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1. PROPOSAL FOR A EUROPEAN PARLIAMENT DECISION
OPINION
on discharge in respect of the implementation of the budget of European Union Agency for Asylum for the financial year 2023
The Committee on the Environment, Climate and Food Safety calls on the Committee on Budgetary Control, as the committee responsible, to incorporate the following into its proposal for a decision:
(2024/2030(DEC))
General considerations
– having regard to the final annual accounts of the European Union Agency for Asylum for the financial year 2023,
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);
– having regard to the Court of Auditors’ annual report on EU agencies for the financial year 2023, together with the agencies’ replies,
2. Considers that regular visits to and from the Agencies are a key aspect of the scrutiny exercised by the European Parliament over them; notes in this regard the success of the ENVI delegation to the EMA in February 2023 and to the ECHA in April 2023, which facilitated constructive dialogue, enhanced transparency, and strengthened the Parliament's oversight role.
–3. havingExpresses regardits tosatisfaction thethat statementthe ofEuropean assuranceCourt asof toAuditors the(ECA) reliabilityhas ofconfirmed the accountslegality and theregularity, legalityin andall regularitymaterial respects, of the underlying transactions provided byunderlying the CourtAgencies' ofannual Auditorsaccounts for the financial year 2023, pursuantas towell Articleas 287the offair therepresentation Treatyof ontheir thefinancial Functioningposition as of the31 EuropeanDecember Union,2023;
– having regard to the Council’s recommendation of 17 February 2025 on discharge to be given to the Agency in respect of the implementation of the budget for the financial year 2023 (05755/2025 – C100024/2025),
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;
– having regard to its decision of 7 May 2025 postponing the discharge decision for the financial year 2023, and the replies from the Executive Director of the European Union Agency for Asylum,
5. Welcomes the fact that the Agencies have implemented effective corrective actions in response to most of the 2022 observations from the ECA; takes note of the 2023 observations regarding the Agencies, particularly those related to ex-ante checks, and emphasises the importance of addressing these issues promptly and thoroughly; calls on the Agencies to maintain their commitment to transparency and accountability through an effective and timely follow-up process;
– having regard to Article 319 of the Treaty on the Functioning of the European Union,
6. Acknowledges the importance of localized initiatives that strengthen health systems and environmental initiatives, while increasing collaboration with Member States and Agencies.
– having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012, and in particular Article 70 thereof,
7. Calls for improvement in the funding distribution approach, prioritizing the reduction of administrative burdens and channelling resources directly to final recipients by simplifying procedures to enhance accessibility to economic players on the ground.
– having regard to Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union, and in particular Article 70 thereof,
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
– having regard to Regulation (EU) No 439/2010 of the European Parliament and of the Council of 19 May 2010 establishing a European Asylum Support Office, in particular Article 36 thereof,
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;
– having regard to Regulation (EU) 2021/2303 of the European Parliament and of the Council of 15 December 2021 on the European Union Agency for Asylum and repealing Regulation (EU) No 439/2010, and in particular Article 55 thereof,
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; invites the Commission to strengthen investments in the public health workforce and enhance coordination mechanisms for responding to emerging threats, such as infectious disease outbreaks; 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, while emphasising the importance of ensuring accountability and transparency throughout this process; emphasizes the importance of maintaining the annual declarations of interest of all management board members, advisory forum members and their alternates updated and accessible;
– having regard to Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council, and in particular Article 105 thereof,
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; considers these important steps to further strengthen the One Health approach ensuring the inclusion of human, animal and plant health, as well as their interactions with the environment; highlights the importance of ensuring good and fair cooperation between the Agencies and increased collaboration with Member States, while cautioning against inefficiencies, duplication of efforts, and overlapping mandates;
– having regard to Rule 102 of and Annex V to its Rules of Procedure,
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;
– having regard to the second report of the Committee on Budgetary Control (A10-0169/2025),
5. Stresses that gender balance in the composition of the top management of our agencies and institutions must be a guideline; notes that the Agency's senior management is currently composed of 67% men and 33% women, according to the figures communicated; calls on the Agency to take this into consideration in future recruitments;
1. Grants the Executive Director of the European Union Agency for Asylum discharge in respect of the implementation of the Agency’s budget for the financial year 2023;
6. Notes that 22,7 % of the Agency's staff are nationals of the Member State where it is located; recalls the importance of geographical balance and encourages the Agency to continue to take the necessary measures to have a balanced and fair geographical representation;
2. Sets out its observations in the resolution below;
7. Acknowledges the lessons learnt during the COVID-19 pandemic, calling for the need for pandemic preparedness and a unified EU response strategy, that utilises digital early warning systems for prompt and efficient decision making.
