Dawn
Primarolo: The issue that the hon. Gentleman raises is not
a new problem with regard to the interpretation of the regulations.
Clearly, an embryo outside the body is subject to regulation. However,
he touches on a practical issue for researchers and regulatory
authorities regarding of the purpose of research. I said that when an
egg is developing into an embryo, either a licence would be needed, or
the egg would need to be destroyed. That is the position.
In answer to the hon.
Gentleman’s second question, that matter was carefully
considered. At every point, the struggle—if I may put it like
that—in drafting legislation is to come up with definitions that
clearly define regulation and therefore make the legality of the
regulation work. The Government settled where they did on that basis.
During the debates on the Floor of the House we found, as I am sure we
will find time and time again as the Bill progresses, that there were
very fine judgments and difficulties when going from biological
definitions and trying to permit scientific development and then
putting that into legislation so that it is capable of
regulation.
Dr.
Harris: I am grateful to the Minister for addressing those
points, and I beg the forgiveness of the hon. Member for Boston and
Skegness for responding to the Minister’s comments before he
finishes the debate. On the second point, the Minister is clearly
saying that all options were considered and that this one was decided
on for good reasons. One must accept that at this stage. I was
interested to hear that the practical issue for researchers working on
eggs could be dealt with in one of two ways. First, she said that that
could be licensed. Obviously that would be possible, although it would
be a burden if the intention of the research was not to produce an
embryo or something capable of resulting in an embryo.
The Minister’s other
option was that the egg would be destroyed. Perhaps she cannot give me
more detail now, but if she could clarify what she means by that in a
letter, I would be grateful. Is she saying that if this was unlicensed
work, but the researcher noticed that an egg was dividing on its own,
as long as that egg was destroyed, there would be no question of the
researcher having to get a retrospective licence or being prosecuted?
That would be a significant reassurance for researchers, some of whom
have contacted me to raise their concerns. I ask her to confirm that
now, or to offer useful clarification in a letter to me and other
members of the
Committee.
Mark
Simmonds: As I said at the beginning, these are probing
amendments. I thank the Minister for her thorough and detailed response
and her clear answers both to the amendments and to the comments made
by the hon. Member for Oxford, West and Abingdon. It was never the
intention of the amendment to remove research on single-cell embryos
from the law. We were looking for greater clarity, not a loss of
clarity. Of
course, I accept the prohibitions that are set out and detailed in this
part of the Bill. I also accept the challenges that the Minister
highlighted of translating biological definitions into legislative
drafting and structure. It is always a challenging journey to do that,
and that will be a common theme as we go through the Committee stage.
It is a challenging juxtaposition to get those two things right. With
those comments, I beg to ask leave to withdraw the amendment.
Amendment, by leave,
withdrawn.
The
Chairman: Those who have served on Committees under my
chairmanship before know that I take a fairly relaxed view of stand
part debates and breadth of discussion. It is often helpful for the
Committee to have a broad-ranging debate on a first set of amendments
as it tends to set the discussion in context. However, I am not
prepared to permit two stand part debates, one at the beginning and one
at the end. Inevitably, in this context, with a fairly narrowly drawn
clause, we have already had a fairly broad debate so I suspect that I
may be minded to consider that a stand-part debate is not necessary. It
is only fair that I should tell the Committee that
now. Clause
1 ordered to stand part of the
Bill.
Clause
2Meaning
of “nuclear
DNA” Question
proposed, That the clause stand part of the
Bill.
Mark
Simmonds: I just have a brief question for the Minister
about the definition of nuclear DNA. Why does the clause not include a
definition of mitochondrial DNA, which is obviously different from
nuclear DNA?
Dawn
Primarolo: The clause specifically deals only with nuclear
DNA, and it was required only to ensure that the new definition in
section 2 of the 1990 Act actually clarified the term
“nuclear” to include the pronucleus of an embryo. That
was specifically what we were trying to do here. We did not go on to
define “mitochondrial” for the same reason that I gave
the hon. Gentleman with regard to the definition of fertilisation in
terms of where it was anchored in 1990. There is an accepted standard
biological term in the case of “fertilisation”, as there
also is in the case of “mitochondrial” and therefore it
was considered not to be
necessary. Mr.
Gary Streeter (South-West Devon) (Con): The Minister says
that the Bill deals only with nuclear DNA, but proposed new section
3ZA(2) and (3) refer to “nuclear or mitochondrial DNA.”
Surely that would warrant a definition.
Dawn
Primarolo: The answer that I just gave to the hon. Member
for Boston and Skegness was that we did not define
“fertilisation” because it was not necessary to have a
definition, since there was a clear biological meaning for HFEA to
interpret. The same is true of “mitochondrial.” What was
necessary was to clarify
DNA to include the pronucleus, and that is why clause 2 is here. The
biological definition of “mitochondrial” stands in the
same way as that of
“fertilisation”.
Mark
Simmonds: I am intrigued by this because later on in the
Bill we are going to be discussing allowing mitochondrial DNA to be
implanted to stop mitochondrial disease, but prohibiting nuclear DNA
from being manipulated to stop nuclear DNA diseases being transferred.
