On discharge in respect of the implementation of the budget of the EU agencies for the financial year 2023

PA_NonLegDec

OPINION

The Committee on the Environment, Public Health and Food Safety calls on the Committee on Budgetary Control, as the committee responsible, to incorporate the following into its proposal for a decision:

General considerations

1. Welcomes the constructive cooperation between the European Parliament and the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) (the Agencies), illustrated, inter alia, by the annual exchanges of views that took place in 2023 in the Committee on the Environment, Public Health and Food Safety (ENVI);

2. Considers that regular visits to the Agencies are a key aspect of the scrutiny exercised by the European Parliament over them; notes to this regard the success of the ENVI delegation to EMA in February 2023 and to ECHA in April 2023;

3. Expresses its satisfaction that the European Court of Auditors (ECA) has declared the transactions of the Agencies underlying the annual accounts for the financial year 2023 to be legal and regular in all material respects, and that their financial position, at 31 December 2023, is fairly represented in all material respects;

4. Welcomes the measures taken by the agencies in light of the European Parliament recommendations in its discharge for the financial year 2022; stresses the importance of increasing the Agencies’ efforts in terms of cooperation with other agencies and international organisations, digitalisation, and gender and geographical balance in senior management positions;

5. Welcomes the fact that the Agencies took effective corrective actions following most of the 2022 observations from the ECA; takes note of 2023 observations for the Agencies, in particular observations related to ex-ante checks, and calls on them to ensure an effective follow-up.

Part I – Discharge in respect of the implementation of the budget of the European Centre for Disease Prevention and Control (ECDC) for the financial year 2023

1. Acknowledges the key role of the ECDC in identifying and assessing current and emerging threats to human health from communicable diseases and related special health issues, in order to enhance the capacity of the Union and the Member States to protect human health through the prevention and control of communicable diseases in humans and related special health issues;

2. Notes that the ECDC mandate was extended following the adoption of Regulation (EU) 2022/2370 which entered into force on 13 December 2022 in order to strengthen the Union's health security framework in the fields of epidemiological surveillance; welcomes the fact that the ECDC began to implement its new mandate by reviewing the modalities of collaboration with its main partners and stakeholders, as well as the structure and content of its Strategy 2021-2027;

3. Welcomes the continued development of the One Health Framework and the creation of the One Health Task Force to strengthen collaboration with EMA, EFSA, EEA and ECHA; highlights the importance of ensuring good and fair cooperation between the Agencies;

4. Welcomes, following the observations in the 2022 discharge, the signing of the Working Arrangements between the ECDC and Health Emergency Preparedness and Response Authority (HERA) in order to avoid overlaps and duplication of efforts;

5. Welcomes the fact that the ECDC was able to deliver 90% of the outputs planned in its Single Programming Document 2023−2025, with 5% of the planned outputs postponed, and 4% cancelled, delayed, not implemented or not applicable by the end of the year.

Part II – Discharge in respect of the implementation of the budget of the European Chemicals Agency (ECHA) for the financial year 2023

1. Acknowledges that the ECHA is key in implementing a growing number of Union legislation that regulates chemicals for the benefit of public health and the environment, as well as for innovation and competitiveness; recognises that the ECHA collects, evaluates and disseminates a vast amount of information on chemicals, helps companies comply with legislation and promotes the safe use of chemicals;

2. Observes that the Agencies budget relies on collected fees and a contribution from the Union’s general budget; takes note with concern that after a rise in 2022, in 2023 the ECHA’s fee income has again decreased, increasing the reliance on the Union to finance its operations; stresses the need to address the lack of predictability of the ECHA’s fee income and reiterates its previous calls to the Commission to improve the ECHA’s budgetary certainty by presenting its proposal to strengthen the governance of ECHA in line with its commitment expressed in the Chemicals Strategy for Sustainability;

3. Recalls the necessity of ensuring adequate staffing reflecting the needs of the European Green Deal and the Union Chemical Strategy for Sustainability, Circular Economy Action Plan and, in particular, the zero pollution target, and the associated increase in tasks;

