Dry pipelines undermining EMEA
pharmafile | October 23, 2003 | News story | |Â Â Â
A dramatic drop in new drug applications is now threatening Europe's medicines regulator the EMEA with a financial crisis, and could hinder plans to expand its role.
In October, the Agency announced it was slashing its budget by E5 million in response to a sharp fall in the number of new drugs submitted for approval, now confirmed at 31 for 2002, down from 58 in 2001 and 54 in 2000.
Called to discuss the EMEA's expected financial problems with the European Parliament's Environment, Public Health and Consumer Policy committee, Executive Director Thomas Lonngren said: "Never has so much money been spent on R&D with so little result".
The EMEA, like its US counterpart the FDA and other national regulators, relies on fees from applicants to fund its work. Earlier this year the FDA said fewer new drug applications had meant "significantly less" users fees from the industry, and in turn less money to fund its drug review operations. The US regulator approved just 16 drugs in 2002, compared to 24 in 2001, and the record 53 in 1996.
Mr Lonngren speculated that one reason for the drop in new drugs was a number of recent large-scale mergers, resulting in less promising projects being abandoned.
One other reason put forward by the industry is the large proportion of R&D funds diverted to develop new drug discovery areas such as genomics and proteomics which have yet to bear fruit.
Merck Chairman Raymond Gilmartin recently said the downturn should not worry investors unduly, and that it represented part of the "somewhat cyclical" nature of pharmaceutical R&D.
The slowdown could also undermine plans to create an enlarged EMEA, which would handle all submission for new and innovative drugs.
The agency's cutbacks mean it may find itself unable to cope with an upturn in new drug applications when it arrives, strengthening the argument to maintain mutual recognition, the secondary European drug licensing option.
European Commission plans to expand the centralised procedure have now been approved in a first vote by the European Parliament, despite resistance from the pharmaceutical industry.
European industry body EFPIA and the UK ABPI have signalled they may be willing to compromise on the issue, in return for important concessions on matters such as data exclusivity periods and direct to consumer communication.
