(15 years ago)
Lords ChamberMy Lords, we turn to Amendments 49 and 50 and the subject of the HFEA and the HTA somewhat late in the evening again. We have now had time to reflect on what the Minister said on 9 March, to read the letter to my noble friend Lord Warner, which the noble Lord thoughtfully copied to me and others, and to compare the two. In reading the debate on 9 March, I realised it had centred on the issues that arise out of the siting of the HFEA rather than on the proposals for the HTA, so I shall start by raising a few issues that are particularly pertinent to the HTA.
Since the previous debate, the Government have announced that the HTA has been appointed as the competent authority to regulate the quality and safety of organs under the EU organ donation directive. The HTA is now the competent authority for two EU directives. I would be grateful if the Minister will explain where this competence will sit under the various options he outlined in his letter to my noble friend Lord Warner. In addition, the HTA’s responsibilities with respect to EU legislation extend across the UK, but the Care Quality Commission’s remit extends to England only. The Minister can see where I am leading with this question because of the statutory implications that such a move might involve. For example, have the Government consulted the Welsh Administration about this matter or would they divide the legislation or extend the geographical remit of the CQC? Indeed, what if the Welsh said no to such matters regulated by the CQC?
We also need to look at the context in which these changes are being proposed. There are loopholes between coroners legislation, the Human Tissue Act and the Police and Criminal Justice Act which the HTA is addressing at the moment. I think it is right to be concerned with the Government’s continued determination to abandon the idea of establishing a chief coroner’s officer, the abolition of the National Policing Improvement Agency combined with proposals to break up the HTA’s functions. Added to the squeeze on resources in the central government’s resource, one should ask what guarantees will continue to be there and where they will be concerning human tissue not being retained without consent.
When the Minister answered this debate on 9 March, he took the trouble to explain in some detail the Government’s thinking about the future of the HFEA and the HTA and spoke about the possible creation of a new health research agency, which I think largely met with a great deal of approval across the House, and I shall return to that matter in a moment. His letter to my noble friend explores the various options that the Government might take with the powers that the Bill will grant them. I know my noble friend Lord Warner will want to explore the contents of that letter, so I shall limit myself to two issues that are still outstanding and need to be addressed before Parliament grants such powers with regard to these two bodies.
The first is the nature of the pick-and-mix proposals for the future of the HFEA and HTA, which the Minister suggested in his reply to the House on 9 March and in his letter to my noble friend, because I do not think it is acceptable to ask for powers fundamentally to change these organisations and not to know at this stage how those changes might be achieved and what they will do. The Minister spoke about this being a road of travel. Roads of travel are fine when one is developing policy but they are more difficult when one is putting into legislation things which will have a direct effect—in this case, on these two organisations.
Secondly, I return to public confidence, which I raised in Committee. I have read the Minister’s reply on the importance of keeping public confidence in the functions of the HFEA and the HTA. It centres around the fact that he is keen to assure the House that the legislation, and the ethics that underpin that legislation creating the HFEA and HTA would not be fundamentally changed. But I am puzzled: I do not see how, as regards the options outlined by the Minister—the orders that would need to be consulted on—he would intend to stop those ethical issues that lie at the heart of that legislation being discussed at length because of the public confidence that resides in them. When change is being proposed, that reassurance and the assurance that the new arrangements will do their job is obviously very important. Option papers do not usually provide the necessary assurance about people’s jobs or functions and, in this case, about where the ethical issues that underpin that legislation would lie.
I feel that the Government have the opportunity to move forward with the creation of a new science body, and the future of the HFEA and the HTA, with a great deal of agreement across the House and with a great deal of good will to make that happen. I do not think that this Bill is the place to start that, which probably is the heart of the problem.
Before the noble Baroness leaves the issue of ethics, if the agency model is developed, which would have a separate ethics committee that I think most of us would accept, does she agree that it is not just simply the ethics of research that is important, it is also the ethnical decisions about developing clinical practice? The need for those to be kept together within the new agency is of paramount importance in order that there is public confidence. Without the setting up of the agency, there will be a huge gap that needs to be filled.
The noble Lord, Lord Willis, makes the point extremely well and much more eloquently than I was able to. It underlines the point that I have been trying to make. Taking the powers to break up the HFEA and the HTA, as it were, is not the way to start that process. The noble Lord makes exactly the right point. The Minister should recognise that there is a great deal of good will to make this happen across the House but not starting here. I beg to move.
My Lords, I declare my interest as chair of the Human Tissue Authority. I and my authority remain concerned about the impact of the Bill on public and professional confidence in the safe and ethical use of human tissue, as has already been raised by my noble friend. My first question to the Minister is to seek reassurance that the HTA’s functions will not be divided. A division of our functions into three or possibly four different parcels would, in my view, risk undermining the legislation that the HTA was set up to implement, increase the regulatory burden on the sectors we regulate and damage public confidence that has been so hard won.
We must not forget that the HTA was established as a result of scandals at Alder Hey and Bristol Royal Infirmary. Those events caused profound grief among affected families, outrage amongst the public and a crisis of confidence. Those events are still recent. The Human Tissue Act, which set up the HTA and was subject to more than 100 of hours of parliamentary scrutiny, was passed in 2004. The HTA began regulating as recently as 2006. In a relatively short period, it has successfully turned around that crisis of confidence. When people know there is effective regulation, they are more confident in donating their tissue for medical research, their organs for transplant and their bodies for medical education and training. Increased public confidence should mean more donation; more donation should increase professional confidence, thereby creating a virtuous circle beneficial for all. More lives are saved; more people are given back their quality of life; and there is more research and surgical skills training for the benefit of the public.
