European data protection authorities have expressed support for the proposed European Biotech Act while emphasizing the need for robust protections for health data in clinical trials.
The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have issued Joint Opinion 3/2026, which endorses the objectives of the European Biotech Act aimed at enhancing the EU's biotechnology sector. However, they caution that regulatory simplification should not compromise the rights of participants in clinical trials. The proposed legislation seeks to unify the regulatory landscape, addressing challenges like high administrative costs and regulatory fragmentation that hinder the biotech industry.
A key recommendation from the Joint Opinion is the establishment of a harmonized legal basis for health data processing in clinical trials. This would alleviate the current inconsistencies faced by sponsors operating across different EU countries. The EDPB and EDPS advocate for legal obligation to be the primary basis for data processing, distinguishing it from informed consent, which remains crucial for ethical participation. They stress that the Act must clearly define conditions and safeguards to protect participants' rights, especially given the sensitive nature of health-related data.
Furthermore, the authorities suggest clarifying the roles of various stakeholders in clinical trials and propose specific recommendations for data retention and secondary use of health data. They highlight the necessity of precise definitions to prevent misinterpretation and ensure compliance with GDPR standards. As the Act integrates AI technologies into clinical trials, the EDPB and EDPS call for clear guidelines on the interplay between the Biotech Act and existing AI regulations, emphasizing the importance of patient safety and data integrity.
In summary, while the European Biotech Act presents a significant opportunity to streamline regulations in the biotech sector, it must not compromise the essential protections for clinical trial participants. The ongoing dialogue between regulatory bodies will be crucial in shaping a framework that balances innovation with ethical standards.