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Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009

Volume 713: debated on Wednesday 21 October 2009

Motion for an Humble Address

Moved By

That an humble Address be presented to Her Majesty praying that the regulations, laid before the House on 1 July, be annulled. (SI 2009/1582).

Relevant Document: 24th Report from the Merits Committee.

My Lords, it might be helpful if I were to outline briefly what the regulations do. Under the HFE Act 2008, the maximum period for which gametes or embryos may be stored was set at 10 years. The regulations before us replace regulations approved in 1991 and 1996 and provide for the circumstances under which the storage period for both gametes and embryos may be extended beyond 10 years. The new criterion for extension is that a person, as a result of medical treatment or a medical condition, has been rendered, or is likely to be rendered, prematurely infertile. In addition, the group of persons able to avail of extended storage is wider than before. Up to now, an eligible person has been either a man or a woman as provider of sperm or eggs, or a woman receiving treatment at an IVF clinic who requires an embryo to be implanted in her in order to conceive. In the future, “eligible persons” will be extended to include people who need to use donated gametes or embryos or a surrogate in order to conceive.

There is also a change to the maximum extension period. Under the existing regulations, gametes or embryos may be stored until the gamete provider or woman to be treated reaches the age of 55. In the regulations before us, the age limit is replaced by a time limit; namely, a maximum storage period of 55 years. After the initial storage period, an extension may be granted for a further period of 10 years, provided that the premature infertility criterion continues to be met. Additional 10-year extensions would then be permissible after that, subject to the same proviso.

I have called this debate because I believe that these regulations take us into ethical territory which, as far as I am aware, has not hitherto been the subject of parliamentary scrutiny. It is ethical territory which, in my opinion, should concern us. There are two main issues that I want to raise. The first is the legal scope created by these regulations for the intergenerational transfer of gametes or embryos. The second is the green light which the Government are apparently giving to the idea of a person or a couple entering into parenthood at an advanced age. When the HFE Act 2008 was being debated in another place, the case was raised of a mother wishing to store her eggs in order to be able to donate them in future to her infertile daughter, who had been born with Turner syndrome, which is a chromosomal disorder that affects about one in 2,500 girls and which almost always entails infertility.

Under the previous regulations, extended storage of gametes or embryos is prohibited if they are intended for donation to another person. That prohibition is lifted in the regulations now before us. There are several consequences of that, but the one I want to focus on is the kind of case cited in the Explanatory Note, in which a mother with a prematurely infertile daughter, born with Turner syndrome, wishes to put her own eggs into extended storage for her daughter’s future use. It seems quite extraordinary that the department and your Lordships’ Merits Committee have nowhere explicitly spelt out, let alone discussed, the implications of this. It means that the infertile daughter would give birth to her own half-sister or half-brother. The provider of the egg would at one and the same time be grandmother and genetic mother of the child so produced. Furthermore, if the mother of the infertile daughter were to use her own egg to create an embryo, which was then stored for her daughter’s eventual use, the daughter would be both the mother and the full sister of the child so produced.

Noble Lords may react in different ways to that idea but, for my own part, I struggle to come to terms with the assumption implicit here that a confused genetic identity of this sort has no impact on the welfare of the child. On the contrary, the impact on the child’s psychological welfare is potentially very significant, when they realise in adulthood who exactly they are. There are also societal implications. It is not accidental that marriage between a woman and her son-in-law is legally prohibited in this country. The origins of this prohibition lie in the Old Testament, but the rationale behind it has to do with the cohesion of society and the undesirability of destroying the traditional structures of kinship. The more one muddies these relationship waters, the more the confusion about the extent of consanguinity in any particular relationship and the more risk there is of genetic abnormalities occurring in children. These are the reasons why we have the Marriage Act in this country, and I do not think that we can simply nod through a set of regulations that have the effect of driving a coach and horses through established societal norms of this significance. As far as I am aware, there is no guidance by the HFEA relating specifically to consanguineous donation of gametes or embryos in the context of the requirement to consider the welfare of the child. That seems to me a very bad omission.

When the Minister was kind enough to facilitate a meeting for me last week with departmental officials, the answer that they gave to me when I raised these issues was that intergenerational donation of gametes and embryos is permitted at the moment. All the regulations do is to allow it to happen in a wider range of circumstances. Frankly, I was surprised by that answer; for a start, I do not believe that we have any data to tell us how many or how few cases of intergenerational transfer there have been up to now. The central point is surely that the kinds of situation that Parliament originally envisaged when it considered permitting the extended storage of gametes or embryos were those in which the gametes or embryos were intended for the person’s own use. Extended storage of gametes and embryos for someone else’s use was made explicitly illegal.

I have not been able to find any reference in Hansard to a debate in either House at any time in which the ethical implications of mother-to-child donation of gametes or embryos or, for that matter, any other donation between close relatives, has been discussed. It may be true that the 1991 and 1996 regulations permitted such donations by default, but it is quite another matter for Parliament to approve regulations whose express purpose is to facilitate them. I therefore need to ask the Minister whether she will take steps to request the HFEA to give further consideration to the ethical implications of intergenerational and interfamilial donation and to drawing up specific guidance relating to it.

Unfortunately, while counselling is offered whenever IVF treatment is being contemplated, that offer does not have to be taken up. On the other hand, there is a requirement that any treatment should take place only with informed consent. Personally, I would argue that fully informed consent is impossible in this area without an appreciation of the moral hazards involved. The fact that relatives donating gametes or embryos may have altruistic motives does not make such donation ethically or socially desirable.

The second situation that these regulations apparently aim to facilitate is that of elderly parenthood. As I mentioned, the criterion for granting an extension of the 10-year storage period is that the person concerned is, or is likely to be, prematurely infertile. No definition is given of what “prematurely” means in practice. Indeed, the Government have studiously avoided any attempt to give one. For a woman, it may be thought that 55 represents about the limit of natural child-bearing age. For a man, I doubt whether there is any medically agreed limit, since men have been known to father children well into their 80s and even their 90s. Only one doctor’s opinion will now be needed to certify that the person is prematurely infertile; the scope for subjective judgment here is wide. We are therefore looking at very different set of possibilities in these regulations from those which have obtained up to now, with the automatic cut-off of age 55. I quite appreciate the reasons why, for a man, it was felt that the age limit was inappropriate. Up to now a man aged 55 wishing to avail of extended storage of his sperm has been unable to do so, which is clearly unfair and arbitrary. But given that the rules need changing, the first question to ask is what the reason is for choosing an across-the-board time limit of 55 years. Why 55?

