Activities of Bas EICKHOUT related to 2023/2156(DEC)
Shadow reports (1)
REPORT on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2022
Amendments (7)
Amendment 1 #
Draft opinion
Paragraph 1
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 3 #
Draft opinion
Paragraph 3
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 7 #
Draft opinion
Paragraph 4 a (new)
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 #
Draft opinion
Paragraph 6
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 11 #
Draft opinion
Paragraph 7 a (new)
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 13 #
Draft opinion
Paragraph 8 a (new)
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 #
Draft opinion
Paragraph 8 b (new)
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.