Health and Social Care Bill
Lord Willis of Knaresborough Excerpts(12 years, 9 months ago)
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Lord Beecham
My Lords, I welcome the noble Baroness’s amendment, particularly because it extends the implicit obligations under Clause 3 from the individual to the locality. It includes individual access, of course, but it speaks in terms of an equitable service being commissioned either for the individual patient’s condition or in their locality, and that enhances to a considerable degree the provision of Clause 3 and its proposed amendment to the 2006 Act. The drafting of proposed new Section 1B is a little odd, it might be thought. The intention is clearly good, but,
“have regard to the need to reduce inequalities between the people of England”,
is a slightly curious phrase. It might be asked, between the people of England and what? The drafting could be improved by the time we get to—actually it will not, as we are on Report. Perhaps it is capable of being improved, let us say.
The noble Baroness has touched on the broader issue of the locality, which raises issues of how the Government might pursue their objectives, which are shared by all sides of the House. There are different organisations in the new structure that will have a responsibility to promote equality, which will include the clinical commissioning groups and the health and well-being boards. Some mechanism ought to provide accountability for both those bodies. In particular, the need to promote equal treatment in a patient-centred service ought to be very much part of the joint strategic needs assessment that should be undertaken by the health and well-being boards, and ought to influence the commissioning. We hope that these regulations will establish that connection and, as the noble Baroness has suggested, lay down a clear structure, though not one that is too prescriptive—a pathway, as she usefully put it, for patients, individually or, as it were, collectively, to raise the issues that concern them through healthwatch.
There is another route that I hope the noble Baroness will agree would be helpful. Local authorities retain the duty of scrutiny of local health services. For that matter, inequalities can arise on the social care side of the health and social care world. Local authorities therefore provide an additional route that would repay further consideration. It ought to be feasible for a health and scrutiny committee, and I serve on one in my own authority, to have regard to the level and type of complaints regarding not only equitability but the standard of service in all parts of the health and social care services in that locality. Therefore, it would be useful if the Minister could liaise with the Local Government Association, perhaps to produce some kind of working model for dealing with this aspect. For example, it may be that the Centre for Public Scrutiny could, in conjunction with the department, the LGA and HealthWatch itself, representing patients, come up with a model that authorities could adopt and promote among their populations to provide clear recourse for dealing with difficulties and complaints about either individual treatment or collective provision that is a matter of local concern.
I hope the Minister will accept the thrust of the amendment and, even if it is not built into the Bill, that action can be taken to fulfil the aspirations that the noble Baroness has outlined.
Lord Willis of Knaresborough
My Lords, briefly, I should like some clarification on this amendment, and I hope that the Minister will be able to provide just that in summing up. There seems to be a real difficulty here. The architecture of the Bill says that we should have a Commissioning Board and local commissioning groups, and that those local commissioning groups will have a great deal of autonomy over the services that they commission—for example, the drug pathways that they permit—in treating particular patients. This amendment appears to say that if the treatment given through the commissioning pathway of one commissioning group is different from that of another commissioning group, you would therefore have recourse to action if you felt, for instance, that the drug regime in one group was unacceptable. Perhaps I could have clarification on that. It is important because there will be that sort of difference in provision, regardless of whether we agree to the local commissioning group position.
Lord Northbourne
My Lords, I intervene briefly to support the noble Baroness, Lady Finlay, because I believe that there will be real problems. The immense complexity of the Bill will lead to tremendous delays and a great deal of misunderstanding among people who feel, rightly or wrongly, that they have failed to get the service or treatment to which they are entitled. I hope the Minister can say something about the possibility of some sort of short-circuit response, whereby people who feel that they have been ill treated can, if necessary, have some kind of help and encouragement to make contact with the right people to resolve their problem.
Lord Willis of Knaresborough
My Lords, it is a very pleasant duty to know that amendments proposed in Committee have been accepted by the Government in their totality. I thank the Minister for doing that. Amendment 11 removes from the Secretary of State the idea of “having regard to the need to”, and gives a clear duty to promote research—and that is the case in Amendment 60, with commissioning boards, and in Amendment 103, with the local commissioning groups.
The broader research community—from the Wellcome Trust; the Academy of Medical Sciences; and members of the organisation that I chair and declare an interest in, the Association of Medical Research Charities—is incredibly grateful to the Minister for persuading his colleague, the Secretary of State, to accept far stronger policy on the duty to research. I also put on record my thanks to noble Lords on all sides of the House, including Cross-Benchers and Front-Benchers, for supporting this. It is very rare that you get such an area, which will clearly make a fundamental difference to patients, bringing the latest research to the bedside as quickly as possible—and to get the whole House to support that.
The result of this, if we make it work, will be the only research-led health service in the world. That is an incredible achievement in your Lordships' House and in many ways surpasses some of the debates that we have had about other areas, which frankly will not make a great deal of difference. I include the debate on Clause 4, which we have just had. I know that Members on the Labour Benches like debating Clause 4; it gives them a feeling of déjà vu. However, in reality, for us as a nation to say that we have a research-led health service, where we can bring our huge clinical research base very quickly to patients, gives us an opportunity not only to deliver wonderful healthcare but to use that as an economic generator right across the world, and to bring high-quality healthcare to people who desperately need it. In fact, they need it a great deal more than we do.
In order for that to work and for these to be more than simply words in a Bill or rhetoric in this House, there have to be mechanisms to ensure that the duty which we have now agreed for the Secretary of State—or which I hope we will agree—concerned with the commissioning board and the commissioning groups, is actually brought to bear. There is nothing left in the Bill which gives me the comfort of saying that is going to happen.
We asked in Committee whether the commissioning board, and indeed the commissioning groups, should have to include in their commissioning plans what activity is taking place in research. If we get the health research authority up and running—I commend the Minister for all that he has done in terms of the special health authority—and if we start to get the 70-day permissions for clinical trials in, we will have a Rolls-Royce system, if I may use that analogy, for bringing research programmes right through into our hospitals for our patient development. However, unless we are able to have that built into the commissioning plans, and unless the commissioning board and the Secretary of State drive that—and this House and another place hold him accountable for that duty—quite frankly, it will be a hollow gesture.
We also sought in Committee a requirement to report on that activity. How telling it would be if patients asked the commissioning groups or their local GP, “What is the activity in the cause that I have?”? We had that wonderful debate earlier on prostate cancer. That is the way in which we will get research developments brought into the clinics and into GPs: by patients being able to query what is happening in research. In thanking my noble friend the Minister, I ask him whether, in responding to this short debate, he will outline to the House very clearly how we are going to make this work. How will we make that duty to promote research into having an NHS that is world-class in terms of its research? How will it work?
Lord Warner
My Lords, I intervene briefly to echo everything that the noble Lord, Lord Willis, has said. We should not rest on our laurels as regards research. I do not want to go over the ground of micromanagement, but the NHS is very quick indeed to forget its responsibilities on research—and I say this as a Minister who was responsible for NHS research and development under the previous Government. We do not want to go back over the micromanagement debate, but the mandate is a critical issue if the NHS is really to keep research at the forefront of its thinking.
