the thorough scientific data that should complement the objectives set;
Amendment 32 #
2020/2260(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Considers, in particular, that the ambitious targets set by the Strategy must not result in a reduction or shortage of food production in the European Union; stresses the importance of European self- sufficiency in the production of healthy and affordable food;
Amendment 42 #
2020/2260(INI)
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Stresses that many Member States have a long tradition in the meat industry; notes that the goal of moving towards a more plant-based diet with less red and processed meat must not negatively affect supply and consumer’s choice; considers that informed consumer choice is key for transition to a sustainable food system;
Amendment 48 #
2020/2260(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. CStresses that food industry has to be supported in order to increase the availability and affordability of healthy and sustainable food options; calls on the Commission also to step up its support for regional food systems and short supply chains, which act as a source of fresh, and sustainable and better quality products for consumers; takes the view that legislation on European public food procurement should be revised in order to fostersupport healthy and sustainable diets, including organic products, as well as local, high- quality food supply systems;
Amendment 62 #
2020/2260(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Urges the Commission to promote alternativesustainable production methods and circular business models, such as consumer-friendly cooperative schemes, in food processing and retail, including specifically for small and medium-sized enterprises;
Amendment 78 #
2020/2260(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. SupportsConsiders that the concept of the establishment of a governance framework and a code of conduct for food and retail businesses, in order to make them accountable and aware of the importance of sustainability and health needs to be further clarified by the European Commission so that food producers and food retail businesses can be aware of the importance of sustainability and health; calls on the Commission to clarify also if the codes of conduct will focus and to which extent on marketing campaigns undertaken by businesses on advertising food products;
Amendment 111 #
2020/2260(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Emphasizes that the primary purpose of food labelling is to provide clear and accurate information to consumers so that they can make informed purchasing decisions;
Amendment 114 #
2020/2260(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Notes consumers' views that the existing regulatory framework does not fully allow for clear and easily understandable information on the nutritional value and therefore welcomes the European Commission's intention to explore and propose new ways to improve food nutritional labelling;
Amendment 115 #
2020/2260(INI)
Draft opinion
Paragraph 6 c (new)
Paragraph 6 c (new)
6c. Stresses that the ‘Farm to Fork’ Strategy, including mandatory front of pack nutrition labelling, provides for other labels that include animal welfare, sustainability and places of origin for certain products categories; considers that in no case should over-labelling confuse customers and therefore stresses the importance of customers education;
Amendment 116 #
2020/2260(INI)
Draft opinion
Paragraph 6 d (new)
Paragraph 6 d (new)
6d. Underlines that using different labels in different Member States might lead to market fragmentation and confuse consumers;
Amendment 128 #
2020/2260(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Regards it as essentialimportant, further, to keep consumers better informed by considering the introducingtion of mandatory origin labelling of foodcertain food products, which wcould be broadened to cover animal welfare, sustainability and pesticide residue levels;
Amendment 136 #
2020/2260(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Stresses the need for clearer rules on information on the origin of honey and in the case of honey originating from more than one EU Member State or third country, which, together with better consumer information, would contribute to an even better position for European beekeepers and honey producers;
Amendment 147 #
2020/2260(INI)
Draft opinion
Paragraph 8
Paragraph 8
Amendment 157 #
2020/2260(INI)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Takes note of the judgment of the Court of Justice of the European Union of 25 July 2018 in Case C-528/16;
Amendment 163 #
2020/2260(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Calls on the Commission to clarify the current legislation on launch a systematic campaign to explain to European consumers the use-by dates concept, and in particular the difference between the dates printed on product packaging: 'use- by dates,' and 'best before' in order to reduce food waste and increase consumption safety of food products;
Amendment 174 #
2020/2260(INI)
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Notes that a study carried out by the European Commission's Joint Research Centre did not identify a precise geographical pattern of dual quality of products; points out, however, that the above-mentioned research has shown the presence of dual quality of certain products in the European single market and therefore considers that the implementation of the ‘Farm to Fork’ Strategy must ensure that products which are not identical should be presented in a different way;
Amendment 181 #
2020/2260(INI)
Draft opinion
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. In order to protect the competitiveness of European businesses, especially small and medium-sized enterprises, and to protect the integrity of the single market, calls on the European Commission to ensure, through a proactive trade and customs policy, that food products imported into the single market comply with strict European food safety regulations;
Amendment 184 #
2020/2260(INI)
Draft opinion
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Stresses that the ‘Farm to Fork’ Strategy must take a stronger regional approach, taking into account the specificities of production in those Member States where there is a risk of food production moving to third countries due to the their proximity; calls on the Commission, therefore, to monitor situation closely in this regard in order to avoid relocating of production to third countries;
Amendment 191 #
2020/2260(INI)
Draft opinion
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Stresses that water is source of strategic importance for the European consumers, and that delivering a Green deal, which includes ‘Farm to Fork’ Strategy, is impossible without prudent water management; further emphasizes that water suppliers are key to achieving sustainability, but notes the insufficiently ambitious approach to water resources in the Strategy;
Amendment 193 #
2020/2260(INI)
Draft opinion
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Stresses that a resistant, secure and reliable food supply chain is the core for ensuring sufficient amount of food products in the cases of pandemics, earthquakes, droughts, flood sand other crisis situations; welcomes, in particular, the European Commission's plan to develop a contingency plan for ensuring food supply and food security in times of crisis; further calls on the European Commission to examine the level of self- sufficiency of the Member States and the European Union as a whole in food production and to report to the European Parliament without delay;
Amendment 196 #
2020/2260(INI)
Draft opinion
Paragraph 11 d (new)
Paragraph 11 d (new)
11d. Points out that over-packaging of food is an important issue that needs EU attention and action as it has consequences for consumers, affects shipping costs, and also has an adverse impact on the environment; reiterates its call on the European Commission to clarify the concept of unnecessary packaging and over-packaging.
Amendment 7 #
2020/2223(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Emphasizes in particular that competition and consumer policies complement each other as they both aim to protect consumers and to ensure the normal functioning of the single market; recalls that the New Consumer Agenda presented by the European Commission as one of its objectives envisages the continuation of the fight against consumer scams, unfair marketing practices and fraud;
Amendment 12 #
2020/2223(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Recalls that the Charter of Fundamental Rights of the European Union states that Union policies shall ensure a high level of consumer protection;
Amendment 13 #
2020/2223(INI)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Recalls that competition rules protect the integrity of the single market and help create a level playing field for businesses, while also undoubtedly helping to better protect consumer rights and promote innovations;
Amendment 20 #
2020/2223(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Notes with concern the growing interest of external actors in strengthening and consolidating their influence in European companies in the context of the crisis caused by the pandemic; calls on the European Commission to closely monitor such trends, and in particular foreign direct investments, in order to ensure and preserve the integrity of the single market;
Amendment 23 #
2020/2223(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Recalls that 73% of the European Union's GDP is generated by services and that the single market for services is less developed than the single market for goods; considers that competition mechanisms can help strengthen the single market for services; emphasizes further that regulatory obligations must be proportionate and must in no way aim to create unjustified administrative barriers that prevent the further strengthening of the single market and fair competition;
Amendment 24 #
2020/2223(INI)
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Notes that the concept of non- economic services of general interest is not defined by European legislation; calls on the European Commission, therefore, to consider how important it would be for the development of competition rules to define the concept of non-economic services of general interest by secondary European legislation;
Amendment 25 #
2020/2223(INI)
Draft opinion
Paragraph 2 d (new)
Paragraph 2 d (new)
2d. Agrees that competition policy also plays a significant role in the EU’s modern industrial policy, with the aim of rendering European companies more innovative and therefore competitive internationally; stresses, however, that European self-sufficiency in the production of critical equipment such as personal protective equipment is crucial for consumer protection;
Amendment 28 #
2020/2223(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Recalls that regulating digital markets constitutes a core responsibility of the Committee on Internal Market and Consumer Protection; in this context, highlights the adoption of the P2B Regulation (Regulation (EU) 2019/11501 ) and notes that ex ante regulatory intervention willaims to address the gaps in ex post competition law enforcement; __________________ 1 OJ L 186, 11.7.2019, p. 57.
Amendment 31 #
2020/2223(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that the existing competition rules do not sufficiently meet the needs of a functioning single market and therefore welcomes the European Commission's intention to correct irregularities in the digital market through competition policy, inter alia through an ex ante regulatory instrument;
Amendment 33 #
2020/2223(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Notes the two legislative initiatives recently proposed by the European Commission: the Digital Services Act (DSA) and the Digital Markets Act (DMA); stresses their important role in complementing and strengthening the competition law enforcement; notes that proposed harmonised rules, better oversight and ex ante obligations will ensure that markets characterised by large platforms acting as digital gatekeepers remain fair and competitive for innovators, businesses, and new market entrants;
Amendment 36 #
2020/2223(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Highlights the importance of a few online operators acting as gatekeepers to the digital economy, including access to e- commerce markets and the consequences on freedom of choice for consumers and access to markets for companies; in this regard particularly emphasizes that out of the 10 000 internet platforms participating in the EU digital market, the seven largest generate as much as 69% of the sector's total revenues; underlines, therefore, the need for an internal market ex ante regulatory instrument to ensure that impacted markets remain fair and competitive; looks forward to seeing this instrument in, without limiting the EU's ability to intervene ex-post via the enforthcoming Digital Markets Act proposalcement of existing EU competition rules;
Amendment 53 #
2020/2223(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Stresses the importance of clear measures to ensure effective enforcement and supervision of competition law at the EU level; underlines that the compliance of provisions must be reinforced with effective and, proportionate and dissuasive penalties;
Amendment 62 #
2020/2223(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to ensure fair and secure access to data for all market participants without prejudice to the rules laid down by the General Data Protection Regulation; notes that it should empower consumers to control their data and provide them with additional rights in terms of data portability and interoperability in order to ensure that the single market for data is based on both, European values and European way of life as well as on fair competition.
Amendment 66 #
2020/2223(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Notes that some digital platforms, despite penalties, have repeatedly violated competition rules; stresses that sanctions for infringers must be effective, proportionate and dissuasive; calls, therefore, on the European Commission to examine whether the sanctions currently imposed on the various forms of infringement of competition rules are sufficiently appropriate and dissuasive and whether they meet general and special prevention; furthermore, calls on the Commission to report to the European Parliament in particular on the effectiveness of the application of structural remedies in EU Competition Law.
Amendment 4 #
2020/2217(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the Commission’s intention to create a genuine single market for data as it will be the backbone of Europe’s data economy; considers that ensuring trust in digital services and in smart products is fundamental for the digital single market to grow and thrive and should be at the heart of both public policy and business models; underlines that that the creation of a single market for data is not an objective per se, but it should allow European companies and citizens to develop and benefit from innovative and competitive services and products;
Amendment 24 #
2020/2217(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Urges the Commission to empower consumers to put them in control of their data and to ensure that the single market for data is grounded in European valueWay of Life's common values such as protection of fundamental rights and fairness in competition; believes that citizens’ data could help in developing innovative green solutionmore sustainable solutions for products and services that would benefit European consumers and companies; asks the Commission to consider how to supportpromote data altruism in full compliance with European legislation;
Amendment 29 #
2020/2217(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Underlines the need to address specific issues that could arise on the control of consumers’ data in particular when the concerned consumers are minors; asks the Commission to clarify the responsibilities for the collection of data and the rules governing consent; furthermore asks the Commission to ensure that the rights of consumers with disabilities are respected at all times and that they can equally benefit from the advantages of the creation of the single market for data;
Amendment 44 #
2020/2217(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Highlights the need to create a singlecommon European data spaces with the aim of ensuring the free flow of non- personal data across borders and sectors; believes furthermore that the framework for the governance of common European data spaces should be built on the principles laid down in the Regulation on free flow of non-personal data; underlines the principle of the free flow of non- personal data as imperative for a single market for data, providing a level playing field for data sharing between stakeholders, taking into account in particular EU SMEs’ needs and allowing them to scale up and operate cross-border in the internal market; considers that business- to-business (B2B) and business-to- government (B2G) data sharing should be voluntary, while mandatory access to data should also be envisaged to remedy potential market failures;
Amendment 52 #
2020/2217(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Believes that mandatory access to data should also be envisaged to remedy potential market failures and considers in this regard that detailed provisions should be laid down in the upcoming Digital Markets Act; underlines that the proposal for a Digital Market Act should lay down provisions according to which economic entities considered as gatekeepers in the internal market should be required to contribute to data sharing with the relevant stakeholders;
Amendment 64 #
2020/2217(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Highlights that the Data Act should lay down provisions for the use of high quality and reliable datasets that are essential for the creation of a well- functioning single European data space and as well as for helping the EU companies to develop high quality products and services across the internal market;
Amendment 73 #
2020/2217(INI)
Draft opinion
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Calls on the Commission to ensure consistency between the Data Act and the framework for the governance of common European data spaces, on the one hand, and the proposals under the Digital Services Act package on the other;
Amendment 84 #
2020/2217(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Underlines the need to improve access to European cloud services and to address interoperability issues, including codes of conduct, certification and standards, in a ‘cloud rulebook’; calls on the Commission to facilitate safe common European data spaces, based on a trustworthy and secure infrastructure with strong cybersecurity tools; considers proportionality to be the guiding principle for data quality and interoperability requirements; calls on the Commission to consider promoting existing standards to avoid unnecessary transaction costs and to provide high quality standards for sectors and data spaces of high importance for significant societal challenges.;
Amendment 1 #
2020/2131(INI)
Draft opinion
Recital 1 a (new)
Recital 1 a (new)
1a. Whereas SMEs are the backbone of the European economy and represent 99% of EU companies;
Amendment 2 #
2020/2131(INI)
Draft opinion
Recital 1 b (new)
Recital 1 b (new)
1b. Whereas European SMEs are currently experiencing unprecedented challenges because of the COVID-19 crisis that threatens their very existence;
Amendment 3 #
2020/2131(INI)
Draft opinion
Recital 1 c (new)
Recital 1 c (new)
1c. Whereas only 17% of SMEs have so far successfully integrated digital technology into their businesses and digitalisation is crucial for a strong economic growth and creation of jobs within the internal market;
Amendment 4 #
2020/2131(INI)
Draft opinion
Recital 1 d (new)
Recital 1 d (new)
1d. Whereas 78% of SMEs see administrative costs as one of the main barriers for their future growth;
Amendment 5 #
2020/2131(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. WStrongly welcomes the SME strategy and shares the Commission’s view that SMEs, are essential to the European economy the backbone of the European economy and absolutely essential for economic growth and job creation as well as for a strong and well- functioning internal market; encourages the Commission to swiftly take further initiatives to properly support EU SMEs with the aim to address both the short- term consequences of the crisis and the long-term challenges such as the digitalisation and the transition to a more sustainable internal market;
Amendment 13 #
2020/2131(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Stresses that the implementation of the SME strategy should focus primarily on supporting SMEs to help them maintain their existence and by aiming at their full recovery and growth, as the COVID-19 crisis has delivered a shock to many SMEs and their crucial role in the everyday life of Europeans; underlines that action should also be taken to support SMEs scaling-up and to enhance their cross- border activities in order to benefit the most from the internal market; recalls that further action should be taken to safeguard SMEs from unfair competition from third countries global players;
Amendment 18 #
2020/2131(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Stresses that improved access to finance and liquidity are necessary to support SMEs and that EU funds together with national measures are necessary to allow companies to bridge liquidity gaps caused by the crisis; highlights that SMEs need support to compensate for loss in revenues, to finance fixed costs and avoid bankruptcies; calls for supporting possible access to diverse financial resources for SMEs in order for them not to be dependant only on banking system but also to consider the use of other means including private equity and crowdfunding;
Amendment 19 #
2020/2131(INI)
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Calls for the synchronisation of all financial tools aimed at supporting SMEs within the internal market; insists that programmes crucial for SMEs competitiveness, development and resilience to the crisis, must be included in the next Multiannual Financial Framework and guaranteeing a necessary level of funding that supports them; COVID-19 support schemes should be tailor-made to address challenges of the different sectors affected and to coordinate EU funding with national and regional initiatives; recovery funding also needs to address additional costs that SMEs in particular have to face when complying with additional safety rules during and after the crisis; the European Investment Bank must also continue to support SMEs in particular as part of the sustainable finance approach;
Amendment 22 #
2020/2131(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Notes that SMEs should not be burdened as little as possible and encourages the Commission to use strong enforcement action to ensure that the single market benefits all businesses and consumers and to counter gold-plating and other regulatory restrictions by making use of all available tools and bodies, such as the SMEs Envoy and the Regulatory Scrutiny Board, in order to create a level playing field in cross-border business in the internal market;
Amendment 31 #
2020/2131(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls for a roadmap towards achieving a major reduction in administrative burden and bureaucracy affecting SMEs in the internal market, to boost SMEs potential for investments and speed up EU economic recovery; this should include the following elements: - supporting SMEs to operate cross- border thus fully reaping the benefits of the internal market; - encouraging scale-up; - strengthening and mainstreaming the SMEs dimension in all impact assessments through a binding SME test performed at an early stage of the impact assessment to analyse the economic impact of legislative proposals, including the compliance costs; - applying of the one-in-one-out rule in such a way that for any additional compliance cost introduced by new legislation, the corresponding amount of compliance cost is reduced; - reducing the regulatory burden through concrete targets at EU and national level (such as a reduction by 30% or cut 1000 outdated rules and regulations), in order to make a real benefit for SMEs to grow and prosper within the EU internal market;
Amendment 37 #
2020/2131(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Highlights the crucial role of data as the lifeblood of the digital economy; supports the Commission in establishing European data spaces for trusted and secure data sharing to ramp up data flows between businesses and with governments; underlines that SMEs must be given a fair share of the added value of the data they generate and highlights that interoperability and non-discriminatory access to data, including platforms’ data, are key to ensure a digital level playing field within the internal market and to successfully deal with challenges and opportunities emerging from data sharing, data security and cybersecurity issues across the whole internal market;
Amendment 43 #
2020/2131(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Points out that there is the need to facilitate the SMEs’ uptake of Artificial Intelligence by promoting the creation of SME cross-border Alliances for AI in strategic value chains within the internal market, as well promoting investment in the next generation of standards, tools and infrastructures to store and process data; points out that it is important to ensure SMEs’ access to and awareness of ICT standards to innovate and provide more tailored digital solutions;
Amendment 46 #
2020/2131(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Stresses that start-ups represent the SMEs with the higher potential to grow in new digital sectors such as AI, IOT and robotics; stresses that also microenterprises and micro-companies, that do not dispose of sufficient resources or infrastructure for digital transformation, must have access to sufficient financial resources and be adequately supported; recalls that also traditional SMEs focused on the sustainable development of the society are threatened heavily by the crisis in several sectors and should be adequately supported;
Amendment 50 #
2020/2131(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Encourages Member States to implement the single digital gateway in an SME-friendly way by cooperating closely with regional and local authorities as well as with the other Member States and by providing easy digital access to information, procedures, and services linked to doing business across borders, including advice on public procurement and funding sources;
Amendment 63 #
2020/2131(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Member States to simplify procurement tendering processes by using the flexibility of the EU’s newCommission’s new guidance within the EU’s public procurement framework and to enhance opportunities for SMEs in the internal market by using digital tools and platforms to expand cross-border procurement; stresses that greensustainable public procurement can make an important contribution to building a sustainable economythe transition to a more sustainable economy and that SMEs need the right support to bring forward this transition;
Amendment 64 #
2020/2131(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Stresses the need to increase the SMEs’ share of government contracts, enhancing their access to public procurement and combating tendering criteria that set requirements beyond the fundamental elements of the service or goods purchased, such as price, quality and sustainability;
Amendment 69 #
2020/2131(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Underlines the fact that late payments account for a quarter of all SME bankruptcies in the EU; urges the Commission to swiftly equip the Late Payment Directive1 with strong monitoring and enforcement tools so as to ensure and promote prompt payments as a norm across the single market, including through an active use of infringement procedures in cases where the Directive is not properly implemented; to that aim, encourages Member States to appoint an independent enforcement authority in charge of monitoring the proper application of the late payment rules and empowered to impose penalties in case of delays in payment times. __________________________ 1 Directive 2011/7/EU of the European Parliament and of the Council of 16 February 2011 on combating late payment in commercial transactions, OJ L 48, 23.2.2011, p. 1.
Amendment 74 #
2020/2131(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
Amendment 80 #
2020/2131(INI)
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Points out that midcap companies that exceed the criteria of the SME definition contribute significantly to growth and job creation with in the internal market, but receive too little support; calls on the Commission to consider a revision of the current SMEs definition and propose an additional separate midcap definition ensuring that small midcaps with 250 to 499 employees in particular can be better relieved and promoted, while making sure that SMEs funding is not reduced for those SMEs meeting the current criteria.
Amendment 26 #
2020/2076(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Considers that, based upon the comprehensive evidence base, the Commission’s new Industrial Strategy should prioritise the economic recovery and citizens' welfare and opportunities, so as to underline the common commitment to rebuilding the Single Market and delivering benefits for all Member States and their citizens; believes that any adopted legislation or set of priorities should be preceded by impact assessments, particularly on potential costs and burdens for European companies, and should respect the “One- in, one-out” principle assumed by President Von der Leyen to cut red tape;
Amendment 94 #
2020/2076(INI)
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Stresses that the digitalization of the Customs Union and reinforced verification before industrial input materials enter the internal market are necessary to ensure that European standards are respected on all imports;
Amendment 95 #
2020/2076(INI)
Draft opinion
Paragraph 9 b (new)
Paragraph 9 b (new)
9 b. Underlines the need to strengthen European industry to develop new markets for a climate-neutral, circular economy and a fully-functioning market for secondary raw materials;
Amendment 96 #
2020/2076(INI)
Draft opinion
Paragraph 9 c (new)
Paragraph 9 c (new)
9 c. Stresses the importance of the EU enhancing cooperation between the European institutions, Member States, the EIB, key industrial and innovative stakeholders, SMEs and building new partnerships in strategic areas, such as the European Battery Alliance (EBA), creating competitive manufacturing value chains in Europe in line with the Green Deal’s digital and environmental objectives;
Amendment 102 #
2020/2076(INI)
Draft opinion
Paragraph 10
Paragraph 10
10. Recalls that the automotive sector is touched by many of the transformations expected inmany sectors which are extremely important for the European economy, such as the fauturomotive seconomy andtor, hasve been deeply affected by the impact of the COVID-19 pandemic; considers that the revised Industrial Strategy should foresee particular actions for thisese sectors, including appropriate financial support which will not adversely affect the competitiveness of the Single Market economy.