3. Instructs its President to forward this decision, and the resolution forming an integral part of it, to the Executive Director of the European Union Agency for Asylum, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).
8. Welcomes the agency's efforts towards an Eco-Management and Audit Scheme (EMAS) certification, which was finally granted in January 2024;
2. PROPOSAL FOR A EUROPEAN PARLIAMENT DECISION
9. 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.
onPart II – Discharge in respect of the closureimplementation of the accountsbudget of the European UnionChemicals Agency for Asylum(ECHA) for the financial year 2023
(2024/2030(DEC))
1. Acknowledges that the ECHA is key in implementing a growing number of Union legislation that regulates chemicals for the benefit of protecting public health and the environment, as well as for innovation and competitiveness; recognises that the ECHA collects, evaluates, and disseminates extensive information on chemicals, assists companies in complying with legislation, and promotes the safe use of chemicals;
– having regard to the final annual accounts of the European Union Agency for Asylum for the financial year 2023,
2. Observes that the Agency's budget relies on collected fees and a contribution from the Union’s general budget; highlights the need to ensure full transparency of collected fees; 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;
– having regard to the Court of Auditors’ annual report on EU agencies for the financial year 2023, together with the agencies’ replies,
3. Recalls the importance of prioritizing efficient resource allocation over increasing staffing levels and stresses the need to allocate staff primarily to scientific roles critical to achieving ENVI objectives, while avoiding unnecessary expansion of the Agency’s workforce;
– having regard to the statement of assurance as to the reliability of the accounts and the legality and regularity of the underlying transactions provided by the Court of Auditors for the financial year 2023, pursuant to Article 287 of the Treaty on the Functioning of the European Union,
4. Cautions against overburdening the ECHA with additional regulatory tasks introduced by new directives and regulations, and emphasizes the importance of maintaining focus on its primary responsibilities under REACH and CLP;
– having regard to the Council’s recommendation of 17 February 2025 on discharge to be given to the Agency in respect of the implementation of the budget for the financial year 2023 (05755/2025 – C100024/2025),
5. 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 Threats to Health Regulation;
– having regard to its decision of 7 May 2025 postponing the discharge decision for the financial year 2023, and the replies from the Executive Director of the European Union Agency for Asylum,
6. 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;
– having regard to Article 319 of the Treaty on the Functioning of the European Union,
7. Notes that, despite falling short of fulfilling key indicators for the identification and prioritisation of hazardous substances, the Agency's 2023 annual report highlights that ECHA screened 61 groups covering approximately 1,380 substances, surpassing its initial target, and identified 320 substances for potential risk management, 280 requiring further data, and 540 requiring no further action; furthermore, acknowledges that by the end of 2023, ECHA had assessed 92% of substances registered above 100 tonnes, leaving fewer than 400 high-tonnage substances still to be evaluated;
– having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012, and in particular Article 70 thereof,
8. 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 and encourages ECHA to promote the use of non-animal testing methods;
– having regard to Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union, and in particular Article 70 thereof,
9. 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; identifies a need for increased localised collaboration with universities, research centers and specialised national services from the Member States;
– having regard to Regulation (EU) No 439/2010 of the European Parliament and of the Council of 19 May 2010 establishing a European Asylum Support Office, in particular Article 36 thereof,
10. Stresses that gender balance in the composition of the top management of our Agencies and institutions must be a guideline; notes that the Agency's senior management is currently composed of 73% men and 27% women, according to the figures communicated; calls on the Agency to take this into consideration in future recruitments;
– having regard to Regulation (EU) 2021/2303 of the European Parliament and of the Council of 15 December 2021 on the European Union Agency for Asylum and repealing Regulation (EU) No 439/2010, and in particular Article 55 thereof,
11. Notes that 29.1 % of its staff are nationals of the Member State where the Agency is located; recalls the importance of geographical balance and encourages the Agency to continue to take the necessary measures to have a balanced and fair geographical representation;
– having regard to Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council, and in particular Article 105 thereof,
12. 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 and calls for its implementation to prioritize efficiency, financial sustainability, and a reduction in regulatory burdens on businesses and Member States, in order to improve effectiveness in delivering ENVI-related objectives;
