Alleged failure to grant access to clinical study reports

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  • Case: 2560/2007/BEH
    Opened on 25 Oct 2007 - Draft recommendation on 19 May 2010 - Decision on 24 Nov 2010
  • Institution(s) concerned: European Medicines Agency
  • Field(s) of law: People's Europe
  • Types of maladministration alleged – (i) breach of, or (ii) breach of duties relating to: Requests for public access to documents [Article 23 ECGAB]
  • Subject matter(s): Dealing with requests for information and access to documents (Transparency)
Research
Author:
Copyright: Stocklib © darren baker

Summary of decision on complaint 2560/2007/BEH against the European Medicines Agency (EMA)

In 2007, researchers from a Danish research and information centre in the field of healthcare turned to EMA and requested access to clinical study reports and corresponding trial protocols for two anti-obesity drugs. They explained that they wanted to conduct an independent analysis, given that, in their view, biased reporting on drug trials was common. EMA refused disclosure on the grounds that it would undermine the drug producers' commercial interests.

In their complaint to the Ombudsman, the complainants alleged that EMA had given insufficient reasons for its refusal to grant access. They claimed access to the documents and defended their view that concerns for patients' welfare should be given priority over concerns for the commercial interests of the drug industry.

The Ombudsman made a preliminary finding that EMA had given insufficient reasons for its refusal to grant access. Consequently, he proposed a friendly solution to EMA and asked it to reconsider the complainants' request and grant access, or provide a convincing explanation as to why no such access could be granted. In its reply, EMA maintained its view that no access could be granted and submitted further reasons in support of its position. Following an inspection of the relevant reports and protocols by his services, the Ombudsman concluded that they did not contain information on the composition of the anti-obesity drugs involved, nor did they contain other commercially confidential information. In his view, their disclosure would consequently not undermine commercial interests. In a draft recommendation, the Ombudsman therefore called on EMA to disclose the documents or provide a convincing explanation as to why no access could be given.

In its reply, EMA stated that it decided to grant the complainants access to the documents requested and indicated a deadline by which it would do so. It further committed itself to taking appropriate measures in order to implement the draft recommendation. In so acting, EMA accepted the Ombudsman's draft recommendation. The Ombudsman closed the case on that basis and applauded the approach taken by EMA in reply to his draft recommendation.