Human Fertilisation and Embryology Bill [Lords]
Dr. Gibson: Just to show that this is not science fiction, will the hon. Gentleman cite the people doing this kind of work, where it has got to, and how long it has been going on?
Dr. Harris: I am happy to do so, and will come to that in a moment. This stem cell technology has made progress in animal models, and in laboratory studies of human cells, in generating gamete precursor cells from bone marrow cells. Bone marrow cells are taken, and gamete precursor cells have been shown to be derived both in animal models and in humans. I am somewhat restricted from going into further detail because I have not seen a recent publication on the human work, and I am reluctant to quote only from New Scientist, unpublished work and the work of researchers.
We do know that there are several leading groups working in this area. In the UK we have Professor Karim Nyernya, who may be known to members of the Committee. He has come to this country because of the legislative support that exists for this sort of research. He has derived sperm from mouse stem cells and has used it to fertilise mouse eggs, and has previously derived early-stage sperm cells, I am told, from human bone marrow. Research in this field is progressing rapidly, and the intention of his research is to look at the possibility of attempting to restore fertility in young men who have undergone chemotherapy. The Bill as drafted effectively places a banit would require a whole new Bill to overturn iton ever using the product of such research to actually treat patients, despite it permitting explicitly the use of gametes that have been grown and matured from gamete stem cells derived from the testes and ovaries, and despite it containing a regulation-making power to allow the use of embryos created from eggs which have been manipulated by cytoplasmic transfer to treat mitochondrial disease.
Mark Simmonds: First, will the hon. Gentleman tell the Committee how many scientists in this country are currently involved in such research? SecondlyI suspect that he plans to address this pointit is theoretically possible to turn an adult skin stem cell into a gamete: one could turn a male adult skin cell into an egg or a female adult skin cell into a sperm. It is theoretically possible, therefore, to produce from stem cells a genetic offspring of one person. I would feel extremely uncomfortably about going down that route.
Dr. Harris: I understand the hon. Gentlemans point, and shall talk in a moment about how that can be precluded using primary legislation and the provision of regulation-making powers. If he is satisfied that it can be so dealt with, I hope that he will accept that we are in exactly the same positionarguably it is a better positionas with the mitochondrial disease regulation-making powers, which might not be as tight as we would want.
I tabled a starred amendment that was not selected, but which was debated in the other place. It can be seen unselected on the amendment paper today, on the Order Paper in the Lords and in the House of Lords Hansard. The amendment would have provided
(a) an egg can be a permitted egg, or
(b) a sperm can be a permitted sperm, even though the egg or sperm has been developed from one or more human cells in a prescribed process designed to treat infertility.
The first reassurance, therefore, is that it would be designed to treat infertility, and I do not think that the
The Chairman: Order. I am sorry to interrupt the hon. Gentleman, but I cannot have private conversations taking place in the Committee Room. Benches are provided outside for that purpose.
Dr. Harris: Even if the provision only went that far, I do not see how any Government could make regulations allowing the sort of thing to which the hon. Gentleman drew attention. Neither do I see how the HFEA could license such a thing. It licenses the treatment of infertility and only allows the use of embryos in such treatment when that is the best way of doing it. The way to treat male infertility is not through the creation of eggs, but through the creation or donation of sperm. I do not think that clinicians would want to go through such a process when the easiest way to treat a man who has his own sperm is not to give him an egg but to provide an egg donor. Similarly, the easiest way to treat a woman who has eggs is not to provide sperm, but to provide a sperm donor.
Nevertheless, after the concerns just raised by the hon. Member for Boston and Skegness were raised in the other place by the noble Earl Howe and others, an amendment was considered there, which specified that the regulations envisaged mustnot may
provide that any sperm be developed from one or more cells of a genetic male and any egg be derived from one or more cells of a genetic female.
That deals with the problem. In Committee in the other place, the Minister and the noble Earl Howe specified that in theory it might be possible to create both an egg and sperm from a male adult stem cell. It is much harder to see how a sperm could be derived from a female cell, because those do not have the essential Y chromosome. As I say, the regulation-making power that I envisage would clearly specify that regulations would proscribe that.
Safety is clearly a concern, as has been mentioned by others, and is catered for in the proposal that I would like the Committee or the Government to consider. If the technology works and has matured, it should be up to Parliament to decide whether it is safe enough for the HFEA to consider licensing it. If Parliament decides that it is not safe enough to allow the HFEA to consider licensing something, Parliament would not draft, confirm or pass the regulations.
Any application would have to be licensed by the HFEA, which Parliament has set up to judge the safety of individual applications of reproductive technology that fall within the law, so there is a second lock.
The HFEA is particularly focused on safety, as is the individual clinician, given the need to take account of the welfare of any child that may result from fertility treatmentwe have had extensive debates on that and know how important Parliament considers it to be.
