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Following its implementation in September 2011, the Management Board reviewed the initial experience with the Agency’s revised policy on the handling of conflicts of interest for scientific-committee members and experts.
The Board endorsed a proposal from the Executive Director to further strengthen the policy taking into account the last six months’ experience.
The amendments clarify involvement in academic trials and in publicly funded research/development initiatives, align risk and related restrictions for the different roles in the scientific decision process, and tighten the rules in the case of grants from pharmaceutical industry.
The Board also endorsed proposals for additional measures to further increase the quality assurance, such as the introduction of a ‘breach of trust’ procedure in case of incorrect or incomplete declarations of interests, and the introduction of ex-post cross checks on the correctness of the declared conflicts of interest, and of the risk mitigation measures.
The Board also adopted a revised policy on the handling of conflicts of interests for its members which follows largely the approach taken for the scientific committee members and experts while acknowledging the fundamentally different role of the Board.
The new policy outlines specific restrictions when Board members do not take part in discussions and decision making.
However, since the Board does not deal with product-specific topics, the type and the nature of restrictions differ from scientific committees.
The new policy enters into force immediately.
New transparency initiatives discussed
The Management Board dedicated a large part of the meeting to the new pharmacovigilance legislation, which will significantly increase the transparency of all pharmacovigilance activities of the Agency and national authorities.
The Agency will increase the transparency of its processes and procedures by publishing the agendas, recommendations, opinions and minutes from its scientific committees, including the Pharmacovigilance and Risk Assessment Committee (PRAC), the human medicines Coordination Group (CMDh) and the Committee for Medicinal Products for Human Use (CHMP).
The Agency will organise public hearings allowing the public to engage with the Agency on safety issues, and will strengthen its current role in ensuring coherent and consistent messages on safety issues across Europe.
The Board considered patients’ expectations for hearings on medicines in Europe and discussed the purpose and added value of public hearings in the context of benefit–risk assessment.
The Agency will prepare a paper for discussion by the PRAC at its inaugural meeting on 19–20 July 2012.
This paper will provide the basis for the rules of procedure on the organisation and conduct of public hearings.