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.

The new policy enters into force immediately and replaces the previous rules, which had been in effect since September 2011.

“Since taking up the leadership of the European Medicines Agency in November, one of my main focuses has been on strengthening the ways the Agency deals with conflicts of interests and transparency,” the Agency’s executive director Guido Rasi said in a statement. “These issues will continue to be a major focus of the Agency’s work over the months and years to come.”

Transparency

In a press statement released last week about the new policy, the agency also reported on initiatives to improve transparency. In response to the Europe’s new pharmacovigilance legislation, which will have a significant impact on transparency issues for national authorities, the EMA will enhance the transparency of its processes and procedures by:

• Publishing agendas, recommendations, opinions, and minutes from its scientific committees, including the Pharmacovigilance and Risk Assessment Committee (PRAC), the human medicines Coordination Group, and the Committee for Medicinal Products for Human Use

• Engaging with the public on safety issues through public hearings, simultaneously ensuring consistent safety messages across Europe

• Preparing a paper on rules of procedure for the organization and conduct of public hearings. The paper will be discussed by PRAC at its inaugural meeting on July 19–20, 2012.