Under these assumptions, an infertile woman, aged 53, whose eggs had been in storage for 30 or 40 years, could credibly claim that she was prematurely infertile and therefore eligible to have her eggs kept in extended storage for another 10 years, well beyond normal child-bearing age, at which point she might choose to have a child by surrogacy. She could do the same with an embryo. An infertile man in his mid-70s could credibly make a similar claim as a reason for storing his sperm. If that kind of request is not to be ruled out of court altogether, under what circumstances should it be granted? What are the questions that a clinic should ask itself? As I have said, there is a legal requirement to consider the welfare of the potential child, including the child’s need for supportive parenting, but what exactly does that consideration entail? The woman or man making the request might well be viewed as someone highly likely to be a supportive and loving parent. Does that mean that their age should be regarded as immaterial? The fact that the Government have blithely inserted a 55-year maximum time limit into these regulations would seem to suggest that it is immaterial.

Paragraph 29 of the evidence base document published by the department refers to the premature infertility test and makes the claim:

“This test will prevent people from storing gametes or embryos after the average natural childbearing age”.

That statement is simply not true. The regulations as they stand would allow people to be granted an extension of storage to a point well beyond natural childbearing age without any check, other than the test of premature infertility.

It is only very recently that Parliament voted for the maximum storage period for embryos and gametes to be set at 10 years. It is therefore, to say the least, a surprise for us to be considering a maximum limit of 55 years so soon afterwards. Indeed, it is not at all satisfactory in my opinion that such radically different rules with the ethical implications that they carry should be introduced by means of a negative instrument. I should like to hear from the Minister whether the HFEA has discussed the issues to which I have referred, and whether it has considered issuing guidance on the matters that clinics should take into account when presented with a request for extended storage by an individual who is, or soon will be, beyond the average age for childbearing or initial parenthood. This matter should not simply be allowed to go by default or left entirely to the discretion of individual clinics. If there is a policy either to discourage or encourage elderly parenthood for those who are deemed prematurely infertile, we are entitled to know about it.

I wish to make one final point before closing. During the passage of the 2008 Act, we debated the issue of saviour siblings—embryos created with a genetic profile designed to enable a brother or a sister to receive treatment for a fatal or serious condition. At the time I referred to this idea as being on the cusp of ethical acceptability. I still believe that. The regulations would allow a saviour sibling embryo to be kept in extended storage for 55 years, subject only to one or other parent having become prematurely infertile or being likely to become prematurely infertile. Having thought about this, I can envisage no circumstances in which such storage could be ethically justified. Why are the Government allowing it?

Looking at the regulations, I think that what is at stake here is the standing and credibility of our systems for delivering assisted conception in this country. In my judgment, that standing is not assisted by what is effectively a complete absence of ethical way-marking posts laid down by Parliament or even by the HFEA as the proxy guardian of ethical standards in this area. Will the Minister take steps to rectify that? I beg to move.

My Lords, first I apologise for arriving in the Chamber a few minutes late. I very much support the noble Earl, Lord Howe. I put my name to the Prayer to Annul and then gave way to the noble Earl to allow him to make the first speech. I was very glad to do so because he has done most of the work and I agree with everything that he has said.

I am a member of the Merits Committee. When the issue came before us, we viewed it with considerable concern but, perhaps in defence of the committee for the brief word of criticism of it, it is fair to say that it is our practice to be cautious in our comments. Indeed, the facts speak for themselves, and we raised the issue with this House as a matter of public interest, which it clearly is. I am extremely concerned about the proposal for 55 years. It sounds like a Rip van Winkle story. What will the person be 55 years after the embryo has been created to the moment that the baby is born? There is an element of the unnatural about it and that concerns me very much.

I have two main points to make. One concerns the medical implications. The first point, as the noble Earl said, is that it requires the opinion of only one medical practitioner, but as far as I can see it does not even need the medical practitioner to see the person who is said to be prematurely infertile. All that is required is a written opinion, which can be done on the papers. That is a very unsatisfactory method. One has to ask whether there has been any animal research on keeping gametes or embryos to see what they are like after 55 years, or even after 40 years. I suspect that the problem is not only in the freezing but the thawing. What will be the position when the embryo or gamete—particularly the embryo—is thawed as late as 40, 45 or 50 years on? We are in uncharted territory. As the noble Earl said, we have moved from five to 10 to 55 years in one go. One might have thought that we would move from 10 to 20, or even to 30, but we have moved to 55 without the medical knowledge. Very distinguished doctors, many of whom are in this House say that they do not know that there is very much difference between 10, 20 or 55 years, but if I may respectfully say so, they do not know. No one has been born after 55 years so the medical problems may be very serious, and it will be after the lifetime of quite a number of Members of this House.

The other thing is the practical considerations. I had the misfortune to try an extremely sad case when couples A and B had their gametes switched. Two children who turned out not to be white were born to an all-white family because they had the gametes of Mr B who came from an ethnic minority. They were twins so six people were damaged: the white family with non-white twins; the black family who never had any children; and the children themselves who were mixed race in a family who adored them but found it difficult to come to terms with what had happened.

Those were mistakes that happened on the day that the families went to the clinic. What sort of tracking will we have over anything up to 55 years? There will not be the same personnel in the clinics and the opportunities for mistakes and for not being as efficient as might be expected stand out. The noble Baroness, Lady Deech, who is not here at the moment was particularly anxious that I should raise those two points not only on my own behalf but on her behalf, bearing in mind that she was the first chairman of the Human Fertilisation and Embryology Authority.

The second chairman. I am grateful to the noble Lord, Lord Winston.

