Clinical Trial Data Transparency and GDPR Compliance: Implications for Data Sharing and Open Innovation

Abstract

Recent EU initiatives and legislations have considerably increased public access to clinical trials data (CTD). These developments are generally much welcomed for the enhancement of science, trust, and open innovation. However, they also raise many questions and concerns, not least at the interface between CTD transparency and other areas of evolving EU law on the protection of trade secrets, intellectual property rights and privacy. This paper focuses on privacy issues and on the interrelation between developments in transparency and the EU’s new General Data Protection Regulation 2016/679 (GDPR). More specifically, this paper examines: (1) the genesis of EU transparency regulations, including the incidents, developments and policy concerns that have shaped them; (2) the features and implications of the GDPR which are relevant in the context of clinical trials; and (3) the risk for tensions between the GDPR and the policy goals of CTD transparency, including their implications for data sharing and open innovation. Ultimately, we stress that these and other related factors must be carefully considered and addressed to reap the full benefits of CTD transparency.