Schedule 3
Human Fertilisation and Embryology Bill [Lords]
9:00 am

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

I beg to move amendment No. 12, in schedule 3, page 59, line 19, leave out ‘sub-paragraph 2’ and insert ‘sub-paragraphs 2 to 2(A)’.

Roger Gale (North Thanet, Conservative)

With this it will be convenient to discuss the following amendments: No. 11, in schedule 3, page 59, line 28, at end insert—

‘(2A) A consent under this Schedule by a deceased person from whom gametes have been retrieved posthumously may be deemed to have been given and not withdrawn if the consultant from whom the couple together were receiving advice or treatment confirms in writing that the deceased was, at the date of death, either receiving treatment or receiving advice in respect of a clear and settled intention to have a child with his partner.’.

No. 13, in clause 22, page 18, line 15, at end insert—

‘(3A) After subsection (4) insert—

“(4A) In default of the exercise of the Authority of its power to make a direction under this section, a judge of the High Court may give permission for gametes stored under Schedule (3)(1)(2A) of this Act to be used within the UK or exported and used outside the United Kingdom.”.’.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

The amendment was tabled by my hon. Friend the Member for Twickenham (Dr. Cable) and it is supported by my hon. Friend the Member for Southport, who gives his apologies to the Committee today that he is detained on a constituency matter. They have asked me to speak to these three amendments, which I am happy to do.

The Committee should understand—hon. Members might already be aware from press coverage—that the amendments relate to a case in the constituency of my hon. Friend the Member for Twickenham, who has taken an active interest in it. They also raise general issues, however, which is why I am happy to introduce them so that we can receive an indication of the Government’s position on these difficult but interesting matters.

This case—I am not going to dwell on it at length, because it is the law that we want to discuss today—relates to a lady, aged 42, whose husband died suddenly in June last year. He was 30 at the time, and the cause of his death was unclear, despite a post mortem. They already had one child, but there were some questions about the woman’s fertility and they wished to have a further child. They went to see a consultant obstetrician and gynaecologist to discuss whether the particular problem that she had might affect her natural conception. Unfortunately, and tragically, the husband died the week following that.

Sperm was then taken from the man posthumously and stored. The legality of that act was confirmed at the first stage, before it was carried out, by an urgent out-of-hours court hearing in the High Court by telephone conference. The Human Fertilisation and Embryology Authority was not represented, which might be relevant to what happened subsequently.

The proposal then was for the sperm to be used in treatment, either in this country or abroad. There are difficulties with the existing law, as set out by the Human Fertilisation and Embryology Act 1990, and I do not think that the problems that this woman is encountering under that Act will be made any easier under the proposals in the Bill. The Government are pretty clear that they take the issue of consent very seriously. The term used is “effective consent”, and there are certain criteria for that. I do not think that anyone could generally describe the proposals in the Bill as a watering down of what existed in 1990.

In the Diane Blood case, which is the only legal precedent for this, sperm was taken from Mr. Blood, albeit not posthumously, but while he was in a coma. I happen to think that that case raises greater issues around the removal of sperm, because there is a potential for assault in such a case, when someone is not dead. It is not possible to assault a dead body, even though there are obvious sensitivities surrounding that.

In the Diane Blood case, the sperm was taken and stored, as I understand it, without a court hearing, and then the question was whether that could be used for treatment without the effective consent. Under the 1990 Act, effective consent for the storage of sperm requires it to be in writing. Effective consent for the use of the sperm in treatment is also required in writing. It must be extant and not withdrawn prior to use. That clearly did not apply in the case of Diane Blood, although she asserted strongly that she and her late husband had had a discussion and that had said that he would have wanted her to have a child after his death. There was certainly no doubt that they wanted to have children together.

In that case, the HFEA would not allow the sperm to be used in treatment in this country and would not allow export, although I understand that it has the discretion to do so. Following a court hearing, the court directed the HFEA to reconsider its decision, taking into account European law. The HFEA, whether or not it did so, decided in the end to allow Diane Blood to export the sperm to a European country—I believe that it was Belgium—although I understand that that was because it had run out of money to fight the case and had been given a steer from the Government, whether appropriately or inappropriately, not to pursue the matter much further.

Obviously, everyone recognises the immense campaigning effort that Diane Blood went through to get to where she was then and, indeed, where she is now: she has children and has helped to effect a change in the law to allow posthumous fathers to be listed on birth certificates when the consent is effective. I remember discussing—I think that it was in this very room—the need for effective consent, so I find myself in the curious position of speaking to this amendment when previously in Committee I felt very strongly that there must be effective consent for posthumous paternity.

