The challenges of the COVID-19 pandemic are well known, and continue to affect countries across the world. What has been impressive during this period has been the ability of the life sciences sector to respond at speed. The UK has been at the forefront, with industry, academia, Government and the NHS collaborating in an unprecedented way to sequence strains, and develop vaccines and treatments to meet the threat head on, and at pace.
UK Government hopes to apply the same set of levers to the “silent pandemics” like cancer, obesity, dementia and ageing. The Life Sciences Vision sets out a new 10-year strategy, targeting seven critical healthcare missions:
- Improving translational capabilities in neurodegeneration and dementia
- Enabling early diagnosis and treatments, including immune therapies such as cancer vaccines
- Sustaining the UK’s position in 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 UK and globally
- Addressing the underlying biology of ageing
- Increasing the understanding of mental health conditions, including work to redefine diseases and develop tools to address them
These are selected as areas that have been neglected for several reasons, such as the cost and complexity of developing appropriate products and the regulatory challenges in getting them approved.
The Vision is described as a high level document setting out ambitions for the coming decade rather than specific programmes. More detail on delivery plans are promised after the Spending Review. It recognises both the strengths and weaknesses of UK life sciences.
Rocket boosters and headwinds
It is undeniable that the NHS is a key strength for the UK, but it is the rich combination of a comprehensive healthcare system with a world-class medicines and biotech industry, clinical research and genomics capability, universities, medical charities and regulator that makes the difference, and provide a differentiator for the UK. Together these form a powerful mix operating collaboratively to create, test and implement new therapeutic approaches.
However, the Vision recognises some of the headwinds that the UK life sciences sector faces. Among these is a relative weakness in the size of the fundraisings available on the UK public markets, in particular when compared to Nasdaq, where valuations for life sciences companies can be 20-30% higher than compared to the LSE, meaning that late-stage capital raising may go overseas. In addition, whilst the UK has a strong pipeline of SMEs, challenges in the UK VC market can result in later stage UK companies looking to US investors, when raising funding to reach their potential.
Rapid access to innovations has also been an issue in the past, although the report points to recent efforts to improve this. Health technology assessment by the National Institute for Health and Care Excellence (NICE) does well in international comparisons. However, widespread uptake across the NHS performs less well.
A challenge that is mentioned, but not tackled head on, is the separation between the health systems of the four UK nations. During the COVID-19 pandemic, these have operated separately and not always with seamless coordination. The best outcomes would flow from the UK working as a whole, and this will require a degree of diplomacy as well as efficiency.
Points to note
There is a great deal more in the Vision than we touch on here, but we focus below on a few areas where we see important policy development.
Bringing together health data in a usable way offers huge potential, and is recognised as a “precondition to the success” of the overall Vision. Doing this effectively means meeting not only technical challenges, but also hurdles of trust and transparency. There are rumbles of concern among both press and public over making health data available to commercial organisations. And, of course, compliance with data protection law must be respected, and must be seen to be respected.
Access to finance
The Vision points to policies and initiatives focussed on improving the accessibility and availability of capital to growing life sciences businesses. New workstreams will look to establish a scale-up taskforce; develop the VC ecosystem; launch a £200m Life Sciences Investment Programme through British Patient Capital, with a view to delivering £600m long-term capital; and strengthen the public markets ecosystem building on Lord Hill’s UK Listing Review.
The recent Taskforce on Innovation, Growth and Regulatory Reform report (TIGRR) highlighted opportunities to review and streamline regulation in the UK following Brexit. The Vision brings together ambitions to makes regulation simple to navigate, and integrated/aligned with the requirements of NICE and NHS England. Three core areas will focus on:
The development of new systems and pathways like the Innovative Licensing and Access Pathway for approval of ground-breaking medicines
For devices, the Vision notes an intention to develop a new best-in-class medical devices framework. This would include elements of the new EU MDR and IVDR regulations, but also “aggressively explore and execute improvements that further support innovation and drive patient safety.
Partnership working and system join-up
Aligning the regulatory role fulfilled by the MHRA with NICE, NHS England, NHSX and the NIHR is likely to offer a real boost to innovators, particularly smaller ones with a limited budget for compliance. At a recent healthtech working group meeting, participants noted the labyrinth of rules and standards that a new product or service must pass through and there was real optimism about the Vision’s promise to cut through this.
Innovation in multi-party commercial deal structures is also highlighted as a likely source of benefit to patients.
The global context
Cooperating internationally, now that the UK stands separate from the EU, will of course be key. Some of the joint regulatory working initiatives already under way are mentioned (Project Orbis, the Access Consortium), along with a commitment to engage enthusiastically in international forums (ICH, IMDRF, MDSAP) and regulatory cooperation via free trade agreements.
The Vision emphases the need to invest in and support clinical research. The NHS will be incentivised to actively participate in research and innovation, and leaders will be expected to support it. The major restructuring of the NHS in England (see our Integrated Care Systems Hub for more information) will create duties for Integrated Care Systems to promote research and innovation.
Now – deliver!
This renewed commitment to life sciences is very welcome. At a time when Government is stretched both in terms of financial resources and attention, a long-term, considered plan is what the sector needs. Some important concerns are brought out – although it is not always clear how Government policy can effectively address them. What we need to see now is consistent, focused delivery in the areas where it can.
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