Multiple Sclerosis

Lord Willis of Knaresborough Excerpts

Thursday 13th October 2011 Lords Chamber

[Earl Howe]

My Lords, I take the noble Lord’s point. NICE is reviewing its clinical guideline. That is not due to be published until 2014. Although we strive to ensure that there is national guidance on the most commonly used medicines and treatments, there will always be instances where decisions have to be made locally. Under the NHS constitution, patients have the right to expect local decisions about the funding of medicines and treatments to be made rationally, following proper consideration of the evidence. We are emphasising to PCTs that they should do just that.

[Lord Willis of Knaresborough]

My Lords, one of the great problems—

[Baroness Gardner of Parkes]

My Lords—

--- Later in debate ---

[Earl Howe]

My Lords, new and innovative treatments for MS are being developed in a number of countries. It is quite clear that any new treatment of this kind should be subject to the rigours of the regulatory system before it is made available to NHS patients. Many of them will not have been fully tested to ensure efficacy and safety, but we will of course examine every novel and innovative treatment that has the potential to benefit patients.

[Lord Willis of Knaresborough]

My Lords—

[Lord Reid of Cardowan]

The Minister will be aware that the move from the large-scale commissioning of health services to smaller-scale commissioning carries a danger for those who will be deemed on the smaller scale not to have sufficient critical mass numbers to command attention. What do the Government intend to do to ensure that conditions such as MS and other chronic conditions are not endangered by that move to small-scale commissioning?

NHS: Clinical Excellence Awards

Lord Willis of Knaresborough Excerpts

Monday 27th June 2011 Lords Chamber

[Earl Howe]

My Lords, the pay structure for clinical commissioning groups is a separate issue from clinical excellence awards, which apply only to those holding a consultant’s contract in the NHS. To the extent that anyone holds a consultant’s contract in any of the clinical commissioning groups, they will be subject to whatever new scheme the DDRB recommends and the Government accept.

[Lord Willis of Knaresborough]

Would my noble friend accept that one of the real challenges is to make sure that people who are working in clinical practice have the opportunity to engage in research? Research salaries are significantly lower than clinicians’ salaries. What is the Minister doing to try to ensure that there is a seamless progression between research and clinical practice and between clinical practice and research?

[Earl Howe]

My Lords, those who hold honorary contracts, who are in general clinical academics, are well represented among those who are awarded clinical excellence awards. We are absolutely clear that that should continue as long as possible. We must incentivise those who do not spend the bulk of their day engaged in treating patients so that we ensure that we have a bank of academic excellence driving forward innovation in the NHS.

Health: Brittle Bone Society

Lord Willis of Knaresborough Excerpts

Monday 6th June 2011 Lords Chamber

[Earl Howe]

My Lords, I shall need a small tutorial from my noble friend on that condition, which is not mentioned in my brief, I fear.

[Lord Willis of Knaresborough]

My Lords, does my noble friend the Minister accept that the charitable sector is absolutely fundamental to medical research in this country, putting over £1.4 billion a year into research? The Brittle Bone Society is one of the charities that does exactly that. However, many of these charitable research organisations fear that the resources that go in through the charitable support fund may be lost at the end of this comprehensive spending period. Will my noble friend give an assurance that that fund will continue at current levels into the future so that the charitable sector in funding research can have the security of knowing that it will not have to find money simply to underpin the research facilities in our universities?

[Earl Howe]

My Lords, the voluntary sector investment programme has a confirmed budget of £25 million for 2011-12. That is the same as the budget allocated last year. I hope that that sends a strong message to commissioners about the role that the voluntary sector plays in health and care. We are sending a message to local authorities and PCTs that the voluntary sector should not shoulder a disproportionate share of any funding cuts that they may have to implement.

Public Bodies Bill [HL]

Lord Willis of Knaresborough Excerpts

Monday 9th May 2011 Lords Chamber

[Lord Newton of Braintree]

My Lords, I wonder whether I might start by expressing my warm thanks to my noble friend Lady Bottomley for intervening in this debate. I had been dithering about whether to do so because for reasons I cannot understand my Front Bench regard me as a bit of a troublemaker on this Bill. Since no one could possibly accuse my noble friend Lady Bottomley of being a troublemaker, she has leant me a cloak of respectability, which I now put on. I agree very much with what she said. I should perhaps declare an historic interest as chair of a hospital trust that did transplants at the time that the Alder Hey events came to light and was, therefore, much interested in the introduction and passage, and the subsequent success, of the Human Tissue Act. So I have some longstanding interest in this.

But even without that, there is a concern that what we may be doing here is upsetting arrangements that appear to have worked pretty well without being at all clear about what we are going to put in their place. My noble friend also referred to her concern, as I have done on an earlier occasion, about whether the Care Quality Commission, which already has more on its plate than it can deal with, can take on any more until it has settled down to what it is seeking to do at the moment. Given the eloquence of the speeches made, particularly those of the noble Baronesses, Lady Deech and Lady Warwick, the noble Lord, Lord Walton, and others, I hope that my noble friend the Minister will give these amendments very careful consideration indeed.