That is because at local level, too often on the provider side of the NHS research is forgotten. It is a Cinderella service which comes second to service delivery, and we end up seeing that people at senior levels and at local level absolve their responsibilities in this area. Nothing is a better example of that than the way in which local ethics committees and the people around them have inhibited the advance and the speedy development of research. I do not think that the Secretary of State can absolve himself of these responsibilities here with just this duty. Year in, year out, he will have to use the standing rules and the mandate to make sure that the NHS’s nose is kept to the research grindstone in the very way that the noble Lord, Lord Willis, has said. I hope that the Minister will be able to convey some of that back in the department as well as on the Floor of the House.
Health and Social Care Bill
Lord Willis of Knaresborough Excerpts(12 years, 11 months ago)
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Lord Willis of Knaresborough
Perhaps not quite in the spirit of Christmas, with regard to the important issue which the noble Baroness, Lady Thornton, raised and the noble Baroness, Lady Williams referred to, it is frankly not good enough to say that there will be a letter, which none of us will actually see apart from those particular people over the Christmas period. The major question which hangs over this House is whether the tribunal’s decision will be made available before the Report stage. Could the Minister give a real Christmas present to this House by saying that, whatever happens, the Report stage will not take place until that decision is available?
Earl Howe
I cannot give that undertaking, for the reasons that I will set out in the letter. The position—which I shall elaborate on when I write—is that the Information Commissioner has requested more time, and in light of that we have made representations to expedite the process as far as possible. However, the advice I have at the moment is that it is highly unlikely, if not impossible, that the judgment will be delivered before we are due to go into the Report stage of the Bill. This is something that we are dealing with at present, and if I can update my noble friend, as well as other noble Lords, when I write, I shall be happy to do that. I do not wish this to be a closed process. All noble Lords in this Committee who have taken part in these debates are very welcome to be copied in.
Health and Social Care Bill
Lord Willis of Knaresborough Excerpts(12 years, 11 months ago)
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“The Health Research Authority
(1) There shall be a body corporate called the Health Research Authority (referred to as “the HRA”).
(2) The Secretary of State shall make all necessary regulations to establish the HRA within 12 months of the Act receiving Royal Assent.
(3) The HRA shall manage a co-ordinated process for all aspects of the approval of health research involving human participants or their data, including—
(a) the provision of ethics committee opinions and other approvals,(b) with the National Institute for Health Research and NHS trusts, delivering a consistent, efficient process for obtaining permission for research carried out under the scope of the Research Governance Framework for Health and Social Care (referred to as “NHS R&D permissions”),(c) with the Medicines and Healthcare Products Regulatory Authority, improving the regulation of clinical trials of medicinal products, and(d) other such functions as may be specified in regulations including those currently being undertaken by organisations which will cease to function following the implementation of future legislation.(4) The HRA shall have the following general functions—
(a) providing general oversight and guidance as it considers appropriate in relation to activities within its remit,(b) publishing annual metrics and indicators on all research approvals within its remit, (c) working with relevant bodies across England, Wales, Scotland and Northern Ireland to address differences in practice and legislation, and providing supporting guidance or codes of practice that apply across the UK,(d) superintending compliance with requirements imposed by legislation relevant to its remit,(e) monitoring developments relating to activities within its remit, and(f) facilitating and promoting health research involving human participants or their data.(5) The HRA must carry out its functions effectively, efficiently and economically.
(6) In carrying out its functions, the HRA must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).
(7) The Special Health Authority known as the Health Research Agency is abolished and its functions transferred to the HRA.”
Lord Willis of Knaresborough
My Lords, I beg to move, at last, Amendment 258 and will speak to Amendments 260A, 260B and 260C, which stand in my name and those of other noble Lords. I put on record my thanks to noble Lords across the Chamber for the way in which they have supported a series of proposals and amendments concerning research. This has been a non-party political area of the Bill and I am deeply grateful to them.
On Monday, the Prime Minister launched a new strategy for UK life sciences with all the hype that he could muster—quite right too, as it is an outstanding document and contribution to life sciences. Our research is world beating, our National Health Service has a patient database unrivalled anywhere in the world and we are putting together a research and governance framework that will make the UK the place to do health and medical research. It is UK patients who will benefit by having novel and ground-breaking treatment literally years earlier than could have been hoped for five years ago when the noble Lords, Lord Darzi and Lord Sainsbury, set out with a very similar message. There is no difference between either side of the House on that issue.
By coincidence, the amendments before us today will help deliver that strategy—and deliver it earlier. At the heart of the delivery platform for the strategy for improved outcomes for patients is the Health Research Authority, established not as a creature of Government but as a full NDPB. In essence, the amendments in this group would put in the Bill the commitments that the Prime Minister gave this week, and that the Secretary of State gave when he accepted the proposals made by the Academy of Medical Sciences in its ground-breaking report, A New Pathway for the Regulation and Governance of Health Research.
To date, establishing the Health Research Authority via the Bill has not been the Government’s preferred option; I think I am safe in saying that to the Minister. Instead, the usual cautious Civil Service-driven approach of creating a temporary vehicle meant that a special health authority was set up on 1 December to carry out many of the functions of a future NDPB. However, much of the confusion, duplication, delay and obfuscation outlined in Sir Mike Rawlins’s report will continue to exist, as we wait for another Bill that may or may not come in the next Session of this Parliament. If a single Member of this House actually believes that any Government would be enthusiastic about bringing in a new Bill, having sat through this particular Bill—which is by no means finished—then, quite frankly, they are on a different planet.
The Minister argues that the special health authority will do almost everything that such a Health Research Authority will do, but is this really the case? Will it really have the authority or the power to change much at all? The research community welcomed, as I did, the transfer of the National Research Ethics Service to the special health authority, but what about the plethora of other regulatory bodies? Ethical approvals, including the storage of tissue, from the HTA, and embryo project licences from the HFEA will still be required. Ethics and Confidentiality Committee approval will still be needed for exemptions to common-law confidentiality. Permissions from the Administration of Radioactive Substances Advisory Committee will be needed if research clinicians wish to administer radioactive substances. All the powers of the Medicines and Healthcare products Regulatory Agency will remain exactly where they are.
As a special health authority, the Health Research Authority has absolutely no authority to deal with the different legislative regulatory arrangements across the devolved nations. It was quite interesting that with Amendment 260, tabled by the noble Lord, Lord Patel, the Government prayed against creating a special health authority because it would be able to deal only with England; it would not be able to deal with the rest of the United Kingdom. This is exactly the sort of organisation that has been set up to deal with this crucial area of health research.
Crucially, there will still be the vexing issue of individual National Health Service research and development approvals. Unless the HRA is set up as an NDPB in this Bill, approval processes, which are often taken sequentially rather than in parallel, with often conflicting advice from different bodies, will continue to cause confusion, delays and frustration, and the UK will continue to see research programmes haemorrhage away to international competitors as clinical trials persist in being problematic—exactly the opposite of what A New Pathway for the Regulation and Governance of Health Research is preaching to us this week.
