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Decision of the European Ombudsman closing his inquiry into complaint 1199/2010/BEH against the European Anti-Fraud Office (OLAF)

The background to the complaint

1. The complainant is a public limited company incorporated under German law. In the early 1990s, it invented a specific inhaler for the treatment of asthma. In 1997, the competent German regional authority prohibited its sale in Germany. Subsequently, the German Federal Ministry of Health, under the safeguard clause procedure foreseen by Article 8 of Directive 93/42/EEC ('the Directive')[1], formally notified the Commission of that prohibition. According to the complainant, the Commission never started a safeguard clause procedure, even though it would have been required to do so under Article 8 of the Directive.

2. On 19 March 2008, the complainant sent a letter entitled "supervisory complaint" ("Dienstaufsichtsbeschwerde") to the European Anti-Fraud Office (OLAF). In that letter, it essentially alleged that a then Commissioner as well as two Commission staff members had knowingly infringed the Directive following notification of the marketing prohibition in Germany. The complainant denounced what he perceived to be corruption and mismanagement on the Commission's part.

3. On 1 April 2008, the complainant submitted a petition (Petition 473/2008) to the Committee on Petitions of the European Parliament ('the Committee on Petitions'). In that petition, it essentially asserted that it alerted the Commission to the above circumstances but that the Commission failed to react adequately. According to the complainant, it emerged from a letter sent by the then Commissioner to a Member of the European Parliament (MEP) that the Commission acknowledged its infringement of Article 8 of the Directive. The Commission would have been required to hear the producer of the inhaler in order rapidly to clarify the matter. Instead, however, the safeguard clause procedure launched in 1997 had never been concluded and the producer of the inhaler was never heard. The complainant also pointed out that, in 2005, the competent German authority renewed the marketing prohibition, this time without notifying the Commission. In the complainant's view, there were serious shortcomings in the EU system of legal protection, given that it, that is, the complainant, had effectively been deprived of a remedy. The complainant submitted that its ensuing economic ruin had knowingly been accepted.

4. On 4 February 2009, the complainant turned to the Ombudsman (complaint 309/2009(NM)BEH) and submitted that the subject-matter of its complaint could be derived from its petition with the Committee on Petitions, which it attached. The complainant also submitted that the Commission had tried to mislead it, lied to it and sought to avoid its responsibility. In its view, the Commission thus knowingly accepted the destruction of its economic existence. Referring to its letter to OLAF of 19 March 2008, the complainant asserted that OLAF, for incomprehensible reasons, transferred the case to IDOC[2]. The latter refused to give the complainant access to information about the outcome of its investigation. The complainant considered that this refusal was aimed at protecting the pharmaceutical industry. Article 228 of the Treaty on the Functioning of the EU empowers the Ombudsman to "conduct inquiries for which he finds grounds". By letter of 11 March 2009, the Ombudsman informed the complainant that there were no grounds for an inquiry into its complaint, given that the Committee on Petitions was dealing with the grievances raised in its complaint. As regards the complainant's remarks on OLAF and IDOC, the Ombudsman stated that it was not clear whether the complainant also wished to complain about those bodies.

5. On 15 February 2010, the complainant again turned to the Ombudsman and complained about the Commission's handling of its complaint, which was transferred to IDOC by OLAF (complaint 452/2010/BEH). On 10 March 2010, the Ombudsman opened an inquiry into this complaint.

6. On 4 May 2010, the complainant submitted the present complaint to the Ombudsman concerning OLAF's handling of its complaint.

The subject matter of the inquiry

7. In its present complaint, the complainant submitted the following allegation and claim:

OLAF failed properly to handle its complaint dated 19 March 2008, by transferring it to IDOC

OLAF should investigate the complaint dated 19 March 2008.

The inquiry

8. The complaint was forwarded to the Acting Director-General of OLAF for an opinion. OLAF's opinion was forwarded to the complainant with an invitation to make observations. The complainant submitted observations on 7 October 2010.

