Pharmacovigilance fees unjustifiably high, says EGA; MiEF, HAI and ISDM present alternatives

The fees to be charged by the European Medicines Agency for pharmacovigilance activities as described in the European Commission's Concept Paper will be very high and disproportional instead of bringing cost-efficiency as described in the Commission's impact assessment of 2008, says the European Generics Medicines Association (EGA), a view largely shared by several other trade groups.

Submitting their comments to the public consultation today, producers of generic medicines are raising major concerns on the Commission's proposal and the huge costs that the EMA might charge for its pharmacovigilance activities.

Greg Perry, EGA director general, stresses: “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.”