Human Fertilisation and Embryology Authority/Human Tissue Authority
(13 years, 10 months ago)
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Baroness Thornton
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.
Baroness Thornton
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.
Lord Mackay of Clashfern
My Lords, I congratulate the noble Baroness on securing this debate at this time; it is perhaps an important interval, which we might not have expected to have but for other activities in the House. As your Lordships will know, I had the privilege of introducing the HFEA legislation all those years ago, so I feel a certain parental responsibility towards the authority that prevents me from wanting to see it perish. However, as children grow up, the needs surrounding them can change and it may well be asked whether all that the HFEA was set up to do needs to be done in quite that way now. For example, when it was set up, IVF was comparatively rare and it would be fair to say that people were somewhat afraid of it. We had the benefit of the report of the noble Baroness, Lady Warnock, suggesting what should happen.
Since that time, IVF has become a much more regularly occurring clinical process. Undoubtedly, there have been questions—for example, about the number of embryos to implant—but these processes take place in other areas as well; there are important risks in many clinical processes and we have authorities that are responsible for monitoring them. There may well be a case, therefore, for considering whether the control of the practice of IVF should continue with the HFEA. Research, too, happens in many areas. It involves important ethical issues, even in other branches of medicine and scientific research. I think that the HFEA was set up primarily from the point of view of that research and its control. Although there may be room for modification, that should continue.
I have had no direct concern with the Human Tissue Authority—I am glad to see its chair taking part in our debate—but I had the privilege of sitting on the Select Committee that looked at the draft Bill. Many questions relating to the Human Tissue Act were raised there. The answer of the then Government was: “If these are mistakes, it is too early to correct them”. I have always thought that the sooner you correct a mistake that you have made, the better. I have no particular concern about the Human Tissue Authority. Our Joint Committee raised the possibility of a degree of co-operation between the two authorities that had not until then existed, although the situation may well have improved since we completed our deliberations. However, it is absolutely clear that the committee found no basis on which these two authorities could properly be put together as a single authority. We were absolutely unanimous and strongly of that view.
Lord Alderdice
My Lords, we are all grateful to the noble Baroness for achieving this short debate—and it is short; one has only a few minutes. For that reason, my noble friend Lord Willis of Knaresborough will address the HFEA, my noble friend Lady Williams of Crosby will have an overall look at the issue and I will focus my attention on the Human Tissue Authority. I declare an interest, because my wife is a consultant histopathologist in the NHS in Northern Ireland. She does not do any forensic or coroner’s work, but I declare the interest in any case.
The assumption in the noble Baroness’s Question is that these bodies—I will refer now only to the Human Tissue Authority—have increased public confidence and patient safety. I am not at all sure that that is in fact the case with the HTA. When I was much younger in medicine, I remember that one government requirement was that 10 per cent of deaths that did not require a coroner’s case PM would be post-mortemed. Why? Because the final judgment about whether or not clinical judgment was correct comes in the court of the full and rigorous autopsy of the pathologist. There is no other way of being certain. Even then, one may not get a final answer.
What has happened over the last few years is that we have achieved not the 10 per cent figure but the almost complete disappearance of such post-mortems. Many histopathologists, especially those who are newly qualified, will no longer carry out post-mortems. The Royal College of Pathologists is looking at whether it should allow pathologists to qualify without having proper experience in post-mortems, because so few of them are being done. One cannot talk about increased public confidence in post-mortems if the outcome has been that almost nobody wants permission for them to be done. That expresses a lack of confidence in post-mortems, not increasing confidence.
I will be more specific. In February of last year, the president of the Royal College of Pathologists wrote to the then Secretary of State, the right honourable Andy Burnham MP, with an eight-page letter—for obvious reasons, I cannot quote it in any detail—expressing the Royal College of Pathologists’ deep lack of confidence in the work of the HTA. He began the letter by saying that the fall-out of the HTA’s actions risked destabilising the provision of post-mortem examination services in England and Wales. He wrote about the concerns not only of the royal college but of the coroners’ service. He talked about the lack of efficiency, citing the work of the CPA, which undertakes external quality assessments for full laboratory services—in other words, histopathology, haematology, microbiology and clinical chemistry. The fee that the CPA requires for inspecting the entire laboratory service is half that which the HTA requires for inspecting just the mortuary. Even in terms of efficiency, therefore, there are serious questions. When the HTA was established, it had a lot of experienced people who had conducted post-mortems, but that is no longer the case.
