242 Amendments of Zofija MAZEJ KUKOVIČ
Amendment 29 #
2013/2135(INI)
Motion for a resolution
Citation 18 a (new)
Citation 18 a (new)
- having regard to the Commission communication entitled ‘A Stronger European Industry for Growth and Economic Recovery’ (COM(2012)0582),
Amendment 30 #
2013/2135(INI)
Motion for a resolution
Citation 18 a (new)
Citation 18 a (new)
- having regard to the European Parliament resolution of 15 March 2012 on a ‘Roadmap for moving to a competitive low carbon economy in 2050’ 1 , __________________ 1 Texts adopted, P7_TA(2012)0086.
Amendment 34 #
2013/2135(INI)
Motion for a resolution
Citation 18 b (new)
Citation 18 b (new)
- having regard to the State of the Union address by Mr Barroso to the European Parliament on 11 September 2013,
Amendment 35 #
2013/2135(INI)
Motion for a resolution
Citation 18 b (new)
Citation 18 b (new)
- having regard to ‘Renewable Energy: a major player in the European energy market’ COM(2012)271,
Amendment 53 #
2013/2135(INI)
Motion for a resolution
Recital A
Recital A
A. whereas climate targets, security of supply, and competitiveness and climate objectives are of the utmost importance for the EU, are inextricabnd deeply linked and, they must be equally addressed and considered on an equal footing;
Amendment 93 #
2013/2135(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas wind and solar energy producing installations peaked at 61% of total electricity output in Germany on June 16, 2013, showing that climate and energy policies are successful and should be seen as a role model boosting regional coordination and cooperation;
Amendment 175 #
2013/2135(INI)
Motion for a resolution
Recital I
Recital I
I. whereas studies indicate that upgrading the grids is the bestone way to improve the internal market, reduce energy costs and boost the competitiveness of industry;
Amendment 186 #
2013/2135(INI)
Motion for a resolution
Recital I a (new)
Recital I a (new)
Ia. whereas Eurostat figures show that around 40% of EU inhabitants already live in urban areas and urbanization is increasing, and renewable energy sources alleviate the particulate pollution that is present in the atmosphere; whereas transportation represents a considerable proportion of emissions and will be positively impacted by efficiency efforts;
Amendment 196 #
2013/2135(INI)
Motion for a resolution
Recital I b (new)
Recital I b (new)
Ib. whereas increased research in various new and sustainable kinds of energy and the exchange of best practice offers the best bid to a long-term solution to the problem;
Amendment 236 #
2013/2135(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Asks the Commission to take a multifaceted approach, the efficiency and cost-effectiveness of which ought to be enhanced byCalls on the Council to adopt and the Member States and the Commission to implement, for the EU 2030 climate and energy framework, an approach combining coordinated and, coherent policies that address in equal measure issues such as competitiveness, energy security and climate objectives (e.g.and ambitious binding targets in terms of GHG emissions reduction, renewable energy sources anddevelopment of RES and development of energy efficiency);
Amendment 249 #
2013/2135(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Asks the Commission to better take advantage of the interactions between these three targets in order for them to boost and strengthen competitiveness and energy security in the EU;
Amendment 276 #
2013/2135(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the European Council to keep up the progress made at EU level and, in order to maintain the continuity of the progress realised at the EU scale, to set ambitious butand realistic objectivetargets for the 2030 EU policies that take account of the economic, social, environmental, international and technological contexts, and to establish a clear, stable, long-term andclimate and energy policies in a cost- effective framework for industries and investorsmanner;
Amendment 309 #
2013/2135(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Considers that to keep the EU in the lead in terms of the development of technologies for a future low carbon economy, the EU shall set a binding target in terms of GHG emissions reduction in its 2030 framework;
Amendment 318 #
2013/2135(INI)
Motion for a resolution
Paragraph 3 d (new)
Paragraph 3 d (new)
3d. Is of the opinion that the development of RES contributes to the achievement of the GHG emissions reduction target, to decrease the need for fossil fuel imports and to increase the diversification of our energy sources; Therefore, considers that the EU shall set a binding target in terms of RES in its 2030 framework;
Amendment 322 #
2013/2135(INI)
Motion for a resolution
Paragraph 3 f (new)
Paragraph 3 f (new)
3f. Considers that the development of energy efficiency contributes to decrease the energy bill, to reduce our energy dependency and our energy trade balance, to the creation of new and non- relocatable activities, to face the rising energy prices and fight climate change; Recalls that the cheapest energy is the energy that is never used; Therefore, considers that the EU shall set a binding target for energy efficiency in its 2030 framework;
Amendment 391 #
2013/2135(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Notes that the investments necessary to achieve industrialisation of the next generation of renewables are currently being withheld due to the uncertainty about European political ambitions in the field of renewables;
Amendment 497 #
2013/2135(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Notes that the EU needs a comprehensive policy framework for 2030 that encourages investment ins and the long- term decarbonisation ofin non-ETS sectors; Underlines the significant unused potential of energy efficiency in specific sectors such as building or transport; Asks therefore calls on the Commission and the Member States to review the non- ETS targets while preserving the flexibility for Member States to define their own ways of meetachieving their effort sharing targets;
Amendment 635 #
2013/2135(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Underlines the importance of an energy strategy focused on boostingincreasing the EU's energy security and, economic and industrial competitiveness in the EU, jobs creation, social aspects and environmental sustainability by means ofthrough measures such as the diversification of supply routes, suppliers and sources and by increasing the, promoting energy efficiency and the increased deployment of RES;
Amendment 784 #
2013/2135(INI)
Motion for a resolution
Paragraph 28 b (new)
Paragraph 28 b (new)
28b. Asks the Commission to implement its set of key employment actions for the low carbon economy, to promote greater use of the EU financial instruments available for Member States, regional and local levels as well as for private sectors for smart low carbon investments, for instance by engaging with the European Investment Bank to further boost its capacity to lend in the field of resource efficiency and renewable energy;
Amendment 785 #
2013/2135(INI)
Motion for a resolution
Paragraph 28 c (new)
Paragraph 28 c (new)
28c. Underlines that the building sector counts for 40% of the EU energy gross consumption and that, according to the International Energy Agency, 80% of the energy efficiency potential in the building sector, and more than 50% in the industry sector, remain unexploited; Sees here a significant potential for reducing energy bills while creating unrelocatable jobs in the EU;
Amendment 797 #
2013/2135(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Calls on the Commission to launch a study analysing new and cost-efficient market designs with a view to ensuring reasonably pricedthe lowest possible electricity toprices for consumers and to preventing carbon leakage; aAsks therefore the Commission to come forward as soon as possible with an additional assessment and recommendations for further actions to prevent the risk of carbon leakage notably for the electricity intensive sectors, caused by reallocation of production facilities outside the EU, focusing in particular on additional scenarios in which limited or no further global action is taken on carbon emission reduction taking into account the international context;
Amendment 831 #
2013/2135(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Invites the Commission to developelaborate a way of measuring competitiveness between the EU and its main competitors, which could, for example, be based on fiscal policies, R&D, innovation, industriallevels of research and development, industry energy prices, environmental and energy prolicies and regulatory burden, wage and productivity levels, geological circumstances, infrastructure, and other relevant factors;
Amendment 845 #
2013/2135(INI)
Motion for a resolution
Paragraph 32 a (new)
Paragraph 32 a (new)
32a. Strongly believes that renewable energy is directly connected to new workplaces and economic growth, particularly with regard to maintaining high quality workplaces in Europe; underlines that the renewables target has the highest potential to spur long term development of high technology based workplaces;
Amendment 46 #
2013/2063(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on the Commission to take the lead in developing and promulgating standards and specifications supporting a safe, reliable and secure cloud; stresses that reliability, security and protection of data is needed for consumer confidence and competitiveness;
Amendment 49 #
2013/2063(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Stresses that standards are based on examples of best practices;
Amendment 50 #
2013/2063(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Insists that standards should enable easy and complete portability and a high degree of interoperability between cloud services; to increase and not limit competitiveness;
Amendment 120 #
2013/2022(INI)
Motion for a resolution
Paragraph 10 – indent 2
Paragraph 10 – indent 2
– education and training measures for healthcare workers in the area of patient and healthcare worker safety;
Amendment 131 #
2013/2022(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Urges the Member States to introduce, or strengthen if they already exist, arrangements for reporting adverse events which make it possible to identify those responsible in the event of a breakdown in the chain of care and learn lessons from such breakdowns and to ensure that all procedures are transparent;
Amendment 141 #
2013/2022(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Urges the Commission to consider once again the calls for the introduction of a database listing good practices with a view to fostering exchanges of such practices among the Member States; an adverse events database could prevent such events occurring in future and could serve as an example of good practice for providers;
