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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-AD-754678

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

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The Committee on the Environment, Public Health and Food Safety gives its opinion to the Committee on Budgetary Control on discharge for the European Medicines Agency's 2022 budget. It recommends granting discharge and sets out findings on the Agency's funding, staff, transparency and tasks. It notes the Agency's 2022 budget of EUR 421 815 000, mostly funded by pharmaceutical industry fees, and stresses the need for transparency and independence. It raises concern over the former London premises and the outstanding rent of €366 million. It calls on the Commission and Council to give the Agency adequate resources and staff for its extended mandate, and asks the Commission to secure a long-term political resolution of the London property issue. It welcomes the Agency's cybersecurity measures, cooperation with other agencies, work on replacing animal testing, and restart of clinical data publication, and calls for an audit of its access-to-documents queuing system.

Committee position. The Committee on the Environment, Public Health and Food Safety recommends, based on the facts available, that discharge be granted to the Executive Director of the European Medicines Agency for the 2022 financial year, and asks the Committee on Budgetary Control to incorporate its suggestions into its motion for a resolution.

Key points

  1. Reiterates the EMA's key role in protecting human and animal health, including raising awareness on antimicrobial resistance and vaccination.
  2. Notes the EMA's 2022 final appropriations of EUR 421 815 000, an 11,22% increase on 2021.
  3. Recalls that 88,27% of 2022 revenue came from pharmaceutical industry fees, 11,70% from the Union budget and 0,02% from other sources, and stresses the EMA is a public authority needing transparency to avoid regulatory capture.
  4. Raises concern over the EMA's former London premises, with outstanding rent and charges of €366 million to the end of the lease in 2039, and calls on the Commission to secure a long-term political resolution.
  5. Calls on the Commission and Council to allocate adequate EU funding so the EMA can carry out all its activities, including on medicine shortages.
  6. Notes that 658 of 662 authorised posts were occupied on 31 December 2022, and that the extended mandate's new tasks need matching staff and resources.
  7. Notes that in 2022 the EMA recommended marketing authorisation for 89 new human medicines and 10 new veterinary medicines, and stresses timely transparency about medicines.
  8. Welcomes the EMA's post-cyberattack cybersecurity measures, including the Information Security Management Steering Committee.
  9. Notes the EMA received 676 access-to-documents requests in 2022 and released 216,666 pages, and calls for detailed information on its queuing system and an audit of its access-to-documents rules.
  10. Welcomes the EMA's cooperation with the European Centre for Disease Prevention and Control and the European Food Safety Authority, and its work on the 3Rs to replace animal testing.
  11. Welcomes the phased restart of clinical data publication and calls on the EMA to stick to transparency rules under the Clinical Trials Regulation and Regulation 1049/2001.
  12. Welcomes the Court of Auditors' reasonable assurance that the EMA's 2022 annual accounts are reliable and its transactions legal and regular, and recommends granting discharge to the Executive Director.

Who is affected

  • The European Medicines Agency: its 2022 budget, staff, property and transparency practices are assessed.
  • The Commission and Council: asked to allocate adequate funding and resolve the London premises issue.
  • The pharmaceutical industry: pays fees that make up most of the EMA's revenue.
  • Applicants for medicine authorisations: benefit from early scientific advice and transparency.

Figures and deadlines

  • EUR 421 815 000: the EMA's total final appropriations for 2022.
  • 11,22%: increase in the EMA's 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 other sources.
  • €366 million: estimated outstanding rent, service charges and insurance for the former London premises to the end of the lease.
  • 2039: year until which the London premises subletting situation will continue.
  • 658 of 662: authorised posts occupied on 31 December 2022.