If the new Government understand that this is the relationship that has developed between the professional bodies—to the point where pathologists are no longer eager to carry out post-mortems—they would not be responsible if they did not take this issue seriously. Should the Government not ask whether the HTA is the best vehicle to carry out what are undoubted requirements for proper procedures to scrutinise this professional work?
Lord Alton of Liverpool
My Lords, the noble Baroness has laid before us a Question that rightly draws attention to two issues: public safety and public confidence. They are the issues that the Minister rightly addressed last week when he kindly and courteously invited us to be given a briefing about the Government’s intentions.
For me the jury is out on these issues. I would certainly want to see, at the very minimum, a reform of the HFEA. The Minister will recall, as other noble Lords will, the debates that we had during the passage of the Bill, when a number of us argued for the creation of a national bioethics commission to oversee some of these ethical issues. I suppose that I subscribe to the cautionary verse of Hilaire Belloc, who said,
“always keep a-hold of Nurse
For fear of finding something worse”.
I would like to see the colour of the Government’s money. I want to see precisely what they have in mind before coming to a conclusion.
It is worth going back, as the noble and learned Lord did in his remarks, to the creation of the HFEA. As the noble Baroness, Lady Warnock, has said, it was necessary to create it—these were the words of the Warnock report—
“if the public is to have confidence”.
She said that it needed to be an “independent body”, that the membership was,
“not to be unduly influenced by sectional interests”,
and that its membership was to include,
“a diverse range of views”.
She also laid great emphasis on what she described as the,
“special status of the human embryo”.
I have a Question on the Order Paper at the moment asking the Minister to update the figures given to us by the noble Lord, Lord Hunt of Kings Heath, during the passage of the legislation two years ago, but the figure that was given then was that some 2 million embryos had been destroyed or experimented on since the passage of the 1990 legislation, so these are not trivial questions. The question of the status of the human embryo has always struck me as central to this argument.
I note that the chair of the HFEA, Professor Lisa Jardine, said in the Guardian on 5 January that,
“the safeguarding of the ‘special status of the embryo’ will be lost”,
if the HFEA is abolished. In an article in the journal Nature last August, it was suggested that,
“losing the HFEA as a discrete body could undermine public confidence”.
The article on Professor Jardine adds that the HFEA,
“carefully shelters human embryos from routine experimentation”.
Perhaps the Minister could tell us whether he has asked how many embryos have been thus spared; surprisingly, the HFEA, via Parliamentary Questions, says that it cannot tell.
Whether it is the unnecessary destruction of human embryos, the dangers caused to women by hyperovulation syndrome—before the Committee met today I passed the Minister a new paper from a German medical magazine about this question, because it goes right to the heart of patient safety—the ethics and mercantile nature of exploiting poorer women through the sale of eggs, an issue that the HFEA is currently considering, or the extraordinary way in which the HFEA has, for instance, pursued Dr Mohamed Taranissi, requiring it to meet legal costs of nearly £190,000, it is obvious, as the current HFEA chief executive stated in a memo, that,
“something clearly has gone wrong—badly wrong over a sustained length of time”.
At the very minimum, I think that reform is needed.
I would therefore be grateful to hear how Her Majesty’s Government propose that there should be what the Minister himself has described as a “lighter touch”. Is that something that people such as me should be fearful of, or should we welcome it? Does it mean that in any sense there will be less regulation? Will the status of the human embryo be diminished further? How will the exercise of the HFEA’s powers through this lighter touch be done? Also, how will the Government ensure that the requirements of the Human Fertilisation and Embryology Act, which stand in place, will be adhered to if the HFEA ceases to exist in its present form? Who will be responsible for the transfer of sensitive data that the HFEA holds? How will independence, freedom from undue influence or sectional interests and a diverse range of views be upheld?
Lord Winston
My Lords, I most grateful to my noble friend Lady Thornton for introducing this debate. It is rather delightful for me to be able, on this rare occasion, to support the Government’s position and to support the Minister—at least, I suspect that I will be supporting him. It is a particular delight to see the noble Lord, Lord Wigley, attending this debate; it was he who, in 1985, broke the Speaker’s Chair in the debate when the Private Member’s Bill came in as part of Enoch Powell’s attempt at legislation. I, of course, can declare an interest as an ex-poacher in this area—I no longer run an IVF unit—and I note that I am followed by a noble Baroness who was a gamekeeper.
