António Fernando CORREIA DE CAMPOS
Constituencies
-
Portugal
Parti socialiste
2009/07/14 - 9999/12/31
Groups
-
S&D
Member
Group of the Progressive Alliance of Socialists and Democrats in the European Parliament
2009/07/14 - 9999/12/31
EP staff
- Member of Conference of Delegation Chairs 2012/04/12 - 9999/12/31
Committees
| Role | Committee | Start | End |
|---|---|---|---|
| Member of | Committee on the Internal Market and Consumer Protection | 2012/01/19 | 9999/12/31 |
| Substitute of | Committee on Industry, Research and Energy | 2012/01/19 | 9999/12/31 |
Show earlier commitees...
Delegations
| Role | Delegation | Start | End |
|---|---|---|---|
| Chair of | Delegation to the EU-Chile Joint Parliamentary Committee | 2012/04/12 | 9999/12/31 |
| Member of | Delegation to the Euro-Latin American Parliamentary Assembly | 2009/09/16 | 9999/12/31 |
| Substitute of | Delegation to the EU-Russia Parliamentary Cooperation Committee | 2009/09/16 | 9999/12/31 |
Show earlier delegations...
| Role | Delegation | Start | End |
|---|---|---|---|
| Member of | Delegation to the EU-Chile Joint Parliamentary Committee | 2009/09/16 | 2012/04/11 |
Contact
Online
- [javascript protected email address]
Brussels
- Phone
- +322 28 45405
- Fax
- +322 28 49405
- Office
- Bât. Altiero Spinelli 14G346
- Full Address
-
- City
- Bruxelles/Brussel
- Zip
- B-1047
- Street
- 60, rue Wiertz / Wiertzstraat 60
Strasbourg
- Phone
- +333 88 1 75405
- Fax
- +333 88 1 79405
- Office
- Bât. Louise Weiss T06151
- Full Address
-
- City
- Strasbourg
- Zip
- CS 91024 - F-67070
- Street
- 1, avenue du Président Robert Schuman
Postal
- Parlamento Europeu
- Rue Wiertz
- Altiero Spinelli 14G346
- B-1047 Bruxelas
Rapporteur
| Opinion | 2013/2005(INI) | Making the internal energy market work |
| Shadow | 2013/0082(COD) | Investment projects in energy infrastructure: notification to the Commission |
| Shadow | 2012/2030(INI) | Completing the Digital Single Market |
| Opinion | 2012/2028(INI) | Feasibility of introducing stability bonds |
| Shadow | 2011/2155(INI) | Internal Market Scoreboard |
| Opinion | 2011/2146(INI) | Reform of the EU State Aid Rules on Services of General Economic Interest |
| Shadow | 2011/0460(NLE) | Supplementary Research Programme for the ITER project (2014-2018) |
| Responsible | 2011/0300(COD) | Trans-European energy infrastructure: guidelines |
| Responsible | 2010/2278(INI) | Single Market for Europeans |
| Opinion | 2010/2099(INI) | Improving the economic governance and stability framework of the Union, in particular in the euro area |
| Shadow | 2010/2012(INI) | Completing the internal market for e-commerce |
| Opinion | 2008/0255(COD) | Medicinal products for human use: information on products subject to medical prescription |
Born
1942/12/14 Viseu- Graduate in law, Coimbra (1966); 'Directeur d'Hôpital' diploma, ENSP, Rennes, France (1969); MPh, John Hopkins University, Baltimore, USA (1978); PhD, ENSP, New University of Lisbon (1982).
- Civil servant, Ministry of Health (1966-1986); University professor (1970-2009).
- Secretariat, Socialist Party (1989-1991); National Committee, Socialist Party (1990-2009); Political Committee, Socialist Party (2009-); Member of the Municipal Assembly, Viseu (2005-2009).
- Member of the Assembly of the Republic, Portugal (1991-1993); State Secretary (one month) (1975); State Secretary (three months) (1979-1980); Minister for Health (nine months) (2001-2002); Minister for Health (33 months) (2005-2008).
- Chair of STOA (Science and Technology Options Assessment Panel).
- Member of the Committee on Health Services Research, WHO/EURO, Copenhagen (1984-1988); Senior Health Care Management Specialist, World Bank, Washington DC (1992-1995).
- Order of Infante Dom Henrique (Grand Cross); Order of Simon Bolivar, Liberator (Grand Cross), Venezuela.
Amendments
| Amendments | Dossier |
| 5 |
2008/0196(COD) Consumer rights (amend. Directives 93/13/EEC and 1999/44/EC; repeal. Directives 85/577/EEC and 97/7/EC)
2010/10/25
IMCO
5 amendments...
Amendment 262 #
Proposal for a directive 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 #
Proposal for a directive 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 545 #
Proposal for a directive Article 4 – paragraph 1 and paragraph 1 a (new) 1. Member States may
Amendment 1548 #
Proposal for a directive 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.
source: PE-450.954
|
| 6 |
2008/0255(COD) Medicinal products for human use: information on products subject to medical prescription
2010/03/02
ITRE
6 amendments...
Amendment 4 #
Proposal for a regulation – amending act 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 #
Proposal for a regulation – amending act 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 #
Proposal for a regulation – amending act Article 1 – point 1 Regulation (EC) No 726/2004 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 #
Proposal for a regulation – amending act Article 1 – point 1 Regulation (EC) No 726/2004 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
Amendment 8 #
Proposal for a regulation – amending act Article 1 – point 1 a (new) Regulation (EC) No 726/2004 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 #
Proposal for a regulation – amending act Article 1 – point 2 a (new) Regulation (EC) No 726/2004 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.
source: PE-438.482
|
| 19 |
2008/0256(COD) Medicinal products for human use: information on products subject to medical prescription
2010/02/18
ITRE
13 amendments...
