Dr.
Harris: Does my hon. Friend accept that there has been
some debate on this in recent years? There was debate both outside and
inside Parliament, on the White Paper and on the draft Bill. Under the
Bill as proposed, there would have to be further debate in Parliament
and outside when regulations were brought allowing the manipulation of
eggs or embryos to tackle the problem of mitochondrial disease. There
has been a lot of debate, and there is plenty of scope for
more.
Dr.
Pugh: I would be much relieved if I thought the fine
detail of this were going to be examined by elected Members, but I do
not think that that is the case. I think it is more likely to be the
object of appreciable debate in the HFEA and nowhere else. It will
simply happen. Even so, it is clear that we must know what we are doing
and what the Bill encompasses. Matters are as simple as
that. 11.30
am The broad clause
prescribes circumstances and processes for which regulations may
provide. I am unhappy about such an approach. Had we moved amendment
No. 21, I would have drawn attention to that. Elsewhere in the
provisions that we have dealt with so far, clause 1(5) allows the
Secretary of State to redefine key terms such as gamete
and embryo. There are genuine anxieties about that. If
fundamental concepts of legislation can be redefined on the hoof,
concern will be expressed. We must be fairly clear about what is
happening. It is not as though any of the learned papers that I have
read so far about the provisions establishes a clear, moral consensus.
That does not exist. We have blank cheque legislation. I used that
expression on Second Reading, and do not repent doing
so. The
more positive way in which to express matters is used by advocates of
the Bill as it stands. They talk of future-proofing legislation.
Future-proofing is a more positive way in which to describe what I
referred to as blank cheque legislation. It is fine. I am all for
future-proofing legislation. I do not have a fundamental difficulty
with the concept per se, as long as we future-proof against a set of
principles and moral ideas that we all clearly understand and we know
where they are
heading. If Lord
Walton, who is from the university of Newcastle, sees no problem with
something with which someone who undertakes research can see scientific
and moral difficulties, then transparently, evidently and empirically
that consensus does not exist. I know the Governments
intentions because they have outlined them on many occasions. They have
said that they do not want to provide a loophole for reproductive
cloning. That is entirely fine, and I dare say that they do not want
genetic manipulation to take place either as a way to deal with
mitochondrial diseases, but that is not what the Bill says. The
Governments intentions and their legislation are two different
things. I am therefore genuinely concerned. In a sense, amendment No. 2
would strike out such matters, but it would also strike out laudable
attempts to address mitochondrial disease where the cause is the
mitochondria per se. People might be unhappy about that. I ask the hon.
Member for Boston and Skegness to correct me if I have not understood
the amendment properly. I do not think that the Committee would be
comfortable with such a dramatic outcome.
Mark
Simmonds: I just wish to assist the hon. Gentleman and
clarify the intentions of amendment No. 2. It would strike out the
Secretary of States regulation-making power because the
decision to allow the mitochondrial research would be inserted into the
Bill. As a result, lines 19 to 24 of clause 3 on page 3 of the Bill
would become
superfluous.
Dr.
Pugh: I am comforted by that explanation and anything that
would make the Governments intentions more clear in the Bill
and leaves discretion where it should be. A clear moral consensus about
what may or may not be done would make me feel more comfortable about
the Bill as a whole. However, if we look at it from the point of view
of the parliamentary draftsman, we must say that it leaves the door
wide open to all sorts of things that the Committee has not even
envisaged.
Mr.
Streeter: I am delighted to serve in Committee under your
chairmanship, Mr. Gale. I rise to support the last two
speakers. Whereas the Bill takes great painsto the credit of
the draftsmanto prescribe and regulate tightly activities that
may or may not take place, we find suddenly in subsection (5), the
subject of amendment No. 2, which I support, that the Government may
make regulations in the future to deal with something that is not
permitted under the Bill at present. To correct the hon. Member for
Southport, I must say that the regulations would be made not by the
HFEA but by the
Government.
Robert
Key: By
Parliament.
Mr.
Streeter: The regulations would be made by the Government
tabling a statutory instrument before Parliament. We know the extent of
scrutiny that that can involveperhaps 90 minutes of debate
which, first and foremost, would be within the Government themselves.
There would then no doubt be a short debate in Parliament.