Amendment 258 would establish the Health Research Authority in primary legislation—now—as an NDPB and set out the HRA’s role in co-ordinating the approval and regulation of health research. Subsection (3) provides for the transfer to and the management of,
“all aspects of the approvals of health research”.
Subsection (3)(a) covers the transfer of functions of the National Research Ethics Service to the HRA when it is established as a full NDPB, but the wording is broad enough to cover other research approvals that could be transferred—for example, those of the Human Fertilisation and Embryology Authority, the Human Tissue Authority, the Ethics and Confidentiality Committee and the Administration of Radioactive Substances Advisory Committee—all without the need for further legislation. This could all be done through secondary legislation in an orderly time and allowing for full consultation.
Subsection (3)(b) covers the HRA’s role in providing NHS R&D permissions, which it would undertake jointly with NHS trusts. Amendment 260C, which I will come to in a minute, allows for a more detailed exploration of the exact role of the HRA in NHS R&D permissions. Subsection (3)(c) covers the HRA’s role in supporting the MHRA in the regulation of clinical trials.
Subsection (4) explores the general functions of the HRA. At the moment, some regulatory organisations are very good at providing advice and support; others, quite frankly, are not. High-quality guidance is needed in some areas, and where this is currently absent or confusing—for example, in the use of patient data in research, which is an absolute minefield—subsection (4)(a) would ensure that researchers apply appropriate standards consistently across all studies, with the HRA becoming an authoritative source of guidance both to support researchers and NHS trusts and to build patient confidence in research.
Subsection (4)(b) would support the HRA’s quality remit, as it would be required to publish,
“annual metrics and indicators on all research approvals”,
while subsection (4)(c) addresses the important area of UK-wide research frameworks. The regulation and governance pathway is currently fragmented across the whole of the United Kingdom. Some research approvals, such as those of the HFEA, apply to the whole of the UK; some apply to England and Wales, with different arrangements in Scotland, as happens with the HTA and the ECC; and some are managed separately in each Administration, as happens with the NHS R&D permissions in individual healthcare trusts. The complexity of the system can create additional barriers for researchers, which is a huge barrier to the UK being the prime destination in terms of research.
Subsection (4)(f),
“facilitating and promoting health research involving human participants or their data”,
is a massive issue, which again, if it were on the face of the Bill, could be dealt with in secondary legislation.
Put simply, Amendment 258 would allow the Health Research Authority to be set up with a minimum of detail, allowing the details to be worked out in consultation with the broad community, and indeed with public consultation, but it would mean that any future government would have to work on putting it into action, rather than waiting for some legislation, which may or may not come down the track. The real issue is that if we are left with a special health authority, we will be left with it in four, five, or perhaps even 10 years’ time. We will have lost the opportunity to move forward. It is that serious.
Amendment 260A is a probing amendment, which sets out the specific health research functions that should be transferred to the Health Research Authority. What we are saying is that, in addition to the National Research Ethics Service, it would be easy in this piece of legislation, which the Government may or may not take forward—and this is entirely a probing amendment—to bring in, in addition to the Ethics and Confidentiality Committee, the research functions of the Human Tissue Authority, the Human Fertilisation and Embryology Authority and the Administration of Radioactive Substances Advisory Committee. It does not require a new Bill to do that. It could simply be done on the back of this Bill.
Amendment 260B is again a probing amendment, which seeks to strengthen the link between the Medicines and Healthcare products Regulatory Agency, the MHRA, and the proposed Health Research Authority. In effect, it would establish a duty of co-operation between the two organisations. It is expected that the new Health Research Authority will take on most aspects of the regulation of health research, except for the regulation of clinical trials of investigational and advanced therapy medicinal products, which will continue to be regulated by the MHRA. This simple amendment seeks clarity from the Government around their expectations for the relationship between the Health Research Authority and the MHRA.
Finally, Amendment 260C is the crucially important probing amendment because what it would do is establish an organisation called the “National Research Governance Service”. This is hugely important because one of the biggest barriers to effective development of clinical trials at the moment is getting NHS R&D permissions. It took one hospital five weeks to get the necessary permissions for a kidney research clinical trial; in another it took 29 weeks. Getting a stroke programme up and running took one week on one site and 35 weeks on another. The average time it takes to get a cancer trial up and running is something like 80 weeks. It is absolute nonsense, and how the Minister can turn to this House and say we have an opportunity to do something about that and not take it is something only the Minister can respond to—which I am pretty sure he will do very strongly and very supportively of these amendments in the near future.
NHS R&D permissions are currently the greatest barrier in the regulation and governance of health research, with multiple, duplicative checks undertaken at every NHS site. The Academy of Medical Sciences recommended creating a national research governance service—this comes directly from the AMS report—within the HRA to centralise as many of these checks as possible to avoid duplication. The Government have ignored this recommendation and instead introduced standard operating procedures and incentives to make improvements to the current system. Only a civil servant could have done that, when in fact what we want is action.
Earl Howe
My Lords, the amendments in this group aim to create a Health Research Authority. My noble friend has explained the rationale for the authority very succinctly and I want to make it clear at the outset that I am on precisely the same page as him as to what he is seeking to achieve for health research. We announced in the Plan For Growth in the Budget in March that we would create a body to combine and streamline the approvals for health research, which are at present scattered across many organisations. We also said that wherever we can achieve this simplification without primary legislation, we will. We have already laid legislation to establish the Health Research Authority, which started its work on 1 December 2011 as a special health authority, as was reported in Monday’s Statement on our strategy for UK life sciences. In that form it will take on a number of key functions and I will come to those in a moment.
Looking ahead, as I mentioned earlier, we will be consulting on the future of the HFEA and the HTA. That consultation, as the noble Lord, Lord Beecham, has pointed out, has been delayed but we are still very much intent on launching it and hope to do so shortly. We look forward to stakeholders’ views on the option of passing the research-related functions of the HFEA to the HRA as proposed in the AMS report. In that regard, where primary legislation is required to consolidate functions, we intend to subject it to pre-legislative scrutiny during the next Session and to introduce it as soon as parliamentary time allows.
It may interest my noble friend to know that I am upbeat. I am advisedly upbeat and want to stress to him and other noble Lords that contrary to the apprehensions that have been expressed, the Health Research Authority will have substantive functions as a special health authority. It will combine and streamline approvals for health research through unification of functions and processes wherever that is possible without additional legislation and through co-ordination where it is not. I say to my noble friend without any hesitation that we can achieve a very high proportion of what we wish to achieve with the HRA in this form as a special health authority. It will bring together functions relating to research ethics committees currently performed by the Secretary of State, the National Patient Safety Agency and strategic health authorities. It will operate a single system for researchers to apply for approval to research ethics committees, NHS trusts, the Medicines and Healthcare products Regulatory Agency, the National Information Governance Board and the Administration of Radioactive Substances Advisory Committee.