Amendment 169 #
2013/2022(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Member States to use the most advanced technological means available to guarantee optimum patient safety, and, in particular, to introduce across the boarstandardised electronic health passports containing all relevant information about the patient, including his or her antecedents;
Amendment 194 #
2013/2022(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls on the Member States to provide patients with information about risks, safety levels and the measures taken to prevent adverse events in healthcare, in order to ensure that patients can give informed consent to the treatment they are being offered and, more generally, to enable patients to learn more about the issue of patient safety, and urges them to inform patients, through the appropriate organisational structures, about complaints procedures and the legal remedies available to them should adverse events in healthcare occur (e.g. through a patients’ rights representative);;
Amendment 209 #
2013/2022(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Calls on the Member States to encourage the submission of reports and the provision of feedback concerning patient safety not only from medical staff, but also from patients and their relatives. Their reporting should be transparent at all levels;
Amendment 231 #
2013/2022(INI)
Motion for a resolution
Paragraph 35
Paragraph 35
35. Calls on the Member States to establish a joint database to be used to compile information concerning adverse events in healthcare and to encourage the use of all relevant data collection mechanisms (including those based on confidential declarations). Patients should be dealt with in accordance with ethical principles and their personal data should be protected;
Amendment 151 #
2013/2006(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Holds that RISE must be geared towards kick-starting investment flows into Europe's south to reinvigorate growth, particularly through smart specialisation and the formation of clusters, including transnational clusters;
Amendment 224 #
2013/2006(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls on the Commission and the Member States to urgently complete the single market for energy, telecoms, green products and venture capital; urges the Commission to promote the use of the 'Made in Europe' brand to strengthen the single market and products of European origin;
Amendment 252 #
2013/2006(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Stresses that public procurement should be an innovation driver; believes that state aid guidelines should be open for innovation-enhancing policy measures; believes that standardisation and ecolabelling havehas an important role to play in the uptake of new technologies;
Amendment 282 #
2013/2006(INI)
Motion for a resolution
Paragraph 30 a (new)
Paragraph 30 a (new)
30a. Calls on Member States to implement the European Union patent without delay;
Amendment 315 #
2013/2006(INI)
Motion for a resolution
Paragraph 33
Paragraph 33
33. Acknowledges the importance of the TTIP undertaking; advocates that it should endeavour to phase out fossil fuel subsidies; advocates newly defining the likeness of products by distinguishing them on the basis of their carbon footprint;
Amendment 363 #
2013/2006(INI)
Motion for a resolution
Paragraph 42
Paragraph 42
42. Welcomes the EIB's capital increase; believes that it should have a 60 % low- carbon investment target by 2020;
Amendment 411 #
2013/2006(INI)
Motion for a resolution
Paragraph 49
Paragraph 49
49. Believes that the creation of national STEM platforms to exchange best practice could be beneficial in setting STEM targets; stresses that engineering and information technology are the most resilient fields for future employment;
Amendment 420 #
2013/2006(INI)
Motion for a resolution
Paragraph 52
Paragraph 52
52. Welcomes the decisions to implement the Youth Guarantee and promote an Alliance for Apprenticeships, especially in the fields of engineering and information technology; calls on industry to offer quality employment or traineeships to young people where possible, and to create quality internships with decent pay;
Amendment 481 #
Amendment 485 #
2013/2006(INI)
Motion for a resolution
Paragraph 61
Paragraph 61
61. Advocates a multi-regional industrial policy approach that relaunches sustainable growth in contracting economies; supports a high value added strategy in the integration of southernregional economies into global value chains;
Amendment 276 #
2013/2005(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Stresses that long-term harmonisation of renewable- and efficiency-related targets and incentives and of auxiliary energy costs across all Member States – or at least greater compatibility in this regard – is essential for a well-functioning internal energy market, at both the wholesale and retail level, and for creating favourable conditions for the long-term development of the low-emission energy sector;
Amendment 302 #
2013/2005(INI)
Motion for a resolution
Paragraph 20 – point 1 (new)
Paragraph 20 – point 1 (new)
(1) Calls on the budgetary authority to provide the Agency for the Cooperation of Energy Regulators (ACER) with the wherewithal to perform its duties and to achieve the goals laid down in the regulation on wholesale energy market integrity, transparency and efficiency; notes that this is necessary in order to complete an integrated and transparent internal electricity and gas market by 2014.
Amendment 311 #
2013/2005(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Urges the Commission and the Member States to coordinate infrastructure projects in a better way, thereby ensuring full EU- wide system connectivity and cost- effectiveness; encourages, to that end, the Commission and the Member States to ensure rapid assessment, selection and implementation of projects of common European interest, especially with regard to electricity and gas trans-border interconnectors, liquefied natural gas and and energy storage infrastructure, which are vital for a well- integrated and well-functioning energy market;
Amendment 406 #
2013/2005(INI)
Motion for a resolution
Paragraph 34
Paragraph 34
Amendment 43 #
2013/0232(COD)
Proposal for a decision
Article 6 – paragraph 1 – point d
Article 6 – paragraph 1 – point d
(d) the demonstration by ESE of its capacity to implement Eurostars-2, including receiving, allocating and monitoring the Union financial contribution, in the framework of indirect management of the Union budget in accordance with Articles 58, 60 and 61 of Regulation (EU, Euratom) No 966/2012, while fully respecting the bottom up approach of the Eurostars-2 programme;
Amendment 45 #
2013/0232(COD)
Proposal for a decision
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4a. In accordance with the principles of transparency and non-discrimination as laid out in Article 60(1) and 128(1) of Regulation (EU, Euratom) No 966/2012, calls for proposals organised by Eurostars-2 shall be published on the web-based Horizon 2020 Participant Portal.
Amendment 46 #
2013/0232(COD)
Proposal for a decision
Article 15 – paragraph 1
Article 15 – paragraph 1
1. By 31 December 2017 the Commission shall conduct an interim evaluation of Eurostars-2. The Commission shall prepare a report on that evaluation which includes conclusions and observations by the Commission. The Commission shall send that report to the European Parliament and to the Council by 30 June 2018. The interim evaluation of Eurostars-2 shall form part of and be compiled with the interim evaluation of Horizon 2020.
Amendment 53 #
2013/0064(COD)
Proposal for a decision
Recital 15
Recital 15
(15) The SST support programme should be financed by the Union in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union18. The maximum amount of Union funding for the SST support programme should be drawn from relevant programmes provided forEUR 70 million in current prices. It should primarily be drawn from the programmes dedicated to space policy in the multiannual financial framework for 2014- 2020, i.e. EGNOS/Galileo and Copernicus, preferably through specific budget lines under these programmes. In certain cases, contributions from the Internal Security Fund and the Horizon 2020 programme should also be possible but should be strictly limited to actions provided for in their basic acts, related to the protection of critical infrastructure and to space and security research respectively. Any increase in the Union contribution should be sought for among Galileo and Copernicus programmes. __________________ 18 OJ L 298, 26.10.2012, p. 1.
Amendment 82 #
2013/0064(COD)
Proposal for a decision
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) manage the funds to be drawn to the SST support programme and ensure the implementation of the SST support programme while providing transparency and clarity regarding the different sources of funding;
Amendment 83 #
2013/0064(COD)
Proposal for a decision
Article 6 – paragraph 1 – subparagraph 2 (new)
Article 6 – paragraph 1 – subparagraph 2 (new)
The Commission shall ensure the complementarity between the SST support programme and research activities related to the protection of space-based infrastructure carried out under the Horizon 2020 programme established by [reference to Horizon 2020 Regulation to be added once adopted]. It shall also facilitate its complementarity with the other European and international activities in this domain.
Amendment 89 #
2013/0064(COD)
Proposal for a decision
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) ownership of SST sensors or data processing capacities and adequate technical and human resources to operate them or data processing capacities;
Amendment 93 #
2013/0064(COD)
Proposal for a decision
Article 7 – paragraph 4
Article 7 – paragraph 4
4. The Member States which comply with the criteria set out in paragraph 1 and which are parties to the agreement referred to in Article 10 shall be eligible for financial contribution from the SST support programme. The Commission shall publish and update on its website the list of Member States and their respective financial contributions.
Amendment 96 #
2013/0064(COD)
Proposal for a decision
Article 8
Article 8
The European Union Satellite Centre (EUSC) shall participate in the implementation of the objective set out in point (c) of Article 3 and shall be eligible for financial contribution up to a ceiling from the SST support programme subject to the conclusion of the agreement referred to in Article 10.
Amendment 103 #
2013/0064(COD)
Proposal for a decision
Article 11 – paragraph 1 – subparagraph 2 – point a a (new)
Article 11 – paragraph 1 – subparagraph 2 – point a a (new)
(aa) Regulation (EU) No [...] of the European Parliament and the Council establishing the Copernicus Programme21a, Article 5 (c). __________________ 21a OJ L ....
