Potential European Pharmacovigilance Fees Criticized

The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities. The fees were described in a Concept Paper from the European Commission, which was released for a public consultation in June 2012. The consultation finished last week and the final paper has not yet been released.

In a statement, Greg Perry, EGA Director General, explained, “Taking all the fees into account (annual fees, PSUR, PASS, and referral fees), the generic medicines industry will be paying for the EMA/EU pharmacovigilance system in a disproportionate manner, while the pharmacovigilance workload for generic substances, which are well known substances with a well-established safety profile, is the lowest.”

To more properly assess the proposed fee structure, EGA has suggested that the EC provides a “clear overview” of the costs associated with all of the new pharmacovigilance activities. In 2008, it was estimated that the total annual increase in fees payable to EMA would be about EUR 10.5 million ($13.7 million), but EGA estimated that the actual contributions could be more than ten times this amount.

EGA has also proposed that for calculating annual fees, Marketing Authorization Holders belonging to the same group of companies and acting under one Pharmacovigilance System Master File should only pay one annual fee per active substance. Otherwise, EGA is concerned that an average-sized generic medicines company with a large portfolio of active substances and marketing authorizations may find itself paying pharmacovigialnce fees of EUR 20 million ($26.1 million).

EMA already requires fees for certain activities, such as reviewing marketing authorization applications, as part of the EMA’s Centralized Procedure. Further fees are being introduced as part of Europe’s pharmacovigilance legislation, which became applicable in July 2012. The legislation requires the EMA to play a greater role in the area of pharmacovigilance.