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Lord Patten: I am talking not about the past but the future. I am talking about the amendment tabled by the noble Lord, Lord Alton. I am not making any comment about any event in the past whatever or

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about any the noble Lord in this House. However, in future it is important that we make it absolutely clear that no one on the authority has any pecuniary interests whatever. That is what transparency means. If in political parties one has to be transparent in this way, declaring our interests—as it is quite proper that we should all have to—in this House and another place, and if people are concerned about transparency in political funding, we must ensure that those who serve on this authority have no pecuniary interests. It would be ethically abhorrent if they were allowed to do so.

Baroness Deech: I first declare an interest as a long-serving former chairman of the HFEA. I have every respect for the views of my noble friend Lord Alton, with whom I am joining forces in our discussion of later amendments, as I have for the views of the noble Lord, Lord Patten. However, I must spring to the defence of the way in which public committees work in this country. I do not believe that my noble friend Lady Warnock was ever actually the chairman of the HFEA, although clearly her work was fundamental in creating it. However, I can assure the Committee that in my time members were appointed according to Nolan principles in every respect. Indeed, as members at one stage we had a bishop, an actress and a rabbi.

Of course a body like that needs some scientists on it. To debar from membership anyone who might make money out of anything associated with IVF would be to debar huge sectors of society—not least counsellors, who have been members, nurses or maybe even those who print leaflets or run nursery schools. There are very many ways in which one might make money out of IVF. However, it is noticeable that the well-known practitioners in the field, and the most regulated, were not members of the authority and were sometimes alleged to make a great deal of money out of this treatment. But if money is perceived as a problem, the Committee may wish to support another amendment that would put more of the work in this field back into the NHS.

The authority members took their work very seriously—and what I say I think applies to all public committees in this country. There is freedom of speech and those who were appointed were articulate, often academic and intelligent and had the freedom to write what they wished to write outside the bounds of the authority. Members of the authority met regularly with pro-life members and listened to what they had to say. Of course, fees had to be charged; it is a general principle in charging clinics that the object of regulation according to this Government should meet the costs of regulation. There was no personal profit to be made by any member of the authority or the authority itself in granting licences to clinics. Indeed, your Lordships may recall that very recently there was an attempt to close a clinic, which caused an enormous furore. It is very difficult because of the law to close a clinic.

That brings me back to the law. This is a country that is run according to the law—positive law not natural law. The members of the authority were

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bound legally by what is in the statute. That is why this House and the House of Commons are, in the end, the ultimate ethical arbitrators. The law comes first and foremost for the authority.

It is self-deluding to imagine that there can be another set of ethics outside the parameters of the law which will affect those who administer it. It is also self-deluding to imagine that members of the authority spent all their time discussing ethics. There was a great deal of work that was mundane and legally required—licensing, inspecting, keeping data, running a computer, overseeing training and so forth. None of that had very much to do with ethics as the word has been bandied about recently, but simply to do with the administration of the law.

That brings me back to the importance of the provisions of the Bill that we are passing in the next few months. The Bill contains the ethics. It would be limiting to insist on one member who spoke always, let us imagine, for animals or against embryo experimentation, because these matters have to be considered under the law and with public consultation. The HFEA has taken full account of public consultation very recently in relation to embryos. There have been other public consultations; for example, about sex selection. The public came out very clearly against sex selection for social reasons and that has remained the rule of the authority and it is in the Bill.

The law is what counts: that is what matters. This string of amendments is designed to tie the authority in a way that would not apply to any other public committee in this country. It would make it look as though IVF were intrinsically dangerous; far more dangerous than a normal pregnancy. After all, many a normal pregnancy ends up in some form of danger.

Collecting figures about OHSS is not as easy as it might seem, because many women come for treatment from abroad and then vanish off the books of the clinic when they go back to wherever they came from. Others may present in hospital with particular problems such as thrombosis and it may not be known that they had IVF. Any amount of data collection in that area is not necessarily accurate. Furthermore, the authority has been criticised for collecting data that are not used and are not necessarily useful.

I hope that the Committee will support the normal, natural, lengthy and complicated way of appointing members of the HFEA, which corresponds in my experience to the way in which all other members of public authorities in this country are appointed—by advertisement, by selection according to criteria, and by expecting of them a commitment to the law and to free speech.