The Government’s arm’s-length bodies review sets out proposals for transferring the HTA’s functions across three or four different organisations. I fear that separating the HTA’s functions would risk undermining the progress that has been made in building public and professional confidence. Leading thinkers have voiced profound concerns about dismantling the HTA. Senior legal academics have said in the Sunday Times:
“The proposals to abolish the Human Tissue Authority—HTA and the divisions of its functions among larger, non-specialist regulators—risk confusion and error in the implementation of the Human Tissue Act 2004, which in turn will erode public confidence”.
In addition, earlier this month, senior consultant surgeons writing in the Guardian said that moves to break up the HTA would,
“undermine professional and public confidence in the area of medical consent”,
and urged,
“the government to think again and stop trying to operate on things that aren't broken”.
I hope that the Minister will listen to these voices.
The Minister has said that the HTA’s health-related functions should transfer to the Care Quality Commission. I am still not clear about the fate of the HTA’s organ donation and research functions. The ALB review does not suggest a home for its organ donation approvals and suggests that its research functions should transfer to a single research regulator.
With regard to organs, the Human Tissue Act requires board approval of highly sensitive and ethically complex cases of organ donation from living people. If this were to be placed with the CQC, how would the Minister meet the statutory requirement that at least three authority board members who are specifically trained in this area review such cases?
With regard to research, the new regulator for health research will provide a potentially helpful way forward for streamlining medical research in the UK, simplifying life for researchers and increasing the quantity and quality of research. The Minister stated at Second Reading that the purpose of this Bill was to streamline the process of regulation and to reduce costs and bureaucracy. I do not see how the proposal to transfer the HTA's research functions to this new regulator would achieve simplification; nor do I believe the proposals would save money. The sectors that the HTA regulates are interrelated and interdependent, and although it regulates a separate research sector, the licensing framework also allows establishments in the post-mortem, patient treatment and anatomy sectors to store tissue for research as well as for other purposes.
I take the post-mortem sector as an example. The proposal would result in at least one-third of post-mortem establishments needing to be licensed by an additional regulator if they wished to store material for research. A similar proportion of establishments storing tissue for patient treatment would also need to be licensed by an additional regulator. The regulatory burden on an estimated 200 establishments would therefore increase, not decrease. So can the Minister explain what impact this proposal will have on the regulatory burden on these establishments? Can he explain who would be responsible for producing the statutory code of practice on consent and who would be responsible for ensuring consistently high standards if the HTA’s functions were divided?
My noble friend Lady Thornton raised concerns about the ethical dimensions of the work being lost in the rush to amend the mechanical processes. I share these concerns. This is a complex ethical landscape. The HTA has the professional expertise to respond to emerging forms of communication such as Facebook and Twitter. These are now being used as conduits for patients looking for organ donors. We are launching consultation on this very issue in May, and this is a good example of how agile and sensitive the authority can be. Can the Minister assure me that the credibility that lay and professional board members bring to the HTA will not be lost in the Care Quality Commission, when the CQC has only a small number of commissioners? An advisory group has been mentioned. If that model is proposed, can the Minister say what guarantee there will be of its independence?
I apologise for raising so many issues at this late hour but there are many issues still to be resolved. In summing up, I say only that the reason the HTA was established has not gone away and there is still work to be done. My argument is not against the Government’s intention to simplify the regulatory landscape; rather, I want to avoid putting at risk the substantial gains that the HTA has made by splitting its functions across a number of different organisations and losing the overall coherent approach which has been so successful in supporting public and professional confidence and ensuring that tissues and organs are used safely and ethically and with proper consent.
I have one final plea. David Thewlis and Stuart Taylor, both parents affected by the events at Alder Hey, brought it all home to me recently when they said:
“All the effort and soul searching that went into the establishing of the Human Tissue Authority cannot afford to be overthrown by abolishing the HTA and splitting its functions”.
I urge noble Lords to take this on board when deliberating the future of the HTA.
The direction of travel for the HFEA is one that we have mapped out. I am not aware that we are considering consulting on keeping the HFEA together. If I am incorrect about that, I will write to the noble Baroness. I understand why she wishes to press me on the point. However, I have not heard this option put forward, and it was not contained in the arm's-length bodies review.
I can assure the noble Baroness that the consultation will give an opportunity to all those with an interest to express their views on where would be the best place to transfer the functions, and on the merits of keeping functions together where appropriate. I recognise that the expertise of the HTA, and the extent to which this will be carried forward, is a key issue. The consultation that we plan will, as I mentioned, give an opportunity for interested parties to express their views on the point.
The noble Baroness, Lady Thornton, asked who would take over the role of competent authority for the EU tissue and organ directives from the HTA. That role will be considered for transfer to other bodies, as with other functions. It involves regulating according to quality and safety standards. We will consult on the most appropriate body for those functions to be transferred to.
My noble friend Lord Willis made clear his view that we should not split research functions. I can tell him that we envisage that the health research agency will cover what is now covered by the approval of research licences. In the context of human embryo research, the legislative requirements that the research is necessary or desirable, and that the use of embryos is necessary, will remain firmly in place. If that consideration includes an assessment of the research technique proposed, it will remain so in future.
The noble Baroness, Lady Thornton, and the noble and right reverend Lord, Lord Harries, asked how we would deal with the devolved Administrations. The intention of the proposals is to reduce both the cost of regulation and the bureaucracy for regulated establishments. It is important that a workable solution is found for the devolved Administrations, while recognising that the subject matter of the legislation is reserved. The Human Fertilisation and Embryology Act extends to the whole of the UK, and the Human Tissue Act extends to England, Wales and Northern Ireland. We hope to agree a way forward with the devolved Administrations that avoids any unnecessary duplication of effort in order to keep costs and bureaucracy for regulated establishments to a minimum. We have had constructive discussions already at official level, and these will continue. The CQC is at present an England-only body. If reserved functions were transferred to the CQC, we would extend its territorial remit in respect of those functions alone.
