UK Diagnostics Industrial Strategy The route to a world-leading diagnostics sector Foreword – Building the diagnostics industry of the future COVID-19 has seen unprecedented levels of partnership between industry, NHS and government, building the rapid expansion of the UK’s diagnostic capacity. The immediate crisis is still with us, and BD, as well as the rest of industry, continue to work productively with government and the NHS to provide the diagnostic tools and capacity that can provide a path out of this crisis. Yet, given BD’s legacy and expertise in diagnostics, we wanted to play our part in setting out a long-term strategy for where we go from here, and the steps needed to realise the government’s objective of creating a world-leading diagnostics industry in the UK. Long before COVID-19, we knew healthcare and life sciences were going to be key sectors for the UK in the 21st century. More and more, innovation and technology will enable individuals to take on responsibility for their own health, while making health systems more productive and resilient. The NHS can be the crucible of this revolution. True population health management, with prevention and early detection at the centre, can transform patient outcomes and drastically alter the way the NHS is able to operate. In delivering this vision, there is also an economic opportunity, which the UK is uniquely well position to lead. With the NHS’ unique and vast data sets, a highly tech enabled population and one of the most advanced ecosystems for cutting-edge medical research, the UK can become one of the hubs for digital diagnosis, based on AI and deep learning; an international leader in 21st century health management. Previous gov- ernment initiatives such as the Life Sciences Industrial Strategy, Sector Deal 1 and Sector Deal 2 have sought to realise these goals, but with insufficient focus on diagnostics. This report seeks to move the thinking on, into this critical area. BD has a long and proud history in the UK, and we can see the huge potential from this transformation. We have consulted widely - with other industry partners, with experts, and across the NHS, and this report takes in the breadth of those contributions. We hope this can be a solid platform for the government to build on - a first look at the ideas and policies that could consolidate and embed the gains we have made, and build them into something lasting and meaningful for patients, the NHS and the wider economy. Mike Fairbourn General Manager, UK & Ireland Becton Dickinson Table of Contents Foreword Executive Summary Overview: the vision for the future of diagnostics Areas for action i. Building the UK as an international diagnostics hub ii. Strategic, coordinated system leadership to increase the role of diagnostics in population health iii. Consolidation and transformation of NHS pathology iv. Democratising access to diagnostics v. Broader diagnosis for better patient safety vi. Commissioning and procurement reform vii. Driving innovation and broadening uptake viii. Regulatory reform Realising the vision for transformation Appendix: full list of recommendations Executive Summary In 2020, as part of the National Testing Strategy, the Secretary of State for Health, Matt Hancock MP, set the challenge for industry to build a diagnostic infrastructure capable of delivering the population scale testing required to respond to the virus.1 In response, industry, NHS and government mobilised at an unprecedented scale, enabling a huge expansion of diagnostic capability, supported by a new delivery infrastructure and unprecedented levels of diagnostic investment. At the time of writing, COVID-19 is still very much with us, and the structures and capabilities for our response are still developing. Yet the time is also right to look at how we can build a lasting legacy from this mobilisation, and harness it towards a sustained transformation in patient outcomes and patient safety. This paper sets out a path forward to do that - the result of consultation across the sector, the NHS and policymakers. It can form the basis for a lasting strategy to embed and expand diagnostic tools across the health system, enabling the shift towards true population health and the next leap forward in patient safety – a smarter, safer NHS. Delivering this will require a whole system approach to transformation, facilitated through national leadership and clear prioritisation. It means economic and commercial reform to build our domestic diagnostic industry, while reforming the NHS and its services to enable those innovations across the system. Whilst this appears a daunting task, we are also clear that meaningful and lasting progress can be achieved through a small set of practical and distinct actions within the main themes. First, we need to build the industry and capacity that can deliver the step change in our diagnostic capability, through a refocusing and retooling of our approach. Cultivating a domestic diagnostics industry, capable of competing internationally, requires a careful, strategic assessment of the role of government, NHS (as the largest customer) and industry. The mechanisms and infrastructure by which life sciences, construction and other industries have been supported by government should now be deployed to develop our diagnostic industry. This effort should be supported by a new programme of targeted support to attract international investment; capital loans or grants, as well as a best in class concierge system, modelled along the structures used by our closest international competitors. That economic plan must be accompanied by a health strategy, which harnesses those capabilities for the maximum public health benefit. National health leaders must set a clear strategy, informed by national clinical priorities (and enabled by the right incentives) for how to use this expansion in our diagnostic assets to deliver lasting health reform, dramatically progressing the goal of preventative population health, and a lasting step forward in-patient safety. That will require focused leadership; a national effort to build the workforce, infrastructure, and capabilities that will enable this shift, and prioritisation from the top to diffuse these changes across the system. Moreover, this expansion in the diagnostic industrial base can only be effective if tied to a modernisation and transformation of our public pathology assets. COVID-19 has shown that NHS pathology networks must be a strategic national asset, but they need national co-ordination and further consolidation to perform that role. That process, in turn, must be accompanied by efforts to reform and modernise those services – national funding should be provided to drive the process of digitalising and integrating our pathology networks, equipping them to play their full role in the modern NHS and make us more resilient to future threats. The steps to build our industrial capacity, provide the strategic leadership and equip our NHS structures should all be geared towards one, overarching goal - enabling the democratisation and personalisation of access to diagnostic tools across our health system. Indeed, it requires expanding our thinking about what constitutes our “health system”, particularly through point of care technologies and at-home testing. This can only be done through the delivery and diffusion of point of care testing across our health infrastructure, and at the core of care pathways. This will require national intervention, support and leadership, to break 1 Department of Health and Social Care. Coronavirus (COVID-19) Scaling up our testing programmes [Internet]. 2020. Available from: https:// assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/878121/coronavirus-covid-19-testing-strategy.pdf down barriers between commissioning budgets. Alongside that, we need to lean into community diagnostic provision – testing better and broader in the community, supported by new facilities and further investment. Delivering change on this scale will require the whole system to adapt. Commissioning and procurement will have to adjust, with targeted measures to value and incentivise prevention across the system. We need to look again at how the system values diagnostic tools; how investment in diagnostics can be financially rewarded, rather than impeded. There has already been a huge amount of innovation in diagnostic capabilities over the past decade. That process needs to be further incentivised and sustained, but the benefits need to be realised for patients – national mechanisms and support needs to be enacted to ensure that uptake is rapid, but also broad – so that patients can truly realise the benefit. Enabling this shift will need a wider process of reform by our regulators. They will need to modernise their processes and adjust, both for this new reality and to wider structural changes, particularly Brexit. To do so, they should look to better integrate themselves into global efforts to harmonise MedTech regulation, and take advantage of existing global pathways and processes. These are the eight key areas of reform needed to realise the vision for transformation; a whole system approach. Taken together, we hope these ideas can form the basis for a national strategy to realise the potential of better, broader and faster diagnosis across our health system. The vision for the future of diagnostics In recent decades, modern health systems have increasingly come to focus on the concept of population health as the underlying principle for their organising structures. Rather than systems designed to treat patients who present with sickness, they should be restructured to identify and engage patients upstream, with a focus on prevention of ill health, or early detection and diagnosis where ill health does arise. The benefits of this approach are now widely understood. Most health conditions are much more amenable to treatment at an earlier stage, with the speed of diagnosis and intervention one of the most significant variables in patient outcomes, particularly in the NHS’ largest disease areas – cancer, CVD and diabetes. That benefit for the patient brings a wider benefit for the system.