Let us deal with the legalities. The Minister is probably aware of this, but for the benefit of the Committee, let me point out that the storage and use of sperm in the UK is governed by the 1990 Act. It is an offence to store or use gametes for treatment except in pursuance of a licence, as we know. Every licence granted under the Act must have as a condition that the provisions of schedule 3 to the Act are complied with, and that requires effective consent. Unless a person has given effective consent, their gametes must not be used in the provision of treatment services to another; used to bring about the creation or subsequent implantation of an embryo; or kept in storage. Effective consent means that it must be in writing, that it must not be withdrawn, and that it must specify what is to happen if the donor dies or loses capacity. As I understand it, the Bill provides for similar provisions, but also for the effective consent to be in writing and signed by the donor.

The HFEA can give a direction authorising the licence holder to arrange for the transfer of gametes overseas under section 24(4) of the 1990 Act. It can also modify the applicability of the requirements of sections 12 to 14 of the Act in respect of that direction.

In the case in the constituency of my hon. Friend the Member for Twickenham, there was no effective consent but leaving aside the question of whether the court was right to allow the sperm to be taken and stored for the time being, we must ask whether the HFEA could use its discretion. The authority is currently unwilling to use its discretion, and setting out Parliament’s intention in this respect might be useful.

There are clearly strong personal factors in this case. There is no doubt, as testified by the consultant, that the couple were seeking to have a child. That is why amendment No. 11 states:

“A consent under this Schedule by a deceased person from whom gametes have been retrieved posthumously may be deemed to have been given and not withdrawn if the consultant from whom the couple together were receiving advice or treatment confirms in writing that the deceased was, at the date of death, either receiving treatment or receiving advice in respect of a clear and settled intention to have a child with his partner.”

There is no doubt that that would apply in this case.

If the Minister was willing to consider the amendment, that would help the lady, as long as she can continue to store the sperm. Otherwise, the further provision that my hon. Friend the Member for Twickenham has proposed would enable a court to intervene to give a second view—I guess that that is the best way of putting it. The question is how rigidly we would like the law to specify that effective consent must be written and thus given in advance, or whether the circumstances in a case could give rise to a reasonable belief—recognised by the law, or a discretionary power—to give flexibility so that a woman widowed in such circumstances would be permitted,  even if they could not use the sperm here, to export the sperm and use it in another country. I think that the question for the Government is whether they will provide a discretionary arrangement in such cases, or look to consider wording similar to that in amendment No. 11, which would enable there to be some testimony as to the intentions and wishes, and thus essentially the consent, of the father.

Clearly there is a problem about whether a person’s intention to have a child with someone when they were alive can be reasonably extended to including the intention for their partner to raise a child on their own in that person’s absence, due to their death. It is very hard to speculate about that. Some people would argue—and I can see the strength of this case—that it is best to err on the side of having the child because there is clearly a committed parent there. I am on record as arguing that children can be brought up very effectively by solo parents, whether widows or single women intending to have a child through in vitro fertilisation. I think that the argument and vote on that matter were won very clearly on the Floor of the House.

I find it quite strange that some newspapers that campaign actively against the removal of the duty on the clinic to consider the need for a father also campaigned actively for the creation of fatherless families in the case of Diane Blood. My position is consistent, assuming the issue of consent can be dealt with. I hope that the Minister will understand that I have not gone into the details of the case as there might well be further hearings. We are discussing legislation, and I wanted to put this as generally as possible while describing the example.

I know that the Minister has seen a letter and briefing that my hon. Friend the Member for Twickenham wrote to the Secretary of State because she replied on 13 March 2008. I will leave her to state the comments that she made in that letter, rather than pre-empting her. I hope that the Minister will understand the point of this proposal and look kindly upon it.

Mark Simmonds (Shadow Minister, Health; Boston and Skegness, Conservative)

I will just make a couple of points about these intriguing amendments to which the hon. Gentleman has spoken. He is absolutely right, and I feel very strongly that there must be effective consent, certainly in writing, for posthumous paternity. It would be very dangerous if we did not stick whenever possible with consent as the cornerstone for the legislation while, at the same time, being extremely sympathetic to individual cases such as that highlighted by the hon. Gentleman. We would be led into the difficult area of property rights and ownership of gametes, of which there is a significant amount of case law in the United States and Australia, but very minimal case law here in the UK.

