Science and TechnologyWritten evidence submitted by The Shelford Group

Introduction

1. The Shelford Group represents the Chief Executives of England’s leading Academic Medical Centres (AMC’s) or Large Teaching Hospitals.

The 10 members collectively employ over 83,000 people with a turnover of £7,279 million. The institutions that make up the Shelford Group are of strategic significance to NHS care, the pharmaceutical industry and the wider UK economy.

2. Members

University Hospitals Birmingham	Oxford University Hospitals
Cambridge University Hospitals	Sheffield Teaching Hospitals
Central Manchester University Hospitals	Newcastle upon Tyne Hospitals
Guy’s and St Thomas’	University College Hospitals
Imperial College Healthcare	King’s College Hospital

Background

3. For several decades the UK has excelled and benefitted from its status as a global leader in the life sciences industry. The Shelford Group believes that there is great potential to secure this position for the future—especially if opportunities for joint working between industry, academic institutions and the National Health Service can be properly developed.

4. The Shelford Group welcomed the publication of the Government’s Life Science Strategy and the Innovation, Health and Wealth—Accelerating Adoption and Diffusion in the NHS reports, both published in December 2011.

5. The Life Sciences Strategy, with the confirmation of a £180 million catalyst fund to help commercialise new medical treatments, is also welcome; though it is a small amount relative to the scale of developing any medicine.. The Innovation, Health and Wealth report makes clear the importance of recognising the £4 trillion a year value of the international healthcare market and emphasises that “the NHS must do more to exploit the commercial value of its knowledge, information, ideas and people.”1

Transfer of Clinical Research and Commercialisation Abroad

6. There has been a dramatic decline in clinical trials in the UK, from 6% of the global total in 2000, to only 1.4% in 2010. Emerging economies are increasingly competitive with developed countries as places for multinational companies to establish their medical research facilities, commission and exploit research.2

7. Local experience shows that a significant proportion of high value licences are made with overseas companies. There appears to be a better appetite for funding life sciences risks in the EU and the United States of America than in the UK. This is in part linked to the end point when the products enter the market—where other healthcare markets are more ready to welcome innovation and the potential benefits obtained, rather than the difficulties of reimbursement.

The Technology Strategy Board

8. The Technology and Strategy Board (TSB) could be ideally placed to assist with commercialisation in the medical arena with large pharmaceutical and bio-tech firms, and also with instrument and device partners. Along these lines it has recently developed a stratified medicine programme in collaboration with the Association of the British Pharmaceutical Industry and the Medical Research Council. This requires industrial partnerships and is an interesting and welcome innovation.

9. However, historically the TSB, although used to the element of risk in the translation and commercialisation of research, is less experienced in dealing with medical academia and the National Health Service.

10. The nature of medical and health sectors means that there are a greater number of variables which can affect the course, speed and ultimate outcome of research. Research can be dependent upon regulatory approvals (with their unspecified timelines) and success in recruiting the number of patients required to further develop emerging clinical research.

11. As such, TSB Funding application and management requirements are less suitable for the exploitation of medical research and have demanding time-lines that are quite unrealistic for clinical trials. In addition, the requirements for lengthy quarterly reports and approvals for minor deviation from spending targets and timelines, severely limits the value of the TSB for commercialisation in the sector.

12. However, with their experience of other sectors and developing partnerships, the TSB could be very useful in commercialisation. But this does require recognition that commercialisation of medical and health research requires a more tailored approach, a more realistic and flexible approach to timeframes and a simplified application and monitoring process and acceptance of metrics that better fit clinical/medical research.

Joint Working across Government; Industry; Academia and the NHS

13. Implementing the recommendations of both reports will require departments such as the Department for Business, Innovation and Skills, the Department for Health and the Cabinet Office to work closely across their respective portfolios.

14. Government departments can also assist in bringing together the joint capabilities or clusters of internationally leading trusts, universities and industry. Concentrating on joint efforts helps provide sufficient density of patients, facilities and investigations for industry to examine rare patients and diseases.

15. One example of this would be the Global Medical Excellence Cluster (GMEC) which provides a precedent in bringing together leading universities, companies and NHS Trusts into a globally competitive base for biomedical research to attract inward investment.

16. Another model of collaboration is The Experimental Medicine Hub between King’s College London, Guy’s and St Thomas’, King’s College Hospital and South London and Maudsley NHS Foundation Trusts and a biopharmaceutical services company Quintiles. This collaboration provides a critical mass of research activity in one location. And the National Institute for Health Research (NIHR) Transnational research partnerships, that include a number of Shelford group members, which have been set up to facilitate, collaborative work with industry to accelerate the commercialisation of Intellectual Property.

17. The value of the research needs to be better recognised and one opportunity is during the appraisals of NHS Trusts. As occurs in universities outputs such as approved patents, industry collaborations and commercial activities should be seen as achievements during review.

18. Also, unlike many universities, the NHS does not have the structure to capture the value of investment in Intellectual Property. Currently the NHS invests more than £1 billion each year into primary research, but as an organisation it lacks an agreed structure to capture the value of that investment in Intellectual Property.

Enhanced Tariffs for Academic Medical Centres to Protect Fundamental Infrastructure for the UK’s Medical Science Industry

19. Academic Medical Centres (AMCs) and large teaching hospitals within the NHS provide the fundamental infrastructure for the UK’s medical science industry. As leading tertiary centres they provide state of the art training and education opportunities for the UK’s clinicians. However, the current NHS funding system is putting these leading research establishments increasingly at a disadvantage.

20. Case-mix funding systems, such as that used in the NHS, operate through allocating funding via payment systems, where a price per unit of activity is paid for service outputs provided by health services. However, these policies and rules do not adequately take complexity of care into account, and therefore the leading hospitals specialising in these more expensive treatments are consistently under-funded.3 In addition, the overheads associated with the delivery of clinical research are not taken into account in NHS funding. In time this will seriously impact the ability of the pharmaceutical industry, AMCs and large teaching hospitals to maintain their existing level of research and development in the UK, with long reaching implications for employment, exports and the economy.

21. The Shelford Group believes that a full review of NHS funding systems, to consider these issues, is required with a view to bringing funding in line with international best practice.

February 2012