EU opens fast track for life-saving drugs to get them sooner to market(&to patients!)

[Lani]

April 7, 2006
BRUSSELS -- The European Union agreed to allow drug companies to put new medicines on the market without going through lengthy regulatory processes in cases where early use of the drug is likely to save lives or ease severe suffering.

The European Commission said the new procedure would ensure patients at risk from deadly disease would be able to get the latest treatment quickly.

Commission Vice President Guenther Verheugen stressed that "the new authorization procedure can only be used under strict conditions so that safety is not endangered." The new "conditional marketing authorization" also would allow the timely use of new medicines to counter emergencies such as a flu pandemic or bio-terrorist attack.

In a statement, the EU said current rules mean it can take 10 years from the discovery of a new drug to its entry on the market. "This might be too long for patients suffering from life threatening diseases," the commission said.

The new system will allow patients to receive new treatments during product development. The new authorizations will be valid for a year and will legally bind companies to complete the studies on the medicines' safety and effectiveness.

Conditional authorization will be granted only if an EU panel judges that the benefits to public health of early use of a new drug outweigh the risk.

Copyright © 2006 Associated Press