(13 years 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.
Lord Walton of Detchant
My Lords, I give very warm support to these amendments, which were so expertly introduced by the noble Lord, Lord Willis. As he said, the report of the Academy of Medical Sciences, after a long period of study and a committee chaired by Sir Michael Rawlins, made a number of important proposals, which the Government, in principle, accepted.
This takes the matter very much further. Following last night’s very exciting and far-sighted Statement by the Government about the developments in research and their sponsorship of translational research, the need to translate the discoveries of basic medical science into practical developments in patient care, the crucial importance of making access available to the NHS database to enable clinical trials to be carried out, and the crucial importance of more rapid access to new medicines and so on through the NHS, it is crucial to recognise that all those proposals are very important. These amendments would carry that forward.
It is also important that the Health Research Agency, which has already been established, is as yet an inadequate vehicle to further the developments to which the noble Lord, Lord Willis, referred in great detail. It is essential to recognise that to carry forward the developments envisaged in the Government’s Statement last night on translational research on the governance of clinical trials and the overall governance of research as a whole in the NHS, something like these amendments must be put in the Bill.
I want to comment briefly on the proposals set out in one of the amendments, to the effect that it would be sensible to remove from the Human Tissue Authority and the Human Fertilisation and Embryology Authority their research components and that these would much more happily settle in the newly defined Health Research Authority. There is a lot of sense in that, because the research carried out by these organisations is important, and it is research that is in many ways crucial to the development envisaged in these amendments.
However, it is important to recognise too that the Human Tissue Authority in its present existence has a major responsibility for regulation—regulating the departments, for instance, in which anatomical work is carried out, and regulating departments of pathology and other teaching functions which are absolutely vital. Similarly, the Human Fertilisation and Embryology Authority is not primarily concerned with research but also has major licensing functions, in licensing organisations in which work under the Human Fertilisation and Embryology Act can be carried out.
I understand that there has been a proposal by the Government that the functions of the HTA and the HFEA might be transferred to the Care Quality Commission. I would only comment, as John McEnroe said, that you cannot be serious. The Government cannot really be serious. This is not an organisation which is set up to handle that type of information. It is crucial to recognise that the Care Quality Commission has very specific responsibilities. It has taken on the responsibilities of three previous bodies, which were involved in looking at healthcare, social care and psychiatric care. It is carrying a major load—
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
Will the noble Lord give way? I am sure the noble Lord will know that through this Bill we cannot transfer the functions of either the HTA or the HFEA to any body at all. Indeed, that was the substance of my undertakings to this House under the Public Bodies Bill debate—that we would defer consideration of those matters until a later Bill. This Bill simply covers the reform of the health service, obviously, and my noble friend has sought to introduce an amendment to set up the Health Research Authority as a statutory body. But I gave an undertaking to this House that I take very seriously: that the consultation process on the transfer of functions from the HTA and the HFEA has to take place. It would be premature for this Bill to cover that matter. For that reason alone, I urge noble Lords to be very cautious about my noble friend’s amendment, about which, nevertheless, I will say some warm words.
I wanted to specifically cover that matter, as I notice the noble Baroness, Lady Warwick, looks as if she wants to rise to her feet. I can understand why, because it is important for the Committee to understand that the matters to which the noble Lord has just referred are matters which we will reach in due course, rather than today.
Lord Walton of Detchant
I am very grateful to the noble Earl for clarifying the position, but it is important that in the longer term we shall have to learn more about the future of those two very important authorities. In the mean time, the crucial importance of these amendments is to clarify in the Bill the responsibilities of this new organisation which is going to be responsible for regulating research in the UK, and which will streamline and improve the present mechanisms for research approval in many different situations. Therefore, I strongly support these amendments.
Lord Patel
My Lords, I hesitated to rise last time because I saw the Minister getting up, and I thought he was about to make a pronouncement to stop the debate because he had a solution to it all, but I realise now that was not the case.
I strongly support the amendment of the noble Lord, Lord Willis. I have my name attached to it. It is crucial that we hear more than just the setting up of the authority, as the Government have announced a few days ago, to take charge of the National Research Ethics Service. I was part of that organisation until I finished my time in the National Patient Safety Agency and was responsible for setting up much of its work, so I take the blame for its shortcomings, if there were any.
