EU industry still unhappy over PV fee burden as legislation nears approval
Published 24 February 2014
European industry bodies have generally welcomed last week's compromise deal on the new fees for pharmacovigilance activities, but are disappointed that the fee level for safety referrals is significantly higher than originally proposed by the European Commission. They are also concerned that industry is being asked to share the whole burden of funding the EU's new pharmacovigilance activities.
The new fee structure, outlined in a draft EU Regulation, is needed to fund extra activities carried out by the European Medicines Agency under the strengthened pharmacovigilance legislation, which became applicable in July 2012. The commission's original fee proposal, put out in the form of a concept paper in June 2012, had to be radically revised after it was attacked from all sides as being "disproportionate", "excessive" and "unfair".