I must say that I was open-mouthed at the quality and the succinctness of the speech of the noble and learned Lord, Lord Mackay of Clashfern, when he introduced the HFE Act. It seemed like a model of what should happen. It is fair to say that at the time it was an essential piece of legislation, which has now passed its day. It is no longer necessary; the research that it regulates is not really suitable for regulation by the HFEA. I believe that other areas of medical research, such as paediatrics, obstetrics, geriatrics and assisted dying, in many ways raise much more important ethical issues on a day-to-day basis. With stem cell research, the HFEA is inadequate for the purpose. A completely different body is needed, since stem cell research is ubiquitous and affects every tissue in the body, including the brain and the liver, and will clearly be an important replacement therapy in future. If it is to be regulated, it needs a different kind of touch.
As for clinical regulation, frankly the HFEA cannot prevent accidents or errors. It has not done that and it cannot do that; no regulatory authority can do that completely, any more than any other way of inspecting laboratories can. It does not prevent exploitation of women, who pay massive fees—in my view unreasonably—and has not helped in the costing of IVF treatment. It is unable to prevent fertility tourism, which goes around British legislation on a regular basis, and has not prevented clinics from collaborating with overseas units in allowing their patients to go to places such as Spain and Russia to seek treatment that they cannot offer themselves—with what kind of relationship, I am not sure.
There is a repeated assertion that the HFEA has always assuaged public concerns about IVF. I think that that was true 20 years ago but it is not true any longer. The public are pretty mature about this area, as was shown clearly by the hybrid embryo Bill. Things have moved on and the public are rather more sophisticated.
Lastly, one of my concerns about the HFEA is that it is extremely costly for men and women who are already paying for these services. I have just checked on the cost at Hammersmith Hospital, a clinic that I used to direct. Effectively, the HFEA requires two extra salaries to be paid and individual patients will pay on average around £300 for the use of IVF licences for their treatment. That seems an unfair burden in an area of medicine that is already extremely burdensome for the patients.
Baroness Williams of Crosby
My Lords, I also congratulate the noble Baroness on securing and introducing this debate. One thing that she pointed to, which concerns many of us, is the extent to which there are huge commercial pressures in this field, which have led in other countries to an almost complete abandonment of what one might describe as the ethical limits that are widely understood in the medical profession. With an issue such as whether a grandmother’s frozen eggs should be used for the purposes of fertilisation, one has to say that the difficulty in reaching a proper conclusion rises daily.
I wish to raise the issue of inspection and the issue raised by my most admired poacher on the question of medical research. First, there clearly has to be some inspection of the clinics that fall under the HFEA. I would be grateful if the Minister could tell us his view of how that inspection will function. It may be more limited than it used to be, as the noble Lord, Lord Winston, and the noble Baroness, Lady Thornton, said, but it must be maintained at the level of day-to-day practice. It is very important that that should be so in order that patients can have some sense of the safety of the enterprise.
On the much bigger issue of medical ethics, raised by the noble Baroness and the noble Lord, we are looking at a tremendous multiplication of the issues around ethics and the massive advance of life sciences. I accept that that cannot be dealt with by the HFEA, with its rather limited terms of reference. We must try to bring together a much more significant body to look at the whole issue of the relationship between ethics and life sciences. In that context, may I sweeten that pill by suggesting to the Minister that one way in which one could develop the great idea of a great society would be to look at a marriage between a body that had status in government terms with the other great bodies that look into these matters—the Nuffield Council on Bioethics, the Royal Society and others? In that way, one might get a genuinely wide spectrum of opinion, including great scientists and ethicists, on the issues that now confront us with life sciences. I believe that, unless we do that, we will quickly run into real problems where dogmatic forces take up resistance to any advances or other dogmatic forces look at the commercial elements as the way to guide our consideration of biological and biochemical ethics in future years.
Baroness Deech
My Lords, I declare an interest as the former chair of the HFEA. For most of my tenure I was paid the princely sum of £8,000 per annum, but it was a burden—nearly a full-time burden—that I undertook with pride and viewed as a privilege, grateful that infertility had not affected me. I wished to help others safely and with respect for their dignity, avoiding exploitation, and I remained in awe of the achievement of the scientists.
