EDPB and EDPS support harmonisation of clinical trials under European Biotech Act, but call for specific safeguards for sensitive health data
The EDPB and EDPS say the proposed European Biotech Act can help reduce fragmentation in clinical-trials rules, but warn that simplification cannot come at the expense of clear safeguards for sensitive health data.
What happened
In a joint opinion, the two EU data protection bodies backed the Commission’s goal of making the clinical-trials environment more coherent across member states. But they also argued that any harmonisation effort needs tighter legal and governance treatment of special-category health data, especially where research efficiency could otherwise be used to justify looser protections.
The opinion effectively supports the direction of travel while drawing a boundary around what regulators will accept: less fragmentation, yes; weaker protections for sensitive medical data, no.
Why it matters
This matters because health-data governance is exactly where policy simplification can become risky if lawmakers treat privacy safeguards as administrative friction rather than core operating constraints. The opinion is also a signal that European regulators are willing to support competitiveness arguments, but only within a framework that preserves high-threshold protections for sensitive data.
Assessment
The important signal is not simply that the EDPB and EDPS commented on another Commission proposal. It is that they are trying to shape the terms on which innovation, harmonisation, and data protection can coexist. For organisations working around clinical trials, health research, or biotech-adjacent platforms, that means governance quality and evidentiary discipline will remain central even when policymakers are under pressure to reduce complexity.