Human Fertilisation and Embryology Bill [Lords]

Public Bill Committee, 5 June 2008.

(Except clauses 4, 11, 14 and 23, Schedule 2, and any new Clauses or new Schedules relating to the termination of pregnancy by registered medical practitioners)

Schedule 3

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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 (Conservative, North Thanet)

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by a deceased person from whom gametes have been retrieved posthumously may be deemed to have been given and not withdrawn if the consultant from whom the couple together were receiving advice or treatment confirms in writing that the deceased was, at the date of death, either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 (Liberal Democrat, Oxford West and Abingdon)

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 (Conservative, Boston and Skegness)

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 (Labour, Bristol South)

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 (Conservative, Salisbury)

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 (Labour, Bristol South)

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 (Liberal Democrat, Oxford West and Abingdon)

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 (Labour, Bristol South)

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 (Liberal Democrat, Oxford West and Abingdon)

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 (Labour, Bristol South)

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 (Conservative, North Thanet)

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

Dawn Primarolo (Labour, Bristol South)

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 (Labour, Coatbridge, Chryston and Bellshill)

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 (Labour, Bristol South)

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 (Conservative, Boston and Skegness)

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 (Labour, Bristol South)

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 (Conservative, Boston and Skegness)

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

Roger Gale (Conservative, North Thanet)

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 (Conservative, Boston and Skegness)

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 (Liberal Democrat, Oxford West and Abingdon)

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 (Labour, Bristol South)

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 (Liberal Democrat, Oxford West and Abingdon)

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 (Conservative, Boston and Skegness)

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 (Labour, Bristol South)

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 (Conservative, Boston and Skegness)

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 (Conservative, Boston and Skegness)

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 (Labour, Bristol South)

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 (Liberal Democrat, Oxford West and Abingdon)

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 (Labour, Bristol South)

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 (Conservative, Boston and Skegness)

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 (Labour, Bristol South)

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 (Conservative, North Thanet)

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 (Labour, Bristol South)

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 (Labour, Bristol South)

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

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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 (Labour, Bristol South)

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 (Liberal Democrat, Oxford West and Abingdon)

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 (Labour, Bristol South)

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 (Conservative, North Thanet)

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 (Conservative, Boston and Skegness)

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.

(Except clauses 4, 11, 14 and 23, Schedule 2, and any new Clauses or new Schedules relating to the termination of pregnancy by registered medical practitioners) - Schedule 3

Roger Gale (Conservative, North Thanet)

I remind the Committee that with this we are discussing 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—

Mark Simmonds (Conservative, Boston and Skegness)

I do not want to rehearse points that the Minister raised this morning and go over old ground, but I have a couple of questions on the Government amendments. The first relates to Government amendment No. 65. Will she clarify whether the expectation under proposed new sub-paragraph (2)(b) of paragraph 2 of schedule 3 to the Human Fertilisation and Embryology Act 1990 is that the gametes, embryos and human admixed embryos will be retained unless consent is withdrawn? Is it a presumption of consent or a presumption of withdrawal?

My second question relates to Government amendment No. 67. Of course, I welcome parents being able to consent on behalf of their children, as we discussed earlier; otherwise, there would be a class of illnesses that was never researched in this way, as, due to the illness, adulthood would not be reached and thus consent would not be obtained. It is absolutely right that these provisions are inserted in the Bill, but what will happen if one parent consents and the other does not? What will happen if one parent disagrees strongly with the consent? Can parents or a parent ultimately withdraw consent after it has been given?

On Government amendment No. 82, I have a simple question. Under the law in Scotland, a child is considered to be under 16, whereas in England it is under the age of 18. What is the reason for that difference?

The issue to which Government amendment No. 102 relates was debated at length in the other place. I thank the Minister for tabling this very long amendment, which I understand supersedes and overrides amendment No. 7, which stands in my name. I am delighted that the Government have taken on board some of the concerns that were expressed by me and by others, but I would like to raise a couple of specific points. One is the interrelationship between proposed new paragraphs 15C(2) and 15C(6)(a), which limits research on the original debilitating disease. What will happen if the individual has another disease that is proven to be scientifically linked to the original disease? That may come about as a result of scientific advances. Will we have to return and alter primary legislation or can the change be made in regulations? Is there a need to alter the Bill?

The other provision in the Government amendment that I am very concerned about is proposed new paragraph 15D(3), whereby if a researcher cannot find a carer who is willing to be consulted on the use of an adult who is unable to give consent in respect of cells, the researcher can nominate someone to act on their behalf, who may not know the adult lacking the ability to consent and may not have that adult’s interests at heart. I am not sure that there are enough safeguards to ensure that such people, who will not necessarily be related to the person who cannot give consent, have the necessary ability and have in mind the interests of the potential patient and person who cannot grant consent. It is very important that sufficient safeguards are in place to ensure that that is the case.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

As we have heard, this is an extensive group of amendments, and I have a number of questions in addition to those that have been asked. I shall try to go through them in the order of the amendments, but I hope that you, Mr. Gale, the Minister and the rest of the Committee will bear with me if my comments end up jumping about.

First, on Government amendment No. 65, I do not necessarily follow how proposed new sub-paragraph (2A) links to proposed new sub-paragraph (2)(c). Proposed new sub-paragraph (2A) states:

“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.”

That seems fair enough, but proposed new sub-paragraph (2)(c) states that

“where the consent is given by virtue of paragraph 8(2ZA) or 14(2)”

it must

“state what is to be done with the embryo or human admixed embryo if the person to whom the consent relates dies”.

Proposed new sub-paragraph (2)(c) adds that the consent

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

The position on proposed new sub-paragraph (2)(b) is straightforward because the person who gives consent and who then dies is the person from whom the embryos are taken, but the question is how the provisions relate to the death of the person who gives consent for that person. My hon. Friend the Member for Southport raised that question independently in a message to me, and I hope that I have done his question justice while raising my own. I hope, too, that the Minister will forgive me if she feels that she has already clarified how the provisions will work, but I did not spot her explanation, so it would be helpful if she clarified the point.

Amendment No. 67 is quite complex. Again, I would be grateful if the Minister clarified what effect the insertion of proposed new sub-paragraphs (3ZA), (3ZB) and (3ZC) will have. Those provisions are mirrored in other amendments, but it is not entirely clear—even reading the amendment in the context of the Bill and the Act as amended—exactly what their effect will be.

My next question relates to some of the Minister’s other amendments. The schedule raises another issue, but it is a matter for the schedule stand part debate, so it will be easier if I return to it then.

I turn now to the substantive Government amendments. It is appropriate at this point to speak to amendments (a) and (b)—

Roger Gale (Conservative, North Thanet)

Order. The hon. Gentleman assumes that there will be a schedule stand part debate. I have yet to decide that, but the way things are going, the debate is becoming very comprehensive indeed.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The case that I want to put in that respect is that there are extensive matters in schedule 3, which is lengthy, that are not subject to the amendments. I can try to bring those matters into my remarks, but—

Roger Gale (Conservative, North Thanet)

Order. The hon. Gentleman is right that there are matters in the schedule that are not covered by the amendments, but it is wrong to assume at this stage that there will necessarily be a stand part debate.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I want to express not an assumption, but a hope. Otherwise, it will be difficult for me to put my points on this extensive schedule because they are totally unrelated to the amendments. I will bow to your discretion at the appropriate time, Mr. Gale.

I am very grateful to the Government for tabling amendment No. 102 and other related amendments. As the Minister will know, several scientific organisations expressed concern when it appeared that the Bill would not permit the use of existing cells. She will be aware of the letter to The Times that was signed by a number of Nobel laureates, headed by Sir Martin Evans, Sir Paul Nurse and Sir John Sulston. It was supported by Sir Ian Wilmut, director of the Medical Research Council centre for regenerative medicine; Sir Richard Sykes, a trustee of the UK Stem Cell Foundation; Lord May of Oxford, a former chief scientific adviser to the Government; Professor Bobrow; Dr. Robin Lovell-Badge; and a number of other leading researchers, all of whom expressed concern.

The current situation is a tribute to the Government’s general handling of the issue since consultation began several years ago. We are now in a position to welcome the fact that they looked into the issue that was raised, consulted the scientific community and came up with an amendment that seems to answer almost all its concerns. I recognise what a job of drafting that was, given the length of the amendments. I know that the Government’s default position might not be to spend a huge amount of time on drafting, so that shows that they recognised that the issue is important.

The same applies to the provision on children. It was not clear that it would be permitted, and the Government expressed the importance of obtaining explicit and specific consent when embryos were created, because of concerns about people’s autonomy. I understand that, as do the members of the research community whom I have spoken to—if I may speak for them—and patients groups. It is particularly pleasing for the Genetic Interest Group, which worked extremely hard on the issue and wrote a letter to Professor Lord Darzi on 25 January, expressing support for the amendment tabled in the other place and standing in the name of Lord Patel.

It is welcome that the Government have not only addressed that issue, but taken the time and made the effort to ensure that the same issues should apply in questions of adults without capacity.

I have tabled two small probing amendments to Government amendment No. 102. Amendment (a) questions the threshold for research to be permitted, which is set out in proposed new paragraph 15G in amendment No. 102. Paragraph 15G(1) states:

“A licence may not authorise the application of paragraph 15F”—

which is to allow the use of existing cell lines—

“unless the Authority is satisfied—

(a) that there are reasonable grounds for believing that scientific research will be adversely affected to a significant extent if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project of research are”

those in respect of which there is an effective consent.

My concern is with the phrase “to a significant extent”, for two reasons. First, that is a different measure from the one used in relation to consent for the use of children’s cells, earlier in the amendment. For example, condition D in proposed new paragraph 15A(5) is expressed in terms of

“reasonable grounds for believing that research of comparable effectiveness cannot be carried out”.

That seems to me to be a very appropriate test. There is a reasonableness test, which is important and which guides the licensing committee or the HFEA in deciding whether they are prepared to license the use of the cells. Also, its reference to comparable effectiveness focuses the question on the outcome of the research, not the convenience of researchers.

I totally accept the Minister’s statement that she would not want a test that merely enabled existing cell lines to be used simply for convenience and because the scientific research might be thought to be “adversely affected”. I understand her concern about leaving it at that; it would clearly adversely affect researchers to have to get consent when they could simply buy in cell lines.

I hope that the Minister accepts that I accept that my amendment on its own is not adequate, but I urge her to consider whether she might use wording such as “comparable effectiveness”, which focuses on outcomes. If that is not done, it will be hard for the HFEA to interpret “significant extent”, whereas

“reasonable grounds for believing that research of comparable effectiveness cannot be carried out”

is much clearer. It will be hard for scientists to know what the HFEA will decide counts as “significant extent”.

I hope that the Minister recognises that there are two ways of doing this and that there may be a slightly better way than the one she has proposed.

Amendment (b) would amend condition B in proposed new paragraph 15G(3). There is a problem, in that conditions B and C might not capture a frequent occurrence. A researcher might have reason to believe that P has died because the cell lines were taken 10 years ago from someone with cancer, but might not know that P had died, in which case condition C would not apply.

There are three possible situations. The first is that the patient has died, in which case condition C would apply, so that is straightforward. Another is that the researcher has no decent reason to believe that the person has died, such as when the cell lines are taken from the biopsy of a healthy person, an umbilical cord or whatever. A third scenario is that the researcher has reason to believe that the person is dead, but does not know. I understand fully the Minister’s point that researchers must take reasonable steps to ensure that they can identify a relative if the person has died. It would not be good enough for the researcher to take the view, “I don’t know if the person’s died, so I’m going to treat them as simply uncontactable, not worry about contacting a relative and press on.” I accept that she made a valid point.

The first aspect of condition B specifies that the researcher must have

“taken all reasonable steps to contact the person”.

It could be possible to resolve the problem that I have identified by adding a further provision that the researcher must also have taken reasonable steps to establish whether the person has died. If they had done both those things, it would be reasonable for the researcher, even if they had a reason to believe that the person may have died, to treat the person as uncontactable, not necessarily dead. I hope that the Minister will accept that that is a concern in the research community, and I hope that she will deal with it in her response, if not now.

I want to draw the Committee’s attention to a couple of other aspects of the amendments. One of them specifies the condition that the person must be likely to regain capacity, but I want to probe whether that is the appropriate test. There may be a situation—I am talking about an adult, not a child who is likely to gain the capacity to consent at some point—in which someone has a clinical condition that makes it possible that they might regain capacity, but difficult to argue that it is likely that they will. I do not want to spend the Committee’s time identifying specific cases, but it would be useful if the Minister considered whether there would be a better test that would enable the provision not to be quite so tight.