The issue we are discussing is why there is a need to set up the Health Research Authority with wider functions than those of NRES. The report produced by the Academy of Medical Sciences identifies serious issues which are important if we are going to deliver on the life sciences strategy announced yesterday and on which I have highly commended the Government; it is excellent. But if we are to deliver on it, we need to streamline the regulatory processes that currently are so cumbersome. For instance, an NHS research and development permission is required at every NHS site where the research is to take place, and the review by the Academy of Medical Sciences confirms that this is perceived to be by far the greatest barrier within the regulation and governance framework. The current process for obtaining research permissions across multiple NHS sites is inefficient and inconsistent. Local negotiation about research contracts and costings is a further source of delay, together with a lack of agreed timelines within which approval decisions are made. Governance arrangements are therefore very important, and the noble Lord, Lord Willis, told us that the report has highlighted that there should be a governance board as part of the Health Research Authority.
The noble Lord gave some examples of delays which had been highlighted by respondents, including in kidney research, stroke research and multiple clinical trials involved in heart research. The solution is to set up an authority which can provide a national research governance service as a part of it. Clinical trials are another example. The noble Lord mentioned how our global share of clinical trials has fallen dramatically. This is particularly related to the fact that it is cumbersome to conduct clinical trials in the UK. To address the challenges identified around clinical trials, improvements are clearly necessary at both the European and the UK level. I know that discussions are going on and that the department is involved in a revision of UK clinical trials, and I hope that they will come to some fruition. The noble Lord also said that the relationship between the new Health Research Agency and the Medicines and Healthcare Regulatory Agency will be crucial in improving the current system. That is an important point, because it was the relationship between the MHRA and clinical trials that at times caused problems.
The problem is that the existing regulation and governance pathways, which evolved in a piecemeal manner over several years, have now become dysfunctional. Although new regulatory bodies and checks have been introduced with good intentions, the sum effect is a fragmented process characterised by multiple layers of bureaucracy and uncertainty in the interpretation of individual pieces of legislation and guidance. This has produced a lack of trust in the system along with duplication and overlap of responsibilities. There is no evidence that these measures have enhanced the safety and well-being of either patients or the public, so the answer lies in now creating a Health Research Authority with multiple functions in order to go forward.
Baroness Warwick of Undercliffe
My Lords, I declare an interest as chair of the Human Tissue Authority, whose work is affected by the review of arm’s-length bodies and is referred to in one of the amendments. The desire to streamline the governance and regulation arrangements to support high-quality research underlies both the Government’s intentions and the amendments relating to the new Health Research Authority. These are laudable aims which I certainly support and which the HTA also supports wholeheartedly. Researchers want to get on with their research, and from their perspective what is important is that they see a seamless end-to-end and proportionate process for regulation and governance. The HTA has always striven to do exactly that within its focused regulatory remit relating to research while ensuring that the interests of the public are protected. But transferring the HTA’s work in research to the new body, as Amendment 260A proposes, may undermine these aims. I want to focus my brief remarks on that point.
The Department of Health clearly has favoured an option to keep all the HTA’s functions together, including research, and will consult on that basis shortly. I believe this is to a large extent because of the HTA’s track record of collaborative working to ensure that the regulatory burden on researchers is minimised. I would be happy to provide a range of examples dealing with NRES, the MHRA, the HFEA, tissue banks and clinical pathology accreditation, but in the interests of brevity I certainly will not iterate them now. Suffice it to say that, in the absence of detail at this stage about how the HRA will operate, it would be premature to make decisions now in haste that we may live to regret later. However, I will briefly set out three reasons why I believe that the HTA’s research functions should not be part of the Health Research Authority.
Lord Turnberg
My Lords, I had a previous bite of this cherry when I spoke at some length in my prayer to take note of the statutory instrument to set up the Health Research Agency a few weeks ago, so I will not be long and will not repeat what I said on that occasion about the need for a research regulatory authority that was more than simply a home for the national research ethics committee. Highly important though that is, my message was that it was essential but not sufficient. If we are to get over the barriers to research posed by the regulatory processes that delay research approval, we must include more functions.
