The European Medicines Agency 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.
The Agency has a policy on handling of conflicts of interests for its scientific experts, including committee members. The current policy was endorsed by the Agency's Management Board in March 2014 and entered into force on 30 January 2015.
The Agency takes a proactive approach to identifying cases where the potential involvement of an expert in Agency activities needs to be restricted or excluded due to interests in the pharmaceutical industry, and to searching for alternative experts where necessary.
The Agency screens each expert's declaration of interests to decide whether or not to include him or her as a member of a committee, working party or other group. It assigns each declaration of interest an interest level based on whether the expert has any interests, and whether these are direct or indirect.
After assigning an intrerest level, the Agency uses the information provided to determine if an expert's involvement should be restricted or excluded in the Agency's specific 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 Agency updated its policy in May 2015 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 a new guidance document.
Revised policy on handling declarations of interests
The European Medicines Agency published its revised policy for scientific committee members and experts in November 2014.
The revisions reflect a more balanced approach to handling conflicts of interests that aims to effectively restrict the involvement of experts with possible conflicts of interests in the Agency’s work while maintaining EMA’s ability to access the best available expertise.
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.
The revised policy includes a number of measures which better 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 a lifetime non-involvement with the concerned company or product;
- 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.
Overall, requirements for experts who are members of scientific committees remain 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.
European expert list
Experts can only be involved in the Agency's activities if they have signed a declaration of interests form and the Agency has assessed his or her interests. All proposed members for its scientific committees have their declarations of interests screened before their formal nomination. Completed declarations of interests and intrest levels for all experts are available in the European expert list.
In March 2012, the Agency's Management Board endorsed a breach-of-trust procedure. This sets out how the Agency deals with incorrect or incomplete declarations of interests by experts and committee members.
The Agency's code of conduct extends the requirements for impartiality and the submission of annual declarations of interests to all staff members working at the Agency.
In February 2012, the Management Board introduced updated rules on how the Agency handles potential conflicts of interests of staff members. These are similar to the principles adopted for committee members and experts. The rules explain the allowable and non-allowable interests for staff, and include strengthened controls on the appointment of individuals as responsible for managing the evaluation of medicines.
New staff must get rid of any interests they have before they can start to work at the Agency.
The completed declaration of interests for management staff are available under Agency structure. All other declarations of interests are publicly available for consultation in person at the Agency.
Management Board members
In December 2015, the Management Board adopted a revised policy on handling competing interests for its members, which will enter into force on 1 May 2016. The revision aligns EMA’s Management Board policy with the Agency’s recently revised policy on handling declarations of interests for scientific committee members and experts.
Also in December 2015, the Management Board endorsed a revised breach-of-trust procedure for Management Board members. This sets out how the Agency deals with incorrect or incomplete declarations of interests by Management Board members and it has been aligned with the procedure for scientific committee members and experts.
All Management Board members must submit a declaration of interests every year. These are available under Management Board members.
Table of contents
- Policies for scientific experts
- Rules for Agency staff
- Policy for Management Board members
- Code of conduct, guidance and forms
Policies for scientific experts
Rules for Agency staff
Policy for Management Board members
|Document(s)||Language||Status||First published||Last updated||Effective Date|
|European Medicines Agency breach of trust procedure on declarations of competing interests for Management Board members||(English only)||adopted||21/06/2012||14/01/2016|
|European Medicines Agency policy on the handling of competing interests of Management Board members||(English only)||adopted||03/04/2012||14/01/2016||01/05/2016|