Amendment 21 #
Proposal for a directive – amending act 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
Amendment 23 #
Proposal for a directive – amending act Article 1 – point -1 (new) Directive 2001/83/EC 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 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC Article 100a – paragraph 1 1. Member States shall allow the marketing authorisation holder to disseminate
Amendment 33 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC 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 36 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC 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 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC Article 100c – point a (a)
Amendment 42 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC Article 100d – paragraph 1 – point b (b) it must
Amendment 43 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC Article 100d – paragraph 1 – point c (
Amendment 47 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC 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 51 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC Article 100g – paragraph 1 – subparagraph 3 The methods may include the voluntary control of information on medicinal products by
Amendment 55 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC 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
Amendment 56 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC 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 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC Article 100h – paragraph 5 5. Member States shall
source: PE-439.168
2010/07/04
IMCO
6 amendments...
Amendment 33 #
Proposal for a directive – amending act 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
Amendment 38 #
Proposal for a directive – amending act Article 1 – point 1 Directive 2001/83/EC Article 86 – paragraph -1 (new) (-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 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC Article 100 a – paragraph 1 1. Member States shall allow the marketing authorisation holder to disseminate
Amendment 48 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC 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
Amendment 55 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC Article 100 c – point a (a) health-related
Amendment 59 #
Proposal for a directive – amending act Article 1 – point 5 Directive 2001/83/EC Article 100 c – point c (c)
source: PE-439.868
|
| 1 |
2008/0257(COD) Medicinal products for human use: pharmacovigilance of products [amend. Regulations (EC) No 726/2004 (Community procedures) and (EC) No 1394/2007]
2010/05/02
ITRE
1 amendments...
Amendment 25 #
Proposal for a regulation – amending act Article 1 – point 11 Regulation (EC) No 726/2004 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
source: PE-438.505
|
| 9 |
2008/0260(COD) Medicinal products for human use: pharmacovigilance of products (amend. Directive 2001/83/EC, Community code)
2010/08/02
ITRE
9 amendments...
Amendment 34 #
Proposal for a directive – amending act 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 #
Proposal for a directive – amending act Article 1 – point 1 – point d Directive 2001/83/EC 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 #
Proposal for a directive – amending act Article 1 – point 3 – point b Directive 2001/83/EC Article 11 - subparagraph 3 For
Amendment 48 #
Proposal for a directive – amending act Article 1 – point 18 – point b Directive 2001/83/EC 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
Amendment 52 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC 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 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC 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 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC 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 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 105 – paragraph 2 The first paragraph shall not preclude the collection of fees to be paid by marketing authorisation holders
Amendment 58 #
Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC 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.
source: PE-438.514
|
| 5 |
2009/2002(BUD) 2010 budget: section III, Commission
2009/08/17
IMCO
5 amendments...
Amendment 1 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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;
Amendment 5 #
Draft opinion 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.
source: PE-427.945
|
| 8 |
2009/2103(INI) Report on the Commission communication on Action against cancer: European partnership
2010/03/02
ITRE
8 amendments...
Amendment 1 #
Draft opinion Recital A a (new) Aa. whereas one third of all cancer cases can be prevented through proper screening and early detection,
Amendment 4 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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;
source: PE-438.394
|
| 2 |
2009/2138(INI) SOLVIT
2009/11/12
IMCO
2 amendments...
Amendment 3 #
Motion for a resolution 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 #
Motion for a resolution 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;
source: PE-430.971
|
| 5 |
2009/2222(INI) Future for social services of general interest
2011/01/03
IMCO
5 amendments...
Amendment 1 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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.
source: PE-458.561
|
| 4 |
2010/2011(INI) Delivering a single market to consumers and citizens
2010/04/14
IMCO
4 amendments...
Amendment 12 #
Motion for a resolution Recital E a (new) Ea. whereas, increasingly, single market and international trade issues are interdependent and affect each other,
Amendment 24 #
Motion for a resolution 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
Amendment 46 #
Motion for a resolution 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 #
Motion for a resolution 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
source: PE-439.939
|
| 25 |
2010/2012(INI) Completing the internal market for e-commerce
2010/06/14
IMCO
25 amendments...
Amendment 5 #
Motion for a resolution Citation 4 a (new) - having regard to the Monti report of 9 May 2010 ('A new strategy for the single market'),
Amendment 6 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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
Amendment 44 #
Motion for a resolution 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 #
Motion for a resolution 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
Amendment 63 #
Motion for a resolution Paragraph 4 4. Calls for
Amendment 69 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 8 8. Calls on the Commission and the Member States to
Amendment 84 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 11 11. Stresses the need to
Amendment 120 #
Motion for a resolution 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
Amendment 121 #
Motion for a resolution 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 #
Motion for a resolution 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-
Amendment 140 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 24 24. Believes that consumer confidence can be built up through European trusted authorities or trust
Amendment 157 #
Motion for a resolution Paragraph 25 25. Calls for
Amendment 163 #
Motion for a resolution 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;
source: PE-442.949
|
| 7 |
2010/2055(INI) Interconnection of business registers
2010/12/05
IMCO
7 amendments...
Amendment 3 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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
Amendment 18 #
Draft opinion Paragraph 7 c (new) source: PE-441.292
|
| 18 |
2010/2079(INI) Simplifying the implementation of the Research Framework Programmes
2010/07/16
ITRE
18 amendments...
