Health and Social Care Bill

Lord Willis of Knaresborough Excerpts

Wednesday 9th November 2011 Lords Chamber

Moved by

[Lord Willis of Knaresborough]

39: Clause 5, page 3, line 16, leave out “have regard to the need to”

[Lord Willis of Knaresborough]

My Lords, if I may, I will say to your Lordships’ Committee that this group of amendments is about Kevin. It is also about Kate. This is perhaps the first time that we have had an opportunity to look at a group of amendments that will have an immediate and direct effect on the patients and patient outcomes. In moving Amendment 39, I will also speak to Amendment 41 standing in my name and those of the noble Baroness, Lady Morgan, and the noble Lords, Lord Walton and Lord Warner.

I should say from the outset that I am extremely supportive of other amendments in this group from noble Lords. Indeed, the fact that noble Lords from every quarter of the House recognised the importance of research and wanted to support this group of amendments demonstrates the real commitment that there is in seeing research at the centre of the new National Health Service.

I listened to the previous debate, and much of the debate on Clause 1, and so far a great deal of the debate has been about structures. Not one piece of empirical evidence has been brought forward that demonstrates that the proposed structures, either now or in previous health Bills, have been there with evidence that they will improve the service. On what we are about to discuss now, there is a mass of empirical evidence to demonstrate that putting research at the centre of the National Health Service will improve patient care and outcomes—and that, if I may respectfully say so, is really what this Bill should be addressing. How do we make things better for our patients and how do we give clinicians the very skills, tools, drugs and procedures that they need to make it better?

Your Lordships received this week a lovely bound book by the British Heart Foundation entitled 50 Years at the Heart of Health. Throughout it there are a number of very interesting statistics. One that I draw to noble Lords’ attention is fact number 24. It says that in 1961 somebody died from cardiovascular disease in the UK every 98 seconds; in 2009, it was every 174 seconds. The reason for that dramatic change was twofold: first, the clinicians dealing with those patients; and, secondly, the research they had at their disposal to make the treatments more effective. We celebrate the fact that we ended up with a significant drop of some 78 per cent in outcomes of deaths, but the reality is that far too many patients still die of cardiovascular disease, and we need the research and new techniques to be able to deal with this.

At the John Radcliffe Hospital, Oxford, an experimental new treatment using gene therapies to help prevent the onset of blindness is in its early stage of clinical trials. The use of gene therapies and of genomics and bioinformatics will make a radical difference to how we deal with our patients in future, offering them if not personalised healthcare at least far more targeted support for whatever disease they have.

Other noble Lords will speak from great professional and personal depth about the use of research and its importance. I declare two interests: first, my belief that training the workforce in giving access to research is the best way in which to improve patient outcomes—and I think noble Lords would agree with that; and, secondly, I chair the Association of Medical Research Charities, whose 127 member charities contribute more than £1 billion a year to medical research, some 30 per cent of all expenditure in this area.

We see daily the results of good clinical practice and research, but we also see the challenges that lie ahead. Of course, the UK starts from a very strong position. We are simply—and again there is clear evidence to support this—the most productive health research nation on earth when you judge the dollar input against research success. That fact was confirmed just last month by the global research report from Thomson Reuters. What we do not do nearly well enough is bring research to clinical practice quickly enough or exploit our advantage vigorously enough. To deal with that we require a quantum change in the regulatory framework and we need to use our NHS patient database far more effectively, which is why I am delighted that Amendment 40A in the name of the noble Lord, Lord Turnberg, who I will call my noble friend, begins the debate about how we use the National Health Service database much more effectively.

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[Earl Howe]

I should be very glad to do so. The noble Lord may not be surprised to hear that, when I was being briefed for this Bill, I had to ask myself that very same question. The definition is there, but I think that it would be helpful if I set out the import of that phrase in its fullest sense.

I hope that I have said enough to encourage noble Lords not to press their amendments, but, in doing so, I reiterate my thanks to all noble Lords who have made such an excellent contribution to this debate.

[Lord Willis of Knaresborough]

My Lords, I thank the Minister for, as ever, a very courteous and thoughtful response to many of the issues which have been raised, in particular his response to Amendment 39 and his undertaking to reconsider “have regard to the need to”, which appears to be a little bit of clumsy draftsmanship that would be unworthy of the Minister himself.

The Minister raised a number of important issues, including that to which the noble Lord, Lord Warner, referred. We have now had a definition of “health service” which includes public health. That means that public health research could lie within some local authorities, because a significant amount of public health will be devolved to local authorities. While I was pleased to hear the Minister say today that those people moving from the National Health Service to local authorities for public health matters would retain National Health Service terms and conditions, the reality is that they will be working under a local authority aegis and that research would therefore be an issue for local authorities rather than Public Health England—or so I understand, but we will probe that later.

On protecting funding, I was particularly grateful for the way in which my noble friend the Minister responded to the idea of ring-fencing. He spoke not of ring-fencing, but said that there had been an increase in budget. It would have been good if he could have made that comment. However, he did say that NIHR would remain a stand-alone organisation. That was news to me; I thought that it was going to move into other organisations. Quite frankly, that is good news. It has a reputation which demonstrates that research is very important and we can track how it is used and when. I thank the Minister for that.