I hope your Lordships will not think that I am indulging myself if I take this opportunity to express my gratitude for the kind words said at the last knockings of the Report stage about my absence at the time through ill health. My particular thanks go to the noble Lords, Lord Pannick and Lord Whitty, for picking up a couple of my amendments, even though they did not get what I would regard as perfect answers. I am also grateful for the very warm words of the shadow Leader of the House, the noble Baroness, Lady Royall, who I am sorry not to see in her place. She was kinder about me that I ever thought I would deserve, and as a result probably caused more upset on these Benches. It would be tempting as a counterpoint to say that my noble friend Lord Taylor of Holbeach saw me here last week and his first words were, “Should you really be here? Wouldn’t you be better off at home?”. But that would be very unfair because he has been genuine solicitous of my welfare and has actually offered to release me from slavery even when he thinks I would not cause trouble. I am very grateful to him.

I have already indicated to my noble friend Lord Howe that I have some sympathy with these amendments and that I shall listen carefully to what he says if he does not want to accept them. I want simply to tell him that what he says will have to be good.

[Lord Willis of Knaresborough]

I rise to speak specifically in support of Amendment 9, to which I have added my name. However, I want first to record my thanks to the noble Earl, Lord Howe, on the Front Bench for the very courteous way in which he has tried to respond to these issues throughout the passage of the Bill. The reality is that we should not be at this particular juncture now. If we had had proper consultation before these proposals came to light, we would have been able to argue the issues out sensibly and carefully. I recall the way the last Government treated the draft tissue and embryo Bill. They created a committee of both Houses that looked carefully at the issues and prepared a report. It was accepted by them and actually changed the legislation that was going through the House. With hindsight, we can always do things differently, as we learnt last Thursday.

I think that Amendment 9 is crucial. The Academy of Medical Sciences made a proposal to create a health research agency that was not just supported by the medical and research professions, but by all the political aspects of all the parties in both Houses of Parliament. It is rare for that to occur. I have argued with the Minister that the real crux of this Bill is not knowing what you are actually going to move to. I think that the concerns about the CQC are a little unfair. The reality of the situation is that the CQC already regulates and inspects a significant number of premises and establishments that deal with the use of embryos, embryo research and the clinical application of techniques using embryos. There is already significant duplication, so to argue that a new body would either increase or decrease duplication would depend on how you finally decide which functions will go to which organisation.

Health research is also crucial. The report of the noble Baroness, Lady Warnock, has rightly been mentioned often today. She established firmly back in the 1980s the fundamental issue of the special nature of the embryo, particularly when dealing with research. The noble Baroness, Lady Deech, is absolutely right that the founding of the HFEA has enabled research using the embryo, particularly when we started to look at stem cells and admixed hybrid embryos, to go through. That is because there has been a regulatory authority for which there has been public as well as clinical and academic support. We throw that away at our peril.

I put it to the Minister in Committee that we could not move to an interim authority for health regulatory research and believe that we could maintain continuity and credibility within the research communities both here and abroad. Unless we establish the health research agency, we will lose ground. It is too important an area for us simply to say, “Well, we'll wait and see’. In his incredibly helpful letter to the noble Baroness, Lady Thornton, the Minister referred to setting up an interim authority. However, in Committee, I proposed to my noble friend that a new clause be inserted in the Health and Social Care Bill to set up the paving legislation for the new regulatory research agency. My noble friend makes it clear in his letter to the noble Baroness that that Bill is now on hold for a while for a variety of reasons. Surely this is an excellent opportunity for the draftsmen to put into that Bill a clause which enables the agency to be set up. At one fell swoop, an early place in the legislative timetable—literally within the next six months could be given to an agency that all of us agree needs to be in place. Amendment 9 offers the Minister the opportunity to respond positively today and we could go ahead with those proposals.

The second part of Amendment 9 deals with the incredibly important business of an ethics committee. Many people who are not involved in the ethical consideration of these issues believe that this is somehow a sop or an add-on. It is not; it is fundamental to maintaining confidence in the research frameworks and the regulatory authorities. I hope that when my noble friend the Minister responds to the amendment he will give us clear direction on how the new agency will have an ethics organisation which meets the aspirations not only of this House but of the research and clinical communities.

[Lord Winston]

My Lords, I have not decided whether I shall vote for or against the amendment if it is pressed. I shall listen very carefully to the Minister’s response.

One of the greatest ethical issues involved in this treatment is its lack of accessibility. It is a highly privileged treatment, because it is mostly in the private sector. It is true that the NHS provides some, but many health authorities have based their fees to some extent on the private sector. Therefore, the hard-pressed PCTs have not been able to offer as many treatments as many people recommend.

When I left practice running a large IVF clinic some five or six years ago, we were charging very much less than is currently charged by clinics. We were still able to turn more than £1 million a year over to research and provide the Hammersmith Hospital with a great deal of surplus income, which was then used to treat other patients.

One of the key issues with which the HFEA has not dealt is the high cost of IVF treatment. In my view, it is a scandal. There are clinics that treat patients for around £3,400 a cycle. It is only when you look at their websites that you see that they are charging up to £1,100 to £3,200 for drugs that should be obtained on contracts at around £500 to £700 per cycle. Embryo freezing will be increasingly required if we are to limit the number of pregnancies that result in multiple births by transferring just one embryo each time. One clinic in London charges £915 for embryo freezing. That is for a mechanised treatment that is extremely easy to do in the laboratory. If that were not enough, the storage fees are £325 a year. Given that liquid nitrogen, which is what the embryos are stored in, costs a few pence a litre, that seems somewhat excessive, even allowing for the costs of regulation. I am afraid that the HFEA has shown itself to be completely unable to deal with this issue at all. This privileged treatment is a shocking issue.