Will the Minister clarify two issues? First, how quickly do the gametes deteriorate after death—how quickly would they have to be removed? Obviously, it would be very stressful and difficult for the wife or partner of the deceased individual to have to make a rapid decision, as I suspect that it would have to be.

Secondly, is there any difference between the consent for the removal of gametes posthumously and the consent for the removal of organs posthumously, or do the same criteria and consent have to apply?

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I am grateful to the hon. Member for Oxford, West and Abingdon for speaking to the amendments so clearly. I absolutely understand his views on this, which are on record. However, the amendments raise a series of important points, and as we start this debate around consent, they go to absolutely the key points.

The key principle of the Human Fertilisation and Embryology Act 1990 was that gametes, including gametes used to create an embryo, should be stored or used only in accordance with the wishes of the man or woman who provided them. To remove any question of doubt concerning those wishes, the Act requires that consent to storage and use of the gametes and embryos must be given in writing. That is what the hon. Member for Oxford, West and Abingdon referred to in terms of “effective consent”, and that requirement is brought forward in schedule 3 to the Bill.

The hon. Member for Boston and Skegness touched lightly on United States case law. The principle of control by consent, rather than ownership, was taken from the recommendations of the Warnock committee, and I believe that that remains valid today. That is why we have continued with it.

Amendment No. 12 would allow consent to be given for posthumous storage and use by a man’s surviving wife or partner, if a clinician who was giving the couple treatment or advice on infertility at the time of the man’s death testified to the couple’s wish to have a child together. With the greatest respect, it cannot be automatically assumed that the deceased would have been willing for his gametes to be recovered, stored and then used by his partner after his death. That raises quite different issues, and is a very different situation from a couple seeking advice and treatment to have a child together in the expectation that they would raise that child together.

My difficulty is that, even if it were known that the deceased would have had concerns about the use of his sperm to conceive a child after his death, the amendment would render those concerns valueless. In such incredibly difficult circumstances, that cannot be allowed. The right to decide whether to pass on one’s biological heritage is a fundamental and it should not be taken away or superseded by the wishes of another person, even those of a surviving partner. The Government are firmly of the view that, in this context, the protection of an individual’s autonomy cannot be allowed to lapse, except in the very specific and narrowly defined circumstances set out in schedule 3.

I recognise, as I am sure every member of the Committee and of the House would, that becoming a parent is the most rewarding and probably the most overwhelming thing we can ever do. It is not difficult to understand how the loss of the chance to have a family that has been planned together can intensify the pain and grief felt at the sudden death of a loving partner. But it is surely right that if a child is conceived after the death of one of their parents, using that parent’s gametes, there must be no doubt whatever that it was the wish of the deceased that the child should be born. The decision to rest on written consent then becomes crucial.

Robert Key (Salisbury, Conservative)

Perhaps the Minister might mention what consideration will be given to the child who is born in these circumstances, because she has not done so. I feel very strongly—on religious, moral and ethical grounds—that the child’s interests should come first in any consideration of these matters. It is one thing to satisfy someone who has suffered the tragic loss of her partner, but we simply should not ignore the fact that a child will be brought into the world who will never have a father.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

The hon. Gentleman makes an important point about how we, as individuals, view that. Although we all recognise that this is about the quality of parenting and how the parent relates to the children, such decisions will raise issues for the parent, and I am sure that those concerned will have thought carefully about that.

I have some sympathy with the hon. Gentleman’s point, but we are looking at whether there is a legal right and what consent means in this difficult area, where there is doubt because written consent has not been provided. I entirely understand the complexities of the debate about explaining the issues involved to a child and the issues that that raises about the child’s right to know. Inevitably, such things would need to be addressed, and I acknowledge that. I was not moving on to make that point, because I was concentrating specifically—particularly given that there is a live legal case—on what the requirements in the Act are, and why they are phrased and presented in the way that they are.

Amendment No. 11 is intended to allow a court to make a decision on the use of gametes when the HFEA has decided to defer a decision. As the hon. Member for Oxford, West and Abingdon said, the amendment relates only to gametes that fall within the circumstances that he outlined—that is, those that have had consent deemed for storage and use after death.

The HFEA has an obligation to consider any licensing issues put before it, including whether the use of gametes is lawful and whether export abroad would be permissible. The HFEA defers making such decisions only where there is a need for more information. In the case of the constituent of the hon. Member for Twickenham, to which the hon. Member for Oxford, West and Abingdon referred, the outcome is still the subject of ongoing legal action. It is not reasonable to expect the court to make a decision if all the facts pertinent to the case are not known. I will not refer specifically to that ongoing case, but export is a consideration.

