# EUR-Lex - 52012SA0015 - EN

Important legal notice

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# 52012SA0015

**Special Report No 15/2012 ‘Management of conflict of interest in selected EU Agencies’ **

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GLOSSARY

Accreditation activities (EASA) : Accreditation represents the process through which EASA evaluates the National Aviation Authorities or qualified entities, who applied for allocation of certain certification tasks to be conducted on Agency's behalf, and authorises this allocation.

Advisory Board (EASA) : The Management Board shall establish an Advisory Board, which it shall consult prior to making decisions in certain specific areas. The Management Board shall not be bound by the opinion of the Advisory Body in its work (see Article 33(4) of EASA Basic Regulation). It comprises organisations representing aviation personnel, manufacturers, commercial and general aviation operators, maintenance industry, training organisations and air sports. In total, the Advisory Board comprises 26 members and an equivalent number of alternate members.

ADol : Annual Declaration of Interest

Board of Appeal (EASA and ECHA) : The Board of Appeal is responsible for deciding on appeals lodged against decisions of the Agency. The Board of Appeal consists of a Chairman and two members and an equivalent number of alternate members.

Certification activities (EASA) : EASA certification of all aeronautical products, parts and appliances designed, maintained or used by persons under the regulatory oversight of EU Member States.

Conflict of interest (actual) : "... a conflict between the public duty and private interests of a public official, in which the public official has private-capacity interests which could improperly influence the performance of their official duties and responsibilities" [1].

Conflict of interest (apparent) : "... an apparent conflict of interest can be said to exist where it appears that a public official’s private interests could improperly influence the performance of their duties but this is not in fact the case" [2].

Conflict of interest (potential) : "A potential conflict arises where a public official has private interests which are such that a conflict of interest would arise if the official were to become involved in relevant (i.e. conflicting) official responsibilities in the future" [3].

DoI : Declaration of interests

EASA : European Aviation Safety Agency

EC : European Commission

ECHA : European Chemicals Agency

EFSA : European Food Safety Authority

EMA (previously EMEA) : European Medicines Agency

NA : National Authority

OECD : Organisation for Economic Cooperation and Development

(Co)rapporteur : Member of the scientific body appointed to (co)lead work and coordination of the specific task (e.g. evaluation of a medicinal product, scientific advice on a specific-product or on general matters, such as: guidelines, data collection, etc.).

REACH Regulation : REACH is the European Union Regulation on chemicals and their safe use (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1)). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The aim of REACH is to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the innovation and competitiveness of the EU chemical industry.

Rulemaking activities (EASA) : Rulemaking process refers to the production of EU legislation related to the regulation of the aviation safety and environmental compatibility.

SDoI (EFSA) : The specific declaration of interest is linked to a specific subject matter or set of subject matters (e.g. substances/product) at a specific meeting or a specific mandate to be covered at one or several meetings.

Stakeholder Consultative Platform (EFSA) : Stakeholder Consultative Platform is composed of EU-wide organisations working in areas related to the food chain and advises EFSA on general matters related to the Authority’s work programme, risk assessment methodologies, etc.

Standardisation activities (EASA) : Standardisation activities refer to the inspections carried out by EASA in the national aviation authorities for ensuring that the EU aviation safety legislation is properly, uniformly and consistently applied.

EXECUTIVE SUMMARY

I. This audit aimed at evaluating the policies and proced- ures for the management of conflict of interest situ- ations for four European Agencies (hereafter "selected Agencies") making vital decisions affecting the safety and health of consumers, namely the European Avi- ation Safety Agency (EASA), European Chemicals Agency (ECHA), European Food Safety Authority (EFSA) and the European Medicines Agency (EMA). Policies and procedures implemented after the Court completed its audit field work (October 2011) have not been evaluated.

II. There are a number of definitions of conflict of interest situations. For the purpose of the Court’s audit, the definition provided in the OECD Guidelines "Managing Conflict of Interest in the Public Service" [4] is used: "...there 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".

III. Certain conflict of interest risks are embedded in the selected Agencies’ structure (e.g. the same organisation is both a management representative and a supplier of services) and in the use of the research performed by the industry. Against this background it is paramount that selected Agencies have robust systems to manage a high inherent risk of conflict of interest.

IV. There is no comprehensive EU regulatory framework dedicated to conflict of interest which would ensure comparable minimum requirements on independence and transparency applicable to all EU Agencies and all key players that influence strategy, operations and decision-making. In the absence of such a regulatory framework, the OECD Guidelines in this respect, which set an international benchmark for designing a comprehensive conflict of interest policy, have been considered as part of a reference framework for this audit.

V. The Court concluded that none of the selected Agencies adequately managed the conflict of interest situations. The shortcomings identified were, however, of varying degrees.

VI. Out of the selected Agencies, EMA and EFSA have developed the most advanced policies and procedures for declaring, assessing and managing the conflict of interest.

VII. Though ECHA has developed Agency-specific policy and procedures for management of conflict of interest, the policy and procedures for ECHA’s staff and Board of Appeal have significant shortcomings.

VIII. The Court found that EASA did not have an Agency-specific conflict of interest policy and procedures. EASA does not obtain or assess the declarations of interest for staff, Management Board, Board of Appeal and experts.

IX. The Court welcomes that all the selected Agencies are continuously developing and enhancing their policies and procedures also in response to different events, outside pressure and the Court’s audit.

X. The Court recommends:

(a) for EASA to develop comprehensive Agency-specific policy and procedures for managing conflict of interest;

(b) for ECHA to implement appropriately policy and procedures for staff and Board of Appeal Members;

(c) for the selected Agencies to improve their conflict of interest policies and procedures by:

(i) screening candidates for conflict of interest before their appointment;

(ii) establishing conflict of interest policies and proced-ures which would ensure that conflict of interest situations are managed to a comparable standard by national authorities performing outsourced tasks (EASA and EMA);

(iii) establishing clear and objective criteria for assessment of declarations of interest and applying them consistently;

(iv) introducing gifts and invitations policies and proced- ures for the entire Agency (EASA, ECHA and EFSA);

(v) developing clear, transparent and consistent breach of trust policies and procedures for the entire Agency;

(vi) improving the transparency of the declared interests during the meetings and in the context of scientific decision-making processes;

(vii) ensuring comprehensive and compulsory training on conflict of interest;

(viii) the selected Agencies in coordination with all the appointing bodies involved should address the post-employment issues;

(d) for the EU legislator, possibly in consultation with other EU Institutions, to consider further developing the EU regulatory framework dedicated to management of conflict of interest situations, using the OECD Guidelines and existing best practices as a reference;

(e) though this report concludes on four selected Agencies, all EU Institutions and decentralised bodies may wish to examine whether the recommendations of this report are relevant and applic- able to them.

INTRODUCTION

BACKGROUND

1. Conflict of interest situations can occur almost in any workplace at any time. If they are not handled correctly they can negatively affect the decision-making process, give rise to scandals and cause reputational damage. This is most evident when public bodies are concerned since it can lead to a loss of faith in their ability to operate impartially and in the best interests of society. There are a number of definitions of conflict of interest situations. For the purpose of the Court’s audit, the definition provided in the OECD Guidelines "Managing Conflict of Interest in the Public Service" [5] (hereafter "OECD Guidelines") is used: "...there are situ- ations 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". In this context, the conflict of interest can be: actual, apparent or potential [6].

2. In recent years a number of alleged cases pertaining to conflict of interest involving certain EU Agencies have been reported in the press and have raised concerns within the European Parliament. In 2011 the European Parliament requested the Court to "undertake a comprehensive analysis of the agencies’ approach to the management of situations where there are potential conflicts of interest" [7].

3. The European Parliament has postponed its approval of the 2010 accounts of EMA and EFSA partly due to what it considers to be an unsatisfactory management of conflict of interest [8].

4. The Court decided to focus on the four agencies where a lack of impartiality was likely to present the highest risk (EASA, ECHA, EFSA and EMA hereafter the "selected Agencies"); these agencies have significant decision-making powers in in areas of vital importance to the health and safety of consumers and their decisions personally affect every EU citizen:

(a) EASA has to maintain and develop a high uniform level of civil aviation safety in Europe. In view of achieving these objectives, EASA issues certification specifications for aircraft, takes decisions regarding the airworthiness and environmental certification, conducts standardisation inspections in the Member States and issues opinions and recommendations to the Commission for enhancing civil aviation safety;

(b) ECHA has an important regulatory role in implementing the EU’s chemicals legislation for the benefit of human health and the envir- onment as well as for innovation and competitiveness. ECHA helps companies to comply with the legislation, advances the safe use of chemicals, provides information on chemicals, performs their labelling and classification and addresses chemicals of high concern;

(c) EFSA has to provide independent information on food and feed safety, thus contributing to a high level of protection of human and animal health. EFSA issues scientific opinions on food ingredients, pesticides, genetically modified organisms, etc. and promotes uniform risk-assessment methodologies for food and feed;

(d) EMA is responsible for the scientific evaluation and supervision of medicines developed by pharmaceutical companies for use in the European Union. In addition, EMA gives scientific advice and assistance to companies for the development of new medicines and publishes guidelines on quality, safety and efficacy requirements. It is considered as the "hub" of a European medicines network comprising over 40 national competent authorities;

(e) In summary, the selected Agencies determine the licensing of aircraft, chemicals, food ingredients and medicines in the EU. Annex I provides an overview of each selected Agency’s objectives and tasks.

5. Clearly all of the Agencies and EU Institutions and other decentralised bodies (e.g. Joint Undertakings, etc.) can be exposed to the risk of conflict of interest and though the conclusions and recommendations of this report relate to the selected Agencies only, other Agencies and EU Institutions may wish to consider if they are relevant for them.

INHERENT RISKS OF CONFLICT OF INTEREST

6. In view of the importance of the decisions taken by selected Agencies, the risks and consequences of poor management of conflict of interest situations are the greatest for them. Some conflict of interest situations relating to past, current or future interests are inevitable and do not necessarily imply improper conduct or corruption. This is often the case in a highly specialised/unique organisation where expertise is in limited supply and industry "competes" for the same experts.

7. The structure and the operations of the selected Agencies (e.g. governance, interaction with third parties, customers, suppliers, etc.) require close cooperation with national authorities and industry. This however entails inherent conflict of interest risks:

- Management Board: In EASA, ECHA and EMA, the Management Board is composed mainly of representatives of the national authorities or Member States. At the same time, EASA and EMA outsource part of their activities to relevant national authorities and take other decisions affecting national authorities (see Box 1). In EFSA, the Members of the Management Board are selected based on their experience and scientific background. However, in accordance with the EFSA's Founding Regulation, four out of the 15 EFSA Management Board Members have a background (including current involvement) in organisations representing consumers and other interests in the food industry. Furthermore, the impartiality of EFSA’s work and decision-making might be jeopardised since three of these organisations represented on the Management Board are also represented in the Stakeholder Consultative Platform [9];

- Involvement of external experts (hereafter "experts"): In carrying out their scientific activities, ECHA, EFSA and EMA work with experts, who have extensive background in the field and may have past or present connections to the industry (such as employment, research funding, etc.). For example, some 3800 experts are involved in EMA’s activities and around 1200 experts in EFSA’s activities. In these three Agencies, the experts are members of the Scientific Committees and Panels directly involved in drafting scientific opinions which underpin vital decisions affecting the health and safety of consumers (e.g. scientific opinions regarding medicines, food, chemicals). In EASA, the experts are mainly involved in rulemaking activities, standardisation inspections in the Member States and to a lesser extent in certification tasks;

- Partnership with stakeholders: Given their scientific and supervisory roles, the selected Agencies work closely with industry or consumer representatives (e.g. manufacturers, operators, distributors, etc.). For example, an important risk factor is that most scientific opinions and decisions prepared by the selected Agencies also use the research carried out or financed by industry.

