EDPB and EDPS support harmonisation of clinical trials under European Biotech Act, but call for specific safeguards for sensitive health data

12 March 2026

The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have adopted a Joint Opinion on the European Commission’s Proposal for a European Biotech Act. The Proposal aims to strengthen Europe’s biotechnology and biomanufacturing sectors, particularly in the area of health, by streamlining the regulatory framework and updating the rules for clinical trials.

The EDPB and the EDPS support the Proposal’s objective of fostering the EU’s competitiveness and addressing existing fragmentation in the application of the Clinical Trials Regulation (CTR). In particular, they welcome the aim to establish a single legal basis for the processing of personal data by sponsors and investigators, which will significantly improve legal clarity across Europe.

At the same time, the EDPB and the EDPS underline that the sensitivity of health and genetic data processed in the context of clinical trials requires a high standard of protection. The Joint Opinion provides several recommendations to ensure that the proposed simplifications do not lower the level of protection for clinical trial participants.

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