Anne DELVAUX

General
Contact
Committees
Dossiers (2)
Bio
Amendments (212)
History
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Constituencies

Belgium Centre Démocrate Humaniste 2009/07/14 - 9999/12/31

Groups

PPE Member Group of the European People's Party (Christian Democrats) 2009/07/14 - 9999/12/31

Committees

Role	Committee	Start	End
Member of	Committee on the Environment, Public Health and Food Safety	2012/01/19	9999/12/31
Substitute of	Committee on Foreign Affairs	2012/01/19	9999/12/31
Substitute of	Committee on Women's Rights and Gender Equality	2012/01/19	9999/12/31

Show earlier commitees...

Role	Committee	Start	End
Member of	Committee on the Environment, Public Health and Food Safety	2009/07/16	2012/01/18
Substitute of	Committee on Civil Liberties, Justice and Home Affairs	2009/07/16	2012/01/18
Substitute of	Committee on Women's Rights and Gender Equality	2010/08/30	2012/01/18

Delegations

Role	Delegation	Start	End
Member of	Delegation to the ACP-EU Joint Parliamentary Assembly	2009/09/16	9999/12/31
Member of	Delegation for relations with the Pan-African Parliament	2009/09/16	9999/12/31
Substitute of	Delegation for relations with South Africa	2009/09/16	9999/12/31

Contact

Online

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http://www.annedelvaux.eu
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Brussels

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+322 28 45154
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+322 28 49154
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Bât. Altiero Spinelli 08F247
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  Bruxelles/Brussel
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Strasbourg

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+333 88 1 75154
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+333 88 1 79154
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Bât. Louise Weiss T09061
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  Strasbourg
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  CS 91024 - F-67070
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Postal

Parlement européen
Rue Wiertz
Altiero Spinelli 08F247
B-1047 Bruxelles

Rapporteur

Opinion	2012/2289(INI)	Millennium Development Goals - defining the post-2015 framework
Shadow	2010/2153(INI)	Evaluation of the management of H1N1 influenza in 2009-2010 in the EU

Born

1970/10/20 Liège

First university qualification in economics and social sciences, Catholic University of Louvain (1992). Degree in communication, Catholic University of Louvain (1994).
Journalist at RTBF (Belgian French-language national broadcasting organisation) (1994-2007). Junior lecturer in journalism at the Catholic University of Louvain (2002-2007).
Member of the Humanist Democratic Centre (since 2007).
Senator and Chairwoman of the Federal Advisory Committee on European Affairs (2007-2009).
Vice-President of the European Movement - Belgium (since 2007).

