EMA Tightens Rules for Committee Members and Experts

May 6, 2015
Philip Ward

Philip Ward is ACT's European editor, phone +44 1244 538583, philipward1@btconnect.com

Applied Clinical Trials

The European Medicines Agency (EMA) has updated its rules on declarations of interests for scientific committee members and experts.

The European Medicines Agency (EMA) has updated its rules on declarations of interests for scientific committee members and experts. The changes are designed to strengthen the agency’s policy by restricting involvement of experts in the scientific assessment of medicines if they plan to take up a job in the pharmaceutical industry.

“The effective management of conflicts of interests is key to ensuring the independence and integrity of the Agency’s scientific recommendations,” says Noël Wathion, EMA’s Chief Policy Adviser. “EMA continually reviews its policy to ensure that the rules are fit for purpose.”

EMA considers that employment in a pharmaceutical company is incompatible with an involvement in the agency’s activities. When a member of a scientific committee or working party informs EMA that he/she intends to work for a pharmaceutical company, the agency will immediately restrict the member from any participation in the evaluation of medicines. If necessary, the Agency will also verify whether the integrity of any ongoing or past scientific reviews in which that person was involved could have been compromised.

EMA’s declaration of interest policy aims for a balanced approach by restricting the involvement of experts with possible conflicts of interests, while maintaining EMA’s ability to access the best available expertise. The updates also include a revised guide on how to complete the Agency’s declaration of interest form.

In March 2014, the EMA management board endorsed a major revision of EMA’s policy on handling declarations of interest for scientific committee members and experts. The revision took into account input from stakeholders at the Agency’s September 2013 public workshop 'Best expertise vs conflicts of interests: striking the right balance'. It entered into force on January 30th.

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