The Government are satisfied—I think we all would be—that the HFEA remains the appropriate authority to decide on the use of gametes and embryos for treatment purposes. As we debate the schedule further, we will probe the issue further, looking specifically at what consent means and at the strict circumstances regarding whether there should be any exceptions.

The hon. Member for Boston and Skegness asked me two questions.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

The Minister may not be able to answer this question immediately and I do not think that she was about to cover the issue, but before she moves on,  does she agree that the HFEA, in such circumstances, has the ability and discretion to authorise the export of gametes?

Following amendments made by the Human Fertilisation and Embryology (Deceased Fathers) Act 2003, which was known as Tony Clarke’s Bill, a man

“may be registered as the father of the child resulting from assisted conception treatment undertaken after the man’s death. However...the man must have consented in writing to the use of his sperm after his death and to being treated as the father of any resulting child.”

Does that imply that Parliament contemplated the fact that there may be circumstances, even after the passage of that Bill, which amended the Act, in which sperm from a donor might be used after his death without written consent, but not necessarily qualifying for registration as the father?

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

The hon. Gentleman takes me into a difficult area, because that question is being considered in a case. He asks the direct question whether the HFEA has the power to license export. The simple answer is yes, but we need to see the outcome of the court action before we can be clear with regard to further points. At the moment, the legislation is clear that consent is written consent, as it would have to be in the case to which he referred.

The hon. Member for Boston and Skegness asked two questions. First, how quickly would the gametes need to be removed? I am told that it is normally within hours of death, up to a maximum of six hours. Secondly, what is the difference between the law governing gametes and the law governing organs? I am not qualified in the law, so if he will forgive me I would rather not go into the vagaries of the matter, but gametes, including their posthumous removal, are governed by common law. The use of gametes to create an embryo is tightly regulated by the 1990 Act, which requires effective consent, so there are two different steps to govern the process. The removal of organs after death is governed by the Human Tissue Act 2004.

In practice, the Human Tissue Act and common law requirements are likely to be similar. Ultimately, it would be for the courts to decide to regulate the removal of gametes and to determine its lawfulness. Removal is under common law; use is set down in the 1990 Act. I hope that that is clear. For people, like me, who are not legally qualified, and even for some who are, the common law raises lots of complex issues.

I hope that I have explained to the hon. Member for Oxford, West and Abingdon why the Government continue to resist the proposals in the amendments. Having put our view on record, and bearing in mind the outstanding legal case, I hope that he and his colleague, the hon. Member for Twickenham, are satisfied that the Committee has discussed the matter properly and that he will not press the amendment to a Division.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

I am grateful to hon. Members for their contributions to the debate, but especially to the Minister for her considered response. There are difficulties when one is seeking to legislate and there is a live case, and I understand that the question of export may come back to court in the near future. However, she has confirmed what I think is indeed beyond doubt—under the Act  and the Bill, the HFEA has the discretion to license exports, even if it is not possible to use sperm in this country because the effective consent requirements have not been met. We must await the outcome of the court case.

The hon. Member for Boston and Skegness asked an interesting question: he wants to know whether there is a difference between taking organs posthumously and the posthumous taking of gametes. Of course, there is. The taking of organs is covered by the Human Tissue Act. Organs can be taken under that Act, but clearly not with the same degree of effective consent that applies in this case. The Human Tissue Act is about the necessary processes and consents, but it certainly does not impose the same degree of consent that is required here, because gametes are special. We are talking about creating new life, and whatever the range of opinion is on the matter there is no disputing the fact that gametes should be treated differently from organs. The consent requirements must therefore be greater.

To respond to the point made by the hon. Member for Salisbury, I have never disagreed with him on any matter in the Bill—except this one. I therefore speak with due caution. I do not think it right to argue that there are welfare considerations for the child. Even if this was allowed, a child would be born who otherwise would not be born, and it would be a wanted child—a child that was loved.

There is no evidence that children do not grow up well adjusted and happy when brought up in the home by a widow or widower. That is despite the drawbacks and disadvantages of losing a parent. Research in this area has tried to track such families, and that has been shown to be the case. I know that the hon. Gentleman takes a different view—he put it well on the Floor of the House. However, the prospect of bringing a child into the world that never had a living father is not a fair consideration in the absence of evidence of harm to the child—real evidence of significant harm—in such circumstances. None the less, I understand the sincerity of his views and the clarity with which he brought them to the fore.

