Introduction
Seven great healthcare challenges
Meeting healthcare challenges
Opportunities for UK life sciences sector
Genomics and health data
New treatments and technologies
Investment and upskilling
Net zero targets
Comment


Introduction

In July 2021 the UK government released its Life Sciences Vision report (the vision).(1) The vision outlines the government's and the life sciences sector's ambitions for the coming decade, updating the 2017 Life Sciences Industrial Strategy report(2) and the Life Sciences Sector Deals,(3) with the overarching aim for the United Kingdom to become "the leading global hub for life sciences".

The vision has involved engagement from a number of organisations, including:

  • the National Health Service (NHS) England;
  • the Welsh government;
  • research institutes;
  • industry associations and academies; and
  • pharmaceutical, medical device and healthcare companies.

The vision recognises that the life sciences sector is one of the most valuable and strategically important industries in the UK economy, and "critical to the country's health, wealth, and resilience". It states that advances in the sector have greatly improved the length and quality of life in the United Kingdom and globally. Further, the vision states that "we stand on the cusp of an era of cures, in which new technologies make previously terminal disease treatable or curable".

In the vision, the government has recognised the considerable contribution that the sector has made to the response to the covid-19 pandemic, which it describes as the greatest challenge of the post-war era. The vision cites several examples of key areas where the UK life sciences sector has played a significant role in the global fight against covid-19, including:

  • the development of the Oxford/AstraZeneca vaccine and the partnerships between industry and the vaccine taskforce (VTF) that have underpinned the United Kingdom's vaccination programme;
  • the RECOVERY trial, identifying safe and effective therapeutics; and
  • the growth of a diagnostics industry that is sequencing emerging covid-19 variants.

This has enabled the United Kingdom to have a world-leading life sciences response to covid-19, through combining a set of existing strengths with new ways of working.

Importantly, the vision notes that the life sciences sector is committed to playing an important role in the transition to "net zero" (ie, carbon neutrality), and considers how the government will support the sector in its aims.

Seven great healthcare challenges

The vision seeks to apply the approach and mindset deployed in respect of the challenges posed by the covid-19 pandemic to tackle seven specific "future disease challenges" – namely:

  • cancer;
  • dementia;
  • mental health;
  • obesity;
  • ageing;
  • respiratory disease; and
  • vaccines.

The ambition of the vision is to leverage the private sector, UK academia and scale and expertise of the NHS to make meaningful progress on tackling these challenges.

The vision also focuses on specific "missions" that are technology or disease specific. In each, there is an opportunity to take a VTF-type approach, with a single empowered decision maker to mobilise private and public sector science and investment.

These missions will also help the NHS to solve some of the biggest healthcare problems facing the current generation. The missions are:

  • improving translational capabilities in neurodegeneration and dementia;
  • enabling early diagnosis and treatments, including immune therapies such as cancer vaccines;
  • sustaining the United Kingdom's position in novel vaccine discovery development and manufacturing;
  • treatment and prevention of cardiovascular diseases and its major risk factors, including obesity;
  • reducing mortality and morbidity from respiratory disease in the United Kingdom and globally;
  • addressing the underlying biology of ageing; and
  • increasing the understanding of mental health conditions, including work to redefine diseases and develop translational tools to address them.

Meeting healthcare challenges

The vision states that the focus on healthcare challenges will be complemented by simultaneously seeking to improve the effectiveness and attractiveness of every element of the UK life science ecosystem.

The UK government states that in order to meet these challenges and undertake these missions, it will work collectively to:

  • build on the United Kingdom's science and research capabilities by making the country the best place in the world to trial and test products at scale, underpinned by the improvement of genomic and health data infrastructure;
  • make the NHS the country's most powerful driver of innovation through:
    • developing, testing and adopting new technologies at a population scale;
    • using new technology to get diagnosis and treatment right the first time; and
    • building genuine trust between the NHS and the sector about what can be achieved by working closely together; and
  • create an outstanding business environment for life science companies – in which incentives and structures are aligned to support company growth, innovation and investment – underpinned by a world-class regulatory environment and financial support to help companies to grow.

The vision focuses on what the government, the NHS, regulators, companies, medical research charities, academia and philanthropy must do to create an environment in which industry can grow and succeed in the United Kingdom, such that patients and the NHS can receive a real benefit.