I was very taken by the Statement that the noble Earl repeated yesterday on the life sciences. It was a marvellous demonstration of the Government’s commitment to research and innovation—I could not have said more myself in many of its aspirations. However, if you were looking for a reason for us to have a fully functioning research regulatory authority, as set out in this group of amendments, you need look no further than that Statement. It points out quite clearly where the barriers to innovation lie—with excessive regulation, access to patient data and delays in taking up innovation into practice.
On regulation, the Statement says:
“Excessive regulation can mean that the uptake of new treatments and technology is slow. That is a challenge felt acutely by an industry that sometimes feels that the return is not there quickly enough to satisfy investors. It is felt even more acutely by patients”.—[Official Report, 6/12/11; col. 685.]
There it is; we need a more strongly established research regulatory authority. Let me give one example of where we are in danger of losing out. The NIHR—the National Institute for Health Research—sponsored the North West Exemplar programme to see whether it could engage both the pharmaceutical industry and the NHS in trying to get approval for multicentre clinical trials in a reasonably short time. This involved getting the strategic health authority in the north-west to convince the various hospital trusts in its area to approve the research as efficiently as possible. It has worked—their rate of research and development committee approvals are rapid and compare very favourably with the rest of Europe. They are certainly better than the rest of the UK.
However, there is a danger of that being lost when we lose the strategic health authorities. The driving force of the strategic health authorities will disappear shortly. That is another reason for a research regulatory authority to take on this leadership role: to drive this exemplar forward and spread its message more widely. We need it, therefore, not only for the National Research Ethics Service and the ethics committee on the use of data—a separate ethics committee—but for many of the other functions described so forcefully by the noble Lord, Lord Willis.
I heard exactly what the Minister said about the HTA and the HFEA, and what my noble friend Lady Warwick of Undercliffe said about the HTA. I accept that that should be looked at as a separate set of items. These amendments would allow that; I do not think that they are obviated. However, we need this critical role if we are to take advantage of our excellence in research and if we are to fulfil the Government’s ambitions, as set out yesterday in the Statement. The dangers are evident already, as we see the pharmaceutical industry withdrawing and moving elsewhere. If we are to draw it back, we must have something in the Bill that sets up a full—and fully empowered—health research authority. I hope that the amendment has some sympathy in the Government.
Lord Warner
My Lords, my name is on Amendment 258. I speak as a former Minister responsible for NHS R&D in the pharmaceutical industry in 2003 and 2004. We were having exactly the same discussions then. Since that time, the National Institute for Health Research has been set up, we have had the Cooksey review, OSCA has been set up, and we have had the review by the Academy of Medical Sciences. All these cases come back to the issue of a faster, smoother regulatory approval system. The same blockages that are being talked about now were being talked about five, six, seven years ago.
In that time the UK has lost large numbers of clinical trials. We continue to lose trials and we are going to lose more to south-east Asia. UK plc suffers while we continue with these present arrangements. I understand the Minister’s anxieties about this. However, at the end of the day it is difficult to see that a new authority would be in place, even with a very smooth passage, until at least a year later than if we went along with the amendment. We need to move faster on this.
I end with one question to the Minister. Have the Government actually talked to the big beasts in science research in this area—to the Wellcome Trust, the MRC, the Academy of Medical Sciences? Have they asked them directly whether they would you sooner have the Willis amendments or wait for a Bill in the next Session. I would like to know what their straight answer to the Minister would be on that particular question.
Baroness Finlay of Llandaff
I have my name on the amendments about setting up the authority. In his response to the questions posed, I hope that the Minister will address how exactly we are going to streamline the process, as has been outlined so eloquently, and whether mechanisms such as commencement orders could be used so that we do not delay the process of speeding up research, because some parts, such as the Human Tissue Authority and the HFEA, are not yet clarified. It would be very sad to go at the slowest pace rather than storm ahead. This Government have demonstrated an understanding of research as an important economic driver to the UK as a whole, but that infrastructure, as suggested in these amendments, has to be in place and cannot wait. I hope, therefore, that the Minister will also address the timetabling in detail when he replies.