Amendment 14 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 10 a (new) 10a. Moreover, considers that for public bodies, the statements of assurance on the reliability of the organization’s annual accounts and on the legality and regularity of the underlying transactions issued by the national Court of Auditors and/or the national Public Auditors should be accepted by the European institutions when auditing the whole methodology of costs;
Amendment 43 #
Motion for a resolution 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
Amendment 54 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 27 27. Welcomes the overall trend towards shortening the average time-to-grant and time-to-pay
Amendment 86 #
Motion for a resolution Paragraph 29 Amendment 90 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 32 32. Calls for substantive improvement of the clarity and accessibility of guidance documents
Amendment 97 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 34 b (new) 34b. Recommends the creation of a more transparent, coherent, and harmonised peer review system based on merit;
Amendment 110 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 40 40. Invites the Commission to assess the
source: PE-445.806
|
| 20 |
2010/2088(INI) GDP and beyond - Measuring progress in a changing world
2010/10/13
ITRE
20 amendments...
Amendment 2 #
Draft opinion Citation 1 (new) - having regard to EU 2020 integrated guidelines for the European economic and employment policies,
Amendment 9 #
Draft opinion 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 p
Amendment 13 #
Draft opinion Recital B Amendment 18 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion Paragraph 1 1. Stresses the need to develop indicators which can complement GDP
Amendment 27 #
Draft opinion Paragraph 1 a (new) 1a. Welcomes the Commission proposals in the Communication GDP and beyond - measuring progress in a changing world;
Amendment 29 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion Paragraph 3 Amendment 50 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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.
source: PE-450.647
|
| 8 |
2010/2095(INI) Industrial Policy for the globalised era
2010/01/12
IMCO
8 amendments...
Amendment 1 #
Draft opinion Paragraph 1 1. Stresses that any ambitious EU industrial policy should be
Amendment 2 #
Draft opinion 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 #
Draft opinion Paragraph 2 2. Notes that the completion of the internal market is essential for the competitiveness and growth of European industry;
Amendment 9 #
Draft opinion Paragraph 3 3. Calls on the Commission to
Amendment 14 #
Draft opinion Paragraph 4 4.
Amendment 24 #
Draft opinion Paragraph 5 5. Underlines that social partners are best qualified to manage the appropriate adjustments following the economic crisis
Amendment 25 #
Draft opinion 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 #
Draft opinion Paragraph 6 a (new) 6a. Underlines the need to improve and facilitate SMEs' access to the financing available on the financial markets.
source: PE-454.466
|
| 11 |
2010/2099(INI) Improving the economic governance and stability framework of the Union, in particular in the euro area
2010/09/22
IMCO
11 amendments...
Amendment 2 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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
Amendment 13 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion Paragraph 9 9.
Amendment 21 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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
source: PE-448.871
|
| 8 |
2010/2109(INI) More efficient and fairer retail market
2011/04/28
IMCO
8 amendments...
Amendment 10 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 6 6. Underlines that retailers and suppliers have a shared responsibility in achieving a more efficient, transparent, and fairer retail market;
Amendment 28 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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
Amendment 53 #
Motion for a resolution 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;
source: PE-462.905
|
| 8 |
2010/2152(INI) New Trade Policy for Europe under the Europe 2020 Strategy
2011/04/03
ITRE
8 amendments...
Amendment 1 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion Paragraph 6 a (new) 6a. Notes that the Commission foresees further use of extraordinary unilateral commercial concessions in case of natural disasters; stresses that the burden of such measures is not evenly borne by all Member States, affecting preferentially specific countries, regions, industry sectors and jobs; calls on the Commission to undertake a careful ex-ante evaluation of the impact of such instruments;
Amendment 47 #
Draft opinion 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;
source: PE-460.632
|
| 15 |
2010/2245(INI) Innovation Union: transforming Europe for a post-crisis world
2011/08/03
ITRE
15 amendments...
Amendment 152 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Subheading 7 a (new), after paragraph 34 Strategy Implementation
Amendment 300 #
Motion for a resolution 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 #
Motion for a resolution 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.
source: PE-460.664
|
| 24 |
2010/2278(INI) Single Market for Europeans
2011/10/02
IMCO
24 amendments...
Amendment 1 #
Motion for a resolution Citation 24 a (new) - having regard to its resolution on 19 February 2009 on Social Economy;
Amendment 19 #
Motion for a resolution 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 37 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Subheading 2 II.
Amendment 77 #
Motion for a resolution Subheading 2 II.
Amendment 104 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 10 10. Calls for measures to set up an adequate legal framework for services of general interest, foundations, cooperatives
Amendment 201 #
Motion for a resolution 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 #
Motion for a resolution 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 217 #
Motion for a resolution Paragraph 17 – introductory part 17. Calls
Amendment 227 #
Motion for a resolution Paragraph 17 – point a (a)
Amendment 243 #
Motion for a resolution Paragraph 17 – point b (b)
Amendment 247 #
Motion for a resolution Paragraph 17 – point c (c)
Amendment 254 #
Motion for a resolution Paragraph 17 – point d (d)
Amendment 258 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 17 – point e (e)
Amendment 266 #
Motion for a resolution 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);
source: PE-458.639
|
| 5 |
2010/2304(INI) European broadband: investing in digitally driven growth
2011/03/25
IMCO
5 amendments...
Amendment 6 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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;
source: PE-460.945
|
| 5 |
2011/0150(COD) European standardisation
2012/02/29
IMCO
5 amendments...
