EDPB-EDPS JOINT OPINION 3/2026 on the proposed European Biotech Act

The  European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have adopted a joint opinion on the European Commission proposal for a Biotech Act.

The joint opinion underlines the importance of ensuring that, while the simplifications proposed in the draft brings clarity and legal certainty, the high standard of protection provided by the GDPR and EUDPR for the processing of personal data relating to health is maintained.

The joint opinion considers that the simplification objectives in the proposed Biotech Act should not lower the level of protection of the fundamental right to protection of personal data of clinical trial participants, taking into account the particularly sensitive nature of the personal data that is normally processed during clinical trials.

The joint opinion also welcomes the proposal in the draft Biotech Act that would permit sponsors and investigators to rely on a single legal basis, Article 6(1)(c) GDPR, for the processing of personal data in clinical trials. The EDPB and the EDPS consider that this could help address the existing fragmentation of the applicable regulatory framework and improve legal clarity for sponsors.