Handling competing interests

The European Medicines Agency (EMA) takes care to ensure that its staff, scientific experts and Management Board do not have any financial or other interests that could affect their impartiality. The Agency has separate policies in place for these groups.

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 Agency 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.

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:

• EMA’s new responsibilities in the area of medical devices; 
• EMA's reinforced role in crisis preparedness.

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 or incomplete 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.

More information

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 current 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.

More information is available in the documents below:

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 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. 

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

Name	Most senior position in final three years of service	End of EMA employment	Intended occupational activity after EMA	Date of EMA decision	Further information
Saint-Raymond, Agnes	Head of International Affairs	30/09/2021	The European & Developing Countries Clinical Trials Partnership (EDCTP)	17/03/2023	Assessment outcome
Sweeney, Fergus	Head of Task Force	31/05/2022	World Health Organisation, Department of Research for Health	15/03/2023	Assessment outcome
Sweeney, Fergus	Head of Task Force	31/05/2022	Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard	18/01/2023	Assessment outcome
Saint-Raymond, Agnes	Head of International Affairs	30/09/2021	Board member (3 years) of the Concept Foundation	17/02/2022	Assessment outcome
Saint-Raymond, Agnes	Head of International Affairs	30/09/2021	World Health Organization Academy	30/06/2022	Assessment outcome
Saint-Raymond, Agnes	Head of International Affairs	30/09/2021	The European & Developing Countries Clinical Trials Partnership (EDCTP)	21/07/2022	Assessment outcome
Wathion, Noel	Deputy Executive Director	30/06/2021	Guest lecturer at Hasselt University	17/08/2021	Assessment outcome
Wathion, Noel	Deputy Executive Director	30/06/2021	Non-remunerated volunteer at Rare Disease Europe (EURORDIS)	26/10/2021	Assessment outcome
Eichler, Hans-Georg	Senior Medical Officer	30/04/2021	Consultant at Dachverband der Sozialversicherungsträger, an Austrian public health and social insurance organisation	23/09/2021	Assessment outcome
Eichler, Hans-Georg	Senior Medical Officer	30/04/2021	Non-remunerated work as volunteer at Rare Diseases Europe (EURORDIS)	29/04/2021	Assessment outcome
Eichler, Hans-Georg	Senior Medical Officer	30/04/2021	Professor of Clinical Pharmacology at the Medical University of Vienna Continue non-remunerated role as vice-chair of the Scientific Advisory Council at the Centre for Innovation in Regulatory Science Continue non-remunerated role as advisor at the Massachussetts Institute of Technology	15/03/2021	Assessment outcome
Saint-Raymond, Agnes	Head of International Affairs	30/09/2021	Continue non-remunerated role as Scientific Advisor for GAP-f at the World Health Organisation, in which they advise on paediatric formulations for essential medicines. Panellist in a session at workshop organised by Nile consulting on 20 October 2021.	23/09/2021	Assessment outcome

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. 

The Agency'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

Information for staff leaving EMA is available below:

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.

More information is available in the documents below: