The European Medicines Agency has published new rules on how it will be handling potential conflicts of interests of panellists on its committees.
The agency says the move is aimed at "balancing out the need to secure Europe’s best scientific experts for the evaluation and supervision of medicines while ensuring that these experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality". The EMA claims that the new rules "are based on three pillars: robustness, efficiency and transparency".
Conflicts of interests are classified into three categories – direct, indirect and no interests. Experts and members of the scientific committees provide a signed declaration of interests form and following this, they are assigned corresponding 'risk levels'. Now the agency will apply "a more proactive approach both in identifying potential conflicts of interests and in searching for alternative experts".
As part of this, the EMA will screen all declared interests of proposed members of its scientific committees "prior to their formal nomination". In areas where conflicts of interests may limit the availability of experts, eg in relation to some rare diseases, the agency will look "proactively for alternative experts by using its established relationships with academia and learned societies".
The EMA added that "all of this is underpinned by an increased level of transparency on declared conflicts of interests throughout the whole scientific review process". In addition, the declarations of interests of all committee members are published on the agency’s website and the plan is to include the declarations of all other experts included in the agency’s database on the site. These are currently available on request.
Noel Wathion, head of Patient Health Protection at the EMA, said that "providing independent, high-quality scientific opinions about medicines to the European Commission and EU Member States is the core function" of the agency. He added that "we take this work seriously and review our processes continuously to be sure that we take all steps necessary to protect our scientific opinion-making against the influence of any improper interests”. It is expected that the new policy will enter into force by the second quarter of 2011.