European regulators are expected to align their processes and guidance to accommodate the EDPB’s recommended approach to processing special categories of personal data.

In January, the European Data Protection Board (EDPB) issued an opinion (Opinion) on the interplay between the General Data Protection Regulation (GDPR) and the Clinical Trials Regulation (CTR), which: (1) confirms that consent under the GDPR and CTR are different concepts; and (2) sets out the EDPB’s recommendations on the appropriate legal basis required for processing personal data in connection with clinical trials conducted in the EEA (which is unlikely to be consent). This Client Alert outlines the background to the Opinion, before delving into the most important guidance and takeaways.