I turn to amendment No. 8, which I tabled. Unlike amendments Nos. 9 and 10, its purpose is not dealt with by the Government amendments. Under the Bill as it stands, it will be possible to store the gametes of children who are about to undergo chemotherapy or some other medical research that threatens their future fertility. Under the quite reasonable provision in paragraph 12 of schedule 3, the tissue could be stored without the explicit specific consent of the person on the basis of that person’s best interests.

That all makes sense. The problem is, however, that for this to be effective, it is important that the storage techniques are correct. The basis of new paragraph 9 is that the gametes are lawfully taken and that their storage is in the best interests of the child. It is hard to meet that test—or certainly more difficult—if the storage procedure that is used fails to meet the requirements of that test. Let us take the example of a biopsy of testicular tissue taken from a child without the capacity to consent, such as a prepubertal boy. If that storage is not done correctly, the procedure is not going to work, even if the clear intention is to provide something that will help the child retain his fertility and thus meet the best interests of that child.

As I understand it, freezing such gonadal tissue is a tricky business. Amendment No. 8 would provide grounds whereby it would be possible—again, under the same best-interest tests—to use part of the tissue that had been taken, frozen and stored to test whether the freezing technique successfully met the purpose for which the tissue was taken: preserving fertility.

I think the Minister understood that that was the intention of the amendment. She made the very fair point that this really ought to be a last resort and that when there was a decent alternative, one would not need to do this. She said that the alternative would be to wait for the child to gain capacity, when he could consent to the use of stored gametes to test the freezing. The problem is that we might be in a position in which it would take some years for that situation to arise.

For example, if the tissue that was frozen was taken from a six-year-old boy with the hope of preserving fertility and, at the age of 14, the child acquired capacity—essentially, competence to consent to research being done, including testing, albeit only for the purpose of research, the fertilisation ability of the sperm, which would not be allowed at present—one could test whether the storage of the six-year-old’s sperm was being carried out correctly. That, however, would be some way done the line, and if it turned out that the storage was done incorrectly, nothing could be done to help either that person—whose tissue had been taken but was not going to be useful—or any other child whose gametes were stored and frozen under the same procedures in the intervening eight years.

There might be a small gap in which some provision is needed to allow this to take place. If, under Government amendment No. 102, it is legitimate, in the best interests of the child, for a child’s cells to be used to create an embryo for research into a disease from which the child and other people are suffering, is there a significant difference between that and using another cell—a gamete cell—to create an embryo by fertilisation for research under the 14-day rule, also in the best interests of that child, even though one could probably do it eventually in a number of years time when the child gained capacity? I would be grateful if the Minister would consider that question.

I have a number of other related points that are specific problems with the schedule. They are not substantial issues, but I would like to save them for a stand part debate, as I have focused all my remarks on this group of amendments. However, if it is your understanding that there will not be a stand part debate, Mr. Gale, I will try and deal with them in the next group.

Roger Gale (Conservative, North Thanet)

Let me clarify the position. If I have caused the confusion, I will resolve it. There are issues contained in schedule 3 that are not covered by amendments. If any hon. Member wishes to raise those issues, they may of course do so. What we cannot do is find ourselves in a situation in which we have thoroughly debated acres of text that we will then debate again during a stand part debate. The hon. Gentleman referred to specific amendments and said that he wanted to discuss them later. I think that that is what he said, but if I misunderstood him, I freely apologise. By the time that we get to the stand part debate, we cannot go back over ground that we have already covered. I think we all understand that.

Brian Iddon (Labour, Bolton South East)

I wish to seek a small assurance from the Minister regarding the Government amendment No. 102, which is complicated. Proposed new paragraph 15D(2) will require a researcher to

“take reasonable steps to identify a person who”

is caring for P

“otherwise than in a professional capacity or for remuneration”.

I am particularly concerned about the phrase “or for remuneration”, because a very close person could be caring for P who was receiving remuneration from a number of sources. For example, the remuneration could be compensation for an accident. I am particularly concerned about what would happen if the carer of P was receiving benefits. Would that regarded under this amendment as remuneration?

Tom Clarke (Labour, Coatbridge, Chryston and Bellshill)

I shall try, Mr. Gale—as we all will—to stick to your guidelines and be specific, but some of the points that I want to raise follow from the point made that my hon. Friend the Member for Bolton, South-East, as well as some of the points raised by the hon. Members for Boston and Skegness and for Oxford, West and Abingdon, although perhaps I will make them from a different perspective.

May I begin by posing the question that the hon. Member for Boston and Skegness asked about Scotland? I am a little confused about that one, and I cannot quite understand why, with some of the issues that we are now addressing, we start at 16 in Scotland. Perhaps the Minister will clarify that.

On Government amendment No. 65, may I concentrate for just a moment on proposed sub-paragraph (2)(a)? I am slightly puzzled by the Minister’s use of the word “storage”. It seems to me that this particular provision reaches well beyond that. It is assumed that, after we die, the cells can be used for various purposes unless we state otherwise. This seems to me to be presumed consent. For the sake of posterity and those who read Hansard closely, may I say for the record that I would not wish my cells to be used for such research after I am gone? It is wrong for all of us to assume that our constituents take the same view on the matter. I would be interested to hear, for example, how the British Medical Association has advised the Minister on this issue?

I thought that the rules on consent in the Bill—I recognise that consent is the essence of what we are discussing—were very tight and that they formed one part of the Bill that was pretty secure. However, Government amendment No. 102 seems to widen things considerably—frankly, beyond what I had anticipated. To go from the tight, robust provisions in the original Bill to around 260 lines on

“Cases where human cells etc. can be used without the consent of person providing them”

seems to me to be changing the ball game somewhat.

Again, to draw on something specific, proposed new paragraph 15D in amendment No. 102 refers to how R—the researcher—can nominate someone who only has to fill the criteria of having

“no connection with the project”.

That is a massive loophole. Conceivably, a researcher could appoint a different researcher on a different project to speak as an advocate for the person who has died. If that is not the case, I would welcome clarification from my right hon. Friend. If that is the case, we all know what the consultation will lead to.

As the Minister knows, I am committed to advocacy, as I was at the time that I was fortunate enough to steer a Bill on disabled persons through the House. Advocacy is of the utmost importance when we consider all Government Bills. However, it is essential to remember that the advocate is not speaking for himself or herself, but for the person. It is not for the advocate to express a view, which might not necessarily be that of the person, and I would like my right hon. Friend to underline that point.

Let me put a specific question in that context. Does the Minister recognise that there seems to be a clear conflict of interest in having the licence holder for the research project nominating the person under proposed new paragraph 15D(3) who is to be consulted on behalf of the person lacking capacity? There is no indication that the person to be consulted on behalf of the person lacking capacity has even to see the person lacking capacity. A lot of clarification is called for.

Before I conclude, I remind Labour Members about the letter dated 25 March that we all received from the Prime Minister. He wrote:

“we will have a free vote on the three new ethical issues on which the house has not previously taken a view”

If the Government amendments are accepted, which I anticipate will happen, we will have a new profound ethical issue to discuss. I hope that the provisions will receive close scrutiny on Report and that my right hon. Friend the Minister will agree that they, too, would thus be the subject of a free vote.

Dawn Primarolo (Labour, Bristol South)

I will try to deal with the questions asked during our debate on consent. I start by responding to the general points made by my right hon. Friend the Member for Coatbridge, Chryston and Bellshill and my hon. Friend the Member for Bolton, South-East about the appointment of a representative when a carer is not available. I remind them that the 1990 Act has requirements on effective consent and what that constitutes. Effective consent is required on the use of embryos, and the Bill seeks to put in place the same. That will cover what the embryo can be used for, the maximum periods of storage for gametes or embryos, what should be done with the embryo or gamete after death, and any other conditions that are wished to be placed on embryo use. That picks up the point that my right hon. Friend the Member for Coatbridge, Chryston and Bellshill made about consent. While there can be general consent—we can agree to the use of our embryos or gametes for all research—we can also specify, if we choose.

To take my right hon. Friend’s example, he might agree to research on particular areas that might be connected with a condition he does not have, but go on to say that he wishes to withhold consent for other areas of research. That can be done, and it is done under the aegis of effective consent in the 1990 Act. With regard to the operation of that consent, the Bill seeks to make sure that for human gametes used to create a human admixed embryo, the use of the embryo and its storage are brought into the same regulations and given the same protection.

The Government amendments deal with the exceptions we are discussing with regard to how consent works and being able to specify the consent, which has to be given. That includes, for instance, counselling and discussions. In this hierarchy, in the particular circumstances mentioned by my right hon. Friend the Member for Coatbridge, Chryston and Bellshill and my hon. Friend the Member for Bolton, South-East—in circumstances in which an individual is incapable of giving consent—the carer is the correct person to go to. The question is if there is not a carer, what happens?

The process in that case follows the provisions of the Mental Capacity Act 2005. This picks up the point made by my right hon. Friend the Member for Coatbridge, Chryston and Bellshill about what he described as an advocate, which may be somebody who is charged with a responsibility under that Act. He also made the specific point that the views expressed have to be those of the individual who they are representing. Clearly, those provisions need to be spelled out in discussion about the safeguards and how they operate between the relevant authorities—in this case the Ministry of Justice and the HFEA—to make sure that is absolutely the case. There is an absolute protection there.

That also covers the point that my hon. Friend the Member for Bolton, South-East made with regard to remunerations. A carer could be in receipt of a payment such as independent living allowance, but that must not interfere with the rights and protections clearly conveyed in the 2005 Act. That is where we are locating ourselves to ensure that we follow through with the same rights that the House has already identified as being necessary in cases where the individual does not have the capacity to provide consent. I hope that that clarifies those points.

Moving on to the points made by the hon. Member for Boston and Skegness about how Scottish law differs—which, as this is a devolved matter, it does quite a lot—I do not feel sufficiently competent to give him a specific answer. I wonder whether he will allow me to get the Scottish Law Officers to give us a proper answer as to how the laws interact, particularly, as he mentioned, around the age of 18.

Mark Simmonds (Conservative, Boston and Skegness)

Of course, I will be more than content with the Minister’s promise to get more detailed advice. However, my understanding of the Bill is that there are parts of it that cover Scotland, so the power is not devolved. It is relevant for the Committee to understand why there are differences between Scotland and England.

Dawn Primarolo (Labour, Bristol South)

I absolutely agree with the hon. Gentleman. May I refer to my experience as a Treasury Minister? The Finance Bill makes legislation for the whole UK, but, nevertheless, at times it has to interact with Scottish law as it has evolved. This is such a case. I will be happy to get that information for the hon. Gentleman so that he is satisfied that there are not any difficulties here.

The hon. Gentleman asked questions about consent, the child, and the interaction of parents. I think he is looking for where the crossover is between the parents and the child’s point of competence. The consent would endure unless it were withdrawn or varied by the parents—I shall come on to the point about what happens when both parents do not agree—or when the child became competent to consent themselves. I do not know whether the hon. Gentleman wanted to know whether it was set for all time or could not be varied, but it can be, under the restrictions that are set out by the Bill.

Parents can withdraw consent, or vary it, but that would be subject to the limits that apply to all effective consents under paragraph (4), given how far the research might have progressed. That is one of the issues, because there might have been a great deal of work and expenditure. We must not talk about destroying all that, and that is a general caveat—can one talk about a general caveat?—and, more, a general requirement within the provisions.

If there were a dispute between the parents, they might have to go to the courts to resolve the matter because that does not fall under the Bill. Parents’ responsibilities and their joint responsibilities are a difficult area, and it would be difficult to legislate on a dispute in a partnership where further use may be disputed. I am afraid that there is no other way, in such limited and regrettable circumstances, that such a matter can be resolved.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful for the clarity that the Minister is putting on this area. Does that mean that the consent of one parent is sufficient in this particular case?

Dawn Primarolo (Labour, Bristol South)

I think that the consent of one parent without the other parent dissenting would be considered to be the consent of the parents, so yes, technically, one parent could be deemed to be speaking on behalf of both. The obligation would be to ensure that the other parent would have to say to the contrary. I think that that is how the law would operate under such circumstances.

The hon. Gentleman asked about whether the provision limits research to the original debilitating disease, or whether it could be extended to linked disorders. If the research into the condition was linked to the original condition, it would be permitted. Research could be into the condition suffered or a similar one. Clearly, any provision in that area must be about either a disease or disability that the child has, or its treatment and care.