Lord Harries of Pentregarth: I support the wise words of the noble Baroness, Lady Deech. The noble Lords, Lord Alton and Lord Patten, made many allegations about the HFEA in detail and it would take a long time to answer them. I am not going to do that, but I should like to focus on one or two points of principle that run throughout the amendments.



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First, I am not sure that everyone is aware of the importance of reproductive technology now to the women of this country. Women are getting married later and having children later, and a higher and higher percentage of women in the population need help in producing babies. Because of the advances of medical technology and the skill of clinicians they can now have the children whom they so desperately want.

It is true that certain people are opposed to reproductive technology in principle, but we need to bear in mind that what we are talking about is what so many women in this country want: help in having children.

Secondly, as regards the make-up of the HFEA, I find it very strange that each of its members should be named as though they had an intrinsic conflict of interest. They do not. The noble Lord, Lord Alton, talked about somebody being neutral. Nobody in this life is totally neutral. If I may say so, the noble Lord, Lord Alton, himself is hardly neutral. I would not want him to be. Who is this neutral person who suddenly appears who has no views on anything and expresses no passion on anything? Of course, the members of the HFEA have views. I agree that it would be very difficult for a person who was totally opposed to the use of assisted reproductive technology in helping women to have babies to be a member of the HFEA. If you are totally opposed to that in principle, it would be very difficult because your job—as the noble Baroness, Lady Deech, said—is to administer the law as Parliament has decided it. That is your job.

Lord Alton of Liverpool: Would my noble and right reverend friend therefore want to see excluded from all the local ethical committees that deal with the animal procedures legislation anyone who is opposed to vivisection?

Lord Harries of Pentregarth: I reiterate what the noble Baroness, Lady Deech, said; namely, that the HFEA makes a point of keeping in touch with people who are totally opposed to every aspect of its work. There may be ways, in particular through the ethics and law committee, that we might be able to involve people more. It need not be totally ruled out. But there is no doubt that the fundamental job of the HFEA is to administer the law as Parliament has decided it.

Pecuniary interest was mentioned. I assure the Committee that before any decision is taken by a licence committee and before any major issue is discussed by the authority, people are asked whether there is any conflict of interest. They have to declare it and if it is a very direct conflict of interest, they have to leave the room and they are not allowed to take part in that discussion. We are extremely aware of possible conflicts of interest.

On the question of collecting data, particularly about OHSS, the HFEA has instituted a very effective system of alerts. If a clinic has a problem—for example, if a person has to go to hospital as a result of hyperstimulation—it reports it to the HFEA, which immediately alerts all the clinics to the incident.

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This system is beginning to work rather well because the HFEA, as well as working with the law, has to work by persuasion and getting clinics on its side. So we have to encourage clinics to adopt better and better practice. One of the ways we do this is through this system of alerts. Of course, the HFEA is not perfect but some of the criticism that has been made tonight does not stand up to serious examination.

Lord Winston: There is a great deal of technical information in the Bill. We have gone through much of it this afternoon and this evening and will go through more. It might be useful and for the benefit of the Committee to discuss Amendment No. 62 in the name of the noble Lord, Lord Alton, on ovarian hyperstimulation syndrome. This is an extremely puzzling condition. It is essentially a response of the ovary to stimulation by the hormone which is given exogenously; that is, by injection, to women whose eggs are needed for IVF. One of the problems about this puzzling condition is that women respond idiosyncratically; that is, some women with a very low dose of FSH—the hormone involved—give a very exaggerated response which is quite unpredictable. Other women, in spite of massive doses of the hormone, do not give this response at all and do not show ovarian hyperstimulation.

You could argue physiologically that virtually all IVF cycles are a form of ovarian hyperstimulation because that is the nature of the beast. Humans were built to ovulate one egg and in order to improve the statistics to get more embryos so that one will be viable there is pressure to get more than one egg in the hope that you will get one embryo. So this is a major problem. While I have great sympathy with the concern of the noble Lord, Lord Alton, about women who are made sick by this technology, I do not consider for a moment that this is because there is a drive in the background to stimulate women so vigorously that one gets lots of eggs for research; rather, it is an attempt to maximise the chances of a successful pregnancy.

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The problem is that the two issues are not related, so you can get large doses of hormones and small numbers of eggs and vice versa. The symptoms of OHSS vary massively. For example, thrombosis, which I agree is a dangerous condition, very often is totally silent, women are not admitted to hospital and they do not even know that they have a thrombosis. Some years ago, the noble Lord, Lord Jenkin, and I sat on a Select Committee looking at the aircraft passenger environment. One of the major issues with which we were concerned was thrombosis after long flights. We saw from the evidence that most of the thromboses were not detected and were not detectable unless you involved subjects—aircraft passengers—in detailed tests. That is a key problem here with OHSS. No matter how carefully the records were taken, they would actually be completely unreliable.

