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:

1. Welcomes the fruitful cooperation between the European Parliament, the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) the (Agencies), shown, inter alia, by the annual exchanges of views that took place in 2024 in the Committee of Public Health (SANT);

2. Considers that regular visits to and from the Agencies are a key aspect of the scrutiny exercised by the European Parliament over them, since they facilitate constructive dialogue, enhance transparency, and strengthen the Parliament's oversight role;

3. Expresses its satisfaction that the European Court of Auditors (ECA) has confirmed the legality and regularity, in all material respects, of the transactions underlying the Agencies' annual accounts for the financial year 2024, as well as the fair representation of their financial position as of 31 December 2024

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

4. 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 show a high level of budget execution; notes that the persistently high level of carry-overs highlighted by ECA point to structural planning challenges that should be addressed;

5. 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 high level of implementation and effective operational planning; emphasizes that future Single Programming Documents should systematically include performance indicators on health equity, the protection of vulnerable groups and environment-related communicable disease risks, in line with ECDC’s One Health approach;

6. Notes with concern ECA’s findings on ECDC’s management and control systems, in particular for certain operational expenditure procurements launched without a proper prior financing decision; calls on the Agency to strengthen ex-ante checks, staff training and documentation of tender evaluations, and to report on corrective measures taken;

7. 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;

8. 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; highlights the extensive risk communication activities undertaken by the ECDC in 2024 in response to emerging outbreaks and large-scale events, including the UEFA European Football Championship and the 2024 Olympic and Paralympic Games, as well as outbreaks of Marburg, mpox and pertussis; notes ECDC’s use of digital engagement strategies, notably the five influencer campaigns deployed in 2024, involving 96 influencers across all EU Member States and reaching more than 10 million citizens with evidence - based messages on vaccination, antimicrobial resistance, HIV/AIDS, sexually transmitted infections and respiratory viruses;

9. Recalls that ECDC performs a range of antimicrobial resistance (AMR) related tasks; acknowledges that the Commission and ECDC support to Member States, while having a potential positive impact, has not yet delivered demonstrable results in reducing AMR; Recalls the need to give the ECDC the necessary tools and data to better monitor AMR and antimicrobial consumption across Europe, assess related public health risks, estimate the burden of resistant infections, integrate the One Health approach to address environmental health risks, and enhance collaboration with the agricultural and veterinary sectors to tackle AMR at all levels, to meet the EU AMR 2030 targets;

10. Notes that in its 2024 Special Report on the EU’s response to the COVID-19 pandemic, the European Court of Auditors found that the ECDC generally managed its response well, while identifying areas for improvement that the Agency is addressing to strengthen future preparedness; notes that ECDC communications were often aimed primarily at experts and not always accessible to the wider public; acknowledges the emphasis placed by the new Director, Pamela Rendi-Wagner, on improving public engagement, as well as the positive steps taken in diversifying campaigns, increasing its audience, engaging with journalists, and using influencers; calls on the Centre to co-design communication strategies with civil society and affected communities, publish plain-language summaries in all EU languages, and cooperate with Union bodies to promote accurate and reliable health information;

11. Underlines the importance of efficient ECDC cooperation between the Agencies and with the Member States to an optimal performance of ECDC and in order to further develop a robust European surveillance system for infectious diseases, based on EU-wide harmonised case definitions, thereby enabling the ECDC to collect comparable and reliable data by country and by region; welcomes the development of the One Health Framework and recalls the need to continuously strengthen the One Health approach;

12. Welcomes that ECDC has accepted all recommendations of the Court made in the 2024 Special Report regarding the modernisation of the European surveillance system and the improvement of data comparability; expects ECDC to deliver on its commitment to review its internal editorial and consultation procedures to ensure more accessible and plain-language public communication, as announced in its reply;

13. Stresses that gender balance in the composition of the top management of EU’s agencies and institutions must be a guideline; regrets 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; calls on the Centre to adopt and implement a comprehensive equality, diversity and inclusion strategy, including concrete targets for balanced geographical representation, and the inclusion of staff with disabilities;

