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Decision of the European Ombudsman closing the inquiry into complaint 642/2012/TN against the European Medicines Agency (EMA)

The complaint was submitted by an EMA employee. She complained that the EMA wrongly required her to sell shares she held in a pharmaceutical company.

When she was recruited by the EMA, the complainant declared her financial interests, which included shares in a pharmaceutical company. The EMA did not consider these shareholdings to be problematic. In 2011, the EMA revised how it handled conflicts of interests and asked its entire staff, including the complainant, to sell her pharmaceutical shares. The complainant considered that the EMA was wrong.

In her decision, the Ombudsman stressed the importance of building and maintaining the public's trust in EU institutions, bodies, offices, and agencies. It is only by building and maintaining such trust that the EU public administration can function effectively. Given the EMA's particularly important role, which is the protection of public health, it is especially important that the EMA take all the necessary steps to build and maintain the public's trust in the EMA.

In the Ombudsman's view, the EMA's new implementing rules sought to give effect to an already existing legal requirement in the EU Staff Regulations on conflicts of interest. Accordingly, no EMA staff, be they existing staff or newly hired staff, should be permitted to hold shares in pharmaceutical companies.

The EMA did not, therefore, commit maladministration when it asked the complainant to sell her shares in a pharmaceutical company.

The background to the complaint

1. The complaint, submitted by an EMA employee, concerns the EMA's rules requiring members of its staff to sell any shares they may hold in pharmaceutical companies.

2. At the time of her recruitment by the EMA, the complainant declared her "financial interests" to the EMA (which included shareholdings in a pharmaceutical company). The EMA did not consider these shareholdings to be problematic.

3. In 2011, the EMA revised its 'Implementing rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency'. The EMA then informed the complainant that, in line with these revised rules, she should dispose of her shareholdings in the pharmaceutical company within six months.

4. The complainant asked the EMA for an exemption from this rule. She also stated, in this context, that, in order to mitigate any risk of a potential conflict of interest, she would agree not to take on any responsibility within the EMA for products directly linked to that pharmaceutical company. The EMA rejected her request for an exemption.

5. The complainant again asked the EMA for an exemption from the rules. She put, forward a number of arguments questioning the validity of the EMA's request that she sell the shares. The EMA rejected this renewed request.

The subject matter of the inquiry

6. In her complaint to the Ombudsman, the complainant alleged that the EMA wrongly requested her, as a staff member, to sell shares in a pharmaceutical company.

7. In support of her allegation, the complainant argued that:

(1) The EMA sought to apply the new conflict of interest rules before these rules entered into force (in February 2012);

(2) The EMA's request to her was wrong because no provision of the new conflict of interest rules indicate that these new rules apply to existing staff who obtained shares before the entry into force of the new rules;

(3) The new conflict of interest rules are discriminatory against one type of declared interest (shareholdings) when compared with other types of declared interests (previous employment and spouse's employment);

(4) The new conflict of interest rules are excessive and disproportionate (she states that the EMA's request would cause her substantial financial loss);

(5) If she sold the shares in question she could be considered to be engaged in insider trading; and

(6) The new conflict of interest rules constitute a retroactive change to her employment agreement.

8. The complainant claimed that she should not be required to sell the shares.

The inquiry

9. On 23 March 2012, the complainant submitted her complaint to the Ombudsman. On 23 April 2012, the Ombudsman asked the EMA to submit an opinion on the complaint. In his request to the EMA, he also posed a number of questions. The EMA submitted its opinion on 22 June 2012. The opinion was forwarded to the complainant with an invitation to make observations. The Ombudsman received the complainant's observations on 25 July 2012.

The Ombudsman's analysis and conclusions

A. The request to sell shares and related claim

Arguments presented to the Ombudsman

10. In her complaint to the Ombudsman, the complainant stated that the EMA expected her to sell her shares in a pharmaceutical company, irrespective of the financial loss such a sale would imply for her.

11. The complainant also argued that the EMA's new rules are discriminatory. She noted that the EMA deals with other forms of interests more leniently, such as those related to the prior employment of a member of staff or to the occupation of the spouse of a member of staff. In sum, the EMA considers that the potential risk of a conflict of interest in such cases is mitigated by the non-involvement of the staff member in i) EMA procedures involving the interests of the company in which he or she worked or ii) procedures involving the interests of the company in which his or her spouse currently works.

