EDPB and EDPS publish European Biotech Act joint opinion
12/03/2026 | EDPB
The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have issued a Joint Opinion on the European Commission's Proposal for a European Biotech Act. The proposal seeks to strengthen the competitiveness of the EU biotechnology and biomanufacturing sectors by streamlining regulatory frameworks and updating clinical trial rules. Both regulators support establishing a single legal basis for data processing by investigators and sponsors, noting that this will reduce fragmentation and improve legal clarity across Europe. However, they stress that the processing of sensitive genetic and health data during trials necessitates high data protection standards. The opinion includes several recommendations to ensure that the proposed simplifications do not undermine the privacy rights of participants.
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