Secondly, one thing that the HFEA claims to be doing is giving accurate information to patients. This morning, I trawled a few IVF clinic websites. A prominent clinic in London—which I can name but will not—argues on the front page of its website a 69 per cent IVF success rate. That figure is repeated twice on the website. It is only when you delve into the small print that you realise that it is nowhere near that. That is the cumulative success rate over several cycles of treatment. Another clinic argues that it has a 30 per cent success rate in women over 40 or 42. That is a biological impossibility given that the implantation rate alone of a patient under 40 is something around 18 per cent per embryo—at best 25 per cent. What the site does not say is that this is for pregnancy but not delivery of a live baby. It does not take into account the vast number of miscarriages that presumably these patients are going through. This kind of misinformation occurs again and again.

The Bridge fertility clinic offers a 71 per cent pregnancy rate per blastocyst treatment and 67 per cent success rate for pre-implantation genetic diagnosis. As someone who has been intimately involved with pregenetic screening of this kind, I find those figures, frankly, quite incredible. Perhaps they depend on very few patients being treated and a good deal of luck. But that is highly misleading. These treatments have not been validated by the HFEA. Presumably, that is why it has allowed advertising to continue.

Then we come to the ways of promoting treatments that are not acceptable in this country. There are several clinics in London alone that offer their services in, for example, Mauritius—that is one of the Harley Street clinics—the USA, India and Spain. There they can display all sorts of unvalidated success rates on their websites and in addition can offer treatments that are not acceptable in the United Kingdom, such as multiple embryo transfer. Why has the HFEA not withdrawn the licences of those clinics? Why has it not argued that this is dishonest and dangerous?

Then, of course, we have the question of the database, which has been referred to already. The database ought to be very valuable but, sadly, in practice it is useless because we cannot follow up patients in the long term. That is a very serious issue. As the Minister knows, epigenetic issues—early experiences in development from fertilisation onwards—may have a profound effect on our health when we become adults. IVF in this country is not followed up in this way, so we have no way of knowing whether some of the treatments or exposures of the human embryo may be more likely to cause damage at a later date.

Then we have the question of another issue, which the HFEA seems to have been totally powerless to deal with. That is the issue of treatments without any evidence base that they work. Let us take the example of immune therapy, which is charged at anything from £1,000 to £3,000 a time, in addition to the already high fees of IVF. Where is the evidence that immune therapy actually improves the success rate of pregnancies? I do not know of that evidence—and, indeed, the treatment may even be damaging or harmful to the patient’s residual immune system.

Then we have preimplantation genetic testing, which is testing of embryos genetically when IVF has previously failed. I accept that preimplantation genetic diagnosis works, as the noble Lord, Lord Walton, has said, and it is a valuable technique in a few patients. However, there is actually no evidence base showing that preimplantation genetic testing in people who do not have a genetic defect, as widely used by many clinics, provides a helpful and improved chance of a pregnancy afterwards. The control trials and the control evidence are not there, and this treatment—if it is done at all—should be done on a research basis. However, the HFEA has failed to license it on that basis. The same applies to the treatment of assisted hatching. These are not small treatments; preimplantation genetic testing is charged in one clinic at £2,690 in addition to the £3,000 or so charged for the IVF and the £800 to £1,000 for the drugs that the patient pays for. At this stage, patients who are desperate will do anything to ignore the avarice of the people who might be treating them. This is a massive issue, as it is with another treatment, widely offered, of assisted hatching, in which a little piece of damage is done to the zona pellucida around the embryo or egg in the hope that it might improve the pregnancy rate. Over many years it has not been shown to be really effective, but it is still widely sold without any proper regulation.

We have heard from a number of speakers in this debate that the HFEA is the envy of the world. If it is the envy of the world, why has no other jurisdiction accepted this method of regulation? It is not used in Singapore, the USA, France, Israel or Australia, the countries that are most successful at reproductive treatments. I am not suggesting for a moment that we should not have a proper culture of regulation or a proper ethical standard in how we deliver medicine, but the current workings of the Act of Parliament are now not suitable for the original purpose. We have outgrown it. With the burgeoning private practice that has occurred with this treatment as a result of the failure to fund it in the health service, we have an increasing problem, which is very far-reaching.

It is true that there are virtually no good academic units in the United Kingdom that really produce cutting-edge research in the field of reproductive biology where it applies to humans. That was not true 30 or 40 years ago, when we led the world, in places such as Cambridge, London, Edinburgh and many other centres in Scotland. Now we cannot find people to appoint to chairs in reproductive medicine. The chair at Hammersmith was left vacant for three years after my retirement, and eventually they decided not to seek anyone to fill it. They could not find somebody who was a suitable academic because people are being attracted to the highly lucrative business that IVF provides. In my view, this is a very serious problem.

One of the most respected academics in this field is Professor Alison Murdoch, in Newcastle, who has pointed out something really quite interesting. I take her view very seriously as I believe that hers is an example of a really well-run, ethical practice. She points out that regulation of in vitro fertilisation is now far greater than regulation of, for example, abortion. That does not seem to make sense. I listened very carefully to the right reverend prelate the Bishop of Guildford. However, does he really believe that the protection of the embryo is more important than the protection of the foetus or the protection of research on the newborn child, the patient who is pregnant or the elderly patient who may be about to die from various diseases? Surely the notion of centralising our research under one body makes good sense, because we can then have a rational basis for important ethical decisions. I shall listen with great intent to how the Minister responds to this debate. However, I am not convinced that, even if we vote for this amendment, it would be a good idea to vote for the preservation of the HFEA as it stands.