Lord Beecham
My Lords, I come to this debate unencumbered by any particular knowledge or experience of the issues addressed by the amendment, but it is apparent that today’s debate is but the latest instalment in a long-running saga, which in a sense reached its peak almost exactly seven months ago on Report of the Public Bodies Bill; many of the arguments that we have heard today were rehearsed on that occasion. It is not without significance that the noble Baroness, Lady Deech, complained at that time that no full and impartial public review of the risks and benefits, including the financial risks, of the proposed abolition of the HTA and the HFEA had actually been undertaken. Members of this Committee are clearly of the same mind as most noble Lords have been.
At that time, the Minister set out his reflections on the points that had been made in that debate. He pointed out that there was a common theme: a desire for greater clarity on where the Government intended to transfer the functions of the HFEA and HTA, and concern that the dispersal of functions across a range of bodies would risk fragmenting regulation. Clearly, those matters are still in the air. The Minister said that he intended to consult in the late summer on the options for where certain functions would be most appropriately transferred, and intended to proceed on the basis that the preferred option was for the HFEA and HTA functions to be transferred to Care Quality Commission, except for certain research-related functions that would transfer to the health research regulatory agency. Consultation would therefore take place. It is now seven months since all that was said. The main justification for not proceeding with what was sought then, and indeed still is now, was that:
“We do not want to add to what is already a substantial Bill”.—[Official Report, 9/5/11; col. 699.]
It might be thought that there were matters of less importance in the Bill, and certainly matters that in many respects were more controversial, than the topic that we are addressing today.
Having said that, I have listened with interest to my noble friend Lady Warwick, who takes a somewhat different view of this. Without the in-depth knowledge that other noble Lords have exhibited on this I hesitate to disagree with her, but for my own part I am persuaded by the force of the arguments made by the noble Lord, Lord Willis, and those distinguished noble Lords who have supported him. It is not good enough, particularly in the light of the Government’s clearly confirmed intention to press on with giving greater emphasis to the role of research, specifically in this field, that we should be told, as I anticipate—perhaps wrongly—that further consultations will take place and at some time there will be a conclusion and then a Bill. Given that legislation must already be piling up for the next Session, which, presumably, unless the rules have changed again, will be a year long, it is unlikely, with pressure from other departments, that this department will obtain the space for a Bill of this kind, so the uncertainty will continue. Uncertainty is almost the worst feature of the present situation; it cannot be good for anyone concerned with the problems of research, from the point of view of either pure research or, more particularly, its development into industry and production. Equally, the ethical side clearly cannot be allowed to drift.
I hope the Minister will, if he cannot commit tonight to reviewing the position, undertake seriously to discuss matters again with the noble Lord, Lord Willis, and those who have supported him tonight, with a view to seeing whether, even at this stage, the Government can change their position and deal once and for all with a significant issue around which there seems to be a considerable degree of consensus in this Committee and in your Lordships’ House.
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.
Lord Fowler
“Charges to overseas visitors
(1) The National Health Service (Charges to Overseas Visitors) Regulations 2011 (S.I. 2011/1556) is amended as follows.
(2) In regulation 6 (services exempted from charges) for paragraph (e) substitute—
“(e) the diagnostic test for evidence of infection with the Human Immunodeficiency Virus (HIV) and counselling associated with that test and its result;(ea) all other services for the treatment of HIV provided to an overseas visitor who has been present in the United Kingdom for a period of not less than six months preceding the time when services are provided;(eb) treatment for sexually transmitted infections other than HIV;”.”
Lord Fowler
My Lords, I will be brief. The amendment aims to remove an anomaly in the law which is both absurd and damaging. As the Select Committee on HIV and Aids said in its report, the priority with HIV should be prevention. For every case we prevent we save, in financial terms, about £300,000 in a lifetime’s treatment, as well as the human cost of that lifetime’s treatment. Antiretroviral drugs preserve life, and thank God for that, but they do not cure. The vast majority of National Health Service treatment for HIV is free, but the present law charges for treatment for a small group of people in this country, which has obvious and, frankly, baleful, effects.