I apologise profusely to the noble Baroness, Lady Emerton, for indicating that “research” meant the work that is coming out of universities and being translated for use at the bedside. She was quite right to remind us that “research” for the purposes of this Bill was all research, and that what should underpin all public policy, in the NHS or anywhere else, is research which gives you evidence to inform policy decisions. I thank her for that rebuke.

[Lord Warner]

I do not want to prolong this debate. I will read very carefully what the Minister said about protection of finance. We may want to come back to this issue to be reassured that all is well.

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[Lord Willis of Knaresborough]

I beg leave to withdraw the amendment.

Amendment 39 withdrawn.

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Moved by

[Lord Willis of Knaresborough]

41A: Clause 5, page 3, line 19, at end insert—
“( ) the proper conduct of research by establishing such structures and procedures as he deems necessary to prevent, detect and impose sanctions on research conduct”

[Lord Willis of Knaresborough]

I shall be very brief. In simple terms, the Secretary of State now has a duty to promote research. Clearly, that research must have integrity, and this amendment is about protecting that integrity. I think that we all agree that medical research is crucial to the UK’s healthcare system, the economy—as the noble Lord, Lord Darzi, made clear in our previous debate—and our standing as an international research community. I make it clear to the Committee that the claim that the incidence of malpractice is widespread is wrong—there is not widespread malpractice in health research or in any part of our research base—but it would also be wrong to say that we have a perfect system and there is not some malpractice.

While peer review is an extremely robust method for assessing the quality of the science and the research, it was never intended as a mechanism to detect fraud. There is an assumption when you peer-review a piece of research that the data are accurate and that what you are doing is looking at the methodology, the evidence and the conclusions to see whether they stand up to scrutiny. You do not simply go back and look at the whole of the data.

We know that there are a number of irregular goings-on at various levels of research, particularly at junior level, from ghost-writing and guest authorship to plagiarism and falsification of data. As science, particularly medical science, relies on trust, it is important that we have a robust system in place which guarantees research integrity as far as it is possible. Andrew Wakefield, who built the case against the use of the MMR vaccine, based his evidence on a very small sample, falsified the data and manipulated patient records. It is clear that we need a system that would prevent that happening again. The reality is that it took seven years before that research was fully retracted and, to this day, the level of MMR vaccine uptake remains below the 95 per cent that we would regard as sufficient to confer immunity on the population. In other words, that incident of malpractice continues to have an effect. Children are being affected as a result and mothers in particular are worried.

The House of Commons Science and Technology Select Committee recently looked at peer review in scientific publications and reported on 18 July. One of its recommendations was:

“Oversight of research integrity in the UK is in need of revision. The current situation is unsatisfactory. We are concerned that the UK does not seem to have an oversight body for research integrity that provides ‘advice and support to research employers and assurance to research funders’, across all disciplines”.

Interestingly, the Government said in response:

“The Government agrees that action on assurance of research integrity is required”.

They went on to say, quite rightly, that it was the responsibility of employers, whether they be universities, research laboratories or private organisations, to guarantee the integrity of their research. They said that they did not want there to be a new research integrity agency or an equivalent, but, instead, a “Research Integrity Concordat”, which brought together universities and bodies involved with research and which the Government would oversee.

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[Earl Howe]

My Lords, Amendment 41A, tabled by my noble friend Lord Willis, will require the Secretary of State to set up a system to ensure that research is conducted properly and ethically and that there are sanctions in place in cases of misconduct. Let me say straight away that I am in agreement with the intention of my noble friend in tabling this amendment; the proper conduct of research is very important, just as proper conduct is critical in clinical practice. All my noble friend’s comments on that theme were extremely pertinent.

Looking at the amendment as it is worded, I can assure my noble friend that there are already systems in place to ensure that research is conducted ethically. Research, as he knows, cannot proceed without ethics committee approval. I realise that this is a probing amendment, but equally, as it is worded, it overlooks an important element in the current system of accountability, because it would risk undermining the clear responsibility in research, as in clinical practice, that employers have for the conduct of their employees and that professional councils have in regulating their members. Both can impose sanctions on researchers if their conduct is found to be inappropriate. I do not see that it is the responsibility of the Secretary of State to impose sanctions on clinical professionals, and it should not be his responsibility to do so for researchers. In the future, the Health Research Authority will continue the good work of the National Research Ethics Service, working with others to prevent misconduct by ensuring that the ethics of research have independently reviewed by research ethics committees.

This evening, I am able to give a new commitment to my noble friend. I am happy to tell him that we intend to publish the draft clauses on research for pre-legislative scrutiny in the second Session of this Parliament. That scrutiny will enable my noble friend and other noble Lords to comment on the detail of our proposals for the Health Research Authority and, in turn, enable us to ensure that future legislation is fit for purpose. I hope my noble friend will welcome that pledge.

If I may, I will cover the question my noble friend asked me about the concordat in a letter to him following this debate. I hope I have reassured him that there are systems in place to ensure good conduct in research. Nevertheless, his points are well made and I shall reflect fully upon them. I can only say at the moment that the Health Research Authority intends to build on these systems. In the light of what I said, I hope my noble friend will feel able to withdraw his amendment.

[Lord Willis of Knaresborough]

I am grateful to my noble friend the Minister for that response. In view of it, I beg leave to withdraw the amendment.

Amendment 41A withdrawn.