Events

Documents

• Text adopted by Parliament, single reading: T9-0245/2024
• Decision by Parliament: T9-0245/2024
• Debate in Parliament: Debate in Parliament
• Committee report tabled for plenary, single reading: A9-0133/2024
• Committee report tabled for plenary: A9-0133/2024
• Supplementary non-legislative basic document: 06180/2024
• Committee opinion: PE754.678
• Amendments tabled in committee: PE757.226
• Committee draft report: PE753.524
• Court of Auditors: opinion, report: OJ C 000 27.10.2023, p. 0000
• Court of Auditors: opinion, report: N9-0096/2023
• Non-legislative basic document: COM(2023)0391
• Non-legislative basic document: EUR-Lex
• Non-legislative basic document published: COM(2023)0391
• Non-legislative basic document published: EUR-Lex
• Non-legislative basic document: COM(2023)0391 EUR-Lex
• Court of Auditors: opinion, report: OJ C 000 27.10.2023, p. 0000 N9-0096/2023
• Committee draft report: PE753.524
• Amendments tabled in committee: PE757.226
• Committee opinion: PE754.678
• Supplementary non-legislative basic document: 06180/2024
• Committee report tabled for plenary, single reading: A9-0133/2024
• Text adopted by Parliament, single reading: T9-0245/2024