Amendment 105 #
2013/0064(COD)
Proposal for a decision
Article 11 – paragraph 1 – subparagraph 2 – point b
Article 11 – paragraph 1 – subparagraph 2 – point b
(b) part of the contribution may also, to a limited extent and in accordance with their basic acts, be drawn from the programmes established by Regulation (EU) No [...] of the European Parliament and the Council establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, and crisis management21a, Article 3(2)(b) and (3)(e) and by Council Decision No […] establishing the Specific Programme implementing Horizon 202022 , Article 2(2)(b) and (c), annex part II, point 1.6.2 (d) and annex part III, point 6.3.4; __________________ 21a OJ L ... 22 COM(2011) 811 final, 30.11.2011. Reference to be updated after adoption.
Amendment 106 #
2013/0064(COD)
Proposal for a decision
Article 11 – paragraph 1 – subparagraph 2 – point c
Article 11 – paragraph 1 – subparagraph 2 – point c
Amendment 108 #
2013/0064(COD)
Proposal for a decision
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The annual appropriations shall be authorised by the budgetary authority within the limits foreseen for this activity under the programmes from which funding has been drawn. Any increase in the Union contribution shall be sought among Galileo and Copernicus programmes.
Amendment 110 #
2013/0064(COD)
Proposal for a decision
Article 13 – paragraph 1
Article 13 – paragraph 1
1. The Commission shall monitor the implementation of the SST Support Programme and inform annually the European Parliament and the Council.
Amendment 111 #
2013/0064(COD)
Proposal for a decision
Article 13 – paragraph 2 – point b
Article 13 – paragraph 2 – point b
(b) effectiveness of the use of resources, in particular taking into account the provision of funds for the EUSC.
Amendment 26 #
2012/2294(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Believes that it is not only subsidies that innovative European companies need, but also better legislation, better links to the research base and better and more diverse access to funding and financing, ranging from grants to loans and equity financing; calls, therefore, on the Member States and the Commission to create appropriate conditions at national and European level;
Amendment 34 #
2012/2294(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Believes that a new sustainable economy for the EU must ensure balanced economic and social development; calls for an ambitious sustainable industrial policy with an emphasis on resource efficiency; stresses that the green economy needs to offer prospects for decent, well-paid jobs, with focus on the protection of the environment;
Amendment 35 #
2012/2294(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Welcomes existing university programmes or work training programmes that focus on ecological, economic and social sustainability, and stresses that there are new educational needs to be fulfilled regarding the development of sustainable jobsan entrepreneurial culture;
Amendment 41 #
2012/2294(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Considers the Eurostat definition of ‘green jobs’ (in the environmental goods and services sector), which for example stipulates that ‘green’ technologies and products must have an environmental protection or resource management purpose as their prime objective, to be useful to avoid diverging statistics, but considers it necessary to further develop an EU- wide uniform definition of green jobs and growth, which would, for example, also include the public transport sector;
Amendment 47 #
2012/2294(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. highlights the role that food production already has in terms of 'green jobs'; stresses the need to further develop the connection between entrepreneurialism and food production to achieve 'green growth' in real terms;
Amendment 48 #
2012/2294(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls on the Commission to develop a systematic approach to eco-innovation policy, with sound framework conditions enabling a level playing fieldtransparent standardized criteria for eco- innovation in businesses and an infrastructure that allows businesses and consumers to make sustainableinformed choices;
Amendment 56 #
2012/2294(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to draw up new legislation and strengthen the existingstrengthen legislation in the field of the development and use of renewable energies and increasing energy efficiency, providing legal certainty and a level playing field by employing transparent standardized criteria for selection, and boosting public and private investment;
Amendment 60 #
2012/2294(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on the Commission to provide a platform enabling the Member States to coordinate their efforts in creating new sustainable jobs and growth;
Amendment 61 #
2012/2294(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Urges the Member States to exchange experience and best practice in the field of employment opportunities when dealing with the economic, social and environmental impact of climate changethe financial crisis;
Amendment 64 #
2012/2294(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recommends that the regional authorities adopt development strategies in line with the objectives of the EU 2020 Strategy, with the aim of creating new jobs in a sustainablto grow the economy;
Amendment 74 #
2012/2294(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
Amendment 82 #
2012/2294(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Welcomes the eco-innovation funding possibilities within the Common Agricultural Policy, and also under the COSME, Horizon 2020 and LIFE programmes;
Amendment 22 #
2012/2259(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Points out that renewable energy is not being developed separately, but as part of the overall energy system; reiterates that funding needs to be allocated under the Connecting Europe programme to finance the development of ICT-based smart grids so as to enable renewable energy to be incorporated more comprehensively and improve the stability of transfer systems; stresses the need to support small and medium-sized enterprises for more opportunities in infrastructure development;
Amendment 44 #
2012/2259(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that the key to unlocking the potential for renewable energy systems and to achieve a decarbonised economy is through the effective support of small and medium-sized enterprises;
Amendment 49 #
2012/2259(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Points to the need for energy and CO2 storage technologies; stresses that energy storage technology is needed to integrate the decentralised renewable resources into the distribution network; maintains that funding needs to be allocated under the Horizon 2020 programme to finance the development of energy and CO2 storage technologies;
Amendment 92 #
2012/2259(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Emphasises that secure, affordable and environmentally sound energy provision is indispensable for the competitiveness of European industry; emphasises, therefore, that the energy supply system needs to be overhauled and the share of RES increased in a manner that is cost-efficient and without prejudice to supply security; suggests that the Commission allow for the effects of the economic crisis and countries’ lower credit ratings, as reflected in the cutbacks – and the degree of risk involved – in renewable energy investment;
Amendment 139 #
2012/2259(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Is concerned that, so far, only some of the renewables on the energy market are economically competitive, although certain other technologies are closing the gap with market prices; agrees with the Commission that all available means must be used to bring the costs down and make RES economically competitive; stresses that the risks to those who invest in renewable energy have to be reduced by means of a clear long-term European strategy;
Amendment 229 #
2012/2259(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Notes that because, in most cases, renewable sources feeding energy into the grid are decentralised, remotely located and weather-dependent, they require infrastructure different from that currently in place, the existing provision having been developed solely for conventional energy; points out that renewables are not being developed separately, but as part of the overall energy system;
Amendment 268 #
2012/2259(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Notes that the development of RES on a major scale, with their remote and weather-dependent feed-in, can cause uncoordinated cross-border energy flows (loop flows) in other Member States – making load reduction increasingly necessary in the interests of supply security – if it does not go hand-in-hand with the requisite development of the grid; stresses the importance of cross-border cooperation and coordination in the construction of grids; is concerned about the state of development of grid infrastructure in the Member States;
Amendment 281 #
2012/2259(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Underscores the need for electricity storage and CO2 storage solutions to facilitate the integration of RES into the energy supply; re-emphasises the urgent need for further research into electricity and CO2 storage;
Amendment 287 #
2012/2259(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Is convinced that waste recovery represents an opportunity for further developing RES and achieving the goals of a European energy plan;
Amendment 294 #
2012/2259(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Is convinced that ICT will in future play a more important role in energy provision and in the management of RES; calls on the Commission to bring forward without delay proposals for the development, promotion and standardisation of smart grids and meters; points out that funding needs to be allocated under the Connecting Europe programme to finance the development of grids so as to increase the incorporation of renewable energy and improve the stability of transfer systems; emphasises that important factors in this regard include not only planning certainty on the providers’ side but also acceptance on the part of consumers, as well as data protection;
Amendment 322 #
2012/2259(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Emphasises that the further development of RES will entail permanent landscape change in Europe; points out that the only way to win public acceptance of RES is through transparent planning, construction and licensing procedures, in which all the stakeholders are involved; stresses that the procedures must be transparent, simplified and more user- friendly for all users;
Amendment 367 #
2012/2259(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Notes that Europe is in the vanguard when it comes to RES technology; emphasises that this is particularly due to the contribution of SMEs; underscores the need to facilitate a competitive environment for the operations and internationalisation of SMEs and to strive to reduce bureaucratic obstacles; stresses that only innovation, based on R&D, can secure Europe’s leading position in RES technology markets;
Amendment 380 #
2012/2259(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Is concerned that R&D has been neglected in certain branches of the renewable energy sector, leading, in some cases, to commercial problems; underscores the need for investment in the further development of existing technologies in order to sustain or achieve competitivity; emphasises investments in renewable energy R&D, particularly in the area of capacity, efficiency and reducing the spatial footprint;
Amendment 390 #
2012/2259(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Welcomes the Commission’s announcement that it will issue a communication on energy technology policy in 2013; calls on the Commission to include a focus on energy and CO2 storage technologies;
Amendment 480 #
2012/2259(INI)
