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 

.  “These issues will continue to be a major focus of the Agency’s work over the  months and years to come.”

 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.

News

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.