I want to ask
the Minister whether the wording of subsection (5) is as tightly drawn
as it might be. Reading with my legal eyes on, I agree that it could
well become a loophole in the hands of future
Governmentsobviously not in those of this Government, who are
sensible, moderate and regulatory and who we are thrilled are in place
at the moment. We could even have a coalition Government; the hon.
Member for Oxford, West and Abingdon could be the Secretary of State
for Health. We do not know what might happen in future.
The clause is capable of a wide
interpretation and I will explain why. If we read it as it might be
drafted without its sub-definitions:
Regulations may provide
that (a) an egg
can be a permitted egg,
or (b) an embryo can be
a permitted embryo, even though
the egg or embryo has had applied to
it in
circumstances set out by regulation, a process also set out by
regulation, which is
designed to prevent the
transmission of serious mitochondrial disease.
Control over the process and
circumstances is entirely in the hands of the people who write the
regulations. As I understand, that could be far wider than the issue
that my hon. Friend the Member for Boston and Skegness referred to,
which is at the back at the Governments mind. That is the
process by which we take a little bit from one egg, mainly the
mothers, and make an egg which is free from genetic diseases.
Who could argue with the desire behind that? However, in my opinion the
wording of the clause goes far beyond that. As technology develops, it
could allow regulations to be made that take us well beyond that in
terms of circumstances and processes that regulate what egg and what
embryo. I hope that
the Government will look again at that point. Many people are concerned
that new section 3ZA(5) is a loophole, probably unintended, but a
loophole nonetheless. It could end in permitting the kind of
reproductive cloning or genetic manipulation that the Government have
rightly set their face against. I hope that when the Minister responds,
she will not brush such concerns aside as they are held by a number of
people. The point is more about drafting than ethics or science. The
drafting of subsection (5) must be looked at
again.
Dr.
Harris: I rise to support the Bill as drafted and to
follow up the point made by the hon. Member for Salisbury. I am
delighted to see the amendments tabled by the hon. Member for Boston
and Skegness. They press for a more permissive approach on the question
of permitted embryos than the Government envisage. The idea behind them
is that we should not need further regulations, and that there is
enough information to show the likelihood that the technique will be
both effective and safe enough to trial under informed consent. In
addition, we have enough confidence in the regulator to ensure that
those two provisions are policed with regard to effectiveness, safety
and consent, so that we do not need Parliament to approve specific
regulations. Those arrangements could be designed by the
HFEA. I have great
sympathy with that approach. I have always pressed for a more
permissive approach, given that we have an authority that everyone says
is wonderful and adept at making the regulations. I know that the
approach proposed by the hon. Member for Boston and Skegness was
proposed in the House of Lords by Lord Walton, who has connections with
Newcastle university where much of this work is being done by Doug
Turnbulls group. Although I have a huge amount of sympathy with
the hon. Gentlemans approach, one would have to have
regulations to prescribe and circumscribe what we want. In the end,
I can see no other way than to provide for the regulations,
although I have sympathy with what he is doing. It is important that
the House indicates very clearly that we want to be able to translate
researchwhich is currently permitted in this areainto
the clinic, and that we signal very strongly that we are minded not to
oppose the concept of regulations, but to ensure that further scrutiny
is of the regulations, not the principle. I am glad to see that there
appears to be widespread support from all sides of the House for this
sort of approach. I hope in the separate clause stand part debate to
identify another area where we need to ensure that research that does
not come under mitochondrial disease can be translated from the clinic
to clinical therapies for patients.
My hon. Friend the Member for
Southport was not really supporting the approach I just set out. He was
arguing that we cannot simply leave it to regulations, because
regulations would be a simple one and a half hour debate in both Houses
under the affirmative procedure, as set out later on in the Bill.
Clearly, whenever we agree to a regulation-making power, we limit the
amount of amendments that can be made to the regulations. So I hope
that the Government would agree, insofar as they can for this
Governmentbecause it may not be in the time scale of this
current Governmentthat if they do propose to introduce these
regulations, they will produce them in draft for consultation. After
that, the regulations could be reconsidered and brought back again
without having to be formally withdrawn. That would be considered quite
a big step in this place: one rarely sees regulations that are laid in
draft withdrawn, so I hope that the Government will take a consultative
approach to the drafting of the regulations.
