On discharge in respect of the implementation of the general budget of the European Medicines Agency for the financial year 2022

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SUGGESTIONS

The Committee on the Environment, Public Health and Food Safety calls on the Committee on Budgets, as the committee responsible, to incorporate the following suggestions into its motion for a resolution:

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;

2. Notes that the EMA's total final appropriations for 2022 amounted to EUR 421 815 000, representing a 11,22% increase compared to the 2021 budget,

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;

4. Notes that 658 of the 662 authorised posts were occupied on 31 December 2022, compared to the 644 posts out of 657 in 2021;

5. Acknowledges that 2022 was still characterised by a significant level of COVID-19 related activities, with a shift from pre and initial marketing authorisation activities to post-authorisation activities

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.

7 Welcomes the fact that, following the cyberattack in December 2020, EMA has taken various measures to further enhance its cybersecurity capabilities, including the establishment in 2021-2022 of the Information Security Management Steering Committee, a senior-level governance board with the primary responsibility to oversee the implementation of the Agency’s Information Security Strategy;

8 Stresses that the replacement of animal testing shall be a priority in medicine development during the application of the 3Rs - replace, reduce and refine animal use for the development, manufacturing and testing of medicines– principles; notes that in November 2022, EMA activated a new Joint 3Rs Working Party of the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Veterinary Medicinal Products (CVMP).

9 Welcomes EMA’s implementation of the EU Regulation 2019/6 on Veterinary Medicinal Products Regulation, aiming to boost innovation and increase availability of safe and high-quality veterinary medicines for treating and preventing animal diseases, as well as the implementation of the EU Regulation 536/2014 on Clinical Trials.

10. Recommends, based on the facts available, that discharge be granted to the Executive Director of the European Medicines Agency in respect of the implementation of the EMA's budget for the financial year 2022.