Amendments

Amendments	Dossier
3	2008/0142(COD) Patients' rights in cross-border healthcare 2010/05/10 ENVI 3 amendments... Amendment 198 # Anne DELVAUX Council position Article 10 – paragraph 2 a (new) 2a. The Commission shall encourage Member States, particularly neighbouring countries, to conclude agreements among themselves and to develop joint action programmes. The Commission shall also encourage the Member States to cooperate to create areas in which patients will have improved access to health care, particularly in cross-border areas. Amendment 202 # Anne DELVAUX Council position Article 11 – paragraph 2 - point a a) no later than…*, measures enabling a health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by a member of a regulated health profession who is legally entitled to do so through developing a ~~non-exhaustive list of elements to be included in the~~single EU prescription template and supporting interoperability of prescriptions; Amendment 204 # Anne DELVAUX Council position Article 11 – paragraph 2 – point c c) no later than…32 measures to facilitate the correct identification of medicinal products or medical devices prescribed in one Member State and dispensed in another, including measures to address patient safety concerns in relation to their substitution in cross-border healthcare where the legislation of the dispensing Member State permits such substitution. The Commission shall consider, inter alia, using, such as priority use of the International Non-proprietary Name ~~and the dosage of medicinal products~~(INN); source: PE-450.566
5	2008/0257(COD) Medicinal products for human use: pharmacovigilance of products [amend. Regulations (EC) No 726/2004 (Community procedures) and (EC) No 1394/2007] 2010/01/03 ENVI 5 amendments... Amendment 21 # Anne DELVAUX Proposal for a regulation – amending act Recital 5 (5) In order to allow all competent authorities to receive and access, at the same time, pharmacovigilance information for medicinal products for human use authorised in the ~~Community~~Union, and share it, the Eudravigilance database should be maintained and strengthened as the single point of receipt of such information. Member States should therefore not impose on marketing authorisation holders any additional reporting requirements. Instead, the Eudravigilance database should simultaneously notify the relevant Member States of reports submitted by market authorisation holders. In order to ensure the high quality of information, Member States should support the development of national and regional pharmacovigilance centres' expertise. National competent authorities should collect the reports from these centres and should then transfer data to Eudravigilance database. The database should be fully accessible to the Member States, the Agency and the Commission, and accessible to an appropriate extent to marketing authorisation holders and the public. Amendment 28 # Anne DELVAUX Proposal for a regulation – amending act Recital 11 (11) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the Agency. Provision should be made to allow adequate funding for pharmacovigilance activities through the collection of fees charged to marketing authorisation holders. The management of those collected funds should be under a permanent control of the Management Board in order to guarantee the independence ofing to pharmacovigilance by the Agency. Amendment 29 # Anne DELVAUX Proposal for a regulation – amending act Recital 15 (15) WFor any new authorised medicinal product on the market for less then 3 years or where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or subject to conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, identified by a black triangle and a corresponding explanatory sentence on the summary of product characteristics, and on the patient information leaflet, and a publicly available list of such medicinal products should be kept up to date by the Agency. Amendment 46 # Anne DELVAUX Proposal for a regulation – amending act Article 1 – point 11 Regulation EC/726/2004 Article 24 – paragraph 2 – subparagraphs 2 and 3 The Agency shall ensure that health-care professionals and the public have ~~appropriate levels of~~ access to the Eudravigilance database, with personal data protection being guaranteed. The Agency shall work together with organisations representing health professionals, patients and consumers to define “the appropriate level of access”. The data held on the Eudravigilance database shall be made publicly accessible ~~in an aggregated format~~ together with an explanation of how to interpret the data. Amendment 80 # Anne DELVAUX Proposal for a regulation – amending act Article 1 – point 18 – point b Regulation EC/726/2004 Article 67 – paragraph 4 "4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency. Thisey shall ~~not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of these activities by the Agency~~receive adequate public funding commensurate with the tasks conferred." source: PE-438.413
19	2008/0260(COD) Medicinal products for human use: pharmacovigilance of products (amend. Directive 2001/83/EC, Community code) 2010/03/15 ENVI 19 amendments... Amendment 37 # Anne DELVAUX Proposal for a directive – amending act Recital 9 (9) ~~Where a medicinal product is~~For newly authorised medicinal products and for medicinal products that are authorizsed subject to the requirement to conduct a post-authorisation safety study or ~~where there are~~are subject to conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to ~~such medicinal products~~all newly authorised medicinal products on the market for less then 3 years, identified as such by a black triangle and a corresponding explanatory sentence on the summary of product characteristics and on the patient information leaflet, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’). Amendment 51 # Anne DELVAUX Proposal for a directive – amending act Recital 10 a (new) (10a) Without any delay, the Commission shall, in collaboration with EMEA, and following consultations with organisations representing patients, consumers, doctors and pharmacists, social health insurers, and Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals. Following an analysis of the above data, the Commission shall, if appropriate, put forward proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals. Amendment 70 # Anne DELVAUX Proposal for a directive – amending act Recital 28 (28) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the national competent authorities. It should be possible to ensure adequate funding for pharmacovigilance activities through the collection of fees. However, the management of those collected funds should be under the permanent control of the national competent authorities in order to guarantee their independence. Amendment 87 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 1 – point c Directive 2001/83/EC Article 1 – point 15 (c) point 15 is replaced by the following: “(15) Post-authorisation safety study: Any study with an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.”;deleted Amendment 92 # Anne DELVAUX 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 specific pharmacovigilance activities and interventions designed to ~~ide~~quantify~~, characterise, prevent or minimise~~ or prevent risks relating to a medicinal product, including the assessment of the effectiveness of those interventions, or to ensure early identification of new risks. Amendment 109 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 3 – point b Directive 2001/83/EC Article 11 – paragraph 3 “For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the ~~statement: “This medicinal product~~following statement, preceded by the symbol : “This medicinal product has been new on the market for less then 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>.” Amendment 124 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 8 Directive 2001/83/EC Article 21a - introductory words AIf the medicinal product responds to unmet medical needs and if its risk- benefit balance may be considered favourable, a marketing authorisation may be granted subject to one or more of the following conditions: Amendment 130 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 8 Directive 2001/83/EC Article 21a – paragraph 2 The marketing authorisation shall lay down deadlines for the fulfilment of the conditions where necessary. If the conditions included in the marketing authorisation are not fulfilled by the relevant deadline, the competent authorities shall have the power and appropriate resources to immediately suspend or revoke the marketing authorisation. Amendment 139 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 14 – point a Directive 2001/83/EC Article 27 – paragraph 1 1. ATwo coordination groups shall be set up: (a) a coordination group for mutual recognition and decentralised procedures shall be responsible for the following ~~purposes: (a~~tasks: (i) the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4; (bii) the examination of questions related to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1), with the exception of all questions relating to pharmacovigilance. For the fulfilment of its tasks, the coordination group for mutual recognition and decentralised procedures shall be assisted by the Committee for Medicinal Products for Human Use referred to in Article 5(1) of Regulation (EC) No 726/2004. (b) A coordination group for pharmacovigilance risk assessment shall be responsible for the following tasks: (i) the examination of questions relating to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r; (cii) the examination of questions relateding to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1)~~. The Agency shall provide the secretariat of this coordination group~~, for all questions relating to pharmacovigilance. For the fulfilment of its pharmacovigilance tasks, the coordination group for pharmacovigilance risk assessment shall be assisted by the European Pharmacovigilance ~~Risk Assessment Advisory~~ Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004. The Agency shall provide the secretariat for these coordination groups. Amendment 157 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 18 b Directive 2001/83/EC Article 59 – paragraph 1 – subparagraphs 2 and 3 “~~The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text~~New important safety warnings shall for a period of 1-year be presented in bold text and preceded by the ~~following symbol  and~~ text “‘New i~~nformation”~~mportant safety warnings’. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included ~~“This medicinal product~~, preceded by the symbol ▼ : ‘This medicinal product has been new on the market for less then 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist, or <name ~~and~~, web-address, postal address and/or telephone number of the national competent authority>”’.” Amendment 158 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 18 – point b Directive 2001/83/EC Article 59 – paragraph 1 – subparagraphs 2 and 3 “~~The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text~~New important safety warnings shall for a period of 1-year be presented in bold text and preceded by the ~~following symbol  and text “New information”~~text “New important safety warnings “. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included ~~“This medicinal product~~, preceded by the symbol : ‘This medicinal product has been new on the market for less then 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist, or <name ~~and~~, web-address, postal address and/or telephone number of the national competent authority>”’.” Amendment 175 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 102 – paragraph 1 – point 1 (1) take all appropriate measures to encourage patients, doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority ~~or the marketing author~~. Those measures shall include training for health professionals and for patients and a public information campaign for patients. Patients’ organisation s shoulder be involved in providing information and training to patients and in developing public information campaigns in cooperation with regulatory bodies. Amendment 179 # Anne DELVAUX 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; Amendment 186 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 102 – paragraph 1 – point 2 (2) ensure that adverse reaction reports and the databases contain the highest quality information possible; Amendment 193 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 102 – paragraph 1 – point 3 a (new) (3a) ensure that the public is given important information in good time on pharmacovigilance concerns relating to the use of a medicinal product and that the data is permanently accessible to the public; Amendment 207 # Anne DELVAUX Proposal for a directive – amending act Article – 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 for the carrying out of those activities by the national competent authorities.~~deleted Amendment 228 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 107 – paragraph 3 – subparagraph 1 and 2 3. Marketing authorisation holders shall be required to submit electronically to the ~~database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’)~~national competent authorities information on all serious suspected adverse reactions that occur in the Community and in third countries within 15 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event. Marketing authorisation holders shall be required to submit electronically to the ~~Eudravigilance database~~national competent authorities information on all non-serious suspected adverse reactions that occur ion the ~~Community~~markets in which they operate, within 9045 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event. Amendment 229 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 107 – paragraph 4 4. Member States shall ~~access reports on adverse reactions through the Eudravigilance database and shall~~ assess the quality of the data received from marketing authorisation holders. They shall, as appropriate, involve patients and health- care professionals in the follow up of any reports they receive and request follow up of such reports to be conducted by the marketing authorisation holders. The marketing authorisation holders shall be required to report any follow up information received to the Eudravigilance database. Amendment 241 # Anne DELVAUX Proposal for a directive – amending act Article 1 – point 21 Directive 2001/83/EC Article 107a 1. The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention ~~from~~by healthcare professionals ~~and patient~~, patients, marketing authorisation holders and programmes for the reporting and prevention of medication errors. Member States shall ensure that reports of such reactions arcan be submitted by means of the national medicines safety web- portals, as well as by mail, telephone and fax. 2. Member States shall, within 15 days following the receipt of the reports referred to in paragraph 1, submit ~~the reports electronically to the Eudravigilance database. Marketing authorisation holders~~electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’) information on all adverse reactions that occur within their territory within 15 days following the receipt of the report or, in the absence of a report, following the day on which the competent authority gained knowledge of the event. Marketing authorisation holders, healthcare professionals and the public shall access those reports through the Eudravigilance database, which must be made permanently accessible without delay. 3. The Member States shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database ~~and~~, to any authorities responsible for patient safety within that Member State and to independent programmes for the reporting and prevention of medication errors. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State. source: PE-438.412
8	2009/0104(CNS) Visas: third countries whose nationals are subject to or exempt from a visa requirement (amend. Regulation (EC) No 539/2001) 2009/10/15 LIBE 8 amendments... Amendment 7 # Anna Maria CORAZZA BILDT, Anne DELVAUX, Monika HOHLMEIER, Mario MAURO, Monica Luisa MACOVEI, NEYNSKY, Nadezhda, Ernst STRASSER, Axel VOSS, Kinga GÁL, Tunne KELAM, Alf SVENSSON, Ria OOMEN-RUIJTEN, Simon BUSUTTIL, Eduard KUKAN, Carlo CASINI, Michael GAHLER, Marietta GIANNAKOU Proposal for a regulation Recital 1 (1) The visa liberalisation dialogue initiated by the Commission with a regional approach and a European perspective, includes countries of the Western Balkans, namely Albania, Bosnia and Herzegovina, the former Yugoslav Republic of Macedonia, Montenegro and Serbia on an equal footing and without any discrimination. The composition of the lists of third countries in Annexes I and II to Regulation (EC) No 539/2001 of 15 March 2001 should be, and should remain, consistent with the criteria laid down in recital (5) thereto. ~~Some third countries, for which the situation has changed as regards these criteria, should be transferred from one Annex to the other~~The same criteria laid down in the roadmaps for visa liberalisation should be applied to all countries concerned. Amendment 8 # Anna Maria CORAZZA BILDT, Anne DELVAUX, Monika HOHLMEIER, Mario MAURO, Monica Luisa MACOVEI, NEYNSKY, Nadezhda, Ernst STRASSER, Axel VOSS, Kinga GÁL, Tunne KELAM, Alf SVENSSON, Ria OOMEN-RUIJTEN, Simon BUSUTTIL, Eduard KUKAN, Carlo CASINI, Michael GAHLER, Marietta GIANNAKOU Proposal for a regulation Recital 1 a (new) (1a) All of the Western Balkan countries that have met the benchmarks should be admitted to the visa-free travel regime from the beginning of 2010. Those countries that, despite having made substantial progress, have not fully met the benchmarks should be granted the same privilege as soon as they meet the benchmarks as set out in the corresponding roadmaps for visa liberalisation. Amendment 11 # Anna Maria CORAZZA BILDT, Anne DELVAUX, Kinga GÁL, Monika HOHLMEIER, Mario MAURO, Monica Luisa MACOVEI, NEYNSKY, Nadezhda, Ernst STRASSER, Axel VOSS, Tunne KELAM, Alf SVENSSON, Ria OOMEN-RUIJTEN, Simon BUSUTTIL, Eduard KUKAN, Carlo CASINI, Michael GAHLER, Marietta GIANNAKOU Proposal for a regulation Recital 2 a (new) (2a) With the aim of furthering the implementation of the Thessaloniki agenda and as part of its regional approach, the Commission should start a visa dialogue with Kosovo and establish a tailor-made roadmap for visa facilitation and liberalisation similar to those established with other Western Balkan countries. This should be without prejudice to Member States' competence as regards the recognition of Kosovo as an independent state. Amendment 15 # Anna Maria CORAZZA BILDT, Anne DELVAUX, Kinga GÁL, Monika HOHLMEIER, Mario MAURO, Monica Luisa MACOVEI, NEYNSKY, Nadezhda, Ernst STRASSER, Axel VOSS, Tunne KELAM, Alf