The consultation on EMA’s draft revised ‘Policy 0044’ on handling of competing interests of scientific committee members and experts closed on 10 November 2024; its final version is expected by the end of 2024. The revision followed recent court rulings (i.e. the appellate judgements of the Court of Justice in Joined Cases C-6/21 and C-16/21 P and Case C-291/22 P) and aims to ensure alignment with the Court’s findings. The policy refers to the competing interests of members, alternates and experts involved in several EMA’s scientific committees, working parties and other groups (e.g. SAGs, AHEGs, ETF, MSSG, MDSSG).

The revised policy confirms the prohibition for individuals currently employed by or holding financial interests in a pharmaceutical company from participating in the Agency’s activities. In case of other interests (e.g. role of investigator or close family member’s interests), pre-defined restrictions can be applied, for example in case of any current interest in a product or products in the same declared condition. In such instances, experts will be excluded not only from final deliberation and voting but also from discussions, in a consistent manner across all EMA activities and roles.

In case of past employment in a pharmaceutical company, past consultancy or strategic advisory role and past activity as (principal) investigator, a unified three-year cooling-off period will be applied. EMA also proposed to similarly extend these provisions to experts from the medical device industry involved in EMA’s activities.