The hon. Gentleman raised the point about someone who might be unable to find a carer and what the appointment of the other person means. I have answered, clearly I hope, that that falls within the confines of the Mental Capacity Act 2005 and the guidelines there. The same answer goes to my right hon. Friend the Member for Coatbridge, Chryston and Bellshill and my hon. Friend the Member for Bolton, South-East. I have answered the Scotland point.

A point was raised about whether a researcher can nominate another researcher—my right hon. Friend the Member for Coatbridge, Chryston and Bellshill touched on that. The answer is no, as it will be governed. It will have to be an appropriate person as set out in the Mental Capacity Act, acting and speaking on behalf of the patient—the individual considered not to have capacity, as my right hon. Friend said. This is a delicate area and it is clearly dealt with in that Act.

I think that I have dealt with the issues raised by the hon. Member for Boston and Skegness, so I will attempt to answer the questions asked by the hon. Member for Oxford, West and Abingdon. If I do not deal with them all, it is because I did not necessarily understand them, so forgive me. However, I will try.

I understand the point that the hon. Gentleman again made about the issue of “significant extent”. As I said in my opening remarks, together with all the consultation and advice that we have had, the Government are trying to weigh the scientific burden of being unable to use existing cells against the rights of the person who donated those cells. I am not convinced by the hon. Gentleman’s alternative wording—he accepts the principle, but is not keen on the word “significant”. I do not think that the wording he suggests is a high enough hurdle for researchers. It is important that “significant extent” is the appropriate test to comply with and it should not be lowered. The heart of his argument seems to be that it is too high, but we have set it there because we think it should be high.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I accept what the Minister says and that simply taking out those words is not satisfactory. I suggested that she might consider using the same wording about the research not being of comparable effectiveness, which she has deemed satisfactory. I agree with her about the other provisions that relate to patients without capacity and children who do not yet have capacity, where there is a different threshold. My concern is not that “significant extent” makes the threshold too high, but rather that it is not easy to interpret. I am at one with her on where she wants to be, but I wonder whether she will consider the alternative wording.

Briefly, I received a message from the Medical Research Council and the Wellcome Trust saying that they support the thrust behind amendment (a) to Government amendment No. 102. Unfortunately, I do not have that in writing, so I accept that at the moment it is hearsay, although it might give the Minister pause to consider the matter, or at least to agree to think about it a little more.

Dawn Primarolo (Labour, Bristol South)

I am absolutely prepared to accept the hon. Gentleman’s word about who supports the amendment and, of course, I always take note of those illustrious bodies. However, here the difference is clear as to why we are not using exactly the same wording. The wording that is used elsewhere refers to cases that involve consent from others. We want to connect that with cases with no consent and have included a worthy higher test for that reason.

I accept the hon. Gentleman’s argument, and I am always happy to reflect on any view held by members of the Committee, but this is an important principle and I am not convinced that other words could be used or that we should lower the test.

The hon. Gentleman asked questions to clarify the effect of interactions between sub-paragraphs (3ZA), (3ZB) and (3ZC). Sub-paragraphs (3ZA) and (3ZB) clarify the fact that, in the limited circumstances referred to later in the schedule, the consent of a parent will be treated as effective consent of the child. That means that all the provisions of schedule 3 that are attached to effective consent apply to the parent. For example, the parent is given the opportunity for counselling and they can vary or withdraw the consent, which is what I said in my opening remarks.

Sub-paragraph (3ZC) clarifies the fact that if a child becomes competent to consent, their parents’ consent is treated as if it were their own, which enables the child—now competent, which is the point made by the hon. Member for Boston and Skegness—to choose with consent at the appropriate time whether they consider it necessary to vary matters. That will ensure that the embryos are not automatically destroyed if the child does not want that to happen.

The hon. Gentleman asked about the interaction starting with parents and crossing over into a competent child or adult, and the issues of storage. He also asked about the intentions of proposed new sub-paragraph (2)(c) in amendment No. 65. The intention is that the parent, at the outset, will specify what should happen to the embryo created using the child’s cells if the child dies and if the parent died later. The consent would have already been given, so further provision is not needed is such a case.

I come to amendment (b), tabled by the hon. Member for Oxford, West and Abingdon to Government amendment No. 102. I took advantage of the break between the morning and afternoon sittings to discuss matters further. I am sure that he appreciates that the Government want to ensure the protection of the rights of the deceased person’s relatives in cases where their relatives have been identified and the researcher wishes to use the tissue. However, I understand that there may be an important point that he is making about when relatives cannot be traced and whether there should be some qualification on whether relative consent is required.

I do not want to make a hasty decision on the basis of today’s discussion. I am sure that members of the Committee appreciate that we are discussing a complex set of exceptions that try to take into account all human rights. However, I want to reflect on our views on the provision, along with what the hon. Gentleman said about it, to see whether a slight problem needs to be tidied up. I shall, of course, keep all members of the Committee informed of the outcome in relation to our decision. I hope, therefore, that he will not press the amendment to a Division, but will give us time to consider the matter.

My last point goes back to that made by my right hon. Friend the Member for Coatbridge, Chryston and Bellshill about nominating somebody if there is not a carer to represent a person who is without capacity. This incredibly important and I bow to his extensive knowledge and experience in this area. It is crucial that we get this right. We would expect and require the HFEA to be satisfied that the appointment was done correctly, that they were representing the individual concerned and that the researcher had undertaken all the checks possible before reaching that stage of appointment. I say to my right hon. Friend that that makes the exceptions very tight indeed and ensures that the concerns that he and the rest of us rightly hold have been properly dealt with.

I think that I have answered all the questions to the best of my ability, and if I find that I have missed anything when I check the record, I will be more than happy to write to members of the Committee.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I confirm that, as far as I am concerned, the Minister has addressed all the points that I raised on the amendments and I have no further comments to make on them. I apologise if I mis-spoke or confused the situation earlier in respect of issues relating to the schedule.

I would also like to thank the Minister for considering amendment (b) to Government amendment No. 102, and I repeat that I do not intend to press either that amendment or amendment (a) to Government amendment No. 102. I look forward to hearing the Minister’s reflections.

On amendment (a), the Minister has confirmed that the test is a higher one. It is helpful that that is understood, unless one is a researcher who now feels that he will be disadvantaged, so there are mixed blessings to these Committee debates.

The Minister says the test is a higher one because, in the case of the child who does not yet have capacity or the patient without capacity, there is a substitute consent involved, whereas here there is not such a substitute consent. That is the first time that that has been explained, and I will, if I may, reflect on whether it is therefore a rebuttal of the argument that the tests should be the same. I hope, however, that I can reflect on whether there is an alternative wording that would retain a higher test but was not as open to interpretation—and possibly misinterpretation—or as difficult to interpret as the current wording. However, I am grateful to the Minister for her responses to the points that I raised.

Mark Simmonds (Conservative, Boston and Skegness)

I join the hon. Gentleman in thanking the Minister for her extremely comprehensive responses, both to my amendments and to the questions I subsequently asked. In that context, I am happy not to press my amendments, which have been superseded by the Government amendments.

I thank the Minister again for tabling those amendments, and I look forward to her clarification of the disparity between Scotland and England. It might be helpful if she circulated that letter to every member of the Committee. I hope she stipulates which parts of the Bill apply to the whole United Kingdom and which only to England and Wales. There are some differences in the Bill, and there is certainly some confusion among those who are concerned with it—not just in Committee, but outside—as to which parts are relevant to which parts of the United Kingdom.

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 30, in schedule 3, page 61, line 32, leave out ‘12’ and insert ‘36’.

Roger Gale (Conservative, North Thanet)

With this it will be convenient to discuss amendment No. 31, in schedule 3, page 61, leave out lines 35 to 39.

Mark Simmonds (Conservative, Boston and Skegness)

We have spent a long time discussing schedule 3, so I will be brief. The amendments are probing and relate to the storage time of the embryos. Under the Bill, storage of the embryos is legal for 12 months. I welcome the Government’s introduction of a cooling-off period, when one person seeking treatment or the gamete donor withdraws consent. Why only 12 months? If there has been a disagreement between two people applying for treatment, lawyers occasionally become involved in an attempt to dispute the decision and it could take much longer than 12 months for the process to be resolved. A longer cooling-off period before an embryo is destroyed may well be necessary—at least the option of an extension to the cooling-off period.

Amendment No. 31, which is probing, expresses concern about the cooling-off period. The explanatory notes say that the cooling-off period allows the embryos to remain lawfully stored while a resolution is reached, but proposed new section 4A(4)(b) in paragraph 7 of schedule 3 allows the embryo to be destroyed before 12 months have elapsed if both parties consent. That appears to be a slight contradiction.

The time is a difficult one for both partners, and decisions could be taken that are subsequently regretted. Removing the provision and instead having a mandatory cooling-off period of 12 months would give both parties an opportunity to reconsider their initial decision.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I note the interesting points made by the hon. Gentleman, although I do not want to comment directly on their merits or otherwise. I want the Minister to confirm whether it is her view, as it is mine, that the courts made the right decision in the case of Natalie Evans. It was difficult for the lady concerned, and there was a great head of steam built up about whether it was right that she was denied the right to use the stored gametes or embryos when the consent had been withdrawn.

My view is that in 1990 Parliament was clear about its intention in such a case, and I would be grateful if the Minister confirmed that the Bill does not change that provision. Despite everyone’s sympathy for people in the position of Natalie Evans, the decisions of the courts in that case were right as far as Parliament had intended.

Dawn Primarolo (Labour, Bristol South)

I can confirm that. At all stages, the principle of importance in the last question is that the consent of both gamete donors has to be there. That is what the courts upheld, which is absolutely right. It has not changed. The Bill does not propose to move away from the principle of consent of both parties in such cases. However, we are trying to recognise the fact that, if one party withdraws consent to storage and use, it is only fair that the other should be informed. When that withdrawal of consent occurs, the Bill places a duty on the clinics to inform the second gamete provider.

The clinics also have a duty to keep the embryos safely stored for one year, until agreement has been reached by both parties with an interest in the embryo. That comes on to the point that I will deal with in a minute—the hon. Gentleman’s second amendment—which is that if both parties say “destroy”, the consent is withdrawn and that happens. That is what it means and that is what the principle is. That is the principle that has been upheld by the court.

The Bill introduces a one-year cooling-off period for the storage, which will be activated immediately in the case of one party withdrawing consent if written notification is received by the clinic storing the embryo that one of the gamete providers is withdrawing consent to continued storage and use.

The cooling-off period will ensure that the embryo remains legally stored for a maximum of 12 months to allow the other gamete provider to be informed of the decision and to allow time for reflection on that decision, with the possibility that both parties might reach a private agreement on the future of the embryo. Clearly, that would be a better solution than ending up in the courts, which we have discussed in relation to other examples. The question is how far any statute should reach into the private relationship between two individuals.

The 12-month period recognises the distress that such a situation can cause to the couples involved, but ensures that the process of reaching a conclusion is not allowed to drift and that clinics can deal with storage. The provision also deals with the fact that the individuals concerned have to recognise the importance of both individuals’ consent and recognises the fact that both can withdraw that consent. I understand the point of amendment No. 30: why should the period not be longer? Yet if the situation cannot be resolved in 12 months, why would we expect it to be resolved in a longer period? These are important and direct issues that should not be left for long before resolution.

On amendment No. 31, where both parties have consented to the destruction of the embryo, that would run completely counter to the whole point of consent, which is about the individual’s responsibilities in coming to those decisions. They cannot be transferred or given a cooling-off period. They are the responsibilities of those two individuals, and once both have said in writing that consent is withdrawn, that is it. That is the right way to proceed.

I understand the desire of the hon. Member for Boston and Skegness to probe this area, which is difficult, but the Government have moved as far as is reasonable, given that in the end—particularly given the circumstances of such treatment—the two individuals have to continue to consent. In distressing circumstances, when one person withdraws consent for a short period, there is at least the opportunity to inform the other donor and for final decisions to be taken. I therefore ask the hon. Gentleman not to press his amendment.

Mark Simmonds (Conservative, Boston and Skegness)

I thank the Minister for her response. Of course, I agree that consent of both gamete donors is essential and it is right that one of the consenters is informed if the other withdraws consent. It is also right that speed is of the essence in resolving these matters. The point I was trying to elucidate with amendment No. 30 is that a dispute, potentially involving lawyers, could last longer than 12 months, and there does not seem to be any option to extend that period. As I understand the Bill, even if such a dispute were still going on at the 12-month cut-off, the embryo or gamete would ultimately be destroyed.

Dawn Primarolo (Labour, Bristol South)

But that happens now. Where there is legal dispute over the requirement to defer the decision, I do not think that that has changed. We are talking about a new, specific cooling-off period that was not present in that circumstance.

