Activities of António Fernando CORREIA DE CAMPOS
Plenary speeches (58)
Clinical trials on medicinal products for human use (debate)
General guidelines for the 2015 budget - Section III (debate)
Common European sales law (debate)
EU justice scoreboard (short presentation)
Local and regional consequences of the development of smart grids (short presentation)
Modernisation of the EU-Mexico Free Trade Agreement - Modernisation of the EU-Chile Free Trade Agreement (debate)
Award of concession contracts - Public procurement - Procurement by entities operating in the water, energy, transport and postal services sectors (debate)
Payment accounts (debate)
Cloud computing (A7-0353/2013 - Pilar del Castillo Vera)
EU space industrial policy (short presentation)
Horizon 2020 - framework programme for research and innovation (2014-2020) - Rules for the participation and dissemination in Horizon 2020 - Specific programme implementing Horizon 2020 - Strategic innovation agenda of the European Institute of Innovation and Technology - European Institute of Innovation and Technology (debate)
Competitiveness of enterprises and small and medium-sized enterprises (2014 - 2020) - Entrepreneurship 2020 action plan - Reigniting the entrepreneurial spirit in Europe (debate)
Connecting Europe Facility - Trans-European transport network (debate)
Completing the European research area by 2014 (debate)
Implementation of REMIT and ACER 2014 budget (debate)
Completing the digital single market (debate)
A new agenda for European consumer policy (short presentation)
Trans-European energy infrastructure (debate)
Trans-European energy infrastructure (debate)
Energy roadmap 2050 (debate)
Feasibility of introducing stability bonds (debate)
Completing the digital single market (short presentation)
Single Market Act II - Concerns of European citizens and business with the functioning of the Single Market (debate)
Commission Question Time
Commission Question Time
Future of the Single Market Act (debate)
Energy policy cooperation with partners beyond our borders (short presentation)
Common system for taxing financial transactions (debate)
Explanations of vote
Internal market scoreboard (debate)
EU development cooperation in support of the objective of universal energy access by 2030 (short presentation)
Revision of the multiannual financial framework to address additional financing needs of the ITER project (debate)
Single market forum (debate)
State aid rules on services of general economic interest (short presentation)
Modernisation of public procurement (debate)
The future of VAT (debate)
EU research and innovation funding (debate)
Seventh EU programme for research, technological development and demonstration (debate)
Innovation Union: transforming Europe for a post-crisis world (debate)
Governance and partnership in the single market - Single market for Europeans - Single market for enterprises and growth - Public procurement (debate)
Governance and partnership in the Single Market - Single market for Europeans - Single market for enterprises and growth - Public procurement (continuation of debate)
Information on medicinal products (Community code relating to medicinal products) - Information on medicinal products (Community procedures for the authorisation and supervision of medicinal products) (debate)
Explanations of vote
Single Market Act (debate)
Innovation partnerships (debate)
Preparations for the European Council meeting (28-29 October) - Preparations for the G20 summit (11-12 November) - Financial, economic and social crisis: recommendations concerning the measures and initiatives to be taken - Improving economic governance and stability framework in the EU, in particular, in the euro zone (debate)
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Completing the internal market for e-commerce (short presentation)
Conclusions of the special ECOFIN Council meeting of 7 September (debate)
Explanations of vote
Food information to consumers (debate)
Standards of quality and safety of human organs intended for transplantation - Action plan on organ donation and transplantation (2009-2015) (debate)
Principle of subsidiarity and universality of social public services in the EU (debate)
Electric cars (debate)
Situation in Chile and EU humanitarian aid strategy (debate)
Online gambling in relation to recent ECJ rulings (debate)
Mutual recognition of professional qualifications (debate)
Joint Programming of research to combat neurodegenerative diseases, in particular Alzheimer’s disease (debate)
Reports (3)
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters PDF (315 KB) DOC (404 KB)
REPORT on the proposal for a regulation of the European Parliament and of the Council on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC PDF (1 MB) DOC (1 MB)
REPORT on a Single Market for Europeans PDF (335 KB) DOC (252 KB)
Shadow reports (7)
REPORT on the proposal for a Council directive amending Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations PDF (391 KB) DOC (434 KB)
REPORT on the proposal for a Council regulation on the Fuel Cells and Hydrogen 2 Joint Undertaking PDF (350 KB) DOC (449 KB)
REPORT on the proposal for a regulation of the European Parliament and of the Council concerning the notification to the Commission of investment projects in energy infrastructure within the European Union and replacing Council Regulation (EU, Euratom) No 617/2010 PDF (244 KB) DOC (368 KB)
REPORT on the proposal for a Council decision on the adoption of a Supplementary Research Programme for the ITER project (2014-2018) PDF (265 KB) DOC (287 KB)
REPORT on completing the Digital Single Market PDF (349 KB) DOC (254 KB)
REPORT on the Internal Market Scoreboard PDF (174 KB) DOC (111 KB)
REPORT Report on completing the internal market for e-commerce PDF (318 KB) DOC (236 KB)
Opinions (5)
OPINION Making the internal energy market work
OPINION on the feasibility of introducing Stability Bonds
OPINION on the reform of EU State aid rules on Services of General Economic Interest
OPINION Communication from the Commission to the European Parliament, the European Council, the Council, the European Central Bank, the Economic and Social Committee and the Committee of the Regions : Reinforcing economic policy coordination
OPINION Proposal for a regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Shadow opinions (22)
OPINION on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
OPINION on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
OPINION on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
OPINION on improving access to finance for SMEs
OPINION on the Energy Roadmap 2050, a future with energy
OPINION on the proposal for a Council regulation on laying down the multiannual financial framework for the years 2014-2020
OPINION on the attractiveness of investing in Europe
OPINION on the proposal for a regulation of the European Parliament and of the Council on food intended for infants and young children and food for special medical purposes
OPINION on the proposal for a decision of the European Parliament and of the Council amending the Interinstitutional Agreement of 17 May 2006 on budgetary discipline and sound financial management as regards the multiannual financial framework, to address additional financing needs of the ITER project
OPINION on the future of VAT
OPINION on a new trade policy for Europe under the Europe 2020 strategy
OPINION on European Broadband: investing in digitally driven growth
OPINION on the future for social services of general interest
OPINION An Industrial policy for the Globalised Era.
OPINION Communication from the Commission to the Council and the European Parliament: GDP and beyond - Measuring progress in a changing world
OPINION Green Paper: The interconnection of business registers
OPINION Proposal for a directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use
OPINION Proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
OPINION Proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
OPINION Proposal for a regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
OPINION Proposal for a directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use
OPINION on the Commission communication on Action Against Cancer: European Partnership
Amendments (746)
Amendment 283 #
2013/2135(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Believes that a forward looking energy and climate policy must be implemented in coherence with the EU's Industrial Policy Agenda for competitiveness; Considers, in this regard, that a binding 2030 renewables target will decrease uncertainty on the mid and long-term perspectives, increasing the confidence of market actors and reducing the cost of capital necessary to unlock private investments;
Amendment 331 #
2013/2135(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Is of the opinion that support schemes, if better usedused efficiently and in compliance with the internal market and the relevant EU state aid rules, could be an appropriate tool to incentivise the development of renewable energy sources (RES) and energy efficiency; sees an important role for the Commission in providing guidance in this regard;
Amendment 360 #
2013/2135(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Notes that some RES should now be considered mature energy sources and their subsidies should therefore be phased out on time order to be able to reallocate these; believes however, that in order to avoid market distortion, this process should be closely linked with the phasing out of direct and indirect subsidies for fossil fuels and non-RES energy sources; such subsidies should be reallocated to research and development (R&D) programmes and RES that are not yet cost- effective; asks the Commission to study the impact of RES priority dispatch on general energy costs;
Amendment 576 #
2013/2135(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14 a. Acknowledges that despite the on- going process of implementation of projects of common interest for energy infrastructures, cross-border interconnection capacity below the Barcelona European Council 2002 target is an obstacle to the integration of renewables, to the internal energy market, and a cause for energy system inefficiency and higher electricity prices; Considers that one of the key objectives of EU energy policy is to stimulate competitive energy costs for the economy and citizens, and therefore calls on the Commission to establish binding targets for minimum cross-border transmission capacity and a clear time-frame for its deployment;
Amendment 2 #
2013/2043(INI)
Motion for a resolution
Recital A
Recital A
A. whereas e-commerce is a channel with enormous potential to combat the economic and financial crisis, strengthen the single market, and create economic growth and employment across the European Union; whereas the Commission’s communication on e- commerce and online services of January 2012 identifies the delivery of goods purchased online as one of the top five priorities for boosting e-commerce by 2015, and its importance has been reiterated by the Council and by Parliament;
Amendment 3 #
2013/2043(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the EU e-commerce market grew by over 20% in 2012; whereas cross- border e-commerce in particular is predicted to multiply by a factor of four; whereas the parcel delivery market is undergoing radical transformations, with new providers entering the market, investment oriented towards innovation, and new services emerging;
Amendment 5 #
2013/2043(INI)
Motion for a resolution
Recital E
Recital E
E. whereas in order to overcome this situation it is vital to boost consumers’ confidence in delivery operators and services, trust in the market and knowledge of their rights and obligations, by ensuring more information and greater transparency regarding the conditions of delivery;
Amendment 9 #
2013/2043(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that accessible, affordable, efficient, and high-quality delivery services are an essential element in the online purchasing of goods and must be promoted by ensuring free and fair competition; notes, however, that many consumers are reluctant to buy online, especially cross- border, because of uncertainties relating to the delivery options available, final delivery, delivery costs or reliability;
Amendment 10 #
2013/2043(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the importance of increasing consumer confidence in the delivery process; considers more transparency and better information on available delivery options, prices and conditions to be paramount for consumers, specifically with respect to the conditions under which consumer orders are shipped and the procedures to follow in case of delay or damage to or loss of goods or delay in their delivery or return;
Amendment 12 #
2013/2043(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Emphasises that it is necessary to promote measures aimed at ensuring consumer choice at the time of purchase; notes the significant gap between consumer expectations and the availability of convenient, innovative services such as relay points or parcel kiosks, track-and- trace solutions, consumer-friendly delivery places and times, or easy return policies;
Amendment 14 #
2013/2043(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Points out that the high cost of cross- border delivery or delivery to remote areas or the outermost regions is one of the main reasons for consumer dissatisfaction; stresses that more affordable delivery options for consumers and SMEssellers, SMEs included, are imperative if long-distance sales and purchases are to increase and there is to be any point in talking of a genuinely single market;
Amendment 25 #
2013/2043(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Highlights the vital role of SMEs in creating growth, innovation, and employment, in particular youth employment; stresses that delivery services are of extreme importance for European SMEs, and that an integrated competitive delivery market ensuring different delivery and logistic support options at affordable prices is a precondition for accessing new markets and reaching more consumers within the EU;
Amendment 26 #
2013/2043(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Emphasises that SMEsbusiness and SMEs in particular need to be able to respond to the needs and expectations of consumers with simpler, faster, more affordable, transparent, reliable and efficient shipping services in the context of cross-border e- commerce; stresses that delivery solutions that do not meet consumer expectations have a direct impact on a business’s brand name, image and competitiveness;
Amendment 47 #
2013/2043(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Calls on the Commission to give the encouragement required for the purpose of setting up comparison websites focusing on the products and services offered by parcel delivery firms and covering the products available, prices, delivery times, and all relevant features of the delivery service, with versions in several languages so as to make for transparency and reliability and strengthen consumer protection;
Amendment 1 #
2013/2005(INI)
Draft opinion
Paragraph A (new)
Paragraph A (new)
A. having regard to the European Parliament resolution of 19 June 2008 on the Commission communication 'Towards a European Charter on the Rights of Energy Consumers' (2008/2006 (INI)),
Amendment 4 #
2013/2005(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Believes that a competition-driven, open, integrated and flexible European energy market will make forit possible to maintain security of supply and achieve lower prices, as well as enhancing Europe’s competitiveness and contributing to economic growth and consumers’ well- being, and that, in order to bring this about, the physical, statutory, and regulatory barriers to market efficiency need to be removed urgently;
Amendment 8 #
2013/2005(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Points to the importance of regional markets and cooperation between Member States in removing barriers, speeding up the integration process and improving network efficiency;
Amendment 11 #
2013/2005(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Urges the Commission to take steps to bring competition rules effectively to bear on the energy sector, especially as regards the delayed transposition and implementation of the third energy package, pressing Member States to comply, preventing them from creating new obstacles and imposing sanctions whenever necessary;
Amendment 13 #
2013/2005(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Highlights that cross border tariffs and tariff pancake hinder cross-border flows of energy, market integration and competition between operators; Calls on the Commission to take measures to tackle this issue;
Amendment 14 #
2013/2005(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Stresses that only with a stable regulatory framework will it be possible to attract the investment necessary for the continuous development of this market;
Amendment 17 #
2013/2005(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls for initiatives to be taken to encourage joint planning of energy networks in order to promote the rationalisation of the European energy network, taking advantage of cross-border synergies and a more efficient infrastructure network, which will translate into lower costs for consumers and industry;
Amendment 19 #
2013/2005(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Draws the Commission's attention to the need for the rapid operational integration of national gas and electricity markets, whose functioning requires the formal adoption and swift implementation of network codes with common rules to define mechanisms for capacity allocation, balancing, charging and interoperability;
Amendment 20 #
2013/2005(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Calls on the Commission to work with the ENTSOs, ACER and other relevant stakeholders to accelerate the delivery the network codes, to de developed in an inclusive and transparent manner;
Amendment 21 #
2013/2005(INI)
Draft opinion
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Alerts the Commission to the need to ensure that legislation strengthening the powers and independence of national regulators is effectively applied, as a means of guaranteeing the efficient operation of the energy market and protecting the interests of consumers;
Amendment 22 #
2013/2005(INI)
Draft opinion
Paragraph 4 d (new)
Paragraph 4 d (new)
4d. Notes that asymmetries in national regulation also lead to asymmetries in competition; calls for ACER's functions and capacities to be boosted so that it will offer more scope for closer cooperation among national regulators in defining a regulatory framework that will not prejudice the functioning of the internal energy market;
Amendment 23 #
2013/2005(INI)
Draft opinion
Paragraph 4 e (new)
Paragraph 4 e (new)
4e. Fully supports level paying field measures creating more decentralised and competitive market models, as they create more opportunities for local energy producers and for new industrial players;
Amendment 25 #
2013/2005(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Notes that market liberalisation has not resulted in significant options or lower prices for final consumers, and in particular for households; urges the Commission to take steps to improvencourage transparency, information, comparison and freedom of consumer choice and to protect vulnerable consumers; advocates support for new arrangements making for effective dispute resolution and restoring the balance of bargaining power between final consumers and suppliers.urges the Member States to invest in social measures and sharing best practices;
Amendment 29 #
2013/2005(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Believes that in order to make consumers more proactive in the management of energy consumption, they need to be made aware of ways to control consumption, of possibilities for energy savings and of energy efficiency and small-scale production; recommends the Commission and Member States to roll- out price comparison websites and consumer-friendly information campaigns, in which local and regional governments should take active part;
Amendment 35 #
2013/2005(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Advocates support for new arrangements making for effective dispute resolution, in particular alternative dispute resolution, for which legislation is currently being drafted, and restoring the balance of bargaining power between final consumers and suppliers, and highlights the need to promote initiatives that will help secure a more active role for consumers in the internal energy market, which will in turn stimulate competition in the market;
Amendment 38 #
2013/2005(INI)
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Highlights the need to prevent energy poverty and avoid inherent market distortions, and urges the Commission to take a specific position on this matter;
Amendment 221 #
2013/2005(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Notes with concern indications that certainthat national action iss are again being taken to influence energy markets, especially as regards efforts to secure the supply of electricity, with Member States implementing national capacity- remuneration mechanisms without fulduly exploring theall potential of cross-border solualternative solutions, in particular in terms of flexibility resources – such as demand side management, storage and physical interconnections –, thus interfering with and distorting market design, as well as potentially creating lock-in effects;
Amendment 249 #
2013/2005(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Recognises that, without prejudice either to the Member States' right to choose their energy mix or to the need for better EU-wide coordination, the EU as a whole must make full use of the potential of all renewable energy sources that are at the disposal of EU Member States;
Amendment 264 #
2013/2005(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Stresses that harmonisation of renewable- and efficiency-related incentives and of auxiliary energy costs across all Member States – or at leasnational subsidies and other incentives are important for the large-scale uptake of renewables in national energy markets; notes that a wide variety of different schemes for promoting renewable energy sources (RES) currently coexist within the European Union, due to disparities between national market features, different potentials and different stages of technology patterns and maturity; notes that greater compatibility in this regard – is essentialmight be an important aspect 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 301 #
2013/2005(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on the Commission and the Member States to jointly assess investments needed to decarbonise the energy sector and develop an EU strategy that prioritises energy efficiency, cost- effective integration of renewables, and markets integration;
Amendment 306 #
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 storage infrastructure and smart transmission and distribution networks, which are vital for a well-integrated and well-functioning energy market;
Amendment 315 #
2013/2005(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Urges the European Commission and the Member states to put in place an efficient congestion management system in order to foster the efficient use of existing gas and electricity transmission capacity, reducing the cost of expanding network capabilities, and facilitate the increased connection of renewable generation sources to the electricity network;
Amendment 318 #
2013/2005(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Calls on the Commission to put in place cross-border and regionally integrated day ahead, intraday and balancing markets in order to help improve system flexibility and the large- scale integration of electricity from renewable energy sources and participation of demand response resources alongside generation;
Amendment 330 #
2013/2005(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Welcomes the Commission's determination to enforce anti-trust and state-aid rules ensuring that a level-playing field is established with equal conditions of access for all market players; Welcomes the announced Commission guidance on best practice and experience gained in renewable energy support schemes, while not forcing Member States to implement abrupt changes in support which destabilise the market and increase costs; notes that support mechanisms should adapt to increase levels of penetration and falling production costs;
Amendment 341 #
2013/2005(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Strongly supports the Commission's efforts to introduce harmonised network codes and rules accordingly to the plan and to ensure the stability and increased innovation-friendliness of the regulatory framework of the internal energy market;
Amendment 350 #
2013/2005(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Calls on the Commission to examine the system adequacy and flexibility of national generation capacities in the short and long term, taking into account all flexibility resources that could contribute to system adequacy before assessing generation adequacy, to develop an EU-wide strategy and to report on the impact of the applied national measures related to capacity assessment and development planning on the internal energy market, taking into account the cross-border aspects of this complementary market design policy; calls, in this regard, on further efforts to be put on the future uptake of energy storage technologies and demand-side responsiveness, all of which are additional sources of flexibility;
Amendment 358 #
2013/2005(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Calls on the Commission and on ENTSO-E to develop a coherent and aligned methodology for generation adequacy in Europe, including the positive contribution of renewable energy sources and in particular variable renewables;
Amendment 359 #
2013/2005(INI)
Motion for a resolution
Paragraph 26 b (new)
Paragraph 26 b (new)
26b. Calls on the Commission to develop guidelines on how Member States should assess the needs for capacity remuneration mechanisms and the characteristics of such mechanisms, so as to minimise distortions to the internal energy market. In particular and among others, mechanisms should be reversible and conditional on the previous exhaustion of all flexibility capabilities.
Amendment 381 #
2013/2005(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Calls on the Commission, the Member States and the relevant stakeholders to improve the quality and availability of the information offered to consumers, to provide them with clear and transparent billing methods and to establish price comparison tools allowing them to make best-informed choices, as well as to set up easy-to-use mechanisms for disputes with supplierffective complaint handling procedures as independent dispute resolution mechanisms; welcomes the proposal of the Commission to establish an information platform on consumer rights;
Amendment 385 #
2013/2005(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Calls on the Commission to encourage further cooperation between the energy and information and communications technology (ICT) sectors, and to review existing instruments fregulatory financingrameworks to encourage energy- related innovations, in order to benefit all the consumers and to facilitate the deployment of smart grids in a user- friendly way, secure and reliable way, taking into account the privacy of the consumer;
Amendment 389 #
2013/2005(INI)
Motion for a resolution
Paragraph 32
Paragraph 32
32. Urges the Member States, and regional and local authorities, to promote ICTinnovative technology solutions in smart grids, and to aim for a prosumer market, takleading into account the increasing need formore flexibility, energy efficiency/savings and demand-side participation;
Amendment 401 #
2013/2005(INI)
Motion for a resolution
Paragraph 33
Paragraph 33
33. Looks forward to the Commission's guidelines to help set ambitious policy objectives with regard to vulnerable consumers, and will assist the Member States in better defining this category of consumers; calls on the Commission to review, in parallel, existing mechanisms and instruments for protecting such consumers in different vulnerable situations, with a view to propose measures aimed at a more coherent and comprehensive approach at EU-level; leaving it to Member States to choose the most suitable instruments for support;
Amendment 410 #
2013/2005(INI)
Motion for a resolution
Paragraph 34
Paragraph 34
34. Calls on the Member States, the Commission and the relevant stakeholders to convert the necessary supporting schemes for all power generators into transparent, homogeneous and market- driven mechanisms in order to create a common market for requested support features – such as energy efficiency, prosumers, cogeneration, renewables and auxiliarygrid support services – in a way that ensures their compatibility;
Amendment 422 #
2013/2005(INI)
Motion for a resolution
Paragraph 34 a (new)
Paragraph 34 a (new)
34a. Calls on the Commission and the Member States to terminate all subsidies and other types of support and state-aid to traditional fossil-based generation as they might prevent transparent price-setting and a level playing field among providers;
Amendment 425 #
2013/2005(INI)
Motion for a resolution
Paragraph 35
Paragraph 35
35. Calls on the Commission to examine thoroughly the implications of integrating low-emission energy sources, especially renewables, into the energy grids with regard to financial support, system-wide technical requirements and adapting the current market design; underlines that the lack of coordinated approach towards those sources has until now prevented their integration within the European energy systemse fact that the current European energy system - which was created around the needs of centralised and conventional generation plants - needs to be adapted to the rapidly rising contribution of distributed generation from renewable energy;
Amendment 438 #
2013/2005(INI)
Motion for a resolution
Paragraph 35 a (new)
Paragraph 35 a (new)
35a. Calls on the Commission to address microgeneration in future European energy legislation, particularly in the context of the EU's future 2030 climate and energy package; calls on the Commission and the Member States to ensure a proper regulatory framework to simulate local energy production and microgeneration;
Amendment 458 #
2013/2005(INI)
Motion for a resolution
Paragraph 37 a (new)
Paragraph 37 a (new)
37a. Urges the Commission to make available sufficient funding for the development of smart distribution grids, which are the most-cost effective way for the large-scale penetration of distributed generation from renewable energy sources while ensuring security of supply and realising energy saving potentials;
Amendment 36 #
2013/0410(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The introduction of the e-Customs in 2011, by which documents supporting imports and exports are no longer kept by the customs administrations but by the economic operators, has led to delays in the conduct of European Anti-fraud Office (OLAF) investigations in the customs area, as OLAF needs the intermediation of these administrations to obtain such documents. Moreover, the 3-year limitation period applicable to customs documents held by the administration, puts additional constraints to the successful conduct of investigations. In order to accelerate the conduct of investigations in the area of customs the Commission should therefore, in certain circumstances and following prior notification to the Member States, have the right to request documents supporting import and export declarations directly from the economic operators concerned. These economic operators should be obliged to provide the Commission with the requested documents.
Amendment 90 #
2013/0410(COD)
Proposal for a regulation
Article 1 – paragraph 5
Article 1 – paragraph 5
Proposed amendment to Regulation (EC) No 515/97
Article 18 h – paragraph 1
Article 18 h – paragraph 1
The Commission may, following a request to the Member State as described in paragraph 1a, obtain directly from the economic operators documents supporting import and export declarations, with respect to investigations related to the implementation of customs legislation as defined in Article 2(1). It shall be required to notify of this request any Member States likely to be involved in a subsequent enquiry.
Amendment 91 #
2013/0410(COD)
Proposal for a regulation
Article 1 – paragraph 5
Article 1 – paragraph 5
Proposal for a Regulation (EC) No 515/97
Article 18 h – paragraph 1
Article 18 h – paragraph 1
1. The Commission may, following a request to the Member State as described in paragraph 1a, obtain directly from the economic operators documents supporting import and export declarations, with respect to investigations related to the implementation of customs legislation as defined in Article 2(1). It shall be required to notify of this request any Member States likely to be involved in a subsequent enquiry.
Amendment 99 #
2013/0410(COD)
Proposal for a regulation
Article 1 – paragraph 9 a (new)
Article 1 – paragraph 9 a (new)
Regulation (EC) No 515/97
Article 30 – paragraph 4
Article 30 – paragraph 4
9a. Article 30(4) is replaced by the following: 4. Data obtained from the CIS may, with the prior authorization of, and subject to any conditions imposed by, the Member State which included them in the System, be communicated for use by national authorities other than those referred to in paragraph 2, third countries and international or regional organizations wishing to make use of themand/or EU agencies which contribute to the protection of the financial interests of the Union and correct application of customs legislation. Each Member State shall take special measures to ensure the security of such data when they are being transmitted or supplied to departments located outside its territory. The provisions referred to in the first subparagraph shall apply mutatis mutandis to the Commission where it has entered the data in the System.
Amendment 52 #
2013/0340(NLE)
Proposal for a directive
Recital 15
Recital 15
(15) A strong and independent competent regulatory authority is a fundamental condition of the European nuclear safety regulatory framework. Its independence and the exercise of its powers impartially and transparently are crucial factors to ensure a high level of nuclear safety. Objective regulatory decisions and enforcement actions should be established without any undue external influence that might compromise safety, such as pressures associated with changing political, economic or societal conditions, or pressures from government departments or any other public or private entities. The negative consequences of the lack of independence were evident in the Fukushima accident. The provisions of Directive 2009/71/Euratom on functional separation of competent regulatory authorities should be strengthened to ensure the regulatory authorities' effective independence and to guarantee that they are provided with the appropriate means and competencies to properly carry out the responsibilities assigned to them. In particular, the regulatory authority should have sufficient legal powers, sufficient staffing and sufficient financial resources for the proper discharge of its assigned responsibilities. The strengthened requirements aiming at ensuring independence in carrying out the regulatory tasks should be however without prejudice to close cooperation, as appropriate, with other relevant national authorities and the European Commission or to general policy guidelines issued by the government not related to thethat do not undermine the national authority's regulatory powers and duties.
Amendment 95 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Directive 2009/71/Euratom
Article 3 – paragraph 12
Article 3 – paragraph 12
12. 'reasonably achievable' means that, in addition to meeting the requirements of good practice in engineering, further safety or risk reduction measures for the design, commissioning, operation or decommissioning of a nuclear installation should be sought and that these measures should be implemented unless it can be demonstrated that they arthe national regulatory authority accepts that they are demonstrated to be grossly disproportionate with regard to the safety benefit they would confer;
Amendment 104 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 6 – point d a (new)
Article 1 – paragraph 1 – point 6 – point d a (new)
Directive 2009/71/Euratom
Article 4 – paragraph 2
Article 4 – paragraph 2
(da) paragraph 2 is replaced by the following: "2. Member States shall ensure that the national framework is maintained and improved when appropriate, taking into accouat regular intervals, and as soon as relevant operating experience, insights gained from safety analyses for operating nuclear installations, development of technology and results of safety research, whenbecome available and relevant." lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:172:0018:0022:EN:PDF)." Or. en (http://eur-
Amendment 105 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2009/71/Euratom
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
(a) is legally and functionally separate from any other public or private entity concerned with the promotion or utilisation of nuclear energy or electricity production;
Amendment 115 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2009/71/Euratom
Article 5 – paragraph 3 – point e
Article 5 – paragraph 3 – point e
(e) to carry out enforcement actions, including penalties in accordance with Article 9a and suspending the operation of a nuclear installation in accordance with the conditions defined by the national framework referred to in Article 4(1).
Amendment 151 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive 2009/71/Euratom
Article 8 b – point b – point v
Article 8 b – point b – point v
(v) external natural and man-made hazards are avoided, where possible, and their impact is minimisedas low as reasonably achievable.
Amendment 155 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive 2009/71/Euratom
Article 8 c – paragraph 1 – point b
Article 8 c – paragraph 1 – point b
(b) defines, documents and re-assesses regularly and at least every teneight years, the design basis of nuclear installations through a periodic safety review, and supplements it by a design extension analysis, to ensure that all reasonably practicable improvement measures are implemented;
Amendment 157 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive 2009/71/Euratom
Article 8 c – paragraph 1 – point f
Article 8 c – paragraph 1 – point f
(f) carries out a specific safety review for nuclear installations which the competent regulatory authority considers to be close to the limit of their operating lifetime as originally foreseen, and for which an extension of the lifetime is requesimplements any measures mandated by the regulatory authority to prevent beyond-design basis accidents before a requested extension of the operating lifetime can be granted.
Amendment 159 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive 2009/71/Euratom
Article 8 c– paragraph 2
Article 8 c– paragraph 2
2. Member States shall ensure that the national framework requires that the granting or the review of a licence to construct and/or operate a nuclear installation should be based upon an appropriate site- and installation-specific safety assessment following an inspection by the national authority.
Amendment 170 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2009/71/Euratom
Article 8e – paragraph 1
Article 8e – paragraph 1
1. Member States shall at least every teneight years arrange for periodic self-assessments of their national framework and competent regulatory authorities and invite an international peer review of relevant segments of their national framework and competent regulatory authorities with the aim of continuously improving nuclear safety. Outcomes of any peer review shall be reported to the Member States and the Commission, when available.
Amendment 175 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2009/71/Euratom
Article 8e – paragraph 2 – introductory part
Article 8e – paragraph 2 – introductory part
Member States, with the support of the competent regulatory authorities, shall periodically arrange, and at least every six years, a system of topical peer reviews and agree on a time-frame and the modalities for implementation within the same time-frame. For this purpose Member States shall:
Amendment 194 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2009/71/Euratom
Article 8e – paragraph 2 – point d a (new)
Article 8e – paragraph 2 – point d a (new)
(da) the topic for the first topical peer review shall be decided no later than three years after the entry into force of this Directive.
