The background to the complaint

1. This complaint concerns the procedure by which the European Commission's Scientific Committee on Health and Environmental Risks ('SCHER') adopted an opinion on the use of non-human primates in research.

2. In 2007, the European Parliament adopted a declaration[1] urging the European Commission to end the use of great apes and wild-caught monkeys in scientific experiments, and to establish a timetable for phasing out scientific experiments using primates. In May 2008, as part of the process of revising Directive 86/609/EEC[2] on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, the Commission requested SCHER, which was set up by Commission Decision 2004/210/EC[3], to issue an opinion on the latest position regarding the possibility of replacing non-human primates in research. SCHER created a special working group to address the Commission's request, and, based on that working group's opinion, adopted its final position in January 2009.

3. In October 2009, the complainant, the European Coalition to End Animal Experiments, turned to the European Ombudsman to complain about the composition of the working group created by SCHER and about the opinion it delivered in January 2009. The complainant was of the view that the Commission failed to ensure that the working group set up by SCHER to examine the possibility of replacing non-human primates in research possessed sufficient expertise in the area of non-human primate research.

The subject matter of the inquiry

4. The Ombudsman decided to open an inquiry into the following allegations:

1) The Commission failed to ensure that the working group established by SCHER to issue the opinion had sufficient expertise in the area of non-human primate research.

2) The Commission failed to ensure that SCHER took due account of evidence supplied by interest groups about the efficacy of non-human primate research and alternatives to it.

The inquiry

5. In January 2009, the Ombudsman opened an inquiry into the complaint, asking the Commission to submit an opinion on the above allegations by 30 April 2010. The Ombudsman also asked the Commission to explain:

1) the procedures and (objective) criteria used for the selection of experts for the working group;

2) whether it gave its agreement to the selection of the external experts in the working group pursuant to Article 7(2) of Commission Decision 2008/721/EC[4];

3) in what way it was "apparent" that SCHER considered all relevant contributions and took into consideration those elements it deemed appropriate.

6. The Ombudsman also asked the Commission to provide copies of the rules of procedure adopted under Article 12 of Commission Decision 2008/721/EC and any other material concerning the rules mentioned in points 3(a) - the creation and organisation of the working groups - and 3(b) - the involvement of external experts - of Annex II of the Decision.

7. The Commission sent its opinion on 8 April 2010. The opinion was forwarded to the complainant, who submitted its observations on 2 June 2010.

8. In order to understand fully the responsibilities, role and competencies of the Commission and of SCHER, the Ombudsman decided to inspect the Commission's file. The inspection took place on 26 July 2011[5].

9. On 6 June 2012, the Ombudsman made a draft recommendation to the Commission and invited it to send a detailed opinion on it by 30 September 2012. The Commission sent its detailed opinion on 16 September 2012. The Ombudsman forwarded it to the complainant, with an invitation to make observations before 31 October 2012. The complainant submitted its observations on 20 December 2012.

The Ombudsman's analysis and conclusions

Preliminary remarks

10. Improving the extent and intensity of EU citizens' participation in the work of the EU institutions, bodies, offices and agencies enhances the democratic nature of the EU[6].

11. Participatory democracy, based on the principles of equality and transparency, improves citizens' trust in the EU and its administration. Increased trust in the EU and its administration is a key element in increasing the effectiveness of both.

12. Citizen participation is especially important in policy areas having a close connection to the legislative process. The possible revision of Directive 86/609/EEC, for which SCHER drafted pre-legislative opinions, constitutes an illustrative example of such a policy area allowing for citizen participation.

13. Article 11(1) of the Treaty on European Union states that the institutions shall, by appropriate means, give citizens and representative associations the opportunity to make known and publicly exchange their views in all areas of Union action. The institutions must therefore determine by which appropriate means citizens and representative associations are to be given the opportunity to make known and publicly exchange their views.

14. The precise manner, that is, the appropriate means by which participatory democracy is made effective in any given circumstance, will depend upon the specific nature of the Union action in question, including the determination of when and how participation is appropriate in a particular process.

