EMA's policy on handling competing interests of scientific committee members and experts ('Policy 0044') 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.
It 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.
The policy applies to members and experts of EMA's scientific committees, working parties, and other bodies, such as the Emergency Task Force (ETF), the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), and the Executive Steering Group on Shortages of Medical Devices (MDSSG).
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) and the Coordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv) also apply this policy.
For more information, see:
The latest revised version of the policy is available below. This version came into effect on 1 May 2025.
EMA's Management Board adopted it in December 2024.
This revision aims to align with the findings in the rulings of the Court of Justice in Joined Cases C-6/21 and C-16/21 P and Case C-291/22 P.
The main changes included in the latest revision of the policy are the following:
For more information, see:
A draft version of the revised policy was open for public consultation from 10 October to 10 November 2024. For more information on the revision and public consultation, including an overview of the comments received from stakeholders, see the documents below.
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:
EMA requires each expert participating in EMA's scientific committees, working parties and other bodies 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:
Procedural guidance is available below to help experts to complete their DoI in the Experts Management Tool.
The guidance highlights key aspects of declaring interests and clarifies what information should be mentioned in which section of the DoI:
EMA has a breach-of-trust procedure in place for scientific committee members and experts, which sets out how it deals with incorrect or incomplete declaration of interests (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 declaration of interests (DoI) every year. These are publicly available under Management Board members.
The latest revision of the policy on handling competing interests for Management Board members came into effect on 1 May 2025. The policy has been revised to align with the revised 'Policy 0044'.
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 Scientific experts.
The completed DoIs for management staff are available under Who we are. All other staff DoIs are available on request.
For related documents, including the application of the rules by analogy to other categories of staff, 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:
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.
| 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 |
|---|---|---|---|---|---|
| Marino, Stefano | Head of Legal Department | 30/04/2024 | Senior Consultant at DLA Piper UK LLP | 09/01/2024 | Stefano Marino – Outcome of assessment of declared occupational activities after leaving the service (January 2024) |
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:
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:
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):