--- Later in debate ---

[Lord Willis of Knaresborough]

Does the Minister not understand the incredulity of many of us? This is a Bill that deals with getting rid of quangos, yet the Minister’s solution is to set up a quango to create time in order to set up a bona fide agency. Surely the Minister sees that by simply delaying the whole process until the agency is in place, everything can be transferred either to the CQC or to the new agency, all at once, without an interim body.

[Earl Howe]

I ask my noble friend to wait a few minutes; I hope I will tell him something that he will welcome.

I turn to the amendments. On Amendments 7 and 8 the issue is not so much the end point that they seek to achieve as the practical implications that they would carry if they were accepted. Let me set out what we plan to do. There will be a full public consultation on our proposals this summer. Alongside that, we will publish an impact assessment, which will include a view about the cost-effectiveness of options for transferring functions. I assure the House that the key comparison for the purposes of the assessment will be between our preferred option and the organisations’ own plans for rationalisation. I hope noble Lords will endorse the idea of a formal impact assessment as the vehicle for doing this. It is a process that, until now, has been accepted by Parliament for general legislative and policy changes. There does not seem to be any obvious reason why that should not be an appropriate way to proceed in this case.

In addition, as I have said previously, there will be a further consultation on the proposed regulations in due course before these are laid. Taken together, these three safeguards should be sufficient to meet the aspirations of noble Lords for achieving a robust evaluation. The approach that we propose on consultation and impact assessment will, I suggest, produce a result that is thorough, transparent, balanced and, therefore, fit for purpose. The amendments, taken literally, would have us go further by suggesting a formal process of independent assessment of cost-effectiveness. This would be neither necessary nor desirable. With the best will in the world, any such assessment would be costly to the public purse, highly subjective—as any assessment of cost-effectiveness is bound to be—and very difficult to measure definitively. Practically, it would get us no further forward than a standard impact assessment. In any issue of this kind, we need to take care that legislation does not set conditions that are impossible to meet. That is why I hope the assurances that I have given will be enough to persuade the noble Baroness not to press these amendments.

In turning to Amendment 9, I will address the question posed by my noble friend Lord Willis. The amendment seeks to ensure that no HFEA or HTA functions would be transferred using the powers in this Bill until the health research regulatory agency has been established. I fully appreciate the reasoning behind this. It very much accords with the Government’s wish to avoid a piecemeal approach to the transfer of functions. In my letter of 27 April to the noble Baroness, Lady Thornton, I said that,

“in principle our preference would be to consult on the draft secondary legislation during 2012 and to commence it after the primary legislation is place that will give the health research regulatory agency the necessary legal basis. In that way, transfer could take place as a single and clear exercise, and in a co-ordinated and least disruptive way”.

In the light of this amendment and the points made today in support of it, I am prepared to go further and give a firm commitment that, subject to the will and views of Parliament, the Government will proceed on the basis of transferring functions from the HFEA and HTA only once the research regulatory agency is established in legislation. I hope that this commitment will satisfy the House. There are problems with including the amendment in the Bill from a legal perspective. It is difficult to envisage how, within this Bill, we could describe with the necessary level of legal certainty the new research body that would need to be established. The detail of what a new regulator will look like and the functions it should hold is a matter for Parliament to debate and determine as and when the relevant legislation comes before it. To make provision for a future body in this Bill risks both describing it in a way that is not accurate, thus making the power to transfer functions redundant, and attempting to limit the discretion of Parliament in relation to future legislation.

The amendment also seeks to provide in this Bill that the research agency,

“must have a separate ethics committee to undertake … ethical consideration functions”

transferred to it from the HFEA and HTA. I fully appreciate the need for assurance that the research regulatory agency will have access to the relevant expertise to deal with the licensing of embryo research and any research-related functions that may transfer to it from the HTA. Therefore, I repeat the assurance that we have consistently given that expertise will follow function, and that we expect that the research agency will have access to expert peer reviewers and others in the relevant fields that are currently available to the HFEA and HTA. However, I suggest that the level of detail on matters such as expert committees is again more appropriate for consideration by Parliament in relation to any legislation that will seek to establish the research regulatory agency rather than attempting to include it prematurely in this Bill.

Although, for the reasons I have given, I cannot accept the amendment, as I indicated at the beginning of my remarks, I would like to believe that noble Lords who have spoken will not now be too far removed from the Government’s own position on these matters. In view of our developed approach to the transfer of functions and our clear intention to consult on our proposals in an open and transparent way, I hope that the noble Baroness will feel able to withdraw the amendment.

Public Bodies Bill [HL]

Lord Willis of Knaresborough Excerpts

Monday 28th March 2011 Lords Chamber

[Baroness Thornton]

My 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.

[Lord Willis of Knaresborough]

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.

[Baroness Thornton]

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.

[Baroness Warwick of Undercliffe]

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.

[Lord Willis of Knaresborough]

My Lords, I apologise to the noble Baroness, Lady Thornton, for missing her opening remarks in introducing the amendment.