4. Acknowledges that in 2023 the ECHA delivered its regulatory tasks under the Union chemicals legislation, in particular REACH and CLP, provided scientific-technical support to the Commission in the implementation of the Chemicals Strategy for Sustainability, as well as preparing and starting work on the implementation of new regulatory tasks under the Drinking Water Directive, the Batteries Regulation and the Serious Cross-Border Threads to Health Regulation;

5. Welcomes the progress made on the Integrated Regulatory Strategy and the Joint Evaluation Action Plan; recognises the advancements in identifying substances and substance groups as candidates for regulatory action; regrets that the ECHA has, however, fallen short on fulfilling key indicators for identification and prioritisation of hazardous substances; stresses the need to complete the identification of hazardous substances to ensure their safe use;

6. Welcomes the ECHA’s efforts to promote the use of alternatives to animal testing for the regulatory assessment of chemicals and to foster understanding of the opportunities and challenges in moving away from animal testing while ensuring a high level of protection of human health and the environment;

7. Notes with concern the difficulty to recruit sufficient experts from Member States to the ECHA’s Scientific Committees, posing a risk to the ECHA’s ability to meet legal deadlines and targets in regulatory processes that are dependent on the Committees’ outputs, in particular in the light of increasing tasks being attributed to the ECHA;

8. Welcomes the ECHA Strategy Statement for 2024 - 2028 adopted in December 2023, which sets out the priorities for the ECHA in implementing its evolving mandate.

Part III – Discharge in respect of the implementation of the budget of the European Environment Agency (EEA) for the financial year 2023

1. Stresses that the EEA provides sound, independent information on the environment; commends the quality of its outputs released in 2023, such as Pathways towards circular plastics in Europe — good practice examples from countries, business and citizens, Assessing the costs and benefits of climate change adaptation and European forest ecosystems: key allies in sustainable development;

2. Acknowledges the adaptability of the EEA, which, in addition to its planned publications for 2023, released additional works on topics ranging from extreme weather to human health, such as The importance on restoring nature in Europe, demonstrating its capacity to inform and fuel current policy debates arising from evolving circumstances;

3. Notes that the EEA is tasked with tracking progress towards the 8th Environment Action programme (‘8th EAP’), which builds on the European Green Deal and sets the framework for Union environmental policy until 2030, with a long-term priority objective for 2050 of living well within planetary boundaries; welcomes the release of its first annual monitoring report in December 2023, on the basis of a set of 28 headline indicators and corresponding targets such as climate change mitigation and adaptation, circular economy and biodiversity;

4. Takes note that, in June 2023 and following a pre-selection by the Commission, a selection by the Management Board and a hearing in ENVI, Leena Ylä-Mononen took over as EEA Executive Director from Hans Bruyninckx, who had served in the role for 10 years; welcomes the swift and effective process which led to this appointment;

5. Welcomes the fact that, following the Discharge Authority’s recommendations of 2022, the EEA has established regular progress monitoring processes for both the implementation of key reports and assessments and recently with a stronger focus on indicators, and has consecutively reached a budget execution rate of 100% of the annual budget, a 100% delivery rate of key reports and assessments, and high engagement with key stakeholders and network partners throughout the year;

6. Takes note with concern that despite the multi-year nature of the EEA’s tasks, an imbalance exists concerning the numbers of permanent versus contractual posts, as well as operational staff versus support staff, leading to a constant need for reskilling as well as an overload of administrative work for scientists; considers that taking into account the substantial increase of workload, and in order to properly perform the tasks on the Union’s goals for, inter alia, climate neutrality, circular economy and nature restoration, the EEA’s staff number should continue to substantially grow in the years to come.