Amendment 205 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2009/71/Euratom
Article 8e – paragraph 4 a (new)
Article 8e – paragraph 4 a (new)
4a. Upon information by the Commission and within three months, the national authority shall instruct the license holder to implement the relevant safety measures identified in the peer review process. The national authority shall impose penalties in accordance with Article 9a if within an additional 6 months the license holder fails to demonstrate a clear progress in the implementation of such measures.
Amendment 206 #
2013/0340(NLE)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2009/71/Euratom
Article 8e – paragraph 4 a (new)
Article 8e – paragraph 4 a (new)
4a. Upon receipt of a request for extension of the operating lifetime of a nuclear installation beyond originally foreseen, the Member State shall invite within six months a peer review of the installation concerned in accordance with paragraph 2.
Amendment 10 #
2013/0314(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) When the above is manifestly impossible, bearing in mind that not all contributors are located within the Union but their data might be essential for a given benchmark, the contributors concerned may, after acquainting themselves with the code of conduct governing the submission of data to the administrator, continue to submit data for that benchmark. In that event, the administrator has to be legally responsible for the quality of the data used to produce the benchmark.
Amendment 16 #
2013/0314(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. This Regulation shall apply to the provision of benchmarks within the Union, the contribution of input data to acertain benchmarks and the use of acertain benchmarks within the Union. It shall encompass the IOSCO principles and shall be applied in proportion to the size of, and the risks arising from, particular benchmarks, their administrators, and the benchmark-setting process, including the number and types of contributors.
Amendment 45 #
2013/0314(COD)
Proposal for a regulation
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
2a. When, owing to the nature and the location of a contributor, the administrator cannot have the code of conduct signed, but considers the data in question to be essential for a given benchmark, it may, after ascertaining that the contributor has acquainted itself with the code of conduct governing the submission of data, continue to accept data for that benchmark. In that event, the administrator shall be legally responsible for the quality of the data used to produce the benchmark.
Amendment 47 #
2013/0314(COD)
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
Amendment 48 #
2013/0314(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) The supervised contributor shall ensure that the provision of input data is not affected by any existing or potential conflict of interest and that, where any discretion is required, it is independently and honestly exercised based on relevant information in accordance with the code of conduct (‘Conflicts of interest’).Does not affect the English version.)
Amendment 50 #
2013/0314(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
(b) The supervised contributor shall have a control framework that ensures the integrity, accuracy and reliability of the input data and that the input data is provided in accordance with the provisions of this Regulation and the code of conduct (‘Adequate controls’).Does not affect the English version.)
Amendment 52 #
2013/0314(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 53 #
2013/0314(COD)
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 56 #
2013/0314(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
Amendment 65 #
2013/0314(COD)
Proposal for a regulation
Article 14 – paragraph 1 – introductory part
Article 14 – paragraph 1 – introductory part
1. Where contributors, comprising at least 20% of the contributors tof a critical benchmark or of a widely used commodity benchmark, as determined by ESMA, have ceased contributing, or there are sufficient indications that at least 20% of the contributors are likely to cease contributing, in any year, the competent authority of the administrator of a critical benchmark shall have the power to:
Amendment 66 #
2013/0314(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point a
Article 14 – paragraph 1 – point a
(a) require supervised entities and contributors of commodity and energy data, selected in accordance with paragraphs 2, to contribute input data to the administrator in accordance with the methodology, code of conduct or other rules;
Amendment 67 #
2013/0314(COD)
Proposal for a regulation
Article 14 – paragraph - 1 (new)
Article 14 – paragraph - 1 (new)
-1. The administrator shall notify the relevant competent authority if it considers the number of contributors to have become inadequate or their distribution to constitute a risk and in any event when 20% of the contributors have ceased, or are likely to cease, contributing. The notification shall be accompanied by a risk analysis and such measures as might serve to mitigate the risks identified.
Amendment 68 #
2013/0314(COD)
Proposal for a regulation
Article 14 – paragraph 2 – introductory part
Article 14 – paragraph 2 – introductory part
2. For a critical benchmark, the supervised entities or a widely used commodity benchmark, as determined by ESMA, the supervised entities or contributors of commodity and energy data that are required to contribute in accordance with paragraph 1 shall be determined by the competent authority of the administrator on the basis of the following criteria:
Amendment 69 #
2013/0314(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point a
Article 14 – paragraph 2 – point a
(a) the size of the supervised entity’s or commodity or energy data contributor’s actual and potential participation in the market that the benchmark seeks to measure;
Amendment 70 #
2013/0314(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) the supervised entity’s or commodity or energy data contributor’s expertise and ability to provide input data of the necessary quality.
Amendment 74 #
2013/0314(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. An administrator shall publish the input data used to determine the benchmark immediately after publication of the benchmark except where publication would have serious adverse consequences for the contributors or adversely affect the reliability or integrity of the benchmark. In such cases publication may be delayed for a period that significantly diminishes these consequences. Any personal data included in iInput data shall not be published in anonymised form.
Amendment 75 #
2013/0314(COD)
Proposal for a regulation
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
1a. Immediately after publication of the benchmark, the administrator shall communicate to the competent authority any grounds for the methodology used to determine the benchmark and any input data which, for the reasons set out in paragraph 1, have not been published.
Amendment 77 #
2013/0314(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. Where a supervised entity intends to enter into a financial contract with a consumer, that supervised entity shall first obtain the necessary information regarding the consumer’s knowledge and experience with respect to the benchmark, his financial situation and his objectives in respect of that financial contract, in accordance with Article 19(4) and (5) of Directive 2004/39/EC, and the benchmark statement published in accordance with Article 15 and shall assess whether referencing the financial contract to that benchmark is suitable for him.
Amendment 84 #
2013/0314(COD)
Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point a
Article 20 – paragraph 2 – subparagraph 1 – point a
(a) administrators authorised or registered in that third country comply with binding requirements which are equivalent to the requirements resulting from this Regulation, in particular taking into account if the legal framework and supervisory practice of a third country ensures compliance with the IOSCO principles on financial benchmarks published on 17 July 2013, or if the legal framework and supervisory practice of a third country ensure compliance with the IOSCO Principles for Oil Price Reporting Agencies, published on 5 October 2012, when oil or commodity benchmarks are involved; and
Amendment 95 #
2013/0314(COD)
Proposal for a regulation
Article 35 – paragraph 2 a (new)
Article 35 – paragraph 2 a (new)
2a. Performing its role in the implementation and monitoring of Regulation (EC) No 1227/2011, the Agency for the Cooperation of Energy Regulators (ACER) shall cooperate with ESMA for the purposes of this Regulation and, without delay, shall supply all information necessary to fulfil its obligations.
Amendment 114 #
2013/0314(COD)
Proposal for a regulation
Annex III – point 6 – introductory part
Annex III – point 6 – introductory part
6. An administrator shall describe and publish with each calculation, to the extent possireasonable without prejudicing duedelaying the date of publication of the benchmark:
Amendment 52 #
2013/0245(NLE)
Proposal for a Regulation
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
(b) to contribute to the objectives of the Joint Technology Initiative on Fuel Cells and Hydrogen, through the development of a strong, sustainable and globally competitive fuel cells and hydrogen sector, in the Unionts dissemination and capacity building across the Union's Member States.
Amendment 56 #
2013/0245(NLE)
Proposal for a Regulation
Article 2 – paragraph 2 – indent 4
Article 2 – paragraph 2 – indent 4
– demonstrate on a large scale, and provided that market competition is not distorted through FCH 2 funding, the feasibility of using hydrogen to support integration of renewable energy sources into the energy systems, including through its use as a competitive energy storage medium for electricity produced from renewable energy sources.
Amendment 61 #
2013/0245(NLE)
Proposal for a Regulation
Article 3 – paragraph 1 – subparagraph 1 – introductory part
Article 3 – paragraph 1 – subparagraph 1 – introductory part
The maximum Union contribution, including EFTA appropriations, to the FCH 2 Joint Undertaking to cover administrative costs and operational costs shall be EUR 700612.5 million, which shall consist of:
Amendment 62 #
2013/0245(NLE)
Proposal for a Regulation
Article 3 – paragraph 1 – subparagraph 1 – point a
Article 3 – paragraph 1 – subparagraph 1 – point a
(a) up to EUR 600525 million corresponding to the contribution committed in accordance with Article 4(1),
Amendment 65 #
2013/0245(NLE)
Proposal for a Regulation
Article 3 – paragraph 1 – subparagraph 1 – point b
Article 3 – paragraph 1 – subparagraph 1 – point b
(b) up to EUR 10087.5 million to match any additional contribution committed above the minimum amount specified in Article 4(1).
Amendment 73 #
2013/0245(NLE)
Proposal for a Regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. For the purpose of valuing the contributions referred to in point (b) of paragraph 2 and clause 13(3)(b) of the Statutes contained in the Annex, the costs shall be determined according to the usual cost accounting practices of the entities concerned, to the applicable accounting standards of the country where each entity is established, and to the applicable International Accounting Standards / International Financial Reporting Standards. The costs shall be certified by an independent external auditor appointed by the entity concerned. The valuation of the contributions shall be verified by the FCH 2 Joint Undertaking. In case of remaining uncertainties, it may be audited by the FCH 2 Joint Undertakinginspected by an auditor appointed by the Commission.
Amendment 84 #
2013/0245(NLE)
Proposal for a Regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. By 31 December 2017 the Commission shall conduct anpromote an external interim evaluation of the FCH 2 Joint Undertaking, which shall assess, notably, the level of participation in, and contribution to, the indirect actions both by the constituent entities of the Members other than the Union, and also by other legal entities. The Commission shall communicate the conclusions thereof, accompanied by its observations, to the European Parliament and to the Council by 30 June 2018.:
Amendment 85 #
2013/0245(NLE)
Proposal for a Regulation
Article 11 – subparagraph 1 a (new)
Article 11 – subparagraph 1 a (new)
1 a. the level of participation in, and contribution to, the indirect actions both by the constituent entities of the Members other than the Union, and also by other legal entities;
Amendment 86 #
2013/0245(NLE)
Proposal for a Regulation
Article 11 – subparagraph 1 b (new)
Article 11 – subparagraph 1 b (new)
1 b. the FCH 2 contribution to the objectives set out in Article 2(1)(b) as assessed, among others, by the following performance indicators: peer-reviewed papers published and their impact factor; number of patents filed and licensed; technological progress achieved as measured by technology readiness level scale; number of businesses started; cash flows generated by new products or applications; number of jobs created; non-EU sector competitive benchmarking;
Amendment 87 #
2013/0245(NLE)
Proposal for a Regulation
Article 11 – subparagraph 1 c (new)
Article 11 – subparagraph 1 c (new)
1 c. the FCH 2 contribution, in quantified terms, to the to the specific technical objectives set out in Article 2(2), as well as the assessment of the economic value of such technical progress;
Amendment 88 #
2013/0245(NLE)
Proposal for a Regulation
Article 11 – subparagraph 1 d (new)
Article 11 – subparagraph 1 d (new)
1 d. The Commission shall communicate the conclusions thereof, accompanied by its observations, to the European Parliament and to the Council by 30 June 2018.
Amendment 90 #
2013/0245(NLE)
Proposal for a Regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Within six months after the winding up of the FCH 2 Joint Undertaking, but no later than two years after the triggering of the winding up procedure referred to in clause 21 of the Statutes contained in the Annex, the Commission shall conduct apromote an external final evaluation of the FCH 2 Joint Undertaking, which shall at least comprehend the elements assessed in the interim evaluation. The results of that final evaluation shall be presented to the European Parliament and to the Council.
Amendment 96 #
2013/0245(NLE)
Proposal for a Regulation
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
Pursuant to Article 8(5) of the Regulation (EU) No .../2013 [the Horizon 2020 Rules for Participation], work plans may provide for justified additional conditions according to specific policy requirements or to the nature and objective of the action, inter alia, that coordinators shall be constituent entities of a Member other than the Union. This should under no condition and throughout the programme raise undue conditions or restrain that willing entities can become a constituent entity of a Member; principles of openness and transparency shall apply throughout the duration of the FCH 2 Joint Undertaking.
Amendment 100 #
2013/0245(NLE)
Proposal for a Regulation
Annex 1 – part 1 – point a
Annex 1 – part 1 – point a
(a) supporting financially research and innovation indirect actions mainly in the form of grants awarded through open calls to participants;
Amendment 101 #
2013/0245(NLE)
Proposal for a Regulation
Annex 1 – part 1 – point a a (new)
Annex 1 – part 1 – point a a (new)
(aa) provide for the timely communication of calls for proposals, availability of legal documentation, evaluation processes and transparency of results;
Amendment 115 #
2013/0245(NLE)
Proposal for a Regulation
Annex 1 – part 7 – point 2 – point a a (new)
Annex 1 – part 7 – point 2 – point a a (new)
(aa) To adopt and make publicly accessible open and transparent rules for willing entities to become constituent entities of a Member of the Joint Undertaking.
Amendment 119 #
2013/0245(NLE)
Proposal for a Regulation
Annex 1 – part 7 – point 2 – point l
Annex 1 – part 7 – point 2 – point l
(l) approve the calls as well as, where appropriate, the related rules for submission, evaluation, selection, award and, review procedures, and transparency norms;
Amendment 144 #
2013/0245(NLE)
Proposal for a Regulation
Annex 1 – part 11 – point 6 a (new)
Annex 1 – part 11 – point 6 a (new)
Amendment 148 #
2013/0245(NLE)
Proposal for a Regulation
Annex 1 – part 17 – point 1 – subparagraph 2 – point c
Annex 1 – part 17 – point 1 – subparagraph 2 – point c
(c) the actions selected for funding, including a breakdown by participant type, including SMEs, and by country and indicating thestatistics, and indication of the financial contribution of the FCH 2 Joint Undertaking to the individual participants and actions.
Amendment 98 #
2013/0139(COD)
Proposal for a directive
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Member States shall ensure that payment service providers make available to consumers athe competent authorities referred in Article 20 develop a common glossary of at least the list of payment services referred to in paragraph 1 and the related definitions, and that provide it to the payment service providers which shall make it available to the consumers.
Amendment 101 #
2013/0139(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Member States shall ensure that payment service providers provide the consumer free of charge with a statement of all fees incurred on their payment account at least annuallypreferably monthly but at least quarterly, via mail or via e-mail, when the account holder has the online banking system associated with the account.
Amendment 50 #
2013/0082(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) the probable year of commissioning and any delays incurred or foreseen to take place;
Amendment 52 #
2013/0082(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
In case of specific bodies, the data and information notified may be accompanied by appropriate comments from Member States. At the request of the Commission, the Member States shall provide any additional information or clarification regarding the data provided.
Amendment 59 #
2013/0082(COD)
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point a a (new)
Article 10 – paragraph 1 – subparagraph 1 – point a a (new)
(aa) identifying cross-border transmission gaps and insufficiencies that hinder the functioning of the energy internal market;
Amendment 27 #
2012/2322(INI)
Motion for a resolution
Recital A
Recital A
A. whereas, in the absence of harmonisation and with due regard to the principle of subsidiarity, the Member States maintain a margin of discretionhave the right to regulate online gambling in accordance with their own values and pursued objectives of general interest;
Amendment 52 #
2012/2322(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the Court of Justice of the European Union (CJEU) has confirmed that the provision of games of chance or gambling is an economic activity, which consequently falls within the scope of fundamental freedoms of the TFEU, notably the free movement of services, and any restrictions imposed thereto need to comply with those provided for by the TFEU, notably under Articles 51 and 52 of particular importance, in which certain restrictions may be justified for reasons of overriding public interest such as consumer protection, the preservation of public order and fraud prevention;
Amendment 131 #
2012/2322(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the Commission to continue to carry out effective checks on compliance with EU law of national laws and practices, and to take legal action against gambling monopolies that do not reduce gambling opportunities or limit promotional activities for gambling in a consistent manner, in linenational laws that do not comply with CJEU case- law;
Amendment 182 #
2012/2322(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the expert group on gambling services and on the Commission to facilitate, as much as possible, the flow of data between regulators in the Member States in order to allow for the establishment of a common system for identifying playersan effective exchange of best practices and the correct application of national laws, by introducing effective measures to combat illegal operators such as the creation of white and black lists of operators, and to make self- exclusion mechanisms applicable throughout the EU;
Amendment 271 #
2012/2322(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Highlights the importance of ensuring that a significant share of gambling revenue continues to flow to social and socio-economic causes of public interest in the Member States; emphasises the contribution that lotteries and casinos make in this connection, and notes that any European approach to the gambling sector must take due account of this specific aspect;
Amendment 350 #
2012/2322(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Recommends the introduction of uniform and pan-European common standards for electronicat the Member States exchange best practices on identification and cross border e-verification services; notes that the different registration procedures across the EU undermine regulated operators, and can push consumers into th, as well as implementing measures such as blacklists and the blocking of websites run by illegal operators, the definition of safe hands of illegal operators; calls, therefore, for registration and identification proced traceable payment solutions and measures to block transactions, in order to ensures to be streamlined and made more efficienthat consumers do not fall into the hands of illegal operators;
Amendment 2 #
2012/2134(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Acknowledges that SMEs contribute enormouslyNotes that 99% of all European businesses are SMEs, providing 85% of employment, and believes that SMEs are thus the driving force in the European economy, having the prime responsibility for the to the creation of employment, sustainable growth and innovation;
Amendment 4 #
2012/2134(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Recalls the variability of SMEs according to investment and innovation criteria and recommends differentiate methods of analyse and support for each model;
Amendment 8 #
2012/2134(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that increased taxation imposed by fiscal adjustment plans in Member States under intervention makes life very difficult for SMEs and consumers; calls for measures allowing SMEs to apply more easily for EU and national programmes and funding; urges the Commission to come forward with an impact assessment study on fiscal adjustment, specifically focusing on SMEs;
Amendment 14 #
2012/2134(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Commission and Member States to support the Business Angels and ensure adequate fiscal support for this funding model;
Amendment 25 #
2012/2134(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Underlines the importance of reducing formalities required to start up a new business and asks the Commission to study the best practices in all Member States and promote the dissemination of success stories;
Amendment 4 #
2012/2133(INI)
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
- having regard to Article 169(1) of the TFEU, stipulating that 'in order to promote the interests of consumers and to ensure a high level of consumer protection, the Union shall contribute to protecting the health, safety and economic interests of consumers, as well as to promoting their right to information, education and to organise themselves in order to safeguard their interests',
Amendment 44 #
2012/2133(INI)
Motion for a resolution
Recital E
Recital E
E. whereas e-commerce, as a means of inclusion, is very useful for consumers with disabilities and those living in rural and remote areas;
Amendment 88 #
2012/2133(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Calls for consumers to be able to exercise their rights simply and effectively in basic areas relating to food, health, energy, transport, financial and digital services, pharmaceuticals and medical devices;
Amendment 105 #
2012/2133(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Points out that EU policies need to promote cooperation between consumer associations and public institutions in all fields, providing easy access to the financial resources required, and to foster the exchange of good practices and knowledge between those associations; notes that a register of European associations should be set up to assist the formation of European associations;
Amendment 118 #
2012/2133(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that educating consumers reduces their risks vis-à-vis dangerous products, speculative financial products and misleading advertising, and that such education and empowerment of consumers needs to be ongoing, from school onwards; considers it important for syllabuses in the Member States to include specific training in this field;
Amendment 148 #
2012/2133(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses that market information must be reliable, clear and comparable, and that it must be accessible not just electronically, but in other forms as well; believes that binding commercial guarantees need to be adopted that ensure the administration of justice in cases where intermediaries become insolvent; emphasises the need to prosecute unfair commercial practices and unfair contract terms or mass market manipulation such as occurred in the Libor and/or Euribor markets; highlights the need to protect consumers ‘trapped’ by a financial product, and those with mortgages who, for reasons not attributable to the consumer, are at risk of being evicted from their homes;
Amendment 163 #
2012/2133(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Highlights the need to provide better protection of the rights of vulnerable consumer groups such as children and the elderly, particularly with regard to transport;
Amendment 175 #
2012/2133(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses that the current financial and economic crisis is weakening the position of consumers in the markets, making them more and more vulnerable, and likely to focus chiefly on the price of goods and services rather than their safety and quality; points out that increasing job insecurity, unemployment rates and the loss of purchasing power are widening inequalities within each country and between countries with negative effects on consumer profiles; emphasises the need to facilitate the right of access to a basic payment account and to ban financial products that are complex and risky for the average consumer;
Amendment 186 #
2012/2133(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Stresses that the quickening process of business concentration affects both the production and marketing of goods and services,; and suggests that consumers should hold at least 20% of democratically elected postdvocates relevant representation for consumers on the management boards of large companies, including those in the financial sector;
Amendment 194 #
2012/2133(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Emphasises that redress mechanisms, such as alternative dispute resolution (ADR), collective dispute resolution or online dispute resolution, must be fast, accessible and effective; stresses that ADR procedures should be resolved within a maximum of 90 days, and that unemployed consumers should, either individually or through a consumer association, have access to free income-based legal aid for court proceedings;
Amendment 2 #
2012/2103(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the Commission communication and underlines the need for concrete policy proposals; believes that it is crucial to agree on the direction of the Union’s long-term policy, not least as regards energy strategy after the 2020 goals, in the interest of predictability for industry and societyconsumers;
Amendment 8 #
2012/2103(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Believes that an open, transparent, integrated, harmonised and competitive internal energy market is needed in order to achieve competitive energy prices, security of supply, sustainability and efficient large- scale deployment of renewable energy, and that the completion of such a market still remains an important challenge for all Member States; welcomes the liberalisation of the internal energy market as a necessary step to cut the cost of electricity and gas for consumers while ensuring that the energy markets become more transparent and better monitored, thereby making for competitive and, from the consumer’s point of view, fair prices; to that end, also considers it essential to ensure that national regulatory authorities function effectively and are coordinated at European level;
Amendment 14 #
2012/2103(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Maintains that the choice of energy mix, although this is a matter for the individual Member States, should allow for the common objectives and, where appropriate, be the subject of a coordinated European approach, as the targets proposed might otherwise not be reached, especially where combining renewable energy sources is concerned; points out that approximate investment needs in terms of energy infrastructure will be impossible to predict without estimating the likely make-up of the energy mix in 2030;
Amendment 16 #
2012/2103(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Considers it vital to focus the attention of the Union and the Member States on investment in infrastructure to enhance energy security and modernisation of the energy supply, bearing in mind that the most effective way to encourage this kind of investment in the long term is to combine it with specific regulatory and fiscal measures and the necessary national public policies;
Amendment 17 #
2012/2103(INI)
Draft opinion
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Maintains that efforts need to be undertaken in order to establish a Europe-wide energy interdependence model aimed at guaranteeing security of supply and preventing national protectionism from confining the markets within the bounds of their self- sufficiency; also considers it essential to eliminate the infrastructure bottlenecks still jeopardising full energy integration, to adopt rules to encourage new competitors to enter the market, and to bear in mind that national energy policy decisions might prove either a help or a hindrance to other Member States;
Amendment 19 #
2012/2103(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Points out that the impact of CO2 capture, transport and storage projects leave behind dangerous waste material that has to be stored; believes that the Commission relies too muchtechnology is still an unknown quantity and that, although they are central to the 2050 decarbonisation targets, projects onf this technologyype could have damaging environmental effects; calls on the Commission to draw up a mid-term report evaluating the results obtained from the use of EU-subsidised experimental carbon capture and storage technologies for coal- fired power stations;
Amendment 24 #
2012/2103(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Emphasises the role of smart grids to allow two-way communication between electricity producers and customers, and points out that smart grids can allow consumers to observe and adapt their electricity use, resulting in lower consumption and in energy efficiency gains;
Amendment 30 #
2012/2103(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Draws attention to the Energy Policy for Europe, which recognises the potential contribution of nuclear power in the areas of competitiveness, cost efficiency, CO2 emission reduction and security of supply; points out that nuclear energy technologies have a potential to meet energy and climate objectives in both the short and longer term, as long as the safety requirements applicable to their operation are fully met, taking into account the entire life cycle of projects;
Amendment 37 #
2012/2103(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Considers that it should be made clear what can be done through energy policy and social policy respectively; believes that the issue of poverty is best dealt with by social policy and not through regulation of energy prices; points out that, whatever the decarbonisation scenario for 2030 or 2050, the assumption is that electricity prices will continue to rise until 2030 and energy and transport expenses will account for an increasingly larger proportion of the burdens falling on families and small and medium-sized enterprises; and therefore considers that attempts will have to be made to cushion the effects of this trend as and where required, through independent regulation by Member States aimed at reducing the outlay which consumers and SMEs will be obliged to incur.
Amendment 389 #
2012/2103(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Highlights the importance of maintaining a European industrial presence in domestic refining, ensuring security of supply, and setting worldwide standards for fuel refining quality and for compliance with environmental requirements, while feeding the downstream sectors such as the petrochemical industry, giving a contribute to growth and jobs in the EU; Stresses the need for additional policy measures that help fighting social and environmental dumping and asymmetric competitive conditions in this industry sector outside the EU;
Amendment 67 #
2012/2044(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Invites the Member States to implement a ‘single market test’ within the framework of their national legislation, taking into account the impact of its standards on citizens and enterprises in the context of the internal market;
Amendment 68 #
2012/2044(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Invites the Commission, the Council and the European Parliament to submit all new European regulations to an ‘e-commerce test’;
Amendment 1 #
2012/2030(INI)
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
- having regard to its resolution of 15 November 2011 on online gambling in the Internal Market P7_TA(2011)0492,
Amendment 3 #
2012/2030(INI)
Motion for a resolution
Citation 27 a (new)
Citation 27 a (new)
Amendment 5 #
2012/2030(INI)
Motion for a resolution
Recital B
Recital B
B. whereas e-commerce and online services are a vital force of the internet and are crucial to the aims of the EU 2020 strategy for the internal market, benefiting both citizens and businesses through intelligent, sustainable and inclusive growth;
Amendment 7 #
2012/2030(INI)
Motion for a resolution
Recital C
Recital C
C. whereas 99% of all European businesses are SMEs, providing 85% of employment, and SMEs are thus the driving force in the European economy, having the prime responsibility for wealth creation, employment and growth, as well as innovation and R&D;
Amendment 9 #
2012/2030(INI)
Motion for a resolution
Recital D
Recital D
D. whereas companies which have developed their internet economy have progressed far more than others, and in the current economic and financial crisis with the generation of employment practically depending on SMEs, it is essential to remove barriers to online commerce so that they can benefit from all its advantages;
Amendment 15 #
2012/2030(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas the Digital Single Market offers a wider choice at more competitive prices to consumers, especially to those living in less accessible, remote or outlying areas, as well as those with reduced mobility, who would otherwise not have access to a wide choice of goods,
Amendment 23 #
2012/2030(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that in times of economic and financial crisis it is essential to take measures to stimulate growth and create employment, and emphasises that completing the Digital Single Market would be a crucial step forward in terms of achieving this goal; calls on the Commission, therefore, to implement its plan for the launching and completion of the Digital Single Market as soon as possible;
Amendment 28 #
2012/2030(INI)
Motion for a resolution
Paragraph 4 – point 1 (new)
Paragraph 4 – point 1 (new)
(1) Considers that fragmentation is also partly due to the poor or late transposition of directives by the Member States, which should be subject to more rigorous scrutiny by the European institutions;
Amendment 29 #
2012/2030(INI)
Motion for a resolution
Paragraph 4 – point 2 (new)
Paragraph 4 – point 2 (new)
(2) Invites the Commission to assess the viability of implementing an 'e-commerce test' as part of all future legislation to ensure that it does not hinder the development of the Digital Single Market;
Amendment 39 #
2012/2030(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls on the Commission to develop a strategy to boost digital entrepreneurship in Europe, focusing on innovative and dynamic SMEs from all sectors so as to ensure high growth potential and innovation and create new jobs in Europe as well as developing new niche markets for SMEs which would not otherwise exist;
Amendment 42 #
2012/2030(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to introduce measures aimed at offering financial support to innovative SMEs, through existing programmes such as the Competitiveness and Innovation Programme (CIP), the new Programme for the Competitiveness of Enterprises and SMEs (COSME) and the Research and Innovation Programme ‘Horizon 2020’, or through the creation of specific programmes, as well as the proposed regulation on venture capital funds;
Amendment 45 #
2012/2030(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls on the Commission to find solutions with a view to improving the EU framework for delivery services, in a way that will allow both businesses and consumers to fully benefit from the Digital Single Market; stresses that this framework should ensure accessible, reliable and speedy delivery, friendly service, an efficient and transparent returns system, and lower prices for cross-border delivery services; not just based on physical borders, but taking into account the distance to the consumer; considers it essential to ensure innovative forms of delivery allowing greater flexibility in terms of choosing a time or place of reception or possible pick-up point with no additional costs attached; considers it crucial to consider measures guaranteeing reasonably priced delivery to the more remote or outlying areas;
Amendment 49 #
2012/2030(INI)
Motion for a resolution
Paragraph 10 – point 1 (new)
Paragraph 10 – point 1 (new)
(1) Recalls the need for an integrated policy approach regarding the completion of the Single Market of transport for all modes (i.e. road cabotage, rail freight, etc.) and environmental legislation in order to avoid inefficiencies of the supply chain and unnecessary cost increases for distance sellers and e-commerce customers.
