Speeding up access to new drugs

doi:10.1136/bmj.e999

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Nigel Hawkes, freelance journalist

¹London, UK

nigel.hawkes1{at}btinternet.com

Plans to cut the time it takes to get innovative treatments into clinical practice are finally to be put out to consultation next month. Nigel Hawkes provides a reminder of the key points

The prime minister promised at the end of last year to give some patients quicker access to new drugs. Was this just an empty aspiration?

No. A lot of thought has been given to a faster access scheme since David Cooksey recommended it in his review of UK health research funding in December 2006. A working group from industry and government produced a plan by November 2009. It sat on a shelf until resurrected two years later.

How would it work?

Medicines that have completed phase III trials (or in exceptional circumstances phase II) and that will treat or prevent life threatening, chronic, or seriously debilitating conditions that lack adequate existing treatments would qualify. Manufacturers would have to apply, and a decision would be promised in 75 days.

How would that be any quicker than licensing, if phase III trials have already been completed?

It usually takes a year or more to get licensing approval after a successful phase III trial. The new process is expected to get these medicines to patients a year earlier than otherwise would be the case. …