EMA Gets Tough on Conflicts of Interest

The Management Board of the European Medicines Agency (EMA) has introduced a range of new measures to strengthen and extend its conflicts of interest (COI) policy for scientific-committee members and experts, as well as for members of the management board.

Taking into account the last 6 months’ experience, the EMA's policy include measures to clarify involvement in academic trials and publically funded R&D initiatives, as well as to align risk and related restrictions for the different roles in the scientific decision process and to tighten rules on grants from the pharmaceutical industry. The new policy also outlines specific restrictions for board members, such as preventing members from participating in discussions and decision making.

Additional measures to support quality assurance were also agreed upon, including the introduction of a breach of trust procedure for incomplete or incorrect declarations of interest and retrospective cross-checking of COI declarations and risk-mitigation measures.

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