Dawn
Primarolo: This has been an interesting debate. There have
been quite a few misunderstandings about the intention of the clause,
which I hope that I can clarify.
Mitochondrial diseases are a
collection of life-threatening conditions caused by mutations in the
small amount of DNA found in the mitochondria. The mutations affect
children and cause illnesses and other conditions such as fatal liver
failure, stroke-like episodes, blindness, profound muscular weakness
and diabetes. Research is currently being carried out under an HFEA
licence to look at ways to avoid mitochondrial diseases.
In recognition of the severity
of those conditions and the potential of this research to provide an
effective treatment, the Bill provides, through a regulation-making
power, for eggs or embryos that have had applied to them a specific
process to avoid serious mitochondrial diseases to be considered as
“permitted” and therefore used in treatment. The
particular process and the particular circumstances in which it would
be appropriate would be detailed in the regulations, and I want to come
back specifically to how we would proceed with such regulations. First,
I shall deal quickly with the
amendments. Amendment
No. 1 adds the words “or life-threatening”, so that the
technique could be used to treat serious or life-threatening
conditions. I say very gently to the hon. Member for Boston and
Skegness that, as I currently see it, that does not add anything to the
Bill, which already allows for serious conditions, and clearly,
life-threatening conditions are serious. The amendment seems
unnecessary at that level, but it would also limit the way that the
technique could be applied by restricting it to eggs only. That would
mean that, if should it transpire, following research, that the best
way to avoid serious mitochondrial disease would be through modifying
recently fertilised eggs— which would therefore, according to
the definition in the Bill, be embryos—it would not be
possible. If the
regulating power were removed, there would be no flexibility to return
to it in future. I want to be absolutely clear that the Bill provides
limited powers for secondary legislation to ensure that the definitions
of gamete and embryo are clear, and strictly limited powers to allow
for the treatment of mitochondrial diseases at the embryonic stage.
They are all affirmative resolutions by both Houses. There has clearly
been some comment about what would precede the debates in both the
Houses, and I shall come to that shortly.
Amendment No. 3 would amend new
schedule 3ZA by including in the types of treatment for which
counselling must be offered a specific reference to
mitochondria. That would ensure that counselling was afforded if
mitochondria of gametes were used in the treatment services rather than
the gametes themselves. The amendment is not necessary because even if
mitochondria were extracted from the egg, the egg would still have to
be used for the purposes of these provisions, and the couple receiving
the treatment would still be offered counselling. There is no need to
add an additional provision. On the relating power included
in clause
3—
Dr.
Harris: Can the Minister clarify that there would not need
to be counselling of the person providing the mitochondria in such a
process, but just the couple having the
child?
Dawn
Primarolo: At this stage I am referring just to the
couple. I am coming on to the regulation-making power, what it can do,
how we would proceed, the sort of questions that may be raised, and why
it is not currently possible to put that into the Bill because of the
process of the research.
The regulation-making power in
the clause is to make secondary legislation, and it is about helping
couples to conceive a child without a serious medical condition. It is
not about reproductive cloning on which the Government are absolutely
clear and committed to a ban. The Bill makes crystal clear the
definitions of what is a permitted embryo and therefore what can be
placed into a woman.
To date, research is looking at
transferring genetic material from a recently fertilised egg from the
couple seeking treatment into a donor egg with the genetic material
removed. That does not involve somatic cell material. It is not
anticipated that it would. The commitment to the ban on reproductive
cloning and oversight of the technique as a whole would be ensured by
setting out the specific process in regulations, and those regulations
would be subject to the affirmative
procedure.
Dr.
Pugh: Will the right hon. Lady give
way?
Dawn
Primarolo: Will the hon. Gentleman be a little patient? He
raised a lot of important issues in respect of how we will proceed with
the regulations, and I intend to answer them.
It is not clear whether the
research will demonstrate more success with eggs or embryos, hence the
matter of whether it is specifically in the Bill. Although to date it
focuses on very recently fertilised eggs, which under the Bill’s
definition would be an embryo, we cannot rule out the possibility that
eggs may offer the most successful treatment. It is therefore essential
that the possibilities are not limited and that all treatment options
are left open by ensuring that the prescribed process could be either
for eggs or embryos. In
addition, details relating to the circumstances of mitochondrial
donation can be provided for under the regulations as and when they are
drafted and consulted on—both points made by the hon. Members
for South-West Devon, for Southport and for Oxford, West and Abingdon.