The noble Baroness, Lady Deech, is as concerned as I am about the practical as well as the medical considerations. To move from 10 years to 55 is not proportionate to the need to store. There are human rights implications for those who are unlucky enough to be unable to have children themselves, to be able to store perhaps for their own future or that of their daughters or, possibly, sons. But there should be a proportionate limit on how long this should be for families who have the right to respect for family life under the European Convention on Human Rights.

As the noble Earl, Lord Howe, said, there are a considerable number of loopholes in the proposals for saviour siblings, which I shall not go into as I would waste the time of the House. As only one of the couple needs to be prematurely infertile, one could easily be 40, 45 or 50 and the other might be considerably older. Although the clinic will give advice as to suitability, it does not have the right to say that the couple who wish to have the child are unsuitable because of age. That is another very difficult matter. I do not think that the sympathy one has for the unhappiness, distress and unfairness of life that some people are unable to have children should be allowed necessarily to sway the other situation on whether 55 years is right. This is a very unsatisfactory increase and I hope that the Minister will reconsider whether this is the appropriate way to go forward.

My Lords, when I first learnt of the proposal outlined in these regulations, I could not believe it. It seemed reasonable that the 2008 Act should set down a period of 10 years as the maximum time embryos and gametes could remain in storage. Today we are being asked to change this—not to 15, 30 or even 40 years, but to 55. That is a dramatic suggestion; it has all kinds of possible implications and it is very worrying that Parliament has spent no time considering the wisdom or rightness of it. Without today’s action by my noble friend we would not be debating it, although perhaps a lifeline might have been thrown from elsewhere.

There are many questions which need to be answered. It seems that the only reason that this step is being contemplated is because an eight year-old girl is suffering from Turner syndrome which, we are told, will render her infertile or might do so. I understand, and my noble friend Lord Howe has confirmed this today, that the figures for Turner syndrome are about one in 2,500, so the percentage of girls born with the condition is in the order of 0.05 per cent. In other words, only one out of every 2,500 girls has the condition. Are we changing the law on these grounds? No; it is fair to say that other diseases, such as cancer, can cause infertility, but I have no knowledge of what percentage of children are likely to get cancer at an early age.

How can anyone say that the children who may suffer from these problems will, when they are older, want a child anyway? By no means every woman wants a child; many do not and, given the figures that came out today, some may be persuaded not to. In any case, the situation would not be a problem for 20 years or possibly more. The reason we are here tonight is that if the time for storing her mother’s eggs were to be only 10 years, it would not be sufficient to allow the mother to become the daughter’s donor. It is on that basis, I understand, that this proposal is before us.

However, that cannot be said to be the end of the argument. Why does it have to be the mother who donates? There are hundreds, if not thousands, of women who have children today by IVF. There is obviously a steady supply of embryos and gametes without using old ones which have been in storage for so long that no one really knows how safe they are. The noble Lord, Lord Winston, whom I am delighted to see in his place, and whom we all admire for his work, is the acknowledged top expert in this field. He is on record as warning that there may be medical risks to the child if frozen eggs are used to make the embryo. He said:

“With regard to egg freezing, the situation is possibly much more serious. Very few animal studies have been done, and very few humans have been born—I am not sure whether any of the children born are yet more than three or four years old”.

I hasten to say that the noble Lord has made it clear that he would not ban egg freezing in the circumstances we are considering, but he is clear in his warning that there may well be risks to the child.

The question we face is whether this is wise or necessary. I still cannot see why it is necessary to elongate the storage period for so long. Surely an eight year-old would make up her mind on the matter before she is 63. Is it really sensible to encourage the birth of a child for whom its father is the father but whose mother is the grandmother and whose aunt is the woman who bore her?

Under the law today, all children have a right to know the details of their birth origins. Would it not be extremely puzzling, not to say worrying, for a child born from such an extraordinary mix of relations and ages to learn of that kind of background? It is the stuff of nightmares. This is far from a simple matter. Generations to come will want to know that we looked at all possible outcomes and discussed every reason and counter-reason for our actions today? We must not let them down.

My Lords, I thank the noble Earl, Lord Howe, for giving us the opportunity to discuss this complex matter today. I am sorry that my noble friend Lord Alton of Liverpool is not in his place; he is having an operation on his back.

As president of the Spinal Injuries Association, I can say that it can be very helpful for people who break their necks and backs, many of them young men who may lose their sexual powers and become impotent, to have their sperm taken while it is still fresh and stored so that it can be used when needed. For people who have cancer and other conditions which may make them infertile, this legislation may also be helpful. However, keeping eggs and sperm for 55 years seems a long time.

The loopholes relating to extended storage include the fact that no age is given for the normal limit for childbearing, and therefore there is no line against which to measure “prematurity”. A full 10-year extension can be granted on the basis of the person being certified as prematurely infertile on any day within the existing 10-year storage period, and the medical practitioner does not have to certify that they will be prematurely fertile for the whole of the subsequent 10-year period. Only one of the persons whose gametes are used to make an embryo needs to be classified as prematurely infertile or likely to become so. The other person whose gametes made the embryo may be well beyond childbearing age but would still benefit from the extension granted to the partner. For example, a man could potentially be granted a 10-year extension in his sixties or seventies; his wife may be of a similar age but they could still potentially have a child, via surrogacy if necessary. A single medical practitioner simply has to give a written opinion that the person is prematurely infertile or likely to become so on the day they are examined; a full 10-year extension would then be given, subject to the 55-year maximum. The individual medical practitioner determines not only whether the person is infertile, but also prematurity. There are genuine differences of opinion in relation to normal childbearing age, particularly in regard to men.

Treatment would then, in theory, be subject to the “welfare of the child” provision. However, considering that the regulations were drafted to allow young women to give birth to their half-sister or half-brother, where the grandmother would be the real mother, the welfare of the child provision seems rather meaningless. It is unlikely that it would be a sufficient safeguard in the case of elderly people being able to have children.

As this is an ethical matter, it is a pity that no right reverend Prelate will be speaking tonight. I hope, in the interests of future children, that these regulations can be improved and made more acceptable for everyone concerned.

