Following the growing debate about patient and expert interest disclosure at the European Medicines Agency (EMA), a discussion about conflict of interest declaration was high priority at the last Patients’ and Consumers’ Working Party (PCWP) meeting on June 16, 2010.

At the meeting, HAI Europe emphasized the importance of complete disclosure and the responsibility of the EMA to enforce its internal rules. The lack of compliance casts a shadow on the reputation, transparency and activities of both the PCWP and of the EMA.

HAI Europe suggested that the EMA these constructive steps:

  • Amend the declaration of interests form, where it now reads:

    The organisation I am employed by receives a grant or other funding from a pharmaceutical company…

    It should read:

    The organisation that I represent, or that I am employed by, receives a grant or other funding from a pharmaceutical company…

  • Host an open tutorial session for all the EMA experts on completing the declaration of interest form. This meeting could also take place online;
  • Establish a calendar for renewal and completion of the declaration of interests form. Any expert who does not deliver an up-to-date form to the EMA should not be consulted. On the other hand, he/she should be prevented from actively engaging in EMA activities, until the situation is rectified.

  • Pro-actively ascertain the accuracy of patient and consumers expert statements in their declarations of interest, by cross-referencing those statements with the most recent financial report of the organization being represented.

Katrina Perehudoff