Amendment 54 #
2012/2030(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission and the Member States to examine the possibilities of simplifying and standardising the VAT rules for cross-border online transactions and of greater EU-wide harmonisation as regards rates and regimes, and to cut red tape with a view to ensuring a simpler, easier, and more efficient system, particularly through the creation of a European one-stop shop; stresses that digitonline cultural products such as e-books, audiovisual products or music should be subject to the same VAT rate as the equivalent product in physical format;
Amendment 65 #
2012/2030(INI)
Motion for a resolution
Paragraph 12 – point 1 (new)
Paragraph 12 – point 1 (new)
(1) Emphasises the importance of addressing micropayments and the high administrative costs often incurred when paying small amounts; notes the increasingly widespread use of payment by mobile phones, smart phones and tablets and that this calls for new responses;
Amendment 68 #
2012/2030(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Emphasises that privacy and data security are major concerns among consumers and tend to discourage them from buying online; considers it necessary to adapt the existing data protection legislation to new challenges and, to prevent situations such as the trading of customer profiles among online enterprises, and to foment innovations in the area of present and future technological developments, e.g. cloud computing;
Amendment 91 #
2012/2030(INI)
Motion for a resolution
Paragraph 21 – point 1 (new)
Paragraph 21 – point 1 (new)
(1) Stresses the importance of fomenting the creation of transparent and trustworthy price comparison websites which can be accessed in various languages, as a means of increasing consumer trust in cross-border trade;
Amendment 94 #
2012/2030(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Welcomes the Commission’s legislative proposals on Alternative Dispute Resolution (ADR) and Online Dispute Resolution (ODR), and underlines the importance of their effective adoption, as well as the need for these mechanisms to be made widely known to consumers and traders so that they can reach the desired level of practical effectiveness;
Amendment 105 #
2012/2030(INI)
Motion for a resolution
Subheading 5
Subheading 5
Setting up the basis for a more competitive and inclusive Europe
Amendment 7 #
2012/2028(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Believes that issuing Stability Bonds enables greater benefits to be drawn from participation in the single currency, by strengthening the position of the euro as a reserve currency and by creating a large common market of European bonds, and should therefore be pursued as soon as possible;
Amendment 20 #
2012/2028(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Believes that the problem of moral hazard could be overcome with a good definition of guarantees and incentive mechanisms for fiscal discipline;
Amendment 21 #
2012/2028(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Believes that only Stability Bonds issued with joint guarantees regulated by strict adherence to the budget proposals, guaranteed by the European Semester, can reap the full benefits;
Amendment 25 #
2012/2028(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Believes that consistent EU legislation is needed in order to introduce Stability Bonds; however, during an unprecedented crisis requiring exceptional measures, the correct procedure shall be to comprehensively interpret the Treaties or perform an accelerated review of them as not to leave unanswered any problems affecting the EU;
Amendment 23 #
2012/2005(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the share in Europe's energy mix accounted for by renewable energy sources (RES) is growing in the short, medium and long term; whereas the large-scale integration of RES asks for adaptation of the grid and improved flexibility;
Amendment 27 #
2012/2005(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas an internal European energy market must be competitive and deliver real choice and transparent information to the consumer who is central in the energy market; whereas an internal energy market might be a way to bring down energy prices and to combat energy poverty;
Amendment 37 #
2012/2005(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas a common EU energy policy is necessary to address the many challenges in the climate and energy field and to create a transparent EU energy market;
Amendment 53 #
2012/2005(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Acknowledges that the trend of rising energy prices is likely to continue given its link to fuel prices, the impact of climate policy and the investments needed to maintain and modernise energy systemsEurope's dependency to fossil fuel imports, the external costs of traditional generation and the investments needed to maintain and modernise energy systems to maintain high levels of security of supply, facilitate the integration of RES, and enable the European internal market;
Amendment 72 #
2012/2005(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Recognises the European added value of better coordinating the Member States' energy policies, in a spirit of solidarity, and of creating efficient and secure trans- border energy systems, thereby creating synergies through improved management of the supply and demand of energy, facilitated through smart technologies at distribution system level;
Amendment 87 #
2012/2005(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Notes the importance of stimulating local cooperatives for renewable energy and collective switching initiatives in increasing citizens participation, improving accessibility of renewable energy and generating financial investments;
Amendment 90 #
2012/2005(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Believes that smart technologies must not be restricted to automatic meter- reading only butdeliver accurate, understandable and user-friendly information to the consumer and must empower this consumer to control his energy use and production; therefore smart technologies must be completed with dynamic, online grid management incorporating such services as grid support services, voluntary demand- side response, energy efficiency services, micro-generation and local or home brokers;
Amendment 113 #
2012/2005(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Emphasises that facilitating microgeneration can empower consumers to have more control over their energy use and reduce energy poverty; calls for special attention to be paid to tenants who are often deterred of generating their own energy;
Amendment 130 #
2012/2005(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses that the internal energy market is not completed yet and that national energy markets falls short of satisfying the needs and expectations of consumers, as they continue to face high prices, a limited choice of suppliers, an overall low quality of services, weak consumer protection and difficulties in switching supplier; stresses, therefore, the need to build a more user- friendly market where consumers can play an active role and become prosumers in the market;
Amendment 142 #
2012/2005(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Believes that the lack of full implementation of internal energy market legislation remains the main obstacle for the completion of this market; underlines the need to tackle structural market distortions, such as ongoing fossil fuel and nuclear subsidies and lack of market transparency; calls on the Commission to increase its efforts to enforce the implementation of the third energy package;
Amendment 158 #
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 prices is secured, where the potential for cogeneration and efficiency demand-side management and storage, 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; notes, in this regard, that a decentralised renewable energy supply reduces the need to build new transmission lines – and hence the associated costs- as decentralised technologies -which can be directly integrated in homes, cities and remote areas- are much closer to the end- consumers;
Amendment 177 #
2012/2005(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Notes in addition that the integration of renewable energy sources will require an enhanced cooperation between transmission and distribution system operators in order to better accommodate the rising share of distributed generation; emphasises the importance to implement new approaches to overcome bottlenecks on the distribution grids, which do not always entail grid extension and reinforcement;
Amendment 212 #
2012/2005(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Notes that a stable regulatory framework – for producers, regulators, network operators, energy suppliers, demand-related service providers and, most importantly, end consumers and prosumers – is essential for a well-functioning internal market and for attracting long-term investment in infrastructure development; underlines that development of network codes anencompassing sound, non- discriminatory and well-balanced rules should lead to harmonisation of proceduresgrid management, market design and interoperability;
Amendment 216 #
2012/2005(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Emphasises the importance of integrated intraday and balancing markets and highlights that, as the current achievements in day-ahead market integration have been encouraging, further steps need to be taken to enable the wider national uptake and European integration of intraday and balancing markets as these market forms are crucial for the efficient integration of large amounts of variable renewable energy sources and for cost-efficient system operation in general;
Amendment 157 #
2012/0288(COD)
Proposal for a directive
Article 1 – point 2 – point a
Article 1 – point 2 – point a
Directive 98/70/EC
Article 7b – paragraph 2
Article 7b – paragraph 2
2. The greenhouse gas emission saving from the use of biofuels taken into account for the purposes referred to in paragraph 1 shall be at least 60 % for biofuels produced in installations starting operation after 1st July 2014. An installation is "in operation" if the physical production of biofuels has taken place. In the case of installations that were in operation on or before 1st July 2014 , for the purposes referred to in paragraph 1, biofuels shall achieve a greenhouse gas emission saving of at least 35% until 31 December 2017 and at least 50% from 1 January 2018. The greenhouse gas emission saving from the use of biofuels shall be calculated in accordance with Article 7d(1). In addition, the greenhouse gas emission savings from the use of biofuels listed in Annex V Part A shall be calculated in accordance with Article 7d (1) only for a quantity equivalent to up to 5% of the total energy of the fuel pool. Above 5%, the GHG emission savings for such biofuels shall be considered equal to the average lifecycle GHG emissions of fossil fuels. For biofuels produced from the feedstocks listed in 'Annex IX Part A of Directive 2009/28/EC, the greenhouse gas emission saving hall be calculated in accordance with Article 7d(1), and their contribution to the calculation of the average greenhouse gas intensity of the fuel pool shall be multiplied by four. For biofuels produced from the feedstocks listed in 'Annex IX Part B, the greenhouse gas emission saving hall be calculated in accordance with Article 7d(1), and their contribution to the calculation of the average greenhouse gas intensity of the fuel pool shall be multiplied by two. For renewable liquid and gaseous fuels of non-biological origin, the greenhouse gas emission saving hall be calculated in accordance with Article 7d(1), and their contribution to the calculation of the average greenhouse gas intensity of the fuel pool shall be multiplied by four.
Amendment 181 #
2012/0288(COD)
Proposal for a directive
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 98/70/EC
Article 7d – Paragraph 6
Article 7d – Paragraph 6
'The Commission shall be empowered to adopt delegated acts pursuant to Article 10a concerning the adaptation to technical and scientific progress of Annex V, including by the revision ofreport by 31 December 2014, and every two years thereafter, on technical and scientific progress regarding the assessment of crop group indirect land-use change values. The report shall, if appropriate, be accompanied, by a proposal to adapt Annex VIII to the best available scientific evidence, to revise the proposed crop group indirect land-use change values; the introduction ofe new values at further levels of disaggregation; the inclusion of (i.e. at a feedstock level); to include additional values should new biofuel feedstocks come to market as appropriate, review the categories of which biofuels are assigned zero indirect land-use change emissions; and theo development of factors for feedstocks from non-food cellulosic and ligno-cellulosic materials.
Amendment 185 #
2012/0288(COD)
Proposal for a directive
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 98/70/EC
Article 7d – Paragraph 7 – subparagraph 1
Article 7d – Paragraph 7 – subparagraph 1
The Commission shall be empowered to adopt delegated acts pursuant to Article 10a concerning the adaptation to technical and scientific progress of Annex IValso if appropriate, make a proposal to adapt Annex IV to the best available scientific evidence, including by the addition of values for further biofuel production pathways for the same or for other raw materials and by modifiying the methodology laid down in Ppart C.
Amendment 51 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 3
Article 2 – paragraph 1 – subparagraph 1 – point 3
(3) ‘'accessory to an in vitro diagnostic medical device’' means an article which, whilst not being an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable or assist the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically assist the medical functionality of the in vitro diagnostic medical device(s) in view of its/their intended purpose(s);
Amendment 54 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 28
Article 2 – paragraph 1 – subparagraph 1 – point 28
(28) ‘'clinical evidence’' means the information that supportsdata, positive and negative, supporting the evaluation of the scientific validity and performance for the use of a device as intended by the manufacturer;
Amendment 55 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 30
Article 2 – paragraph 1 – subparagraph 1 – point 30
(30) ‘'performance of a device’' means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analyticalattainment of technical capabilities, analytical performance and, where applicable, the clinical performance supporting the intended purpose of the device;
Amendment 56 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 35
Article 2 – paragraph 1 – subparagraph 1 – point 35
(35) ‘'performance evaluation’' means the assessment and analysis of data to establish or verify theat the device performs as intended by the manufacturer, including the technical, analytical and, where applicable, the clinical performance of a device;
Amendment 59 #
2012/0267(COD)
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 1
Article 4 – paragraph 5 – subparagraph 1
With the exception of Article 59(4), the requirements of this Regulation shall not apply to devices classified as class A, B and C, in accordance with the rules set out in Annex VII, and manufactured and used only within a single health institution, provided manufacture and use occur solely under the health institution's single quality management system, and the health institution is compliantaccredited with standard EN ISO 15189 or any other equivalent recognised standard. Member States may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 61 #
2012/0267(COD)
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2 a (new)
Article 4 – paragraph 5 – subparagraph 2 a (new)
By way of derogation from the first subparagraph, devices classified as class D and required to be used for transfusion or transplantation purposes, may be manufactured and used within a single health institution without fulfilling the full requirements of this Regulation, provided that they comply with the conditions defined in the first subparagraph, essential requirements in Annex I, applicable harmonized standards referred to in Article 6 and applicable common technical specifications referred to in Article 7. This derogation is applicable only if, and for as long as such devices are not available on the market as CE marked.
Amendment 63 #
2012/0267(COD)
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 1
Article 8 – paragraph 6 – subparagraph 1
Proportionate to the risk class and the type of device, manufacturers of devices shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service, and to apply any necessary corrective action, hereinafter referred to as ‘'post-market surveillance plan’'. The post-market surveillance plan shall set out the process for collecting, recording, communicating to the electronic system on vigilance referred in Article 60 and investigating complaints and reports from healthcare professionals, patients or users on suspected incidents related to a device, keeping a register of non-conforming products and product recalls or withdrawals, and if deemed appropriate due to the nature of the device, sample testing of marketed devices. Part of the post-market surveillance plan shall be a plan for post-market follow-up in accordance with Part B of Annex XII. Where post-market follow-up is not deemed necessary, this shall be duly justified and documented in the post- market surveillance plan and subject to approval by the competent authority.
Amendment 71 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 8 – point b
Article 22 – paragraph 8 – point b
(b) the legitimate interest in protecting commercially sensitive information, to the extent that it does not undermine public health protection;
Amendment 75 #
2012/0267(COD)
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. In the case of devices classified as class C and D, other than devices for performance evaluation, the manufacturer shall draw up a summary of safety and performance. It shall be written in a way that is clear to the intended user. This summary shall be accompanied by the dataset collected during the clinical investigation and the post-market clinical follow-up. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 40 and shall be validated by that body.
Amendment 76 #
2012/0267(COD)
Proposal for a regulation
Article 26 – paragraph 7
Article 26 – 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. Based on this exchange of information and on best practices established across Member States, the Commission shall define, within 2 years of the entry into force of this Regulation, guidelines for the procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies to be carried out by national authorities concerned.
Amendment 77 #
2012/0267(COD)
Proposal for a regulation
Article 28 – paragraph 1 a (new)
Article 28 – paragraph 1 a (new)
1a. Subcontracting shall be limited to only specific tasks connected with the conformity assessment and the need to subcontract such tasks shall be duly justified to the national authority.
Amendment 78 #
2012/0267(COD)
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
1a. Any subsidiaries of the applicant conformity assessment body which are involved in the conformity assessment process, in particular those located in third countries, shall be subject to the application for notification mechanism and its assessment as described in Article 30.
Amendment 79 #
2012/0267(COD)
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. The Commission shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body of the requirements set out in Annex VI or the obligations to which it is subject. It may also commence such investigations on its own initiative, including the unannounced inspection of the notified body by a joint assessment team whose composition meets the conditions set out in Article 30(3).
Amendment 80 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 9 – subparagraph 1 – introductory part
Article 40 – paragraph 9 – subparagraph 1 – introductory part
The Commission mayshall, by means of implementing acts, specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies, for any of the following aspects:
Amendment 81 #
2012/0267(COD)
Proposal for a regulation
Article 47 – paragraph 4
Article 47 – paragraph 4
4. Where demonstration of conformity with the general safety and performance requirements based on clinical performance data or parts thereof is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the characteristics of the device and, in particular, its intended purpose(s), the intended performance and the claims of the manufacturer. The adequacy of demonstration of conformity with the general safety and performance requirements based on the results of analytical performance evaluation alone shall be duly substantiated in the technical documentation referred to in Annex II. Exemption from demonstration of conformity with general safety and performance requirements based on clinical data under the first subparagraph shall be subject to prior approval by the competent authority.
Amendment 82 #
2012/0267(COD)
Proposal for a regulation
Article 47 – paragraph 5
Article 47 – paragraph 5
5. The scientific validity data, the analytical performance data and, where applicable, the clinical performance data shall be summarised as part of a clinical evidence report referred to in Section 3 of Part A of Annex XII. The clinical evidence report shall be included or fully referenced in the technical documentation referred to in Annex II relating to the device concerned. and be made accessible to the public through the electronic system referred to in Article 51 at the time the device is placed on the market.
Amendment 83 #
2012/0267(COD)
Proposal for a regulation
Article 48 – paragraph 4
Article 48 – paragraph 4
4. All clinical performance studies shall be designed and conducted in a way that the rights, safety and well-being of the subjects participating in such clinical performance studies are protected and that the clinical data generated in the clinical performance study are going to be reliable and robust. Realization of the clinical performance studies shall be subject to a positive opinion by the responsible Ethics Committee.
Amendment 84 #
2012/0267(COD)
Proposal for a regulation
Article 49 – paragraph 6 – subparagraph 2
Article 49 – paragraph 6 – subparagraph 2
Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patient shall be taken into account. Realization of the clinical performance studies shall be subject to a positive opinion by the responsible Ethics Committee.
Amendment 85 #
2012/0267(COD)
Proposal for a regulation
Article 51 – paragraph 1 – point a
Article 51 – paragraph 1 – point a
(a) the registration of clinical performance studies in accordance with Article 50 and the clinical data generated;
Amendment 86 #
2012/0267(COD)
Proposal for a regulation
Article 51 – paragraph 1 – point c
Article 51 – paragraph 1 – point c
(c) the information related to clinical performance studies conducted in more than one Member State and the clinical data generated in case of a single application in accordance with Article 56;
Amendment 87 #
2012/0267(COD)
Proposal for a regulation
Article 51 – paragraph 2
Article 51 – paragraph 2
2. When setting up the electronic system referred in paragraph 1, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article […...] of Regulation (EU) No [Ref. of future Regulation on clinical trials]. With the exception of the information referred to in Article 50 and in Article 51 (a), (c) and (d), the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission.
Amendment 88 #
2012/0267(COD)
Proposal for a regulation
Article 51 – paragraph 3
Article 51 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 for determining which other information regarding clinical performance studies collated and processed in the electronic system shall be publicly accessiblethe technical requirements and parameters to allow interoperability with the EU database for clinical trials on medicinal products for human use set up by Regulation (EU) No [Ref. of future Regulation on clinical trials]. Article 50(3) and (4) shall apply.
Amendment 89 #
2012/0267(COD)
Proposal for a regulation
Article 53 – paragraph 1
Article 53 – paragraph 1
1. If the sponsor introduces modifications to a clinical performance study that are likely to have a substantial impact on the safety or rights of the subjects or on the robustness or reliability of the clinical data generated by the study, he shall notify the Member State(s) and the Ethics Committee concerned of the reasons for and the content of those modifications. The notification shall be accompanied by an updated version of the relevant documentation referred to in Annex XIII.
Amendment 90 #
2012/0267(COD)
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 30 days after notification, unless the Member State concerned has notified the sponsor of its refusal based on considerations of public health, patient safety or public policyduly justified refusal.
Amendment 91 #
2012/0267(COD)
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Where a Member State has refused, suspended or terminated a clinical performance study, or has called for a substantial modification or temporary halt of a clinical performance study, or has been notified by the sponsor of the early termination of a clinical performance study on safety grounds, that Member State shall communicate such facts and its decision and the grounds therefore to all Member States and the Commission by means of the electronic system referred to in Article 51.
Amendment 92 #
2012/0267(COD)
Proposal for a regulation
Article 55 – paragraph 3
Article 55 – paragraph 3
3. Within one year from the end of the clinical performance study, the sponsor shall submit to the Member States concerned a summary of the results of the clinical performance study in form of a clinical performance study report referred to in Section 2.3.3 of Part A of Annex XII. together with all the data collected during the clinical performance study, including negative findings. Where, for scientific reasons, it is not possible to submit the clinical performance study report within one year, it shall be submitted as soon as it is available. In this case, the clinical performance study protocol referred to in Section 2.3.2 of Part A of Annex XII shall specify when the results of the clinical performance study are going to be submitted, together with an explanation.
Amendment 93 #
2012/0267(COD)
Proposal for a regulation
Article 56 – paragraph 2
Article 56 – paragraph 2
2. In the single application, the sponsor shall propose one of the Member States concerned as coordinating Member State. If that Member State does not wish to be the coordinating Member State, itConcerned Member States shall agree, within six days of submission of the single application, with anotherhich Member State concerned that the latter shall be the coordinating Member State. If no other Member State accepts to be the coordinating Member State, the Member State proposed by the sponsor shall be the coordinating Member State. If another Member State than the one proposed by the sponsor becoms and the Commission shall agree, in the framework of the attributions of the Medical Devices cCoordinating Member State, the deadlines referred to in Article 49(2) shall start on the day following the acceptancon Group, on clear rules for designating the coordinating Member State.
Amendment 94 #
2012/0267(COD)
Proposal for a regulation
Article 57 – paragraph 1 – introductory part
Article 57 – paragraph 1 – introductory part
1. The sponsor shall fully record and register in the electronic system on clinical investigations referred to in Article 51, any of the following:
Amendment 96 #
2012/0267(COD)
Proposal for a regulation
Article 57 – paragraph 4 – subparagraph 1
Article 57 – paragraph 4 – subparagraph 1
In the case of a clinical performance studyinvestigation for which the sponsor has used the single application referred to in Article 56, the sponsor shall report any event as referred to in paragraphs 1 and 2 by means of the electronic system referred to in Article 51. Upon receipt, this report shall be transmitted electronically to all Member States concerned.
Amendment 98 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 a (new)
Article 59 – paragraph 3 a (new)
3a. Member States and the Commission shall develop and guarantee the interoperability between national records and the electronic system on vigilance referred to in Article 60, to ensure the automated export of data to this system, while avoiding duplication of registries.
Amendment 100 #
2012/0267(COD)
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – paragraph 2
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission and to the notified bodies, to the notified bodies and without prejudice to the preservation of intellectual property, to healthcare professionals and the public. The data referred to in points (a) to (e) of Article 60(1) shall not be considered commercially confidential information.
Amendment 101 #
2012/0267(COD)
Proposal for a regulation
Article 60 – paragraph 3
Article 60 – paragraph 3
Amendment 103 #
2012/0267(COD)
Proposal for a regulation
Article 90 – paragraph 2
Article 90 – paragraph 2
2. It shall apply from [fivthree years after entry into force].
Amendment 104 #
2012/0267(COD)
Proposal for a regulation
Annex 5 – section 1 – paragraph 1 – point 15
Annex 5 – section 1 – paragraph 1 – point 15
15. in case of devices classified as class C or D, the summary of safety and performance, and the full dataset collected during the clinical study and the post- market clinical follow-up.
Amendment 105 #
2012/0267(COD)
Proposal for a regulation
Annex 8 – section 1 – point 4 – point 4.4 – introductory part
Annex 8 – section 1 – point 4 – point 4.4 – introductory part
4.4. The notified body shall randomly perform unannounced factory inspections to the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred to in Section 4.3. or be performed in addition to this surveillance assessment. The notified body shall establish a plan for the unannounced inspections which shall not take a periodicity lower than one inspection per year and shall not be disclosed to the manufacturer.
Amendment 107 #
2012/0267(COD)
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.1 – point 1.2.1.4
Annex 12 – section 1 – point 1 – point 1.2.1 – point 1.2.1.4
1.2.1.4 The analytical performance full dataset shall be summarised as part ofaccompany the clinical evidence report and may be summarised as part of it.
Amendment 108 #
2012/0267(COD)
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.5
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.5
1.2.2.5 Clinical performance full dataset shall be summarised as part ofaccompany the clinical evidence report and may be summarised as part of it.
Amendment 109 #
2012/0267(COD)
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 2
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 2
– For devices classified as class C according to the rules set out in Annex VII, the clinical performance study report shall include the method of data analysis, the study conclusion and the relevant details of the study protocol and the full dataset;
Amendment 110 #
2012/0267(COD)
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 3
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 3
– For devices classified as class D according to the rules set out in Annex VII, the clinical performance study report shall include the method of data analysis, the study conclusion, the relevant details of the study protocol and the individual data pointsfull dataset.
Amendment 111 #
2012/0267(COD)
Proposal for a regulation
Annex 12 – section 1 – point 2 – point 2.2 – paragraph 1
Annex 12 – section 1 – point 2 – point 2.2 – paragraph 1
Every step in the clinical performance study, from first consideration of the need and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, as for example those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964 and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, in 2008. Conformity with the above principles shall be granted through a favourable opinion of the concerned Ethics Committee.
Amendment 112 #
2012/0267(COD)
Proposal for a regulation
Annex 12 – section 1 – point 2 – point 2.3 – point 2.3.3 – paragraph 1
Annex 12 – section 1 – point 2 – point 2.3 – point 2.3.3 – paragraph 1
A ‘'clinical performance study report’', signed by a medical practitioner or any other authorised person responsible, shall contain documented information on the clinical performance study protocol, results and conclusions of the clinical performance study, including negative findings. The results and conclusions shall be transparent, free of bias and clinically relevant. The report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents. The report shall also include as appropriate any protocol amendments or deviations, and data exclusions with the appropriate rationale. The report shall be accompanied by the clinical evidence report as described in point 3.1 and be accessible to the public with the placing on the market of the device through the electronic system referred to in Article 51.
Amendment 113 #
2012/0267(COD)
Proposal for a regulation
Annex 12 – section 1 – point 3 – point 3.3
Annex 12 – section 1 – point 3 – point 3.3
3.3 The clinical evidence data and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer's post-market surveillance plan referred to in Article 8(5) which shall include a plan for the device post-market follow-up in accordance with Part B of this Annex. The clinical evidence data and its subsequent updates through post-market follow-up shall be accessible to the public through the electronic systems referred to in Art. 51 and Art. 60.
Amendment 97 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
The implantable or other invasive products, intended to be used for human beings, which are listed on a non-exhaustive basis in Annex XV, shall be considered medical devices for the purposes of this Regulation, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose.
Amendment 103 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 36 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 36 – introductory part
(36) ‘clinical data’ means all the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:
Amendment 104 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 36 – indent 3
Article 2 – paragraph 1 – subparagraph 1 – point 36 – indent 3
– published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
Amendment 105 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 36 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 36 a (new)
(36a) ‘performance’ means the ability of a device to produce the effect intended by the manufacturer relative to the medical condition, including attainment of technical capabilities and clinical claims;
Amendment 114 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 1
Article 8 – paragraph 6 – subparagraph 1
Proportionate to the risk class and the type of device, manufacturers of devices, other than custom-made devices, shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service and to apply any necessary corrective action, hereinafter referred to as ‘post-market surveillance plan’. The post- market surveillance plan shall set out the process for collecting, recording, communicating to the electronic system on vigilance referred to in Article 62 and investigating complaints and reports from healthcare professionals, patients or users on suspected incidents related to a device, keeping a register of non-conforming products and product recalls or withdrawals, and if deemed appropriate due to the nature of the device, sample testing of marketed devices. Part of the post-market surveillance plan shall be a plan for post-market clinical follow-up in accordance with Part B of Annex XIII. Where post-market clinical follow-up is not deemed necessary, this shall be duly justified and documented in the post- market surveillance plan and subject to approval by the competent authority. Second subparagraph shall not apply to class III medical devices.
Amendment 119 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 4 a (new)
Article 15 – paragraph 4 a (new)
Amendment 137 #
2012/0266(COD)
Proposal for a regulation
Article 24 – paragraph 8 – point b
Article 24 – paragraph 8 – point b
(b) the legitimate interest in protecting commercially sensitive information, providing that it does not conflict with public health protection;
Amendment 142 #
2012/0266(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance. It shall be written in a way that is clear to the intended user. This summary shall be accompanied by the dataset collected during the clinical investigation and the post-market clinical follow-up. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 42 and shall be validated by that body.
Amendment 143 #
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. Based on this exchange of information and on best practices established across Member States, the Commission shall define, within 2 years after the entry into force of this Regulation, guidelines for the procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies to be carried out by national authorities concerned.
Amendment 145 #
2012/0266(COD)
Proposal for a regulation
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
1 a. Subcontracting shall be limited to only specific tasks connected with the conformity assessment and the need to subcontract such tasks shall be duly justified to the national authority.
Amendment 146 #
2012/0266(COD)
Proposal for a regulation
Article 31 – paragraph 1 b (new)
Article 31 – paragraph 1 b (new)
1b. Any subsidiaries of the applicant conformity assessment body which are involved in the conformity assessment process, in particular those located in third countries, shall be subject to the application for notification mechanism and its assessment as described in Article 32.
Amendment 151 #
2012/0266(COD)
Proposal for a regulation
Article 37 – paragraph 1
Article 37 – paragraph 1
1. The Commission shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body of the requirements set out in Annex VI or the obligations to which it is subject. It may also commence such investigations on its own initiative, including the unannounced inspection of the notified body by a joint assessment team whose composition meets the conditions set out in Article 32(3).
Amendment 155 #
2012/0266(COD)
Proposal for a regulation
Article 42 – paragraph 10 – subparagraph 1 – introductory part
Article 42 – paragraph 10 – subparagraph 1 – introductory part
The Commission mayshall, by means of implementing acts, specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects:
Amendment 162 #
2012/0266(COD)
Proposal for a regulation
Article 49 – paragraph 3
Article 49 – paragraph 3
3. WExcept for class III devices, where demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performances intended and the claims of the manufacturer. The adequacy of demonstration of conformity with the general safety and performance requirements based on the results of non- clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, has to be duly substantiated in the technical documentation referred to in Annex II. Exemption from demonstration of conformity with general safety and performance requirements based on clinical data under the first subparagraph shall be subject to prior approval by the competent authority.
Amendment 163 #
2012/0266(COD)
Proposal for a regulation
Article 49 – paragraph 5
Article 49 – paragraph 5
5. The clinical evaluation and its outcome shall be documented in a clinical evaluation report referred to in Section 6 of Part A of Annex XIII which shall be included or fully referenced in the technical documentation referred to in Annex II relating to the device concerned and be made accessible to the public through the electronic system referred to in Article 53 at the time the device is placed on the market.
Amendment 165 #
2012/0266(COD)
Proposal for a regulation
Article 50 – paragraph 1 – introductory part
Article 50 – paragraph 1 – introductory part
1. Clinical investigations whether they are carried out with the purpose of placing on the market of a medical device or its post- marketing study shall be subject to Articles 50-60 and Annex XIV if they are conducted for one or more of the following purposes:
Amendment 166 #
2012/0266(COD)
Proposal for a regulation
Article 51 – paragraph 6 – subparagraph 1
Article 51 – paragraph 6 – subparagraph 1
Member States shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor, the institution of the investigation site(s) and the investigators involved, as well as free of any other undue influence. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In the assessment, the view of at least one person whose primary area of interest is non- scientific shall be taken into account. The view of at least one patient shall be taken into account. Realization of the clinical investigation shall be subject to a positive opinion by the responsible Ethics Committee.
Amendment 167 #
2012/0266(COD)
Proposal for a regulation
Article 52 – paragraph 3 – point b
Article 52 – paragraph 3 – point b
(b) protection of commercially sensitive information; data on adverse events and safety data shall not be considered commercially sensitive information;
Amendment 168 #
2012/0266(COD)
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. When setting up the electronic system referred in paragraph 1, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article […...] of Regulation (EU) No […/….../...]. With the exception of the information referred to in Article 52, and point (d) of Article 53(1) the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission.
Amendment 169 #
2012/0266(COD)
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 for determining which other information regarding clinical investigations collated and processed in the electronic system shall be publicly accessiblethe technical requirements and parameters to allow interoperability with the EU database for clinical trials on medicinal products for human use set up by Regulation (EU) No […/…]. Article 52(3) and (4) shall apply.../...].
Amendment 170 #
2012/0266(COD)
Proposal for a regulation
Article 55 – paragraph 2
Article 55 – paragraph 2
2. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 30 days after notification, unless the Member State concerned has notified the sponsor of its refusal based on considerations of public health, patient safety or public policyduly justified refusal.