8. Against this background it is paramount that the selected Agencies are able to manage such inherent risks of conflict of interest.

BOX 1

EXAMPLES OF CONFLICT OF INTEREST RISKS INHERENT TO THE STRUCTURE OF THE AGENCY

In EMA, the Management Board, comprised mainly from representatives of National Authorities (NAs), decides the remuneration for scientific services provided to the Agency by NAs. The Court in a Specific Annual Report [10] has noted the need to introduce a system based on an NA’s actual costs. Such a system has not been introduced to date and EMA’s Management Board rejected the most recent proposal [11].

A tender procedure to outsource the certification tasks to qualified entities [12] was ongoing in EASA at the time of the audit. Hitherto it delegated certification tasks only to the accredited NAs on the basis of framework contracts concluded without any tendering procedures. The charges paid by EASA in respect of the assigned tasks are stipulated in framework contracts. For the same tasks, the flat rates are different among the NAs and they are not based on actual costs.

According to the legal framework of EASA, the NAs are audited by the Agency in the context of standardisation and accreditation processes, while their interests are represented at the level of the Management Board.

A REFERENCE FRAMEWORK

9. For effective management of the conflict of interest situations, the selected Agencies need to have an adequate reference framework.

10. The regulatory framework relevant to EU institutions and decentralised bodies (hereafter "EU regulatory framework") consists of the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Communities (hereafter "Staff Regulations"), other EC decisions and guidelines for management of conflict of interest. A more detailed list of the reference framework dealing with conflict of interest is presented in Annex II.

11. Staff Regulations contain a number of very general requirements relating to the ethical principles which should be observed by public officials [13]: independence, integrity, objectivity, impartiality and loyalty. The Commission has issued decisions [14] and guidelines for their practical implementation.

12. The Commission’s Internal Control Standard No 2 "Ethical and Organisation Values" requires to have in place procedures to ensure that all staff are aware of the relevant ethical and organisational values, in particular ethical conduct, avoidance of conflict of interest, fraud prevention and reporting of irregularities.

13. In addition to the above, three of the four selected Agencies have developed their own Agency-specific conflict of interest policies and proced- ures (a summary of the Agencies’ policies and procedures is presented in Annex III).

14. As far as the public sector at large is concerned there are generally accepted OECD Guidelines. In addition, OECD has also published specific guidelines regarding post-employment issues: "Post Public Employment-Good Practices for Preventing Conflict of Interest" [15].

AUDIT SCOPE AND APPROACH

AUDIT SCOPE

15. The audit evaluated policies and procedures for the management of conflict of interest situations for four selected Agencies making vital decisions affecting the safety and health of consumers, namely:

- EASA provides safety certificates for civil aviation which require that its staff have a high technical knowledge which is typically gained by working in the industry or for the NA. There is a risk that agency staff with such a background are involved in taking decisions that benefit their former (and/or possibly future) employer;

- ECHA manages the REACH regulation which aims at ensuring a high level of protection of human health and the environment. It provides scientific and technical advice on chemicals which can have a major financial impact on companies operating in the sector;

- EFSA provides information on risks related to food safety. It provides scientific and technical advice on food which can have a major financial impact on companies operating in the sector;

- EMA plays a coordinating role in the authorisation and maintenance of medicinal products in the EU. It has to rely on trials conducted by organisations and companies that have vested interests in the products concerned.

16. The audit focused on key players including organisations working with the selected Agencies who have an important role in the scientific decision-making process and operational activities:

- Members of the Management Boards;

- Members of Scientific advisory Panels, committees, forums and other experts;

- Agencies’ staff, in particular Directors and key scientific decision-making personnel;

- Members of Boards of Appeal (EASA, ECHA); and

- Stakeholders’ organisations.

17. The audit did not cover conflict of interest situations that could arise in procurement and recruitment procedures. These procedures are subject to the annual audits of the Court.

18. The Court did not assess specific conflict of interest situations as such since this would involve an intensive examination of the circumstances of those situations as well as arbitrary judgements. The Court cannot assess the validity of the methods which selected Agencies use to assess the results of research funded by industry.

19. It should be noted that all of the selected Agencies are continuously developing and enhancing their policies and procedures also in response to different events, outside pressure and the Court’s audit. Policies and procedures implemented after the Court completed its audit field work (October 2011) have not been evaluated.

AUDIT APPROACH

20. The audit aimed to answer the following main audit question:

- Do the selected Agencies adequately manage conflict of interest situations?

and two specific questions:

- Are there adequate policies and procedures in place to manage conflict of interest situations?

- Have selected Agencies adequately implemented their policies and procedures on management of conflict of interest situations?

21. The Agency-specific policies and procedures drafted in the context of the specific legislative requirements applicable to each of them as well as their implementation were assessed using the regulatory framework (see Annex II) relevant to EU institutions and decentralised bodies, the more comprehensive OECD Guidelines and best practices identified in the selected Agencies. In the absence of a comprehensive EU regulatory framework, the OECD Guidelines have been considered as part of a reference framework for this audit since they set an international benchmark for designing a comprehensive conflict of interest policy. OECD Guidelines were used in all cases not (or insufficiently) covered by the EU regulatory framework. The OECD Guidelines are addressed to governments and public institutions at large, aiming to help them to design and implement an efficient conflict of interest policy.

22. The audit work carried out included the following:

- Analysis of the selected Agencies’ regulatory framework;

- Meetings with the selected Agencies’ management, Agencies’ staff and various boards (Management Board, Advisory Board, Board of Appeal);

- Analysis of a questionnaire completed by the selected Agencies;

- Desk review of selected Agencies’ policies, procedures, internal guidelines, declarations of interests, minutes of the Scientific Panels/Committees’ meetings, staff’s personal files, etc.; and

- Examination of how selected Agencies applied their policies and procedures to the specific cases (e.g. staff, experts, Members of the Management Board), including a number of published cases pertaining to conflict of interest (non-governmental organisations, European Ombudsman, media, etc.).

23. The Court presents its observations on a chronological basis i.e. the pol- icies and procedures are analysed for the key players as they apply to the stages of initial appointment (e.g. such as the appointment of experts to the Scientific Committee), while they are at the Agency (including training and the acceptance of gifts, etc.) and when they leave (including obligations when taking up new posts that might result in a conflict of interest).

OBSERVATIONS

EU REGULATORY FRAMEWORK

24. The selected Agencies are bound by the Staff Regulations (see Box 2).

25. However, the independence requirements set in the Staff Regulations and the Commission guidelines refer only to staff. Other key players involved in decision-making processes such as Members of Management Boards and experts are not covered by them.

26. Provisions on Agencies’ independence and transparency requirements can be found in each selected Agency’s Founding Regulation, but the extent of requirements varies considerably between the selected Agencies (see Annex IV). These provisions refer to the requirements to fill in and publish annual and specific declarations of interest, to make public the agendas and the minutes of the meetings of the scientific bodies and various boards (e.g. Management Board, Board of Appeal), to publish the results of the scientific studies, etc. As shown in Annex IV, the legal requirements for independence and transparency are stricter for EFSA and EMA, less stringent for ECHA (e.g. no obligation to publish the declarations of interest) and the least prescriptive for EASA (e.g. no obligation to fill in declarations of interests).

BOX 2

STAFF REGULATIONS PROVISIONS REGARDING CONFLICT OF INTEREST:

an official must notify any personal interest that might impair his/her independence [16];

mitigating measures must be taken [17];

officials shall seek approval for engaging in outside activities and declare gainful employment of spouses [18]; and

officials continue to be bound by the duties of integrity and discretion after leaving office as regards the acceptance of certain appointments or benefits and must notify any employment entered into for two years after leaving the service [19].

27. Hence there is no comprehensive EU regulatory framework dedicated to conflict of interest which would ensure comparable minimum requirements on independence and transparency applicable to all EU Agencies and to all key players that influence strategy, operations and decision-making. Annex V provides a comparison between the EU regulatory framework (except for Agencies’ Founding Regulations and Agency-specific policies and procedures) and the OECD Guidelines.

BEFORE WORKING WITH THE AGENCIES

CANDIDATES ARE NOT ADEQUATELY SCREENED

28. In general, the nomination and appointment procedures in EASA, ECHA [20] and EMA do not include adequate screening of the candidates (i.e. experts, Members of the Management Board and of the Board of Appeal) in relation to conflict of interest situations. However, the members of Management Boards and a number of experts (ECHA and EMA) are nominated or appointed by Member States, national bodies or EU Institutions (i.e. Commission, Council, etc.) and the selected Agencies have no or limited influence over their appointment.

29. EFSA’s appointment rules for experts foresee the screening of candidates’ declarations of interest. However, the screening is not based on clearly specified criteria in cases of conflict of interest situations.

30. In most cases, it is therefore only after the candidates’ appointment that a conflict of interest is identified. Furthermore, selected Agencies have no power to replace Members of the Management Board or experts in cases where their interests are assessed as incompatible with their role in the Agency (see Box 3).

BOX 3

EXAMPLE OF A LACK OF SCREENING OF CANDIDATES

A member of the Scientific Committee was appointed by the Commission and the declaration of interest was evaluated by EMA only after his [21] appointment. Whilst the evaluation showed conflicting interests which should have precluded his appointment, EMA could not dismiss him.

31. OECD Guidelines recommend screening processes as part of selection procedures to identify and deal with conflict of interest situations at an early stage [22].

ELIGIBILITY CRITERIA FOR STAKEHOLDERS’ ORGANISATIONS IN EMA ARE INCOMPLETE

32. The selected Agencies generally have adequate arrangements for engaging with stakeholders’ organisations interested in their work. In order to be represented on various of the selected Agencies bodies, these organisations must meet certain eligibility criteria.

33. However, these criteria do not always set clear standards to be met. The transparency criterion in EMA requires that the sources of funding of patient and consumers organisations are disclosed annually. There are, however, no minimum standards for an acceptable financing structure thus potentially allowing patient or consumer organisations fully financed by one pharmaceutical company to participate in EMA’s activities.

34. In addition, EMA did not have any eligibility criteria for healthcare professionals’ organisations which can be involved in EMA’s activities in the same manner as for example patient or consumer organisations.