The Ombudsman's analysis and conclusions

Preliminary remarks

9. In its observations, the complainant questioned the meaningfulness of inquiries conducted by OLAF and IDOC against Commission staff members, since both of these bodies form part of the Commission's services. In the complainant's view, these two bodies could exercise their functions in an independent and impartial manner, only if they were to operate under the supervision of Parliament, but not if supervised by the Commission. The complainant further referred to its submission in complaint 452/2010/BEH regarding this matter. The Ombudsman does not consider that the complainant's statements are intended to be a new claim. In any event, however, it appears useful to point out that the Ombudsman's mandate is limited to inquiring into instances of maladministration in the activities of the institutions, bodies, offices and agencies of the EU. The complainant's statements, however, even if understood as constituting a new claim, would appear to advocate a change of the current legal framework by the EU legislature. Such a claim would, therefore, not appear to relate to an instance of maladministration which could be reviewed by the Ombudsman.

10. In view of their factual connection, it is appropriate to consider the complainant's allegation and claim together.

A. Allegation of improper handling of complaint and related claim

Arguments presented to the Ombudsman

11. The complainant alleged that, by transferring the complaint dated 19 March 2008 to IDOC, OLAF failed to handle it properly. It claimed that OLAF should investigate the complaint dated 19 March 2008.

12. In its opinion, OLAF stated that it evaluated the information submitted by the complainant in its disciplinary complaint. However, OLAF did not consider the suspicions raised by the complainant sufficiently serious for a recommendation to be made to the Director of OLAF that an investigation should be opened. OLAF asserted that the complainant put forward vague presumptions and subjective conclusions to explain why the Commission did not open a safeguard clause procedure. Referring to the case-law of the Court of Justice, OLAF submitted that it cannot open an investigation without a sufficiently serious suspicion[3]. OLAF asserted that the Commission's alleged inactivity could, at most, constitute a breach of the Staff Regulations. Given that Commission staff was concerned, the matter would fall within the competence of IDOC. In view of the above, the case-handler dealing with the case proposed to OLAF's Management Board that the case should be closed as a 'non-case', and that it should be forwarded to IDOC. On 8 October 2008, OLAF's relevant decision was forwarded to IDOC, together with the documents submitted by the complainant. In conclusion, OLAF submitted that its handling of the case was fully in line with its mandate and the legal framework governing its activities. OLAF, therefore, considered the complainant's allegation and claim to be unfounded.

13. In its observations, the complainant expressed its surprise that OLAF considered that it had not submitted sufficiently substantive information suggesting corruption and/or proving a clear disciplinary offence. The complainant referred, in this respect, to the proof which, in its view, it had furnished to the Commission concerning allegedly untrue statements that had been made by one of its Directors-General. The complainant considered, therefore, that OLAF should have investigated its complaint. The complainant also pointed to an opinion of Parliament's Legal Affairs Committee concerning its petition, dated 1 June 2010, which unambiguously referred to an 'intentional inactivity' on the Commission's part. In the complainant's view, the fact that the Commission had not, in more than 13 years, concluded the safeguard clause procedure in line with the Directive was a clear indication of corruption, since there was no other possible explanation for such inactivity. The complainant further considered that if OLAF had taken seriously the initial information submitted to it, the damage it, that is, the complainant, had suffered might have been avoided. According to the complainant, OLAF's submissions in its opinion called into doubt the very purpose of its existence. The complainant also stated that it had lost all confidence in any further investigations which might be carried out by OLAF or IDOC.

14. Referring to OLAF's mandate, as interpreted in the case-law of the Court of Justice and quoted by OLAF, the complainant noted that OLAF is, among other things, entrusted with the task of investigating suspicions of "other illegal activities detrimental to the financial interests of the European Union". The complainant pointed out that the Commission's failure to act on the basis of the information which the complainant had submitted to it had given rise to enormous economic losses suffered by society at large, itself, other companies, and sickness insurance schemes. This was confirmed in a recent report on German TV. In the complainant's view, only the pharmaceutical industry benefitted from the marketing prohibition of its product. In the complainant's view, such an outcome corroborated a suspicion of corruption. The complainant stated that it intended to bring an action for damages before the Court of Justice, which had already granted it legal aid. However, before doing so, it would await the outcome of its petition. The complainant expressed the hope that the Committee on Petitions would rapidly reach a conclusion on its petition, and establish a committee of inquiry. The complainant further hoped that the latter would thoroughly and comprehensively clarify the matter which should, in turn, provide real results. In the complainant's view, its case was an example of the system having completely failed. The complainant stated that, with the support of the Committee on Petitions, and the Ombudsman, it hoped to bring about "political change".

