The Agency requires each expert to provide information on their interests in the pharmaceutical industry and in the medical-device industry in a declaration of interests (DoI). 

EMA screens each DoI and assigns it an interest level, based on whether the expert has any interests, and whether these are direct or indirect.

For more information and to view the DoIs of individual experts, see European experts.

EMA uses the information provided to determine if an expert's involvement should be restricted or excluded in specific EMA activities, such as the evaluation of a particular medicine. It bases these decisions on:

• the nature of the interests declared;
• the time since the interest occurred;
• the type of activity that the expert will be undertaking.

The policy reflects a balanced approach and aims to effectively restrict involvement of experts with possible competing interests in the Agency's work while maintaining EMA's ability to access the best available expertise.

It includes measures to take into account the nature of a declared interest before determining the length of time any restrictions may apply:

• non-involvement with a company or product throughout an expert's mandate will result from them having held an executive or lead role in the development of a medicine during previous employment with a pharmaceutical company;
• for the majority of declared interests, a three-year cooling-off period is foreseen, whereby restrictions decrease over time and distinguish between interests that remain current and those within the previous three years;
• there is no cooling-off period if certain types of interest are no longer present, such as financial interests. 

Requirements for members of scientific committees are stricter than for experts participating in advisory bodies and ad-hoc expert groups. Requirements for committee chairs and members in a lead role such as rapporteurs are stricter than for other committee members.

Current revision of this policy

The current revision of the policy on handling competing interests of scientific experts and committee members brought it in line with:

Accordingly, this policy now applies to members of EMA's Emergency Task Force (ETF) and Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), as well as to the Executive Steering Group on Shortages of Medical devices (MDSSG).

The revised policy came into effect on 1 January 2023, following adoption by EMA’s Management Board in December 2022.

Previous revisions to the policy have included the following:

• Restricting involvement in the assessment of medicines by those planning to take up a job in the pharmaceutical industry
• Alignment of the rules on close family members with those for Management Board members
• Requirement for members and alternates of EMA’s Committee for Advanced Therapies (CAT) to declare interests in the biotechnology and medical-device sectors
• Requirement to declare interests in relation to personal or organisational involvement in the re-purposing of a medicine.

The policy takes input from stakeholders into account, including input provided at a public workshop on Best expertise vs conflicts of interests: striking the right balance in September 2013.

Breach-of-trust procedure

EMA has a breach-of-trust procedure in place, which sets out how it deals with incorrect orincomplete DoIs by scientific experts and committee members: