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.