OUTSOURCED SCIENTIFIC AND/OR OPERATIONAL ACTIVITIES ARE NOT ADEQUATELY MONITORED

35. Management of conflict of interest is very important when the activities of the selected Agencies are outsourced, since these activities are not under the selected Agencies’ direct control. EASA and EMA outsource significant parts of their scientific and/or operational activities to NAs.

36. EASA uses framework contracts with NAs, which have to ensure that there is no conflict of interest at the level of the outsourced tasks. EASA has, however, no clear criteria and methodology to verify NAs’ conflict of interest policies and procedures and their implementation. There is no evidence that EASA carries out such verification.

37. EMA’s conflict of interest policies and procedures do not cover national experts working on the tasks outsourced to the NAs. EMA does not perform any verification of the conflict of interest policies and procedures of the NAs.

WORKING WITH THE AGENCIES

AGENCY-SPECIFIC POLICIES AND PROCEDURES ARE DEVELOPED BY EMA, ECHA AND EFSA ...

38. Of the selected Agencies, EMA and EFSA have developed the most advanced frameworks for declaring, assessing and managing conflict of interest dealing specifically with industry-related risks.

39. A key role in the management of conflict of interest lies with the declar-ation of interest where individuals disclose their personal circumstances pertinent to conflict of interest as defined by selected Agencies’ policies and procedures.

40. Conflict of interest policies and procedures of ECHA, EMA and EFSA require declarations of interests (mostly annually) from staff, Members of the Management Boards, Boards of Appeal, scientific boards, panels and forums.

41. ECHA developed a conflict of interest policy soon after it was set up. A new "Policy for Managing Potential Conflicts of Interests" was adopted by ECHA’s Management Board on 30 September 2011. The policy is applic- able to the entire Agency and all of its activities [23]. It introduces a more comprehensive form of the declaration of interest as well as the requirement for staff to complete them annually.

42. EMA has developed a number of clear and realistic descriptions as to what circumstances can lead to a conflict of interest. For the evaluation of experts, EMA and EFSA have defined specific criteria, such as: financial interests, employment, member of a scientific body, consultancy, research funding, intellectual property rights, close family members, gifts and invitations, etc. which could give rise to conflict of interest. Depending on the type of activities and whether they are ongoing or performed in the past (last five years), the policies and procedures foresee restrictions for holding certain positions or for participation in different phases of the decision-making process. EMA has developed a clear matrix where the interests declared are linked with a set of prescriptive outcomes (see Annex VI).

43. In addition to EFSA’s system of annual declarations of interests, the Agency also introduced an additional layer for the experts, who are required to:

- make specific declarations of interests before each meeting of the Scientific Committee, Panels and Working Groups; and

- declare orally during the meeting any unforeseen interests concerning agenda items.

44. Specialised software for declarations of interest has been used by EFSA since May 2008 in order to ensure the traceability of the assessment process. EMA has also developed certain applications/databases for managing the process of evaluating the declarations of interest. ECHA has no such software to support management and assessment of the declarations of interest.

... BUT NOT BY EASA

45. EASA, except for its Approvals and Standardisation Department, does not have an Agency-specific conflict of interest policy and procedures. Declarations of interest are not obtained or assessed by EASA on a regular basis.

IMPLEMENTATION OF POLICIES AND PROCEDURES IN ECHA HAS SIGNIFICANT SHORTCOMINGS

ECHA DOES NOT REVIEW INTERESTS DECLARED BEFORE TASKS ARE ASSIGNED TO STAFF

46. Under ECHA’s previous policy and procedures, staff members were obliged to complete a declaration at the time of their appointment [24]. The initial declarations had to be updated when changes occurred.

47. The declarations of staff members examined by the Court were kept in sealed envelopes in personal files and had not been reviewed and assessed by ECHA for conflict of interest. ECHA fully relied upon the staff’s obligation to spontaneously inform superiors if they were aware of any conflict of interest, notwithstanding any previously submitted declar- ation. An examination of the sealed declarations of interest revealed cases that should have been addressed by management as shown in Box 4.

POLICIES AND PROCEDURES TO ASSESS AND MANAGE CONFLICT OF INTEREST SITUATIONS AT ECHA’S BOARD OF APPEAL ARE NOT ADEQUATE

48. The Board of Appeal deals with appeals from any natural or legal person affected by decisions taken by this Agency. It consists of a Chair and two other permanent members, who are ECHA’s staff, as well as additional and alternate members who are not ECHA’s staff. It is an independent body within ECHA and has its own code of conduct.

BOX 4

EXAMPLES OF SEALED DECLARATIONS OF INTEREST NOT ASSESSED BY ECHA

One senior member of staff declared the rent of an apartment to one of the companies with a large number of applications in ECHA.

One senior member of staff declared past employment in a large company with many applications dealt with in his unit.

One junior member of staff declared past work in projects funded by one company as well as his spouse’s employment in that company with a large number of pending requests in ECHA.

49. Permanent Board of Appeal Members are obliged to complete annual declarations of interest. Alternate and additional Board of Appeal Members are obliged to complete annual declarations of interest and submit specific declarations of interest before being assigned to a case.

50. The responsibility for reviewing the declarations of interest and for hand- ling situations of conflict of interest resides with the Secretariat and the Chair. There is however no formal procedure or documentation of checks carried out at the time when the Board of Appeal starts working on a particular case and there is full reliance on the declarations from permanent Board of Appeal Members.

51. The Court found that the Board of Appeal does not possess sufficient information to make informed decisions as to whether a conflict of interest situation exists. Information is only available in respect of the appellant company, but not on all the companies which have direct interest in the case of an appeal (e.g. (co)registrant company of the chemical substance).

52. The declarations of interest of the Board of Appeal Members do not disclose the details of all substances and cases these members worked with before joining ECHA (see Box 5).

BOX 5

EXAMPLE OF INADEQUATE MANAGEMENT OF CONFLICT OF INTEREST SITUATIONS IN ECHA’S BOARD OF APPEAL

Two Members of the Board of Appeal declared ownership and/or work in the REACH regulation area [25]. However, policies and procedures do not prevent them from being assigned to cases with past or current connections to them.

ASSESSMENT AND MANAGEMENT OF DECLARED INTERESTS ARE NOT ALWAYS ADEQUATE

53. According to the OECD Guidelines, organisations should provide a clear description of what circumstances and relationships can lead to a conflict of interest situation [26]. The onus for declaring the interest lies with the individual. The organisation’s administrative process should simply ensure that the information disclosed is properly assessed and kept up-to-date. Clear resolution measures should be stated in the policies and procedures dealing with conflict of interest situations, for example, liquidation of the interest, restricted access to particular information, transfer of the official to a non-conflicting function, resignation from the conflicting private capacity function, etc.

INADEQUATE DOCUMENTATION OF MANAGEMENT BOARD MEMBERS’ CONFLICT OF INTEREST ASSESSMENT

54. In all the selected Agencies, the review of declarations of interests of Management Board Members and the decisions taken in this respect are not adequately documented.

INFORMATION AVAILABLE IS NOT ALWAYS USED

55. The selected Agencies do not always make use of information provided by the persons concerned and readily available to these Agencies (CVs, previous declarations of interests, information in media, etc.) to check the declarations of interests. The audit revealed a number of cases, where a check of such information would have revealed problems (see Box 6).

LACK OF CLEAR ASSESSMENT CRITERIA AND INCONSISTENT APPLICATION

56. In ECHA, although the policy [27] requires the declarations of all interests potentially causing a conflict, it does not specifically deal with the situations arising from current financial interests, past employment, past consultancy and similar activities. Unlike EMA and EFSA, the interests incompatible with the individual’s role in ECHA are not defined, nor are the mitigating measures for the most common risks set out. The assessment of the conflict of interest situations therefore depends on the judgement of the responsible individual.

BOX 6

EXAMPLES OF NOT USING THE INFORMATION AVAILABLE FOR ASSESSMENT OF THE DECLARATIONS OF INTEREST

In EMA and EFSA, later declarations of interest of certain experts had clear inconsistencies with their previous declarations of interest. The Agencies did not always seek clarifications from the experts.

In ECHA, one employee did not declare all past employments for the last five years as is required by the policy. A simple check of declaration of interest against the CV of the employee would have revealed this.

A Member of EMA’s Scientific Committee was found by EMA to be in conflict of interest situation, due to his private interests. EMA concluded that this expert could not be a Member of the Scientific Committee. Despite this, the expert continued to participate in the meetings of the Scientific Committee and has been reappointed by the EC for a new term of three years. The updated declaration of interests of this expert no longer mentioned the interests related to the organisation concerned. This was inconsistent with the previous assessment and with the published CV.

57. Assessment criteria for the evaluation of conflict of interest for EFSA’s scientific experts lack clarity which on occasions led to questionable assessments, as demonstrated in Box 7.

BOX 7

EXAMPLES OF QUESTIONABLE ASSESSMENT OF CONFLICT OF INTEREST IN EFSA DUE TO LACK OF CLARITY

Conflicting roles of the scientific experts: advocates and reviewers of the same concepts

In EFSA, the majority of the members of one scientific body of this Agency have been advocates of a concept (through previous publications, participation in workshops and expert groups, etc.) which has been subject to analysis by the same scientific body.

In another case, two of EFSA’s experts were simultaneously providing consultancy/advice to a private organisation, while they were reviewing the same concept as members of the EFSA scientific body.

In both cases, EFSA concluded that there was no conflict of interest.

Inconsistent treatment of conflict of interest

In EFSA, the conflict of interest arising from membership of a non-profit, worldwide organisation funded primarily by the agri-alimentary industry and extensively involved in EFSA’s activities has been treated differently for the Members of the Management Board and for the experts.

In the case of EFSA’s Management Board, two members gave up their positions in that organisation following media criticism of conflict of interest.

There are, however, six experts with links to this organisation (e.g. Members of Board of Trustees, Members of Scientific Committees).

58. In the Court’s view, out of the selected Agencies, EMA has the clearest set of assessment criteria for experts. Annex VI illustrates good practices applied in EMA for the evaluation of the most typical situations for experts and linking them to clear outcomes in terms of restrictions (if any) applied to the expert’s activities in EMA. However, the Court found cases in which these criteria were not adequately applied (see Box 8).

59. The OECD Guidelines recommend that any conflict of interest policy takes into account the particular risk attached to certain categories of individuals. They require that organisations identify relevant conflict of interest situations and implement measures to mitigate the related risks [28].

BOX 8

EXAMPLES OF INADEQUATE RISK ASSESSMENT FOR EMA’S SCIENTIFIC COMMITTEE MEMBERS

Two experts were wrongly assigned by EMA the lowest risk level although they were employed in the past by pharmaceutical companies whose activities should have led to a higher risk level under EMA’s policy on conflict of interest. These interests should have restricted the participation in the committee’s activities. The risk levels have been raised by EMA later only when new draft policies were being rolled out.

One expert was a consultant of pharmaceutical companies until August 2007. Under the new conflict of interest policy, his evaluation should have led to restrictions on product or company level in case of specific or cross-product involvement (e.g. quality control of a number of medicinal products). However, EMA did not request further information from the expert and the declaration was wrongly assessed as requiring no restrictions.