Amendment 171 #
2012/0266(COD)
Proposal for a regulation
Article 55 – paragraph 2 a (new)
Article 55 – paragraph 2 a (new)
2a. Assessment by the Member State of the request by the sponsor for a substantial modification to a clinical investigation shall be in accordance with Article 51(6).
Amendment 172 #
2012/0266(COD)
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
1. Where a Member State has refused, suspended or terminated a clinical investigation, or has called for a substantial modification or temporary halt of a clinical investigation, or has been notified by the sponsor of the early termination of a clinical investigation on safety grounds, that Member State shall communicate such facts and its decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 53.
Amendment 173 #
2012/0266(COD)
Proposal for a regulation
Article 57 – paragraph 2 – subparagraph 2
Article 57 – paragraph 2 – subparagraph 2
If the investigation is conducted in more than one Member State the sponsor shall notify all Member States concerned of the early termination in one Member State and of the overall end of the clinical investigation. That notification shall be made within 15 days from the overall end of the clinical investigation in one or more Member States.
Amendment 174 #
2012/0266(COD)
Proposal for a regulation
Article 57 – paragraph 3
Article 57 – paragraph 3
3. Within one year from the end of the clinical investigation, the sponsor shall submit to the Member States concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in Section 2.7 of Chapter I of Annex XIV, together with all the data collected during the clinical investigation, including negative findings. Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year, it shall be submitted as soon as it is available. In this case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XIV shall specify when the results of the clinical investigation are going to be submitted, together with an explanation.
Amendment 175 #
2012/0266(COD)
Proposal for a regulation
Article 58 – paragraph 2
Article 58 – paragraph 2
2. In the single application, the sponsor shall propose one of the Member States concerned as coordinating Member State. If that Member State does not wish to be the coordinating Member State, itConcerned Member States shall agree, within six days of submission of the single application, with anotherhich Member State concerned that the latter shall be the coordinating Member State. If no other Member State accepts to be the coordinating Member State, the Member State proposed by the sponsor shall be the coordinating Member State. If another Member State than the one proposed by the sponsor becomes coordinating Member State, the deadline referred to in Article 51(2) shall start on the day following the acceptancMember States and the Commission shall agree, in the framework of the attributions of the MDCG, on clear rules for designating the coordinating Member State.
Amendment 176 #
2012/0266(COD)
Proposal for a regulation
Article 59 – paragraph 1 – introductory part
Article 59 – paragraph 1 – introductory part
1. The sponsor shall fully record and register in the electronic system on clinical investigations referred to in Article 53, any of the following:
Amendment 177 #
2012/0266(COD)
Proposal for a regulation
Article 59 – paragraph 4 – subparagraph 1
Article 59 – paragraph 4 – subparagraph 1
In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 58, the sponsor shall report any event as referred to in paragraphs 1 and 2 by means of the electronic system referred to in Article 53. Upon receipt, this report shall be transmitted electronically to all Member States concerned.
Amendment 179 #
2012/0266(COD)
Proposal for a regulation
Article 61 – paragraph 3 a (new)
Article 61 – paragraph 3 a (new)
3a. Member States and the Commission shall develop and guarantee the interoperability between national records and the electronic system on vigilance referred to in Article 62, to ensure the automated export of data to this system, while avoiding duplication of registries.
Amendment 181 #
2012/0266(COD)
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission and to the notified bodies, to the notified bodies and without prejudice to the preservation of intellectual property, to healthcare professionals and the public. The data referred to in points (a) to (e) of Article 62(1) shall not be considered commercially confidential information.
Amendment 182 #
2012/0266(COD)
Proposal for a regulation
Article 62 – paragraph 3
Article 62 – paragraph 3
Amendment 185 #
2012/0266(COD)
Proposal for a regulation
Article 78 – paragraph 6 a (new)
Article 78 – paragraph 6 a (new)
6a. The MDCG may establish standing or temporary panels of experts in specific areas of medicine, or in relevant technical areas, with a view to implementing this Regulation and providing scientific advice to the MDCG.
Amendment 186 #
2012/0266(COD)
Proposal for a regulation
Article 82 – paragraph 1
Article 82 – paragraph 1
1. Members of the MDCG, of the advisory panels to the MDCG and staff of the EU reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner. They shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs. Upon request, the declaration of interests shall be accessible to the public. This Article shall not apply to the representatives of stakeholder organiszations participating in the sub- groups of the MDCG.
Amendment 195 #
2012/0266(COD)
Proposal for a regulation
Annex 5 – section 1 – paragraph 1 – point 18
Annex 5 – section 1 – paragraph 1 – point 18
18. in case of devices classified as class III or implantable devices, the summary of safety and clinical performance, accompanied by the full dataset collected during the clinical investigation and the post-market clinical follow-up.
Amendment 205 #
2012/0266(COD)
Proposal for a regulation
Annex 8 – point 4 – point 4.4 – introductory part
Annex 8 – point 4 – point 4.4 – introductory part
4.4. The notified body shall randomly perform unannounced factory inspections to the manufacturer and, if appropriate, of the manufacturer’s suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred to in Section 4.3. or be performed in addition to this surveillance assessment. The notified body shall establish a plan for the unannounced inspections which shall not take a periodicity lower than one inspection per year and must not be disclosed to the manufacturer.
Amendment 207 #
2012/0266(COD)
Proposal for a regulation
Annex 13 – part B – point 1
Annex 13 – part B – point 1
1. Post-market clinical follow-up, hereinafter: PMCF, is a continuous process to update the clinical evaluation referred to in Article 49 and Part A of this Annex and shall be part of the manufacturer’s post- market surveillance plan. To this end, the manufacturer shall proactively collect, register in the electronic system on vigilance referred to in Article 62 and evaluate clinical data from the use in or on humans of a device which is authorised to bear the CE marking, within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence.
Amendment 208 #
2012/0266(COD)
Proposal for a regulation
Annex 13 – part B – point 3
Annex 13 – part B – point 3
3. The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the technical documentation and be sent periodically to the concerned Member States.
Amendment 209 #
2012/0266(COD)
Proposal for a regulation
Annex 13 – part B – point 4
Annex 13 – part B – point 4
4. The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 49 and Part A of this Annex and in the risk management referred to in Section 2 of Annex I. If through the PMCF the need for corrective measures has been identified, the manufacturer shall implement them and inform the concerned Member States.
Amendment 210 #
2012/0266(COD)
Proposal for a regulation
Annex 14 – part I – point 1 – paragraph 1
Annex 14 – part I – point 1 – paragraph 1
Every step in the clinical investigation, from first consideration of the need and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, as for example those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th World Medical Association General Assembly in Helsinki, Finland, in 1964, and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, in 2008. Accordance with these principles shall be guaranteed by means of a favourable opinion from an ethics committee.
Amendment 211 #
2012/0266(COD)
Proposal for a regulation
Annex 14 – part I – point 2 – point 2.7
Annex 14 – part I – point 2 – point 2.7
2.7. The clinical investigation report, signed by the medical practitioner or other authorised person responsible, shall contain a critical evaluation of all thell clinical data collected during the clinical investigation, including negative findings and a critical evaluation of such data, including negative findings and must be publicly accessible through the electronic system referred to in Article 53.
Amendment 42 #
2012/0192(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) In a clinical trial the safety and, rights and well-being of subjects should be protected and the data generated should be relevant, reliable and robust.
Amendment 43 #
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. The conduct of a clinical trial should be conditioned to prior approval by an Ethics Committee.
Amendment 49 #
2012/0192(COD)
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) Whereas most clinical trials are implemented for the assessment of therapies consisting of large samples of patient populations, the present Regulation should not discriminate patients suffering from rare and ultra- rare diseases and should integrate the specificities of low-prevalence conditions when assessing a trial.
Amendment 55 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – introductory part
Article 2 – paragraph 2 – point 3 – introductory part
(3) ‘Low-intervention clinical trial’: a clinical trialstudy which fulfils all of the following conditions:
Amendment 58 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point b
Article 2 – paragraph 2 – point 3 – point b
(b) according to the protocol of the clinical trial, the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment in any ofin the Member States concerned;
Amendment 61 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘Non-interventional study’: a clinical study other than a clinical trial; and a low interventional clinical trial as defined in Article 2 (2) and (3), respectively.
Amendment 63 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 6
Article 2 – paragraph 2 – point 6
(6) ‘Normal clinical practice’'Best current proven intervention': the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder; in accordance with the current reliable scientific evidence; (This amendment applies throughout the text.)
Amendment 64 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 10 a (new)
Article 2 – paragraph 2 – point 10 a (new)
(10a) 'Ethics Committee': an independent body in a Member State, which includes healthcare professionals, laypersons and at least one well-experienced knowledgeable patient or patient representative, for the review of the scientific, medical and ethical aspects of a clinical trial and whose responsibility is to protect the rights, safety and well-being of subjects and to provide public assurance of that protection.
Amendment 65 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 13
Article 2 – paragraph 2 – point 13
(13) ‘Sponsor’: an individual, company, institution or organisation which takes responsibility for the initiation and, management and/or financing of the clinical trial;
Amendment 66 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 15
Article 2 – paragraph 2 – point 15
(15) ‘'Subject’': an individual who freely and voluntarily participates in a clinical trial, either as recipient of an investigational medicinal product or as a control;
Amendment 67 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 19
Article 2 – paragraph 2 – point 19
(19) ‘'Informed consent’': a process by which a subject freely and voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate;
Amendment 71 #
2012/0192(COD)
Proposal for a regulation
Article 3 – paragraph 1 – indent 2
Article 3 – paragraph 1 – indent 2
– the data generated in the clinical trial are going to be relevant, reliable and robust.
Amendment 73 #
2012/0192(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4a Role of and guidelines for Ethics Committees 1. An authorisation for the conduct of a clinical trial by a competent authority of a Member States may be given after and only if the concerned Ethics Committee has given its approval. 2. The Commission shall, within one year, come forward with guidelines for Member States on Ethics Committees in order to streamline procedures and make it easier to conduct trials in several Member States, without compromising the safety of subjects.
Amendment 74 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
Amendment 75 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 77 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within sixfifteen days following submissionthe appointment of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 80 #
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 2, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, and 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 82 #
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 threfive 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 84 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 2
Article 6 – paragraph 1 – point a – point i – indent 2
– the relevance and acceptability of the clinical trial, taking account of the current state of scientific knowledge, and of whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products;
Amendment 85 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 3
Article 6 – paragraph 1 – point a – point i – indent 3
– the reliability and robustness of the data generated in the clinical trial, taking account of statistical approaches, design of the trial and, methodology (including sample size and randomisation, comparator and endpoints); and the prevalence of the condition, especially for rare diseases (which affect no more than five persons per 10 000), and ultra-rare diseases (which meet a prevalence threshold of no more than one affected person per 50 000).
Amendment 86 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a – point ii – indent 2
Article 6 – paragraph 1 – point a – point ii – indent 2
– the characteristics of the intervention compared to normal clinical practicethe best current proven intervention;
Amendment 87 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a – point ii – indent 4 a (new)
Article 6 – paragraph 1 – point a – point ii – indent 4 a (new)
- the life-threatening and debilitating effects of certain diseases, such as some rare and ultra-rare diseases for which there are limited existing treatment options
Amendment 89 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph 1 – introductory part
The reporting Member State shall submit Part I of the assessment report, including its conclusion, already comprising the views of the concerned Ethics Committee, to the sponsor and to the other Member States concerned within the following time periods:
Amendment 91 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 120 days from the validation date for low-intervention clinical trials;
Amendment 93 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 235 days from the validation date for clinical trials other than low- intervention clinical trials;
Amendment 95 #
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 3045 days from the validation date for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 98 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account. and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, the reasons for such deviation shall be stated in the assessment report.
Amendment 104 #
2012/0192(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a
Article 7 – paragraph 1 – subparagraph 1 – point a
(a) compliance with the requirements for the protection of subjects and informed consent as set out in Chapter V;
Amendment 105 #
2012/0192(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a a (new)
Article 7 – paragraph 1 – subparagraph 1 – point a a (new)
(aa) compliance with national legislative provisions related to ethics.
Amendment 106 #
2012/0192(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Each Member State concerned shall complete its assessment within twenty days from the validation date. It may request, with justified reasons, additional explanations from the sponsor regarding the aspects referred to in paragraph 1 only within that time period.
Amendment 107 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 2
Article 8 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within ten days from the assessment date or the last day of the assessment referred to in Article 7, whichever is later.
Amendment 109 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. Where the Member State concerned has not notified the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of the clinical trial, provided that it was considered a low-intervention clinical trial in accordance with Article 5(2).
Amendment 110 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. TFor the purposes of this Article, the Member States concerned shall not request additional explanations from the sponsor after the assessment date.
Amendment 111 #
2012/0192(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In addition, the views of the concerned Ethics Committee shall be taken into account.
Amendment 113 #
2012/0192(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
Where the sponsor so requests, the application for authorisation of a clinical trial, its assessment and the decision shall be limited to the aspects covered by Part I of the assessment report.
Amendment 114 #
2012/0192(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
After the notification of the decision on the aspects covered by Part I of the assessment report, the sponsor mayshall apply for an authorisation limited to aspects covered by Part II of the assessment report. In this case, that application shall be assessed in accordance with Article 7 and the Member State concerned shall notify its decision with regard to Part II of the assessment report in accordance with Article 8. Failure in approval granting on any of the Parts I and II of the application file results in refusal of the authorization of the clinical trial.
Amendment 115 #
2012/0192(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
This Chapter is without prejudice to the possibility for the sponsor to submit, following the refusal to grant an authorisation or the withdrawal of an application, an application for authorisation to any intended Member State concerned. That application shall be considered as a new application for authorisresubmission of the application. It must be accompanied by any previous assessment report, by the considerations of another clinical trialconcerned Members States, and it must highlight the changes or the reasons justifying the resubmission of the application file.
Amendment 120 #
2012/0192(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 2 – point b a (new)
Article 14 – paragraph 4 – subparagraph 2 – point b a (new)
(ba) refusal of the Ethics Committee to approve the conduct of the clinical trial.
Amendment 123 #
2012/0192(COD)
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 124 #
2012/0192(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 1
Article 19 – paragraph 1 – subparagraph 1
Each Member State concerned shall notify the sponsor through the EU portal as to whether the substantial modification is authorised, whether it is authorised subject to conditions, or whether authorisation is refused. Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within fifteen days from the assessment date.
Amendment 125 #
2012/0192(COD)
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2 – point b a (new)
Article 19 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal of the Ethics Committee to approve the conduct of the clinical trial.
Amendment 126 #
2012/0192(COD)
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision already comprising the views of the concerned Ethics Committee, within tfifteen days from the validation date.
Amendment 127 #
2012/0192(COD)
Proposal for a regulation
Article 20 – paragraph 7
Article 20 – paragraph 7
7. Where the Member State concerned has not notified the sponsor of its decision within the time periods set out in paragraphs 5 and 6, the substantial modification shall be considered as authorised, provided that it was considered a low-intervention clinical trial in accordance with Article 5(2).
Amendment 128 #
2012/0192(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Each Member State concerned shall assess, for its territory, the aspects of the substantial modification which are covered by Part II of the assessment report within tfifteen days from the validation date according to the procedure as referred to in Article 7(1).
Amendment 129 #
2012/0192(COD)
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the assessment date or the last day of the assessment referred to in Article 22, whichever is later.
Amendment 130 #
2012/0192(COD)
Proposal for a regulation
Article 23 – paragraph 2 – subparagraph 2 – point b a (new)
Article 23 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal of the Ethics Committee to approve the conduct of the clinical trial.
Amendment 131 #
2012/0192(COD)
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Where the Member State concerned has not notified the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on the substantial modification of aspects covered by Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of the substantial modification provided that it remains a low-intervention clinical trial in accordance with Article 5(2).
Amendment 133 #
2012/0192(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
The Commission shall be empowered to adopt delegated acts in accordance with Article 85 in order to amendcomplete Annexes I and II with the objective to adapt them to technical progress or to take account of global regulatory developments.
Amendment 138 #
2012/0192(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. Written information given to the subject and/or the legal representative for the purposes of obtaining his or her informed consent shall be kept concise, clear, relevant, and understandable to a lay person. It shall include both medical and legal information that shall be explained orally by a medical doctor to the subject. It shall inform the subject about his or her right to revoke his or her informed consent.
Amendment 139 #
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 research protocol has been endorsed by an Ethics Committee, with expertise in the relevant disease;
Amendment 140 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h a (new)
Article 31 – paragraph 1 – point h a (new)
(ha) The research protocol has been endorsed by an Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics;
Amendment 143 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
Within one year from the end of a clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trial, the clinical study report (CSR) and the full dataset of clinical trial data. These elements shall be made publicly accessible through the EU database.
Amendment 145 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2
Article 34 – paragraph 3 – subparagraph 2
Amendment 147 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 4
Article 34 – paragraph 4
4. For the purpose of this Regulation, if a suspended or temporarily halted clinical trial is not restarted, the date of the decision of the sponsor not to restart the clinical trial shall be considered as the end of the clinical trial. In the case of early termination, the date of the early termination shall be considered as the date of the end of the clinical trial. After 12 months of temporary halt, the clinical trial's data shall be submitted to the EU database and made publicly accessible, even if incomplete.
Amendment 149 #
2012/0192(COD)
Proposal for a regulation
Article 37 – paragraph 2
Article 37 – paragraph 2
2. The investigator shall immediately report serious adverse events to the sponsor, to the Agency and to the competent authority of the concerned Member States, unless the protocol provides, for certain adverse events, that no reporting is required. The investigator shall record all serious adverse events. Where necessary, the investigator shall send a follow-up report to the sponsor.
Amendment 151 #
2012/0192(COD)
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
Unless other Union legislation requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least fivetwenty years after the end of the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation.
Amendment 153 #
2012/0192(COD)
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
Any sponsor may delegate any or all of its logistic tasks to an individual, a company, an institution or an organisation. Such delegation shall be without prejudice to the scientific and ethical responsibility of the sponsor.
Amendment 166 #
2012/0192(COD)
Proposal for a regulation
Annex 2 – part 4 – point 4 – indent 2 a (new)
Annex 2 – part 4 – point 4 – indent 2 a (new)
- the rationale for the modification proposed;
Amendment 167 #
2012/0192(COD)
Proposal for a regulation
Annex 3 – part 1 – point 4 a (new)
Annex 3 – part 1 – point 4 a (new)
4a. The sponsor shall keep detailed records of all adverse events reported to it by the investigator(s) and register them in the EU portal.
Amendment 199 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – introductory part
Article 2 – paragraph 2 – point 3 – introductory part
(3) ‘Low-intervention clinical trialstudy’: a clinical trial which fulfils all of the following conditions: (Horizontal amendment applying throughout the text. Adopting it will necessitate corresponding changes.)
Amendment 209 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point b
Article 2 – paragraph 2 – point 3 – point b
(b) according to the protocol of the clinical trial, the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment in any ofin the Member States concerned;
Amendment 215 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘Non-interventional study’: a clinical study other than a clinical trial and a low interventional clinical trial as defined in Article 2, second paragraph, points (2) and (3), respectively;
Amendment 218 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 6
Article 2 – paragraph 2 – point 6
(6) ‘Normal clinical practice’Best current proven intervention': the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder; in accordance with the current reliable scientific evidence; (Horizontal amendment applying throughout the text. Adopting it will necessitate corresponding changes.)
Amendment 261 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
Amendment 263 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 268 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within sixfifteen days following submission of the application dossier, the proposed reportingappointment, this Member State shall notify the sponsor through the EU portal of the following:
Amendment 274 #
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 2, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, and 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 281 #
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 threfive 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 309 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph 1 – introductory part
4. The reporting Member State shall submit Part I of the assessment report, including its conclusion, already comprising the views of the concerned Ethics Committee, to the sponsor and to the other Member States concerned within the following time periods:
Amendment 311 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 120 days from the validation date for low-intervention clinical trials;
Amendment 314 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 235 days from the validation date for clinical trials other than low- intervention clinical trials;
Amendment 318 #
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 3045 days from the validation date for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 320 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, the reasons for such deviation shall be stated in the assessment report.
Amendment 341 #
2012/0192(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Each Member State concerned shall complete its assessment within twenty days from the validation date. It may request, with justified reasons, additional explanations from the sponsor regarding the aspects referred to in paragraph 1 only within that time period.
Amendment 349 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 2
Article 8 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision already comprising the views of the concerned Ethics Committee, within ten days from the assessment date or the last day of the assessment referred to in Article 7, whichever is later.
Amendment 363 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. Wherith regard to low-intervention clinical trials, in case the Member State concerned has not notified the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of the clinical trial, provided that it was considered a low-intervention clinical trial in accordance with Article 5 (2).
Amendment 374 #
2012/0192(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In addition, the views of the concerned Ethics Committee shall be taken into account.
Amendment 389 #
2012/0192(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
Where the sponsor so requests, the application for authorisation of a clinical trial, its assessment and the decision shall be limited to the aspects covered by Part I of the assessment report.
Amendment 390 #
2012/0192(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
After the notification of the decision on the aspects covered by Part I of the assessment report, the sponsor mayshall apply for an authorisation limited to aspects covered by Part II of the assessment report. In this case, that application shall be assessed in accordance with Article 7 and the Member State concerned shall notify its decision with regard to Part II of the assessment report in accordance with Article 8. Failure in granting approval on either Part I or II of the application file shall result in refusal of the authorization of the clinical trial.
Amendment 400 #
2012/0192(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 2 – point b a (new)
Article 14 – paragraph 4 – subparagraph 2 – point b a (new)
(ba) refusal by the Ethics Committee to approve the conduct of the clinical trial.
Amendment 411 #
2012/0192(COD)
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 420 #
2012/0192(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the assessment date.
Amendment 421 #
2012/0192(COD)
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2 – point b a (new)
Article 19 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal by the Ethics Committee to approve the conduct of the clinical trial.
Amendment 426 #
2012/0192(COD)
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the validation date.
Amendment 427 #
2012/0192(COD)
Proposal for a regulation
Article 20 – paragraph 7
Article 20 – paragraph 7
7. Wherith regard to low-intervention clinical trials, in case the Member State concerned has not notified the sponsor of its decision within the time periods set out in paragraphs 5 and 6, the substantial modification shall be considered as authorised, provided that it was considered a low-intervention clinical trial in accordance with Article 5 (2).
Amendment 430 #
2012/0192(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Each Member State concerned shall assess, for its territory, the aspects of the substantial modification which are covered by Part II of the assessment report within tfifteen days from the validation date, according to the procedure referred to in Article 7, paragraph 1.
Amendment 432 #
2012/0192(COD)
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the assessment date or the last day of the assessment referred to in Article 22, whichever is later.
Amendment 434 #
2012/0192(COD)
Proposal for a regulation
Article 23 – paragraph 2 – subparagraph 2 – point b a (new)
Article 23 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal by the Ethics Committee to approve the substantial modification of the clinical trial.
Amendment 435 #
2012/0192(COD)
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Wherith regard to low-intervention clinical trials, in case the Member State concerned has not notified the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on the substantial modification of aspects covered by Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of the substantial modification. , provided that it remains a low-intervention clinical trial in accordance with Article 5 (2).
Amendment 530 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
3. Within one year from the end of a clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trial, the clinical study report (CSR) and the full dataset of clinical trial data. These elements shall be made publicly accessible through the EU database.
Amendment 602 #
2012/0192(COD)
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
Unless other Union legislation requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least fivetwenty years after the end of the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation.
Amendment 18 #
2011/2288(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Believes that the EU's future attractiveness relies on maintaining its reputation for quality, specialisation and a skilled workforce, while reducing business cost that allows productivity and efficiency gains;
Amendment 23 #
2011/2288(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Highlights that continued investment in Human Capital and the mobility of professionals are preconditions in achieving such skilled workforce;
Amendment 24 #
2011/2288(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Stresses the important contribution of smart regulation towards simplification and reduction of administrative and business costs, namely in the context of SMEs;
Amendment 28 #
2011/2288(INI)
Draft opinion
Paragraph 4 – point a
Paragraph 4 – point a
a) become a leader in new kinds of economic technology, such as sustainable and digital economies, key enabling technologies and renewable energy, and strengthen the focus in achieving leadership in the areas where Grand Societal Challenges offer the prospect for rising future global markets,
Amendment 36 #
2011/2288(INI)
Draft opinion
Paragraph 4 – point b a (new)
Paragraph 4 – point b a (new)
ba) put forward incentives and support mechanisms for those companies willing to enter and expand into external markets,
Amendment 37 #
2011/2288(INI)
Draft opinion
Paragraph 4 – point b b (new)
Paragraph 4 – point b b (new)
bb) promote standards that contribute towards developing innovation in new products and services, by facilitating access to markets, enabling interoperability between new and existing products, services and processes, enhancing user protection, and giving consumers confidence in innovative products and services,
Amendment 45 #
2011/2288(INI)
Draft opinion
Paragraph 4 – point d a (new)
Paragraph 4 – point d a (new)
da) continue to remove existing barriers to the Single market, by promoting the free movement of capital, labour, products and services, building on the attractiveness of a market of 500 million Europeans and stimulating business competitiveness;
Amendment 51 #
2011/2288(INI)
Draft opinion
Paragraph 4 - point d a (new)
Paragraph 4 - point d a (new)
da) continue to build a strong public research base with close links to industry and society at large, in order to underpin technological innovation and private investment in R&D;
Amendment 53 #
2011/2288(INI)
Draft opinion
Paragraph 4 – point d b (new)
Paragraph 4 – point d b (new)
db) prioritise the maintenance in the EU of a strong manufacturing base, namely in sectors where Europe has kept traditionally a strong position, such automobile, aerospace, pharmaceuticals or chemistry, and in new high-technology areas where a strong industrial base is an underpinning element of product, process and service innovation, and of job creation,
Amendment 56 #
2011/2288(INI)
Draft opinion
Paragraph 4 – point d c (new)
Paragraph 4 – point d c (new)
dc) take advantage of the historical heritage of Europe by fostering the cultural industries, sports and tourism as growing and attractive markets,
Amendment 58 #
2011/2288(INI)
Draft opinion
Paragraph 4 – point d d (new)
Paragraph 4 – point d d (new)
dd) foster the trans-Atlantic economy as our current main commercial trade and foreign direct investment partner, taking better advantage of skilled job flows across the two regions and building on the potential for strengthening the innovation economy,.