SVENSSON, Ria OOMEN-RUIJTEN, Simon BUSUTTIL, Eduard KUKAN, Carlo CASINI, Michael GAHLER, Marietta GIANNAKOU Proposal for a regulation Recital 4 a (new) (4a) As regards Albania and Bosnia and Herzegovina, the Commission should, without delay and not later than in the spring of 2010, present its report on the achievements made by those two countries in meeting all the benchmarks set in the roadmap. Amendment 16 # Anna Maria CORAZZA BILDT, Anne DELVAUX, Kinga GÁL, Monika HOHLMEIER, Mario MAURO, Monica Luisa MACOVEI, NEYNSKY, Nadezhda, Ernst STRASSER, Axel VOSS, Tunne KELAM, Alf SVENSSON, Ria OOMEN-RUIJTEN, Simon BUSUTTIL, Eduard KUKAN, Carlo CASINI, Michael GAHLER, Marietta GIANNAKOU Proposal for a regulation Recital 4 b (new) (4b) Thereafter and without delay, the Commission should present a proposal for the corresponding amending regulation. Without prejudice to the legal framework under which the European Union will be operating by the spring of 2010 and the role that the European Parliament, for its part, could play, the Council commits itself to immediately finalise the corresponding Council regulation extending the visa-free travel regime to Albania and Bosnia and Herzegovina. The Council calls upon Member States and the Commission to then take all necessary legal and technical measures to ensure immediate implementation of the visa-free travel regime. Amendment 17 # Anna Maria CORAZZA BILDT, Anne DELVAUX, Kinga GÁL, Monika HOHLMEIER, Tunne KELAM, Mario MAURO, NEYNSKY, Nadezhda, Ernst STRASSER, Alf SVENSSON, Axel VOSS, Tunne KELAM, Ria OOMEN-RUIJTEN, Simon BUSUTTIL, Eduard KUKAN, Carlo CASINI, Michael GAHLER, Marietta GIANNAKOU Proposal for a regulation Recital 4 c (new) (4c) The Council, while commending the relevant recent progress achieved by Albania and Bosnia and Herzegovina towards meeting the benchmarks, calls on the relevant Albanian and Bosnia and Herzegovina authorities to adopt, without delay, the necessary reforms to fully meet the benchmarks. Amendment 18 # Anna Maria CORAZZA BILDT, Anne DELVAUX, Kinga GÁL, Monika HOHLMEIER, Tunne KELAM, Mario MAURO, Monica Luisa MACOVEI, NEYNSKY, Nadezhda, Ernst STRASSER, Alf SVENSSON, Axel VOSS, Ria OOMEN-RUIJTEN, Simon BUSUTTIL, Eduard KUKAN, Carlo CASINI, Michael GAHLER, Marietta GIANNAKOU Proposal for a regulation Recital 4 d (new) (4d) The Council asks the Commission to assist the relevant authorities of Albania and Bosnia and Herzegovina in this respect. Amendment 21 # Anna Maria CORAZZA BILDT, Simon BUSUTTIL, Anne DELVAUX, Kinga GÁL, Monika HOHLMEIER, Tunne KELAM, Mario MAURO, Monica Luisa MACOVEI, NEYNSKY, Nadezhda, Ria OOMEN-RUIJTEN, Ernst STRASSER, Alf SVENSSON, Axel VOSS, Eduard KUKAN, Carlo CASINI, Michael GAHLER, Marietta GIANNAKOU Proposal for a regulation Article 1 - paragraph 1 - point a a (new) Regulation (EC) No 539/2001 Annex I - part 1 (aa) in Part 1, the references to Albania and Bosnia and Herzegovina are replaced by the following: "Albania, Bosnia and Herzegovina ------------------- ** The exemption from the visa requirement granted to holders of biometric passports will apply in accordance with Community law" source: PE-429.562
22	2009/2104(INI) Report on the Commission communication: Action Plan on organ donation and transplantation (2009-2015): strengthened cooperation between Member States 2010/02/17 ENVI 22 amendments... Amendment 1 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Citation 8 a (new) - having regard to the report by David Matas and David Kilgour entitled 'Bloody Harvest. The killing of the Falung Gong for their organs', Amendment 3 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Recital H H. whereas ~~it is recognised that, ideally, the best way of fighting against organ trafficking and trafficking in person~~the trafficking of organs and of human beings for the purpose of ~~the~~ remov~~al of~~ing organs ~~is to increase the number of available organ~~constitutes a severe violation of human rights, Amendment 4 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Recital H a (new) Ha. whereas there is a strong link between illegal organ trafficking and the trafficking of persons for the purpose of removing organs and the legal system of organ donation because, on the one hand, the non-availability of organs in the legal system acts as an incentive for illegal activities, and, on the other, illegal activities severly undermine the credibility of the legal system of organ donation, Amendment 5 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Recital J J. whereas living donation ~~rates also differ substantially between Member States, and it seems that not all Member States realise their potential for living donation~~can be a helpful additional measure for patients who cannot get the organ they need via post- mortem transplantation, but emphasising that living donation can only be considered if any illegal activity and payment for the donation has been ruled out, Amendment 8 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 1 1. Welcomes the ~~proposal to establish a European~~ Action Plan on Organ Donation and Transplantation ~~for the period 2009- 2015~~(2009-2015) adopted by the European Commission in December 2008, which sets out a cooperative approach between Member States through a set of priority actions, based on the identification and development of common objectives and the evaluation of donation and transplantation activities through agreed indicators that might help to identify benchmarks and best practices; Amendment 9 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 2 2. Looks forward to the Commission´s above-mentioned proposal for a directive, which should set quality and safety requirements for the donation, procurement, testing, preservation, transportation and distribution of organs across the EU; stresses, nonetheless, that the forthcoming legislative framework should not create an excessive administrative burden for Member States; points out that the new legislative document should complement and reinforce efforts made by Member States to achieve an active and efficient method of coordination without preventing the introduction or maintenance of more stringent measures;deleted Amendment 12 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 4 4. Considers that to ensure that organs available for therapy are not wasted, it is important that there ~~are no legal barriers to~~is a clearly defined legal framework regarding their use and that society trusts the donation and transplantation system; Amendment 13 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 7 a (new) 7a. Welcomes the activities of Eurotransplant and Scanditransplant, but notes that exchanges of organs outside these systems and between these systems can be significantly improved, especially for the benefit of patients in small countries; Amendment 14 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 9 (renumbering) 96a. Emphasises that the identification of potential donors has been considered one of the key steps in the process of deceased donation; stresses that the appointment of a key donation person at hospital level (transplant donor coordinator), whose main responsibility is to develop a proactive donor detection programme and optimize the entire process of organ donation, is the most important step towards improving donor detection and organ donation rates; Amendment 15 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 10 10. Stresses that donation should be voluntary, unpaid and altruistic, and take place in clearly defined legal and ethical contexts; Amendment 16 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 12 12. Endorses measures which aim at protecting living donors and ensuring that organ donation is made altruistically and voluntarily, without any payment other than compensation which is strictly limited to ~~cover~~making good the expenses ~~and inconvenience relating to donation~~incurred in donating an organ, such as travel expenses, childminding costs, loss of earnings or recovery costs, prohibiting any financial incentives or disadvantages for a potential donor; urges Member States to define the conditions under which compensation may be granted; Amendment 21 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 17 17. Calls on Member States to reach the full potential of deceased donation by establishing efficient systems for identifying organ donors and by promoting transplant donor coordinators in hospitals across Europe; asks Member States to evaluate the use of organs from "expanded" criteria donors~~, taking into account~~ (i.e. older donors or those who have certain diseases), taking into account donor and recipient protection and the quality and safety aspects; Amendment 22 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 18 18. ~~Calls on Member States to explore the promotion of donation from living donors as a complement to deceased~~Emphasises that living donation should be seen as subsidiary to post- mortem donations and should only serve as a last resort where no suitable alternative, such as organs from a deceased donor, is available; advises the Member States to allow living donation only among close relatives and between spouses owing to the implicit danger of exploitation; insists that Member States that extend living donation to other groups must have strict regulations in place to prevent any kind of pressure being exerted or payment being made for the donations;. Amendment 24 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 18 a (new) 18a. Stresses that living donors should be treated in accordance with the highest medical standards and without any financial burden for themselves when a medical problem occurs which is caused by the transplantation process, and any loss of earning as consequence of the transplantation or any medical problem should be avoided. The donors should be protected against discrimination in the social system. Amendment 25 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 23 23. ~~Points out that there is a link between organ shortage and organ trafficking and trafficking in persons for the purpose of the removal of organs; e~~Emphasises that any commercial exploitation of organs that denies an equitable access to transplantation is unethical, is inconsistent with the most basic human values, contravenes Article 21 of the Convention on Human Rights and Biomedicine and is prohibited under Article 3(2) of the EU Charter on Fundamental Rights; stresses that increasing organ availability in the Member States will contribute to a better control of these practices by avoiding citizens of the Union having to search for an organ outside the EU and national legislative and ethical frameworks; Amendment 26 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 23 a (new) 23a. Points out that the organ shortage and organ trafficking and trafficking in persons for the purpose of the removal of organs are linked in two ways: firstly, increased organ availability in the Member States would contribute to better monitoring of these practices, by obviating any need for EU citizens to consider seeking an organ outside the EU, and, secondly, illegal activity seriously undermines the credibility of the legal organ donation system: Amendment 27 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 23 b (new) 23b. Repeats the recommendations on the fight against the organ trade made in the Adamou-report on organ donation and transplantation1 and takes the view that these should be taken fully into account by the Commission when drafting the action plan; insists that awareness of the problem within the Commission and Europol needs to be increased; 1 European Parliament resolution of 22 April 2008 on organ donation and transplantation: Policy actions at EU level (2007/2210 (INI)) Amendment 28 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 23 c (new) 23c. Emphasises the importance of the World Health Assembly to be held in May 2010 and urges the Commission and the Council to fight strongly at WHO level for the principle of voluntary and unpaid donation; Amendment 29 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 23 d (new) 23d. Welcomes the joint Council of Europe/United Nations study on trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs; Amendment 30 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 23 e (new) 23e. Notes the report by David Matas and David Kilgour entitled 'Bloody Harvest. The killing of the Falun Gong for their organs', and asks the Commission to present a report on the allegations made in the book to the European Parliament and the Council; Amendment 31 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 24 a (new) 24a. Strongly rejects the behaviour of some health insurance organisations in encouraging patients to participate in transplant tourism and asks the Member States to monitor strictly and punish such behaviour; Amendment 32 # Peter LIESE, Miroslav MIKOLÁŠIK, Anne DELVAUX, Thomas ULMER Motion for a resolution Paragraph 24 b (new) 24b. Emphasises that patients who have received an organ under illegal circumstances cannot be excluded from healthcare in the European Union; points out that as in any other case a distinction should be drawn between the punishment for illegal activity and the need for treatment; source: PE-439.156
1	2010/0208(COD) Genetically modified organisms GMOs: possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory 2011/03/17 ENVI 1 amendments... Amendment 18 # Catherine SOULLIE, Françoise GROSSETÊTE, Anne DELVAUX, Pilar AYUSO, Theodoros SKYLAKAKIS, Horst SCHNELLHARDT, Elisabetta GARDINI, Sergio BERLATO Proposal for a regulation - amending act Recital 2 (2) Under this set of legislation, GMOs for cultivation shall undergo an individual risk assessment before being authorised to be placed on the Union market. In accordance with the conclusions of the Environment Council of 4 December 2008, this risk assessment should be enhanced, particularly by taking better account of regional and local circumstances in the context of the assessment by the European Food Safety Authority. The aim of this authorisation procedure is to ensure a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market. The same high level of protection of health and the environment should be sought and maintained throughout the territory of the Union. source: PE-460.799
47	2010/2153(INI) Evaluation of the management of H1N1 influenza in 2009-2010 in the EU 2010/12/20 ENVI 47 amendments... Amendment 2 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Elena Oana ANTONESCU Motion for a resolution Citation 23 – having regard to the report by the French Senate's committee of inquiry into influenza A entitled ‘Influenza A (H1N1)v: reflections on the first pandemic of the 21st Century’, published on 29 July 201012 , 12 http://www.senat.fr/notice- rapport/2009/r09-685-1-notice.htmldeleted Amendment 7 # Anne DELVAUX, Françoise GROSSETÊTE, Philippe JUVIN, Richard SEEBER, Esther de LANGE Motion for a resolution Recital A A. whereas the national and international health authorities, including the WHO, were aware as early as May 2009 that the H1N1 influenza was not virulent, with this moderate virulence being confirmed by the very low mortality rate observed as a result of this influenza ‘pandemic’ in 1 http://www.who.int/mediacentre/news/statements/2010/h1n1_vpc_20100810/en/print.html comparison with the officially recognised figures for seasonal influenza,deleted Amendment 9 # Esther de LANGE, Anne DELVAUX Motion for a resolution Recital A A. whereas the national and international health authorities, including the WHO, ~~were aware as early as~~stated in May 2009 that the H1N1 influenza was ~~not virulent, wi~~at the t~~his moderate virulence be~~ime causing con~~firmed by the very low mortality rate observed as a result of~~ ly mild illness, but that it could only be hoped (thius ~~influenza ‘pandemic’ in comparison with the officially recognised figures for seasonal influenza~~not taken for granted) that this pattern would continue, Amendment 12 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE, Elena Oana ANTONESCU Motion for a resolution Recital A a (new) Aa. whereas, under the International Health Regulations (IHR) – a legal instrument binding on the states parties to it – the remit of the WHO includes public health surveillance, coordinating international public health measures and, in relation to potentially pandemic viruses, determining current phases of alert on a scale of one to six, Amendment 13 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE, Elena Oana ANTONESCU Motion for a resolution Recital A b (new) Ab. whereas the phases of a global pandemic are determined in accordance with the provisions of the IHR and in consultation with other organisations and institutions and with the Member States affected, Amendment 14 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Esther de LANGE, Françoise GROSSETÊTE Motion for a resolution Recital B B. whereas the criteria for defining a ‘pandemic’, adopted by the WHO in 2009 and based solely on the propagation of the virus while discounting the severity of the infection, distorted the meaning of the word ‘pandemic’ and triggered a false alarm worldwide, with that alarmism giving rise to inappropriate public health decisions and a disproportionate response among the public and administrations of the European Union and its Member States,deleted Amendment 22 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Esther de LANGE, Françoise GROSSETÊTE Motion for a resolution Recital B a (new) Ba. Considering the high degree of unforeseeability and severity of how the pandemic was going to unfold, always with the possibility that the pandemic might worsen in Europe, as it did in 1918 and 1968; Amendment 23 # Anne DELVAUX, Richard SEEBER Motion for a resolution Recital B b (new) Bb. whereas, on the basis of the WHO pandemic alert and subsequent recommendations, the Member States responded rapidly, in line with the precautionary principle, using what resources they had available to implement public health action plans; whereas the move to the highest level of alert, indicating the presence of a pandemic, gave rise in some cases to public health decisions that were disproportionate; Amendment 24 # Anne DELVAUX, Richard SEEBER, Esther de LANGE Motion for a resolution Recital B c (new) Bc. Considering that under the principle of subsidiarity, the preparation and the reaction towards the health risks in the European Union fall within the competence of the Member States; that the treaty of Lisbon exhorts the Member States to strengthen the co-operation, the division of information and good practices within the framework of the WHO and the existing structures of the EU; that the reinforcement of the measurements of coordination taken by the Commission and the Member States, with the support of the ECDC and the EMEA within the