Amendment 108 #
2020/2076(INI)
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Considers that the revised Industrial Strategy should aim at achieving self-sufficiency for the EU in the production of protective medical equipment and active ingredients for the production of medicines in order to guarantee the availability of products to consumers and avoid weakening and fragmenting the Single Market by imposing export restrictions between Member States.
Amendment 111 #
2020/2076(INI)
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Highlights the need to develop smart IP policies to uphold and strengthen Europe’s industrial sovereignty and competitiveness and promote a global level playing field, while better combating IP theft.
Amendment 113 #
2020/2076(INI)
Draft opinion
Paragraph 10 b (new)
Paragraph 10 b (new)
10 b. Underlines that new technologies such as Artificial Intelligence (AI), the Internet of Things (IoT) and robotics play a key role, proportional to their potential to contribute to development of industrial processes and innovations, offering benefits for consumers through innovative products and services and for businesses through optimised performance; underlines that the industrial policy should take into account Union’s legal framework for consumer safety and liability should fit in due time technological developments and ensure high level of consumer protection, creation of trust in new technologies and legal certainty for businesses;
Amendment 87 #
2020/2023(INI)
Draft opinion
Paragraph 17 a (new)
Paragraph 17 a (new)
Amendment 4 #
2020/2019(INL)
Draft opinion
Recital C a (new)
Recital C a (new)
Ca. Whereas Regulation (EU) 2017/23941a has a pivotal role in enhancing cooperation amongst national authorities in the field of consumer protection; __________________ 1aRegulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (OJ L 345, 27.12.2017, p. 1).
Amendment 7 #
2020/2019(INL)
Draft opinion
Recital C b (new)
Recital C b (new)
Cb. Whereas Regulation (EU) 2016/6791a (GDPR) establishes the rules on the processing of personal data and on the protection of personal data; __________________ 1a 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).
Amendment 9 #
2020/2019(INL)
Draft opinion
Recital C c (new)
Recital C c (new)
Cc. Whereas Directive 2002/58/EC1a ensures that all communications over public networks maintain respect for a high level of data protection and privacy; __________________ 1aDirective 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).
Amendment 10 #
2020/2019(INL)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the “CPC Common Position COVID-19”3 issued by the Commission and the Consumer Protection Cooperation (CPC) authorities of the Member States on the most recent reported scams and unfair practices in relation to the COVID-19 outbreak; stresses the necessity to better protect consumers by providing reliable and transparent information on malpractices, such as misleading claims and scams for products in high demand; calls on all platforms to cooperate with the Commission and the competent authorities of the CPC network and members of the European Consumer Centres (ECC) to better identify illegal practices, take down scams and asks the Commission to constantly review the common guidelines for the placement and/or sale of items and services of a false, misleading or otherwise abusive content for consumers; believes such guidelines should not only seek to apply Union and national consumer law, but to proactively seek to put in place the means to react to the crisis in the market rapidly; __________________ 3European Commission / Consumer Protection Cooperation (CPC) Network, Common Position of CPC Authorities, “Stopping scams and tackling unfair business practices on online platforms in the context of the Coronavirus outbreak in the EU”.
Amendment 32 #
2020/2019(INL)
Draft opinion
Paragraph 2
Paragraph 2
2. Welcomes efforts to bring transparency to advertising online and considers that further clarity and guidance is needed as regards professional diligence and obligations for platforms; believes that where advertisers and intermediaries are established in a third country, they should designate a legal representative, established in the Union, who can be held accountable for the content of advertisementsproducts they sell, in order to allow for consumer redress in the case of false or misleading advertisements;
Amendment 39 #
2020/2019(INL)
Draft opinion
Paragraph 3
Paragraph 3
3. Asks the Commission to clarify what sanctions or other restrictions those advertisement intermediaries and platforms should be subject to if they knowingly accept false or misleading advertisements; believes that online platforms should actively monitor the advertisements shown on their sites, stresses the importance of common understanding order to ensure they do not profit from false or misleading advertisements, including from influencer marketing content which is not being disclosed as sponsoredn what constitutes false or misleading advertisement; underlines that advertisements for commercial products and services, and advertisements of a political or other nature are different in form and function and therefore should be subject to different guidelines and rules;
Amendment 54 #
2020/2019(INL)
Draft opinion
Paragraph 4
Paragraph 4
4. While recalling earlier efforts, asks the Commission to further review the practice of End User Licensing Agreements (EULAs) and to seek ways to allow greater and easier engagement for consumers, including in the choice of clauses; notes that EULAs are often accepted by users without reading themso far the consumer has no choice but to agree with the terms of EULAs; moreover notes that when a EULA does allow for users to opt-out of clauses, platforms may require users to do so at each use; asks the Commission to introduce guidance for platforms on how to better inform consumers about the terms of EULAs, such as a pop-up message comprising key information thereof;
Amendment 62 #
2020/2019(INL)
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines that EULAs should always make the sharing of all data with third parties optional unless vital to the functioning of the services, under the terms of EULAs, consumers should be free to give consent for sharing some or all of their data with third parties, unless there are legal grounds for the lawfulness of sharing of data; asks the Commission to ensure that consumers can still use a connected device for all its primary functions, even if a consumers do not give or withdraws their consent to share non- operational data with the device manufacturer or third parties;
Amendment 74 #
2020/2019(INL)
Draft opinion
Paragraph 7
Paragraph 7
7. Notes the rise of “smart contracts” based on distributed ledger technologies; asks the Commission to analyse if certain aspects of “smart contracts” should, that need to be clarified and ifprovide guidance should be giventhereabout, in order to ensure legal certainty for businesses and consumers; asks especially for the Commission to work to ensure that such contracts with consumers are valid and binding throughout the Union; that they meet the standards of consumer law, for example the right of withdrawal under Directive 2011/83/EU4 ; and that they"smart contracts" are not subject to national barriers to application, such as notarisation requiremen when it comes to their validity requirements as consumer contracts; __________________ 4 Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).
Amendment 79 #
2020/2019(INL)
Draft opinion
Paragraph 8
Paragraph 8
8. Stresses that any future legislative proposals should seek to remove current and prevent potentially new unjustified barriers in the supply of digital services by online platforms, as well as foster an online environment free of illegal content that would be detrimental to Union consumers and the economy of the Union; underlines, at the same time, that new Union obligations on platforms must be proportional and clear in nature in order to avoid unnecessary regulatory burdens or unnecessary restrictions; underlines the need to prevent gold-plating practices of Union legislation by Member States.
Amendment 51 #
2020/2018(INL)
Motion for a resolution
Recital E
Recital E
E. whereas in its communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 19 February 2020 “Shaping Europe’s digital future”, the Commission committed itself to adopting, as part of the Digital Services Act package, new and revised rules for online platforms and information service provider; to reinforcing the oversight over platforms’ content policies in the EU; and, to looking into ex ante rules to ensure that large platforms with significant network effects, acting as gatekeepers, remain fair and contestable for innovators, businesses, and new market entrants; including SMEs, start-ups, entrepreneurs and new market entrants; believes that the Digital Services Act should complement the existing legal framework together with other relevant legislation, such as rules on consumer protection, enforcement, product safety, market surveillance, competition, geo-blocking, audio-visual media services, copyright and the General Data Protection Regulation;
Amendment 61 #
2020/2018(INL)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission’s commitment to submit a proposal for a Digital Services Act package, consisting of a directive amending the E-Commerce Directive and a proposal for a Regulation on ex-ante rules on large platforms with a gatekeeper role, and, on the basis of Article 225 of the Treaty on the Functioning of the European Union (TFEU), calls on the Commission to submit such a package on the basis of the relevant Articles of the Treaties, following the recommendations set out in the Annex hereto;
Amendment 80 #
2020/2018(INL)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
(a) Stresses the importance to address the remaining unjustified obstacles to the Digital Single Market and avoid protectionist measures, which are sometimes used by Member States to boost national competition. For example, settling the costs of cross-border disputes, suppliers’ restrictions to selling cross- border, delivery-related matters, taxation rules, limited cross-border access to goods and services due to differences in intellectual property rights law, access to information on the relevant regulatory requirements, complex administrative procedures, as well as ensuring that no new barriers are created;
Amendment 87 #
2020/2018(INL)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Considers that the main principles of the E-Commerce Directive, such as the internal market clause, freedom of establishment and the prohibition on imposing a general monitoring obligation should be maintained; underlines that the principle of “what is illegal offline is also illegal online”, as well as the principles of consumer protection and user safety, should also become guiding principles of the future regulatory framework; highlights that all platforms must have the same duty to protect consumers whereby asymmetrical legislation which targets only certain market actors can be introduced solely as a means to tackle market-related problems;
Amendment 103 #
2020/2018(INL)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that a future-proof, comprehensive EU-level framework and fair competition are crucial in order to promote the growth of European small- scale platforms, small and medium enterprises (SMEs), micro companies, entrepreneurs and start-ups, prevent market fragmentation and provide European businesses with a level playing field that enables them to better profit from the digital services market and be more competitive on the world stage;
Amendment 117 #
2020/2018(INL)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Takes the view that a level playing field in the internal market between the platform economy and the "traditional" offline economy, based on the same rights and obligations for all interested parties - consumers and businesses - is needed; considers that social protection and social rights of workers, especially of platform or collaborative economy workers should be properly addressed in a specific instrument, accompanying the future regulatory framework;
Amendment 133 #
2020/2018(INL)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Considers that the Digital Services Act should be based on public values of the Union protecting citizens’ rights should aim to foster the creation of a rich and diverse online ecosystem with a wide range of online services, favourable digital environment and legal certainty to unlock the full potential of the Digital Single Market; believes that the EU should focus on removing existing obstacles in the Digital Single Market and on ensuring consumer and fundamental rights protection as one of the main objectives of the reform of the E-Commerce Directive; considers in this context that the Single Market objective can only be achieved if consumer trust is ensured; believes that the updated E-Commerce rules must clearly establish that consumer law and product safety requirements fall within their scope of application in order to ensure legal certainty;
Amendment 169 #
2020/2018(INL)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that information society services providers, and in particular online platforms andincluding social networking sites - because of their wide-reaching ability to reach and influence broader audiences, behaviour, opinions, and practices - bear significant social responsibility in terms of protecting users and society at large and preventing their services from being exploited abusively.
Amendment 182 #
2020/2018(INL)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Recalls that recent scandals regarding data harvesting and selling, Cambridge Analytica, fake news, political advertising and manipulation and a host of other online harms (from hate speech to the broadcast of terrorism) have shown the need to revisit the existing rules and reinforce protection of fundamental rights online;
Amendment 207 #
2020/2018(INL)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that this problem is aggravated by the fact that often the identity of these companies cannot be establishfraudulent companies and individuals cannot be established; and therefore, consumers cannot seek compensation for the damages and losses experienced;
Amendment 230 #
2020/2018(INL)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to require service providers to verify the information and the identity of the business partners with whom they have a contractual commercial relationship,; business partners should be the ones in charge of notifying the service provider about any change in their business activity (for example, cessation of business activity) and to ensure that the information they provide is accurate and up-to-date;
Amendment 249 #
2020/2018(INL)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
Amendment 260 #
2020/2018(INL)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Stresses that existing obligations, set out in the E-Commerce Directive and the Directive 2005/29/EC of the European Parliament and of the Council (‘Unfair Commercial Practices Directiveʼ)3 on transparency of commercial communications and digital advertising should be strengthened; points out that pressing consumer protection concerns about profiling, targeting and personalised pricing cannotshould be addressed by, among others, by clear transparency obligations and left to consumer choice aloneinformation requirements; __________________ 3 Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to- consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (OJ L 149, 11.6.2005, p. 22).
Amendment 265 #
2020/2018(INL)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Notes the increasing use of digital platforms and applications in eHealth, and in particular the importance of telemedicine and consumer health informatics; considers that the Digital Services Act package must ensure that digital eHealth services provide citizens with only accurate, verified and scientifically-based facts while also effectively protecting their personal data.
Amendment 276 #
2020/2018(INL)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Believes that while AI-driven services, currently governed by the E- commerce Directive, have enormous potential to deliver benefits to consumers and service providers, the new Digital Services Act should also address the challenges they present in terms of ensuring non-discrimination, transparency and explainability of algorithms, as well as liability; points out the need to monitor algorithms and to assess associated risks, to use high quality and when possible unbiased datasets, as well as to help individuals acquire access to diverse content, opinions, high quality products and services;
Amendment 285 #
2020/2018(INL)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Considers that consumers should be properly informed and their rights should be effectively guaranteed when they interact with automated decision-making systems and other innovative digital services or applications; considers it essential that automatic decision-making systems do not generate unfairly biased outputs for consumers in the single market; believes that it should be always possible for consumers to be properly informed about interacting with automated decision-making, and about how to reach a human with decision- making powers to request checks and corrections of possible mistakes resulting from automated decisions, as well as to seek redress for any damage related to the use of automated decision-making systems;
Amendment 296 #
2020/2018(INL)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Underlines the importance of the use of data by digital platforms and that the accumulation of vast amounts of data by large technological enterprises creates imbalances in bargaining power and, thus, leads to the distortion of competition in the Single Market;
Amendment 298 #
Amendment 304 #
2020/2018(INL)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Stresses that the existence and spread of illegal and harmful content online is a severe threat that undermines citizens' trust and confidence in the digital environment, and which also harms the economic development of healthy platform ecosystems in the Digital Single Market and severely hampers the development of legitimate markets for digital services;
Amendment 320 #
2020/2018(INL)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Notes that there is no ‘one size fits all’ solution to all types of illegal and harmful content and cases of mdisinformation online; believes, however, that a more aligned approach at Union level, taking into account the different types of content and services offered by a platform, will make the fight against illegal content more effective;
Amendment 321 #
2020/2018(INL)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Notes that there is no ‘one size fits all’ solution to all types of illegal and harmful content and, including cases of mdisinformation online; believes, however, that a more aligned approach at Union level, taking into account the different types of content, will make the fight against illegal and harmful content more effective;
Amendment 338 #
2020/2018(INL)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Considers that voluntary actions and self-regulation by online platforms across Europe have brought some benefits, but additionaleen proven unsatisfactory and much stronger measures are needed in order to ensure the swift detection and removal of illegal and harmful content online;
Amendment 344 #
2020/2018(INL)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Believes that where intermediaries are established in a third country, they should designate a legal representative, established in the Union, who can be held accountable for the products they offer;
Amendment 361 #
2020/2018(INL)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to address the increasing differences and fragmentations of national rules in the Member States and to propose concrete legislative measures including a notice- and-action mechanism, that can empower users to notify online intermediaries of the existence of potentially illegal or harmful online content or behaviour; is of the opinion that such measures would guarantee a high level of users' and consumers' protection while promoting consumer trust in the online economy;
Amendment 373 #
2020/2018(INL)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Stresses that maintaining safeguards from the legal liability regime for hosting intermediaries with regard to user-uploaded content and the general monitoring prohibition set out in Article 15 of the E-Commerce Directive are still relevant and need to be preserved; stresses however, that the liability regime necessitates further clarification regarding active and passive hosting in the situation when intermediaries have control over data by selecting, using and modifying it in order to optimise or promote it;
Amendment 380 #
2020/2018(INL)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Bearing in mind the importance of intellectual property for the European economy as a whole, as well as for the normal functioning of the Single Market – especially with regard to freedom to provide services, and furthermore assuming that intellectual property is often infringed on Internet platforms, considers that the future regulatory framework should ensure effective enforcement of IPR provisions, especially with regard to the removal of illegal content from the digital platforms;
Amendment 392 #
2020/2018(INL)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Notes that while online platforms, such as online market places, have benefited both retailers and consumers by improving choice and lowering prices, at the same time, they have allowed sellers, in particular from third countries, to offer products which often do not comply with Union rules on product safety and do not sufficiently guarantee consumer rights; stresses, in this context, the need for a possibility to always identify manufacturers and sellers of products from third countries; underlines that if one of the services provided by a platform can be considered a marketplace ("hybrid platforms"), the rules should fully apply to that part of the business; and asks the online marketplaces to enhance their cooperation by exchanging information on the seller of these products with the market surveillance and the custom authorities;
Amendment 398 #
2020/2018(INL)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Notes that while online platforms, such as online market places, have benefited both retailers and consuustomers by improving choice and lowering prices, at the same time, they have allowed sellers, in particular from third countries, to offer products which often do not comply with Union rules on product safety and do not sufficiently guarantee consumer rights;
Amendment 411 #
2020/2018(INL)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Stresses that it is unacceptable that Union consuustomers are exposed to illegal and unsafe products, containing dangerous chemicals, as well as other safety hazards;
Amendment 454 #
2020/2018(INL)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Considers that by reducing barriers to market entry and by regulating large platforms, an internal market instrument imposing ex-ante regulatory remedies on these large platforms has the potential to open up markets to new entrants, including SMEs, entrepreneurs and start-ups, thereby promoting consumer choice and driving innovation beyond what can be achieved by competition law enforcement alone;
Amendment 461 #
2020/2018(INL)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Believes that the ex-ante regulatory instrument should ensure fair trading conditions on all platforms, including possible additional requirements – for example, a list of obligations /prohibitions – for those that play a gatekeeper role;
Amendment 471 #
2020/2018(INL)
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
(a) Believes that the root cause of the remaining unjustified obstacles in the digital single market stem from different regulatory choices at Union and at national level, imperfect or inadequate transposition, implementation and enforcement of Union legislation, insufficient administrative capacity and practices in Member States, as well as from protectionist measures carried out by Member States; calls on the Commission to address those causes in close cooperation with Member States;
Amendment 480 #
2020/2018(INL)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Considers that a central regulatory authority should be established which should be responsible for the oversight and compliance with the Digital Services Act and have supplementary powers to tackle cross-border issues; it should be entrusted with strong investigation and enforcement powers; stresses that cooperation between national as well as other Member States’ authorities, civil society and consumer organisations is of utmost importance for achieving effective enforcement;
Amendment 509 #
2020/2018(INL)
Motion for a resolution
Annex I – part I – paragraph 1 a (new)
Annex I – part I – paragraph 1 a (new)
The Digital Services Act should contribute to the removal of the existing unjustified obstacles to the digital single market, which many times arise from protectionist measures by Member States, as well as ensuring that no new barriers are created;
Amendment 510 #
2020/2018(INL)
Motion for a resolution
Annex I – part I – paragraph 2
Annex I – part I – paragraph 2
The Digital Services Act should guarantee that online and offline economic activities are treated equally and on a level playing field which fully reflects the principle that “what is illegal offline is also illegal online”; this principle does not however exclude that due to specific nature of online environment and easiness to manipulate with users on mass scale, certain activities allowed offline might not be allowed online;
Amendment 516 #
2020/2018(INL)
Motion for a resolution
Annex I – part I – paragraph 3
Annex I – part I – paragraph 3
The Digital Services Act should provide consuustomers and economic operators, especially micro, small and medium-sized enterprises, with legal certainty and transparency;
Amendment 524 #
2020/2018(INL)
Motion for a resolution
Annex I – part I – paragraph 6 – indent 1 – introductory part
Annex I – part I – paragraph 6 – indent 1 – introductory part
- a comprehensive revision of the E- Commerce Directive, in the form of a Directive, based on Articles 53(1), 62 and 114 TFEU, consisting of:;
Amendment 534 #
2020/2018(INL)
Motion for a resolution
Annex I – part I – paragraph 6 – indent 1 – subi. 2
Annex I – part I – paragraph 6 – indent 1 – subi. 2
- clear and detailed procedures and measures related to the removal of illegal and harmful content online, including a harmonised legally-binding European notice-and action mechanism;
Amendment 543 #
2020/2018(INL)
Motion for a resolution
Annex I – part I – paragraph 6 – indent 2
Annex I – part I – paragraph 6 – indent 2
- an internal market legal instrument in the form of a Regulation, based on Article 114 TFEU, imposing ex-ante obligations on large platforms with a gatekeeper role in the digital ecosystem, complemented by an effective institutional enforcement mechanism.
Amendment 550 #
2020/2018(INL)
Motion for a resolution
Annex I – part II – paragraph 1
Annex I – part II – paragraph 1
In the interest of legal certainty, the Digital Services Act should clarify which digital services fall within its scope. The new legal act should follow the horizontal nature of the E-Commerce Directive and apply not only to online platforms but to all digital services, which are not covered by specific legislation;
Amendment 572 #
2020/2018(INL)
Motion for a resolution
Annex I – part III – paragraph 1 – indent 1
Annex I – part III – paragraph 1 – indent 1
- clarify to what extent “"new digital services”", such as social media networks, collaborative economy services, search engines, wifi hotspots, online advertising, comparison tools, cloud services, content delivery networks, and domain name services fall within the scope of the Digital Services Act;
Amendment 579 #
2020/2018(INL)
Motion for a resolution
Annex I – part III – paragraph 1 – indent 3
Annex I – part III – paragraph 1 – indent 3
Amendment 583 #
2020/2018(INL)
Motion for a resolution
Annex I – part III – paragraph 1 – indent 4
Annex I – part III – paragraph 1 – indent 4
- clarify of what falls within the remit of the "illegal content”", definition making it clear that a violation of EU rules on consumer protection, product safety or the offer or sale of food or tobacco products and counterfeit medicines, also falls within the definition of illegal content; it is also necessary to clarify what falls under "harmful content" and "disinformation";
Amendment 590 #
2020/2018(INL)
Motion for a resolution
Annex I – part III – paragraph 1 – indent 5
Annex I – part III – paragraph 1 – indent 5
- define “"systemic operator”" by establishing a set of clear economic indicators that allow regulatory authorities to identify platforms which enjoy a significant market position with a “"gatekeeper”" role playing a systemic role in the online economy; such indicators could include considerations such as whether the undertaking is active to a significant extent on multi-sided markets, or has predominant influence over its users, the size of its network (number of users), its financial strength, access to data, accumulation of data, vertical integration, the importance of its activity for third parties’ access to supply and markets, etc.