Amendment 59 #
2011/2288(INI)
Draft opinion
Paragraph 4 – point d e (new)
Paragraph 4 – point d e (new)
de) push forward new bankruptcy laws to encourage a second chance policy to foster entrepreneurship and the re-start of new business, building on the advantage provided by the capital of experience acquired by failed entrepreneurs;
Amendment 1 #
2011/2155(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
– having regard to the Commission Staff Working Document of 24 February 2012 "Making the Single Market Deliver", Annual Governance check-up 2011, published by the European Commission,
Amendment 2 #
2011/2155(INI)
Motion for a resolution
Citation 2 a (new)
Citation 2 a (new)
– having regard to the Commission's Staff Working Paper of 24 February 2012 "Reinforcing effective problem-solving in the Single Market - unlocking SOLVIT's potential at the occasion of its 10th anniversary",
Amendment 3 #
2011/2155(INI)
Motion for a resolution
Citation 2 b (new)
Citation 2 b (new)
– having regard to the statement of the Members of the European Council of the 30th January 2012 entitled "Towards growth-friendly consolidation and job- friendly growth" regarding the governance of the Single Market and the commitment to "swiftly and fully implement at the national level" what Member States have already agreed, to deliver the full potential of the Single Market,
Amendment 4 #
2011/2155(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the importance of a functioning internal market was highlighted during the first Single Market Forum (2-4 October 2011, Krakow, Poland) and in particular in the Krakow Declaration, and the subsequent Parliament resolution on the outcome of the Single Market Forum (P7_TA(2011)0543) in which the single market is described as the most powerful tool for putting Europe back on the path to growthsustainable growth and job creation;
Amendment 6 #
2011/2155(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the publication of the Internal Market Scoreboard has consistently helped to reduce the transposition deficit, butenhance transposition of Single Market rules by providing objective and substantive data on transposition and implementation of these rules by the Member States, and whereas objective data should remain at the core of the Internal Market Scoreboard exercise; whereas a more qualitative approach needs to be takenadopted which looks beyond the figures and identifies the reasons for this deficit;
Amendment 7 #
2011/2155(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the publication of the Internal Market Scoreboard has consistently helped to reduce the transposition deficit, but whereas a more qualitative approach needs to be takennevertheless some Member States are still failing fully to meet their objectives of correct and timely transposition of European legislation into national law, therefore more systematic, independent monitoring is needed in order to ensure proper implementation and transposition of single market legislation with the adoption of a more qualitative approach which looks beyond the figures and identifies the reasons for this deficit;
Amendment 8 #
2011/2155(INI)
Motion for a resolution
Recital E
Recital E
E. whereas although the Internal Market Scoreboard and the Consumer Market Scoreboard are used in different contexts and have different methodologies with different scopes and different sets of indicators, they share the overall aim of improving the functioning of the internal market;
Amendment 12 #
2011/2155(INI)
Motion for a resolution
Recital G
Recital G
G. whereas the current average deficit of 1.2 % is in accordance withonce more above the 1% target agreed by the Heads of State and Government in 2007, but the latest trend shows that more Member States (16) are fmany Member States have reduced the number of directives remailning to comply with this targetbe transposed;
Amendment 15 #
2011/2155(INI)
Motion for a resolution
Recital H
Recital H
H. whereas 9085 directives remain untransposed in at least one Member State (the fragmentation factor is 6 %) and thus cannot produce their full effect in the single market;
Amendment 16 #
2011/2155(INI)
Motion for a resolution
Recital I
Recital I
I. whereas threewo directives are more than two years behind their transposition deadline, in direct violation of the ‘zero tolerance’ target set by the Heads of State and Government in 2007;
Amendment 18 #
2011/2155(INI)
Motion for a resolution
Recital K
Recital K
K. whereas more accurate information is needed on the quality of transposition, and whereas the Commission's Pilot Project can be used in tandem with the Internal Market Scoreboard to detect transposition failures and act rapidly to solve them;
Amendment 19 #
2011/2155(INI)
Motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas better quality in the drafting of adopted legislation could help reduce delays in the transposition of EU law;
Amendment 20 #
2011/2155(INI)
Motion for a resolution
Recital L
Recital L
L. whereas the Lisbon Treaty introduced for the first time the possibility of immediate fines imposed by the European Court of Justice in the event of non- communication of transposition measures;
Amendment 21 #
2011/2155(INI)
Motion for a resolution
Recital N
Recital N
N. whereas, when internal market rules are misapplied, the lack of an operativeefficient redress systems can hinder the effectiveness of citizens' rights by obliging them to start long, slow judicial proceedings in order to defend themselves;
Amendment 22 #
2011/2155(INI)
Motion for a resolution
Recital S
Recital S
S. whereas, although SOLVIT's capacity has recently been improved thanks to better staffing, it is nevertheless important to consolidate itit is important to consolidate and further develop SOLVIT's presence and capacities in all layers of the national administrations in order to guarantee its maximum efficiency and best results;
Amendment 23 #
2011/2155(INI)
Motion for a resolution
Recital T
Recital T
T. whereas SOLVIT should not be a substitute forcomplement to the European Commission's legal work on infringement proceedings by alerting the European Commission on specific issues with the transposition and implementation of EU law in the Member States;
Amendment 24 #
2011/2155(INI)
Motion for a resolution
Recital U
Recital U
U. whereas the Commission is preparing a new strategy to reinforce SOLVIT, and the possibility of giving it a specific legal basis is being considered;
Amendment 26 #
2011/2155(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Internal Market Scoreboard and SOLVIT as important tools with which to achieve better functioning of the, albeit of a different nature, to monitor and identify problems in the transposition and implementation of EU law, but also to identify gaps and bottlenecks in the Single Market, with a view to encouraging action for a better functioning internal market;
Amendment 27 #
2011/2155(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Welcomes the fact that the Commission willhas merged the Internal Market Scoreboard, Your Europe and SOLVIT reports into a single report, which will allow a, Your Europe Advice, SOLVIT, IMI and single points of contact reports into a single comprehensive report, the Annual Governance Checkup, which allows for a reader-friendly, holistic assessment of the functioning of the single market;
Amendment 28 #
2011/2155(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Considers that constant and frequent monitoring of the progress made by Member States is one of the key factors in encouraging them to step up their efforts; Welcomes in this regard the Commission's announcement that a distinct Internal Market Scoreboard will continue to be published each year in or around the summer; notes with concern however that separate reports for each of the different elements of the Annual Governance Check- up could divert the focus away from a holistic approach, and deviate the efforts of the Commission's services towards reporting rather than solving problems highlighted in the Annual Governance Checkup;
Amendment 31 #
2011/2155(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Welcomes the fact that considerable progress has been registered in reducing the number of long overdue directives and calls on Member States to continue their good efforts in this respect;
Amendment 33 #
2011/2155(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to carry out a qualitative assessment of the type oflassify outstanding infringements in the Internal Market Scoreboard that distinguishes between infringementsaccording to those which may be easily resolved and those which result in outright disagreement between the Commission and the Member States;
Amendment 36 #
2011/2155(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Takes note of the Commission's success with the EU Pilot; cautions, however, that while this may have resulted in a lower number of infringement cases, it may leave the Commission to deal with the most difficult cases in the formal infringement proceedings which could also be the cause of longer duration of infringement cases; fears that this will result in longer delays in resolving internal market gaps;
Amendment 37 #
2011/2155(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Takes note that almost 50% of pending Internal Market infringement proceedings relate to areas of taxation and environment; Calls on Member States to dedicate particular attention to better and timelier transposition and implementation of EU rules in these two areas;
Amendment 38 #
2011/2155(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission to ensure that infringements of EU law are met with timelpursued swiftly by infringement proceedings;
Amendment 39 #
2011/2155(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Commission to make more use of SOLVIT as a first port of call for complaints concerning a misapplication of EU law in a cross- border context; calls also on the Commission to ensure that cases which could not be resolved by SOLVIT are appropriately followed up;
Amendment 40 #
2011/2155(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Calls on the Commission to provide support for Member States in the transposition of EU law by developing new tools such as transposition guidelines and a transposition helpdesk;
Amendment 44 #
2011/2155(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
Amendment 46 #
2011/2155(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to complement the Internal Market Scoreboard by providinge evaluations of findings further to petitions submitted to the European Parliament on single market problems and to incorporate this in the Annual Governance Check-up; stresses that the petitions process should be better utilised to improve the EU's legislative process;
Amendment 48 #
2011/2155(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to ensure that correlation tables are made public, to reduceinsist that Member States formally accept a reduction in numerical targets limiting the transposition and compliance deficit for national legislation to 0.5 % for the transposition deficit and 0.5 % for the compliance deficit respectively, and to ensure more effective application of infringement proceedings by means of numerical targets relating to the stages of the procedure, since, as the Commission identified in the Single Market act, these are necessary to thorough and comprehensive implementation of single market legislation;
Amendment 49 #
2011/2155(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls on Member States to systematically provide proper correlation tables setting out how Internal Market Directives are applied in national regulations;
Amendment 50 #
2011/2155(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Calls on the Commission to take measures to improve the quality of drafting in European legislation; welcomes the efforts devoted to better and smarter law-making and encourages all three institutions involved in the legislative process to constantly endeavour to improve the quality of the legislation they jointly produce;
Amendment 51 #
2011/2155(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on the Commission to find ways to increase coordination between tools such as SOLVIT, Your Europe Advice, the Enterprise Europe Network, European Consumer Centres and, the European Employment Service, andIMI and the points of single contact to avoid duplication of efforts and resources;
Amendment 53 #
2011/2155(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to propose ways of better integrating tools such as SOLVIT with the Petitions process of the European Parliament;
Amendment 54 #
2011/2155(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Emphasizes that, over the years, the SOLVIT network has proved to be simple, fast and cost-effective in solving problems affecting citizens and business in misapplication of single market rules; Notes nevertheless that the SOLVIT network remains largely fragmented and underused; Urges the Commission to concentrate more efforts in trainings, education and exchange of best practice between staff employed in the Solvit networks;
Amendment 55 #
2011/2155(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Member States to ensure that SOLVIT centres are appropriately staffed and that there is the necessary degree of coordination and communication with all instances of the national administrations to ensure that decisions are implemented, as well as with the different services of the European Commission, to ensure that decisions are implemented; calls on the Commission to modernise the 2001 Commission Recommendation on principles for using "SOLVIT" - the Internal Market Problem Solving Network, in line with what is proposed in the Commission Staff Working Document "Reinforcing effective problem-solving in the Single Market";
Amendment 56 #
2011/2155(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Notes that cumbersome social security procedures are one of the main concerns of citizens discouraging mobility of workers in Europe; Calls for more resources for SOLVIT to be dedicated to dealing with social security cases;
Amendment 57 #
2011/2155(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to focus on deliveringcontinue its efforts to offer citizens and businesses an integrated virtual package of information and help services, particularly by further developing the Your Europe portal as the single online gateway to all information and help; Notes however the importance of direct human contact and in this regard suggests complementing these efforts with a single live point of contact for citizens and consumers via the Commission's representative offices in each Member State; takes the view that bringing liaison officers from SOLVIT, Your Europe Advice, the Enterprise Europe Network, European Consumer Centres and the European Employment Service together within the representative offices would meet this aim, as well as resulting in better coordination and cohesion; calls on the Commission to consider the feasibility of giving SOLVIT a specific legal basis;
Amendment 60 #
2011/2155(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on the Commission to report on the feasibility of providing Commission staff for the single live points of contact in each Member State; considers that this could be a solution to the staffing problems identified by SOLVIT in various national public administrations; calls on the Commission to consider the feasibility of giving SOLVIT a specific legal basis;
Amendment 61 #
2011/2155(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on the Commission to ensure the setting up of online Points of Single Contact via e-government portals in all Member States in the official language of the host country and in English; notes that the Points of Single Contact are key for the implementation of the services directive; regrets the fact that only one third of available online e-government portals provide access to online electronic procedures; calls on the Member States to provide user-friendly information in several EU languages regarding online administrative rules and procedures regarding the provision of services, in order to facilitate cross-border business in Europe;
Amendment 62 #
2011/2155(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission to consider including findings of Eurobarometer surveys in the Annual Governance Checkup as part of its evaluation to better inform decision-making;
Amendment 63 #
2011/2155(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Notes the recent Commission publications on 'The 20 main concerns', which stemmed from the resolution of 20 May 2010[1], highlights the information, legislative and implementation gaps which persist within the Single Market, as well as the lack of knowledge among consumers and businesses with regard to their rights and obligations, which prevents them from reaping the benefits of the Single Market; undertakes, and calls on the Commission and Member States, to enhance communication with citizens on the rights they derive from the Single Market; [1] P7_TA(2010)0186 (Grech Report).
Amendment 64 #
2011/2155(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to identifyreport on the main internal market obstacles particular to citizens and consumers with a disability and to arrange for special efforts to be made to remove such obstacles;
Amendment 66 #
2011/2155(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Notes the success of the first Single Market Forum as an opportunity for businesses and citizens to familiarise themselves with the rules ofto audit the progress of the Single Market and help citizens and businesses to familiarise themselves with their rights, entitlements and obligations within the single market; welcomes this event as an opportunity to further highlight the existing obstacles to the proper functioning of the single market; reiterates the importance of the Commission and the Member States taking action to eliminate these obstacles and to bring citizens' and businesses' concerns to the fore; calls on the Commission and the Member States to maintain this momentum and to continue to engage and empower stakeholders by conducting regular Single Market Forums, supplementing these with frequent visits to assess and promote the single market in the individual Member States;
Amendment 7 #
2011/2146(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Is of the opinion that any reform of EU State Aid rules on Services of General Economic Interest (SGEIs) should reflect and be aligned with the new economic and social realities of Member States; Considers that the introduction of a more practical and pragmatic approach towards State Aid rules in the sector could potentially help to contain the re- emergence of protectionist attitudes at Member State level which act as a direct threat to the completion of the Single Market;
Amendment 8 #
2011/2146(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Takes the view that SGEIs' operating criteria should take account of market efficiency, continuity of supply and fair access for everyone at an affordable price, without losing sight of the effective safeguarding of social rights and consumer protection, democratic control and accountability;
Amendment 12 #
2011/2146(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Considers it crucial to combat the legal uncertainty caused by cases brought before the European Court of Justice and infringement proceedings opened by the Commission, by providing a clear and rigorous definition of SGEIs, such that public services mission and responsibilities are properly defined by clear rules rather than on an ad hoc basis by ECJ case law, and differentiating them from services of general non-economic interest (SGIs);
Amendment 90 #
2011/2107(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Takes the view that scientific excellence is the most important criterion for allocating competitive funding for research; however, acknowledges that the use made to date of structural funds for R&D has not yet produced enough satisfactory results in closing the research and innovation performance gap among Member States, highlights the importance of succeeding in this objective in order to avoid a two-speed European economy; is of the opinion that renewed approaches are necessary at European level to enhance R&D competitiveness in underperforming Member States; believes that the potential for European programmes to build up excellence across Europe by taking advantage of the learning opportunity offered by leading European R&D institutions has not yet been fully explored; calls on increased programme capacity for trans-national researcher training; stresses the need for new approaches to enable trans-national twinning arrangements among Universities and Research Organizations, envisaging institutional mutual learning on governance mechanisms, human resources and IPR policies, funding, education, research and innovation organizational schemes, and business and societal involvement;
Amendment 238 #
2011/2107(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Highlights the need to give full consideration to the important differences among the companies encompassed by the current definition of "SME", when formulating support instruments for innovation; stresses that innovation support should be prioritized to company developmental stages in which bottlenecks have been recognized, namely at the seed, start-up and early phases; highlights that small-sized companies are the main innovators in Europe and calls for support to venture capital funding for innovative enterprises; stresses the need to tailor new and existing instruments to take due account of the limited resources such companies dispose of, in order to deal with administrative and procedure barriers associated with European funding programmes; is of the opinion that successful programmes such as Eurostars have achieved an important experience in responding to the needs of innovative companies and therefore should be reinforced;
Amendment 241 #
2011/2107(INI)
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Believes that instruments such as the Joint Technology Initiatives play an important role in supporting industry- driven innovation; stresses the need to take effective measures in improving transparency and open access to such instruments by SMEs and the public research sector;
Amendment 242 #
2011/2107(INI)
Motion for a resolution
Paragraph 17 c (new)
Paragraph 17 c (new)
17c. Notes that public procurement offers an untapped opportunity for promoting R&D-based innovation; stresses the need for new measures to support pre- commercial procurement and identify pre- commercial procurement opportunities;
Amendment 293 #
2011/2107(INI)
Motion for a resolution
Paragraph 23 a (new) – after subheading 5
Paragraph 23 a (new) – after subheading 5
Amendment 318 #
2011/2107(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Considers that the Cooperation programme plays an essential role in promoting trans-national collaborative research across the EU; takes the view that top-down definition of narrow themes for calls for proposals hinders both scientific competition across institutions and private sector participation; calls on a more extended use of broader calls with the aim of boosting scientific excellence and involvement of research-driven SMEs and highlights the need for greater flexibility in consortia size definition;
Amendment 326 #
2011/2107(INI)
Motion for a resolution
Paragraph 25 b (new)
Paragraph 25 b (new)
25b. Notes that large-scale projects are often subject to heavy project administration and to bureaucratic burdens which hinder scientific output; favours a shift in balance towards smaller sized projects;
Amendment 329 #
2011/2107(INI)
Motion for a resolution
Paragraph 25 c (new)
Paragraph 25 c (new)
25c. Considers the ERC as a case of success in promoting scientific excellence and the European Research Area; believes its success factors should be emulated across other instruments, whenever applicable; believes the size of the program should be significantly increased and this could be achieved both by a greater allocation of EU funds to the ERC, and by extending agreements with Member States for the national funding of ERC selected proposals;
Amendment 330 #
2011/2107(INI)
Motion for a resolution
Paragraph 25 d (new)
Paragraph 25 d (new)
25d. Believes there is further potential for extending the scope of the ERC concept to collaborative and multidisciplinary research projects, provided they maintain a bottom-up nature and scientific excellence is kept as the major selection criterion;
Amendment 331 #
2011/2107(INI)
Motion for a resolution
Paragraph 25 e (new)
Paragraph 25 e (new)
25e. Takes the view that priority large- scale research infrastructures are important pillars of the European Research Area and therefore EU funding should be extended after the preparatory phase, and linked to trans-national access and training of researchers;
Amendment 9 #
2011/2084(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the Internet gambling marketsector is growing constantly, outside the control of the Member States whose nationals can access the offerings in question,
Amendment 130 #
2011/2084(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Respects the decision by a number of Member States to ban Internet gambling totally; is opposed to government monopolies over on-line gambling, however or partially or to keep a monopoly on that sector – which, under Court of Justice case law, they are entitled to do – in order to contain the gambling phenomenon, protect young people and compulsive gamblers, and combat fraud and tax evasion;
Amendment 144 #
2011/2084(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Insists, however, that Member States which open up the Internet gambling market must ensure complete transparency and make non-discriminatory competition possible; suggests, in this instance, to the Member States that they introduce a licensing model which makes it possible for anyRespects the right of any Member State, as provided for in Court of Justice case law, to restrict the number of operators and the types and scale of offerings, with the proviso, however, that Member States must ensure complete transparency and make non-discriminatory competition possible among European gambling providers meeting the conditions imposed by Member States to apply for a licence;
Amendment 155 #
2011/2084(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Is of the opinion that the principle of mutual recognition of licences on the gambling market does not apply, but that nevertheless, in keeping with the internal market, simplified licence application procedures should be set up in some Member States;
Amendment 170 #
2011/2084(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls – in keeping with the principle of ‘active subsidiarity’ principle – for a common regulatory framework laying down binding high-level minimum standards with regard to preventing gambling addiction and betting fraud and to protecting young people; states that, where a provider complies with those minimum standards, the other Member States should recognise this accordingly, but may set further conditionwithout prejudice to national laws that rule out the award of licences; is of the opinion that a pan- European code of conduct for Internet gambling could be a first step;
Amendment 181 #
2011/2084(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls on the Commission, should no other agreement be reached, to propose a directive without infringing the subsidiarity principle, to promote an expansion minimum standards; states that, if necessary, thought should be given to stepped-up cooperation between Member States cooperation among Member States’ regulatory bodies in areas related to on-line gambling;
Amendment 265 #
2011/2084(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Points to the need for pragmatic solutions with regard to advertising for, and sponsoring of, sports events by Internet gambling providers; is of the opinion that common advertising standards should be adopted which sufficiently protect vulnerable consumers, but at the same time make sponsorship of international events possible, and that advertising bans are in any case ineffectiveto respect the power of Member States to regulate gambling services and permitted forms of promotion or advertising;
Amendment 2 #
2011/2082(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Underlines the needNotes that, given the impact of ageing societies on labour markets, savings and consumption patterns and public expenditure in the years to come, to shiftand also in the context of the economic and financial crisis affecting the EU, there is now a shift going on from direct taxation further to indirect taxation, and that this means that VAT is now a key instrument of macroeconomic policy;
Amendment 17 #
2011/2082(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Stresses that, as a result of the complexity of rules and administrative constraints, businesses often see the current VAT system as an obstacle to the completion of the sinternalgle market; notes that the varying nature of the current VAT arrangements for intra-EU trade tends to reflect negatively on businesses, and especially on SMEs;
Amendment 28 #
2011/2082(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Notes thatBelieves it is important to ensure convergence between on-line and physical environments, so as to put an end to the existing discrimination in terms of differenting VAT rates and complex administrative procedures that are a major burden for development of e-commerce; stresses that e-retailers have greater difficulty toenormous problems selling goods and services in other Member States, leaving the true potential of the single market untapped;
Amendment 34 #
2011/2082(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses the need to develop a strategy at EU level for fighting tax avoidance in the context of VAT in relation to the parallel/informal economy, the aim being to prevent distortions of competition between enterprises and ensure a level playing field, while avoiding huge losses to the public treasury and breaches of social and labour legislation;
Amendment 41 #
2011/2082(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Welcomes the Digital Internal Market study; calls on the Commission to improve interoperability of electronic signatures and to consider revision and extension of the Electronic Signature directive in order to reduce the administrative burden foron enterprises, especially SMEs;
Amendment 45 #
2011/2082(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Stresses the importance of establishing, by 1 January 2015, the 'single counters' for VAT, and proposes the standardisation of invoices at EU level;
Amendment 47 #
2011/2082(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Notes that according to the subsidiarity principle Member States should keep their possibility to decide on reduceddiffering levels of VAT in certain sectors in order to better implement European and national policies or, on the basis of national historical, economic, social, cultural or environmental factors.;
Amendment 55 #
2011/2082(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Recalls that the creation of new own resources is a provision of the Treaty of Lisbon, and welcomes the Commission's recent proposal for 2014-2020 for the introduction of a Europe-level VAT as a source of financing for the EU budget;
Amendment 4 #
2011/2080(ACI)
Draft opinion
Recital A
Recital A
A. whereas the Committee on Industry, Research and Energy is committed to development of the ITER project, that offers the prospect of an almost limitless supply of clean energy, and therefore its financing should not be discontinued;
Amendment 6 #
2011/2080(ACI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas the ITER project has a strong European component with important spill-over effects in terms of research and innovation;
Amendment 7 #
2011/2080(ACI)
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. whereas it offers an important economic opportunity for European industry and engineering in the construction of the ITER infrastructure and offers great potential as a future technological and industrial area;
Amendment 14 #
2011/2080(ACI)
Draft opinion
Paragraph 3
Paragraph 3
3. Supports the idea to use a mix of different financial resources, including the use of the available margins under the different headings of the MFF, - namely the unused margins of the current agricultural year’s budget left under the expenditure ceilings for Heading 2 and unused margins of Heading 5, or other additional funds, such as the Flexibility Instrument - to address additional short- term financial needs for ITER in 2012 and 2013;
Amendment 20 #
2011/2080(ACI)
Draft opinion
Paragraph 5
Paragraph 5
5. Reiterates its concerns about the cost explosion of the ITER project; stresses the need for proper management and precise financial planning for ITER; stresses the need for F4E to pursue the implementation of improved project management and control systems;
Amendment 21 #
2011/2080(ACI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls attention to the fact that the current level of contingency is too small to account for the financial risks inherent to the technological complexity of ITER; emphasises the need to pursue efforts to rebuild adequate contingency levels;
Amendment 21 #
2011/0460(NLE)
Proposal for a decision
Recital 3
Recital 3
(3) In the framework of the negotiations to obtain the support of the other ITER parties to fix the site for ITER in Europe, the Agreement between the European Atomic Energy Community and the Government of Japan for the Joint Implementation of the Broader Approach Activities in the Field of Fusion Energy Research was concluded in 2007 setting out complementary joint fusion research activities in the territory of Japan to ensure the rapid start-up of high performance operation of ITER. The Broader Approach activities and other ITER related activities are channelled through the European Joint Undertaking for ITER and the Development of Fusion Energy. The funding of the Broader Approach activities is mainly ensured by in kind contributions from some members of the European Joint Undertaking for ITER and the Development of Fusion Energy, while the remaining part of the Euratom contribution is covered by the Euratom budget. The 2012 European Fusion Development Agreement (EFDA) Roadmap to the Realisation of Fusion Energy identifies the need for the continuous financial support for key projects, and for research and development activities in key domains, until the start date of ITER's functioning, in order to resolve the scientific and technological challenges leading to the realisation of fusion energy.
Amendment 34 #
2011/0460(NLE)
Proposal for a decision
Recital 6 a (new)
Recital 6 a (new)
(6a) Despite cost containment measures which should continue to be implemented, the ITER project may continue to incur cost overruns due to its scientific nature, and to its high magnitude and technological risk. This should not threaten the limited resources of the Union Budget and the implementation of other important Union policies, namely in the Heading "Competiveness for growth and employment". The ring-fencing of the Union budget against such cost overruns needs to benefit from the appropriate legal safeguards.
Amendment 45 #
2011/0460(NLE)
Proposal for a decision
Article 3 – paragraph 1
Article 3 – paragraph 1
The Programme shall be funded by the Multiannual Financial Framework over and above the MFF ceilings, namely outside Heading 1A. Any cost overruns above the maximum contribution defined in Article 2 shall have no impact on the Union's Budget and shall be funded by contributions of the Member States, based on a call rate applied to each Member State's Gross National Income (GNI) as defined for the purposes of calculating GNI own resource contribution to the General Budget of the European Union. Those contributions shall be considered as external assigned revenue for the Programme in accordance with [Article XX of Regulation (EU) No XX/2012 of the European Parliament and the Council [New Financial Regulation] .
Amendment 687 #
2011/0438(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 2
Article 25 – paragraph 1 – subparagraph 2
The minimum time limit for the receipt of tenders shall be 405 days from the date on which the contract notice was sent.
Amendment 751 #
2011/0438(COD)
Proposal for a directive
Article 27 – paragraph 4 – subparagraph 2
Article 27 – paragraph 4 – subparagraph 2
Contracting authorities shall not reveal to the other participants solutions proposed or other confidential information communicated by a candidate participating in the negotiations without its agreement. Such agreement shall not take the form of a general waiver but shall be given with reference to the intended communication of specific solutions or other confidential information.
Amendment 891 #
2011/0438(COD)
Proposal for a directive
Article 39 – paragraph 1 – subparagraph 2
Article 39 – paragraph 1 – subparagraph 2
For this purpose, contracting authorities may seek or accept advice from administrative support structures or from third parties or market participants, provided that such advice does not have the effect of precluding competition and does not result in a violation of the principles of non-discrimination and transparency or serve to debar any entity consulted from participating in the procurement procedure concerned.
Amendment 1021 #
2011/0438(COD)
Proposal for a directive
Article 48 – paragraph 3
Article 48 – paragraph 3
3. Contracting authorities shall send a notice of the result of the award of contracts based on a dynamic purchasing system within 48 days of the award of each contract. They may, however, group such notices on a quarterly basis. In that case, they shall send the grouped notices within 48 days of the end of each quarter.
Amendment 1066 #
2011/0438(COD)
Proposal for a directive
Article 55 – paragraph 3 – subparagraph 1 – point d a (new)
Article 55 – paragraph 3 – subparagraph 1 – point d a (new)
(da) where the economic operator has been involved in conducting or providing studies, advice, and consultations as referred to in Article 39(1).
Amendment 509 #
2011/0437(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1 – point c a (new)
Article 8 – paragraph 5 – subparagraph 1 – point c a (new)
(ca) gambling activities involving money being placed on games of chance run by bodies awarded exclusive rights by one or more Member States pursuant to a published law, regulation or administrative provision and authorised in accordance with the Treaties;
Amendment 419 #
2011/0401(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
The maximum overall amount for the Union financial contribution from Horizon 2020 to the non-nuclear direct actionsresearch of the Joint Research Centre shall be EUR 2212 million2,52% of the total Horizon 2020 budget.
Amendment 1804 #
2011/0401(COD)
Proposal for a regulation
Annex II – Breakdown of the budget – table
Annex II – Breakdown of the budget – table
I Excellent science, of which: 27818 32,8% 1. The European Research Council 15008,7% 2. Future and Emerging Science and Technologies 35053,4% 3. Marie Curie actions on skills, training and career development 6503 9,1% 4. European research infrastructures (including eInfrastructures) 2802 II Industrial leadership, of which: 3,5% 5. Widening Excellence 20280 0,9% 6. Science and Society 15580 of which 500 for 1. Leadership in enabling and industrial technologies* 0,3% II Industrial leadership, of which: 24,0% 1. Leadership in enabling and industrial technologies* EIT17,2% 2. Access to risk finance** 4000 4,0% 3. Innovation in SMEs 700 2,8% III Societal challenges, of which: 358887,7% 1. Health, demographic change and wellbeing; 9077 of which 292 for EIT 10,2% 2. Food security, sustainable agriculture, marine and maritime research and the 4694 of which 150 for EIT,9% bio- economy; 3. Secure, clean and efficient energy 6537 of which 210 for EIT7,1% 4. Smart, green and integrated transport 7690 of which 247 for EIT 8,0% 5. Climate action, resource efficiency and raw materials 3573 of which 115 for EIT 6. Inclusive, innovative and secure societies 4317 of which 138 for EIT 3,6% 6. Understanding European societies and societal changes 2,0% 7. Protecting freedom and security in Europe 1,9% European Institute of Innovation and Technology (EIT) 1542 + 1652*** 3,1% Non-nuclear direct actions of the Joint Research Centre 2212 2,5% TOTAL 87740 100%
Amendment 135 #
2011/0359(COD)
Proposal for a regulation
Article 32 – paragraph 3 – subparagraph 1 – introductory part
Article 32 – paragraph 3 – subparagraph 1 – introductory part
3. Unless it concerns tWhe renewal of an audit engagement in accordance with the second subparagraph of Article 33(1) a public interest entity puts the audit out to tender, the recommendation of the audit committee referred to in paragraph 2 of this Article, shall be prepared following a selection procedure organized by the audited entity respecting the following criteria:
Amendment 153 #
2011/0302(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Major investments are needed to modernise and expand Europe's energy infrastructure and to interconnect networks across borders to meet the Union's energy and climate policy objectives of competitiveness, sustainability and security of supply in a cost-effective way. The estimated investment needs in energy infrastructure up to 2020 amount to EUR 1 trillion, of which ca. EUR 200 billion in electricity and gas transmission and storage infrastructures considered of European relevance. Among projects of European relevance, approximately EUR 100 billion of investments is at risk of not being delivered due to obstacles related to permit granting, regulation and financing according to the Commission Staff Working Paper to the Transport, Telecommunications and Energy Council of 10 June 2011 "Energy infrastructure investment needs and financing requirements".
Amendment 159 #
2011/0302(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The 4 February 2011 European Council called upon the Commission to streamline and improve authorisation procedures and to promote a regulatory framework attractive to investment. The European Council underlined that the bulk of the investment would have to be delivered by the market with costs recovered through tariffs. The European Council recognised that public finance was needed for projects required from a security of supply or solidarity perspective, which were unable to attract market based financing. It also underlined the need to modernise and expand Europe's energy infrastructure and to interconnect networks across borders, in order to make solidarity between Member States operational, to provide for alternative supply or transit routes and sources of energy and develop renewable energy sources in competition with traditional sources.
Amendment 251 #
2011/0302(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 12
Article 2 – paragraph 1 – point 12
(12) "bottleneck" means a physical and/or functional barrier that leads to a system break affecting the continuity of long- distance flows. Such a barrier can be absorbed by new infrastructure such as bridges or tunnels that address problems as for example gradients, curve radii, gaug and which can be surmounted by creating new infrastructure. The need to upgrade existing infrastructure shall not be considered as a bottleneck;
Amendment 351 #
2011/0302(COD)
Proposal for a regulation
Article 6 – paragraph 1 A (new)
Article 6 – paragraph 1 A (new)
Amendment 383 #
2011/0302(COD)
Proposal for a regulation
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3 a. After the aforementioned eligibility conditions are fulfilled, the selection should follow the projects' degree of contribution to one or more of the following relevant objectives: a) promoting the further integration of the internal energy market and the interoperability of electricity and gas networks across borders; b) enhancing the Union's security of energy supply, by enhancing system resilience and security of systems operation; c) contributing to a sustainable development and protection of the environment, inter alia by ensuring transmission of renewable electricity from generation to major consumption centres and storage sites. As matter of urgency for the annual work programmes of the Connecting Europe Facility for 2013 and 2014, priority shall be given to projects contributing to the promotion of further integration and the interoperability of electricity and gas networks across borders, notably reduction or elimination of energy isolation.
Amendment 386 #
2011/0302(COD)
Proposal for a regulation
Article 7 – paragraph 4 A (new)
Article 7 – paragraph 4 A (new)
4a. Actions relating to projects of common interest with synergies in at least two of the sectors covered by the CEF, as listed in part IIIa of the annex, shall be eligible to receive financial aid from the Union under this Regulation.
