Publication of Clinical Trials Data: A New Approach to Transparency in the European Legislative Framework

Abstract

The European legislative framework is quickly moving towards transparency of the clinical trials data. The European Medicines Agency (EMA)'s Policy/0070, entered into force on January 1, 2015, marked a complete change of approach, moving from a reactive access, upon any interested parties' request, to a proactive publication of the clinical trials data. This approach will be further straightened with the entry into force of Regulation (EU) No. 536/2014 on clinical trials (CT Regulation), expected in 2019, following the activation of the European portal and database. The purpose of ensuring the transparency of the clinical trials data has to be balanced with compelling interests, including, in particular, the protection of the commercially confidential information (CCI) of the sponsors. The criteria to identify what data shall be considered as CCI and what specific reasons might be given by sponsors to support a request for keeping certain data confidential are not clearly stated by the applicable regulations. Moreover, European case law has not discussed this issue in the merits yet and, thus, no clarifications have been provided so far. This article intends to trace the development of the EMA's transparency policy, and make comparisons between the publication requirements under Policy/0070 and the CT Regulation, with particular regard to the issue of the protection of the sponsors' CCI.