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.

Scientific committee members and experts

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.

Policy 44: European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts

AdoptedLegal effective date: 01/01/2023Reference Number: EMA/136875/2022

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 orincomplete DoIs by scientific experts and committee members: 

European Medicines Agency breach of trust procedure for competing interests of and disclosure of confidential information by scientific committees’ members and experts

AdoptedReference Number: EMA/154320/2012 Rev.3

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

Standard operating procedure for arrangements for handling of conflicts of interests for European Medicines Agency scientific meetings

AdoptedLegal effective date: 08/10/2012Reference Number: SOP/EMA/0126Summary:

To describe the procedure for handling of conflicts of interests at the level of the European Medicines Agency’s scientific meetings, i.e. the risk minimisation measures and documented evidence in relation to conflicts of interests for meeting participants (members, alternates and other experts) before, during and after the meeting.

Guidance on handling scientific committee/other (scientific) expert group member’s declared intention to become an employee in a pharmaceutical company, a medical device company or in the biotechnology sector

AdoptedReference Number: EMA/267183/2015Summary:

In order to ensure a consistent approach to the handling of such situations, the need for further guidance in this field has been identified.

Procedural guidance on inclusion of declared interests in the European Medicines Agency’s electronic declaration of interests form (for scientific committees’ members and experts)

Legal effective date: 30/01/2015Reference Number: EMA/627294/2014 Rev.1Summary:

This guidance aims at helping scientific committees’ members and experts to complete the European Medicines Agency’s (EMA) electronic declaration of interests form (e-DoI) and EMA staff to guide experts in completing the form correctly. It highlights key aspects of declaring interests and clarifies what information should be mentioned in which section of the e-DoI. A correctly completed form will speed up the EMA evaluation process of declarations of interests.

Rules of engagement for patients’ organisations and their representatives in repurposing activities and impact on involvement in EMA activities

Confidentiality undertaking for observers

Management Board members

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.

Policy 58: European Medicines Agency policy on the handling of competing interests of Management Board members

AdoptedLegal effective date: 01/01/2023Reference Number: EMA/MB/89374/2020 Rev.1

European Medicines Agency breach of trust procedure on declarations of competing interests for Management Board members

AdoptedReference Number: EMA/MB/309079/2012 Rev.3

All Management Board members must submit a DoIevery 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.

Staff members

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:

The European Medicines Agency code of conduct

AdoptedReference Number: EMA/385894/2012 rev.1

Appendix to the European Medicines Agency code of conduct

Decision of the European Medicines Agency on rules relating to Articles 11, 11a and 13 of the Staff Regulations concerning the handling of declared interests of staff members of the European Medicines Agency and candidates before recruitment

Reference Number: EMA/259494/2016, Rev.5

Decision on rules concerning the handling of declared interests of national experts on secondment, trainees, interims and visiting experts of the European Medicines Agency

Reference Number: EMA/831515/2022

Standard operating procedure for conducting checks for conflicts of interest of the European Medicines Agency employees assigned duties relating to medicinal products for human or veterinary use

AdoptedLegal effective date: 01/06/2023Reference Number: SOP/EMEA/0101

Decision of the European Agency for the Evaluation of Medicinal Products of 1 June 1999 concerning the terms and conditions for internal investigations into the prevention of fraud, corruption and any illegal activity de...

AdoptedReference Number: EMEA/1500/99/EN

Staff members leaving EMA

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
Sweeney, Fergus	Head of Task Force	31/05/2022	Cancer Drug Development Forum (CDDF)	19/10/2023
Sweeney, Fergus	Head of Task Force	31/05/2022	World Health Organisation, Department of Research for Health	15/03/2023	Fergus Sweeney - Assessment outcome of occupational activities after leaving the service (March 2023)
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	Fergus Sweeney - Assessment outcome of occupational activities after leaving the service (Jan 2023)

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:

Guidance for usage of application form related to Article 16 of the Staff Regulations

European Medicines Agency privacy statement for the publication of post-employment decisions regarding senior staff (Article 16 of Staff Regulations)

Reference Number: EMA/641439/2020

Declaration of intention to engage in an occupational activity after leaving the European Medicines Agency

Best practice guide for staff leaving the European Medicines Agency

Reference Number: EMA/70197/2013 Rev. 1

Annual reports on independence

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:

2023 European Medicines Agency annual report on independence

AdoptedReference Number: EMA/114673/2023

2022 European Medicines Agency annual report on independence

AdoptedReference Number: EMA/2588/2023

2021 European Medicines Agency annual report on independence

AdoptedReference Number: EMA/759921/2021

2020 European Medicines Agency Annual Report on Independence

Reference Number: EMA/34780/2021

2018-2019 European Medicines Agency annual reports on independence

Reference Number: EMA/425399/2019

2016 and 2017 annual report on independence

AdoptedReference Number: EMA/463632/2017

2015 annual report on independence

AdoptedReference Number: EMA/175527/2016