Secondly, there is the important issue that was just raised by the noble Baroness, Lady Deech. As the noble Baroness pointed out, a large number of people come from overseas for these treatments, spend a

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variable amount of time in the United Kingdom, may be hospitalised overseas and may be hospitalised here. It would be inappropriate to try to keep those sorts of records. It would be an unreasonable burden when there are much more important records that we might be considering; for example, the children born as a result of this treatment, which is not in the Bill. I referred to that at Second Reading. I feel that while we in the medical fraternity understand the concern, at present one has to say that this extremely puzzling and common condition is not predictable and does not routinely end in hospitalisation. One of the reasons why the royal college and the HFEA figures vary so much is that there is no definition of severe ovarian hyperstimulation. That is a real issue if you are going to try to keep records.

Baroness Barker: I apologise to the Committee for my absence earlier this afternoon, which was unavoidable. In the absence of my noble friend Lady Williams of Crosby, I will make a few points on the first three amendments proposed by the noble Lord, Lord Alton. We support him in his request in Amendment No. 21 for reports and information about the amount of resources put towards various different types of research. Bearing in mind the comments made by the noble Lord, Lord Patten, earlier, I caution the noble Lord, Lord Alton, not to draw conclusions based simply on the amount of government funding for particular types of research. If the noble Lord, Lord Patten, is right that a great deal of commercial investment is being made into certain types of research, it is entirely legitimate that the Government might seek to fund the type of research that is not of greatest commercial value but which has a greater public health value, even though it is more difficult to fund. I caution against some of the interpretations that might be made of the data.

I listened to the noble Lord, Lord Alton, on Amendment No. 22, and his quote from the noble Baroness, Lady Warnock, on the formation of her committee. The thought that immediately struck me was, “That was then”. Since 1990, the system of appointments to public bodies has changed dramatically. What the noble Baroness, Lady Warnock, talked about is a thing of the past. There is now far greater transparency in public appointments, and that applies to the HFEA as much as to other bodies.

The question in my mind on this amendment is, “Is it right to impose on one member of the authority a particular duty?”. I think that it may not be. My understanding is that all members of a public body must pay regard to ethical issues, and none of them should be there if they do not. They may come to collective judgments, but it is a common responsibility.

As for Amendment No. 23, other Members of the Committee have talked about the issue of expertise with far greater authority than I could. It is always the case that the pool of people from which one selects some of the membership for specialist bodies must have extensive involvement in the field. That is not a new or unique situation in public appointments.

Finally, the noble Lord, Lord Alton, talked about payments made to the regulator by the clinics it

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regulates. In a number of different fields, and pensions is one—I see the noble Baroness, Lady Hollis, on the Benches opposite—it is not uncommon for regulators to be paid by the bodies they regulate provided that there is a clear remit in law regarding what the charges should be for. The HFEA was set up in that way. The fact that two sorts of bodies are engaged in the same field does not necessarily give rise to a conflict of interest.

Lord Elton: I agree entirely with the noble Baroness, Lady Barker, on the normality of a regulator being funded by the regulated bodies. The noble Lord, Lord Alton, raised an anxiety about the possible effect on the decisions made. It would be helpful if we were told whether there is any relationship between the funds received by the regulator from the regulated bodies and the nature of the decisions it makes. If there is no connection between the decisions and the volume of money received, the anxiety recedes. On the other hand, if there is a connection, then the noble Lord’s case would be advanced. Although I would think that the former was the case, I should like to be reassured about it.

The noble Baroness, Lady Deech, pointed out, as have others, that it would be odd if a single member of a body was required to pay particular attention to ethics and to ensure that everyone else also paid particular attention. The duty should lie equally on all members. She preceded the point with the interesting statement that there is only one ethics: the ethics set in law. It seems that we are at a point where events are always proceeding ahead of the law, so it is constantly necessary to bear in mind the ethical questions raised by new developments. Again, it is unfortunate that we could not have discussed a bioethical advisory body at the beginning of our debates. I hope that the usual channels and business managers will find a method of devising a grouping to allow us to do that at the beginning of Report, because it is central to this law.

