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

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 this order. 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.