Transparency in clinical trials

The European Parliament voted overwhelmingly in April 2014 in favour of transparency and the safety of its citizens. The new Regulation of Clinical Trials no longer considers clinical trial reports to be trade secrets and as a result they are now publicly accessible.
However, although the European Medicines Agency (EMA) had expressed support for the publication of and access to the results of all clinical trials, now this organisation is making a restrictive interpretation of European regulation of clinical trials and intends to limit access to data from clinical trials by means of strict confidentiality requirements.

In Europe, the reactions were not long in coming and at all levels.
OCU, faced with the 180º about turn from the EMA, has contacted the Spanish representatives Belén Sánchez-Crespo and Laura Franqueza Eznarriaga Garcia of the Spanish Agency for Medicines and Health Products, concerning the discussion that the Board of EMA will hold on 12 June about the EMA policy on transparency.
OCU has expressed concern about the change of position and requests that the policy of transparency and publication of data is maintained.
OCU also argues that:
• It would endanger the fundamental right of access to information due to the high number of constraints and confidentiality requirements.
• Viewing data only on screen is contrary to the regulation of clinical trials adopted in April by the European Parliament and the Council.
• States and the European Parliament have indicated that clinical reports should not be considered as commercially confidential.
The BEUC (the European Consumers' Organisation), meanwhile, has addressed in similar terms the director of the European Medicines Agency. We will continue watching what happens in the coming months.