Mark Simmonds (Conservative, Boston and Skegness)

I am aware of that, but I do not think it addresses the point that a dispute may be going on that could be resolved one way or the other and which, obviously, becomes hypothetical once the embryo has been destroyed. Nevertheless, I think the discussion has been useful.

Dawn Primarolo (Labour, Bristol South)

Perhaps I was not clear enough. Where there is a legal dispute and the courts are involved, the HFEA can defer a decision. I have referred to that before with regard to one of the cases we talked about. That position has not changed. This is not about where there is an interaction with the courts, so it is not an absolute. This is where there is not, and we are hoping that two individuals will simply sort it out themselves.

Mark Simmonds (Conservative, Boston and Skegness)

That is an extremely helpful intervention, if I may say so. On that basis, I beg to ask leave to withdraw the amendment.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I have six brief issues to raise. I apologise to the Committee for having read the schedule, which is where I went wrong. I was hoping that the Committee could get away earlier.

My first question relates to the provisions on page 60 of the Bill, which amend paragraph 2 of schedule 3 to the 1990 Act. I was hoping that the Minister would explain the purpose of that measure and, in particular, whether it conflicts with a later paragraph—paragraph 6(4) of schedule 3 to the Bill, which is also on page 60 of the Bill and which introduces new sub-paragraph (3) to existing paragraph 4 of the 1990 Act. It states:

“Where the terms of any consent to the use of an embryo...include consent to the use of an embryo or human admixed embryo whose creation may be brought about in vitro using embryo A, that consent to the use of that subsequent embryo or human admixed embryo cannot be varied or withdrawn once embryo A has been used for one or more of the purposes mentioned in sub-paragraph (2)(a) or (b).”

Sub-paragraphs (2)(a) and (b) relate to treatment services and projected research.

Substituted sub-paragraph (5) on page 60 of the Bill states:

“In the case of a consent falling within sub-paragraph (4)(b), the terms of the consent may be varied, or the consent may be withdrawn, in accordance with this Schedule either generally or in relation to—

(a) a particular embryo or particular embryos, or

(b) a particular human admixed embryo or particular human admixed embryos.”

I just want reassurance. I do not have significant doubts that the Bill as amended is correct and that the Act will be correct, but it is not obvious—nor was I able to find it in the explanatory notes—why it seems that people can pick and choose their consent and withdraw consents around embryos, whereas elsewhere it says that they cannot withdraw once the process has been started.

I can understand why people do not want the expense of a research project doing something and consent being retrospectively withdrawn in the middle of the project. It just seems to me that there may be some inconsistency. I hope that I have explained that.

Mark Simmonds (Conservative, Boston and Skegness)

Has the hon. Gentleman noticed in the explanatory notes the phrase “chain of consent”, which relates to paragraph 14 of schedule 3 to the Bill? It may go some way to shining light on the area he is discussing.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am grateful to the hon. Gentleman for suggesting that this issue is more complex even than that. That may be the solution or it may be an extra complexity. I am sure that some reading will have to be done.

My next point relates to the concern around proposed new sub-paragraph (5), which is inserted by paragraph 6 of schedule 3 to the Bill. It can be found at the top of page 61, in line 5. The distinction is between the way that this is dealt with for embryos and the way it is handled for human admixed embryos. Paragraph 4(2) of schedule 3 as it will be amended states:

“Subject to sub-paragraph (3), the terms of any consent to the use of an embryo”

—that is, not human admixed embryo—

“cannot be varied, and such consent cannot be withdrawn, once the embryo has been used—

(a) in providing treatment services”,

which clearly does not apply to human admixed embryos, which is why it is a different construction in sub-paragraph (5) of the measure as it will be amended, or

“(aa) in training persons in embryo biopsy, embryo storage or other embryological techniques”,

which is the problem.

Ian Gibson (Labour, Norwich North)

Could the hon. Gentleman take it more slowly, please? It is impossible to follow, and we are trying hard to do our job.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I will try to oblige. I would like to refer to paragraph 6 of schedule 3, in particular to draw attention to the impact of sub-paragraph (3) in amending paragraph 4(2) of the schedule to the Act, because the schedule to the Bill amends the schedule to the Act. I would like to contrast that with what paragraph 6(5) of schedule 3 to the Bill does to the same paragraph—that is, paragraph 4 of the schedule to the Act—when it inserts sub-paragraph (5). This can be found near the top of page 61 of the Bill. It deals with human admixed embryos.

My point was that paragraph 4(2) of the schedule to the Act, as amended, would say that

“the terms of any consent to the use of any embryo, that is, not human admixed embryo (“embryo A”)”

—that is, not “human admixed embryo”—

“cannot be varied, and such consent cannot be withdrawn, once the embryo has been used—

(a) in providing treatment services”.

That, rightly, does not appear for the human admixed embryos in paragraph 5, because there is no question of human admixed embryos being used for treatment services,

“(aa) In training persons in embryo biopsy, embryo storage or other embryological techniques,”

which is not covered in sub-paragraph (5) and which I am suggesting could usefully be done, and

“(b) for the purposes of any project of research.”

Paragraph 5(4), which is shorter, now states:

“Where the terms of any consent to the use of a human admixed embryo (“human admixed embryo A”) include consent to the use of a human admixed embryo or embryo whose creation may be brought about in vitro using human admixed embryo A, that consent to the use of that subsequent human admixed embryo or embryo cannot be varied or withdrawn once human admixed embryo A has been used for the purposes of any project of research.”

I may be wrong, because that deals with a chain of embryos and “any embryo” may cover “human admixed embryo”, but what concerns me is that there does not seem to be provision for human admixed embryos to be used for training people in the handling of blastocysts, if it is possible to create a blastocyst, and in things to do with embryological storage. One of the reasons for introducing human admixed embryos is a shortage of eggs, and it may well be that there is no better use of a human admixed embryo than for training, since it preserves the use of eggs and precious embryos, which should be used in treatment services, for those purposes.

However, I feel that there may be something missing, which relates to the third point I want to make. I may be wrong—I usually am, when it comes to questioning Government amendments to complex pieces of legislation—but amendment No. 66, which I will not be speaking to, does not seem fully to amend the schedule. The Committee will notice that amendment No. 66 inserts “(ba)” into line 12 on page 62 of schedule 3, but it does not amend line 8, and line 8 would appear to have an amendable part—that is, the insertion of “(ba)” into line 8. The effect of not amending paragraph 6 in schedule 3 to the Act as amended is that:

“A person’s gametes or human cells must not be used to bring about the creation of any embryo in vitro unless there is an effective consent by that person to any embryo, the creation of which may be brought about with the use of those gametes or human cells, being used for one or more of the purposes mentioned in paragraph 2(1)(a), (b) and (c)”.

That does not include testing. However, the Government are seeking to amend the Act with the amendment to schedule 3:

“An embryo the creation of which was brought about in vitro must not be received by any person unless there is an effective consent by each relevant person in relation to the embryo to the use of one or more of the purposes mentioned in paragraph 2(1)(a), (b)”

—it is now (ba)—“and (c)”.

Perhaps for training purposes it is a matter of receipt rather than use, but I am not certain of that. I would be grateful if the Minister could clarify whether that is an omission.

My fourth point is to ask the Minister whether she can explain what is meant by paragraph 10 of schedule 3 on page 62. It is about the use of embryos obtained by lavage. The explanatory notes specify that its purpose is to prevent embryos taken from a woman being used in research, but perhaps the Minister could explain why it was felt necessary to have it in the Bill now. Was there a gap? What was the impact of that gap? What could have happened had the provision not been introduced? It was mentioned briefly in the other place, but on reading it in Hansard, it was not entirely clear what it meant.

My fifth point is one that I raised incorrectly in consideration of the amendments, and the Minister did not address it in her comments. On page 64, paragraph 10(3)(b), there is a provision to ensure that consent is not required for storage. It states that the position meant is one where

“the patient is likely to regain that capacity”.

My point was whether “likely” is the right test given that it suggests a greater than 50 per cent. chance, two thirds of a chance, that capacity will be restored. Sometimes it is impossible to say whether it will be restored; in some circumstances it is possible but unlikely. Where is that dividing line to be drawn? It would be helpful if the Minister could give some indication, now or at a later stage, about what she means.

My final point is to draw an issue to the attention of the Minister. This is for information only—I do not expect her to respond. On page 65, proposed new paragraph 13(1) at line 16, the discussion about human admixed embryos describes them as being used for the purposes of “any project of research”, and it is the same in line 21. That provides a mismatch, which we discussed earlier with respect to the earlier part of the schedule in the first group of amendments.

A similar problem arises in schedule 2 about the issue of testing on human admixed embryos. I do not believe that schedule 2 has been amended to provide for the use of human admixed embryos in the testing of embryos. Obviously, I cannot talk about schedule 2 now as it was considered in Committee on the Floor of the House, but I draw attention to the fact that if the Government are right, they are right in both places and if there is a problem, it may apply in both places.

Mark Simmonds (Conservative, Boston and Skegness)

I am sure that hon. Members who thought that they understood how consents were going to work are now completely confused, as indeed am I. I wish to make three succinct points, the first of which is about written consent that will be rightly retained and also the consent that must be signed under the Bill. Can the Minister say whether there is evidence that written, but unsigned, consent—as under the 1990 Act—has led to misuse, or inappropriate use or storage of gametes and embryos? My second point relates to paragraph 4(3) of the 1990 Act and the withdrawing of consent. I see no mention in the Bill of those who are physically incapacitated who wish to withdraw and direct another to sign on their behalf. If I have interpreted the Bill correctly, such people can do so in respect of consent, but not for withdrawal. Why is that the case?

My third point follows that made by the hon. Member for Oxford, West and Abingdon. It would be helpful if the Minister could clarify the specific nature of consents under paragraph 8. Are separate consents required for the storage of gametes and for the embryo created by the gametes, as they are for admixed embryos? Such matters might be explained by the phrase “the chain of consent” that is used in the explanatory notes, which—to be fair—is why the hon. Gentleman could not find it. The reference to that is in paragraph 89 of the explanatory notes.

Dawn Primarolo (Labour, Bristol South)

I had no idea that the hon. Member for Oxford, West and Abingdon aspired to be a parliamentary draftsman. If that is the career he is heading towards, he has demonstrated his ability well this afternoon, although one of the enormous skills of parliamentary counsel is—thank goodness—to listen carefully and have specific instructions about intent and what is expected under the law, and make sure that it is covered. As the hon. Gentleman progressed through his questions, he answered them.

The hon. Gentleman said that the schedule is about enabling a person to give either general consent about how an embryo may be used or specific consent in relation to a particular embryo. Consent can therefore be specific. The provision needs to reflect all of that and show that, having given general consent, a person can vary it or withdraw any of their consents. However, that is limited by paragraph 4 under which consent cannot be withdrawn when an embryo has been used and has progressed a long way into a research project. All the references that the hon. Gentleman made to the schedule picked up each one of those interactions and reinforced them. That is the only way in which to handle matters and I am sure that the parliamentary draftsmen will be fascinated to read how closely he has followed the accuracy of their drafting. Many people with fantastic qualifications, along with the hon. Gentleman and his considerable skills, have examined the Bill to see that that is what it will deliver.

The hon. Gentleman thought that a reference was missing in respect of training. He is not right. If he passes his mind back to our earlier debate, embryos cannot be created for the purpose of training. The reference is not missing because such action cannot take place. The Government do not intend embryos to be created for training alone; they can be used for training and that is covered under paragraph 6(3). There is no omission there either. Of course, training is part of a treatment licence. It is not possible for a licence to be granted for training in connection with human admixed embryos under schedule 2. That is reflected in schedule 3, which is why there is no consent provision; it cannot be done in the first place.

The hon. Gentleman returned to a point that we debated concerning amendment (b) to Government amendment No. 102, which specifically touched on a research project. I have already told him that I would consider that point.

The hon. Member for Boston and Skegness—

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am sorry, but I think that there has been a misreading. I do not think that amendment (b) to Government amendment No. 102 has anything to do with the issues that I raised about the limitations on research and the threshold that research must reach. I think that the Minister might be referring to another amendment, although I do not think that it was amendment (b).

Is it the Minister’s understanding that it will not be possible for human admixed embryos to be used in a research project for training—they can obviously be used only for research—or does she consider that training is an integral part of research and that there will therefore not be a problem training new researchers in how to manipulate human admixed embryos? It that was the case, it might be helpful if she would specify that.

Dawn Primarolo (Labour, Bristol South)

I thought that I had made it clear during a previous debate that the Government see training as an integral part of research. We do not see the necessity for a licence for training only and we do not permit that.