framework of WHO, reinforces the effectiveness of the national measures. Amendment 25 # Anne DELVAUX, Richard SEEBER Motion for a resolution Recital B d (new) Bd. Considering that the pharmaceutical industry had to answer to a sudden, pressing and exponential request of supply of vaccines requested by the Member States; that this one had to develop in a very great urgency a new vaccine likely to answer the virus; Amendment 26 # Anne DELVAUX, Richard SEEBER Motion for a resolution Recital B e (new) Be. Considering that some Member States had more means than others to answer and to anticipate this emergency; that some, more than others, could, because of their financial capacities, to supply themselves before others in vaccine supplies; considering that the initial recommendations of vaccination required the acquisition of double doses before the good immunogenicity of the vaccine showed that only one amount was enough; Amendment 28 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE Motion for a resolution Recital C C. whereas the exaggerated costs arising from the management of this crisis in the Member States are primarily a direct consequence of the EU's lack of independence and critical acumen in relation to the risk evaluation conducted by the WHO,deleted Amendment 40 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE Motion for a resolution Recital E E. whereas this systematic vaccination strategy is based essentially on an approach that relies on blind faith in the effectiveness of influenza vaccines, without taking into account scientific data that contradict that belief (see Cochrane journals), and the majority of the studies available on the efficacy of the medicinal products, including vaccines, have been conducted by pharmaceutical companies, meaning that no objective proof has been provided of the efficacy of influenza vaccines,deleted Amendment 56 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Esther de LANGE, Françoise GROSSETÊTE Motion for a resolution Recital G G. whereas significant changes are required to the current healthcare system in the EU and its Member States in order to achieve general public health objectives, as opposed to a purely pharmacological approach,deleted Amendment 60 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Françoise GROSSETÊTE Motion for a resolution Recital I I. whereas confidence in vaccines against H1N1 influenza was also undermined by the partial transfer from the manufacturer to the Member State, in the purchase contracts, of liability for any side effects,deleted Amendment 69 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE Motion for a resolution Recital J ~~J. whereas information has been garnered by various parliamentary committees and evaluation missions conducted in the EU Member States on the action taken to combat H1N1 influenza,~~deleted Amendment 74 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Esther de LANGE, Françoise GROSSETÊTE, Elena Oana ANTONESCU Motion for a resolution Subheading 1 ~~INDEPENDENCE~~COOPERATION Amendment 75 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER Motion for a resolution Paragraph 1 1. ~~Calls for~~Requests that the prevention plans established in the EU and its Member States to be revised ~~to make them sufficiently autonomous~~in order to gain in effectiveness, in coherence and of flexib~~le to be adapted as swiftly as possible and on a case by case basis to the actual risk, based not least on the latest scientific information available~~ility by a better coordination of the instruments installed but also of the scientific data available. For this purpose, it is in particular advisable to reinforce the mandate of the Committee of Public Health whose action should be more based on an intergovernmental level and whose composition should reflect a better representativeness of the executive decisions; Amendment 80 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Esther de LANGE, Françoise GROSSETÊTE, Elena Oana ANTONESCU Motion for a resolution Paragraph 1 a (new) 1a. Emphasises the need to reinforce cooperation between Member States within the EU in the management of the response to a pandemic, within the framework of WHO, according to the International Health Regulation of 2005 ; Amendment 81 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE, Elena Oana ANTONESCU Motion for a resolution Paragraph 1 b (new) 1b. Wants to reinforce the collaboration between Member States by ensuring coherent risk assessment and risk management for fast evolving threats at EU level by putting in place, where necessary, additional structures and coordination mechanisms; Amendment 82 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE Motion for a resolution Paragraph 1 c (new) 1c. Is delighted about the fact that the Commission committed itself studying the possibility of a revision and, should this happen, a long-term reinforcement of the legal base of Health Security Committee; Amendment 83 # Anne DELVAUX, Richard SEEBER, Françoise GROSSETÊTE Motion for a resolution Paragraph 1 d (new) 1d. Requests to give a special attention to the preparation between sectors within the framework of the co-operation between Member States within the Health Security Committee; Amendment 84 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU Motion for a resolution Paragraph 1 e (new) 1e. Urges the WHO to revise the definition of a pandemic, taking into consideration, when a virus is detected, not only its geographical spread but also its severity; Amendment 85 # Anne DELVAUX, Richard SEEBER, Esther de LANGE, Elena Oana ANTONESCU Motion for a resolution Paragraph 1 f (new) 1f. Claims that work on the legal basis relating to the implementation of the joint buying guarantee to the Member States an equitable access and a reasonable price to the most effective vaccines as well as the respect of the European legislation in terms of the manufacturer responsibility; Amendment 86 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Elena Oana ANTONESCU Motion for a resolution Paragraph 1 g (new) 1g. Calls on the Member States to involve health professionals more closely at every stage in the preparation and application of strategies for preventing and combating pandemics; Amendment 87 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE Motion for a resolution Paragraph 1 h (new) 1h. Urges the European Union to allot more means to the research and the development while conforming to the objective which it assigned to allocate 3% of the European GDP to the R & D; more specifically claim an increase in the investments dedicated to a better evaluation and anticipation of the impact of an influenza virus as well in period between pandemic as at the beginning of a pandemic; Amendment 88 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Esther de LANGE, Françoise GROSSETÊTE Motion for a resolution Paragraph 1 i (new) 1i. Welcomes the Commission's commitment to develop a mechanism for joint procurement of vaccines and antiviral medication which allows Member States, on a voluntary basis, a common acquisition of these products or common approaches to contract negotiations with the pharmaceutical industry; Recalls that only the seeking for joint solutions for a common purchasing of vaccines and antiviral medications will ensure equitable access, at the lowest price for the Member States; Amendment 89 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Françoise GROSSETÊTE Motion for a resolution Paragraph 1 j (new) 1j. Calls for continued investment in national epidemiological, serological and virological surveillance centres; Amendment 90 # Anne DELVAUX, Richard SEEBER, Françoise GROSSETÊTE Motion for a resolution Paragraph 2 2. Takes the view that the powers of the European Centre for Disease Prevention and Control (ECDC) should be reinforced so that the EU has its own means of assessing the severity of infection risk, by establishing, if necessary, its own health alert scale independent of international organisations such as the WHO;deleted Amendment 95 # Anne DELVAUX Motion for a resolution New subheading 2 a (new) INDEPENDENCE Amendment 97 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Françoise GROSSETÊTE Motion for a resolution Paragraph 3 3. ~~Demands that robust, credible~~Points out the need for and effective ~~scientific procedures be introduced for the evaluation of medicinal products recommended in the event of health emergencies, and more particularly in genuine pandemic~~, independent, transparent and balanced scientific report for the evaluation of the drugs including in health emergency situations; Amendment 100 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU Motion for a resolution Paragraph 3 a (new) 3a. Underscores the need for studies independent of the pharmaceutical companies on vaccines and antiviral medications, including with regard to the monitoring of vaccination coverage; Amendment 101 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Françoise GROSSETÊTE Motion for a resolution Paragraph 4 4. Calls for immediate clarifications on the effectiveness of the influenza vaccination strategies recommended in the EU, given the weight of evidence casting doubt on their effectiveness, the absence of reliable data guaranteeing that effectiveness and the lingering uncertainties surrounding their benefit- risk profile;deleted Amendment 114 # Anne DELVAUX, Richard SEEBER, Elena Oana ANTONESCU Motion for a resolution Paragraph 5 5. Calls in particular on the European Commission and the EMA to review the accelerated authorisation procedures for the placing on the market of medicinal products designed to respond to a health crisis, in order to ensure ~~correct~~a full assessment of the benefit-risk profile associated with the use of those medicinal products; Amendment 117 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU Motion for a resolution Paragraph 5 a (new) 5a. Wants to ensure that the scientific experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality; Request the development of a European code of conduct relating to the exercise of the scientific function of expert in any European authority in charge of safety, of the management and the anticipation of the risks ; require that each expert subscribe to the ethical principles of this code of conduct before any taking up the duties ; Amendment 118 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU Motion for a resolution Paragraph 5 b (new) 5b. Asks that experts who are involved in the pharmaceutical sector could be consulted but should be excluded from decision-making ; Amendment 119 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Françoise GROSSETÊTE, Elena Oana ANTONESCU Motion for a resolution Paragraph 5 c (new) 5c. Requests the installation of a definition of the conflict of interest which is common to all the European agencies ; Amendment 132 # Anne DELVAUX, Richard SEEBER Motion for a resolution Paragraph 8 8. ~~Considers~~Recognises that the conflicts of interest apparent in the case of some experts ~~who advise the European institutions to give rise~~could lead to suspicions of undue influence and ~~to undermine the overall~~harm the credibility of the European health agencies and their recommendations; ~~calls in particular for the EMA and ECDC to revise forthwith their current and future expert screening procedures to ensure complete transparency;~~ Amendment 147 # Anne DELVAUX, Richard SEEBER, Françoise GROSSETÊTE Motion for a resolution Paragraph 10 10. Calls for full liability for the quality, safety and effectiveness of a medicinal product to rest with the manufacturer, as required by EU law; Amendment 150 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU Motion for a resolution Paragraph 10 a (new) 10a. Is aware of the need to communicate more clearly and transparently to help the publics to facilitate the risk communication; Underlines the necessity to arrive to only one and single message bound for the citizens as soon as the health hazard was evaluated ; insists on the importance of consistent communication of the Member States regarding the informative contents of the message (as for the nature of the virus, with the nature of the risk and in the manner of securing and curing); Amendment 151 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Esther de LANGE, Françoise GROSSETÊTE Motion for a resolution Paragraph 10 b (new) 10b. Requires a global European strategic approach for the so-called “at-risk” groups on how to reach them and communicate with them in case of pandemics; Amendment 152 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN Motion for a resolution Paragraph 10 c (new) 10c. Calls to build relationships of trust with the media concerned with disseminating public health messages; Request the setting-up of a select group of available experts to answer questions from journalists at all times, as well as the availability of a spokesperson; Amendment 153 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Elena Oana ANTONESCU Motion for a resolution Paragraph 10 d (new) 10d. Stresses the need for accountability of information professionals and the prudence required in the processing of health information messages a fortiori in the context of a pandemic; Amendment 155 # Anne DELVAUX Motion for a resolution Subheading 3 ~~COOPERATION~~deleted Amendment 156 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN, Françoise GROSSETÊTE Motion for a resolution Subheading 3 a (new) Within the framework of the common and liable management of supply of vaccines, request to think over the possibility of easing the access of developing countries to vaccinal products in case of a pandemic; Amendment 158 # Anne DELVAUX, Philippe JUVIN, Richard SEEBER, Elena Oana ANTONESCU Motion for a resolution Paragraph 11 11. ~~Demands precise definition of~~Requests to specify and clarify the roles, duties, remits, limits, relations and responsibilities of the key actors and the structures of management of the medical threats at the level of the EU which are the European Commission, the ECDC, the EMA and the Member States and also of more informal entities such as the Health Security Committee, the HEOF and the ‘public health’ group, composed of senior officials able to intervene in the decision- making process regarding the management of a health crisis; Amendment 163 # Anne DELVAUX, Richard SEEBER, Philippe JUVIN Motion for a resolution Paragraph 12 12. Expresses its approval of the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis where the positive benefit-risk profile of their preventive/therapeutic effect is clearly demonstrated and indisputable, in order to obtain, for a given product, advantageous rates approaching its cost price;deleted source: PE-454.473
14	2011/0092(CNS) Taxation of energy products and electricity: restructuring the Community framework 2011/11/11 ENVI 14 amendments... Amendment 26 # Anne DELVAUX Proposal for a directive Recital 1 a (new) (1a) Genuine consistency needs to be ensured within the European Union in relation to the taxation of the various energy sources, and a framework for the taxation of renewable energies needs to be introduced. Amendment 27 # Anne DELVAUX Proposal for a directive Recital 2 (2) It is necessary to ensure that the internal market ~~continues to function properly~~functions in an optimum manner in a context of new requirements relating to the limitation of climate change, to the use of renewable energy sources and to energy savings, as endorsed by the Presidency Conclusions of the European Council of 8-9 March 2007 and of 11-12 December 2008. Amendment 28 # Anne DELVAUX Proposal for a directive Recital 2 a (new) (2a) Account needs to be taken of the practical consequences of a new tax deal, particularly at a time when Europe is in the throes of a financial and economic crisis, the effects and implications of which need to be gauged. In this connection, the data collected during the impact study need to be brought up to date. Amendment 29 # Anne DELVAUX Proposal for a directive Recital 3 (3) Taxation related to CO2 emissions can be an ~~cost-~~effective means for Member States to foster environmentally sustainable behaviour among consumers and polluting sectors and to achieve the reductions of greenhouse gasses necessary according to Decision 406/2009/EC of the European Parliament and the Council of 23 April 2009 on the effort of Member States to reduce their greenhouse gas emissions to meet the Union’s greenhouse gas emission reduction commitments up to 2020 as regards sources not covered by the Union scheme under Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC. In view of the potential role of CO2-related taxation, the proper functioning of the internal market requires common rules on that taxation. Amendment 31 # Anne DELVAUX Proposal for a directive Recital 5 (5) Therefore, provision should be made for energy taxation to consist of two components, CO2-related taxation and general energy consumption taxation. In order for energy taxation to adapt to the operation of the Union scheme under Directive 2003/87/EC Member States should be required to explicitly distinguish between those two components. This would also allow distinct treatment of fuels that are biomass or made from biomass, provided that they meet the sustainability criteria set out in Article 17 of Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources. Amendment 34 # Anne DELVAUX Proposal for a directive Recital 8 (8) In the interest of fiscal neutrality, the same minimum levels of taxation should apply for each component of energy taxation, to all energy products put to a given use. Where equal minimum levels of taxation are thus prescribed, Member States should, also for reason of fiscal neutrality, ensure equal levels of national taxation on all products concerned. Where needed, transitional periods for the purposes of equalising those levels which take due account of Member States’ specificities should be foreseen. Amendment 35 # Anne DELVAUX Proposal for a directive Recital 9 (9) The minimum levels of CO2-related taxation should be fixed in the light of the national targets for Member States as laid down in Decision 406/2009/EC on the effort of Member States to reduce their greenhouse gas emissions to meet the Union’s greenhouse gas emission reduction commitments up to 2020. Since that Decision recognises that efforts to reduce their greenhouse gas emissions should be fairly distributed between the Member States, transitional periods should be fixed ~~for certain Member States~~. Amendment 39 # Anne DELVAUX Proposal for a directive Recital 13 (13) As regards the possibility for Member States to apply a lower level of taxation to commercial than to non-commercial use of gas oil as motor fuel, this provision would appear to be no longer compatible with the requirement to improve energy efficiency and the need to address the growing