Strategic Inquiry: OI/5/2025/KR

Case title: How EU agencies deal with ‘revolving door’ cases

Date: Thursday, 29 January 2026

Remote meeting

Present

EMA representatives

• Head of the Legal Department
• Head of Staff Relations and Support, Member of the Joint Committee

Ombudsman representatives

• Koen ROOVERS, Inquiries Officer
• Ludovica AQUINO, Inquiries Officer
• Jennifer KING, Legal Expert
• Tobias FLUCK, Inquiries Trainee
  
  

Purpose of the meeting

The purpose of the meeting was for the Ombudsman inquiry team to clarify outstanding questions that had arisen in the course of the inspection of the policy documents and individual case files submitted by EMA.

This inquiry builds on previous cases of the Ombudsman related to how the EU administration, including EU Agencies, apply the rules on post-service activities of (former) staff members^[1].

Introduction and procedural information

The Ombudsman inquiry team introduced themselves, thanked the EMA representatives for meeting with them and set out the purpose of the meeting. They outlined the legal framework that applies to meetings held by the Ombudsman, in particular, that the Ombudsman would not disclose any information identified by EMA as confidential, without EMA’s prior consent.^[2]

The Ombudsman inquiry team informed the EMA representatives that they would receive a draft of the inspection meeting report to verify its accuracy. The report would then be made public. No confidential information would be included in the report or otherwise provided to any third party.

Considering EMA’s interactions with the private sector, EMA representatives welcomed the Ombudsman’s work on the matter with a view to learning from and contributing to this inquiry.

Documents inspected

• European Medicines Agency Policy on the handling of competing interests of Management Board members (Policy 0058) of 12 December 2024 (EMA/MB/89817/2024)
• Rules of Procedure of the Management Board of 7 October 2021
• (EMA/MB/115339/2004/en/Rev.8)
• Code of Conduct of the European Medicines Agency of 2025
• Decision of the Executive Director on transparency measures for senior staff leaving the Agency of 12 September 2024 (EMA/394879/2024)
• Decision of the Management Board on outside activities and assignments and occupational activities after leaving the Service of 4 October 2018 (EMA/MB/568497/2018)
• Joint Committee General Opinion 22/2022 on standard conditions for intended occupational activities of 15 December 2022 (EMA/100803/2022)
• Joint Committee Opinion 27/2020 on criteria and restrictions for senior staff applying for occupational activities within two years after leaving the Agency of 4 November 2020 (EMA/504095/2020)
• Best Practice Guide for Staff leaving the Agency of 20 May 2015 (EMA/70197/2013 Rev. 1)
• Guidance published on the Agency’s intranet on ‘Occupation after leaving the Agency’
• Decision Table regarding outside activity during unpaid leave established based on Article 4 of Commission Decision C(2018) 4048 annexed to the Decision of the Management Board of 4 October 2018 (EMA/MB/568497/2018)
• Guidance published on the Agency’s intranet on ‘Outside activities during active service or unpaid leave’
• Communication on conduct and ethical standards for the participation of EMA staff members in the election campaign to the European Parliament of 23 April 2024
• Seven application files for post-service activities of former senior and managerial staff members
• One application file for staff members’ external activities while on unpaid leave
  
  

Information exchanged

The Ombudsman inquiry team had shared several questions with EMA in advance.

1) Members of the Management Board – post-mandate activities

a) Policies

The Ombudsman inquiry team acknowledged that this topic was not part of the questions sent in advance of the meeting. EMA representatives fully collaborated and addressed all queries raised by the Ombudsman inquiry team during the meeting.

The Ombudsman inquiry team highlighted that EMA’s Management Board members are not covered by any policy for post-mandate activities. They asked if such a post-mandate activity could, under certain circumstances, cause a conflict of interest. 

The EMA representatives explained that the composition of EMA’s Management Board is well assigned in Article 65(1) of Regulation 726/2004 (“EMA’s Founding Regulation”), according to which:

“The Management Board consists of one representative of each Member State, two representatives of the Commission, two representatives of the European Parliament, two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations appointed for a term of three years, which may be renewed.”

