EMA issues new conflict of interest rules
Wants to ensure impartiality of scientific experts
The European Medicines Agency (EMA) has published rules designed to prevent conflicts of interest among scientific experts manning its advisory panels.
EMA said the new rules ‘aim 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.’
Under the system, conflicts of interests are classified into three categories: direct, indirect and no interests. Experts and members of EMA scientific committees must sign a declaration detailing financial or other interests potentially affecting their judgment, with EMA assigning corresponding risk levels.
Accordingly, ‘involvement of the expert may be restricted taking into account…the interest declared, the time passed since the interest occurred and the [EMA work] of…the expert…’, EMA said.
It added: ‘The new rules are based on: robustness, efficiency and transparency’ and will come into force by June 2011.