EU drug watchdog rewrites conflict of interest rules

The European Medicines Agency (EMA) is revising its ‘competing interests’ policy for experts and members of scientific committees. The new rules are expected to be adopted by the end of the year, following a public consultation.

The Agency said the changes will reset the balance that it must strike between securing the best scientific advice and ensuring that experts do not have commercial interest that could compromise their impartiality.

Ground rules for EMA advisors restrict scientific experts in a ‘proportionate manner’, the Agency said, depending on the specific nature of their declared interest and the advice they provide.

A series of recent court rulings have prompted the Agency to reassess its policy to rule out any possible doubts as to the impartiality of EMA’s assessments. The scope of the policy relates to the handling of competing interests of members, alternates and experts involved in the activities of scientific committees, working parties and other groups.

The EMA has always prohibited individuals currently employed by or holding financial interests in a pharmaceutical company from participating in the Agency’s activities, and this will remain unchanged. However, in case of other interests (e.g. role as investigator or close family member’s interests), an individual’s participation in certain activities may be possible, but subject to pre-defined restrictions.

The revision of the policy means that any current interest in a product will lead to restrictions not only on the product concerned but also on products in the same declared condition. Restrictions of an individual’s participation will apply not only to final deliberation and voting but also to discussions.

Full details of the revision are available from the EMA.