This debate, for which I am grateful, is about public confidence. It is not about confident, or self-confident, doctors; nor is it about how wonderful and trustworthy our doctors and embryologists are. If that were the issue, we would not need regulation in many walks of professional life and the controversy surrounding the Public Bodies Bill would fade away. It is easy in these surroundings or among researchers and specialists to forget how sensitive the issues of IVF and embryos are, and how very concerned the public are. The most vivid event during the passage of the Human Fertilisation and Embryology Bill three years ago was the hundreds of members of the public protesting outside this Palace about the possible extension of embryo research to animal hybrids. If your name, like mine, is associated with embryo research, you are the recipient of hundreds of letters about it, and not always peaceful or unthreatening ones. As the noble Baroness, Lady Warnock, said in her esteemed report of 1984, the public want to know that some principles are involved. It is also not to be forgotten that most of the treatment in this country is private, and therefore a great deal of money is involved and the need for protection is all the greater. European law, as referred to by the noble Lord, Lord Winston, is a weakness in that protection but unavoidable.
Any analogy with the progress of science in the US, which is largely unregulated, is false. The US has been home to some of the scandals that have echoed around the world, whether it was a clinician using his own sperm, octuplets or the sale of eggs and sperm by needy college students for large sums of money. That is not a road that we wish to risk going down, but we are not risking it under the Government’s proposal. Those who want to see the HFEA abolished seem to think that there will then be no regulation and that they will be free to do what they want, and quickly. But no—the law will be the same; consent will be needed exactly as before, and so will licences. Taking the processes into other organisations can be guaranteed to be no faster, no less bureaucratic and no cheaper; just worse. IVF is not routine because, although it is practised very often, any one treatment can throw up not only ethical issues that are known to us, such as saviour siblings, but also new ones, as the science progresses every day. One cannot separate the collection of embryos and eggs from patients from their storage, their storage from donation for research, donation for research from new research and stem cell work, and none of that from the great database, patient guidance and reliable statistics and health screening of donors. The risks will be too great and the gains from the government proposal nil, and our international reputation will suffer.
We are talking about an annual expenditure of £7 million, of which only £1.5 million to £2 million comes from the Government, and even this, I am told, could be reduced. Certainly patients will still have to pay for regulation if the tasks of the HFEA are dismembered, so it will be no cheaper for them either. Placing the regulation with the CQC is misguided. This is a new organisation. There have already been hints that it is overburdened and its operations have not always been met with praise. There is no improvement in public confidence there; nor will the public be persuaded that embryos will be treated with respect and that there will be bounds on embryo research if it is handed over to unknowns and not the accountable and expert figures of the HFEA. Review, yes; reversal, no.
Baroness Warwick of Undercliffe
My Lords, in congratulating my noble friend on the timeliness of this debate, I must declare my interest as chair of the Human Tissue Authority.
As my noble friend said, the authority was set up as a result of the organ retention scandals at Alder Hey and Bristol. The retention of children's organs—including in some cases their hearts—without the consent or knowledge of their parents, rightly created outrage. It resulted in a crisis of public confidence. At the time, David and Hazel Thewlis, representatives of those affected, said:
“The Human Tissue Act has provided a new foundation for the people of this country ... consent was the cornerstone of the Act, and this must colour all of the work of the Human Tissue Authority”.
The authority has put informed consent at the centre of everything it does, and by doing so it has ensured the safe and ethical use of human tissue. I can confidently say that it has turned around the crisis in public confidence. However, it would be misguided to be complacent. The improvement is by no means universal or fully embedded. The reasons why we were set up have not gone away.
I am not hidebound or precious about which bodies should do the work, nor are my authority members. What we are concerned about is ensuring that the advances we have made are not lost, particularly the hard-won confidence of the public in the proper use of organs and tissue. We believe that the current proposals to transfer our functions to three or possibly four different organisations risk undermining the progress that has been made.
Paula O’Leary, of the Alder Hey parents’ support group PITY II, said recently:
“We fought hard for 10 years … who is to say this is not going to start up all over again?”.
