Data Protection Rules Could Seriously Impede Clinical Trials In Europe

The European Data protection Board ("EDPB"), which is composed of representatives of the national data protection authorities and the European Data Protection Supervisor, recently adopted an Advisory Opinion ("Opinion") on the interplay between the European Union's Clinical Trials Regulation ("CTR") and the General Data Protection Regulation ("GDPR"). In an upcoming blog post, we will discuss the Opinion in detail, including its significance beyond clinical trials. However, the Opinion raises one major issue that deserves highlighting here.

The EDPB's Opinion advocates a restrictive approach to the use of consent as a legal basis for processing personal data for research activities in the context of a clinical trial protocol. This may require a change of the existing approach for many actors in the area of clinical trials and make it very difficult for commercial pharma organizations to conduct clinical trials for research purposes in the EU. A "legitimate