EMA Revises Conflict-of-Interest Policy

November 19, 2014
The Pharm Exec staff

Pharmaceutical Executive

The European Medicines Agency (EMA) has published its revised policy on handling declarations of interests for scientific-committee members and experts.

The European Medicines Agency (EMA) has published its revised policy on handling declarations of interests for scientific-committee members and experts.

The revisions strive for a more balanced approach in restricting the involvement of experts with possible conflicts of interests in the Agency’s work, while maintaining access to expertise.

The new measures include the following:

  • 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, e.g. rapporteurs, are stricter than requirements for the other committee members.

All EMA scientific committee members and experts are required to submit their updated declarations of interests by the end of January 2015, when the new policy enters into force. The Agency will screen each expert’s declaration and assign an ‘interest level’. The interest level assigned and the nature of his or her involvement in EMA activities will determine the restrictions applied.