By David Talbot, Consultant, London
The government yesterday announced that it is to carry out a review of the life sciences sector under the name Innovative Medicines and MedTech Review. It aims, in a sentence, to consider how to speed up patient access to cost-effective and innovative medicines, devices and diagnostics.
This is in response to the fact that, at present, it takes more than a decade and £1 billion on average to bring a new drug to market, and the government believes new practices are now desperately needed. The review will examine how new approaches to developing medicines, diagnostics and devices could speed up access for NHS patients, how more collaborative work between companies and regulatory bodies could lead to more efficient assessments, how charities and patient groups can help improve access, and what can be done to improve rapid adoption of medical innovations into clinical practice. Indeed, it is worth noting the timing of the government’s announcement comes just weeks after Simon Stevens’ Five Year Forward View that the NHS will ‘raise its game’ on health technology.
Sterling stuff, but what does it actually mean in practice? The announcements amount to a thinly-veiled rebuke to NICE and its dealings, with industry and political disquiet building over months. Criticism of NICE and its decisions is nothing new. It was created by the then Health Secretary Frank Dobson in 1999 as Labour faced a public relations crisis on health. The 1997 election pledge to “Save the NHS” clashed with the reality that the state could never afford to provide every suitable treatment for every patient. So Labour handed over the responsibility of sharing out scarce resources to an outside body – NICE.
From its inception NICE has been accused of being a covertly politicised system of rationing and as a way for government to take the sting out of, usually, tabloid stories that cancer patients are being denied what are always described as “life-saving” drugs.
NICE officially welcomed the government’s announcement, but as part of the announcement, George Freeman MP, the Life Science Minister, launched a review into the role of NICE and the Medicines and Healthcare Products Regulatory Agency, with the aim to produce recommendations for “radical change” early next year. It is highly unlikely that any new a fund will have the remit to throw money at new drugs and devices with no evidence, more that the evaluation process used to approve new entries to the market will change.
Ironically, NICE is envied abroad, where it is viewed as a cost-cutting body. Germany and France joined Australia, Canada and Sweden in setting up NICE-like bodies to control their drugs bill. There is a general feeling that NICE needs reform, not to be scrapped. NICE can only operate in the already set parameters of the NHS, which is notoriously slow in embracing new and emerging technologies and drug treatments. There is, however, unease about the practicalities of the proposed changes – which includes linking patients personal health records to pharmaceutical company records to discover how effective treatments are – including safety concerns over fast-tracking new treatments, and fear over handing NHS data to drug companies (particularly in light of the care.data programme’s difficulties). But the political direction has been set, and speed is now the necessity.