Amendments

Dossier

20

2023/2156(DEC) 2023/12/04 ENVI 20 amendments... Amendment 1 # Bas EICKHOUT Draft opinion Paragraph 1 1. Reiterates the key role of the European Medicines Agency ('the EMA') in protecting and promoting human and animal public health by assessing and supervising medicines for human or veterinary use and protecting public health by raising awareness on key issues including antimicrobial resistance and prevention of communicable diseases through vaccination; Amendment 10 # Cristian TERHEŞ, Emmanouil FRAGKOS, Robert ROOS Draft opinion Paragraph 6 b (new) 6 b. Notes with deep concern that the "COVID-19 vaccines safety update" report released periodically by the European Medicines Agency shows many side effects including 12,000 spontaneous reports of fatal outcomes in the EU; 2a _________________ 2a https://www.ema.europa.eu/en/human- regulatory/overview/public-health- threats/coronavirus-disease-covid- 19/covid-19-medicines/safety-covid-19- vaccines Amendment 11 # Bas EICKHOUT Draft opinion Paragraph 7 a (new) 7 a. Notes that in 2022, the Agency received 676 requests for access to documents less compared to 2019 (783 requests) or 2021 (710 request) and released 216,666 pages, more compared to 165,943 in 2021 but considerable less than the 318,013 in 2019; notes that the Agency applies a queuing mechanism to manage processing of multiple access to documents requests from the same requester representing a bottleneck for a timely access to documents held by EMA and discouraging requesters to introduce new requests; calls on the Agency to provide detailed information on the number of access to documents requests remaining inactivated in the queuing system and the average time spent in the queuing system before being activated; calls on for a launch of an audit on EMA rules to process access to documents requests, the queuing mechanism, their evolution over time and the effects on applicants; Amendment 12 # Alexandr VONDRA Draft opinion Paragraph 7 a (new) 7 a. 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, for monitoring vaccine safety and reporting side effects, as well as on antimicrobial consumption and resistance; Amendment 13 # Bas EICKHOUT Draft opinion Paragraph 8 a (new) 8 a. Notes with regret that the publication of clinical data and clinical study reports, initiated in 2016, was put on hold at the end of 2018 due to the relocation from London to Amsterdam and subsequently due to the Covid-19 pandemic; welcomes the announcement for a phased restart of clinical data publication for centrally authorised medicines beyond the scope of COVID-19. Calls on the Agency to stick to the transparency rules and obligations laid down in the Clinical Trials Regulation adopted in 2014 as well as in the Regulation 1049/2001; Amendment 14 # Bas EICKHOUT Draft opinion Paragraph 8 b (new) 8 b. Calls on the Commission to ensure that EMA receives adequate resources to implement the tasks that were assigned to the Agency by adoption of the Clinical Trials Regulation and avoid staff shortages that will negatively affect the Agency’s transparency policy, including in regards of timely publication of clinical data, meeting minutes and timely responses to the access to documents requests; regrets that in order to comply with its new obligations. Amendment 15 # Cristian-Silviu BUŞOI Draft opinion Paragraph 9 a (new) 9 a. Notes that potential liabilities arising, until June 2039, from the lease on the Agency’s former office premises in London remain an ongoing issue; recalls, based on the Court’s report of 2022, that on 31 December 2022, the total estimated outstanding rent, associated services charges and landlord insurance to be paid by the EMA up to the end of the lease term was €366 million; welcomes the efforts of the Agency to sublet its former premises since July 2019 to a company belonging to the WeWork group; notes with concern the uncertainties surrounding the financial performance of the WeWork group which, on 6 November 2023, filed for Chapter 11 of the US Bankruptcy Code for its branches in the US and Canada. Acknowledges that subletting the Agency’s premises in a third country is not in line with its founding Regulation (EC) 726/2004 and that it requires the Agency to divert significant resources from its public health activities; notes that the situation has not been resolved after four years since the European Parliament first asked for a political resolution on the matter; urgently calls on the Commission to secure a long-term political resolution of this issue and to allow the Agency to fully focus its efforts on its public health mission; Amendment 16 # Stanislav POLČÁK Draft opinion Paragraph 9 a (new) 9a. Notes that in March, the EMA started to operate under a new extended mandate which recognises the role played by the Agency during the pandemic and gives it additional responsibilities in the area of coordination and crisis response; notes, in this context, that it is essential to ensure funding commensurate with this extended mandate in the future; Amendment 17 # Tiemo WÖLKEN Draft opinion Paragraph 9 a (new) 9 a. Welcomes the fact that the Court of Auditors has stated that it has obtained reasonable assurances that the EMA’s annual accounts for 2022 are reliable and that the underlying transactions are legal and regular; Amendment 18 # Stanislav POLČÁK Draft opinion Paragraph 9 b (new) 9b. Notes that this extended mandate also provides the framework for the creation of DARWIN EU, a model for gathering real evidence from across the EU on diseases, populations and the use and efficacy of medicines and vaccines throughout their lifecycle; sees this as a potentially major change in medicines regulation; Amendment 19 # Tiemo WÖLKEN Draft opinion Paragraph 9 b (new) 9 b. Invites the EMA to continue promoting cooperation with other Union agencies and international organisations, and fostering dialogue with stakeholders and citizens; Amendment 2 # Tiemo WÖLKEN Draft opinion Paragraph 1 1. Reiterates the key role of the European Medicines Agency ('the EMA') in protecting and promoting human and animal public health by fostering scientific excellence in assessing and supervising medicines for human or veterinary use for the benefit of public and animal health in the Union; Amendment 20 # Stanislav POLČÁK Draft opinion Paragraph 9 c (new) 9c. Welcomes the fact that 52% of applicants who have been granted a positive opinion for their medicinal product have received scientific advice or protocol assistance from the EMA during the development phase of their product, with this figure rising to 78% for applicants for medicinal products with new active substances; is of the opinion that early advice has the potential to significantly streamline the approval process and lead to the development of safe and effective medicinal products; Amendment 3 # Bas EICKHOUT Draft opinion Paragraph 3 3. Recalls that the EMA is a fee- funded agency, with 88,27 % of its 2022 revenue stemming from fees paid by the pharmaceutical industry for services provided, 11,70 % stemming from the Union budget and 0,02 % from various other sources; Stresses that despite the majority of funding coming from private sources, the EMA is a public authority; underlines that public trust and guarantee of the Agency’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 pharmaceutical legal and regulatory framework in the EU; Amendment 4 # Tiemo WÖLKEN Draft opinion Paragraph 3 a (new) 3 a. Notes with concern ongoing property-related obligations in regards to the Agencys former premises in London; takes good note of the fact that the Agency and its Management Board are concerned that the Agency must on top of its tasks also manage commercial property in a third country leading to a diversion of its human and financial resources from its public health responsibilities for the EU citizens; Notes with concern that this situation on subletting its former London premises will continue until 2039; takes note that on 31 December 2022, the total estimated outstanding rent, associated services charges and landlord insurance to be paid by the Agency up to the end of the lease term was €366 million; Amendment 5 # Tiemo WÖLKEN Draft opinion Paragraph 3 b (new) 3 b. Stresses that despite the majority of funding coming from private sources, the EMA is a public authority; underlines that public trust and guarantee of the Agency’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 pharmaceutical legal and regulatory framework in the EU; Amendment 6 # Tiemo WÖLKEN Draft opinion Paragraph 3 c (new) 3 c. Notes however that inadequate resources for the EMA may undermine the ability of the Agency to deliver on its mission and calls on the Commission and Council to allocate adequate EU funding to ensure the Agency has enough resources to carry out all of its activities on the wide range of regulatory mechanisms including facilitating the development and access to medicines, supporting research and innovation and its responsibilities for monitoring and mitigating potential or actual shortages of critical medicines without any delay; Amendment 7 # Bas EICKHOUT Draft opinion Paragraph 4 a (new) 4 a. Welcomes the extension of the EMA’s mandate; underlines that this addition of new tasks and its increasing workload needs to be accompanied by adequate corresponding increases in the staff and resources, and that a shortage of staff puts the continuity of its operations under significant pressure and threatens the quality of the EMA’s work. Amendment 8 # Bas EICKHOUT Draft opinion Paragraph 6 6. Notes that EMA recommended in 2022 marketing authorisation for 89 new human medicines, including 41 new active substances, and 10 new veterinary medicines, including 3 new active substances and 2 vaccines.; reiterates that transparency and the timely release of information about medicines is key to reinforcing public trust in regulatory decisions and the medicines placed onto the EU market; Amendment 9 # Cristian TERHEŞ, Emmanouil FRAGKOS, Robert ROOS Draft opinion Paragraph 6 a (new) 6 a. Notes the role that the EMA plays in implementing measures to enable flexible regulatory processes and stresses the fact that EMA did not ensure the safety and efficacy of the authorised vaccines; Notes that the conditional market authorisation to COVID-19 vaccines was granted under the condition that the benefits of the vaccines far outweighed their potential risks; Notes that this condition was not met since in the COVI committee hearing the Pfizer representative Janine Small has specifically stated that, when the vaccines have entered the market, they "did not know if the vaccines are stopping the spread of the virus", as well as commissioner Didier Reynders has stated in the European Parliament Plenary in Strasbourg on 28 April 2021 that, "while putting in place the Digital Green Certificate, we have to live with the fact that there are still scientific uncertainties regarding COVID-19. We do not yet have full scientific evidence about the effects of vaccination or recovery from the virus"; 1a _________________ 1a https://multimedia.europarl.europa.eu/en/ webstreaming/covi-committee- meeting_20221010-1430-COMMITTEE- COVI; https://www.europarl.europa.eu/doceo/doc ument/CRE-9-2021-04-28-ITM- 004_EN.html source: 757.131

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