I will return to where I began. It is surely right that the Government and Parliament should look for opportunities to streamline regulatory mechanisms, as long as this is done in a way that preserves the legal functions, and the ethical underpinning of those functions that Parliament has put in place. The Bill provides us with the means to do that in respect of the HFEA and the HTA. In view of the Government's broader concessions on the Bill, and our intentions to consult widely on the proposed transfers of functions and to protect existing ethical and legislative safeguards, I hope that noble Lords will not press their amendments.
I thank the Minister for another detailed response. I also thank the noble Lord, Lord Willis, the noble Baroness, Lady Deech, the noble and right reverend Lord, Lord Harries, and my noble friends Lady Warwick and Lord Warner. I counted 17 to 20 questions that the Minister was asked. He gave us a great deal of information, some of which was useful and very interesting. However, I do not think that he answered all the questions.
The Minister raised the issue of us not being convinced. We are not being perversely unconvinced. The problem is that there are still too many unknowns about this part of the Bill. Extensive consultation in the summer, to which the noble Earl has referred on many occasions, is after the decision has been taken and after the powers have been taken.
For example, the Minister was pressed on the concern about registers and databases. His answer was that the decision would be part of the consultation, that they would not be dissipated and that there would be options put in the consultation. That is not a satisfactory answer at this point. The same goes for the impact assessment, which will be carried out in the context that the Government will have already taken the powers to do what they want to do.
On the ethical issues that I raised, the Minister suggested that those would go with whoever it seemed appropriate to be the responsible body. Frankly, at this stage of the Bill, an answer that has “whoever” in it is not satisfactory. There is widespread agreement that the medical research agency proposals sound promising, but that simply underlines the point that we should not proceed with including these two bodies in the Bill at this point.
The Minister has said several times that it is a complex process. We agree, and indeed the noble Lord, Lord Willis, made an extremely good suggestion about one way to simplify the process by using forthcoming legislation. Having been the Minister responsible for several Bills that might have been called Christmas-tree Bills, I am not sure that he does not have a very good point.
That begs the question: what is the hurry? If streamlining can be achieved without powers being taken in this Bill, money can be saved—as several noble Lords have said—without taking such powers, and a much larger discussion will be taking place as we move forward. It seems to me that those points remain outstanding.
At this point in our consideration, I do not think that we have reached a satisfactory and conclusive point in our discussions about the HFEA and HTA. I hope that we can resolve and clarify the remaining and outstanding uncertainties on this issue before Third Reading, and I very much welcome the fact that the Minister has said that he will be responding to certain points. I am sure that he is prepared to continue those discussions and I hope that we can resolve them before Third Reading. Otherwise, I fear that we may have to return to this issue. I beg leave to withdraw the amendment.
(15 years ago)
Lords ChamberMy Lords, I would do best to refer my noble friend to the impact assessment, which provides a detailed breakdown of the figures that I have just given. I acknowledge that we have had to make assumptions in drawing up the impact assessment. Those can be challenged, and I am aware of the figures that my noble friend has referred to. But I do not believe that changing the figures—and they are bound to change in the nature of the exercise—will make a significant difference to the overall cost. The assumptions made in the modelling are based on the best available evidence that we have at the moment.
Among many others, the Conservative MP Sarah Wollaston recently argued in the Daily Telegraph:
“I cannot see that it makes sense to foot the bill for redundancies for the entire middle layer of NHS management only to be re-employing many of them within a couple of years”.
As the Minister has said, the Government’s assessment of the redundancies varies between 600 and 1,200. Can I tempt the Minister to give us his best guess of how many of those redundant managers will be re-employed within the NHS within two years? Indeed, does the Minister think that this is an acceptable use of taxpayers’ money?
We expect that about 60 per cent of management and administrative staff currently employed in PCTs and strategic health authorities will transfer to the new GP consortia or the NHS commissioning board. Those are straight transfers. As for those who leave the service, we have included claw-back arrangements in the redundancy scheme so that, if any employee returns to work for the NHS in England within six months, they will be required to repay any unexpired element of their compensation.
(15 years ago)
Lords ChamberMy Lords, I shall speak also to Amendments 93, 150 and 151. On Second Reading, many noble Lords expressed their disquiet at the inclusion in the Bill of the HFEA and the HTA. At the time, I wondered if they were included because the Minister’s department insisted that the Department of Health had to offer something up to the Bill, so the poor old HFEA and HTA were the sacrificial lambs. Indeed, in its own review of the arm’s-length bodies, the Department of Health gives a much more measured suggestion of the deliberation and consultation before decisions were taken about the HFEA and HTA over a timescale that is the life of this Parliament. Unless something has changed about the expected length of this Parliament, it seems precipitate and unnecessary to include these bodies in the Bill.
In a meeting convened by the Minister—the noble Earl, Lord Howe—to discuss this important matter with interested parties, which I was pleased to attend, he was concerned to reassure us about the consultation and discussion to take place before decisions were reached. We can add to those reassurances the proposal, as I understand it, that in the next Session—in other words, after May 2012—primary legislation will be introduced to establish a new science regulator in the department. If that is the case, the passage of that legislation would allow proper consultation and scrutiny across the field including the work of the HFEA and the HTA, which is the way in which such reforms should be carried out. So I ask again: why is it necessary for these bodies to be included in the Bill?
The HFEA and the HTA almost symbolise the concerns that noble Lords have expressed in relation to the constitutional propriety of the Bill in giving Ministers powers to amend primary legislation. Both organisations would have their work and their regulation fragmented unnecessarily when they need to be left alone to get on with the jobs that they do very well—although there is always room for improvement—until a proper period of consultation and pre-legislative scrutiny, which I am sure the noble Earl would wish to have, can precede the introduction of the science regulator Bill or whatever it will be called. That is the way to proceed.
What do these bodies do? The HTA licenses and inspects organisations that store and use human tissue for purposes such as research, patient treatment and post-mortem examination, teaching and public exhibitions. It also gives approval for organ and bone marrow donations from living people, including anatomy and stem cells and cord blood; public display—that is, the public display of any human body parts in various forms—post mortems; coroners; and transplants.