During their mandate, EMA, in line with Policy 0058 – European Medicines Agency policy on the handling of competing interests of Management Board members, actively monitors for risks of conflicts of interest. When informed of a Management Board member’s intent to take employment, for example in a pharmaceutical or medical device company, it immediately restricts them from further participation in the Management Board and EMA activities. Management Board members nominated by their respective Member States are usually the Heads of their respective National Competent Health Authority (NCA) and are therefore not subject to the EU Staff Regulations. After the termination of their mandate, EMA considers that it is rather for the NCAs to ensure that no conflicts of interest arise because they have a contractual relationship with the respective Management Board members.

The Ombudsman representatives asked how EMA could react if it considered that the applicable rules of an NCA were insufficient.

The EMA representatives acknowledged that, based on the current legal framework, they have limited room for manoeuvre in such cases but affirmed that they would do ad hoc assessments of conflicts of interest and internally ensure that there is no undue lobbying vis-à-vis EMA.

2) (Former) Senior staff members – post-service activities

a) Policies

The EMA representatives explained that the Agency applies Commission Decision C(2018) 4048 by analogy to the Agency’s staff and provided the Ombudsman inquiry team with all relevant policy documents.

Legal basis for Mitigating Measures with a duration of more than two years

The EMA representatives confirmed that restrictive measures imposed under Article 16 of the Staff Regulations can go beyond the two-year notification period. However, since especially contractual and temporary agents are likely to have a professional life after the expiration of their contracts with the Agency, EMA commits itself not to disproportionately obstruct the future career paths.

Therefore, EMA seeks an additional legal basis in cases where restrictions exceed a duration of two years, mainly for proportionality reasons vis-à-vis the restriction of the staff member’s fundamental rights. In this respect, EMA justifies certain restrictions additionally relying on the codes of conduct of national bar associations. In balancing the proposed restrictions with the fundamental right to work, EMA also reflects the role of the staff member and their involvement in decision making or strategic questions of EMA’s litigation.

EMA’s distance clause for former staff members moving to the pharmaceutical industry

EMA considers a distance clause for former staff members who move to the pharmaceutical industry. In this regard, the Ombudsman inquiry team asked whether EMA applies a similar distance clause for staff members who move to service providers for the pharmaceutical industry, such as consultancy and or legal advice roles.

The EMA representatives explained that its definition of ‘pharmaceutical industry’[3] is as wide as possible to include consultancies and other service providers. Its meaning was expanded over time to account for the increasing number of actors involved in the research and development of pharmaceutical products. This means that it encompasses also the more recent entities offering services linked to pharmaceuticals and medical devices.

b) Timely submission and handling of Article 16 notifications

The Ombudsman inquiry team asked how many notifications of post-service activities EMA received in the past.

The EMA representatives explained that the number of departing staff members is relatively low and that most staff retire after leaving EMA.

The Ombudsman inquiry team asked whether EMA suspends the 30-working-day deadline if an application is incomplete or if a staff member submits new elements. Furthermore, they asked if the expiration of the time limit is counted as an implicit acceptance of the application.

The EMA representatives explained that they do not formally stop the clock. However, they may defer the time limit and inform the staff member about the deferral. In such a case, EMA makes the staff member aware that the extension does not constitute an implicit acceptance. Overall, the Agency has never had a case in which a staff member did not await EMA’s decision before taking on the post-service activity.

The Ombudsman inquiry team asked whether late notifications could have an impact on EMA’s assessment.

The EMA representatives affirmed that they try to accommodate staff members and issue decisions as early as possible. However, the assessment process remains unchanged in order not to compromise its quality.

c) Process for handling Article 16 notifications, including the role of the Joint Committee

The EMA representatives explained that all applications are assessed by the Joint Committee after a first verification of completeness by the HR department. In addition, the HR department informs the staff member’s line manager for two reasons, namely that the line manager:

i. can help to establish the facts of the application and thereby support the assessment of the post-service activity.

ii. needs to be aware of the staff member’s departure to enforce any measures while still at EMA, such as the withdrawal of access to certain sensitive files.

In cases of doubt about the application, the Joint Committee always contacts the line manager, to establish the facts about the application, but it might not disclose the name of the staff member’s future employer for confidentiality reasons.

Overall, the composition of the Joint Committee ensures that a broad range of perspectives from the Agency is considered. For instance, the Head of Stakeholders and External Communication or Head of Regulatory are or have been members of the Joint Committee. The Joint Committee submits an opinion to the Executive Director after having discussed the case in a meeting or via a written procedure. The Executive Director can revert to the Joint Committee should he or she have open questions before taking a final decision. 

