Handling of competing interests: revised rules for committee members and experts

10 October 2024

Public consultation on updated policy to run until 10 November 2024

EMA is revising its policy on handling of competing interests of scientific committee members and experts (‘Policy 0044’). Stakeholders are invited to comment on the draft revised policy until 10 November 2024 using an online questionnaire. The adoption of the final version by EMA’s Management Board is expected by the end of the year.

EMA’s handling of competing interests reflects the balance the Agency has to strike to fulfil its legal obligations: ensuring that committee members and experts involved in the Agency’s activities have no conflicts of interest with pharmaceutical companies that could compromise their impartiality, while also securing access to the best scientific expertise.

The policy sets out the ground rules on which EMA involves experts in its work. It has provided a robust framework for managing possible competing interests over many years, by applying restrictions to 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 proposed 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.

The scope of the policy relates to the handling of competing interests of members, alternates and experts involved in the activities of the Agency’s scientific committees, working parties and other groups (e.g. scientific advisory groups (SAGs), ad hoc expert groups (AHEGs)) as well as other bodies (i.e. Emergency Task Force (ETF), Medicines Shortages Steering Group (MSSG), Medical Devices Shortages Steering Group (MDSSG)).

Main changes introduced in the revised policy

As a general rule, EMA’s policy has always prohibited individuals currently employed by or holding financial interests in a pharmaceutical company from participating in the Agency’s activities, and this will remain unchanged. However, in case of other interests (e.g. role as investigator or close family member’s interests), an individual’s participation in certain activities may be possible, but subject to pre-defined restrictions. The revision of the policy, in line with the findings of the recent court rulings, is driven by the following elements:

• Any current interest in a product should lead to restrictions not only on the product concerned but also on products in the same declared condition;
• Restrictions of an individual’s participation should apply not only to final deliberation and voting but also to discussions;
• The handling of competing interests needs to be consistent across EMA activities (i.e. between committees and SAG / AHEGs) and across roles.

As a consequence, the main changes proposed to the policy include:

• Increased and aligned restrictions across roles and groups for experts with a current interest in a product: in such cases, experts will continue to be excluded from procedures related to the product concerned but now also for products in the same declared condition. Experts with an interest as principal investigator and investigator will now be subject to the same restrictions.
• Aligned restrictions across roles and groups, in case of past employment in a pharmaceutical company, of a past consultancy or strategic advisory role and of past activity as (principal) investigator, with a unified three-year cooling-off period. Consequently, the same rules that already applied to committee members 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.
• Strengthened handling of competing interests in the medical device industry, in light of EMA’s extended mandate in this area. Similarly to the existing provisions for the pharmaceutical industry, it is proposed that current employment, consultancy or strategic role on general matters and financial interests in the medical device industry will not be compatible with any involvement in EMA’s activities.
• Introduction of new rules to handle certain interests in research organisations, for example in case of involvement in a unit that develops or manufactures medicinal products or medical devices or acts as a marketing authorisation applicant or holder for a medicinal product. In such cases, proportionate mitigation measures are proposed by analogy to what applies to the pharmaceutical industry.
• The revised policy continues to allow and further clarifies the use of the ‘expert witnesses’: such experts can be called upon by EMA, in situations where specific expertise is required that can only be provided by a few individuals, e.g. in niche areas, but who have certain competing interests. In such cases it might be in the interest of public health to invite these individuals to testify and give specialist advice on specific issues, yet without allowing them to take part in the deliberations of the relevant body.

About EMA’s approach to handling competing interests

The requirement for experts to declare their interests in the pharmaceutical industry has been rooted in EMA’s practice since the Agency started operating in 1995. ‘Policy 0044’ on the handling of competing interests of scientific committees’ members and experts was implemented in 2004 and has been revised on a regular basis since then, demonstrating EMA’s commitment to its obligation to manage potential conflicts of interest.

The management of competing interests takes into account:

• the nature of the declared interest: e.g. more stringent restrictions are imposed on direct interests with closer link to a pharmaceutical company (e.g. consultancy) as opposed to indirect interest (e.g. close family members’ interest);
• the timeframe during which such interest occurred (current vs past interests);
• the type of activity in which the individual participates (e.g. advisory vs decision-making, roles of (vice) chairpersons or rapporteur).

Based on these principles, the policy defines interests that are incompatible with participation in any of the Agency’s activities and interests where involvement is possible but subject to certain restrictions.

Policy 0058 on the handling of competing interests of Management Board members, and EMA’s staff rules, will also be revised in line with the changes that will be introduced to Policy 0044 following the public consultation, as relevant.