15. The EU institutions necessarily have a margin of discretion when deciding upon the precise manner in which participatory democracy is made effective. This is all the more so in areas which are technically complex. This notwithstanding, the institutions should always ensure that they can justify objectively how they have exercised that margin of discretion.

A. Allegation that the Commission failed to ensure that the working group established by SCHER had sufficient expertise in the area of non-human primate research

Arguments presented to the Ombudsman

16. In its opinion, the Commission stated that, in May 2008, it invited SCHER to deliver an opinion on the use of non-human primates in biomedical research, production and testing of products and devices. Given the specialised nature of the request, SCHER decided to set up a working group to be composed of scientific experts in the field. This working group was, however, established before Commission Decision 2008/721/EC had been adopted. Therefore, in the present case, the relevant legal basis for the establishment of the working group is Commission Decision 2004/210/EC.

17. According to Commission Decision 2004/210/EC, scientific committees may invite specialised external experts possessing the relevant scientific knowledge and expertise to contribute to their work. They may also create specific working groups when there is a need for external expertise to fulfil the mandate of a given scientific committee.  The Decision goes on to state that, when the committee adopts scientific opinions, it shall draw on the expertise of the working group. Further guidance on working groups is provided in the Rules of Procedure[7], according to which, a working group is chaired by a member of the scientific committee setting it up (in this case a member of SCHER), and its members, associated members and external experts are designated by the chair in consultation with the scientific committee. The Rules of Procedure also make it possible to invite external experts "possessing particular and relevant knowledge" to contribute to the work of the scientific committee or its working group.

18. Consequently, in the present case, the decision to establish a working group to assist SCHER in preparing a scientific opinion on the use of non-human primates in research was within SCHER's remit. The members and experts of the working group were to be designated by its chair, in consultation with SCHER. The decision as to the relevance of the scientific knowledge and expertise of the experts invited was also within SCHER's remit. The Commission only had to agree with SCHER's initiative to invite the experts. The Commission underlined that the relevant eligibility criteria for the selection of experts were (i) relevant scientific knowledge (Article 8(1) of Commission Decision 2004/210EC), and (ii) particular and relevant knowledge (paragraph 9 of the Rules of Procedure). However, Commission Decision 2004/210/EC provides no specific procedure for the selection of experts.

19. Regarding the substance of the complainant's allegation, the Commission explained that SCHER first identified experts to be invited to join the working group on the use of non-human primates in research by reviewing scientific literature. This was followed by a public call for information, published on the website of the Commission's Directorate-General for Health and Consumer Policy on 15 May 2008. The call led to (a) the submission of 628 scientific articles and 84 written comments, and (b) contacts with the scientific institutions which provided scientific material. This procedure enabled SCHER to identify a group of experts who carry out relevant research or studies in areas where it considered it needed specific expertise.

20. Further to this process, and after verifying (a) compliance with the Rules of Procedure, (b) the compatibility of the establishment of the working group with the available budget, and (c) the absence of specific interest which might be considered prejudicial to the working group members' independence in relation to the issues to be considered by the working group, the Commission agreed to invite the experts identified by SCHER. The assessment of the scientific knowledge and expertise of the experts was, however, within SCHER's remit.

21. The Commission pointed out that SCHER is an independent scientific committee and, in accordance with Commission Decision 2004/210/EC, it was that body's responsibility to decide on the establishment and composition of the working group to assist it in the preparation of the opinion which the Commission had requested. Therefore, it was not the Commission's role to select and designate the experts of the working group. In fact, the Commission's role was to check compliance with the provisions of Commission Decision 2004/210/EC and with the Rules of Procedure. The Commission was satisfied that SCHER had correctly applied all the applicable rules and procedures. In addition, the Commission had no information casting doubts on the appropriateness of the substance of the decisions taken by SCHER. Nor did the Commission have any reason or grounds to disagree with SCHER's decision to designate the experts in question or to request additional or different experts to be designated in the working group. Finally, the Commission considered that SCHER was able to deliver an informed opinion addressing all the questions raised in its request for an opinion.