There is a distinct difference between the two kinds of DNA, depending
on where they are located within the cell. That is why I am intrigued
as to why there is no distinct definition between the
two.
Dawn
Primarolo: And the answer I am giving is that, where a
definition is contentious, where it is challenged, as it was between
“nuclear” and “pronuclear”, it is necessary
to define. Where it is not, as with “fertilisation” and
“mitochondrial”, it is not necessary because the
biological terms stand. It is not that the Bill is silent on this: it
is anchored by the clear understanding.
Robert
Key (Salisbury) (Con): What a pleasure it is to serve
under your chairmanship, Mr. Gale. Clause 2 of the Bill
refers at the end of the first line to
“the definition of
‘non-medical fertility
services’” in
section 2(1) of the 1990 Act, but the 1990 Act does not mention
“non-medical fertility services”. It is rather important,
since we are dealing with definitions right at the start of the
process, that we are absolutely sure what is meant by the term
“non-medical fertility services”—the phrase is in
quotes in the Bill. I am not at all sure at the
moment. 11.15
am
Dawn
Primarolo: I shall make sure that the hon. Gentleman and
the members of the Committee have a full definition of what that means,
to ensure that they understand the position. I have a feeling that it
will come up later, when we discuss the European Union tissue
directive. I am trying not to jump ahead of myself in the
Bill.
Dr.
Harris: The Government, with the draft Bill, helpfully
provided the 1990 Act as amended by the regulations—I think that
they were the European tissue directive regulations. The regulations
inserted the reference to “non-medical fertility
services”. Those services would
be “any services that are
provided, in the course of a business, for the purpose of assisting
women to carry children, but are not medical, surgical or obstetric
services.” The
European directive required us to widen the scope of some of our
regulations to include that. I commend that document, because it gives
the 1990 Act not only as amended by the draft Bill, but also as amended
by the
directive.
Robert
Key: On a point of order, Mr. Gale. It seems
appropriate for that document to be made available to the Committee, if
the Bill as we have it does not take account of
that.
The
Chairman: The hon. Gentleman pre-empts the announcement
that I was about to make. That document will be made available. I
apologise that it is not here. Why I apologise, I am not sure. I do not
think that it is my responsibility, but we will make sure that it is
made
available.
Dawn
Primarolo: It is this
document. Mike
Penning (Hemel Hempstead) (Con): Where is
it?
Dawn
Primarolo: It was circulated with the Bill. If it is not
in the room as
well—
The
Chairman: Order. For clarification, we will ensure that
that document, whether or not it has been circulated, is made available
in the room in time for this afternoon’s sitting. Everyone
happy?
Mark
Simmonds: May I say one final thing on clause 2? I am
trying to draw information. Unusually, I am not particularly happy with
the Minister’s response. I understand about the broader
definition. As I said before, that will be one of the main challenges
and themes running through the Bill. However, there are distinct
differences between mitochondrial DNA, nuclear and pro-nuclear DNA. I
think it would be sensible if the relevant individuals went back and
gave some thought to whether that distinction needs to be made clear in
the Bill. Question
put and agreed
to. Clause 2
ordered to stand part of the
Bill.
Clause
3Prohibitions
in connection with
embryos
Mark
Simmonds: I beg to move amendment No. 1, in
clause 3, page 3, line 7, at
the end insert ‘except
when the egg has in prescribed circumstances undergone a prescribed
process designed to prevent the transmission of serious or
life-threatening mitochondrial
diseases.’.
The
Chairman: With this it will be convenient to discuss the
following amendments: No. 2, in
clause 3, page 3, leave out lines 19 to
24. No. 33, in
schedule 4, page 67, line 8, after
‘gametes’, insert ‘including the
mitochondria,’.
Mark
Simmonds: Clause 3 deals with prohibitions in connection
with embryos. Amendment No. 1 relates to the transfer of some serious
and life-threatening diseases through the mitochondrial part of the
cell—the outside part, surrounding the nucleus—which can
be translated through generations. I am supportive of mitochondrial
research, which could make a significant contribution to
eradicating—certainly reducing the incidence of—some
serious diseases that are passed on through the generations. The
amendment would place a reference to mitochondrial transplant in the
Bill, rather than in a regulation-making power. Such a serious area of
medical research clearly
throws up, as other parts of the Bill do, important moral and ethical
issues, which Parliament needs to debate
thoroughly. You may or
may not be aware, Mr. Gale, that there are no mitochondria
in sperm. Scientists are working to remove the nucleus of a cell of a
woman with a mitochondrial disease, place the cytoplasm of a healthy
woman’s egg in there, and then fertilise it. Once normal
mitochondria are established, future generations will also have normal
mitochondria. The controversial part of this is that the resulting
child will have 99.5 per cent. of the mother’s genetic material,
100 per cent. of the father’s genetic material and clearly 0.5
per cent. from a third party, although the DNA in the
mitochondria—this is the part that I think is very
significant—carries no information that defines any human
attributes. Indeed,
Professor Turnbull at Newcastle university has carried out under
licence a process whereby an ovum from a woman with a mitochondrial
disease has been fertilised by her partner’s sperm. As soon as
the first cell is formed, it contains two pronuclei, one from the woman
and one from the partner, containing 100 per cent. of his
DNA and 99.95 per cent. of hers. However, at the moment, the licence
from the HFEA does not allow this embryo to be implanted in the woman.
