Roger Gale (North Thanet, Conservative)

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

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and Embryology Act 1990 is that the gametes, embryos and human admixed embryos will be retained unless consent is withdrawn?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 (Shadow Minister, Innovation, Universities and Skills; Oxford West & Abingdon, Liberal Democrat)

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 (North Thanet, Conservative)

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

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 (North Thanet, Conservative)

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

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 (North Thanet, Conservative)

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 (Bolton South East, Labour)

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 (Coatbridge, Chryston & Bellshill, Labour)

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

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

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

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

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

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

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

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

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

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

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

Roger Gale (North Thanet, Conservative)

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

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

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

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

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

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

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

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

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

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

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

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

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 (Norwich North, Labour)

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

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

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

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

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

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

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

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

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

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

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

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

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.