By April 2013, it is intended also to bring in functions currently performed by the Secretary of State on the advice of the National Information Governance Board’s ethics and confidentiality committee. The Health Research Authority will also work closely with the bodies I have just mentioned, as well as the Care Quality Commission, the Human Fertilisation and Embryology Authority, the Human Tissue Authority and the National Institute for Health Research to co-ordinate relevant functions, processes and standards. That is why, despite my noble friend’s understandable desire to see an NDPB established as soon as possible, I suggest to him that for practical purposes, setting aside the HFEA issue for one moment, the amendment is unnecessary.
However, there is another reason why it would not be right to establish the agency in this Bill—it would not be for the good of research in this country. I say that for the following reasons: it would weaken parliamentary scrutiny by stopping Parliament being able to debate primary legislation on the functions of the agency because it would consign much of the detail to secondary legislation—I do not think that is something that in the past your Lordships’ House has been keen on. It would pre-empt public consultation; for example, on the future of the HTA and the HFEA, and in my view it would put haste ahead of getting it right by dealing with a complex issue without due discussion and consideration.
Lord Willis of Knaresborough
I am listening carefully to what my noble friend is saying. However, Amendment 258 would not compromise in any way the consultations which he has rightly promised on the HTA and the HFEA. The proposed new subsection (3)(a) in Amendment 258 refers to,
“the provision of ethics committee opinions and other approvals”.
It does not state what those other approvals are. Therefore, if the amendment were passed, the Minister could consult in a year’s time or in two years’ time and come to a decision without compromising those approvals.
Earl Howe
I hear what my noble friend says but I cannot agree that his approach is the best for research in this country. Very real risks would accompany trying to shoehorn a very important and complex issue into this Bill in what I have to say to my noble friend is an inappropriate legislative form. The noble Lord, Lord Warner, asked about the view of the Academy of Medical Sciences on this matter. The last time that I spoke to staff at that body, which was not very long ago, they were dead set against my noble friend’s approach. They believe that the approach the Government are taking, which is a step-by-step approach, is exactly right. They recognise that the Special Health Authority can achieve a very great deal, we do not need to rush into primary legislation and we would do very much better to take our time over that process.
My noble friend mentioned the devolved Administrations. We have also directed the Health Research Authority to collaborate with the devolved Administrations in the exercise of its functions. We expect it to maintain effective communications with the UK health departments on the practical implications of implementing legislation, policy and guidance, building on the success of the national research ethics service at developing a single UK-wide system for research ethics committee review. Therefore, I do not regard that problem as at all insurmountable.
We agree with the intention behind Amendment 260C of improving the consistency and efficiency of reviews of the bodies carrying out research. We consider the National Institute for Health Research to be a more appropriate mechanism than the Health Research Authority for taking action to achieve outcome improvements, such as those called for in the Academy of Medical Sciences report. My noble friend may wish things were otherwise but noble Lords need to remember that NHS trusts are autonomous bodies. It is important that there is a clear division between the responsibilities accepted by them when planning and conducting research and the responsibilities of the body that regulates their practice. In this environment, the NIHR is in a strong position to support and influence them. The NIHR has already introduced mechanisms to achieve the effect of Amendment 260C through its co-ordinated system for gaining NHS permissions, its research support services framework of standard operating procedures and good practice guidance and its research passport scheme. It is also introducing benchmarks for NHS trusts’ performance in the initiation and delivery of research. NIHR funding will become conditional on meeting such benchmarks, so there is a direct incentive for NHS organisations to comply with those benchmarks.
As regards the Health Research Authority monitoring developments relating to activities within its remit, I thank my noble friend for raising the horizon-scanning point. I will gladly consider that further to see what can be done.
In sum, I do not see this amendment as appropriate. I appreciate that my noble friend intended it as a probing amendment, but I hope that I have set out clearly why I do not think that this would be the right way to go. Noble Lords can be relaxed that we are already embarked on a course which should deliver major improvements in all the areas where we want to see improvements as regards the clinical trials process in this country. As I say, I am optimistic that we are embarked on the road to the sunlit uplands in this sense. We will in due course—I hope that that will be sooner rather than later—come to a point where we can embody these things in primary legislation. However, I urge noble Lords to consider the need to take our time and to consider those matters very carefully.
Lord Willis of Knaresborough
My Lords, I thank the Minister, as always, for his courteous and passionate reply to this debate. He has used the words upbeat, relaxed and enthusiastic about the amendments and the aim behind them and I appreciate what he said. He made the point—and has made it often—that the Special Health Authority, which was set up on 1 December, will be able to take on, over a short period of time, many of the functions which I have outlined in Amendment 258. I would be grateful if the Minister would put in writing the timetable for delivering all those elements. It would be hugely advantageous to know just how they would fit and dovetail in.
My noble friend Lord Warner—well, he is a friend—commented on the views of the Wellcome Trust and the Academy of Medical Sciences; the Minister said that the Academy of Medical Sciences was against the Willis amendment. In fact, the last time that we met the Academy of Medical Sciences—the noble Lord, Lord Turnberg, and I were on the same platform with it about a month ago—the academy made it clear that, while it did not want to have any detail in the Bill because that would compromise the detailed discussions, it was happy to see the architecture in the Bill. This is something which the Wellcome Trust supported; in fact, I was helped by both the trust and the Academy of Medical Sciences in drafting these amendments. The Association of Medical Research Charities, which I chair, was also incredibly helpful. There are, perhaps, some crossed wires here.
On Amendment 260C, I hear what the Minister says about bringing those two issues together, particularly for the R&D functions of NHS trusts. I said that there is a real issue about autonomous organisations. Why has the NIHR not actually done it? If this is the biggest obstacle to getting clinical trials developed quickly in the UK, why has it not already forged those relationships, and what confidence do we have that it will be able to do so over the next year or so?
This has been a good debate and I am incredibly grateful to noble Lords throughout the House for their support for these amendments. I still believe that the proposals in Amendment 258 could be in the Bill but given the Minister’s assurances and his willingness to debate these issues further, I beg leave to withdraw the amendment.
Life Sciences
Lord Willis of Knaresborough Excerpts(12 years, 11 months ago)
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Earl Howe
The planning horizon for research, as my noble friend will know, has always been a long one. With the increasing cost of research, particularly in later stage clinical trials, companies end up making an extremely significant investment in order to bring one molecule to the market. What we seek to achieve for big pharma in this package of measures is a sense that we in the UK have, as it were, an unrivalled ecosystem that brings together business, researchers, clinicians and patients to translate discovery into clinical use for medical innovation within the NHS. What we want them to appreciate is that the UK provides an environment and infrastructure that supports pioneering researchers and clinicians to bring innovation to the market earlier and more easily so that this country becomes the location of choice for investment. I am thinking here particularly of our proposals for setting up academic health science networks that will span the NHS. That is our ambition. I am thinking of the early access scheme for medicines, which was mentioned in the Statement. We want to break down the regulatory barriers to speeding up clinical trials that have beset the industry. For all those reasons, I should like the industry to see this as facilitating a shorter time horizon. However, we cannot do anything to get around the essential safety and quality standards that the patient and the citizen rightly insist upon.
