Handling competing interests

The European Medicines Agency (EMA) takes care to ensure that its scientific experts, staff 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 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, including as a member of a scientific committee, working party or other group, due to interests in the pharmaceutical industry. 

The current version of the policy entered into force on 1 January 2021:

The Agency requires each expert to provide 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 then 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.

Since 2015, EMA has updated the policy to:

  • restrict involvement of experts in the assessment of medicines if they plan to take up a job in the pharmaceutical industry. This restriction is reflected in the PDF icon guidance document
  • clarify the restrictions if an expert takes up a job in industry and to align the rules on close family members for committee and working party members interests with those for Management Board members in October 2016;
  • require members and alternates of EMA’s Committee for Advanced Therapies (CAT) to declare interests in the biotechnology and medical device sectors which could affect their impartiality;
  • require experts to declare interests in relation to their personal or organisation’s involvement in the re-purposing of a medicine.

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

Breach-of-trust procedure

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

EMA updated the procedure in 2015 to align it with the policy on handling competing interests and to take into account experience since its first endorsement by EMA's Management Board in 2012.

More information is available in the documents below: 

Staff members

EMA's code of conduct extends the requirements for impartiality and the submission of annual 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.

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:

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

Eicher, 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

PDF icon Assessment outcome

Alteri, Enrica

Head  of Human Medicines Research & Development Support Division

30/06/2020

Giving several lectures on the EU regulatory system as temporary lecturer at Geneva University

19/02/2021

PDF icon Assessment outcome

Rasi, Guido

Executive Director

15/11/2020

Scientific Director of Sanita Informazione – Consulcesi

Chairman of the Clinical Trials Centre at the A.Gemelli polyclinic of Sacro Cuore University

23/04/2021

PDF icon Assessment outcome

Rasi, Guido Executive Director 15/11/2020

Professor of microbiology at Tor Vergata University

Member of CoRE Advisory Committee

Member of MRCT Advisory Committee

Member of Royal College of Physicians

07/12/2020 PDF icon 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

More information is available in the documents below:

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.

The policy first entered into force in 2016 and EMA updated it to clarify certain restrictions and align certain rules and definitions with the policy for scientific experts. The latest version took effect on 1 July 2020. 

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

More information is available in the documents below:

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:

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