2021/2132(DEC) 2020 discharge: European Medicines Agency (EMA)
Lead committee dossier:
Progress: Procedure completed, awaiting publication in Official Journal
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | CONT | ZDECHOVSKÝ Tomáš ( EPP) | CHINNICI Caterina ( S&D), CSEH Katalin ( Renew), EICKHOUT Bas ( Verts/ALE), KUHS Joachim ( ID), CZARNECKI Ryszard ( ECR), OMARJEE Younous ( GUE/NGL) |
Committee Opinion | ENVI | CANFIN Pascal ( Renew) | Monika BEŇOVÁ ( S&D), Kateřina KONEČNÁ ( GUE/NGL), Ljudmila NOVAK ( PPE), Michèle RIVASI ( Verts/ALE), Alexandr VONDRA ( ECR) |
Lead committee dossier:
Subjects
Events
2022/05/04
EP - Text adopted by Parliament, single reading
Documents
2022/05/04
EP - Debate in Parliament
2022/05/04
EP - Decision by Parliament
Documents
2022/04/07
EP - Committee report tabled for plenary, single reading
Documents
2022/04/07
EP - Committee report tabled for plenary
Documents
2022/03/31
EP - Vote in committee
2022/03/29
EP - Amendments tabled in committee
Documents
2022/03/02
EP - Amendments tabled in committee
Documents
2022/02/16
CSL - Supplementary non-legislative basic document
Documents
2022/01/19
EP - Committee draft report
Documents
2022/01/17
EP - Committee opinion
Documents
2021/09/29
EP - CANFIN Pascal (Renew) appointed as rapporteur in ENVI
2021/09/14
EP - Committee referral announced in Parliament
2021/07/28
EP - ZDECHOVSKÝ Tomáš (EPP) appointed as rapporteur in CONT
2021/06/30
EC - Non-legislative basic document
Documents
2021/06/30
EC - Non-legislative basic document published
Documents
Documents
- Text adopted by Parliament, single reading: T9-0161/2022
- Decision by Parliament: T9-0161/2022
- Committee report tabled for plenary, single reading: A9-0103/2022
- Committee report tabled for plenary: A9-0103/2022
- Amendments tabled in committee: PE729.970
- Amendments tabled in committee: PE704.733
- Supplementary non-legislative basic document: 06003/2022
- Committee draft report: PE698.974
- Committee opinion: PE699.211
- Non-legislative basic document: COM(2021)0381
- Non-legislative basic document: EUR-Lex
- Non-legislative basic document published: COM(2021)0381
- Non-legislative basic document published: EUR-Lex
- Non-legislative basic document: COM(2021)0381 EUR-Lex
- Committee opinion: PE699.211
- Committee draft report: PE698.974
- Supplementary non-legislative basic document: 06003/2022
- Amendments tabled in committee: PE704.733
- Amendments tabled in committee: PE729.970
- Committee report tabled for plenary, single reading: A9-0103/2022
- Text adopted by Parliament, single reading: T9-0161/2022
Votes
Décharge 2020: Agence européenne des médicaments - Discharge 2020: European Medicines Agency - Entlastung 2020: Europäische Arzneimittel-Agentur - A9-0103/2022 - Tomáš Zdechovský - Proposition de résolution (ensemble du texte) #
2022/05/04 Outcome: +: 559, -: 55, 0: 27
Amendments | Dossier |
20 |
2021/2132(DEC)
2021/12/08
ENVI
20 amendments...
Amendment 1 #
Draft opinion Paragraph 1 1. Emphasises the important role of the European Medicines Agency (‘the EMA') in protecting and promoting
Amendment 10 #
Draft opinion Paragraph 10 a (new) 10a. Recommends, in particular, that sufficient additional resources be allocated to the EMA to improve its competence in the fight against medicine shortages. Invites the European Commission to evaluate in detail the feasibility of granting the EMA additional capacity to manage shortages, incorporating the desirable future transformation of the European Shortages Monitoring Platform into a proper and effective common European database;
Amendment 11 #
Draft opinion Paragraph 11 11.