The Ombudsman inquiry team noted that certain inspected cases seemingly contain merely a general opinion of the Joint Committee. They asked whether, in those cases, the Joint Committee relied on general information only, instead of on a fully-fledged assessment.

The EMA representatives confirmed that the Joint Committee is always informed about an application and conducts its independent assessment. If the Joint Committee concludes that the situation described in the application clearly falls under one of the scenarios covered by the general opinion, it may base its assessment on this general opinion. Thereby the Joint Committee ensures consistency among its decisions.

The Ombudsman representatives asked who was consulted to establish a list of barred court cases for staff members working on litigation.

The EMA representatives explained that such consultations were organised on a case-by-case basis, depending on the required information. This includes the legal department but can also concern other potentially relevant parts of the Agency. In general, the Joint Committee is committed to broad consultations to ensure that all possible cases are identified in the context the increasing complexity of agreements between law firms and their clients. However, the EMA representatives admitted that such a wider consultation was not included in the Joint Committee opinion, because this is considered as being part of standard internal checks. They noted that this information could be added to the opinion.

The Ombudsman inquiry team asked whether there has ever been a request for a post-service activity that EMA has not authorised, and which kind of activities would generally be refused.

The EMA representatives stated that they had never prohibited an activity until now. In general, EMA would consider prohibiting especially lobbying-related activities before the expiration of a cooling-off period. It adopted the Executive Decision on Senior Staff in 2020 to create a consistent framework on such authorisations in anticipation of the retirement of many senior staff members in the Agency. However, most of their Article 16 applications did not raise any conflict of interests, since the activities concerned mainly voluntary work or academic commitments. Moreover, the reputational damage of past conflicts of interest in EU bodies have had a considerable educational value for all agencies. Therefore, the EMA representatives noted that the culture of compliance with conflict-of-interest policies has significantly evolved.

d) Applying the right to be heard of notifying (former) staff members in case a notification is refused or conditionally accepted

The EMA representatives stated that the right to be heard was not a formal requirement since the staff member is aware about the possible outcomes of his or her application from the start and that they would accommodate any request to be heard by the Executive Director. However, they stated that they would consider allowing staff members to add comments after the Joint Committee has issued its opinion and before the Appointing Authority takes its final decision.

e) Informing former staff members of the means of redress in case they are not satisfied with the Article 16 decision

The EMA representatives indicated after the meeting that EMA will include the following sentence in the decisions issued under Article 16 of the Staff Regulations: “This is an administrative decision, against which an appeal may be lodged under Article 90(2) of the Staff Regulations.”

f) Publication of decisions (or information) on post-employment activities of former staff members

The EMA representatives explained that the 2020 Executive Decision on Senior Staff obliges EMA to make information on post-employment activities of former staff members public for two years, counting from the day of the termination of the staff member’s contract. The publication period of two years was adopted considering the two-year notification period under Article 16 of the Staff Regulations and following a recommendation of the EDPS, which the EMA representatives offered to share with the Ombudsman inquiry team after the meeting. The EMA representatives added that the information is not destroyed after two years but will be retained internally, in line with the applicable retention period and remains accessible through different procedures. However, they signalled their availability to reconsider the two-year publication timeframe, provided that this cannot be considered in contradiction with the EDPS recommendation.

The Ombudsman representatives asked how a lifelong restriction on post-employment activities, such as the prohibition to be involved in certain court cases, could continue to be enforceable after EMA has removed the related summary information from its website. They pointed out that EMA’s policy deviates from other EU institutions in which restrictions remain publicly available without any temporal limits.

The EMA representatives reiterated the importance to balance transparency and data protection obligations and pointed out that the obligations imposed by national bar associations provide an additional layer of scrutiny for lawyers. EMA would immediately contact the concerned law firms if it became aware of any breaches of confidentiality obligations by its former staff.

The Ombudsman inquiry team asked if ongoing restrictions were still available on a need-to-know basis after the two-year publication period had ended.

The EMA representatives confirmed that all information on staff members with applicable restrictions remains available in an internal registry available to all staff members.

g) Monitoring compliance of former staff members with obligations stemming from Article 16

The Ombudsman representatives asked how EMA defines such an involvement in court cases and how it would realize that a future employer may receive a case in which the former staff member was involved while at EMA.