Amendment 66 #
Draft legislative resolution 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 #
Proposal for a regulation Recital 12 (12) Standards can contribute to helping European policy address the major
Amendment 145 #
Proposal for a regulation Article 4 – paragraph 2 2. Each European and national standardisation body shall
Amendment 152 #
Proposal for a regulation Article 5 – paragraph 1 – introductory part 1. European standardisation bodies shall ensure
Amendment 200 #
Proposal for a regulation 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.
source: PE-480.857
|
| 6 |
2011/0156(COD) Food intended for infants and young children and food for special medical purposes
2012/01/17
IMCO
2 amendments...
Amendment 120 #
Proposal for a regulation Article 9 – paragraph 3 3. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide adequate consumer information
Amendment 125 #
Proposal for a regulation 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..
source: PE-478.332
2012/01/18
ITRE
4 amendments...
Amendment 13 #
Proposal for a regulation 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 #
Proposal for a regulation Recital 29 (29)
Amendment 61 #
Proposal for a regulation Article 9 – paragraph 3 3. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide adequate consumer information
Amendment 66 #
Proposal for a regulation Article 9 – paragraph 4 4.
source: PE-480.536
|
| 3 |
2011/0177(APP) Multiannual financial framework for the years 2014-2020
2012/06/20
IMCO
3 amendments...
Amendment 1 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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.
source: PE-492.553
|
| 9 |
2011/0187(COD) Roaming on public mobile communications networks within the Union. Recast
2011/12/21
IMCO
9 amendments...
Amendment 30 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 65 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 1 – paragraph 1 – subparagraph 1 This Regulation introduces a common approach to
Amendment 140 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 239 #
Proposal for a regulation Article 14 – paragraph 1 – subparagraph 2 – introductory part This basic personalised pricing information shall include the
Amendment 257 #
Proposal for a regulation 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.
source: PE-478.641
|
| 8 |
2011/0261(CNS) Common system of financial transaction tax
2012/01/03
IMCO
8 amendments...
Amendment 14 #
Proposal for a directive 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 #
Proposal for a directive 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 #
Proposal for a directive 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 #
Proposal for a directive Article 1 – paragraph 2 2. This Directive shall apply to all financial transactions
Amendment 44 #
Proposal for a directive Article 8 – paragraph 2 – subparagraph 2 – point a (a) 0.
Amendment 47 #
Proposal for a directive Article 8 – paragraph 2 – subparagraph 2 – point b (b) 0.0
Amendment 49 #
Proposal for a directive Article 9 – paragraph 3 3. Each party to a transaction,
Amendment 51 #
Proposal for a directive 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.
source: PE-483.683
|
| 3 |
2011/0299(COD) Trans-European telecommunications networks: guidelines
2012/07/16
ITRE
3 amendments...
Amendment 118 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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.
source: PE-494.476
|
| 9 |
2011/0300(COD) Trans-European energy infrastructure: guidelines
2012/08/05
ITRE
9 amendments...
Amendment 248 #
Proposal for a regulation 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 t
Amendment 431 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 14 – paragraph 6 6. The Commission
Amendment 578 #
Proposal for a regulation Article 14 a (new) Amendment 627 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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.
source: PE-487.726
|
| 28 |
2011/0302(COD) Connecting Europe Facility
2012/10/10
TRAN, ITRE
20 amendments...
Amendment 153 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 351 #
Proposal for a regulation Article 6 – paragraph 1 A (new) 1a. The indicative amount of 15%1 of the budget allocation foreseen in the energy sector shall be allocated in the form of financial instruments. __________________ 1 The percentage is given on the basis of the proposed Commission figures
Amendment 383 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 10 – paragraph 3 – point b (b) co-financing rates may be increased to
Amendment 480 #
Proposal for a regulation Article 10 – paragraph 5 5. Co-financing rates mentioned above may be increased by up to 10 percentage points
Amendment 481 #
Proposal for a regulation 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 #
Proposal for a regulation Article 15 – paragraph 1 1.
Amendment 542 #
Proposal for a regulation 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 #
Proposal for a regulation Article 17 – paragraph 4 4. The multiannual work programmes in the field of energy and telecommunications
Amendment 558 #
Proposal for a regulation 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
Amendment 559 #
Proposal for a regulation Article 17 – paragraph 6 – point a Amendment 560 #
Proposal for a regulation Article 17 – paragraph 6 – point b Amendment 561 #
Proposal for a regulation Article 17 – paragraph 6 – point c Amendment 568 #
Proposal for a regulation Article 21 – paragraph 3 Amendment 570 #
Proposal for a regulation Article 21 – paragraph 4 Member States shall inform the Commission
Amendment 576 #
Proposal for a regulation 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
source: PE-496.337
2012/10/17
TRAN, ITRE
8 amendments...
Amendment 721 #
Proposal for a regulation Annex – Part II - Point a - point 1 1. Northern Seas offshore
Amendment 722 #
Proposal for a regulation Annex – Part II - Point a - point 2 2. North-South electricity Developing
Amendment 723 #
Proposal for a regulation Annex – Part II - Point a - point 3 3. North-South gas Increasing interconnection Belgium, Ireland, interconnections in capacities
Amendment 725 #
Proposal for a regulation 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
Amendment 726 #
Proposal for a regulation Annex – Part II - Point a - point 5 5. North-South gas Strengthening regional Austria, Bulgaria, Czech interconnections in gas connections
Amendment 728 #
Proposal for a regulation 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 #
Proposal for a regulation Annex – Part II - Point a - point 7 7. Baltic Energy Market
Amendment 730 #
Proposal for a regulation Annex – Part II - Point a - point 8 8. Southern Gas Corridor
source: PE-497.891
|
| 1 |
2011/0359(COD) Statutory audit of public-interest entities: specific requirements
2012/10/19
ITRE
1 amendments...