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. Maintains that a transitional period is necessary in order to establish European support schemes;
Amendment 28 #
2012/2042(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Shares the view that support programmes funded with public resources should be delivered in the most cost- effective possible form, especially at a time when the EU economy is still recovering from its worst crisis in decades; in this regard, the quality of the programmes should remain at the very least at the same level;
Amendment 36 #
2012/2041(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Underlines that the key objective of any AMR strategy is to maintain the efficiency of existing antimicrobials by using them responsibly at the correct therapeutic level only when strictly prescribed over a limited time at the appropriate dosage, and reducing the use of antimicrobials in general and especially of Critically- Important Antimicrobials (CIAs) in human and veterinary medicine; we need to enhance surveillance of the use of antimicrobials in babies and young children, as well as in clinical treatment, where there is a need to control and measure antimicrobial use;
Amendment 41 #
2012/2041(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that more efforts are needed to control the use of antimicrobials in the veterinary sector; strongly disapproves of the uncontrolled prophylactic use of antimicrobials in animal husbandry; controls on, and the criteria for, imports of food from non-Member States should be enhanced, particularly owing to the potential that such imports may contain traces of antimicrobials;
Amendment 68 #
2012/2041(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. With a view to limiting the use and easy availability of antimicrobial agents, welcomes Member States’ initiatives to review the legal status of all oral, inhaled and parenteral antibiotics (namely antimalarial, antiviral and antifungal drugs) that remain available to patients without a prescription; antibiotics should not be available in EU Member States without a prescription, i.e. sold freely, as this encourages people to self-treat, often on the basis of inaccurate assumptions;
Amendment 69 #
2012/2041(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. With a view to limiting the use and easy availability ofinappropriate use and uncontrolled access to antimicrobial agents, welcomes Member States' initiatives to review the legal status of all oral, inhaled and parenteral antibiotics (namelymicrobials (including antimalarial, antiviral and antifungal drugs) that remain available to patients without a prescription;
Amendment 76 #
2012/2041(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and Member States, in accordance with the competent EU Agencies, to devise and promote prudent use guidelines aimed at reducing non-essential and inappropriate exposure to antimicrobials in human and veterinary medicine, livestock farming, agriculture, aquaculture and horticulture;
Amendment 85 #
2012/2041(INI)
Motion for a resolution
Paragraph 9 c (new)
Paragraph 9 c (new)
9c. Calls on the Commission and Member States to increase the exchange of best practice on preventing and reducing healthcare associated infections (HAIs);
Amendment 103 #
2012/2041(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of establishing an effective European network of national surveillance systems in the human health and veterinary sectors, based on uniform standards for all Member States, in order to facilitate the compilation of clear, comparable, transparent and timely reference data on antimicrobial drug usage; believes this should be based on the existing monitoring networks operated by EFSA, the ECDC European Surveillance of Antimicrobial Consumption Network (ESAC-net), the ECDC European Antimicrobial Resistance Surveillance Network (EARS-net), and the EMA European Surveillance of Veterinary Antimicrobial Consumption (ESVAC);
Amendment 105 #
2012/2041(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on Member States to promote closer inter-sectoral collaboration between relevant authorities and sectors to encourage a more integrated veterinary-human health approach and monitor the implementation of national antimicrobial resistance strategies;
Amendment 113 #
2012/2041(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Notes that the encouragement of appropriate antimicrobial use depends on a change of attitude and, practice and education among patients, farmers and practitioners in the spheres of veterinary and human medicine; considers that more effective and continuous educational and training measures should be taken at both national and European level;
Amendment 151 #
2012/2005(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Believes that the lack of full implementation and effective transparency of internal energy market legislation remains the main obstacle for the completion of this market;
Amendment 174 #
2012/2005(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses that modernising the existing infrastructure, and building new, intelligent and flexible generation, transmission, distribution and storage infrastructure, is essential for a well-integrated and well- connected energy market, where supply at affordable and competitive prices is secured, where the potential for cogeneration and efficiency, and for exploiting renewable and unconventional energy sources, is fully exploited, and where no Member State remains isolated from the European gas and electricity networks;
Amendment 84 #
2012/0337(COD)
Proposal for a decision
Recital 19
Recital 19
(19) Action to deliver the priority objectives should be taken at different levels of governance, in line with the principle of subsidiarity and the latest scientific developments.
Amendment 86 #
2012/0337(COD)
Proposal for a decision
Recital 20
Recital 20
(20) ETransparency based engagement with non-government actors is important in ensuring the success of the programme and the achievement of its priority objectives.
Amendment 90 #
2012/0337(COD)
Proposal for a decision
Recital 22
Recital 22
(22) There is significant scope for reducing greenhouse gas emissions and enhancing energy and resource efficiency in the Union. This will ease pressures on the environment and bring increased competitiveness and new sources of growth and jobs through cost savings from improved efficiency, commercialisation of innovations and better management of resources over their whole life cycle.
Amendment 93 #
2012/0337(COD)
Proposal for a decision
Recital 23
Recital 23
(23) Environmental problems and impacts continue toincreasingly pose significant risks for human health and wellbeing, especially regarding the quality and security of the food supply, whereas measures to improve the state of the environment can be beneficial.
Amendment 97 #
2012/0337(COD)
Proposal for a decision
Recital 24
Recital 24
(24) The full and even implementation of the environment acquis across the Union is a sound investment for the environment, a secure food supply, and human health, and also for the economy.
Amendment 102 #
2012/0337(COD)
Proposal for a decision
Recital 26
Recital 26
(26) Environmental objectives should be supported by adequate investments., and the use of Public Private Partnerships should be encouraged
Amendment 109 #
2012/0337(COD)
Proposal for a decision
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
(b) to turn the Union into a resource- efficient, green, innovative and competitive low- carbon economy;
Amendment 113 #
2012/0337(COD)
Proposal for a decision
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) to secure private and public investment for environment and climate policy and get the prices right;
Amendment 116 #
2012/0337(COD)
Proposal for a decision
Article 2 – paragraph 1 – point i a (new)
Article 2 – paragraph 1 – point i a (new)
(ia) to maximize the supply and access to healthy food;
Amendment 146 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 15
Annex 1 – point 15
15. In many cases, action to achieve these objectives will be required primarily at national, regional or local level, in line with the principle of subsidiarity. In others, additional measures at EU level will be needed. Since environment policy is a sphere of shared competence in the EU, one of the purposes of this programme is to create common ownership of shared goals and objectives and ensure a level playing field for businesses and public authorities. Clear goals and objectives and the exchange of Best Practice also provide policy makers and other stakeholders, including regions and cities, businesses and social partners, and individual citizens, with a sense of direction and a predictable framework for action.
Amendment 222 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 27
Annex 1 – point 27
27. The Europe 2020 Strategy's ‘Resource- efficient Europe’ Flagship Initiative aims to support the shift towards an economy that is efficient in the way it uses all resources, decouples absolutely economic growth from resource and energy use and its environmental impacts, reduces GHG emissions, enhances competitiveness through efficiency and innovation and promotes greater energy security. The Roadmap to Resource Efficient Europe and, the Roadmap for moving to a competitive low- carbon economy and the exchange of best practice between Member States are key building blocks of the Initiative, setting out the framework for future actions to deliver on these objectives.
Amendment 352 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 52 – subparagraph 1 – point f a (new)
Annex 1 – point 52 – subparagraph 1 – point f a (new)
(fa) Availability and access to high quality, healthy food in the EU has significantly improved
Amendment 456 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 91 – subparagraph 1 - point a
Annex 1 – point 91 – subparagraph 1 - point a
(a) A majority of cities in the EU are implementing policies for sustainable urban planning and design, including a sustainable food supply.
Amendment 106 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 2011/92/EU
Article 1 – paragraph 2 – point a – indent 1
Article 1 – paragraph 2 – point a – indent 1
Amendment 137 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 2
Article 1 – point 2
Directive 2011/92/EU
Article 2 – paragraph 3 – subparagraph 1
Article 2 – paragraph 3 – subparagraph 1
3. PIn the case of projects for which the obligation to carry out assessments of the effects on the environment arises simultaneously from this Directive and other Union legislation shall be subject toMember States shall seek to introduce coordinated or joint procedures fulfilling the requirements of the relevant Union legislation where this seems appropriate.
Amendment 151 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 2
Article 1 – point 2
Directive 2011/92/EU
Article 2 – paragraph 3 – subparagraph 4
Article 2 – paragraph 3 – subparagraph 4
Amendment 166 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 3
Article 1 – point 3
Directive 2011/92/EU
Article 3 – point a
Article 3 – point a
(a) population, human health, and biodiversity, with particular attention to species and habitats protected under Council Directive 92/43/EEC(*) and Directive 2009/147/EC of the European Parliament and of the Councilhuman beings, fauna and flora;
Amendment 171 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 3
Article 1 – point 3
2011/92/EG
Article 3 – point b
Article 3 – point b
(b) land, soil, water, air and, climate changand the landscape;
Amendment 180 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 3
Article 1 – point 3
Directive 2011/92/EU
Article 3 – point c
Article 3 – point c
(c) material assets, and the cultural heritage and the landscape;
Amendment 193 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 4 – point a
Article 1 – point 4 – point a
3. For projects listed in Annex II, the developer shall, where necessary and appropriate, provide information on the characteristics of the project, its potential impact on the environment and the measures envisaged in order to avoid and reduce significant effects. The detailed list of information to be provided is specified in Annex II.A.
