Underpinning medical innovation: the Life Sciences Industrial Strategy

The Office for the Strategic Coordination of Health Research (OSCHR) has released a new report to the UK government outlining a proposed Life Sciences Industrial Strategy intended to make the UK a global hub for clinical research and medical innovation.

The strategy sets out a vision for a Health Advanced Research Programme (HARP) led by a coalition of major UK funders (including the government) to support large research infrastructure and other high-risk programmes to create ‘entirely new industries in healthcare’, with the 100,000 Genomes Project cited as an example (although in fairness, a nascent genomics industry did exist before the project began in 2012).

A focus on genomic medicine

Genomics in medicine is emphasised as an important area for attention within the proposed HARP, where it is suggested that the existing industry can be further grown and the recent recommendations of the Chief Medical Officer’s Generation Genome report met by a number of measures, notably:

1. Ensuring funding is made available for full genome sequencing of the 500,000 people that make up UK Biobank and supporting informatics infrastructure to make the resulting data available to ‘the whole field of precision medicine’, in alignment with the existing Genomics England programme.
2. Capturing the data generated by a commissioned whole genome sequencing service in NHS England as a national genomics dataset linking whole genome sequence to phenotype.
3. Completing the NHS pathway for routine whole genome sequencing of cancer samples with appropriate patient consent, building on learning from Genomics England and with a 2-4 week turnaround time for results and ‘systematic application of genomic data in the management of patients with all forms of solid and liquid tumours’.
4. Supporting a programme in high-throughput microbiological genomic sequencing to address the issues of rapid diagnosis and antibiotic resistance, both in the UK and in the developing world.
5. Creating a National Genomics Board to oversee all these measures

A golden share for the NHS?

The strategy notes that NHS involvement will be essential for projects such as those proposed, and suggests that some benefits arising from biomedical data must be returned to the NHS, including access to technology. This could be in the form of a ‘golden share’ in commercial enterprises built on the data held by the Department of Health or NHS England to ensure on ongoing UK base and NHS benefits. This is a shrewd suggestion, implicitly acknowledging that the UK public are generally happier about their data benefiting the NHS than companies – though whether this measure would satisfy the suspicion with which pharma and biotech companies are sometimes regarded is not clear.

A key role for the NHS is envisaged for other potential HARP projects, too, including creating a cohort of patients and associated platform to support development and testing of new potential diagnostic and screening tools, using a host of technologies from genetic and epigenetic analysis to biomarkers, biological sensors and cognitive function assessment. This is suggested to be likely to attract ‘substantial new inward investment’ for the UK. Importantly, the strategy also calls for cross-sector involvement in governance from the NHS, major charities and the UK Research Institute (UKRI).

Cross-cutting areas for action

The strategy goes on to make recommendations for broad supportive action in five key areas:

1. Science: supporting an internationally competitive science base
2. Growth: supporting an environment that encourages commercial growth.
3. NHS: facilitating better care for patients through better collaboration and faster adoption of innovations
4. Data: making the best use of data and digital tools for research and patient care
5. Skills: ensuring access to a pool of talented people

All of these make sense, though whether the financially pressured UK government will appreciate the economic case made for boosting investment in biomedical and health research from 1.6% to at least 2.6% GDP remains to be seen, though suggestions that over 10,000 new jobs should be created in the life sciences sector may be more attractive. This would certainly justify the additional calls for expanded high-quality STEM education and opportunities, including in technical training, entrepreneurship, data sciences and maths, as well as more support for cross-sector movement in the form of sabbaticals, joint appointments, and other partnerships between industry and the NHS.

Faster access to innovations

In seeking to build on the work of the Accelerated Access Review, the strategy says it should be used to encourage investment in clinical research within the NHS, particularly via Academic Health Science Centres and Networks and the National Institute for Health Research. Various practical measures are proposed to underpin collaboration between industry, the NHS and regulators such as NICE and the MHRA to develop streamlined processes for commercial access (including from SMEs), conditional reimbursement and clinical implementation subject to agreed assessments and milestones. The aim is to see the UK as a leading country for the swift uptake of innovative and cost-effective healthcare products by 2023.

Dealing with data

With respect to data, the strategy recommends building on previous work by the National Data Guardian to create an NHS approach to generating useful real-world health data for easy access by researchers (academic, commercial and third sector) with streamlined ethical and legal approval processes. It sensibly calls for NHS Digital and NHS England to ‘set out clear and consistent national approaches to data and interoperability and requirements for data access agreements’, and is forward-looking enough to also propose development of a commercial framework to capture ‘the value in algorithms generated using NHS data’. A number of digital innovation hubs covering regions of 3-5 million people are proposed as part of the NHS approach, with a view to expansion to the whole population.

A realistic vision?

OSCHR Chair Prof Sir John Bell says in his introduction that the strategy is intended to build on existing strengths to put the UK ‘in a world-leading position to take advantage of the health technology trends of the next 20 years’ – an aim that is more important than ever as the country moves towards Brexit and must work harder to attract overseas investment.

A deliberately closer association between the NHS and the life sciences industry lies at the heart of all the recommendations; it is acknowledged that this may push many out of their comfort zone, but John Bell claims this is not contrary to the NHS’s founding principle of universal care, free at the point of use but rather is ‘central to ensuring and improving it for future generations’ and complementing the current NHS Five-Year Forward Review. Genomics may well be the testing ground for this ambitious aim. Much depends on how carefully plans are enacted; if patient care is kept firmly at the forefront, with prosperity and economic growth also promised, then the necessary public support may be forthcoming.