12. The complainant also considered the new EMA rules to be excessive and disproportionate. She pointed out that, as a Scientific Advisor at the EMA, she was not involved in the scientific assessment of an application for a marketing authorisation (she pointed out that her role in the procedure was merely administrative). Therefore, she argued, there was not even a theoretical risk of a conflict of interest arising.

13. The complainant also questioned the legality of the EMA's request to staff to sell shares. She pointed out that the EMA employees had access to non-public material information concerning the companies in question. As a result, she argued, any such sales could be viewed as "insider trading".

14. The complainant finally questioned whether the new rules, which changed the terms of her employment agreement with the EMA, could be enforced retroactively.

15. The complainant concluded by stating that she was deeply concerned by the way the EMA brought in and enforced the new rules. She considered it unfair and unjustified that current staff members have to suffer the consequences of the mishandling of a case concerning a former Executive Director of the EMA[1].

16. In its opinion, the EMA stated that, in 2008, the Internal Audit Service of the European Commission carried out an audit of the EMA. In its report, the Internal Audit Service raised questions about the EMA's conflict of interest procedures. In that context, the Internal Audit Service sought more robust procedures and more extensive documentation to mitigate any possible conflicts of interest that might arise when staff members with previous experience from the pharmaceutical industry carried out tasks for the EMA.

17. The EMA added that in 2011, following the departure of the previous Executive Director and issues related to a French medicinal product, a number of private bodies, as well as the European Parliament, became extremely concerned about conflicts of interest at the EMA, including conflicts of interest concerning EMA staff, experts involved in the evaluation processes, and members of the Management Board. In addition, in September 2011, the Court of Auditors carried out an audit on conflict of interest issues and procedures at the EMA[2]. The concern about conflicts of interest led to the EMA's budget discharge being postponed both for the year 2009 and 2010.

18. The EMA then reviewed all its procedures and policies thoroughly in order to address the concerns raised, which related to risks of conflicts of interest rather than actual conflicts of interest. According to the EMA, at the point in time of submitting its opinion, the standards to be achieved had not yet been fully stabilised.

19. The EMA stated that external parties, such as the Commission and Parliament, demand that the EMA eliminate, in respect of staff, experts and others, any risk of conflicts of interest. The EMA thus has to address the perception of risk that any direct or indirect interests may create and which would impair the work of the EMA and by extension undermine or have a negative impact on its work on behalf of other European bodies.

20. The EMA stated that in respect of its staff, specific rules were put in place regarding direct and indirect interests, in addition to the relevant rules in the Staff Regulations and the Code of Conduct. Following the opinion of the Staff Committee, the Implementing rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency were adopted by the Management Board on 9 June 2011. Under Article 110 of the Staff Regulations, implementing rules are adopted following the agreement of the European Commission. However, the situation was urgent and the Management Board therefore adopted the rules on 9 June 2011, pending the agreement of the Commission. This status was notified to the Commission, which had no objections. The College of Commissioners later agreed, with no material changes, to the rules already adopted by the Management Board. The Management Board finally adopted the rules on 1 February 2012.

21. Following the adoption of the rules on 9 June 2011, the EMA wrote to all staff, including the complainant, holding direct financial interests in the pharmaceutical industry, asking them to dispose of such interests by the end of 2011.

22. According to the EMA, assignment of staff with shareholdings in companies in the pharmaceutical industry to tasks not relevant to the companies in question could theoretically have resolved the risk of an actual conflict of interest. However, it would not solve the perception of such a risk. For the 17 staff concerned, transfers to other duties would have posed some practical problems. In addition, the pressure created and the degree of concern expressed by private bodies and the European Parliament regarding conflicts of interest was at such a level that transfer of staff would not have been sufficient. The EMA therefore had no option but to eliminate the potential risk represented by direct financial interests in order to satisfy these parties and especially the European Parliament as the co-legislator and co-party of the budget authority. Accordingly, staff were asked to dispose of direct financial interests. The complainant refused to do so and the EMA therefore assigned her to alternative duties as of 1 June 2012, trying its best to balance the interests involved by assuring her career at the same time as mitigating the situation.