The advances made by science throw up new and sometimes complex ethical issues for the HTA to address. The cavalier use of body parts for research without the knowledge or consent of patients and their families was a huge scandal, leading to public indignation. Many in your Lordships’ House will recall the time and the thought given to the creation of a regulatory framework that would command public confidence. I fail to see what has changed that can allow any slackening off of the responsibility that the HTA bears for the use of human tissue.
The HFEA is the UK’s independent regulator of treatment using eggs and sperm and of treatment and research involving human embryos. It sets standards for and issues licences to centres and provides authoritative information for the public, particularly for people seeking treatment, donor-conceived people and donors. Very importantly, it also determined a policy framework for fertility issues which are sometimes ethically and clinically complex. The HFEA Act 2008 includes provisions for research on different types of embryos and changes the definition of legal parenthood for cases involving assisted reproduction. Therefore, the work of both bodies is of enormous scientific importance apart from anything else.
The arm’s-length body review in July 2010 concluded that the HFEA carries out essential functions which satisfy,
“the criteria for being undertaken by an arm’s-length body”.
The review states that the HFEA,
“deals with issues that are judicially and ethically complex and contentious”.
The HFEA is a world-respected model which has been used by other jurisdictions to deal with extremely technical and legally complex areas of practice. We have to ask what will happen to the high level of expertise and experience in both organisations and whether it will be in the public interest to transfer regulatory functions to other organisations where this knowledge may be lost to the detriment of patient safety.
I know that some noble Lords, particularly some of our very respected medics, for sometimes differing reasons have expressed the view that time has moved on since the original reason was established for setting up these bodies, human fertilisation is not the novelty that it once was, these medical procedures no longer need the attention of their own regulator and therefore change is necessary. That is a powerful argument but I disagree with it, or at least I have yet to be convinced. It seems to me that the powerful reasons that brought these two bodies into existence, and the reason we in Parliament paid such close attention to establishing their duties, responsibilities and independence, are still as potent today as they were when they were founded. These are not primarily medical or scientific reasons but concern the need to maintain public confidence in the uses to which human tissue is put, and sometimes in the very controversial issues arising out of human fertility and procreation.
Time and consideration need to be given to the contribution to scientific research made by the HTA and the HFEA, and, of course, they should carry out their respective functions in a cost-effective and efficient manner with appropriate public accountability. We may wish to see change in the way that the HTA and the HFEA functions are carried out but I believe many of the changes needed could be achieved without their inclusion in the Bill. Change should be helpful in achieving the broader stated aims of reducing bureaucracy and saving money rather than simply focusing on a reduction in the number of arm’s-length bodies. By and large, by the way, I believe that both bodies have sought to make and have succeeded in making improvements in their work and functions in recent times. I believe that more now even than at Second Reading, given the Government’s proposals on research. As the proposals for the reorganisation of the NHS are discussed it seems to me that the future of the HTA and the HFEA need more time and much more consideration. Apart from anything else, the CQC, which it is proposed should become the healthcare regulator for the HTA and fertility treatment, will have neither the time nor the expertise to carry out this function until it has swallowed the regulation of the whole of the rest of medical and social care. One might imagine that if a scandal arises in four or five years’ time regarding either fertility regulation or the use of human tissues, the excuse will be given that the CQC was too preoccupied with the rest of its enormous brief to give these matters the important attention that they warrant. I beg to move.
My Lords, I have added my name to Amendments 92 and 93 in part in a spirit of helpfulness—I hope that is the case—to the Minister as I have traversed the same ground as him on Department of Health arm’s-length bodies. In 2003-04, I was the Minister who reviewed DH arm’s-length bodies and halved their number. Therefore, I cannot claim to be against reducing the number of Department of Health arm’s-length bodies. Indeed, my sins are fully catalogued by this Government in annexe B of their document on the arm’s-length body review, which was published last year. Therefore, I own up fully to these past misdemeanours. However, as I have previously said about the Government’s own arm’s-length body review, although I do not necessarily agree with every aspect of it, it comprises a serious, comprehensive, clear and coherent set of proposals, unlike some of the things which emerged from other departments under this Bill. Therefore, I do not in any way wish to argue that it was not a thorough piece of work.
I must apologise to the Committee if I was not sufficiently clear and I will be happy to write to those who have participated in this debate to make the position clearer. I was seeking to say that we do not wish to take a disjointed, piecemeal approach. There is a natural flow of process that, if Parliament agrees, can lead us to a position where we are able in one move, so to speak, to transfer the various functions more or less simultaneously—although I would not wish to undertake that the whole thing would be done on the same day—so as to arrive at that point.
In our view it is desirable to consult during the late summer of this year. We will then set about the process of designing statutory instruments based on that consultation and go out to consultation on them. All being well, we will then introduce a second-Session health Bill that will have within it the provisions to establish a single research regulator, assuming that that is what we decide to do. Therefore, the whole process should work in a seamless way. However, I shall be very happy to write to noble Lords setting that out.
I return to the point at which I left off, which is to express the hope that the noble Baroness will not press her amendment this evening. I hope that she will accept our assurance that we have a clear intention to consult on the proposed transfers of functions and that she will be willing to withdraw the amendment.
My Lords, I thank everybody who has contributed to this debate. I knew that it would be an interesting debate and a long one. I have been told by my noble friend that I have to be brief, as the Committee still has a lot of things to get through and the rest of us can go home when we have finished this. As I say, I thank all those who have taken part in this debate. The remarks of the noble and learned Baroness, Lady Butler-Sloss, were forensic and, as usual, very helpful. The noble Lord, Lord Walton of Detchant, spoke with great wisdom and knowledge about both the HFEA and the HTA. The noble Lord, Lord Newton, spoke wisely about the CQC. Having been one of the architects of the CQC in the previous Government, I wish to put on record that I very much admire the work that it does. However, it is being asked to do a great deal more, which worries me.