My Lords, I speak as someone who is no scientist, nor a philosopher, nor a jurist, but as a Member of your Lordships’ House who senses that we may be looking at an issue that has not been subject to proper parliamentary scrutiny in another place—and, were it not for my noble friend’s excellent Motion, would have had no proper scrutiny in your Lordship’s House, let alone any full discussion by the general public. It is easy to sneer them away, particularly in the scientific community, but the general public have perfectly proper ethical concerns.

Mine are twofold. First, I instinctively distrust the thought of scrambling the generations—indeed, to use shocking language, I dislike it intensely. However, these points have been very well made by my noble friend Lord Howe from the Front Bench and, if I may say respectfully—to use the argot of the trade—by the noble and learned Baroness, Lady Butler-Sloss, and, indeed, by the noble Baroness, Lady Masham, to whose excellent speech we have all just listened. In the interests of time, I shall not elaborate on or repeat what they have said, because we have only a short debate.

The scrambling of the generations is a purely utilitarian approach to the problems of humanity. That is my first reason for disliking these regulations. My second, to which I shall speak a little more, is that they also have an equally utilitarian, nay almost casual, disregard for the later welfare of those who have been born in this way. There is absolutely no concern expressed—not by the department, the Government or anyone else from officialdom—for the welfare of these children, once they find out that the person they thought was their mother was also their half-sister, and that the person they have happily been calling Granny, they should actually have been calling Mummy. I do not think that has struck home at all, but it is true.

There is, perhaps, an intention by the Government to prevent children born in this way, by regulation, learning about their background and from whence they have sprung. I am sure that the Minister will, with her characteristic openness, wish to say “Yes” or “No” to the Government’s intentions about transparency, and whether they intend to move to prevent a child from knowing that they came as someone who has been born through scrambling of the generations.

Also, the Minister cannot deny that the Government are making absolutely no provision to deal with the seemingly certain emotional distress for children, if they find out that they have been born in that way. I have tried to think about their psychological confusion. If I had suddenly found that out as a teenager, I would have fallen prey to it, just like that, and to the identity crises on stilts that would surely follow—born, as they were, as the result of what seems to be a developing, full-on Eugenics Society policy from the Government.

I have two points with which to conclude, in the interests of time. The Government seem to have given no thought whatever to what to do after creating an open door to the manufacture of genetic backgrounds. Those may indeed be within, first, hitherto legally prohibited degrees of relationship and, secondly, there is the possibility of unhealthy relationships developing within the family. I do not criticise the Minister, as I shall get straight answers to these points, but that is what these regulations do. I really would suggest, with respect to the Minister, that the Government should take these regulations away, think again, allow a proper public debate and bring them back to the House in a more seemly fashion.

My Lords, I listened with great care to the speech by the noble Earl, Lord Howe. He made quite a complicated speech and I may miss some of the points that he made, for which I apologise. He raises a few issues which it seems rather surprising that he has not raised beforehand. First, however, I was sorry to hear that the noble Lord, Lord Alton, is unwell. We have been adversaries over this issue for a long time, but we are certainly not enemies, and I hope that he is better very quickly.

My first point is that nothing in this particular aspect of the legislation changes the possibility of older women being treated. There is no specific area of guidance for that. It is still technically possible, and will be under law, to transfer a donated egg to a woman who is of a particular age unspecified in the Act of Parliament. That does not change, and it is actually a far more likely problem with in vitro fertilisation and might well be something that your Lordships would view with some alarm. The use of an egg which has been frozen for a long period under these circumstances would clearly be a much rarer event. It is not really likely that it would happen often; it might happen more often with sperm, because sperm are relatively easy to store and have certainly been stored for this length of time in the past.

The issue of transgenerational embryos is a tricky one, and I understand and recognise the concern of a number of people who have spoken against such transfers. The problem is that we do not really have evidence—although the noble and learned Baroness, Lady Butler-Sloss, made an impassioned speech on this—that this is necessarily harmful to the welfare of the child, providing that there is no secrecy and that it is done with openness, as it has been in a number of parts of the world. For example, I believe that it was first done in South Africa some 10 or 15 years ago. There is an issue, then, about always keeping this kind of thing under surveillance, but again, that is quite possible without the storage of embryos or sperm. That can always happen, and the storage aspects are irrelevant to this, for they simply mean that you could do that for a longer time afterwards.

The actual problem that we have to contemplate is one that we tried to deal with in discussing the Bill as it went though Parliament; that is, the issue of secrecy. Now, there is something of a misapprehension here about premature fertility. Your Lordships have, perhaps, forgotten that it is possible to be prematurely infertile at the age of six months. It is not just a question of Turner syndrome—although, to the noble Baroness, Lady Knight, I must say God forbid we should not have compassion for the rare cases that, like that syndrome, affect a few children, for they are as deserving of our compassion as anyone else. I accept that it is quite a rare event, but there are many other instances where a child will be made infertile, particularly by deliberate medical treatment.

Increasingly, cancers are treated by heavy radiation or toxic drugs that destroy their gametes, and if those gametes can be stored at the age of two or three—an ideal time biologically, as it turns out—then that is what the 55-year limit protects. You might say that 55 years is a long time, but if you actually think about it logically it is not. Certainly, men of 55 are capable of having another child, and generally still consider that they might wish to.

We are now living at a time that is very different from even 20 years ago. A paper was published in the Lancet two weeks ago by Dr Christensen from Denmark. His paper is a beautiful piece of serious mathematics, which I do not think anybody doubts. It shows that, of the children born in the last decade, more than half will have a life expectancy of greater than 100. Our society is changing and people will work for much longer; it is inevitable. People will have quite different recreation. Many aspects of our society, including pensions, will have to change. It is quite feasible that women may wish to bear children, perfectly acceptably, a little later in life. It is possible, therefore, that this is something that the very occasional woman in her middle age might want to consider, though not necessarily at present.

