EMA has published the revised version of its policies on the handling of competing interests of scientific committee members and experts (‘Policy 0044’) and of the EMA Management Board members (‘Policy 0058’). These policies set out the ground rules on which EMA involves them in its work. The revised policies were adopted by the Management Board in December 2024 and will apply as of May 2025.
Policy 0044 was revised to implement recent court judgements, and its draft revised version was open for public consultation from 10 October to 10 November 2024. EMA received 35 comments from a wide range of stakeholders, including academia, research organisations or learned societies, patients’ and healthcare professionals’ organisations, and the pharmaceutical industry.
Respondents recognised the importance of having clear rules to manage competing interests and broadly acknowledged EMA’s efforts to achieve this in a balanced and proportionate way. Following the public consultation, and after considering the comments received, no major changes were made to the policy, but EMA introduced some clarifications.
EMA’s policy on handling competing interests of Management Board members (‘Policy 0058’) has been revised to align, where needed, with the revised Policy 0044.
The comments submitted as part of the public consultation on Policy 0044 and EMA’s response to them are summarised in a high-level overview document which also outlines the general principles guiding the revision of the policy. In addition, individual comments from stakeholders are also published, and EMA will supplement the document in the coming weeks to add explanations on how each individual comment was considered.
Policy 0044 has provided a robust framework for managing competing interests over many years, by applying restrictions to scientific committees’ members’ and experts’ involvement in a proportionate manner, considering in particular the nature of the declared interest and the type of activity where the expert was involved (e.g. decision-making committees vs advisory bodies).
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) have required the Agency to adjust certain aspects of its approach. The revisions to the policy ensure alignment with the Court’s findings and aim to rule out any possible doubts as to the objective impartiality of EMA’s assessments.