In an open letter from the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) to the EMA’s executive director, Thomas Lonngren, the Agency is criticized for failing to monitor and implement its conflict of interest procedures for board members.

These accussations stem from CEO’s earlier report on incomplete declarations of interest made by patient representatives at the Agency.

ISDB & MiEF raise key shortcomings of the EMA conflict of interest procedures:
  • EMA experts are not required to declare the interests of their households, while this is information commonly requested on conflict of interest forms at national drug agencies;

  • EMA experts are only asked to declare financial interests in pharmaceutical companies if they exceed 50,000 euros;

  • More than 1 in 4 EMA experts have a ‘high risk level’ of conflict of interest, particularly with respect to product-specific decisions.
Continue reading the open letter
The Agency’s response to the open letter, covered in the BMJ article ‘European drug regulator is criticized over patient representatives’ conflicts of interest‘, mentioned that an updated conflict of interest policy was agreed at an Agency meeting on 10 June 2010 and is due to be adopted in October.

Katrina Perehudoff