What this has done is simply to take a compassionate look at all possible opportunities, with wisdom to the future. It is clearly not going to be a common occurrence. British statistics tell us that very few women over the age of 50—or even 45—request treatment for infertility. There are a few. They are generally, of course, women who are taken very carefully through the process. I am surprised that your Lordships are concerned about the fact this should be a matter for just one doctor’s opinion. That, to my mind, does not make sense. As far as I am aware, in legislation, the only times that we require two practitioners are, first, if we are committing somebody after 30 days because they are mentally unfit; and, secondly, for an abortion under the Abortion Act 1967. Medical treatments are not performed with multiple doctors taking decisions. I can say for certain that it is quite possible for five or six doctors who see a patient to misdiagnose premature infertility. I have seen it happen. Mistakes can always be made. Indeed, I have foolishly made that mistake from results after other doctors have made that comment, and then a patient has got pregnant.

I listened carefully to what the noble and learned Baroness, Lady Butler-Sloss, said; she said that this was unnatural. I do not wish to take issue with her because she is one of the wisest Members in the Chamber. However, I have to say that the whole procedure of in vitro fertilisation is unnatural. Taking an antibiotic is unnatural. Medical treatment is not natural. What we try to do with medical treatment is often a compromise; it is an attempt to find something that preserves and maintains the sanctity of life in whatever way we feel is appropriate. The noble Baroness also mentioned—and I fear I have to disagree with her—that there has been no animal research on embryo freezing. There has been, over a long period. Dr David Whittingham, who first froze embryos in the mouse over 30 years ago, regularly took tranches of embryos from that store every five years to examine the changes in them and then transfer them to the mouse uterus. Over 30 years he never found any change in their fertility.

It is perfectly true, as the noble Baroness, Lady Knight, said, that I am concerned about the freezing of eggs. Indeed, I am quite concerned about the freezing of embryos. However, the evidence from my laboratory is nothing to do with long-term storage. Once in liquid nitrogen, the molecules hardly move at all. The changes are, on any scientific basis, bound to be very slight. There may be the most remote risk from background radiation, but Dr Whittingham’s experiments did not show any such risk, which is something he tried to elicit. No, the problem with embryo freezing and the reason why I am concerned, particularly about egg freezing, is that the process that we use may cause epigenetic changes immediately in that gamete. That is something that we will have to explore and we need to continue to take under surveillance. This is something, of course, which should be done in our society. Any responsible medical society should try to improve the quality of follow-up to do that. That has not been part of the Act of Parliament, but maybe it is something that we should look at.

Furthermore, I am puzzled about introducing the issue of switching embryos. The noble Baroness mentioned the noble Baroness, Lady Deech. The switching of embryos can, of course, occur at any time, but I do not think that there is any evidence that the safeguards for long-term storage in proper laboratories, which are regulated by Human Fertilisation and Embryology Authority, are likely to be at any greater risk at any time simply because storage is long-term and staff have changed. Staff change in many in vitro fertilisation units at yearly intervals.

I have to take issue with the noble Lord, Lord Patten. The scientific community cares passionately about ethics. Indeed, if you look at the literature on the ethics of in vitro fertilisation, you will find that the majority of papers which take account of ethical issues have been published by practitioners in the field, often, but not always, after consultation with ethicists.

Finally, even if we decide that longer-term storage is not possible, there is no doubt that there are a number of women who are requesting storage for longer than 10 years at the moment. I get e-mails—very pathetic ones—from women whom I no longer treat, but who have run out of time and whose circumstances would still be appropriate for having a child. Nobody here would doubt that. In cases of donor treatment, they sometimes want to have the same donor as a parent. That is not unreasonable; I know a number of patients who have wanted that. There is a risk that we might destroy that. Our biggest problem, and the concern that we should be addressing, is that when we start to have very punitive legislation, we have seen that, in practice, these patients go overseas. Once they do so, the very problem to which the noble Lord, Lord Patten, referred—the question of secrecy—is much more likely. In fact, if you prevent this practice, you will increase secrecy of parentage—exactly what you do not want to see. I beg noble Lords to think about that if they decide to press a Division on this Motion, which I hope they will not do. Also, the other problem that we are very concerned about is that we know that when women and families go overseas, they are exploited and not cared for as well as they would be under the regulations which Parliament has so wisely enacted in this country.

My Lords, I wonder whether, under the rules of debate, I might be permitted to make sure that the point I was making was clearly understood. I am looking at the rules of debate and I think I am allowed to do that. Very briefly, I was not criticising the storage or the limit. It was the 55 years of storage that I was concerned about. Having read what the noble Lord, Lord Winston, had said, there has, as far as I know, been no work done beyond 30 years. That was the point that I was making; I think I may have been misunderstood.

My Lords, very briefly, I am aware of the time, but there are assurances from the usual channels that we are not limited to an 8.30 pm finish for this debate. I will be very quick indeed. I made some remarks, when these matters were considered previously, about the welfare of the child provision, particularly the importance of considering fathers in that respect. I seek some assurances from the Minister in respect of government policy on the importance of fatherhood in consideration of these matters.

The right honourable Hilary Armstrong, when she was Minister for social exclusion, gave what many of us considered to be an absolutely outstanding speech on 29 June 2006, in which she outlined government policy. She said:

“But government can’t do it all, and throughout my career I have seen the critical importance of good parenting. And fathers are as crucial a part of this as mothers. It is an obvious, but profoundly important statement that fathers have a key role to play in caring, loving, guiding and protecting their children. Research from the National Child Development Study has demonstrated that quality involvement—fathers who read for their child, take interest in their education—is closely linked with the absence of behavioural difficulties, greater academic motivation, and greater psychological resilience. The list of positive outcomes goes on and on. In short, fathers matter. And this is why fathers—indeed all parents and caregivers—must be considered as part of the vanguard in our drive against persistent social exclusion”.

Furthermore, page 5 of the Engaging Fathers document produced by the Department for Children, Schools and Families states under the heading, “Key research findings”:

“What are the gains for children of engaging fathers? Positive father involvement in their children’s learning is associated with better educational, social and emotional outcomes for children, including: better examination results, better school attendance and behaviour, less criminality, higher quality of later relationships, better mental health”.

Those are government statements of government policy in relation to this.

The welfare of the child provision in the measure that we are discussing does not require clinics to consider the presence or existence of fathers or their active involvement in the welfare of their children. I seek assurances from the Minister that government policy in regard to the importance of fathers still obtains. If that is the case, does she consider that a further strengthening of the welfare element of these regulations is required in order to make that policy as explicit as other members of the Government have made it in the past?

