European Medicines Agency's Management Board endorses revised EMA code of conduct

Press release 17/06/2013

Board also discusses the future challenges of the European medicines network

At its meeting held on 13 June 2013, the European Medicines Agency's (EMA's) Management Board adopted the revised EMA code of conduct, which aims to ensure that the Agency maintains the highest professional standards of integrity, transparency and independence. The EMA code of conduct was first adopted in 1999, with a revised version adopted on 16 December 2004.

As the Agency adopted new rules on conflicts of interests for members of the Management Board, members of scientific committees, experts and staff in 2012, the code has been reviewed and updated to reflect current needs and the new rules in place.

The revised code of conduct is a comprehensive consolidation of documents and policies, which sets out the practice for members of the Agency's Management Board, scientific committees, experts and staff on direct and indirect interests, and the necessity to declare them in order to avoid and manage potential conflicts of interests. The chair of the Board, Sir Kent Woods, acknowledged that this document reflects the progress made by the Agency, particularly in the area of strengthening rules on conflicts of interests.

Positive assessment of last year's operations

The Board gave a positive assessment of the Agency's operations in 2012, and of its management and internal control system. This analysis and assessment of the Executive Director's annual activity report is carried out by the Board annually, as required by the Financial Regulation. The analysis highlights, among other topics, the Agency's initiatives in the area of involvement of civil society (including the establishment of a procedure for systematic participation of patients in scientific-advisory-group meetings), the notable progress towards increased transparency, and the launch of the Scientific Coordination Board to deal with the increasing complexity of the system.

Preparing for future challenges

Executive Director Guido Rasi presented the outcome of the Agency's initiative to re-shape the EMA to be ready to handle future challenges and give its scientific committees the best possible support, to keep delivering high-quality, consistent opinions.

The Board was presented the details of the planned re-organisation of the Agency and expressed its support for the proposed new structure. The changes are the result of a review announced in December 2012. These changes are expected to improve the efficiency and effectiveness of the Agency's operations, at a time when all public bodies are being asked to achieve more without increased resources.

As part of this review, the Agency is reflecting on how to better support the scientific work of its committees, and the Board was updated on this ongoing work.

The chair of the Committee for Medicinal Products for Veterinary Use (CVMP), Anja Holm, who reported on the activities of the Committee, presented her views on how to optimise the scientific expertise of the Committee and working parties, and how to better involve experts in the CVMP scientific assessment.

Public hearings

The Board was also presented with the Agency's current thinking on the organisation and conduct of public hearings. Public hearings are a highly anticipated provision of the new pharmacovigilance legislation. The Board welcomed the Agency's commitment to implement a process for public hearings that ensures that they add value to the evaluation of medicines by enriching regulatory decision-making with valuable 'community knowledge' and alternative ways of learning and thinking about issues. Rules of procedure for the conduct of public hearings are being defined and will be released for public consultation once they have been adopted by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC).

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