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

The Agency's PDF iconpolicy on the handling of competing interests of scientific committee members and experts allows the Agency to identify cases where the potential involvement of an expert as a member of a committee, working party, other group or in any other Agency activity needs to be restricted or excluded due to interests in the pharmaceutical industry.

The Agency screens each expert's declaration of interests (DoI) and assigns each DoI an interest level based on whether the expert has any interests, and whether these are direct or indirect. For more information and experts' DoIs, see European experts.

After assigning an interest level, the Agency uses the information provided to determine if an expert's involvement should be restricted or excluded in specific activities of the Agency, 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 current revised policy reflects a balanced approach to handling competing interests that aims to effectively restrict the 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 a number of measures which take into account the nature of the declared interest before determining the length of time any restrictions may apply:

  • an executive role, or a lead role in the development of a medicine during previous employment with a pharmaceutical company will result in non-involvement with the concerned company or product during the term of the mandate;
  • for the majority of declared interests a three-year cooling-off period is foreseen. Restrictions to involvement decrease over time and make a distinction between current interests and interests within the last three years;
  • for some interests, such as financial interests, there continues to be no cooling-off period required when the interest is no longer present.

Requirements for experts who are members of scientific committees are stricter than for those participating in advisory bodies and ad-hoc expert groups. Similarly, requirements for chairs and members in a lead role, e.g. rapporteurs, are stricter than requirements for the other committee members.

The revised policy entered into force on 30 January 2015. EMA subsequently 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 in May 2015. This restriction is reflected in the PDF iconguidance document .
  • to 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.

The revised policy takes into account input from stakeholders at the Agency's September 2013 public workshop Best expertise vs conflicts of interests: striking the right balance.

Breach-of-trust procedure

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

The Agency updated the procedure in April 2015 to align it with the current version of the policy on handling competing interests and to take into account experience gained since it was first endorsed by EMA's Management Board in 2012.

Staff members

The Agency'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 completed DoIs for management staff are available under Agency structure. All other DoIs are available on request.

Tthe Management Board revised its rules on how the Agency handles potential competing interests of staff members in October 2016. The revised rules are similar to the principles adopted 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.

Management Board members

The PDF iconpolicy on handling competing interests for Management Board members and PDF iconbreach-of-trust procedure aligns with the policy on handling competing interests and breach-of-trust procedure for scientific committee members and experts.

EMA's Management Board adopted the current version of the policy and trust of-breach procedure in December 2015. This policy entered into force on 1 May 2016 and was subsequently updated in October 2016 to clarify restrictions for positions in a governing body of a professional organisation and to align the rules on grants or other funding with those for committee members and experts.

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

Annual review of policies on independence

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

For more information, see Code of conduct and reports.

Policy for scientific experts

Rules for Agency staff

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