Activities of Tiemo WÖLKEN related to 2023/2156(DEC)
Shadow opinions (1)
OPINION on discharge in respect of the implementation of the general budget of the European Medicines Agency for the financial year 2022
Amendments (6)
Amendment 2 #
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 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 4 #
Draft opinion
Paragraph 3 a (new)
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 #
Draft opinion
Paragraph 3 b (new)
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 #
Draft opinion
Paragraph 3 c (new)
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 17 #
Draft opinion
Paragraph 9 a (new)
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 19 #
Draft opinion
Paragraph 9 b (new)
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;