Human Fertilisation and Embryology Bill [Lords]

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Dawn Primarolo: Thank you, Mr. Gale. This is a complex and important series of amendments on the issue of consent. As I go through them and explain their purpose, I will also reflect on the way in which hon. Members’ amendments interact with them, because some do approximately the same thing. As you rightly said, there are amendments to Government amendment No. 102, so it seems appropriate to explain how the measures interact.
As we have discussed, consent forms one of the cornerstones of the 1990 Act. A person’s gametes cannot be used to create embryos without their express consent. Schedule 3 replaces the consent provisions in the 1990 Act, bringing them up to date to reflect new techniques for creating embryos by, for example, requiring consent for the use of cells to create embryos.
The Government listened carefully to concerns raised in another place about the framework for consent in relation to the use of stored cells and cells from children with serious diseases, but we also made it clear that any exceptions to the requirement for consent would need to be compatible with convention rights. The Government amendments in this group provide for certain exceptions, while providing safeguards in recognition of those rights.
Amendments Nos. 7, 9 and 10, which were tabled by the hon. Member for Oxford, West and Abingdon, provide for similar exemptions to the need for consent, although they do not cover—I do not mean to imply criticism—all the eventualities covered by the Government amendments, such as the right of a child who becomes competent to consent and situations regarding adults who lack capacity. I hope that that will become clear when I outline the Government amendments.
Dr. Harris rose—
Dawn Primarolo: I have not actually said very much yet, but I will give way to the hon. Gentleman.
Dr. Harris: As the author of amendments Nos. 8, 9 and 10, I should say that I fully accept that amendments Nos. 9 and 10 do not deal with adults without capacity or with some of the conditions and provisions that the Government amendments do. Perhaps it will save the Minister some time if I say that she does not need to explain why that is the case. I accept that her amendments—certainly once she has explained them, or accepted my amendments to them—are better than amendments Nos. 9 and 10.
Dawn Primarolo: I am grateful for that. I had intended to do what the hon. Gentleman said. He is very knowledgeable about these issues and he will want to make his own representations to the Committee—I would not dream of doing that for him.
I turn now to exemptions for consent requirements for the use of stored tissue. With regard to stored cells, the Government amendments apply only to cells taken and stored before the commencement of the Bill’s provisions. The exception applies only if the HFEA is satisfied that the cells are anonymous and that the donor cannot be identified, or that the licence holder cannot reasonably trace the donor.
If the researcher can identify and trace the donor, unless the donor consents themselves, the cells cannot be used. If the person identifies the donor, and they are found to be deceased, consent would be required from a person such as a close relative, as set out in the hierarchy model found in the Human Tissue Act 2004. Before the cells can be used, the HFEA must be satisfied that scientific research would be adversely affected to a significant extent if the only cells that could be used were cells for which consent had been obtained.
The amendments reflect the fact that rare or well-researched samples are a valuable asset for better understanding and treating serious diseases. We have weighed the burden of being unable to use those cells against the rights of the person who originally donated them, and we believe that we have struck the right balance with the amendments.
On consent for the use of cells from children, the amendments apply when those children would never be able to give their consent because of age or lack of capacity. This is the case with children affected by certain aggressive forms of diseases such as muscular dystrophy, Batten disease and spinal muscular atrophy. To that end, the amendments propose that children with such conditions who are too young to consent, or who lack capacity, should be excluded from the requirement for effective consent, if a person with parental responsibility gives consent. This exception is subject to strict safeguards that ensure that a child’s cells cannot be used unless the HFEA is satisfied that the child suffers from a serious medical condition, that the research is intended to increase knowledge about the condition or its treatment, and that there are reasonable grounds for believing that research of comparable effectiveness could not be carried out using the cells of a person who could give their own consent.
I turn to consent for the use of cells from adults who lack capacity. Following further consideration of the exception relating to cells from children, it became clear that it was also desirable to make provision to enable the use of cells from an adult who lacked capacity in very limited circumstances. That would be to address situations when, for example, rare genetic conditions led to the sudden onset of lifelong incapacity. Following the precedent of the Mental Capacity Act 2005, the Government amendments propose that in such cases, the researcher would need to approach the carer of the individual and consult them about the views or the wishes of the person involved.
Again, this exception is subject to a number of stringent safeguards. The HFEA must be satisfied—at the time the adult lacks capacity and is unlikely to have capacity again—that the adult suffers from a serious medical condition, that the proposed research is intended to increase knowledge about the condition or its treatment, that there is no evidence that the adult would have refused to participate and, most importantly, that there are reasonable grounds for believing that research of comparable effectiveness could not be carried out using the cells of a person who could have given their own consent.
In all cases, it will be for the researcher to provide evidence that satisfies the HFEA that all conditions have been met before a licence to undertake the research may be given. The exemptions are rooted in exceptional circumstances. The potential for benefits to the sufferers of serious conditions must be too great to overlook, and any research that can be undertaken in the hope of better treating or curing those conditions must be allowed to continue.
I shall pass over amendment No. 8 and deal with amendment No. 32, which was tabled by the hon. Member for Boston and Skegness. One of the conditions is that the gametes were removed from the child lawfully before they turned 18, and another is that the child is not competent to consent. If a child were able to consent, it would not be appropriate to store their gametes without consent. The child must be about to undergo medical treatment that is likely to impair their fertility, and the storage of gametes must be in the child’s best interest. In addition, if the child becomes competent, they can decide what to do with their stored gametes.
