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EMA gets more transparent with documents and conflicts of interest

18.10.2010

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest, which should make the processes in these two areas more efficient. The new rules handling potential conflicts of interests for members of EMA's scientific committees, including CHMP and COMP, are based on three pillars: robustness, efficiency and transparency. Conflicts of interests are classified into three categories - direct, indirect and no interests. In an overview of allowable interests, EMA noted that scientific committee members cannot participate in discussions, final deliberations or voting for a product if the member is or has served within the past two years as a principal investigator (PI) in a clinical trial for a related or competitor product. The policy, which was endorsed by EMA's Management Board, is expected to enter into force by the second quarter of 2011. In areas where conflicts of interests may limit the availability of experts, the Agency will look proactively for alternative experts by using its established relationships with academia and learned societies. The new policy on access to documents takes into account recommendations made by the European Ombudsman, which earlier this year criticized EMA for its transparency when the agency refused to grant public access to reports on adverse drug reactions. The new policy defines how EMA will proactively disclose such documents in the future.

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