– having regard to Rule 102 of and Annex V to its Rules of Procedure,
Part III – Discharge in respect of the implementation of the budget of the European Environment Agency (EEA) for the financial year 2023
– having regard to the second report of the Committee on Budgetary Control (A10-0169/2025),
1. Stresses that the EEA provides sound, independent and up-to-date scientific 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, acknowledges the outmost importance of the EEA to reach the Union’s climate goals; appreciates the EEA’s support of members of the ENVI committee by providing excellent, up-to-date data and information;
1. Approves the closure of the accounts of the European Union Agency for Asylum for the financial year 2023;
2. Acknowledges the adaptability of the EEA, which, in addition to its planned publications for 2023, produced additional works on topics ranging from extreme weather to human health, including The Importance of Restoring Nature in Europe, demonstrating its capacity to inform and contribute to policy debates arising from evolving circumstances;
2. Instructs its President to forward this decision to the Executive Director of the European Union Agency for Asylum, the Council, the Commission and the Court of Auditors, and to arrange for its publication in the Official Journal of the European Union (L series).
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, while investing in competitiveness as outlined in the Draghi report; 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;
3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION
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;
with observations forming an integral part of the decisions on discharge in respect of the implementation of the budget of the European Union agencies for the financial year 2023
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;
(2024/2030(DEC))
6. Stresses that gender balance in the composition of the top management of our Agencies and institutions must be a guideline; welcomes the fact that the Agency's senior management is currently composed of 50% men and 50% women, according to the figures communicated;
– having regard to its decision on discharge in respect of the implementation of the budget of the European Union Agency for Asylum for the financial year 2023,
7. Notes that 20.1 % of its staff are nationals of the Member State where the Agency is located; recalls the importance of geographical balance and encourages the Agency to continue to take the necessary measures to have a balanced and fair geographical representation;
– having regard to Rule 102 of and Annex V to its Rules of Procedure,
8. 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 in the Agency, 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 required tasks linked to 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 and this should be reflected in the financial resources allocated to the Agency.
– having regard to the functioning of the Common European Asylum System, the respect and proper implementation and enforcement of the rules and the sustainable and appropriate financial support of the EUAA are essential to ensure the system of shared responsibility and solidarity among the Member States of the European Union;
9. Cautions against overburdening the EEA with additional tasks arising from new directives and regulations, emphasizing the need to focus on its primary responsibilities; stresses the importance of ensuring that resources are not diluted by attempting to address an overly broad range of objectives, which could compromise the quality and impact of its outputs;
– having regard to the OLAF Final Report (OC-2022-0717) on the European Union Agency for Asylum finalised in October 2024, and made available in March 2025 to Members of the Committee on Budgetary Control,
Part IV – Discharge in respect of the implementation of the budget of the European Food Safety Authority (EFSA) for the financial year 2023
– having regard to the letters sent by the Chair of EUAA in March 2025 and the Executive Director of European Union Agency for Asylum in July 2025,
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;
– having regard to the exchange of views with representatives from OLAF, the European Union Agency for Asylum and DG Home on 15 July 2025,
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; stresses the need for these efforts to remain firmly grounded in robust, evidence-based policy-making, including the establishment of a Union chemicals data platform, to ensure that decisions are informed by the best available scientific data and promote effective and balanced regulatory outcomes;
– having regard to the second report of the Committee on Budgetary Control (A10-0169/2025),
3. Cautions against overburdening the EFSA with additional tasks linked to broader initiatives such as the Farm to Fork and Union Chemical strategies, emphasizing that its primary focus should remain on food safety and core chemical risk assessments;
A. whereas all Union decentralised agencies must be transparent and fully accountable to the citizens of the Union for the funds entrusted to them as Union bodies;
4. 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 place to increase the speed of the Risk Assessment process;
