Handling competing interests

The draft revision of EMA's policy on handling competing interests of scientific committee members and experts ('policy 0044') was available for public consultation between 10 October and 10 November 2024. 

EMA is currently reviewing the comments received. 

It will publish them together with the final revised policy after EMA's Management Board adopts this document.

This revision will align with findings of recent court rulings, Court of Justice in Joined Cases C-6/21 and C-16/21 P and Case C-291/22 P.

The main changes include the following:

• Increased and aligned restrictions across roles and groups for experts with a current interest on a product, including exclusion from procedures related to the product concerned and also products in the same declared condition. Experts with an interest as principal investigator and investigator will be subject to the same restrictions. 
• Aligned restrictions across roles and groups, including a unified 3-year cooling-off period for past employment in a pharmaceutical company, consultancy / strategic advisory role, and past activity as (principal) investigator. The same rules will apply to experts involved on an ad-hoc basis that apply to Committee members.
• Strengthened handling of competing interests in the medical device industry
• New rules to handle certain interests in research organisations
• Clarification on the use of expert witnesses for providing specialist advice on specific issues

EMA's Management Board is expected to adopt the final revised policy by the end of 2024.

For more information, see:

• Handling of competing interests: revised rules for committee members and experts (10/10/2024)

Previous revisions

EMA has been requiring experts to declare their interests in the pharmaceutical industry since it started operating in 1995. 

EMA implemented ‘policy 0044’ on the handling of competing interests of scientific committee members and experts in 2004. 

The policy has been revised on a regular basis, demonstrating EMA’s commitment to manage potential conflicts of interest. 

It includes input provided at a public workshop on Best expertise vs conflicts of interests: striking the right balance in September 2013.

Subsequent revisions included: 

• Changes following specific legislative requirements for members and alternates of EMA’s Committee for Advanced Therapies (CAT)
• Restriction in involvement of members and experts planning to take up a job in the pharmaceutical industry
• EMA's new responsibilities in the area of medical devices
• EMA's reinforced role in crisis preparedness

EMA's policy on handling competing interests of scientific committee members and experts allows it to restrict or exclude the potential involvement of an expert in any EMA activity, due to interests in the pharmaceutical industry or in the medical-device industry.

This includes members of EMA's scientific committees, working parties and other bodies.

EMA 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). 

It 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 EMA's work while maintaining its ability to access the best available expertise.

This 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.

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: 

EMA's Management Board endorsed the first version of this procedure in 2012.

EMA updated this procedure in December 2022 to align it with the current revision of its policy on handling competing interests of scientific experts and committee members and to include the other bodies added with this revision.

For related documents, select the expandable panel below (via the arrow symbol):

EMA's policy on handling competing interests for Management Board members and breach-of-trust procedure align with those for scientific committee members and experts.

All Management Board members must submit a DoI every year. These are publicly available under Management Board members.

The applicable revision of the policy on handling competing interests for Management Board members came into effect on 1 January 2023. 

The policy first entered into force in 2006. Since then, EMA has updated the policy to clarify the restrictions and to align the rules and definitions with the policy for scientific committee members and experts.

EMA's code of conduct extends the requirements for impartiality and the submission of annual declaration of interests (DoIs) to all staff members working at the Agency.

New staff must get rid of any interests they have before they can start to work at the Agency.

The rules on how the Agency handles potential competing interests of staff members are similar to the principles for committee members and experts. They explain the allowable and non-allowable interests for staff, and include controls on the appointment of individuals as responsible for managing the evaluation of medicines.

For more information, see Scientifc experts.

The completed DoIs for management staff are available under Who we are. All other staff DoIs are available on request.

For related documents, select the expandable panel below (via the arrow symbol):

All EMA staff members must request permission to engage in an occupational activity within a two-year period of leaving EMA.

This rule is based on Article 16 of the EU Staff Regulations and the European Commission rules on outside activities and assignments and occupational activities after leaving the service, which apply to EMA by analogy:

• Regulation No 31 (EEC), 11 (EAEC), laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Economic Community and the European Atomic Energy Community
• Commission Decision on outside activities and assignments and on occupational activities after leaving the
  Service 

EMA's Executive Director or Management Board issues a decision that may impose restrictions on the staff member's intended occupational activity, to mitigate any potential competing interests in future. 

As of December 2020, EMA's decisions regarding senior staff members leaving EMA are publicly available in the register below for a two-year period following their end of employment at EMA. 

Register of EMA decisions on senior staff members leaving EMA

For the purposes of this register, EMA defines senior staff as staff members who held any of the following positions during their final three years of service:

• Executive Director
• Deputy Executive Director
• Adviser
• Head of Division
• Head of Task Force
• Head of Legal Department

For more information on EMA's organisational structure including its senior staff, see Who we are. 

EMA's annual reports provide a summary on all staff, including senior staff, that were subject to Article 16 restrictions in a given year. This describes the restrictions that apply for each role. To access this information, use the link below:

• Annual reports and work programmes

For related documents, select the expandable panel below (via the arrow symbol):

As of 2015, EMA reviews all of its policies on independence and rules for handling competing interests and their implementation annually, and publishes an annual report.

The reports include results of breach-of-trust procedures, any controls carried out, initiatives planned for the following year and recommendations for improvement.

To find all EMA annual reports on independence, select the expandable panel below (via the arrow symbol):