60. However, in some cases, selected Agencies’ policies and procedures contain gaps or clear disparities between the level of actual or perceived risk of a conflict of interest and the level of restrictions imposed and measures taken to mitigate the risks (see Box 9).

BOX 9

EXAMPLES OF INCONSISTENT AND INCOMPLETE POLICIES

EMA

Staff members are not allowed to have financial interests or patent ownerships but family members may. For one category of staff (e.g. Scientific Secretary to the Scientific Committee), family interests do not lead to any restrictions on the employee’s involvement in the product-related activities. Direct interests (e.g. current financial interest) of household members are not taken into account in determining the acceptable level of participation in the Agency’s activities for the experts even if the spouse of the member of the Scientific Committee has a significant shareholding in a pharmaceutical company.

In the case of past employment in the pharmaceutical companies, the restrictions imposed on experts (e.g. Scientific Committee Members) are less strict than those imposed on staff in the same circumstances, even though the experts play a more vital role in the scientific process of the Agency.

EMA checks conflict of interest before the appointment of a product team leader/member for the initial marketing authorisation for medicines for human use or a project manager for initial marketing authorisation for veterinary medicines. However, there is no equivalent procedure for Members of a Scientific Committee when they are being appointed as (co)rapporteurs.

The restrictions imposed on experts when they or their organisation receive a grant from the pharmaceutical industry are inadequate. For example, a current beneficiary of the grant from a company would not be prevented from being a (co)rapporteur for the medicine from that company.

EFSA

EFSA requires that the interests held by the family members and relatives belonging to the same household or under the care of the members of the household have to be disclosed in the declarations of interest [29]. Contrary to EMA, its policy does not clarify which interests of the close family members are allowed and the restrictions to be applied.

POLICIES AND PROCEDURES ON GIFTS AND INVITATIONS DO NOT ALWAYS EXIST AND ARE INCOMPLETE

61. ECHA and EMA have issued guidance on gifts and invitations. For ECHA, the policies and procedures are only applicable to staff, but not to Members of Committees, Forum and Management Board. EFSA has a policy on invitations for staff only, EASA does not have an Agency-specific policy on gifts and invitations, but for its staff it refers to the Commission’s guidance on gifts and invitations. Under OECD Guidelines, conflict of interest policies should cover those arising from all forms of gifts [30].

BREACH OF TRUST POLICIES AND PROCEDURES DO NOT EXIST OR THERE IS A LACK OF OBJECTIVE ASSESSMENT CRITERIA

62. Breach of trust policies and procedures refer to the circumstances when an individual fails, intentionally or through negligence, to fulfil his obligations of declaring in a complete and timely manner the interests which may impair his independence. Policies and procedures should clearly define the consequences of not declaring the interests and the sanctions to be applied.

63. The Staff Regulations stipulate that the institution shall take any appropriate measures if an official failed, in performance of his duties, to deal with a conflict of interest matter. However, they do not set out specific measures and sanctions to be taken or applied to officials in breach of their obligations to declare conflict of interest.

64. The selected Agencies do not have breach of trust policies and proced- ures to deal specifically with cases where staff members fail to declare all their relevant interests (e.g. family, financial interests, etc.). In addition, EMA and EASA do not have breach of trust policies and procedures for the Management Board members, experts and Board of Appeal members (applicable to EASA only).

65. ECHA introduced new general breach of trust provisions for staff, experts, members of the Management Board and Board of Appeal in their new "Policy for Managing Potential Conflicts of Interests" adopted on 30 September 2011 [31].

66. EFSA has breach of trust provisions for experts of Panels/Scientific Committees in its policy on declarations of interests [32]. The failure to fulfil in a timely and complete manner the obligations of declaring the interests will be considered a "prima facie breach of trust" [33] towards the Authority resulting in appropriate action, even dismissal. The policy does not include equivalent sanctions for the Members of the Management Board, the experts of the working groups and the Authority’s own staff.

67. In two cases, EFSA initiated breach of trust procedures which led to the resignation of the respective experts from the Scientific Panels. In these cases, EFSA reviewed the scientific outputs to which experts contributed. This review aimed at assessing the expert’s influence and contribution to the final scientific output/decision and to determine any bias due to his conflict of interest. The procedures did not include, however, clear and objective criteria laying down which circumstances would lead to sanctions, including the dismissal of a Member of a Panel/Scientific Committee.

68. The OECD Guidelines cite a wide variety of consequences: disciplinary actions and criminal prosecution along with cancellation of tainted decisions and contracts. Non-disclosure of conflict of interest is generally considered a serious breach, which results in a disciplinary action or even criminal penalties in several countries [34].

TRANSPARENCY OF INTERESTS DECLARED AND SCIENTIFIC DECISION-MAKING PROCESSES SHOULD BE IMPROVED

69. The requirement for transparency in the decision-making process and the handling of conflict of interest is set out in the selected Agencies’ founding regulations as well as in the Agency-specific (except EASA) policies and procedures for managing conflict of interest. Different legal requirements and practices exist among the selected Agencies in respect of transparency which are summarised in Annexes IV and VII.

70. The OECD Guidelines define transparency as one of the core prin- ciples when dealing with conflict of interest situations [35]. It stipulates that declarations of private interests, as well as arrangements for resolving conflicts, should be clearly recorded, to enable the organisation to demonstrate that a specific conflict has been appropriately identified and managed.

TRANSPARENCY OF ANNUAL DECLARATIONS OF INTERESTS

71. EASA does not obtain any declarations of interests. The other three selected Agencies make public the annual declarations of interests of executive staff (Executive Director), scientific experts (Members of the Scientific Committees, Panels, Working Groups) and Management Board Members.

TRANSPARENCY OF SPECIFIC DECLARATIONS OF INTERESTS

72. All selected Agencies publish the minutes of the Management Board meetings on their websites. EFSA even broadcasts the audio recordings of the Management Board meetings. However, the minutes do not contain any information related to the assessment of conflict of interest.

73. EFSA and ECHA also publish the minutes of the meetings of the Scientific Panels and Committees on their website. The SDoIs provided for by EFSA’s policy (see paragraph 43) are not made public, but brief conclusions on the assessment of conflict of interest are included in the minutes of the meetings, which are published on EFSA’s website. They include the conflict of interest identified and the measures applied (e.g. observer with no voting rights, exclusion from the discussions concerning a specific topic, exclusion from the activities of the panel/working group, etc.). EASA publishes the minutes of the consultative bodies’ meetings concerning rulemaking activities. However, minutes of the meetings which would include assessment of conflict of interest of the Agency’s staff and experts involved in rulemaking, standardisation and certification activities are not published. EMA does not make public the minutes of the meetings of the scientific bodies which would contain the assessment of conflict of interest.

TRANSPARENCY IN THE SCIENTIFIC DECISION-MAKING PROCESS

74. There are different degrees of transparency across the selected Agencies as regards the scientific decision-making process. Some of these differences result from the specific fields of competency of each selected Agency, the level of confidentiality required and the internal rules and regulations.

75. EFSA’s founding regulation and the internal rules on the operations of the Scientific Committee, Panels and working groups allow observers to be invited to the experts’ meetings. However, the agendas of the EFSA’s working groups are not published in advance. In addition, the working groups’ outputs are not published. This lack of publicity impairs the possibility of observers to follow the meetings.

76. Several shortcomings have been identified in the published minutes of the experts’ meetings (ECHA, EFSA), which impair the transparency of their activities:

- published minutes do not always contain details on the agenda item or substance affected by the declared interests;

- limited disclosure of the information on the discussions and the conclusions reached in some meetings.

TRAINING ON CONFLICT OF INTEREST NEEDS TO BE STRENGTHENED

77. ECHA has two types of training that deal with the management of conflict of interest:

- the "Ethics and conduct at work" training covers general information about staff obligations in respect of conflict of interest, integrity, the policy on gifts and other issues related to the code of conduct. This training is voluntary for all staff and its attendance was limited;

- the training on "Staff declarations and guidance" contains more detailed information in respect of declarations of interest, the policy on gifts and other aspects of the conflict of interest policies and procedures. This training is compulsory but the Court was unable to ascertain levels of attendance.

78. EMA and EFSA organise training sessions on conflict of interest for newcomers (staff) and thus there is a dissemination of guidance on interests to be declared and conflict of interest.

79. EASA only provides training on ethics and related provisions of the Staff Regulations to newcomers (staff) but not on conflict of interest per se.

80. The OECD Guidelines make explicit reference to training as a means to be used to provide practical examples and concrete steps to be taken for identifying and resolving conflict of interest situations [36].

LEAVING THE AGENCIES — "REVOLVING DOORS" AND "INSIDER INFORMATION"

81. When officials or experts leave public service to work in the private sector, there is a risk that they abuse their position by taking advantage of "insider information" acquired in the course of their public duties to benefit the private company they join. If not properly managed, these risks undermine public trust in organisations. The movement of key personnel between the public and private sector is known as the "revolving door" phenomenon.

82. Obligations of the officials and other servants of the EU after leaving the service are laid down in the Staff Regulations. "Officials intending to engage in an occupational activity, whether gainful or not, within two years of leaving the service shall inform their institution thereof " [37]. In particular circumstances, as foreseen in Article 16 of Staff Regulations, the EU institution or Agency may even forbid that engagement. It is the responsibility of individuals to provide disclosure of post-employment information. According to OECD Guidelines, such a responsibility should be clearly communicated to the individuals and reinforced in the employment arrangements [38].

83. Furthermore, the OECD published specific guidelines related to post-employment issues, remedies and benchmarks [39]. According to these guidelines, major post-employment conflict of interest arise when the public officials:

- seek future employment outside the public service;

- are involved in lobbying public institutions;

- switch sides in the same process; and

- use "insider information".

84. The OECD Guidelines emphasise the fact that negotiations for future employment by a public official prior to leaving the office is widely regarded as a conflict of interest situation [40].

85. The experts, the Members of the Management Board and external Members of the Board of Appeal are not bound by the Staff Regulations, so the post-employment provisions are not applicable to them and there are legal limitations for enforcement of such post-employment obligations upon them. The selected Agencies’ policies and procedures for management of conflict of interest do not foresee any obligations and restrictions regarding their post-employment.

86. Provisions on post-employment are included in the implementing rules of Staff Regulations on outside activities, adopted by the selected Agencies and are similar with those of the Commission. In addition, EFSA issued Agency-specific implementing rules regarding post-employment at the end of 2010.

87. The selected Agencies require their employees to fill in an application for authorisation to engage in an occupation after leaving the Agency. However, there are no rules and criteria on how these applications should be assessed and which post-employment activities would be considered incompatible with their previous role in the respective Agency.

88. In general, the selected Agencies failed to perform a thorough assessment of post-employment cases, in order to anticipate and prevent "revolving doors" type of conflict of interest situations. An example of shortcomings is shown in Box 10.