Amendment 471 #
2011/0302(COD)
Proposal for a regulation
Article 10 – paragraph 3 – point a
Article 10 – paragraph 3 – point a
(a) the amount of Union financial aid shall not exceed 50% of the eligible cost of studies and/or of works;
Amendment 474 #
2011/0302(COD)
Proposal for a regulation
Article 10 – paragraph 3 – point b
Article 10 – paragraph 3 – point b
(b) co-financing rates may be increased to a maximum of 870% for actions which based on the evidence referred to in Article 15(2) (a) of Regulation (EU) No XXXX/2012 [Guidelines for trans-European energy infrastructure], provide a high degree of regional or Union-wide security of supply, or strengthen solidarity of the Unioncontribute to the sustainable development targets or comprise highly innovative solutions.
Amendment 480 #
2011/0302(COD)
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. Co-financing rates mentioned above may be increased by up to 10 percentage points for actions having cross-sector synergies, reachingover the percentages laid down in paragraphs 2 to 4 of this article for each of the following actions: (a) any action with synergies between at least two of the sectors (transport, energy or telecommunications) covered by the CEF. The Union financial aid shall be drawn from the sectoral budgets provided for in Article 5(1), in proportion to each sector's involvement in the action. (b) actions helping to achieve climate mitigation objectives, enhancing climate resilience or reducing the greenhouse gas emissions. This increase should not apply to co- financing rates referred to in Article 11.
Amendment 481 #
2011/0302(COD)
Proposal for a regulation
Article 10 – paragraph 5 A (new)
Article 10 – paragraph 5 A (new)
5a. The Commission shall propose, in the annual and multiannual programmes under Article 17, the criteria for the granting of the cofinancing rates laid down in this article.
Amendment 538 #
2011/0302(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Actions eligible for supported by means of financial instruments shall be selected on a first come first served basis and shall seek sectoral diversification in accordance with Articles 3 and 4 as well as gradual geographical diversification across the Member States, in accordance with Article 17 of this Regulation, shall seek sectoral and geographical diversification among the Member States and shall comply with the following criteria: (a) respond to the objectives of the Europe 2020 strategy; (b) represent European added value; (c) ensure non-distortion of competition in the internal market; (d) present a leverage/multiplier effect with regard to Union support.
Amendment 542 #
2011/0302(COD)
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. Financial instruments may be combined with grants funded from the Union budget, including under this Regulation, provided that this is necessary to ensure the project is viable.
Amendment 554 #
2011/0302(COD)
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The multiannual work programmes in the field of energy and telecommunications shall provide strategic orientation in the field of projects of common interest and may include specific projects of common interest.
Amendment 558 #
2011/0302(COD)
Proposal for a regulation
Article 17 – paragraph 6 – introductory part
Article 17 – paragraph 6 – introductory part
6. Acting in accordance with the procedure referred in paragraph 1, the Commission, when establishing multiannual and sectoral annual work programmes, shall establish the selection and award criteria in line with the objectives and priorities laid down: in Articles 3 and 4 of this Regulation and in Regulation (EU) No XXXX/2012 [TEN-T Guidelines], (EU) No XXX 2012 [Guidelines for trans-European energy infrastructure] or (EU) No XXX/2012 INFSO Guidelines]. The following factors shall be taken into account: (a) the maturity of the action in the project development and preparation stages and the soundness of the implementation proposed; (b) the leverage effect of Union support on public and private investment and the single market; (c) the need to overcome specific financial obstacles and lack of market-finance, linked to the nature or urgency of the project; (d) the costs and benefits including economic, social, greenhouse gas and/or other environmental impacts, and accessibility; (e) the cross-border dimension and ability to reduce or end the isolation of Member States, in any sector.
Amendment 559 #
2011/0302(COD)
Proposal for a regulation
Article 17 – paragraph 6 – point a
Article 17 – paragraph 6 – point a
Amendment 560 #
2011/0302(COD)
Proposal for a regulation
Article 17 – paragraph 6 – point b
Article 17 – paragraph 6 – point b
Amendment 561 #
2011/0302(COD)
Proposal for a regulation
Article 17 – paragraph 6 – point c
Article 17 – paragraph 6 – point c
Amendment 568 #
2011/0302(COD)
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
Amendment 570 #
2011/0302(COD)
Proposal for a regulation
Article 21 – paragraph 4
Article 21 – paragraph 4
Member States shall inform the Commission continuousregularly, if relevant through the interactive geographical and technical information systems, which in case of the trans-European Transport networks is TENtec, about the progress made in implementing projects of common interest and the investments made for this purpose including the amount of support used for climate change objectives.
Amendment 576 #
2011/0302(COD)
Proposal for a regulation
Article 24 – paragraph 3
Article 24 – paragraph 3
3. The committee shall ensure a horizontal overview of the work programmes referred in article 18 to ensure their consistency and that synergies are identified and, exploited and assessed between sectors.
Amendment 721 #
2011/0302(COD)
Proposal for a regulation
Annex – Part II - Point a - point 1
Annex – Part II - Point a - point 1
1. Northern Seas offshore Developing an integrated Belgium, Denmark, grid (“NSOG”) offshore electricity grid in France, Germany, Ireland, grid (“NSOG”) the North Sea, the Irish Luxemburg, the Sea, the English Channel, Netherlands, Sweden, the the Baltic Sea and United Kingdom neighbouring waters and associated grid developments (interconnections, internal on-shore grid reinforcement) to transport electricity from renewable offshore energy sources to centres of consumption and storage and to increase cross- border electricity exchange
Amendment 722 #
2011/0302(COD)
Proposal for a regulation
Annex – Part II - Point a - point 2
Annex – Part II - Point a - point 2
Amendment 723 #
2011/0302(COD)
Proposal for a regulation
Annex – Part II - Point a - point 3
Annex – Part II - Point a - point 3
3. North-South gas Increasing interconnection Belgium, Ireland, interconnections in capacities for North-Southand other Luxembourg, France, Western Europe ("NSI gas flows in Western relevant infrastructure Germany, Italy, Malta, the West Gas"): Europe to further difor North-South reversifyble Netherlands, Portugal, routes of supply and gas flows in Western Spain, the United Europe to remove Kingdom bottlenecks, further diversify routes, enhance security of supply and increase short-term gas Kingdom deliverability thus making full use of alternative external supplies, and optimising the LNG terminals and gas storage infrastructure
Amendment 725 #
2011/0302(COD)
Proposal for a regulation
Annex – Part II - Point a - point 4
Annex – Part II - Point a - point 4
4. North-South electricity Strengthening Austria, Bulgaria, Czech interconnections in interconnections and Republic, Cyprus, Central Eastern and South internal lines in North- Germany, Greece, Eastern Europe ("NSI South and East-West Hungary, Italy, Poland, East Electricity"): directions to complete theand with third Romania, Slovakia, internal market and Sloveniacountries to complete the Slovenia internal market and/or integrate generation from renewable energy sources
Amendment 726 #
2011/0302(COD)
Proposal for a regulation
Annex – Part II - Point a - point 5
Annex – Part II - Point a - point 5
5. North-South gas Strengthening regional Austria, Bulgaria, Czech interconnections in gas connections between and other Republic, Cyprus, Central Eastern and South the Baltic Sea region, therelevant infrastructures, Germany, Greece, Eastern Europe ("NSI Adriatic and Aegean Seasincluding LNG and CNG, Hungary, Italy, Poland, East Gas"): andin the Black Sea, notably Romania, Slovakia,East Romania, Slovakia, Mediterranean Basin and Slovenia between the Baltic Sea region, the Adriatic and Aegean Seas and the Black Sea, notably to to enhance diversification Slovenia and security of gas supply
Amendment 728 #
2011/0302(COD)
Proposal for a regulation
Annex – Part II - Point a - point 6
Annex – Part II - Point a - point 6
6. Baltic Energy Market Developing Denmark, Estonia, Interconnection Plan in interconnections between Finland, Germany, Latvia, electricity ("BEMIP Member States in the Lithuania, Poland, Electricity"): Baltic region and Sweden reinforcing internal grid infrastructures accordingly, to end isolation of the Baltic States and to foster market integration in the region and integrate generation from renewable energy sources
Amendment 729 #
2011/0302(COD)
Proposal for a regulation
Annex – Part II - Point a - point 7
Annex – Part II - Point a - point 7
7. Baltic Energy Market Ending the isolation ofGas infrastructure Denmark, Estonia, Interconnection Plan in the three Balticbetween Member States and Finland, Germany, Latvia, gas ("BEMIP Gas"): Finland by ending single Lithuania, Poland,in the Baltic region, Lithuania, Poland, reinforcing gas internal Sweden grid infrastructures accordingly, to end the isolation of the three Baltic States and Finland supplieand their dependency and Sweden on a single supplier and to increasinge diversification of suppliand security of gas supply and routes in the Baltic Sea region
Amendment 730 #
2011/0302(COD)
Proposal for a regulation
Annex – Part II - Point a - point 8
Annex – Part II - Point a - point 8
8. Southern Gas Corridor Transmission of gas fromInfrastructure for the Austria, Bulgaria, Czech ("SGC"): the Caspian Basin, Centralransmission and storage Republic, Cyprus, France, Asia, the Middle East andof gas, including Germany, Greece, the East Mediterranean liquefied and compressed Hungary, Italy, Poland, Basin to the Union to natural gas terminals to Romania, Slovakia, enhance diversification of Slovenia gas supply and routes from the Caspian Basin, Central Asia, the Middle East and the East Mediterranean Basin to the Union
Amendment 248 #
2011/0300(COD)
Proposal for a regulation
Article 3 – paragraph 5
Article 3 – paragraph 5
5. For electricity and gas projects falling under the categories set out in points 1 and 2 of Annex II, the Agency shall submit, within twohree months from the date of receipt of the proposed lists of projects of common interest set out in the first subparagraph of paragraph 4, an opin reasoned recommendation to the Commission on the proposed lists of projects of common interest, in particular taking into account the consistent application ofproposing: - for each regional list, a ranking of projects aggregated by clusters, in a limited number of categories, according to their priority; - a single Union-wide list of projects of common interest, aggregated according to the corresponding clusters; In its analysis the Agency shall take into account the criteria set out in Article 4 across the Groups, and, the results of the analysis carried out by the ENTSOs for Electricity and Gas in accordance with point 2.6 of Annex III, and their consistent application across the Groups. The Agency shall also take into account the consistency of the projects with a coherent expansion of the network in regard to economic efficiency, cross- border operational integration, as well as the specific potential of each region to best contribute towards reaching the Union’s energy and climate policy goals. The opinion of the Agency shall be adopted in accordance with the procedure in Article 15(1) of Regulation No 713/2009.
Amendment 431 #
2011/0300(COD)
Proposal for a regulation
Article 6 – paragraph 5 a (new)
Article 6 – paragraph 5 a (new)
5a. The power given to the coordinator in order to take measures for facilitating the project(s) implementation shall be defined between the concerned member States and the Commission.
Amendment 550 #
2011/0300(COD)
Proposal for a regulation
Article 13 – paragraph 6 – subparagraph 4
Article 13 – paragraph 6 – subparagraph 4
The cost allocation decision shall be published. Articles 19, 20 and 22 of Regulation (EC) No. 713/2009 are applicable.
Amendment 573 #
2011/0300(COD)
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The Commission may, in cooperation with ACER, shall issue guidelines regarding the incentives laid down in this Article in accordance with Article 18(1) to (3) of Regulation (EC) No 714/2009 and Article 23 (1) of Regulation (EC) No 715/2009, taking into account national specificities, where necessary.
Amendment 578 #
2011/0300(COD)
Proposal for a regulation
Article 14 a (new)
Article 14 a (new)
Amendment 627 #
2011/0300(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point a a (new)
Article 17 – paragraph 1 – point a a (new)
(aa) regularly updated information on the work of the Groups established pursuant to Article 3(2) including the agenda and the minutes of the meetings while excluding any commercially secret information;
Amendment 630 #
2011/0300(COD)
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Article 18 a Regulation EC No 713/2009 is hereby amended as follows: Art. 22 (a)shall be replaced by the following: Fees shall be due to the Agency for requesting an exemption decision pursuant to Article 9 (1) and any other services provided by the Agency pursuant to [Regulation on guidelines for trans- European energy infrastructure and repealing Decision No 1364/2006/EC].
Amendment 810 #
2011/0300(COD)
Proposal for a regulation
Annex V – point 6 – introductory part
Annex V – point 6 – introductory part
(6) For electricity transmission and storage, the cost-benefit analysis shall at least take into account the impacts on the indicators defined in Annex III. In line with the methods applied for the elaboration of the latest available ten-year network development plan in electricity, it shall in addition notably take into account the impacts of the project on the following, as well as benefits incurred by an accelerated project realization offsetting grid congestion costs due the deployment of all technology options listed under Annex II (1a), or a combination thereof:
Amendment 822 #
2011/0300(COD)
Proposal for a regulation
Annex V – point 11
Annex V – point 11
(11) The methodology shall define the analysis to be carried out, based on the relevant input data set, by calculating the results of the objective function with and without each project. The analysis shall identify the Member States on which the project has net positive impacts (beneficiaries) and those Member States on which the project has a net negative impact (cost bearers). Each cost-benefit analysis shall include sensitivity analyses concerning the input data set, the commissioning date of different projects in the same area of analysis and other relevant parameters, as well as risk assessment.
Amendment 118 #
2011/0299(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) facilitate sustainable deployment of trans-European digital service infrastructures, their interoperability and coordination at European level, their operation, maintenance and upgrading, as well as the development of synergies with other energy or transport infrastructures in order to reduce their overall cost.
Amendment 121 #
2011/0299(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 5 a (new)
Article 2 – paragraph 1 – point 5 a (new)
(5 a) contribute to the creation of highly- qualified posts in the conception, construction, use and maintenance of the networks and the development of digital services, which will benefit European industry.
Amendment 203 #
2011/0299(COD)
Proposal for a regulation
Annex 1 – section 1 – point a
Annex 1 – section 1 – point a
(a) Innovative management, mapping & services. Technical assistance measures, where necessary for deployment and governance, shall include project and investment planning and feasibility studies, in support of investment measures and financial instruments. Mapping of pan- European broadband infrastructure will develop an on-going detailed physical surveying and documentation of relevant sites, analysis of rights of way, assessments of potential for upgrading existing facilities, etc. ItThe procedure may be based on Article 12.4 of Directive 2002/21/EC (the common regulatory framework for electronic communications networks and services) and should follow the principles of the Directive 2007/2/EC (of the European Parliament and of the Council of 14 March 2007 establishing an infrastructure for spatial information in the European Community (the INSPIRE Directive) and related standardisation activities. Technical assistance measures may also support replication of successful investment and deployment models.
Amendment 14 #
2011/0261(CNS)
Proposal for a directive
Recital 1
Recital 1
(1) The recent financial crisis has led to debates at all levels about a possible additional tax on the financial sector and in particular a financial transactions tax (FTT). This debate stems from the desire to ensure the financial sector contribute to covering the costs of the crisis and that it is taxed in a fair way vis-à-vis other sectors for the future; to dis-incentivise excessively risky activities by financial institutions; to complement regulatory measures aimed at avoiding future crises and to generate additional revenue for general budgets with the aim of contributing to the budgetary consolidation processes now under way or specific policy purposes geared to economic growth.
Amendment 16 #
2011/0261(CNS)
Proposal for a directive
Recital 1 a (new)
Recital 1 a (new)
(1a) Even though the debate at world level has not resulted in any agreement, the Union must take on a leadership role in this area. This will enable it to set an example with a balanced and successful tax, and to open the way for this example to be followed by other international partners at a later stage.
Amendment 29 #
2011/0261(CNS)
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17a) The benefits to be gained from applying this measure are independent of the intended destination of revenue and this discussion should therefore be held in a different context, notably in the context of the proposal concerning the multiannual financial framework 2014- 2020.
Amendment 32 #
2011/0261(CNS)
Proposal for a directive
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Directive shall apply to all financial transactions, on which fulfil any of the following condition thats: (a) at least one party to the transaction is established in a Member State and that a financial institution established in the territory of a Member State is party to the transaction, acting either for its own account or for the account of another person, or is acting in the name of a party to the transaction; (b) the instrument that is the target of the transaction has been issued by entities that are established in the Union.
Amendment 44 #
2011/0261(CNS)
Proposal for a directive
Article 8 – paragraph 2 – subparagraph 2 – point a
Article 8 – paragraph 2 – subparagraph 2 – point a
(a) 0.15% in respect of the financial transactions referred to in Article 5;
Amendment 47 #
2011/0261(CNS)
Proposal for a directive
Article 8 – paragraph 2 – subparagraph 2 – point b
Article 8 – paragraph 2 – subparagraph 2 – point b
(b) 0.015% in respect of financial transactions referred to in Article 6.
Amendment 49 #
2011/0261(CNS)
Proposal for a directive
Article 9 – paragraph 3
Article 9 – paragraph 3
3. Each party to a transaction, includingwith the exception of persons other than financial institutions, shall become jointly and severally liable for the payment of the tax due by a financial institution on account of that transaction, in case that financial institution has not paid the tax due by it within the time limit set out in Article 10(4).
Amendment 51 #
2011/0261(CNS)
Proposal for a directive
Article 9 – paragraph 4 a (new)
Article 9 – paragraph 4 a (new)
4a. The transfer of rights in respect of a financial instrument resulting from a transaction shall have legal force only when the corresponding tax has been paid.
Amendment 30 #
2011/0187(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) A Single Market for telecommunications cannot be said to exist while significant price differences exist between domestic and roaming prices; therefore the ultimate aim of this Regulation should be to eliminate roaming charges altogether, thus establishing a pan-EU mobile communications market.
Amendment 42 #
2011/0187(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) In order to allow for the development of a more efficient and competitive market for roaming services, there should be no restrictions that prevent undertakings from effectively negotiating wholesale access for the purpose of providing roaming services. However, at present there are obstacles to the access to such wholesale roaming services, due to differences in negotiating power and in the degree of infrastructure ownership of undertakings. The removal of these obstacles would facilitate the development of alternative and innovative roaming services and offers for customers, in particular from virtual network operators. It would also facilitate the development of pan-European services.
Amendment 65 #
2011/0187(COD)
Proposal for a regulation
Recital 42 a (new)
Recital 42 a (new)
(42a) Operators should take the appropriate measures to ensure that cross-border consumers do not face problems due to their cross-border location, such as roaming charges while they are still in their home country.
Amendment 78 #
2011/0187(COD)
Proposal for a regulation
Recital 68
Recital 68
(68) Transparency also requires that providers furnish information on roaming charges, in particular on the Eurotariff and the all-inclusive flat-rate should they offer one, when subscriptions are taken out and each time there is a change in roaming charges. Home providers should provide information on roaming charges by appropriate means such as invoices, the internet, TV advertisements or direct mail. All information and offers should be clear, understandable, comparable and transparent with regard to prices and service characteristics. Advertising of roaming offers and marketing to consumers should fully comply with consumer protection legislation, in particular with Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (‘Unfair Commercial Practices Directive’)1. Home providers should ensure that all their roaming customers are aware of the availability of regulated tariffs for the period concerned and should send a clear and unbiased communication to these customers describing the conditions of the Eurotariff and the right to switch to and from it. _____________ 1 OJ L 149, 11.6.2005, p. 22
Amendment 95 #
2011/0187(COD)
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 1
Article 1 – paragraph 1 – subparagraph 1
This Regulation introduces a common approach to ensuringbring about a truly single market in mobile communications. The first step is to put in place an transitional period to ensure that users of public mobile communications networks when travelling within the Union do not pay excessive prices for Union-wide roaming services in comparison with competitive national prices, when making calls and receiving calls, when sending and receiving SMS messages and when using packet switched data communication services, thereby contributing to the smooth functioning of the internal market while achieving a high level of consumer protection, fostering competition and transparency in the market and offering both incentives for innovation and consumer choice. The second step is to put in place the necessary measures which would enable the abolition of the concept of roaming within the whole Union, ensuring identical prices throughout the Union.
Amendment 140 #
2011/0187(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a With effect from 1 July 2014, the retail prices for calls, SMS and data use shall be identical, irrespective of whether the customer is roaming or not. Until 30 June 2016, the retail price caps as laid down in Article 7, Article 9 and Article 12 shall have effect.
Amendment 235 #
2011/0187(COD)
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 1
Article 14 – paragraph 1 – subparagraph 1
To alert a roaming customer to the fact that he will be subject to roaming charges when making or receiving a call or when sending an SMS message, each home provider shall, except when the customer is at least 18 years old and has notified his home provider that he does not require this service, provide the customer, automatically by means of a Message Service, without undue delay and free of charge, when he enters a Member Statecountry other than that of his home network, with basic personalised pricing information on the roaming charges (including VAT and in the currency of his home bill) that apply to the making and receiving of calls and to the sending of SMS messages by that customer in the visited Member Statecountry.
Amendment 239 #
2011/0187(COD)
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 2 – introductory part
Article 14 – paragraph 1 – subparagraph 2 – introductory part
This basic personalised pricing information shall include the maximumactual charges (including VAT and in the currency of his home bill) the customer may be subject to under his tariff scheme for:
Amendment 257 #
2011/0187(COD)
Proposal for a regulation
Article 15 – paragraph 1 – subparagraph 1
Article 15 – paragraph 1 – subparagraph 1
Home providers shall ensure that their roaming customers, both before and after the conclusion of a contract, are kept adequately informed of the charges which apply to their use of regulated data roaming services, both inside and outside the Union, in ways which facilitate customers' understanding of the financial consequences of such use and permit them to monitor and control their expenditure on regulated data roaming services in accordance with paragraphs 2 and 3. The safeguard mechanisms referred to in paragraph 3 shall not apply to pre-paid customers.
Amendment 1 #
2011/0177(APP)
Draft opinion
Paragraph 1
Paragraph 1
1. Points out that the MFF should provide the necessary financial means to implement the initiatives of the Single Market Act in order to make better use of the potential of the internal market in ensuring the future competitiveness and inclusive and sustainable economic growth of the EU;
Amendment 7 #
2011/0177(APP)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Reiterates the need to ensure adequate funding for completion of the ínternal market, which serves some 500 million citizens, representing a credible solution for overcoming the economic and financial crisis which the EU is experiencing;
Amendment 8 #
2011/0177(APP)
Draft opinion
Paragraph 5
Paragraph 5
5. Warmly welcomes the proposed Connecting Europe Facility for financing major infrastructure projects to support the creation of the single energy market and of the digital single market while enhancing free movement of goods, services and people and ensuring stepped-up protection for consumers, who will thus be able to have access to a market which is more transparent and more competitive in terms of supply and prices; stresses that the financing needs in this area are tremendous and that it will be impossible for the proposed allocation to cover them; argues therefore that greater emphasis should be put on innovative financing mechanisms such as the EU project bonds.
Amendment 13 #
2011/0156(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Directive 2009/39/EC foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses: 'food intended to meet the expenditure of intense muscular effort, especially for sportsmen' and 'food for persons suffering from carbohydrate metabolism disorders (diabetes)'. With regard to food intended to meet the expenditure of intense muscular effort, no successful conclusion could be reached as regard the development of specific provisions due to widely diverging views among Member States and stakeholders concerning the scope of the specific legislation, the number of sub-categories of the food to be included, the criteria for establishing composition requirements and the potential impact on innovation in product development. With a view to the proper functioning of the internal market this category of food should be governed by Regulation 1924/2006 and should meet the requirements laid down in that regulation. As regards special provisions for food for persons suffering from carbohydrate metabolism disorders (diabetes), a Commission report concludes that the scientific basis for setting specific compositional requirements is lacking.
Amendment 40 #
2011/0156(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) Adequate transitional measures are necessaryThe Commission will take adequate measures to ensure legal certainty during the transition to the implementation of this Regulation and to enable food business operators to adapt to the requirements of this Regulation.
Amendment 61 #
2011/0156(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide adequate consumer information and, must not be misleading and shall be based on scientific data validated by the Authority.
Amendment 66 #
2011/0156(COD)
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. TheResponsibility for dissemination ofng any useful information or recommendations with reference to the categories of food referred to in Article 1(1) may be madshall lie exclusively bywith persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care. and shall be based on scientific data that can be independently verified.
Amendment 120 #
2011/0156(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide adequate consumer information and, must not be misleading and must be based on scientific data validated by the Authority.
Amendment 125 #
2011/0156(COD)
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. The drawing up and dissemination of any useful information or recommendations with reference to the categories of food referred to in Article 1 (1) may be made exclusively by persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care and must be based on scientific data that can be independently verified..
Amendment 66 #
2011/0150(COD)
Draft legislative resolution
Recital 2
Recital 2
(2) European standardisation also helps to boost the competitiveness of enterprises by facilitating in particular the free movement of goods and services, network interoperability, means of communication, technological development and innovation. Standards produce significant positive economic effects, for example by promoting economic interpenetration on the internal market and encouraging the development of new and improved products or markets and improved supply conditions. Standards thus normally increase competition and lower output and sales costs, benefiting economies as a whole and consumers in particular. Standards may maintain and enhance quality, provide information and ensure interoperability and compatibility, thereby increasing safety and value for consumers.
Amendment 83 #
2011/0150(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Standards can contribute to helping European policy address the major societal challenges such as climate change, sustainable resource use, ageingchallenges of the 21st century such as globalisation, the economic and financial crisis, climate change, sustainable resource use, population ageing, internal-market weaknesses, and innovation in general. By driving the development of European or international standards for goods and technologies in these expanding markets, Europe could create a competitive advantage for its companies and facilitate trade, in particular for SMEs, which account for a large proportion of European companies.
Amendment 145 #
2011/0150(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Each European and national standardisation body shall promptlywithin 30 days reply to, and take due account of, any comments received from any other European and national standardisation body and the Commission with respect to any such draft.
Amendment 152 #
2011/0150(COD)
Proposal for a regulation
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. European standardisation bodies shall ensure an appropriateffective representation of small and medium-sized enterprises (hereinafter 'SME'), consumer organisations and environmental and social stakeholders, in particular through the organisations referred to in Annex III, at the policy development level and at least at the following stages of the development of European standards or European standardisation deliverables:
Amendment 200 #
2011/0150(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. When a Member State considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union legislation, it shall inform the Commission thereof, substantiating its complaint in detail.