The fact that so many noble Lords wish to speak to the amendment at this hour indicates that this is an issue of significance to your Lordships’ House. In Committee, my noble and learned friend Lord Mackay ended his remarks by saying that he had helped to give birth to the baby that was the Human Fertilisation and Embryology Authority but that perhaps it was now time to let the child move out, or words to that effect. Before a child moves out into the world, it is important that a responsible parent—and I think that the House should regard itself as a responsible parent—knows that it is safe to do so. However, the reality is that during the passage of the Bill, and in particular during the Committee stage and in the clarification given since then, many questions asked on behalf of the HFEA and the HTA, as the noble Baroness has just indicated, have not been answered. That is regrettable. I think that the House accepts that what the Government are trying to do has a great deal of merit; it is just that it requires organisations to be properly set up before the functions are transferred.

As I have said on two previous occasions, I am not against what the Government are ultimately trying to do. However, before we get rid of two organisations in which the public have great confidence and whose operation is tried and tested, we should be absolutely clear about what will happen to their functions. Although the Minister has made tremendous attempts to satisfy inquiries from noble Lords on all sides of the House, I think that his letter of 22 March to the noble Lord, Lord Warner, raises more issues than it resolves. I am sure that the noble Lord will go through that letter in great detail and therefore I do not intend to do so. However, some of the comments in it indicate that two organisations appear to be in the running to inherit most of the functions of the Human Tissue Authority and the Human Fertilisation and Embryology Authority —the Medical Research Agency and the Care Quality Commission. I was delighted that the Chancellor made it clear in his Statement last week that the Medical Research Agency is going to be set up but, as many noble Lords have said, that announcement was made literally only a week ago. We know nothing about the way in which the organisation will work, other than the report of the Academy of Medical Sciences suggesting that an agency overlooking the whole of medical research would be a good thing.

As for the Care Quality Commission, it is itself an organisation in its infancy and learning how to do its business. Indeed, there are significant complaints about the Care Quality Commission. That is not an overarching criticism. It is inevitable that when a new organisation sets itself up, particularly one that inherited so many problems from its predecessors, there will be difficulties, yet here we are, saying that we will lump another major piece of work with it.

In Committee, the Minister made it clear that the existing personnel would be transferred en bloc into the new organisations, yet in the letter to the noble Lord, Lord Warner, there is no mention of key personnel being transferred into the Care Quality Commission. I understand that staff are seeking posts elsewhere. They will move out of the organisation. If we are not careful, there will be nothing to transfer and we will be looking for new personnel in these key posts. Will the Minister clarify that issue?

The new Medical Research Agency will not be set up until the latter part of this Parliament at the earliest. The Minister floated the idea that some of its functions could be transferred early using the Public Bodies Act—regulation and inspection of clinical services could go to the Care Quality Commission, for example. There is a further suggestion that all but the research functions of both the HTA and the HFEA could be transferred under the Public Bodies Act, as it will then be, with the final process completed following the setting up of the Medical Research Agency. Such hypothetical and confusing scenarios to break up two well-respected and well-worked regulators will do little for public confidence in either of these two areas. It will do little for clinician confidence and will certainly do nothing for research community confidence either. It is important that the agency is set up, properly staffed and has clear terms of reference agreed with both Houses of Parliament before we transfer these key functions to it.

One function that has been set out by the Academy of Medical Sciences, which is a clear pathway, is an ethical structure. We argued when we were looking at the draft Bill and your Lordships in this House argued during the passage of the Human Fertilisation and Embryology Act that we ought to have some form of parliamentary ethics committee. At least the Academy of Medical Sciences has said that there ought to be an overarching ethics committee to look at both areas. But if clinical ethics are not dealt with by that organisation, who will deal with them? Where within the Care Quality Commission are the sort of important ethical considerations that are necessary if we are to transfer all these functions to that body?

I can see the attraction of a method of transfer of functions to avoid primary legislation. I understand why the Minister would want to go down that road, particularly given the enormously strong public scrutiny over legislation concerning the Human Tissue Authority and embryology and stem cells over the past five years, but the idea that if the scrutiny is only in both Houses of Parliament it will be less severe does not hold up. There are 200 new MPs in the other place who were not party to any of this legislation when it went through. It is highly optimistic to believe that there will not be very detailed scrutiny of any new arrangements. I suggest to the Minister in all humility that he accepts the amendment before us tonight or makes some provision to satisfy our concerns. He should seek a comprehensive solution to the problem that the Government have created for themselves. I for one—and, I suspect, many of your Lordships—would agree that there is a way forward from this. The Medical Research Agency is a good idea. There is a possibility of transferring some of the functions to the Care Quality Commission, but it needs to be done en bloc, rather than piecemeal, so that there is a danger of undermining two excellent regulators, which have public confidence, the confidence of most clinicians and the confidence of the research community.

[Baroness Deech]

My Lords, I declare an interest as a former chair of the HFEA. My name is on this amendment, and I support every word of what previous speakers have said. Those who oppose this amendment consist largely of those who are impatient about the shackles that regulation imposes and wish to be free of them. They will not be if this government scheme goes ahead. As researchers and clinicians, they will have to deal with at least two departments or bodies in place of one, which can be guaranteed to be no quicker or cheaper.

