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and I am reluctant to quote only from New Scientist, unpublished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 ban—it would require a whole new
Bill to overturn it—on 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? Secondly—I suspect that he plans to address this
point—it 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. Gentleman’s 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 position—arguably it is a
better position—as 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
“that— (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
use of one person to provide both egg and sperm could be described as
treating infertility. Even if the regulation-making power only went
that far, it could not
permit— 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 “must”—not
“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 treatment—we 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
mentioned—members of the Committee have received letters and a
briefing from the head of the research department, Professor Michael
Whitaker, the dean of development of the faculty of medical sciences at
Newcastle university expressing his concern about the failure of the
Bill to consider that—will pursue research projects to develop
treatments for fertility that are illegal under primary legislation,
and that would require another Bill in 10 or, judging by precedent, 20
years. That has consequences for future patients, but how would it be
possible to obtain funding for research and to safeguard the careers of
researchers if research funders know that that research is directed
toward a treatment that is banned by primary legislation? It does not
make sense, given what we said about mitochondrial disease. Can we
claim to be an attractive country to researchers on adult as well as
embryonic stem cells when we close down the possibilities of such
therapies? 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 treatment—there are
tens of thousands of such patients—to 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 patients—they 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 consultation—it is important to recognise that they
did so—they 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” even
“for additional regulation on this
issue”,
and that the Bill should provide for that.
I would not go as far as that—I think that the Bill should
provide for regulation-making
powers. 12.45
pm 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 Government’s
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 2004—nearly 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
man’s 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
have the opportunity to say, that only adult stem cell technologies
would be allowed, or that induced pluripotent stem cell technologies
would be allowed if they come to fruition. One could argue that one
could clone an embryo, derive stem cells from it and then derive
gametes from them, and they would be genetically identical because one
was using a cloned embryo of the person whose somatic cell was
used—from the patient who is infertile. However, if that could
be done through adult stem cell technology, the structure of the Human
Fertilisation and Embryology Act 1990 would require it to be done
without the derivation of embryos and it would require the HFEA to ask
questions about that. Scientists and clinicians will take the path of
least regulatory and scientific resistance because they want to bring
their research to fruition.
Dr.
Gibson: Is not the real difficulty in such
research—the hon. Gentleman will know that I am in favour of
research if it will lead to something—that 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: Given the time, I do not want to go into the
science of
this—
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 clause’s 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 woman’s life until ovulation of that particular egg. I do not
really want to go into the matter—I have been drawn into
it.
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