B. whereas the European Union Agency for Asylum, as a Union body entrusted with significant responsibilities and resources, has a corresponding duty to act with the highest standards of transparency, accountability and exemplary conduct, thereby ensuring the trust of Union citizens and institutions;
5. Notes with concern 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;
C. whereas Parliament's role in respect of the budget discharge is specified in the Treaty on the Functioning of the European Union (TFEU), in the Financial Regulation and in the Framework Financial Regulation;
6. 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 increased support of the Focal Points Network, mainly focusing on support in the area of data collection and communication; encourages EFSA to even further increase its efforts to protect animal welfare and promote the use of non-animal testing methods, also in its cooperation with other institutions;
D. whereas OLAF, as the Union’s anti-fraud body, has a duty to provide the European Parliament with timely and adequate access to its findings in order to enable effective discharge scrutiny;
7. Stresses that gender balance in the composition of the top management of our Agencies and institutions must be a guideline; notes that the EFSA's senior management is currently composed of 63% men and 38% women, according to the figures communicated; calls on the Agency to take this into consideration in future recruitments;
1. Recalls the role of Parliament within the discharge procedure, as governed by the TFEU, the Financial Regulation and its rules of procedure;
8. Notes that 41.8 % of its staff are nationals of the Member State where the Agency is located; recalls the importance of geographical balance and encourages the Agency to continue to take the necessary measures to have a balanced and fair geographical representation;
2. Recalls that on 7 May 2025 Parliament decided to postpone the decision on the 2023 discharge of the European Union Agency for Asylum (‘the Agency’);
9. Highlights that the European Parliament adopted two resolutions at the beginning of the mandate to object to Maximum Residues Levels (MRLs) for pesticides due to cumulative and synergistic effects not having been taken into account in EFSA’s reasoned opinion;
3. Underlines the paramount importance of acting responsibly and transparently in the implementation of the Union budget; insists that any failure to uphold these principles seriously undermines public trust;
10. Welcomes the fact that the EFSA continued implementing its new organisational structure that was put in place in 2022 to reflect the Transparency Regulation; notes that the Transparency Regulation required the Commission to develop and adopt a ‘General Plan for Risk Communication’, which has not been presented by the Commission despite the preparatory work completed by the EFSA; highlights the need to continuously improve efficiency and transparency in the EFSA’s process architecture.
The outcome of the investigation of the European Anti-Fraud Office (OLAF)
11. Encourages EFSA to expand its efforts in horizon scanning and early identification of emerging risks in the food and feed chain, particularly in areas linked to climate change and the increasing complexity of global supply chains; stresses the importance of adopting proactive approaches to risk assessment and mitigation to ensure the resilience of the Union’s food system.
4. Notes that OLAF made an anonymised version of its final report on the investigation available to the Members of the Committee on Budgetary Control in March 2025 and to the Committee on Civil Liberties, Justice and Home Affairs in July 2025; deplores the delayed access to the investigation, which was granted only in March despite the request made by the rapporteur in December 2024, with OLAF’s reply citing objections from the Management Board of European Union Agency for Asylum; insists that access to the report should have been given to CONT members earlier to guarantee the exercise of their mandate adequately;
12. Underlines the significance of enhancing public engagement and outreach activities, including leveraging digital tools to increase public access to scientific information and the rationale behind EFSA’s decisions; calls for the development of user-friendly platforms that promote greater understanding and foster citizen participation in the food safety dialogue.
5. Is aware that OLAF’s investigations shall be conducted continuously over a period which must be proportionate to the circumstances and complexity of the case; is concerned about the length of OLAF’s investigations as it undermines the ability of the discharge authority to consider their findings efficiently; insists on the crucial role of timely investigations in maintaining effective Parliament oversight; calls on OLAF to review and speed up the procedure of completing and sharing investigations with the Discharge Authority; stresses that such delays undermine the ability of CONT members to effectively exercise their oversight mandate and calls for measures to ensure prompt access to investigation reports in the future;
13. Notes the growing importance of alternative protein sources and novel foods in achieving the Union’s sustainability goals; calls on the EFSA to prioritize the development of robust scientific frameworks for assessing the safety and nutritional impact of these products, ensuring that innovation is underpinned by rigorous risk assessment standards.