Amendment 6 #
2010/2304(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Considers that the investment risks involved in rolling out new networks can be reduced by measures to drive demand, in particular in the areas of e-procurement, e-commerce, e-governance, e-health services, interactive e-education, and smart meters; calls on the Commission to clarify state aid rules that may damage demand; highlights the importance of public pre-commercial procurement of R&D-based solutions for these sectors as a means to stimulate a virtuous cycle of technological development and demand for high-speed broadband services;
Amendment 11 #
2010/2304(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Stresses that in order to optimize impact and societal benefit, broadband deployment should be coupled with demand-awareness information and educational programmes;
Amendment 17 #
2010/2304(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Acknowledges the slow absorption of Structural Funds for broadband infrastructure investments and the need for guidance on the use of such instruments; calls on a thorough analysis of such funding instruments in order to identify and remove the bottlenecks deterring its utilisation by Member States and Regions;
Amendment 18 #
2010/2304(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Believes that extending broadband access to rural and remote areas, where market incentives are lower, plays an important role in geographic and social cohesion, enhancing the attractiveness of territories and the competitiveness of companies; considers that public support should prioritize the roll-out of broadband infrastructure to such areas;
Amendment 19 #
2010/2304(INI)
Draft opinion
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Calls on Member States to promote and extend high-speed open access connectivity to important public infrastructures located in remote areas (schools, hospitals, other public institutions) as a means to improve public service, and to anchor high-speed connectivity in remote regions, thereby decreasing investment costs for local private distribution;
Amendment 1 #
2010/2278(INI)
Motion for a resolution
Citation 24 a (new)
Citation 24 a (new)
- having regard to its resolution on 19 February 2009 on Social Economy;
Amendment 19 #
2010/2278(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas existing forms of enterprises faces obstacles in developing their cross border activities in the Single Market due to an absence of European statutes, in particular social enterprises such as foundations, associations and mutual societies,
Amendment 34 #
Amendment 35 #
Amendment 37 #
2010/2278(INI)
Motion for a resolution
Paragraph - 1 a (new)
Paragraph - 1 a (new)
-1a. Believes that for the development of a European competitive Social Market Economy - Single Market legislations, policies and measures should encompass and foster an appropriate social dimension. Considers that a horizontal social progress clause in the form of an overarching Regulation - which explicitly makes economic freedoms respect the fundamental social rights, gives priority to fundamental social rights in case of conflict and protects and upholds the right to collective action and the right to strike as proposed in the social progress protocol is needed. This would be in line with Article 9 TFEU and the Charter of Fundamental Rights of the European Union - is the most appropriate way to uphold citizens and social rights;
Amendment 38 #
2010/2278(INI)
Motion for a resolution
Paragraph -1 b (new)
Paragraph -1 b (new)
-1b. Considers it essential that the Single Market Act include an ambitious agenda for social and consumer protection in the form of the insertion of a social clause in all legislation related to the internal market, legislation on services of general economic interest, a legislative agenda to strengthen workers’ rights, an ambitious legislative package for consumer protection that makes a difference to the daily lives of citizens and better tax coordination by means of harmonization of the corporate tax base and VAT rates;
Amendment 76 #
2010/2278(INI)
Motion for a resolution
Subheading 2
Subheading 2
II. Common principles and valuesGeneral assessment
Amendment 77 #
2010/2278(INI)
Motion for a resolution
Subheading 2
Subheading 2
II. Common principles and valuesGeneral assessment - put Europeans at the heart of the single market
Amendment 104 #
2010/2278(INI)
Motion for a resolution
Paragraph 7 – point 7.4
Paragraph 7 – point 7.4
7.4. a new regulation on the recognition of professional qualifications, on improving and modernising human resources mobility, and on providing equal access and opportunities for citizens;
Amendment 149 #
2010/2278(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls for measures to set up an adequate legal framework for services of general interest, foundations, cooperatives and, mutual societies and associations, to prevent legal uncertainty and to ensure there are socially oriented corporate institutions and socially innovative corporate projects in the area of services of general interest promotion of other social economy enterprises (cooperatives, mutual societies, associations and foundations) as well as of other social economy projects;
Amendment 172 #
Amendment 174 #
Amendment 201 #
2010/2278(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls for a network of interconnected cross-border transport infrastructure which is both interoperable and sustainable and should be enhanced on the basis of Europe’s social and economic needs taking in account European environmental objectives in tackling climate changes effects and promoting energy savings and efficiency; draws particular attention to this added value of the TEN-T network which provides an efficient framework for the movement of people and goods within the EU. Supports a core network of priority projects with EU funding, which adhere to those principles;
Amendment 202 #
2010/2278(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Welcomes the creation of real rights for passengers for intra EU travel in the aviation, rail maritime and coach and bus sectors and recognises these rights are essential for facilitating the free movement of persons within the Single Market; The review of implementation of those passengers rights in all modes of transportation through legislative proposals would include adequate protection for consumers in such areas as package travel, bankruptcies and excessive charges for services, paying attention to the use of new technologies in an intelligent and sustainable transport system by supporting integrated ticketing;
Amendment 211 #
Amendment 212 #
Amendment 217 #
2010/2278(INI)
Motion for a resolution
Paragraph 17 – introductory part
Paragraph 17 – introductory part
17. Calls for short-term strategies:on the Commission to endorse the following list of proposals as key priorities of the European Parliament;
Amendment 227 #
2010/2278(INI)
Motion for a resolution
Paragraph 17 – point a
Paragraph 17 – point a
(a) to enhance European market surveillance, improve access to basic banking services, create a single integrated mortgage market and remove tax obstacles and double taxation; In order to guarantee that Single Market measures are citizen-centred and ensuring full respect of social and workers rights, it is of paramount importance to insert a social clause in all single market legislation aiming at safeguarding labour law, working conditions and workers rights by building upon the positive acquis represented by article 1.6, article 1.7 and recital 14 of Directive 2006/123/EC on services in the internal market and article 2 of Council Regulation 1998/2679/EC on the functioning of the internal market in relation to the free movement of goods among the Member States; consider it necessary to have a meaningful assessment of the social, consumer, environmental, economic and employment aspects prior to any legislative proposal for the Single Market (prop 29 and 30);
Amendment 243 #
2010/2278(INI)
Motion for a resolution
Paragraph 17 – point b
Paragraph 17 – point b
(b) to implementStresses the role of the Services of General Economic Interest as basic rights for the European citizens, as fundamental pillar of the European social market economy (and as shock absorber for citizens and e-commerce policy in order to increase citizens’ and consumers’ confidence when shoppnterprises during the crisis) and calls for a legislative framework on SGEI - on the basis of art.14 and protocol 26 of TFEU - in order to avoid law uncertainty, to guarantee possibility of public authorities providing, executing and organising these services in a way that meets users needs, to ensure quality and affordable universal services access to public transports, energy, water, housing, banking services; (proposal 25) We stress the role of social economy entities which represent a valuable alternative business model which operate successfully in the market by providing services, employment and social inclusion and call on the Commission to submit proposals for European statutes for associations, mutual societies and foundations and to take support measures enabling the development of the Statute for a European Cooperative Society (SCE) ing onlinerder to create a ‘level playing field’ with other type of enterprises (proposal 47);
Amendment 247 #
2010/2278(INI)
Motion for a resolution
Paragraph 17 – point c
Paragraph 17 – point c
(c) to devise an action plan against counterfeiting and piracy as a major preventive tool, in order to ensure that goods circSpecific provisions are needed to foster more and better jobs therefore: we call for a revision of the Directive on posting of workers, to ensure the principle of equal pay for equal work and the freedom of exercise of fundamental rights, including the right or freedom to strike; we welcome the Commission’s proposal to bring forward a consultation with the social partners in order to create a European framework for the advance planning of industrial restructuring and we call for such framework of consultating in the Single Market are safeon of social partners to be extended to all relevant sectors of the Single Market; we ask for a revision of the directive on pension funds in order to coensume, of the appropriate standard and legalre the full portability of the pension rights, contributes and entitlements, and to guarantee conditions for safe pension schemes through a proper regulation and supervision of pension funds. (Proposals 30, 31 and 32);
Amendment 254 #
2010/2278(INI)
Motion for a resolution
Paragraph 17 – point d
Paragraph 17 – point d
(d) to develop an effective communication policyCalls for immediate and coordinated actions to foster smart, inclusive and sustainable growth and employment by completing and improving the infrastructures onf the Single Market Act, based on a policy audias the Trans European networks of transport, energy, R&D, high-speed internet assccessing its tangible benefit (tangibility) to citizens; for all and a European Radio Spectrum through strategic projects to be steered and financed at EU level, notably with Euro projects bonds, and by adopting specific measures for lifelong learning, recognition of professional qualifications, introduction of professional cards, to (actions 26, 27, 28, 32, 33, 34, 35);
Amendment 258 #
2010/2278(INI)
Motion for a resolution
Paragraph 17 – point d a (new)
Paragraph 17 – point d a (new)
(da) To exploit the full potential of the Single market for the citizens we ask: to enhance European market surveillance and to guarantee an efficient legal framework on Products’ Safety; to increase consumer protection guaranteeing transparency, comparability and competition relating to the creation of an integrated mortgage, to the right to access to basic banking services and transparent disclosure for bank charges; to remove tax obstacles and double taxation; (actions 39, 40, 41, 42 and 43);
Amendment 261 #
2010/2278(INI)
Motion for a resolution
Paragraph 17 – point e
Paragraph 17 – point e
(e) to introduce a system of benchmarks, based on the horizontal social clause, to assess the relevance of all Single Market measures in terms of their social impact, tangibility and feasibilityAn action plan against counterfeiting as a major preventive tool, to guarantee that goods circulating in the Single Market are safe to consume, of the appropriate standards; and improving internal and external customs control in the area of product safety (action 39);
Amendment 266 #
2010/2278(INI)
Motion for a resolution
Paragraph 17 – point e a (new)
Paragraph 17 – point e a (new)
(ea) Stress the need to take further steps, including legislative measures, in relation to corporate governance and Corporate Social Responsibility for the development of policies leading towards sound and responsible remuneration policies, enhancement of employee consultation and participation, valorisation of long- term shareholder commitment, adequate participation of women in management and decision-making boards and sustainable growth objectives (Proposal 38);
Amendment 152 #
2010/2245(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Welcomes the Commission to make strong progress in improving career prospects for researchers and increasing their mobility between research sectors and across national borders. This would help ensure an adequate supply of researchers and enhance the quality of EU research and innovation. Researchers across the EU should be able to benefit from the right training, attractive career conditions and the removal of barriers to mobility;
Amendment 153 #
2010/2245(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Notes that social innovation is a Human Capital challenge where Universities must play an enhanced role through education, life-long training, research, innovation and entrepreneurship; highlights the importance of more open and modernised Universities and the need for greater University autonomy in defining strategic priorities and own course of action in response to societal priorities;
Amendment 157 #
2010/2245(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Acknowledges that responding to societal demands while preserving academic freedom and institutional diversity puts strong demands on Universities, their leadership and governance mechanisms; calls on the Commission to design a coordinated action at European level (a kind of Bologna II initiative) aimed at cross- fertilizing best practices for innovation in the University system. Building on the existing examples of institutional excellence (in the EU and abroad), such programme should envisage institutional mutual learning on governance mechanisms, human resources and IPR policies, funding, education, research and innovation organizational schemes, and societal involvement;
Amendment 158 #
2010/2245(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12c. Notes an existing skills gap in Universities in what concerns an improved and proactive interaction with the business sector; calls on the Commission to launch a new European- wide programme for training and education of University managers, of technology transfer officers, and of technology broker professionals and to issue guidelines for the professionalization of such careers in Universities;
Amendment 159 #
2010/2245(INI)
Motion for a resolution
Paragraph 12 a (new), after subheading 3 "Simplification, defragmentation, financing and standardisation"
Paragraph 12 a (new), after subheading 3 "Simplification, defragmentation, financing and standardisation"
12a. Stresses that important opportunity costs are associated with more traditional EU expenditure sectors and points to the need to align strategic EU2020 priorities with budgetary policy; therefore calls for a greater share of the EU budget to be allocated to R&D and innovation;
Amendment 160 #
2010/2245(INI)
Motion for a resolution
Paragraph 12 b (new), after subheading 3 "Simplification, defragmentation, financing and standardisation"
Paragraph 12 b (new), after subheading 3 "Simplification, defragmentation, financing and standardisation"
12b. Highlights the comparative small size of the EU R&D&I budget as compared to Member States’ budgets which account for the majority of public research funding; therefore, calls for a greater emphasis on funding instruments with a leveraging effect on national research expenditure, on private investment, and on EIB funding, to promote coordination of efforts and to stimulate investment up to European target goals;
Amendment 192 #
2010/2245(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Stresses that to create a true Innovation Union by 2020 and to complete the European Research Area by 2014 the European Union needs the pan- European research infrastructures, such as the Biological and Medical Sciences Research Infrastructure (BMS RI) projects; stresses that it will therefore be of key importance to develop appropriate funding mechanisms for their sustainable implementation;
Amendment 208 #
2010/2245(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Stresses that full consideration and understanding of the specificities associated with company size, developmental stage, and activity sector are required when designing funding instruments; calls for urgent action to tackle major bottlenecks, at the seed and start-up developmental stages; highlights the fact that successful instruments such as RSFF and CIP are inadequate to address the funding gap at such stages and calls for adequate funding instruments and policy incentives to leverage private investment, namely in seed and venture capital;
Amendment 226 #
2010/2245(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Highlights that cohesion funds earmarked for innovation go to large extent unspent due to unsuitable administrative requirements and to the need for matching funds unavailable at times of financial constraint; notes that this fact contributes to the widening economic gap among Member States, which lies at the core of the present Euro area crisis; calls for reform and streamlining of structural funds, to make them accessible for the restructuring of the economic actors involved, especially SMEs;
Amendment 269 #
2010/2245(INI)
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. Acknowledges that governmental procurement tends to focus on lower cost, risk-averse technology; calls on the European Commission to issue best- practice guidelines and training programmes for public procurers at Member-State level, aiming at developing skills in complex pre-commercial and innovative procurement, based on Member State and third country (USA) experience;
Amendment 270 #
2010/2245(INI)
Motion for a resolution
Paragraph 29 b (new)
Paragraph 29 b (new)
29b. Urges the Commission to issue pre- commercial and innovative procurement targets and to regularly monitor their application at Member State-level, working towards identifying and removing obstacles;
Amendment 271 #
2010/2245(INI)
Motion for a resolution
Paragraph 29 c (new)
Paragraph 29 c (new)
29c. Notes that innovative SMEs face problems in accessing funding for internationalization and international trade credit insurance, among other barriers, and highlights the need to implement new support measures for SMEs under the framework of the revised Small Business Act and the expected Communication on International Trade Policy and SMEs;
Amendment 299 #
2010/2245(INI)
Motion for a resolution
Subheading 7 a (new), after paragraph 34
Subheading 7 a (new), after paragraph 34
Strategy Implementation
Amendment 300 #
2010/2245(INI)
Motion for a resolution
Paragraph 34 a (new), after subheading 7 a (new)
Paragraph 34 a (new), after subheading 7 a (new)
34a. Invites the European Commission to translate the current strategic document “Innovation Union” into an action plan with specific objectives and with measurable and time-framed targets; calls on the Commission to monitor progress regularly, assessing obstacles and putting forward mechanism to enable improvement, reporting regularly to the European Parliament and the Council;
Amendment 301 #
2010/2245(INI)
Motion for a resolution
Paragraph 34 b (new), after subheading 7 a (new)
Paragraph 34 b (new), after subheading 7 a (new)
34b. Invites the European Commission to assess specific instruments of the European Innovation Policy against our main external competitors (USA, Japan, and BRIC countries) and report on their comparative performance towards innovation.
Amendment 1 #
2010/2152(INI)
Draft opinion
Paragraph -1 (new)
Paragraph -1 (new)
-1. Welcomes a strengthened commitment and a more pro-active approach towards opening access to new markets as a means to promote economic growth and enterprise competitiveness; stresses the importance of ensuring fair and reciprocal access to public procurement markets between the EU and third countries;
Amendment 15 #
2010/2152(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Takes note of the pace of ongoing negotiations on the set on bilateral free trade agreements that cover only a part of the EU's overall international trade; stresses that greater and more pressing attention should be paid to emerging markets of strategic importance; stresses the need to reduce the existing trade deficit with China and to conquer increased access to this expanding market;
Amendment 18 #
2010/2152(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Stresses that an enhanced emphasis placed on international market access for service providers should not come to the detriment of trade in industrial goods; stresses the need to provide international market opportunities to the European industry sector;
Amendment 19 #
2010/2152(INI)
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Highlights that in the present economic context, SMEs are the most affected companies by non-tariff barriers and foreign regulatory systems, while facing difficult access to international trade funding and credit insurance; calls on the Commission to address the trade obstacles faced by SMEs given their importance for the European economy;
Amendment 22 #
2010/2152(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Highlights the importance of promoting convergence or equivalence in international standards and certification practices with third countries; calls on a strengthened link between external and single market regulations to reduce unnecessary costs for enterprises and to eliminate regulatory barriers and speed up innovation and access to trade;
Amendment 23 #
2010/2152(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Stresses that such harmonization can not be carried out at the expense of lower technical, health and safety and consumer protection standards; calls on the Commission to protect EU standards and to effectively enforce them next to importers and economic operators that commercialize their products in Europe;
Amendment 43 #
2010/2152(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
Amendment 47 #
2010/2152(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Highlights the fact that, in the context of globalization, a more open international trade system produces differential impacts across European countries, affecting internal cohesion; calls on the need to expand and simplify the European Globalization Adjustment Fund as an instrument that helps fighting the negative effects of globalization; in addition, calls for the mobilisation of the relevant EU internal policies, such as support for innovation and SMEs, to accelerate restructuring and adaptation to new trade conditions in disadvantaged regions;
Amendment 10 #
2010/2109(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Highlights that retailers are offering diverse and modern ways of selling goods and services and contribute to wider consumer choice and flexible employment opportunities, in particular for youth;
Amendment 16 #
2010/2109(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the EU institutions to give the highest political prominence to the retail sector as a pillar of the Single Market Act and a vehicle for restoring public confidence in the single market;
Amendment 20 #
2010/2109(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Underlines that retailers and suppliers have a shared responsibility in achieving a more efficient, transparent, and fairer retail market;
Amendment 28 #
2010/2109(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Is concerned that restrictive national rules, divergent interpretations and inadequate enforcement impede free movement of goods and services in the EU; stresses that requirements for extra tests and registrations, non-recognition of certificates and standards, territorial supply constraints and similar measures create extra costs for consumers and retailers, in particular SMEs, thus limiting the potential usefulness of the single market to European citizens and the business world;
Amendment 33 #
2010/2109(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Recognises the need to further analyse price differences in the EU, in order to ensure price transparency and comparability for consumers, without prejudice to national fiscal and labour market rules, thereby making for more enlightened choices while fostering greater confidence in cross-border trade;
Amendment 42 #
2010/2109(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Encourages business federations, supported by the Commission, to provide more information, training and legal advice to stakeholders on their rights and the instruments at their disposal, such as SOLVIT, and to support the exchange of best practice among themselves;
Amendment 45 #
2010/2109(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Stresses that a fragmented payment system is an obstacle to trade; calls on the Commission to improve SEPA in order to develop a basic payment service available for all cards, increasing transparency in transaction costs and reducingmaking for fair redistribution of interchange fees, and to ensure faster bank transfers within the EU, and to impose an obligation on payment card management and issuing companies to allow access to their networks on competitive terms, so as to remove obstacles to competition;
Amendment 53 #
2010/2109(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Notes the concern expressed by parts of civil society and SMEs about the increase in shopping centres and the decrease in local shops and markets in remote areas and town centres; stresses that retail planning should not sacrifice consumers’ freedom of choice, especially when they live in less accessible regions, such as islands, mountain areas, or sparsely populated regions, or their mobility is reduced;
Amendment 2 #
2010/2099(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. whereas any eventual penalties associated with breaching of Stability and Growth Pact (SGP) targets must result from either insufficient will to comply or fraud and never from incapacity to comply due to reasons beyond the Member State’s capacity,
Amendment 3 #
2010/2099(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. whereas the SGP’s targets must be compatible not only with the Europe 2020 strategy, but also with other compromises concerning expenditure on research and development, environment, education, poverty eradication and development aid,
Amendment 10 #
2010/2099(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Development by the Commission of the adequate analytical tools and expertise to investigate in-depth the reasons behind the persistent divergent trends within the euro area, including the impact of common policies on the differentiated economic systems within it (Recommendation 1 – indent 3a (new)),
Amendment 12 #
2010/2099(INI)
Draft opinion
Paragraph 8
Paragraph 8
8. Establish a Union Semester for dealing with the Integrated Guidelines at national and Union-level, providing room for an enlarged debate on financial issues and on the economic situation of the EU including consultation with the Union-level social partners, strengthening the macroeconomic social dialogue, which would enable a real and timely contribution by all parties concerned (Recommendation 1, Indent 7),
Amendment 13 #
2010/2099(INI)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Introduce a stronger assessment of the Stability and Convergence Programmes (SCPs), from the point of view of their interconnections with other Member States targets and those of the Union before adoption of the policies envisaged in the SCPs at national level (Recommendation 1 – Indent 11),
Amendment 17 #
2010/2099(INI)
Draft opinion
Paragraph 8 d (new)
Paragraph 8 d (new)
8d. Establish a requirement for Member States to provide additional information, if a substantial concern arises that the policies conducted may jeopardise the proper functioning of the internal market, the Economic and Monetary Union (EMU) or endanger the targets set by the Union, namely in the Europe 2020 strategy (Recommendation 1 – Indent 17),
Amendment 19 #
2010/2099(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Not to make the following recommendation: launchClarify and increase the transparency of the Excessive Deficit Procedure (EDP)/Excessive Debt Surveillance Procedure (EDSP) on the basis of gross debt levels. The EDF/EDSP including detailed regular reports on the debt dynamics and development, would be triggered for all Member States in which government debt level exceeds the 60% threshold and is not diminishing at satisfactory pace. The EDP would be on stand-still as long as the country fulfils its MTFO and would be abrogated once the debt level is below 60. (deletion of Recommendation 2, Indent 1), reinforcing the importance attributed to debt and to the interconnection between debt and deficit as well as to their dynamic evolution,
Amendment 21 #
2010/2099(INI)
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Establish a country-specific differentiated time frame for the process of fiscal consolidation that will occur no later than 2015, with a view to realigning all public deficit levels with the requirements set out in the SGP (Recommendation 2 – indent 3a (new)),
Amendment 23 #
2010/2099(INI)
Draft opinion
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Establish a monitoring and other deterrent mechanisms including public warnings for Member States that have not reached their MTFO or are not approaching it at the agreed pace (Recommendation 2 – Indent 4),
Amendment 32 #
2010/2099(INI)
Draft opinion
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Establish, within one year, a permanent European Monetary Fund as a last resort borrowing and lending mechanism based on existing experiences (the European Financial Stability Facility, the European Financial Stabilisation Mechanism and the European balance of payments instrument) with clear rules on the decision-making procedure, funding, conditionality for loans and monitoring) (Recommendation – 4, Indent 1),
Amendment 37 #
2010/2099(INI)
Draft opinion
Paragraph 16
Paragraph 16
16. Reinforce and update, namely bearing in mind the Europe 2020 targets, the Union cohesion policy in close cooperation with the European Investment Bank (EIB) in order to reduce structural weaknesses and increase the competitiveness of weaker economic and outermost regions (Recommendation 5, Indent 2), , in particularly by facilitating the financing needs of SMEs and their successful participation in the internal market,
Amendment 1 #
2010/2095(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses that any ambitious EU industrial policy should be basfounded on the social market economy and that it should aim to reduce transaction costs for a competitive and sustainable industry in Europe, enablmust be based on a strong internal market, both within EU borders and in its external dimension; takes the view, ing the efficient allocation of resources through markets; takes the view, therefore, that binding quantitative targets for industry or public procurement should be avoidedis connection, that all industrial policy instruments (such as R&D policy, regional and cohesion policy, competition policy, trade policy and 'smart regulation') must be brought to bear in addressing the opportunities and challenges of globalisation;
Amendment 2 #
2010/2095(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Takes the view that EU industrial policy should also be based on practical projects which bring tangible benefits to European businesses and citizens, such as the GMES, Galileo and ITER projects;
Amendment 4 #
2010/2095(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Notes that the completion of the internal market is essential for the competitiveness and growth of European industry; calls on the Commission to identify the scope for efficiency-enhancing harmonisation and improved governance in the framework of the forthcoming Single Market Actstresses that European industries need a proper framework to create and develop goods and services at European level and welcomes in this context the proposals set out in the 'Single Market Act'; in this context, calls on the Commission to identify the scope for efficiency-enhancing harmonisation and improved governance in the framework of the Single Market Act, particularly in the field of VAT, intellectual property rights and the EU patent, global standardisation, labelling and specific sectoral standards;
Amendment 9 #
2010/2095(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Commission to extend and continue the Better Regulation strategy, creating 'one- stop-shop' schemes and promoting online cross-border administrative solutions, taking into account the particular needs of SMEs; states that ‘competitiveness proofing’ should be included in the impact assessments of future legislative proposals;
Amendment 14 #
2010/2095(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. CTakes the view that innovation underpins any industrial policy; calls on the Commission and Member States to foster key technologies through an innovation-friendly and technology- neutral framework; encourages public authorities to support public acceptance of new technologies, based on scientific evidence; takes the view, in this context, that public procurement can play an important role by placing more emphasis on stimulating innovation and promoting sustainable products, particularly through the development of pre-commercial public procurement, where the European Union is lagging significantly behind its main competitors; encourages public authorities to support public acceptance of new technologies, based on scientific evidence; considers it essential to strengthen human capital, in particular by taking steps to prevent the brain drain from Europe and by promoting the creation of clusters in innovative fields so as to guarantee growth and industrial competitiveness in the EU, notably through public-private partnerships;
Amendment 24 #
2010/2095(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines that social partners are best qualified to manage the appropriate adjustments following the economic crisis; notes that state intervention in restructuring should be limited to the mitigation of and welcomes the suggestion included in the Single Market Act that a consultation exercise be launched with the social hpardship and re- qualification of the labour force and that an expansion of EUtners with a view to establishing a European framework for the advance planning of business restructuring, aimed at the more efficient use of funds for restructuring purposes should be avoided;
Amendment 25 #
2010/2095(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Reiterates the need to make swift progress in relation to the interconnection of the European business register, as a means of ensuring that information is transparent and reliable for both producers and consumers;
Amendment 29 #
2010/2095(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Underlines the need to improve and facilitate SMEs' access to the financing available on the financial markets.
Amendment 2 #
2010/2088(INI)
Draft opinion
Citation 1 (new)
Citation 1 (new)
- having regard to EU 2020 integrated guidelines for the European economic and employment policies,
Amendment 9 #
2010/2088(INI)
Draft opinion
Recital A
Recital A
A. having regard to the urgent need to launch a debate on the limitations of GDP as a yardstick for measuring and evaluating the success of economic policyerformance and, by association, the wellbeing of societiesocial progress,
Amendment 13 #
2010/2088(INI)
Draft opinion
Recital B
Recital B
Amendment 18 #
2010/2088(INI)
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. whereas there is a need for a concise and actionable set of comparable, robust and valid indicators addressing the key economic, social and environmental dimensions of human well-being, for informing policy-making,
Amendment 21 #
2010/2088(INI)
Draft opinion
Recital B b (new)
Recital B b (new)
Bb. whereas a distinction between current and future well-being should be made; whereas it should be underlined that sustainability also needs to be assessed both in its economic and environmental dimensions,
Amendment 22 #
2010/2088(INI)
Draft opinion
Recital B c (new)
Recital B c (new)
Bc. whereas to adequately gauge the level of social inclusion, social inequality and income distribution for policy-making should be considered,
Amendment 23 #
2010/2088(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses the need to develop indicators which can complement GDP and have as their objective the provision of more exhaustive information to support political decisions, notably where they incorporate such factors as the social and environmental dimensions, development, quality of life, public health, research, social equality and the level of employmentin assessing societal progress along the three pillars of economic, social and environmental dimensions and have as their objective the provision of more exhaustive information to support political decisions;
Amendment 27 #
2010/2088(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Welcomes the Commission proposals in the Communication GDP and beyond - measuring progress in a changing world;
Amendment 29 #
2010/2088(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Considers that achieving and sustaining quality of life comprehends important and consensual factors such as health, education, culture, employment, housing and environmental conditions. Therefore, indicators that measure such factors are also important and should be given more relevance;
Amendment 31 #
2010/2088(INI)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Points to the need for such data to be available in near real-time, allowing timely political responses;
Amendment 33 #
2010/2088(INI)
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Calls on the need to develop indicators that focus more closely on the household level perspective, reflecting income, consumption and wealth as a means to better reflect the citizens’ concerns on material well-being;
Amendment 39 #
2010/2088(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the need to develop selected indicators that complement average statistical measurements by reflecting distribution and inequality across social groups;
Amendment 41 #
2010/2088(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Calls on the Commission to reinforce efforts for developing a Sustainable Development Scoreboard that assesses from an environmental and economic point of view the preservation and investment in resources required to ensure future well-being (comprising natural resources, physical and human capital);
Amendment 43 #
2010/2088(INI)
Draft opinion
Paragraph 3
Paragraph 3
Amendment 50 #
2010/2088(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Supports the European Commission efforts to develop methodologies to assess and communicate progress on the major strands of environmental protection policy;
Amendment 51 #
2010/2088(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Recalls on the global impact of environmental changes and stresses the importance for such indicators to be accepted and comparable outside the EU territory;
Amendment 52 #
2010/2088(INI)
Draft opinion
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Supports the Council’s recommendation to extend the National Accounts to environmental and social issues by setting internationally accepted methods;
Amendment 53 #
2010/2088(INI)
Draft opinion
Paragraph 3 d (new)
Paragraph 3 d (new)
3d. Calls for a more extensive use of such selected indicators in relevant policy documents as a means to better reflect citizens' concerns and match it with coherent policy-making;
Amendment 54 #
2010/2088(INI)
Draft opinion
Paragraph 3 e (new)
Paragraph 3 e (new)
3e. Notes that continuing research, and investment in the capabilities of Statistical offices is needed in order to improve upon what has been achieved; identify the gaps in available information, and where necessary to construct new indexes;
Amendment 55 #
2010/2088(INI)
Draft opinion
Paragraph 3 f (new)
Paragraph 3 f (new)
3f. Notes that no additional statistical offices or bodies are needed; calls for an extended cooperation between the national offices and Eurostat.
Amendment 14 #
2010/2079(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas a strong research base is required to foster a more innovative Europe in support of a knowledge-based economy,
Amendment 27 #
2010/2079(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Considers that EU monitoring and financial control should be primarily aimed at safeguarding public funds and combating fraud, whilst distinguishing clearly between fraud and errors; asks the Commission to include the definition of "error" in all binding legal documents;
Amendment 31 #
2010/2079(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Believes that European research funding should be more trust-based and risk- tolerant towards participants at all stages, with flexible EU rules that can be applied in accordance with national regulations and practices while ensuring accountability and adequate management of funds;
Amendment 32 #
2010/2079(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Requests that beneficiaries who receive grants under FP should be informed about the Commission relevant audit strategies; recommends disseminating these strategies via the National Contact Points and include them in Cordis;
Amendment 33 #
2010/2079(INI)
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Believes that the advantages of having a Certificate on the Methodology of the Costs approved by the Commission should be far more disseminated;
Amendment 35 #
2010/2079(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Agrees and recommends broader acceptance of usual accounting practices for the eligible costs of participants once they have been clearly defined and agreed upon, especially for average personnel cost methodologies, provided that these procedures are in accordance with national rules and certified by, national authorities, leaving enough flexibility to each beneficiary to use either actual personnel costs methodology or average personnel costs methodology;
Amendment 39 #
2010/2079(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
Amendment 43 #
2010/2079(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Supports the reduction in combinations of funding rates and methods for defining indirect costs across the different instruments and between activities (management, research, demonstration and dissemination); acknowledges that neither the current differentiation between universities/research centres, industry and SMEs nor the differentiation between activities (management, research, demonstration and dissemination) should be abolishshould be maintained;
Amendment 54 #
2010/2079(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Supports the acceptance of average personnel costs only if based on a sufficient number of categories according to the organisation’s structure and individuals’ payrolls;
Amendment 82 #
2010/2079(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Welcomes the overall trend towards shortening the average time-to-grant and time-to-pay but expresses some reservations about the generalisedand supports a wider use of larger-scope calls and calls with cut-off dates, as a means to decrease uncertainty on funding opportunities for SMEs and encourage participation;
Amendment 86 #
2010/2079(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
Amendment 90 #
2010/2079(INI)
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. Welcomes the proposal of the Commission on removing the legal requirement for an opinion by committees of Member State representatives on the selection decisions on individual projects as a way to significantly decrease time-to- grant and administrative burden;
Amendment 93 #
2010/2079(INI)
Motion for a resolution
Paragraph 32
Paragraph 32
32. Calls for substantive improvement of the clarity and accessibility of guidance documents (e.g. financial rules),, which should be compiled in a handbook and translated into the EU official languages;
Amendment 97 #
2010/2079(INI)
Motion for a resolution
Paragraph 33 a (new)
Paragraph 33 a (new)
33a. Considers that each of the documents provided by the Commission should clearly establish its legal status, specifying both who is bound by their contents and also how they are bound;
Amendment 104 #
2010/2079(INI)
Motion for a resolution
Paragraph 34 a (new)
Paragraph 34 a (new)
34a. Stresses the need for increased transparency concerning the process of topic selection for calls which should ensure relevant stakeholder participation;
Amendment 106 #
2010/2079(INI)
Motion for a resolution
Paragraph 34 b (new)
Paragraph 34 b (new)
34b. Recommends the creation of a more transparent, coherent, and harmonised peer review system based on merit;
Amendment 110 #
2010/2079(INI)
Motion for a resolution
Paragraph 36
Paragraph 36
36. Recommends a reduced set of rules and common principles for funding to govern EU funding for R&D and calls for coherence and harmonisation in the implementation and interpretation of the rules and procedures; stresses the need to apply this common set of rules across the whole FP and associated instruments and within the Commission, regardless of the entity or executive agency in charge of implementation;
Amendment 116 #
2010/2079(INI)
Motion for a resolution
Paragraph 40
Paragraph 40
40. Invites the Commission to assess the usefuleffectiveness of each individual instrument, within each programme, to select those that have a distinctive role in supporting R&D and to increase cowards the achievement of specific policy goals and calls for the reduction of the diversity of instruments whenever effectiveness or dination between them according to areas of interestsstinctive contribution is not clearly demonstrated, whilst maintaining enough flexibility to accommodate projects’ specificities according to size;
Amendment 3 #
2010/2055(INI)
Draft opinion
Recital C a (new)
Recital C a (new)
Ca. whereas, if we wish to know everything about a product or service, we must know everything about who is selling us the product or service, since transparency creates trust;
Amendment 4 #
2010/2055(INI)
Draft opinion
Recital D a (new)
Recital D a (new)
Da. whereas the fragmentation of the rules on registering companies damages consumers as well as the business world and the economy;
Amendment 6 #
2010/2055(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Is convinced that improved and easy access to information is necessary to assist small and medium-sized enterprises, which represent a key element in the backbone of the European economy and the main motor for creating jobs, economic growth and social cohesion in Europe, as it contributes to the reduction of their administrative burdens;
Amendment 8 #
2010/2055(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Believes that any strategy for exiting the crisis and improving the operation of the single market must involve greater transparency and cooperation in cross- border mechanisms, which will boost the confidence of the 500 million European consumers;
Amendment 12 #
2010/2055(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Points out the importance of automated communication between European business registers based on standards and allowing interoperability, which will boost transparency and confidence in the operation of the single market;
Amendment 14 #
2010/2055(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Insists on the importance for competent authorities and citizens to have access to reliable, steady and updated company information; stresses the importance of further merging of the BRITE, IMI and the European Business Register (EBR) data and systems to put into place a single information access point for internal market stakeholders and thus reinforce consumers, reducing the costs of transactions for both producers and consumers by concentrating information, and thus reinforce cross-border commerce, especially cross-border electronic commerce, and economic growth in the Union.