Lord Willis of Knaresborough
My Lords, I welcome the Statement from my noble friend. I realise that other noble Lords want to get in. I should like to ask a few brief questions. First, we have to recruit patients on to trials. It is interesting that there is a proposal automatically to opt patients in to trials—or at least have access to them. How will that be achieved? Will it be achieved through this Bill? Secondly, will the £180 million catalyst fund for the valley of death replace the Health Innovation Challenge Fund that currently operates between the Department of Health and the Wellcome Trust? If not, where will the £180 million come from?
Earl Howe
My Lords, I shall answer the second question first. The £180 million biomedical catalyst fund is a completely new fund for industry. Its object is to nurture innovative technologies from the academic or commercial sector through to companies with products or technology platforms in order to attract private equity. I shall probably need to write to my noble friend with further details of where the money is coming from. It is coming from the budget of BIS, rather than my own department, and it is therefore necessary for me to ask my colleagues in BIS precisely where the money emanates from. I am happy to let my noble friend know.
The proposal to which he referred is only a proposal. We are suggesting that the public should be asked whether the NHS constitution should be changed so that patients are aware that their data, as now, can be used in anonymised form for research. Our intention is to ask more patients whether they wish to be approached for research if that research is relevant to them. As the Statement made clear, we know that more than 70 per cent of the public wish to be informed if a piece of medical research is relevant to them. Patients are keen to be involved in this. It is important to have a public dialogue about the extent to which patients may be approached so that they may know in advance that there is a possibility of a project being relevant to them. We are formulating these proposals now and it will be some time before we issue the consultation. I shall make sure that I let my noble friend know as our proposals crystallise in this area.
I can, in fact, answer my noble friend’s earlier question as to whether the Health Innovation Challenge Fund is being replaced. No, it will continue.
Health and Social Care Bill
Lord Willis of Knaresborough Excerpts(12 years, 11 months ago)
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Baroness Morgan of Drefelin
My Lords, I rise to speak to Amendments 130, 131, 147, 150, which are in my name. I have also added my name to Amendments 215 and 218. These are very big groups and the Minister has my sympathy. I am sure he is listening very carefully to all the advice that he is receiving. I would particularly like to add my support to the remarks made about the power of procurement to promote innovation.
I want to speak about research and the research duty. My amendments are designed to add weight to the research duties in the Bill and follow on from the excellent debate on Clause 5 in relation to the Secretary of State’s research duty. I thank the Minister for his letter, which he has circulated to those who took part in that debate, although I fear that it may have raised rather more questions than it has answered. I apologise to the noble Earl for that, and I would like to go through a few of them now. I declare an interest as chief executive of a medical research charity, Breast Cancer Campaign.
In the debate on the research duty in Clause 5, many excellent examples of research were highlighted. It might be useful very briefly to reflect again on the impact that research has on the lives of people in this country, and to mention a report on cancer survival rates by Macmillan Cancer Support that had a great impact in the media last week. It highlighted that people now live nearly six times longer after their cancer diagnosis than was the case 40 years ago. Many noble Lords will be aware that for nine of the 20 cancers studied by Macmillan, median survival time is three years or less, with little improvement since the 1970s. The report highlighted the achievements that research has made but also that there is an awful lot more work to do.
It is also important to remember that there is a lot of research about quality of life. For instance, median survival time for breast cancer has doubled since the 1970s. Investment in research has played a fundamental role in this and yet more than 12,000 women still die from breast cancer every year. As I said, research is not only about improving survival rates. Many women with advanced breast cancer live with complex support requirements that are frequently not met, as evidenced by the research published recently by Breast Cancer Care and funded by my charity, which raises serious questions about pain control, for example. Ensuring that the NHS is committed to supporting research is absolutely key to addressing long-term improvements in survival but also improvements in quality of life for patients today.
Amendments 130 and 131 are intended to strengthen the research duty that has been placed on the Commissioning Board. Amendment 39, which we talked about a few days ago, removed the phrase “have regard to the need to” from the research duty on the Secretary of State, thereby strengthening it, and Amendment 130 seeks to do the same for the research duty on the Commissioning Board. During the debate on Clause 5, the noble Lord, Lord Willis, explained eloquently why the words “have regard to the need to” in the clause would be better removed ,and how by doing that we would have greater clarity and a better statement of intent would be established. So it would be helpful if the Minister could explain why we need to see those qualifying words in this clause. It would be particularly useful to be given practical examples of the effect that removing the words would have, because I suspect that they are not necessary and that the Bill might be better off without them.
I was also extremely heartened to hear the Minister say that he sympathised with me and with many other noble Lords when we argued that the research duty should be strengthened and that he would undertake a “closer consideration” of the research duty. I would welcome hearing a little more about his thoughts on that today, particularly whether any amendments to Clause 5 could be in the making, and whether they could be read across into Clause 20.
Moving on to Amendment 131, this seeks further clarity on the meaning of,
“research on matters relevant to the health service”.
I do not want to rehearse the arguments made previously in relation to Clause 5 and the wording of this phrase except to request a further explanation of its definition, including practical examples to aid our understanding which I hope the Minister will be able to provide either today or later in writing. In correspondence, the Minister helpfully clarified that public health was covered by the current definition, which was an important point for the noble Lord, Lord Warner, as I recall. However, the intention of Amendment 131 is to seek further clarification and a definition of the phrase so that we can understand whether it is sufficiently comprehensive. Public health is one issue that we are very clear about. It is covered, but we need to be confident that the duty is comprehensive in that regard. I believe that a more substantial definition is required and I am pleased to have the opportunity to request this today. For example, with this definition in place, what are the implications for NHS staff who are involved in supporting research? Will there, for example, be sufficient research nurses to support research activity, will clinical training incorporate time for research and how will research successes be recognised and encouraged as part of NHS career progression and structures?
In terms of what we know about the Commissioning Board, what will it be doing with respect to research? The Government have attempted to reassure noble Lords that the Commissioning Board is aware of the need to promote research and indeed that one of the board’s most important functions will be to support a culture that promotes research and innovation. I welcome this but I feel that in practice there is still very little detail about how this will happen. It appears that research will not form one of the six key portfolios of the board, but will fall under the commissioning development portfolio. Will this include, as I believe the Minister’s letter suggested, the development of commissioning tools and commissioning guidance ensuring that patient care is commissioned so as to support the conduct of research in the NHS? I note with interest that the Government are committed to ensuring that the systems and processes for commissioning used by the NHS Commissioning Board and clinical commissioning groups will ensure that research is promoted, supported and funded by the NHS, including the tariff, commissioning guidance and processes for authorising and supporting the development of clinical commissioning groups. That is important, but I would be grateful if the Minister were able to provide further detail on the activities of the Commissioning Board in relation to research.