We have probably gone as far as we can with the amendments, and I am grateful to the Minister for expressing her views. My hon. Friend the Member for Twickenham, who has worked as tenaciously in this case, as he always does, will be satisfied that we have discussed the matter. He will obviously be disappointed that the Minister does not look favourably on the amendments, but I understand her position. I am sure that we all hope, at least on the personal matter, that the consideration of the case by the court or by the HFEA produces an outcome that brings satisfaction to the lady concerned.

I beg to ask leave to withdraw the amendment.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I beg to move amendment No. 64, in schedule 3, page 59, line 22, leave out from ‘disability’ to ‘and’ in line 27 and insert

‘(a “person unable to sign”), and any notice under paragraph 4 by a person unable to sign varying or withdrawing a consent under this Schedule, is to be taken to comply with the  requirement of sub-paragraph (1) as to signature if it is signed at the direction of the person unable to sign, in the presence of the person unable to sign’.

Roger Gale (North Thanet, Conservative)

With this it will be convenient to discuss Government amendments Nos. 72 to 1 and 83 to 98.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I shall be brief. The amendments are technical and are the result of further scrutiny of the Bill. Amendment No. 64 replaces the phrase “the incapacitated person” with the phrase “person unable to sign” to distinguish those who are incapacitated due to illness, injury or physical disability from those who lack the capacity to consent, which is relevant in the context of later amendments to the schedule.

In the other place, a query was raised about the phrase “child donor” in proposed new paragraph 9 of schedule 3 to the 1990 Act if it refers to a child patient. To prevent confusion, minor technical amendments have been made.

Tom Clarke (Coatbridge, Chryston and Bellshill, Labour)

I understand what the Minister says about taking on board discussions in another place. We have moved on from using the words “child donor” to using “C”. However, that appears elsewhere in the Bill, and I wonder whether it might create further loopholes. Has the Minister considered using other words—for example, “child patient”—rather than simply adhering to “C”?

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I am grateful for my right hon. Friend’s intervention. On his first point, I do not think that there will be any confusion in substituting the letter “C” to replace the words “child donor”. We are clearly talking in the context of a child. Similarly, I do not see that there is inconsistency in replacing the word “patient” with the letter “P”. As we have discussed, in the exceptions in schedule 3, it is important to have consistency. After the discussions and queries that arose in another place, I was advised that those changes give greater clarity than the current wording and raise no further difficulties in interpretation.

Mark Simmonds (Shadow Minister, Health; Boston and Skegness, Conservative)

The Minister has partially answered my point. I understand that the amendments are about clarity and consistency. In the original Bill, in some cases the child donor is referred to as “C” and in others as the “child donor”. The amendment provides consistency throughout the Bill and I have no problem with it.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I am grateful to the hon. Gentleman for his intervention. Clearly, in areas as complex as this and the 1990 Act, it is important to have consistency and clarity throughout the legislation. I assure my right hon. Friend the Member for Coatbridge, Chryston and Bellshill that the measure delivers that clarity and consistency and therefore prevents any further misunderstanding or difficulty in interpreting the legislation.

Mark Simmonds (Shadow Minister, Health; Boston and Skegness, Conservative)

I beg to move amendment No. 27, in schedule 3, page 59, line 35, after ‘storage’, insert ‘, embryo testing’.

Roger Gale (North Thanet, Conservative)

With this it will be convenient to discuss amendment No. 29, in schedule 3, page 60, line 36,after ‘storage’, insert ‘, embryo testing’.

Mark Simmonds (Shadow Minister, Health; Boston and Skegness, Conservative)

Under the 1990 Act, consent must, quite correctly, specify the purposes for which any gametes or embryos are used. The Bill enhances that provision so that in addition to being able to consent to the use of embryos for treatment or research, a person may also specify that an embryo can be used in the training of embryologists. Again, that is quite correct and I welcome it. It is right that those undergoing treatment are able to choose what, if anything, extra embryos are used for. Some people who donate embryos may prefer them to be used for the treatment of other infertile couples, while others may not like the prospect of their embryos being used by other people and would prefer them to be used for research or training.

Training is essential and vital, and these challenging procedures must be completed accurately. Without scientists who are well trained in research and IVF techniques, success rates for IVF will inevitably be lower and research could become less fruitful.