To achieve the desired growth and success, the vision focuses on four key themes:

  • building on the new ways of working from covid-19 to tackle future disease missions;
  • building on the United Kingdom's science and clinical research infrastructure and harnessing the United Kingdom's unique genomic and health data;
  • supporting the NHS to test, purchase and spread innovative technologies more effectively so that cutting-edge science and innovations can be embedded widely across the NHS as early as possible and rapidly adopted in the rest of the world; and
  • creating the right business environment in the United Kingdom in which companies can access the finance to grow, be regulated in an agile and efficient way and manufacture and commercialise their products in the United Kingdom.

Opportunities for UK life sciences sector

The overarching opportunity for the UK life sciences sector is to work collaboratively with the United Kingdom's best academics, the NHS and regulators to accelerate the development of new drugs, diagnostics, medical technologies and digital tools to bring life-changing innovations to patients faster.

The vision states that the current proposal builds on the success of the 2017 Life Sciences Industrial Strategy report and the Life Sciences Sector Deals, while recognising that the context has changed significantly since those publications, in light of circumstances including:

  • the United Kingdom's departure from the European Union;
  • the impact of the covid-19 pandemic; and
  • the organisational transformation of the NHS in England.

The vision states that it is the changes in the NHS both in terms of organisational structure in England and service delivery post-pandemic across the United Kingdom that offer the greatest opportunity to deepen collaboration and trust between the government, the NHS and the life sciences sector.

The vision is a comprehensive assessment of key areas in which the life sciences sector may focus and further develop over the next 10 years. A detailed assessment of all of these is beyond the scope of this article but some are worth considering in more detail.

Genomics and health data

At the heart of the vision are plans to build on the United Kingdom's existing strengths in genomics and health data.

The government said that it wants to "make the UK a highly effective and efficient place in which to test and trial new technologies for the most important healthcare challenges" and build on the United Kingdom's existing strengths in genomics and health data to do so. In this respect, it plans to "fully integrate genomics into health service delivery through the Genomic Medicine Service" and "harness the NHS's unique health data to understand and tackle population health challenges", among other things.

On genomics specifically, the vision is for the United Kingdom to "create the most advanced and integrated genomic research healthcare ecosystem in the world" over the next 10 years. The government said that there is an opportunity to "deliver genomics-enabled clinical trials" and has pledged to "radically improve" clinical trials regulation so as to "create a more efficient and effective research environment".

In relation to health data, the government said that "high quality health data will be one of the primary drivers of global life sciences research and innovation and improved health outcomes" over the next 10 years. It said that simplifying the governance and oversight of NHS health data is a "precondition" for the success of the new vision.

In order to support the government's vision of a healthcare system that is able to focus more on early diagnosis, treatment and the prevention of disease and that harnesses cutting-edge innovation, the vision acknowledges that data should be accessible in a trustworthy and transparent way. This is a significant opportunity that will underpin transformative improvements in health outcomes and service delivery, and will provide invaluable insights that will support the development of new medicines and technologies.

One of the actions identified in the vision is to "provide innovators with smoother and quicker access to reliable, high quality 'real world' data alongside clinical and genomic data". The government said that this would:

  • support more effective and efficient clinical trials;
  • provide a more streamlined regulatory approval process through the accumulation of a robust body of data; and
  • allow a more accurate and reliable assessment of new innovations.

In pursuit of that aim, the government has pledged to establish accredited "trusted research environments" through which NHS data can be accessed. It also said that it would overhaul the governance on data access:

to ensure that patients, NHS organisations and registries have the confidence and clarity they need to engage with innovators, bringing more consistency and efficiency in decision-making whilst adhering to the highest data protection standards.

New treatments and technologies

Other measures outlined in the vision include plans for a new framework for the reimbursement of digital health technologies and digital therapeutics as well as renewed support for "the innovative use of off-patent drugs and technologies where no approved treatment exists, to address unmet patient need". Given the potential value of repurposed medicines, this is encouraging and will be of interest to manufacturers of such medicines.

The vision also notes that digital healthcare products are not currently well regulated anywhere in the world and pledges that the Medicines and Healthcare products Regulatory Agency (MHRA) would "deliver the world's leading regulatory model for digital health products". Given the new MHRA guidance in respect of the approval of biosimilar medicines in the United Kingdom post-Brexit, where the MHRA has streamlined the process and removed the need for confirmatory clinical efficacy trials should it be supported by the science, this is another potentially trailblazing development for the MHRA.

Further reforms to UK medical devices regulations are also contemplated, as are plans to build up the United Kingdom's life sciences manufacturing capabilities in "target areas" such as cell and gene therapies over the coming decade.

The vision also proposes regulatory actions designed to reduce the time that it takes for new medicines and health technologies to be adopted by the NHS.

