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EMA Constricts Revolving Door Policy for Expert Advisors

May 12, 2015

The European Medicines Agency is tightening its rules around conflicts of interest, barring individuals who take jobs in industry from serving on any of its advisory committees.

Last fall, the EMA attempted to strike a balance between preventing potential conflicts and retaining access to specialists by requiring independent consultants to recuse themselves from committees during the time a potential conflict exists.

Now the agency is going a step further and clarifying that individuals who plan to take a job with a private company, and thus pursue that firm’s interests, cannot participate on advisory panels, according to Wednesday’s updated guideline.

The ban takes effect the moment a person notifies the EMA of pending employment, regardless of whether a contract has been signed. The agency will then inform the individual and the nominating authority of its action, removing the person’s name from the agency’s database of experts.

If the person in question is the rapporteur of a committee, an alternate will fill in while the agency looks for a replacement.

The EMA policy differs from that for FDA advisory committees, which almost always include an industry expert who speaks on behalf of sponsors.

Read the revised guideline at www.fdanews.com/05-06-15-EMAguideline.pdf. — Lena Freund