Amendment 18 #
2010/2055(INI)
Draft opinion
Paragraph 7 c (new)
Paragraph 7 c (new)
7c. Proposes that this one-stop shop for information, with mandatory registration for businesses, should be supervised by a European authority and should be available in all the EU's official languages; calls for effective ways of publishing its existence to be guaranteed so that all stakeholders can use this one- stop shop to obtain clear and reliable information on European companies;
Amendment 5 #
2010/2012(INI)
Motion for a resolution
Citation 4 a (new)
Citation 4 a (new)
- having regard to the Monti report of 9 May 2010 ('A new strategy for the single market'),
Amendment 6 #
2010/2012(INI)
Motion for a resolution
Citation 4 b (new)
Citation 4 b (new)
- having regard to the resolution of Parliament P7_TA(2010)0186 of 20 May 2010 on delivering a single market for consumers and citizens,
Amendment 11 #
2010/2012(INI)
Motion for a resolution
Citation 22 A (new)
Citation 22 A (new)
- having regard to Commission Regulation (EU) No 330/2010 of 20 April 2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of vertical agreements and concerted practices,
Amendment 18 #
2010/2012(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas e-commerce facilitates and promotes the development of new market niches for SMEs which would not otherwise exist,
Amendment 23 #
2010/2012(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas e-commerce offers a wider choice to consumers, especially to those living in less accessible, remote or outlying areas, as well as those with reduced mobility, who would otherwise not have access to a wide choice of goods,
Amendment 28 #
2010/2012(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. having regard to the Commission communication on the digital agenda, which recognises that consumers in the EU very often opt to engage in transactions with firms based outside the US, for example in the US, a factor which points to the need to develop a policy for encouraging global forms of e-commerce,
Amendment 36 #
2010/2012(INI)
Motion for a resolution
Recital I
Recital I
I. whereas e-commerce users have a right to compensation when they are affected by illegal practices, but in practice they face substantial barriers in bringing such cases to court due to high costlack of information on the legislation applying in the different Member States, long and complex procedures and, the risks associated with litigation, particularly in cross-border cases, and high costs,
Amendment 44 #
2010/2012(INI)
Motion for a resolution
Recital K A (new)
Recital K A (new)
Ka. whereas the existing vertical distribution agreements are often used to avoid or restrict on-line sales, thus denying retailers access to wider markets, undermining consumers' rights to a wider choice and better prices, and thus creating barriers to the expansion of commerce,
Amendment 57 #
2010/2012(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for an active policy to enable citizens and businesses to benefit fully from the internal market, which offers good quality goods and services at competitive prices; considers that this is all the more essential in the current economic crisis as a means of fighting against growing inequalities and protecting vulnerable consumersconsumers who are vulnerable, live in remote locations or have reduced mobility, low-income groups, and small and medium-sized businesses which are particularly concerned to join the world of e-commerce;
Amendment 63 #
2010/2012(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls for standardisationefforts to seek the highest common denominator of pre- contractual information in e-commerce, while retaining a minimum harmonisation approach for face-to-face contracts in specific sectors, such as health services or estate agentso as to ensure transparency and trust between consumers and sellers;
Amendment 69 #
2010/2012(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Advocates the development of an appropriate, efficient, safe and innovative system of on-line payment which can offer consumers freedom and choice as regards mode of payment, does not involve fees which might undercut or limit choice, and ensures protection of the consumer's data;
Amendment 72 #
2010/2012(INI)
Motion for a resolution
Paragraph 6 a(new)
Paragraph 6 a(new)
6a. Stresses the need to clarify the impact of the VAT package on crossborder postal services, with a view to avoiding legal uncertainty and price increases; the VAT exemption for universal postal services under the EU's VAT directive must not be affected by a new fiscal rule based on the place of supply of services;
Amendment 77 #
2010/2012(INI)
Motion for a resolution
Paragraph 7 a(new)
Paragraph 7 a(new)
7a. Suggests creating a 'one-stop shop' system at European level with a view to finding crossborder solutions for administering Member States' different rules and regulations, as in the case of declaration and payment of VAT or other applicable taxes;
Amendment 81 #
2010/2012(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls on the Commission and the Member States to ensureput an end to discrimination against consumers on the grounds of electronic address or residence, ensuring the effective implementation of Article 20(2) of the Services Directive, and calls on the Commission to propose a provision for access to products delivered cross-border, in line with that article of the directive;
Amendment 84 #
2010/2012(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls for an integrated political approach to the completion of the single market in transport, covering all modes (including cabotage by road, rail freight, etc), as well as to environmental legislation, with a view to preventing inefficiencies in the supply chain or unnecessary cost increases for distance sellers and e-commerce clients;
Amendment 89 #
2010/2012(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls for measures to be taken in order to contribute towards an increase in the number of internet users and the improvement of the quality, price and speed of the net in those countries and regions within the Union that do not have a good-quality connection, ensuring that broadband access is available throughout the EU by 2013;
Amendment 105 #
2010/2012(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the need to review rules on exclusive and selective distributionmonitor the application of the rules recently adopted in Commission Regulation (EU) No 330/2010 of 20 April 2010 on exclusive and selective distribution, on the basis of market information from the interested parties and national competition authorities, and, where necessary, to review those rules in order to reduce barriers to online sales;
Amendment 120 #
2010/2012(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to extend the rules governing distance contracts so as also to cover contracts concluded between consumers and professional traders in online auctions and contracts for tourist services (airline tickets, hotel accommodation, car rental, leisure time services and so on) ordered individually over the internet;
Amendment 121 #
2010/2012(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Stresses that users (consumers and vendors) require legal certainty when operating on-line, and welcomes the Commission's suggestion in its communication 'A digital agenda for Europe' of updating the rules on the limited liability of information society services so as to keep up with technological progress, in the context of the e-commerce directive (see the communication's footnote no 13);
Amendment 135 #
2010/2012(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Shares the Commission’s view that alternative dispute resolution mechanisms (ADR), such as mediation and arbitration or out-of-court settlements, can be an expedient and attractive option for consumers; notes that some private operators, such as on-line platforms, have established successful initiatives to boost consumer confidence, using internal dispute resolution instruments; urges Member States to encourage the development of ADR and collective redress to enhance the level of consumer protection and maximise compliance with legislation; recalls the positive experiences of SOLVIT and of the network of European Consumer Centres; calls for the creation of a European e- consumer information system which would offer detailed guidance and information about rights and obligations in the digital market; but emphasises that such mechanisms should complement and not substitute judicial or administrative means of enforcement;
Amendment 140 #
2010/2012(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Stresses the need to develop and standardise rules offering a high level of legal protection to minors, and encourages the launching of information and training campaigns for parents, teachers and guardians to make them aware of their responsibility in educating children about risks on the use of on-line commerce and the importance of vigilance on children's use of the internet;
Amendment 146 #
2010/2012(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Invites the Commission to continue investigating the reasons why consumers reject e-commerce, with a view to drawing up effective guidelines for suitable legislation, and suggests creating a 'scoreboard' dedicated exclusively to e- commerce with the aim of obtaining a behavioural picture of the on-line consumer and identifying the factors which affect and determine such consumers' choices;
Amendment 151 #
2010/2012(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Believes that consumer confidence can be built up through European trusted authorities or trustmark indicators that guarantee the reliability and quality of goods placed on the cross-border electronic market; considers that a sustainable European trustmark needs to be established, with clear and transparent rules and under the supervision of the Commission;
Amendment 157 #
2010/2012(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls for a grant programme to be established and for use to be made of existing financial instruments for projects to increase users’ confidence in e- commerce, including educational and information campaigns and projects verifying online services in practice (such as 'mystery shopping'); emphasises the need to create an electronic learning module based on the Dolceta project (Development of On-Line Consumer Education Tools for Adults);
Amendment 163 #
2010/2012(INI)
Motion for a resolution
Paragraph 26 A (new)
Paragraph 26 A (new)
26a. Invites the Commission to launch a dialogue between interested parties and the US, with a view to examining means of developing a transatlantic electronic market;
Amendment 12 #
2010/2011(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas, increasingly, single market and international trade issues are interdependent and affect each other,
Amendment 24 #
2010/2011(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Expresses its concern that the re- emergence of economic protectionism could result in fragmentation of the single market; is concerned that the current economic and financial debaclecrisis could be used as a justification for reviving protectionist measures in various Member States;
Amendment 46 #
2010/2011(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Takes the view that the old perception of the single market as being primarily tied to economic considerations needs revisiting and that this has been made even more necessary by the importance which the Treaty of Lisbon has attached to the single market; stresses that all those involved in shaping and implementing the single market need to adopt a more holistic approach, fully integrating citizens’ concerns, particularly in relation to economic, social, health and environmental issues and consumer protection;
Amendment 56 #
2010/2011(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls for a new paradigm of political thinking, with citizens and consumers occupying a central role in the relaunch of the single European market; holds the view that this can be achieved by making the European citizen the main political variablea major beneficiary in the determination and formulation of Union legislation and policy;
Amendment 1 #
2009/2222(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Considers that social services of general interest (SSGI) play a comprehensive role in implementation of the principles set out in Article 3 of the Treaty on European Union (TEU) and Articles 9 and 14 of the Treaty on the Functioning of the European Union (TFEU), particularly with regard to the development of a highly competitive social market economy and the promotion of economic, social and territorial cohesion in the Union; stresses here that it is important to reinforce the social dimension of the internal market by taking better account of the special nature of SSGI, with emphasis on a pragmatic approach in which the accessibility, universality, fairness, quality and efficiency of such services are the prime considerations;
Amendment 7 #
2009/2222(INI)
Draft opinion
Subheading 1 a (new)
Subheading 1 a (new)
1a. Stresses the importance of involving political and institutional players, civil society and stakeholders, promoting a holistic appproach to services of general interest that takes account of Europe's citizens and of SMEs, which are often overlooked in this area of the European social economy;
Amendment 15 #
2009/2222(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Draws attention to the substantial proportion of total employment in the EU, and of public financing in the Member States, that is accounted for by SSGI; believes that, against a background of economic and budgetary crisis, a balanced approach needs to be adopted, based on preserving the quality of social services and making them more effective; considers, therefore, that discussion is required with a focus on the relationship between public procurement rules and SSGI, particularly with regard to new management approaches such as in-house procurement and increased emphasis on quality criteria in the tender selection process, ensuring the participation of SMEs on an equal footing;
Amendment 26 #
2009/2222(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Believes a legislative package needs to be introduced including a regulatory framework for economic services of general interest, on the basis of Article 14 TFEU, defiining services of general interest and delimiting the impact of market rules. These rules should distinguish clearly between economic and non-economic services of general interest and should, simultaneously, consolidate and clarify the general principles and common conditions for the operationality of such services.
Amendment 30 #
2009/2222(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Draws attention to the range of public- service models in Europe and the fact that observance of the principle of subsidiarity is therefore a further consideration which should inform discussions aimed at clarifying the link between the European level and local, regional and national levels.
Amendment 3 #
2009/2138(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas the SOLVIT network, when it is fully operational, will be able to prevent excessive recourse being had to the judicial system, where procedures are often complex, and mechanisms for guaranteeing the defence of individuals frequently hamper access to justice,
Amendment 23 #
2009/2138(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls on the Member States to set up web pages linked to the European SOLVIT portal, featuring a compilation of successful cases and of best practice with regard to settling disputes by means of this mechanism;
Amendment 1 #
2009/2103(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas one third of all cancer cases can be prevented through proper screening and early detection,
Amendment 4 #
2009/2103(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Considers that the current funding available to fight cancer in the EU is inadequate to result in the necessary research and coordination as well as to provide decent preventive information for EU citizens;
Amendment 6 #
2009/2103(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Considers that existing FP7 funding allocated to the fight against cancer should be used more efficiently through, for example, better coordination between the different cancer research centres in the EU;
Amendment 8 #
2009/2103(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the Commission to encourage the Member States to share all information gathered so far as well as best practices in order to reduce any future and existing overlapping of efforts funded through Community programmes;
Amendment 9 #
2009/2103(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission to use the existing European Centre for Disease Prevention and Control (ECDC) by adding non-communicable diseases to its mandate and by using it as the headquarters for EU cancer research where all the data already collected in each Member State could be harnessed and analysed in order to provide scientists and doctors with best practices and greater knowledge of the disease;
Amendment 11 #
2009/2103(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Urges the Commission to encourage those Member States with high cancer mortality to reform their national cancer registries in order to provide the data necessary for better informed and more focused policies;
Amendment 12 #
2009/2103(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Finds the proposed structure lacking in so far as there is no clear definition of specific action objectives, such as how to achieve the integration of all Member States’ plans in the fight against cancer by 2013, and calls on the Commission to rectify this lack of focus;
Amendment 13 #
2009/2103(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Considers that the fight against cancer requires a real and accountable action plan that sets clear and ambitious goals that go beyond the mere collection of existent data such as the Commission currently proposes; considers also that fighting cancer is a long-term battle and believes, therefore, that the Commission should propose long-term plans instead of a Partnership that is currently foreseen to work only from 2009 to 2013 under the current proposed structure;
Amendment 1 #
2009/2002(BUD)
Draft opinion
Paragraph 3
Paragraph 3
3. Welcomes the slight increase in chapters 12 01 and 12 02, which it deems necessary due to the benefits of the single market for the EU economy as a whole, in particular during the economic downturn; calls therefore on the Commission to bring forward proposals on how to remove the remaining barriers to the single market in order to increase such benefits; emphasises the importance of the services sector for the single market and deems therefore the implementation of the Services Directive a key priority; encourages the Commission to strengthen its efforts towards an evidence-based policy based on sound market knowledge, economic analysis and the choice of appropriate instruments; asks the Commission in addition to cooperate closely with the Member States and to develop an administrative culture of simpler regulation and effective problem- solving; stresses the need to put administrative procedures relating to the implementation of directives online and simplify administrative formalities in the implementation of essential measures, and not merely in the ex post evaluation thereof; points out in this context the importance of workshops, exchange of officials and other training activities to assist officials and judges in correctly transposing, applying and enforcing single market rules, encouraging the simplification thereof and avoiding the creation of new barriers;
Amendment 2 #
2009/2002(BUD)
Draft opinion
Paragraph 4
Paragraph 4
4. Welcomes the creation of a separate budget line for the SOLVIT network in the 2009 Budget and asks for its further strengthening in the 2010 Budget; calls on Member States to increase the human and financial resources allocated to this network, which constitutes an effective free-of-charge out-of-court dispute settlement mechanism, preventing cases from entering the judicial system, which very often tends to complicate matters and within which existing mechanisms aimed at guaranteeing the defence of individuals frequently stand in the way of access to justice; asks the Commission to strengthen its efforts to finance training and promotion activities of the SOLVIT network in all Member States; encourages the Commission also to accelerate the streamlining of the different services providing information and advice regarding the single market; strongly supports, therefore, the concept of Single Market Assistance Services through the creation of a single-entry webpage;
Amendment 3 #
2009/2002(BUD)
Draft opinion
Paragraph 5
Paragraph 5
5. Considers the increase in the amount, allocated in chapter 14 04, for the 2013 Customs Programme to be justified and appropriate to achieve the goals in this policy area, such as reinforcing security and protection of the now extended external borders, supporting the fight against illicit trafficking and fraud and improving the efficiency of customs systems; emphasises the fact that the Programme contributes to the achievement of these goals by improving coordination and cooperation between Member States, promoting the exchange of best practices and know-how and monitoring the correct application of Community legislation;
Amendment 4 #
2009/2002(BUD)
Draft opinion
Paragraph 6
Paragraph 6
6. Points out the role of consumer policy in chapter 17 02 in the development of an internal market with safe products and services, equal rights for all consumers and a level playing field for companies; emphasises the importance of closenotes, however, that it is on the decrease and that this is incompatible with the ambitious programme of cooperation between the Community, Member States and third countries, including the United States and China, on more effective enforcement mechanisms in order to achieve greater consumer confidence, in particular during the economic downturn; urges the Commission to develop a knowledge base, as well as training programmes, in the area of market surveillance which will strengthen the existing cooperation structures between the competent authorities; calls on the Commission to propose further Community action to reinforce the European Consumer Centres; considers common efforts in the area of consumer education, in particular regarding financial literacy and communication systems and networks, independently of the age and the level of education of consumers, a priority;
Amendment 5 #
2009/2002(BUD)
Draft opinion
Paragraph 7
Paragraph 7
7. Recognises and stresses the importance of monitoring consumer markets through the consolidation of a scoreboard and related market studies based on the collection of data on consumer behaviour and the functioning of those markets; calls therefore for a further preparatory action entitled 'Monitoring measures in the field of consumer policy' which would allow for the continuation of existing surveys and studies and the financing of further market studies, thus improving the quality of the Consumer Markets Scoreboard.
Amendment 34 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 8
Recital 8
(8) In order to ensure the collection of any necessary additional data about the safety of authorised medicinal products, competent authorities should be empowered to require post-authorisation safety studies at the time of the granting of the marketing authorisation or later, and this requirement should be included as a condition of the marketing authorisation. If the conditions included in the marketing authorisation are not met within the deadline set, the competent authorities should have the power and appropriate resources to immediately suspend or revoke the marketing authorisation.
Amendment 41 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point d
Article 1 – point 1 – point d
Directive 2001/83/EC
Article 1 – point 28b
Article 1 – point 28b
(28b) Risk management system: a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks already detected, and risks identified subsequently, relating to a medicinal product, including the assessment of the effectiveness of those interventions.
Amendment 42 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 11 - subparagraph 3
Article 11 - subparagraph 3
For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the following statements: “This(a) "This newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions. All suspected adverse reactions should be reported to <name and, web-address, postal address and telephone number of the national competent authority>, or reported directly to the pharmacy"; (b) An exclamation mark surrounded by a red triangle. This symbol shall also appear on the outer packaging, accompanied by an indication that it is advisable to read the package leaflet before taking the medicinal product.
Amendment 48 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 3
Article 59 – paragraph 1 – subparagraph 3
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statements shall be included: (a) “This newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions. All suspected adverse reactions should be reported to <name and, web-address of the national competent authority>, postal address and telephone number of the national competent authority>,or reported directly to the pharmacy"; (b) An exclamation mark surrounded by a red triangle. This symbol shall also appear on the outer packaging, accompanied by an indication that it is advisable to read the package leaflet before taking the medicinal product.
Amendment 52 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1 a (new)
Article 102 – paragraph 1 – point 1 a (new)
(1a) conduct public awareness campaigns on the importance of reporting adverse reactions and possible ways of doing so;
Amendment 55 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 3 a (new)
Article 102 – paragraph 1 – point 3 a (new)
(3a) take the necessary steps to enable the public to report adverse reactions, in particular by ensuring that appropriate forms are available at pharmacies, drawn up in line with technical criteria and complying with the principles of simplified language and structure, accessible to the general public; these forms shall be sent by the pharmacists to the competent authorities;
Amendment 56 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 103 – paragraph 2 a (new)
Article 103 – paragraph 2 a (new)
The Member States shall cooperate with each other in order to develop the appropriate skills and capacities to supervise the pharmacovigilance system on their territory.
Amendment 57 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 105 – paragraph 2
Article 105 – paragraph 2
The first paragraph shall not preclude the collection of fees to be paid by marketing authorisation holders foras a contribution to the carrying out of those activities by the national competent authorities.
Amendment 58 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 3 a (new)
Article 106 – point 3 a (new)
(3a) A summary of the periodic safety update reports showing the assessment made by the competent authorities, including the analysis of the risk-benefit balance of the medicinal product.
Amendment 25 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 25
Article 25
The Agency, in collaboration with the Member States, shall develop standard web-based structured forms for the reporting of suspected adverse reactions by health-care professionals and patients. Forms intended for patients must be designed according to technical criteria conforming to the principles of clear structure and simplified language accessible to the general public; they must be obtainable on the Internet and in pharmacies. The forms must include the information required to enable reports to the authorities to be made by pharmacies or directly by patients, by post, by fax, or electronically.
Amendment 21 #
2008/0256(COD)
Proposal for a directive – amending act
Recital 10
Recital 10
(10) Provisions should be established to ensure that only high-quality non- promotional information about the benefits and the risks of authorised medicinal products subject to medical prescription may be disseminatedmade available. The information should take into account patients needs and expectations in order to empower patients, allow informed choices and enhance the rational use of medicinal products. Therefore, any information to the general public on authorised prescription-only medicinal products should comply with a set of quality criteria. (Replacing the term 'disseminated' with 'made available' applies throughout the text. Adopting this amendment will necessitate corresponding changes throughout.)
Amendment 23 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 86 – paragraph 1 – indent 1 a (new)
Article 86 – paragraph 1 – indent 1 a (new)
(-1) The following indent shall be inserted after the first indent of Article 86(1): "- drawing the general public's attention to a specific medicinal product, using therapeutic indications or signs and symptoms,"
Amendment 28 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100a – paragraph 1
Article 100a – paragraph 1
1. Member States shall allow the marketing authorisation holder to disseminate, either directly or indirectly through a third party, information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII.
Amendment 33 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100b – point b
Article 100b – point b
(b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different way, provided that it clearly contains an accurate representation of the risks and benefits of the medicinal product;
Amendment 33 #
2008/0256(COD)
Proposal for a directive – amending act
Recital 10
Recital 10
(10) Provisions should be established to ensure that only high-quality non- promotional information about the benefits and the risks of authorised medicinal products subject to medical prescription may be disseminatedmade available. The information should take into account patients’ needs and expectations in order to empower patients, allow informed choices and enhance the rational use of medicinal products. Therefore, any information to the general public on prescription-only medicinal products should comply with a set of quality criteria. (The replacement of the word ‘disseminated’ with the term ‘made available’ applies to the text as a whole. Adopting this amendment will necessitate corresponding changes throughout)
Amendment 36 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100c – introductory part
Article 100c – introductory part
Information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio, or in general newspapers and magazines or in the form of inserts or supplements to them. It shall only be made available through the following channels:
Amendment 37 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100c – point a
Article 100c – point a
(a) health-related publications as defined by the Member State of publictechnical and scientific magazines in the field of health, or magazines addressed to the general public whose main content is in the field of health, brochures, leaflets and other categories of printed information, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 38 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
(-1) In paragraph 1 of Article 86, after the first indent, the following indent is inserted: “– drawing the attention of the general public to medicinal products by means of references to therapeutic indications or to signs and symptoms,”
Amendment 42 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 1 – point b
Article 100d – paragraph 1 – point b
(b) it must take into accoube geared to the patient, the general needs and expectations of patiento better meet his or her needs;
Amendment 42 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 1
Article 100 a – paragraph 1
1. Member States shall allow the marketing authorisation holder to disseminate, either directly or indirectly through a third party, information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII.
Amendment 43 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 1 – point c
Article 100d – paragraph 1 – point c
(c) it must be based on evidence, be verifiable and include a statement on the level of evidence; Does not affect the English version)
Amendment 47 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 2 – point c
Article 100d – paragraph 2 – point c
(c) a statement indicating that the information is disseminated by a marketing authorisation holder and naming the holder;
Amendment 48 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b
Article 100 b – point b
(b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different wayand more readily comprehensible way, provided that it manifestly constitutes an accurate representation of the risks and benefits associated with the medicinal product;
Amendment 51 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100g – paragraph 1 – subparagraph 3
Article 100g – paragraph 1 – subparagraph 3
The methods may include the voluntary control of information on medicinal products by self-regulatory or co- regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings available in the Member States.
Amendment 55 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100h – paragraph 2 – subparagraph 2
Article 100h – paragraph 2 – subparagraph 2
Internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites or the appearance therein of unsolicited material actively distributed to the general public or members thereof. Those websites shall not contain web-TVdisseminate video material.
Amendment 55 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point a
Article 100 c – point a
(a) health-related publications as defined by the Member State of publicscientific and technical journals or magazines aimed at the general public with mainly health-related content, booklets, leaflets, and other categories of printed information, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 56 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100h – paragraph 3
Article 100h – paragraph 3
3. The Member State where the Internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website in relation to medicinal products subject to medical prescription.
Amendment 57 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100h – paragraph 5
Article 100h – paragraph 5
5. Member States shall allow mrequire that: (a) Marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directive. The statement shall identify the national competent authority monitoring the website concerned. It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval; (b) Registered Internet websites include on each of their pages, in a prominent position, a hyperlink to the web page of the Eudrapharma database, together with an explanatory note informing users that this is the official database developed by the European Medicines Agency.
Amendment 59 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
(c) written answers to requests for information ofrom a member of the general public. Verbal questions must be recorded.
Amendment 4 #
2008/0255(COD)
Proposal for a regulation – amending act
Recital 1
Recital 1
(1) On 20 December 2007, the Commission submitted a Communication to the European Parliament and the Council concerning the "Report on current practices with regard to the provision of information to patients on medicinal products". The report concludes that Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information on medicinal products. Experience gained from the application of the current legal framework has also shown disparities in the interpretation of the Community rules on advertising, and between national provisions on information, highlighting the urgent need for a more precise distinction between advertising and information.
Amendment 5 #
2008/0255(COD)
Proposal for a regulation – amending act
Recital 4
Recital 4
(4) Directive 2001/83/EC provides that certain types of information are subject to control by the Member States' national competent authorities prior to their dissemination. This concerns information about non-interventional scientific studies based on experimental observation, or accompanying measures to prevention and medical treatment, or information which presents the medicinal product in the context of the condition to be prevented or treated. In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should also be made for certain types of information to be subject to prior vetting by the European Medicines Agency (hereinafter referred to as the 'Agency'), and for the Agency to monitor the measures to be taken by the manufacturer following a report of adverse reactions, and the consequent immediate updating of the literature.
Amendment 6 #
2008/0255(COD)
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 1
Article 20b – paragraph 1
1. By way of derogation from Article 100g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency prior to its dissemination, unless this information is given on an internet website where responsibility for monitoring the content disseminated rests with a Member State in accordance with Article 100h of Directive 2001/83/EC.
Amendment 7 #
2008/0255(COD)
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 3
Article 20b – paragraph 3
3. The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC, stating the grounds for its decision, within 6120 days after receipt of the notification. If the Agency does not object within 6120 days, the information shall be deemed accepted and may be published.
Amendment 8 #
2008/0255(COD)
Proposal for a regulation – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – point l
Article 57 – paragraph 1 – point l
(1a) In Article 57(1), point (l) shall be replaced by the following: (l) Creating a database on medicinal products, to be accessible to the general public, in all the official languages of the EU, and ensuring that it is updated, and managed independently of the commercial interests of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner, designed for the non-expert public;
Amendment 9 #
2008/0255(COD)
Proposal for a regulation – amending act
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 2
Article 57 – paragraph 2
(2a) In Article 57, paragraph 2 shall be replaced by the following: 2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively. The database shall subsequently be extended to include any medicinal product placed on the market within the Community. Where appropriate, the database shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC. The Commission shall, in consultation with the Member States, issue guidelines on data fields which could be included and which may be accessible to the public. This database shall be actively promoted to European citizens. The information submitted by holders of marketing authorisation and approved by the national authorities shall be sent to the Agency by those authorities and included in its database available to the public.
Amendment 262 #
2008/0196(COD)
Proposal for a directive
Recital 12 a (new)
Recital 12 a (new)
(12a) Gambling activities, including lottery and betting transactions, should be excluded from the scope of this Directive in view of the very specific nature of these activities which entail implementation by the Member States of other and more stringent consumer protection measures not aiming at the completion of the Internal Market.
Amendment 524 #
2008/0196(COD)
Proposal for a directive
Article 3 – paragraph 4 – subparagraph 1 (new)
Article 3 – paragraph 4 – subparagraph 1 (new)
This Directive shall not apply to gambling activities, which involve wagering a stake with pecuniary value in games of chance, including lotteries, casino games and betting transactions.
Amendment 540 #
Amendment 545 #
2008/0196(COD)
Proposal for a directive
Article 4 – paragraph 1 and paragraph 1 a (new)
Article 4 – paragraph 1 and paragraph 1 a (new)
1. Member States may not maintain or introduce, in their national laws, provisions diverging from those laid down in this Directive, including more or less stringent provisions to ensure a different level of as long as they guarantee a higher degree of consumer protection. 1a. The rights resulting from this Directive shall be exercised without prejudice to the provisions of another Community act governing consumer protection.
Amendment 1548 #
2008/0196(COD)
Proposal for a directive
Annex 2 – paragraph 1 – point d a (new)
Annex 2 – paragraph 1 – point d a (new)
(da) excluding or hindering the consumer's right to instruct and authorise a third party to conclude a contract between the consumer and the trader and/or to take steps which are meant to lead to, or facilitate, the conclusion of a contract between the consumer and the trader.