Brussels, 14 September 2012 - The fees to be charged by the European Medicines Agency (EMA) 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. 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”.
For the calculation of the annual fees, the EGA therefore proposes that Marketing Authorisation Holders (MAHs) belonging to the same group of companies* and acting under one Pharmacovigilance System Master File (PSMF) should only be required to pay one annual fee per active substance. The EGA has estimated that if MAHs belonging to the same entity are considered as separate, an average-sized generic medicines company could have to pay a “maximum” fee of € 20 million on annual pharmacovigilance fees alone because of the large portfolio of active substances and MAHs.
In order to properly assess the proposed fee structure, the EGA suggests that a clear overview of the costs associated with all new pharmacovigilance activities is provided. Originally, it was anticipated in the impact assessment of 2008 that the total annual increase in fees payable to the EMA would be about € 10.5 million. Now, according to EGA calculations, contributions to the EMA could be more than 10 times the originally estimated annual fee level for the entire industry.
The EGA underlines that it is important for the fees to be set transparently and proportionally for generic medicines. “We would like to point out that prices of medicines have been sharply decreasing while regulations and fees are constantly increasing adding a large financial burden to the generic medicines industry and jeopardising its sustainability. The proposed fees may also lead to significant drug shortages in the European Union as companies will be obliged to reduce their portfolios”, Greg Perry comments.
* Commission communication on the Community marketing authorisation procedures for medicinal products - Application of Article 4(3)(11) of Directive 65/65/EEC in the context of the mutual recognition procedure