6. Stresses that protecting the Union budget must remain a core value of sound financial management, which all Union institutions are duty-bound to uphold, including agencies and decentralised bodies that must set a clear example of responsibility and transparency in the use of European public funds; reiterates the need for strengthened coordination and cooperation within the anti-fraud institutional framework, particularly to address the need for faster and more efficient OLAF investigations, thereby aligning these efforts with the broader goal of safeguarding Union finances;
14. Calls for closer collaboration between the EFSA and the ECDC to enhance the monitoring and assessment of zoonotic diseases and antimicrobial resistance; stresses the need for a unified approach to safeguarding public health through a ‘One Health’ perspective.
7. Calls on the Agency and OLAF to make an anonymised summary of the OLAF report publicly available, to the extent legally possible, in the interest of transparency and public trust;
Part V – Discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2023
8. Takes note that OLAF issued disciplinary and administrative recommendations following the investigation;
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;
9. Observes that, concerning the disciplinary recommendations, the Management Board decided, as a follow-up, not to open disciplinary proceedings and instead issued written recommendations with a warning and requested to the Executive Director concrete proposals by way of corrective actions, and a timetable for their implementation as soon as possible; acknowledges that in line with this request, the Executive Director has submitted to the Management Board the following documents, which include:
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, adopting an expedited mechanism under special conditions;
– the Recommendations made by the Management Board;
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;
– the current state of affairs in the Agency with regard to each Recommendation; and
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; urges the EMA to further cooperate with relevant agencies and actors to combat new, rare and difficult-to-diagnose cancers; reiterates the need to pay special attention to often misdiagnosed conditions among women and girls and to be conscious of class bias in health related issues and pharmacological needs;
– the additional corrective actions to be implemented with the inclusion of a provisional timeline for their implementation; calls on the Management Board to follow up on the recommendations and report back to the discharge authority on their full and timely implementation;
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 full 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 ;
10. Regrets that the Management Board has decided after intense deliberations not to implement OLAF’s disciplinary recommendations, including the initiation of disciplinary proceedings against the EUAA Executive Director or any other staff in the Agency, despite OLAF’s significant findings, which appear to be systematic and which undermine trust in the Agency’s leadership; emphasises that this decision raises questions about the Board’s commitment to accountability and responsibility, in line with institutional expectations, and acknowledges the Board’s deliberate choice not to implement the recommendations after reviewing the issues raised; stresses that Parliament will remain particularly attentive to the corrective actions undertaken; expects the Agency to demonstrate exemplary follow-up, high standards, clear responsibility for implementation of corrective measures and full accountability; calls on the Agency to ensure transparent reporting to Parliament by, inter alia, sharing the minutes of Management Board deliberations with Parliament, to strengthen parliamentary oversight;
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;
11. Notes that the Executive Director prepared a “Vision Statement on leadership implementing the changes in EUAA” with corrective actions implemented and corrective actions to be implemented; requests the Agency to inform the discharge authority of the corrective actions implemented and to be implemented, along with deadlines for their completion;
7. Stresses that gender balance in the composition of the top management of our agencies and institutions must be a guideline; notes that the Agency's senior management is currently composed of 60% men and 40% women, according to the figures communicated; calls on the Agency to take this into consideration in future recruitments;
12. Expresses concern that the administrative recommendations addressed the practice of staff evaluations being conducted by heads of sector rather than heads of unit, as well as shortcomings in the management of conflicts of interest within the Agency;
8. Notes that the Agency has concluded an internal environmental audit in 2023 with a view to obtaining EMAS certification in 2024;
13. Welcomes that starting in 2025, heads of unit will conduct staff evaluations as foreseen in the applicable rules;
9. Recommends the establishment of a formal framework for joint procurement of essential medicines across Member States, modelled on the success of the COVID-19 vaccine procurement process, for ensuring equitable access to high-quality medicines through economies of scale.
14. Strongly deplores the weaknesses in the management of conflicts of interest within the Agency, particularly the flawed handling of complaints by the Management Board against decisions made by the Executive Director; insists that such practices undermine the Agency’s integrity and credibility; calls on the Agency to promptly inform the discharge authority of the corrective actions and organisational changes put in place; stresses that only a robust and exemplary framework for conflict of interest management will be considered acceptable;
10. 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.