Amendment 207 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 4 – point a
Article 1 – point 4 – point a
Directive 2011/92/EU
Article 4 – paragraph 4
Article 4 – paragraph 4
4. When a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the competent authority shall, where necessary, take account of selection criteria related to the characteristics and location of the project and its potential impact on the environment. The detailed list of selection criteria to be used is specified in Annex III.
Amendment 212 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 4 – point b
Article 1 – point 4 – point b
Directive 2011/92/EU
Article 4 – paragraph 5 – introductory part
Article 4 – paragraph 5 – introductory part
5. The competent authority shall make its decision pursuant to paragraph 2, on the basis of the information provided by the developer and taking into account, where relevant, the results of studies with which it is familiar, preliminary verifications or assessments of the effects on the environment arising from other Union legislation. The decision pursuant to paragraph 2 shall:
Amendment 215 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 4 – point b
Article 1 – point 4 – point b
Directive 2011/92/EU
Article 4 – paragraph 5 – point a
Article 4 – paragraph 5 – point a
Amendment 254 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 2 – subparagraph 1 – introductory part
Article 5 – paragraph 2 – subparagraph 1 – introductory part
2. The competent authority, after having consulted the authorities referred to in Article 6(1) and the developer, shall determine the scope and level of detail of the information to be included by the developer in the environmental report, in accordance with paragraph 1 of this Article, if the operator asks for this. In particular, it shall determininclude:
Amendment 359 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) ) the main reasons for choosing the project as adopted, in the light of the other alternatives considered, including the likely evolution of the existing state of the environment without implementation of the project (baseline scenario);
Amendment 372 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 2 – subparagraph 1
Article 8 – paragraph 2 – subparagraph 1
1. If the consultations and the information gathered pursuant to Articles 5, 6 and 7 conclude that a project will have significant adverse environmental effects, the competent authority shall, as early as possible and in close cooperation, discuss with the authorities referred to in Article 6(1) and the developer, shall consider whether the environmental report referred to in Article 5(1) should be revised and the project modified to avoid or reduce these adverse effects and whether additional mitigation or compensation measures are needed under the relevant law.
Amendment 377 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
If the competent authority decides to grant development consent, it shall, in accordance with the relevant legislation, ensure that the development consent includes measures to monitor the significant adverse environmental effects, in order to assess the implementation and the expected effectiveness of mitigation and compensation measures, and to identify any unforeseeable adverse effects.
Amendment 383 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 2 – subparagraph 3
Article 8 – paragraph 2 – subparagraph 3
Amendment 455 #
2012/0297(COD)
Proposal for a directive
Article 3
Article 3
Projects for which the request for development consent was introduced before the date referred to in the first subparagraph of Article 2(1) and for which the environmental impact assessment has not been concluded before that date shall be subject to the obligations referred to in Articles 3 to 11 of Directive 2011/92/EU as amended by this D, pending entry into force of the amended directive.
Amendment 478 #
2012/0297(COD)
Proposal for a directive
Annex – point 1
Annex – point 1
Directive 2011/92/EU
Annex II.A
Annex II.A
Amendment 86 #
2012/0267(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings.
Amendment 111 #
2012/0267(COD)
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.
Amendment 120 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
(12a) ‘ device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development.
Amendment 144 #
2012/0267(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 174 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 259 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 2
Article 40 – paragraph 2 – subparagraph 2
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safeas specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and sperformance that is at least equivalent, as specified in Section 5.4 of Annex VIII ancificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established in Sfection 3.5 of Annex IX.
Amendment 309 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 160 #
2012/0266(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) There is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices. In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial, with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and manufacture of medical devices, the manufacturers should take special care when using nanoparticles that can be released to the human body and those devices should be subject to the most severe conformity assessment procedure and the same standards.
Amendment 164 #
2012/0266(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) It is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors as laid down in the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the different parts of this Regulation, to enhance understanding of the legal requirements and thus to improve regulatory compliance by the relevant operators. Conditions enabling small and medium-sized enterprises with smart specialisation to have easier access to this market should be established.
Amendment 181 #
2012/0266(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) Transparency and better information that is understandable, reliable, objective, easily accessible and non-promotional are essential to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
Amendment 184 #
2012/0266(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) For high-risk medical devices, in the interests of increased transparency, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.
Amendment 193 #
2012/0266(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products. For medical devices in classes IIa, IIb and III, an appropriate level of involvement of a notified body shouldall be compulsory, with medical devices in class III requiring explicit prior approval of their design and manufacture before they can be placed on the market.
Amendment 197 #
2012/0266(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) The rules on clinical investigations should be in line with major international guidance in this field, such as the international standard ISO 14155:2011 or any subsequent version of it on good clinical practice for clinical investigations of medical devices for human subjects and the most recent (2008) version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects to ensure that clinical investigations conducted in the Union are accepted elsewhere and that clinical investigations conducted outside the Union in accordance with international guidelines can be accepted under this Regulation.
Amendment 206 #
2012/0266(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) The assessment of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State coordination, with the objective of sharing resources and ensuring consistency regarding the corrective action, and transparency of procedures should be ensured.
Amendment 213 #
2012/0266(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) The Commission should provide scientific, technical and corresponding logistic support to the coordinating national authority and ensure that the regulatory system for medical devices is effectively and uniformly implemented at Union level based on sound scientific evidence.
Amendment 214 #
2012/0266(COD)
Proposal for a regulation
Recital 63
Recital 63
(63) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, the integrity of the person, the principle of free and informed consent, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property, as well as the Convention on Human Rights. This Regulation should be applied by the Member States in accordance with those rights and principles.
Amendment 221 #
2012/0266(COD)
Proposal for a regulation
Recital 68
Recital 68
(68) To allow economic operators, notified bodies, Member States and the Commissionespecially SMEs, to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements to be taken for its proper application. However, parts of the Regulation that affect directly Member Sates and the Commission should be implemented as soon as possible. It is particularly important that by the date of application, a sufficient number of notified bodies are designated in accordance with the new requirements to avoid any shortage of medical devices on the market. Also at the date of application, existing notified bodies that handle class III devices, shall be subject to an application for notification in accordance with Article 31.
Amendment 230 #
2012/0266(COD)
Proposal for a regulation
Article 1 – paragraph 7 a (new)
Article 1 – paragraph 7 a (new)
7a. The regulation of medical devices at Union level shall not interfere with the freedom of Member States to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation.
Amendment 259 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 27 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 27 – introductory part
(27) ‘reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoration of the technical and functional safety of the used device; routine device maintenance service activities are not included in this definition;
Amendment 285 #
2012/0266(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. A device offered by means of information society services as defined in Article 1(2) of Directive 98/34/EC to a natural or legal person established in the Union shall comply with this Regulation at the latest whenby the day on which the device is placed on the market.
Amendment 385 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person, including health institutions as specified at Art. 4.4, who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation.
Amendment 395 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 3 b (new)
Article 15 – paragraph 3 b (new)
3b. The legal or natural person referred to in paragraph 1 shall establish a maximum number of times a single-use device can be reprocessed and shall ensure that the device is not reprocessed more times than this level.
Amendment 484 #
2012/0266(COD)
Proposal for a regulation
Article 28 – paragraph 7
Article 28 – paragraph 7
7. Member States shall provide the Commission and the other Member States with information on their procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto. Such information shall be publicly available
Amendment 507 #
2012/0266(COD)
Proposal for a regulation
Article 33 – paragraph 9
Article 33 – paragraph 9
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly. The full details of the notification, including annexes, shall be made publicly available.
Amendment 517 #
2012/0266(COD)
Proposal for a regulation
Article 35 – paragraph 4
Article 35 – paragraph 4
4. Three years after notification of a notified body, and again every third year thereafter, the assessment to determine whether the notified body and its subsidiaries and sub contractors still satisfies the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established and a joint assessment team designated in accordance with the procedure described in Article 32(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body with the requirements set out in Annex VI. The full results of the assessments shall be published.
Amendment 522 #
2012/0266(COD)
Proposal for a regulation
Article 36 – paragraph 3
Article 36 – paragraph 3
3. In the event of restriction, suspension or withdrawal of a notification, the Member State shall immediately inform the Commission which shall take appropriate steps to ensure that the files of the notified body concerned are either processed by another notified body or kept available for the national authorities responsible for notified bodies and for market surveillance at their request.