First, if the charges result in no treatment, it is dangerous to the individual and endangers his own life. Secondly, it means that the man or woman affected is likely to spread the disease to others and add to the casualty list, although effective treatment reduces onward transmission by something like 96 per cent. Thirdly, such a charging law acts as an obvious deterrent to people coming forward for treatment and testing, which is the whole aim of policy, and negates it. Therefore, the effect of the present law is against all the policy aims of public health—a point very strongly put by the National AIDS Trust, to which I pay tribute.
Lord Davies of Stamford
This is a very difficult situation and I am very much in sympathy with the noble Lord’s amendment, but I wonder whether he would address the one reservation and concern on which I imagine I may not be alone: if we cease to charge for HIV treatment and diagnosis, as the noble Lord suggests, that could constitute an incentive for people to come to this country to exploit that possibility, given what he has already said about the expense and difficulty of receiving that treatment. Indeed, it could be an incentive for people to deliberately overstay their visa or become illegal immigrants to this country.
Lord Fowler
I will obviously deal with that issue, because it is crucial. If the noble Lord would be as patient as I have been in waiting for the opportunity of this debate, then all will be revealed to him.
It is probably the black African population who are most affected by the current policy, yet it is here that the Government’s policy of prevention has been most concentrated. We need to remember that late diagnosis of HIV, leading to the late start of treatment, is one of the major causes of serious ill health and early death. Yet, here we are, pursuing a policy that deters treatment and testing, from which the only logical result can be that late diagnosis. If you want a monetary argument, you have to add the additional costs of treatment for that individual plus the cost of those who may be further infected. On the face of it, it is not a prudent financial policy.
Why do we therefore pursue such an apparently reactionary and foolish policy? Here I come to the noble Lord’s point. Only one argument has ever been put forward. It is that if the rule were to be lifted there would be a danger of “health tourism”. This is an argument based entirely on assertion. As far as I can see, there is no evidence whatever for it. My Select Committee looked at this point, as the noble Lord will know because he has read the committee’s report on this matter. The same rule is not applied in Scotland, Wales or Northern Ireland—either as policy or in practice. Has there been an influx of those suffering with HIV to Edinburgh, Cardiff or Belfast? Of course not. My Select Committee could find absolutely no evidence in this respect. If there is such evidence, I invite the Minister to give it or any other evidence that she may have on health tourism, because, so far, it has never been put.
The crucial point against the law in England is that it is not enforced in any event. It is incapable of being enforced. The patients are usually destitute. A hospital gives the treatment. Then it pursues the charges. Then it finds out that the patient cannot pay and it writes off the whole amount. As one of our witnesses said, it is a constant circle of nonsense. That is the position that is being defended at present.
I have not yet heard any sensible defence of the present position. As a matter of principle, Parliament should not pass laws which cannot be enforced; and as a matter of practice, Parliament should not pass laws which add to the problems of public health and do not reduce them. If the Government are serious about their intent to put prevention first, this law should be repealed. I beg to move.
Baroness Gould of Potternewton
My Lords, I am very pleased to support the amendment. I was also very pleased to see that, in the response to the HIV Select Committee report, the Government are reviewing their current policy, which excludes some people from HIV treatment. The HIV Select Committee was absolutely right to say that it is wrong to charge anyone with HIV treatment and care.
For me, it is not only a question of health, it is a question of humanity. I find it incredible that this position survives. I have to say this with great regret, because I spent a long time trying to persuade my Government that something should be done about this, with little success. The argument was made very much in the way that my noble friend said about health tourism. I hope, although I am not clear from the words of the Minister in replying to the debate in December, whether that is still in their thinking. She said,
“we must avoid creating any incentive for people to come to the UK for the purpose of free HIV treatment”.—[Official Report, 1/12/11; col. 492.]
