EMA Revises Policy on Conflict of Interests

November 20, 2014
Pharmaceutical Technology Editors

Revised EMA policy reflects more balanced approach and experts are to submit updated declarations of interests by end of January 2015.

The European Medicines Agency (EMA) announced that its revised policy relating to conflict of interests for scientific committee members and experts has been published. According to EMA, the revision reflects a more balanced approach that aims to effectively restrict the involvement of experts with possible conflicts of interests in EMA’s work while maintaining the agency’s ability to access the best available expertise.

Noel Wathion, EMA’s chief policy adviser, noted in a press statement that an overly rigid approach could limit the availability of expertise needed to ensure the robust scientific assessment of medicines. “The updated policy should now allow a level of involvement better tailored to the interest profile of each expert,” said Wathion.

The revised policy has been endorsed by the Management Board in March 2014. It takes into account input from stakeholders at EMA’s September 2013 public workshop “Best expertise vs conflicts of interests: striking the right balance.”

“The priority of EMA is to ensure that the integrity of our scientific assessments of medicines is not compromised by private interests in the pharmaceutical industry,” explained Wathion. Measures in the revised policy will 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 now results 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 EMA advisory bodies and ad-hoc expert groups. Similarly, requirements for chairs and members in a lead role, such as rapporteurs, are stricter than requirements for the other committee members.

EMA scientific committee members and experts must submit their updated declarations of interests by the end of January 2015. The agency will then screen each expert’s declaration and assign an ‘interest level,’ which determines the restrictions applied on the individual.

EMA will publish the assigned interest level of each expert in an updated declaration of interest to ensure a transparent process. The new policy will come into force on 30 January 2015.

Source: EMA