Criticisms have been made of the style or overlap of inspections, but that is not the point. Those faults can be remedied. Inspection can be delegated or contracted out. What is at issue is the continued existence and symbolism of one integrated body—the HFEA and the HTA—representing lay and clinical interests, accountable to patients through consultations and to Parliament, speaking with one voice to government and to the world. The HFEA may be alone among the many bodies listed in this Bill that has an international significance and symbolism. Google it, and you will see twice as many thousands of references internationally as in the UK. It has achieved a presence in the world that has helped to give UK science a good reputation and has enabled this country to be the first legally to embrace embryo research for stem cells and as the object of study around the world. Other advanced countries have national ethics committees, such as the United States and France, or HFEA-type regulators, such as Canada, California and parts of Australia. They will be aghast that where the UK led the way it is now abandoning its respected structure.

Now we have to look at the unanswered questions—indeed, there are more unanswered questions at this stage of the Bill relating to these two bodies than there were a few months ago. Noble Lords have referred to them. There is a failure of governance in the plans put forward in the Bill. Plans is too positive a word for an outline of future options which may or may not involve primary legislation and may or may not be predicated on the establishment of an unknown new body—a general medical research regulator—about which we know next to nothing. The notion of an all-purpose regulatory body for medical research is a possibility mentioned in a letter kindly sent by the Minister to those interested in this amendment and available in the Library. However, there is no information in that letter as to when and whether it will be created and how much will be in its scope. There are no powers in this Bill to set it up; it will have to be provided for in separate primary legislation when time allows. But the new body is a linchpin of the planned dismembering of the HFEA and the shifting of embryo research away from it. How much confidence can UK and overseas researchers who may come here have in our system, while years may go by before it is reconsidered? It will be like the familiar experience of being forced into a single lane on the motorway with a coned-off section indicating improvements but with absolutely nobody working inside the coned-off section and no end in sight. If this amendment is not passed, the attractiveness of the UK research environment may plummet immediately. Just as staff may drift away, so will researchers.

As others have said, the future division of functions has not yet been settled, but we know that there is already a risk that the CQC will be overburdened. If there is an overlap between the CQC and the HFEA in licensing, the CQC should be relieved by dropping HFEA-type inspections. In the mean time, the welfare of patients and children will be at risk. It is not clear what functions will go to the CQC and we do not know where the all-important database will go. In a few years’ time, children will be entitled to ask how about their parentage. Who will safeguard the answers? Who will enable researchers to carry out anonymised research from that database? The future governance and organisation of IVF and related matters has been cast into even greater doubt than before in this latest attempt to sort out the detail, which goes to show what a bad idea it was to unpick the HFEA in the first place.

--- Later in debate ---

[Earl Howe]

My Lords, I do not think that I am chancing my arm by saying that that is my understanding of what the impact assessment ought to look like in that a typical impact assessment will have within it several alternatives so that it is possible to compare different options. I would be happy to come back to the noble and right reverend Lord with a definite answer on that but my understanding from previous impact assessments is that that kind of benchmarking ought to be possible.

The noble Baroness, Lady Thornton, has previously raised her concerns about where the ethical framework for any new arrangements will sit. Ethical safeguards, for example concerning the embryos and gametes that can be used in treatment, the need to consider the welfare of the child and the need for consent in respect of human tissue, are clearly enshrined in legislation in accordance with the wishes of Parliament. These safeguards will continue to remain firmly in place and will underpin the regulation of treatment and research as currently, by whoever is responsible for regulating. Where there are specific ethical issues surrounding new treatments, the department will consider how best to commission expert advice on an individual basis, as is currently being done for mitochondrial transfer, for example.

A number of noble Lords have shown interest in and support for the Government’s announcement last week, as part of the growth review, about streamlining research regulation and governance. The Government announced in the Plan for Growth on 23 March that they will create a health research regulatory agency to combine and streamline approvals for health research which are at present scattered across many organisations. As a first step, the Government will establish this year a special health authority with the National Research Ethics Service as its core. When established, the new agency will work closely with the Medicines and Healthcare Products Regulatory Agency to create a unified approval process and promote proportionate standards for compliance and inspection within a consistent national system of research governance.

This will reduce the regulatory burden on firms and improve the timeliness of decisions about clinical trials and hence the cost-effectiveness of their delivery in the UK, and has clear support from the Academy of Medical Sciences review of medical research regulation and governance.

In this context, it is important for me to remind the House of a key point. Here I refer particularly to the question posed by the noble and right reverend Lord, Lord Harries. The AMS report recognised at paragraph 9.5.1 that there are significant benefits in bringing all medical research regulation, including embryo research currently undertaken by the HFEA, within the remit of a single health research regulatory agency. Indeed, remarks made by Sir Michael Rawlins in the Guardian on 11 January firmly backed up that view. We agree with that proposition but again the consultation will invite views on it.

My noble friend Lord Willis expressed his fears about the Government adopting a piecemeal approach to reorganisation, as did some other noble Lords. I accept that our approach to the HFEA and the HTA may indeed seem rather complex. The powers of the Public Bodies Bill will enable us to transfer some of the functions of the HFEA and HTA to other bodies but they do not enable us to do everything that we have set out in the arm’s-length body review. In order to abolish the HFEA and HTA, or to transfer their research-related functions to any new research agency, we will require powers under future primary legislation.