Investment and upskilling

A key aim of the government is to make the United Kingdom the most attractive location in Europe to start and grow a life sciences business and the vision identifies steps to improve access to finance in the life sciences sector. To support such growth, it also acknowledges the importance of improving skills in the life sciences sector and developing a strong talent pool.

Net zero targets

The green agenda now underpins many governmental policies. The vision is no different and the life sciences sector has a key role in supporting initiatives such as the UK government's net zero target.

Healthcare currently contributes around 5% of the United Kingdom's carbon emissions and there are emerging initiatives across the life sciences sector aimed at reducing this, with life sciences companies committing to reduce their environmental footprints. In October 2020 the Greener NHS National Programme(4) published its new strategy, Delivering a 'Net Zero' National Health Service.(5) This report highlighted that, left unabated, climate change will disrupt care, with poor environmental health contributing to major diseases, including cardiac problems, asthma and cancer. The report set out trajectories and actions for the entire NHS to reach net zero carbon emissions by 2040 for the emissions that it controls directly and by 2045 for those that it can influence (eg, those embedded within the supply chain).

The vision supports the transition to net zero. It notes that the life sciences sector is committed to playing an "enthusiastic role" in this respect and that the government will work with the sector to support this process. It further identifies areas in which the life sciences sector may support government and industry targets on net zero. These include:

  • supporting the development of preventative healthcare and early diagnosis technologies that reduce the need for prolonged treatment of advanced illness and frequent visits to hospitals and other healthcare settings. The argument is that to be sustainable, the NHS needs to focus on the right interventions early in the course of disease with a reinvigorated approach to delivering innovations for the major diseases that drive most morbidity and mortality, with predictive and monitoring technologies, genomics and data used to prevent, detect, diagnose and treat disease early, rather than concentrating on late-stage disease, which is usually more costly and delivers poorer outcomes. This is also in line with the commitments already in place in the NHS Long Term Plan;(6)
  • optimisation and digitisation of the United Kingdom's medicines and healthcare regulatory system, which will reduce paper usage and allow virtual inspections of manufacturing and clinical trials sites;
  • supporting the development and deployment of green manufacturing technologies and working with the medical technology sector to explore advances in materials science and new technologies such as artificial intelligence and opportunities to utilise sustainable, reusable and recyclable materials in new products;
  • ensuring that the life sciences can play a prominent role in cross-sectoral forums and work on net zero initiatives; and
  • improving the sustainability and carbon footprint of manufacturing processes, removing plastics and other non-renewables from products and, where this is not feasible, work with the sector on new materials science.

Comment

It goes without saying that such an ambitious plan creates significant opportunities for the continued growth and development of the United Kingdom's life sciences sector, as well as making the life sciences sector a focus for net zero targets. There are considerable opportunities for investment and to drive value creation for the sector, with the government, medical research charities and the NHS taking the same mission-orientated approach to innovation seen in the pandemic across a range of diseases with patients benefiting from new ways of working, the NHS operating as a data-driven test forum for new technologies, and government making the UK an attractive commercial and operating environment for companies to innovate, grow and invest.

In this sense, the government is seeking to leverage the lessons learned from the pandemic to shape the future of the UK life sciences sector and deliver world-class treatments and outcomes for patients and the community. The government is also seeking to take advantage of this approach to make tangible improvements to the United Kingdom's deep inequalities of health, which the pandemic has highlighted and worsened. Finally, the government envisages using the United Kingdom's unique life sciences, engineering and health capabilities to help define and set evidence-based global standards and rules.

The vision does not set out the specific programmes through which these will be delivered. Following the Spending Review in November 2021, the government will set out its delivery plan and governance for taking this work forward and the sector will have the opportunity to decide where it wishes to coinvest. This is an area that many involved with the life sciences sector in the United Kingdom will be watching closely and it reiterates the UK government's commitment to supporting innovation and technology as a pathway for future economic growth and prosperity. Given the strength of the response to the pandemic from the UK life sciences sector, this is exciting and encouraging.

For further information on this topic please contact Sarah Taylor or Anna Harley at Pinsent Masons by telephone (+44 20 7418 8250) or email ([email protected] or [email protected]). The Pinsent Masons website can be accessed at www.pinsentmasons.com.

Endnotes

(1) To access the Life Sciences Vision report, click here.

(2) To access the Life Sciences Industrial Strategy report, click here.

(3) To access the Life Sciences Sector Deals, click here.

(4) For further information, click here.

(5) To access the Delivering a 'Net Zero' National Health Service report, click here.

(6) To access the NHS Long Term Plan, click here.