The amendment would put embryo testing, which is not in the Bill, on the list of embryological techniques. It would be helpful if the Minister clarified why embryo testing is omitted, although other categories are included. This is particularly important in pre-implementation genetic diagnosis, or PGD, which is set to increase as more illnesses and diseases are found to have a gene marker. Skills and experiences of embryo testing will become even more important. The amendment would put that in the Bill, so that that people who may choose to use their extra embryos and give consent would understand the full range of techniques covered by the phrase “embryological techniques”. Amendment No. 29 is a consequential amendment.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

I am pleased to speak to the amendment, because it relates to a provision that was not originally included, but which I and many other people had felt for a long time should have been. The history is that there was always a feeling that there was an omission in the original legislation, because it did not provide for consent to the use of embryos for training purposes.

It was always difficult for clinics to know how new people could learn embryological techniques, because although training is an integral part of what any scientific laboratory or clinic does, it cannot always be said to be a necessary part of treatment or an integral or necessary part of research. There was always a fudge, and clinics and laboratories were always concerned that they might be found to be acting outside the law, and that it would be difficult to find enough people trained in difficult techniques.

My noble Friend Baroness Tonge proposed a form of words like that which has now been adopted, but unfortunately a peer, or peers, intervened to assert that it was not necessary, and some momentum developed around that idea. The Minister, whom I thought was about to accept the amendment in principle, said that she would reflect on it. However, everything was put right on Report and the Government returned with the provision that is now paragraph 4(2) of schedule 3.

Is the hon. Member for Boston and Skegness making the case that some people who give consent for embryos to be used might agree specifically to their use in training people for general IVF work, but not for PGD, because of the sensitivities about that? I think he is making that case, and arguing that therefore the consent needs to specify it. I would be interested to hear whether the Minister thinks that it is a matter for primary legislation, because merely separating out embryo testing in paragraph 4(2) does not provide that the consent form will be that detailed.

The key question, regardless of the fate of the amendment, is what the detail of the consent forms will be, and whether the Government intend to tell the HFEA that its code of practice must make it clear that consent forms must in turn make it clear, in terms, that PGD requires specific consent.

I do not see a problem with that, because I recognise that there may be those who have concerns about training people to do something that they think is unethical on personal grounds, even though they accept the destruction of embryos. That would not be a problem, because I think that the consent form is already relatively detailed. I would be grateful if the Minister confirmed that the issue may well be dealt with just in terms of how the consent is obtained, rather than by making detailed specifications in primary legislation, although our debate and the point that the hon. Member for Boston and Skegness is making will certainly draw the attention of the HFEA to the issue.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

Schedule 2 introduces the provisions that allow embryos to be used for the purposes of training persons in embryological techniques, including embryo biopsy and embryo storage. There are consequential provisions in schedule 3, relating to consent to the use of embryos for this purpose. We might, I think, come on to a discussion of that, so perhaps it is sensible to answer one of the questions that has been posed in that context.

A provision to allow training is necessary because it is appropriate for embryologists to practise certain techniques before carrying them out in treatment—for example, embryo biopsy, in which cells are removed from the embryo to be tested for genes that result in serious medical conditions. There is no specific provision to allow embryologists to train in that technique. The Bill will rectify that to allow training for embryo biopsy.

Following discussion in another place, as the hon. Member for Oxford, West and Abingdon said, the training provision was widened to include not only embryo biopsy, but techniques involved in embryo storage, such as vitrification and other embryological techniques. The Bill states that training purposes can include

“embryo biopsy, embryo storage or other embryological techniques”.

Amendments Nos. 27 and 29 would amend the consent provisions in relation to training of embryologists to list embryo testing specifically as one of the purposes for which consent can be given in relation to embryos being used in training.

The embryological technique primarily associated with embryo testing is embryo biopsy. The Bill already allows for other embryo testing techniques, including some  that are not embryo biopsy. The amendment’s only effect would be to specify other techniques associated with embryo testing in the list of purposes before the catch-all purpose of “other embryological techniques”.

As the two specific techniques listed are the only examples and there is another catch-all purpose, which will allow other embryo testing techniques, I do not feel that amendment would add anything to the provisions. Perhaps the hon. Member for Boston and Skegness can tell us exactly what is missing. The two specific techniques and the catch-all purpose cover all the techniques that he wishes to identify, so I take it that he has tabled the amendments to probe and to satisfy himself on this important issue. I therefore hope that he will not press them to a Division.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

If the hon. Member for Boston and Skegness does not mind my intervening again, I interpret the point of his amendment to be identifying whether people will have an opportunity to consent to the specific purpose of training for PGD. He may be reassured by schedule 3(2) of the 1990 Act, which says that a consent

“may specify conditions subject to which the embryo may be so used”.