BOX 10

EXAMPLE OF SHORTCOMINGS RELATED TO ASSESSMENT OF POST-EMPLOYMENT ACTIVITIES

In EFSA, a "revolving doors" case which arose in 2008 was investigated by the European Ombudsman [41], who stated in his draft recommendations that:

(a) EFSA should make clear that negotiations themselves by leaving staff members concerning future jobs of the "revolving doors" type may amount to a conflict of interest. In this regard, it concluded that such negotiations already may lead to a conflict of interest.

(b) EFSA failed to observe the relevant procedural rules and to carry out a sufficiently thorough assessment of the conflict of interest arising from the move of an employee to a company acting in EFSA’s field of competency.

CONCLUSIONS AND RECOMMENDATIONS

89. The Court concluded that none of the selected Agencies adequately managed the conflict of interest situations. A number of shortcomings of varying degrees have been identified in Agency-specific policies and procedures as well as their implementation (see the Table).

TABLE

OVERVIEW OF SELECTED AGENCIES’ MANAGEMENT OF CONFLICT OF INTEREST SITUATIONS [1111]

| Experts | Staff | Management Board | Board of Appeal |

EASA | | | | |

ECHA | | | | |

EFSA | | | | N/A |

EMA | | | | N/A |

Key | |

Management of conflict of interest situations is not adequate, as the Agency-specific policies and procedures are absent | |

Management of conflict of interest situations is not adequate, as the Agency-specific policies and procedures and/or implementation have significant shortcomings | |

Management of conflict of interest situations is not adequate, as the Agency-specific policies and procedures and/or implementation have shortcomings | |

Management of conflict of interest situations is adequate | |

Not applicable, as this Agency does not have a Board of Appeal | N/A |

90. Out of the selected Agencies, EMA and EFSA developed the most advanced policies and procedures for managing conflict of interest. ECHA’s policies and procedures are incomplete and less precise, EASA does not have any.

RECOMMENDATION 1

EASA should create comprehensive Agency-specific policies and procedures on the management of conflict of interest. ECHA should improve its policy by introducing clear assessment and evaluation criteria of declared interests. All selected Agencies should (establish or) continue developing conflict of interest policies and procedures that effectively address their specific risks.

91. The selected Agencies lack adequate policies and procedures to identify a conflict of interest before a candidate (i.e. experts, members of the Management Board and of the Board of Appeal) is appointed.

RECOMMENDATION 2

Candidates in the selected Agencies should be screened for conflict of interest before their appointment. Mitigating measures should be put in place if a decision is taken to appoint them knowing that there is a conflict of interest situation.

92. Conflict of interest related to tasks outsourced by EASA and EMA is outside of their direct control and not adequately monitored.

RECOMMENDATION 3

EASA and EMA should establish policies and procedures which would ensure that conflict of interest situations are managed to a comparable standard by those performing outsourced tasks.

93. The management of conflict of interest whilst working with a selected Agency requires a number of different measures, with the declarations of interest having a key role. There are shortcomings in the assessment of these declarations and management of conflict of interest situations across all of the selected Agencies, notably a lack of clear assessment criteria and/or their inconsistent application. The implementation of ECHA’s policies and procedures for staff and the Board of Appeal have significant shortcomings.

RECOMMENDATION 4

The selected Agencies should establish clear and objective criteria for the assessment of declarations of interest and apply them consistently using all the information easily available to the selected Agencies. Furthermore, ECHA should significantly improve the implementation of conflict of interest policies and procedures for staff and the Board of Appeal Members.

94. Out of the selected Agencies, only EMA has a policy on gifts and invitations that applies to the entire Agency.

RECOMMENDATION 5

EASA, ECHA and EFSA should have gifts and invitations policies and procedures that cover the entire Agency.

95. The selected Agencies do not have adequate breach of trust policies and procedures applicable to the entire Agency.

RECOMMENDATION 6

The selected Agencies should develop clear, transparent and consistent breach of trust policies and procedures that cover the entire Agency.

96. The issue of transparency with respect to the publication of annual declarations of interests is properly dealt with by all selected Agencies, except EASA. However, the selected Agencies are less transparent in terms of the publication of interests declared during the meetings of the Management Board and scientific bodies and in the context of the scientific decision-making process.

RECOMMENDATION 7

The selected Agencies should fully disclose interests declared during meetings and in the context of scientific decision-making process. EASA should put in place a system of declarations of interest and ensure transparency by publishing them on its website.

97. Training on conflict of interest is provided by all selected Agencies, but in ECHA and EASA shortcomings of varying importance were found.

RECOMMENDATION 8

The selected Agencies should have comprehensive and compulsory training on conflict of interest. In particular, EASA should put in place specialised training on conflict of interest for all parties concerned (e.g. staff, Members of the Management of Board and Members of Board of Appeal).

98. The Court’s audit identified a number of significant shortcomings in the selected Agencies’ policies and procedures regarding post-employment:

(a) Lack of provisions that address risks associated with post-employment activities of experts and Members of the Management Board and the Board of Appeal;

(b) Absence of objective criteria as to what situations constitute conflict of interest;

(c) Negotiations for future employment are not covered by current policies and procedures of selected Agencies.

RECOMMENDATION 9

The selected Agencies in coordination with all the appointing bodies involved should address the post-employment issues.

99. There is no comprehensive EU regulatory framework dedicated to conflict of interest which would ensure comparable minimum requirements on independence and transparency applicable to all EU Agencies and to all key players that influence strategy, operations and decision-making.

RECOMMENDATIONS 10 AND 11

The EU legislator, possibly in consultation with other EU Institutions, may wish to consider further developing the EU regulatory framework dedicated to management of conflict of interest situations, using the OECD Guidelines and existing best practices as a reference.

All EU Institutions and decentralised bodies may wish to examine whether the recommendations made to the selected Agencies are rele- vant and applicable to them.

This Report was adopted by Chamber IV, headed by Mr Louis GALEA, Member of the Court of Auditors, in Luxembourg at its meeting of 5 September 2012.

For the Court of Auditors

+++++ TIFF +++++

Vítor Manuel da Silva Caldeira

President

[1] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, OECD, Paris, 2003, p. 24.

[2] See footnote 1.

[3] See footnote 1.

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

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

[6] Managing Conflict of interest in the Public Service: OECD Guidelines and country experiences, p. 24.

[7] Resolution of the European Parliament of 10 May 2011 on the 2009 discharge: performance, financial management and control of EU agencies (OJ L 250, 27.9.2011, p. 269).

[8] http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7-TA-2012-0173+0+DOC+XML+V0//EN&language=EN#BKMD-70 http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7-TA-2012-0175+0+DOC+XML+V0//EN&language=EN#BKMD-77

[9] Stakeholder Consultative Platform is composed of EU-wide organisations working in areas related to the food chain and advises EFSA on general matters related to the Agency's work programme, risk assessment methodologies, etc.

[10] Paragraph 16 of the Report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s reply (OJ C 366, 15.12.2011, p. 27).

[11] Reply to paragraph 16 of the Report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s reply.

[12] A qualified entity is defined as "a body which may be allocated a specific certification task by, and under the control and the responsibility of, the Agency or a national aviation authority". Article 3(f) of Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (EASA’s Founding Regulation) (OJ L 79, 19.3.2008, p. 1).

[13] In this context, the term "official" has a broader meaning, encompassing permanent staff and other categories of EU servants, such as temporary staff, auxiliary staff and contract staff.

[14] For example, Administrative Notice No 85-2004/ 29.6.2004 Commission Decision C(2004) 1597/10 on outside activities and assignments.

[15] OECD, Paris, 2010.

[16] Article 11a of the Staff Regulations.

[17] Article 11a of the Staff Regulations.

[18] Article 12b and Article 13 of the Staff Regulations.

[19] Article 16 of the Staff Regulations.

[20] ECHA’s policy adopted in September 2011 (MB/45/2011/D) introduced a requirement that candidates nominated to the Risk Assessment Committee (RAC) and the Committee for Socio-Economic analysis (SEAC) have to complete declarations of interests before their appointment by the Management Board.

[21] For the sake of convenience, the masculine form is employed in this report to designate persons of either gender.

[22] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, p. 34.

[23] ECHA’s new policy was not implemented at the time of the audit, and therefore the implementation of previous policy and procedures has been tested by the Court.

[24] ECHA’s new policy was not implemented at the time of the audit, and therefore implementation of previous policy and procedures has been tested by the Court. See also paragraph 41.

[25] E.g. help with registration of chemical substances, general consultancy on the REACH Regulation.

[26] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, p. 28 to 30.

[27] Policy for Managing Potential Conflicts of Interests (MB/45/2011/D), adopted by the Management Board on 30 September 2011.

[28] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, p. 28 to 29.

[29] Implementing Act to the Policy on Declarations of Interest — Guidance document on Declarations of Interest ( 8 September 2009), in force until 21 February 2012.

[30] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, p. 33.

[31] Policy for Managing Potential Conflicts of Interests (MB/45/2011/D), adopted by the Management Board on 30 September 2011.

[32] EFSA Implementing Act to the Policy on Declarations of Interest — Guidance Document on Declarations of Interest ( 8 September 2009), in force until 21 February 2012.

[33] Idem.

[34] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, p. 75 to 76.

[35] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, p. 16, 26 and 31.

[36] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, p. 17.

[37] Article 16 of the Staff Regulations of Officials of the European Communities and Articles 11, 54 and 81 of the Conditions of employment of other servants of the European Communities.

[38] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, p. 29 and 30.

[39] Post-Public Employment — Good Practices for preventing Conflict of Interest.

[40] Managing Conflict of Interest in the Public Service: OECD Guidelines and country experiences, p. 24.

[41] Draft recommendations of the European Ombudsman in his inquiry into complaint 775/2010/ANA against the European Food Safety Authority, as published on the European Ombudsman’s website, 7 December 2011.

[1111] Seeparagraphs 15 to 23 (Audit Scope and Approach).

