Mark
Simmonds: Clause 1 concerns the meaning of
“embryo” and “gamete”. I have tabled the
amendments—I acknowledge that they are probing
amendments—as an attempt to extract from the Government the
logic behind the changes to the 1990 Act and to determine whether this
is merely to do with scientific advancement, or whether there is
something more fundamental behind the changes proposed. The amendments
would bring the wording of the provisions back in line with that in the
1990 Act, which essentially says that there is not a true embryo unless
the embryo has been fertilised. The amendments would make the
definition clearer than what is proposed in the
Bill. Before
I run through the differences between the amendments, I would ask the
Minister about the fact that changes due to scientific
advancement—for example, clone embryos and licensed hybrids,
which are based on the court judgement that was made—are allowed
under the wording of the 1990 Act. If those have been allowed under the
wording of the 1990 Act, why is there a necessity to change that Act in
the way proposed in the
Bill? Amendment
No. 17 addresses the fact that there is no definition of fertilisation
anywhere else in the Bill. It would be helpful to understand why that
is the
case. Dr.
Ian Gibson (Norwich, North) (Lab): I dread making this
intervention, but whenever I see the word “zygote”, I
always think that it is a single cell. I do not want to get into
arguments meaning that a later process is rolled out of order because
of some “Oxford English Dictionary” definition. Would the
hon. Gentleman like to say where the two-cell zygote comes from? Two
cells are never a zygote; one cell is a zygote. The hon. Gentleman was
once a zygote; that was when he was a single cell with everything else
to do in terms of multiplying and so
on.
Mark
Simmonds: As indeed was the hon. Gentleman. That was why I
said that these were probing amendments. I am attempting to draw from
the Government exactly why these changes to the 1990 Act have been put
in the Bill. I do not think that there is a definition of fertilisation
elsewhere in the Bill, so it would be helpful if the Minister would
establish why that was the
case. With amendment
No. 18, we want to understand about
the “cells of the female
germ lines at any stage of
maturity”. There is no
definition of “eggs”, which include the cells of the
female germ line. Amendment No. 19 relates to “sperm”,
which includes “cells of
the male germ line at any stage of maturity”,
and, again, there is no definition of that
in this part of the
Bill. 10.45
am
Dr.
Harris: I declare an interest as a member of the British
Medical Association medical ethics committee, although I will not seek
to speak about the Bill in
Parliament on behalf of the BMA or the ethics committee, except where
stated. The group of
probing amendments is useful because it gives the Government the
opportunity to clarify why they have chosen such a formula for the
definitions. I would note, however, that they are clearly probing
amendments, because without the deletion of the proposed new subsection
(1)(b) in subsection (2), one would still include an egg that was in
the process of fertilisation in the definition of
“embryo”. My
understanding is that there has always been some doubt about whether an
egg in the process of fertilisation would be covered by the 1990 Act.
The provisions would put it beyond doubt that it would. The alternative
would be that an embryo was not created until the process of
fertilisation was complete. I would be grateful if the Government could
explain, for reasons of clarity, why they have gone for the suggestion
that an egg “in the
process of fertilisation or...undergoing any other process capable
of resulting in an
embryo” is the chosen
option. My
concern with the Government’s formulation is that some work is
being done on eggs. Eggs are extremely fascinating cells from a
scientific point of view, and a lot of insights into fertility and
basic biology are made by studying eggs. It is quite possible that,
during the study of eggs, an egg might spontaneously divide through the
process of parthenogenesis. Although the resulting entity does not
develop much further, it is a dividing egg. For example, activating an
egg either by the application of some compounds, or by providing an
electric charge, can result in parthenogenesis. I would be grateful if
the Minister could clarify whether such an egg undergoing
parthenogenetic division—without the addition of sperm and in
its haploid state—would still be an embryo for that
purpose. If that is the
case, it means for researchers something that was raised in the House
of Lords regarding a potential offence. Any researcher working on eggs
without a licence from the Human Fertilisation and Embryology
Authority, as they are permitted to do under regulations passed almost
immediately after the 1990 Act, would run the risk of finding that they
had created something defined under the Bill as an embryo if a
parthenogenetically dividing egg—after just one
division—was considered to be one. Without a licence,
researchers would be committing an offence, albeit inadvertently and
with no intention of creating an embryo, and although something had
been created that clearly could not develop beyond its initial
division, because it had only half the chromosomes. No one is
suggesting that a parthenogenetically dividing egg in vitro could
develop significantly
far. The worry is that
if one creates an accidental “embryo”—under the
definition proposed—one finds that one is liable to prosecution,
or that one would need a licence for all work in case an embryo was
created. That would defeat the purpose of much of the appropriate
deregulation that was created after the 1990 Act to allow gametes to be
studied in isolation without a process of fertilisation or
cloning—clearly that would require a licence. I would be
grateful if the Minister could offer any reassurance or provide her
understanding about whether people currently working
in egg research without a licence for embryos would have to go through
the expensive and over-regulatory process of having to get a
licence. I am not sure
whether the hon. Member for Norwich, North has a good point about
amendment No. 17, but as I say, it is a probing amendment. My other
point is about amendments Nos. 18 and 19. The question of whether the
Government were being helpful or unhelpful by defining eggs
as “including cells of the
female germ line at any stage of
maturity” was
explored thoroughly in the Lords. I came to the view, which was shared
by people from the science community, that the formulation given by the
Government was helpful for a number of reasons, but mainly because if
that was not in the definition of eggs, the permitted eggs and
permitted sperm approach taken in clause 3 would not, without major
amendment, allow in vitro maturation of gametes to be used in the
creation of embryos. Sometimes, particularly with young children whose
fertility is being preserved prior to chemotherapy, a biopsy would be
taken of spermatogonal or ovarian tissue, and gametes would hopefully
be derived from those gonadal stem cells in vitro. They would not be
stem cell derived gametes; they would be gonadally derived. Without
specifying that, it is extremely difficult to construct legislation
that allows such a thing. I was reassured by debates in the Lords that
the Government are doing the right thing with this definition, although
there were a number of concerns. I hope that the Government will
confirm that their approach is right.
