How we got access to clinical study reports in 2011 despite EMA’s steadfast refusal

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

We applied for access in June 2007, but 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 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We have also written a more comprehensive 26-page report: Getting access to unpublished clinical trials at the European Medicines Agency.

All the documents in the case are available below.

1. Our application for access, 29 Jun 2007

2. EMA’s first reply to us, 20 Aug 2007

3. Our appeal to EMA, 24 Aug 2007

4. EMA’s second reply to us, 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 summarises the allegations and claims, 25 Oct 2007

8. 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 EMA for further information, 18 Mar 2008

11. 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 EMA, 22 Jan 2009

14. Reply from EMA to the Ombudsman, 26 Feb 2009

15. The Ombudsman asks EMA for further clarification, 10 Mar 2009

16. Reply from 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 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 EMA to the Ombudsman, 31 Aug 2010

23. The Ombudsman closes the case, 24 Nov 2010

24. EMA’s press release about widened public access to documents, 30 Nov 2010

25. Our letter to the Ombudsman about EMA’s new policy, 1 Dec 2010

26. Our reminder to EMA about not having received the documents, 17 Dec 2010

27. The Ombudsman’s comment on the difference between EMA’s change in policy and the proposal made by the Ombudsman, 4 Jan 2011