At the plenary meeting of the European Data Protection Board (EDPB), held in March 2026, the EDPB-EDPS Joint Opinion No. 3/2026 on the Proposal for a Regulation establishing a legal framework to strengthen European measures in the biotechnology sector, in particular in the field of health (European Biotech Act) was adopted.

The Opinion emphasises that the sensitivity of health data and genetic data processed in the context of clinical trials requires a high level of protection. Recommendations are therefore made to ensure that the proposed simplifications do not lead to a reduction in the level of protection afforded to participants in clinical trials. It is also highlighted that the envisaged legislative act should specify whether the actors involved in the financing and conduct of interventional clinical trials act as sole or joint data controllers, in order to ensure a clear allocation of responsibilities.

In this context, it should be noted that the European Data Protection Board had previously adopted the EDPB-EDPS Joint Opinion no. 2/2026 on the Proposal for a Digital Omnibus Regulation.

Given that this proposal aims to simplify the European Union's digital regulatory framework, the Opinion points out that some of the proposed amendments raise significant concerns, as they may adversely affect the level of protection afforded to individuals and may make the enforcement of data protection legislation more difficult.

Consequently, the EDPB and EDPS urge the legislators not to adopt the proposed amendments to the definition of personal data, as they go far beyond a specific or technical amendment to the GDPR. Moreover, they do not accurately reflect, and clearly go beyond, the case law of the Court of Justice of the European Union and would result in a significant narrowing of the concept of personal data.

Further information is available at: https://edpb.europa.eu/news

Legal and Communication Department

A.N.S.P.D.C.P