23. The EMA argued that all its staff has access to confidential information regarding the applications made by the pharmaceutical industry, as well as the status of these applications. The way in which the information structure is set up and organised in order to allow staff to carry out their duties without restriction is to have an open access arrangement that is less bureaucratic, less costly in IT terms and supports flexibility. Flexibility is needed in the normal work as well as in the event of an emergency situation with a medical product, enabling the available staff to deal with such a situation at short notice. According to the EMA, it is not possible to segregate the information within the EMA as the way in which the processes flow and the information that is held in integrated databases would make for undesirable blockages and problems in the execution of the work. Staff in different parts of the organisation need access to various parts of the same information in order to carry out their duties. The question of financial advantages as a result of privileged information could thus never be excluded.

24. In respect of the complainant's specific arguments, the EMA referred to Article 7 in the final rules, which states that an employee "shall not hold ... direct interests specified in the Annex(es) to these rules during his employment with the Agency". In line with this Article, current or future staff could not hold shares in the pharmaceutical industry. This Article is in line with Article 11a.3 of the Staff Regulations, which states that "an official may neither keep nor acquire, directly or indirectly, in undertakings which are subject to the authority of the institution to which he belongs or which have dealings with that institution, any interest of such kind or magnitude as might impair his independence in the performance of his duties." This Article applied to the complainant's employment contract in line with Article 11 of the conditions of employment of other servants. In addition, the EMA Code of Conduct states, under 'Direct Interest' that "[i]t follows from Article 63(2) of Council Regulation (EC) No 726/2004 that the holding of direct interests is in principle incompatible with being a member of the Management Board, committee or working party and by analogy, of EMEA staff. In order to remain in office, the individual concerned would have to take appropriate action to suppress the conflict."

25. According to the EMA the new rules reflect explicitly the content of Article 11a(3) of the Staff Regulations and the EMA Code of Conduct, which both apply to the complainant. The new rules do not therefore constitute a retroactive change to her conditions of employment.

26. The EMA stated that direct financial interests can be disposed of or put into blind trusts[3], whereas previous work in the pharmaceutical industry cannot be dealt with in the same way. In respect of staff with conflicts of interest as a result of previous experience in the pharmaceutical industry, the EMA has put in place mitigating actions to prevent them from working on products for specific periods of time.

27. The EMA does not consider its rules to be excessive. They are necessary for the performance of its tasks and responsibilities in the field of medicines, given the major commercial interests and impact on patients that are at stake.

28. The EMA does not believe that the rules on insider trading would be breached by the complainant disposing of her shares in the pharmaceutical industry. It stated that none of the other staff concerned who disposed of their shares have been considered by the relevant authorities to have breached any such rules.

29. In her observations on the EMA's opinion, the complainant acknowledged the legitimacy of the pressure put on the EMA in respect of the conflicts of interest issue. However, she does not agree with the EMA’s claim of urgency to justify the implementation of the draft implementing rules in 2011 given that the first concerns were already raised in 2008 by the Commission's Internal Audit Service.

30. The complainant stated that the EMA's Staff Committee had raised concerns as regards “how the rules will apply to existing employees potentially holding shares and/or patents in pharmaceutical or other relevant industries”. The Staff Committee had suggested that it “should be clarified if the policy will apply retrospectively and how long current employees will be given to dispose of relevant interests”. In response to the Staff Committee’s concerns, the EMA management merely stated that the employees concerned would be contacted individually and requested to dispose of their assets within 6 months. The complainant stated that she is not privy to the comments of the Commission in relation thereto. Irrespective of this, she continues to question the legality of implementing the draft Implementing rules. The complainant also maintains that the new scheme for handling declared interests of existing staff and the request to dispose of existing financial interests is not reflected in the provisions of the final implementing rules that came into force on 1 February 2012. In her view, setting a time limit of six months for disposal, on the basis of the draft implementing rules, was arbitrary and non-enforceable.