Amendment 594 #
2020/2018(INL)
Motion for a resolution
Annex I – part III – paragraph 1 – indent 5
Annex I – part III – paragraph 1 – indent 5
- define “systemic operator” by establishing a set of clear economic indicators that allow regulatory authorities to identify platforms with a “gatekeeper” role playing a systemic role in the online economy; such indicators could include considerations such as whether the undertaking is active to a significant extent on multi-sided markets, or has predominant influence over its users, the size of its network (number of users), its financial strength, access to data, vertical integration, the importance of its activity for third parties’ access to supply and markets, etc.
Amendment 618 #
2020/2018(INL)
Motion for a resolution
Annex I – part IV – paragraph 1 – subparagraph 1 – indent 2
Annex I – part IV – paragraph 1 – subparagraph 1 – indent 2
- that measure should apply only to business-to-business relationships, and should be without prejudice to the rights of users under the GDPR, as well as the right to internet anonymo the possibility orf being an unidentified useronymous on the internet; the new general information requirements should review and further enhance Articles 5 and 10 of the E- Commerce Directive in order to align those measures with the information requirements established in recently adopted legislation, in particular the Unfair Contract Terms Directive5 , the Consumer Rights Directive and the Platform to Business Regulation. __________________ 5 Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts, most recently amended by Directive (EU) 2019/2161 of the European Parliament and of the Council of 27 November 2019 amending Council Directive 93/13/EEC and Directives 98/6/EC, 2005/29/EC and 2011/83/EU of the European Parliament and of the Council as regards the better enforcement and modernisation of Union consumer protection rules (OJ L 328, 18.12.2019, p. 7).
Amendment 619 #
2020/2018(INL)
Motion for a resolution
Annex I – part IV – paragraph 1 – subparagraph 1 – indent 2 a (new)
Annex I – part IV – paragraph 1 – subparagraph 1 – indent 2 a (new)
- Measures to address the problem of fake profiles of users and service providers should be explored by the Commission. Information society service providers and users should be identifiable by authorities if needed; this would be the case if they commit an illegal activity online. The Commission should come up with measures that allow judiciary authorities to identify and catch in a very agile way those users that carry out illegal activities (to protect both, users and platforms), while preserving the data protection rights of each user. The creation of a digital identity could be a solution to this challenge.
Amendment 641 #
2020/2018(INL)
Motion for a resolution
Annex I – part IV – paragraph 1 – subheading 3
Annex I – part IV – paragraph 1 – subheading 3
3. Transparency rRequirements on commercial communications
Amendment 645 #
2020/2018(INL)
Motion for a resolution
Annex I – part IV – paragraph 1 – subheading 3 – indent 3
Annex I – part IV – paragraph 1 – subheading 3 – indent 3
- The transparency requirements should include the obligation to disclose who is paying for the advertising, including both direct and indirect payments or any other contributions received by service providers; those requirements should apply also to platforms, even if they are established in third countries; consumers and public authorities should be able to identify who should be held accountable in case of, for example, false or misleading advertisement; these transparency requirements should also empower advertisers vis-a-vis advertising services, when it comes to where and when ads are placed; more efforts are needed to make sure that illegal activities cannot be funded via advertising services;
Amendment 649 #
2020/2018(INL)
Motion for a resolution
Annex I – part IV – paragraph 1 – subheading 3 – indent 3 a (new)
Annex I – part IV – paragraph 1 – subheading 3 – indent 3 a (new)
- The transparency requirements should also apply to targeted adverts; criteria for profiling targeted groups and optimisation of advertising campaigns must be made clear to verify any abuse. Users should be aware and have previously given their consent if they are going to receive targeted adverts;
Amendment 651 #
2020/2018(INL)
Motion for a resolution
Annex I – part IV – paragraph 1 – subheading 3 – indent 3 b (new)
Annex I – part IV – paragraph 1 – subheading 3 – indent 3 b (new)
- Specific requirements in regard to behavioural advertising, including micro targeting, should be introduced in order to protect public interest; behavioural advertising based on certain characters, i.e. exposing mental or physical vulnerabilities, should not be allowed at all, while some other characteristics should be allowed only under the opt-in condition by the users;
Amendment 686 #
2020/2018(INL)
Motion for a resolution
Annex I – part IV – paragraph 1 – subparagraph 4
Annex I – part IV – paragraph 1 – subparagraph 4
The compliance of the due diligence provisions should be reinforced with effective, proportionate and dissuasive penalties, including the imposition of fines.;
Amendment 688 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – title
Annex I – part V – title
V. MEASURES RELATED TO TACKLING ILLEGAL AND HARMFUL CONTENT ONLINE
Amendment 690 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – paragraph 1 – introductory part
Annex I – part V – paragraph 1 – introductory part
The Digital Services Act should provide clarity and guidance regarding how online intermediaries should tackle illegal and harmful content online. The revised rules of the E- Commerce Directive should:
Amendment 694 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – paragraph 1 – indent 1
Annex I – part V – paragraph 1 – indent 1
- clarify that any removal or disabling access to illegal or harmful content should not affect the fundamental rights and the legitimate interests of users and consumers;
Amendment 711 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – paragraph 1 – indent 4
Annex I – part V – paragraph 1 – indent 4
- introduce new transparency and independent oversight of the content moderation procedures and tools related to the removal of illegal and harmful content online; such systems and procedures should be available for auditing and testing by independent authorities.
Amendment 723 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – paragraph 2 – indent 1
Annex I – part V – paragraph 2 – indent 1
- apply to illegal online content or behaviour as well as to harmful content including disinformation;
Amendment 727 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – paragraph 2 – indent 2
Annex I – part V – paragraph 2 – indent 2
- rank different types of providers, sectors and/or illegal and harmful content;
Amendment 732 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – paragraph 2 – indent 4
Annex I – part V – paragraph 2 – indent 4
- allow users to easily notify by electronic means potentially illegal or harmful online content or behaviour to online intermediaries;
Amendment 738 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – paragraph 2 – indent 7
Annex I – part V – paragraph 2 – indent 7
- specify the requirements necessary to ensure that notices are of a good quality, thereby enabling a swift removal of illegal content; such requirement should include the name and contact details of the notice provider, the link (URL) to the allegedly illegal or harmful content in question, the stated reason for the claim including an explanation of the reasons why the notice provider considers the content to be illegal, and if necessary, depending on the type of content, additional evidence for the claim;
Amendment 741 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – paragraph 2 – indent 8
Annex I – part V – paragraph 2 – indent 8
Amendment 745 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – paragraph 2 – indent 9
Annex I – part V – paragraph 2 – indent 9
Amendment 751 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – paragraph 2 – indent 11
Annex I – part V – paragraph 2 – indent 11
- create an obligation for the online intermediaries to verify the notified content and reply in a timely manner to the notice provider and the content uploader with a reasoned decision;
Amendment 762 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – subheading 2 – indent 1
Annex I – part V – subheading 2 – indent 1
- The decision taken by the online intermediary on whether or not to act upon content flagged as illegal or harmful should contain a clear justification on the actions undertaken regarding that specific content. The notice provider, where identifiable, should receive a confirmation of receipt and a communication indicating the follow-up given to the notification.
Amendment 763 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – subheading 2 – indent 1
Annex I – part V – subheading 2 – indent 1
- The decision taken by the online intermediary on whether or not to act upon content flagged as illegal should contain a clear justification on the actions undertaken regarding that specific content. The notice provider, where identifiable, should receive a confirmation of receipt and a communication indicating the follow-up given to the notification.
Amendment 765 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – subheading 2 – indent 2
Annex I – part V – subheading 2 – indent 2
- The providers of the content that is being flagged as illegal or harmful should be immediately informed of the notice and, that being the case, of the reasons and decisions taken to remove or disable access to the content; all parties should be duly informed of all existing available legal options and mechanisms to challenge this decision;
Amendment 770 #
2020/2018(INL)
Motion for a resolution
Annex I – part V – subheading 2 – indent 4
Annex I – part V – subheading 2 – indent 4
- If the redress and counter-notice have established that the notified activity or information is not illegal nor harmful, the online intermediary should restore the content that was removed without undue delay or allow for the re-upload by the user, without prejudice to the platform's terms of service.
Amendment 808 #
2020/2018(INL)
Motion for a resolution
Annex I – part VI – paragraph 1
Annex I – part VI – paragraph 1
The Digital Services Act should propose specific rules for online market places for the online sale of products and provision of services to consumers.
Amendment 811 #
2020/2018(INL)
Motion for a resolution
Annex I – part VI – paragraph 2 – indent 3
Annex I – part VI – paragraph 2 – indent 3
- ensure that online marketplaces make it clear into which country the products are sold or services are being provided, regardless whether they are provided by that marketplace, a third party or a seller established inside or outside the Union;
Amendment 814 #
2020/2018(INL)
Motion for a resolution
Annex I – part VI – paragraph 2 – indent 4
Annex I – part VI – paragraph 2 – indent 4
- ensure that online marketplaces remove any misleading information given by the supplier or by customers, including misleading guarantees and statements made by the supplier;
Amendment 831 #
2020/2018(INL)
Motion for a resolution
Annex I – part VI – paragraph 2 – indent 6
Annex I – part VI – paragraph 2 – indent 6
- once the product has been removed, oblige online marketplaces to inform consumers of any safety issues and of any action required to ensure that recalls are carried out effectively;
Amendment 839 #
2020/2018(INL)
Motion for a resolution
Annex I – part VI – paragraph 2 – indent 8
Annex I – part VI – paragraph 2 – indent 8
- address the liability for online marketplaces if the online marketplace has not informed the consumer that a third party is the actual supplier of the goods or services, thus making the marketplace contractually liable vis-à-vis the consumer; liability should also be considered in case the marketplace provides misleading information, guarantees, or statements;
Amendment 856 #
2020/2018(INL)
Motion for a resolution
Annex I – part VII – paragraph 2 – indent 1
Annex I – part VII – paragraph 2 – indent 1
- set up an asymmetric ex-ante mechanism to prevent (instead of merely remedy) unfair market behaviour by “"systemic platforms”" in the digital world, building on the Platform to Business Regulation; such mechanism should allow regulatory authorities to impose remedies on these companies with a significant market position in order to address market failures, without the establishment of a breach of regulatory rules;
Amendment 857 #
2020/2018(INL)
Motion for a resolution
Annex I – part VII – paragraph 2 – indent 1
Annex I – part VII – paragraph 2 – indent 1
- set up an ex-ante mechanism to prevent (instead of merely remedy) unfair market behaviour by “systemic platforms” in the digital world, building on the Platform to Business Regulation; such mechanism should allow regulatory authorities to impose remediesanctions on these companies in order to address market failures, without the establishment of a breach of regulatory rules;
Amendment 862 #
2020/2018(INL)
Motion for a resolution
Annex I – part VII – paragraph 2 – indent 2
Annex I – part VII – paragraph 2 – indent 2
- empower regulatory authorities to issue orders prohibiting undertakings, which have been identified as “"systemic platforms”", from the following practices, inter alia: discrimination in intermediary services; making the use of data for making market entry by third parties more difficult; data envelopment used to expand dominant position in adjacent markets, incurring in self-preferencing of their own products and services and engaging in practices aimed at locking- in consumers; undertakings should be given the possibility to demonstrate that the behaviour in question is justified, yet they should bear the burden of proof for this;
Amendment 866 #
2020/2018(INL)
Motion for a resolution
Annex I – part VII – paragraph 2 – indent 2 a (new)
Annex I – part VII – paragraph 2 – indent 2 a (new)
- explore other ex-ante remedies that prevent the creation of new systemic platforms. In addition to reactive ex-ante mechanism, the Digital Services Act should envisage preventive mechanisms that prevent the creation of digital gatekeepers;
Amendment 873 #
2020/2018(INL)
Motion for a resolution
Annex I – part VII – paragraph 2 – indent 3
Annex I – part VII – paragraph 2 – indent 3
- clarify that some regulatory remedimeasures should be impoaddressed ton all ”"systemic platforms”" without the need for a decision by a regulatory authority, such as prohibition for “"systemic platforms”" to engage in self- preferencing or in any practices aimed at making it more difficult for consumers to switch suppliers, or other forms of discrimination that exclude or disadvantage other businesses;
Amendment 875 #
2020/2018(INL)
Motion for a resolution
Annex I – part VII – paragraph 2 – indent 4
Annex I – part VII – paragraph 2 – indent 4
- empower regulatory authorities to adopt interim measures and to impose finpenalties on “"systemic platforms”" that fail to respect the different regulatory obligations imposed on them;
Amendment 878 #
2020/2018(INL)
Motion for a resolution
Annex I – part VII – paragraph 2 – indent 5 a (new)
Annex I – part VII – paragraph 2 – indent 5 a (new)
- ensure that users of "systemic platforms" will be able to effectively control results of algorithms suggesting them specific content; users should be properly informed of all the reasons why specific content is suggested to them;
Amendment 883 #
2020/2018(INL)
Motion for a resolution
Annex I – part VII – paragraph 2 – indent 6
Annex I – part VII – paragraph 2 – indent 6
- imposensure high levels of interoperability measures requiring “"systemic platforms”" to share appropriate tools, non-rivalrous data, data, expertise, and resources deployed in order to limit the risks of users and consumers’ lock-in and the artificially binding users to one systemic platform with no possibility or incentives for switching between digital platforms or internet ecosystems and to empower users in deciding what kind of content they want to see. As part of those measures, the Commission should explore different technologies and open standards and protocols, including the possibility of a mechanical interface (Application Programming Interface) that allows users of competing platforms to dock on to the systemic platform and exchange information with it.
Amendment 892 #
2020/2018(INL)
Motion for a resolution
Annex I – part VIII – paragraph 1 a (new)
Annex I – part VIII – paragraph 1 a (new)
However, additional efforts with clear actions are necessary in order to address remaining obstacles in the digital single market and protectionist practices, such as: settling the costs of cross-border disputes, suppliers’ restrictions to selling cross-border, delivery-related matters, taxation rules, limited cross-border access to goods and services due to differences in intellectual property rights law, access to information on the relevant regulatory requirements, complex administrative procedures.
Amendment 908 #
2020/2018(INL)
Motion for a resolution
Annex I – part VIII – paragraph 4
Annex I – part VIII – paragraph 4
The central regulator should coordinate the work of the different authorities dealing with illegal and harmful content online, enforce compliance, fines, and be able to carry out auditing of intermediaries and platforms.
Amendment 39 #
2020/2017(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to include the education sector in the regulatory framework for high-risk AI applications given the importance of ensuring that education continues to contribute to the public good and given the high sensitivity of data on pupils, students and other learners; underlines that data sets used to train AI should be reviewed to avoid reinforcing gender stereotypes and other biases;
Amendment 2 #
2020/2007(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas the Professional Qualifications Directive facilitates the intra-EU labour mobility and the Services Directive realises the free movement of services, but the full potential of the single market for services and professionals can still be further improved and developed and the barriers for the free movement of services and professionals removed;
Amendment 8 #
2020/2007(INI)
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. whereas the COVID-19 crisis has caused an unprecedented economic crisis, and unlocking the full potential of the single market as well as enhancing the free movement of workers and services by making full use of the mutual recognition of professional qualifications and freedom to provide services under the Services Directive can facilitate the recovery process and put the economy back on track after the crisis;
Amendment 11 #
2020/2007(INI)
Draft opinion
Recital A c (new)
Recital A c (new)
Ac. whereas different regulatory choices at both the European and national level, imperfect and inadequate transposition of relevant directives, excessive requirements, lack of clear rules and fragmentation create the obstacles to fully benefit from the free movement of workers and services;
Amendment 13 #
2020/2007(INI)
Draft opinion
Recital A d (new)
Recital A d (new)
Ad. whereas in March 2020 the Commission has issued the Guidelines concerning the exercise of the free movement of workers during COVID-19 outbreak, which sets out the principles for an integrated approach to effective internal borders management to protect public health while preserving the integrity of the internal market;
Amendment 15 #
2020/2007(INI)
Draft opinion
Recital A e (new)
Recital A e (new)
Ae. whereas the Council has adopted a recommendation on a coordinated approach to the restrictions of free movement in response to the COVID-19 pandemic, which aims at increasing the transparency and predictability of free movement across the EU for both citizens and enterprises;
Amendment 18 #
2020/2007(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Highlights that, in the present health crisis, free movement of workers in the field of health services clearly demonstrates the benefits of the PQD; recalls that the aim of PQD is to facilitate the professionals to provide their services across Europe whilst guaranteeing an improved level of protection for consumers and citizens, which is particularly important during the pandemic crisis,
Amendment 21 #
2020/2007(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. underlines the great importance of free movement of workers and services in overcoming the recession and increased unemployment rates caused by the COVID-19 pandemic, reiterates that further removal of the existing barriers within the single market is essential in order to fully benefit from its potential; regrets that the Recovery Plan proposed by the Commission lacks ambition when it comes to the movement of workers and services and fails to fully recognise its importance as a tool for economic recovery;
Amendment 41 #
2020/2007(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses that while it is a competence of Member States to regulate a certain profession, they must respect the limits of the principles of non- discrimination and proportionality, as explicitly stipulated in the Proportionality Test Directive; calls on the Commission to provide structured assistance and issue guidance to Member States on how to conduct ex-ante proportionality assessments of new national regulation of services according to the Proportionality Test Directive;
Amendment 45 #
2020/2007(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the Member States to reduce bureaucratic obstacles, and, as quickly as possible, make it possible to obtain electronically the documents needed for the cross-border provision of services as well as facilitate the cross- border activities of workers in regulated professions;
Amendment 48 #
2020/2007(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Takes into consideration that the harmonisation inspired by the Professional Qualifications Directive gained success within several professions; further proclaims that Member States should reconsider and coordinate rules governing entry and exercise requirements in relation to specific activities or professions;
Amendment 51 #
2020/2007(INI)
Draft opinion
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Stresses, that, according to the Single Market Scoreboard 2020, further improvements are needed to ensure the free movement of professionals, especially in the field of recognising professional qualifications;
Amendment 66 #
2020/2007(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Encourages the Commission to fully and effectively enforce existing rules; calls for alternative resolution mechanisms to be assessed and for infringement procedures to be applied swiftly and rigorously whenever breaches of relevant legislation are identified or disproportionate burdens introduced;
Amendment 68 #
2020/2007(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Encourages Member States to work together in order to guarantee the continuity of work of cross-border workers during the pandemic crisis, taking into account their specific situation and in order to preserve the free movement of services and workers in regulated professions within the internal market;
Amendment 71 #
2020/2007(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Reiterates that Member States should follow the Council Recommendation on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic, adopted on 13th October 2020 in order to avoid any disruption in the internal market and free movement of workers and services;
Amendment 73 #
2020/2007(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to improve tools such as the Points of Single Contact and the Single Digital Gateway where appropriate, to provide guidelines to help Member States streamline procedures, in particular for SMEs; calls and on the Member States to use such tools to provide workers, consumers and businesses with prompt, accurate and easily accessible information regarding their rights and obligations related to free movement within the single market.
Amendment 78 #
2020/2007(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Recalls that cross-border health care services fall within the ambit of freedom to provide services as stated by the Court of Justice of the EU; notes that Cross-border Health Care Directive was adopted also on basis of Article 114 TFEU; regrets that Cross-border Health Care Directive creates additional obstacles to provision of cross-border health care services when compared to the case-law of the Court of Justice applying the Treaty provisions on free movement of services; underlines the necessity that these additional obstacles are removed, underlines that a better coordination and promotion of best practices between Member States and cross-border mobility of health professionals are beneficial and particularly important during the COVID- 19 pandemic;
Amendment 3 #
2020/1998(BUD)
Draft opinion
Paragraph 1
Paragraph 1
1. Recognises the need for the EU budget to continue to support recovery, convergence, reforms, fair and inclusive sustainable long-term growth and competitiveness of the European economy to address structural weaknesses of the economies and strengthen their resilience and other EU priorities such as social, economic and territorial cohesion and regional development, climate action, green transition, digitalisation and innovation, security and the management of migration, to avoid widening of the divergence in the Union, while acknowledging that the COVID-19 pandemic has provided a new and unexpected challenge on economic and health sector that the EU and its Member States need to respond determinedly and provide efficient solutions at the EU level;
Amendment 12 #
2020/1998(BUD)
Draft opinion
Paragraph 2
Paragraph 2
2. Reminds that cohesion is a shared competence between the EU and Member States and that as a main public investment policy it will play a major role in mitigating the economic and social impact and it will also play a crucial role in the recovery path from the COVID-19 pandemic consequences; emphasises that cohesion policy isis fundamental and most recognised policy that has shaped the Union we know today, based on a solidarity and its goal is to reduce economic, social and territorial disparities between Member States and within the EU and regionslong with strengthening economic, territorial and social resilience within the EU and regions for a more harmonious development that will help the Union to remain globally competitive; emphasizses in that context that programmes managed under European Structural and Investments (ESI) Funds support and contribute significantly to sustainable solutions for fair and long-term inclusive economic growth, investments and competitiveness, as well as high quality, safe and secure working and living conditions of the citizens, including equal opportunities, social justice and non- discrimination; in order to maximise the impact of ESI Funds, it is essential that Member State authorities at all levels work closely with each other and in partnership with employers, trade unions, academics, non-governmental organisations and other stakeholders;
Amendment 22 #
2020/1998(BUD)
Draft opinion
Paragraph 3
Paragraph 3
3. Notes that the budget for the year 2021 starts the new programming period 2021-2027 and that it should reflect the principles and priorities of an updated and reoriented Multiannual Financial Framework (MFF) and contribute effectively to the mitigation of the social and, economic and health impact of the COVID-19 pandemic, while carefully considering available resources, including new own resources, as well as budgetary rules and principles that will ensure realistic, immediate and satisfactory implementation;
Amendment 34 #
2020/1998(BUD)
Draft opinion
Paragraph 5
Paragraph 5
5. Welcomes the enhanced flexibility in cohesion policy – increased co- financing, anti-crisis use of EU funds - introduced in March and April 2020 and believes that it - should be maintained also in MFF 2021-2027 as a mechanism that will act as a safeguard of the Union economy during turbulent and unpredictable times;
Amendment 52 #
2020/1998(BUD)
Draft opinion
Paragraph 9
Paragraph 9
9. Calls on the Member States to share clearly and determinedly their post-crisis plans, strategies, ambitions and expectations as well as acknowledge their shared role in preparation for a coordinated EU approach., which will enable high- quality and measurable results that will lead to long-term sustainable growth;
Amendment 186 #
2020/0361(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) Moreover, complex national regulatory requirements, fragmented implementation and insufficient enforcement of legislation such as Directive 2000/31/EC have contributed to high administrative costs and legal uncertainty for intermediary services operating on the internal market, especially micro, small and medium sized companies.
