On discharge in respect of the implementation of the budget of the EU agencies for the financial year 2024

OPINION

The Committee on Public Health calls on the Committee on Budgetary Control, as the committee responsible, to incorporate the following into its motion for a resolution:

Part I – Discharge in respect of the implementation of the budget of the European Centre for Disease Prevention and Control for the financial year 2024

1. Takes note that the European Centre for Disease Prevention and Control (ECDC) core budget for 2024 amounted to EUR 93.9 million, representing an increase of 4.2% compared with the 2023 budget; notes further that the implementation rate of commitment appropriations reached 99.1%, while 74.7% of the total budget was paid during the year; observes that EUR 22.8 million was carried forward from 2023 into 2024, of which EUR 21.9 million was paid, corresponding to a utilisation rate of 95.8%; considers that these figures reflect sound financial management and a high level of budget execution;

2. Notes that, in 2024, the ECDC successfully completed or was in the process of completing 99% of the outputs set out in its Single Programming Document (SPD) 2024–2026; observes that, out of a total of 122 defined outputs, 76 were completed, 45 were ongoing, and one output was postponed; considers this to reflect a very high level of implementation and effective operational planning;

3. Notes that, as part of the review of its mandate, the ECDC received an additional 73 posts (comprising both Temporary Agents and Contract Agents) during the period 2021–2024; observes that 2024 was again characterised by a high level of recruitment activity, driven by the increase in authorised posts, the implementation of the Early Warning and Response System (EWRS) project, and a significant number of replacement recruitments;

4. Notes that, in August 2024, the ECDC activated its Public Health Emergency (PHE) plan for a period of approximately five weeks, in response to the expansion of mpox caused by MP clade II in the Democratic Republic of the Congo (DRC); acknowledges that the activation of the PHE plan enabled the Centre to reallocate essential resources in order to support the European Union (EU) Member States and the European Commission; notes that, during this period, ECDC published multiple epidemiological updates, including the development of a methodology for assessing mpox clade II transmission patterns at both the national and global levels;

5. Recalls that the European Court of Auditors criticised the Centre’s communication during the COVID-19 pandemic for being insufficiently clear and understandable to the wider public; takes note that the ECDC continues to face challenges in making its technical outputs accessible to the general public, as scientific reports are often drafted in language primarily aimed at professionals and policymakers rather than lay audiences; acknowledges the need to further strengthen the clarity and accessibility of the Centre’s public communication; notes, in this regard, that ECDC’s new Director, Pamela Rendi-Wagner, has emphasised the importance of improving public engagement and messaging;

6. Stresses that gender balance in the composition of the top management of EU’s agencies and institutions must be a guideline; notes that the Centre’s senior management is currently composed of 67% men and 33% women (the same as it was in 2023), according to the figures communicated; calls on the ECDC to take this into consideration in future recruitments.

Part II – Discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2024

1. Notes that the total budget for 2024 (revenues and expenditure) amounted to EUR 478,482,000, representing a 6.8% increase compared with the 2023 budget (EUR 448,003,000); notes further that four amending budgets were adopted during the year, increasing the budget appropriations by EUR 13,380,000 to cover the rent for the London premises, as well as part of the salary adjustment applicable from July 2024; observes that the draft financial outturn for 2024 shows a surplus of EUR 4,594,984.37, corresponding to 0.9% of the approved budget (EUR 491,862,000, including amending budgets), compared with a surplus of EUR 20,939 (0.005%) in 2023;

2. Notes with concern that the situation regarding Agency’s premises in London became increasingly challenging; stresses that three of the four amending budgets processed in 2024 were required to increase the EC contribution and the miscellaneous revenue to cover part of the rent for the London premises; regrets that the matter has a potential impact on the Agency’s capacity to focus on its core activities and to deliver its public and animal health objectives; calls on the Commission to secure a long-term political resolution of this issue;

3. Notes that the European Medicines Agency (EMA) is a largely fee-funded agency, with 89.78% of its 2024 C1 revenue stemming from fees paid by the pharmaceutical industry for services provided. which is a further increase from 88.21% in 2023; notes with concern that only 21 companies provided half of these fees received for drug authorisations; regrets that this funding structure raises long-term concerns of creating a conflict of interest and compromise independence in drug evaluation, supervision, and safety monitoring;

4. Notes that in 2024, the EMA recommended 114 new human medicines for marketing authorisation, including 46 new active substances, and 25 new veterinary medicines, including 2 new active substances, and one positive opinion adopted recommending one new maximum residue limit (MRL); notes that 6 PRIME-designated medicines were recommended for approval, helping patients to benefit as early as possible from promising medicines that target unmet medical needs; welcomes the Agency’s maintenance of 15 orphan status designations under the EU framework for orphan medicines, the purpose of which is to encourage the development and marketing of medicines for patients with rare diseases;

5. Notes that the adoption of Regulation (EU) 2024/568 on fees and charges payable to the EMA represents an important milestone in strengthening the financial sustainability of the European medicines regulatory network; notes that the transition to the new fee system required extensive collaboration across the Agency, involving over 100 experts to optimise processes, integrate regulatory and fee systems, and provide comprehensive stakeholder support;

6. Takes note that the number of judicial challenges against the EMA and/or the EC, relating to alleged breaches of Union pharmaceutical law or procedural irregularities, remains high; observes that, during 2024, EMA was involved in 12 court cases, without the assistance of external counsel; notes further that five judgments/orders were delivered by the Court of Justice of the European Union in the course of the year;

7. Stresses that gender balance in the composition of the top management of EU’s agencies and institutions must be a guideline; notes that the Agency's senior management is currently composed of 56% men and 44% women, according to the figures;

8. Insists on adopting further rules to prevent revolving door problem where staff members move between EMA and the pharmaceutical industry involving scientific experts;

9. Supports the activities related to the establishment and maintenance of the Union list of critical medicines, and approaches to strengthen the security of supply of those medicines; emphasizes the Agency's role in supporting the European Health Union, including addressing medicine shortages in the EU;

Conclusion

Recommends, based on the facts available, that discharge be granted to the Executive Directors of the Agencies in respect of the implementation of the budget of the European Union Agencies for the financial year 2024.