Amendment 135 #
Proposal for a regulation Article 32 – paragraph 3 – subparagraph 1 – introductory part 3.
source: PE-498.010
|
| 2 |
2011/0401(COD) Horizon 2020 - Framework Programme for Research and Innovation 2014-2020
2012/04/07
ITRE
1 amendments...
Amendment 1804 #
Proposal for a regulation Annex II – Breakdown of the budget – table I Excellent science, of which:
source: PE-492.805
2012/06/29
ITRE
1 amendments...
Amendment 419 #
Proposal for a regulation Article 6 – paragraph 2 – subparagraph 2 The maximum overall amount for the Union financial contribution from Horizon 2020 to the non-nuclear direct
source: PE-492.656
|
| 1 |
2011/0437(COD) Award of concession contracts
2012/10/23
IMCO
1 amendments...
Amendment 509 #
Proposal for a directive 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;
source: PE-497.782
|
| 5 |
2011/0438(COD) Public procurement
2012/12/07
IMCO
5 amendments...
Amendment 687 #
Proposal for a directive Article 25 – paragraph 1 – subparagraph 2 The minimum time limit for the receipt of tenders shall be 4
Amendment 751 #
Proposal for a directive 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.
Amendment 891 #
Proposal for a directive 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 #
Proposal for a directive 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.
Amendment 1066 #
Proposal for a directive 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).
source: PE-492.858
|
| 3 |
2011/0460(NLE) Supplementary Research Programme for the ITER project (2014-2018)
2013/03/01
ITRE
3 amendments...
Amendment 21 #
Proposal for a decision 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 #
Proposal for a decision 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 #
Proposal for a decision 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]
source: PE-506.175
|
| 6 |
2011/2080(ACI) Financial framework 2007-2013: additional financing needs of the ITER project (amend. Interinstitutional Agreement of 17 May 2006 on budgetary discipline and sound financial management)
2011/10/18
ITRE
6 amendments...
Amendment 4 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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
Amendment 20 #
Draft opinion 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 #
Draft opinion 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;
source: PE-474.005
|
| 8 |
2011/2082(INI) Future of VAT
2011/07/22
IMCO
8 amendments...
Amendment 2 #
Draft opinion Paragraph 1 1.
Amendment 17 #
Draft opinion 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 sin
Amendment 28 #
Draft opinion Paragraph 3 3.
Amendment 34 #
Draft opinion 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 #
Draft opinion 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
Amendment 45 #
Draft opinion 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 #
Draft opinion Paragraph 6 6. Notes that according to the subsidiarity principle Member States should keep their possibility to decide on
Amendment 55 #
Draft opinion 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;
source: PE-469.966
|
| 7 |
2011/2084(INI) Online gambling in the Internal Market
2011/08/09
IMCO
7 amendments...
Amendment 9 #
Motion for a resolution Recital A A. whereas the Internet gambling
Amendment 130 #
Motion for a resolution Paragraph 6 6. Respects the decision by a number of Member States to ban Internet gambling totally
Amendment 144 #
Motion for a resolution Paragraph 7 7.
Amendment 155 #
Motion for a resolution Paragraph 8 8. Is of the opinion that the principle of mutual recognition of licences on the gambling market does not apply
Amendment 170 #
Motion for a resolution Paragraph 9 9. Calls – in keeping with the
Amendment 181 #
Motion for a resolution Paragraph 10 10. Calls on the Commission,
Amendment 265 #
Motion for a resolution Paragraph 18 18. Points to the need
source: PE-469.976
|
| 10 |
2011/2107(INI) Green Paper: From challenges to opportunities: towards a common strategic framework for EU research and innovation funding
2011/06/21
ITRE
10 amendments...
Amendment 90 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 23 a (new) – after subheading 5 23a. Stresses that the Common Strategic Framework for EU Research and Innovation Funding has an important role to play in supporting Innovation in Europe; however, warns against the danger of spreading funding of Research and Innovation too thinly across a variety of activities, fields, and objectives; calls for the doubling of the European funds allocated to Research and Innovation activities in order to support the achievement of the EU2020 objectives; highlights the more encompassing nature of the Common Strategic Framework for Research and Innovation Funding as compared to its predecessor programme FP7 and warns that this element should not work to dilute the need for such funding target increase; stresses the importance of using European funds to leverage investment from both private sector and Member States;
Amendment 318 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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;
source: PE-467.207
|
| 3 |
2011/2146(INI) Reform of the EU State Aid Rules on Services of General Economic Interest
2011/02/09
IMCO
3 amendments...
Amendment 7 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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);
source: PE-472.026
|
| 44 |
2011/2155(INI) Internal Market Scoreboard
2012/03/26
IMCO
44 amendments...