With regard to the point made by the hon. Member for Boston and Skegness, I am not aware that there has ever been an issue about unsigned consents, so I cannot specifically reassure him on that point. I suppose that it is a bit of a reassurance to say that there has never been such an issue, but I will go back and double check on that point.

Mark Simmonds (Conservative, Boston and Skegness)

If that is the case—I am sure that the Minister is correct—it gives rise to a question about the necessity of adding a signature to a system that is working perfectly well already.

Dawn Primarolo (Labour, Bristol South)

I am sure that the hon. Gentleman would accept that if a signature were made explicit, most of us would sign consent automatically. However, I cannot tell him whether we have ever had a consent that has not been signed. The point is to make it explicit. However, in this matter, we would all ensure that we signed it, particularly bearing in mind that that could have implications for future research. As my right hon. Friend the Member for Coatbridge, Chryston and Bellshill said, there might be areas of research to which we would not want to consent. I will return to the matter, but I am unable at the moment to give the hon. Gentleman specific details at the moment.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I raised six points. The Minister has said that the first one arose due to a misunderstanding of intention and I shall look at what she has said. I accept that she has dealt with the second and third points in respect of training matters.

I asked whether the Minister could give an explanation on the provisions on lavage, and the hon. Member for Boston and Skegness, who can speak for himself, indicated that he was also interested in that answer. I have also raised substantively—twice—the threshold for the patient being likely to regain capacity in respect of amended paragraph 10 of schedule 3 to the 1990 Act. I would be grateful if the Minister could respond to those two issues only, having had her amusing fun with my asking questions about the schedule.

Dawn Primarolo (Labour, Bristol South)

I have answered the hon. Gentleman’s questions specifically with regard to consent and to that point. I put all his points together by explaining how they interact in the schedule. If the hon. Gentleman is still dissatisfied after reading Hansard, I will be more than happy to correspond with him and make sure that the letters are circulated to every member of the Committee. I am not trying to avoid answering his questions, but if he wants complex answers about the interaction of a whole range of things with which he can be satisfied, he could always give me notice. That would ensure that I understood before he said it, as well as when he said it, exactly what was his intention so that I would not misinterpret it.

The hon. Member for Boston and Skegness raised a point about the amendment to paragraph 4 of schedule 3 to the 1990 Act concerning whether people who are physically incapacitated can withdraw consent. Yes, they can. Provision is made in paragraph 3 of schedule 3 to the Bill, which amends paragraph 1 of schedule 3 to the 1990 Act. I hope that he will be able to reflect on that after the Committee, and if he is still not satisfied, I would, of course, be happy to come back to him.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The record will show that I made no criticism of the Minister either in my opening remarks or in my intervention. I accept that the first point that I raised was about a complex interaction, and I did not expect her necessarily to be able to satisfy me on that.

I am grateful to the Minister for explaining the position with regard to testing, which was not immediately apparent to me in respect of human admixed embryos. More importantly, she explained that under this regime, training was very clearly going to be permitted on human admixed embryos and that it was part and parcel of the research licence. I am not the only person who has expressed concerns about this—people working in the field want clarification—so I am grateful to her for that.

I did not think, however, that it was unreasonable to ask for an explanation of paragraph 10 of the schedule. The explanatory notes merely say:

“Paragraph 7 of Schedule 3 to the 1990 Act is amended by paragraph 10 of Schedule 3 to the Bill to prohibit the use of an embryo taken from a woman to create an embryo in vitro or to create a human admixed embryo in vitro.”

I merely asked whether this was just tidying up, or whether there had been a problem or a concern expressed and what was the mischief that this was seeking to amend.

Dawn Primarolo (Labour, Bristol South)

And I did answer the hon. Gentleman’s point. I say again that this relates to the question of consent that is in the 1990 Act regarding women and lavage. Paragraph 10 simply makes it clear that that has not been superseded. It makes it clear that the embryo taken from the woman is tied up with questions of consent, in general or specifically. It cannot be used to create a human admixed embryo, so the consent on that issue in the 1990 Act is linked to this schedule. That is the answer that I gave him.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

If that is the case, I am grateful to the Minister for reiterating that and I will go away and study that.

Finally, I have raised three times now the position of a patient likely to regain capacity and whether we have the correct threshold. I do not think that this is a question of interaction or of how the consent arrangements fall. There is a specific provision. I wish to ask whether there will be patients in certain conditions in which it will be very difficult to judge whether “likely” is the right test. I think that that will create problems, and it struck me that it might be possible, before the Bill completes its passage, to provide clarity on that.

Schedule 4

Mark Simmonds (Conservative, Boston and Skegness)

I have one or two questions for the Minister about counselling and the circumstances in which it should be offered. I certainly do not believe that counselling should be mandatory, but it should be offered and it should be effective. It is important that counselling is provided by skilled professionals who are experienced in such matters, so I have some questions.

Do counsellors working in this field have specialised training or expertise, or are they counsellors in other areas as well? Is there a division between counsellors who work with people undergoing treatment and counsellors who work with those who have donated gametes? Are they different kinds of counsellors who require different training, or do they come from the same generic group of individuals? Is there any charge for the counselling service? If so, is it merely a charge to recoup the costs, or is it a revenue-generating exercise as well? Finally, are the guidelines set by the HFEA, or is it up to each individual clinic to set its own guidelines?

Dawn Primarolo (Labour, Bristol South)

On the question of the fee, the cost of counselling is covered in the cost of the treatment services—it is all wrapped up. On the question of who sets the guidelines, a code of practice is set as guidance for clinics on how to offer counselling. The code states specifically that patients need to be aware of the offer, that it needs to be routine, that it should include written information and that it should give the names of qualified counsellors in the area, who may also have wider qualifications. The counsellor’s role needs to be explained, as well as when they are available and how to access the service. Obviously, there should be no pressure to accept counselling, but sufficient time should be given to consider the offer.

I am afraid that I do not know the answer to the hon. Gentleman’s question about the division of counsellors’ roles, so I will have to write to him. The HFEA sets the code of practice, counselling is included within the cost of treatment, and counsellors need to be specialised. I will respond to his last point as soon as I can.

Clause 15

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 5, in clause 15, page 11, line 47, leave out ‘ten’ and insert ‘seven’.

Roger Gale (Conservative, North Thanet)

With this it will be convenient to discuss amendment No. 34, in clause 15, page 12, line 3, leave out ‘ten’ and insert ‘seven’.

Mark Simmonds (Conservative, Boston and Skegness)

Amendment No. 34 is a consequential amendment to amendment No. 5, so I shall concentrate on the latter. It is, I acknowledge, a further probing amendment, which relates to how long gametes and embryos can be kept in storage. At the moment, embryos can be kept for five years, and then for five years beyond that, if the couple chooses. Will the Minister put on record what evidence exists that embryos and gametes are of sufficient quality after and up to 10 years? For how long afterwards does she believe that embryos can be kept in storage without deteriorating, if there is indeed evidence to support that?

Is the Minister concerned that removing the five-year break will result in fewer couples giving their embryos for research as they will not necessarily be reminded of the possibility after the five years? As the 1990 Act lasted for 18 years, I think that the general view in the Committee is that we wish this Bill, after it becomes an Act, to last similarly long. Is it possible to change the time period under regulation if future techniques allow longer storage?

I think that a recent case forms the basis of an amendment that has been tabled by the hon. Member for Oxford, West and Abingdon. A young girl, because of treatment she has received, will not be able to have children later on in life. However, she is of such a young age that even if her mother donates an egg for her now, after the 10-year period has elapsed, she will still not be old enough to have a child. Regulations might allow that situation to be changed as scientific techniques develop and, again, it could be amended by new clause 2, which was tabled by the hon. Gentleman.

Dawn Primarolo (Labour, Bristol South)

I recognise that limits on the storage of gametes and embryos can cause some concern. The length of storage needs to ensure fairness, while also taking into account the safety of freezing. I believe that the statutory 10-year period for gametes, with extended storage for medical reasons, remains appropriate. I also consider that the same limits should be applied to embryos. Therefore, the Bill brings storage limits into line with each other.

The Warnock report proposed a 10-year period. I suppose that the hon. Gentleman is quite right about which years one picks—it is arbitrary. Five years was the decision of Parliament. In the 24 years since the report was published, there has been no body of evidence to suggest that using embryos that have been frozen for 10 years endangers a mother or child. There is a possibility of change—the hon. Gentleman pointed to the regulating power—enabling an extension beyond 10 years in specific circumstances, but that is something that would need to be considered later. At this point, because we can see that there is an application to go further, it seems sensible to go for 10 years. I suppose that his guess might be as good as anyone else’s. That is the reason for settling at 10 years, but allowing variation under specific circumstances and having the regulatory power in place, if it is necessary to extend it further in the future.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful to the Minister for that explanation and for the confirmation that there are regulatory powers for changing what is in the Bill, if scientific advancement allows. In that context, I beg to ask leave to withdraw the amendment.

Roger Gale (Conservative, North Thanet)

With this it will be convenient to discuss new clause 2—Extension of statutory storage period for treatment of blood relatives

‘(1) The Human Fertilisation and Embryology (Statutory Storage Period) Regulations (S.I. 1991/1540) are amended as follows.

(2) In regulation 2(1) for “paragraph (2)” substitute “paragraphs (2) and (2A)”.

(3) After regulation 2(2) insert—

“(2A) The circumstances referred to in paragraph (1) are that the gametes were provided by a person who has given written consent for them to be used by another person—

(a) who is a blood relative of the person providing the gametes,

(b) whose fertility was, in the written opinion of a registered medical practitioner, significantly impaired on the date on which the gametes were provided, and

(c) who was aged under 45 on the date on which the gametes were provided.”.’.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I wanted to draw attention to something that has already been touched upon: a problem with not only the current storage legislation, but the regulations. The Minister will be aware of the case that I am going to cite on behalf of my hon. Friend the Member for Hazel Grove (Andrew Stunell), who has been assiduously pursuing the issue for one of his constituents. He raised it on Second Reading and wrote to the Minister on 14 May to set out the problems. I thought that it would be useful to summarise the situation and to quote from that letter, with the permission of my hon. Friend.

The problem is that the regulations for storing gametes were set by the Human Fertilisation and Embryology (Statutory Storage Periods) Regulations 1991, which could, in theory, be amended under the current Bill. In this case, there is a woman whose daughter suffers from Turner syndrome. That is not life-threatening—a relatively normal life can be led with treatment—but one of its features is infertility. In this case, the mother wishes to donate her own eggs so that her daughter will be able to have children by IVF treatment in the future. The problem is that the time limit for storing gametes is set at 10 years. Regulations state that gametes must be donated before the donor reaches the age of 36, which creates a problem in this family and, presumably, others. If the mother donated before the age of 36, the 10 years would expire when her daughter was still only 18 and therefore extremely unlikely to be ready to use the eggs.

The Committee will be aware that the current regulations provide for an exception if the gametes are stored for the use of the donor. However, according to a letter received by my hon. Friend the Member for Hazel Grove from the HFEA, the reason for the 10-year limit is that it is best if clinics are not overburdened by the number of samples in storage. I accept that there is a regulatory issue, so the question is whether there could be exceptional circumstances in which samples might be permitted to be stored for longer than 10 years, for example if donated eggs are intended for another family member who is infertile, which is the case that my hon. Friend has made in a number of forums. Would new clause 2 achieve that? If not, might an amended version?

There is discretion on retrieving eggs after the age of 36. In exceptional circumstances, clinics can use eggs from women over the age of 36, but I think that everyone is aware—the Minister is, of course—that fertility and thus the efficacy of the treatment diminishes rapidly after that point.

Even if the drafting of new clause 2 is not perfect—if there are imperfections, it is through no fault of my hon. Friend—I hope that its intention is clear. It states that an exception can be made when a person

“has given written consent for them to be used by another person...(a) who is a blood relative of the person providing the gametes...(b) whose fertility was, in the written opinion of a registered medical practitioner, significantly impaired on the date on which the gametes were provided, and...(c) who was aged under 45 on the date on which the gametes were provided.”

This is not a unique case—I am conscious of the fact that we should not legislate to provide for an individual case—and I wonder whether an amendment could be made. Obviously, we do not need primary legislation, so I would understand if the Minister said that the Government wished to consider the matter themselves and introduce their own regulations to allow for an exception.