Amendment 208 #
2020/0361(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Such a substantial connection to the Union should be considered to exist where the service provider has an establishment in the Union or, in its absence, on the basis of the existence of a significant number of users in one or more Member States, or the targedirecting of activities towards one or more Member States. The targeting of activities towards one or more Member States can be determined on the basis of all relevant circumstances, including factors such as the use of a language or a currency generally used in that Member State, or the possibility of ordering products or services, or using a national top level domain. The targedirecting of activities towards a Member State could also be derived from the availability of an application in the relevant national application store, from the provision of local advertising or advertising in the language used in that Member State, or from the handling of customer relations such as by providing customer service in the language generally used in that Member State. A substantial connection should also be assumed where a service provider directs its activities to one or more Member State as set out in Article 17(1)(c) of Regulation (EU) 1215/2012 of the European Parliament and of the Council27 . On the other hand, mere technical accessibility of a website from the Union cannot, on that ground alone, be considered as establishing a substantial connection to the Union. __________________ 27 Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L351, 20.12.2012, p.1).
Amendment 213 #
2020/0361(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) This Regulation should complement, yet not affect the application of rules resulting from other acts of Union law regulating certain aspects of the provisionfully harmonises the rules applicable to intermediary services in the internal market with the objective to ensure a safe and trusted online environment, effective protection of fundamental rights and a favourable business climate. Accordingly, Member States should not adopt or maintain additional national requirements on those matters falling within the scope of this Regulation. This does not preclude the possibility to apply other national legislation applicable to providers of intermediary services, in particular Directive 2000/31/ECaccordance with Union law, including Directive 2000/31/EC, in particular its Article 3, with the exception of those changes introduced by this Regulation, Directive 2010/13/EU of the European Parliament and of the Council as amended,28 and Regulation (EU) …/.. of the European Parliament and of the Council29 – proposed Terrorist Content Online Regulation. Therefore, this Regulation leaves those other acts, which are to be considered lex specialis in relation to the generally applicable framework set out in this Regulation, unaffected. However, the rules of this Regulation apply in respect of issues that are not or not fully addressed by those other acts as well as issues on which those other acts leave Member States the possibility of adopting certain measures at national level. . __________________ 28 Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (Text with EEA relevance), OJ L 95, 15.4.2010, p. 1 . 29Regulation (EU) …/.. of the European Parliament and of the Council – proposed Terrorist Content Online Regulation
Amendment 224 #
2020/0361(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to achieve the objective of ensuring a safe, predictable and trusted online environment, for the purpose of this Regulation the concept of “illegal content” should be defined broadly and also covers information relating to illegal content, products, services and activities. In particular, that concept, including fake online profile accounts. Illegal content is often spread online precisely via fake online profile accounts. Namely, false representation in the ‘online world’ should not be legal as it is also not legal to falsely present oneself in the ‘offline world’. This approach is an evident manifestation of the principle that what is illegal offline should not be allowed to remain legal online. Moreover, the concept of “illegal content” should be understood to refer to information, irrespective of its form, that under the applicable law is either itself illegal, such as illegal hate speech or terrorist content and unlawful discriminatory content, or that relates to activities that are illegal, such as the sharing of images depicting child sexual abuse, unlawful non- consensual sharing of private images, online stalking, the sale of non-compliant or counterfeit products, the non-authorised use of copyright protected material or activities involving infringements of consumer protection law. In this regard, it is immaterial whether the illegality of the information or activity results from Union law or from national law that is consistent with Union law and what the precise nature or subject matter is of the law in question.
Amendment 249 #
2020/0361(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) The concept of ‘dissemination to the public’, as used in this Regulation, should entail the making available of information to a potentially unlimited number of persons, that is, making the information easily accessible to users in general without further action by the recipient of the service providing the information being required, irrespective of whether those persons actually access the information in question. The mere possibility to create groups of users of a given service should not, in itself, be understood to mean that the information disseminated in that manner is not disseminated to the public. However, the concept should exclude dissemination of information within closed groups consisting of a finite number of pre- determined persons. Interpersonal communication services, as defined in Directive (EU) 2018/1972 of the European Parliament and of the Council,39 such as emails or private messaging services, fall outside the scope of this Regulation. Information should be considered disseminated to the public within the meaning of this Regulation only where that occurs upon the direct request by the recipient of the service that provided the information. Services, such as internet infrastructure services or cloud service providers, which are provided at the request of parties other than the content providers and only indirectly benefitting the latter, should not be covered by the definition of online platforms. __________________ 39Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (Recast), OJ L 321, 17.12.2018, p. 36
Amendment 257 #
2020/0361(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The relevant rules of Chapter II should only establish when the provider of intermediary services concerned cannot be held liable in relation to illegal content provided by the recipients of the service. Those rules should notby no means be understood to provide a positive basis for establishing when a provider can be held liable, which is for the applicable rules of Union or national law to determine. Furthermore, the exemptions from liability established in this Regulation should apply in respect of any type of liability as regards any type of illegal content, irrespective of the precise subject matter or nature of those laws.
Amendment 278 #
2020/0361(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) In order to benefit from the exemption from liability for hosting services, the provider should, upon obtaining actual knowledge or awareness of illegal content, act expedwitihouslt undue delay to remove or to disable access to that content. The removal or disabling of access should be undertaken in the observance of the principle of freedom of expression. The provider can obtain such actual knowledge or awareness through, in particular, its own-initiative investigations or notices submitted to it by individuals or entities in accordance with this Regulation in so far as those notices are sufficiently precise and adequately substantiated to allow a diligent economic operator to reasonably identify, assess and where appropriate act against the allegedly illegal content.
Amendment 281 #
2020/0361(COD)
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) The exemption of liability should not apply where the recipient of the service is acting under the authority or the control of the provider of a hosting service. In particular, where the provider of the online platform that allows consumers to conclude distance contracts with traders does not allow traders to determine the basic elements of the trader-consumer contract, such as the terms and conditions governing such relationship or the price, it should be considered that the trader acts under the authority or control of that platform.
Amendment 282 #
2020/0361(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) In order to ensure the effective protection of consumers when engaging in intermediated commercial transactions online, certain providers of hosting services, namely, online platforms that allow consumers to conclude distance contracts with traders as a functionality of their service, should not be able to benefit from the exemption from liability for hosting service providers established in this Regulation, in so far as those online platforms present the relevant information relating to the transactions at issue in such a way that it leads consumers to believe that the information was provided by those online platforms themselves or by recipients of the service acting under their authority or control, and that those online platforms thus have knowledge of or control over the information, even if that may in reality not be the case. This is the case where the online platform operator fails to clearly display the identity of the trader following this Regulation. In that regard, is should be determined objectively, on the basis of all relevant circumstances, whether the presentation could lead to such a belief on the side of an average and reasonably well-informed consumer. In particular, it is relevant whether the online platform operator withholds such identity or contract details until after the conclusion of the trader- consumer contract, or is marketing the product or service in its own name rather than using the name of the trader who will supply it.
Amendment 291 #
2020/0361(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) Consumers should be able to safely purchase products and services online, irrespective of whether a product or service has been produced in the Union. For that reason, traders from third countries should establish a legal representative in the Union to whom claims regarding product safety could be addressed. Providers of intermediary services from inside the Union as well as from third countries should ensure compliance with product requirements set out in Union law.
Amendment 310 #
2020/0361(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Since 2000, new technologies have emerged that improve the availability, efficiency, speed, reliability, capacity and security of systems for the transmission and storage of data online, leading to an increasingly complex online ecosystem. In this regard, it should be recalled that providers of services establishing and facilitating the underlying logical architecture and proper functioning of the internet, including technical auxiliary functions, can also benefit from the exemptions from liability set out in this Regulation, to the extent that their services qualify as ‘mere conduits’, ‘caching’ or hosting services. Such services include, as the case may be, wireless local area networks, domain name system (DNS) services, top–level domain name registries, certificate authorities that issue digital certificates, cloud infrastructure services or content delivery networks, that enable or improve the functions of other providers of intermediary services. Likewise, services used for communications purposes, and the technical means of their delivery, have also evolved considerably, giving rise to online services such as Voice over IP, messaging services and web-based e-mail services, where the communication is delivered via an internet access service. Those services, too, can benefit from the exemptions from liability, to the extent that they qualify as ‘mere conduit’, ‘caching’ or hosting service.
Amendment 331 #
2020/0361(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) The territorial scope of such orders to act against illegal content should be clearly set out on the basis of the applicable Union or national law enabling the issuance of the order and should not exceed what is strictly necessary to achieve its objectives. In that regard, the national judicial or administrative authority issuing the order should balance the objective that the order seeks to achieve, in accordance with the legal basis enabling its issuance, with the rights and legitimate interests of all third parties that may be affected by the order, in particular their fundamental rights under the Charter. In addition, where the order referring to the specific information may have effects beyond the territory of the Member State of the authority concerned, the authority should assess whether the information at issue is likely to constitute illegal content in other Member States concerned and, where relevant, take account of the relevant rules of Union law or international law and the interests of international comity. Since intermediaries should not be required to remove information which is legal in their country of establishment, national and Union authorities should be able to order the blocking of content legally published outside the Union only for the territory of the Union where Union law is infringed and for the territory of the issuing Member State where national law is infringed.
Amendment 346 #
2020/0361(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) In order to achieve the objectives of this Regulation, and in particular to improve the functioning of the internal market and ensure a safe and transparent online environment, it is necessary to establish a clear and balanced set of harmonised due diligence obligations for providers of intermediary services. Those obligations should target illegal content and aim in particular to guarantee different public policy objectives such as consumer protection, the safety and trust of the recipients of the service, including minors and vulnerable users, protect the relevant fundamental rights enshrined in the Charter, to ensure meaningful accountability of those providers and to empower recipients and other affected parties, whilst facilitating the necessary oversight by competent authorities.
Amendment 353 #
2020/0361(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) In that regard, it is important that the due diligence obligations are adapted to the type and nature and size of the intermediary service concerned. This Regulation therefore sets out basic obligations applicable to all providers of intermediary services, as well as additional obligations for providers of hosting services and, more specifically, online platforms and very large online platforms. To the extent that providers of intermediary services may fall within those different categories in view of the nature of their services and their size, they should comply with all of the corresponding obligations of this Regulation. Those harmonised due diligence obligations, which should be reasonable and non- arbitrary, are needed to achieve the identified public policy concerns, such as safeguarding the legitimate interests of the recipients of the service, addressing illegal practices and protecting fundamental rights online.
Amendment 358 #
2020/0361(COD)
Proposal for a regulation
Recital 36 a (new)
Recital 36 a (new)
(36a) Providers of intermediary services should also establish a single point of contact for recipients of services, allowing rapid, direct and efficient communication.
Amendment 372 #
2020/0361(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To ensure an adequate level of transparency and accountability, providers of intermediary services should annually report, in accordance with the harmonised requirements contained in this Regulation, on the content moderation they engage in, including the measures taken as a result of the application and enforcement of their terms and conditions. However, so as to avoid disproportionate burdens, those transparency reporting obligations should not apply to providers that are micro- or, small or medium sized enterprises as defined in Commission Recommendation 2003/361/EC.40 __________________ 40 Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium- sized enterprises (OJ L 124, 20.5.2003, p. 36).
Amendment 376 #
2020/0361(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Providers of hosting services play a particularly important role in tackling illegal content online, as they store information provided by and at the request of the recipients of the service and typically give other recipients access thereto, sometimes on a large scale. It is important that all providers of hosting services, regardless of their size, put in place easily accessible, comprehensive and user-friendly notice and action mechanisms that facilitate the notification of specific items of information that the notifying party considers to be illegal content to the provider of hosting services concerned ('notice'), pursuant to which that provider can decide whether or not it agrees with that assessment and wishes to remove or disable access to that content ('action')following the applicable law ('action'). Such mechanisms should be clearly visible on the interface of the hosting service and easy to use. Provided the requirements on notices are met, it should be possible for individuals or entities to notify multiple specific items of allegedly illegal content through a single notice. The obligation to put in place notice and action mechanisms should apply, for instance, to file storage and sharing services, web hosting services, advertising servers and paste bins, in as far as they qualify as providers of hosting services covered by this Regulation. Providers of hosting services could, as a voluntary measure, conduct own-investigation measures to prevent content which has previously been identified as illegal from being disseminated again once removed. The obligations related to notice and action should by no means impose general monitoring obligations.
Amendment 385 #
2020/0361(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The rules on such notice and action mechanisms should be harmonised at Union level, so as to provide for the timely, diligent and objective processing of notices on the basis of rules that are uniform, transparent and clear and that provide for robust safeguards to protect the right and legitimate interests of all affected parties, in particular their fundamental rights guaranteed by the Charter, irrespective of the Member State in which those parties are established or reside and of the field of law at issue. The fundamental rights include, as the case may be, the right to freedom of expression and information, the right to respect for private and family life, the right to protection of personal data, the right to non-discrimination and the right to an effective remedy of the recipients of the service; the freedom to conduct a business, including the freedom of contract, of service providers; as well as the right to human dignity, the rights of the child, the right to protection of property, including intellectual property, and the right to non- discrimination of parties affected by illegal content. Providers of hosting services should act upon notices without undue delay, taking into account the type of illegal content that is being notified and the urgency of taking action. The provider of hosting services should inform the individual or entity notifying the specific content of its decision without undue delay after taking a decision whether to act upon the notice or not.
Amendment 396 #
2020/0361(COD)
Proposal for a regulation
Recital 42 a (new)
Recital 42 a (new)
(42a) A hosting service provider may in some instances become aware, for instance through a notice by a notifying party or through its own voluntary measures, of information relating to certain activity of a recipient of the service, such as the provision of certain types of illegal content, that reasonably justify, having regard to all relevant circumstances of which the hosting service provider is aware, the suspicion that the recipient may have committed, may be committing or is likely to commit a serious criminal offence involving a threat to the life or safety of person, such as offences specified in Directive 2011/93/EU of the European Parliament and of the Council. In such instances, the hosting service provider should inform without delay the competent law enforcement authorities of such suspicion, providing all relevant information available to it, including where relevant the content in question and an explanation of its suspicion. This Regulation does not provide the legal basis for profiling of recipients of the services with a view to the possible identification of criminal offences by hosting service providers. Hosting service providers should also respect other applicable rules of Union or national law for the protection of the rights and freedoms of individuals when informing law enforcement authorities.
Amendment 401 #
2020/0361(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) To avoid disproportionate burdens, the additional obligations imposed on online platforms under this Regulation should not apply to micro or, small or medium sized enterprises as defined in Recommendation 2003/361/EC of the Commission,41 unless their reach and impact is such that they meet the criteria to qualify as very large online platforms under this Regulation. The consolidation rules laid down in that Recommendation help ensure that any circumvention of those additional obligations is prevented. The exemption of micro- and small enterprises from those additional obligations should not be understood as affecting their ability to set up, on a voluntary basis, a system that complies with one or more of those obligations. __________________ 41 Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium- sized enterprises (OJ L 124, 20.5.2003, p. 36).
Amendment 403 #
2020/0361(COD)
Proposal for a regulation
Recital 43 a (new)
Recital 43 a (new)
(43a) To similarly avoid unnecessary regulatory burdens, certain obligations should not apply to hosting service providers often referred to as closed online platforms where, within the framework of an organised distribution network operating under a common brand, the provider of the intermediary service has a direct organisational, associative, cooperative or capital ownership link with the recipient of the service or where the intermediary service solely aims to intermediate content between the members of the organised distribution framework and their suppliers.
Amendment 405 #
2020/0361(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) Recipients of the service should be able to easily and effectively contest certain decisions of online platforms that negatively affect them. Therefore, online platforms should be required to provide for internal complaint-handling systems, which meet certain conditions aimed at ensuring that the systems are easily accessible and lead to swift, non- discriminatory and fair outcomes. In addition, provision should be made for the possibility of out-of-court dispute settlement of disputes, including those that could not be resolved in satisfactory manner through the internal complaint- handling systems, by certified bodies that have the requisite independence, means and expertise to carry out their activities in a fair, swift and cost- effectivimple, affordable, expedient and accessible manner. The possibilities to contest decisions of online platforms thus created should complement, yet leave unaffected in all respects, the possibility to seek judicial redress in accordance with the laws of the Member State concerned.
Amendment 416 #
2020/0361(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) Action against illegal content can be taken more quickly and reliably where online platforms take the necessary measures to ensure that notices submitted by trusted flaggers through the notice and action mechanisms required by this Regulation are treated with priority,out delay and in accordance with the rules of the profession but without prejudice to the requirement to process and decide upon all notices submitted under those mechanisms in a timely, diligent and objective manner. Such trusted flagger status should only be awarded to entities, and not individuals, that have demonstrated, among other things, that they have particular expertise and competence in tackling illegal content, that they represent collective interests and that they work in a diligent and objective manner. Such entities can be public in nature, such as, for terrorist content, internet referral units of national law enforcement authorities or of the European Union Agency for Law Enforcement Cooperation (‘Europol’) or they can be non-governmental organisations and semi- public bodies, such as the organisations part of the INHOPE network of hotlines for reporting child sexual abuse material and organisations committed to notifying illegal racist and xenophobic expressions online. For intellectual property rights, organisations of industry and of right- holders could be awarded trusted flagger status, where they have demonstrated that they meet the applicable conditions. The rules of this Regulation on trusted flaggers should not be understood to prevent online platforms from giving similar treatment to notices submitted by entities or individuals that have not been awarded trusted flagger status under this Regulation, from otherwise cooperating with other entities, in accordance with the applicable law, including this Regulation and Regulation (EU) 2016/794 of the European Parliament and of the Council.43 __________________ 43Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA, OJ L 135, 24.5.2016, p. 53
Amendment 417 #
2020/0361(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) Action against illegal content can be taken more quickly and reliably where online platforms take the necessary measures to ensure that notices submitted by trusted flaggers through the notice and action mechanisms required by this Regulation are treated with priority, depending on the severity of the illegal activity, without prejudice to the requirement to process and decide upon all notices submitted under those mechanisms in a timely, diligent and objective manner. Such trusted flagger status should only be awarded to entities, and not individuals, that have demonstrated, among other things, that they have particular expertise and competence in tackling illegal content, that they represent collective interests and that they work in a diligent and objective manner. Such entities can be public in nature, such as, for terrorist content, internet referral units of national law enforcement authorities or of the European Union Agency for Law Enforcement Cooperation (‘Europol’) or they can be non-governmental organisations and private or semi- public bodies, such as the organisations part of the INHOPE network of hotlines for reporting child sexual abuse material and organisations committed to notifying illegal racist and xenophobic expressionscontent online. For intellectual property rights, organisations of industry and of individual right- holders could be awarded trusted flagger status, where they have demonstrated that they meet the applicable conditions. The rules of this Regulation on trusted flaggers should not be understood to prevent online platforms from giving similar treatment to notices submitted by entities or individuals that have not been awarded trusted flagger status under this Regulation, from otherwise cooperating with other entities, in accordance with the applicable law, including this Regulation and Regulation (EU) 2016/794 of the European Parliament and of the Council.43 __________________ 43Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA, OJ L 135, 24.5.2016, p. 53
Amendment 418 #
2020/0361(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) The misuse of services of online platforms by frequently providing manifestly illegal content or by frequently submitting manifestly unfounded notices or complaints under the mechanisms and systems, respectively, established under this Regulation undermines trust and harms the rights and legitimate interests of the parties concerned. Therefore, there is a need to put in place appropriate and proportionate safeguards against such misuse. Information should be considered to be manifestly illegal content and notices or complaints should be considered manifestly unfounded where it is evident to a layperson, without any substantive analysis, that the content is illegal respectively that the notices or complaints are unfounded. Under certain conditions, online platforms should temporarily suspend their relevant activities in respect of the person engaged in abusive behaviour. This is without prejudice to the freedom by online platforms to determine their terms and conditions and establish stricter measures in the case of manifestly illegal content related to serious crimes, with due regard to the rights and legitimate interests of all parties involved, including the applicable fundamental rights of the recipients of the service as enshrined in the Charter. Providers of hosting services could, as a voluntary measure, introduce own-investigation measures to prevent accounts which have previously been identified as illegal from reappearing once removed. The obligations related to notice and action should by no means impose general monitoring obligations. For reasons of transparency, this possibility should be set out, clearly and in sufficiently detail, in the terms and conditions of the online platforms. Redress should always be open to the decisions taken in this regard by online platforms and they should be subject to oversight by the competent Digital Services Coordinator. The rules of this Regulation on misuse should not prevent online platforms from taking other measures to address the provision of illegal content by recipients of their service or other misuse of their services, in accordance with the applicable Union and national law. Those rules are without prejudice to any possibility to hold the persons engaged in misuse liable, including for damages, provided for in Union or national law.