Amendment 1 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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
Amendment 6 #
Motion for a resolution Recital D D. whereas the publication of the Internal Market Scoreboard has consistently helped
Amendment 7 #
Motion for a resolution Recital D D. whereas the publication of the Internal Market Scoreboard has consistently helped to reduce the transposition deficit,
Amendment 8 #
Motion for a resolution 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 #
Motion for a resolution Recital G G. whereas the current average deficit of 1.2 % is
Amendment 15 #
Motion for a resolution Recital H H. whereas
Amendment 16 #
Motion for a resolution Recital I I. whereas t
Amendment 18 #
Motion for a resolution Recital K K. whereas more accurate information is needed on the quality of transposition
Amendment 19 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Recital N N. whereas, when internal market rules are misapplied, the lack of
Amendment 22 #
Motion for a resolution Recital S S. whereas,
Amendment 23 #
Motion for a resolution Recital T T. whereas SOLVIT should
Amendment 24 #
Motion for a resolution Recital U U. whereas the Commission is preparing a new strategy to reinforce SOLVIT
Amendment 26 #
Motion for a resolution Paragraph 1 1. Welcomes the Internal Market Scoreboard and SOLVIT as important tools
Amendment 27 #
Motion for a resolution Paragraph 3 3. Welcomes the fact that the Commission
Amendment 28 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to c
Amendment 36 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 7 7. Calls on the Commission to ensure that infringements of EU law are
Amendment 39 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 11 Amendment 46 #
Motion for a resolution Paragraph 14 14. Calls on the Commission to
Amendment 48 #
Motion for a resolution Paragraph 16 16. Calls on the Commission to ensure that correlation tables are made public, to
Amendment 49 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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
Amendment 53 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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
Amendment 56 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 19 19. Calls on the Commission to
Amendment 60 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 22 22. Calls on the Commission to
Amendment 66 #
Motion for a resolution Paragraph 24 24. Notes the success of the first Single Market Forum as an opportunity
source: PE-486.092
|
| 12 |
2011/2288(INI) Attractiveness of investing in Europe
2012/02/21
ITRE
12 amendments...
Amendment 18 #
Draft opinion Paragraph 3 3. Believes that the EU's future attractiveness relies on maintaining its reputation for quality, specialisation and a skilled workforce
Amendment 23 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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;
source: PE-480.654
|
| 91 |
2012/0192(COD) Clinical trials on medicinal products for human use
2013/02/27
ITRE
59 amendments...
Amendment 42 #
Proposal for a regulation Recital 1 (1) In a clinical trial the safety
Amendment 43 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 2 – paragraph 2 – point 3 – introductory part (3) ‘Low-intervention clinical trial’: a clinical
Amendment 58 #
Proposal for a regulation 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
Amendment 61 #
Proposal for a regulation Article 2 – paragraph 2 – point 4 (4) ‘Non-interventional study’: a clinical study other than a clinical trial
Amendment 63 #
Proposal for a regulation Article 2 – paragraph 2 – point 6 (6)
Amendment 64 #
Proposal for a regulation 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 #
Proposal for a regulation Article 2 – paragraph 2 – point 13 (13) ‘Sponsor’: an individual, company, institution or organisation which takes responsibility for the initiation
Amendment 66 #
Proposal for a regulation Article 2 – paragraph 2 – point 15 (15)
Amendment 67 #
Proposal for a regulation Article 2 – paragraph 2 – point 19 (19)
Amendment 71 #
Proposal for a regulation Article 3 – paragraph 1 – indent 2 – the data generated in the clinical trial are going to be relevant, reliable and robust.
Amendment 73 #
Proposal for a regulation 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 #
Proposal for a regulation Article 5 – paragraph 1 – subparagraph 2 Amendment 75 #
Proposal for a regulation Article 5 – paragraph 1 – subparagraph 3 Amendment 77 #
Proposal for a regulation Article 5 – paragraph 2 – introductory part 2. Within
Amendment 80 #
Proposal for a regulation 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
Amendment 82 #
Proposal for a regulation 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
Amendment 84 #
Proposal for a regulation 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
Amendment 85 #
Proposal for a regulation 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
Amendment 86 #
Proposal for a regulation Article 6 – paragraph 1 – point a – point ii – indent 2 – the characteristics of the intervention compared to
Amendment 87 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point a (a) within
Amendment 93 #
Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point b (b) within
Amendment 95 #
Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point c (c) within
Amendment 98 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point a a (new) (aa) compliance with national legislative provisions related to ethics.
Amendment 106 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 8 – paragraph 5 5.
Amendment 111 #
Proposal for a regulation 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 #
Proposal for a regulation Article 11 – paragraph 1 Where the sponsor so requests, the application for authorisation of a clinical trial
Amendment 114 #
Proposal for a regulation Article 11 – paragraph 2 After the notification of the decision on the aspects covered by Part I of the assessment report, the sponsor
Amendment 115 #
Proposal for a regulation 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
Amendment 120 #
Proposal for a regulation 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 #
Proposal for a regulation Article 17 – paragraph 2 – introductory part 2. Within
Amendment 124 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 127 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 129 #
Proposal for a regulation 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
Amendment 130 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 27 – paragraph 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 85 in order to
Amendment 138 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 34 – paragraph 3 – subparagraph 2 Amendment 147 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 153 #
Proposal for a regulation 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 #
Proposal for a regulation Annex 2 – part 4 – point 4 – indent 2 a (new) - the rationale for the modification proposed;
Amendment 167 #
Proposal for a regulation 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.
source: PE-506.087
2013/03/01
ENVI
2 amendments...
Amendment 530 #
Proposal for a regulation 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 #
Proposal for a regulation 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
source: PE-506.161
2013/03/06
ENVI
30 amendments...