Roger Goss from Patient Concern said:
“Dividing would be diluting. That would be going back down the hill in terms of protecting patients' rights to exercise informed consent”.
The best way of making sure that does not happen is to maintain a clear focus on the safe and ethical use of human tissues and organs across all our sectors. To do that, we need to keep our functions together. That way, we maintain a consistently rigorous approach to consent, and guarantee an individual’s right to decide, in life and in death, what happens to their bodies and the bodies of their loved ones.
The HTA is a small organisation with a broad remit. Our activities are interdependent. There are pathologist researchers, and researchers treating patients with tissue. Researchers study organs to improve the success of transplants. They are all regulated by the HTA and the ethical issues are common to all the sectors that we regulate. The gift of organs and tissues is a special one, giving rise to special ethical considerations. During the passage of the Human Tissue Act, consent was described as the golden thread through all our activities. That is why there is a single set of core standards across all the sectors that we regulate under the Act.
We are a lean organisation. The money that we get from the Department of Health is £1 million a year, about one-sixth of our total cost. We have to earn the rest. What we do makes a difference. Last year, we approved 1,100 organ donations from living people. Since we began regulating, these numbers have increased year by year. We work to give more people the gift of life offered by organ transplants. When tissue is used in medical treatments—such as the use of bone marrow stem cells in cancer treatments, or skin for burns victims—people can be confident that they are safe and good quality and have been donated with consent. If stem cells are collected from umbilical cord blood for potential future use, we safeguard the safety of mother and child and the quality of the cells. Our regulation of mortuaries means that individuals and their families can have confidence that their loved ones are treated with dignity and respect. In research, too, people can know that tissue will be kept only with their consent or the consent of their family, so they can be confident that their wishes will be respected.
I have no quarrel with the Government’s intention to simplify the regulatory landscape. My plea is simply that we do not jeopardise the gains that the HTA has made by spreading its functions across a number of disparate organisations and losing the coherent overall approach that has been so successful in promoting public and professional confidence in the safe and ethical use of tissues and organs.
Lord Willis of Knaresborough
My Lords, I congratulate the noble Baroness on this debate. Indeed, it is—as the noble Baroness, Lady Deech, said to me when I came into the Room—like Groundhog Day: we are back again debating exactly the same things. I thought that we had put these issues to bed. I do not, in fact, oppose my noble friend’s proposals on principle. It is right that we constantly look at the organisations and that we constantly review their procedures to make sure that they meet the times. Nor do I claim infallibility for either the HFEA or the HTA. They are not infallible and are in constant need of reform and refreshment. However, it is the lack of clarity over what is proposed, the lack of any consultation on the proposals, and in particular the lack of any public involvement in these proposals that makes me concerned about the future functions of both the HTA and the HFEA.
On 13 October last year, in response to a Question from the noble Baroness, Lady Deech, the Minister said that,
“20 years ago it may have made sense to look at a single body for carrying out the functions undertaken by the HFEA”.
He went on to say:
“Times have moved on”.—[Official Report, 13/10/10; col. 512.]
However, it was not 20 years ago that Parliament discussed this issue; in fact, it was three years. It is three years since the Joint Committee on the Human Tissue and Embryos (Draft) Bill, which I was privileged to chair—four members of that committee are in the Moses Room today—carried out detailed scrutiny of proposals to amalgamate the HFEA, the Human Tissue Authority and the MHRA into a single authority, RATE. The unanimous view of the committee and of Parliament during debate on the successor Bill was to retain separate regulators. No one proposed amendments to change that during the passage of the Bill. There was unanimity in both Houses that the use and practice of both tissue and embryos should remain separate and that they should in fact have separate regulators. What is more, that was the overwhelming view of the medical and scientific community, including the Royal College of Obstetricians and Gynaecologists, the BMA, the Royal Society, the Association of Medical Research Charities, the Academy of Medical Science, the Royal College of Nursing, the Wellcome Trust, the MRC and the Royal College of Pathologists. What has changed since 2008 to mean that all that is no longer appropriate?