The EMA representatives said that, notwithstanding public information on a staff member’s restrictions, EMA cannot be held responsible for internal discussions about confidential information between the former staff member and their new employer. Should EMA become aware of any breach of confidentiality obligations by a former staff member, it would act immediately.

The EMA representatives said that they do not proactively monitor former staff members. However, EMA ensures compliance with the obligations under Article 16 of the Staff Regulations through regular trainings during the entire employee lifecycle management (from onboarding until offboarding).

At the staff member’s departure, he or she is reminded of Article 16 in an offboarding interview with HR and a separate letter. In addition, the internal register of former staff members with restrictions reinforces the awareness of current staff and the culture of compliance at the Agency. When receiving a specific signal about potential non-compliance, EMA would try to establish the facts by contacting the former staff member and their employer and then start an administrative inquiry into the seriousness of the non-compliance and the seniority of the former staff member. In the most severe case, this procedure could entail disciplinary measures.

The EMA representatives added that they consulted DG HR of the European Commission for best practices on monitoring because EMA adopted the Commission’s implementing rules by analogy.

h) Communication of conditional authorisations (including mitigating measures) to the future employer of a former staff member

The EMA representatives confirmed that they proactively communicate such information in cases of senior staff members. However, they stated that there were only few cases in which such a notification was necessary.

The Ombudsman inquiry team asked whether EMA’s final decision includes a reminder that the staff member should communicate any restrictions to their future employer. They mentioned that the Commission, in certain cases, asks the staff member to forward restrictions to their future employer and provide proof thereof.

The EMA representatives stated that final decisions currently do not include such a reminder but that they would consider adding this in future decisions.

3) Senior staff members - external activities while on unpaid leave

a) Policies - Commission decision C(2018) 4048 final – Title three: staff members on leave on personal grounds

See part 2(a) above. EMA follows the process provided for in the Commission’s rules on outside activities.

b) Process for handling requests for authorisation

In practical terms, the procedure of requesting unpaid leave to pursue an outside activity (staff member still in active service) includes initial consultation with the staff member's management lines, followed by a HR opinion prior to the final decision by the Executive Director.

Conclusion of the meeting

The inquiry team thanked the EMA representatives for their time and for the explanations provided. The EMA representatives agreed to share with the Ombudsman the EDPS recommendation, its definition of ‘pharmaceutical industry’ and the signed decision of one the inspected cases. The meeting ended.

Brussels, 20/04/2026

Koen ROOVERS                                                                                         Jennifer KING

Inquiries Officer                                                                                           Legal Expert

 

 

[1] For reference, How the European Commission manages ‘revolving doors’ moves of its staff members (case OI/1/2021/KR); How the European Banking Authority (EBA) handled the move of its former executive director to become CEO of a financial industry lobby group (case 2168/2019/KR) and How the European Defence Agency (EDA) handled the application by its former Chief Executive to take on senior positions at Airbus (case OI/3/2021/KR)

[2] Article 4.8 of the European Ombudsman’s Implementing Provisions.

[3] Pharmaceutical company is defined as follows in the EMA rules on handling declared interests of staff and candidates: “any legal or natural person whose focus is to research, develop, manufacture, maintain, market and/or distribute medicinal products. The definition also includes companies to which activities relating to the research, development, manufacturing, maintenance, marketing and/or distribution of medicinal products (which might also be carried out in house) are outsourced on a contractual basis.

Contract Research Organisations (CROs) or consultancy companies providing advice or services relating to the above activities, or to activities linked with marketing authorisation or other regulatory procedures (e.g. initial applications, variations) fall under the definition of a pharmaceutical company.

Legal or natural persons which do not fall within the scope of the above definition but (i) control (i.e. own a majority stake in, or otherwise exercise a significant influence in the decision-making processes of the relevant pharmaceutical company), (ii) are controlled by or (iii) are under common control of a pharmaceutical company, shall be considered as pharmaceutical companies for the purposes of these rules.”
See the Annex on p.7: https://www.ema.europa.eu/en/documents/other/decision-european-medicines-agency-rules-relating-articles-11-11a-13-staff-regulations-concerning-handling-declared-interests-staff-members-european-medicines-agency-candidates-recruitment_en.pdf.