Will the development of commissioning tools and guidance as defined be sufficient to embed a culture of research in the NHS? While we have heard that the tariff for patient care will incorporate the costs of patients who are taking part in research projects, how will infrastructure costs be captured? Obviously I am thinking about the cost, for example, of storing tissue for research purposes. I fear that what we have been provided with so far is a number of ad hoc references to research that do not attempt to embed comprehensively a research culture into the NHS or set out a vision of what the research duties would mean in practice.
That brings me to Amendments 147 and 150. Two clear opportunities to ensure that the board is accountable for its actions with respect to the research duty now present themselves in relation to the business plan and the annual plan. I note with interest—and I believe that many others have noticed this—that the board must publish a business plan setting out how it proposes to exercise its functions in that year and in each of the next two following years, and at the end of the year it must also publish an annual report on how it intends to exercise its functions. There is therefore a great opportunity here. However, I am puzzled as to why Clause 20 establishes that the business plan and the annual plan must report how the board proposes to discharge its duties only under new Sections 13E and 13P, and likewise explain in the annual report its performance under those sections, which cover the duties on the improvement of quality of services and public involvement in consultation by the board. Again that is very important, but there is no comparative requirement with respect to new Section 13L and the duty on research. Again, there is an opportunity here to improve the feedback loop. I would be grateful if the Minister could explain what plans there might be to bring forward government amendments or to accept the amendments now before the Committee.
Lord Willis of Knaresborough
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.
Health Research Authority (Establishment and Constitution) Order 2011
Lord Willis of Knaresborough Excerpts(13 years ago)
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Lord Turnberg
My Lords, this instrument is to set up the Health Research Authority as a special health authority. The main reason given for taking this step rather than the primary legislation route is because there is some urgency in finding a home for the national research ethics committees that will soon find themselves homeless when the strategic health authorities and the National Patient Safety Agency go out of business.
I can, of course, understand why it is necessary to go down this rapid secondary legislation route because even if the Health Research Authority were to find a place in the current Health and Social Care Bill, it would still be a couple of years before it would be fully enacted and we need something sooner. However, there remains the question of why it cannot be put into the Bill as well so that there can be a smooth transition from this temporary solution to a more permanent one. No doubt, we will be exploring that when we come to debate it later in the Bill.
The anxiety remains that we will have to wait a considerable amount of time before we see another round of primary legislation to set up a permanent agency. In our debates on the Bill yesterday, we heard about the doubts being expressed about when we will see further legislation. Can the Minister enlarge on the hint he gave in the debate last week that we might see something relevant to this in 2012?
It might be helpful if I said a few words about why the establishment of a health research authority or agency is so important. It comes directly from the recommendations in the Academy of Medical Sciences’s report A New Pathway for the Regulation and Governance of Health Research which the Government commissioned last year and which, to their credit, they have endorsed enthusiastically. The report described in great detail the current regulatory burden faced by clinical researchers and proposed a number of solutions, the most important of which was setting up this agency. It pointed out how the UK research effort is being undermined by an overly complex regulatory and governance environment and how this has caused a fall in the UK’s global share of patients in clinical trials of all types, as well as a marked increase in the time needed to navigate a very complex research approval process. Regulation has grown as new regulatory bodies have been set up, often in response to some scandal or other, and often with seemingly good reason, but without any consideration of the overall impact of yet another new hurdle and without any evidence whatever that they have improved the safety of patients or the public.
The problem is confounded by the delays and duplication in the governance arrangements within individual NHS trusts. They are now thought to be the single greatest barrier to health research, especially where several trusts are involved in multicentre trials, for example. There is a definite need for a regulatory pathway that allows us to cut through all this unnecessary and complex bureaucracy while at the same time ensuring the safety and interests of patients.
Now we have a research regulatory authority as an important government response, and we have to see how it is going to achieve all that is expected of it. First, the National Research Ethics Service, with its 80 or so local ethics committees, has done a marvellous job in the past few years in streamlining the ethics approval process. It has, for example, made it much easier for those engaged in multicentre research proposals to gain approval. Preserving its function has been vital, but unfortunately moving it by itself from one body to another will do no more than preserve the status quo. It simply moves it from one home to another, yet the research regulatory agency was expected to do so much more.
My questions for the noble Earl are: will the authority have any more responsibilities? For example, will it have any of the responsibilities currently undertaken by the ethics and confidentiality committee of the National Information Governance Board? That committee advises the Secretary of State on whether permission should be given to researchers wanting to use data about patients where it is not possible to gain consent. It is a very important safeguard for patients, but it means that researchers have to have two sets of ethical permission to do the research, one from a normal ethics committee and another from this committee, and that causes all sorts of delays. Can we expect some streamlining here? I see in the Explanatory Memorandum to this order that that might be on the horizon. If so, can the Minister give any further information on that and on when it might happen?
Then there is the problem posed by the delays caused by the local R&D committees in each of the NHS trusts. They can hold up research for months, especially if more than one trust is involved in multicentre research proposals. For example, Cancer Research UK said that the average time for a multicentre research grant to be approved was over 600 days. Can the noble Earl say whether the new authority will have any role in easing that problem, perhaps by ensuring that limits are set on the times that trusts can take in considering proposals? Will it, for example, be able to vet research proposals in such a way that it can save local R&D committees from each having to repeat much of the straightforward common areas of a proposal, leaving them to check on aspects of specific local importance? That would certainly help to speed up the process.
The excellent report from the academy outlines a whole range of other regulatory bodies and functions that could and should be rolled up into the new authority. I shall not go into them, save to recommend that noble Lords who have not read the report might find it of some interest.
A research regulatory authority or agency has enormous potential for good if we can get it right. If we do, all will benefit—the researchers, certainly, but most importantly the patients, who will access new treatments sooner and more efficiently. We will gain economically too, because we will regain something that we are already losing: the investment from the pharmaceutical industry, which is watching our debates with interest.
We owe a debt of gratitude to the Government for setting up this authority and removing the uncertainty surrounding the ethics committee, but much more needs doing. I look forward with interest to the response of the noble Earl, Lord Howe.
Lord Willis of Knaresborough
My Lords, first, I apologise to the noble Lord, Lord Turnberg, for arriving one minute into his speech; I did not realise that the earlier business would have been dispatched so summarily this afternoon. I am grateful to him for introducing the debate and giving us an opportunity to address the issues he raised ahead of discussions during the passage of the Health and Social Care Bill, to which there are clear amendments on some of these issues. Like him, I say to the Minister without hesitation that I welcome the establishment of this special health authority. He promised it in answer to questions some time after I had arrived in the House and saw the need to move on the academy’s report as quickly as possible, and I compliment him and the Government for moving so speedily; there is no issue about that.
The need to find a home for the National Research Ethics Service was important. There was haemorrhaging of staff and good will and, in terms of any research project, it is important that you have a stable, effective and well respected ethics service. We probably have the best research ethics service in the world. We welcome the appointment of Janet Wisely, the current chairman of NRES, as the new chief officer for the Health Research Authority; she is well respected and that level of continuity will serve us well.
