The Industrial Strategy – Life Sciences Sector Deal 2 report is broken down by themes with each identifying what progress has been made by each of the sector and Government. A summary of these themes and the general findings are set out below:
1. Ideas, including to be the world’s most innovative economy, strengthening the UK environment for clinical research and raising the intensity of R&D in the UK
The innovative economy:
- Industrial Strategy Challenge Fund wave 3 investment: the Government is allocating £79m R&D funding in the new Accelerating Detection of Disease 3 challenge, which falls under the Industrial Strategy’s AI and Data Grand Challenge.
- Additional investment of up to £50m in the digital pathology programme as a first step towards making this a truly national asset to support early diagnosis and deliver more efficient NHS services.
- A commitment to sequence at least one million whole genomes within five years, including 500,000 whole genomes through the NHS.
- Building on previous work in relation to genomics and the UK Biobank, Genomics England will undertake work on a new service to enable genomic volunteers to pay for a personalised report on their unique genetic makeup and with the volunteer's permission, make the genetic data available to researchers and scientists.
- A commitment to continue working to establish the Health Advanced Research Programme (HARP).
Strengthening the UK environment for clinical research:
Recognising that more can be done to improve the clinical research environment for life sciences companies, the Sector Deal 2 commits to continue improving the speed and efficiency of clinical trials by:
- Establishing five centres for late-phase commercial research.
- Exploring opportunities to recognise and incentivise NHS Trusts and GP practices acting as participant identification centres.
- Continuing to improve research set-up timelines.
- Addressing challenges in NHS workforce resourcing to deliver commercial research.
Moreover, action will be taken to consolidate the UK’s position in delivering novel and innovative trials by:
- Promoting the UK’s expertise in designing and delivering innovative trials.
- Enabling industry, including SMEs, and the wider research community to access advice to support innovative trial design.
- Delivering a skills programme to embed expert understanding of how innovative studies can be run across the NHS.
The Government wants to build on action to increase the UK’s R&D spend to reach 2.4 per cent of GDP by 2027 by:
- Working across UKRI and industry to develop a roadmap to achieve 2.4 per cent.
- Announcing additional budget support including £1.6 billion to strengthen the UK’s leadership in science and innovation.
- A new government ambition to triple industry contract and collaborative R&D spend in the NHS to over £900m
2. Business Environment, including to be the best place to start and grow a business, supporting the growth of life sciences manufacturing, NHS innovation and collaboration and innovative regulation
Making the UK a global hub for advanced therapies manufacturing
Provides detail on how the £146m Industrial Strategy Challenge Funding announced in 2017 for medicines manufacturing has been directly targeted at advanced therapies, including £21m invested to establish Advanced Therapy Treatment Centres. These centres are intended to develop easily-run solutions for the adoption of cell and gene therapies that can be rolled out across the NHS.
NHS Blood and Transplant are expanding their infrastructure to facilitate adoption of cell and gene therapies.
Growth of life sciences manufacturing:
£8 million Industrial Strategy Challenge Fund funding was announced as an initial step to facilitate the application of digitally-enabled technologies for medicines manufacturing.
Up to £121 million was announced for the Made Smarter Programme to support the transformation of manufacturing, including in life sciences.
Improving the UK environment for businesses to scale up
Last years deal outlined the Government’s response to address scale up issues with an action plan to release over £20 billion of patient capital investment over 10 years.
The Government is going further to increase opportunities for pension funds to invest in the sector by addressing regulatory barriers and announcing plans to help them invest in growing UK businesses through the British Business Bank.
NHS innovation and collaboration
The Government had committed to implementing the Accelerated Access Review including £86 million funding to support innovators and the NHS. It is now going further by:
- Enhancing and strengthening the Accelerated Access Collaborative (AAC).
- Improving patient access to more innovations by giving the AAC more flexibility over the number of products it can support as long as they deliver good value.
- Seeking to build stronger testing infrastructure to improve the innovation infrastructure.
- Tackling the challenge of spreading the best innovations across the system through a new health tech funding requirement.
The MHRA has set out how it will be the most forward-thinking regulator – an essential part of a strong business environment for life sciences – ensuring it remains at the forefront in the priority areas in the strategy by:
- Supporting advanced therapies manufacturing by developing a framework for point-of-care manufacture.
- Leading the way on precision medicine by developing a clear UK regulatory pathway for genomic medicines and genetic tests.
- Promoting patient access and safety, building on the success of the Early Access to Medicines Scheme (EAMS). The MHRA will work with industry and other partners to define a supportive framework for the collection of real-world data during the scheme.
Patient safety is paramount to MHRA’s regulatory activities. The Sector Deal 2 commits the Agency to:
- Assess the feasibility of using artificial intelligence (AI) to identify safety signals in large datasets of health records.
- Explore whether a MHRA Yellow Card Biobank can be developed to capture genetic information from patients experiencing adverse drug reactions (ADRs).
The Life Sciences Industrial Strategy made clear that the improved use of health-related data is an enormous opportunity to make the UK the home of data-driven life sciences research, innovation and development, while delivering improved outcomes for NHS patients. The Government is laying down the building blocks to realise the full potential of the scale and diversity of NHS data, while also maintaining public trust. This work falls under three broad themes:
- Ensuring secure and appropriate use of patient data
- Creating the right framework for commercial agreements involving data.
- Investments to improve NHS Digital’s core services; and to develop the Local Health and Care Record Exemplars and the Digital Innovation Hubs programmes.
- Supporting and expanding digitally-enabled clinical research.
- Creating a regulatory framework fit for the future and able to keep pace with technological developments, such as AI. For example the MHRA has successfully bid into the Industrial Strategy’s Regulator’s Pioneer Fund for £740,000 to work with NHS Digital on a proof-of-concept pilot to develop synthetic datasets that mimic real-world data to validate algorithms, including AI algorithms used in medical devices. If successful, the synthetic datasets will be made available to innovators and act as a regulatory sandbox to help with product validation.
The Government has renewed its offer of Life Sciences Opportunity Zone status, so that areas of existing or emerging strength can apply for the designation to help raise their profile at an international level.
The Government will continue to work with Sir John Bell, in collaboration with the leading UK cluster organisations and national centres of excellence, to make the UK life sciences landscape easier for investors to navigate and support growth.
The budget committed £20 million to further develop the plan for a central section of East-West rail between Oxford and Cambridge.
- On apprenticeships, the report highlights recent changes that allow for increased flexibility in use of Apprenticeship Levy funds and steps to make it easier for SMEs to take on apprenticeships.
- The Government is committed to increasing the uptake of science, technology, engineering and maths (STEM) through an external working group led by the Department of Education.