EDPB and EDPS Support Harmonization of Clinical Evaluations under the European Biotechnology Act

In March 2026 – The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) adopted a joint position on the European Commission's proposal concerning the European Biotechnology Act. The aim of the proposal is to strengthen Europe's biotechnology and biomanufacturing sectors, especially in health, by streamlining the regulatory framework and updating rules for clinical evaluations. The EDPB and EDPS support the goal of the proposal to enhance EU competitiveness and address the current fragmentation in the application of clinical evaluation regulations. They also emphasize that the sensitivity of health and genetic data processed in connection with clinical evaluations requires high standards of protection. This will help create a framework that safeguards clinical trial participants and provides legal certainty for researchers. "A competitive biotechnology sector in Europe requires a predictable and harmonized legal environment. However, this harmonization must be accompanied by strong guarantees, including clear delineation of roles and responsibilities of all involved parties, to ensure trust in scientific research and accountability," adds European Data Protection Supervisor Wojciech Wiewiórowski.