22. In its observations, the complainant maintained its complaint. It noted that SCHER invited the experts to the working group in agreement with Commission. Therefore, the Commission's role was to ensure that SCHER chose specialised external experts possessing the relevant scientific knowledge and expertise. In its opinion, the Commission accepted that it had the power to reject experts invited by SCHER when it stated that it "had no reason and no ground to disagree" with SCHER's choice. Consequently, the question is whether the Commission was correct in coming to this conclusion. The complainant never claimed that the Commission's role was to select the experts itself. In fact, its role was to ensure that SCHER had invited suitable experts.

23. The complainant also noted that, when the Commission decided to request a scientific opinion on the use of non-human primates in research, it had three scientific committees at its disposal. It chose to use SCHER even though it was ill-suited to the task both in terms of its remit and its membership. The complainant argued that the other two scientific committees were not any better-suited. Since it lacked the necessary expertise, SCHER decided to set up a working group. This was, the complainant stated, the proper step to take. It was, however, essential that the expertise within the working group be appropriate to the mandate which the Commission gave SCHER and that the best available experts on all aspects of the mandate be approached. For these reasons, it was particularly important that the Commission perform its role of ensuring, in accordance with Commission Decision 2004/210/EC, that the best use of external experts be made. First, in view of its own lack of expertise on non-human primate research, and the alternatives to it, SCHER was not well-placed to know who the best experts were. The Commission could not therefore simply assume that SCHER's choice was appropriate. Second, SCHER was not in a position to evaluate the advice which the working group had given it. Consequently, the working group provided advice directly to the Commission and the latter based its legislative proposal on that advice.

The Ombudsman's assessment leading to a draft recommendation

24. The work of scientific committees, such as SCHER, constitutes an important element in the Commission's pre-legislative work[8]. Scientific committees ensure that the Commission obtains the necessary scientific advice to carry out its role correctly[9]. The work of such committees must be based on the principles of (i) technical excellence, (ii) independence and impartiality, and (iii) transparency[10].

25. The complainant first reproached the Commission for creating scientific committees which do not have in-depth expertise in very specific scientific areas, such as the one concerning the use of non-human primates in research. The Ombudsman noted that it is necessary for committees to have, by means of their members, a sufficient breadth of expertise to understand and evaluate a wide range of scientific issues. However, this does not imply that such committees should not, when they consider it necessary, obtain advice on specific issues from persons possessing in-depth knowledge of those specific issues. The Ombudsman underlined, in this respect, that it is vital that such committees have (i) the technical capacity to identify precisely the areas in which their scientific knowledge needs to be complemented by advice from external experts, and (ii) the capacity to understand fully the complementary scientific advice provided to them[11].

26. The Ombudsman emphasised that committees have a broad margin of discretion in identifying (i) their needs in relation to assistance from external experts and (ii) the most appropriate experts to provide that assistance. The Ombudsman also noted that the decision to consult external experts and the choice of specific experts by SCHER meant that SCHER had to make scientific assessments of its needs and of the abilities of specific external experts to meet those needs. The Ombudsman underlined that his inquiry did not seek to replace the scientific assessment carried out by SCHER and endorsed by the Commission. Rather, the Ombudsman had to examine whether the methodology which SCHER applied to appoint experts in the field of the use of non-human primates in research complied with the applicable legal rules and principles of good administration, and whether, in so doing, SCHER made any manifest errors of assessment.

27. The Ombudsman underlined that the task of identifying precisely the areas in which a committee needs advice from external experts, and the subsequent task of choosing external experts to provide that advice, must not be influenced by a desire to obtain any pre-determined outcome in relation to the issues being studied. Rather, committees should carry out these tasks on the basis of an objective, non-predetermined analysis of what the issues to be studied are; what assistance they need to understand fully the issues facing them; and which experts are best placed to provide that assistance.