The Ombudsman's assessment

15. The Ombudsman's long-established practice is to consider that there are no grounds for him to inquire into a complaint if the complainant has addressed a petition to Parliament on the same subject-matter, and if the Committee on Petitions has dealt with, or is dealing with it[4]. The Ombudsman applies the same reasoning in cases in which an allegation or claim relates to the subject-matter of a petition[5].

16. The Ombudsman opened his present inquiry on the understanding that the complaint submitted to him has a different subject-matter to that of the complainant's petition to the Committee on Petitions. The complainant's petition 473/2008, which was declared admissible by the Committee on Petitions, and which it is currently examining, essentially concerns the Commission's alleged failure to conclude the safeguard clause procedure. In its complaint to the Ombudsman, however, the complainant alleged that OLAF failed to handle properly its complaint in which it, that is, OLAF, was alerted to the alleged misconduct of certain Commission staff members in connection with the safeguard clause procedure.

17. In the course of the Ombudsman's inquiry it became clear, however, that the subject-matter of the present allegation and claim, although not identical to that of petition 473/2008, is closely related to the latter. Thus, in order to assess whether OLAF's assessment satisfied the requirements of a proper investigation, the Ombudsman would necessarily also have to evaluate the Commission's conduct in relation to the safeguard clause procedure. It is, however, precisely that issue which is currently being considered by the Committee on Petitions. Having reviewed both the complainant's and OLAF's submissions in the course of the Ombudsman's inquiry, it therefore appears that the subject-matter of the complainant's allegation and claim, on the one hand, and of its petition, on the other, are inextricably linked. It is true that, in these circumstances, the Ombudsman could decide to limit his inquiry to the procedural aspects of OLAF's assessment alone, thereby merely ascertaining whether OLAF made proper use of the powers at its disposal in order to investigate the complainant's complaint. Taking such an approach would not require the Ombudsman to assess OLAF's substantive assessment of the case. However, the complainant has repeatedly submitted that it has suffered damage as a result of the Commission's alleged infringement of the Directive. It, therefore, emerges from its submissions that the complainant is interested in a substantive evaluation of its case. In these circumstances, it would not serve a useful purpose to focus on the procedural aspects of OLAF's assessment alone.

18. In its observations, the complainant made it clear that it considered that the Committee on Petitions should establish a committee of inquiry. The Ombudsman, therefore, understands from the complainant's submissions that it wishes Parliament to deal with its case. However, given that the Committee on Petitions is currently assessing the complainant's case, Parliament is, in effect, already dealing with it.

19. In view of the above, the Ombudsman considers that there are no grounds for further inquiries at this point in time. However, he would like to emphasise that this finding does not preclude the complainant from submitting a new complaint concerning OLAF's investigation, once the Committee on Petitions has finalised its assessment of the Commission's conduct and has closed the petition.

B. Conclusions

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

There are no grounds for further inquiries on the Ombudsman's part into the complainant's allegation and claim.

The complainant and OLAF will be informed of this decision.


P. Nikiforos Diamandouros

Done in Strasbourg on 17 December 2010

[1] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1). Article 8 of the Directive essentially provides that, once notified under that procedure, the Commission shall enter into consultation with the parties concerned as soon as possible. It shall subsequently inform the notifying Member State and certain other interested parties whether the measures taken, such as, for instance, a Member State's prohibition of placing a device on the market, are justified.

[2] IDOC is the Commission's Investigation and Disciplinary Office.

[3] Case C-11/00 Commission v ECB [2003] ECR I-7147, paragraph 141; Case C-15/00 Commission v EIB [2003] ECR I-7281, paragraph 164.

[4] See, for instance, the Ombudsman's decisions on complaint 646/97/IJH; complaint 880/2005/TN, paragraph 1.2; complaint 830/2005/JMA, paragraphs 1.4-1.6; 431/2008/ELB, paragraphs 13-14; and complaint 2036/2008/(CD)BEH, paragraph 5.

[5] See the Ombudsman's decision on complaint 880/2005/TN, paragraph 1.4.