I think that this needs to be changed in the actual Bill rather than
through regulation-making
powers. Amendment No. 2
removes the regulation-making power, which would be superfluous if the
reference was included in the Bill.
Amendment No.
33 is a consequential amendment that, if mitochondria donation is
permitted under amendment No. 1, ensures that consent is received from
a person whose mitochondria are used in treatment. Mitochondria are
tiny parts of the gamete, so it is important that the Bill refers not
just to whole gametes but also to parts of gametes, and it is
absolutely important that consent remains a fundamental cornerstone of
the Bill and this particular part of the
Bill.
Robert
Key: I think I am right in saying that I am the only
Back-Bench member of this Committee who is a veteran of the 1990
Standing Committee—although I am delighted to acknowledge the
Minister as another veteran of that Bill. The amendment raises issues
that are absolutely fundamental to this Bill. I entirely support what
my hon. Friend has been saying about this specific issue. However, it
raises the more fundamental issue of the purpose of the legislation and
the process by which we need to consider it.
In the 1990 Act, we tried to set
out the broad framework and established the HFEA as the body of
specialists charged with carrying out the wishes of Parliament. That
was one reason why the HFEA was never designed to be made up of people
who were, on the one hand, very pro-science and pro the processes
involved, and on the other hand, deeply philosophically and ethically
opposed to it. That was not the function of the HFEA.
In terms of the legislation now
before us, the pre-legislative scrutiny Committee of both Houses, on
which I and others here sat, was equally clear that Parliament’s
role was to establish the broad legislative framework, and the moral
and ethical dimensions
within which regulations should be made, by those who best knew what was
happening. One of the problems from 1990 onwards—it was
inevitable and it was forecast—was that science would always be
ahead of Parliament. Parliament’s duty was to ensure that the
Government of the day could take account of improvements in medical
science and technology, of movements in public attitude and in the
scientific approach to the moral and ethical issues. It was to ensure
that the regulatory body made the final judgment on individual cases
and applications for research projects and clinical trials. That is
what we are up against here. Since I, along with the
pre-legislative joint Committee, recommended this procedure, I would
prefer to see this particular clause stand as it is, and certainly not
see it removed. That does not devalue what my hon. Friend the Member
for Boston and Skegness has said. He is absolutely right. However, it
does mean that we should not tinker with the fundamental principle that
it is for Parliament to set the broad parameters and for the regulatory
authority to decide the
detail. Dr.
John Pugh (Southport) (LD): The business end of this group
of amendments relates to subsection (5), which is related in turn to
subsection (6), which repeals a section of the Human Reproductive
Cloning Act 2001—which, I believe, is repealed in full elsewhere
in this piece of legislation. There are some anxieties about doing
that, but there is a desirable goal to be achieved, namely, preventing
the transmission of serious mitochondrial disease. I support attempts
to achieve that. The problem is that there are many ways to do it.
Pre-screening
is one way with which we are familiar. However, if we look at nuclear
transfer, which appears to be the object of the regulations mentioned
in the Bill, there are different ways in which that may be done. There
is the simple case of transferring one person’s egg into another
person’s cytoplasm. There is also the transferring of a
fertilised embryo into the cytoplasm of a third person. That creates
some concerns. Lord Walton announced in the House of Lords that
researchers at Newcastle university had found successful ways of doing
that, and he pointed it out as something else that was new and which
could be authorised by the legislation and subsequent
regulations. It is an
inescapable fact that some mitochondrial diseases are not a product of
diseased mitochondria per se, but have an origin in the nucleus of the
cell itself. That is an indisputable scientific fact, and I do not
think there is any argument about it. It would follow from that,
necessarily, that regulations are therefore capable of prescribing in
this particular case manipulation of the nucleus of human cells or some
form of connected engineering. The Minister can contradict me on that,
but it seems to me a fairly transparent reading of the legislation as
it stands before us. It does not seem to be the
case—particularly as we have not repealed the Human Reproductive
Cloning Act 2001—that there is a loophole whereby cloning can
also be authorised.
There are genuine ethical
concerns here. I am concerned that this is, in a sense, carte blanche.
It is an opportunity for a number of things to happen, some of which we
will be comfortable with, and some of which
we will not. Lord Walton, in the House of Lords, said that he thought
this probably was encompassed by the legislation. However, in a less
than complimentary article in Nature, Dr. Chinnery, who
conducted the research to which Lord Walton referred,
said: “I
wouldn't feel comfortable doing it [in patients] now for a number of
reasons ... There are a number of scientific, legal and ethical
issues—we've got to engage in a debate to ensure that society
feels this is the right thing for us to
do.” Who is going to
engage in the debate? It seems to me that if we leave the clause as it
stands, the debate is only going to be had in the HFEA and nowhere
else.
| 