I would say again to my hon.
Friend the Member for Southport that there was considerable debate
about this during the consultation period, considerable debate around
this in the White Paper, and considerable debate on the draft Bill. It
was considered by a Joint Select Committee of both Houses and I think
there has been plenty of public, as well as parliamentary,
debate.
Dr.
Pugh: The point that I made that my hon. Friend has not
addressed was in connection with the different ways in which one could
tackle mitochondrial disease, either by doing something with the
nucleus or by cell transfer. One represents a clear step in the
direction of genetic engineering; the other, one could argue, does not
to the same extent. My hon. Friend may not see that distinction, but
other people do. If there is that kind of moral divideit is a
significant moral divide, though it may not be significant for
everybodywould it not be more appropriate not to regulate but
to tighten the legislation sufficiently to circumscribe what the
legislation intends to facilitate?
Dr.
Harris: I accept that point and I wanted to come on to it,
along with the point made by the hon. Member for South-West Devon,
because there is a small problemwhich I admit I did not notice
during the Bills passage through the Lordswith the
phrasing of subsection (5). I just wanted to finish the point that I
was making on the amendments more broadly.
Mitochondrial
DNA, which causes some mitochondrial disease, represents about 0.5 per
cent. of the genes that humans have. The DNA in the mitochondria do not
code for any human attributes. These are genes that have been preserved
through evolution from bacterial inclusions in cells, and therefore are
common across many species, though they will differ between
species. On that
basis, if one accepts that it is possible to change the DNA in
mitochondria without its being considered germ-line gene therapy or
germ-line gene engineering, because we restrict that to nuclear DNA,
then I would argue that it is probably not appropriate to have the same
consent arrangements for donors of mitochondria as for donors of
nuclear DNA. So I question whether amendment No. 33, even within the
construct that the hon. Member for Boston and Skegness has put, is
appropriate, because it gives a status to the mitochondria in respect
of consent that they do not deserve because they do not pass on
recognisable human attributes, which is the basis for the very strong
consenting arrangements that the Minister has
proposed. I would be
grateful if the Minister could clarify that, as at the moment it is not
clear whether there is, or needs to be, any difference in the consent
arrangements for the donor of mitochondrial DNA. Clearly donors must
consent to the donating of the tissue, but it is not clear whether that
is done under the strong and strict consent arrangements that exist
under the Human Tissue Act 2004, or whether the Government envisage
going further and introducing regulations to raise the status of that
donation. I am not convinced that we need to raise the status, as it is
a tissue donation. I would not want it to be seen as a donation of a
genetic attribute, as that would make it more difficult for us to
defend what the Government are doing, with my support, in the
Bill. 11.45
am As this has been
raised, it is appropriate to speak about subsection (6). However, we
will come that in the next debate, so I will not mention it now. On the
issue raised by my hon. Friend the Member for Southport and the hon.
Member for South-West Devon, there may be a problem. I have seen a
document from Human Genetics Alertan organisation with which I
generally disagree in principle and in practicethat points out
this issue. Some mitochondrial diseases, including serious ones, are
transmitted by nuclear DNA coding for some of the proteins in the
mitochondria. The argument would be that the current wording of
subsection (5) would permit in the regulations a process by which the
egg or embryo could have nuclear transfer as the prescribed process, or
at least gene transfer into the nucleus designed to prevent the
transmission of serious mitochondrial disease. The Government have
already said that that is not their intention and I do not believe that
it is the intention of the researchers working on this in Newcastle
university and elsewhere. They have made that absolutely clear. I do
not believe that any Government would produce regulations permitting
that, or that the HFEA, even if it could, would issue a licence for it.
However, if that is the case, perhaps the Government would consider
making that clear in subsection (5) of proposed new
section 3ZA, which sets out what the regulations may provide. They might
for example, at the end of the section
even though the egg or embryo has
had applied to it in prescribed circumstances a prescribed process
designed to prevent the transmission of serious mitochondrial
disease add
transmitted by DNA in the mitochondria.
As I said, the two hon. Members
who spoke before have raised a valid and fair point and I would be
grateful if the Minister could address that in her
response.
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