EMA Responds to Transparency Criticism

Following recent accusations that the European Medicines Agency (EMA) puts companies’ commercial interests ahead of public safety, EMA has responded by emphasizing recent agency initiatives at the agency to improve data access.

Earlier this month, the British Medical Journal (BMJ) published an article, entitled "Opening up data at the European Medicines Agency," which described efforts by the authors to obtain access to unpublished trial reports at the EMA concerning the antiobesity drugs, rimonabant and orlistat. The authors first requested access on June 29, 2007, but did not receive the data until Feb. 1, 2011, after intervention by the European Ombudsman. In particular, the authors claim that the regulator was protecting drug company profits above patient welfare by withholding access to the data. In a press statement released in 2010, the European Ombudsman also accused EMA of maladministration for not granting access to the reports.

Protection of commercial interests was the EMA’s over-riding argument," explained the article. "It would undermine the protection of commercial interests to allow us access, it said, as the documents represented the full details of the clinical development programme and the most substantial part of the applicant’s investment."

The authors argued, however, that the clinical study reports and protocols are based on well-known principles that can be applied to any drug trial. They also explained the consequences of selective reporting.

"Comparisons of published drug trials with unpublished data available at drug regulatory agencies have shown that the benefits of drugs have been much over-rated and the harms under-rated. Comparisons of trial protocols with published papers have also shown widespread selective reporting of favourable results," claims the article.

In response, EMA has outlined moves it has made to increase access to data and transparency.

"The authors make what appears to be a compelling call for more transparency by the regulatory authorities," said EMA in a letter to the BMJ. "However, they do so by ignoring the steps taken by the European Medicines Agency since it was established in 1995 and the latest actions and policy adopted over the last few years."

In November 2010, EMA implemented a new access to documents policy, which the agency claims has "pushed transparency further forward than in most other drug regulatory authorities." EMA also added that the extended access to documents and reactive disclosure of documents will be complemented by an "extended proactive publication" of these documents over the next few years.

Additionally, EMA drew attention to its recently launched EU Clinical Trials Register, which will enable patients and doctors to find information about clinical trials taking place in Europe.

"Further developments of this system are planned in the future, including publication of summaries of clinical trial results," said the EMA.

"Our case sets an important precedent," said the BMJ article. "On 30 November 2010 the EMA declared it would widen public access to documents, including trial reports and protocols. We recommend that the FDA and other drug regulatory agencies should follow suit. Access should be prompt—for example, within three months of the regulator’s decision—and documents should be provided in a useful format."