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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

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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

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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.

Baroness Knight of Collingtree: 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?

Baroness Thornton: 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

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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.

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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.

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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

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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.

Earl Howe: 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.

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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.

Coroners and Justice Bill

Main Bill Page

Report (1st Day) (Continued)

8.54 pm

Clause 14 : Post-mortem examinations

Amendment 32

Moved by Baroness Finlay of Llandaff

32: Clause 14, page 7, line 31, at end insert-

"( ) The coroner should, whenever possible, seek to ascertain the wishes of the deceased's relatives prior to the post mortem examination and such wishes may-

(a) specify-

(i) the possible extent and purposes of the examination, and

(ii) the possible retention and future use of tissue samples, in accordance with guidance that shall be published by the Chief Coroner in conjunction with the Medical Adviser,

(b) be conveyed to the practitioner asked to undertake the post-mortem examination, and

(c) be regarded as appropriate consent in relation to the provisions of the Human Tissue Act 2004 (c. 30)."

Baroness Finlay of Llandaff: My Lords, I shall speak also to Amendment 33. Amendment 32 is in keeping with the Government's desire to make investigations at post-mortem more relevant and helpful to the family of the deceased, as in paragraph 37 of the draft charter for the bereaved.

At post-mortem, it is often possible to go beyond the needs of the coroner and to get information relevant to relatives' future health. Currently, it is a criminal offence for a pathologist to undertake work to further examine tissues if the wishes of the relatives are not known at the time of the post-mortem. Indeed, it is illegal for the pathologist to remove small samples of tissue for further examination, irrespective of what he finds, even if the coroner is no longer involved.

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It is also important to remember that if the wishes of the relatives are known, such as that they want a post-mortem which is to the absolute minimum, a pathologist can satisfy the needs of the state and still meet some of the wishes of the relatives by modifying the way in which the post-mortem is undertaken. A clear example of that is if, in the body cavities, it is quite obvious that the cause of death is natural and what the cause of death is, it may not be necessary to undertake a full examination, including slicing the brain.

The first report from the Human Tissue Authority revealed that post-mortems are being undertaken in complete ignorance of the wishes of the relatives, and it made recommendations. However, the second report shows that problems still persist and that the wishes of the relatives are still not known by the pathologist. Sadly, that is probably because the Human Tissue Authority cannot influence how coroners work.

Some coroners try to get round that before a post-mortem by trying to gain permission from the relatives for the blocks and slides to be retained so that they form part of the medical record. One would think that that would be good, humane and ethical practice. Sadly, some coroners do not go to the effort of obtaining that additional consent. Amendment 33 is designed as an enabling provision so that the Human Tissue Act can have flexibility without any possibility of return to the post-mortem practices which led to the 2004 Act. It will allow it to be brought closer to the Human Tissue (Scotland) Act 2006.

The present problems fall into two categories: first, the inability to provide work for the benefit of the state; and, secondly, the inability to provide work for the benefit of the deceased's relatives. For the benefit of the state there are three broad groups: the first is forensic research. Research into shaken baby syndrome currently demands consent from the person accused of murder. There is no alternative. Research intended to prevent severe miscarriages of justice is in fact prohibited by law.

Secondly, when the cause of death of an infant is not ascertained, the death is classified as being due to sudden infant death syndrome. A small proportion of those are unnatural deaths, but the vast majority are likely to be due to infections or other processes which are not yet identified. If there is a second death in that family, it could be essential to be able to go back and refer to tissues because you may then show that there was an inadequate immune response, for instance, to infection, which had not previously been detected because some highly sophisticated techniques would need to be used to stain the tissues.

The third area where the needs of the state are not being met at the moment is public health. The classic example is research into hidden infections. There was a recent important investigation into new variant Creutzfeldt-Jakob disease which planned to take a tiny sample from the spleen of each deceased person at post-mortem. The coroners perceived that obtaining consent was outside their remit so that important Department of Health-funded research folded and we have no idea what the true incidence is of new variant CJD.

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