That allows the HFEA, for example, to tell clinics in its guidance or code of practice that patients should be given the opportunity to specify conditions. I have not seen the consent form for that area and, as training has been specifically identified, new consent forms will have to be arranged, but the hon. Gentleman may wish to probe the Minister further on her understanding of the question.

The provision is “may” specify, not “must”, which I think is appropriate, but I urge those considering such matters to listen to the concerns raised by the hon. Gentleman, which I share. There must be the ability for consents to be specific in this area, even though only a very small proportion of people giving consent will want to volunteer a specific exclusion. However, they must have that right; it is only right and proper that they do.

I hope that those remarks are helpful to the hon. Gentleman, and that the Minister might consider coming back on the particular issue of the consent form at a later date.

Mark Simmonds (Shadow Minister, Health; Boston and Skegness, Conservative)

I thank the hon. Gentleman for his contribution on the amendments, which has been helpful and, as always, detailed.

The purpose of tabling the amendments was to raise the importance of these issues with the HFEA, particularly with regard to the point about the specificity of consent, which the hon. Gentleman re-emphasised. The Minister has, as always, been very clear, yet she seemed to be arguing on the one hand that embryo testing is a separate area, while on the other arguing that it is a subset of other areas in the Bill.

Clearly, this is a probing amendment and the importance of the issue has been put on the record by me and by the hon. Gentleman. The HFEA needs to clarify the fact that it will be possible to be specific.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I am happy to correct a point that I made early in my remarks: there are consequential provisions to schedule 3 relating to consent for the use  of embryos for this purpose. I need to expand on that: in relation to the point raised by the hon. Gentleman, it means absolutely that the person has to consent. That clearly raises issues around it being made absolutely clear and consent being given for each process. When we get on to other amendments, he will see how that is reinforced and continues to be underlined. Written consent is necessary.

Mark Simmonds (Shadow Minister, Health; Boston and Skegness, Conservative)

I understand that. The Minister’s intervention has helped to clarify the fact that the consent form can specify, in detail, subsets of consent that are not in the Bill—if I have correctly understood what she said. Someone will therefore be able to consent for their gametes or embryos to be used just for embryo testing. If that is the case, I beg to ask leave to withdraw the amendment.

Mark Simmonds (Shadow Minister, Health; Boston and Skegness, Conservative)

I beg to move amendment No. 28, in schedule 3, page 59, leave out lines 36 to 40.

This is a probing amendment. I fully support the consent that must be at the heart of the Bill, and it is right that people should know and understand what they are consenting to and the purposes for which their gametes are used. We must ensure, however, that this necessary cornerstone of the Bill is not over-bureaucratic, hindering potential research. Not only may it be difficult to keep track of what each individual has consented to, but there could be a problem if a cell line has been developed from a person’s gametes and is ready for use in clinical trials but the donor has not consented to that particular use. This could result in the work being wasted and having to be repeated.

When researchers start a project, they may specify the terms of reference to which donors consent, but, as we all know, science and research develop. Will consent have to be regained for research outside the original terms of the consent, and will researchers have to go back to the original donor for additional consent as science moves on?

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

The Bill requires consent from any person whose cells or gametes are used to create a human admixed embryo. Consent is also required for the subsequent use of any embryos created.

The amendment would remove the provision that requires the consent to be linked to a research project and that enables a person to specify conditions subject to which their embryo can be used. The purpose of that provision is to mirror the consent provisions for human embryos, which enable a donor to place limits on how any embryo created using their genetic material can be used.

The provisions also allow a person to place conditions on the consent, such as specifying that their cells may be used only for projects of a specific nature—for example, research on motor neurone disease.

Accepting the amendment would mean that each person could give only a general written consent before the cells or gametes may be used for any research project involving admixed embryos, without the individual necessarily being fully informed. I say to the hon. Member for Boston and Skegness that the intention—I  think it is his as well—is that admixed embryos should reflect the same consent provisions as for human embryos and the use of genetic material.

It is not the intention that we create a broad general consent, and it should not be possible for that to happen. We are quite clear about what we are doing. If the hon. Gentleman feels that we are being unnecessarily restrictive—we do not think that we are—I am happy to hear further points on the matter. I would certainly want to satisfy myself that there is a mirror here, and I would go away and ensure in discussions with parliamentary counsel that that is clear. We are not seeking to put different bureaucratic arrangements in place; we are seeking to ensure that the procedures are the same as for embryos. I hope that that clarifies the point for him.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

I wanted to wait until the Minister explained the point of this subsection before making a contribution. The treatment of human admixed embryos seems to be different from that of general embryos. In respect of the use of embryos generally, the illustrative text says:

“A consent... must specify one... of the following purposes—...