Amendment 425 #
2020/0361(COD)
Proposal for a regulation
Recital 48
Recital 48
Amendment 445 #
2020/0361(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) To ensure an efficient and adequate application of that obligation, without imposing any disproportionate burdens, the online platforms covered should make reasonable efforts to verify the reliability of the information provided by the traders concerned, in particular by using freely available official online databases and online interfaces, such as national trade registers and the VAT Information Exchange System45 ,and the Union Rapid Alert System for dangerous non-food products (Rapex) or by requesting the traders concerned to provide trustworthy supporting documents, such as copies of identity documents, certified bank statements, company certificates and trade register certificates. They may also use other sources, available for use at a distance, which offer a similar degree of reliability for the purpose of complying with this obligation. However, the online platforms covered should not be required to engage in excessive or costly online fact-finding exercises or to carry out verifications on the spot. Nor should such online platforms, which have made the reasonable efforts required by this Regulation, be understood as guaranteeing the reliability of the information towards consumer or other interested parties. Such online platforms should also design and organise their online interface in a way that enables traders to comply with their obligations under Union law, in particular the requirements set out in Articles 6 and 8 of Directive 2011/83/EU of the European Parliament and of the Council46 , Article 7 of Directive 2005/29/EC of the European Parliament and of the Council47 and Article 3 of Directive 98/6/EC of the European Parliament and of the Council48 . __________________ 45 https://ec.europa.eu/taxation_customs/vies/ vieshome.do?selectedLanguage=en 46Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council 47Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to- consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’) 48Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers
Amendment 455 #
2020/0361(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) Online advertisement plays an important role in the online environment, including in relation to the provision of the services of online platforms. However,Online advertising is a significant source of financing for many digital business models and an effective tool to reach new customers, not least for small- and medium sized companies. However, there are some instances when online advertisement can contribute to significant risks, ranging from advertisement that is itself illegal content, to contributing to financial incentives for the publication or amplification of illegal or otherwise harmful content and activities online, or the discriminatory display of advertising with an impact on the equal treatment and opportunities of citizens. To ensure consumer protection online advertisement should be subject to proportionate and meaningful transparency obligations. In addition to the requirements resulting from Article 6 of Directive 2000/31/EC, online platforms should therefore be required to ensure that the recipients of the service have certain individualised information necessary for them to understand when and on whose behalf the advertisement is displayed. In addition, recipients of the service should have information on the main parameters used for determining that specific advertising is to be displayed to them, providing meaningful explanations of the logic used to that end, including when this is based on profiling. The requirements of this Regulation on the provision of information relating to advertisement is without prejudice to the application of the relevant provisions of Regulation (EU) 2016/679, in particular those regarding the right to object, automated individual decision-making, including profiling and specifically the need to obtain consent of the data subject prior to the processing of personal data for targeted advertising. Similarly, it is without prejudice to the provisions laid down in Directive 2002/58/EC in particular those regarding the storage of information in terminal equipment and the access to information stored therein.
Amendment 469 #
2020/0361(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) Very large online platforms may cause societal risks, different in scope and impact from those caused by smaller platforms. Once the number of recipients of a platform reaches a significant share of the Union population, the systemic risks the platform poses could have a disproportionately negative impact in the Union. Such significant reach should be considered to exist where the number of recipients exceeds an operational threshold set at 45 million, that is, a number equivalent to 10% of the Union population. The operational threshold should be kept up to date through amendments enacted by delegated acts, where necessary. Such very large online platforms should therefore bear the highest standard of due diligence obligations, proportionate to their societal impact and meansAccordingly, the number of average monthly recipients of the service should reflect the recipients actually reached by the service either by being exposed to content or by providing content disseminated on the platforms’ interface in that period of time. The operational threshold should be kept up to date through amendments enacted by delegated acts, where necessary. The threshold should be designed to target the largest platforms with a reach in the Union that could lead to a systemic impact. Such very large online platforms should therefore bear the highest standard of due diligence obligations, proportionate to their societal impact and means, placing such due diligence obligations on smaller companies, especially micro, small and medium sized companies would be disproportionate.
Amendment 474 #
2020/0361(COD)
Proposal for a regulation
Recital 56
Recital 56
(56) Very large online platforms are used in a way that strongly influences safety online, the shaping of public opinion and discourse, as well as on online trade. The way they design of their services is generally optimised to benefit their often advertising- driven business models and can cause societal concerns. In the absence of effective regulation and enforcement, they can set the rules of the game, withoutsometimes amplify the dissemination of illegal content. Effective regulation and enforcement is needed to effectively identifying and mitigatinge the risks and the societal and economic harm they can cauat may arise. Under this Regulation, very large online platforms should therefore assess the systemic risks stemming from the functioning and use of their service, as well as by potential misuses by the recipients of the service, and take appropriate mitigating measures.
Amendment 490 #
2020/0361(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) The audit report should be substantiated, so as to give a meaningful account of the activities undertaken and the conclusions reached. It should help inform, and where appropriate suggest improvements to the measures taken by the very large online platform to comply with their obligations under this Regulation, without prejudice to its freedom to conduct a business and, in particular, its ability to design and implement effective measures that are aligned with its specific business model. The report should be transmitted to the Digital Services Coordinator of establishment and the Board without delayin 30 days following its adoption, together with the risk assessment and the mitigation measures, as well as the platform’s plans for addressing the audit’s recommendations. The report should include an audit opinion based on the conclusions drawn from the audit evidence obtained. A positive opinion should be given where all evidence shows that the very large online platform complies with the obligations laid down by this Regulation or, where applicable, any commitments it has undertaken pursuant to a code of conduct or crisis protocol, in particular by identifying, evaluating and mitigating the systemic risks posed by its system and services. A positive opinion should be accompanied by comments where the auditor wishes to include remarks that do not have a substantial effect on the outcome of the audit. A negative opinion should be given where the auditor considers that the very large online platform does not comply with this Regulation or the commitments undertaken.
Amendment 496 #
2020/0361(COD)
Proposal for a regulation
Recital 62
Recital 62
(62) A core part of a very large online platform’s business is the manner in which information is prioritised and presented on its online interface to facilitate and optimise access to information for the recipients of the service. This is done, for example, by algorithmically suggesting, ranking and prioritising information, distinguishing through text or other visual representations, or otherwise curating information provided by recipients. Such recommender systems can have a significant impact on the ability of recipients to retrieve and interact with information online. Often, they facilitate the search for relevant content for recipients of the service and contribute to an improved user experience. They also play an important role in the amplification of certain messages, the viral dissemination of information and the stimulation of online behaviour. Consequently, very large online platforms should ensure that recipients are appropriately informed, and can influence the information presented to them through making active choices. They should clearly present the main parameters for such recommender systems in an easily comprehensible manner to ensure that the recipients understand how information is prioritised for them and why. They should also ensure that the recipients enjoy alternative options for the main parameters, including options that are not based on profiling of the recipient.
Amendment 500 #
2020/0361(COD)
Proposal for a regulation
Recital 63
Recital 63
(63) Advertising systems used by very large online platforms could pose particular risks and require further public and regulatory supervision on account of their scale and ability to target and reach recipients of the service based on their behaviour within and outside that platform’s online interface. Very large online platforms should ensure public access to repositories of advertisements displayed on their online interfaces to facilitate supervision and research into emerging risks brought about by the distribution of advertising online, for example in relation to illegal advertisements or manipulative techniques and disinformation with a real and foreseeable negative impact on public health, public security, civil discourse, political participation and equality. Repositories should include the content of advertisements and related data on the advertiser and the delivery of the advertisement, in particular where targeted advertising is concerned.
Amendment 506 #
2020/0361(COD)
Proposal for a regulation
Recital 64
Recital 64
(64) In order to appropriately supervise the compliance of very large online platforms with the obligations laid down by this Regulation, the Digital Services Coordinator of establishment or the Commission may require access to or reporting of specific data. Such a requirement may include, for example, the data necessary to assess the risks and possible harms brought about by the platform’s systems, data on the accuracy, functioning and testing of algorithmic systems for content moderation, recommender systems or advertising systems, or data on processes and outputs of content moderation or of internal complaint-handling systems within the meaning of this Regulation. Investigations by researchers on the evolution and severity of online systemic risks are particularly important for bridging information asymmetries and establishing a resilient system of risk mitigation, informing online platforms, Digital Services Coordinators, other competent authorities, the Commission and the public. This Regulation therefore provides a framework for compelling access to data from very large online platforms to vetted researchers, where relevant to a research project. All requiremenests for access to data under that framework should be proportionate and appropriately protect the rights and legitimate interests, including trade secrets and other confidential information, of the platform and any other parties concerned, including the recipients of the service.
Amendment 520 #
2020/0361(COD)
Proposal for a regulation
Recital 68
Recital 68
(68) It is appropriate that this Regulation identify certain areas of consideration for such codes of conduct. In particular, risk mitigation measures concerning specific types of illegal content should be explored via self- and co-regulatory agreements. Another area for consideration is the possible negative impacts of systemic risks on society and democracy, such as disinformation or manipulative and abusive activities. This includes coordinated operations aimed at amplifying information, including disinformation, such as the use of bots or fake accounts for the creation of fakintentionally inaccurate or misleading information, sometimes with a purpose of obtaining economic gain, which are particularly harmful for vulnerablecertain groups of recipients of the service, such as children. In relation to such areas, adherence to and compliance with a given code of conduct by a very large online platform may be considered as an appropriate risk mitigating measure. The refusal without proper explanations by an online platform of the Commission’s invitation to participate in the application of such a code of conduct could be taken into account, where relevant, when determining whether the online platform has infringed the obligations laid down by this Regulation.
Amendment 613 #
2020/0361(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
(b) set out uniformharmonised rules for a safe, predictable and trusted online environment, where fundamental rights enshrined in the Charter are effectively protected.
Amendment 614 #
2020/0361(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b – point i (new)
Article 1 – paragraph 2 – point b – point i (new)
i) facilitate innovations, support digital transition, encourage economic growth and create a level playing field for digital services within the internal market while strengthening consumer protection and contributing to increased consumer choice.
Amendment 659 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d – indent 1
Article 2 – paragraph 1 – point d – indent 1
Amendment 665 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d – indent 2
Article 2 – paragraph 1 – point d – indent 2
— the targedirecting of activities towards one or more Member States.
Amendment 681 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point g
Article 2 – paragraph 1 – point g
(g) ‘illegal content’ means any information,, which, in itself or by its reference to an activity, including the sale of products or provision of services but in particular fake online profile account, is not in compliance with Union law or the law of a Member State, irrespective of the precise subject matter or nature of that law;
Amendment 720 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point n
Article 2 – paragraph 1 – point n
(n) ‘advertisement’ means information designed and disseminated to promote the message of a legal or natural person, irrespective of whether to achieve commercial or non-commercial purposes, and displayed by an online platform on its online interface against remuneration specifically in exchange for promoting that information;
Amendment 728 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point p
Article 2 – paragraph 1 – point p
(p) ‘content moderation’ means the activities undertaken by providers of intermediary services aimed at detecting, identifying and addressing illegal content or information incompatible with their terms and conditions, provided by recipients of the service, including measures taken that affect the availability, visibility and accessibility of that illegal content or that information, such as demotion, demonetisation, disabling of access to, or removal thereof, or the recipients’ ability to provide that information, such as the termination or suspension of a recipient’s account;
Amendment 761 #
2020/0361(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) upon obtaining such knowledge or awareness, acts expedwitihouslt undue delay to remove or to disable access to the illegal content.
Amendment 787 #
2020/0361(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
Providers of intermediary services shall not be deemed ineligible for the exemptions from liability referred to in Articles 3, 4 and 5 solely because they carry outtake the necessary voluntary own-initiative investigations or other activiti measures aimed at detecting, identifying and removing, or disabling of access to, illegal content, or take the necessary measures to comply with the requirements of Union law, including those set out in this Regulation, without prejudice to freedom of expression.
Amendment 790 #
2020/0361(COD)
Proposal for a regulation
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
Providers of intermediary services shall ensure that such measures are accompanied with appropriate safeguards, such as oversight, documentation and traceability or additional measures to ensure that own- initiative investigations are accurate, legally justified and do not lead to over- removal of content.
Amendment 830 #
2020/0361(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point b a (new)
Article 8 – paragraph 2 – point b a (new)
(ba) the territorial scope of an order addressed to a provider that has its main establishment or, if the provider is not established in the Union, its legal representation in another Member State is limited to the territory of the Member State issuing the order;
Amendment 833 #
2020/0361(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point b b (new)
Article 8 – paragraph 2 – point b b (new)
(bb) if addressed to a provider that has its main establishment outside the Union, the territorial scope of the order, where Union law is infringed, is limited to the territory of the Union or, where national law is infringed, to the territory of the Member State issuing the order;
Amendment 857 #
2020/0361(COD)
Proposal for a regulation
Article 8 a (new)
Article 8 a (new)
Article 8a Injunction orders Member States shall ensure that recipients of a service are entitled under their national law to seek an injunction order as an interim measure for removing manifestly illegal content.
Amendment 897 #
2020/0361(COD)
Proposal for a regulation
Article 10 – title
Article 10 – title
Points of contact for authorities, the Commission and the Board
Amendment 903 #
2020/0361(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Providers of intermediary services shall make publiccommunicate to their Digital Service Coordinator of establishment, the Commission and the Board the information necessary to easily identify and communicate with their single points of contact.
Amendment 908 #
2020/0361(COD)
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Article 10a Point of contact for recipients of a service 1. Providers of intermediary services shall establish a single point of contact allowing for direct communication, by electronic means, with the recipients of their services. The means of communication shall be user-friendly and easily accessible. 2. Providers of intermediary services shall make public the information necessary to easily identify and communicate with their single points of contact for recipients.
Amendment 925 #
2020/0361(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Providers of intermediary services shall include information on any restrictions that they impose in relation to the use of their service in respect of information provided by the recipients of the service, in their terms and conditions. That information shall include information on any policies, procedures, measures and tools used for the purpose of content moderation, including information about algorithmic decision-making and human review. ItProviders of intermediary services shall also include information on the right to terminate the use of the service. The possibility to terminate must be easily accessible for the user. Information on remedies and redress mechanisms shall also be included in the terms and conditions. The terms and conditions shall be set out in clear and unambiguous language and shall be publicly available in an easily accessible format.
Amendment 975 #
2020/0361(COD)
Proposal for a regulation
Article 13 – paragraph 1 – introductory part
Article 13 – paragraph 1 – introductory part
1. Providers of intermediary services shall publish, at least once a year, clear, easily comprehensible and detailed reports on any content moderation they engaged in during the relevant period. Those reports shall include, in particular,including information on the following, as applicable:
Amendment 989 #
2020/0361(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point c
Article 13 – paragraph 1 – point c
(c) meaningful and comprehensible information about the content moderation engaged in at the providers’ own initiative, including the number and type of measures taken that affect the availability, visibility and accessibility of information provided by the recipients of the service and the recipients’ ability to provide information, categorised by the type of reason and basis for taking those measures;
Amendment 1064 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. Where the notice contains the name and an electronic mail address of the individual or entity that submitted it, the provider of hosting services shall promptly, without undue delay, send a confirmation of receipt of the notice to that individual or entity.
Amendment 1081 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 6 a (new)
Article 14 – paragraph 6 a (new)
6a. Providers of hosting services could, as a voluntary measure in line with provisions Article 6, conduct own- investigation measures to prevent illegal content which has previously been identified as illegal from being disseminated again once removed. The obligations related to paragraph 1 to 6 shall by no means impose general monitoring obligations on hosting services.
Amendment 1096 #
2020/0361(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Where a provider of hosting services decides to remove or disable access to or radically restrict the visibility of specific items of information provided by the recipients of the service, or to suspend or terminate monetary payments related to those items, irrespective of the means used for detecting, identifying or removing or disabling access to or for restricting the visibility or monetisation of that information and of the reason for its decision, it shall inform the recipient, at the latest at the time ofwithout undue delay and at the latest within 24 hours after the removal or disabling of access, of the decision and provide a clear and specific statement of reasons for that decision.
Amendment 1102 #
2020/0361(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a
Article 15 – paragraph 2 – point a
(a) whether the decision entails either the removal of, or the disabling of access to, the or radical restriction of the visibility of, the information or the suspension or termination of monetary payments related to that information and, where relevant, the territorial scope of the disabling of access;
Amendment 1120 #
2020/0361(COD)
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. Providers of hosting services shall publishupon request share the decisions and the statements of reasons, referred to in paragraph 1 in a publicly accessible database managed by the Commissionwith the Digital Service Coordinator of establishment. That information shall not contain personal data.
Amendment 1129 #
2020/0361(COD)
Proposal for a regulation
Article 15 a (new)
Article 15 a (new)
Amendment 1157 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) decisions to remove or not to remove or disable access to the information;
Amendment 1158 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) decisions to suspend or terminate or not to suspend or terminate the provision of the service, in whole or in part, to the recipients;
Amendment 1161 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point c
Article 17 – paragraph 1 – point c
(c) decisions to suspend or terminate or not to suspend or terminate the recipients’ account.
Amendment 1166 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point c a (new)
Article 17 – paragraph 1 – point c a (new)
(ca) decisions to radically restrict the visibility of content provided by the recipients,
Amendment 1171 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point c b (new)
Article 17 – paragraph 1 – point c b (new)
(cb) decisions to restrict the ability to monetise content provided by the recipients,
Amendment 1182 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Online platforms shall handle complaints submitted through their internal complaint-handling system in a timely, and diligent mandner, objective mannerly and in accordance with the rules of the profession. Where a complaint contains sufficient grounds for the online platform to consider that the information to which the complaint relates is not illegal and is not incompatible with its terms and conditions, or contains information indicating that the complainant’s conduct does not warrant the suspension or termination of the service or the account, it shall reverse its decision referred to in paragraph 1 without undue delay.
Amendment 1189 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 4 a (new)
Article 17 – paragraph 4 a (new)
4a. Online platforms shall ensure that the decisions, referred to in paragraph 4 are taken by lawyers with at least five years of professional experience.
Amendment 1194 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 5
Article 17 – paragraph 5
5. The decisions referred to in paragraph 4 may exceptionally be taken by automated means in which case, the Online platforms shall ensure that thesuch decisions, referred to in paragraph 4, are not solely taken on the basis of automated means are supervised by lawyers with at least five years of professional experience.
Amendment 1213 #
2020/0361(COD)
Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 1 – point a
Article 18 – paragraph 2 – subparagraph 1 – point a
(a) it is impartial and independentndependent, including financially independent, and impartial of online platforms and recipients of the service provided by the online platforms and of individuals or entities that have submitted notices;
Amendment 1236 #
2020/0361(COD)
Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 1 – point e
Article 18 – paragraph 2 – subparagraph 1 – point e
(e) the dispute settlement takes place in accordance with clear and fair rules of procedure that are clearly visible and easily accessible to all parties concerned and in full compliance with all applicable law.
Amendment 1242 #
2020/0361(COD)
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2a. The Digital Services Coordinator shall reassess on a yearly basis whether the certified out-of-court dispute settlement body continues to fulfil the listed criteria. If this is not the case, the Digital Services Coordinator shall revoke the status from the out-of-court dispute settlement body.
Amendment 1251 #
2020/0361(COD)
Proposal for a regulation
Article 18 – paragraph 5
Article 18 – paragraph 5
5. Digital Services Coordinators shall notify to the Commission the out-of-court dispute settlement bodies that they have certified in accordance with paragraph 2, including where applicable the specifications referred to in the second subparagraph of that paragraph as well as out-of-court dispute settlement bodies whose status has been revoked. The Commission shall publish a list of those bodies, including those specifications, on a dedicated website, and keep it updated.
Amendment 1264 #
2020/0361(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. Online platforms shall take the necessary technical and organisational measures to ensure that notices submitted by trusted flaggers through the mechanisms referred to in Article 14, are processed and decided upon with priority and without delay.
Amendment 1265 #
2020/0361(COD)
Proposal for a regulation
Article 19 – paragraph 1 a (new)
Article 19 – paragraph 1 a (new)
1a. The notices submitted by trusted flaggers do not in any way affect other notices. All notices submitted under those mechanisms referred to in Article 14 are processed and decided upon without delay and in accordance with the rules of the profession.
Amendment 1349 #
2020/0361(COD)
Proposal for a regulation
Article 20 – paragraph 4 a (new)
Article 20 – paragraph 4 a (new)
4a. Providers of hosting services could, as a voluntary measure in line with provisions Article 6, conduct own- investigation measures to prevent suspended accounts from reappearing before the suspension is lifted. The obligations related to paragraph 1 to 4 shall by no means impose general monitoring obligations on hosting services.
Amendment 1352 #
2020/0361(COD)
Proposal for a regulation
Article 21
Article 21
Amendment 1353 #
2020/0361(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
Amendment 1358 #
2020/0361(COD)
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
Amendment 1361 #
2020/0361(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 2
Article 21 – paragraph 2 – subparagraph 2
Amendment 1381 #
2020/0361(COD)
Proposal for a regulation
Article 22 – paragraph 1 – point c
Article 22 – paragraph 1 – point c
Amendment 1391 #
2020/0361(COD)
Proposal for a regulation
Article 22 – paragraph 1 – point f
Article 22 – paragraph 1 – point f
(f) a self-certification by the trader committing to only offer products or services that comply with the applicable rules of Union law and where applicable confirming that all products have been checked against the Union Rapid Alert System for dangerous non-food products (Rapex).