Amendment 634 #
2012/0266(COD)
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1 – point a
Article 61 – paragraph 1 – subparagraph 1 – point a
(a) any serious incident in respect of devices made available on the Union market;
Amendment 638 #
2012/0266(COD)
Proposal for a regulation
Article 61 – paragraph 3 – subparagraph 1
Article 61 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage and facilitate healthcare professionals, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 641 #
2012/0266(COD)
Proposal for a regulation
Article 61 – paragraph 4
Article 61 – paragraph 4
4. Manufacturers of custom-made devices shall immediately report any serious incidents and field safety corrective actions referred to in paragraph 1 to the competent authority of the Member State in which the device in question has been made available.
Amendment 652 #
2012/0266(COD)
Proposal for a regulation
Article 63 – paragraph 1 – subparagraph 1
Article 63 – paragraph 1 – subparagraph 1
Member States shall take the necessary steps to ensure that any information regarding a seriousn incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 61 is, at national level, evaluated centrally by their competent authority, if possible together with the manufacturer.
Amendment 655 #
2012/0266(COD)
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
2. The national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions, taking into account criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of harm and severity of harm, clinical benefit of the device, intended and potential users, and population affected. They shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action. They shall monitor the manufacturer's investigation of the incident.
Amendment 656 #
2012/0266(COD)
Proposal for a regulation
Article 63 – paragraph 3 – subparagraph 1
Article 63 – paragraph 3 – subparagraph 1
In the case of devices referred to in the first subparagraph of Article 1(4) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for medicinal products, or the European Medicines Agency (EMA), that was consulted by the notified body in accordance with the second subparagraph of Article 42(2).
Amendment 657 #
2012/0266(COD)
Proposal for a regulation
Article 63 – paragraph 3 – subparagraph 2
Article 63 – paragraph 3 – subparagraph 2
In the case of devices covered by this Regulation in accordance with point (e) of Article 1(2) and where the serious incident or field safety corrective action may be related to the tissues or cells of human origin utilised for the manufacture of the device, the competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for human tissues and cells that was consulted by the notified body in accordance with the third subparagraph of Article 42(2).
Amendment 659 #
2012/0266(COD)
Proposal for a regulation
Article 63 – paragraph 6 – subparagraph 1 – point a
Article 63 – paragraph 6 – subparagraph 1 – point a
(a) where similar serious incidents related to the same device or type of device of the same manufacturer occur in more than one Member State;
Amendment 660 #
2012/0266(COD)
Proposal for a regulation
Article 63 – paragraph 7 – subparagraph 1 – point a
Article 63 – paragraph 7 – subparagraph 1 – point a
(a) to monitor the investigation of the serious incident by the manufacturer and the corrective action to be taken;
Amendment 661 #
2012/0266(COD)
Proposal for a regulation
Article 63 – paragraph 7 – subparagraph 1 – point b
Article 63 – paragraph 7 – subparagraph 1 – point b
(b) to consult with the notified body that issued a certificate in accordance with Article 45 for the device in question regarding the impact of the serious incident on the certificate;
Amendment 662 #
2012/0266(COD)
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
Manufacturers of devices classified in class IIb and III shall report to the electronic system referred to in Article 62 any statistically significant increase in the frequency or severity of incidents that are not seriousall incidents or of expected undesirable side-effects that have a significant impact on the risk-benefit analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons when weighted against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents or expected undesirable side-effects in respect of the device, or category or group of devices, in question during a specific time period as established in the manufacturer's conformity assessment. Article 63 shall apply.
Amendment 664 #
2012/0266(COD)
Proposal for a regulation
Article 66 – paragraph 1 – point a
Article 66 – paragraph 1 – point a
(a) typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices;
Amendment 665 #
2012/0266(COD)
Proposal for a regulation
Article 66 – paragraph 1 – point b
Article 66 – paragraph 1 – point b
(b) harmonised forms for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers as referred to in Articles 61 and 64;
Amendment 666 #
2012/0266(COD)
Proposal for a regulation
Article 66 – paragraph 1 – point c
Article 66 – paragraph 1 – point c
(c) timelines for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers, taking into account the severity of the event to be reported as referred to in Articles 61 and 64;
Amendment 675 #
2012/0266(COD)
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. The Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every fourtwo years and the results thereof shall be communicated to the other Member States and the Commission. The Member State concerned shall make a summary of the results accessible to the public.
Amendment 687 #
2012/0266(COD)
Proposal for a regulation
Article 70 – paragraph 3 – point 1 (new)
Article 70 – paragraph 3 – point 1 (new)
(1) Where the concerned devices are to be recalled, the economic operator shall make all reasonable efforts to complete the recall before the end of clearly defined period communicated to it by the competent authority as referred to in paragraph 1,
Amendment 809 #
2012/0266(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.1 – introductory part
Annex 6 – point 3 – point 3.1 – point 3.1.1 – introductory part
3.1.1. A notified body shall be capable of carrying out all the tasks assigned to it by this Regulation with the highest degree of professional integrity and the requisite technical competence in the specific field, whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility. The process shall be monitored to ensure that it is of the requisite quality.
Amendment 820 #
2012/0266(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.3 – indent 5
Annex 6 – point 3 – point 3.2 – point 3.2.3 – indent 5
– the types of qualifications (knowledge, experience and other competence) required for carrying out standards-based conformity assessments in relation to medical devices as well as the relevant qualification criteria;
Amendment 837 #
2012/0266(COD)
Proposal for a regulation
Annex 6 – point 4 – point 4.1
Annex 6 – point 4 – point 4.1
4.1. The notified body's decision-making process must be transparent and shall be clearly documented, including the process for the issue, suspension, reinstatement, withdrawal or refusal of conformity assessment certificates, their modification or restriction and the issue of supplements.
Amendment 78 #
2012/0192(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) In a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable and robust. The interests of the participants should always take priority over other interests.
Amendment 80 #
2012/0192(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation, and approval by an ethics committee prior to commencement.
Amendment 244 #
2012/0192(COD)
Proposal for a regulation
Article 3 – paragraph 1 – indent 1
Article 3 – paragraph 1 – indent 1
the rights, safety, dignity and well-being of subjects are protected; and
Amendment 253 #
2012/0192(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work.
Amendment 260 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sponsor shall propose one of the Member States concerned as reporting Member StateMember States concerned shall determine which state shall be the reporting Member State according to an established procedure based on objective criteria which are set by the Commission.
Amendment 269 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six14 days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 276 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 214 days, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 279 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within three14 days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 299 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a – point ii – indent 4
Article 6 – paragraph 1 – point a – point ii – indent 4
Amendment 317 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 359 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3 a (new)
Article 8 – paragraph 2 – subparagraph 3 a (new)
Notwithstanding the first and second subparagraphs, in case of other conflict, the Member States involved shall attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision on the conclusion after having heard the Member States involved, and, if appropriate, having taken advice from the European Medicines Agency.
Amendment 365 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Member States concerned shall notmay request additional explanations from the sponsor after the assessment date for the purpose of carrying out continuous monitoring of the ethics and safety of clinical research on humans.
Amendment 409 #
2012/0192(COD)
Proposal for a regulation
Article 15
Article 15
A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation.
Amendment 460 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal.
Amendment 463 #
2012/0192(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been ducomprehensively and comprehensibly informed of the nature, significance, implications and risks of the clinical trial, and after having received the corresponding information in writing. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given.
Amendment 478 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is consideredduly taken into account by the investigator;
Amendment 481 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point h a (new)
Article 30 – paragraph 1 – point h a (new)
(ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;
Amendment 490 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the explicit wish of a minor who is capable of forming an opinion and assessing this informationchild to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or her age and maturity; the investigator acts in the interests of protecting children's rights;
Amendment 498 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h d (new)
Article 31 – paragraph 1 – point h d (new)
(hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol;
Amendment 513 #
2012/0192(COD)
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.
Amendment 592 #
2012/0192(COD)
Proposal for a regulation
Article 52 – paragraph 3
Article 52 – paragraph 3
3. The investigator’s brochure shall be updated whenevere new safety information becomes available, and at least once per year.
Amendment 25 #
2012/0066(COD)
Proposal for a directive
Recital 6 a (new)
Recital 6 a (new)
(6a) The producer registration requirements and format must, where appropriate, be consistent with Article 16(3) of, and Annex X, part A to, Directive 2012/19/EU of the European Parliament and of the Council on waste electrical and electronic equipment.
Amendment 30 #
2012/0066(COD)
Proposal for a directive
Article 1 – point -1b (new)
Article 1 – point -1b (new)
Directive 2006/66/EC
Article 4 – paragraph 2
Article 4 – paragraph 2
-1b. Article 4(2) is replaced by the following: '2. The prohibition set out in paragraph 1(a) shall not apply to button cells with a mercury content of no more than 2% by weight until 31 December 2014.'
