Medical Schools Council (MSC) and the Association of UK University Hospitals (AUKUH) – Written evidence (LSI0081)

In addressing these issues from a bio-medical perspective, it is important for the Committee to understand that the NHS is not simply an expense line in the UK’s profit and loss account – but a public good which the public wishes to have provided and from which Society derives great benefit – a huge asset from the balance sheet perspective. Further, the NHS is a great deal more than direct patient care – its key pillars are research and education leading to ever-enhanced patient outcomes.

Science and innovation

3. What can be done to ensure the UK has the necessary skills and manpower to build a world class life sciences sector, both within the research base and the NHS?

The members of the Association of UK University Hospitals (AUKUH) and of the Medical Schools Council (MSC) work at the complex interface between the NHS, universities, funders and the commercial life sciences sector. Medical Schools and their cognate NHS Trusts and associated boards are the most significant sites of collaboration and innovation in the health service and offer a natural cooperation and coordination forum for discussion and planning. The UK’s model of close collaboration between the NHS and universities has permitted huge advances – for example technology enhanced surgery – as a direct result of this model. They also educate and train current and future generations of researchers and healthcare workers and so are ideally placed to ensure effective implementation of the proposed strategy – if current barriers to implementation can be removed.

There needs to be wider funding and support for Doctoral Training Partnerships linked to a number of Research Councils given the multi-disciplinary nature of Life Sciences. As regards discovery science relevant to this sector, the model of PhD cohort training as advocated by the Wellcome Trust, is a durable and effective model. Essentially, a group comprising two or more Basic Scientist PhDs and two Clinical Scientist PhDs work on common projects. They meet regularly and each PhD student is supervised by both a basic scientist and a clinician. This is attractive to both commercial and charitable funders. Another effective model which operates at both graduate and postgraduate level is the Knowledge Transfer Partnership programme, which can encourage the development of professional expertise and collaborative research between industry and an academic/NHS partner. Again, there needs to be clearer alignment between this programme and the Life Sciences industrial strategy to ensure that this a feasible option at scale. In the same vein, undergraduate provision to address any skills gaps in the sector and the role of degree apprenticeships needs to be considered.

In terms of ensuring a “world-class” sector, maintaining the UK’s involvement in global and EU research funding streams is essential. More broadly, the infrastructure that permits global collaboration to take place and which will be essential for undertaking any basic and translational science, and for attracting world-class staff into the sector must be maintained. Brexit undoubtedly poses a threat and the Government must be encouraged to adopt a strategy that welcomes international talent and facilitates long term settlement in the UK for research workers and their families. The proposal for a recruitment fund to attract exceptional researchers to the UK is welcome.

Significantly greater investment must also be made in the whole clinical workforce at all stages of their careers and in particular in the clinical academic workforce which is shrinking. Reversal of this trend must be a priority. Supporting Professional Activities (SPAs), which encompass, research, education, continuous professional development etc but which lie outside direct patient care need to be available at 25% not 10% of a doctor’s time as is becoming the case for new consultant appointments. It will also be necessary to develop the portfolio of roles within the NHS which will facilitate the clinical outcomes of the research themes John Bell has identified. For example, the wider use of Physician Associates, and of healthcare technicians who are specialists in personalised healthcare technology, and greater opportunities for nurse-led research and development.

Industrial Strategy

6. Does the Life Sciences strategy contain the right recommendations? What should it contain/what is missing? How will the life sciences strategy interact with the wider industrial strategy, including regional and devolved administration strategies? How will the strategies be coordinated so that they don’t operate in ‘silos’?

MSC and AUKUH believe that this is an outstanding report. It has their complete support. They are determined to ensure that no stone is unturned in facilitating its delivery throughout the UK – and not simply within the Golden Triangle. There are impediments to delivery in the current system and they need to be rapidly identified and overcome if the UK is to compete at pace and scale in a fast-moving global environment. The establishment of UKRI brings an opportunity to support industry-academic collaborations in a more flexible and agile way to ensure that the UK’s world-leading research is translated into patient benefit and economic growth for the whole of the UK. The environment must continue to support research across the whole ecosystem of academia, industry, the NHS and charities – this must also extend to Government with more joined up, evidence based decision making between departments and administrations.

There are many examples of innovative and productive collaborations between the NHS and universities. Indeed, the development of functional joint research governance and leadership arrangements between academic centres and Trusts is key to success. Extending this more comprehensively to industry will be an important development.