Amendment 199 #
Proposal for a regulation Article 2 – paragraph 2 – point 3 – introductory part (3) ‘Low-intervention clinical
Amendment 209 #
Proposal for a regulation 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
Amendment 215 #
Proposal for a regulation 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 #
Proposal for a regulation Article 2 – paragraph 2 – point 6 (6) ‘
Amendment 261 #
Proposal for a regulation Article 5 – paragraph 1 – subparagraph 2 Amendment 263 #
Proposal for a regulation Article 5 – paragraph 1 – subparagraph 3 Amendment 268 #
Proposal for a regulation Article 5 – paragraph 2 – introductory part 2. Within
Amendment 274 #
Proposal for a regulation 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
Amendment 281 #
Proposal for a regulation 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
Amendment 309 #
Proposal for a regulation 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 #
Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point a (a) within
Amendment 314 #
Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point b (b) within
Amendment 318 #
Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point c (c) within
Amendment 320 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 8 – paragraph 4 4. W
Amendment 374 #
Proposal for a regulation 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 #
Proposal for a regulation Article 11 – paragraph 1 Where the sponsor so requests, the application for authorisation of a clinical trial
Amendment 390 #
Proposal for a regulation Article 11 – paragraph 2 After the notification of the decision on the aspects covered by Part I of the assessment report, the sponsor
Amendment 400 #
Proposal for a regulation 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 #
Proposal for a regulation Article 17 – paragraph 2 – introductory part 2. Within
Amendment 420 #
Proposal for a regulation 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
Amendment 421 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 427 #
Proposal for a regulation Article 20 – paragraph 7 7. W
Amendment 430 #
Proposal for a regulation 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
Amendment 432 #
Proposal for a regulation 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
Amendment 434 #
Proposal for a regulation 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 #
Proposal for a regulation Article 23 – paragraph 4 4. W
source: PE-506.160
|
| 80 |
2012/0266(COD) Medical devices
2013/05/08
IMCO
40 amendments...
Amendment 97 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 36 – indent 3 – published
Amendment 105 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 119 #
Proposal for a regulation Article 15 – paragraph 4 a (new) 4a. The Commission shall, by means of implementing acts, establish practical guidelines and EU standards to ensure the safe reprocessing of single use medical devices that guarantee at least the same level of safety and performance as compared to the original device. In doing so, the Commission shall ensure that such standards are consistent with the latest scientific evidence, the relevant ISO standards or other international technical standards adopted by recognized international standard-setting organizations, provided that they guarantee at least the same level of safety and performance as ISO standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 137 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 42 – paragraph 10 – subparagraph 1 – introductory part The Commission
Amendment 162 #
Proposal for a regulation Article 49 – paragraph 3 3.
Amendment 163 #
Proposal for a regulation 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
Amendment 165 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 [
Amendment 169 #
Proposal for a regulation Article 53 – paragraph 3 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 for determining
Amendment 170 #
Proposal for a regulation 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
Amendment 171 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 174 #
Proposal for a regulation 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 #
Proposal for a regulation Article 58 – paragraph 2 2.
Amendment 176 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 182 #
Proposal for a regulation Article 62 – paragraph 3 Amendment 185 #
Proposal for a regulation 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 #
Proposal for a regulation 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 organi
Amendment 195 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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
source: PE-510.666
2013/05/17
IMCO
40 amendments...
Amendment 97 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 36 – indent 3 – published
Amendment 105 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 119 #
Proposal for a regulation Article 15 – paragraph 4 a (new) 4a. The Commission shall, by means of implementing acts, establish practical guidelines and EU standards to ensure the safe reprocessing of single use medical devices that guarantee at least the same level of safety and performance as compared to the original device. In doing so, the Commission shall ensure that such standards are consistent with the latest scientific evidence, the relevant ISO standards or other international technical standards adopted by recognized international standard-setting organizations, provided that they guarantee at least the same level of safety and performance as ISO standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 137 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 42 – paragraph 10 – subparagraph 1 – introductory part The Commission
Amendment 162 #
Proposal for a regulation Article 49 – paragraph 3 3.
Amendment 163 #
Proposal for a regulation 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
Amendment 165 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 [
Amendment 169 #
Proposal for a regulation Article 53 – paragraph 3 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 for determining
Amendment 170 #
Proposal for a regulation 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
Amendment 171 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 174 #
Proposal for a regulation 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 #
Proposal for a regulation Article 58 – paragraph 2 2.
Amendment 176 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 182 #
Proposal for a regulation Article 62 – paragraph 3 Amendment 185 #
Proposal for a regulation 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 #
Proposal for a regulation 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 organi
Amendment 195 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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
source: PE-510.666
|
| 42 |
2012/0267(COD) In vitro diagnostic medical devices
2013/05/07
IMCO
42 amendments...
Amendment 51 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 3 (3)
Amendment 54 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 28 (28)
Amendment 55 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 30 (30)
Amendment 56 #
Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 35 (35)
Amendment 59 #
Proposal for a regulation 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
Amendment 61 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 71 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 40 – paragraph 9 – subparagraph 1 – introductory part The Commission
Amendment 81 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 83 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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 [
Amendment 88 #
Proposal for a regulation Article 51 – paragraph 3 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 for determining
Amendment 89 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 91 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation Article 56 – paragraph 2 2.
Amendment 94 #
Proposal for a regulation 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 #
Proposal for a regulation Article 57 – paragraph 4 – subparagraph 1 In the case of a clinical
Amendment 98 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 101 #
Proposal for a regulation Article 60 – paragraph 3 Amendment 103 #
Proposal for a regulation Article 90 – paragraph 2 2. It shall apply from [
Amendment 104 #
Proposal for a regulation 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 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 108 #
Proposal for a regulation Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.5 1.2.2.5 Clinical performance full dataset shall
Amendment 109 #
Proposal for a regulation 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 #
Proposal for a regulation 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
Amendment 111 #
Proposal for a regulation 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 #
Proposal for a regulation Annex 12 – section 1 – point 2 – point 2.3 – point 2.3.3 – paragraph 1 A
Amendment 113 #
Proposal for a regulation 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.
source: PE-510.668
|
| 3 |
2012/0288(COD) Fuels and energy from renewable sources: transition to biofuels to deliver greenhouse gas savings
2013/05/08
ITRE
3 amendments...
