Apr 25, 2014 - that does not see research as integral to improving care, a workforce lacking research and analysis skill
Medical Innovation Consultation Team Department of Health Richmond House 79 Whitehall London SW1A 2NS By email: Medicalinnovationbill@dh.gsi.gov.uk 25 April 2014 RE: Legislation to encourage medical innovation: a consultation Summary: 1. We welcome the ambition of the Bill in seeking to address the important issue of encouraging medical innovation; innovation and its adoption can be low and slow in the NHS and there is much that can be done to improve this. 2. The draft Medical Innovation Bill appears to focus on one perceived barrier to innovation: the threat of litigation for doctors who try new treatments. Through speaking to our members we are not aware that fear of litigation is a barrier to innovation, but recognise that professional standards bodies may be better placed to comment on this. Some of our member charities have consulted clinicians with whom they have close links and have not been able to identify any notable fear of litigation among those doctors. 3. Our vision for research in the NHS1, prepared in conjunction with charities, professional bodies, clinicians, patient groups and others, identified the major barriers as an NHS culture that does not see research as integral to improving care, a workforce lacking research and analysis skills required for innovative thinking, leadership at all levels that values research, inflexible and unresponsive regulation, a medicines pricing system that does not encourage the adoption of innovation, and a lack of sharing of best practice and dissemination of research findings. A systemic approach is required to tackle these and truly and effectively encourage medical innovation for the benefit of patients. This requires all stakeholders to play an active role and work together: medical professionals; regulators; public, private and charity research funders; patient groups; and government. 4. We are concerned that some provisions in the Bill in current form could have unintended consequences and as a result may even be harmful, bypassing the important and necessary frameworks in place that ensure patient safety. Such provisions in the Bill for a case by case approach in isolation and a reliance on Multidisciplinary Teams (MDT) may be an inappropriate way to ensure responsible innovation. Research and innovation are by their nature, risky. We believe it needs to be coordinated, with a clear way to track outcomes and to share learning. The case by case approach promoted by this Bill risks subverting valuable research and safety processes that have been refined through the years, and could have unintended consequences. 5. We have set out some possible ways to improve innovation, including a possible greater operational role for Academic Health Science Networks, which oversee research and adoption but may potentially be able to review proposals for the use of innovative treatments. Although we would not rule out that a more local approach may be required, the best mechanism through which to do this needs much further thought.
1
AMRC (2013), Our vision for research in the NHS. http://www.amrc.org.uk/publications/our-vision-research-nhs
6. If the Bill were to proceed we would urge caution and encourage an active dialogue with the medical research community to try to address these important concerns about effective regulation to protect patient safety. We would be happy to carry on the conversation of how medical innovation can be achieved with the Department of Health and the other relevant bodies. Introduction 7. The Association of Medical Research Charities is the membership organisation of the leading medical and health charities funding research in the UK and overseas. Our vision is charities delivering high-quality research to improve health and wellbeing for all. Securing the best environment for medical research and innovation in the UK is key to achieving this. 8. Our members invested over £1.2 billion into UK medical research in 2012 and have consistently spent more than £1 billion on research over the past five years. Much of this investment supports research in the NHS, either directly or as part of university-funded studies. Charities want to see this research translated into benefit for patients; for this we need an NHS that is open to research and innovation and quickly adopts novel treatments. 9. The Medical Innovation Bill has a laudable aim but currently focuses on making clinical negligence law clearer to address the perceived barrier of a fear of litigation among doctors. We believe that there are other, more significant barriers to innovation; scarce parliamentary and government time might be better used to have a broad debate about how to tackle some of the barriers we have already identified that slow innovation, research and adoption. Progress of the Bill would require careful consideration of some of the unintended consequences that might result from the principles and protocols it lays down. Barriers to innovation 10. Innovation occurs on a continuum, from bench to bedside. Innovations may occur in a laboratory or in the clinic, often as a result of research. But to truly benefit patients, they must progress along the continuum through development and testing and then be adopted throughout the healthcare system. The UK has a world-leading medical research environment; effective systematic approaches to clinical research have evolved over time. In seeking to speed innovation we must be cautious not to inadvertently undo this. 11. Through speaking to our members we are not aware that fear of litigation is a barrier to innovation, but recognise that professional standards bodies may be better placed to comment on this. Some of our member charities have consulted clinicians with whom they have close links and have not been able to identify any notable fear of litigation among those doctors. 12. There are however many other important barriers to innovation that AMRC has been made aware of when talking to clinicians, patients, and other members of the medical research community. 13. Some of these barriers are within the NHS. In May 2013, AMRC published Our vision for research in the NHS2 alongside a survey of nearly 400 medical health professionals on their experience of engaging in research3. Our vision was prepared in conjunction with charities, professional bodies, clinicians, patient groups and others. Through extensive consultation work, we identified the barriers to research and innovation within the NHS and set out practical steps to address them. NHS England welcomed the report and we are 2