It might help if I provided a rough outline of how and when we could take this forward. We intend publicly to consult on proposals to transfer all the HFEA and HTA functions to other bodies in the late summer of this year. During 2012-13, under the provisions of the Bill, we will prepare draft orders for formal consultation dealing with the transfer of functions, other than research functions. If appropriate, we would then be able to lay the orders before Parliament. This process would enable noble Lords and other interested parties to see, comment on and debate the proposals, as they progress.

Without the inclusion of these bodies in Schedule 5, we would have to provide for the transfer of their functions entirely within future primary legislation. I simply say again, particularly to the noble Lord, Lord Warner, that not including these bodies would significantly increase the risk that the underlying ethical provisions of the Human Fertilisation and Embryology Act and the Human Tissue Act were reopened for debate.

[Lord Willis of Knaresborough]

Would it not be possible to include a new clause in the Health and Social Care Bill to set up the new medical research agency and leave to consultation and secondary legislation the details that would follow? That would at least give certainty to that organisation and, with a new Bill in the second part of the Parliament, put it into the parliamentary timetable much earlier than envisaged.

[Earl Howe]

In theory, my noble friend makes a constructive suggestion. We have considered that option and, I am afraid, rejected it on the grounds that the Health and Social Care Bill is big enough as it is, and contains a substantial programme of modernisation. It would be possible to Christmas-tree that Bill almost ad infinitum, and we have decided that that would not be helpful. With the Health and Social Care Bill, we seek to focus on the modernisation agenda, pure and simple. I am sorry to disappoint my noble friend, who makes a perfectly sound point, but I am afraid that we are not going to do that.

As I made clear earlier, I confirm to my noble friend that the CQC will have staff transferred into it. The intention is that expertise in staff and advice will follow the functions. Unfortunately, we cannot be definite about exactly which functions will be transferred to the CQC or elsewhere until after the summer consultation. If, standing here, I were to say exactly how that would work, I would be pre-empting the results of that consultation. I agree on the desirability of having clarity and certainty, and our aim is that there should be more clarity and certainty for HFEA and HTA staff after the consultation.

The noble Baroness, Lady Warwick, asked a number of detailed questions about the effect of our proposals on bodies regulated by the HTA and the way that its functions are performed. The case that she put eloquently was an argument in favour of keeping the HTA’s functions together. I understand her point of view; however, I reassure her that we will consult on the option of keeping the HTA’s functions together. We will not consult simply on one model, let alone pre-empt the results of the consultation.

Public Bodies Bill [HL]

Lord Willis of Knaresborough Excerpts

Wednesday 9th March 2011 Lords Chamber

However, the brands of these two bodies are very strong among the public and in a lot of other areas, and they have many powerful supporters. I can still remember the parents of Alder Hey children keeping a very beady eye on me as I took the Human Tissue Bill, which set up the HTA, through your Lordships’ House in 2004. These two bodies handle very sensitive issues and they are not necessarily essential for setting up a new health research regulator. I would leave them alone, apart from securing some efficiency gains. That is why I support the amendment.

[Lord Willis of Knaresborough]

My Lords, I added my name to Amendments 92 and 93. I congratulate the noble Baroness, Lady Thornton, on presenting a reasoned case for both amendments. I also congratulate the noble Lord, Lord Warner, on being able as a Minister to say that we should get rid of the HFEA and the HTA and now arguing that we should retain them. That is quite a trick—I am sorry; I should not use “trick” in East Anglia references.

I support the amendments not because I believe that the Government have got it wrong, but because in presenting Schedules 5 and 7, and in the Explanatory Notes to the Bill, they have failed to present a convincing argument for changing from two well respected regulators to something that has not been explained well and clearly leaves a lot of questions to be answered. There is a need for an equivalent of the Human Tissue Authority. Sometimes we overplay the organ retention scandal. It happened in one hospital in one area. The practice was not rife through the whole research base; it is important to state that. Nevertheless, there is a need for a regulator. In the case of the Human Fertilisation and Embryology Authority, despite the fact that so much time has elapsed since the original regulator was put in place, science is changing dramatically and the research, particularly on cytoplasmic hybrid embryos—admixed embryos—was something that the HFEA rightly referred back to government to ask for a view, whereupon the legislation was updated.

I had the pleasure in 2007, when I was in the other place, of chairing a Joint Committee on the Human Tissue and Embryos Bill. When the noble Lord, Lord Warner, presented the idea of a regulatory authority for tissues and embryos, I was hugely in support. It made good sense to bring everything together; it was efficient; and the less unnecessary regulation we have, the better. However, while I was initially supportive, I was staggered by the response from a host of organisations that supported two regulatory bodies. I remember a consultative session one evening in Portcullis House when all the organisations that were opposed to any research on embryos, or any use of the embryo other than for its God-ordained purpose, came together and argued for the regulators to stay on the ground that this would protect the embryo. I left with a clear understanding that the principled, ethical and moral stance on the special relationship of the embryo taken by the noble Baroness, Lady Warnock, was something that the Human Fertilisation and Embryology Authority had taken to heart and incorporated into its regulatory function. To be fair, the Government listened to the Joint Committee and dropped their proposals, which is why we are where we are today. The Minister has made it clear in several forums that this is not a rerun of RATE, and I fully accept that. However, he must today make absolutely clear how tissue and embryos will be protected in the new regulatory and research environment. If you throw out the current organisations, it is clearly necessary for the Minister to clarify what will replace them.

