6 October 2017
The government began setting out plans for a new industrial strategy to address the ‘long-term challenges to the UK economy’ with a green paper from the Department of Business, Enterprise, Innovation and Skills (BEIS) in January 2017. Building our Industrial Strategy included proposals for industry-driven transformational ‘Sector Deals’ in key industries, including the life sciences, to include ‘sector-specific innovation funds matched by industry’ such as the current Biomedical Catalyst funding programme from the Medical Research Council and Innovate UK, which is intended to accelerate the development of innovative healthcare products.
Genomics veteran Prof Sir John Bell was asked to lead development of the life sciences sector strategy. At the end of August, his report to the UK government outlining proposals for a Life Sciences Industrial Strategy was published, along with the announcement of £197 million Industrial Challenge Fund money available over four years for the development of novel technologies for the manufacture of medicines.
Meanwhile, over the summer the House of Lords Science and Technology Committee has been conducting an inquiry on the same subject. Written evidence submissions to the Life Sciences and the Industrial Strategy Inquiry have now closed, and the committee (which, unlike its House of Commons counterpart, boasts almost 25% female membership) will begin hearing oral evidence in October. Exactly what this inquiry will achieve given that the government has in effect largely endorsed the industrial proposals by publishing them is open to question (and many, possibly most submissions to the Inquiry will have been made before this), but the bottom line will be scrutiny.
The original call for evidence said that the committee would ‘investigate issues such as whether the Government has the necessary structures in place to support the life sciences sector; how the NHS can use procurement to stimulate innovation and the contents of the new life sciences industrial strategy, when published’. The PHG Foundation consultation response picked up on selected questions posed by the Lords.
One major issue considered in the consultation is what it will take to encourage investment and growth to build a vibrant, world-leading sector. The PHG Foundation evidence highlighted the need for more support (financial and otherwise) for new models of collaborative working and cross-sector movement of staff between industry, academia, the NHS and biomedical charities. It was impossible to omit mention of the serious risk posed by Brexit to attracting and retaining the best talent with respect to life sciences research and innovation, as well as the need to bolster education and training at all levels in science, technology, engineering and maths (STEM). It was suggested that recreating the post of Life Sciences Minister sitting between both the Department of Health and Department of Business, Energy and Industrial Strategy ‘would have a strongly beneficial effect’ signalling global ambitions and underpinning ‘constructive and cooperative health and industrial policy’.
The PHG Foundation view is that the Accelerated Access Review and outcomes are likely to boost the availability of innovative treatments for NHS patients, which is a good thing for patients and developers alike. However, it will be important to ensure that it is also good for the NHS; with lessons from the Cancer Drugs Fund in mind, robust oversight will be needed to ensure that the NHS is not obliged to pay for innovative treatments that are not shown during trials to be cost-effective at improving outcomes. Similarly, where innovative treatments and other tools are shown to be clinically useful and cost-effective, there need to be mechanisms to make them available to NHS patients across the country, not just in centres of research or teaching excellence where trials tend to take place.
One critical area for ensuring this works is engaging with health professionals and commissioners; the PHG Foundation calls for explicit recognition that ‘successful adoption of innovations by health professionals requires a more holistic approach than merely educating them in their use’. It was felt that the Pathway Transformation Fund to help integrate life sciences innovations into clinical practice is a critical first step in this direction, but proposed that the Life Sciences Industrial Strategy should make specific and additional provision to support industrial efforts to ‘inform and work with frontline health professionals, commissioners and patients on how innovations can be most effectively put to use in the NHS’. Wider measures include the need to support development of national clinical guidance and consideration of wider issues relevant to healthcare uptake ‘such as the imperatives for responsible data sharing within the NHS’ – and proposals to incorporate scrutiny of performance in supporting the availability and uptake of health innovations across the NHS into evaluation processes for the Academic Health Science Networks (AHSNs).
Returning to Brexit issues, the PHG Foundation evidence notes then need for a robust funding strategy for UK life sciences (to include NHS collaboration); streamlining of the Tier 2 visa process and the creation of a high-level science recruitment fund to mitigate against the loss of STEM expertise; and careful legislative compliance with the EU to ensure smooth ongoing trading relations. Whilst the scope for regulatory improvement was said to be correspondingly limited, it was suggested that the UK can build constructively on its past record of pragmatic life sciences legislation ‘stressing feasibility and collaboration between the NHS and industry’.
The response specifically warned that it would be essential for the UK to retain access to European Medicines Agency (EMA) data and manpower by negotiating a position that will ‘closely mirror the current relationship between UK regulatory agencies and the EMA’ and do all that is possible to maintain this close working relationship, such as enshrining key EU legislation such as the European Medicines Directive and the General Products Safety directive in UK law. Without this, the UK’s desirability as a place for commercial life sciences and pharmaceutical development will be seriously compromised, especially given that the movement towards more personalised medicine, smaller trial groups and product markets will only exacerbate the risk of slower and more costly licensing processes.
In all, there are plenty of steps that can be taken via the Life Sciences Industrial Strategy to protect and promote both health and wealth for the UK. One of Sir John Bell’s focus points in his proposals for the Strategy is that the UK’s real treasure lies in the mass of health-linked data from clinical care and research in the NHS. He told the Guardian: “All the value is in the data and the data is owned by the UK taxpayer…The worst thing we could do is give it away for free”. Can the UK protect and promote the interests of both patients and taxpayers? Failure isn’t really a viable option, so the final Strategy has to play a major role in success.