Amendment 157 #
Proposal for a directive Article 1 – point 2 – point a Directive 98/70/EC 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 #
Proposal for a directive Article 1 – point 3 – point a Directive 98/70/EC Article 7d – Paragraph 6 'The Commission shall
Amendment 185 #
Proposal for a directive Article 1 – point 3 – point b Directive 98/70/EC Article 7d – Paragraph 7 – subparagraph 1 The Commission shall
source: PE-510.481
|
| 14 |
2012/2005(INI) Implementation of the Single European Sky legislation
2013/05/08
ITRE
14 amendments...
Amendment 23 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 2 2. Acknowledges that the trend of rising energy prices is likely to continue given its link to fuel prices,
Amendment 72 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 5 5. Believes that smart technologies must
Amendment 113 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 8 8. Stresses that the internal energy market is not completed yet and that national energy markets fall
Amendment 142 #
Motion for a resolution 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 #
Motion for a resolution 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
Amendment 177 #
Motion for a resolution 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 #
Motion for a resolution 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
Amendment 216 #
Motion for a resolution 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;
source: PE-510.685
|
| 4 |
2012/2028(INI) Feasibility of introducing stability bonds
2012/12/06
IMCO
4 amendments...
Amendment 7 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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;
source: PE-491.254
|
| 19 |
2012/2030(INI) Completing the Digital Single Market
2012/06/08
IMCO
19 amendments...
Amendment 1 #
Motion for a resolution 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 #
Motion for a resolution Citation 27 a (new) - having regard to the Monti report of 9 May 2010 on a new strategy for the single market,
Amendment 5 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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
Amendment 65 #
Motion for a resolution 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 #
Motion for a resolution 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
Amendment 91 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Subheading 5 Setting up the basis for a more competitive and inclusive Europe
source: PE-492.884
|
| 2 |
2012/2044(INI) 20 main concerns of European citizens and business with the functioning of the Single Market
2012/12/04
IMCO
2 amendments...
Amendment 67 #
Motion for a resolution 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 #
Motion for a resolution 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’;
source: PE-487.715
|
| 10 |
2012/2103(INI) Energy roadmap 2050, a future with energy
2012/01/10
ITRE
1 amendments...
Amendment 389 #
Motion for a resolution 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;
source: PE-496.501
2012/07/11
IMCO
9 amendments...
Amendment 2 #
Draft opinion 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
Amendment 8 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion Paragraph 5 5. Points out that the impact of CO2 capture, transport and storage
Amendment 24 #
Draft opinion 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 #
Draft opinion Paragraph 7 7. Draws attention to the Energy Policy for Europe, which recognises the
Amendment 37 #
Draft opinion 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.
source: PE-500.382
|
| 10 |
2012/2133(INI) New agenda for European Consumer Policy
2013/01/25
IMCO
10 amendments...
Amendment 4 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 10 10. Highlights the need to provide better protection of the rights of vulnerable consumer groups such as children and the elderly
Amendment 175 #
Motion for a resolution 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
Amendment 186 #
Motion for a resolution Paragraph 13 13. Stresses that the quickening process of business concentration affects both the production and marketing of goods and services
Amendment 194 #
Motion for a resolution 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
source: PE-504.100
|
| 5 |
2012/2134(INI) Improving access to finance for SMEs
2012/10/16
IMCO
5 amendments...
Amendment 2 #
Draft opinion Paragraph 2 2.
Amendment 4 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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;
source: PE-497.974
|
| 12 |
2012/2322(INI) Online gambling in the internal market
2013/04/11
IMCO
6 amendments...
Amendment 27 #
Motion for a resolution Recital A A. whereas, in the absence of harmonisation and with due regard to the principle of subsidiarity, the Member States
Amendment 52 #
Motion for a resolution 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
Amendment 131 #
Motion for a resolution 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
Amendment 182 #
Motion for a resolution 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
Amendment 271 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 16 16. Recommends th
source: PE-508.193
2013/04/18
IMCO
6 amendments...
Amendment 27 #
Motion for a resolution Recital A A. whereas, in the absence of harmonisation and with due regard to the principle of subsidiarity, the Member States
Amendment 52 #
Motion for a resolution 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
Amendment 131 #
Motion for a resolution 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
Amendment 182 #
Motion for a resolution 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
Amendment 271 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 16 16. Recommends th
source: PE-508.193
|
| 37 |
2013/2005(INI) Making the internal energy market work
2013/04/29
IMCO
16 amendments...
Amendment 1 #
Draft opinion 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 #
Draft opinion Paragraph 1 1. Believes that a competition-driven, open, integrated and flexible European energy market will make
Amendment 8 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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
Amendment 29 #
Draft opinion 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 #
Draft opinion 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 #
Draft opinion 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;
source: PE-508.255
2013/05/08
ITRE
21 amendments...
Amendment 221 #
Motion for a resolution Paragraph 14 14. Notes with concern
Amendment 249 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 17 17. Stresses that
Amendment 301 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution Paragraph 26 26. Calls on the Commission to examine the system adequac
Amendment 358 #
Motion for a resolution 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 #
Motion for a resolution 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 #
Motion for a resolution 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 e
Amendment 385 #
Motion for a resolution 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
Amendment 389 #
Motion for a resolution Paragraph 32 32. Urges the Member States, and regional and local authorities, to promote
Amendment 401 #
Motion for a resolution 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
Amendment 410 #
Motion for a resolution 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
Amendment 422 #
Motion for a resolution 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 #
Motion for a resolution 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 th
Amendment 438 #
Motion for a resolution 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 #
Motion for a resolution 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;
source: PE-510.735
|
António Fernando CORREIA DE CAMPOS on
Activities
Term 7 14.07.2009 / ...
All references link to europarl.euHistory
(these mark the time of scraping, not the official date of the change)
| active | changed |
Old
New
True |