Amendment 1404 #
2020/0361(COD)
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
2. The online platform shall, upon receiving that information, make reasonable efforts to assess whether the information referred to in points (a), (d) (e) and (ef) of paragraph 1 is reliable through the use of any freely accessible official online database, like the Rapex system or online interfaces made available by a Member States or the Union or through requests to the trader to provide supporting documents from reliable sources. The online platform shall require that traders promptly inform them of any changes to the information referred to in points (a), (d), (e) and (f) and regularly repeat this verification process.
Amendment 1413 #
2020/0361(COD)
Proposal for a regulation
Article 22 – paragraph 3 – subparagraph 1
Article 22 – paragraph 3 – subparagraph 1
Where the online platform obtains indications that anyinformation under paragraph 1, letter (f) is inaccurate it shall remove the product or service directly from their online platform and if any other item of information referred to in paragraph 1 obtained from the trader concerned is inaccurate or incomplete, that platform shall request the trader to correct the information in so far as necessary to ensure that all information is accurate and complete, without delay or within the time period set by Union and national law.
Amendment 1459 #
2020/0361(COD)
Proposal for a regulation
Article 22 a (new)
Article 22 a (new)
Article 22a Obligation to inform consumers and authorities about illegal products and services 1. Where an online platform allows consumers to conclude distance contracts with traders, it shall be subject to additional information obligations for consumers. Where the online platform becomes aware of the illegal nature of a product or services offered by a trader on its interface it shall: (a) immediately remove the illegal product from its interface and inform relevant authorities about it; (b) maintain an internal database of content removed and/or recipients suspended pursuant to Article 20 to be used by internal content moderation systems tackling the identified risks; (c) where the online platform has the contact details of the recipients of its services, inform such recipients of the service that have purchased said product or service during the past twelve months about the illegality, the identity of the trader and options for seeking redress; (d) compile and make publicly available through application programming interfaces a repository containing information about illegal products and services removed from its platform in the past six months along with information about the concerned trader and options for seeking redress.
Amendment 1476 #
2020/0361(COD)
Proposal for a regulation
Article 23 – paragraph 2 a (new)
Article 23 – paragraph 2 a (new)
2a. Member States shall refrain from imposing additional transparency reporting obligations on the online platforms, other than specific requests in the context of exercising their supervisory powers.
Amendment 1503 #
2020/0361(COD)
Proposal for a regulation
Article 24 – paragraph 1 – point c a (new)
Article 24 – paragraph 1 – point c a (new)
(ca) contracted amount of payment for online advertising expressed in euros if it is a paid advertisement.
Amendment 1512 #
2020/0361(COD)
Proposal for a regulation
Article 24 – paragraph 1 b (new)
Article 24 – paragraph 1 b (new)
3. Providers of intermediary services shall obtain consent from the recipients of their service, in order to provide them with micro targeted and behavioural advertisement. Providers of intermediary services shall ensure that recipients of services can easily make an informed choice when expressing their consent by providing them with meaningful information.
Amendment 1552 #
2020/0361(COD)
Proposal for a regulation
Article 26 – paragraph 1 – introductory part
Article 26 – paragraph 1 – introductory part
1. Very large online platforms shall identify, analyse and assess, from the date of application referred to in the second subparagraph of Article 25(4), at least once a year thereafter, any significant systemic risks stemming from the functioning and use madedissemination of illegal content ofn their services in the Union. This risk assessment shall be specific to their services and shall include the following systemic risks:
Amendment 1567 #
2020/0361(COD)
Proposal for a regulation
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
(b) any negative effects for the exercise of the fundamental rights to respect for private and family life, freedom of expression and information, the prohibition of discrimination and the rights of the child, as enshrined in Articles 7, 11, 21 and 24 of the Charter respectively through dissemination of illegal content;
Amendment 1604 #
2020/0361(COD)
Proposal for a regulation
Article 27 – paragraph 1 – introductory part
Article 27 – paragraph 1 – introductory part
1. Very large online platforms shall put in place reasonable, proportionate and effective mitigation measures targeting illegal practices, tailored to the specific systemic risks identified pursuant to Article 26. Such measures may include, where applicable:
Amendment 1661 #
2020/0361(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point b
Article 28 – paragraph 1 – point b
(b) any voluntary commitments undertaken pursuant to the codes of conduct referred to in Articles 35 and 36 and the crisis protocols referred to in Article 37.
Amendment 1665 #
2020/0361(COD)
Proposal for a regulation
Article 28 – paragraph 2 – point a
Article 28 – paragraph 2 – point a
(a) are independent from the very large online platform concerned and have not provided any other service to the platform in the previous 12 months;
Amendment 1767 #
2020/0361(COD)
Proposal for a regulation
Article 31 – paragraph 4
Article 31 – paragraph 4
4. In order to be vetted, researchers shall be affiliated with academic institutions, be independent from commercial interests, disclose the funding of the research, have proven records of expertise in the fields related to the risks investigated or related research methodologies, and shall commit and be in a capacity to preserve the specific data security and confidentiality requirements corresponding to each request.
Amendment 1783 #
2020/0361(COD)
Proposal for a regulation
Article 31 – paragraph 7
Article 31 – paragraph 7
Amendment 1808 #
2020/0361(COD)
Proposal for a regulation
Article 33 a (new)
Article 33 a (new)
Article 33a Algorithm transparency 1. When using automated decision making, the very large online platform shall upon request provide the Commission with the necessary information to assess the algorithms used. 2. When carrying out the assessments referred to in paragraph 1, the Commission shall consider the following elements: (a) the compliance with corresponding Union requirements; (b) potential negative effects on fundamental rights, including on consumer rights, through dissemination of illegal content; 3. Following an assessment the Commission shall communicate its findings to the very large online platform and allow it to provide additional explanation. 4. Where the Commission finds that the algorithm used by the very large online platform does not comply with point (a) or (b) of paragraph 2 of this Article, the Commission shall inform the Digital Service Coordinator of establishment of the very large online platform.
Amendment 1846 #
2020/0361(COD)
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. The Commission and the Board shall encourage and facilitate the drawing up of voluntary codes of conduct at Union level to contribute to the proper application of this Regulation, taking into account in particular the specific challenges of tackling different types of illegal content and systemic risks, in accordance with Union law, in particular on competition and the protection of personal data. The Commission shall also encourage and facilitate regular review and adaption of the Codes of conduct to ensure that they are fit for purpose.
Amendment 1853 #
2020/0361(COD)
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where significant systemic risk within the meaning of Article 26(1) emerge and concern several very large online platforms, the Commission may invite the very large online platforms concerned, other very large online platforms, other online platforms and other providers of intermediary services, as appropriate, as well as civil society organisations and other interested partierelevant stakeholders, to participate in the drawing up of codes of conduct, including by setting out commitments to take specific risk mitigation measures, as well as a regular reporting framework on any measures taken and their outcomes.
Amendment 1864 #
2020/0361(COD)
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. When giving effect to paragraphs 1 and 2, the Commission and the Board shall aim to ensure that the codes of conduct clearly set out their objectives, contain key performance indicators to measure the achievement of those objectives and take due account of the needs and interests of all interested parties, including citizens, at Union level. The Commission and the Board shall also aim to ensure that participants report regularly to the Commission and their respective Digital Service Coordinators of establishment on any measures taken and their outcomes, as measured against the key performance indicators that they contain. Key performance indicators and reporting commitments should take into account differences in size and capacity between different participants.
Amendment 1945 #
2020/0361(COD)
Proposal for a regulation
Article 41 – paragraph 2 – subparagraph 1 – point e
Article 41 – paragraph 2 – subparagraph 1 – point e
(e) the power to adopt proportionate interim measures to avoid the risk of serious harm, without prejudice to fundamental rights.
Amendment 1978 #
2020/0361(COD)
Proposal for a regulation
Article 44 – paragraph 2 – point b a (new)
Article 44 – paragraph 2 – point b a (new)
(ba) the conditions met to justify any order to act against illegal content and to provide information taken that derogates from the internal market clause in accordance with Article 3 of Directive 2000/31/EC.
Amendment 2039 #
2020/0361(COD)
Proposal for a regulation
Article 47 – paragraph 2 – point a a (new)
Article 47 – paragraph 2 – point a a (new)
(aa) contributing to the effective application of Article 3 of Directive 2000/31/EC to prevent fragmentation of the digital single market;
Amendment 2088 #
2020/0361(COD)
Proposal for a regulation
Article 49 – paragraph 1 – point d a (new)
Article 49 – paragraph 1 – point d a (new)
(da) monitor derogations from the internal market clause in accordance with Article 3 of Directive 2000/31/EC and ensure that the conditions for derogation are interpreted strictly and narrowly to ensure consistent application of this Regulation;
Amendment 2089 #
2020/0361(COD)
Proposal for a regulation
Article 49 – paragraph 1 – point e
Article 49 – paragraph 1 – point e
(e) support and promote the development and implementation of European standards, guidelines, reports, templates and code of conducts in close collaboration with relevant stakeholders as provided for in this Regulation, as well as the identification of emerging issues, with regard to matters covered by this Regulation.
Amendment 2164 #
2020/0361(COD)
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
1. In the context of proceedings which may lead to the adoption of a decision of non-compliance pursuant to Article 58(1), where there is an urgency due to the risk of serious damage for the recipients of the service, the Commission may, by decision, order proportionate interim measures against the very large online platform concerned on the basis of a prima facie finding of an infringement, without prejudice to fundamental rights.
Amendment 2209 #
2020/0361(COD)
Proposal for a regulation
Article 59 – paragraph 1 – introductory part
Article 59 – paragraph 1 – introductory part
1. In the decision pursuant to Article 58, the Commission mayshall impose on the very large online platform concerned fines not exceeding 6% of its total turnover in the preceding financial year where it finds that that platform, intentionally or negligently:
Amendment 7 #
2020/0322(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) Health provisions of the Treaties are still largely under-used in terms of the purposes they could be used to achieve. The aim is therefore to ensure that this Regulation makes the best possible use of the legal bases on health set out in the Treaty, in order to manifest the European Union’s strong health policy while preserving the normal functioning of the single market during serious cross-border threats to health.
Amendment 13 #
2020/0322(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide preparedness and response to all cross- border threats to health, the legal framework for epidemiological surveillance, monitoring, early warning of, and combating serious cross-border threats to health, as set out in Decision No 1082/2013/EU, needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators, and cooperation by Member States with the European Centre for Disease Prevention and Control (ECDC). Moreover, in order to ensure effective Union response to novel cross- border threats to health, the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of EU reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. The capacity for contact tracing should be strengthened via the creation of an automated system, using modern technologies without prejudice to the protection of personal data.
Amendment 14 #
2020/0322(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods, which provide for special obligations and tools for monitoring, early warning and combatting specific threats of a cross-border nature. Those measures include, in particular, relevant Union legislation in the area of common safety concerns in public health matters, covering goods such as pharmaceutical products, medical devices, personal protective equipment (PPE) and foodstuffs, substances of human origin (blood, tissues and cells, organs), and exposure to ionising radiation.
Amendment 22 #
2020/0322(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) To this end, Member States should provide the Commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. Information provided by the Member States should include the elements that Member States are obliged to report to the World Health Organization (WHO) in the context of the International Health Regulations (IHR)15 . In turn, the Commission should report to the European Parliament and to the Council on the state of play and progress with preparedness, response planning and implementation at Union level, including on corrective actions, every 2 years to ensure that national preparedness and response plans are adequate. In order to support the assessment of these plans, EU audits in Member States should be conducted, in coordination with the ECDC and Union agencies. Such planning should include in particular adequate preparedness of critical sectors of society, such as energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. __________________ 15World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
Amendment 33 #
2020/0322(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) As serious cross-border threats to health are not limited to Union borders, joint procurement of medical countermeasures should be extended to include European Free Trade Association States and Union candidate countries, in accordance with the applicable Union legislation. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU. The Commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council16 . The European Commission shall pay special attention to ensure that joint procurement of medical countermeasures within the meaning of Article 12, also includes procurement of orphan drugs. __________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
Amendment 37 #
2020/0322(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In order to achieve transparency, the Commission shall provide to the European Parliament complete, timely and accurate information on the ongoing negotiations and give an access to the tender documents for the purposes of carrying out the procedure referred to in Article 12 of this Regulation.
Amendment 57 #
2020/0322(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) This Regulation ensures coordinated action at European Union’s level, in order to avoid the closure of internal borders and the paralysis of the internal market, which could threaten the circulation of basic supplies, including medicines, medical products and personal protective equipment (PPE). It is therefore necessary to ensure the correct implementation of European law in the field of export restrictions through a permanent notification mechanism.
Amendment 59 #
2020/0322(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) The European Commission shall ensure that, at the time of the declaration of a state of emergency, the number of accommodation facilities in hospitals in the Member States as well as the number of available accommodation units in intensive care units in the Member States are known, for the purpose of cross- border movement of patients.
Amendment 61 #
2020/0322(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Inconsistent communication with the public and stakeholders such as healthcare professionals can have a negative impact on the effectiveness of the response from a public health perspective as well as on, encourage the dissemination of false information but also negatively affect economic operators. The coordination of the response within the HSC, assisted by relevant subgroups, should, therefore, encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication, based on robust and independent evaluation of public health risks, to be adapted to national needs and circumstances. Such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. Given the cross-sectoral nature of this type of crises, coordination should also be ensured with other relevant constituencies, such as the Union Civil Protection Mechanism established by Decision (EU) 2019/420 of the European Parliament and of the Council17 . __________________ 17Decision (EU) 2019/420 of the European Parliament and of the Council of 13 March 2019 amending Decision No 1313/2013/EU on a Union Civil Protection Mechanism (OJ L 77I , 20.3.2019, p. 1).
Amendment 66 #
2020/0322(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) The occurrence of an event that corresponds to serious cross-border threats to health and is likely to have Union-wide consequences should require the Member States concerned to take particular control or contact-tracing measures in a coordinated manner in order to identify people already contaminated and those persons exposed to risk. The Commission shall ensure the secure processing of such data and shall ensure that they are treated in accordance with the personal data protection. Such cooperation could require the exchange of personal data through the system, including sensitive information related to health and information about confirmed or suspected human cases of the disease, between those Member States directly involved in the contact-tracing measures. The exchange of personal data concerning health by the Member States has to comply with Article 9(2)(i) of Regulation (EU) 2016/679 of the European Parliament and of the Council18 . __________________ 18Regulation (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).
Amendment 81 #
2020/0322(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘medical countermeasure’ means medicinal products for human use and medical devices as defined in Directive 2001/83/EC of the European Parliament and of the Council23 and in Regulation (EU) 2017/745 of the European Parliament and of the Council24 or other goods or services for the for the purpose of preparedness and response to a serious cross-border threat to health among which especially drugs for the treatment of orphan diseases. __________________ 23 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 24Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
Amendment 82 #
2020/0322(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8a) ‘green lines’ means passable and safe passage transit corridors that in case of declared public health emergency at Union level allows Member States to preserve the free circulation of essential goods and medical countermeasures.
Amendment 83 #
2020/0322(COD)
Proposal for a regulation
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
1. The Health Security Committee (‘HSC’) is hereby established. It shall be composed of representatives of all the Member States, in two working formations:
Amendment 84 #
2020/0322(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point d
Article 4 – paragraph 2 – point d
(d) adoption of opinions and guidance, including on specific response measures for the Member States for the prevention and control of serious cross-border threats to health while taking into account the proper functioning of the single market.
Amendment 86 #
2020/0322(COD)
Proposal for a regulation
Article 4 – paragraph 6 – point c a (new)
Article 4 – paragraph 6 – point c a (new)
(ca) remote digital working in situations when the HSC cannot physically meet for justified reasons.
Amendment 95 #
2020/0322(COD)
Proposal for a regulation
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
4a. The Union preparedness and response plan also provides for measures to ensure the normal functioning of the single market during serious cross-border threat to health.
Amendment 100 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
(ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; access to diagnostic services during emergencies; basic and safe gender- sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 145 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3a. In accordance with the principle of transparency, the Commission shall regularly inform the European Parliament on the negotiations and other details of the joint procurement of medical countermeasures.
Amendment 147 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 3 b (new)
Article 12 – paragraph 3 b (new)
3b. The European Parliament reserves at all times the right to inspect the uncensored content of all contracts concluded in proceedings under this Article.
Amendment 159 #
2020/0322(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Member States are responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely and, complete and accurate information, data and documents transmitted and exchanged through the digital platform.
Amendment 165 #
2020/0322(COD)
Proposal for a regulation
Article 22 – paragraph 2 – point c a (new)
Article 22 – paragraph 2 – point c a (new)
(ca) take into account the need for the normal functioning of the single market, in particular the existence of green lines for free circulation of food and other medical countermeasures.
Amendment 166 #
2020/0322(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point c
Article 25 – paragraph 1 – point c
(c) activation of support from the ECDC as referred to in Regulation (EU) …/… [OJ: Please insert the number of Regulation ECDC [ISC/2020/12527]] to mobilise and deploy the EU Health Task Force. and in particular the establishment of a list of accommodation facilities in intensive care units in the Member States for the purpose of potential cross-border relocation of patients;
Amendment 167 #
2020/0322(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point c a (new)
Article 25 – paragraph 1 – point c a (new)
(ca) green lines under Article 25a of this Regulation.
Amendment 169 #
2020/0322(COD)
Proposal for a regulation
Article 25 a (new)
Article 25 a (new)
Article 25a Free movement of goods and services 1. After recognising a public health emergency under Article 23 of this Regulation, green lines shall be set up to allow the free movement of food and medical countermeasures within the internal market. The Commission is empowered to adopt delegated acts to supplement this Regulation with provisions on the establishment of the green lines referred to in the first subparagraph of paragraph 1. 2. Only on condition that the Commission grants prior authorisation Member States may, in accordance with Article 36 of TFEU, impose export restrictions on medical countermeasures concerning another Member State or Member States during a public health emergency at Union level. Upon receiving a request for prior authorisation referred to in the first subparagraph of paragraph 2 from a Member State, the Commission shall decide whether to grant it without delay. If within five days the Commission has not granted the prior authorisation in question, it shall be deemed granted.
Amendment 171 #
2020/0322(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
By 2025 and every 5 years thereafter the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council. The evaluation shall be conducted in accordance with the Commission’s better regulation guidelines. The evaluation shall include, in particular, an assessment of the operation of the EWRS and the epidemiological surveillance network, as well as the coordination of the response with the HSC and the impact of the Regulation on the proper functioning of the single market during serious cross-border threats to health.
Amendment 5 #
2020/0104(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The outbreak of the COVID-19 pandemic in early 2020 changed the economic outlook for the years to come in the Union and in the world, calling for an urgent and coordinated response from the Union in order to cope with the enormous economic and social consequences for all Member. The challenges linked to the demographic context have been amplified by COVID-19. The current COVID-19 pandemic as well as the previous economic and financial crisis have shown that developing sound and resilient economies and financial systems built on strong economic and social structures helps Member States to tackle and respond more efficiently to shocks and recover more swiftly from them. The medium and long- term consequences of the COVID-19 crisis on health care sector and overall economy will critically depend on how quickly Member States’ economies will recover from the crisis, which in turn depends on the fiscal space Member States have available to take measures to mitigate the social and economic impact of the crisis, and on the resilience of their economies. Reforms and investments to address structural weaknesses of the economies and strengthen their resilience will therefore be essential to set the economies back on a sustainable and cohesive recovery path and avoid further widening of the divergences in the Union.
Amendment 9 #
2020/0104(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The implementation of reforms contributing to achieve a high degree of resilience of domestic economies, strengthening adjustment capacity and unlocking growth potential are among the Union’s policy priorities. They are therefore crucial to set the recovery on a sustainable path and support the process of upward economic and social convergence. This is even more necessarycrucial in the aftermath of the pandemic crisis to pave the way for a swift recovery and long-term economic development.
Amendment 13 #
2020/0104(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Past experiences have shown that investment is often drastically cut during crises. However, it is more than essential to support investment with European added value that can contribute in this particular situation to speed up the recovery and strengthen long- term growth potential. Investing in green, sustainable and digital technologies, capacities and processes aimed at assisting clean energy transition, boosting energy efficiency in housing, overall productivity and other key sectors of the economic are important to achievepromote and to achieve inclusive long- term sustainable economic growth and help create jobdecent and high-quality jobs for all, along with improving living standards. It will also help make the Union more resilient and less dependent by diversifying key supply chains.
Amendment 15 #
2020/0104(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Past experiences have shown that investment is often drastically cut during crises. However, it is essential to support investment in this particular situation to speed up the recovery and strengthen long- term growth potential. Investing in green and digital technologies, capacities and processes aimed at assisting clean energy transition, boosting energy efficiency in housing and other key sectors of the economic are important to achieve sustainable growth and overall help create jobs, as well as foster mid-term competitiveness. It will also help make the Union more resilient and less dependent by diversifying key supply chains. and boosting a knowledge based economy
Amendment 22 #
2020/0104(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Against this background, it is necessary to strengthen the current framework for the provision of support to Member States and provide direct financial support to Member States through an innovative tool. To that end, a Recovery and Resilience Facility (the ‘Facility’) should be established under this Regulation to provide effective financial and significant support to step up the implementation of reforms and related public investments in thethat will entail an improvement of the sustainability and competitiveness of Member States economics. The Facility should be comprehensive and should also benefit from the experience gained by the Commission and the Member States from the use of the other instruments and programmes.
Amendment 23 #
2020/0104(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Against this background, it is necessary to strengthen the current framework for the provision of support to Member States and provide robust direct financial support to Member States through an innovative tool. To that end, a Recovery and Resilience Facility (the ‘Facility’) should be established under this Regulation to provide effective financial and significant support to step up the implementation of reforms and related public investments in the Member States. The Facility should be comprehensive and should also benefit from the experience gained by the Commission and the Member States from the use of the other instruments and programmes.
Amendment 27 #
2020/0104(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Recovery and Resilience Facility should be carried out to address the unprecedented impact of the COVID-19 crisis on health care sector and overall economy. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [EURI].