Mark Simmonds (Conservative, Boston and Skegness)

My concern with new clause 2 is about the extremely broad nature of the phrase “blood relative”. Has the hon. Gentleman thought about narrowing it down to a sibling, son or daughter of the donor to exclude third cousins twice removed and so on?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

That is a fair point. There are questions about whether the wording is broad. I am not wedded to the wording of the new clause, so I accept that it might need further work. I have never claimed to be a parliamentary draftsman, despite what was said earlier, and I do not seek to be one. My cup overflows already.

I wish to make a further point about surrogacy. I have not tabled an amendment on this, but any provision would be very similar to new clause 2, so the matter relates to this debate. The Human Fertilisation and Embryology (Statutory Storage Period for Embryos) Regulations 1996 specify the period for which gametes and embryos respectively can be stored in cases where the patient is, or will become, permanently infertile. In extending the normal five-year storage period, the regulations enable patients to preserve their last chance to conceive their own genetic child until the female patient in question is approximately aged 55. Although the Bill extends the normal embryo storage period from five to 10 years, which I think is a good idea, it does not amend the special regulations for extended storage. I think there is a case for the regulations to be updated to benefit patients conceiving their own children through surrogacy. Surrogacy patients are explicitly excluded and, in practice, it seems to me—and to those advising me—that it is utterly arbitrary that a woman who has had her ovaries removed due to cancer can store her eggs and embryos until she is 55, but a woman who has had a hysterectomy due to cancer can store her eggs or embryos for only 10 years. That seems to be somewhat unfair, so I was wondering if the Minister would consider there to be scope to bring the situations more into line—if not in this Bill, through regulations.

Dawn Primarolo (Labour, Bristol South)

I ask the hon. Gentleman not to press new clause 2 to a Division because I think that he raises a number of difficult issues with regard to some aspects of the regulation. As he has pointed out, there are regulation-making powers under the 1990 Act, and the Bill allows changes to regulations, such as those relating to statutory storage periods of gametes.

The hon. Gentleman made the point that it is not always wise to make primary legislation on the basis of one case. Perhaps if I could tell him when the regulations will be available for consideration, he might rightly feel—as I do—that that would be the appropriate place to raise these considerations. New policies will be proposed in regulations and they will need to be consulted on. The timetable for those regulations is such that the drafts will likely be available toward the end of this year.

I think that the points that the hon. Gentleman raises could be appropriately dealt with in that consultation and the consideration of those regulations, rather than through new clause 2, because there will be other points to consider. For example, the hon. Gentleman touched on surrogacy, which is not addressed by the new clause. There might well be other exceptional circumstances, but it would be wise to address them all in one place in the regulations.

I hope the hon. Gentleman and the hon. Member for Hazel Grove accept that the Government see that this issue needs to be addressed and intend to ensure that that happens during the consideration of the regulations, which will take place before the end of the year. That will be the appropriate point of the consultation to add in some of the points that the hon. Gentleman is suggesting.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I thank the Minister for that response, although she did not necessarily say that she agreed that there should be a solution. I think she did accept that there was a problem in this case.

Dawn Primarolorose—

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am sorry if I misunderstood.

Dawn Primarolo (Labour, Bristol South)

No, no, with respect, I do not know whether there will be a solution. I agree with the hon. Gentleman that it would be desirable to find a solution and the appropriate vehicle for this is the regulations. At this time, I do not know, so that is my only point.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I apologise to the Minister. I am satisfied that she recognises that there is a problem and that she suggests that rather than trying to amend primary legislation through new clause 2, or another version of it, the appropriate time would be either during the drafting of regulations, or their redrafting following the consultation. I am delighted because she has confirmed that there will be a consultation on drafts, which we discussed earlier. That is always good when regulations are being considered because once they are laid, it is impossible to amend them unless the regulations are withdrawn.

I am grateful to the Minister for indicating that she hopes that the drafts will capture, if possible, a solution to a problem that she acknowledges. I am sure that my hon. Friend the Member for Hazel Grove, who might be listening to the debate using new or old technology, will share my gratitude—and, I suspect, that of his constituent—to the Minister for her positive response.

Clause 16

Clause 17

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 142, in clause 17, page 12, line 23, at end insert—

‘(1A) In subsection (1)(b) for “equipment is” substitute “equipment and premises are”’.

Although the premises would have been inspected before the licence was granted or renewed, it is also important for the person responsible to ensure that the right equipment and parts of the premises are used for each procedure, and that there is no risk of cross-contamination between admixed embryos and IVF embryos, for example. On my visit to the Centre for Life in Newcastle I saw that it undertakes different types of medical research or treatment in separate parts of the same building. It is obviously the responsibility of the licence holder to ensure that there is no transfer or confusion between the two.

There is an inconsistency. There is no mention of equipment and premises in clause 17, yet in clause 18(d) and (e) they are mentioned as specific reasons for the potential revocation of the licence. Will the Minister explain that inconsistency?

Dawn Primarolo (Labour, Bristol South)

The amendment would add a requirement to section 17 of the 1990 Act to ensure that it would be a duty of the person responsible to secure appropriate premises as well as equipment in which to carry out activities as they are licensed under the Act. Furthermore, the requirements of the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007, which incorporate the European Union tissue and cells directive into the 1990 Act, would apply to any embryos that are intended for human application. The directive made various extensions to licence conditions, which are set out in schedule 3A to the Act and incorporated by section 14A. The provisions ensure that appropriate equipment and materials are used as well as suitable facilities and premises. It means that any licence that relates to gametes and embryos intended for human application must satisfy those conditions. If they do not, they will be in breach of the licence.

I hope that I have put the hon. Gentleman’s mind at rest. The HFEA always ensures that the person responsible will secure the appropriate premises as part of the licence application. The suitability of the premises is already part of the HFEA inspection process so the twin arrangements are catered for and, if that were not the case, it would be a breach of the licence,

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful to the Minister for clarifying the fact that there is not an inconsistency between the two clauses. I beg to ask leave to withdraw the amendment.

Clause 18

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 143, in clause 18, page 13, line 29, after ‘person’, insert

‘and is so qualified by training and experience’.

The amendment relates to the variation of a licence. Under section 16 of the 1990 Act, the initial applicant had to satisfy the licensing committee that the character, qualifications and experience of the applicant were suitable. My understanding is that, under this Bill, the person to whom the licence is transferred will not need to satisfy the authority that they are anything more than suitable. There is a difference between those two definitions. One could have a suitable character without the required qualifications and necessary experience. Is the Minister happy with that difference? Would she not prefer a more robust system, with a new inspection under the person responsible or the licence holder?

Will the Minister also clarify whether there is a prohibition on the sale of a licence? Can a licence effectively be bought and sold within the context of the criteria I have just mentioned?

I have one further issue with regard to this amendment. In proposed new section 18A(3), a very clear distinction is made between

“the person responsible”

and

“the holder of the licence (if different).”

Will the Minister say how many licences have been granted where the person responsible and the licence holder are not the same person? In the revocation categories, again, it refers only to “the person responsible”, not the licence holder, which implies that one, “the holder of the licence”, is a subset of the other, “the person responsible”. If they are different, why are they not different in the revocation categories, and if they are the same, why is there a distinction in the first part of clause 18?

Roger Gale (Conservative, North Thanet)

The hon. Gentleman has indicated a rather broad range of questions, which effectively constitute a stand part debate. I am perfectly content with that.

Dawn Primarolo (Labour, Bristol South)

The Bill simplifies provisions in order to allow the HFEA to determine applications by a licence holder in a more flexible manner. However, this does not change the strict criteria for determining whether people are suitable to be the person responsible. That remains the same.

In 2005, the HFEA, in consultation with stakeholders, took a decision to revise its assessment process for the person responsible, and there are now formal assessments to ensure that the designated person is proficient in their role and up to date with the latest developments in their field. This process consists of various assessments that the person must satisfy. For a research licence, for example, the assessment consists of three workbooks that must be completed by the designated responsible person. One is on the regulatory framework, one is on quality management and risk, and the third covers research regulations. The workbooks also include details outlining certain person specifications, including qualifications. They state all relevant medical, biological, scientific or professional healthcare qualifications, and require the applicant to demonstrate experience, including experience and extensive knowledge of fertility-related management, clinical and scientific developments and treatments, including ethical viewpoints.

The hon. Member for Boston and Skegness went on, as he did before, to ask about the process and refusals in varying or revoking a licence. All the decisions relating to granting, revoking, suspending or varying a centre’s licence are taken by the licence committee of the authority, based on inspection. Inspections need to assess quality, effectiveness of the clinical management, and a whole list of things that I will not read into the record. I will write to him about them.

He asked specifically whether a licence could be sold, passed on or transferred to another responsible person. It could be, but the HFEA must approve any transfer of licence, and it would need to be satisfied that the transfer would go to a responsible person and under all the conditions that I have outlined, as agreed after the 2005 consultation process.

I do not know the answer to the hon. Gentleman’s last question about whether there is a difference between a responsible person and a licence holder. I have a feeling that there is not, but I do not want to commit myself unnecessarily to that and I will come back to him. I hope that he is satisfied that measures are still there to ensure that the responsible person is properly qualified and experienced in the relevant fields, and that the HFEA will scrutinise the licence and the responsible person very closely.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful to the Minister for that reply. The only outstanding issue is the one to which she referred at the end. It would be helpful if after the Committee I could explain to her in more detail what I feel is not consistent. Perhaps I was not clear enough in my explanation—I will not go through it again now, but it is something that should be looked at. I am happy to receive a response from the Minister after she has had a chance to discuss it with her officials and I beg to ask leave to withdraw the amendment.

Clause 19

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 144, in clause 19, page 15, line 12, leave out subsection (7).

Roger Gale (Conservative, North Thanet)

With this it will be convenient to discuss amendment

No. 145, in clause 19, page 15, line 14, at end insert—

‘(8) Notification to the applicant of a decision whether to grant or refuse a licence must be given within a specified time period to be determined by regulation.’.

Mark Simmonds (Conservative, Boston and Skegness)

Again, I shall be brief; these are probing amendments. Perhaps the Minister could clarify why on page 15 there seems to be some duplication. In clause 19A there are four distinct categories:

“In the case of a decision to grant a licence, the Authority shall give notice of the decision to—

(a) the applicant, and

(b) the person who is to be the person responsible”.

and those seem to be exactly the same for the four categories: granting, revocation and the two types of variation. I understand that in clause 19A(7) a distinction is drawn with subsections (2) and (4), but I cannot see why it is broken down into four distinct categories under 19A and not two or three. The people who must be notified after decisions are taken are exactly the same. That is the purpose of amendment No. 144.

Amendment No. 145 has been tabled because there are clearly delays that can be damaging both to business and research—particularly the latter as research grants elapse after a certain period of time. Under the current provisions, the authority can take as long as it chooses to decide whether to grant or refuse a licence. The amendment would ensure that the authority understands that it would be helpful if a specific time period—specified in the regulations after consultation—could be set out to help provide clarity. Perhaps the Minister and her officials could give that some thought.

Most public bodies have specific time scales within which they must respond. For example, the Department of Health is supposed to respond to correspondence from MPs within 20 days. I am sure that the Minister will be the first to acknowledge that that is not always the case, but attempts are always made to ensure that the time scale is met. There is concern within the industry—if I can call it that—that there may have been unacceptable and unreasonable delays in specific circumstances. I would not seek to specify the time period in the Bill; that will have to come through discussions and be put through regulations after consultation. However, it is a key point and requires addressing.

Dawn Primarolo (Labour, Bristol South)

I understand the hon. Gentleman’s point perfectly and the reasons why he seeks to set a time limit, or at least to get an indication of one. This issue is often raised. I accept that the HFEA should respond in reasonable time, and recognise that regulations would allow a suitable period to be determined in consultation with interested parties.

However—the hon. Gentleman touched on this, so I think that what I am about to say might help—setting out such a time limit in statute would restrict the HFEA in having the added flexibility that might be needed in certain situations in the more complex licence applications. I can reassure him and the Committee, however, that the HFEA is committed to notifying the applicant of its decision either to grant or refuse a licence within set time scales. It has a self-imposed target of three months for licence applications, and four for any new treatment and storage licences. It is right that we allow it that flexibility.

Over the past 12 months—I accept that this would not necessarily apply to the more complex applications—the HFEA has received three applications for research licences, all of which were processed and decided upon within the required three months. That indicates that currently it is processing applications in a timely fashion, although we would expect it to be thorough as well. I hope that the hon. Gentleman accepts that his probing amendment on time limits is dealt with.