28. When, in April 2008, SCHER decided to create a working group to assist it in producing an opinion on the use of non-human primates in research, it appointed one of its members as Chair of the working group ('the Chair'). In cooperation with SCHER's Scientific Secretariat, the Chair identified certain external experts and then sent them information about the requested opinion by e-mail. The Chair requested this "first line" of experts to identify other experts who, in view of their special expertise covering the areas needed to provide an overall view on the topic in question, could be invited to be members of the working group.

29. On the basis of the replies and recommendations of the first line of experts, the Chair identified, between April and May 2008, further areas of expertise to be covered and sought to identify further external experts in these areas.

30. In this context, SCHER, in its plenary meeting of 6 May 2008, set up the working group which, as stated in the relevant meeting report, included at that time "2 members of SCHER, 2 external members from the previous Sanco SC on Health and Animal Welfare and 1 external member from industry". The report of the meeting also stated that "[i]n the first [working group] to be held end of June/beginning of July, it will be decided which kind of other expertises are eventually needed." It was also decided that a public consultation on the "working mandate" and a call for information would be published, giving the wider public the possibility to comment and contribute to the topic[12]. It was also foreseen that this would allow SCHER to identify the further experts needed for the working group. These considerations were reproduced in the minutes of SCHER's plenary meeting, held on 15 July 2011.

31. In its plenary meeting of 9 September 2008, SCHER concluded, that, as evidenced in the relevant minutes of that meeting, all fields of expertise needed for the preparation of the opinion had been covered.

32. The Ombudsman noted in this context that the Chair's communications to the first line of experts were formulated in neutral terms, thus implying that the Chair had not taken any pre-determined view as regards the outcome of the studies to be carried out. Rather, the Chair sought, in an objective and non- predetermined manner, to identify what the issues to be studied were and what assistance was needed fully to understand those issues.

33. However, the Ombudsman had concerns as regards the methodology the Chair used in order to identify the experts who would provide that assistance. As noted above, SCHER's work must comply with the principles of (i) excellence, (ii) independence and impartiality, and (iii) transparency. The principle of excellence implies that the persons chosen to assist SCHER should be the most accomplished experts available in the field concerned. Choosing the appropriate person thus implies, the Ombudsman underlined, a comparative assessment of available candidates. The Ombudsman did not doubt that, when the Chair sought to identify the first line of experts and when the first line of experts sought to identify further experts, they all acted in good faith and to the best of their ability. However, and while accepting that it is possible that the Chair might in fact have selected the most suitable experts to form part of the working group[13], the Ombudsman considered that, as a matter of correct methodology, the expert selection system used by the Chair was not appropriate to guarantee (i) excellence, (ii) independence and impartiality, and (iii) transparency in the selection of experts. The Ombudsman considered that, as a matter of principle, there was no guarantee that the Chair had been aware of all the relevant experts in the field in question. While the subsequent advice from the first line of experts as regards who else might have been a suitable expert went some way in alleviating this problem, this advice again did not guarantee that all relevant experts were considered. The Ombudsman was of the view that the correct means of identifying the largest possible number of experts possessing the requisite expertise would have been to make public the Commission's need for experts and to issue a call inviting experts to express their interest in forming part of the working group. Only then could a full comparative assessment have been carried out to determine which candidates were best suited to providing the necessary advice to SCHER.

34. The comparative assessment should then have been properly documented in order to show that the most suitable candidates had been chosen[14]. That assessment should have been publicly accessible, whilst paying due regard to the need to comply with data protection rules[15].

35. The Ombudsman noted that, in the present case, the Commission made a public request for information. The request was published on the website of the Commission's Directorate-General for Health and Consumer Policy on 15 May 2008. This led to the submission of more than 600 scientific articles and 84 written comments. According to the Commission, this procedure enabled SCHER to identify a group of experts to cover the required areas of scientific expertise. The Ombudsman accepted that a careful review of this documentation by the Chair and the first line of experts should have greatly facilitated the task of identifying relevant experts. Nonetheless, such a method of identifying experts is necessarily uncertain and potentially incomplete. It would, in the Ombudsman view, be necessary to supplement it by also issuing a call specifically aimed at identifying relevant experts.