The Joint Committee also carefully considered the regulation of research using not only human embryos but also admixed embryos, including cytoplasmic hybrid embryos. The fact that a single regulatory authority could make decisions in the round—recognising that groundbreaking research was but a short step away from clinical practice—appeared to us at the time to be a distinct advantage. I believe that it remains a distinct advantage today. Indeed, it is because a single authority, independent of the Government, was able to exercise its regulatory duties over all activities involving the human embryo that confidence in this extremely sensitive, ethical and emotive area of human science has progressed with support from the public. Also, because there was an experienced independent regulator, science was able to triumph over the reactionary views of the then health Chief Medical Officer, who regarded admixed embryos as “Yuk”.
Crucially, where is the evidence that such change as is being proposed will benefit science and clinical practice and improve public confidence? Of course, there is a strong argument—the noble Lord, Lord Winston, made it in our committee—that fertility treatments using embryos are now commonplace and should be regulated like any other medical procedures. If the Minister believes that, let us have a public debate about it. Likewise, if the recent report of the Academy of Medical Sciences into the broader issue of the regulation and governance of medical research is going to be the blueprint for the new proposals, let us have a public consultation and a public debate on it. Let us not rush into removing organisations that have huge public confidence and the confidence of clinicians, as it would be rather like throwing out the baby with the bathwater.
Baroness Wheeler
My Lords, I, too, thank my noble friend Lady Thornton for initiating this debate, as well as other noble Lords who have spoken with much experience and in-depth knowledge on this matter. It is particularly timely as the Government consider their response to the major concerns about the inclusion of the HFEA and HTA among the bodies to be abolished under the Public Bodies Bill, whose Committee stage discussions we are set to resume.
As has been stated, we on these Benches can speak with some authority on this matter, having, as the House will be aware, closely examined the case for merging the HFEA and HTA into a single body just over two years ago while we were in Government. We came to the firm conclusion that two distinct independent regulatory bodies needed to be retained to oversee the areas of human tissue and assisted reproduction.
As the BMA has stated, the UK has been well served by the HFEA and the HTA, and both have been used as models for other jurisdictions in dealing with extremely technical and legally complex areas of practice. The RCN has said in respect of the HFEA that the current high level of expertise and experience within the body is extremely valuable and that it would not be in the public interest to transfer regulatory functions to other organisations, as this knowledge might be lost to the detriment of patient safety. The HFEA’s chair, Professor Lisa Jardine, has described areas covered by the HFEA as the most controversial area of medicine apart from assisted dying, the most morally difficult and carefully legislated-for area and the most tightly regulated.
The HTA, born out of the terrible events at Alder Hey and Bristol hospitals, and the crisis in public confidence over unauthorised retention of babies’ organs and tissues, has in our view established hard-won trust and respect among the public and professionals. My noble friend Lady Warwick is right to express concern that this will be lost if the current clear focus of the HTA is diminished in the transfer of its functions and role.
This does not mean that we do not recognise the scope for review and change within either body, or how the regulatory framework may be developed in the future. Both bodies themselves acknowledge this. We also recognise that many in the key professional groups involved are supportive of such changes as bringing all medical research regulation, including embryo research, within the remit of a single medical research regulatory authority, as recommended by the Academy of Medical Sciences. However, time and space would be needed for independent examination and review of this and the broader issues of how functions should be delivered in future and the risks, benefits and costs, rather than just the current focus on how functions are to be transferred.
We are concerned that the Government’s process is to transfer functions to bodies that are as yet undeveloped and untested in this area of expertise. The Care Quality Commission is very much an organisation in transition and development, as it plans to take on a range of new duties and work envisaged in the Health and Social Care Bill. The role and possible functions of the new medical research body, and of the health and social care information centre, need much more work and development. All this is in the context of the Department of Health having its work cut out, taking on a huge volume of work, responsibilities and functions that will come its way from the abolition or reorganisation of many of the other bodies due to be axed in the Public Bodies Bill.
This is also at a time when the Government themselves are committed to large-scale staff reductions in the Department of Health. There are also key issues of accountability and independence at stake. Professional bodies and clinicians directly regulated by the HFEA, for example, of course have a key view of the changes needed, but they are not the only stakeholders, as speakers in this afternoon’s debate have underlined.
Dismantling the HFEA and HTA, diluting their accountability and handing over their powers to Ministers and civil servants on such sensitive issues needs public involvement and stakeholder conversation, as speakers have pointed out. How would the new organisations be independently scrutinised and accountable? How much money would be saved from transferring the functions of the HFEA and HTA to the CSQ and new bodies? Will the Minister explain in more detail the timetable that he is currently working to for consultation and development of the new framework?