One of the recommendations within John Bell’s strategy is the enhanced support for Life Science clusters, including establishing the right infrastructure to support growth, but also to ensure joined-up operations between the clusters to facilitate a “single front door” to UK research and development. There is no doubt that having an integrated approach to national, industrial, regional and local strategies, will be a challenge. But, effective coordinating activity around such clusters will be a way of ensuring that regional approaches to industry growth meet the needs of the regional demographic and the regional healthcare system in a more consistent way. Both MSC and AUKUH support this development and the exploitation across the entire geography of the UK. The unique demographics of the regions means that regional clusters are likely to have more focused impact but this is unlikely to be without national implications. An example is the joint Life Sciences initiative between QMUL and Bart’s Health NHS Trust, which harnesses expertise in genomic and phenotype mapping of the local population to address the inequalities in healthcare provision and to directly inform personalised patient care.

The report rightly emphasises the role of the NHS as a partner to realise this ambition. Life Sciences remains an area of government that is reserved to Westminster yet health is devolved to the four nations. The report emphasises NHS England but makes little reference to the NHS in the other 3 nations. 14.9% of UK Health Research expenditure is outwith England of which 11.8% is in Scotland (UKCRC, 2015). It will be important that attention is paid to the NHS in all 4 devolved nations for the impact of this report to be realised.

The programmes proposed as part of the Health Advanced Research Programme are welcome and the four suggested opportunities have real potential. Other well-argued blue sky suggestions should not be excluded from the HARP initiative.

7. What opportunities for small and medium sized enterprises (SMEs) are there/should there be in the strategy? How can they be involved in its development and implementation?

The Life Sciences Strategy also touches on fiscal and tax reform to ensure that the UK’s tax environment is internationally competitive in supporting long-term investment. It might be prudent to be more explicit about the ways in which the tax system, as it is currently established, inhibits research activity and the collaboration that the Strategy is endorsing: greater integrated working between industry, the NHS, and the research sector is hindered by tax regulations which govern space usage and dictate segregated working between industry and academic researchers. SMEs are vital in delivering exponential growth to industry, and therefore consideration should be given to minimising the impact of business and VAT rates for SMEs which are engaged in joint Life Science research and development.

SMEs are crucial to the economy. Mutually beneficial partnerships with academic centres should therefore be encouraged and facilitated. Universities need to be cognisant of the cash flow pressures under which SMEs operate and be realistic in their expectations of the contributions from each party. Risks should be shared together with IP in order to facilitate rapid commercialisation. Additional skills in business and entrepreneurship should be developed within universities. SMEs working in devices, diagnostics and digital technologies are widely spread across the UK and need to be nurtured.

8. Where should the funding come from to support the implementation of the strategy?

The Life Sciences Strategy makes clear that the UK falls well behind its competitors in R & D spend as a proportion of GDP. In order to remain internationally competitive, we support the suggestion that spending increase to 2.6% of current GDP in order to move the UK into the top quartile – which already includes the US, Japan, Korea, China and Germany. A possible decrease in GDP as a result of Brexit should not be permitted to influence back-tracking on the suggested investment. Investment in R & D is a logical and constructive method for climbing out of recession.

Funding to support the implementation of the strategy should be, 1/3 public funding for long-term investment in infrastructure, expertise, and skills development; 1/3 business-funded R&D and private investment; 1/3 joint public and private investment awards.

9. How do the devolved administrations and city regions fit into the strategy? Scotland has its own life sciences strategy, how will the two interact?

There is a governance tension in that Health is a devolved activity whereas the Office for Life Sciences although a reserved aspect of Government functions through NHS England. This creates administrative complexity and makes the necessary coordination challenging. The contributions of the different regions and nations needs to be exploited and supported - the strategy currently focuses almost entirely in England and on the Golden Triangle whereas the significant health burden is to be found in more rural areas with rapidly growing ageing populations. Trickle down benefit to deprived areas of the country from this approach is less likely to success than an overt involvement with regional organisations and the devolved nations. Their healthcare administrations need to be equally engaged and supported. Ensuring a joined up strategy should be a priority for all four Governments. In addition, it should be recognised that our best health care innovations are often developed in partnership with academics – the triple helix of industry, academia and NHS is a strength of the UK which should be supported.

NHS procurement and collaboration

10. How can public procurement, in particular by the NHS, be an effective stimulus for innovation in the Life Sciences Sector? Can it help support emerging businesses in the Life Sciences sector?

The NHS is both a driver for innovation and a market for innovative technologies, treatments and products. Unfortunately, the NHS procurement processes massively inhibit and put off SMEs and research organisations. Examples include tendering for research software (E-dge for CPMS), drugs for clinical trials and bidding for research networks (eg NIHR CRN and NIHR clinical trials units). In all cases the complexity and arcane rules make it very difficult to bid and put many off, especially SMEs. Rigid policy-based approaches reduce and stifle innovation and mechanisms to address this need to be found. Trusts need effective champions for research and innovation to achieve the necessary culture change for more rapid adoption.