Amendment 29 #
2020/0104(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Reflecting the European Green Deal as Europe’s sustainable growth strategy, together with other economic development objectives, and the translation of the Union’s commitments to implement the Paris Agreement and the United Nations’ Sustainable Development Goals, the Facility established by this Regulation will contribute to mainstreaming climate actions and environmental sustainability and to the achievement of an overall target of 25 % of the EU budget expenditures supporting climate objectives.s long as they may not hinder European Union’s industry growth capacity, affected as it has been by COVID-19 crisis
Amendment 35 #
2020/0104(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to implement these overall objectives, relevant actions will be identified during the Facility’s preparation and implementation, and reassessed in the context of the relevant evaluations and review processes. Also, due attention should be paid to the impact of the national plans submitted under this Regulation on fostering not only the green transition, but also the digital transformation and the development of a knowledge based economy. They will both play a priority role in relaunching and modernising our economy.
Amendment 36 #
2020/0104(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to implement these overall objectives, relevant actions will be identified during the Facility’s preparation and implementation, and reassessed in the context of the relevant evaluations and review processes. Also, due attention should be paid to the impact of the national plans submitted under this Regulation on fostering not only the green transition, but also the digital transformation. They will both play a prioritycrucial role in relaunching, transforming and modernising our economy.
Amendment 41 #
2020/0104(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) The Facility’s general objective should be the promotion of economic, social and territorial cohesion for a more harmonious development across Member States. For that purpose, it should contribute to improving the resilience and adjustment capacity of the Member States, mitigating the social and economic impact of the crisis which can strengthen citizens’ trust in European institutions, and supporting the green and digital transitions aimed at achieving a climate neutral Europe by 2050, thereby restoring the growth potential of the economies of the Union in the aftermath of the crisis, fostering employment creation and to promoting sustainable growththat would lead to fostering high-quality job creation for all and promoting sustainable, inclusive long-term economic growth fuelled by eco-efficiency improvements, health care resilient measures, climate actions and social inclusion policies .
Amendment 53 #
2020/0104(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure its contribution to the objectives of the Facility, the recovery and resilience plan should comprise measures for the implementation of reforms and public investment projects through a coherent recovery and resilience plan. The recovery and resilience plan should be consistent with the relevant country- specific challenges and priorities identified in the context of the European Semester, with the national reform programmes, the national energy and climate plans, the just transition plans, and the partnership agreements and operational programmes adopted under the Union funds. To boost actions that fall within the priorities of the European Green Deal and the Digital Agenda, the plan should also set out measures that are relevant for the green, sustainable and digital transitions. The measures should enable a swift deliver of targets, objectives and contributions set out in national energy and climate plans and updates thereof. All supported activities should be pursued in full respect of the climate and environmental priorities of the Union.
Amendment 66 #
2020/0104(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In order to ensure the national ownership and a focus on relevant reforms and investments, Member States wishing to receive support should submit to the Commission a recovery and resilience plan that is duly reasoned and substantiated. The recovery and resilience plan should set out the detailed set of measures for its implementation, including targets and milestones, and the expected impact of the recovery and resilience plan on growth potential,sustainable and inclusive long-term growth potential, attraction of investments, high-quality job creation for all and economic, territorial and social resilience for a better reaction on different types of asymmetrical and symmetrical shocks; it should also include measures that are relevant for the green and the digital transitions, health care resilient measures, stronger competitiveness; it should also include an explanation of the consistency of the proposed recovery and resilience plan with the relevant country- specific challenges and priorities identified in the context of the European Semester. Close cooperation between the Commission and the Member States should be sought and achieved throughout the process.
Amendment 72 #
2020/0104(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The Commission should assess the recovery and resilience plan proposed by the Member States and should act in close cooperation with the Member State concerned. The Commission will fully respect the national ownership of the process and will therefore take into account the justification and elements provided by the Member State concerned and assess whether the recovery and resilience plan proposed by the Member State is expected to contribute to effectively address challenges identified in the relevant country-specific recommendation addressed to the Member State concerned or in other relevant documents officially adopted by the Commission in the European Semester; whether the plan contains measures that effectively contribute to the green and the digital transitions, better health care resilience, stronger competitiveness and to addressing the challenges resulting from them; whether the plan is expected to have a lasting impact in the Member State concerned; whether the plan is expected to effectively contribute to strengthen the growth potential,sustainable and inclusive long-term growth potential, attraction of investments, high-quality job creation for all and economic, territorial and social resilience of the Member State, mitigate the economic and social impact of the crisis and contribute to enhancing economic, social and territorial cohesion for a more harmonious development across Member States; whether the justification provided by the Member State of the estimated total costs of the recovery and resilience plan submitted is reasonable and plausible and is commensurate to the expected impact on the economy and employment; whether the proposed recovery and resilience plan contains measures for the implementation of reforms and public investment projects that represent coherent, effective and adequate actions; and whether the arrangement proposed by the Member State concerned are expected to ensure effective implementation of the recovery and resilience plan, including the proposed milestones and targets, and the related indicators.
Amendment 103 #
2020/0104(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The general objective of the Recovery and Resilience Facility shall be to promote the Union’s economic, social and territorial cohesion for a more harmonious development by improving the resilience and adjustment capacity of the Member States, mitigating the social and economic impact of the crisis which can strengthen citizens’ trust in European institutions, and supporting the green and digital transitions, thereby contributing to restoring the growth potential of the economies of the Union, fostering employment creation in the aftermath of the COVID-19 crisis, and promoting sustainable growtheconomic long-term growth fuelled by eco-efficiency improvements, health care resilient measures, climate actions and social inclusion policies.
Amendment 105 #
2020/0104(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The general objective of the Recovery and Resilience Facility shall be to promote the Union’s economic, social and territorial cohesion by improving the resilience and adjustment capacity of the Member States, mitigating the social and economic impact of the crisis, and supporting the green a competitive knowledge based economy and digital transitions, thereby contributing to restoring the growth potential of the economies of the Union, fostering employment creation in the aftermath of the COVID-19 crisis, and promoting sustainable and competitive growth.
Amendment 108 #
2020/0104(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. To achieve that general objective, the specific objective of the Recovery and Resilience Facility shall be to provide Member States with financial support with a view to achieving the milestones and targets of reformsstructural reforms ( including those of public administration systems) and investments as set out in their recovery and resilience plans. That specific objective shall be pursued in close cooperation with the Member States concerned.
Amendment 141 #
2020/0104(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The outbreak of the COVID-19 pandemic in early 2020 changed the economic outlook for the years to come in the Union and in the world, calling for an urgent and coordinated response from the Union in order to cope with the enormous economic and social consequences for all Member. The structural challenges linked to the demographic context with asymmetrical consequences for Member States have been amplified by COVID-19. The current COVID-19 pandemic as well as the previous economic and financial crisis have shown that developing sound and resilient economies and financial systems built on strong economic and social structures helps Member States to respond more efficiently to shocks and recover more swiftly from them. The medium and long-term consequences of the COVID-19 crisis will critically depend on how quickly Member States’ economies will recover from the crisis, which in turn depends on the fiscal space Member States have available to take measures to mitigate the social and economic impact of the crisis, and on the resilience of their economies. Reforms and investments to address structural weaknesses of the economies and strengthen their resilience will therefore be essential to set the economies back on a sustainable and cohesive recovery path and avoid further widening of the divergences in the Union.
Amendment 147 #
2020/0104(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The recovery and resilience plans shall be consistent with the relevant country-specific challenges and priorities identified in the context of the European Semester, in particular those relevant for or resulting from the greenknowledge based economy and digital transition. The recovery and resilience plans shall also be consistent with the information included by the Member States in the national reform programmes under the European Semester, in their national energy and climate plans and updates thereof under the Regulation (EU)2018/199921 , in the territorial just transition plans under the Just Transition Fund22 , and in the partnership agreements and operational programmes under the Union funds. _________________ 21Regulation (EU)2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action. 22 […]
Amendment 162 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point b
Article 15 – paragraph 3 – point b
(b) an explanation of how the plan strengthens the growth potential, job creation and economic and social resilience of the Member State concerned, mitigates the economic and social impact of the crisis the improvement of the business fabric,, and its contribution to enhance economic, social and territorial cohesion and convergence;
Amendment 163 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point b
Article 15 – paragraph 3 – point b
(b) an explanation of how the plan strengthens the growth potential, job creation and economic and social resilience of the Member State concerned, mitigates the economic and social impact of the crisis, the improvement of the business fabric, and its contribution to enhance economic, social and territorial cohesion and convergence;
Amendment 166 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point b
Article 15 – paragraph 3 – point b
(b) an explanation of how the plan strengthens the growth potential, job creation and economic, territorial and social resilience of the Member State concerned, mitigates the economic and social impact of the crisis, and its contribution to enhance economic, social and territorial cohesion and convergence;
Amendment 168 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point c
Article 15 – paragraph 3 – point c
(c) an explanation of how the measures in the plan are expected to contribute to the greenknowledge based economy and the digital transitions or to the challenges resulting from them;
Amendment 175 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point h
Article 15 – paragraph 3 – point h
(h) the accompanying measures that may be needed; amongst other issues the reduction of national bureaucracies and increase of public private partnerships
Amendment 183 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – introductory part
Article 16 – paragraph 3 – introductory part
3. The Commission shall assess the importance and coherence of the recovery and resilience plan and its contribution to the greenknowledge based and digital transitions, as well as competitive economy and for that purpose, shall take into account the following criteria:
Amendment 186 #
2020/0104(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Past experiences have shown that investment is often drastically cut during crises. However, it is essential to support investmentstrategic investments with European added value in this particular situation to speed up the recovery and strengthen long- term growth potential. Investing in green and digital technologies, capacities and processes aimed at assisting clean energy transition, boosting energy efficiency in housing and other key sectors of the economic are important to achieve sustainable growth and help create jobs. It will also help make the Union more resilient and less dependent by diversifying key supply chains.
Amendment 190 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point b
Article 16 – paragraph 3 – point b
(b) whether the plan contains measures that effectively contribute to the greenknowledge based economy and the digital transitions as to develop a competitive economy or to addressing the challenges resulting from them;
Amendment 191 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point d
Article 16 – paragraph 3 – point d
(d) whether the recovery and resilience plan is expected to effectively contribute to strengthen the long-term growth potential, attraction of investments, high-quality job creation, for all and economic, territorial and social resilience of the Member State, mitigate the economic and social impact of the crisis, and contribute to enhance economic, social and territorial cohesion for a more harmonious development across Member States;
Amendment 196 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point f
Article 16 – paragraph 3 – point f
(f) whether the recovery and resilience plan contains measures for the implementation of reforms and public investments projects that represent coherent actions, and they might as well help job growth and the development of a knowledge based society;
Amendment 197 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point f
Article 16 – paragraph 3 – point f
(f) whether the recovery and resilience plan contains measures for the implementation of reforms and public investments projects that represent coherent, effective and adequate actions;
Amendment 207 #
2020/0104(COD)
(f) the arrangements for providing access by the Commission to the underlying relevant data, from the regional, local and national administrations.
Amendment 217 #
2020/0104(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Against this background, it is necessary to strengthen the current framework for the provision of support to Member States and provide robust direct financial support to Member States through an innovative tool. To that end, a Recovery and Resilience Facility (the ‘Facility’) should be established under this Regulation to provide effective financial and significant support to step up the implementation of reforms and related public and private investments in the Member States. The Facility should be comprehensive and should also benefit from the experience gained by the Commission and the Member States from the use of the other instruments and programmes.
Amendment 228 #
2020/0104(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Recovery and Resilience Facility should be carried out to address the unprecedented impact of the COVID-19 crisis especially on health care, tourism, creative industry and sports sector. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [EURI].
Amendment 303 #
2020/0104(COD)
Proposal for a regulation
Recital 14
Recital 14
Amendment 403 #
2020/0104(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In order to ensure the national ownership and a focus on relevant reforms and investments, Member States wishing to receive support should submit to the Commission a recovery and resilience plan that is duly reasoned and substantiated. The recovery and resilience plan should set out the detailed set of measures for its implementation, including targets and milestones, and the expected impact of the recovery and resilience plan on growth potential,sustainable and inclusive long-term growth potential, stimulating business environment, high- quality job creation and economic, territorial and social resilience; it should also include measures that are relevant for the green and the digital transitionssustainable green, digital and demographic transitions, health care resilient measures, convergence, stronger competitiveness, including recovery of tourism, creative industry and sports sector; it should also include an explanation of the consistency of the proposed recovery and resilience plan with the relevant country-specific challenges and priorities identified in the context of the European Semester. Close cooperation between the Commission and the Member States should be sought and achieved throughout the process.
Amendment 424 #
2020/0104(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The Commission should assess the recovery and resilience plan proposed by the Member States and should act in close cooperation with the Member State concerned. The Commission will fully respect the national ownership of the process and will thereforealso take into account the synergies created between the recovery and resilience plans of different Member States and the complementarity between those plans and other investment plans at national level that take into account the justification and elements provided by the Member State concerned and assess whether the recovery and resilience plan proposed by the Member State is expected to contribute to effectively address challenges identified in the relevanlatest country- specific recommendations addressed to the Member State concerned or in other relevant documents officially adopted by the Commission in the European Semester; whether the plan contains measures that effectively contribute to the green and the digital transitions and tosustainable green, digital and demographic transitions, better health care resilience, strong competitiveness, recovery of tourism, creative industry and sports sector and overall economy as well as addressing the challenges resulting from them; whether the plan is expected to have a lasting impact in the Member State concerned; whether the plan is expected to effectively contribute to strengthen the growth potential,sustainable and inclusive long-term growth potential, stimulating business environment, high- quality job creation and economic, territorial and social resilience of the Member State, mitigate the economic and social, social and demographic impact of the crisis and contribute to enhancing economic, social and territorial cohesion for a more harmonious development across Member States; whether the justification provided by the Member State of the estimated total costs of the recovery and resilience plan submitted is reasonable and plausible and is commensurate to the expected impact on the economy and employment; whether the proposed recovery and resilience plan contains measures for the implementation of reforms and public and private investment projects that represent coherent actions; and whether the arrangement proposed by the Member State concerned are expected to ensure effective implementation of the recovery and resilience plan, including the proposed milestones and targets, and the related indicators.
Amendment 463 #
2020/0104(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) To ensure that the financial support is frontloaded in the initial years after the crisis, and to ensure compatibility with the available funding for this instrument, the allocation of funds to the Member States should be made available until 31 December 20246. To this effect, at least 60 percent of the amount available for non- repayable support should be legally committed by 31 December 2022. The remaining amount should be legally committed by 31 December 20246.
Amendment 480 #
2020/0104(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) The request for a loan should be justified by the financial needs linked to additional reforms and investments included in the recovery and resilience plan, notably relevant for the green and digital transitions, and by therefore, by a higher cost of the plan than the maximum financial contribution (to be) allocated via the non-repayable contribution. It should be possible to submit the request for a loan together with the submission of the plan. In case the request for loan is made at a different moment in time, it should be accompanied by a revised plan with additional milestones and targets. To ensure frontloading of resources, Member States should request a loan support at the latest by 31 August 20246. For the purposes of sound financial management, the total amount of all the loans granted under this Regulation should be capped. In addition, the maximum volume of the loan for each Member State should not exceed 4.7% of its Gross National Income. An increase of the capped amount should be possible in exceptional circumstances subject to available resources. For the same reasons of sound financial management, it should be possible to pay the loan in instalments against the fulfilment of results.
Amendment 1166 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point d
Article 16 – paragraph 3 – point d
(d) whether the recovery and resilience plan is expected to effectively contribute to strengthen the growth potential, job creation, and economic, territorial and social resilience of the Member State, mitigate the economic and social, social and demographic impact of the crisis, and contribute to enhance economic, social and territorial cohesion;
Amendment 36 #
2020/0101(COD)
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) No 1303/2013 as regards exceptional additional resources and implementing arrangements under the Investment for growth and jobs goal and the European territorial cooperation goal to provide assistance for fostering crisis repair in the context of the COVID-19 pandemic and preparing a green, digital and resilient recovery of the economy (REACT-EU)
Amendment 38 #
2020/0101(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) Member States have been affected by the crisis due to the consequences of the COVID-19 pandemic in an unprecedented manner. The crisis hampers growth in Member States, which in turn aggravates the serious liquidity shortages due to the sudden and important increase in public investments needed in their health systems and other sectors of their economies. In addition, there is a feasible concern that patients' access to health care services will be limited in the medium and longer term. It also needs to be acknowledged and seriously considered that profound health inequalities across and within EU will most likely be exacerbated, thus deepening unmet medical needs and reducing the overall social cohesion in Member States. This has created an exceptional situation which needs to be addressed with specific measures.
Amendment 48 #
2020/0101(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) In order to redress huge shocks to the economy stemming from the exceptional restrictions put in place by Member States to contain the COVID-19 spreadingspread of COVID-19 and the risks of an asymmetric recovery stemmarising from the different national means available in different Member States, which resultinged in serious impacts on the functioning of the Internal Market, the European Council endorsed on 23 April 2020 the “Roadmap for recovery” with a strong investment component, called for the establishment of the European Recovery Fund and mandated the Commission to analyse the needs so that the resources would be targeted towards the sectors and geographical parts of the Union most affected, while clarifying also the link with the Multiannual Financial Framework for 2021-2027.
Amendment 51 #
2020/0101(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) In accordance with Regulation [European Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the European Investment and Structural Funds should be carried out to address the unprecedented impact of the COVID-19 crisis. Such additional resources should be used to ensure compliance with the time limits provided for in Regulation [ERI]. Moreover, additional resources for economic, social and territorial cohesion, particularly in the most deprived regions, should be made available through a revision of the multiannual financial framework for 2014- 2020.
Amendment 52 #
2020/0101(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) An additional exceptional amount of EUR 58 272 800 000 (in 2018 current prices) for budgetary commitment from the Structural Funds under the Investment for growth and jobs goal, for the years 2020, 2021 and 2022 and where justified by a Member State, also for the years 2023 and 2024, should be made available to support Member States and regions most impacted in crisis repair in the context of the COVID-19 pandemic or preparing a green, digital and resilient recovery of health systems and the economy, with a view tothe intention of deploying resources quickly to the real economy through the existing operational programmes. Resources for 2020 stem from an increase in the resources available for economic, social and territorial cohesion in the multiannual financial framework for 2014-2020 whereas resources for 2021 and 2022 and, where applicable, for 2023 and 2024, stem from the European Union Recovery Instrument. Part of the additional resources should be allocated to technical assistance at the initiative of the Commission. The Commission should set out the breakdown of the remaining additional resources for each Member State in a delegated act on the basis of an allocation method based on the latest available objective statistical data concerning Member States’ relative prosperity and the extent of the effect of the current crisis on their economies and societies to ensure harmonious development according to the principles of cohesion policy by promoting economic, social and territorial cohesion. The allocation method should include a dedicated additional amount for the rural, insular, mountainous and outermost regions given the specific vulnerability of their economies and societies. In order to reflect the evolving nature of the effects of the crisis, the breakdown should be revised in 2021 on the basis of the same allocation method using the latest statistical data available by 19 October 2021 to distribute the 2022 tranche, and where relevant, 2023 and 2024 tranches, of the additional resources.
Amendment 68 #
2020/0101(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) In order to allow maximum flexibility to Member States for tailoring crisis repair actions in the context of the COVID-19 pandemic or preparing a green, digital and resilient recovery of health systems and the economy, allocations should be established by the Commission at Member State level. Furthermore,, while taking into consideration those most impacted by the crisis. Furthermore, it should provide the possibility for usingof use of any additional resources to support aid for the most deprived should also be provided for. In addition, it is necessary to establish ceilings concerning the allocation to technical assistance at the initiative of the Member States while allowing maximum flexibility to the Member States as to its allocation within operational programmes supported by the ERDF or the ESF. It should be clarified that there is no need to respect the ESF minimum share for the additional resources. Nevertheless, the fact that the operational strength of the ESF should be maintained must not be disregarded. Taking account of the expected quick spending of the additional resources, the commitments linked to those additional resources should only be decommitted at the closure of the operational programmes.
Amendment 75 #
2020/0101(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In order to complement the actions already available under the scope of support of the ERDF, as extended by Regulations (EU) 2020/460 and (EU) 2020/558 of the European Parliament and of the Council5 , Member States should continue to be allowed to use the additional resources primarily for investments in products and services for health services, for providingincluding cross-border health services. Resources should be used to provide equal services for all citizens, as well as support in the form of working capital or investment support to SMEs, in operations contributing to the transition towards a digital and green economy, infrastructure providing basic services to citizens living in rural, insular, mountainous and outermost regions, or economic support measures for those regions most dependent on sectors most affected by the crisis, such as tourism which generates about 10% of the EU's GDP, employs about 13 million workers and is the fourth largest export industry. The data shows that it is necessary to revitalize this economic sector as soon as possible, and it is especially important for all Member States in which tourism is of strategic importance. Technical assistance should also be supported. It is appropriate that the additional resources are focused exclusively under the new thematic objective “"Fostering crisis repair in the context of the COVID-19 pandemic and preparing a green, digital and resilient recovery of the economy”", which should also constitute a single investment priority, to allow for simplified programming and implementation of the additional resources. _________________ 5 Regulation (EU) 2020/460 of the European Parliament and of the Council of 30 March 2020 amending Regulations (EU) No 1301/2013, (EU) No 1303/2013 and (EU) No 508/2014 as regards specific measures to mobilise investments in the healthcare systems of Member States and in other sectors of their economies in response to the COVID-19 outbreak (Coronavirus Response Investment Initiative) (OJ L99, 31.3.2020, p. 5); Regulation (EU) 2020/558 of the European Parliament and of the Council of 23 April 2020 amending Regulations (EU) No 1301/2013 and (EU) No 1303/2013 as regards specific measures to provide exceptional flexibility for the use of the European Structural and Investments Funds in response to the COVID-19 outbreak, (OJ L 130, 23.4.2020, p. 1).