environmental impact of transport and should therefore be deleted. Article 9(2) of Directive 2003/96/EC authorises certain Member States to apply a reduced rate on heating gas oil. That provision is no longer compatible with the proper functioning of the internal market and with the wider objectives of the Treaty. ItConsideration should therefore be ~~deleted~~given to deleting it, subject to the findings of a fresh study of the impact this would have on households during a period of economic crisis. Amendment 43 # Anne DELVAUX Proposal for a directive Recital 17 (17) Care should be taken to ensure that households, which have been hard-hit by the economic and financial crisis, with some being pushed into social insecurity and energy poverty by the extreme economic conditions, are not further penalised by an increase in the tax burden. Exemption or reductions to the benefit of households and charitable organisations may form part of social measures defined by Member States. The possibility to apply such exemptions or reductions should, for reasons of equal treatment between energy sources, be extended to all energy products used as heating fuel and electricity. In order to ensure that their impact on the internal market remains limited, such exemptions and reductions should be applied only to non-business activities. Amendment 52 # Anne DELVAUX Proposal for a directive Recital 20 (20) Article 15(3) of Directive 2003/96/EC allows Member States to apply to agricultural, horticultural and piscicultural works as well as to forestry not only the provisions generally applicable to business uses but also a level of taxation down to zero. A~~n examination of that option has revealed that as far as general energy consumption taxation is concerned its maintenance would be~~ s regards CO2 related taxation the treatment of the sectors concerned should take accountrary to the Union's wider policy objectives unless it is linked to a counterpart ensuring advances in the field of energy efficiency. As regards CO2 related taxation the treatment of the sectors concerned should be aligned to the rules applying to industrial sector of the size and output of holdings. In the farming sector, such taxation should also be based on carbon capture capacity, such as that afforded by permanent grasslands. Amendment 56 # Anne DELVAUX Proposal for a directive Recital 28 (28) Every ~~fiv~~three years and for the first time by the end of 2015, the Commission should report to the Council on the application of this Directive, examining in particular the minimum level of CO2- related taxation in the light of the evolution of the market price in the EU of the emission allowances, the impact of innovation and technological developments and the justification for the tax exemptions and reductions laid down in this Directive, including for fuel used for the purpose of air and maritime navigation. The list of sectors or sub-sectors deemed to be exposed to a significant risk of carbon leakage shall be the subject of regular review, in particular taking into account the availability of emerging evidence. Amendment 76 # Anne DELVAUX Proposal for a directive Article 1 – paragraph 1 – point 13 – point a – point i Directive 2003/96/CE Article 15 – paragraph 1 – point h (h) energy products used as heating fuel and electricity if used by households and/or by organisations recognised as charitable by the Member State concerned. In the case of such charitable organisations, Member States shall confine the exemption or reduction to use for the purpose of non- business activities~~. Where mixed use takes place, taxation shall apply in proportion to each type of use. If a use is insignificant, it may be treated as nil~~; Amendment 81 # Anne DELVAUX Proposal for a directive Article 1 – paragraph 1 – point 13 – point b Directive 2003/96/CE Article 15 - paragraph 3 3. Member States may apply a level of general energy consumption taxation down to zero on the consumption of energy products and electricity used for agricultural, horticultural, aquacultural works and in forestry. The beneficiaries shall be subject to arrangements that must lead to increased energy efficiency broadly equivalent to those that would have been achieved if the standard Union minimum rates had been observed. Amendment 86 # Anne DELVAUX Proposal for a directive Article 1 – paragraph 1 – point 21 Directive 2003/96/CE Article 29 - paragraph 1 Every ~~fiv~~three years and for the first time by the end of 2015, the Commission shall submit to the Council a report on the application of this Directive and, where appropriate, a proposal for its modification. source: PE-475.879
11	2011/0172(COD) Energy efficiency 2011/07/11 ENVI 11 amendments... Amendment 129 # Peter LIESE, Anne DELVAUX, Vladko Todorov PANAYOTOV, Jo LEINEN, Sophie AUCONIE Proposal for a directive Article 4 – paragraph 4 a (new) 4a (new) Member States shall draw up national roadmaps to provide details about national strategies to reduce carbon emission of the building stock by 80% in 2050 compared to 1990 levels. These national shall be adopted by January 1, 2014 (for public buildings), by January 1, 2015 (for commercial buildings), and by January 1, 2017 (for private buildings), and will also establish intermediary targets for average energy consumption of the building stock 2020, 2030, and 2040. Amendment 143 # Peter LIESE, Anne DELVAUX, Vladko Todorov PANAYOTOV Proposal for a directive Article 6 – paragraph 1 1. Each Member State shall set up an energy efficiency obligation scheme. This scheme shall ensure that either all energy distributors or all retail energy sales companies operating on the Member State's territory achieve annual energy savings equal to 1.5% of their energy sales, by volume, in the previous year in that Member State ~~excluding energy used in transport~~. This amount of energy savings shall be achieved by the obligated parties among final customers.The Member States shall apply the scheme to all sectors. Amendment 187 # Peter LIESE, Anne DELVAUX, Radvilė MORKŪNAITĖ-MIKULĖNIENĖ, Vladko Todorov PANAYOTOV, Sophie AUCONIE, Elisabetta GARDINI Proposal for a directive Article 7 – paragraph 2 2. Member States shall ensure that enterprises not included in the second subparagraph of paragraph 1 are subject to an energy audit carried out in an independent and cost-effective manner by qualified and/or accredited experts at the latest by 30 June 2014 and every three years from the date of the previous energy audit. Audits may be carried out by in- house experts, provided that these are qualified and accredited, that they are not directly engaged in the activity audited, and that the Member state has put in place a scheme to assure and check their quality. Amendment 205 # Peter LIESE, Anne DELVAUX, Renate SOMMER Proposal for a directive Article 8 – paragraph 1 – subparagraph 4 In case of heating and cooling, where a building is supplied from a district heating network, a heat meter shall be installed at the building entry. In multi-apartment buildings, individual heat consumption meters shall also be installed to measure the consumption of heat or cooling for each apartment. Where the use of individual heat consumption meters is not technically feasible, individual heat cost allocators, in accordance with the specifications in Annex VI(1.2), shall be used for measuring heat consumption at each radiatorMember States shall ensure that in buildings with several units (residential and commercial), whose units are supplied with heat and domestic hot water from central systems the consumption is measured for each unit; Member States shall introduce rules for the annual consumption-based cost allocation of heat and domestic hot water in these buildings. Exceptions are allowed if the installation of measuring devices or the consumption based cost allocation turns out to be technically and/or economically not feasible, e.g. in high efficient buildings. The metering of cooling is optional. Amendment 304 # Peter LIESE, Anne DELVAUX, Radvilė MORKŪNAITĖ-MIKULĖNIENĖ Proposal for a directive Article 12 – paragraph 5 – subparagraph 3 a (new) 5a. Furthermore, Member States may make provisions for continuous and long- term feed-in tariffs, if appropriate on a diminishing scale, in the case of electricity produced by small scale and micro cogeneration units. Amendment 307 # Peter LIESE, Anne DELVAUX, Renate SOMMER Proposal for a directive Article 13 – paragraph 1 1. With a view to achieving a high level of technical competence, objectivity and reliability, Member States shall ensure that, by 1 January 2014, ~~certification schemes or equivalent~~ qualification schemes are ~~available~~provided for providers of energy services, energy audits and energy efficiency improvement measures, including for installers of building elements as defined in Article 2(9) of Directive 2010/31/EU. The Member States examine, whether their respective own educational and retraining systems cover the required knowledge. Amendment 309 # Peter LIESE, Anne DELVAUX, Vladko Todorov PANAYOTOV, Renate SOMMER Proposal for a directive Article 13 – paragraph 2 2. Member States shall make publicly available the ~~certification schemes or equivalent~~ qualification schemes referred to in paragraph 1 and shall ~~cooperate among themselves and with the Commission~~work on comparisons between and recognition of the schemes. This shall be without prejudice to directive 2005/36/EC. Amendment 319 # Peter LIESE, Renate SOMMER, Anne DELVAUX, Miroslav OUZKÝ, Radvilė MORKŪNAITĖ-MIKULĖNIENĖ Proposal for a directive Article 15 – paragraph 1 – subparagraph 1 – point b a (new) (ba) provisions on listed buildings which are officially protected as part of a designated environment or because of their special architectural or historic merit with a view to give owners more flexibility to implement energy efficiency measures to these buildings in line with generally accepted conservation practices, i.e. thermal insulation of the outer shell (walls, roof, windows), bearing in mind a balanced weighing of cultural conservation and energy efficiency Amendment 320 # Peter LIESE, Anne DELVAUX, Renate SOMMER Proposal for a directive Article 15 – paragraph 1 – subparagraph 1 – point b b (new) (bb) the removal of regulated prices which do not reflect costs. Amendment 330 # Peter LIESE, Anne DELVAUX Proposal for a directive Article 19 – paragraph 2 – subparagraph 1 2. By 3~~0 April 2014, and every three years thereafter,~~1 December 2013 at the latest, the Member States shall submit supplementary reports with information on national energy efficiency policies, action plans, programmes and measures implemented or planned at national, regional and local level to improve energy efficiency in view of achievingprovide the Commission with national energy efficiency plans which describe how the Member States intend to achieve the national energy efficiency targets referred to in Article 3(1). The Commission shall assess those plans and may refuse them or propose amendments thereto. Every two years, the Member States shall provide the Commission with a report on the implementation of their national energy efficiency ~~targets referred to in Article 3(1)~~plans. The reports shall be complemented with updated estimates of expected overall primary energy consumption in 2020, as well as estimated levels of primary energy consumption in the sectors indicated in Annex XIV(1). The Commission shall, not later than 30 September 2013, provide a template as guidance for the supplementary reports. This template shall be adopted in accordance with the advisory procedure referred to in Article 20(2). The supplementary reports shall in any case include the information specified in Annex XIV. When setting their national energy efficiency plans, the Member States shall take into account cost- effective energy efficiency measures and the risk of carbon leakage. When setting their national energy efficiency action plans, Member States shall ensure the promotion of a system approach, e.g. for lighting, at national level, to encourage the use of additional energy saving potentials existing beyond the single product approach. Amendment 342 # Peter LIESE, Anne DELVAUX, Vladko Todorov PANAYOTOV, Sophie AUCONIE Proposal for a directive Article 19 – paragraph 5 – subparagraph 2 The Commission shall also monitor the impact of implementing this Directive on Directive 2003/87/EC, Directive 2009/28/EC as well as Directive 2010/31/EC. Until 30/06/2013 at the latest, the European Commission should come forward with a proposal to adjust the Effort Sharing Decision (Decision No 406/2009/EC of the European Parliament and of the Council). source: PE-475.843
9	2011/0275(COD) European Regional Development Fund (ERDF): support to the Investment for growth and jobs goal 2012/05/31 ENVI 9 amendments... Amendment 15 # Sophie AUCONIE, Mario PIRILLO, Anne DELVAUX, Gaston FRANCO, Philippe JUVIN Proposal for a regulation Article 2 The ERDF shall contribute to the financing of support which aims to reinforce economic, social and territorial cohesion by redressing the main regional imbalances through support for the sustainable development and structural adjustment of regional economies, including the conversion of declining industrial regions and regions lagging behind. Amendment 17 # Sophie AUCONIE, Mario PIRILLO, Riikka PAKARINEN, Anne DELVAUX, Gaston FRANCO, Philippe JUVIN Proposal for a regulation Article 3 – paragraph 1 – subparagraph 1 – point c (c) investments in social, sports, health and educational infrastructure; Amendment 21 # Sophie AUCONIE, Mario PIRILLO, Pilar AYUSO, Anne DELVAUX, Gaston FRANCO, Philippe JUVIN Proposal for a regulation Article 3 – paragraph 1 – subparagraph 2 ~~In more developed regions, the ERDF shall not support investments in infrastructure providing basic services to citizens in the areas of environment, transport, and ICT.~~deleted Amendment 37 # Sophie AUCONIE, Anne DELVAUX, Gaston FRANCO, Peter LIESE Proposal for a regulation Article 4 – paragraph 1 – point b – point ii ii) at least 610% of the total ERDF resources at national level shall be allocated to the thematic objective set out in point 4 of Article 9 of Regulation (EU) No […]/2012 [CPR]. Amendment 43 # Sophie AUCONIE, Mario PIRILLO, Anne DELVAUX, Gaston FRANCO, Philippe JUVIN Proposal for a regulation Article 5 – point 4 – point a (a) promoting the production and distribution of renewable and low-carbon energy sources; Amendment 44 # Sophie AUCONIE, Mario PIRILLO, Riikka PAKARINEN, Anne DELVAUX, Gaston FRANCO, Philippe JUVIN Proposal for a regulation Article 5 – point 4 – point e (e) promoting low-carbon strategies ~~for~~– including sustainable mobility and clean public transport – for all types of region, particularly urban areas; Amendment 50 # Sophie AUCONIE, Mario PIRILLO, Anne DELVAUX, Gaston FRANCO, Pilar AYUSO, Philippe JUVIN Proposal for a regulation Article 5 – point 6 – introductory part (6) protecting the environment, biodiversity and ecosystems and promoting resource efficiency: Amendment 52 # Sophie AUCONIE, Mario PIRILLO, Riikka PAKARINEN, Anne DELVAUX, Gaston FRANCO, Philippe JUVIN Proposal for a regulation Article 5 – point 6 – point b (b) addressing the significant needs for investment in the water sector to reduce leakage and meet the requirements of the environmental acquis; Amendment 63 # Sophie AUCONIE, Mario PIRILLO, Riikka PAKARINEN, Anne DELVAUX, Gaston FRANCO, Philippe JUVIN Proposal for a regulation Article 5 – point 9 – point a (a) investing in health, sports and social infrastructure which contribute to national, regional and local development, reducing inequalities in terms of health status, and transition from institutional to community- based services; source: PE-489.523
11	2011/2023(INI) Towards a stronger European disaster response: the role of civil protection and humanitarian assistance 2011/05/13 ENVI 11 amendments... Amendment 1 # Philippe JUVIN, Theodoros SKYLAKAKIS, Anne DELVAUX, Bogusław SONIK, Christine DE VEYRAC, Françoise GROSSETÊTE, Sophie AUCONIE, Antonyia PARVANOVA, Gaston FRANCO Motion for a resolution Citation 1 a (new) - having regard to Article 122 of the Treaty on the functioning of the European Union, Amendment 2 # Philippe JUVIN, Theodoros SKYLAKAKIS, Anne DELVAUX, Bogusław SONIK, Christine DE VEYRAC, Françoise GROSSETÊTE, Sophie AUCONIE, Antonyia PARVANOVA, Gaston FRANCO Motion for a resolution Citation 1 b (new) - having regard to Article 222 of the Treaty on the functioning of the European Union (the solidarity clause) which lays down that ‘the Union and the Member States shall act jointly in a spirit of solidarity if a Member State is the object of a terrorist attack or victim of a natural or man-made disaster’, Amendment 3 # Philippe JUVIN, Anne DELVAUX, Theodoros SKYLAKAKIS, Bogusław SONIK, Françoise GROSSETÊTE, Christine DE VEYRAC, Sophie AUCONIE, Antonyia PARVANOVA, Gaston FRANCO Motion for a resolution Citation 1 c (new) - having regard to Article 23 of the Treaty on the functioning of the European Union, Amendment 4 # Philippe JUVIN, Anne DELVAUX, Theodoros SKYLAKAKIS, Bogusław SONIK, Christine DE VEYRAC, Françoise GROSSETÊTE, Sophie AUCONIE Motion for a resolution Citation 1 d (new) - having regard to the 1994 Oslo Guidelines on the use of foreign military and civil defence assets in disaster relief, Amendment 7 # Philippe JUVIN, Anne DELVAUX, Theodoros SKYLAKAKIS, Bogusław SONIK, Christine DE VEYRAC, Françoise GROSSETÊTE, Sophie AUCONIE, Antonyia PARVANOVA, Gaston FRANCO Motion for a resolution Recital A A. whereas the European Union and its Member States are faced with seven major risks: earthquakes and tsunamis; fires, including forest fires; flooding and landslides; industrial and nuclear accidents; terrorist attacks; natural disasters; and major pandemics; whereas there has been a dramatic increase in the number and severity of these natural and man-made disasters affecting the Union and its citizens, as well as other countries and regions around the world, as tragically demonstrated by the recent severe catastrophe in Japan which was hit by a combination of earthquake, tsunami and nuclear catastrophe, with a corresponding increase in the loss of life and in economic, social and environmental damage and damage to cultural heritage, Amendment 11 # Philippe JUVIN, Anne DELVAUX, Theodoros SKYLAKAKIS, Bogusław SONIK, Christine DE VEYRAC, Françoise GROSSETÊTE, Sophie AUCONIE, Antonyia PARVANOVA, Gaston FRANCO Motion for a resolution Recital B B. whereas the recent tragedies, notably the Haiti earthquake and the Pakistan floods, have demonstrated that the main tools available to the EU for responding to disasters (humanitarian aid and the EU Civil Protection Mechanism) proved to be working well for what they were designed for and given the circumstances, but whereas there is ~~scope~~a vital need for improvement in terms of effectiveness, efficiency, co~~herence~~ordination