As my noble friend Lord Fowler said, there is no evidence to support the claims of HIV health tourism if the charging is ended. In 2008, the National Aids Trust produced a report on the myth of HIV tourism, demonstrating that such claims are wholly unfounded. Data from the Health Protection Agency show that the average time between a migrant arriving in the UK and an HIV diagnosis is almost five years. That is an awfully long time for someone coming on the basis of health tourism. For me, it is the absolute clincher as to why this is all such nonsense. Further, government reports have suggested that asylum seekers have no prior detailed knowledge of the UK's asylum policies, welfare benefits or entitlement to treatment. That would apply equally to HIV.
HIV charges, as the noble Lord, Lord Fowler, said, are not applied in Scotland, Wales or Northern Ireland. We would have seen some movement from London or anywhere in England to those nations if people wanted to access free treatment. If individuals do not move from London to Edinburgh to access free treatment, it is difficult to believe that they move from, say, Harare to London, for that reason. Another reason makes that claim somewhat ludicrous. A report published yesterday by the HPA shows that 5.9 per cent of TB patients are HIV-infected. TB treatment is free for those people; but the HIV treatment is charged. I do not know how one differentiates between those treatment costs, and, again, it just shows how stupid the position is.
In addition, since 2004, when the charges for HIV treatment were first implemented in England, there has been a 13-fold increase in access to anti-retroviral treatment in low and middle-income countries around the world, with sub-Saharan Africa seeing the greatest increase in the absolute numbers of people receiving treatment. ART coverage of all those who need it now stands at nearly 50 per cent in those regions and continues to increase. It is most unlikely that those able to purchase a flight to the UK will be unable to purchase ART in their own country. Having HIV does not in itself prevent removal from this country if a person is in breach of the Immigration Rules, as was established at the European Court of Human Rights in the case of N. Therefore, there is no reason for someone who knows they have HIV to migrate to the UK believing that their HIV-positive status will secure settled residence and ongoing access to treatment.
However, there is another criterion which, again, I had not appreciated until yesterday. A situation arises from the new Immigration Rules that have just come into force which further entrenches the way that HIV treatment charges deter African men and women in particular from finding out about their HIV status or going for treatment. Now, anyone with an unpaid NHS debt of over £1,000 will routinely have further immigration-related applications, whether to remain or for re-entry, refused. In the past, it was possible to encourage people coming forward for testing and treatment on the basis that it would have no impact on their immigration status. That is no longer possible as, if you are not entitled to free HIV treatment, your immigration status can be affected. As the noble Lord, Lord Fowler, said, these people are destitute and do not have the money. As a consequence of this change, they could now be removed from this country, which is something that never happened before.
There is also the whole question of costs. It seems to me that not removing charging continues to increase the cost to the NHS arising from HIV treatment charges. Ending charges for HIV treatment will actually save the NHS money by preventing new HIV infections and by identifying HIV early, when it can be effectively treated, so reducing the need for hospitalisation and other costly care when people with HIV become seriously ill. Reducing the level of undiagnosed HIV and increasing the proportion of people with HIV on effective ART will reduce the number of HIV transmissions occurring in the UK. I think that the noble Lord, Lord Fowler, said that preventing one onward transmission of HIV saves between £280,000 and £360,000 in treatment costs over a lifetime. People who are diagnosed late or who do not access treatment become seriously ill and will often require expensive in-patient care—a week’s stay costing between £15,000 and £25,000, and there may be many repeat visits to hospital. Surely it is cheaper to provide no deterrents to early testing and treatment.
It is sound common sense to remove this costly and inhumane restriction from the NHS (Charges to Overseas Visitors) Regulations. I hope that perhaps, not today but when the review is over, we will hear sound common sense from the Government.
The Lord Bishop of Newcastle
My Lords, I strongly support the amendment, and I shall be very brief. I believe that it is high time to put an end to the singling out of HIV as the only infectious disease which is subject to treatment charges. I believe that exempting HIV from charges is necessary to save lives, to protect public health and to safeguard NHS resources. Ensuring that everybody who needs treatment receives it is the key point. Charges deter people from accessing treatment and from testing for HIV. Why is it that HIV is the only serious communicable disease for which treatment is not provided free of charge? It is inconsistent and confusing, and undermines efforts to prevent further infection. Removing the charges will prevent many premature deaths in the United Kingdom, and will reduce long-term costs and transmission of HIV. This is why I hope the Minister will look very kindly on this amendment.