My Lords, I thank the noble Earl, Lord Howe, for his Motion, which has precipitated this debate. These matters are so important that it is vital that this House debates them extensively. Therefore, I welcome this evening’s debate.

When I looked at these regulations for the first time a couple of weeks ago my initial reaction was that they raised a whole raft of new, very important ethical issues. Having studied them in detail and listened to tonight’s debate, I am now not convinced that that is the case. I say that because when noble Lords started to debate the Bill that became the 2008 Act, we had a considerable number of debates about omissions from that Bill. That Bill amended the 1990 Act. The 2008 Act was criticised for not containing a sufficient basis of principle. However, the principles which the noble Baroness, Lady Warnock, set down in her work back in 1990 endure and govern all decisions in this field; for example, that the welfare of the child should be paramount and the treatment of embryos should be of the highest order. I say that so that we do not take these regulations completely out of context, as I think there is a considerable danger that we might do that.

I make that point because I listened to the speeches of the noble Lords, Lord Patten and Lord Bates, with great care. Both of them raised important issues but those were extensively debated in this House during the passage of the 2008 Act. We discussed openness about donation and came to the conclusion, after considerable discussion, that that should be encouraged but that it is a decision best made by families. We debated the need for a father extensively and reached a conclusion with which the noble Lord, Lord Bates, disagrees, but none the less represented the view of this House and another place.

This matter has become more important for reasons which have absolutely nothing to do with reproductive medicine but concern developments in other areas of science. For example, survival rates from childhood leukaemia are now considerably higher than they have ever been previously. The noble Lord, Lord Winston, talked about our ageing society. I have a further statistic, which I hope is as engaging as the one he mentioned. It is now reckoned that every day the average life expectancy of an individual increases by 15 minutes, so people are living longer and a considerable number of them will live very long lives. A life span that we now consider represents old age may, in the not too distant future, be viewed as representing middle age. That is the context in which we should consider these regulations.

I understand that when the regulations came before the Merits Committee, noble Lords asked whether records of donated gametes, embryos and donors were not more likely to be lost if the current 10-year period were extended to 55 years, as proposed. I note that the review period remains 10 years. That important fact may have been overlooked. Because of the ending of donor anonymity and the new provision for the creation of human admixed embryos for research, never for implantation in a woman, that was introduced in the 2008 Act, clinics, the HFEA and others are required to have much higher standards of record-keeping than has ever been the case previously. Individual practitioners and clinics face severe penalties if they fail in that regard.

The noble Earl, Lord Howe, referred to intergenerational donation. Noble Lords will have seen the briefing from the Turner Syndrome Society and will have read about some of the cases. We are not talking about people who are being selfish as regards wishing that their children might have a family in due course. Many of those people are taking a very considered and thoughtful approach to the matter. The society cited the example of the lady who did not wish her daughter to be forced to contemplate becoming pregnant at the age of 18 or 19; she wanted her to be able to do that at a later stage, as other young women do when they enter settled relationships. I understand entirely the concern of the noble Earl, Lord Howe, about confusion over identity. However, it is currently permissible for a woman to donate embryos or to be a surrogate for her sister. Many families do that because they wish to have children. There is not yet any evidence that the children born in those circumstances are any more confused about their identity than others because the relevant decision has been taken in a completely different atmosphere of openness and sensitivity than was the case in the past.

As regards removing the upper age limit, I understand entirely the concern that children could be born to old mothers. However, I believe that that issue was first discussed shortly after the birth of Louise Brown, who was born in Boundary Park Hospital, Oldham, and has been discussed ever since then. That is why I think there is no absolute cut-off limit. The matter should be kept under review and is one to which Parliament should return from time to time. We should not forget that the decision to allow somebody to have fertility treatment is always an individual clinical decision, which always includes an assessment of the welfare of the child who will be born as a result. I agree with the noble Earl, Lord Howe, that there is a case for there to be more guidance but I do not believe that these regulations in themselves introduce sufficiently new and substantial ethical issues that they should not be passed by this House.

My Lords, I am grateful to the noble Earl and other noble Lords for their informed and valuable contributions. I hope I can provide assurance that these regulations put in place the necessary safeguards and that we are taking on board many of the complex issues that have been raised.

These regulations allow for storage periods for embryos and gametes to be extended for longer than the 10 years set out in the 2008 Act. Storage can be extended for further 10-year periods if the person to be treated or the gamete provider is, or is likely to become, prematurely infertile. The maximum time period embryos or gametes can remain in storage is 55 years from the day they were first placed there. These regulations replace two previous sets of regulations—one relating to extended storage periods for embryos and one relating to gametes. It was necessary to update the regulations to take account of changes in the 2008 Act and it was an opportunity to review the policy in this area.

Two key changes are introduced by the regulations. The first significant change is to eligibility for extended storage. The regulations permit extension by the gamete provider or the person to be treated. The “person to be treated” is defined in the regulations as the woman to whom the gametes or embryos will be transferred or the person to whom they are allocated. Unlike the previous regulations, this now includes where donated gametes or embryos are to be used by someone who is, or is likely to become, prematurely infertile, and where a prematurely infertile woman needs to use a surrogate.

These provisions will help real people in difficult circumstances, as outlined by my noble friend Lord Winston in his perceptive remarks. He knows about the tragic circumstances facing people to which I will refer later in my remarks. A situation was brought to the attention of Parliament during the debates on the 2008 Act in another place. A Member spoke on behalf of a constituent whose daughter suffers from Turner syndrome—a genetic condition with symptoms including infertility—who wishes to store her eggs for her daughter to use in later life. Without these regulations, extension beyond 10 years would not have been possible and storage would have expired before the daughter was of an age to make the choice about whether or not to use the eggs. These regulations rectify that situation, permitting storage where the intended recipient meets the necessary criteria, and providing them with the hope of having a child with genetic links to them. These regulations also provide for storage extension where a woman needs to use a surrogate—for instance, because she does not have a womb. The additional storage period allowed in the regulations gives couples time to find and arrange a surrogacy without having to rush into an arrangement because the storage period is expiring.