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ANNEX I

STRUCTURE AND GOVERNANCE OF THE SELECTED AGENCIES — ECHA

| European Chemicals Agency (Helsinki) |

| ECHA |

Legal Base (Founding Regulation) | Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency |

Objectives | To ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards relating to substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. To ensure that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public. To coordinate communication concerning the REACH Regulation and in its implementation. |

Tasks | To manage and carry out the technical, scientific and administrative aspects of the REACH Regulation.To ensure consistency at Union level in relation to these aspects.To provide the Member States and the institutions of the Union with the best possible scientific and technical advice and scientific guidance.To perform classification and labelling of chemical substances deriving from the CLP Regulation (EC) No 1272/2008. |

Management Board | 27 Members from the EU Member States6 representatives of the Commission, including 3 members without voting rights appointed to represent interested parties2 representatives of the European Parliament |

Board of Appeal | The Board of Appeal guarantees the processing of appeals of any party affected by the ECHA’s decisions and concludes on these appeals. The Board of Appeal consists of a Chairman and two members who are employees of ECHA. In addition, the Management Board has appointed alternate and additional Members of the Board of Appeal who are not employees of ECHA. |

Committees /Panels; Advisory Boards/Forums | Committee for Risk AssessmentMember States CommitteeCommittee for Socio-Economic AnalysisForum for Exchange of Information on Enforcement which coordinates a network of Member States authorities responsible for enforcement of REACH Regulation. |

STRUCTURE AND GOVERNANCE OF THE SELECTED AGENCIES — EASA

| European Aviation Safety Agency (Cologne) |

| EASA |

Legal Base (Founding Regulation) | Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency |

Objectives | To maintain a high uniform level of civil aviation safety in Europe and to ensure the proper functioning and development of civil aviation safety. |

Tasks | To issue opinions and recommendations to the Commission.To issue certification specifications, including airworthiness codes and acceptable means of compliance, and any guidance material for the application of the Basic Regulation and its implementing rules.To take decisions regarding airworthiness and environmental certification, pilot certification, air oper- ation certification, third country operators, inspections of Member States and investigation of undertakings.To conduct standardisation inspections of the competent authorities in the Member States. |

Management Board | 27 members from the EU Member States1 representative of the Commission |

Board of Appeal | The Board of Appeal is responsible for deciding on appeals lodged against decisions of the Agency. The Board of Appeal consists of a Chairman and two Members and an equivalent number of alternates, who are appointed by the Management Board from a list of qualified candidates adopted by the European Commission. There are two technically qualified members and one legally qualified member, who is the Chairperson of the Board. They are not members of EASA’s staff. |

Committees /Panels; Advisory Boards/Forums | Advisory Board: it assists the Management Board in its work and comprises organisations representing avi- ation personnel (5), manufacturers (5), commercial and general aviation operators (9), maintenance industry (1), training organisations (1), air sports (1), airports (1), Air Traffic Control (1), IFATCA (1) and an Executive Secretary. In total, the Advisory Board comprises 26 members and an equivalent number of alternates. The Advisory Group of National Authorities (AGNA) is composed of one person per Member State and provides a mechanism for the involvement of the national authorities in the rulemaking process. The Safety Standards Consultative Committee (SSCC) provides the EASA with advice on the content, priorities and execution of the Agency’s Rulemaking Programme. It is composed of representatives from organisations and trade associations representing the industries, professions and end user groups concerned. |

STRUCTURE AND GOVERNANCE OF THE SELECTED AGENCIES — EMA

| European Medicines Agency (London) |

| EMA |

Legal Base (Founding Regulation) | Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency |

Objectives | To coordinate the scientific resources that the Member States’ authorities make available to the Agency for the authorisation and supervision of medicinal products for human and veterinary use. To provide the Member States and the institutions of the European Union with scientific advice on medicinal products for human or veterinary use. |

Tasks | To coordinate the scientific evaluation of medicinal products which are subject to Union marketing authorisation procedures.To coordinate the supervision of medicinal products which have been authorised within the Union (pharmaco-vigilance).To advise on the maximum limits for residues of veterinary medicinal products which may be accepted in foodstuffs of animal origin.To coordinate verification of compliance with the principles of good manufacturing practice, good laboratory practice and good clinical practice.To record the status of marketing authorisations granted for medicinal products. |

Management Board | 27 members from the EU Member States2 representatives of the European Commission2 representatives of the European Parliament2 representatives of patients’ organisations1 representative of doctors’ organisations1 representative of veterinarians’ organisations |

Board of Appeal | Not applicable |

Committees /Panels; Advisory Boards/Forums | Committee for medicinal products for human useCommittee for medicinal products for veterinary useCommittee for orphan medicinal productsCommittee on herbal medicinal productsPaediatric CommitteeCommittee for advanced therapyWorking parties and other groups |

STRUCTURE AND GOVERNANCE OF THE SELECTED AGENCIES — EFSA

| European Food Safety Authority (Parma) |

| EFSA |

Legal Base (Founding Regulation) | Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety |

Objectives | To provide scientific opinions and scientific and technical support for legislation and policies which have a direct or indirect impact on food and feed safety. To provide independent information on risks relating to food safety. To contribute to the achievement of a high level of protection of human life and health. To collect and analyse data needed to allow characterisation and monitoring of risks. |

Tasks | To issue scientific opinions and studies.To promote uniform risk-assessment methodologies.To assist the Commission.To search analyse and summarise the requisite scientific and technical data.To identify and characterise emerging risks.To establish a network of organisations operating in similar fields.To provide scientific and technical assistance in crisis management.To improve international cooperation.To provide the public and interested parties with reliable, objective and easily comprehensible information.To take part in the Commission’s rapid alert system. |

Management Board | 14 members appointed by the Council in consultation with the European Parliament (from a shortlist of candidates drawn up by the European Commission). Four of these members have a background in organisations representing consumers and interests in the food chain.1 representative of the Commission. |

Board of Appeal | Not applicable |

Committees /Panels; Advisory Boards/Forums | (a)Scientific Committee and 10 Scientific Panels:Additives and products or substances used in animal feed (FEEDAP)Animal health and welfare (AHAW)Biological hazards (BIOHAZ), including BSE-TSE-related risksContaminants in the food chain (CONTAM)Dietetic products, nutrition and allergies (NDA)Food additives and nutrient sources added to food (ANS)Food contact materials, enzymes, flavourings and processing aids (CEF)Genetically modified organisms (GMO)Plant health (PLH)Plant protection products and their residues (PPR)EFSA’s Scientific Panels are responsible for EFSA’s risk assessment work including delivering scientific opinions.(b)Advisory Forum: it connects EFSA with the national food safety authorities and advises EFSA on scientific matters, its work programme and priorities.(c)Stakeholder Consultative Platform: it is composed of EU-wide organisations working in areas related to the food chain and advises EFSA on general matters related to the Agency’s work programme, risk assessment methodologies, etc. |

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ANNEX II

REFERENCE FRAMEWORK ON ETHICS AND CONFLICT OF INTEREST

EU REGULATIONS AND GUIDELINES

Staff Regulations of Officials and Conditions of Employment of Other Servants of the European Community — Regulation No 31 (EEC) with subsequent amendments laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Economic Community and the European Atomic Energy Community (CEOS) [1]. The relevant articles for independence/prevention of conflicts of interests: Articles 11, 11a, 12b, 13, 15, 16, 17 of the Staff Regulations, Articles 11, 54, 81 and 124 of the CEOS;

EC Code of Good Administrative Behaviour — Commission Decision 2000/633/EC, ECSC, Euratom of 17 October 2000 amending its Rules of Procedure [2];

EC Guidelines on Ethics and Conflict of Interests, covering the following topics: gifts, decorations and honours, activities of spouse or partner, external activities;

Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the budget of the European Communities (Article 52) [3];

Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (Article 32) [4].

THE SELECTED AGENCIES’ REGULATIONS

Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency;

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (in particular articles 88(2), 88(3) and 90(5), 90(6));

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (in particular articles 25(1), 28(3), 28(4), 32(1), 37, 38, 42, 48);

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Article 63(2)).

THE SELECTED AGENCIES’ MAIN POLICIES AND PROCEDURES DEALING WITH ETHICS, CODE OF CONDUCT AND CONFLICT OF INTEREST

EUROPEAN AVIATION SAFETY AGENCY (EASA)

EASA Code of Good Administrative Practice for the staff in their relation with the public (ED Decision 2009/078);

Standardisation Inspectors’ Code of Conduct (WI.STDI.00015-001/ 29 July 2010);

EASA Management Board Decision 06-2011 adopting the Rules of Procedure of the Management Board;

EASA Management Board Decision 01-2011 adopting the guidelines for the allocation of certification tasks to National Aviation Authorities and qualified entities;

Decision 2007/006/A of the Executive Director on outside activities and assignments ( 2 February 2007);

Decision 2009/169/E of the Executive Director laying down rules on the secondment to the European Aviation Safety Agency of national experts ( 11 December 2009).

EUROPEAN CHEMICALS AGENCY (ECHA)

Policy for Managing Potential Conflicts of Interests (MB/45/2011/D, adopted by the Management Board on 30 September 2011) [5];

Guidance on conflicts of interest and invitations and gifts as well as declarations of commitment, confidentiality and interests (ED/01/2007, Decision of the Executive Director of 31 October 2007);

ECHA guidance on conflicts of interest for ECHA Committees and Forum Members, their advisers and invited experts;

Code of good administrative behaviour for the staff of the European Chemicals Agency in relation with the public (adopted by the Management Board on 13/ 14 February 2008, MB/11/2008);

Code of conduct of the (regular/alternate/additional) Members of the Board of Appeal (BoA/02/2010, adopted by the Board of Appeal on 22 June 2010) [6];

Management Board Rules of procedure (MB/02/2007, adopted by the Management Board on 30 September 2009) [7];

Rules of procedure for the Member State Committee (MB/50/2010, adopted by the Management Board on 30 September 2010) [8];

Rules of procedure for the Committee for Risk Assessment (MB/05/2010, adopted by the Management Board on 4 March 2010) [9];

Rules of procedure for the Committee for Socio-Economic Analysis (MB/06/2010, adopted by the Management Board on 4 March 2010) [10];

Rules of procedure for the Forum for Exchange of Information on Enforcement (MB/35/2011, adopted by the Management Board on 21 June 2011) [11];

Commission decision on outside activities and assignments of 28 April 2004 adopted by ECHA per analogy in 2008 (Commission decision C(2008)3471);

Rules applicable to seconded national experts of ECHA of 28 June 2007 (MB/08/2007);

Management Board decision of 23 April 2009 on internal investigations in relation to the prevention of fraud and corruption (MB/30/2009).

EUROPEAN FOOD SAFETY AUTHORITY (EFSA)

EFSA Code of Good Administrative Behaviour (adopted by Management Board on 16 September 2003);

EFSA Practical Guide to Staff Ethics and Conduct (2010);

Code of conduct of the Management Board of EFSA (adopted by Management Board on 16 June 2011);

Rules of Procedure of the Management Board of EFSA (adopted by Management Board on 31 March 2009 and updated on 20 October 2011);

EFSA Policy on Declarations of Interest (adopted by Management Board on 11 September 2007) [12];

Implementing Act to the Policy on Declarations of Interest. Guidance Document on Declarations of Interest (adopted by Executive Director on 8 September 2009);

Implementing Act to the Policy on Declarations of Interests. Procedure for identifying and handling potential conflicts of interest (adopted by Executive Director on 8 September 2009);

Decision concerning the establishment and operations of the Scientific Committee, Scientific Panels and of their working groups (adopted by Management Board on 17 December 2009);

Decision of the Executive Director concerning the selection of Members of the Scientific Committee, Scientific Panels and experts to assist EFSA with its scientific work (adopted by Executive Director on 14 March 2011);

EFSA Stakeholder Consultative Platform: Terms of Reference (adopted by Management Board on 17 June 2010);

Post sensitivity assessment and management in EFSA (adopted by Executive Director on 27 January 2009 and updated on 26 October 2011);

Decision implementing articles 16, 17(2) and 19 of the Staff Regulations and articles 11 and 91 of the Conditions of Employment of Other Servants (adopted by Executive Director on 7 December 2010);

Decision of the Executive Director on declaration of interests in the context of EFSA procurement contracts and grants (adopted by Executive Director on 5 April 2011).

