On 1 February 2011, we got access to the clinical study reports and their corresponding protocols of placebo controlled trials of two anti-obesity pills, rimonabant and orlistat, submitted by the manufacturers to the EMA for obtaining marketing approval in the European Union.

We applied for access in June 2007, but the EMA did not grant us access arguing that it would undermine the protection of commercial interests. We appealed to the European Ombudsman and after 3,5 years and 133 pages of correspondence between the EMA, the European Ombudsman and us we got access.

We have described the case briefly here: Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ 2011;342:d2686.

We have also written a more comprehensive 26-page report: Getting access to unpublished clinical trials at the European Medicines Agency.

This report and all the documents in the case are available here as PDF files.

  1. Our application for access, 29 Jun 2007
  2. The EMA's first reply to the Nordic Cochrane Centre, 20 Aug 2007
  3. Our appeal to the EMA, 24 Aug 2007
  4. The EMA's second reply to the Nordic Cochrane Centre, 17 Sept 2007
  5. Our appeal to the European Ombudsman, 8 Oct 2007
  6. The Ombudsman confirms the reception of the complaint, 12 Oct 2007
  7. The Ombudsman summaries the allegations and claims, 25 Oct 2007
  8. The EMA's opinion on the allegations and claims to the Ombudsman, 30 Jan 2008
  9. Our letter to the Ombudsman, 26 Feb 2008
  10. The Ombudsman asks the EMA for further information regarding certain aspects of the complaint, 18 Mar 2008
  11. The EMA replies to the Ombudsman, 28 Apr 2008
  12. Our letter to the Ombudsman, 17 Jun 2008
  13. The Ombudsman proposes a friendly solution to the EMA, 22 Jan 2009
  14. Reply from the EMA to the Ombudsman, 26 Feb 2009
  15. The Ombudsman asks the EMA for further clarification, 10 Mar 2009
  16. Reply from the EMA to the Ombudsman, 7 Apr 2009, and letter to us from the Ombudsman, 21 Apr 2009
  17. Our letter to the Ombudsman, 19 May 2009
  18. Our letter to the Ombudsman, 31 Aug 2009
  19. Inspection of the EMA’s files by the Ombudsman Institution, 6 Oct 2009
  20. The Ombudsman's draft recommendation, 19 May 2010
  21. The Ombudsman's press release, 7 Jun 2010
  22. Reply from the EMA to the Ombudsman, 31 Aug 2010
  23. The Ombudsman closes the case, 24 Nov 2010
  24. The EMA's press release about widening public access to documents, 30 Nov 2010
  25. Our letter to the Ombudsman about the EMA's new policy, 1 Dec 2010
  26. Our reminder to the EMA about not having received the documents, 17 Dec 2010
  27. The Ombudsman comments on the difference between the EMA's change in policy and the proposal made by the Ombudsman, 4 Jan 2011