If we do not allow even a regulation-making power, UK researchers such as the one I mentionedmembers of the Committee have received letters and a
We heard earlier this year of the difficulty that many cancer patients have in getting fertility treatment, whether that is safeguarding their fertility through the freezing of sperm, eggs and embryos, which is not necessarily known to work long term, and accessing such treatment on the NHS. The technology provides the only chance for patients who have not had sperm or eggs frozen before their treatmentthere are tens of thousands of such patientsto have their own children, even before we consider the problem of the shortage of donor gametes. In response to the failure of the NHS to preserve the fertility of cancer patients, the Department of Health spokesman said in December:
We recognise how important it is for cancer patients to be assured that all possible steps will be taken to preserve their ability to have children.
I am suggesting that there is a solution for those for whom preservation by gamete storage simply comes too late.
My proposal has the support of a number of organisations that represent patientsthey want the clause to be amended. Infertility Network UK supports the proposal, recognising that the HFEA must ensure safety, effectiveness and ethical approval, as does Progress Educational Trust.
Patient organisations are not the only ones to urge a change to the measure. When the Government issued their consultationit is important to recognise that they did sothey asked whether there should a regulation-making power. In response, the BMA said:
The BMA agrees that the use of artificial gametes in treatment should be prohibited for the time being. Aside from safety issues, the ethical implications of the use in treatment of artificial gametes have yet to be fully explored. The inclusion of a regulation-making power, however, would be an appropriate way of future proofing the legislation. In view of the likely sensitivities around this issue...we hope that these regulations will be required to go through the affirmative procedure so that there is proper scrutiny by Parliament.
The British Fertility Society, which represents fertility clinicians, would go further than my proposal. It said:
It is the majority view of the BFS that primary legislation is not necessary to ensure good clinical practice. The BFS expects that existing clinical governance regulations and the regulations under the EU Tissues and Cells directive will mean that there is no requirement
for additional regulation on this issue,
and that the Bill should provide for that. I would not go as far as thatI think that the Bill should provide for regulation-making powers.
When asked, scientific organisations have expressed support, which is not surprising because they are all charged with ensuring that it is possible to translate research into the clinic. In response to the consultation, the MRC said:
We agree that there should be inbuilt flexibility to allow the use of artificial gametes if and when research findings demonstrate that this would be beneficial.
In response to the Governments proposition
that the use of artificial gametes in assisted reproduction treatment should not be permitted but that the HFE Act should contain a regulation-making power giving Parliament more flexibility to allow the use of artificial gametes in future should it wish to do so,
the Academy of Medical Sciences said:
Agreed, but it is important that research on artificial gametes is permitted.
As the hon. Member for Norwich, North, will remember, the Royal Society expressed a view in its evidence to the Science and Technology Committee inquiry into human reproductive technologies in 2004nearly four years ago. It said:
At present, it is too early to say whether so-called synthetic eggs and sperm obtained by the in vitro differentiation of embryonic stem cells
or adult stem cells
will provide an alternative source of functionally normal gametes. Clearly, further developments in this area need to be followed closely. However, we do not feel at this time that these recent developments raise any additional ethical or scientific issues that are not adequately addressed in the existing legislation.
We have a situation in which patients want a regulation-making power and scientists back it, and because the procedure is possible as a result of adult stem cell research, it is less ethically difficult than many of the issues that we have debated in the Bill, so on what basis do the Government want to oppose this proposal? They have said that they are concerned about the possible eventual derivation of an egg from a mans stem cell, and I accept that the concern has been raised elsewhere, but it can be addressed by specifying that regulations can prevent such a procedure.
The last part of the jigsaw is whether a regulation-making power that prevents the derivation of sperm from anything other than male genetic cells and the derivation of eggs from anything other than female genetic cells raises issues of discrimination.
Dr. Pugh: My hon. Friend read a quote that mentioned gametes developed from embryonic stem cells. Clearly, there is a difference between ensuring fertility by making up for what the gonads do not produce. In the case of gametes from embryonic stem cells, the paternity or maternity of the child produced would go back to somebody who was unborn. Does my hon. Friend see a moral difference there? Would he wish that to be embodied in regulations?
Dr. Harris: Clearly, there is a difference. That is why regulations can make it clear, and the House would
Dr. Gibson: Is not the real difficulty in such researchthe hon. Gentleman will know that I am in favour of research if it will lead to somethingthat we start with a diploid cell and end up with a haploid cell? How do we get rid of the extra chromosomes? How are they selected? What kind of gamete would it be? It would have only half the chromosomes that are present in the adult cell, so there will be a big difference in the genetic material.
Dr. Harris: All right. I have in my hand a scientific background briefing paper from the University of Newcastle that explains exactly how the process would work. The point is that one derives a gamete precursor, which goes through the usual process of myosis to produce the immature gamete that would be used. I have to tell the hon. Member for Norwich, North that the same issue exists to a certain extent in relation to the clauses reference to a permitted egg. As we know from our earlier discussion, a permitted egg is cells of the female germ line at any stage of maturity. At what point eggs go through myosis to halve the number of chromosomes is a contentious issue because they are frozen mid-myosis throughout most of a womans life until ovulation of that particular egg. I do not really want to go into the matterI have been drawn into it.
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