31. The complainant also maintained that classifying current personal interests as generally "not allowed", whereas other direct interests (such as, previous employment in a pharmaceutical company) and indirect interests (such as family member's current financial interests) are "allowed with restrictions" (that is, they are allowed provided the member of staff has no involvement in procedures involving medicinal products of the declared pharmaceutical company) is discriminatory and disproportionate, especially if the disposal of shares and/or patents result in significant financial losses.

32. The complainant also maintained that the new policy constitutes a retroactive change of her employment conditions.

33. The complainant noted the EMA's argument that assigning her to other tasks could theoretically have resolved the risk of conflicts of interests. In the complainant's view, any perception of a conflict of interests could have been easily rebutted by clarifying the work that Scientific Administrators effectively perform, their lack of influence on decisions and outcomes of procedure, as well as by confirming staff members' non-involvement with specific products. The complainant argued that her non-involvement in procedures relating to the pharmaceutical company concerned would also have satisfied the requirements of Article 11a of the Staff Regulations which stipulates that “members of staff shall not, in the performance of their duties, deal with a matter in which, directly or indirectly, they have any personal interest such as to impair their independence”.

34. The complainant did not consider convincing the EMA's statement that staff members have not been challenged for insider trading in the context of their disposal of pharmaceutical industry shares.

35. As regards the EMA's statement that the complainant refused to dispose of her shares, she gave the following chronology of events. Following the request to dispose of her shares, dated 29 June 2011, she contacted her bank, her tax accountant, as well as the EMA Personnel Department to obtain clarifications as to the implications of disposing of the shares. The EMA Personnel Department stated, in an e-mail dated 8 July 2011, that: "[i]n response to your question about the consequences of not disposing of your shares within the given timeframe the answer is that you would not be in compliance with the Agency rules and your case would have to be reviewed at that point. Only under the very exceptional circumstances in which you would be put in a financial disadvantage by disposing of your shares (i.e. it would greatly undermine your pension) then you should explain this with supporting documents and your case would be looked into."

36. The complainant stated that her bank informed her that, at that point in time, there was a "hold recommendation" for these stocks. The complainant's tax accountant highlighted possible financial disadvantages due to a change in German tax law (future capital gains from alternative investments would be subject to taxation). In line with this information, the complainant explained to the EMA, in a letter dated 7 September 2011, the reasons why a disposal of the shares would pose a financial disadvantage to her and thus impact on her pension. In contrast to the EMA, the complainant considers her potential financial loss to be excessive and disproportionate to the goal of allaying the perception of a risk of conflicting interests.

37. According to the complainant, the EMA rejected her request to be exempted from having to dispose of the shares without further substantiation. At no point, neither in written correspondence, nor during personal meetings, did the EMA management indicate that putting the shares into a "blind trust" could eliminate the perceived conflict of interest. However, the complainant understands that this would have required her to set up a trust fund and to enter into a contract with, and pay for, a fiduciary third party to handle investments on her part. The complainant pointed out that the shares in question were intended as a long-term investment as part of her retirement provision. She had therefore no intention to trade in them. In addition, to her knowledge, named shares cannot be put into a "blind trust".

38. The complainant stated that as the draft implementing rules had not yet entered into force in autumn 2011, she did not feel a need to continue the dialogue with the EMA management regarding the matter at that point in time. However, in January 2012, the EMA asked her to confirm the disposal of her shares given that the six months for doing so had elapsed. The complainant still did not feel obliged to sell her shares and accept a financial loss on the basis of a draft rule. The complainant was then told that she was the only staff member who had not sold her shares and that it may result in disciplinary actions against her. During two subsequent meetings with the EMA management, the EMA emphasised the difficulties and mounting external pressure that had arisen following the events leading to the departure of its former Director. According to the complainant, she was told that, while unfortunate, she would have to accept potential personal financial loss, just as all other staff concerned, because the EMA did not want any staff member to hold shares.

39. In respect of the EMA's argument that it tried to "assure her career", the complainant stated that that was not how she experienced the handling of the situation. The complainant stated that she was never informed about the supposedly acceptable solution of putting her shares into a "blind trust", but she was merely repeatedly asked, and put under undue pressure without legal basis, to dispose of her shares. Furthermore, following her reassignment in March 2012, she had to wait four weeks for the EMA to specify the timing and role of her new assignment, which was psychologically very straining. She also received her new job description just one week before the planned start date of her new assignment. The decision to reassign her negatively affected her reputation. Given the increasing uncertainty about her professional future at the EMA, and the feeling that she could no longer contribute in a meaningful way to its tasks, the complainant resigned on 30 April 2012, well in advance of the expiration of her employment contract.