Lord Willis of Knaresborough
My Lords, I am delighted to continue. It is a punishment for coming a minute late that we have a Division half way through. While welcoming the special health authority, it is important to look at the order that has been referred to the Grand Committee. What we see, particularly under the heading “Functions of the Authority”, is the wonderful phrase in Article 3(1)(b),
“such other functions; as the Secretary of State may direct”.
What concerns me is that, while this organisation is set up as temporary, it could in fact simply continue indefinitely. There is no time limit on it.
As the noble Lord, Lord Owen, said in the debate yesterday, we have a real issue over the Government’s promises that there will be legislation. In reality, what we have been promised is a draft Bill in the next Session of Parliament, which will deal with research, education and training and any other such matters. As the noble Lord said yesterday, the Government will not be terribly enthusiastic about introducing another Bill. It will probably take us to 2013—or even beyond that—before a draft Bill is fully considered. That takes us right up to the end of this Parliament; perhaps to the final year or final Session of this fixed-term Parliament. Are we really saying that we are going to have a Bill of such importance and magnitude coming before Parliament at that stage? Quite frankly, I have my doubts despite the best intentions of the noble Earl, Lord Howe. If that is the case, we will see this temporary authority simply running on beyond the next election. Unless the Minister can give us a clear indication today of how long this organisation is going to stay in place, whether it has an end date and whether we will have actual, not draft, legislation, then I for one will continue to press the point.
Why do I say this is important? It is because it is not just the research ethics service that is in limbo. Several other organisations are in limbo as well. We have had the Public Bodies Bill. We have two organisations, the Human Tissue Authority and the Human Fertilisation and Embryology Authority, in limbo and running down their permanent staff. There is a real question about their future and significant elements of both may—I stress “may”—come into this new authority.
My first question is: when Article 3(1)(b) says,
“such other functions; as the Secretary of State may direct”,
is there a plan or an intention to take key elements out of the Human Tissue Authority and Human Fertilisation and Embryology Authority and move them into this organisation? The legislation is there for that to happen. It does not need any further primary legislation. Secondly, there is the issue of the Medicines and Healthcare Regulation Agency. What is going to happen to that? It is another organisation that is intricately involved with the research agenda and again there is an element of uncertainty about its future. Is there any intention to move parts of that into the new agency? Is that what we mean by “any other such functions”?
The other issue is the research and development permissions for each NHS trust. The noble Lord, Lord Turnberg, summed it up quite admirably. The main thrust of the Academy of Medical Sciences’s excellent report—which, to be fair, politicians on all sides of the House, including the Minister, have supported and agreed—is the key point that the noble Lord, Lord Turnberg, made. Recruiting people to trials can take over 600 days and while there is a commitment, quite rightly and importantly made last year by the Government, to go to a 70-day average period, how is that going to be driven? Paragraph 3(a)(i) refers to,
“the facilitation and promotion of research”.
Is that what this order actually means, and is it what the Minister means? When I asked him in a Question for Written Answer—I am sorry, but I do not have the reference; Hansard will find it—whether there was any requirement for legislation in order to ensure that NHS foundation trusts become actively involved as part of their duty to promote research and clinical trials, the clear response from the Minister was that there is no need for that because there is perfectly sufficient legislation at the moment for that to happen. I do not know how that is going to happen. If we are going to have an authority, other than the National Research Ethics Service, that simply treads water on every other aspect of research, we will be missing a trick because we could be two, three or four years away from having a permanent solution.
In conclusion, I ask the Minister what work the special health authority will do to prepare for new functions which may come down the line with the new Health Research Authority. What timescales does the Minister envisage for the establishment for the new Health Research Authority and for it becoming operational? Does he have a clear timeline that is not simply in terms of legislation? Indeed, what preliminary work will be done to pave the way for the new national research governance service, which was going to be swept into this organisation too? I think I can give the Minister eight out of 10 for making a commitment to the House. He has made a promise, and I thank him for that, but can we please now have some flesh on these bones as well so that we know what direction of travel we are heading in so that we can all get on the bus?
Baroness Finlay of Llandaff
My Lords, I would add my words of welcome to the principles of research which have been supported by the Government. I know that the Minister has done much personally to promote this. In welcoming the Health Research Authority as a special health authority, I also echo the words: “The problem is this: for how long and where will it lead to?”. The current regional ethics committees that are going will be covered in this, but they are only half the problem in relation to research. The other half is R&D committees in trusts. There is a separate committee for every trust and people who want to undertake multi-centre research have to take their research through them. If you are researching into rare diseases, you may have to go through every trust in the country in order to be able to recruit enough patients to enter into whatever study you are conducting. That could be 100 or so different committees. It means that researchers have to sign up at every trust. Each trust behaves quite differently. Some speed research through in about two weeks, but others become extremely fussy. Unfortunately, that fussiness often focuses on things like the patient information sheet. The committees will spend time requesting redrafts of that sheet, but the redraft may be rejected by another trust. Researchers end up going around in circles for months on end in what is in fact a pretty futile activity.
That is because the original research ethics committee which looked at the proposal will have to go through everything, including the consent form, the patient information sheet and so on. The committee also has to look at the protocol of the study itself and the science behind it. If the science is bad, that is really when the research programme should be stopped in its tracks. That is the role of the ethics committee, and if it does its job properly, it could centralise all these other factors and look at them.
Apart from the duplication taking time for researchers, it is duplication across the whole country with people doing exactly the same job and coming to slightly different, but often not very consequentially different, conclusions. There is duplication at many levels. One could say that if something is good enough for the research ethics committee, it really should be good enough across the board. If it is not, there is a question about the research ethics committee and the way it functions, and it needs to be looked at again because it is not up to scratch.
There are quite a few things that I hope can be centralised, and it will be helpful if the Minister will clarify what will and will not be centralised. For example, will checks on the principal investigator’s qualifications to undertake the research be centralised? Will the protocol of a study and the science behind it be scrutinised with patient information sheets and patient consent forms? Will there be a way of informing the trust that that has been done adequately and does not have to be done again? At a local level, of course the trust has to look to see whether it has the right research facilities and the right infrastructure. That is not usually about the nature of the research but more about whether it is in a position to participate. That is a feasibility check at a local level. That could be done very quickly, but it needs a different mindset. I am concerned that with the push to autonomy for all the different trusts, a trust can say, “No, we’re not going to play ball with this. We want to have our own processes and do our own research ethics rather than participate at a national level”, which might strengthen its R&D committee processes.
An issue not being addressed in this order is indemnity for research. Are there plans to establish an all-England research risk pool or some kind of centralised and co-ordinated indemnity so that we free research processes and stop risk-averse behaviour at local level? Sometimes, risk aversion, which is an inappropriate interpretation of risk, is making some of these committees particularly nitpicking in their processes. I recognise that that might need primary or secondary legislation, but I urge the Minister to take away the amendments that we have tabled to the Health and Social Care Bill and think very carefully about them because they would solve quite a large part of this problem. They would not solve it all, but this order is an interim measure, and it cannot last for years because the gaps will widen and we will then carry on losing research from our shores. We are all aware of the urgent need to turn that traffic around and to bring pharmaceutical and all other types of research back because it is a strength and an economic earner for this country if we can get it right. The infrastructure is critical.