14 Calls on the ECDC to pursue continuous improvements in efficiency, including by optimising internal processes, making full use of digital tools and better aligning staffing and budgetary resources so as to ensure that high-quality results are delivered without unnecessary delay;

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

15. 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;

16. Notes with concern that the situation regarding Agency’s premises in London continues to be 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 budgetary 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 resolution of this issue in order for the Agency to fully focus its resources on implementing its public health mission and the recently expanded mandate, addressing public health crises and report to Parliament about corrective action taken;

17. Notes that the 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; highlights the need to ensure full transparency of these revenues;

18. Notes that in 2024, the EMA recommended 114 new human medicines for marketing authorisation, which constitutes an increase in activity of 48% compared to 2023, including 46 new active substances, representing an increase in 17% of their evaluation compared to 2023, 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 (in 2023, 17) 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;

19. Notes that, according to the European Court of Auditors’ 2024 Special Report, the most important clinical trials for COVID-19 vaccines were conducted outside the Union and authorised by non-EU regulators, requiring the EMA to rely heavily on external data; stresses the need to strengthen the Union’s capacity to generate its own clinical evidence in order to reduce dependency and enhance strategic autonomy in health research, while ensuring that the resulting medicines and vaccines are accessible and affordable to everyone; recalls that, in the same report on the EU’s response to the COVID-19 pandemic, the Court concluded that the EMA generally managed its crisis response well within the limits of its mandate and resources, while identifying areas for improvement; acknowledges that the Agency is implementing lessons learned to reinforce preparedness for future public health emergencies, while noting that the Court considers it premature to assess their effectiveness; underlines the need for the EMA to ensure full transparency in regulatory decision-making, safeguard the independence of scientific assessments, and prevent any external political, commercial or geopolitical influence on authorisations; calls for enhanced cybersecurity measures, clearer public communication on quality-assurance processes, and regular reporting to Parliament on cyber incidents affecting EU health agencies);

20. 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;

21. Takes note of the number of judicial challenges against the EMA and/or the EC, relating to alleged breaches of Union pharmaceutical law or procedural irregularities; 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; calls on EMA to reduce litigation risks by further increasing transparency, including through proactive publication of clinical data and assessment reports, improved stakeholder consultation when developing guidelines and policies, and timely, accessible explanations of its decisions for patients and healthcare professionals;

22. 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, in a positive increment from 2023; calls on the Agency to adopt a comprehensive equality, diversity and inclusion strategy with concrete targets and monitoring, including gender-balanced and geographically diverse decision-making bodies and to maintain a zero-tolerance approach to harassment and discrimination;

23. Calls for consistent application of EU and EMA rules on post-employment activities, cooling-off periods, and transparency; calls on EMA to regularly report on their implementation; emphasizes adopting measures to prevent conflicts of interest and ensure transparency in expert assessments; underlines that managing conflicts of interest is crucial for accountability, scientific integrity, and public trust; stresses that inadequate screening of competing interests risks undermining EMA’s impartiality; calls on EMA to strengthen and clarify conflict-of-interest rules, safeguard expert independence, and ensure full transparency in expert selection and scientific advice.

24. Supports the activities related to the establishment and maintenance of the Union list of critical medicines, as well as the collection of data related to critical shortages and stocks of critical medicines; recalls the need to give the EMA the necessary tools to prevent and mitigate critical shortages in cooperation with Member States; emphasizes the Agency's role in supporting the European Health Union, including addressing medicine shortages in the EU;

25. Calls on EMA to pursue continuous improvements in efficiency, including by optimising internal processes, making full use of digital tools and better aligning staffing and budgetary resources so as to ensure that high-quality results are delivered without unnecessary delay;

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.

ANNEX: DECLARATION OF INPUT

The rapporteur for opinion declares under her exclusive responsibility that she did not include in her opinion input from interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from representatives of public authorities of third countries, including their diplomatic missions and embassies, to be listed in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.

INFORMATION ON ADOPTION BY THE COMMITTEE ASKED FOR OPINION