40. On the basis of the above, the complainant maintained that the EMA's request to its staff, in June 2011, to dispose of any shares in the pharmaceutical industry was unjustified. She insisted that irrespective of the nature and source of the pressure that the EMA was under, this did not justify non-adherence to principles of good governance. She insisted that requiring staff to accept significant and irrevocable financial losses to address perceptions of risk of conflict of interest, especially without a legal basis, is excessive and disproportionate.

The Ombudsman's assessment

41. The Ombudsman first notes that it emerges from the complainant's observations that she resigned from her position at the EMA in April 2012, soon after the Ombudsman opened his inquiry and even before the EMA had submitted an opinion in relation to the allegation and claim of the complainant. As such, the complainant's claim, that she should not be required to sell the shares, is rendered devoid of purpose. However, the Ombudsman will take a position on the allegation of the complainant, which is that the EMA wrongly requested her to sell her shares in a pharmaceutical company.

42. The Ombudsman stresses the importance of building and maintaining the public's trust in EU institutions, bodies, offices and agencies. It is only by building and maintaining such trust that the EU public administration can function effectively.

43. Public trust in the EU public administration can be severely undermined if members of staff, outside experts that assist in the decision-making of the EU public administration or members of management boards are affected by conflicts of interest.

44. Conflicts of interests are situations in which the private interests and affiliations of a public official create, or have the potential to create, conflict with the proper performance of his/her official duties[4].

45. Any measures taken by the EU institutions to manage conflicts of interest issues should respect the applicable legal rules as well as principles of good administration. Applying principles of good administration would imply ensuring that measures imposed to avoid and to deal with conflicts of interests should be both effective and proportionate to the objective sought.

46. As noted above, it is important for the entire EU public administration to avoid not only real conflicts of interest, but also the risk and perception thereof. The Ombudsman underlines, however, that it is particularly important for the EMA to have, and to be perceived as having, an irreproachable policy and practice as regards conflicts of interests, given its important societal role, namely the protection of public health. The Ombudsman and the public are also cognisant that the work of the EMA has major commercial implications, most notably as regards the authorisation of medicines. As such, it is important to be particularly vigilant as regards ensuring that the EMA avoids any conflicts of interests.

47. The Ombudsman notes that Article 11a(3) of the Staff Regulations requires that "[a]n official may neither keep nor acquire, directly or indirectly, in undertakings which are subject to the authority of the institution to which he belongs or which have dealings with that institution, any interest of such kind or magnitude as might impair his independence in the performance of his duties."[5] (Emphasis added)

48. As regards interests of a kind as might impair the independence of a staff member in the performance of his or her duties, an EMA staff member who owns, or is the beneficial owner[6] of, shares in a pharmaceutical company will be in a conflict of interests if he or she works on procedures or duties related to that company, given that the holding of shares in the company (including the beneficial ownership of such shares) can result in a loss of objectivity by that staff member[7]. It may even be the case that a conflict of interests could arise where the EMA staff member concerned would work on issues relating to pharmaceutical companies that compete with the company whose shares are owned, directly or indirectly, by the EMA staff member. This is so because any action of the EMA relating to those competing pharmaceutical companies may have an indirect impact on the economic interests (and therefore the share price) of the company whose shares are owned by the EMA staff member.

49. In the present case, the Ombudsman notes that the complainant directly owned shares in a major pharmaceutical company. As such, the EMA was entitled to consider that the nature of her interests in that company might impair the independence of the complainant in the performance of her duties at the EMA.

50. Article 11a(3) of the Staff Regulations also makes reference to the need to ensure that the magnitude of an interest held by a staff member does not impair the independence of the staff member in the performance of his or her duties. The Ombudsman agrees that if a staff member were to hold only an insignificant shareholding in a relevant company, it is not likely that his or her independence might be impaired by the shareholding concerned.