We on these Benches again urge the Government to reconsider their position and remove the HFEA and HTA from the bodies to be deleted under Schedule 5.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
I start by expressing my thanks to the noble Baroness, Lady Thornton, for tabling this debate, and to all speakers for raising their concerns on this very important set of issues. Let me say immediately that the need to maintain public confidence in every part of the NHS is absolutely vital, particularly in areas as delicate as embryology and human tissue.
I can offer your Lordships absolute reassurance today that our plans do not represent any threat to patient safety, nor to the safeguards held within the legislative framework of provisions within the Human Fertilisation and Embryology Act and the Human Tissue Act.
The Department of Health carried out its review of arm’s-length bodies and published its recommendation in July 2010. We recognise the important role that the Human Fertilisation and Embryology Authority and the Human Tissue Authority have played in the regulation of their respective areas over the years. We thank them sincerely for it. Our recommendations in respect of these bodies took account of the complexities and sensitivities attached to the particular areas in which they operate.
We are not rushing. We have allowed for the full length of the planned Parliament to take these changes to their conclusion. That is far longer than any other change proposed within the department’s review, a decision that reflects both the importance of the two bodies and a recognition that we need to consult fully on, and settle, the detail of all the changes. However, we are clear that a more joined-up system needs to be formed.
With the establishment of the Care Quality Commission, and the Academy of Medical Sciences’ recommendation for a new health research agency, new alternative structures have become available to ensure a more cohesive system for both healthcare and health research regulation that will benefit patients, health professionals and researchers. It is therefore our intention that the healthcare-related licensing functions of the HFEA and HTA will transfer to the CQC.
The CQC already regulates a wide range of NHS and independent healthcare providers. It registers them and ensures that they are meeting essential standards of safety and quality. It takes action if services drop below these essential standards and acts quickly if people’s rights or safety are at risk. It undertakes investigations where there are concerns about quality, seeks the views of people who use services and informs people about the quality of those services. Noble Lords will recognise that this is similar to the roles undertaken by the HFEA and HTA, on a smaller scale, in respect of the regulation of infertility treatment and activities involving the use of human tissue.
We estimate that about 80 per cent of the centres currently licensed by the HFEA are either regulated by the CQC or in premises that it regulates. The CQC also covers 60 per cent of the centres licensed by the HTA. It therefore seems wasteful, and indeed unsustainable, to continue to have these regulatory systems running in parallel. It makes sense to streamline, and ultimately to trust the CQC with the responsibility. There is no reason why the CQC should not be able to fulfil that responsibility as effectively as do the HFEA and HTA now.
The noble Baroness, Lady Thornton, asked about the multiple birth policy. That is an issue that concerns the safety of patients and their children, and it would fit very well into the CQC’s remit.
Noble Lords will be aware of the Academy of Medical Sciences’ report on the regulation and governance of medical research. The report has made recommendations for simplifying the complex framework of regulation. In particular, it suggests the introduction of a new health research agency. The report has been embraced by a wide range of groups and experts. It recognises that there are significant benefits in bringing all medical research regulation, including embryo research, within the remit of a single medical research regulatory authority. The Government welcome the report and are considering their response.
The noble Lord, Lord Alton, referred to Lisa Jardine’s comments about the threat to the status of the embryo. I emphasise that the intention is to co-ordinate health research regulation better so that the system is streamlined without changing or compromising the safeguards. Current quality and ethical safeguards for research involving the use of a human embryo, for example, must be necessary for the research to be approved, and will remain very firmly in place. It is worth reflecting that, although the statutory requirement that the use of embryos is necessary and that the research is necessary or desirable will remain in place, a research regulatory authority with a broad outlook across medical research would be well positioned to make that assessment.
The noble Baroness, Lady Thornton, asked who would be the keeper of ethical safeguards. I would say simply that the ethical safeguards are laid out in legislation, as agreed by Parliament.
The noble Baroness, Lady Deech, suggested that those in favour of the Government’s proposals think that they will not be regulated at all. I have not gained that impression. The letters from professional bodies—the British Fertility Society, the Royal College of Obstetricians and Gynaecologists and leading clinicians—show clearly that they understand that regulation and legislative provisions will remain firmly in place.
