The European Medicines Agency has unveiled plans for updating its policy on potential conflicts of interest for scientific-committee members and experts, aiming for a more balanced, tailored and transparent approach from when it goes live in January next year.
While the priority has always been to ensure the integrity of scientific assessments of medicines is not compromised by private interests in pharma, it was also recognised that “an overly-rigid approach may limit the availability of expertise”, said Noel Wathion, the EMA’s Chief Policy Adviser, explaining the rationale behind the move. “The updated policy should now allow a level of involvement better tailored to the interest profile of each expert”.
As such, the revised policy includes a number of measures which, the regulator says, better take into account the nature of the declared interest before determining the restrictions that might apply. For example, an executive or a lead role in medicine development during prior employment with a pharma company now results in a lifetime non-involvement with the concerned company or product.
Also, for the majority of declared interests a three-year cooling-off period is foreseen, and restrictions to involvement fade over time. However, for some interests, such as financial ones, 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, while those for chairs and members in a lead role are stricter than than those for other committee members.
To ensure transparency, updated declarations of interest will now be published on the EMA’s website, it said.