I am pleased that the noble Baroness, Lady Deech, continues to support us as we work towards resolving this matter. The noble and learned Lord, Lord Mackay of Clashfern, my noble friend Lord Winston and the noble Lord, Lord Patel—a trio of very distinguished professionals in their respective ways—said that, although progress has been made, the most important thing is to make more progress. I am not a scientist but in a way the scientists and the experts got us into trouble on both these issues and that led to the creation of the HFEA and the HTA, as imperfect as they might be. Those bodies were established to tackle the need to regulate and to restore public confidence. That is where we came in, as it were. It seems to me that challenges and problems still exist in terms of public confidence, to which I will return in a moment.
I accept that if we need to move to a more overarching medical research body, we need to go through a proper process. I am not convinced that the powers granted to the Government in this Bill are the way to do that or that what looks like a rather complex and very piecemeal process is the right way forward. However, I am grateful to the Minister for explaining this in great detail.
I am worried. A floating ethical framework sprang into my mind because I could not see where the ethical framework of what is being proposed will sit. If we cannot see where it will sit, what hope is there for the public? It seems to me that that is where the Government need to start. It is not a question of having a mechanical process and saying, “We will put this bit here and that bit somewhere else and have a regulation that will make sure that the research goes somewhere else”, because if we cannot understand where the ethics sit we are in very serious trouble.
The Minister has given us a great deal to think about and I am grateful to him for his detailed answer. I will read the record and I look forward to receiving his letter. We will need to think about what he had to say and discuss it further before Report. I will not press the amendment now, so I beg leave to withdraw it.
(15 years ago)
Lords ChamberFollowing on from that very helpful question, may I ask specifically about the mobile X-ray units in London, which we have discussed before in your Lordships’ House? These were funded through pooling relatively small amounts of funding from the PCTs across London, organised by the strategic health authority. Those bodies are about to disappear, so what will happen in the transition period to those mobile units and how will the new arrangements work with the consortia that are being planned?
My Lords, the position for 2011-12 is that the NHS in London will fund Find and Treat. During the next year, the NHS will consider future funding, taking into account the final evaluation of the service by the Health Protection Agency and the emerging guidance from NICE. As regards the more medium-term agenda, the Government’s strategy is for a much more joined-up service. We will have the public health service working both locally and nationally. We will also have the GP consortia commissioning treatment at a local level. I hope that, as the system evolves, the noble Baroness will see that there is no loss of momentum in this very important area.
(15 years, 1 month ago)
Lords ChamberMy Lords, the noble Baroness, Lady Murphy, has provided us with an opportunity to discuss this important issue, for which we should all be grateful. The Government published their new mental health strategy, No Health without Mental Health: A cross-government mental health outcomes strategy for people of all ages, on 2 February. It is designed to set the framework for the policy and development of mental health services for at least the next five years. It is accompanied by a call for action to set out the principles of change and urge co-ordinated action in delivering the strategy. I join other noble Lords in saying that this is an aspirational document and there is no doubt that it makes a powerful case. However, as is this Government’s habit, it does not contain goals and target-setting as a means to reach its objectives.
I welcome the strategy’s acknowledgement that mental health problems cost England £105 billion every year and that this burden spreads beyond health services to education, employers, the social security benefits system, housing, the criminal justice system, and families and communities. I also welcome its demonstrating how effective interventions and initiatives can reduce that burden and prevent needless suffering to individuals and their families.
I think that we are all familiar with policy documents that are excellent and long on analysis of the problem in question but unfortunately bring to bear solutions that lack the same passion, drive and specificity. I think that I am not alone in expressing this concern—the noble Lord, Lord Newton, and my noble friend Lord Patel are but two of the others who have done so. In the same week that the Government launched their mental health strategy, the Commons debated the revolution in the NHS that is the Health and Social Care Bill and the uncertainties that it may bring. At the same time, hundreds and thousands of people with a mental health problem will face a test of their incapacity evidence which is already suggesting great unfairness and causing great distress. If one adds to this the local cuts which threaten services that are vital to many, one concludes that the Government must expect a level of anxiety about the deliverability of the strategy.
I commend the work of the voluntary sector in this area. I did a trawl through the websites of Mind, SANE and Rethink to see what they had to say about the Government’s plans. I also had a look at their blogs to gauge their members’ reactions. Like most noble Lords and me, they give a general welcome to the strategy. However, I shall quote what someone on the Mind website said:
“The county council will cease to provide funding for our local branches of Mind, or indeed for any services for people will mental health problems. We, (mental health service users who attend any of the pitifully few groups or agencies available) were told that this is so we can all have more ‘choice’ by opting to fund organisations ourselves with personal budgets. In reality, people with life-long mental health problems are being weeded out at every stage of trying to access these budgets and will therefore be unable to attend anything. Centres such as those provided by local Mind charities may well have to close if there are no longer people who can afford to attend them. So much for ‘choice’. The future health and stability of those now left unsupported does not appear to concern the council. At a time when council budgets are being slashed, social care is under a great threat. Any talk of a ‘strategy for mental health’ is somewhat meaningless in the circumstances, particularly for anyone with long term problems”.
That is a point of view that the Government need to take very seriously.
Will the Government’s strategy work? For people who experience mental health problems, I suggest that it has to work. It is legitimate to ask questions about how it might be delivered. I agree with the noble Baroness, Lady Hollins, on the lack of mention of funding for research in the document. I make two points. First, multidisciplinary commissioning is vital for pathways of care. Some of the matters will fall within the remit of the public health authorities, some with the NHS Commissioning Board and some with GP consortia. This may risk fragmentation of provision. If co-ordination and co-operation are so important, why are the Government abolishing the National Mental Health Development Unit as part of their rationalisation of the arm’s-length bodies?