AMRC (2013), Our vision for research in the NHS. http://www.amrc.org.uk/publications/our-vision-research-nhs ComRes, funded by AMRC (2013), Headline findings: Medical Research among Healthcare Professionals in England http://www.amrc.org.uk/publications/medical-research-among-healthcare-professionals-england. ComRes interviewed 392 English GPs, hospital doctors and nurses online between 21st March 2013 and 5th April 2013. 3
currently working with them and other NHS organisations on how best to promote research and innovation within the health service. 14. Other barriers also exist outside of the NHS. These include a regulatory system that can make it time-consuming and expensive to setup clinical trials, a licensing system that is not equipped or flexible enough to deal efficiently with the most novel and innovative treatments, and a science budget that is being eroded by inflation, thus reducing the UK’s capacity for fundamental research on which innovation and medical progress is based. The Medical Innovation Bill 15. We support the ambition of the Medical Innovation Bill to find ways to encourage medical innovation. Our vision for research in the NHS indentified that innovation and adoption were slower than anyone would like. However in focusing on clarifying clinical negligence law, the Bill misses an opportunity to address some of the important barriers that we know are preventing patients from benefiting from medical innovation. We do not think that the introduction of this Bill will be enough to achieve its aim of encouraging medical innovation and it may even have some unintended consequences. 16. We are concerned that some provisions in the Bill in current form could even be harmful, bypassing the important and necessary frameworks in place that ensure patient safety. Such provisions for a case by case approach in isolation and a reliance on Multidisciplinary Teams (MDT) may be an inappropriate way to manage innovation and prevent irresponsible practice. It is important that innovation, whether resulting from clinical practice or through research, occurs within a proper framework to preserve patient safety, to track outcomes and to share learning. It needs a cohort approach. The Bill therefore risks subverting these important processes. 17. Without a framework in place to share findings with other doctors, the Bill is unlikely to lead to innovation at a scale or pace that patients and the NHS need. If the results of an innovative treatment aren’t made available to other clinicians it doesn’t allow a larger research study to take place or to identify when something wasn’t successful or had harmful consequences and should therefore be avoided by other clinicians. 18. The legislation proposes that the decision to innovate should be taken within the MDT. These teams are not consistent throughout the NHS and we are concerned that they may not have the necessary skills or time to assess innovative proposals. Furthermore, they are busy meetings with already great responsibility for ensuring high-quality routine care for patients, making them possibly not well placed to consider the delicate and complicated matter of potential innovative and untested treatments. Encouraging Innovation 19. A systemic approach is required to truly and effectively encourage medical innovation for the benefit of patients and maintain the UK’s position as a world leader in medical research. This requires all stakeholders to play an active role and work together: medical professionals; regulators; public, private and charity research funders; patient groups; and government. 20. The continuum described above can on average take 17 years, involves numerous organisations and currently faces many hurdles. The current government has made many welcome steps to tackle these, as they set out to do in the Strategy for UK Life Sciences. We are particularly pleased to hear that the Health Research Authority has received funding to streamline NHS R&D approvals through a single Application and Approval, and that the MHRA is implementing the Early Access Scheme. These two recent announcements, among others, are addressing barriers long-recognised by the medical research community. They will help ensure research funded by charities, industry and the
government will face fewer barriers and that innovations stemming from that research will reach those patients most in need sooner. 21. We also welcome the local focus being taken by the Department of Health. CLARHCs and, more recently, AHSNs, have been helpful developments introduced to encourage a joined up approach to research and innovation in the NHS. AHSNs may be able to provide a valuable source of oversight and advice on clinical innovation in their area. AHSNs and many other NHS organisations are still in their infancy and still evolving and we would therefore be reluctant to suggest further boards be created until the existing structures become settled. However, bearing in mind the aims of this Bill to encourage innovation, the Department of Health could explore the role of AHSNs and how best to make research expertise available to doctors wishing to innovate responsibly. In time, the Department could consider whether a panel linked to AHSNs is needed at a more local level, perhaps one for each Trust, to manage and promote innovative thinking within the organisation. These would be ideally placed to help tackle the barriers highlighted in this response and, most crucially, engender a culture change in the NHS to encourage innovation at a local level. Their links to regional and national boards would enable the coordination of innovation and its diffusion across the health service, in line with the government’s Innovation Health and Wealth priorities. Our thinking on such a panel is at an early stage but we do not see any need for legislation to enable their implementation. 22. We welcome the opportunity the bill presents to discuss how we can improve innovation and we would be happy to carry on the conversation of how medical innovation can be achieved with the Department of Health and the other relevant bodies. Yours sincerely,
Sharmila Nebhrajani Chief Executive Email: ceoffice@amrc.org.uk