The HFEA was far from perfect but it commands huge support from the research and clinical communities and, in particular, from the public. Ultimately, we regulate to protect the public and not simply to ensure efficient and effective clinical practice. However, the Government have now given us some clarification and we should at least examine the proposals that they are making.

In terms of research, I strongly support the report of the Academy of Medical Sciences. It makes good sense to establish a health research agency and to try to bring all medical research together under one body. Indeed, as the Health and Social Care Bill is almost totally devoid of any reference to medical research, at least there would be a regulatory body, run by clinicians and scientists, with some clear understanding about the way that medical research is carried out. Therefore, I believe that the proposal for bringing all medical research together is excellent. It certainly gives me confidence that, provided the Government accept the recommendation of the Academy of Medical Sciences for a new health research agency, their proposals will take us forward in a much more positive sense.

Will the Minister assure the Committee that regulation regarding research and research techniques will also reside with the health research agency? The idea of placing research under the new agency but putting the regulation of research techniques under a different agency is totally unacceptable. Will the Minister also confirm that the new health research agency does not require primary legislation and that it can be established relatively quickly without such legislation? If he is able to confirm that, can he assure the Committee that when the Bill goes to the other place there will be a clear timetable for setting up the agency? That will provide some clarity about the path ahead regarding research.

Where clinicians have a strong case is that there is a sense that techniques approved for clinical application should come within the regulatory framework of NICE or the CQC. I have some clear reservations about the CQC and I recognise that the Government will have to make the case. My qualification is that the CQC is untried, and there is a huge difference between inspecting care homes and inspecting clinics which use the most advanced techniques of assisted conception, PGD, the use of saviour siblings and so on.

In closing, will the Minister assure the Committee that the current team of specialists dealing with clinical application in the HFEA and the HTA will be transferred en bloc and kept together within the new organisation so that we do not lose impetus or, more worryingly, make mistakes? There is, I believe, a coming together in terms of what the Government want and preserving the best of what the HTA and the HFEA have to offer. I think that the Minister has to make the case but I believe that the Committee is listening.

[Baroness Butler-Sloss]

My Lords, I have been looking with interest at the very helpful parliamentary briefing, particularly on the HFEA and the statutory functions that fall into four main groups. I am very concerned about each area. If licensing is to go into the Care Quality Commission, as has already been mentioned, will that commission have the same level of expertise to deal with the really difficult cases that may come up? I speak as a former judge who had a case where semen was put into the wrong eggs. Two families found that the non-white semen had been put into white eggs, and the children born to the white family were not white. It was the most appalling story. It caused grief to two families and, of course, to the twin children. It became public knowledge. It was a case that I tried. What is needed is careful regulation of the clinics and expertise in what the clinics are doing.

Another matter I would like to raise in particular with the Minister, and one which has not yet been raised in this evening’s debate, is the collection of data, the division of information, and the maintenance of a register. What is happening, according to the Government, is that the licensing and regulating will go to the Care Quality Commission but the provision of the information, the data collection, will go somewhere else.

What rather shocked me was the last paragraph of the helpful briefing saying that the arrangements for the transfer of the information-related functions will be based on assessments, and functions will be integrated into the most appropriate body. We do not know where the data functions will be going, which I find extremely disturbing. It leads me to the view that this plan to abolish both the HFEA and the HTA, whose functions are going to be divided, has not been given the sufficient thought or impact assessment one would have hoped for. We have not yet been given good reasons why these two functioning bodies should be got rid of.

I entirely support the wise words of the noble Lord, Lord Warner. It may very well be that each of these bodies could be streamlined, pared to the bone, have less back-up staff and cost less money. However, having asked in another debate on this Public Bodies Bill, “If something works, why break it?”, I say that these two organisations appear to work and so it is premature, at least, to be abolishing them now.

Human Fertilisation and Embryology Authority/Human Tissue Authority

Lord Willis of Knaresborough Excerpts

Tuesday 1st February 2011 Grand Committee

[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.

Human Fertilisation and Embryology: Regulation

Lord Willis of Knaresborough Excerpts

Wednesday 13th October 2010 Lords Chamber

[Earl Howe]

My Lords, I recognise the experience of the noble Baroness and I pay tribute to her time as chair of the HFEA. The review that we have conducted has been based on a close examination of the functions of every arm’s-length body. Whereas some 20 years ago it may have made sense to look at a single body for carrying out the functions undertaken by the HFEA, she will agree that the functions concerned are very different. Times have moved on and we think that there is a more logical way to parcel out those functions which does not dilute in the slightest the efficacy or the efficiency of the regulatory action.

[Lord Willis of Knaresborough]

My Lords, I beg to disagree with my noble friend. What remains the same, as the noble Baroness, Lady Warnock, said, is the fact that we must enshrine in legislation and through regulation the very special status of the embryo. Since 1991, the HFEA has carried out that function very effectively indeed and it has done so because it has the support of the British people. As regards bringing these regulations in house, will the Minister say why the public should have more confidence in him as the Minister than in an independent regulator?

[Earl Howe]

My Lords, I need to make it clear that our proposal is not to bring the regulation in house; it is to distribute the regulatory function between several different bodies. I also emphasise that there is absolutely no suggestion that we are changing the special status of the embryo. We have no plans to re-examine those parts of the legislation which recognise that status. We fully recognise the role which the HFEA has played in establishing the UK as a world leader in this area, but times change and so has the way in which we regulate the delivery of healthcare. That is the basis on which we have looked at this.