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Faulkner of Worcester, L.
Filkin, L.
Foulkes of Cumnock, L.
Gale, B.
Gilbert, L.
Gordon of Strathblane, L.
Grantchester, L.
Grocott, L.
Hart of Chilton, L.
Haskel, L.
Haworth, L.
Henig, B.
Hilton of Eggardon, B.
Hollick, L.
Hollis of Heigham, B.
Howarth of Breckland, B.
Howarth of Newport, L.
Howells of St. Davids, B.
Hoyle, L.
Hughes of Woodside, L.
Hunt of Chesterton, L.
Jay of Ewelme, L.
Jay of Paddington, B.
Jones, L.
Judd, L.
King of West Bromwich, L.
Kinnock, L.
Kinnock of Holyhead, B.
Kirkhill, L.
McDonagh, B.
McIntosh of Haringey, L.
McIntosh of Hudnall, B.
McKenzie of Luton, L.
Massey of Darwen, B.
Maxton, L.
Moonie, L.
Morgan of Drefelin, B.
Morgan of Huyton, B.
Morris of Handsworth, L.
Morris of Yardley, B.
Patel of Blackburn, L.
Pendry, L.
Pitkeathley, B.
Quin, B.
Rendell of Babergh, B.
Robertson of Port Ellen, L.
Rooker, L.
Rosser, L.
Royall of Blaisdon, B.
Simon, V.
Smith of Gilmorehill, B.
Soley, L.
Taylor of Bolton, B.
Temple-Morris, L.
Thornton, B.
Tunnicliffe, L.
Wall of New Barnet, B.
Warwick of Undercliffe, B.
Wedderburn of Charlton, L.
West of Spithead, L.
Whitaker, B.
Whitty, L.
Wilkins, B.
Winston, L.
Young of Norwood Green, L.

Amendments 29 and 30 not moved.

Amendment 31

Moved by Lord Bach

31: Clause 12, page 6, line 37, leave out from "service"" to end of line 38 and insert "means service in-

(a) an action or operation against an enemy (within the meaning given by section 374 of the Armed Forces Act 2006 (c. 52)),

(b) an operation outside the British Islands for the protection of life or property, or

(c) the military occupation of a foreign country or territory."

Amendment 31 agreed.

Consideration on Report adjourned until not before 8.27 pm.

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

Motion for an Humble Address

7.27 pm

Moved By Earl Howe

Earl Howe: 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.

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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.

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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,

21 Oct 2009 : Column 766

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.

Baroness Butler-Sloss: 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

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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.

7.45 pm

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

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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.

Lord Winston: The second.

Baroness Butler-Sloss: 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.

Baroness Knight of Collingtree: 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.

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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.

Baroness Masham of Ilton: 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.

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