11. How can the recommendations of the Accelerated Access Review be taken forward alongside the strategy? Will the recent changes to the NHS England approval process for drugs have a positive or negative effect on the availability of new and innovative treatments in the NHS? How can quick access to new treatments and the need to provide value for money be reconciled?

When George Foreman was Minister for Life Sciences – a post which has unfortunately been cut – he announced the Innovative Medicines and Medical Technology Review. This became the Accelerated Access Review but the focus was still how to speed up patient access to cost effective and innovative medicines, devices and diagnostics. Although the report came out nearly a year ago there is still no formal government response merely references to the need to be mindful of the need to ensure affordability.

The issue of excess treatment costs directly inhibits NHS trusts from undertaking clinical trials that will generate the evidence to inform evidence-based commissioning with improved clinical outcomes and reduced costs.

It is important to understand how the Accelerated Access Review will be implemented in the NHS of the devolved nations.

12. How can collaboration between researchers and the NHS be improved, particularly in light of increased fiscal pressures in the NHS? Will the NHS England research plan help in this regard? How can the ability of the NHS to contribute to the development of and adopting new technology be improved?

More needs to be done to cement effective partnerships between universities, the NHS and industry.

Unfortunately the NHS England research plan has no detail consisting mainly of broad statements https://www.england.nhs.uk/wp-content/uploads/2017/04/nhse-research-plan.pdf

However, NIHR has been transformative over the last decade and Professor Whitty’s recent review promises a constructive way forward. NHSE and CCGs need to understand the requirement within the bigger picture to fund Excess Treatment Costs (ETCs). as new models of care, treatments and interventions will often ultimately save money.

Bristol has for example just been awarded a £2.8 million NIHR HTA grant to look at the use of biologics for ophthalmology. The ETCs are indeed large and despite fine words from NHSE and CCGs saying they would support the trial, a decision confirming this has yet to be taken.

The other challenge is how to join up existing research and AHSNs. Many AHSNs seem to do some research/implementation, but not linked to major studies already underway. AHSNs work on a shorter timescale and so although they should be good at putting research into practice, they are not. A fund for implementation of good research / start-up of implementation costs etc., would be an effective way to address this. The research landscape is also somewhat crowded with a variety of centres, networks and co-ordinating groups and care needs to be taken to ensure that local strengths are built upon and information sharing optimised. Team science needs to become a reality for the benefit of the whole of the UK.

Another issue is that SMEs producing innovative products can find it challenging to engage with the NHS. Efforts must be made to improve uptake of innovative products by the NHS, building on the promising early start being made by Academic Health Science Networks. It is clear that NHS procurement approaches and systems for setting reimbursement tariffs, together with the sheer number of purchasing or commissioning organisations within the NHS, can, make it very difficult for SMEs to find a route to market. This should be reconsidered if the NHS is to be a good customer for the sector.

Despite these caveats the interwoven nature of the NHS, academia, and industry provide a unique strength of the UK and should be strongly supported through flexible and agile funding.

Responsibility and accountability?

13. Who should take responsibility for the implementation of the Life Sciences Industrial Strategy and to whom should they be accountable? What should the UK Government’s role be? What should the role of the academic, charitable and business sectors be?

The establishment of UKRI provides an ideal vehicle for the delivery of the strategy by ensuring that the Research Councils and Innovate UK respond to identified priorities and support NHS-Industry-academic collaborations in an agile manner. It will be important to involve the whole of the UK and not just England.

However accountability for the success of the Strategy should ultimately rest with Government, and growth should be measured by the Government’s Annual Life Sciences Competitive Indicators. Implementation will inevitably require cross-sector and cross-institutional working, and any organisation receiving public funding within the Life Sciences remit should be accountable, through annual reviews, for reporting on success against investment.

15. Does the Government have the right structures in place to support the life science sector? Is the Office of Life Sciences effective? Should the Government appoint a dedicated Life Sciences Minister? If so, should that Minister have UK-wide or England-only responsibilities?

We would support the reinstatement of a Life Sciences Minister with a UK-wide remit. In order to derive maximum benefit from the digital revolution anonymised patient data from every interaction within the NHS needs to be captured and made available for research. Patient outcomes are demonstrably better in research active environments, patients are keen to become involved in trials and rapid progress is required to allay concerns if this unique opportunity is not to be lost. A clear and consistent way forward for access to anonymised patient data for research, in the context of the recommendations of the National Data Guardian, is probably the single most important recommendation this Committee could make.

Brexit

16. What impact will Brexit have on the Life Sciences sector? Will the strategy help the sector to mitigate the risks and take advantage of the opportunities of Brexit?

Scientific collaboration across borders and the free movement of people has been hugely beneficial to the Life Sciences Sector in the UK and the current situation poses a grave threat.

17. How should the regulatory framework be changed or improved after Brexit to support the sector?

For access to global markets the UK needs to continue to remain aligned with the EU

15 September 2017