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EMA's policy on conflict of interest: improvements needed (June 2010)

In an open letter, ISDB and Medicines in Europe Forum (MiEF) draw the attention of the European Medicines Agency (EMA)’s executive manager to the need for the EMA to better implement its own basic rules on conflict of interest notably at the management board level. They also share more general comments on the need for the EMA to strengthen its policy on the conflict of interest of experts working with the Agency. Read on...

Excerpts from the Open Letter :
The EMA has failed to implement its basic policy on conflict of interest at the management board level. Civil society representatives can provide valuable input into the European Medicines Agency work and such collaboration should be encouraged. However, evidence indicates that there is a risk of abuse by groups that receive their core funding from the pharmaceutical industry. This particular scenario demands a commitment from the Agency to proactively monitor representatives to ensure the independence of stakeholders involved in EMA’s activities. The EMA has failed to validate the accuracy of experts’ statements even at Management Board level, which decides on the political orientations of the Agency. Most notably, two patient group representatives on the EMA Management Board did not meet basic EMA rules on conflict of interest, by not even declaring the financial ties of their organisations with the pharmaceutical industry.

The EMA’s conflict of interest policy in general needs to be strengthened. Much available evidence implies that commercial interests bias regulatory science. Despite that knowledge, EMA’s conflict of interest policy is not only insufficiently monitored and hardly implemented, but also too weak. A very first step to improve the situation would be to improve EMA’s transparency practices.

© Medicines in Europe Forum, International Society of Drug Bulletins
, June 2010

> Click here to download the Open Letter (pdf, 158 Ko).

> Click here for the online Dossier "Medicines in Europe".