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Exhibit 945

Decision of the European Ombudsman closing his inquiry into complaint 2560/2007/BEH against the European Medicines Agency

Exhibit 945 ยท Legal decision

Decision of the European Ombudsman closing his inquiry into complaint 2560/2007/BEH against the European Medicines Agency

The Ombudsman therefore found that EMA's refusal to grant access to the requested documents constituted an instance of maladministration.

Researchers at the Nordic Cochrane Centre asked the European Medicines Agency on 29 June 2007 for clinical study reports and trial protocols on anti-obesity drugs, and the Agency refused on commercial-interest grounds. The Ombudsman found the refusal maladministration and issued a draft recommendation that EMA grant access or give a convincing explanation why it could not. EMA accepted the recommendation and committed to grant access, and the Ombudsman closed the inquiry on that basis.

Source
European Ombudsman (P. Nikiforos Diamandouros)
Date
24 November 2010
Quoted from
Decision, para. 84 (draft recommendation at para. 88; conclusion at Part B)
Grade
Primary record
Document
https://web.archive.org/web/20101204132101/http://www.ombudsman.europa.eu/cases/decision.faces/en/5459/html.bookmark
Accessed
2026-11-10
Cited by
Findings citing this exhibit
Note
The decision text is read from the Ombudsman's own page as captured by the Wayback Machine on 4 December 2010; the current ombudsman.europa.eu page (/en/decision/en/5459) loads by script and returns no text to automated fetch.

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