Amendment 41 #
2012/0066(COD)
Proposal for a directive
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2006/66/EC
Article 6 – paragraph 2 – subparagraph 2 a (new)
Article 6 – paragraph 2 – subparagraph 2 a (new)
2a. The following subparagraph is added to Article 6(2): 'Stocks of batteries and accumulators intended for use in cordless power tools which were lawfully placed on the market before the aforementioned date may be sold until no later than 31 December 2017.'
Amendment 45 #
2012/0066(COD)
Proposal for a directive
Article 1 – point 4
Article 1 – point 4
Directive 2006/66/EC
Article 12 – paragraph 7
Article 12 – paragraph 7
4. Article 12(7) is deleted; replaced by the following: '7. Before the Commission proposes amending or supplementing Annex III it shall consult with relevant stakeholders, in particular producers, collectors, recyclers, treatment operators, environmental organisations, consumer organisations and employee associations. It shall inform the committee referred to in Article 24(1) of the outcome of this consultation.'
Amendment 7 #
2012/0049(COD)
Proposal for a regulation
Article 1 – point 2
Article 1 – point 2
Regulation (EC) No 106/2008
Article 6 – paragraph 1
Article 6 – paragraph 1
1. For the duration of the Agreement central government authorities within the meaning of Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts, shall, without prejudice to Union and national law and economic criteria, specify energy- efficiency requirements not less demanding than the Common Specifications for public supply contracts having a value equal to or greater than the thresholds laid down in Article 7 of that Directive. Contracting authorities at regional and local level shall be encouraged by Member States to use these requirements. This Article shall apply without prejudice to the provisions laid down in Article 5 of and Annex III(f) of thepoint (f) of Annex III to Directive […./..2012/EU][ of the European Parliament and of the Council on energy efficiency and repealing Directive 2004/8/EC and 2006/32/EC].
Amendment 77 #
2012/0042(COD)
Proposal for a decision
Recital 2
Recital 2
(2) Pursuant to Article 9 of Decision No 406/2009/EC requires the Commission to assess modalities to include greenhouse gas emissions and rehas been assessing the movdals resulting from activities related to land use, land use change and forestry into the Union'sities related to LULUCF sector in the Union and the Member States' greenhouse gas emission reduction commitments, whilstith the aim of ensuring the permanence and the environmental integrity of the contribution of theLULUCF sector, and providing fors well as accurate monitoring and accounting of the relevant emissions and removals. This Decision should, therefore, as a first step. As a result of this assessment the Commission is proposing a so-called LULUCF legislative package comprising two interlinked legislative acts: a decision on accounting rules for LULUCF, as a first step, and a legislative act on the formal inclusion of the LULUCF sector in the Union and the Member States' greenhouse gas emission reduction commitments, as a second step, which are interlinked. This Decision should, therefore, set out accounting rules applicable to greenhouse gas emissions and removals from the LULUCF sector. To ensure the preservation and enhancement of carbon stocks in the interim, it should also provide for Member States to adopt LULUCF Action Plans setting out measures to limit or reduce emissions, and to maintain or increase removals, from the LULUCF sector. The second legislative proposal on the formal inclusion of the LULUCF sector in the Union and the Member States' greenhouse gas emission reduction commitments will follow subsequently.
Amendment 96 #
2012/0042(COD)
Proposal for a decision
Recital 4
Recital 4
(4) The LULUCF accounting rules should reflectake into account efforts made in the agriculture and forestry sectors to enhance the contribution of changes made to the use of land resources to the reduction of emissions. The Union and its Member States should jointly fulfil the commitment of the cap of 3.5 per cent as specified in the UNFCCC Decision 2/CMP.7. agreed in Durban. The modalities of this joint fulfilment will be prepared by the Commission in a separate, second legislative act on formal inclusion of the LULUCF sector in the Union and the Member States' greenhouse gas emission reduction commitments within the LULUCF legislative package. This Decision should provide for accounting rules applicable on a mandatory basis to the forestry activities of afforestation, reforestation, deforestation and forest management, and to the agricultural activities of grazing land management and cropland management. It should also provide for accounting rules applicable on a voluntary basis to revegetation and wetland drainage and rewetting activities.
Amendment 141 #
2012/0042(COD)
Proposal for a decision
Article 1
Article 1
This Decision sets out accounting rules applicable to emissions and removals resulting from land use, land use change and forestry activities as a first step towards the formal inclusion of the LULUCF sector in the Union and the Member States' greenhouse gas emission reduction commitments pursuant to Article 9 of the Decision No 406/2009/EC. It also provides for Member State LULUCF Action Plans to limit or reduce emissions and to maintain or increase removals, and for the evaluation of those plans by the Commission.
Amendment 48 #
2012/0035(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Member States have been confronted towith a steady rise in pharmaceutical expenditure over the last decades, leading to the adoption of increasingly innovative and complex policies to manage the consumption of medicines in the framework of their public health insurance systems. In particular, Member States’ authorities have implemented a broad range of measures to control the prescription of medicines, to regulate their prices or to establish the conditions of their public funding. Such measures mainly aim at promoting public health by ensuring the availability of adequate supplies of medicinal products on equal terms to all EU citizens at reasonable costs, while ensuring the financial stability of public health insurance systems. Medicines classed as essential on the WHO list should be available to patients in all Member States, whatever the size of the market.
Amendment 66 #
2012/0035(COD)
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products with the reference product, are ascertained in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, where legitimate reservations have arisen from knowledge newly obtained, Member States should therefore not re- reassess the elements on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product.
Amendment 72 #
2012/0035(COD)
Proposal for a directive
Recital 15
Recital 15
(15) In accordance with Directive 2001/83/EC, intellectual property rights do not provide a valid ground to refuse, suspend or revoke a marketing authorisation. By the same token, applications, decision-making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which, as such, are independent from the enforcement of intellectual property rights. The national authorities in charge of those procedures, when examining an application with respect to a bioequivalent generic medicinal product, should not request information concerning the patent status of the reference medicinal product and should not, but they should be allowed to examine the validity of an alleged violation of intellectual property rights should the bioequivalent generic medicinal product be manufactured or placed on the market subsequently to their decision. ConsequentlyThat responsibility may not be removed from Member States. Without prejudice to the responsibility of Member States to examine information, intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the Member States.
Amendment 73 #
2012/0035(COD)
Proposal for a directive
Recital 15 a (new)
Recital 15 a (new)
Amendment 75 #
2012/0035(COD)
Proposal for a directive
Recital 15 b (new)
Recital 15 b (new)
(15b) The transparency, integrity, and independence of decision-making within national authorities should be ensured through publication of the names of the competent authorities and the procedural steps leading to pricing and reimbursement decisions.
Amendment 82 #
2012/0035(COD)
Proposal for a directive
Article 1 – paragraph 2 – subparagraph 1 – point a
Article 1 – paragraph 2 – subparagraph 1 – point a
(a) voluntary contractual agreements, subject to verification of elements concerning the efficacy and/or relative efficacy or the proper use of the given medicine, concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions for the agreed period;
Amendment 90 #
2012/0035(COD)
Proposal for a directive
Article 2 – point 5 a (new)
Article 2 – point 5 a (new)
(5a) "voluntary contractual agreement" as referred to in Article 1(2), point (a) means an agreement concluded between public authorities and the marketing authorisation holder for a medicinal product which is neither mandatory or required by law nor is the agreement the only alternative to be included in the national pricing and reimbursement scheme.
Amendment 99 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 690 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. However, wWith respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time- limit shall likewise be 90 days. With respect to generic medicinal products, that time limit shall be 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 113 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 5
Article 3 – paragraph 5
5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 690 days of receipt of this additional information. However, wWith respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time- limit shall likewise be 90 days. With respect to generic medicinal products, that time limit shall be in all events 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
Amendment 124 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 9
Article 3 – paragraph 9
9. If the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The decision shall be communicated to the holder of the marketing authorisation, who shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies. The decision and a summary justification shall be made available to public view.
Amendment 131 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
Member States shall ensure that a decision onto approve or reject an application submitted in accordance with the requirements laid down in the Member State concerned, by a marketing authorisation holder to increase the price of a medicinal product is discussed, adopted, and communicated to the applicant within 690 days of its receipt of the application.
Amendment 137 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
In case of an exceptional number of applications, the time limit set out in this paragraph may be extended once only for a further 690 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in this paragraph.
Amendment 147 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 4 – subparagraph 2
Article 4 – paragraph 4 – subparagraph 2
The applicant shall furnish the competent authorities with adequate information, including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 690 days of receipt of this additional information. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
Amendment 160 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Member States shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 690 days of the receipt of the application. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 690 days of receipt of this additional information. If the derogation is granted, the competent authorities shall forthwith publish an announcement of the price increase allowed.
