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DRAFT OPINION (2023/2156(DEC))

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

ENVI-PA-754678

Committee on the Environment, Public Health and Food Safety · Rapporteur: Pascal Canfin

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This is a draft opinion by Parliament's Committee on the Environment, Public Health and Food Safety on granting discharge to the European Medicines Agency for its 2022 budget. It recommends discharge and sets out findings on the agency's budget, revenue, staffing, medicines authorisations, cybersecurity, animal testing and veterinary rules.

Committee position. The committee recommends, based on the facts available, that discharge be granted to the Executive Director of the European Medicines Agency for the implementation of its 2022 budget, and asks the Committee on Budgets to include its suggestions in the discharge resolution.

Key points

  1. The committee calls on the Committee on Budgets to include its suggestions in the discharge resolution.
  2. It restates the European Medicines Agency's role in protecting human and animal public health by assessing and supervising medicines.
  3. It notes the agency's total final appropriations for 2022 of EUR 421 815 000, an 11,22% increase on 2021.
  4. It recalls that the agency is fee-funded: 88,27% of 2022 revenue came from pharmaceutical industry fees, 11,70% from the Union budget and 0,02% from other sources.
  5. It notes that 658 of 662 authorised posts were occupied on 31 December 2022, against 644 of 657 in 2021.
  6. It acknowledges that 2022 still involved significant COVID-19 related activities, shifting from pre- and initial marketing authorisation to post-authorisation activities.
  7. It notes that the agency recommended marketing authorisation in 2022 for 89 new human medicines, including 41 new active substances, and 10 new veterinary medicines, including 3 new active substances and 2 vaccines.
  8. It welcomes measures taken after the December 2020 cyberattack, including the 2021-2022 Information Security Management Steering Committee overseeing the agency's information security strategy.
  9. It stresses that replacing animal testing should be a priority under the 3Rs principles, and notes the November 2022 launch of a joint 3Rs working party of the human and veterinary medicines committees.
  10. It welcomes the agency's implementation of Regulation 2019/6 on veterinary medicinal products and Regulation 536/2014 on clinical trials.
  11. It recommends that discharge be granted to the agency's Executive Director for the implementation of the 2022 budget.

Who is affected

  • The European Medicines Agency: the opinion recommends granting discharge for its 2022 budget and reviews its finances and activities.
  • The pharmaceutical industry: it pays fees that made up 88,27% of the agency's 2022 revenue.
  • The Committee on Budgets: it is asked to incorporate the suggestions into its discharge resolution.

Figures and deadlines

  • EUR 421 815 000 — the agency's total final appropriations for 2022.
  • 11,22% — the increase in the 2022 budget compared to 2021.
  • 88,27% — share of 2022 revenue from pharmaceutical industry fees.
  • 11,70% — share of 2022 revenue from the Union budget.
  • 0,02% — share of 2022 revenue from various other sources.
  • 658 of 662 — authorised posts occupied on 31 December 2022.
  • 644 posts out of 657 — occupied in 2021.
  • 89 new human medicines, including 41 new active substances, and 10 new veterinary medicines, including 3 new active substances and 2 vaccines — recommended for marketing authorisation in 2022.