The European Medicines Agency (EMA) published a detailed revision of their policy on handling competing interests for scientific committee members and experts. This revision is essential, as it ensures that experts involved in the EMA’s activities do not possess conflicts of interest that could undermine their impartiality. By focusing on the handling competing interests, the EMA aims to strengthen its governance and maintain trust in its processes.

Background and Purpose

The EMA is revising its policy on handling competing interests, known as ‘Policy 0044’. This revision aims to ensure that experts involved in the Agency’s activities do not have conflicts of interest.

Public Consultation

The draft revised policy is currently open for public consultation until 10 November 2024. Stakeholders should provide feedback via an online questionnaire. The EMA’s Management Board expects to adopt the finalized version by year-end.

Main Changes Introduced

• Current Interests in Products: Experts with ongoing interests in a product will face restrictions not only concerning that product but also others in the same declared condition. These limitations extend to discussions, encompassing more than just final deliberations and voting.
• Principal Investigators and Investigators: Experts acting as principal investigators will now face the same restrictions as those with direct ties to pharmaceutical companies.
• Past Employment and Roles: A unified three-year cooling-off period will be enforced for experts with past roles in pharmaceutical companies, consultancy positions, or investigator activities. This approach aligns the rules for committee members and ad-hoc experts.

Consistency Across Roles and Groups

The revised policy is designed to ensure consistent handling of competing interests across all EMA activities. This includes interactions between committees, Scientific Advisory Groups (SAG), and Ad-hoc Expert Groups (AHEGs).

Nature and Timeframe of Interests

The updated policy distinguishes between the nature of declared interests, such as direct versus indirect ties, and the timing of those interests, specifying current versus past involvement. Stricter restrictions are applied for members with direct interests strongly linked to pharmaceutical companies.

Previous Policy and Revisions

The original policy was first implemented in 2004 and has been revised several times. Previous updates included limitations on involvement in medicine assessments for those intending to transition into the pharmaceutical industry. It also includes aligning rules for close family members with those for Management Board members.

Stakeholder Input and Transparency

The revised policy considers input from stakeholders, reflecting feedback received during public workshops. The EMA seeks to balance the necessity for expert insights with the need to prevent conflicts of interest, ensuring both transparency and public trust.

Broader Application

The new policy will also be applicable to members of the EMA’s Emergency Task Force (ETF) and other executive steering groups. This change demonstrates EMA’s expanded roles in medical device oversight and crisis preparedness.

Overall, this revision highlights the EMA’s commitment to maintaining the integrity and impartiality of its scientific assessments. It will also ensure access to the best available expertise by effectively addressing the handling of competing interests.