Amendment 167 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
If there is an exceptional number of applications, the relevant time limit set out in paragraph 3 may be extended once only for a further 690 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in paragraph 3
Amendment 173 #
2012/0035(COD)
Proposal for a directive
Article 5 a (new)
Article 5 a (new)
Article 5a Member States shall ensure that the patient or the insured person also genuinely has the benefit of the agreed reimbursement prices. Any possible lack of transparency at dispensaries which results in distortion because of failure to present prices transparently shall be avoided.
Amendment 185 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 690 days of its receipt. However, wWith respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time- limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 1530 days, provided that the reference medicinal product has already been included in the public health insurance system.
Amendment 196 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 690 days of receipt of this additional information. However, wWith respect to medicineal products for which Member States use health technology assessment as part of their decision-making process, the time- limit shall likewise be 90 days. With respect to generic medicinal products, that time limit shall be 1530 days, provided that the reference medicinal product has already been included in the public health insurance system. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
Amendment 205 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 6
Article 7 – paragraph 6
6. Irrespective of the organisation of their internal procedures, Member States shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this Article and the price approval procedure set out in Article 3 does not exceed 1280 days. However, wWith respect to the medicinal products for which Member States use health technology assessment as part of their decision-making process, the time limit shall likewise not exceed 180 days. With respect to generic medicinal products, that time limit shall not exceed 360 days, provided that the reference medicinal product has already been included in the public health insurance system. Those time- limits may be extended in accordance with paragraph 5 of this Article or Article 3(5).
Amendment 221 #
2012/0035(COD)
Proposal for a directive
Article 8
Article 8
Amendment 233 #
2012/0035(COD)
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Measures referred to in paragraph 1, including any evaluation, expert opinion or recommendation on which they are based, shall be published in an appropriate publication and made available to public view.
Amendment 249 #
2012/0035(COD)
Proposal for a directive
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend or revoke decisions relating to the price of a medicinal product or its inclusion within the public health insurance system. Member States may not, however, under any circumstances, be deprived of the power to verify intellectual property.
Amendment 269 #
2012/0035(COD)
Proposal for a directive
Article 16 – paragraph 4 – subparagraph 1
Article 16 – paragraph 4 – subparagraph 1
The Commission may send its observations to the Member State which has communicated the draft measure within threewo months.
Amendment 278 #
2012/0035(COD)
Proposal for a directive
Article 19 a (new)
Article 19 a (new)
Article 19a Monitoring and Reporting 1. Three years after entry into force of this Directive the Commission shall submit a report to the European Parliament and to the Council assessing the enforcement of this Directive. 2. The Commission shall be equipped with sufficient resources to monitor the enforcement of the Directive.
Amendment 64 #
2011/2194(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
Takes the view that the 7th EAP should include specific objectives on how to specifically deal with the urban environmentfor improving the impact of the urban environment, and thereby the impact of any odours, dust and noise on human health and wellbeing;
Amendment 86 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – point 4 – paragraph 7
Annex 1 – point 4 – paragraph 7
Further public-public partnerships and public-private partnerships may be launched under Horizon 2020 where they meet the defined criteria. This may include partnerships on Iinformation and Ccommunication Ttechnologies in the areas of Pphotonics and Rrobotics, on sustainable process industries, on bio-based industries, on telemedicine and home treatment appliances, and on security technologies for maritime border surveillance.
Amendment 119 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – part III – point 1 – paragraph 2 a (new)
Annex 1 – part III – point 1 – paragraph 2 a (new)
Research gaps in the area of infectious, poverty-related, and neglected diseases must be addressed through research and innovation activities driven by patients’ needs. By supporting innovative global partnerships to develop prevention, diagnostic, treatment, and telemedicine tools, excellent science can be accelerated, and the Union can respect its global commitments.
Amendment 121 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – part III – point 1 – paragraph 3
Annex 1 – part III – point 1 – paragraph 3
An increasing disease and disability burden in the context of an ageing population places further demands on health and care sectors. If effective health and care is to be maintained for all ages, efforts are required to improvespeed up decision -making inand awareness-raising in disease prevention and treatment provision, to identify and support the dissemination of best practice in the healthcare sector, and to support integrated care and the uptake of technological, organisational and social innovations empowering older persons in particular to remain active and independent. Doing so will contribute to increasing, and lengthening the duration of, their physical, social, and mental well- being.
Amendment 134 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – part III – point 1 – point 1.4 – paragraph 1
Annex 1 – part III – point 1 – point 1.4 – paragraph 1
There is a need for an improved understanding of health and disease, in people of all ages, so that new and better prevention measures, diagnosis and treatments can be developed. Interdisciplinary, translational research on the patho-physiology of disease is essential to improve the understanding of all aspects of disease processes, including a re- classification of normal variation and disease based on molecular data, and to validate and use research results in clinical applications. Translational research projects aimed at applying laboratory findings more quickly and efficiently into medical practice should be particularly supported, especially in those areas of high unmet need, such as haematology/oncology, rare diseases and antimicrobial resistance.
Amendment 138 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – part III – point 1 – point 1.5 – paragraph 1
Annex 1 – part III – point 1 – point 1.5 – paragraph 1
There is a need forto support the development of more effective preventive vaccines (or alternative preventive interventions) and evidence- based vaccination schemes fand evidence-based vaccination schemes for an expanded range of diseases, including poverty-related diseases such as HIV/AIDS, tuberculosis, malaria and neglected diseases. Similarly, knowledge about the main risk factors of disease, as well as behavioural science, can be used to devise effective prevention strategies addressing these risk factors an expanded rd aiming at promoting healthy lifestyles and the importangce of diseases. Thishealthy food. This has a tremendous potential to reduce the burden of chronic diseases, but relies on a better understanding of disease and disease processes and their consequent epidemics, and thaton clinical trials and associated studies arebeing undertaken.
Amendment 145 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – part III – point 1 – point 1.11 – paragraph 1
Annex 1 – part III – point 1 – point 1.11 – paragraph 1
There is a need to support the development of scientific tools, methods and statistics for rapid, accurate and predictive assessment of the safety, efficacy and quality of health technologies including new drugs, biologics, advanced therapies and medical devices. This is particularly relevant for new developments in domains including those concerning vaccines, cell/tissue and gene therapies, organs and transplantation, specialist manufacturing, bio banks, new medical devices, diagnostic/treatment procedures, genetic testing, interoperability, telemedicine and e-health, including privacy aspects. Similarly, support for improved risk assessment methodologies, testing approaches and strategies relating to environment and health are required. There is also a need to support the development of relevant methods for assisting the assessment of ethical aspects of the above domains.
Amendment 154 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – part III – point 2 – title
Annex 1 – part III – point 2 – title
2. Food safety, healthy food and food security, sustainable agriculture, marine and maritimeountain research and the bio- economy
Amendment 168 #
2011/0402(CNS)
Proposal for a decision
Recital 8
Recital 8
(8) In order to maintain and increase the Union's industrial leadership there is an urgent need to stimulate private sector research and development and innovation investment, promote research and innovation with a business driven agenda and accelerate the development of new technologies which will underpin future businesses and economic growth. Part II "Industrial leadership" should support investments in excellent research and innovation in key enabling technologies and other industrial technologies, facilitate access to risk finance for innovative companies and projects, and provide Union wide support for innovation in small and medium-sized enterprises, primarily by lowering the entry threshold for small and medium-sized enterprises.
Amendment 374 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – point 4 – paragraph 7
Annex 1 – point 4 – paragraph 7
Further public-public partnerships and public-private partnerships may be launched under Horizon 2020 where they meet the defined criteria. This may include partnerships on Information and Communication Technologies in the areas of Photonics and Robotics, on sustainable process industries, on bio-based industries and, on telemedicine and home treatment appliances, on security technologies for maritime border surveillance.
Amendment 597 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – section 3 – point 1 – paragraph 4
Annex 1 – section 3 – point 1 – paragraph 4
All of these activities will be undertaken in such a way as to provide support throughout the research and innovation cycle, strengthening the competitiveness of the European based industries and SMEs and development of new market opportunities.
Amendment 642 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – section 3 – point 1 – point 1.11 – paragraph 1
Annex 1 – section 3 – point 1 – point 1.11 – paragraph 1
There is a need to support the development of scientific tools, methods and statistics for rapid, accurate and predictive assessment of the safety, efficacy and quality of health technologies including new drugs, biologics, advanced therapies and medical devices. This is particularly relevant for new developments in domains including those concerning vaccines, cell/tissue and gene therapies, organs and transplantation, specialist manufacturing, bio banks, new medical devices, diagnostic/treatment procedures, genetic testing, interoperability, telemedicine and e-health, including privacy aspects. Similarly, support for improved risk assessment methodologies, testing approaches and strategies relating to environment and health are required. There is also a need to support the development of relevant methods for assisting the assessment of ethical aspects of the above domains.
Amendment 664 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – section 3 – point 2 – introductory part
Annex 1 – section 3 – point 2 – introductory part
2. Food safety, healthy food and food security, sustainable agriculture, marine and maritimeountain research and the bio- economy