Potential European Pharmacovigilance Fees Criticized - - BioPharm International

ADVERTISEMENT

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 10.5 million Euros, 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 Authorisation 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 authorisations may find itself paying pharmacovigialnce fees of 20 million Euros.

EMA already requires fees for certain activities, such as reviewing marketing authorization applications as part of the EMA’s Centralised 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.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
April 11, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
FDA Develops Alternative Assay to Increase Availability of Influenza Vaccines
April 10, 2014
Merck Announes Management Changes
April 7, 2014
Author Guidelines

Click here