Human Fertilisation and Embryology Bill [Lords]

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The Chairman: 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.
Dr. Harris: 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—
The Chairman: 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.
Dr. Harris: 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.
1.15 pm
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.
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.
The Chairman: 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.
Dr. Brian Iddon (Bolton, South-East) (Lab): 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?
Mr. Tom Clarke (Coatbridge, Chryston and Bellshill) (Lab): 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.
1.30 pm
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.
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