36. The Ombudsman also underlined that a call specifically aimed at identifying relevant experts would not limit the Chair's margin of discretion to decide who would be an appropriate expert. He emphasised that the procedure outlined above would greatly facilitate the Chair's task of choosing experts, by making available to him/her the names of all possible candidates.

37. The Ombudsman pointed out that the formalities involved in requesting relevant experts to manifest their interest did not need to be any more onerous than those the Commission adopted when, on 15 May 2008, it published its request for information on its website.

38. The failure to make a public call for relevant experts to express their interest implied that, in the present case, the Commission was unable to guarantee that it met the requirements of participatory democracy (see paragraphs 9-14 above).

39. On the basis of the above considerations, the Ombudsman made a draft recommendation to the effect that the Commission should consider modifying its rules concerning the establishment of scientific committees to require that, when it deems it necessary to (a) have recourse to external experts and (b) identify the best possible candidates, it publishes a call inviting experts to express their interest.

Arguments presented to the Ombudsman after his draft recommendation

40. In its reply to the Ombudsman's draft recommendation, the Commission explained that the Scientific Committee concerned was set up and carries out its functions on the basis of Commission Decision 2004/210/EC. This Decision was repealed by Commission Decision 2008/721/EC[16].

41. The main reason for adopting Commission Decision 2008/721/EC was to improve the structure and working procedures of the Committees, and to ensure access to highly qualified scientific expertise in a flexible advisory structure. With this purpose, Commission Decision 2008/721/EC established a 'Pool of Scientific Advisors on Risk Assessment', composed of experts in one or more of the fields of competence of the committees, or on related subjects, covering collectively the widest possible range of disciplines.

42. In addition, the Commission established a database of external experts which is permanently open for applications from interested scientists.

43. Thus, the procedures for the selection of experts for the working groups now include: (i) a search in the 'Pool of Scientific Advisors on Risk Assessment'; (ii) a search in the Commission's database of external experts; and (iii) a web-based call for experts, in cases in which suitable expertise cannot be found. The selection process is properly recorded in order to document its transparency.

44. On the basis of the above, the Commission considers that the current procedures for the selection of experts are in accordance with the draft recommendation of the Ombudsman.

45. In its observations, the complainant stated that it had no comments to make on the Commission's reply.

The Ombudsman's assessment after his draft recommendation

46. As noted above, citizens' participation in areas having a close connection to the legislative process, such as the opinions drafted by SCHER in relation to the possible revision of Directive 86/609/EEC, constitutes an important element of participatory democracy. The Treaty on European Union requires the institutions to determine by which appropriate means citizens are to be given the opportunity to make known and publicly exchange their views. The institutions however have a margin of discretion as regards the way in which participatory democracy is made effective, especially when technically complex issues are involved. Nonetheless, this margin of discretion has to be exercised in a justifiable and objective manner.

47. As noted in paragraph 32 above, the Ombudsman had concerns as regards the methodology the Chair used in order to identify the external experts who would provide assistance to SCHER. He noted that SCHER's work must comply with the principles of (i) excellence, (ii) independence and impartiality, and (iii) transparency. The principle of excellence implies that the persons chosen to assist SCHER should be the most accomplished experts available in the field concerned. Choosing the appropriate person thus implies, the Ombudsman underlined, a comparative assessment of available candidates. The Ombudsman then considered that, as a matter of correct methodology, the expert selection system used by the Chair was not appropriate to guarantee (i) excellence, (ii) independence and impartiality, and (iii) transparency in the selection of experts.

48. The Ombudsman then took the view that the correct means of identifying the largest possible number of experts possessing the requisite expertise would have been to make public the Commission's need for experts and to issue a call inviting experts to express their interest in forming part of the working group. Only then could a full comparative assessment have been carried out to determine which candidates were best suited to providing the necessary advice to SCHER. The comparative assessment should then have been properly documented in order to show that the most suitable candidates had been chosen. That assessment should have been publicly accessible, whilst paying due regard to the need to comply with data protection rules.

