On December 16, 2025, the EU Commission unveiled its proposal for the Biotech Act. The proposal, which is only the first part of a bigger initiative for regulating biotechnologies, focuses primarily on the health sector. The Commission took the opportunity to broadly revise the Clinical Trial Regulation (“CTR”) – see our blog post here. In particular, it sought to better align the CTR requirements with those of the General Data Protection Regulation (“GDPR”). This blog post provides an overview of those revisions relating to the processing of personal data during clinical trials.Continue Reading EU Biotech Act Suggests Clarifying Data Protection Rules For Clinical Trials
EU Commission
EU Parliament Adopts AI Act
Earlier this week, Members of the European Parliament (MEPs) cast their votes in favor of the much-anticipated AI Act. With 523 votes in favor, 46 votes against, and 49 abstentions, the vote is a culmination of an effort that began in April 2021, when the EU Commission first published its proposal for the Act.
Here’s what lies ahead:Continue Reading EU Parliament Adopts AI Act
National Transposition of the EU Representative Actions Directive: What is the Current Status?
The EU Representative Actions Directive (“RAD”) was meant to have been transposed by all EU member states by December 25, 2022. However, the EU Commission announced on January 27, 2023, that only three out of the 27 EU member states have properly transposed the RAD into their national legislation as required, and that it will now start issuing formal notices to the remaining countries to transpose the RAD as soon as possible.
As reported in our previous blog post, the RAD aims to harmonize member state frameworks on collective actions (i.e., whereby multiple claimants may lodge a claim or claims as a group) across the EU. It sets minimum requirements with respect to collective actions on a wide range of topics, including data protection matters (see also our blog post on the implications of RAD for data protection infringements and our separate blog post on the Court of Justice of the EU’s interpretation of Article 80(2) GDPR on data protection-related collective actions). This blogpost provides an overview of the RAD and its implementation status by EU member states.Continue Reading National Transposition of the EU Representative Actions Directive: What is the Current Status?