European Medicines Agency tightens conflicts-of-interests policies with immediate effect
The European Medicines Agency has today published its updated policy on conflicts of interests of the scientific experts and committee members it uses in its work. The policy was endorsed by the Agency's Management Board on 22 March 2012.
The updated policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research. It aligns restrictions for the different roles in the scientific decision-making process and tightens the rules on grants from the pharmaceutical industry.
The policy 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. “These issues will continue to be a major focus of the Agency's work over the months and years to come.”
Today also sees the publication of a new policy on suspected breaches of trust, which sets out a procedure for how the Agency deals with incorrect or incomplete declarations of interests by experts and committee members.
In addition, the Agency has introduced a policy on conflicts of interests of Management Board members. This largely follows the policy for scientific experts and committee members, while acknowledging the fact that the Board does not deal with specific medicines.
These policies demonstrate how seriously the Agency takes the risks of conflicts of interests of its staff, experts and Management Board members. The Agency takes care to ensure that these people do not have any financial or other interests that could affect their impartiality.
Over the past year, the Agency has strengthened its policies on and transparency over potential conflicts of interests. Its actions include:
- Publication of an online list of European experts and their declarations of interests in September 2011;
- In January 2012, requesting access to declarations of interests submitted to medicines regulatory authorities in European Union (EU) Member States, so that the Agency can conduct cross-checks of the information provided at national and at European levels;
- Publication of the risks levels for European experts in February 2012;
- Revision of the rules on conflicts of interests of staff members and publication of declarations of interest of Agency management in February 2012.
Experts cannot be involved in the Agency's activities until they have submitted a signed declaration of interests and the Agency has assessed his or her risk level. Declarations of interests and risk levels are constantly kept up to date.