(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
Human Fertilisation and Embryology Bill [Lords]
1:00 pm
Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and 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.