EMEA rejects call to allow more conditional drug approvals

Any attempt to extend the scope of conditional marketing authorisations into areas that are not life-saving will be firmly resisted because of the potential dangers to patients, according to the executive director of the EMEA.

Thomas Loenngren said the UK Cooksey Review, authored by David Cooksey and published by the Treasury, had recommended that conditional marketing authorisations of medicines should be allowed more frequently than is possible under the existing rules. "I think that is very dangerous because of the failure rate between Phase II and getting final product approval," he said.

Widening the concept of conditional approvals to non-life threatening diseases would be tantamount to using patients as guinea pigs. Loenngren said the issue was still on the political agenda in the UK. However, the UK could not act independently and grant its own conditional approvals "because all the new medicines come to us".

Conditional marketing authorisation was introduced in 2006 as part of the 2004 reform of EU pharma legislation. It allows companies to launch products in Europe without having initially provided all the data normally required for marketing authorisation.

But this is allowed only when the benefits to public health of early access to medicines for outweigh the risks of incomplete clinical trial data. There must be a major therapeutic advantage for patients in desperate need. The CHMP must also be satisfied that comprehensive data is likely to be provided later.

So far the CHMP has recommended six conditional marketing authorisations: three in 2006 and another three in 2007. The medicines are Pfizer's Sutent (sunitinib), Biocodex's Diacomit (stiripentol), Tibotec's Prezista (darunavir), Amgen's Vectibix (panitumumab), Merck's Isentress (raltegravir) and GSK's Tyverb (lapatinib).