Lord Hunt of Kings Heath
My Lords, I congratulate the noble Lord, Lord Fowler, and my noble friend Lady Gould, on their perseverance. I think they have been waiting for about three days for this amendment. Clearly, they have pointed out the anomaly in the law and the perverse incentive under the current situation; in particular, the fact that if charges result in no treatment, there is danger to the individual and risk of spreading the disease, and that knowledge of charging prevents people from coming forward for testing and treatment. As my noble friend Lady Gould has just said, the contrast with other infectious diseases such as TB clearly points this out as an anomaly.
I too was interested in the answer to the question about health tourism. We have been given a pretty convincing response. The experience of Scotland, Wales and Northern Ireland is very clear. I also found very interesting the question of cost against benefit. It appears that very little money is raised by the charge, but that it is a disincentive for people to come forward. If they do not come forward, the cost to the system in the end is much greater. It seems to me a pretty convincing argument. I know there is a review, but we encourage the noble Baroness to anticipate that review and give good news to your Lordships tonight.
Baroness Northover
My Lords, I am very grateful to my noble friend Lord Fowler for the constructive way in which he has raised this amendment and I pay credit, as others have to done, to his continuing, enormous commitment to improving HIV services for all. I also pay tribute to other noble Lords who contributed to this debate and to this long battle over many years. I will commit to having considered by Report the arguments and proposals set out by my noble friend.
The Department of Health is indeed currently concluding an internal review of the current policy to charge some people for HIV treatment. We will be concluding this review by the new year, including any discussions with the other government departments which will have an interest. The review has considered many of the issues raised by noble Lords today. These include the increasing evidence of the public health benefits of early diagnosis and the role of HIV treatment in reducing onward transmission of HIV.
In the UK, around 25 per cent of people with HIV are unaware of their infection, which means they are unable to benefit from effective treatment and risk transmitting HIV to others. Promoting HIV testing to reduce undiagnosed HIV and late diagnosis remain important priorities for HIV prevention. We would be very concerned if our current policy were to deter people from testing for HIV, even though testing has always been free of charge to all. Those already entitled to free HIV treatment and care include asylum seekers and, from 1 August this year, failed asylum seekers receiving specific support packages from the UK Border Agency. Further, failed asylum seekers who are already receiving HIV treatment when their asylum application and any appeal fails continue to receive free HIV treatment up to the point that they leave the country, regardless of whether or not they receive the UK Border Agency support.
However, I acknowledge that a small number of vulnerable people will not be covered by the current exemptions and they may be deterred from accessing HIV testing services because they cannot afford treatment or are confused about the entitlement to free NHS treatment.
The world has made huge progress against the HIV epidemic in the 30 years since AIDS was first identified. Globally, new infections have fallen, and nearly 7 million people are on ARV treatment. While there is currently no significant evidence of health tourism in relation to HIV, in considering any changes to our current policy we must make sure we that we do not create an incentive for people to come to the UK for the purpose of free HIV treatment, without compromising our overriding responsibility for public health. I stress again that our overriding responsibility is to public health. As my noble friend Lord Fowler said, the Select Committee on HIV examined the issue of health tourism.
In conclusion, the department's review identified and considered many of the issues raised today. We are now looking urgently at how these can best be addressed. I assure my noble friend that we will provide a clear position in time for Report. I hope that in the light of this he will feel able to withdraw his amendment.
Lord Fowler
My Lords, I thank the Minister for that very sympathetic and understanding reply. We obviously understand that a review is taking place and take comfort from the fact that it will be complete by Report. She will have noticed that support has come from all parts of the House. I think that it would have come from the Liberal Democrats; I know that they share this view. Therefore, every party, including the Bishops' Bench—for which I am very grateful—is represented. Perhaps I may say that the House has left its visiting card on the issue. We look forward to Report and to the statement of policy that I am sure will come by then. Given the Minister’s assurance, I beg leave to withdraw the amendment.