and visibility of the EU assistance as a whole, Amendment 14 # Philippe JUVIN, Theodoros SKYLAKAKIS, Anne DELVAUX, Bogusław SONIK, Christine DE VEYRAC, Françoise GROSSETÊTE, Sophie AUCONIE, Antonyia PARVANOVA, Gaston FRANCO Motion for a resolution Recital B a (new) Ba. whereas, moreover, during a number of crises, particularly the tsunami of 26 December 2004, many questions were raised about the lack of systematic scenarios or protocols at European level for responding to these seven major risks and the inadequate visibility of Europe's action in relation to the overall effort, Amendment 28 # Philippe JUVIN, Theodoros SKYLAKAKIS, Anne DELVAUX, Bogusław SONIK, Christine DE VEYRAC, Françoise GROSSETÊTE, Sophie AUCONIE, Antonyia PARVANOVA Motion for a resolution Recital G G. whereas an integrated European all- hazards approach aimed at responding to crises at all stages of their life cycle is the most effective strategy to deal with disasters; whereas this approach should link~~ing~~ disaster prevention (including mitigation and risk reduction), preparedness, response and recovery ~~is the most effective strategy to deal with disasters~~, Amendment 38 # Philippe JUVIN, Anne DELVAUX, Bogusław SONIK, Christine DE VEYRAC, Françoise GROSSETÊTE, Sophie AUCONIE, Gaston FRANCO Motion for a resolution Paragraph 2 2. Underlines the need to rationalise and simplify the functioning of the current European disaster response and to optimise resources available for common benefit, whilst encouraging all Member States to contribute and thus guarantee European solidarity; considers, accordingly, that the EU’s reaction capacity should form part of an integrated multi-risk approach based on ‘bottom-up’ delegated management, on the voluntary sector and on Member States’ specialisations in one or more risk areas; Amendment 59 # Philippe JUVIN, Anne DELVAUX, Bogusław SONIK, Christine DE VEYRAC, Françoise GROSSETÊTE, Sophie AUCONIE Motion for a resolution Paragraph 6 6. ~~Re-affirms the~~Emphasises that the European disaster response system should respect of the principle of double subsidiarity ~~concerning the capability of the Member States to use their own assets, especially in any case of conflicting national needs~~vis-à-vis the Member States and the United Nations, i.e. that it should respect the national and regional competences of each Member State on the one hand, and the coordinating role played by the United Nations in disaster relief operations on the other; points out that this strategy should live up to the expectations of the United Nations, which see clear value added in creating a European pole with a response capability; Amendment 68 # Philippe JUVIN, Anne DELVAUX, Bogusław SONIK, Françoise GROSSETÊTE, Sophie AUCONIE Motion for a resolution Paragraph 10 10. Considers advance planning and the preparation of operations by developing reference scenarios, mapping Member States’ assets potentially available for deployment in EU disaster relief operations and contingency planning as key elements of an enhanced EU disaster response and essential for rapid deployment and immediate appropriate response to each emergency; calls on the Commission and the Member States to implement these measures immediately and without prejudice to other actions; calls, finally, on the Commission to launch a feasibility study on the merits of setting up, allocating European research budget funding to, and naming European reference laboratories to combat bioterrorism and identify victims; source: PE-464.916
3	2011/2051(INI) CAP towards 2020: meeting the food, natural resources and territorial challenges of the future 2011/03/22 ENVI 3 amendments... Amendment 8 # Anne DELVAUX Draft opinion Paragraph 1 1. Calls for the post-2013 CAP to pursue food objectives and secure the relevant funding which encourage new forms of sustainable agricultural production which save energy, reduce the use of chemicals and exploit the potential of ecosystems more effectively; points out that it must be capable of responding to environmental challenges, such as climate change, depletion of resources, water pollution and soil erosion, ~~etc.~~without this threatening the viability of farms or their existence throughout the EU; Amendment 35 # Anne DELVAUX Draft opinion Paragraph 4 4. Calls for ~~a reinforcement of the concept of funding for both pillars subject to the fulfilment of a number of~~sufficient funds to be made available to achieve ambitious environmental and biodiversity ~~criteria~~targets, so that high- quality food can be produced using sustainable practices; points out that sufficient funding is the only guarantee of the success of targeted agri-environmental measures; Amendment 50 # Anne DELVAUX Draft opinion Paragraph 5 5. Emphasises that ~~mandatory greening~~greater consideration for the environment that respects ecosystems will not only benefit the environment, but also ensure a sustainable future for EU farming; this greening of European agriculture is only worthwhile and will only be possible if the agricultural practices of the EU’s developed and emerging country partners follows suit; source: PE-460.983
8	2012/0190(COD) Reducing CO2 emissions from new passenger cars: modalities for reaching the 2020 target 2013/02/28 ENVI 4 amendments... Amendment 24 # Karl-Heinz FLORENZ, Matthias GROOTE, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Recital 2 (2) It is appropriate to clarify that for the purpose of verifying compliance with the target of 95gCO2/km, CO2 emissions should continue to be measured in accordance with Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information and its implementing measures and innovative technologies. However, studies carried out by the Commission have demonstrated that the test procedures used to measure CO2 emissions under that Regulation have not prevented an increased utilisation of flexibilities by manufacturers which have resulted in alleged CO2 emissions reductions that are not attributable to technological improvements and cannot be achieved in real driving on the road. Regulation (EC) No 715/2007, and the New European Drive Cycle (NEDC), should therefore be amended as a matter of urgency, and at the latest by the end of 2014, in order to ensure that test procedures reflect adequately the CO2 emissions generated by real driving on the road. The next step should be to incorporate the World Light Duty Test Procedure (WLTP), which is currently being developed under the auspices of the United Nations Economic Commission for Europe, into Union law as soon as possible after it has been finalised. The Commission should consider whether there is a need to supplement the WLTP, by incorporating additional provisions, when integrating it into Union law in order to ensure that test procedures reflect adequately the emissions generated by real driving on the road Amendment 55 # Karl-Heinz FLORENZ, Matthias GROOTE, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Recital 8 (8) The Regulation requires the Commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real CO2 emissions behaviour of cars. This work is proceeding through the development of a World Light Duty Test procedure in the framework of the United Nations Economic Commission for Europe but is not yet complete. In view of this, Annex I to Regulation (EC) No 443/2009 establishes emission limits for 2020 as measured according to Regulation (EC) No 715/2007 and Annex XII to Regulation (EC) No 692/2008. As soon as possible after it has been finalised, however, the test cycle should be incorporated into Union law. The Commission should consider whether there is a need to supplement the WLTP, by incorporating additional provisions, when integrating it into Union law in order to ensure that test procedures reflect adequately the emissions generated by real driving on the road. When the test procedures are amended, the limits set in Annex I should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles. Amendment 75 # Karl-Heinz FLORENZ, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Article 1 – point 1 a (new) Regulation 2009/443/EC Article 1 – paragraph 2 a (new) (1a) In Article 1 the following paragraph is inserted after paragraph 2: "From 2025 onwards, this Regulation sets an average emissions target for the new car fleet of between 65 and 75 g CO2/km, as outlined in Article 13(5)." Amendment 151 # Karl-Heinz FLORENZ, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Article 1 – point 10 – point c Regulation 2009/443/EC Article 13 – paragraph 5 5. ~~Bis 31.~~ By 31 December 2014, the Commission shall review the specific emissions targets, modalities and other aspects of this Regulation in order to establish the CO2 emission targets for new passenger cars for the period beyond 2020.’ The purpose of this review shall be to set, for the period beyond 2025, an average emissions target for the fleet of new cars of between 65 and 75 g CO2/km. On the basis of this review, which shall include an overall assessment of the impact on the car industry and its dependent industries, the Commission shall, if appropriate, make a proposal to amend this Regulation in a way which is cost-effective and as neutral as possible from the point of view of competition and ensures the achievement of the Union's long term objectives in combating climate change. source: PE-506.077 2013/03/22 ENVI 4 amendments... Amendment 24 # Karl-Heinz FLORENZ, Matthias GROOTE, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Recital 2 (2) It is appropriate to clarify that for the purpose of verifying compliance with the target of 95gCO2/km, CO2 emissions should continue to be measured in accordance with Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information and its implementing measures and innovative technologies. However, studies carried out by the Commission have demonstrated that the test procedures used to measure CO2 emissions under that Regulation have not prevented an increased utilisation of flexibilities by manufacturers which have resulted in alleged CO2 emissions reductions that are not attributable to technological improvements and cannot be achieved in real driving on the road. Regulation (EC) No 715/2007, and the New European Drive Cycle (NEDC), should therefore be amended as a matter of urgency, and at the latest by the end of 2014, in order to ensure that test procedures give an accurate picture of the CO2 emissions generated by real driving on the road. The next step should be to incorporate the World Light Duty Test Procedure (WLTP), which is currently being developed under the auspices of the United Nations Economic Commission for Europe, into Union law as soon as possible after it has been finalised. The Commission should consider whether there is a need to supplement the WLTP, by incorporating additional provisions, when integrating it into Union law in order to ensure that test procedures give an accurate picture of the emissions generated by real driving on the road Amendment 55 # Karl-Heinz FLORENZ, Matthias GROOTE, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Recital 8 (8) The Regulation requires the Commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real CO2 emissions behaviour of cars. This work is proceeding through the development of a World Light Duty Test procedure in the framework of the United Nations Economic Commission for Europe but is not yet complete. In view of this, Annex I to Regulation (EC) No 443/2009 establishes emission limits for 2020 as measured according to Regulation (EC) No 715/2007 and Annex XII to Regulation (EC) No 692/2008. As soon as possible after it has been finalised, however, the test cycle should be incorporated into Union law. The Commission should consider whether there is a need to supplement the WLTP, by incorporating additional provisions, when integrating it into Union law in order to ensure that test procedures give an accurate picture of the emissions generated by real driving on the road. When the test procedures are amended, the limits set in Annex I should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles. Amendment 75 # Karl-Heinz FLORENZ, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Article 1 – point 1 a (new) Regulation 2009/443/EC Article 1 – paragraph 2 a (new) (1a) In Article 1 the following paragraph is inserted after paragraph 2: "From 2025 onwards, this Regulation sets an average emissions target for the new car fleet of between 65 and 75 g CO2/km, as outlined in Article 13(5)." Amendment 151 # Karl-Heinz FLORENZ, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Article 1 – point 10 – point c Regulation 2009/443/EC Article 13 – paragraph 5 5. ~~Bis 31.~~ By 31 December 2014, the Commission shall review the specific emissions targets, modalities and other aspects of this Regulation in order to establish the CO2 emission targets for new passenger cars for the period beyond 2020.’ The purpose of this review shall be to set, for the period beyond 2025, an average emissions target for the fleet of new cars of between 65 and 75 g CO2/km. On the basis of this review, which shall include an overall assessment of the impact on the car industry and its dependent industries, the Commission shall, if appropriate, make a proposal to amend this Regulation in a way which is cost-effective and as neutral as possible from the point of view of competition and ensures the achievement of the Union's long-term objectives in combating climate change. source: PE-506.077
5	2012/0191(COD) Reducing CO2 emissions from new light commercial vehicles: modalities for reaching the 2020 target 2013/02/28 ENVI 5 amendments... Amendment 17 # Karl-Heinz FLORENZ, Matthias GROOTE, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Recital 2 (2) It is appropriate to clarify that for the purpose of verifying compliance with the target of 147 g CO2/km, CO2 emissions should continue to be measured in accordance with Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information and its implementing measures and innovative technologies. However, studies carried out by the Commission have demonstrated that the test procedures used to measure CO2 emissions under that Regulation have not prevented an increased utilisation of flexibilities by manufacturers which have resulted in alleged CO2 emissions reductions that are not attributable to technological improvements and cannot be achieved in real driving on the road. Regulation (EC) No 715/2007, and the New European Drive Cycle (NEDC), should therefore be amended as a matter of urgency, and at the latest by the end of 2014, in order to ensure that test procedures reflect adequately the CO2 emissions generated by real driving on the road. The next step should be to incorporate the World Light Duty Test Procedure (WLTP), which is currently being developed under the auspices of the United Nations Economic Commission for Europe, into Union law as soon as possible after it has been established. The Commission should consider whether there is a need to supplement the WLTP, by incorporating additional provisions, when integrating it into Union law in order to ensure that test procedures reflect adequately the emissions generated by real driving on the road. Amendment 39 # Karl-Heinz FLORENZ, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Recital 9 (9) The Commission ~~has~~should assessed the availability of footprint data and its use as the utility parameter in the formulae in Annex I. This data is available and its potential use has been assessed in the impact assessment, on the basis of that assessment it is concluded that thedata on utility parameters other than mass and their use as utility parameter ~~used~~s in the formula ~~for 2020 should be mass~~e in Annex I. Amendment 40 # Karl-Heinz FLORENZ, Matthias GROOTE, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Recital 10 (10) The Regulation requires the Commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real CO2 emissions behaviour of cars. This work is proceeding through the development of a World Light Duty Test procedure in the framework of the United Nations Economic Commission for Europe but is not yet complete. In view of this, Annex I to Regulation (EC) No 443/2009 establishes emission limits for 2020 as measured according to Regulation (EC) No 715/2007 and Annex XII to Regulation (EC) No 692/2008. As soon as possible after it has been finalised, however, the test cycle should be incorporated into Union law. The Commission should consider whether there is a need to supplement the WLTP, by incorporating additional provisions, when integrating it into Union law in order to ensure that test procedures reflect adequately the emissions generated by real driving on the road. When the test procedures are amended, the limits set in Annex I should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles. Amendment 59 # Karl-Heinz FLORENZ, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Article 1 – point 1 a (new) Regulation (EU) No 510/2011 Article 1 – paragraph 2 a (new) (1a) In Article 1, the following paragraph is added: ‘(2a) From 2025 onwards, this Regulation sets a target within a range of 100 g CO2/km to 115 g CO2/km for the average emissions of new light commercial vehicles, as specified in Article 13(1).’ Amendment 77 # Karl-Heinz FLORENZ, Peter LIESE, Anne DELVAUX, Toine MANDERS Proposal for a regulation Article 1 – point 4 – point a Regulation (EU) No 510/2011 Article 13 – paragraph 1 By 31 December 2014, the Commission shall review the specific emissions targets, modalities and other aspects of this Regulation in order to establish the CO2 emission targets for new light commercial vehicles for the period beyond 2020. The aim of this review shall be to set an average emissions target for the fleet of new light vehicles for the period after 2025 which falls within a range of 100 to 115 g CO2/ km. On the basis of this review, which shall include an overall assessment of the impact on the car industry and its dependent industries, the Commission shall, if appropriate, make a proposal to amend this Regulation in a way which is cost-effective and as neutral as possible from the point of view of competition and ensures the achievement of the Union's long term objectives in combating climate change. source: PE-506.129