51. The Ombudsman is not aware of the value of the shareholding of the complainant. However, the Ombudsman notes that the complainant herself indicated that the sale of her shares would impact significantly on her. The Ombudsman therefore surmises that, in the present case, the staff member concerned did not hold only an insignificant shareholding in a relevant company. As such, the EMA was entitled to consider that the magnitude of her shareholding might impair the independence of the complainant in the performance of her duties at the EMA.

52. The complainant argues that her duties at the EMA, where she worked as a scientific officer, were not such that she could influence the decisions of the EMA. Even if this view were found to reflect accurately the complainant's role within the EMA, the Ombudsman considers that the complainant's shareholding in a pharmaceutical company would still be problematic. The Ombudsman is of the view, in sum, that shareholdings in pharmaceutical companies may also be problematic even where the EMA staff member concerned does not and will not work directly on procedures or duties related to those pharmaceutical companies. She notes that EMA staff members may, through their work at the EMA, become aware of sensitive non-public information that relates to the commercial prospects of pharmaceutical companies (such as the status of a marketing authorisation procedure relating to a company's products or the products of a competing company). It is important that the public be reassured that there is not even the possibility that any choices of staff as regards their share portfolios[8] are not even inadvertently related to the information the person concerned may have obtained in the context of his or her work at the EMA.

53. In this respect, the Ombudsman notes that the EMA has expressly confirmed to the Ombudsman that it operates an open access IT system. Such an open access IT system is needed, the EMA stated, in the context of EMA's normal work (staff in different parts of the EMA need access to various parts of the same information in order to carry out their duties) and in the context of an emergency situation with a medical product (an open access IT system enables all available staff to deal with an emergency situation with a medicinal product at short notice). According to the EMA, it is thus not possible to segregate information within the EMA. It stated that blocking process flows and the information held in integrated databases would make for undesirable blockages and problems in the execution of the EMA's work. In sum, all EMA staff must have access even to confidential information regarding the marketing authorisation applications made by the pharmaceutical industry, including the current status of these applications.

54. In the above context, the Ombudsman agrees that it is proper that the EMA instructs all staff not to purchase any shares in any pharmaceutical companies. They should also instruct staff being recruited by the EMA that they should dispose of any significant shareholdings in pharmaceutical companies they may already hold, either directly or indirectly[9], before taking up employment in the EMA.

55. As regards the complainant's argument that the EMA discriminates, in terms of the strict conditions it applies, between situations of share ownership and situations where staff previously worked for a pharmaceutical company, the Ombudsman notes that the specific additional mechanism by which ownership of shares in pharmaceutical companies can be problematic, as described in paragraphs 52 and 53 above, also justifies why EMA must treat share ownership in pharmaceutical companies more strictly than situations where a member of staff worked previously for a pharmaceutical company.

56. As regards the complainant's argument that the EMA retroactively applied new rules to her, the Ombudsman notes that the above principles are derived directly from Article 11a(3) of the Staff Regulations. She notes that Article 11a(3) of the Staff Regulations has existed since 2004. As such, the EMA should have been applying such a policy since 2004. It should have, in sum, informed all staff recruited from 2004 that they should not acquire or keep shareholdings in pharmaceutical companies. Staff entering the service after 2004 would thus have had the option of complying with this requirement or refusing the offer to take up employment at the EMA.

57. The EMA, evidently, did not comply with Article 11a(3) of the Staff Regulations until 2012, when it finally put in place, through the revision of its 'Implementing rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency', a policy of not allowing staff to hold shares held in pharmaceutical companies.

58. The EMA has, through its new policy, sought to give effect to an already existing legal requirement, namely Article 11a of the Staff Regulations. Even if the EMA may have failed in the past to give full effect to this legal requirement, any such failure cannot be used as a reason not to adopt policies and practices giving full effect to this rule.

59. Relatedly, as regards the complainant's argument that the EMA applied the new implementing rules before their coming into force, the Ombudsman notes that the EMA's decision rejecting the complainant's request to revoke the order to sell her shares was based directly on Article 11a(3) of the Staff Regulations and not the new implementing rules. The Ombudsman considers the objective of Article 11a(3) of the Staff Regulations to be sufficiently precise as to constitute, on its own, a direct legal basis allowing the EMA to require that its staff dispose of shares they may hold in pharmaceutical companies.

