EMA Updates and Strengthens Policy on Conflicts of Interest

The European Medicines Agency (EMA) has recently published an update to the Agency’s Policy on conflicts of interests of members of scientific committees and experts. The updated policy, which will apply from May 2025, is a result of a recent decision of the Court of Justice in Joined Cases C‑6/21 P and C‑16/21 P and Case C-291/22 P which required the EMA to adjust certain aspects of its approach. The updated Policy means that, where experts have a current interest in a product, they will be excluded from procedures related not only to the product concerned but also for products in the same declared condition. Experts who play the role of principal investigator and investigator will be subject to the same restrictions. Rules requiring a three year cooling off period related to past employment in a pharmaceutical company that already apply to members of Committees will now also apply to experts who may be brought into the assessment process on an ad-hoc, consultative basis to provide their input on specific points. Reflecting the EMA’s increasing role in the medical device industry, individuals involved in EMA activities cannot be current employed by, nor may they provide consultancy or strategic advice on general matters and financial interests to the medical device industry.