EUROPEAN MEDICINES AGENCY (EMA)

The EMEA Code of Conduct (EMEA/6470/03/2368, 18 August 2006) [13];

European Medicines Agency policy on the handling of conflicts of interests of Scientific Committee Members and experts (EMA/513078/2010, 13 October 2010) [14];

Overview of the Allowable Interests for the EMA Scientific Activities (EMA/358101/2010, 13 October 2010) [15];

Decision of the Management Board on the adoption of implementing rules for external activities (EMEA/MB/143750/2007);

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 (EMA/565945/2009, 9 June 2011);

Communication on professional integrity at the EMA — conflicts of interest arising from personal relationships (EMA/511563/2010, 7 September 2010);

Executive Director Decision laying down rules on the secondment of national experts to the Agency (EMA/545578/2011, 1 August 2011) [16]

Revised criteria to be fulfilled by patients’ and consumers’ organisations involved in European Medicines Agency (EMA) activities (EMA/MB/24913/2005 rev.1 adopted 13 September 2011).

OECD GUIDELINES

Managing Conflict of Interest in the Public Service: OECD Guidelines and Country Experiences, OECD, Paris, 2003;

Post-Public Employment: Good Practices for Preventing Conflict of Interest, OECD, Paris, 2010.

[1] OJ P 45, 14.6.1962, p. 1385.

[2] OJ L 267, 20.10.2000, p. 63.

[3] OJ L 248, 16.9.2002, p. 1.

[4] OJ L 357, 31.12.2002, p. 1.

[5] http://echa.europa.eu/documents/10162/17208/mb_45_2011_d_policy_conflict_i nterest_en.pdf

[6] http://echa.europa.eu/documents/10162/13573/code_of_conduct_en.pdf

[7] http://echa.europa.eu/documents/10162/17208/mb_02_2007_final_rules_of_pro cedure_en.pdf

[8] http://echa.europa.eu/documents/10162/13578/mb_50_2010_rop_msc_en.pdf

[9] http://echa.europa.eu/documents/10162/13608/mb_04_06_2010_revison_rop_comittees_en.pdf (pages 16–30)

[10] http://echa.europa.eu/documents/10162/13608/mb_04_06_2010_revison_rop_comittees_en.pdf (pages 31–45)

[11] http://echa.europa.eu/documents/10162/13577/mb_35_2011_revised_rop_of_the_forum_en.pdf

[12] http://www.efsa.europa.eu/en/topics/topic/independence.htm

[13] http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004924.pdf

[14] http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/10/WC500097905.pdf

[15] http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/10/WC500097906.pdf

[16] http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/01/WC500038456.pdf

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ANNEX III

OVERVIEW OF THE AGENCY-SPECIFIC POLICIES AND PROCEDURES APPLICABLE TO STAFF EXPERTS, MANAGEMENT BOARD AND BOARD OF APPEAL

| EASA | ECHA | EFSA | EMA |

| Experts | Employees | Management Board | Board of Appeal | Scientific Committees’ Members and other experts | Employees | Management Board | Board of Appeal | Scientific Committee and Panels’ Members and other experts | Employees | Management Board | Advisory Forum and other consultative bodies | Scientific Committees’ Members and other experts | Employees | Management Board |

Conflict of interest policies and procedures | No | No | No | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |

Declarations of interests and related policies | No | No | No | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |

Policies for screening the candidates (experts, Management Board, Board of Appeal) | No | N/A | No | No | Yes [1], [2] | N/A | No | No | Yes | N/A | No | No | No | N/A | No |

Conflict of interest policies for the outsourcing of scientific activities | No | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | No | N/A | N/A |

Policy on gifts and invitations | No | No | No | No | No | Yes | No | Yes | No | Yes [3] | No | No | Yes | Yes | Yes |

Breach of trust procedures | No | No | No | No | Yes [2] | Yes [2] | Yes [2] | Yes [2] | Yes | No | No | No | No | No | No |

Post-employment policies ("revolving door" policies) | No | Yes | No | No | No | Yes | No | No | No | Yes | No | No | No | Yes | No |

[1] Only for Risk Assessment Committee and the Committee for Socio-Economic Analysis.

[2] Policy for managing Potential Conflicts of Interests (MB/45/2011/D), adopted by the Management Board on 30 September 2011. The implementation of this policy has not been tested.

[3] EFSA has a policy on invitations only.

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ANNEX IV

INDEPENDENCE AND TRANSPARENCY REQUIREMENTS STATED IN THE SELECTED AGENCIES’ FOUNDING REGULATIONS

| EASA | ECHA | EFSA | EMA |

| Experts | Staff (including the Executive Director) | Management Board | Board of Appeal | Scientific Committees’ Members and other experts | Staff (including the Executive Director) | Management Board | Board of Appeal | Scientific Committee and Panels’ Members and other experts | Staff (including the Executive Director) | Management Board | Advisory Forum and other consultative bodies | Scientific Committees’ Members and other experts | Staff (including the Executive Director) | Management Board |

General independence requirements | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |

General transparency requirements | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |

Annual Declarations of interests (ADoIs) | No | No | No | No | Yes | Legal requirement for the Executive Director only | Yes | Yes | Yes | Legal requirement for the Executive Director only | Yes | Yes | Yes | No | Yes |

Specific Declarations of interest (SDoIs) | No | No | No | Yes | Yes | Legal requirement for the Executive Director only | Yes | Yes | Yes | Legal requirement for the Executive Director only | Yes | Yes | Yes | No | Yes |

Requirement to publish the ADoI | No | No | No | No | No, but the ADoIs should be accessible to the public on request | Executive Director – No, but the ADoIs should be accessible to the public on request | No, but the ADoIs should be accessible to the public on request | No | Yes | Legal requirement for the Executive Director only | Yes | Yes | Yes | No | Yes |

Requirement to publish the SDoI/oral declaration of interest during the meetings | No | No | No | No | No | No | No | No | Yes | Legal requirement for the Executive Director only | Yes | Yes | Yes | No | Yes |

Requirement for policy and implementing rules on acceptance of gifts | No | No | No | No | No | No | No | No | No | No | No | No | Yes | No | Yes |

Requirement to make public the agendas and the minutes of the meetings | No | No | Yes | No | Yes | Yes | No | No | Yes | No | Yes | No | No | No | Yes |

Requirement to publish the results of the scientific studies and opinions | Yes | Yes | N/A | N/A | Yes | Yes | N/A | N/A | Yes | Yes | N/A | N/A | Yes | Yes | N/A |

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ANNEX V

MANAGEMENT OF CONFLICT OF INTEREST — COMPARISON BETWEEN THE OECD GUIDELINES AND THE EU REGULATORY FRAMEWORK

Areas | OECD Guidelines | EU Regulatory Framework (except for Agencies’ Founding Regulations and Agency-specific policies and procedures) |

Scope and objectives | The OECD Guidelines set the first international benchmark for designing and implementing a comprehensive conflict of interest policy. The Guidelines are addressed to governments and public institutions, aiming to help them to design and implement an efficient conflict of interest policy. The Guidelines also provides a comparative overview of policies implemented in 30 OECD member countries to identify and resolve conflict of interest situations, showing overall trends, good practices and emerging areas where improvements could be made. | General obligations for identification and management of conflict of interest are laid down in the Staff Regulations, which are applicable to all EU officials. NB: Practical guidelines issued at the level of each DG were not analysed in the scope of the audit. More detailed decisions and guidelines on conflict of interest were issued by the European Commission (EC), which are applicable to its staff. |

Categories of individuals | The OECD Guidelines refer to public officials in general, with a particular attention to: Policymakers and public office holders in the most senior positions (e.g. ministers);Public officials working in key functions of the state, such as law enforcement (e.g. judges, prosecutors, tax officials);Decision-makers in sensitive areas at the interface between the public and private sector (e.g. contract managers, auditors, etc). | The Staff Regulations refer only to staff (officials, temporary agents, contract and auxiliary agents). Other individuals with a significant role in the decision-making process, such as: Members of the Management Board, experts, Members of Board of Appeal, etc., are not bound by the Staff Regulations. The selected Agencies (EFSA, EMA and ECHA) adopted policies and procedures for staff and other categories of individuals with decision-making power (e.g. experts, Members of the Management Board, Members of the Board of Appeal) |

Core values and principles (objectivity, impartiality, integrity) | Public officials and public organisations should not only act within the letter of the law, but also respect broader public service values such as disinterestedness, impartiality and integrity. | Public officials should carry out their duties with objectivity, impartiality and loyalty to the EU (Staff Regulations, Article 11). These values are reinforced in the Rules of Procedures of the European Commission (Decision 2000/633/EC, ECSC, Euratom). |

Definition of conflict of interest | The OECD Guidelines define the conflict of interest as "a conflict between the public duty and private interests of a public official, in which the public official has private-capacity interests which could improperly influence the performance of their official duties and responsibilities". In this context, the conflict of interest can be: actual, apparent or potential. | The Staff Regulations stipulate that the official shall not, in performance of his duties, deal with a matter such as to impair his independence, in particular, family and financial interests (Article 11a). However, the conflict of interest is not defined in the Staff Regulations. |

Conflict of interest policy — general requirements | According to the OECD Guidelines, a modern approach to a conflict of interest should: Identify risks to the integrity of public organisations and public officials.Prohibit specific unacceptable forms of private interest.Make public organisations and individual officials aware of the circumstances in which conflicts can arise.Ensure that effective procedures are deployed for the identification, disclosure, management, and promotion of the appropriate resolution of conflict of interest situations. | The Staff Regulations identify certain risk areas for conflict of interest, such as: outside activities, family relationship, gifts and other benefits, inside information and post-employment. However, the Staff Regulations do not identify specific circumstances in which conflicts can arise nor indicate unacceptable forms of private interests. |

Declaration/disclosure of interests | According to the OECD Guidelines, one of the core principles for managing conflict of interest is transparency and scrutiny. Initial disclosure on appointment — Public officials’ private interests should be disclosed appropriately, to enable adequate control and management of a resolution. The public officials should disclose their relevant interests on appointment and thereafter at regular intervals. Such disclosure is usually formal, is required to be presented periodically (usually annually) and in writing. In-service disclosure in office — Public officials should promptly disclose all relevant information about a conflict of interest when circumstances change after the initial disclosure has been made or when new situations arise. | According to the Staff Regulations, the officials have the obligation to notify the Appointing Authority of any personal interest that may impair his/her independence (Article 11a). Thus, the officials should spontaneously inform the hierarchical superiors about any interests, which in their view can create a conflict of interest situation. However, there is no obligation for the EU officials to fill in a declaration of interests on appointment and periodically thereafter (e.g. annually). |

