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

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.