15. Notes the recognition by both the Management Board and the Executive Director of the seriousness of the allegations and the issues raised; acknowledges, however, that the Executive Director expressed scepticism, citing extraordinary workload during crises, which cannot be used as justification for dismissing the findings; considers that the recognition must be accompanied by decisive corrective measures, timely implementation, and full accountability to the discharge authority;
Conclusion
16. Notes with concern the repeated failures in governance, including the inability of the Management Board to exercise timely and effective oversight; regrets that several of the irregularities could have been prevented with better internal controls and proactive engagement from the Management Board; insists that this institutional failure must be addressed structurally, not just procedurally;
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 European Union Agencies for the financial year 2023.
17. Deplores the issues of poor administration, especially in the area of human resources, with serious irregularities, particularly in appointment and selection procedures in breach of Staff Regulations of Officials and the Conditions of Employment of Other Servants; is aware that during the period from 2019 to 2022, the Agency faced challenging circumstances, such as the COVID-19 pandemic, the activation of the Temporary Protection Directive, or the entry into force of the EUAA Regulation with a new mandate, competences, and responsibilities; rejects however any attempt to use such circumstances as justification for non-compliance with binding legislation ; calls the Agency to fully align its recruitment processes with the applicable rules, and insists on the adoption of strict, transparent, and merit-based procedures, accompanied by enforceable guidelines and subject to close oversight by the discharge authority;
ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT
18. Welcomes that the practice of appointing managers ad interim has been discontinued as from January 2023;
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.
19. Recalls that one of the core duties of the Management Board is to give general orientation for the Agency’s activities and to ensure that the Agency fullfil its mandate effectively; considers that in order to give general orientation the Management Board needs to be aware and duly informed of applicable legislation to the Agency as well as critical developments in the management of the Agency; deplores the repeated shortcomings in this regard and calls on the Agency to establish efficient, systematic and transparent communication procedures with the Management Board;
INFORMATION ON ADOPTION BY COMMITTEE ASKED FOR OPINION
20. Calls on the European Commission, who has two seats on the Management Board, to actively support and assist other board members in their understanding of the rules applicable to the Agency, and to identify and disseminate the lessons learnt from this particular case as part of broader prevention efforts; calls on the Agency to report back to the discharge authority on the measures taken to improve communication with the Management Board;
21. Welcomes the suggestion made by the Commission during the exchange of views on the possibility to share Joint Services in certain horizontal areas across the decentralised Agencies, as this would help to better manage processes and make a more efficient use of resources; encourages the Commission to explore this possibility and propose concrete actions in this regard;
22. Calls on the Agency to establish an independent internal ethics function and emphasizes the importance of having robust whistle-blower protection rules in line with Directive (EU) 2019/1937; stresses that internal reporting channels must be confidential, credible and trusted by staff at all levels;
23. Highlights that although some of the events date back to the years 2021, 2022 and earlier, the OLAF investigation was only concluded in 2024; emphasises that it cannot be yet concluded that these issues have been fully resolved; stresses that the Discharge Authority retains the full right to exercise its oversight responsibilities until the situation is entirely remedied and clarified; calls on the Executive Director and the Management Board to recognise and address any structural weaknesses in both the Agency’s human resources management and the Management Board’s oversight functions, and to take effective measures to prevent the recurrence of similar issues and reserves the right to withhold or condition future discharge decisions, should the Agency fail to deliver full structural reform;
24. Notes with particular concern the extremely high staff turnover rates as mentioned in the OLAF report, without the management being able to provide a satisfactory explanation; calls on the Executive Director and the Management Board, and in particular the Commission representatives within it, to put in place systematic exit interviews with all resigning staff, to document the findings comprehensively, and to report to the discharge authority on the results and progress achieved in this regard in the framework of the 2024 discharge procedure;
25. Commends the Agency's staff for their dedication and commitment in executing their tasks despite challenging circumstances; considers essential to foster a positive work environment by promoting good practices at the human resources level and rewarding merit-based performances; urges the Management Board and the Executive Director to ensure that the Agency is a safe and supportive workplace that encourages open communication and empowers individuals to speak up without fear of retaliation; calls on the Agency to ensure that all reports of professional misconduct are taken seriously and thoroughly investigated, with appropriate follow-up actions taken to maintain integrity and trust within the organisation;
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26. Refers, for other observations, to its resolution of 7 May 2025 with observations forming an integral part of decisions on discharge in respect of the budget of the European Union agencies.