Proposed new section 19 provides that reasons must be given for certain licensing decisions and provides an opportunity for representations to be made before a decision is taken. It sets out the person to whom notice is to be given when the decision is made. The new provisions set it out that if the HFEA agrees to an application from a licence holder or person responsible to vary or revoke, it does not need to give reasons for its decisions when giving notice to the specified persons. That makes sense, because the HFEA is granting what was requested. That measure is aimed at reducing the unnecessary bureaucratic measures that have also been mentioned. When a decision goes against a request, proposed new section 19A(5) will require the applicant to be given reasons for the refusal. I think that that provision satisfies the concerns raised in relation to the amendment.

The hon. Gentleman then asked about the reason for the different categories. It is to cover the different areas—granting, revocation, application or any other variation—so that they are all covered by slightly different notification requirements based on the relevant application. I accept that that might appear more complicated in the Bill, but in practice it will speed up and make clear what applies in the case of different decisions. I hope that that deals with his questions.

Mark Simmonds (Conservative, Boston and Skegness)

Again, I thank the Minister for her response. Amendment No. 144 is really a probing amendment on which she has clearly satisfied me. I hear what the she says about amendment No. 145, but I urge her and the relevant officials in the Department to monitor the situation carefully, because there is concern among those applying for licences.

I am intrigued that the Minister says that there has been no delay in applications in the past 12 months—that is not what people have been telling me. What was the point of Tuesday’s debate on delegated powers to speed up the process, if it does not need speeding up? From what she has said today, the process seems to be working well. I suspect, however, that because of the additional potential licence areas with which the HFEA will have to cope when the Bill is enacted, it will receive more licence applications than it has to date. The situation therefore needs to be monitored carefully.

Dawn Primarolo (Labour, Bristol South)

I hope that I did not convey any complacency in explaining what has happened in the 2007-08 period. I accept that comments have been made, and the hon. Gentleman is right about needing to be vigilant and ensuring that the process continues to be accurate and timely—without unwarranted delay—unless there is complexity.

Mark Simmonds (Conservative, Boston and Skegness)

I confirm that the Minister certainly did not give the impression of complacency on this particular occasion. On that note, I am happy to beg to ask leave to withdraw the amendment.

Clause 20

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 146, in clause 20, page 15, line 38, at end insert—

‘(2A) No more than four consecutive suspensions under subsection (1) can be granted, totalling a maximum period of twelve months.’.

The amendment relates to the number of consecutive suspensions that the HFEA may allow. Of course it is right that the HFEA should have the power to suspend a licence quickly and efficiently if it has reasonable grounds to believe that the terms of the licence might be broken. It also has the power to renew such a suspension indefinitely.

The amendment will either place an upper restriction on the number of times that a suspension may be renewed to a period of up to one year or establish why that is not acceptable to the Government. Clearly, a suspension for even a short period could be damaging to a business or research project that had a licence up to that point. In my view, it is correct that a decision should be made within a year. By then, the appeal process should have been gone through, if appropriate, and the authority should have had sufficient time in which to investigate, clarify its concerns and rectify any problems.

I would like to make an additional point if I may, Mr. Gale, about the timing of the appeal procedure. How quick will it be? Will it be dealt with within the three-month period, or is that one of the main reasons why there is no limit on the number of times that a suspension may be renewed? Clearly, if appeals can be heard and clarified expeditiously, that will benefit the authority and those who previously had a fully operational, licensed business or research facility.

Dawn Primarolo (Labour, Bristol South)

Proposed new section 19C retains the right of the authority to suspend a licence, where it considers there are grounds to do so, for a period of three months and for further periods of three months after that, if it sees fit. In my view and in the experience of the authority, given the work that it has undertaken, that is the correct way to proceed and there should be no specification of the number of times that a suspension period has been repeated.

The hon. Member for Boston and Skegness touched on a case from June 2007 in which the HFEA used its powers to suspend a licence for three months, and then suspended it for another three months while it considered an updated report. He will be aware that there was interaction with the High Court in that case and a judicial review of the decision. I am sure he accepts that it is quite difficult to have a maximum period in such circumstances, because the suspension is needed until a decision is taken and there might be external factors to consider, such as judicial appeal or a High Court judgment.

Where we are is right. The period should be three months, with an option to suspend again. Clearly, we expect things to be speeded up—part of the flexibility given in the appeals procedure and the structure of the licensing committee is to ensure that matters are dealt with in that period. That will further reduce the time involved. However, to pick an exceptional case and then argue for a limit given those exceptional circumstances is incorrect. I hope the hon. Gentleman accepts that.

The hon. Gentleman then asked about the period for the appeal. The new provisions permit an appeal to be made within 14 days. Within the new framework for appeals, that will be set out in regulations. Safeguards remain in place to ensure that the suspension continues pending resolution of the appeal in order to protect public safety. It is right that we do not have a maximum period because of other interactions. It is right that we give the HFEA, as we have elsewhere in the Bill, the opportunity to speed up those considerations wherever possible. However, it would be unwise of us, with sometimes complex cases, to set a maximum period when the right resolution could not be achieved. We are talking about patient safety and quality of care. I hope that the hon. Gentleman accepts my comments.

Mark Simmonds (Conservative, Boston and Skegness)

I thank the Minister for that response. I accept her arguments, particularly on judicial review and the time that those often complex cases take. I also take her reassurance on a focus on speeding up the decisions and considerations wherever possible. It is right that safety and quality of provision have to be fundamental to everything that happens under the Bill.

Following that explanation from the Minister, I beg to ask leave to withdraw the amendment.

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 147, in clause 20, page 16, line 4, at end insert—

‘(6) During a period of suspension all necessary, suitable and appropriate steps must be taken by the Authority to ensure there is no damage to the cells, embryos and gametes that were the responsibility of the licence holder or person responsible when the licence was suspended.’.

The amendment relates to the authority having the power to suspend a licence quickly and efficiently in cases where there are reasonable grounds for the terms of a licence perhaps having been broken. Obviously, for the authority to have that right is correct. However, is it right that during the suspension the people undergoing treatment at that centre could suffer or, worse, lose their embryos or gametes?

I am not sure from either the 1990 Act or the Bill whether there is a duty on the authority to ensure that clients are unaffected during a licence suspension and can continue treatment at other licensed premises. Therefore, there is a crossover in how that impacts on the confidentiality of information going between the two.

Also, what happens to the gametes and embryos stored in a facility that is ultimately closed or has its licence removed? Are they transferred automatically to another facility under the auspices and guidance of the HFEA, or are they just allowed to wither, so to speak?

Dawn Primarolo (Labour, Bristol South)

I assure the hon. Gentleman that the HFEA, within its requirements when it suspends a licence, has to issue special directions. Those special directions allow for the continued storage of gametes and embryos at the clinic. The HFEA would also expect the clinic to make appropriate arrangements for the continued treatment of its patients if a licence were revoked. Furthermore, it would expect gametes and embryos to be moved to another licensed clinic.

As with suspension, the HFEA would also expect the clinic to make appropriate arrangements for the continued treatment of its patients. The HFEA already has the power to do that, so I do not think it necessary to give it further powers under the Bill.

The hon. Gentleman has raised a series of important questions, but I hope that in each of those circumstances continued treatment of patients, safe storage and/or transfer of gametes and embryos will all be dealt with under the special directions, which are part of the licensing requirements.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful to the Minister for clarifying the safety and continuing existence of those gametes and embryos that have been put in storage in these particular licence facilities, were one to have a licence revoked or suspended. On that basis, I beg to ask leave to withdraw the amendment.

Clause 21

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 148, in clause 21, page 17, line 2, leave out from ‘wholly’ to ‘and’ in line 3 and insert

‘of persons who were not members of the initial grant, revocation or variation committee.’.

I hope the Minister will confirm that the amendment is not necessary, and that what it proposes already happens in practice. Clearly, however, it is important that those who were involved in an original decision are not also involved in the appeals process. It is certainly important that the appeals process is not only seen to be fair and independent, but is fair and independent, and that there are therefore no prejudices that might have been instilled through the original process.

We have discussed this before. There are, however, concerns surrounding conflict of interest on the licensing committee, and having an entirely new appeals committee mandated in the Bill would prevent such an incidence occurring, and in particular prevent it from occurring again.

Dawn Primarolo (Labour, Bristol South)

The clause provides for regulations to ensure that membership of the appeals committee is made up wholly or partly of persons who are members of the authority. Regulations relating to the appeals process will be forthcoming to deal with consideration under the affirmative procedure, and they will come into force at the time of the commencement of the relevant provisions in the Bill. In conjunction with the HFEA, we are considering the details of those regulations, which will be the subject of public consultation prior to consideration by both Houses. The issue that the hon. Gentleman raises with regard to appeals committees, who sits on those committees, and their connection or otherwise to the original decision, will be addressed at that point. I therefore hope he does not feel the need to press the amendment to a vote.

Mark Simmonds (Conservative, Boston and Skegness)

I am pleased that the Minister has confirmed that the matter will be addressed in regulations. It is clearly a very important part of the appeal process, and there has to be confidence that this is a fair process among those applying for licences or appealing against the revocation or variation of licences, which is not driven by themselves. Regarding future consultation, the Government had an enormous amount of time to consult before the Bill was introduced in Parliament, and in many cases they did so extremely thoroughly, and with extreme diligence. Why has consultation about this particular part of the Bill not taken place?

Dawn Primarolo (Labour, Bristol South)

To remind the hon. Gentleman, the 1990 Act prevents anyone who took part in proceedings resulting in the appeal from taking part in the appeal. That is already the case. By ensuring that the appeal is heard by different people, it reduces the potential bias and makes certain that the process is impartial. Under the 1990 Act, members of the appeals committee would not have heard the initial proceedings, although they would all be members of the authority. The new power will enable the committee to be comprised, wholly or partially, of non-authority members, thus allowing for further improvements in the impartiality of the appeals committee. For those reasons, and because of the difficulty of getting the balance that we need, careful consideration is required. With respect, if we were presumptuous and consulted on draft regulations, even though the House had not agreed we had the power to do that before the Bill received Royal Assent, that could cause confusion and difficulty. It is partly about process, but also about the difficult and complex issues that we need to take in a steady fashion.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful for that clarification and explanation, and I understand the Minister’s points about consulting on draft regulations before the Bill has completed its passage through Parliament, but she will also be aware of the concerns expressed earlier by the hon. Member for Oxford, West and Abingdon and me that draft regulations are rarely amended in that sense when they come before Parliament. However, I accept that they will have to be debated under the affirmative procedure.

Dawn Primarolo (Labour, Bristol South)

I assure the hon. Gentleman that they will be thoroughly consulted on in draft form. It is such an important issue that I would hope that we would reach consensus before Parliament has its final approach under the affirmative procedure in both Houses.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful for that intervention. Of course, we all hope that consensus can be reached on such important issues, but the Minister will certainly be aware from the passage of the Bill that consensus on such complex issues is sometimes difficult to achieve. None the less, I listened to what she said. I am pleased that the matter will be clarified in future regulations and will undergo detailed consultation. I hope that when the regulations come before Parliament under the affirmative procedure, the issues will be addressed specifically. On that basis, I beg to ask leave to withdraw the amendment.

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 149, in clause 21, page 17, line 32, at end insert

‘within 28 days of the appeals committee meeting.’.

Again, the issue is the time scale. It concerns the appeals committee and the appeals procedure. Any case that reaches the appeals committee is likely to be lengthy and indeed costly, so it is right that the appeals committee should give its judgment as swiftly as possible to resolve the case either way, prevent undue delay and produce clarity. I do not stipulate that 28 days is the correct figure—it may well be longer than that—but I want to put on record the concern that the appeals procedure could take too long. Will the Minister inform the Committee how long appeals committees take from start to finish? What gap exists between the time when it is clear that somebody wants to appeal and the time when the process starts in detail?

Will the Minister also confirm whether the regulations could be changed so that during the appeals committee, the appellant and the HFEA can give both oral and written evidence, and that that evidence can be made public so that people can see exactly what the process is in a transparent and effective way? Why will written and oral evidence be given and made public only at the initial licensing committee stage and not at the appeals stage?

Dawn Primarolo (Labour, Bristol South)

On the question of time limits, the limit of 28 days, from the meeting and the point of the hon. Gentleman’s amendment, is a reasonable period, to be perfectly honest, within which an appellant should be informed of a decision. However, we understand that in practice, it is likely to occur much sooner than that. Of the two recent appeals, one took seven days and one took 18 days.