That would include consideration of whether all the donor information
would apply to the mitochondrial donors. There is also scope to
amend specifically the relevant consent provisions through the
regulations. In addition, separately from the regulations, it would be
standard practice in a clinic that any person donating eggs or material
used to create an embryo, such as cells, would provide consent and be
given the opportunity for
counselling. Returning
to the point made by the hon. Member for Salisbury about the importance
that Parliament sets on broad parameters and the way that we have
proceeded in all the debates since 1990, the first step would be to
prepare draft regulations for consultation. Because of the issues that
will be raised, a full consultation would be undertaken in much the
same way as we have done in respect of many aspects of the
Bill. The results of
the consultation would be considered. Amended drafts would be made
available, if necessary for further consultation before matters came to
this House and the other place for debate and affirmative resolution.
Because there are so many questions that we cannot yet answer, the Bill
provides for the principle, but not the means—the regulations.
They can be drafted only when the research is at a more advanced stage.
That satisfies the dual principles that Parliament seeks to achieve. We
want to approve—and rightly so—the specific details of
the techniques prescribed in the
regulations. The
regulating power would allow for consideration and consultation. It
would be necessary to gather the views of the public, ethicists and
relevant stakeholders on the appropriateness of using donor eggs for
that specific process. That would need to be considered at that stage.
The Bill provides the flexibility for further consideration by the
public and Parliament, and for the specific details of the techniques
to be specified in regulations. More importantly, the Bill allows that
once the safety of the technique is established and not before. The
provisions of the Bill will provide opportunities for couples to have a
child safe in the knowledge that they will not suffer from serious
mitochondrial conditions that may affect their families. That is
precisely the intent. On that basis, I hope that the hon. Member for
Boston and Skegness will reflect on the fact that his amendments would
weaken the intent and curtail the debate so that it can be held at the
appropriate time, when we have more accurate indications of the science
and what we might be agreeing
to. 12
noon
Dr.
Pugh: The Minister used the phrase “crystal
clear”. My point is that it is not crystal clear from the
phrasing of the Bill that interference with somatic cells of the
nucleus is prohibited. In fact, as the Bill is written, it is allowed.
She has said that regulation will preclude that, but regulation is not
legislation, and she might not be the regulator in the future. Would
she confirm that? I know what the Government’s intentions are
and I know what the regulations are likely to address if she is the
Minister, but the Bill as it stands allows what I said, even though it
does not want to do
so. The second point
that I want to make, briefly, is about the scope of regulation, which
the Minister has not really responded to. We are debating a Bill about
human fertilisation and we are allowing “embryo”,
“egg”, “sperm” and “gametes”
to be redefined by regulation. If the hon. Member for Norwich, North
were here and we had a terrorism Bill with a clause saying that
“terrorism” could be redefined by regulation at a date
subsequent to the passing of the Bill, he would be frankly appalled.
There is an issue about the range of regulation, and also about what
regulation can do and what it
does. Dawn
Primarolo: I said to the hon. Gentleman that I did not
agree with his interpretation. More people take my view than take his.
This is precisely the type of debate that has taken place since the
1980s about interpretations of what is possible and of the law. I
believe that the fears that he holds will not come to pass, and I am
convinced that the Bill protects that. I am grateful for what he says
about what he believes will be done if I am the Minister—that
would be the case—but I have absolute confidence that every
parliamentarian in the House, whoever happened to be the Minister at
the relevant time, would ensure that the scrutiny of the proposals was
commensurate with the clear wishes of the
House.
Dr.
Harris: Will the Minister give
way?
Dawn
Primarolo: Just a minute, please. The clear wish of the
House—in the past, now and in the future—is for the
issues to be scrutinised thoroughly. The reverse would be true if we
tried to put an incomplete definition in the Bill that did not stand
the test of time because it was drafted before the knowledge was
available.
Dawn
Primarolo: I give way, once more, to the hon.
Gentleman.
Dr.
Harris: I am grateful to the Minister for giving way to
Opposition spokespeople who are probing her. I am grateful for her
answer, which is clear as far as it goes. I raised a specific point
that was made more generally by two other members of the Committee.