ANNEX: DECLARATION OF INPUT
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he included in his report input on matters pertaining to the subject of the file that he received, in the preparation of the report, prior to the adoption thereof in committee, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:
1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register
Nina Gregori, Executive Director of EU Asylum Ageny
2. Representatives of public authorities of third countries, including their diplomatic missions and embassies
The list above is drawn up under the exclusive responsibility of the rapporteur.
Where natural persons are identified in the list by their name, by their function or by both, the rapporteur declares that he has submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.
INFORMATION ON ADOPTION IN COMMITTEE RESPONSIBLE
Date adopted
24.9.2025
18.2.2025
Result of final vote
0:
20
58
8
17
0
7
Members present for the final vote
Georgios Aftias, Arno Bausemer, Joachim Stanisław Brudziński, José Cepeda, Caterina Chinnici, Tamás Deutsch, Dick Erixon, Daniel Freund, Esteban González Pons, Niclas Herbst, Monika Hohlmeier, Virginie Joron, Ondřej Knotek, Giuseppe Lupo, Marit Maij, Csaba Molnár, Fidias Panayiotou, Jacek Protas, Julien Sanchez, Jonas Sjöstedt, Carla Tavares, Tomáš Zdechovský
Grégory Allione, Vytenis Povilas Andriukaitis, Pascal Arimont, Bartosz Arłukowicz, Sakis Arnaoutoglou, Anja Arndt, Thomas Bajada, Alexander Bernhuber, Barbara Bonte, Stine Bosse, Lynn Boylan, Delara Burkhardt, Pascal Canfin, Annalisa Corrado, Antonio Decaro, Ondřej Dostál, Pietro Fiocchi, Emma Fourreau, Anne-Sophie Frigout, Heléne Fritzon, Gerben-Jan Gerbrandy, Andreas Glück, Hanna Gronkiewicz-Waltz, Anja Hazekamp, Esther Herranz García, Martin Hojsík, Pär Holmgren, Romana Jerković, Radan Kanev, Stefan Köhler, Ewa Kopacz, András Tivadar Kulja, Katri Kulmuni, Peter Liese, Javi López, César Luena, Elżbieta Katarzyna Łukacijewska, Ignazio Roberto Marino, Tilly Metz, Dolors Montserrat, Dan-Ştefan Motreanu, Jana Nagyová, Rasmus Nordqvist, Jacek Ozdoba, Jutta Paulus, Carola Rackete, Massimiliano Salini, Silvia Sardone, Majdouline Sbai, Lena Schilling, Jonas Sjöstedt, Sander Smit, Claudiu-Richard Târziu, Ingeborg Ter Laak, Beatrice Timgren, Dimitris Tsiodras, Filip Turek, Ana Vasconcelos, Aurelijus Veryga, Kristian Vigenin, Alexandr Vondra, Emma Wiesner, Michal Wiezik, Milan Zver
Substitutes present for the final vote
Dirk Gotink, Rudi Kennes, Erik Marquardt, Şerban Dimitrie Sturdza, Vlad Vasile-Voiculescu, Michal Wiezik
Stefano Cavedagna, Per Clausen, Valérie Deloge, Gabriella Gerzsenyi, Jens Gieseke, Sunčana Glavak, Nicolás González Casares, Michalis Hadjipantela, Matteo Ricci, Chloé Ridel, André Rodrigues, Bruno Tobback, Raffaele Topo, Laurence Trochu
FINALMembers VOTEunder BYRule ROLL216(7) CALLpresent BYfor THEthe COMMITTEEfinal RESPONSIBLEvote
Salvatore De Meo, Nora Junco García, Alexander Jungbluth, Julien Leonardelli
FINAL VOTE BY ROLL CALL BY THE COMMITTEE ASKED FOR OPINION
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