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We have also written a more comprehensive 26-page report: Getting access to unpublished clinical trials at the European Medicines Agency.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