49. In its reply to the draft recommendation, the Commission indicated that the procedure for the selection of scientific experts is now based on Commission Decision 2008/721/EC. In accordance with this Decision, the current procedures for the selection of experts for the working groups now include: (i) a search in the 'Pool of Scientific Advisors on Risk Assessment'; (ii) a search in the Commission's database of external experts; and (iii) a web-based call for experts, in cases in which suitable expertise cannot be found. That selection process is properly recorded in order to document its transparency.

50. The Ombudsman again underlines the Commission's margin of discretion when determining how it chooses external experts. He also considers that the new system chosen by the Commission constitutes a significant improvement on the procedure which SCHER used in the case at hand.  The Ombudsman notes that the facts of the present case relate to a highly specialised area, namely, the use of non-human primates in research. The Ombudsman expects that, in the event that the Commission were to (a) require external expertise on a similar highly specialised area in the future, and (b) find, after a search in the 'Pool of Scientific Advisors on Risk Assessment' and in its own database of external experts, that the appropriate expertise is not available, it will issue a web-based call for experts. In this context, and with due regard to the above caveat, he concludes that the Commission agrees with the spirit and the wording of his draft recommendation and that it is committed to respect such approach in the future.

B. Allegation that the Commission failed to ensure that SCHER took due account of evidence supplied by interest groups

Arguments presented to the Ombudsman

51. The complainant alleged that the Commission failed to ensure that SCHER took due account of the evidence supplied by interest groups about the efficacy of non-human primate research and alternatives to it. It argued that, while SCHER was entitled to form its own judgement, it ignored relevant materials, especially a large number of peer-reviewed articles supplied by the complainant. It also failed to provide a detailed analysis of the available evidence.

52. In its opinion, the Commission stated that SCHER was under no obligation to take into account evidence supplied by interest organisations. In fact, when carrying out its tasks, SCHER invariably considers all relevant contributions and, within its margin of discretion, takes into consideration the elements which it deems appropriate, in particular, those that it considers to be of sufficiently good scientific quality. It is apparent, the Commission stated, that SCHER did so with diligence and fairness in the present case. It added that SCHER remains fully independent in drawing its conclusions. It is expected to focus in its opinions on the question posed by the Commission, and not to address additional issues which stakeholders mention in their contributions, to make a summary of all public opinions or to reply to individual concerns. The Commission therefore considered that the complainant's allegation is based on a misconception of the mission and nature of SCHER, and of the Commission's responsibility and powers in relation to SCHER.

53. In response to the Ombudsman's question as to why it was "apparent" that SCHER considered all relevant contributions, the Commission noted that SCHER published a call for information on its website on 15 May 2008. It received 628 relevant scientific articles and 84 written comments from NGOs, industry, academia, public authorities and individuals. SCHER's secretariat uploaded the contributions onto its intranet with automatic notifications to the members of the working group. The working group considered these contributions during its meetings of 5 June, 16 July, 30 September and 22 October 2008. The Commission's representatives were present at these meetings. Then, on 6 November 2008, SCHER held a public hearing during which it heard 48 representatives of various stakeholders, that is, 15 representatives of academia, 7 representatives of animal welfare NGOs, 6 representatives of scientific institutions, 6 representatives of the industry, 6 members of public institutions, 6 government officials and 2 representatives of other NGOs. In addition to the discussions at the public hearing, SCHER accepted further written comments and contributions until 12 November 2008. These comments, together with the result of the hearing, were considered by the members of the working group at meetings held on 12 November and 10 December 2008. The Commission's representatives were present at these meetings.

54. The Commission underlined that, as concerns the efficacy of non-human primate research and alternatives to it, it is evident from the content of SCHER's opinion that it did address this issue, which was specifically mentioned in the submissions of animal welfare groups (see paragraphs 3.1.3 on infectious diseases and 3.1.4 on neurosciences of the final opinion). In conclusion, the Commission stated that SCHER considered all the relevant contributions presented by the stakeholders. The working procedure applied by SCHER, and verified by the Commission, ensured due consideration of all the relevant evidence and contributions submitted by interest groups. SCHER was required to deliver an independent scientific opinion. Although it was not requested to do so, SCHER also addressed in its opinion issues relating to the efficacy of non-human primate research and alternatives to it which were raised by certain interest groups.

