As of 1 May 2025, new rules at the European Medicines Agency (EMA) are into force and refine how patients and representatives can participate as experts in medicine regulation. These rules are integrated into a revised policy on handling “competing interests” (known as EMA Policy 004) and introduce stricter conditions on who can join EMA scientific committees and expert groups.
This is important because patients and patient representatives are few in number but bring essential real-life insights to the table. They risk being excluded from key discussions simply because they have also advised pharmaceutical or medical device companies on how to better address unmet needs and patient priorities in product development.
The need to avoid assess conflict of interest
The policy was revised to implement recent EU court judgements (Court of Justice in Joined Cases C-6/21 and C-16/21 P and Case C-291/22 P). The court found gaps in the EMA’s previous rules for managing potential conflicts of interest. These gaps particularly affected healthcare professionals and researchers who, while contributing their scientific expertise to private innovative companies, might also be invited to evaluate competing products due to their recognised knowledge. To address these risks, the EMA updated its Policy 0044 in December 2024. It also revised its Management Board members’ Policy 0058 to ensure consistent criteria for involving external experts.
EFA position on the new policy
In November 2024, EFA responded to the European Medicine Agency’s (EMA) public consultation on the update of the draft Policy 0044. In total, 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.
In our response to the consultation, EFA called for better understanding of what patient collaboration with industry actually involves. We stressed that patients are not companies but those who may join research projects or advisory boards to improve care and outcomes, not for profit. EFA also asked EMA to recognise the time, effort and expertise that patients invest when contributing to their regulatory activities.
How is patient involvement affected with the new EMA Policy 0044?
Five main changes in the revised policy will affect patient involvement:
- Expanded restrictions for current links with single companies: EMA has introduced increased and aligned restrictions across roles and groups for experts with a current interest on a product. For example, if a medical or patient expert has a connection to a company related to a product under review, they may now be fully excluded from any discussion in EMA committees and working groups.
- Unified and stricter cooling-off period: Aligned restrictions across roles and groups, now revise the involvement of an expert during the past 3 years, including employment in a pharmaceutical company, consultancy / strategic advisory role, and past activity as (principal) investigator.
- Enhanced medical device industry oversight: a novelty in the policy are the stricter rules for experts with current financial interests in the medical device industry, aligning them with the existing provisions for the pharmaceutical industry.
- New rules for research organisations: experts involved in research organisations that develop or manufacture medicinal products or medical devices (e.g. university hospitals or innovation networks), or act as marketing authorization applicants or holders, will face similar restrictions as those in the pharmaceutical industry.
- Introduction of expert witnesses: people with specific expertise can be invited to provide specialist advice without participating in deliberations, ensuring public health interests are served while managing potential conflicts. This creates a more limited way for patients to contribute their lived experience.
The new rules enhance transparency and impartiality in EMA’s scientific assessments. But they also risk making it difficult for patients to be heard in the process. Patient perspectives bring depth to scientific discussions, helping ensure that medicines are not only safe and effective, but also meet real-life needs.
EFA calls for more understanding of existing patient collaboration with the pharmaceutical industry, so patients may continue with their involvement in EMA processes.
The policy applies as of 1 May 2025 and is due to be revised by 30 April 2028.
For more information on patient experts involvement in EU regulatory processes, you can read EFA’s recent submission to the European Commission consultation on the conflict of interest of experts involved in EU Health Technology Assessment procedures.