The second main policy change is to replace the age limit set out in the previous regulations with a maximum time period of 55 years. We recognise that there has to be a set storage limit and that any time period chosen inevitably involves an element of subjectivity. I hope I can explain why we decided on 55 years. The age limit of 55 years set out in the previous regulations was based on the upper age when a woman would no longer be able naturally to bear children. However, this meant that men who were prematurely infertile were prevented from extending storage beyond the age of 55, despite the fact that they were still prematurely infertile at that age—for instance, after cancer treatment when they were younger. The age limit, therefore, was not sufficiently flexible to meet individual circumstances. The age limit has been replaced by a more equitable time limit of a maximum period of 55 years from the day the embryos or gametes were first put into storage. The limit of 55 years reflects the principle of trying to ensure that no one will be worse off under the new regulations than they were under the previous “55 years of age” rule—in other words, to ensure that no one is disadvantaged by the new provisions. For example, the new provisions enable a woman to put her eggs in storage for her prematurely infertile infant daughter to use when she is older, and they enable the woman to do so for up to 55 years, subject, as the noble Baroness, Lady Barker, said, to confirmation by a doctor every 10 years that the daughter remains prematurely infertile. It is important to remember that storage can be extended only for 10-year periods and it requires a registered medical practitioner to certify that the person to be treated is prematurely infertile. Once a person is no longer prematurely infertile, no further extension of storage is possible. At each 10-year extension, a registered medical practitioner will be required to provide a statement that the person to be treated is still prematurely infertile. This change maintains a maximum limit while allowing clinical discretion to be exercised in relation to a specific patient.

I understand the concerns expressed about the well-being of children born to older parents. These regulations do not encourage conception after the natural child-bearing age. It is only people who are prematurely infertile who may extend storage. Once a person ceases to be prematurely infertile—and, in a woman’s case, becomes naturally infertile—they would not be able to extend storage of their embryos or gametes. Each application for extended storage is considered on a case-by-case basis with a registered medical practitioner deciding whether, based on their clinical judgment, that person is prematurely infertile. A further safeguard is that, before treatment can be undertaken, there is a legal duty on the clinic to consider the welfare of the child. This House has had many discussions about what the welfare of the child involves and I hope to be able to offer some comfort to the noble Earl about what is going to happen next in that respect.

Will the noble Baroness clarify a point for me? I understood her to say that the end will be set at the point the person becomes infertile. Surely the mother could become infertile before 55 years is up. Would her egg then remain in storage?

The point is whether she is prematurely infertile, not just infertile. Of course, around the age of 55, women generally become infertile.

I will try to respond to individual points that noble Lords have made. I apologise to the Coroners and Justice Bill crew about this, but I accept that the noble Earl is keen that we should have a full explanation on the record, which is perfectly reasonable.

The Human Fertilisation and Embryology Authority code of practice sets out the factors that a clinic should consider in relation to the welfare of the child test. These factors include taking a medical and social history from the patient and their partner and considering any circumstances where any child born may experience serious physical or psychological harm or circumstances that may lead to an inability to care for the child. The clinic also has a duty to offer counselling to those undergoing treatment. This gives patients the opportunity to discuss any concerns that they may have with a specialist counsellor.

The noble Earl, Lord Howe, and the noble Lord, Lord Patten, asked about guidance on intergenerational donation. The HFEA is considering the issue and the guidance that it needs to provide for clinics. The Ethics and Law Advisory Committee of the HFEA is discussing issues around interfamilial donation, including intergenerational donation, and will recommend to the HFEA whether it should provide additional guidance. In fact, it discussed these issues at its meeting today. It will be making recommendations to the authority, which will discuss those at its December meeting. The noble Earl asked about the guidance provided on consanguinity. As I said, that is being discussed and we can expect guidance on those issues.

The noble Earl, Lord Howe, and several other noble Lords asked how premature infertility is assessed. My noble friend Lord Winston gave a much more adequate answer than I probably could. It is assessed on a case-by-case basis and it would be inappropriate to include an exhaustive list of qualifying conditions. The HFEA provides guidance on when storage can be extended, listing chemotherapy treatment for cancer, for example. The extension should remain a clinical decision, allowing registered medical practitioners to take account of individual circumstances alongside the HFEA guidance.

The noble Earl asked why there had not been debate about the storage regulations. The 2008 Act was subject to extensive scrutiny in this House and debate by Parliament. Parliament did not deem it necessary for these regulations to be subject to the affirmative procedure. The storage regulations are subject to the negative procedure and were not required to be debated. Parliament did not deem that to be necessary, for some of the reasons outlined by the noble Baroness, Lady Barker, when the 1990 Act was passed and a draft of these regulations was approved by both Houses.

I hope that I have given some insight into why the period of 55 years was chosen. The noble and learned Baroness, Lady Butler-Sloss, is right that this is, to an extent, subjective, but I hope that we have given an explanation. We have gone to the limits of what we think may be necessary. If we had chosen a shorter period, we might have found ourselves back here in a year’s time because we had not covered all the eventualities and had disadvantaged people.

The noble and learned Baroness, Lady Butler-Sloss, also asked about the number of people affected by storage extension. The extension of storage is a rare occurrence, as most people find the 10-year period quite adequate. A case study of an NHS clinic showed that approximately 5 per cent of people with gametes or embryos in storage extend that storage currently. The Government estimate an increase of perhaps 50 per cent—that is 900 people—under the new regulations. This is taking into account the additional circumstances for which storage can be extended—for example, for teenage cancer patients and Turner syndrome patients. We estimate that only a few will need a further 10-year extension beyond the 20th year of storage.

The noble Earl, Lord Howe, asked what a clinic should ask itself in assessing the welfare of the child and whether age should be considered. The clinic will assess the welfare of the child in accordance with the HFEA code of practice. This requires the clinic to consider the child’s need for supportive parenting. While there is no absolute rule on age, each case would be considered on its facts and it would be reasonable for a clinic to take age into account before it took a decision.