The second point is the greater societal challenge. We have to recognise that cuts will bring restrictions to education opportunities, unemployment and debt. The impact on people’s lives and their mental health cannot be underestimated. Debt and the risk of homelessness and family breakdown will have a huge, spiralling effect on stress and anxiety levels. There will be an even greater need for these services to be got right.
In recent times under the Labour Government, we saw the start of a positive change in public attitudes. Evidence clearly showed that we need to support people in the workplace and the wider community. I will be very interested to learn from the Minister the answer to the questions that the noble Baroness, Lady Murphy, and others have posed in this debate.
(15 years, 1 month ago)
Grand Committee
To ask Her Majesty’s Government how they will maintain public confidence and patient safety following the abolition of the Human Fertilisation and Embryology Authority and the Human Tissue Authority.
My Lords, it seems appropriate that we are having a short debate on the proposed abolition of the HFEA and the HTA, as one might say that it is a sort of warm-up for the debates that we will be having when the Public Bodies Bill restarts its Committee stage, which I hope will be soon.
This morning, the British Heart Foundation announced that it is spending £50 million on stem cell research in the hope that one day it will be as easy to recover from a heart attack as it is to repair a broken bone. A year ago, the groundbreaking partnership was announced between the Multiple Sclerosis Society and the UK Stem Cell Foundation to pump-prime and speed up stem cell research. This perhaps reflects science’s fast-moving progress in relation to stem cell research and the wonders that it might bring to medicine over the next few years. Right now, the HFEA is conducting a consultation on the ethics of sperm and egg donation. This issue is often in the media, which is unsurprising given what donation involves—that is, making children who may not be genetically related to their parent or parents.
As medical science advances, there seem to be more, not fewer, ethical issues to address in this area. To underline this point, not long ago—in fact, in March last year—the noble Earl the Minister and I were dealing with the regulations arising out of the Human Fertilisation and Embryology Act 2008 relating to the disclosure of information for research purposes and parental orders regarding the adoption of children born of surrogate mothers, among other matters. These are both highly sensitive and important issues concerning ethical and safeguarding matters and both rest in the hands of an HFEA accountable to the Minister and to Parliament.
In preparing for this debate, I used as my starting point what both organisations do and I tried to work out how these functions might be undertaken in the new regime that the noble Earl kindly outlined to some of us not long ago. The HTA licenses and inspects organisations that store and use human tissue for purposes such as research, patient treatment, post-mortem examinations, teaching and public exhibitions. It also approves organ and bone marrow donations from living people. Its work covers anatomy, stem cells, cord blood, public display—that is, the public display of human body parts in various forms—post-mortems, coroners and transplants. It is clear to me that the HTA covers a wide but related range of competencies, as well as the ones that were behind the organisation being established with such care some years ago.
The ethical issues that arise all the time as a result of the advances in science throw up new and sometimes very complex issues. Public indignation at the cavalier use of body parts for research without the knowledge or consent of patients and their families was huge and many in your Lordships’ House will recall the thought and time that were given to creating a regulatory framework that would command public confidence. The Bill was given more than 100 hours of direct parliamentary scrutiny in both Houses, not counting pre-legislative scrutiny or investigation by Select Committees. I fail to see what has changed that can allow any slackening off of the responsibility that the HTA bears for the uses of human tissue.
The HFEA is the UK’s independent regulator of treatment using eggs and sperm and of treatment and research involving human embryos. It sets standards for and issues licences to centres; provides authoritative information for the public, particularly for people seeking treatment, donor-conceived people and donors; and, very importantly, determines the policy framework for fertility issues, which are sometimes ethically and clinically complex. The Human Fertilisation and Embryology Act 2008 includes provisions for research on different types of embryos and changes the definition of legal parenthood for cases involving assisted reproduction. More than 200 hours were spent scrutinising this and previous legislation in both Houses, not counting the need for Select Committees and pre-legislative scrutiny. I make this point to emphasise that Parliament took its time to get these things right. It seems to me that, if Parliament is going to change the HFEA and the HTA, it needs to take time to do that also.
The Government argue that the HFEA’s licensing function could be moved and that its very sensitive records should become a responsibility elsewhere. I remind noble Lords that, on every occasion that Parliament has discussed human fertility since the 1980s, it has agreed that human embryos have a unique status and that their use for treatment and research requires special oversight.
Some say that IVF treatment has become so common that its regulation should be normalised in some way. I point out that, although public opinion has indeed moved, there are still powerful forces wishing to stop or limit the use of assisted conception and there are still the unscrupulous who would wish to profit from, for example, the longing of parents to have a baby. In addition, there is a very real danger that important research will be frustrated by people who have strong and hostile views should the responsibility for ethical review be removed from the responsible but supportive environment fostered by the HFEA.
The HFEA plays an important role in actively improving standards by, for example, being responsible for several consultations on issues of best practice, such as the ones to which I have referred. Reducing multiple pregnancies by limiting the number of embryos transferred has been and remains an important part of its work. My question is whether the Care Quality Commission will take on the important role of ensuring that clinics’ results are not achieved regardless of the perinatal mortality associated with multiple pregnancy.
The Human Fertilisation and Embryology Act is the focus for interactions between doctors, nurses and scientists. I suppose that these interactions could take place elsewhere. However, all the disciplines have vested interests and I point out, with the greatest respect, that organisations such as the Royal College of Obstetricians and Gynaecologists, the Royal College of Nursing, the Association of Clinical Embryologists and the British Fertility Society do not have the same impartial image enjoyed by the HFEA. The public have learnt to trust the HFEA and, indeed, the HTA. These bodies act as a bulwark between the sensational headlines in the less responsible press and those who are working in the field. Who would take on that role if either of these bodies was abolished? Would Andrew Lansley, or indeed the noble Earl, be prepared to act as that bulwark?