29	2012/0192(COD) Clinical trials on medicinal products for human use 2013/03/01 ENVI 12 amendments... Amendment 80 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Philippe JUVIN, Filip KACZMAREK, Richard SEEBER, Georgios KOUMOUTSAKOS 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, and approval by an ethics committee prior to commencement. Amendment 463 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Philippe JUVIN, Filip KACZMAREK, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 29 – paragraph 1 1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been ducomprehensively and comprehensibly informed of the nature, significance, implications and risks of the clinical trial, and after having received the corresponding information in writing. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given. Amendment 474 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Anja WEISGERBER, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 30 – paragraph 1 – point a (a) the informed consent of the legal representative has been obtained~~, whereby~~; consent shall represent the subject's presumed will and may be revoked at any time, without detriment to the subject; Amendment 478 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Alda SOUSA, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Anja WEISGERBER, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 30 – paragraph 1 – point c (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is ~~considered~~duly taken into account by the investigator; Amendment 481 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Alda SOUSA, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Anja WEISGERBER, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Philippe JUVIN, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 30 – paragraph 1 – point h a (new) (ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol; Amendment 487 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Anja WEISGERBER, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Philippe JUVIN, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 31 – paragraph 1 – point b (b) the minor has received all relevant information in a way adapted to his or her age and maturity, from ~~professionals~~a medical doctor (either the investigator or member of the trial team) trained or experienced in working with children, regarding the trial, the risks and the benefits; Amendment 491 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Anja WEISGERBER, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 31 – paragraph 1 – point c (c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator ~~in accordance with his or her age and maturity;~~ Amendment 496 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Anja WEISGERBER, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Philippe JUVIN, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 31 – paragraph 1 – point h b (new) (hb) the corresponding scientific guidelines of the Agency have been followed; Amendment 498 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Anja WEISGERBER, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Philippe JUVIN, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 31 – paragraph 1 – point h d (new) (hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol; Amendment 513 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 32 – paragraph 1 – point e (e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject. Amendment 532 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Richard SEEBER 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 and to the public EudraPharm database a summary of the results of the clinical trial. Amendment 570 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 40 – paragraph 2 a (new) 2 a. The responsible Ethics Committee shall be involved in the assessment of this information. source: PE-506.158 2013/03/06 ENVI 17 amendments... Amendment 253 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Georgios KOUMOUTSAKOS Proposal for a regulation Article 4 a (new) Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work. Amendment 260 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Philippe JUVIN, Richard SEEBER, Georgios KOUMOUTSAKOS Proposal for a regulation Article 5 – paragraph 1 – subparagraph 2 The ~~sponsor shall propose one of the Member States concerned as reporting Member State~~Member States concerned shall determine which state shall be the reporting Member State according to an established procedure based on objective criteria which are set by the Commission. Amendment 264 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 5 – paragraph 1 – subparagraph 3 Where the proposed reporting Member State does not wish to be the reporting Member State, it shall agree with another Member State concerned that the latter will be the reporting Member State. If no Member State concerned accepts to be the reporting Member State, the proposed reporting Member State shall be the reporting Member State.deleted Amendment 269 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 5 – paragraph 2 – introductory part 2. Within ~~six~~14 days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following: Amendment 276 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Alda SOUSA, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG 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~~14 days, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State. Amendment 280 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG 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 ~~three~~seven days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State. Amendment 310 # Peter LIESE, Anne DELVAUX, Jolanta Emilia HIBNER, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG, Anna ROSBACH Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point a (a) within ~~10 days from the validation date~~25 days, but no earlier than 15 days after receipt of the successfully validated application, for low-intervention clinical trials; Amendment 313 # Peter LIESE, Anne DELVAUX, Jolanta Emilia HIBNER, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG, Anna ROSBACH Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point b (b) within ~~25 days from the validation date~~35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low- intervention clinical trials; Amendment 317 # Peter LIESE, Anne DELVAUX, Jolanta Emilia HIBNER, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG, Anna ROSBACH Proposal for a regulation Article 6 – paragraph 4 – subparagraph 1 – point c (c) within ~~30 days from the validation date~~40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product. Amendment 321 # Peter LIESE, Anna ROSBACH, Anne DELVAUX, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Philippe JUVIN, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG 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, it shall state the reasons for this deviation in the assessment report. Amendment 359 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 8 – paragraph 2 – subparagraph 3 a (new) Notwithstanding the first and second subparagraphs, in case of other conflict, the Member States involved shall attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision on the conclusion after having heard the Member States involved, and, if appropriate, having taken advice from the European Medicines Agency. Amendment 375 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Richard SEEBER 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, including a significant number of medical doctors, who collectively have the necessary qualifications and experience. Amendment 409 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Alda SOUSA, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Philippe JUVIN, Filip KACZMAREK, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 15 A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation. Amendment 412 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 17 – paragraph 2 – introductory part 2. Within ~~four~~ten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following: Amendment 425 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Filip KACZMAREK, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 20 – paragraph 5 – subparagraph 2 Notification shall be done by way of one single decision within ten days from the ~~validation date~~assessment date according to Article 6 (4). Amendment 454 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Alda SOUSA, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Horst SCHNELLHARDT, Elena Oana ANTONESCU, Richard SEEBER, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 28 – paragraph 1 – point d (d) the subject or, where the subject is not able to give informed consent, his or her legal representative has had the opportunity, in a prior interview with a medical doctor who is the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the clinical trial, and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment; Amendment 460 # Peter LIESE, Anne DELVAUX, Anna ROSBACH, Jolanta Emilia HIBNER, Margrete AUKEN, Thomas ULMER, Alojz PETERLE, Miroslav MIKOLÁŠIK, Paolo BARTOLOZZI, Zofija MAZEJ KUKOVIČ, Elena Oana ANTONESCU, Horst SCHNELLHARDT, Philippe JUVIN, Filip KACZMAREK, Richard SEEBER, Georgios KOUMOUTSAKOS, Dagmar ROTH-BEHRENDT, Jutta HAUG Proposal for a regulation Article 28 – paragraph 3 3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal. source: PE-506.160
12	2012/0267(COD) In vitro diagnostic medical devices 2013/05/13 ENVI 12 amendments... Amendment 86 # Peter LIESE, Alda SOUSA, Margrete AUKEN, Paolo BARTOLOZZI, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Zofija MAZEJ KUKOVIČ, Renate SOMMER, Miroslav MIKOLÁŠIK Proposal for a regulation Recital 27 (27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings. Amendment 111 # Peter LIESE, Christel SCHALDEMOSE, Alda SOUSA, Paolo BARTOLOZZI, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Zofija MAZEJ KUKOVIČ, Renate SOMMER, Mairead McGUINNESS, Richard SEEBER, Miroslav MIKOLÁŠIK Proposal for a regulation Article 1 – paragraph 6 6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders. Amendment 115 # Peter LIESE, Alda SOUSA, Margrete AUKEN, Paolo BARTOLOZZI, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Zofija MAZEJ KUKOVIČ, Renate SOMMER, Nora BERRA, Miroslav MIKOLÁŠIK Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 4 (4) ‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including testing services offered to lay persons by means of information society services; Amendment 120 # Peter LIESE, Christel SCHALDEMOSE, Alda SOUSA, Margrete AUKEN, Paolo BARTOLOZZI, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Zofija MAZEJ KUKOVIČ, Renate SOMMER, Mairead McGUINNESS, Richard SEEBER, Nora BERRA, Miroslav MIKOLÁŠIK Proposal for a regulation Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new) (12a) ‘ device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development. Amendment 144 # Peter LIESE, Christel SCHALDEMOSE, Alda SOUSA, Margrete AUKEN, Paolo BARTOLOZZI, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Zofija MAZEJ KUKOVIČ, Renate SOMMER, Mairead McGUINNESS, Richard SEEBER, Miroslav MIKOLÁŠIK Proposal for a regulation Article 4 a (new) be addressed by physicians qualified in genetic counselling. The form and extent of this genetic counselling shall be defined according to the implications of the results of the test and their significance for the person or the members of his or her family, including possible implications concerning procreation choices. 5. Consent. A device may only be used for the purpose of a genetic test after the person concerned has given free and informed consent to it. The consent has to be given explicitly and in writing. It can be revoked at any time in writing or orally. 6. Testing of minors. In case of minors the informed consent of the parents or legal representative shall be obtained; consent must represent the minor’s presumed will and may be revoked at any time, without detriment to the minor. In case of incapacitated adults not able to give informed legal consent, the informed consent of the legal representative shall be obtained; consent must represent the presumed will and may be revoked at any time, without detriment to the person. Devices predicting a genetic condition that has implications for diseases in adulthood or for family planning shall not be used in minors unless preventive means are available before reaching the age when the person tested is able to give consent. 7. A device may only be used for the determination of sex in connection with prenatal diagnosis, if the determination fulfils a medical purpose and if there is a risk of serious gender specific hereditary diseases. By way of derogation of Article 2(1) and (2) this also applies to products which are not intended to fulfil a specific medical purpose. 8. The provisions of this Article on the useArticle 4a 1. A device may only be used for the purpose of a genetic test if the indication is given by persons admitted to the medical profession under the applicable national legislation after a personal consultation. 2. A device may be used for purposes of a genetic test only in a way that the rights, safety and well-being of the subjects are protected and that the clinical data generated in the course of the genetic testing are going to be reliable and robust. 3. Information. Before using a device for the purpose of a genetic test the person mentioned in paragraph 1 shall provide the person concerned with appropriate information on the nature, the significance and the implications of the genetic test. 4. Genetic counselling. Appropriate genetic counselling is mandatory before using a device for the purpose of predictive and prenatal testing and after a genetic condition has been diagnosed. It shall include medical, ethical, social, psychological and legal aspects and has to of devices for the purpose of genetic tests do not prevent the Member States from maintaining or introducing for reasons of health protection or public order more stringent national legislation in this field. Amendment 174 # Peter LIESE, Alda SOUSA, Margrete AUKEN, Paolo BARTOLOZZI, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Zofija MAZEJ KUKOVIČ, Renate SOMMER, Miroslav MIKOLÁŠIK Proposal for a regulation Article 12 – paragraph 4 4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken. Amendment 177 # Peter LIESE, Paolo BARTOLOZZI, Anne DELVAUX, Thomas ULMER, Renate SOMMER, Miroslav MIKOLÁŠIK Proposal for a regulation Article 13 – paragraph 1 – point a (a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline~~, and at least two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices~~; Amendment 179 # Peter LIESE, Paolo BARTOLOZZI, Anne DELVAUX, Thomas ULMER, Renate SOMMER, Miroslav MIKOLÁŠIK Proposal for a regulation Article 13 – paragraph 1 – point b (b) ~~five~~two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. Amendment 189 # Peter LIESE, Alda SOUSA, Margrete AUKEN, Paolo BARTOLOZZI, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Renate SOMMER, Miroslav MIKOLÁŠIK Proposal for a regulation Article 22 – paragraph 8 – point e a (new) (ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices. Amendment 259 # Peter LIESE, Margrete AUKEN, Paolo BARTOLOZZI, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Zofija MAZEJ KUKOVIČ, Renate SOMMER, Miroslav MIKOLÁŠIK Proposal for a regulation Article 40 – paragraph 2 – subparagraph 2 In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, ~~when available, or with other solutions chosen by the manufacturer to ensure a level of safe~~as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and spe~~rformance that is at least equivalent, as specified in Section 5.4 of Annex VIII an~~cificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established in Sfection ~~3.5 of Annex IX~~. Amendment 282 # Peter LIESE, Margrete AUKEN, Paolo BARTOLOZZI, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Renate SOMMER, Miroslav MIKOLÁŠIK Proposal for a regulation Article 49 – paragraph 2 – subparagraph 1 a (new) In case of more than one Member State concerned, where there is a disagreement on whether the clinical performance study should be approved, the member states concerned shall make an attempt to agree on a conclusion. If no conclusion is found, the European Commission takes a decision after hearing the member states concerned, and if appropriate taking advice from EMA. Amendment 309 # Peter LIESE, Alda SOUSA, Margrete AUKEN, Paolo BARTOLOZZI, Anne DELVAUX, Anna ROSBACH, Thomas ULMER, Zofija MAZEJ KUKOVIČ, Renate SOMMER, Miroslav MIKOLÁŠIK Proposal for a regulation Article 59 – paragraph 3 – subparagraph 1 The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up. source: PE-510.740
5	2012/2103(INI) Energy roadmap 2050, a future with energy 2012/09/18 ENVI 5 amendments... Amendment 16 # Peter LIESE, Anne DELVAUX, Esther de LANGE, Richard SEEBER, Sophie AUCONIE Draft opinion Section 1 – paragraph 2 2. Finds it regrettable that the Commission has based all decarbonisation scenarios on the assumption of global climate action and has not carried out any analysis to identify the EU's ambitions in the event that global action is delayed; also regrets that the Commission has omitted to look into a scenario based on high levels of efficiency and renewable energy, which would be the most resilient to a higher oil price; Amendment 28 # Peter LIESE, Anne DELVAUX, Esther de LANGE, Sophie AUCONIE Draft opinion Section 1 – paragraph 3 3. Supports the conclusion that decarbonisation of the EU by 2050 is feasible and will require high levels of investments; calls on the Commission to create clarity and stability for investors by reducing over-regulation and by setting a clear, ~~technology-neutral goal~~ambitious and binding targets for emissions reductions, efficiency and renewable energy, based on a high efficiency and renewables scenario for 2030; Amendment 41 # Peter LIESE, Anne DELVAUX, Esther de LANGE, Sophie AUCONIE Draft opinion Section 1 – paragraph 4 4. Calls on the Commission to propose a clear 2030 goal by setting a ~~single~~n ambitious target for CO2 reduction which takes into account renewable energy and efficiency targets; reiterates the need to at the minimum meet the milestones for emission reduction stated in the low-carbon roadmap and to put forward a~~ll needed measure~~ppropriate levels for the various targets promptly; Amendment 54 # Peter LIESE, Anne DELVAUX, Esther de LANGE, Richard SEEBER, Sophie AUCONIE Draft opinion Section 1 – paragraph 5 5. Calls on the Commission to develop sound ways of financing the energy transition, including a strengthened ETS, innovation initiatives such as Horizon 2020, an increased involvement of the EIB in the finance of renewable energy and energy efficiency projects and market- based mechanisms; Amendment 62 # Peter LIESE, Anne DELVAUX, Esther de LANGE Draft opinion Section 1 – paragraph 6 6. Calls on the Commission to step up the development and deployment of low- carbon technologies and in particular, to strengthen the role of renewable energy sources – including by increasing their commercialisation, to step up the efficient use of energy sources, and to phase out fuel subsidies that encourage wasteful consumption and, together with other market deficits like market concentration, regulated energy prices and the lack of liquidity in intra-day and balancing markets, hinder the competitiveness of mature renewable energy technologies; source: PE-496.354