Amendment 12 #
Draft opinion Paragraph 11 a (new) 11a. Notes with satisfaction the exceptional transparency measures the EMA implemented with regard to medicines for COVID-19, including accelerated publication timelines for clinical data and providing more information to the general public such as publication of the product information with details of the conditions of use at the time of the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) on the marketing authorisation application; publication of the full European public assessment report (EPAR), within three days of authorisation by the Commission; publication of clinical data submitted to the EMA in support of the applications for COVID-19 medicines after the authorisation of a medicine and once personal data have been anonymised; and the publication of the full risk management plan for authorised COVID- 19 medicines; invites the EMA to apply the same transparency measures to all products regulated by the EMA;
Amendment 13 #
Draft opinion Paragraph 14 14. Notes,
Amendment 14 #
Draft opinion Paragraph 14 14. Notes,
Amendment 15 #
Draft opinion Paragraph 15 15. Notes with satisfaction that the EMA cooperates with other agencies, in particular with the European Centre for Disease Prevention and Control and with the European Food Safety Authority, including on the European Vaccination Information Portal
Amendment 16 #
Draft opinion Paragraph 15 a (new) 15a. Highlights the importance of involving the relevant stakeholders, such as representatives of health professionals, of patients and of other parties, in the light of the alarming prevalence of disinformation regarding the COVID-19 pandemic in the conversation on protection of public health and calls on the EMA to continue the development of this conversation as actively as possible, based on the latest scientific knowledge;
Amendment 17 #
Draft opinion Paragraph 15 b (new) 15b. Welcomes the fact that tackling increasing antimicrobial resistance (in particular through supporting the development of new medicines, collecting data on veterinary antimicrobial consumption and promoting responsible use of such medicines) remains one of the EMA’s priorities, even in the light of the current situation;
Amendment 18 #
Draft opinion Paragraph 15 c (new) 15c. Emphasises that the COVID-19 pandemic is impacting all aspects of health care, including the availability of medicines due to supply chain disruptions; considers that the situation has only served to highlight the need, of which we were already aware, to ensure the highest possible level of self- sufficiency in the development and production of medicines within the European Union; welcomes the EMA’s commitment to continue contributing to the development and strengthening of the European Union’s response system in the event of reduced availability of medicines;
Amendment 19 #
Draft opinion Paragraph 15 d (new) 15d. Welcomes the level of assistance that the EMA has provided to companies developing vaccines and medicines against COVID-19; lauds its consistently scientific approach, which places the health of EU citizens above all else;
Amendment 2 #
Draft opinion Paragraph 1 1. Emphasises the important role of the European Medicines Agency (‘the EMA') in protecting and promoting public human and animal health by making independent, science-based recommendations on the quality, safety and efficacy of medicines, and providing scientific advice and incentives to stimulate the development and improve the availability of innovative new medicines;
Amendment 20 #
Draft opinion Paragraph 15 e (new) 15e. Welcomes the EMA’s efforts to increase the level of transparency of its decision-making, as evidenced, for example, by the publication of data from clinical trials submitted in the marketing authorisation process for COVID-19 medicines or the increased level of communication with the media and the public; feels that this transparent approach is crucial in the current situation;
Amendment 3 #
Draft opinion Paragraph 2 2. Notes that
Amendment 4 #
Draft opinion Paragraph 2 2. Notes that, owing to the global COVID-19 pandemic, 2020 was an extremely challenging year for the EMA, requiring a shift in its priorities and extreme agility and resilience to maintain the EMA’s activities while supporting enhanced collaboration between Member States to manage the supply of medicines and global efforts to combat the pandemic in a new and challenging environment;
Amendment 5 #
Draft opinion Paragraph 5 a (new) 5a. Stresses that despite the majority of funding coming from private sources, the EMA is a public authority; underlines that the perception of the EMA’s independence and integrity is crucial and therefore a high degree of transparency needs to be ensured through all its activities to avoid regulatory capture and ensure citizens maintain their faith in the marketing authorisation system in the Union;
Amendment 6 #
Draft opinion Paragraph 6 6.
Amendment 7 #
Draft opinion Paragraph 8 8. Is pleased that the EMA successfully maintained the quality and continuity of its operations whilst relocating its seat to its final premises in Amsterdam following the United Kingdom’s withdrawal from the Union; notes that potential liabilities arising from the lease on the EMA’s former office premises in London remain a matter of concern; recognises that the EMA was able to respond effectively to the workload associated with the COVID-19 pandemic and welcomes the work on facilitating access to new vaccines and therapeutics to treat and prevent the spread of COVID- 19;
Amendment 8 #
Draft opinion Paragraph 10 10. Welcomes the proposal to extend the EMA’s mandate but expresses concern that the addition of significant new tasks and its increasing workload over the years has not been accompanied by sufficient corresponding increases in the EMA's staff and resources, and that such a shortage of staff puts the continuity of its operations under significant pressure and threatens the quality of the EMA's work;
Amendment 9 #
Draft opinion Paragraph 10 10. Welcomes the proposal to extend the EMA’s mandate but expresses concern that the addition of significant new tasks and its increasing workload over the years has not been accompanied by corresponding increases in the EMA's staff and resources, and that such a shortage of staff puts the continuity of its operations under significant pressure at an already critical time;
source: 700.624
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