Lord Northbourne: We are discussing membership of the authority but I have not heard the slightest mention of anyone in it who has knowledge of or interest in the well-being of children. Since children are the results and outcomes of the authority’s efforts, should they not be represented?

Baroness Deech: Perhaps I may add an eminently evident and obvious point—that many members of the authority were social workers, nurses, parents, teachers and others with similar concerns. Others were experts in computing, which is obviously important, while others were councillors or men of the cloth, as I said. All those professions were taken account of, and that work is by no means a soft option. The Committee will wish to know that in my day it was extremely badly paid, although that may have changed. One did this sort of job not for glory or for pay but simply out of commitment. It was a very heavily loaded, time-consuming and demanding job in which one learnt a great deal, both pleasurable and painful. The welfare of the child was the number one ethical principle embedded in the law, and it is

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embedded in the statute that your Lordships are considering. The principles include the welfare of the child, the safety of the mother and baby, respect for the embryo, the autonomy and dignity of every individual involved in treatment and the receipt of treatment, and, more recently, the saving of life. You can ask for no broader or more all-encompassing ethical principles than those.

Lord Patel: First, Amendment No. 21 refers to resources for embryonic stem cell research and adult stem cell research. At Second Reading, the Minister gave an answer which identified the level of resources going into each area of research. However, does the noble Lord, Lord Alton, accept that the Medical Research Council based its decision on best science and not necessarily on whether there was equity among the different areas simply for the sake of being equitable?

On my second point, I have much more sympathy with the noble Lord, Lord Alton. Amendment No. 62 refers to the hyperstimulation of ovaries. My professional colleague, the noble Lord, Lord Winston, very lucidly set out the difficulties of collecting those data. However, my sympathy with the noble Lord lies in the fact that I should like to see greater patient safety being promoted in all aspects of medicine. I know that the Minister is also interested in patient safety. I hope that all the units that provide in vitro fertilisation adhere to the excellent guidelines produced by the Royal College of Obstetricians and Gynaecologists, which the noble Lord mentioned, to try to reduce the incidence of moderate and severe hyperstimulation of ovaries. However, as I said, we have heard about the difficulties of data-collecting due to problems of definition, and that would just create an extra burden without producing any return.

Baroness Royall of Blaisdon: The HFEA’s role is to license and monitor all clinics and centres carrying out fertility treatment, such as IVF and donor insemination, and centres undertaking human embryo research and also to regulate the storage of sperm, eggs and embryos. I am indebted to both the noble and right reverend Lord, Lord Harries, and the noble Baroness, Lady Deech, for their clear explanation of the growing need for assisted reproduction and of the fundamental roles of the HFEA, which must include adherence to the law. The HFEA has a duty under Section 7 of the 1990 Act to produce annual reports. These are an overview of what the authority has done over the past year, as well as a forward look at the coming year.

I turn to Amendment No. 21, tabled by the noble Baroness, Lady Williams, and the noble Lord, Lord Alton. I entirely refute the noble Lord’s statement about false jingoism and false hopes, but I believe that the idea outlined in the amendment is good in principle. However, the HFEA does not have a role in regulating or licensing adult stem cell research. It would therefore not have the remit, nor would it be appropriate, for the HFEA to produce annual reports on the resources spent on adult stem cell research in the UK. As my noble friend Lord Darzi outlined in his closing speech

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at Second Reading, from 2004-05 to 2005-06, the Medical Research Council provided funding of £14.7 million. Over the same period, the MRC provided £16.5 million for embryonic stem cell research.

Further, although the HFEA licenses human embryonic stem cell research, it does not provide funding for it and therefore does not have a role in recording the information on resources put into this research. I feel that it would be the role of the UK Stem Cell Bank, research councils or the scientific community as a whole to monitor and make available information regarding the volume of activity in stem cell research in the UK. I very much hope that they will do so.

I turn to Amendments Nos. 22 and 23, tabled by the noble Lord, Lord Alton. The skills and expertise needed among HFEA members are considered by the chair of the HFEA in consultation with the Department of Health. Subsequently, appointments are made by the Appointments Commission on behalf of the Secretary of State for Health, following advertisements in the UK press. I am grateful to the noble Baroness, Lady Deech, for, among other things, her clear explanation of the appointments process. It involves advertisements in the national press, as I said, and they are in line with the Nolan principles; it is a transparent process. These processes have improved over the past 10 years, as noble Lords have said.


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