UK legislation on these matters is the envy and the blueprint for the world. In Australia, for example, the states of Victoria, South Australia and Western Australia have legislated to establish statutory oversight bodies. In 2000, the Singapore Cabinet appointed a bioethics advisory committee to examine the ethical, legal and social issues arising from biomedical research and development. Again, that is not a government department but a stand-alone, arm’s-length body.
I am not opposed to change and improvement and I am not opposed to these proposals for the sake of it. I support change to make organisations more effective—for example, by sharing back-office functions or other facilities, by changing regulatory functions or by testing to see whether functions could be performed more effectively elsewhere. It might be that the proposals that the Government have suggested so far for the HTA and the HFEA will provide efficient regulation of some of their functions through the CQC and possibly through the still-to-be-created academy of medical science. However, none of the proposals answers the question that is the subject of this debate: where would the ethical and safeguarding issues that are at the heart of the work of both these bodies sit?
I am aware that the Government have said that there is no intention to revisit the ethical and safeguarding provisions in the HFE Act or the principles of consent underpinning the HTA, but they have so far failed to address how the ethical and safeguarding functions might satisfactorily be carried out were these organisations not to exist. I cannot see the CQC or an academy of science being an appropriate body. That leaves us the Secretary of State and the Government, which is where we came in all those years ago with Alder Hey and the challenges posed by the new embryo and fertility advances of the 1980s. I suggest that public confidence in this area is best established through the independence of the bodies that regulate—the HTA and the HFEA—and that the Government need to rethink their proposals.
(15 years, 2 months ago)
Lords ChamberWe have not reached a view on this because the JCVI’s advice remains unchanged. In fact, current evidence shows that children under five are not the age group with the highest risk of death. The age group with the highest risk of death from the flu that is circulating currently is middle-aged adults. Nevertheless, those with risk factors have the highest risk of severe disease and death from flu compared with healthy age groups. However, I can tell my noble friend that nothing is set in stone. We do not wish to constrain the JCVI in any way and we will listen to its advice, as we always do.
My Lords, during the H1N1 pandemic, two organisations stood out as being essential to delivering a pandemic strategy: the Health Protection Agency, for its science, strategic planning and advice; and the PCTs, for their support and co-ordination on the ground. Both are due to be abolished in the next two years. Can the Minister inform the House about the Government’s pandemic plans, including, for example, the ordering of sufficient vaccine, both after the abolition and during the transition?
The noble Baroness asks an important question. The Government’s plans are to create what we are calling Public Health England, which will be the new public health service based centrally, linked closely to public health efforts in local authorities with local directors of public health. A pandemic vaccination campaign would be mobilised through those channels. I am clear that we have proper plans for the transition, which the noble Baroness rightly mentions as being a time when we need to have a specific focus on public health protection. The present plan, as she knows, is to bring the Health Protection Agency functions within the Department of Health so that there is a clear line of accountability from the Secretary of State downwards. I am clear that that is right. We will still have the expert advice that we do now from the people who are currently employed in the Health Protection Agency. That is an additional safeguard.
(15 years, 2 months ago)
Lords ChamberMy Lords, I congratulate my noble friend Lord Turnberg on this debate. Indeed, of all the speakers who have contributed today I particularly welcome the noble Baroness, Lady Jolly, to our debates and our deliberations for the future. I also need to congratulate all the speakers who have contributed today, because we have had a really excellent debate. We probably needed about two or three hours longer than we have had; maybe we need to do that.
I want to raise two matters, one strategic and one specific. Since June we have debated or had Questions on, among other things, cancer, diabetes, chronic pain, Parkinson’s disease, epilepsy, social care, COPD, neurological conditions, dementia and many others. I cannot recall a single debate or Starred Question where the issue of how services would be either safeguarded or delivered under the proposed reforms of the NHS was not raised in one way or another. The Conservative-led Government have been telling us this comforting notion that your family doctor will commission the services that you need—and who better to do so? I am on the record as saying that I support that in principle. However, Conservative MP Sarah Wollaston rather let the cat out of the bag when she wrote in the Guardian on 4 January:
“I know many GPs who are keen to tackle the redesign of care and even the issue of failing colleagues, but I know none that are interested in EU competition law. If commissioners cannot design care pathways free from the spectre of lawsuits from private providers, they will hand over to commercial commissioners prepared to take the rap”.
I think that that means that private commissioners may turn to private providers at the expense of NHS providers because of the intimidation, or their interpretation, of EU competition law. Will the Minister confirm the role that EU competition law will play in the forthcoming reforms? For example, will GP commissioners be able to choose NHS providers where they offer the best quality and comprehensive service even if they are not the cheapest, without fear of legal challenge from private enterprise cherry-picking the most lucrative contracts? The Minister will know that I have long been a supporter of choice and diversity within the NHS, but the question of how we achieve that might lead to a fundamental dividing line opening up between us.
The EU competition rules being used as a regulator for NHS services through Monitor provide us with a huge problem. The problem, if I might put it in shorthand, is that health-providing companies owned by shareholders and hedge funds are not independent providers; they are accountable to owners who want to see a profit. So patients and organisations that promote the interests of long-term conditions, for example, are correct to be asking how health services owned and run by these people will have their long-term interests at heart. These are the questions that we will need to answer when we look at the NHS Bill that is promised next week.
What role does the Minister envisage for the market, for competition and for the private sector as a result of these proposed reforms? Does he believe that collaboration or competition is the best way to run our health service? I promise noble Lords that the noble Baroness, Lady Finlay, and I have not collaborated in asking that question. These are very big issues to which, as I have said, I suspect we need to return for longer and deeper consideration.
I conclude by raising a specific issue—in many ways, a perfect example of the anxieties that are being raised in all quarters. This concerns GP commissioning and the future of cancer expertise in the new system, and I thank both Cancer Research UK and Macmillan Cancer Support for drawing this to my attention. Before I go on, I add my congratulations to the noble Lords, Lord Crisp and Lord Kakkar, who asked questions that drilled down into the detail that we are going to have to address, as indeed did my noble friend Lord Winston.