55. In its observations, the complainant accepted that SCHER, and its working group, were obliged to take into account contributions only if they were relevant and of sufficient scientific quality. Also, it was for SCHER to decide on the weight to be given to the particular contributions and to draw conclusions from them. However, the Commission only stated that it received and took into account 628 "relevant" scientific articles and 84 written comments. It did not specify how many scientific articles and written comments SCHER, or its working group, rejected because they were irrelevant or of insufficient scientific quality. It also failed to specify whether the rejected contributions were provided by animal protection groups and, if so, how many were so rejected and for what reasons. Similarly, it did not specify who carried out the filtering process and against which criteria.

56. The complainant also asked whether the Commission's statements should be understood to mean that each member of the working group read all 628 articles and 84 written comments. It added that the Commission should explain how much of the information contained in these materials was discussed at the working group meetings. In this respect, the complainant added that, while the Commission claims to have been present at all the working group meetings, it did not produce the minutes of those meetings.

57. The complainant argued that the Commission cannot demonstrate that the process was fair and objective by simply stating that all the information submitted to it was "taken into account". It added that the best way to determine whether the working group took into account all relevant information submitted to it is by examining the final opinion. There is, it argued, very little evidence in SCHER's final opinion to show that the working group indeed took into account the material provided by animal protection NGOs demonstrating the lack of efficacy of non-human primate research or the availability and potential of alternatives to it. Similarly, in the complainant's view, the final opinion fails to mention the voluminous evidence it provided on the availability and potential of alternative research methods. The complainant was therefore of the opinion that the working group simply ignored evidence which did not fit into the paradigm which its "inexpert members" supported, namely, that non-human primate research works and alternatives do not work. The complainant argued that SCHER, or its working group, should have (i) considered all the relevant contributions objectively and fairly, (ii) discussed the pertinent and opposing views, and (iii) eventually, justified its conclusions. Instead, the working group was highly selective in the contributions it considered and in its final conclusions. Even if, as the Commission claimed, the working group considered the various contributions, this was not sufficiently demonstrated in the final opinion.

The Ombudsman's assessment

58. Whereas, as noted above, the Commission failed to issue a call inviting relevant experts to express their interest in becoming members of the working group, it did issue a call for relevant papers to be submitted. As a result, it obtained 628 "relevant" scientific articles and 84 written comments. The Ombudsman commends the Commission for having done so in the present case.

59. The complainant, however, alleges that the Commission did not take due account of all the papers submitted to it.

60. The Ombudsman underlines that he cannot substitute his appraisal for the scientific appraisal of an expert group constituted with the aim of giving advice on a highly specialised and technical subject, such as, in this case, the use of non-human primates in research. The Ombudsman's analysis will, therefore, be limited to verifying whether the procedures used to review the documents were appropriate and whether there is evidence of a manifest error by SCHER.

61. The Ombudsman notes that all the contributions which SCHER received were made available to all the members of the working group. The working group met four times before making its draft opinion available to the general public. Furthermore, it also held a public hearing, during which members of the public could also contribute to the debate on the content of the opinion. Finally, two further working group meetings were held before the final opinion was adopted in January 2009.

62. The Commission's file on these actions, which the Ombudsman's services inspected, documents in detail the different stages of the process that led to the acceptance of the final opinion. The Commission's file contains numerous drafts of the opinion with the changes and suggestions made by the members of the working group (shown in track changes). It also contains details of the discussions which took place. The reactions of the members of the working group in their internal e-mail correspondence provide evidence of a thorough and structured consideration of the contributions. Further, the Ombudsman underlines that the Commission's file contains several detailed hand-written notes which, in the Ombudsman's view[17], show that the working group carried out a meticulous and structured analysis of different aspects of the topic at hand.