Anne DELVAUX on

Activities

Term 7 14.07.2009 / ...

All references link to europarl.eu

History

(these mark the time of scraping, not the official date of the change)

2013-05-03

active

changed

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2013-05-02

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2012-02-05

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Birth	added	date 1970-10-20 place Liège
CV	added	First university qualification in economics and social sciences, Catholic University of Louvain (1992). Degree in communication, Catholic University of Louvain (1994). Journalist at RTBF (Belgian French-language national broadcasting organisation) (1994-2007). Junior lecturer in journalism at the Catholic University of Louvain (2002-2007). Member of the Humanist Democratic Centre (since 2007). Senator and Chairwoman of the Federal Advisory Committee on European Affairs (2007-2009). Vice-President of the European Movement - Belgium (since 2007).
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Name	added	aliases annedelvaux delvaux anne DELVAUX DELVAUX Anne Anne DELVAUX AnneDELVAUX anne delvaux delvaux delvauxanne DELVAUXAnne full Anne DELVAUX sur Anne family DELVAUX familylc delvaux
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assistants	added	local MOULIN Yves accredited BOISDEQUIN Delphine BOLDRINI Sandra FRERE Luc

Facebook	added	http://www.facebook.com/pages/Anne-DELVAUX/191732377536227
Twitter	added	https://twitter.com/annedelvaux

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