Amendment 88 #
2020/0101(COD)
(9a) In order to enable equal access to health care, reduce unmet medical needs and increase resilience to future health crises, additional resources for the ERDF should also be used to develop centres of excellences for specific disease and health crises around the EU by providing financial support for the procurement of medicinal products and medical devices, as well as supporting the additional specialization of already established centres for complex diseases and virus research. Stronger health cooperation, coordination and resilience can be fostered by developing a network of centres of excellence around the EU, evenly deployed between Member States and its regions, each specialised in providing specific treatment for all European citizens that are in need of a such health service and treatment.
Amendment 89 #
2020/0101(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) For the ESF, Member States should primarily use the additional resources to support the modernisation of the labour market, health and social systems, as well as comprehensive lifelong learning strategies in order to negate long-term unemployment and support job maintenance, including through short-time work schemes and significant support to self-employed, job creation, in particular for people in vulnerable situations and those who are living in rural, insular, mountainous and outermost regions, support to youth employment measures, education and training, skills development and to enhance access to social services of general interest, including for children for all citizens, including children. Special attention should be given to measures supporting training and mobilisation of health and social care workers, particularly in the context of increasing resilience for potential future crises. It should be clarified that in the present exceptional circumstances support to short-time work schemes for employees and the self- employed in the context of the COVID-19 pandemic can be provided even when that support is not combined with active labour market measures, unless the latter are imposed by the national law. Union support to those short-time work schemes should be limited in time.
Amendment 104 #
2020/0101(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) In order to ensure that Member States have sufficient financial means to swiftly implement crisis repair actions in the context of the COVID-19 pandemic and preparing a green, digital and resilient recovery of health systems and the economy, it is necessary to provide a higher level of initial pre- financing payment or, where applicable, annual pre- financing, for the quick implementation of actions supported by the additional resources. This pre-financing rate will serve as a defence mechanism against the economic and social consequences, as the beneficiaries of the Funds need a strong momentum in ensuring the financial liquidity. The initial pre- financing to be paid should ensure that Member States have the means to arrange for advance payments to beneficiaries where necessary and to reimburse beneficiaries quickly following the submission of payment claims, as more current available resources mean more opportunities to react.
Amendment 111 #
2020/0101(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) With a view to alleviating the burden on public budgets regarding crisis repair in the context of the COVID-19 pandemic and preparing a green, digital and resilient recovery of health systems and the economy, Member States should be given the exceptional possibility to request a co- financing rate of up to 100 % to be applied to the separate priority axes of operational programmes providing support from the additional resources.
Amendment 113 #
2020/0101(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) In order to enable Member States to deploy the additional resources for crisis repair quickly in the context of the COVID-19 pandemic and preparing a green, digital and resilient recovery of the health systems and economy within the current programming period, it is justified to exempt, on an exceptional basis, Member States from the need to comply with ex ante conditionalities and requirements on the performance reserve and application of the performance framework, on thematic concentration, also in relation to the thresholds established for sustainable urban development for the ERDF, and requirements on preparation of a communication strategy for the additional resources. It is nevertheless necessary that Member States carry out at least one evaluation by 31 December 2024, or by 31 December 2026 where additional resources are made available for budgetary commitment in 2023 and 2024, to assess the effectiveness, efficiency and impact of the additional resources as well as how they contributed to achieving the goals of the new dedicated thematic objective. To facilitate the availability of comparable information at Union level, Member States are encouraged to make use of the programme-specific indicators made available by the Commission. In addition, while carrying out their responsibilities linked to information, communication and visibility, Member States and managing authorities should enhance the visibility of the exceptional measures and resources introduced by the Union, in particular by ensuring that potential beneficiaries, beneficiaries, participants, final recipients of financial instruments and the general public are aware of the existence, volume and additional support stemming from the additional resources.
Amendment 130 #
2020/0101(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) With a view to allow the targeting of these additional resources to the geographic areas where they are most needed, as an exceptional measure and without prejudice to the general rules for allocating Structural Funds resources, particularly in the most deprived regions, the additional resources allocated to the ERDF and the ESF are not to be broken down per category of region. However, Member States are expected to take into account the different regional needs and development levels in order to ensure that focus is maintained on less developed regions, in accordance with the objectives of economic, social and territorial cohesion set out in Article 173 TFEU. Member States should also involve local and regional authorities, as well as relevant bodies representing civil society, in accordance with the partnership principles.
Amendment 135 #
2020/0101(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) In order to facilitate the transfers authorised by the changes introduced under this Regulation, the condition laid down in Article 30(1)(f) of the Financial Regulation regarding the use of appropriations for the same objective should not apply in respect ofto those transfers.
Amendment 139 #
2020/0101(COD)
Proposal for a regulation
Recital 19
Recital 19
Amendment 145 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – title
Article 92 b – title
Exceptional additional resources and implementing arrangements for the Investment for growth and jobs goal and the European territorial cooperation goal to provide assistance for fostering crisis repair in the context of the COVID-19 pandemic and preparing a green, digital and resilient recovery of the economy (REACT-EU)
Amendment 148 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 1
Article 92 b – paragraph 1
1. TUp to 95% of the additional resources referred to in Articles 91(1a) and 92a (‘the additional resources’) shall be made available under the Investment for growth and jobs goal to, and a minimum of 5 % of those resources shall be made available under the European territorial cooperation goal. In both cases, the additional resources shall provide assistance for fostering crisis repair in the context of the COVID-19 pandemic and preparing a green, digital and resilient recovery of the economy (REACT-EU). The additional resources shall be used to implement technical assistance pursuant to paragraph 6 of this Article and the operations implementing the thematic objective in paragraph 10 of this Article.
Amendment 162 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 5 – subparagraph 6
Article 92 b – paragraph 5 – subparagraph 6
Each Member State shall allocate the additional resources available for programming under the ERDF and the ESF to operational programmes involving public authorities as well as relevant bodies representing civil society, in accordance with the partnership principle, bearing in mind that this approach adds value to the implementation of European public policies. Up to 5 % of the additional resources shall be used for cross-border projects.
Amendment 174 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 8 – subparagraph 1
Article 92 b – paragraph 8 – subparagraph 1
8. The additional resources not allocated to technical assistance shall be used under the thematic objective set out in paragraph 10 to support operations fostering crisis repair in the context of the COVID-19 pandemic or, focusing for example on the revitalization of tourism, health and other hardest-hit sectors, as well as preparing a green, digital and resilient recovery of the economy.
Amendment 182 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 8 – subparagraph 3
Article 92 b – paragraph 8 – subparagraph 3
For the ERDF, the additional resources shall primarily be used to support investment in products and services for health infrastructure, systems and services, including cross-border health services, to provide support in the form of working capital or investment and advisory support to SMEs, investments contributing to the transition towards a digital and green economy, investments in infrastructure providing basic services to citizens living in rural, insular, mountainous and outermost regions, and economic measures in the regions which are most dependent on sectors most affected by the crisis such as tourism. Additional resources may also be used to develop centres of excellence for specific diseases and health crises around the EU by providing financial support for the procurement of medicinal products and medical devices, as well as supporting the additional specialization of already established centres for complex diseases and virus research, which will enable equal access to health care, reduce unmet medical needs and increase resilience to future health crises.
Amendment 194 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 8 – subparagraph 4
Article 92 b – paragraph 8 – subparagraph 4
For the ESF, the additional resources shall primarily be used to support the modernisation of the labour market, health and social systems, as well as comprehensive lifelong learning strategies in order to negate long-term unemployment and support job maintenance, including through short-time work schemes and significant support to self- employed, even when that support is not combined with active labour market measures, unless the latter are imposed by national law. The additional resources shall also support job creation, in particular for people in vulnerable situations and for those living in rural, insular, mountainous and outermost regions, youth employment measures, education and training, skills development, in particular to support the twin green and digital transitions, and to enhance access to social services of general interest, including for children. Special attention shall be given to measures supporting training and the mobilisation of health and social care workers, particularly in the context of increasing resilience for potential future crises.
Amendment 214 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 9 – subparagraph 5
Article 92 b – paragraph 9 – subparagraph 5
The revised financing plan set out in Article 96(2)(d) shall set out the allocation of the additional resources for the years 2020, 2021 and, where applicable, for 2022, 2023 and 2024, without identifying amounts for the performance reserve and with no breakdown per category of regions.
Amendment 217 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 9 – subparagraph 6
Article 92 b – paragraph 9 – subparagraph 6
By way of derogation from Article 30(1), requests for the amendment of a programme submitted by a Member State shall be duly justified and shall in particular set out expected impact of the changes to the programme on fostering crisis repair in the context of the COVID- 19 pandemic and preparing a green, digital and resilient recovery of health systems and the economy. They shall be accompanied by the revised programme.
Amendment 38 #
2020/0036(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) A fixed and unanimously accepted by the Member States long-term objective is crucial to contribute to economic and societal transformation, jobs, growth, and the achievement of the United Nations Sustainable Development Goals, as well as to move 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 59 #
2020/0036(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Achieving climate neutrality should require a contribution from all economic sectors, proportional long-term commitment by the EU budget and should be adapted to sectoral and regional specificities in order to make the transition economically viable, just and socially fair. In light of the importance of energy production and consumption on greenhouse gas emissions, the transition to a sustainable, affordable and secure energy system relying on a well-functioning internal energy market is essential. The digital transformation, technological innovation, and research and development are also important drivers for achieving the climate-neutrality objective.
Amendment 104 #
2020/0036(COD)
(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 competitiveness of the economy; energy and food security 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; 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; different regions need an individual pace towards achieving climate neutrality, which can only be set after comprehensive impact assessment taking into account the effect on regional development, industry and employment.
Amendment 116 #
2020/0036(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) The transition to climate neutrality requires changes across the entire policy spectrum, ambitious and sustained financing and a collective effort of all sectors of the economy and society, as illustrated by the Commission in its Communication ‘The European Green Deal’. The European Council, in its Conclusions of 12 December 2019, stated that all relevant Union legislation and policies need to be consistent with, and contribute to, the fulfilment of the climate- neutrality objective while respecting a level playing field, and invited the Commission to examine whether this requires an adjustment of the existing rules.
Amendment 124 #
2020/0036(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The Commission, in its Communication ‘The European Green Deal’, announced its intention to assess and make proposals for increasing the Union’s greenhouse gas emission reduction target for 2030 to ensure its consistency with the climate-neutrality objective for 2050. In that Communication, the Commission underlined that all Union policies should contribute to the climate-neutrality objective and that all sectors should play their part. By September 20201, the Commission should, based on a comprehensive impact assessment and taking into account its analysis of the integrated national energy and climate plans submitted to the Commission in accordance with Regulation (EU) 2018/1999 of the European Parliament and of the Council36 , reviewpropose a revision of the Union’s 2030 target for climate and, explore options for a new 2030 target of 50up to 55 % emission reductions compared with 1990 levels and propose commensurate funding through the EU budget to achieve the possible new target. Where it considers necessary to amend the Union’s 2030 target, it should make proposals to the European Parliament and to the Council to amend this Regulation as appropriate. In addition, the Commission should, by 30 June 2021, assess how the Union legislation implementing that target would need to be amended in order to achieve emission reductions of 50up to 55 % compared to 1990. _________________ 36Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1).
Amendment 128 #
2020/0036(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The Commission, in its Communication ‘The European Green Deal’, announced its intention to assess and make proposals for increasing the Union’s greenhouse gas emission reduction target for 2030 to ensure its consistency with the climate-neutrality objective for 2050. In that Communication, the Commission underlined that all Union policies should contribute to the climate-neutrality objective and that all sectors should play their part. By September 2020, the Commission should, based on a comprehensive impact assessment and taking into account its analysis of the integrated national energy and climate plans submitted to the Commission in accordance with Regulation (EU) 2018/1999 of the European Parliament and of the Council36 , review the Union’s 2030 target for climate and explore options for a new 2030 target of 50up to 55 % emission reductions compared with 1990 levels. Where it considers necessary to amend the Union’s 2030 target, it should make proposals to the European Parliament and to the Council to amend this Regulation as appropriate. In addition, the Commission should, by 30 June 2021, assess how the Union legislation implementing that target would need to be amended in order to achieve emission reductions of 50up to 55 % compared to 1990. _________________ 36Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1).
Amendment 133 #
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 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 Union measures have led to loss of regional competitiveness and jobs in sectors of the economy or that a Member State’s measures are inconsistent with the climate-neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience and reduce vulnerability to climate change.
Amendment 136 #
2020/0036(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The Commission should ensure a robust and objective assessment based on the most up to date scientific, technical and socio-economic findings, and representative of a broad range of independent expertise, and base its assessment on relevant information including information submitted and reported by Member States, reports of the European Environment Agency, best available scientific evidence, including the reports of the IPCC and a comprehensive socio-economic and sectoral impact assessment of any proposed new target. Given that the Commission has committed to exploring how the EU taxonomy can be used in the context of the European Green Deal by the public sector, this should include information on environmentally sustainable investment, by the Union and Member States, consistent with Regulation (EU) 2020/… [Taxonomy Regulation] when such information becomes available. The Commission should use European statistics and data where available and seek expert scrutiny. The European Environment Agency should assist the Commission, as appropriate and in accordance with its annual work programme.
Amendment 151 #
2020/0036(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In order to provide predictability and confidence for all economic actors, including businesses, workers, investors and consumers, to ensure that the transition towards climate neutrality is well adjusted to the socio-economic realities in all regions and irreversible, to ensure gradual reduction over time and to assist in the assessment of the consistency of measures and progress with the climate- neutrality objective, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to set out a trajectory for achieving net zero greenhouse gas emissions in the Union by 2050Commission should carry a comprehensive socio-economic and sectoral impact assessment. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making37 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 37 OJ L 123, 12.5.2016, p. 1.
Amendment 158 #
2020/0036(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Climate change is by definition a trans-boundary challenge and a coordinated action at Union level is needed to effectively supplemenort and reinforce national and regional policies. Since the objectives of this Regulation, namely to achieve climate neutrality in the Union by 2050, cannot be sufficiently achieved by the Member States alone, but can rather, by reason of the scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve those objectives,
Amendment 163 #
2020/0036(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
This Regulation sets out a binding objective of climate neutrality in the Union by 2050, adopted unanimously by the Member States, in pursuit of the long-term temperature goal set out in Article 2 of the Paris Agreement, and provides a framework for achieving progress in pursuit of the global adaptation goal established in Article 7 of the Paris Agreement.
Amendment 179 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. TUpon agreement, the relevant Union institutions and the Member States shall take the necessary measures at Union and national level respectively, to enable the collective achievement of the climate- neutrality objective set out in paragraph 1, after taking into account the social, economic and territorial context as well the importance of promoting fairness and solidarity among Member States.
Amendment 185 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. By September 20201 and after conducting socio-economic and sectoral impact assessment, the Commission shall reviewpropose a revision of the Union’s 2030 target for climate referred to in Article 2(11) of Regulation (EU) 2018/1999 in light of the climate-neutrality objective set out in Article 2(1), and explore options for a new 2030 target of 50up to 55% emission reductions compared to 1990 and propose commensurate funding through the EU budget to achieve the possible new target. Where the Commission considers that it is necessary to amend that target, it shall make proposals to the European Parliament and to the Council as appropriate.
Amendment 202 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 4
Article 2 – paragraph 4
4. By 30 June 20212, the Commission shall assess how the Union legislation implementing the Union’s 2030 target would need to be amended in order to enablpropose the achievement of 50up to 55 % emission reductions compared to 1990 and to achieve the climate-neutrality-objective set out in Article 2(1), and consider taking the necessary measures, including the adoption of legislative proposals, in accordance with the Treaties.
Amendment 220 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – introductory part
Article 3 – paragraph 3 – introductory part
3. When settproposing a trajectory in accordance with paragraph 1, the Commission shall consider the following:
Amendment 230 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point b a (new)
Article 3 – paragraph 3 – point b a (new)
(ba) ongoing and projected economic downturns due to symmetric or asymmetric shocks resulting in loss of jobs and regional decline;
Amendment 262 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point j
Article 3 – paragraph 3 – point j
(j) the best available and most recent scientific evidence, including the latest reports of the IPCC and a comprehensive socio-economic and sectoral impact assessment.
Amendment 280 #
2020/0036(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – introductory part
Article 5 – paragraph 1 – subparagraph 1 – introductory part
By 30 September 20234, and every 5 years thereafter, the Commission shall assess, together with the assessment foreseen under Article 29(5) of Regulation (EU) 2018/1999:
Amendment 293 #
2020/0036(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point b
Article 5 – paragraph 2 – point b
(b) the adequacy of Union measures and funding to ensure progress on adaptation as referred to in Article 4.
Amendment 296 #
2020/0036(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where, based on the assessment referred to in paragraphs 1 and 2, the Commission finds that Union measures are inconsistent with the climate-neutrality objective set out in Article 2(1) or inadequate to ensure progress on adaptation as referred to in Article 4, or that the progress towards either the climate-neutrality objective or on adaptation as referred to in Article 4 is insufficient, or that Union measures have led to loss of competitiveness and jobs in specific regions, it shall take the necessary measures in accordance with the Treaties, at the same time as the review of the trajectory referred to in Article 3(1).
Amendment 302 #
2020/0036(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 – introductory part
Article 6 – paragraph 1 – subparagraph 1 – introductory part
By 30 September 20234, and every 5 years, thereafter the Commission shall assess:
Amendment 306 #
2020/0036(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 – point b
Article 6 – paragraph 1 – subparagraph 1 – point b
(b) the adequacy of relevant national measures to ensure progress on adaptation as referred to in Article 4 and the various external to the Member States factors that influence the progress, including a state of force majeure.
Amendment 309 #
2020/0036(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Where the Commission finds, under due consideration of the collective progress assessed in accordance with Article 5(1), that a Member State’s measures are inconsistent with that objective as expressed by the trajectory referred to in Article 3(1) or inadequate to ensure progress on adaptation as referred to in Article 4, or that Union measures have led to loss of competitiveness and jobs in specific regions, it may issue recommendations to that Member State. The Commission shall make such recommendations publicly available.
Amendment 313 #
2020/0036(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point a
Article 6 – paragraph 3 – point a
(a) the Member State concerned shall take due account of the recommendation in a spirit of solidarity between Member States and the Union and between Member States, unless the latter have duly-justified objections to the draft recommendation;
Amendment 323 #
2020/0036(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point d
Article 7 – paragraph 1 – point d
(d) best available scientific evidence, including the latest reports of the IPCC; and a comprehensive socio-economic and sectoral impact assessment; and
Amendment 124 #
2019/2190(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Is convinced that the weak cybersecurity of connected devices can compromise product safety, and that this needs to be addressed in the revision of the relevant rules; therefore calls on the Commission to ensure that the scope of the GPSD also takes into account cybersecurity challenges by ensuring all the devices be remained up-to-date with continuously evolving industry web standards;
Amendment 138 #
2019/2190(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to speed up its efforts to develop a European cybersecurity certification scheme for AI, IoT and robotics products, in accordance with the EU cybersecurity framework, and to create mandatory certification schemes for consumer products that can be quickly updated to adapt to current risks without hindering innovation; further calls on the Commission to launch guidance on cybersecurity requirements and proper market surveillance mechanisms;
Amendment 141 #
2019/2190(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Is concerned that, since the beginning of the crisis caused by the pandemic, several EU Member States have had to return protective medical equipment imported from third countries, such as medical masks, because they failed to meet safety requirements as they were faulty products; calls on the European Commission to pay particular attention to the safety of medical devices when procuring crisis equipment supplies and creating common European reserve of emergency medical equipment.
Amendment 161 #
2019/2190(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Encourages the strengthening of the mutual cooperation among national authorities and bodies related to product safety such as consumer protection authorities, cybersecurity authorities, data protection authorities and customs authorities to ensure proper enforcement of relevant aspects related to consumer rights and product safety;
Amendment 226 #
2019/2190(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Asks the Commission to ensure that online marketplaces to enhance their cooperation with the competent authorities, consult Rapex before placing products on their websites, remove unsafe products swiftly, exchange information on sellers that break the rules, take effective measures against them and their supply chain, andput in place a robust business user authentication in line with product verification processes, and also develop an easily accessible tool for consumers to report unsafe products;
Amendment 19 #
2019/2171(INI)
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
- having regard to the Council conclusions on enhancing cooperation with Western Balkans partners in the field of migration and security of 5 June 2020,
Amendment 71 #
2019/2171(INI)
Motion for a resolution
Recital G
Recital G
G. whereas BiH is a migrant transit route, and reception capacities remain insufficient for hostingintegrated border management as well as reception capacities for migrants and asylum seekers present in the country remain insufficient;
Amendment 279 #
2019/2171(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Notes the increased migratory pressure on the country; calls for effective inter-institutional coordination of migration and border management in the face of a mounting humanitarian crisis; calls for equistable burden-sharing and adequate support for local communities hosting temporary reception centres; underlines the need toishing of reception capacities away from the EU external border, preferably at the entry points of migrants to the country; underlines the need for the European Commission, EU agencies and international organisations to provide assistance to BiH in ensureing appropriate reception conditions and to boosin boosting the relevant capacityies for processing incoming migrants and asylum- seeker claims and , where applicable, conducting return procedures; urges BiH to conclude an agreement with the European Asylum Support Office (EASO); calls on the EU to step up its support to BiH’s authorities, namely with regard to operational assistance;
Amendment 302 #
2019/2171(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Urges BiH to step up its efforts against cross-border crime, especially human trafficking, and to ensure swift conclusion of the status agreement with the European Border and Coast Guard Agency (Frontex) that would facilitate better protection of borders in full respect for fundamental rights, while helping fight cross-border crimecooperation with neighbouring countries and relevant EU agencies (Europol, Eurojust, Frontex) against cross-border crime, especially human trafficking¸ migrant smuggling networks, firearms and drug trafficking;