In this morning’s edition of The Times, George Freeman MP, Minister for Life Sciences, unveiled his Innovative Medicines Review, which aims to significantly speed up UK approval of new drugs and devices.
The Minister told The Times, “This will transform the landscape of drug development from the 20th-century model to a world in which the NHS becomes a partner in innovative testing, proving and adopting new drugs and devices in research studies with real patients.”
His proposals and the timeline for consultation have not been made fully public yet but three planks of his strategy have been revealed:
- Allowing earlier testing in humans and in smaller patient cohorts, especially in rare diseases
- Linking electronic health records and the pharma industry’s trials data to facilitate easier identification of personalised therapies and the patients most likely to benefit
- Payment by results for pharma to allow effective personalised treatments to recoup their investment costs
NICE, the Association of the British Pharmaceutical Industry (ABPI) and the Association of Medical Research Charities (AMRC) have all come out in support, and given the imminent election, it is highly likely that the consultation will launch very shortly, so that the Government has concrete proposals to unveil before purdah begins.
It’s not clear when any real changes would come about. The current Pharmaceutical Price Regulation Scheme (PPRS) agreement runs until 2019, but the next Government will be under considerable pressure from the press, patients, the research community and industry to move fast, so we could see results much sooner.
None of these proposals are simple or uncontroversial so this Review is likely to be the focus of much time and effort in the health policy sphere.
The advantages of earlier testing will need to be carefully balanced with safety concerns, linking patient data and industry databases is likely to inflame privacy concerns, and “payment by results” sounds suspiciously like the ill-fated Lansley Value Based Pricing/Value Based Assessment proposals.
The Review potentially gives Government a little respite from two separate policy headaches: the ongoing need for NICE reform, given the lack of movement on value based assessment and the Cancer Drugs Fund overspend, and the Saatchi Bill which, despite support from No. 10 and DH, is widely opposed by medics, charities and many in the health policy world.
While it will be a tall order to put both of these to bed through what is at this stage merely a consultation, some definitive action from the Life Sciences Minister could allow the Saatchi Bill to be quietly stalled and give an indication of where NICE reform may be going.
Freeman is a useful figurehead for this review: well liked on both sides of the House and with real world experience of the issues. Let’s hope he delivers on this promise.