Assessment of the interests disclosed | The organisations should assess the completeness of disclosure, by ensuring that the disclosure of interests contains sufficient details on the conflicting interests to enable an informed decision to be made about the appropriate resolution. The organisations should assist full disclosure of interests and ensure that the interests disclosed are properly assessed and maintained in up-to-date form. | The Staff Regulations state that in case of conflicting interests "the Appointing Authority shall take any appropriate measure, and may in particular relieve the official from responsibility in this matter" (Article 11a.2). The Staff Regulations do not provide details regarding the assessment of the interests disclosed (e.g., completeness, update information, etc). |

Screening process | The OECD Guidelines recommend the use of preventive measures that deal with conflict of interest situations. One of these measures is the screening of candidates/organisations during the selection process. This requires the identification in advance of any relevant interests and discussion of possible strategies or resolution of identified conflicts. | There are no provisions in the Staff Regulations which would require the screening of candidates for possible conflict of interest during the selection process. |

Sensitive areas and policy requirements for various categories of individuals | The OECD Guidelines recommend that, in addition to the general policy for all public officials, particular attention should be paid to senior positions and sensitive areas: Policymakers and public office holders in the most senior positions; Public officials working in key functions of the state, such as law enforcement;- Decision-makers in sensitive areas at the interface between the public and private sector. Measures used for these groups should take into consideration the categories of public officials. In general, the higher the position, the stricter the policy and the more transparency is requested. | There are no similar requirements in the Staff Regulations.The Agencies’ Founding Regulations foresee different obligations for various categories of individuals (e.g. executive staff, Members of the Management Board, experts, Board of Appeal, etc). |

"At risk" areas for conflict of interest situations | Organisations need to consider reviewing existing management arrangements on a regular basis to assess whether they remain adequate in recognising potential risk areas. The Guidelines mention the following "at risk" areas: additional employment, inside information, contracts, gifts and other forms of benefits, family and community expectations, outside appointments and activity after leaving public office. | The Staff Regulations include provisions for the following risk areas for conflict of interest: gifts and other benefits, outside activities, family relationship (spouse of the official in gainful employment), inside information and obligations after leaving the office (Articles 11, 12b, 13, 16 and 17). The EC has issued internal guidelines for dealing with these risk areas. |

Outside activity/Additional employment | The OECD Guidelines recommend clear definition of circumstances of outside activities (employment or appointment), authorisation process and resolution measures. Additional employment — Define circumstances, including the required authorisation procedure, under which public officials may engage in outside employment, while retaining their official position. Outside appointments — Define circumstances, including the required authorisation procedure, under which a public official may undertake an appointment on the board or controlling body of a NGO, professional or commercial organisation, etc, which is involved in a contractual, regulatory or sponsorship arrangement with the employing organisation. | The Staff Regulations stipulate that the official should seek permission before engaging in an outside activity or assignment: "An official wishing to engage in an outside activity, whether paid or unpaid or to carry out an assignment outside the Communities, shall first obtain permission of the Appointing Authority. Permission shall be refused only if the activity interferes with the official’s duties or it is incompatible with the interests of the institution." (Article 12b) The EC Decision 85-2004/ 28.4.2004 on outside activities and assignments provides further details, such as: prohibited activities (professional and commercial activities), maximum net remuneration (4,500 euro/p.a.), special provisions for officials on leave on personal grounds, authorisation procedure, post-employment obligations, etc. This decision applies only to the EC staff (i.e. officials, temporary, auxiliary and contract staff). |

Personal and family relationship | The OECD Guidelines recommend that the organisation’s policy is adequate in recognising conflict of interest arising from expectations placed on public officials by their family and community. | The Staff Regulations require that officials disclose the gainful employment of the spouse. If the nature of the spouse’s employment is incompatible with the duties of the official, the Appointing Authority will decide whether the official shall continue his post or be transferred to another post. (Article 13) |

Gifts and other benefits | The OECD Guidelines recommend that the organisation’s policy is adequate in recognising conflict of interest arising from gifts and other benefits. | The Staff Regulation stipulate that an official shall not, without the permission of the Appointing Authority, accept any honour, decoration, favour, gift or payment of any kind. (Article 11). The EC issued internal guidelines on gifts and hospitality, which were updated on 7 March 2012. Gifts and hospitality should only be accepted if in line with or if required by social convention, courtesy or diplomatic usage. Explicit prior permission by the Appointing Authority is required for a gift worth between 50 euro and 150 euro. Authorisation for gifts of a higher value than 150 euro will be refused by the Appointing Authority. |

Inside information | The organisations should ensure that any information which is not made public and/or is confidential, it is understood to be privileged and is effectively protected for improper use or disclosure. | Confidentiality obligations for officials are foreseen at Article 17 of the Staff Regulation: "1.An official shall refrain from any unauthorised disclosure of information received in the line of duty, unless that information has already been made public or is accessible to the public.2.An official shall continue to be bound by this obligation after leaving the service." |

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ANNEX VI

EMA EVALUATION MATRIX

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1 July 2011

EMA/XXXXXX/2011

Unit/Sector name

Evaluation of Conflicts of Interests Form

(in relation to specific EMA activity)

Please note that once the evaluation is completed, this form should be filed, together with all relevant supporting documentation (emails, copy of Public Declaration of Interests and Confidentiality Undertaking form, etc.) in the product or meeting folder, as appropriate. |

Name of Expert: |

Date of Declaration of Interest under evaluation: |

EMA Activity (subject of this evaluation) |

| | | | |

| Name of meeting | Role Chair / Member / Alternate Observer / Core member | Topic of meeting | Date of meeting |

Committee | | | | |

Working Party | | | | |

SAG | | | | |

Other meeting | | | | |

| | | | |

| Scope of Inspection | Product |

Inspection | | |

| | | | |

Other activity (please provide details): |

- EW = Expert Witness

Evaluation |

| | | | | | | | |

Evaluate the interests declared against the activity for which the involvement of the Expert is required. Please fill-in the background of the appropriate cell in white and record the outcome in the Table 3. |

| | | | | | | | |

| | Committee Chair | Working Party Chair | Committee / WP member/ Expert | Inspection | Guideline Dev. | SAG Chair / member | EW* |

Employee | Current | 1 | 1 | 1 | 1 | 1 | 1 | 1 |

0 to 2 | 1 | 2 | 3 | 5 | [3] | 4 | EW |

>2 to 5 | 1 | 2 | 4 | 5 | 7 | 7 | EW |

Consultant/ Strategic Advisory Role | Current | 1 | 1 | 1 | 1 | 1 | 3 | EW |

0 to 2 | 1 | 2 | 3 | 5 | [3] | 4 | EW |

>2 to 5 | 1 | 2 | 4 | 5 | 7 | 7 | EW |

Financial Interest | Current | 1 | 1 | 1 | 1 | 1 | 1 | EW |

Patent | Current | 1 | 1 | 1 | 1 | 1 | 1 | EW |

Principal Investigator | Current | 1 | 2 | 3 | 5 | [3] | 4 | EW |

0 to 2 | 1 | 2 | 3 | 5 | 7 | 7 | EW |

>2 to 5 | 1 | 2 | 4 | 5 | 7 | 7 | EW |

Investigator | Current | 1 | 2 | 4 | 5 | 7 | 7 | EW |

0 to 2 | 1 | 2 | 4 | 5 | 7 | 7 | EW |

>2 to 5 | 1 | 7 | 7 | 7 | 7 | 7 | 7 |

Grant | Current | 6 | 7 | 7 | 7 | 7 | 7 | 7 |

Outcome of Evaluation |

|

Please fill-in the background of the appropriate cell in white following the legend to record the outcome: e.g. 1 – No involvement, 3 – No involvement in discussions, deliberations, voting for... Where outcome is 1, 7 or where the expert is to be used as Expert Witness, no further details need to be given. Where outcome is 2, 3 or 4: list products and indications concerned under relevant columns. Where outcome is 5 or 6: list Company concerned. Legend: |

|

Outcome | Impact |

1 | No involvement in activity |

2 | To be replaced for the discussions, final deliberations and voting as appropriate in relation to the relevant product or a competitor product. | Product: | Indication: |

3 | Where Individual product involvement is declared: No involvement with respect to procedures involving the relevant product or a competitor product in the relevant indication i.e. no part in discussions, final deliberations and voting as appropriate as regards these medicinal products.Cannot act as Rapporteur for these products.[Cannot act as Rapporteur for development of guidelines in concerned therapeutic area].Where cross product / general involvement is declared: No involvement (as outlined above) with respect to products from the specified company.Cannot act as Rapporteur for products from the relevant company(ies). | Product: | Indication: |

4 | Where Individual product involvement is declared: Involvement in discussions only with respect to procedures involving the relevant product or a competitor product i.e. no part in final deliberations and voting as appropriate as regards these medicinal products.Cannot act as Rapporteur for these products.Where cross product / general involvement is declared: Involvement in discussions only with respect to products from the specified company.Cannot act as Rapporteur on products from the relevant company(ies). | Product: | Indication: |

5 | Cannot participate in Inspections relating to the relevant company (all products) nor in (product specific) inspections relating to competitors to the named product(s). | Company: |

6 | To be replaced for the discussions, final deliberations and voting as appropriate in relation to any medicinal product from the relevant company giving a grant or other funding to the institution. | Company: |

7 | Full involvement – No restriction |

Expert Witness | Where declared interested are such that involvement in the relevant activity is not possible, consideration may be given to involvement as Expert Witness. EW may testify and give specialist advice on a specific issue by providing information and replying to any questions. |

Date: Signature |

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ANNEX VII

TRANSPARENCY OF DECLARATIONS OF INTERESTS AND DECISION-MAKING PROCESS

Area | Type of document published on Agency’s website | EASA | EMA | EFSA | ECHA |

Management | Declaration of interest of Executive Director | No | Yes | Yes | Yes |

Curriculum vitae of Executive director | Yes | Yes | Yes | Yes |

Declarations of interest of Agency’s management (e.g. Directors, Head of Units) | No | No | Yes | No |

Declaration of interest of Management Board Members | No | Yes | Yes | Yes |

Curriculum vitae of Management Board Members | No | Yes (not for all) | Yes | Yes |

Declarations of interest of Board of Appeal | No | N/A | N/A | No |

Minutes of the meetings of the Management Board | Yes | Yes | Yes [3] | Yes |

Experts | List of Experts or Members of committees | No | Yes | Yes | Yes |

Declaration of interest of Experts | No | Yes | Yes | Yes |

Curriculum vitae of Experts | No | Yes [2] | Yes | Yes |

Minutes of the meetings of the Scientific Committees and bodies and experts | Yes (not for all) [1] | Yes (not for all) | Yes | Yes |

Results of the scientific studies | Yes | Yes | Yes | Yes |

Other | Public consultations on independence policy | No | No | Yes | No |

Involvement of external evaluators in the recruitment of the scientific bodies’ experts | No | No | Yes | No |

Possibility of external observers to participate in the scientific bodies’ or Management Board’s meetings | Yes | Yes | Yes | Yes |

[1] EASA publishes the minutes of the consultative bodies’ meetings concerning rulemaking activities. However, minutes of the meetings which would include assessment of conflict of interest are not published.

[2] For Members of the Committees.

[3] EFSA audiocasts live on its website the meetings of the Management Board.

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