(c) use for the purposes of any project of research,

and may specify conditions subject to which the embryo may be so used.”

In the case of an admixed embryo, it states that the consent

“must specify use for the purposes of a project”—

not “any” project of research—and then goes on to say

“may specify conditions”.

There is a difference, and if the Minister is saying that she will look to see whether it is right that there is a reason for that, I welcome it. I am not sure that I can see that.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

Yes, that is precisely my point. We want the same as we have elsewhere. We want a person to be able to give broad consent if they choose, but if they want to specify a condition—to go back to our previous debate—that should also be open to them.

This is a question of the drafting of the Bill, rather than of the Government’s intention. In my view, the Government’s intention is to continue to hold the position as we do for embryos—that a person can give broad consent if they choose, or specify conditions if they choose. That is what this measure is supposed to provide.

I understand absolutely the point that the hon. Member for Oxford, West and Abingdon is rightly making, which is that we need to ensure that “a” project has the same meaning, so that the wording does not put in more. I have told the Committee that my officials are having discussions with parliamentary counsel to ensure that that is what the wording delivers. I assure hon. Members that that is the intention, but if for some reason the wording does not do that, we will need to come back to the Committee. However, that is the clear intention and our understanding.

Mark Simmonds (Shadow Minister, Health; Boston and Skegness, Conservative)

Again, I thank the hon. Member for Oxford, West and Abingdon for his contribution. I also thank the Minister for her response. She confirmed that the consent provisions mirrored those for human embryos and that discussions were taking place to  clarify the disparities in the Bill that have been highlighted. On that basis, I beg to ask leave to withdraw the amendment.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I beg to move amendment No. 65, in schedule 3, page 60, line 1, leave out sub-paragraph (4) and insert—

‘(4) For sub-paragraph (2) substitute—

“(2) A consent to the storage of any gametes, any embryo or any human admixed embryo must—

(a) specify the maximum period of storage (if less than the statutory storage period),

(b) except in a case falling within paragraph (c), state what is to be done with the gametes, embryo or human admixed embryo if the person who gave the consent dies or is unable, because the person lacks capacity to do so, to vary the terms of the consent or to withdraw it, and

(c) where the consent is given by virtue of paragraph 8(2ZA) or 14(2), state what is to be done with the embryo or human admixed embryo if the person to whom the consent relates dies,

and may (in any case) specify conditions subject to which the gametes, embryo or human admixed embryo may remain in storage.

(2A) A consent to the use of a person’s human cells to bring about the creation in vitro of an embryo or human admixed embryo is to be taken unless otherwise stated to include consent to the use of the cells after the person’s death.

(2B) In relation to Scotland, the reference in sub-paragraph (2)(b) to the person lacking capacity is to be read as a reference to the person—

(a) lacking capacity within the meaning of the Age of Legal Capacity (Scotland) Act 1991, or

(b) being incapable within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000.”’.

Roger Gale (North Thanet, Conservative)

With this it will be convenient to discuss the following: Government amendments Nos. 66 to 71.

Amendment No. 32, in schedule 3, page 63, line 25, leave out ‘18’ and insert ‘16’.

Government amendments Nos. 82 and 99.

Amendment No. 9, in schedule 3, page 65, line 7, at end insert—

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

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. Harrisrose—

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I have not actually said very much yet, but I will give way to the hon. Gentleman.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

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 (Minister of State (Public Health), Department of Health; Bristol South, Labour)

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.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

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”.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I am sorry. I misunderstood the hon. Gentleman; I thought that he was satisfied on all his amendments. Amendment No. 8 would extend provision to allow the use of gametes from children for research  into the preservation of their fertility without their consent. In some cases, that would be tissue from the testes or ovary that could be matured into gametes in vitro but, in the case of some boys who had reached puberty but were not competent to consent, the measure would facilitate storage of a sperm sample.

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.

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.

Roger Gale (North Thanet, Conservative)

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 (Shadow Minister, Health; Boston and Skegness, Conservative)

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.

I thank the Minister for her clarification of my amendment No. 32, which has put my mind at rest. I shall address my initial remarks to amendment No. 7. I confirm that amendment No. 102 supersedes amendment  No. 7. I think that we all accept that the valuable work on pre-existing cell lines would have been lost if the amendments had not been tabled. I accept the potential for increased costs, in both money and time, of replacing the valuable cell lines in place at the moment. I support Government amendment No. 102, but I have some specific questions for the Minister to address in her response.