Health and Social Care Bill

My Lords, I am delighted to follow the noble Baroness, Lady Morgan, and particularly to support her comments about the duties in respect of research. But perhaps I may also say that the noble Baroness, Lady Thornton, raised a very important issue in her opening remarks, which is the definition of the difference between a duty to provide and a duty to commission. There is a subtle but important difference between the two. Commissioning, as the noble Lord, Lord Warner, clearly stated, is something for which there is a huge budget, so it is very important indeed that it is used effectively. I was particularly interested in Amendment 129A tabled by the noble Lord, Lord Warner. We are all puzzled about the Government’s intentions in terms of prizes and incentives to encourage innovation and to bring research out of the labs, if you like, to the bedside. There are some extremely good examples of this. The noble Lord, Lord Warner, mentioned the work of his noble friend Lord Darzi, particularly the Health Innovation Challenge Fund. I have just finished chairing the fund’s three-year review, and it is interesting to note that three years into the five-year programme, new devices, technologies and procedures are being brought forward from research to clinical outcome. Some 13 of these are now up and running, and some are quite remarkable. We have seen the groundbreaking research to deal with the onset of blindness being undertaken at Oxford. Within five years we will have gene therapies that will make a huge difference to patients suffering from a whole range of conditions, including macular degeneration. That will have a massive effect not only on patients’ lives, but also on the health service budget itself. It is important work and there are other good examples on which we need to move forward. I want to speak specifically to Amendments 215 and 218 tabled in my name and those of the noble Baroness, Lady Morgan, and the noble Lords, Lord Patel and Lord Turnberg. I should also declare an interest as chair of the Association of Medical Research Charities. Amendment 215 concerns the role and responsibilities of clinical commissioning groups towards research and includes, within their commissioning plans, how they intend to execute their duty as defined in new Section 14X. That commissioning groups should have a duty to promote research was recommended by Professor Steve Field, the chair of the NHS Future Forum, when he said in his report: "““Support for research and innovation is also important for evidence-based commissioning and practice, so the report recommends that commissioning consortia should have a duty to promote research and innovation and the use of research evidence in the NHS””—" a recommendation which was immediately taken by the Government, to their credit, and, indeed, was welcomed by the medical research community. It is important that that is in new Section 14X as inserted by Clause 22 of the Bill. However, as the Bill stands, there is a duty on commissioning groups to promote research but absolutely no mechanism to make sure that it is actually done. There is a duty without the wherewithal. Amendment 215—it is a simple but effective amendment—does exactly that by making it clear that the CCG commissioning plan should include clear evidence about how commissioning groups propose to carry out their duty to promote research. I cannot believe that the Government cannot accept that very simple amendment to put that into practice. I think it is very helpful. However, this amendment goes further than that because it seeks clarification from the Minister about ““evidence based commissioning”” and how a ““research aware culture”” is to be embedded in the NHS through clinical commissioning groups—the very things that Professor Field recommended and the Government supported from the Future Forum. Clinical commissioning groups will have to report in their commissioning plans how they have sought improvements in quality of services, patient care and, indeed, how they have worked alongside their counterparts in health and well-being boards when developing their plans. Why not include in those plans how research is being used too? It makes good sense to have that as a separate issue. If the clinical commissioning groups’ approach to commissioning services is to be informed by evidence, then research is a fundamental part of securing that evidence. Research and patient benefits are two sides of the same coin. By making research part of the commissioning plan for CCGs, Amendment 215 would automatically trigger a requirement for outcomes to be included in the commissioning report. Also in the commissioning report—a matter alluded to the noble Baroness, Lady Morgan—was how the costs for non-commercial clinical research in the NHS were to be met and, specifically, the role that excess treatment costs play in supporting this. Clearly, the Government decision to confirm the continuation of this funding stream to support, in particular, charitable funders undertaking clinical studies in the NHS is very much welcome. However, there is considerable uncertainty around just what is being proposed by the Government, particularly following the Minister’s comments on 5 November. I cannot stress sufficiently just how crucial the medical research charities are to medical research in the NHS. In 2009-10 more than 3,000 clinical studies were conducted using NHS patients. Thirty-seven per cent of them were funded by AMRC charities and, in the case of clinical trials for cancer, 75 per cent of all cancer patients involved in clinical trials were on Cancer Research UK funded trials. Clarifying how costs will be apportioned is hugely important. The Minister has assured us that systems and processes will be in place for meeting these costs but implied that both the NHS Commissioning Board and clinical commissioning groups will have a role in ensuring that they are funded by the NHS. However, as clinical commissioning groups will commission secondary care, will excess treatment costs occurring on a research study taking place in secondary care come from a clinical commissioning group’s budget? Similarly, if the NHS Commissioning Board is responsible for commissioning primary care, will the NHS Commissioning Board be liable to cover the excess treatment costs associated with research studies conducted in primary care? At present, these costs are covered via the PCT commissioning budgets. In its review, the Academy of Medical Sciences identified that mechanisms in place for trusts to claim these costs were not clear, they were not consistent and, in turn, led to many trusts becoming disincentivised to undertake clinical research. In fact, there are examples of PCTs refusing to meet excess treatment costs in certain studies, leading to delays in getting the studies set up and therefore effecting patient outcomes and care. The Bill is an opportunity to send out a clear message and I hope that in responding the Minister will be able to put the record straight and, if not, to write to us as he often does. Amendment 218 examines the role of the NHS Commissioning Board and how it will assess and encourage research to be undertaken by the NHS. Within the new structure there are a large number of bodies with research functions or an interest in research. There is the National Institute for Health Research; the NHS Commissioning Board; Public Health England; the Health Research Authority to be set up; NICE; and, of course, local commissioning care groups. NIHR will stay in the Department of Health, outside the NHS Commissioning Board, and retain its research budget to provide funds to support the infrastructure for research with clinical research networks and biomedical research centres and units. It is essential that this infrastructure is appropriately aligned with NHS activities. The NHS Commissioning Board will include a medical director who, I understand, will have responsibility for research. Presumably this will include executing the NHS Commissioning Board’s duties towards research. Can the Minister confirm that is the case? What is not clear is where the buck stops with regard to the leadership of research culture throughout the NHS. The Government have accepted a commitment to embed a research culture in the NHS. Amendment 218 is an attempt to clarify the role of the NHS Commissioning Board's duty to promote research and its duty to lead CCGs in their duty as well. This amendment recognises that co-ordination between all the bodies will be critical to identify and implement national strategic priorities for research. The link between the NHS Commissioning Board and the CCGs will be crucial. If we do not get that right, and we do not get the leadership, then heaven knows where we will get to. CCGs will need clear leadership from the NHS Commissioning Board as to how they are expected to carry out their duty towards research, which is why the Commissioning Board’s research leadership role must be made clear. We have evidence from programmes of work such as the North West Exemplar Programme that we need a culture shift in the UK better to embed research as a core part of the NHS. The intention behind Amendment 218 is simply to make it a requirement for NHS Commissioning Board to assess the performance of each CCG when carrying out its duty to promote research. This would complete a virtuous circle whereby both the NHS Commissioning Board and the local commissioning groups would have to define how they would carry out their duty on research and then report on it in a way that could be openly challenged. It seems a sensible way to progress and gives a clear definition as to what should happen. I hope the Minister will accept both Amendments 215 and 218.