Government review aims to speed up NHS access to new medicinesBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g7090 (Published 24 November 2014) Cite this as: BMJ 2014;349:g7090
The government has launched another review into how to accelerate access to new drugs, devices, and diagnostics.
George Freeman, minister for life sciences, said, “By revolutionising the way in which we look at getting medicines and devices into the NHS we will make sure that this country is the best place in the world for 21st century medical innovation.”1
This is not the first such review, and it comes at a time when the first medicine to be “fast tracked” under the Early Access to Medicines Scheme has recently been designated. This is a cell therapy for cancer developed by a US company, Northwest Biotherapeutics, and under the terms of the scheme it may be made available to patients once it has completed phase II trials, shortening the development process.
Freeman’s announcement did not mention the early access scheme, so the new review may be broader in scope; that scheme is restricted to medicines for patients with conditions that have no effective treatments. The drug industry has long argued that problems of access to new medicines are much wider than this, and it welcomed the announcement of the review, which is expected to be entrusted to an independent organisation, to begin in the New Year and report next summer.
The industry faces the problem of long development times enforced by tough regulations, meaning that when medicines reach the market the patent window in which to recoup development costs is short, and prices are correspondingly high. A shorter development period could thus have a double benefit, allowing patient access more quickly and, in theory, making lower prices possible.
Freeman told the Financial Times, “We increasingly can’t afford either to let our patients wait that long [or] afford to pay the sunk development costs in a very short patent window.” Politically, the announcement may serve to blunt the arguments from Maurice Saatchi, the peer whose bill to ease what he believes are restrictions on cancer research has gained some support in parliament. It could also reassure the industry that it is being heard.
The review is likely to focus on encouraging clinical trials in the United Kingdom and streamlining the approval process by engaging with regulators and the National Institute for Health and Care Excellence (NICE) early in the process. Freeman hopes that NHS patient data may be exploited to shorten the development process. But the words used in the announcement did not shed much light on this; it said that the review will examine “how new approaches to the development of medicines, diagnostic[s] and devices, based on precision medicine and emerging technologies, could speed up access to innovative products for NHS patients.”
Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry (ABPI), said, “We have long called for such an initiative in response to increasing evidence of the need for a holistic approach to UK life sciences. This needs to bring together the life science industrial strategy with the health system, linking licensing, value assessment, and NHS commissioning to deliver increased patient access to new, innovative medicines.”
He added, “We particularly welcome the minister’s commitment to get medical innovations to patients quicker . . . this has previously been recognised by the ABPI as being the main challenge to delivering the government’s Strategy for Life Sciences.”2
It was essential, said Whitehead, that the review should consider NICE’s role. “The ABPI is calling for NICE to change the way it evaluates new medicines and [to] align with the changing regulatory model. It is vital that industry is able to fully participate in the review from the outset and we are more than prepared to do so,” he said.
Matthew Norton, head of policy at Alzheimer’s Research UK, said, “As research continues to make progress, it’s vitally important that new medicines can be made available swiftly to the people who need them.
“Efforts to streamline the complex regulatory process could play an important part in helping deliver new drugs sooner, and continued investment in research is also vital for ensuring that promising leads for new treatments are taken forward.”
Cite this as: BMJ 2014;349:g7090
Log in using your username and password
Log in through your institution
Register for a free trial to thebmj.com to receive unlimited access to all content on thebmj.com for 14 days.
Sign up for a free trial