Over the last 15 months some of our Monitor Deloitte colleagues have been working with the Office of Life Sciences to help the UK establish a programme of accelerated access to clinical innovation for NHS patients and a healthy environment for the Life sciences industry. This week's blog introduces the latest results of our involvement – the publication of a 'How to Guide' from early idea development through to large scale adoption.

The UK is home to a dynamic healthcare and life science industry. This is driven by supportive national policies, strong investment, a reputation for scientific research, a large pool of academic talent and our universal NHS. The following statistics illustrate just how important this industry segment is to the UK1

  • the NHS sees over 1 million patients every 36 hours
  • NHS expenditure on medicines in 2014-15 was £15.5bn
  • NHS expenditure on clinical supplies, medical devices and consumables was £4.5bn in 2011/12
  • the UK Life Science Strategy included an investment of £310m to support the discovery, development and commercialisation of research
  • the UK has a strong heritage in medical innovation: for example UK led research reduced the time taken to sequence the human genome from 10 years to less than a day
  • the UK is renowned for health research and has the most integrated clinical research systems in the world, the NIHR (National Institute for Health Research)
  • the UK life sciences industry turns over c. £50bn annually.

However, not all news is positive. Although the UK is seen as a leader in many areas, we are falling behind in the adoption of some categories of clinical innovation and the UK life science industry has lost global prominence relative to a number of other markets. For example although the number of new clinical trials registered grew between 2006-20122 we now risk losing out on new trials where the NHS is no longer seen as the gold standard of care, e.g. in the use of innovative cancer drugs and diagnostics3.

To address these challenges and with the intention of making the UK the global leader in Life Sciences, the minister for Life Sciences, George Freeman MP, announced the Accelerated Access Review in November 2014 and the review's independent chair was appointed in March 2015. The stated aim of the review was to consider how to speed up patient access to cost-effective and innovative medicines, devices and diagnostics.4

Since March 2015 Deloitte has been supporting the Office for Life Sciences in a number of work streams of the Accelerated Access Review. Our first piece of work was an assessment of the barriers to getting patients faster access to innovation with partners King's Fund and CASMI (Centre for Sustainable Medical Innovation). In this month long engagement we spoke to over 50 people across the health ecosystem and held workshops with more than 135.

Many individual barriers were found and we classified them under four key headingsiii:

  1. stakeholders and organisations are not aligned with the explicit goal of working together to bring innovations more reliably and rapidly to patients
  2. many incentives in the current system are counterproductive for the adoption of innovation
  3. data and evidence is not being used as an effective enabler
  4. cultural barriers such as risk aversion and mistrust between NHS and industry.

The draft recommendations from the review were published in October 20155 A key finding was that SMEs can find it difficult to navigate the innovation pathway. One of the areas identified as a quick win in the draft recommendations was providing a how to guide for innovators and small to mid-sized Life Science and Digital Health firms. We therefore supported the OLS in early 2016 to develop this guide. This was published by the Department of Health on 25th May in beta version6. This beta version is the first published draft of a live document and invites any feedback to the Accelerated Access Review team on how to improve usability and content. It will be updated regularly to reflect the fast moving policy and stakeholder landscape in this space.

When the final AAR recommendations are released, which is expected to be in late summer, the guide will be updated to include the recommendations on changes to the innovation environment as part of the review.

This guide is the first time that the entire clinical innovation pathway landscape for innovators in the NHS has been mapped out, from early idea development through to large scale adoption. Details of parts of the innovation pathway have long been mapped out by organisations such as NICE (National Institute of Health and Clinical Excellence) and NIHR (National Institute of Health Research), but this guide makes navigating pathway accessible for all. The intention is that the guide should prove a major step forward in the adoption of innovation in the NHS, and will be particularly helpful for innovators new to the UK health environment or those interested in learning about best practice to accelerate the adoption of a product already under development. The true test of the guide will be in how it achieves its aim of providing a greater understanding of the pathways for adoption of clinical innovation in the NHS and facilitating the adoption of SME products in the med tech and digital categories.

Footnotes

1 https://www.gov.uk/government/organisations/office-for-life-sciences
2 http://www.appliedclinicaltrialsonline.com/decline-clinical-trials-central-and-eastern-europe-fluctuation-or-trend
3 https://www.gov.uk/government/publications/medical-treatment-innovation-barriers-and-opportunities
4 https://www.gov.uk/government/news/major-investment-in-life-sciences
5 https://www.gov.uk/government/publications/accelerated-access-review-interim-report
6 https://www.gov.uk/government/publications/innovation-pathway-for-nhs-products

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