Part IV – Discharge in respect of the implementation of the budget of the European Food Safety Authority (EFSA) for the financial year 2023

1. Welcomes the EFSA's' contribution to the safety of the Union food and feed chain, and its considerable efforts in providing risk managers with comprehensive, independent and up-to-date scientific advice on questions linked to the food chain, communicating clearly to the public on its outputs and the information on which they are based, and cooperating with interested parties and institutional partners to promote coherence and trust in the food safety system;

2. Welcomes the involvement of the EFSA in ENVI’s work and more generally the engagement of EFSA with initiatives related to the Farm to Fork and the Union Chemical strategies, with a particular emphasis on pesticides, nutrition, animal welfare, and chemical risk assessment, including establishing an Union chemicals data platform;

3. Notes that the EFSA closed 660 scientific questions in 2023, slightly below the target of 673 but better than the result achieved since 2020; highlights the need to decrease the amount of questions in stock; welcomes the measures put in please to increase the speed of the Risk Assessment process;

4. Takes note that, according to the Annual Strategy Survey launched by the EFSA asking for feedback from its customers, partners, and stakeholders who are directly or indirectly involved in the delivery of the EFSA’s scientific opinions, the EFSA’s ability to provide its advice in a timely manner remains a point of attention as in the previous year; calls on the EFSA to implement the necessary measures to improve this aspect;

5. Highlights the need for the EFSA to develop strong cooperation with all its stakeholders, including the other Agencies for better connection and outputs dissemination; welcomes the fact that the EFSA developed cooperation with Member States, including with the increase support of focal points, mainly focusing on support in the area of data collection and communication;

6. Welcomes the fact that the EFSA continued implementing its new organisational structure that was put in place in 2022 to reflect the Transparency Regulation; highlights the need to improve efficiency and transparency in the EFSA’s process architecture.

Part V – Discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2023

1. Reiterates the key role of the EMA in protecting human and animal health by assessing and supervising medicines for human or veterinary use and protecting public health by raising awareness on key issues including antimicrobial resistance and prevention of communicable diseases through vaccination;

2. Notes that in 2023, the EMA recommended for marketing authorisation 77 new human medicines, including 39 new active substances, and 14 new veterinary medicines, including 9 new active substances; welcomes the fact that the EMA confirmed seventeen orphan-status designations under the Union framework for orphan medicines, the purpose of which is to encourage the development and marketing of medicines for patients with rare diseases;

3. Notes the EMA decision to lift its COVID-19 business continuity measures, in alignment with the World Health Organisation declaration of the end of COVID-19 as a public health emergency of international concern; welcomes the fact that it enabled the EMA to shift its focus to address other challenges, including the finalisation of the EMA’s extended mandate obligations, of the medical devices and in vitro medical devices regulations (MDR/IVDR), and the first reflections on the EC proposal for the revision of the general Union pharmaceutical legislation for human medicines;

4. Welcomes the EMA’s efforts to contribute to Union priorities, including via inter alia the implementation of the Union Beating Cancer Plan, the Union Chemical Strategy for Sustainability and the European One Health Action Plan against Antimicrobial Resistance.

5. Recalls that the EMA is a fee-funded agency, with 88,21 % of its 2023 revenue stemming from fees for applications for marketing licenses for pharmaceutical products and for post-authorisation activities, 11,43 % stemming from the Union budget and 0,36 % from various other sources; highlights the need to ensure transparency of these revenues and welcomes the fact that in the future the EMA will have the obligation to publish in its activity report the annual revenue received per type of fee and charge according to Regulation (EU) 2024/568;

6. Notes that in 2023 the EMA received 6 965 requests for information and 709 requests for access to documents and that the EMA applies a queuing system that leads to delays in the treatment of the requests; emphasises the importance of transparency in the EMA operations, hence the need to ensure a timely access to information and documents;

7. Notes that the situation regarding the EMA’s former premises in London became increasingly challenging in 2023, with a need for the EMA to dedicate significant levels of resources to managing commercial real estate in a third country, endangering its core activities; calls on the Commission to secure a long-term political resolution of this issue and to allow the EMA to fully focus its efforts on its public health mission.

Conclusion

1. 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 EU agencies for the financial year 2023.

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

The Chair in his capacity as rapporteur for the opinion declares under his exclusive responsibility that he did not receive input from any entity or person to be mentioned in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.