63. As regards the diligence of the working group, the Ombudsman notes that the Commission initially requested that the opinion be adopted by the end of October 2008. For that reason, SCHER foresaw that the working group would meet four times[18]. However, eventually, six working group meetings took place and the final opinion was only adopted in January 2009. On the basis of the inspected Commission's file, the Ombudsman finds that the additional working group meetings and the subsequent delay in delivering the final opinion resulted from the need for further discussion about the submissions received by the working group.

64. The Ombudsman does not consider the fact that SCHER's final opinion does not contain references to specific papers submitted to it or references to any specific positions taken in such papers to constitute proof of its failure to take due consideration of the extensive documentation submitted to it.

65. In these circumstances, and especially on the basis of the information obtained during his inspection, the Ombudsman has not identified any procedural or manifest error of assessment in the way the working group (and SCHER) processed and took into account the contributions, comments and observations received between April and November 2008, when drafting its opinion on the use of non-human primates in research.

66. In light of the above findings, the Ombudsman considers that there is no maladministration in connection with the complainant's second allegation.

C. Conclusions

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

1) The Commission has accepted the Ombudsman's draft recommendation.

2) As regards the second allegation, the Ombudsman finds no maladministration.

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

 

P. Nikiforos Diamandouros

Done in Strasbourg on 4 February 2013

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[1] Written declaration 40/2007, OJ 2008 C 187, p. 168.

[2] OJ 1986 L 358, p. 1.

[3] Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment, OJ 2004 L 66, p. 45.

[4] Commission Decision of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC, OJ 2008 L 241, p. 21. The date of adoption of the Decision was corrected to 5 September 2009 via a corrigendum published in OJ 2010 L 244, p. 34.

[5] For reasons of confidentiality, the precise content of the documents inspected cannot be disclosed. The Ombudsman will therefore only refer to such content to the extent that such reference still guarantees the confidential nature of the information contained in the documents.

[6] Article 10(3) of the Treaty on European Union states that every citizen shall have the right to participate in the democratic life of the Union and that decisions shall be taken as openly and as closely as possible to the citizen. Article 15 of the Treaty on the Functioning of the European Union states that, in order to promote good governance and ensure the participation of civil society, the Union’s institutions, bodies, offices and agencies shall conduct their work as openly as possible.

[7] Rules of Procedure of the Scientific Committee on Consumer Products, the Scientific Committee on Health and Environmental Risks, and the Scientific Committee on Emerging and Newly Identified Health Risks, SCs/01/04 final, adopted on 7 September 2004, enclosed with the Commission's opinion on the present complaint.

[8] In the present case, this concerned the possible revision of Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes.

[9] Recital 6 of Commission Decision 2004/210/EC recognises that "sound and timely scientific advice is an essential requirement for Commission proposals, decisions and policy relating to consumer safety, public health and environment".

[10] Recital 7 of Commission Decision 2004/210/EC states that "the advice of the Scientific Committees on matters relating to consumer safety, public health and the environment must be based on the principles of excellence, independence and impartiality, and transparency".

[11] Recital 8 of Commission Decision 2004/210/EC provides that "it is essential that the Scientific Committees make best use of external expertise in the EU and beyond".

[12] The public consultation and the call for information were published on SCHER’s website and ran in parallel from 15 May to 6 June 2008. According to the Commission's calculations, it received around 700 scientific articles and 140 written comments. The Commission found 628 of these articles and 84 of these comments to be particularly relevant.

[13] The appointed experts were active members of the scientific community, working in universities, research centres, charity organisations, NGOs, medical and biological institutions and consultancy organisations.

[14] The Ombudsman did not see any evidence in the Commission’s file to show that any comprehensive comparative assessment of possible candidates was carried out.

[15] The Ombudsman noted that point 9.7 of the 2008 Rules of Procedure of the Scientific Committees expressly states that the selection process of advisors and external experts to participate in Working Groups "should be properly recorded in order to document the transparency of the process".

[16] Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2001/210/EC, OJ 2008 L 241, p.21.

[17] Again, due to their highly technical and specialised nature, the Ombudsman is not in a position to verify their scientific adequacy.

[18] As evidenced in one of the first e-mails which SCHER's secretariat sent to scientific experts in April 2008.