The noble Earl also asked why extended embryo storage should be allowed in saviour sibling cases. I remind noble Lords that the test here is whether the person who needs to use the embryo is prematurely infertile, not whether the embryo is being created with the intention of being a saviour sibling.

The noble and learned Baroness, Lady Butler-Sloss, asked whether it was safe to store embryos for this period, and about the evidence. The exchange of information between her and my noble friend Lord Winston means that I need not go into detail about the safety of the storage of embryos. The noble and learned Baroness also asked about one medical practitioner being needed to certify premature infertility. My noble friend also answered that question much more adequately than I did.

The noble and learned Baroness, Lady Butler-Sloss, and other noble Lords asked about incidents and accidents and the need for tracking. Clinics already have storage systems in place for persons up to 55 years of age. The noble Baroness, Lady Barker, remarked on how much these must be improved and how safe they need to be.

The noble Baroness, Lady Knight, asked about Turner syndrome and why it must be the mother who donates. Again, my noble friend Lord Winston answered that and talked about the need for compassion. We should recognise that the storage of the mother’s embryos offers a choice to the child when she becomes a woman. She does not have to use the embryos, but this will offer her a choice. For some people, having a child who is genetically linked to them is extremely important. If science can offer them that opportunity, who are we to deny them?

The noble Baroness, Lady Knight, also asked about the number of children who develop cancer. It is estimated that 1,500 children under 15 are diagnosed with cancer every year. Because of improvements in cancer treatment, we are pleased that many more of them survive. Again, if science can offer them the opportunity to have children in later life, why would we wish to prevent that?

The noble Baroness, Lady Masham, asked about registered practitioners and premature infertility. A medical practitioner must certify that the person is, or is likely to become, prematurely infertile. If a practitioner considers that a person will only be temporarily infertile, that person will not meet the criteria of the regulations. If a person does not meet the criteria and then their position changes and their fertility is recovered within 10 years, the 10-yearly reassessment will ensure that the embryos are not stored any longer than they need to be.

The noble Baroness, Lady Masham, also asked about older couples having a child by surrogacy. Embryos would remain in storage only if the gamete donor, the woman to be treated or the person to whom the embryo was allocated was, or was likely to become, prematurely infertile. In this case, it would be difficult to argue that either member of an elderly commissioning couple would be prematurely infertile, and therefore they would not be eligible under the regulations.

The noble Lord, Lord Patten, asked whether there was a discussion among the general public. The regulations were subject to a 12-week public consultation, which ran from January to March of this year. One hundred and sixty-six comments on the regulations were received. They represented the views of a diverse mix of bodies: professional organisations, public interest groups and interested individuals. Meetings were also held with key stakeholders. The noble Lord also raised the issue of emotional distress caused to children born through intergenerational donation. Clinics must be satisfied that patients have the opportunity to receive counselling before treatment. They must consider the welfare of the child before providing treatment. If donation is involved, clinics must also provide patients with information about the importance of telling the child about the donation. When that is linked to the guidelines that are now being considered, I hope that the noble Lord will be satisfied that these things are being considered.

The noble Lord, Lord Patten, also raised the issue of opening the door to previously prohibited relations. Under the Sexual Offences Act 2003, the prohibition of family relationships and incest relates to sexual acts, not to the genetic makeup of any resulting offspring. The regulations do not change the law relating to prohibited relationships. The same safeguards that have always been there remain. The noble Lord, Lord Bates, is famous in this Chamber for his concerns about the importance of families and fathers. The issue of fathers was extensively debated during the passage of the HFE Bill. The House passed provisions which require clinics to consider the child’s need for supportive parenting before providing assisted conception. The policy ensures that all parents are valued.

In summary, the key features of the storage regulations are that the same infertility criteria for extension apply irrespective of whether gametes or embryos are being stored; that storage of embryos and gametes can be extended beyond 10 years where one of the gamete providers or the person who is to be treated is or is likely to become prematurely infertile; that an extension can be permitted in cases where the embryo or gamete was donated to a person who had premature infertility, including where a surrogate would be used; and that any extension should be for successive 10-year periods, until a maximum period of 55 years, provided that the relevant consents are in place and the criteria of premature infertility continue to be fulfilled within every 10-year period.

In conclusion, these regulations are very important to the people who need them. They permit embryos to remain in storage to ensure that there is adequate time for women or couples who are prematurely infertile to complete their families. I commend the regulations to the House.

My Lords, I shall be very brief as I am conscious of the hour. I thank all noble Lords who have taken part in this debate and I also express my gratitude to the Minister for her very full reply. I was encouraged by some of it and shall have to go away and read other parts of it. Like my noble friend Lady Knight, I was puzzled by one part of the noble Baroness’s answer in relation to premature infertility. Surely the question of whether someone is or is not prematurely infertile turns not only on an assessment of that individual but also on what is considered to be the biological limit of fertility in the average person—man or woman. I do not think that the Minister fully addressed that part of the issue; nor did she address the point that the regulations could technically permit a child to be born well beyond a woman’s natural limit for child-bearing, because the final extension of a full 10 years could be granted when a woman was aged 53.

The noble Baroness, Lady Barker, said that these regulations do not in effect take us into new ethical territory. I beg to say to her that I believe they do because the extended storage of gametes and embryos for the purpose of donation or surrogacy was made expressly illegal under the 1991 and 1996 regulations.

The noble Lord, Lord Winston, to whom I listened with great care and respect, suggested that elderly parenthood does not really raise any ethical issues at all. Again, I respectfully disagree with that if that was his view. My sole reason for wanting to call this debate was to say that there are ethical issues here and that they need to be talked about and thought about, especially from the point of view of the child. All too often people talk about these things solely or mainly from the point of view of the infertile person. It is not a question of a lack of compassion but of looking at these matters in the round, and I was very encouraged to hear that the HFEA is indeed doing that and is actively considering issuing further guidance. I welcome that assurance.

I suppose that I could not reasonably have hoped for a revised set of regulations to substitute for these but, at the very least, it will be good and positive if this debate sends a strong signal to the HFEA that the question of the child’s welfare in the context of the issues raised this evening should be given a lot more careful thought. With that, I beg leave to withdraw the Motion.

Motion withdrawn.