60. However, as regards the details of how such shares should be disposed of, such as the precise time-limit within which the sale must occur, the EMA clearly could not rely directly on Article 11a(3) of the Staff Regulations, but rather had to adopt implementing provisions on the basis of Article 110 of the Staff Regulations.

61. As regards the precise time period chosen by the EMA for staff to dispose of shares, the Ombudsman notes that the EMA has a margin of discretion in determining a time-limit for selling shares. That margin of discretion has to be exercised on the basis of the following two principles: (i) the time-limit cannot be so long as to open even the possibility that staff might choose when to sell their shares on the basis of insider knowledge; and (ii) the time-limit cannot be so manifestly short that it puts a disproportionate burden on staff in respect of organising the sale. The Ombudsman considers the six-month time-limit set by the EMA to be reasonable in this respect.

62. It is thus indisputable that, as of 1 February 2012, the EMA could have required the complainant to sell her shares within 6 months. The Ombudsman notes that, before 1 February 2012, the EMA asked the complainant to dispose of her shares. While the EMA was entitled to ask the complainant to dispose of her shares before 1 February 2012, it was not entitled, before 1 February 2012, to impose a time deadline for such a sale.

63. However, the Ombudsman notes, the EMA, in light of the concerns expressed by the complainant, did not impose the requirement to sell the shares within a given time limit. Instead, the EMA reassigned the complainant to other tasks. The Ombudsman considers that this was an appropriate temporary measure, at least until 1 February 2012 when the implementing rules came into effect.

64. The Ombudsman insists, however, that only a sale of the shares in question, imposed by the EMA after 1 February 2012, with a deadline of 1 August 2012, would constitute the long-term solution to the potential conflicts of interest issue, especially in light of the way in which access to information is organised within the EMA (see paragraph 53 above).

65. As the complainant left the EMA in April 2012, it no longer became necessary for the EMA to follow through with its request to the complainant to sell her shares.

66. On the basis of the above, the Ombudsman does not consider that the EMA imposed any new rules in respect of the complainant before those new rules came into force

67. The Ombudsman finally underlines that she does not consider that the EMA's general policy as regards the disposal by staff of direct interests in pharmaceutical companies to be disproportionate given the need for the EMA to ensure that its staff are not even suspected of having a conflict of interests and, relatedly, given the need for the EMA build and maintain the trust of EU citizens in its work.

B. Conclusion

On the basis of the inquiry into this complaint, the Ombudsman closes it with the following conclusion:

There has been no maladministration.

The complainant and the EMA will be informed of this decision.

 

Emily O'Reilly

Done in Strasbourg on 10 January 2014


[1] The Ombudsman understands the complainant is referring to the events surrounding the retirement of the former Executive Director of the EMA (see the EMA press release of 31 March 2011, available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/03/news_detail_001227.jsp&mid=WC0b01ac058004d5c1)

[2] See Report of the Court of Auditors at http://eca.europa.eu/portal/pls/portal/docs/1/17190743.PDF.

[3] Transfer of the complainant's funds into a blind trust would, the EMA notes, have effectively neutralised the conflict for the complainant, at the same time as not engendering any loss for her.

[4] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, OECD, Paris, 2003, p. 28.

[5] The Ombudsman's emphasis.

[6] The Ombudsman notes that Art 11a(3) states that "an official may neither keep nor acquire, directly or indirectly, in undertakings which are subject to the authority of the institution to which he belongs or which have dealings with that institution, any interest of such kind or magnitude as might impair his independence in the performance of his duties." (Emphasis added)

[7] The Ombudsman notes in this respect, that one of the reasons companies remunerate their staff through the award of shares in the company, or the reward of preferential rights to purchase shares in the company, is to generate long-term staff loyalty and commitment to that company.

[8] Such choices include "buy decisions", "sell decisions" or "hold decisions".

[9] Indirect ownership could include, the Ombudsman notes, beneficial ownership through trusts. Although the EMA suggests that the complainant could have put her shares in a trust, the Ombudsman considers that the use of trusts by EMA staff to hold shares in pharmaceutical companies may also be problematic unless strict conditions are complied with.