European Medicines Agency (EMA) executive director Guido Rasi has accepted, "with immediate effect," the resignation of Eric Abadie as chair of the Agency's human-use drugs panel.
Dr Abadie resigned as chair of the EMA's Committee for Medicinal Products for Human Use (CHMP) following the termination of his role as scientific adviser to the director-general of France's health products safety agency, Agence Francaise de Securite Sanitaire des Produits de Sante (Afssaps), during a reorganisation last December. His position as head of the CHMP, which he has chaired since 2007, was unpaid, and the EMA has said that it cannot afford to pay him a salary.
The reorganisation at Afssaps follows a period of controversy at the agency, largely centering on its failure to withdraw Servier's diabetes drug Mediator (benfluorex), which was widely prescribed in France for weight loss, until 2009, by which time as many as 2,000 deaths had been linked to the drug. Regulators in other nations had taken it off the market five or six years earlier.
More recently, Afssaps has come under attack for its perceived failure to act on the faulty breast implants made by the now-bankrupt firm Poly Implant Prothese (PIP) SA.
At the CHMP, vice-chair Tomas Salmonson takes over leadership on an interim basis to ensure continuity of operations, and elections for the new chair will take place in due course, says the EMA.
Meantime, the Agency has now published its updated policy on conflicts of interests of the scientific experts and committee members which it uses in its work.
The updated policy, which replaces previous rules in place since last September, 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.
Commenting on the new policy, Mr Rasi said that since taking up leadership of the EMA in November, one of his main focuses has been on strengthening the ways in which the Agency deals with conflicts of interest and transparency. "These issues will continue to be a major focus of the Agency's work over the months and years to come," he added.
The EMA has also published a new policy covering suspected breaches of trust, which sets out a procedure for how it deals with incorrect or incomplete declarations of interests by experts and committee members. In addition, it has launched a policy on conflicts of interest relating to the members of its Management Board. This largely follows the policy for scientific experts and committee members, while acknowledging the fact that the Board does not deal with specific medicines.
Over the past year, the EMA has strengthened its policies on, and transparency over, potential conflicts of interests, with actions including: - publication in September 2011 of an online list of European experts and their declarations of interests; - in January this year, requesting access to declarations of interests submitted to drug regulatory authorities in European Union (EU) member states, so that it can conduct cross-checks of the information provided at national and European levels; - publication in February this year of the risk levels for European experts; and - also in February, revision of the rules on conflicts of interests of staff members and public declarations of interest of Agency management.
Experts cannot be involved in EMA activities until they have submitted a signed declaration of interests and the Agency has assessed their risk level, and such declarations and risk levels are constantly kept up to date, says the EMA.
"These policies demonstrate how seriously the Agency takes the risks of conflicts of interests of its staff, experts and Management Board. The Agency takes care to ensure that these people do not have any financial or other interests that could affect their impartiality," it adds.