Health and Social Care Bill
Lord Willis of Knaresborough Excerpts(13 years ago)
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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.
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.
“( ) 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.
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.
Health and Social Care Bill
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Earl Howe
My Lords, I have yet to hear from at least one of those consultants. Clearly it is for them to explain why they added their names. I am trying to explain to my noble friend that I see grave problems in accepting an amendment of this kind because in practice it is a non-issue, and because the idea that this is a matter for public policy is one that we should perhaps have a further conversation about. I am not convinced that my noble friend is introducing a matter that should go into statute. It is probably best if we defer further debate on this subject. I have listened carefully to my noble friend and other noble Lords who have spoken. I am happy to have a conversation with him after the Committee stage. I understand the issue that he has raised and I hope that he will accept that, but I see considerable difficulties in trying to frame an amendment in a way that will do precisely what he wants.
Lord Willis of Knaresborough
Could I help my noble friend? A sensible suggestion was made that this was more a role for Monitor than anything that should be in an amendment to the Bill. Would my noble friend agree that when this comes back, either later in Committee or on Report, we should look at whether Monitor should carry out the new duty, proposed in the Bill, to reduce inequalities? That might be a better way of moving forward.
Earl Howe
I shall be happy to look at that. Of course, Monitor has a role in making sure that a foundation trust adheres to the conditions of its authorisation, one of which is that its principal purpose will be to serve NHS patients. There could be mileage in that and I would be happy to look at it.
NHS Commissioning Board Authority (Establishment and Constitution) Order 2011
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Lord Turnberg
My Lords, many of the points that I might have raised have been raised by my noble friends, but I still have some concerns and quite a lot of confusion as to what this body will do. Will it have budgetary responsibilities from day one and, if not, when will it start having some responsibilities for the huge amount of money at its disposal? What controls will be placed upon it? If it is going to meet in public only occasionally, who will hold it to account if things seem to be going wrong? What role will the Secretary of State play if it does not seem to be delivering what it should? It has an enormous set of responsibilities. Will it have sub-committees or will it be decided, among the five non-execs and others, how it will go about its business? I find the whole thing rather confusing at this stage. It would be nice to have some clarity and I hope that the noble Earl will be able to give it.
Lord Willis of Knaresborough
Perhaps I might say first to my noble friend that I support and appreciate the idea of bringing forward a special health authority to shadow the new Commissioning Board. That is right and proper but, like other noble Lords, I think the idea of doing that is a little confusing before we have had a chance to examine this proposal in Committee, and to test it against the large number of amendments which are coming in to tease out what role the Commissioning Board will ultimately perform and what its form and functions will be.
I do not want to add to the questions asked by my noble friend Lady Barker, the noble Baroness, Lady Thornton, and the noble Lord, Lord Warner, all of which I am sure the Minister will get to in his response, but I particularly want to raise one issue with my noble friend. It is the question of research; he will not be surprised that I have raised that. In another place, the Government conceded that research ought to be put into the Bill and that it will be a duty not only of the Secretary of State but of the Commissioning Board and commissioning groups to promote research. At the moment, research within the NHS is of course promoted by the Chief Medical Officer of health, who has responsibilities for the National Institute for Medical Research. To be fair, I think that Sally Davies carries that job out very well indeed. She has done a remarkable job since the Cooksey report and the setting-up of OSCHR with the identifying of resources within the NHS for research. We are starting to see the fruits of that work; indeed, during the passage of the health Bill I hope to be able to speed up the process of getting a special health authority for research and, ultimately, a new research authority.
However, will this shadow authority have a duty to commission research? In which case, will that budget be within the £80 billion to £100 billion identified by noble Lords? Will it in fact take over the duties currently held by the Chief Medical Officer, Sally Davies, or will she continue to retain them and report to the Commissioning Board? In short, where will NHS research reside and who will have authority for it in making the decisions within the new arrangements?
Baroness Finlay of Llandaff
My Lords, I too would like to ask a question in relation to conflict of interest. As the noble Baroness, Lady Barker, has said, it seems that conflict of interest is much more likely to be in the non-financial sphere than the financial sphere. Would members of the board be expected to declare it, perhaps particularly in relation to their own health and that of members of the family who may be affected by commissioning decisions? Also, who will the Commissioning Board be required to take advice from in its commissioning decisions and who will it be required to work with? Will education and training, just as with research, actually become a core duty of the Commissioning Board at the outset or will it come along later? I note that it is said that this is a transition process and that the Commissioning Board will ultimately have responsibility for primary medical services. However, I would be grateful if the Minister could explain at what point that transition will occur, whether it will be phased across the country gradually or happen all in one go, and what plans are being made for the potential risks that can occur with such a major transition of funding from the current system, with the whole of primary medical services being taken over by the Commissioning Board.
Health and Social Care Bill
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Earl Howe
I will happily consider that between now and Report, as indeed I will consider all the points that have been powerfully made in this debate. I have quite a lot more to say in answer to various questions that have been raised, and I hope that I will be given the opportunity to do so.
The Government’s amendment, quite consciously, does not confer any new powers on the Secretary of State. It requires him to exercise his existing powers to provide an existing system. The duty means that he would have to intervene if the system was failing and ineffective. He has a range of powers, including the powers to provide or commission training under Section 63 of the 1968 Act, as referred to in subsection (2) of the Government’s amendment. However, the point is that future legislation may add further powers to those that the Secretary of State already has, and that is what I cannot pre-empt in my reply today.
Lord Willis of Knaresborough
My Lords, I am sorry to interrupt. I have listened carefully to the whole debate today and it seems that we are hampered by the fact that we do not know what is going to go into this new Bill or indeed when it is going to appear. The Minister has been consulting on this issue for nearly 18 months. Will he give the House a clear understanding that in the next Queen’s Speech there will be two Bills, one of which will deal with education and training while the other deals with research? Could he give the House that assurance so that we know what the timetable is for the delivery of these elements?
Earl Howe
I would like nothing more than to give that assurance but unfortunately I cannot, as I am not in a position to know what the Government’s programme in the next Session is going to be. I know that it is the hope and wish of many noble Lords that we will have a social care and health Bill.
Lord Willis of Knaresborough
This is important. I understand what the Minister is saying but at least he could have given us guidance that such Bills would have been in the next Queen’s Speech. If we are talking about another period of two years or more, we are looking at total confusion for that period of time in terms of the delivery of education, training and, later on, research. That cannot be what the Government want; it certainly cannot be what the Minister wants.
Earl Howe
My noble friend knows—very well, I hope—how important research is to Ministers in my department, how important education and training are and how important it is that we have a system for the provision of social care that commands the support of all parties. A Bill of that kind is something that we dearly wish to see coming to Parliament as soon as possible. However, he will understand that I am not in a position to give any undertaking about the next Session, much as I would love to be able to wave a wand and do so.
Perhaps I could be allowed to answer some of the questions that have been asked of me.