Clinical trial data: get them while you canBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g63 (Published 06 January 2014) Cite this as: BMJ 2014;348:g63
All rapid responses
In the article above, the authors recommend readers to get the data they might need from the European Medicines Agency (EMA) while they can, in light of potential changes to the EMA’s access to documents policy. (1)
The agency’s transparency requirements are enshrined in the EU directive 200/83/EC which regulates pharmaceutical products, as well as EU in the European freedom of information Regulation (Regulation 1049/2001) which governs public access to documents at European Union’s institutions and agencies.
At Prescrire, an independent drug bulletin, we have conducted drug reviews on all new products and indications entering the EU and French market since 1981. Our reviews assess the added therapeutic value of each new medicine/indication and are based on the independent appraisal of the evidence. (2) In order to do so, we frequently request various types of unpublished documents from the European Medicines Agency, in accordance with current EU regulations.
Over the last nine years our experience with the Agency could best be described as a mixed bag.
Having widely reported on the shortcomings of the previous EMA access to documents policy from 2005 to 2009, (3) we then witnessed a change of heart from 2010 onwards: with more documents being promptly delivered by the EMA and more questions being answered.
Yet some of this openness came to a halt in 2013, when we faced a regression with consecutive delays in response and data delivery, a shift in procedures and a change of tone. We were told “Please accept our sincere apologies for the delay. The EMA is facing a very high number of requests, hence the late response”. Straightforward requests for periodic safety update reports were either delayed or left unanswered. Once, after requesting a periodic safety update report, the agency asked for permission to reveal our identity to the marketing authorisation holder, in order to be able to respond. In general, documents to which access had been previously granted were no longer available or only supplied after intense correspondence. Strangely enough, during that same year the agency uploaded other process-related documents to its website (agendas, meeting minutes, etc). So when it comes to transparency compliance at the EMA, is Peter being robbed to pay Paul?
It is hard to pinpoint the reasons for such shifts, but during 2013 the EMA has faced legal action by 2 pharmaceutical companies, underwent a major reorganisation and appointed a new head of legal services with a long career in the pharmaceutical industry. Regardless of any underlying cause, the EMA is falling short and not fully meeting its transparency obligations established in EU legislation. So, as far as we see it, this window is ajar, not open.
(1) Doshi P, Groves T “Clinical trial data: get them while you can”. BMJ 2014;348:g63
(2) Prescrire Editorial Staff “How we work: Prescrire's complex, collective editing process has been fine-tuned over the years”. April 2009. Available at:
Accessed 26 June 2013.
(3) Prescrire Editorial Staff “Legal obligations for transparency at the European Medicines Agency: Prescrire’s assessment over four years”. Prescrire International 2009; 18 (103) : 228-233.
Competing interests: No competing interests