EMEA fee hike
Nature Biotechnology, April 2005
PETER J. VERMIJ
On March 31, the European Commission (EC) proposed to raise fees for the authorization of pharmaceuticals at the European Medicines Agency (EMEA).
Although the agency received 51 new applications in 2004—a sharp rise from the 39 received in 2003—the increase was not introduced specifically to deal with higher numbers of applications as they are expected to slow. Instead, the fee hike would mainly cover additional tasks such as more intensive post-authorization monitoring. These will be undertaken starting in November 2005 as the new legislation comes into force.
The annual fees will go up by 10% as of 2006 and a new and variable fee for yet unspecified 'scientific services' will be introduced. In addition, biotech companies falling in the small and medium-sized enterprises category would get deferments and discounts. The industry's total contribution to EMEA's budget would thus increase slightly from 68.1% this year to 68.4% in 2006.
Another measure would introduce new fees that would range between those for new products and traditional generics for follow-on biologics, known as 'biosimilars.'
The European bioindustry association EuropaBio in Brussels welcomes the new fee as an acknowledgment that biosimilars need more review than traditional generics.
© NPG/Peter J. Vermij