As the Minister will know, the cancer networks have been an absolutely integral and important tool in improving outcomes for cancer patients. The Government have said in the new cancer strategy, Improving Outcomes: A Strategy for Cancer, published yesterday, that cancer networks will continue to be funded during the transition period to GP commissioning. How will GP consortia make use of the expertise currently available in cancer networks to help in the effective commissioning of high-quality and seamless cancer services? How will the Government ensure that the functions currently provided by networks are not lost and standards compromised under the new commissioning regime? Will the Government ensure that cancer networks are funded throughout the transition period until 2014? Will that funding include funding that cancer networks receive from PCTs at the moment as well as directly from the Department of Health? How will GP consortia be incentivised to ensure that the critical functions of cancer networks are still carried out as they commission cancer services?
I am happy if the Minister wants to write to me about those questions; it is unfair to expect him to answer them in detail at this moment. But they are very important, and I look forward to his remarks.
(15 years, 2 months ago)
Lords Chamber
To ask Her Majesty’s Government what is the reported increase in the incidence of influenza since the end of November; and how many adults and children suffering from influenza were admitted to hospital or died in December.
My Lords, influenza-like illness, or ILI, has increased from 13 to 98 GP consultations per 100,000 people since November. The department does not currently collect data on hospital admissions. As of 6 January, there were 783 patients with ILI in critical care beds in England, and 50 flu- related fatal cases verified by the Health Protection Agency in the UK.
I thank the Minister for that Answer. Last June, I asked him about the 50 per cent cut in the communications budget for the Department of Health. He said that,
“every programme of communication or marketing has to be justified by the evidence that it will do some good”.—[Official Report, 30/6/10; col. 1798.]
We know that pregnant women are particularly vulnerable to the H1N1 strain of influenza, and HPA’s data show that the risk of mortality for pregnant women is sevenfold greater than that for non-pregnant women. Even so, midwives received a letter from Andrew Lansley, dated 16 December, encouraging them to vaccinate pregnant women. Does the Minister think that it is possible that, had the Government acted earlier and had a public campaign, had they not cut their public health communications budget, and had Andrew Lansley sent a letter in October rather than December, the lifes of at least one pregnant woman might have been saved?
My Lords, it is quite difficult to substantiate that suggestion, because the immunisation figures do not bear out the noble Baroness’s argument. The level of vaccine uptake in the over-65s is 70 per cent, which is better than in most countries of Europe. Among the at-risk under-65s, it is 45.5 per cent, which is comparable to the past two years. Therefore, it is not clear that a generalised campaign would have added value.
On the question of pregnant women, the normal procedure is for the Chief Medical Officer to write to all GPs in the summer, setting out all the at-risk groups. She did that in June. We were then alerted in December by the Health Protection Agency to a worryingly high number of pregnant women who had contracted influenza, so we wrote to both the BMA and the Royal College of Midwives to emphasise the desirability of encouraging that group of patients to get vaccinated. We did the right thing, which was to respond to emerging data.
(15 years, 2 months ago)
Lords ChamberMy Lords, perhaps I may start by wishing the Minister and other noble Lords a very happy new year and by commending the Minister for his patience: he finally got to make the Statement. I welcome the Statement and congratulate the Minister and his colleagues on making progress in building on the work that the noble Lord knows we were trying to do on this important and tragic matter, to which I had a personal commitment. Of the haemophiliac community, almost 2,000 of the 5,000 infected people have died in the intervening period. For those with hepatitis C, it has become more urgent that the ex gratia payments should be reviewed.
This is a campaign about which we know people feel strongly. One of the saddest documents that I have read recently was a letter to the Prime Minister, written in October on behalf of the campaign for all those infected. It described how about 100 people travelled to London to listen to a debate and to lobby for the day. A number of them were very sick, including a double liver transplantee. There were widows, young people who had lost their fathers and another person whose son had died only weeks before. They felt very aggrieved by the business in the other place, which did not produce the results that they had expected. A shocked and saddened group of people struggled down the stairs from the Public Gallery to leave Parliament. The letter concluded by saying:
“It is not an Act of Parliament that is needed, but an act of political will”.
To an extent, that is what has happened today. Indeed, their disappointment was added to before Christmas when they were expecting the announcement that we now have before us. I particularly welcome the extra amounts of money available and the fact that these will not be taken into account for the purposes of taxation and means-tested residential social care support, but I have some questions for clarification.
The first question concerns how the money will be distributed. The Statement says that a new trust is going to be established. Will the Minister expand on how the money is to be distributed through that trust? Will the trust be like the ones that exist at the moment or do the Government envisage something new and different? I should like some information about how the money will be made available and how it will be distributed. I would also like some clarification on prescription charges, because the Government’s decision to abandon free prescription charges for people with long-term conditions has obviously impacted on the groups that we are referring to. I know that the Minister suggested that the prescription charges will be mitigated, but can he clarify whether that will cover, for example, those in the early stage of hepatitis C, not only stage 2? Will it cover everyone encompassed by the different stages of these conditions?
The areas that I feel are less welcoming concern the issues that have been discussed in this House on many occasions to do with considerations about mortgages, life insurance and travel insurance for people affected by these conditions. I cannot see anything in the review that suggests that consideration has been given to these matters. They form part of the completion and closure that is needed. I would also like an assurance from the Minister about support for the Haemophilia Society, particularly as I understand that the Government will be working with the society to help to deliver the information programme that is going to be necessary to ensure that people in this community take advantage of the benefit that the Government are offering.
My final questions concern where the money to fund this is coming from. If the Government are successful in persuading Scotland and Wales to expand this scheme, which I hope sincerely they will be, how is that to be funded? That is the question that those Administrations will be addressing. However, I very much welcome this Statement and I congratulate the Minister and his colleagues on the progress that they have made.