EMA Revises Policy on Conflicts of Interests


Applied Clinical Trials

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 new policy was endorsed by the Management Board in March 2014, and comes into force on January 30, 2015.

The revisions take into account input from stakeholders at the EMA’s September 2013 public workshop “Best expertise versus conflicts of interests: striking the right balance.” Also, they 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 its ability to access the best available expertise, according to EMA.

“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,” said Noel Wathion, EMA’s Chief Policy Adviser. “But over recent years we also have recognized that an overly-rigid approach may 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.”

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 those for the other committee members.

All EMA scientific committee members and experts must submit their updated declarations of interests by the end of January 2015. 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.

The revised policy includes a number of measures that 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. Also, for most declared interests, a three-year cooling-off period is foreseen.

Furthermore, the revisions recognize that 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.

To ensure that this process is transparent, the updated declaration of interest and the assigned interest level of each expert will be published on the EMA website.

Read the full release here.

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