There are three key points that I want to make at this juncture. First—I say this especially to my noble friend Lord Willis—my department is planning to undertake a public consultation exercise this summer about where HFEA and HTA functions are best transferred. We regard this as a key part of the process. We will consult on any subsequent use of powers agreed in the Public Bodies Bill to effect those transfers. Effectively, therefore, there will be two consultations.
The noble Lord, Lord Alton, understandably said that he would like to see the colour of the Government’s money before reaching a view on these issues. As yet, no final decisions have been reached on exactly which functions will go to the CQC, the potential health research agency, the Health and Social Care Information Centre or elsewhere. The exact detail of how the powers in the Public Bodies Bill might be used will be considered further and in detailed discussion with the HFEA, HTA, CQC and key stakeholders and in public consultation.
Secondly, our plans are about streamlining the functions of the regulatory bodies concerned. I regard that as the precursor to the lighter touch referred to by the noble Lord, Lord Alton. The lighter touch itself will revolve around the design of systems, which will ensure that the burden of bureaucracy is lessened overall for the NHS and other organisations. The CQC and the HFEA will play a leading role in the development of an efficient approach.
I stress again that, despite what some commentators have said, there is no intention to revisit the ethical provisions and safeguards in the HFE Act, the principles set out in the Warnock report, or the principles of consent underpinning the Human Tissue Act. The proposed powers in the Public Bodies Bill could not be used to do any of those things. The noble Baroness, Lady Thornton, asked what had changed regarding the principles that were debated at length in both Houses of Parliament. The answer is: nothing. The HFE Act provisions that recognise the special status of the human embryo will remain in place, entirely as they are now, as will the provisions in the Human Tissue Act that ensure that donors’ and families’ rights and safety are protected.
The noble Baroness, Lady Thornton, said that she did not have a closed mind to some sort of reorganisation of functions, and I am hope I am right in detecting the same message from the noble Baronesses, Lady Deech and Lady Warwick, and my noble friend Lord Willis. That is welcome. All would say, as I have explained on previous occasions, is that if we cannot secure a place for the HFEA and HTA with the Public Bodies Bill then we will have to look to a future health Bill to support the transfer of functions, however we decide that that transfer should be conducted. However, to move into primary legislation would mean that the safeguards enshrined within the HFEA and HTA Acts would then be open to parliamentary scrutiny and vulnerable to amendment. I know that very few noble Lords would relish that scenario.
Thirdly, we envisage that our proposals should offer benefits to patients, healthcare professionals and researchers. We want the streamlining of regulation and reduction in the number of regulators to mean a less burdensome and bureaucratic system, both for the NHS and for the independent sector. We will work with the HFEA and HTA to try to ensure that those with the necessary expertise will follow their functions to the new arrangements so that it is not lost.
We have received significant numbers of representations from professional bodies and clinicians who are directly regulated by the HFEA, expressing support for the Government’s proposal to include the HFEA in the Public Bodies Bill. Many also expressed concern about the HFEA’s current approach to regulation. I have placed these in the Library.
My noble friend Lady Williams asked about legitimate public concerns about patient safety. I point out that the EU tissues and cell directive sets out robust provisions for safety and quality, covering assisted reproduction and the human application of tissue and cells. The role of competent authority to regulate against the requirements of the directive and standards for quality and safety will remain in place to ensure that patient safety remains a key consideration.
The noble Lord, Lord Alton, asked where the Government saw the information functions going. We will have to consult on that issue carefully with all the bodies concerned. We will give due regard to the sensitivity and confidentiality of the nature of the information currently held by the HFEA and HTA, and we envisage that it will be a key area on which we will consult.
My noble and learned friend Lord Mackay and my noble friend Lord Willis referred to the proposal two or three years ago to form RATE. This is a completely different proposal; RATE simply involved replacing the HFEA and HTA with a single organisation that would undertake all the functions of the two bodies in their entirety. The proposal was rejected because the benefits of doing so for embryo research, for example, were not apparent. The current proposal to indentify where individual functions might best be placed is a different approach and has more potential obvious benefits, such as more streamlining and cohesion.
My noble friend Lady Williams asked why the Government did not set up a national bioethics committee. The consideration of specific ethical issues by bodies such as Nuffield and parliamentary scrutiny committees remains the preferred approach.