The amendment relates to the age at which the gametes of a child could be stored without their consent. Under the amendment, the gametes must have been taken from the child before they reached the age of 16, otherwise, they could not be stored without their consent. That would mean that if a 17 or 18-year-old lacked competence to consent and was about to undergo medical treatment that was likely to impair their fertility, their gametes could not be stored because they would not have been taken before they reached the age of 16. I concede that it would be unusual for a 16 or 17-year-old not to be competent to consent, but that is not in itself a reason not to offer them the same protection as others in the exceptional circumstances in which they are not competent.
Let me deal with the amendments to Government amendment No. 102.
Dr. Harris: To clarify the situation, I would be grateful if the Minister dealt with amendment No. 8, which is not reflected in her own amendments. It deals with a different matter:
“Cases where consent not required for use in research to preserve fertility”.
The Government see several problems with the amendment, and our primary concern relates to the importance of consent. Provisions in the 1990 Act and the Bill are based on the fundamental principle of consent that we have been considering all morning. Consent is particularly important in the context of creating embryos from a person’s gametes. Equally, using a person’s gametes without consent should happen only with very strong justification.
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Successfully treated children whose gametes were stored without consent would, in the majority of cases, gain competence. It would be appropriate at that stage for them to make a decision about the use of their own gametes, including whether they wanted research to be carried out on them.
When gametes are not being used to create embryos, research on them is not in the remit of the HFEA. That means that an HFEA licence is not needed to carry out the research and the requirement for consent is governed by common law. Any research carried out in such circumstances might be possible with parental consent and if the research could be demonstrated to be in the best interests of the child, but that would ultimately be for a court to decide.
The Government feel that the requirement for consent is very important and that it should be deviated from only in very exceptional circumstances, such as when there are no other options. In the circumstances that the amendment addresses, it could be possible to obtain consent from the person prior to any research. Additionally, there would be scope for research through other means. We do not think that the circumstances proposed warrant an exception to the general principle of consent, especially in the light of alternative options. I thus ask the hon. Gentleman not to press the amendment to a Division, although I am sure he will want to make a contribution, to which I would be happy to respond.
May I finally deal with amendments (a) and (b) to Government amendment No. 102, which were tabled by the hon. Member for Oxford, West and Abingdon? The Government amendment will ensure that, among other safeguards, the HFEA must be satisfied that scientific research will be adversely affected to a “significant extent” before research may be undertaken using cells stored before commencement of the Act where effective consent to the use in embryo research is not in place.
Amendment (a) would remove the words “significant extent”, thus meaning that scientific research need be adversely affected by only a small degree before such cells could be used without effective consent being in place. As I have already stated, we have weighed the scientific burden of being unable to use existing cells against the rights of the person who originally donated them. To strike the right balance, we have taken the view that science must be affected to a significant extent. This delicate balance takes account of scientific need while protecting the rights of the donor. If I may be a little more specific, the research must be adversely affected as opposed to temporarily inconvenienced, or having extra checks caused that could be completed in a short time. The Government used such wording in the amendment to ensure that the effect would be significant and adverse.
Amendment (b) relates to the efforts that a licence holder must have made to have satisfied the HFEA that a person is not able to be contacted. The Government amendments require the licence holder to satisfy the HFEA either that the person is unable to be contacted, or, if they are dead, that consent has been obtained from a relative or close friend. This means that if a licence holder is unable to contact an individual—because the samples that they have are anonymous, or they do not have enough information to make contact—the cells may be used, subject to the other safeguards. If a researcher has reason to believe that the individual is dead—for example if their age when they made the donation and the period for which the cells have been stored indicate that the person would be aged 130, which would be unlikely—it is reasonable to take the appropriate steps. They must therefore contact a close relation or other person in accordance with the hierarchy in the Human Tissue Act and obtain their consent.
The amendment would require the researcher to know that the individual was deceased, rather than to have reason to believe it. It would not have a large impact on the provisions, but it could cause confusion. If a researcher possesses information suggesting that a person is deceased, they should take steps to obtain consent. Requiring the researcher to know that a donor is dead would not be clear because it would not be apparent what information the researcher would need to know for certain and what steps they would need to take to obtain that. We would not expect licence holders to close their mind to facts in their possession that suggested a person was dead before going to the relatives. The Government amendments require licence holders to act reasonably, which is as it should be. If the concern is about anonymous tissue that is so old that it is clear that the donor would be deceased, that is not a problem. If the cells are anonymised, they can be used without consent even if it is likely that the donor is dead.
I think that this will be quite a substantial debate. I have introduced the broad thrust of the Government amendments, so I will be happy to listen carefully, as always, to what other Members say about the matter and then respond.
The Chairman: The arcane aspects of scheduling and formally putting motions are not always understood, even by Committee members, so let me explain the process. For the moment, only Government amendment No. 65 has been moved. The rest are being debated but have not been moved. In due course, and at the appropriate time, I propose to call Government amendments up to No. 102 en bloc. If any hon. Members who have tabled amendments wish to move them—I think that that relates to amendments Nos. 32, 8 and 7, in addition to amendments (a) and (b) to Government amendment No. 102—they must indicate that they wish to do so, and I will call them at the appropriate time. I hope that that is clear.
Mark Simmonds: This is a critical debate. The Minister’s exposition clarified to a certain extent the changes proposed after a very significant debate in the other place. The Government amendments and the amendments tabled by the hon. Member for Oxford, West and Abingdon and myself demonstrate that there is unanimity across the political parties about the necessity to change the original measures dealing with the complex matters of consent and exceptions to consent.
It being twenty-five minutes past Ten o’clock, The Chairman adjourned the Committee without Question put, pursuant to the Standing Order.
Adjourned till this day at One o’clock.
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