Even if she proposes to do nothing about it, will she accept the
principle of what regulations could provide, even if that is not her
intention or, in her judgment, the intention of any future Minister? Is
it her view that the provisions might permit a process designed to
prevent the transmission of serious mitochondrial disease transmitted
by nuclear DNA, not just by mitochondrial DNA? If she accepts that that
is possible, and that people might therefore think that it is possible
in the future by regulation, does she see any merit in having a look at
that before Report to determine whether—very carefully and so as
not to preclude any scientific advance—the provision could be
narrowed sufficiently to make it absolutely clear to those who worry
about a slippery slope and over-permissive legislation regarding
genetic alteration that there may be scope to narrow things
somewhat?
Dawn
Primarolo: To answer the point about redefining or adding,
which was raised by the hon. Member for Southport: no. It is simply
incorrect to assert that they can be redefined by secondary
legislation.
The hon. Member for Oxford, West
and Abingdon is theoretically correct, and if he can think of a better
way of doing that, that is fine. However, nobody has so far managed to
do so—including him, during pre-legislative scrutiny.
The Government have stated
clearly that there should be a prohibition of genetic modification such
as the Bill provides, so it is, frankly, dangerous for the hon.
Gentleman to move into the sphere of what might theoretically be
possible, even though it is prohibited, because he undermines the
principles in the Bill to which he is
committed. I think we
have had a very interesting debate. This is a very difficult
area—there are not many simple areas in the Bill—but I
hope that the thoroughness of the consultation and the extensive
contributions that have been made to the process satisfy members of the
Committee that the Bill is as accurate and as well crafted as possible,
and that there is therefore no reason not to proceed with the
arrangements in the clause. When the hon. Member for Boston and
Skegness replies, I sincerely hope that he will consider withdrawing
his amendment, at least to allow further reflection, rather than
pressing it to a
Division.
Dr.
Harris: I thank the Minister for responding to my point. I
appreciate it when she addresses a point that I raise. I accept that
there is a risk of being over-prescriptive for fear of something that
is theoretically possible. She knows that I want to see something that
allows Parliament to have confidence in regulation, but that is not
over-regulatory as far as scientists, researchers and clinicians are
concerned. I want something that allows this country to be seen as a
properly regulated, ethical place in which to do research, but a place
that allows research to go on.
I confess that I did not spot
this issue in the pre-legislative scrutiny period. I do not find it
easy to acknowledge that it was pointed out to me by Human Genetics
Alert, an organisation that, I think, gets it wrong a lot of the time
and interprets incorrectly some of the proposals that we are
addressing. The Minister has accepted that there is a point here. I
have not thought about what the drafting would be, but I think that she
has given an invitation to others to look at whether there can be
drafting that makes it very clear that we are not envisaging the
alteration of nuclear DNA. She mentioned that the Bill provides for a
ban on the alteration of nuclear DNA, which is found in proposed new
section 3ZA(4), which
states: “An
embryo is a permitted embryo if...no nuclear or mitochondrial DNA
of any cell of the embryo has been altered”.
That situation is altered, as
far as mitochondrial DNA is concerned, under subsection (5), or at
least that is the intention. In other words, the ban that rightly
exists on nuclear DNA alteration is in the same terms as the ban on
mitochondrial DNA alteration, which subsection (5) overturns subject to
regulations. Although I
am reassured—the Minister knows I am reassured—of the
Government’s intention on the existing ban, other people may
consider that this provision does allow regulations to make provision
on that. While I accept the Minister’s sincerity, and indeed
her judgment, if it is possible for this to be dealt with at a later
stage, I think that we
should. Dawn
Primarolo: Does the hon. Gentleman accept that it is
absolutely the Government’s intention to ban this? I understand
the point that he is making. Although I am utterly convinced that this
work has been done, I will do all I can in this process as the
Minister—including reflecting on the point he has made—to
ensure that what I am saying is absolutely correct and there are no
lacunae or any way that the situation could be
undermined.
Dr.
Harris: I absolutely accept the Minister’s position
and that she does not envisage any alteration to nuclear DNA being
permitted under regulations. I also said that I agreed with her
judgment that no other Government would permit this. Such interventions
show her to be the thoughtful and helpful Minister who she is. It is
extremely valuable that she has given us the opportunity to think
further about whether action might be necessary—I accept that
she does not say that it is necessary to do something—and, if it
is judged necessary, whether it can be done without being
over-restrictive.
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