2019/2073(DEC) 2018 discharge: European Medicines Agency (EMA)
Next event: Indicative plenary sitting date, 1st reading/single reading 2020/03/31
Lead committee dossier:
Next event: Indicative plenary sitting date, 1st reading/single reading 2020/03/31
Progress: Awaiting committee decision
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | CONT | CZARNECKI Ryszard ( ECR) | NOVAKOV Andrey ( EPP), WOLTERS Lara ( S&D), CSEH Katalin ( Renew), KUHS Joachim ( ID), EICKHOUT Bas ( Verts/ALE), OMARJEE Younous ( GUE/NGL) |
Committee Opinion | ENVI | CANFIN Pascal ( Renew) | Stanislav POLČÁK ( PPE) |
Lead committee dossier:
Subjects
Events
2020/03/31
Indicative plenary sitting date, 1st reading/single reading
2020/01/22
EP - Committee opinion
Documents
2019/12/05
EP - Committee draft report
Documents
2019/10/01
EP - CZARNECKI Ryszard (ECR) appointed as rapporteur in CONT
2019/09/18
EP - Committee referral announced in Parliament, 1st reading/single reading
2019/09/04
EP - CANFIN Pascal (Renew) appointed as rapporteur in ENVI
2019/06/27
EC - Non-legislative basic document
Documents
2019/06/27
EC - Non-legislative basic document published
Documents
Documents
- Committee opinion: PE641.162
- Committee draft report: PE639.917
- Non-legislative basic document: COM(2019)0316
- Non-legislative basic document: EUR-Lex
- Non-legislative basic document published: COM(2019)0316
- Non-legislative basic document published: EUR-Lex
- Non-legislative basic document: COM(2019)0316 EUR-Lex
- Committee draft report: PE639.917
- Committee opinion: PE641.162
Amendments | Dossier |
7 |
2019/2073(DEC)
2019/12/11
ENVI
7 amendments...
Amendment 1 #
Draft opinion Paragraph 2 2. Recalls that the Agency is a fee- funded agency, with 89,69 % of its 2018 revenue stemming from fees paid by the pharmaceutical industry, 10,28 % stemming from the Union budget and 0,03 % stemming from external assigned revenue; and stresses its concerns that the high reliance on direct fees from industry may compromise the public perception of the Agency's independence;
Amendment 2 #
Draft opinion Paragraph 5 5. Stresses that a number of the Agency’s activities were scaled back, delayed or postponed due to Brexit or other external circumstances; notes with concern that the Agency pointed to a lack of adequate resources for facing a workload that is increasing due to new tasks and legislation, and specifically to the loss of short term contract staff due to relocation and specifics of labour legislation in the Netherlands; calls on all the relvant authorities, including the Dutch authorities, to take action to ensure that the agency is moved as quickly and efficiently as possible to its permanent headquarters so that its work and the assessment of medicine safety are not adversely affected;
Amendment 3 #
Draft opinion Paragraph 5 5. Stresses that a number of the Agency’s activities were scaled back, delayed or postponed due to Brexit or other external circumstances; notes with concern that the Agency pointed to a lack of adequate resources for facing a workload that is increasing due to new tasks and legislation, and specifically to the loss of short term contract staff due to relocation and specifics of labour legislation in the Netherlands; regrets that the implementation of the Agency's policy on publication of clinical data has been put on hold as part of its business continuity plan, which was put in place to deal with the consequences of Brexit;
Amendment 4 #
Draft opinion Paragraph 6 6. Highlights the fact that in 2018, the Agency recommended 94 new medicines for marketing authorisation (84 for human use and 10 for veterinary use), and that those included 46 new active substances (42 for human use and 4 for veterinary use);
Amendment 5 #
Draft opinion Paragraph 7 7. Notes that in 2018 the second and third phases of the business continuity plan were implemented, in order to safeguard the core activities of the Agency; stresses, in this respect, the need to ensure maximum transparency, expertise and independence in the agency's work;
Amendment 6 #
Draft opinion Paragraph 8 8. Is concerned about the delays observed in the development of the EU clinical trials portal and database; draws attention, in that connection, to the need to solve the problem of the agency's IT infrastructure, which is under heavy strain;
Amendment 7 #
Draft opinion Paragraph 8 a (new) 8 a. Welcomes that, in February 2018, the General Court upheld, in three landmark judgments, the Agency's decision to release documents in accordance with Regulation (EC) No 1049/20011a regarding public access to European Parliament, Council and Commission documents; whereas two decisions of the General Court have been appealed by pharmaceutical companies; _________________ 1aRegulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
source: 641.163
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