Although I appreciate that the amendment would guarantee that the decision was communicated within a specific time frame, given that practice is already better than that, it is not an issue that needs to be put into primary legislation. In the two cases concerned, when a decision was reached, I am informed that the appellant was informed within 18 days. In the appeals process, the whole decision is considered, and the decision is challengeable. That means that the appeals committee would have to be provided with the same information, and it is on that basis that it needs to look at the information in a particular form. If the hon. Gentleman is not satisfied with that answer—

Dawn Primarolo (Labour, Bristol South)

May I finish my sentence? I am certainly prepared to go back and clarify with the HFEA the point that the hon. Member for Boston and Skegness is making.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am sorry to interrupt the Minister, but it is difficult to catch her attention, and I wanted her to finish her remarks. Are the regulations under this section, and proposed new sections 20A and B, under the affirmative or negative procedure? I did not think that they were listed under the affirmative list on page 34 of the Bill, or relevant page of the Act as it will be amended, although I may have missed something, and I apologise if I have done so.

Dawn Primarolo (Labour, Bristol South)

I am happy to confirm for the hon. Gentleman that they are the regulations would fall under the affirmative procedure, and that they would be produced in draft for consultation. I said in response to a previous amendment that, although there is not always consensus on some of the issues in the Bill, I hope to ensure, as the consultation would, that before the draft regulations came to the House and the other place for consideration under the affirmative procedure, there was a great deal of agreement about their provisions.

Mark Simmonds (Conservative, Boston and Skegness)

Again, I thank the Minister for her response. I had been led to believe that they were affirmative resolutions.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I missed a little bit of the debate in which the timing was discussed, but neither page 34 of the Bill, nor the Act as it will be amended, includes the new section. Although I do not doubt the Minister’s intention—it is right that the affirmative procedure should be used—perhaps I have not quite understood where affirmative regulations are listed.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful for that intervention, but when the hon. Gentleman momentarily left the Committee Room, the Minister confirmed that the regulations would be introduced on an affirmative basis, as she has just done again in response to the hon. Gentleman’s intervention. I am prepared to take the Minister’s word for it.

Dawn Primarolo (Labour, Bristol South)

Let me put it this way: if there was any doubt that they were not affirmative, they are affirmative now, because I said so.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful to the Minister for that intervention, and for the reassurance that she will seek further clarity from the HFEA. I would be interested in the response that she receives. On that basis, I beg leave to withdraw the amendment.

Clause 24

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 6, in clause 24, page 20, line 10, at end insert—

‘(5) A relevant individual can also be an individual who has reached the age of 18 whose genetic parent was a relevant individual under subsection (4) but did not themselves consult the register and is themselves deceased.’.

There are many circumstances in which a child of a donor-conceived person would like to know their genetic background, and it is now widely accepted that knowing that background is beneficial. A person’s sense of identity is tied up with where they came from, and an increasing number of diseases and illnesses are found to have some basis in our genes, so knowing one’s genetic background is beneficial.

Some people choose not to consult the register, and we should all respect their decision. We would not allow anyone to consult the register if a living donor-conceived person has themselves chosen not to. However, in a specific case where a donor-conceived person has died, their children might like to know their genetic background. The amendment would allow for that person to consult the register only in the case where the donor-conceived person has died.

In the other place, the matter was discussed extensively and the Minister in the other place promised to consider that particular issue further. That is why I tabled the amendment—to try to understand where the Government have got to in their thought process with regard to that point. I accept that it is a complex issue, and indeed I see why the Government, after due consideration of the reading of the Bill in the other place, have decided not to make an appropriate amendment in this area.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I want to raise questions about some of the assertions made in respect of this matter. While I do not oppose the provision of information to people who are interested where that information is held, and it is quite clear in advance that the donor understands that information might be made available, one has to consider the privacy of parents and individuals who do not want their children—that relates to the point raised by the amendment—or people more generally to know that they were donor-conceived.

It is important to identify the key points. My understanding is that it is clearly of benefit to know whether there is a genetic issue in terms of health, that the Bill already provides for that, and that we are talking in these provisions about identifying information generally speaking. The amendment at least is about getting more information and identifying information. Obviously, it is important that people understand that they are not seeking to marry or enter a sexual relationship with someone who is related to them.

One has to be careful, however, before one asserts for sure that there is significant benefit from knowing one’s genetic background, because there may a disbenefit from discovering a family secret: for example, that there was infertility and donor insemination, that that had been kept secret from the person concerned, or that there may have been infidelity involved. It is not clear to me from looking at what little evidence there is in this area that it has been established that someone will always benefit from being able to know their genetic identity and to establish their genetic background; or, for that matter, that people have an absolute right, or even a very strong arguable right, to have that information.

Mark Simmonds (Conservative, Boston and Skegness)

The hon. Gentleman is right to make those points, and that is why it is important that the amendment can apply only to those whose parent is deceased. I think that that makes a significant difference, certainly with some of the “family secrets” that the hon. Gentleman seems to be mentioning. I think that they start to dissipate once the person involved has died.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I do not want to get too heavily involved in the generational issue here, because the provisions are prospective, but one can envisage a situation whereby the grandparents of the person seeking the information did not want it known in their family that infertility services had been used. I think that the provision will have to be prospective since a couple of years ago, so we are talking a number of decades hence, but the amendment would provide that those people do not have any opportunity to prevent not just the child who was conceived from finding out—as is the right under the Bill, regardless of whether I think it is a strong right or always beneficial—but a third party, and it is a third party from their point of view. I will be interested to hear the Minister’s response to the amendment. I understand the basis upon which the hon. Gentleman has tabled amendment. One can imagine that it would be of real interest and significance to an individual. That was said in the House of Lords and I do not dispute the sincerity of people who believe that, but I think that what is left out of these debates all the time, especially in the House of Lords, is the right of the people who were patients receiving fertility treatment to have some privacy.

I am a great believer in people who are having fertility treatment telling their children, at an appropriate age, that they were conceived through donor insemination, but it is not my view that they must do that and it is clearly not the Government’s view, because the Government are not forcing them to do so or automatically releasing information.

I think that the Government are absolutely right, because family dynamics are complex and it is not right for the state to wade in in that way. While the amendment is relatively modest in that respect, here and in other debates I urge consideration for the privacy and memory of the parents and patients. If they have not told someone, the fact of it being found out means that they have, essentially, concealed it. That has implications for all sorts of things, including people being written in and out of wills regardless of their legal entitlement to inherit. A can of worms exists here, and I think that that is why we must have caution in all these areas.

Dawn Primarolo (Labour, Bristol South)

I agree with the points that the hon. Gentleman has just made. I will answer specifically the questions I was asked by the hon. Member for Boston and Skegness regarding the Government’s position. The Bill allows for donor-conceived people, on reaching the age of 16, to contact the HFEA to find out non-identifying information about their donor. This information is, rightly, accessible to donor-conceived people, and has a direct impact on them.

The purpose of allowing donor-conceived people access to information about their donor is to fill a gap in the knowledge that they have about themselves. Many donor-conceived people feel they are missing important information about who they are and where they came from, because one set of genetic information is missing. Information, including identifying information about the donor, is intended to help to address that, and it is for those reasons that provisions are made to allow such people to find out about their donor. Donors sign up to donate on the understanding that such information will be available.

The intention behind the amendment is to shift down a further generation, to allow children of donor-conceived people to contact the HFEA to obtain information from the register regarding their parent’s donor, in a situation where the parent has died and did not make contact with the HFEA. The amendment would allow the child of a donor-conceived person to find out whether they are related to someone with whom they are having, or intend to have, an intimate relationship. In effect, it means giving a child access to details of their parent’s donor conception that the parent had chosen not to access. We can envisage that a parent may well have decided quite intentionally not to access that information, and may have regarded it as personal and highly sensitive. It also raises the question of situations in which the donor-conceived person is not dead but is incapacitated. What do we do then? Should their children be able to go to the HFEA?

The Government said that they would give the issue very careful consideration since it was raised in another place. We remain of the view, having looked again and considered the issues, that access to the HFEA’s register should continue to focus on those directly affected, and that it should be up to the donor-conceived person to decide whether to access the information available to them and who they subsequently choose to pass that information to—including their own offspring.

While we realise that there may be compelling circumstances, it would be difficult to limit access to that specific situation, and wider access to the register would raise broader issues around access to sensitive and personal information. I am also of the view that, on donating, a donor is able to prepare for possible contact from a donor-conceived child, and to envisage the time span in which that may occur. I do not think that it is reasonable for the donor to be much older and unable to expect at what point in time a possible contact might be made.

Although I understand the point made by the hon. Member for Boston and Skegness, we must allow a donor-conceived individual to decide to whom they pass on information if they have accessed it. No one else should have the right to access that information. I hope that that clarifies the Government’s view for the hon. Gentleman. We consider this to be fundamental in terms of the rights of the individuals concerned and I hope that he will not press the amendment.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I rise briefly to say that I wholly endorse what the Minister has said, the reasons that she has given and the thinking behind it. The Government were right to say that they would reflect on this as it was raised with a great deal of support in the House of Lords. However, as I said, I do not think that the other place considered some of the points that the Minister has just mentioned. It was quite reasonable for the hon. Member for Boston and Skegness to raise the issue, but the Minister’s comments apply not just to this amendment, but to the whole area. I hope that we will have a chance this afternoon, albeit briefly, to discuss the implication of what she has just said for some of the other arrangements.

Mark Simmonds (Conservative, Boston and Skegness)

I thank the Minister for her response. Sometimes if one moves probing amendments in Committee, one tends to agree more with the response rather than the initial amendment. At least the Minister has kindly put on the record that detailed consideration of the debate took place in the House of Lords, and she comprehensively set out the reasons for the decision that the Department, and she as the relevant Minister, have made in not changing the Bill. On that note, I beg to ask leave to withdraw the amendment.

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 36, in clause 24, page 23, line 42, at end insert—

‘(10) In this section “reasonable period” means a period of no longer than 3 months’.

The amendment relates to the definition of “reasonable period”. In this section there does not seem to be any definition of what is deemed to be a reasonable period, despite the phrase being used in subsections (6)(b) and (7)(b). I would be grateful if the Minister could clarify her perception of a reasonable period, and whether it will be specified and set down in regulations or whether it will be interpreted as and when appropriate by the HFEA.

Dawn Primarolo (Labour, Bristol South)

We believe it right that if donors wish to ask for specified non-identifying information about the child, they should be able to do so. That right should be made clear in the Act. The clause sets out two possible routes for finding out that information. Information about the number, sex and year of birth of children born from donations is held on the HFEA’s register.

Where donors have donated through a licensed clinic or regulated sperm donation service, the most obvious route for their inquiry will be through that clinic or regulated service. Subsections (6) and (7) provide that the HFEA need not comply with the request from a donor if the clinic or regulated sperm donation service where the donor donated is still operating. That is unless the donor has asked for the information first and the clinic has failed to respond within a reasonable time period, or if it has notified the donor that the information is not held. In such cases, the donor can seek the information from the HFEA, which must comply if it has the information.

The amendment would specify a reasonable time period, which would not exceed three months. If the clinic had not provided the information to the donor within the specified time period, the donor would be able to go straight to the HFEA. I recognise that three months might be considered a reasonable period in which to receive the information, but to specify it in the Bill would be over-prescriptive and bureaucratic, and would not allow the HFEA to determine the policy in the flexible manner that we have set out. I am sure that the hon. Member for Boston and Skegness can understand that it might not always be able to comply with three months, given the access points, the types of information that might be held and the different places that donors might have to go to. We would expect that to be done without unnecessary delay, but I would ask him not to press for a three-month limit to be put in the Bill.

Mark Simmonds (Conservative, Boston and Skegness)

I thank the Minister for that clarification. I tabled the amendment to ensure that she and the HFEA understood the importance of the speed of provision of information and of putting pressure on clinics to provide it as quickly as possible. However, of course I understand her sensible points about being over-prescriptive in the Bill and thereby reducing flexibility. I very much hope that the HFEA will take on board comments made and perhaps even set out in guidelines an initial time scale for providing such information wherever possible. On that basis, I beg to ask leave to withdraw the amendment.

Steve McCabe (Labour, Birmingham, Hall Green)

I am advised that we will probably not be able to complete the clause stand part debate in the time that some of us might have hoped. Consequently, I beg to move that further consideration of the Bill be now adjourned.

Roger Gale (Conservative, North Thanet)

Let me make the position plain. These are extremely complex issues and require a very high level of concentration, if we are to do them justice. I speak for nobody other than myself in saying that I find this quite difficult to follow, and the Chair needs to follow it very carefully. I believe that three hours in one sitting is long enough. I am perfectly happy to suspend the sitting and come back, but it seems that we have covered a great deal of ground today. I think that a period of reflection might refresh us all and allow hon. Members to have a good stand part debate on Tuesday morning.

Further consideration adjourned.—[Steve McCabe.]