Dawn
Primarolo: The drafting and the consultation about
updating the legislation worked from the 1990 Act. During the passage
through Parliament of the Bill that became that Act, the point at which
the regulation of a human embryo should begin was discussed
extensively. As a result, the Act provides that it should begin at the
initiation of the process of fertilisation, rather than at the point at
which the embryo reaches two cells.
To answer the point raised by
the hon. Member for Boston and Skegness about the definition of
fertilisation, the 1990 Act did not seek to define fertilisation. It
was felt that that was a common term used in biology and that the HFEA
should make a decision about the term and what it meant within
legislation. As he pointed out in his opening remarks on the probing
amendments, that Act has stood us in good stead and works. That is a
specific answer. We sought to ensure that we were maintaining the
position by keeping the wording that an embryo includes
“an egg that is in the process of
fertilisation”.
The Science and Technology
Committee stated in its 2005 report “Human Reproductive
Technologies and the Law” that the definition of an embryo
should be changed to begin only at the two-cell stage. That was based
on concerns that research might be restricted into the treatment of
mitochondrial diseases. Those concerns have been met in the Bill, first
through the definition of “embryo”, as it now includes
any human embryo created by any process, not just fertilisation, and,
secondly, by removing the prohibition on the genetic modification of an
embryo for research. Mitochondrial disease research has already been
licensed by the HFEA and the changes in the Bill
bring
further clarification on that matter. That answers the point with regard
to legal cases. We seek
to put the position beyond doubt by ensuring that it is reflected in
legislation, rather than dealt with by reference to a court judgment. I
appreciate that these are probing amendments, but they would reverse
the position outlined in the 1990 Act, so that, for the purposes of the
legislation, an embryo would not come into existence until the two-cell
stage—the point at which the nucleus of an embryo fully forms
for the first time. They would, in effect, remove single-cell embryos
from regulation, meaning that the creation, keeping, storage and use of
single-cell embryos would fall outside the law.
Research on
single-cell embryos could then be undertaken without a licence,
provided the cell did not divide, and it has clearly been the view of
Parliament that we cannot allow the creation, keeping, storage and use
of single-cell embryos to fall outside the law. These embryos should be
regulated in the same way as embryos at the two-cell stage or later.
The Government’s position is therefore that the existing
principle, which remains unchanged since it was formed in 1990, should
be upheld. The
definitions of “egg” and “sperm” in clause
1 are of equal importance to the Bill and to the HFEA, because terms
such as “gamete”, “sperm” and
“egg” are vital in setting out the authority’s
regulatory remit. While we are often clear about what these terms mean
from a biological point of view, definitions can be interpreted
differently in the context of legislation. These definitions are
designed to set out an effective remit for the authority, clearly
indicating what biological material it regulates. How are we to make
sure that biological definitions can be interpreted through a
regulatory framework? That has always been the challenge. It was the
challenge faced by the Committee that considered the 1990 Bill, and, as
the hon. Gentleman rightly said, the resulting Act has stood us in good
stead. The definitions
of the terms “gamete”, “sperm” and
“egg” were drafted to include cells of the germ line at
any stage of maturity, and it should be noted that the wording of this
provision follows the precedent of section 3A of the 1990 Act, which
was inserted by the Criminal Justice and Public Order Act 1994 and
ensured that female germ line cells taken from an embryo or foetus
could not be used in treatment.
The Bill is
drafted to include germ line cells to ensure that the storage and use
of ovarian tissue containing immature egg cells to create embryos is
regulated by the HFEA and that, following maturation in the laboratory,
any egg produced can be used in treatment. It also sets out a
prohibition on placing anything other than a permitted egg, sperm or
embryo into a woman, and so it is important that the definition of
“gamete” includes immature cells of the female germ line.
This ensures that the use of in vitro maturation within the context of
assisted conception treatment is regulated and permitted. I am sure the
hon. Gentleman understands that this is particularly important for
women who are undergoing chemotherapy or radiotherapy and will lose
their future fertility. Freezing mature eggs is difficult and often
unsuccessful, whereas freezing ovarian tissue containing immature eggs
is much more reliable.
The legislation that deals with
these difficult and complex areas needs to be as clear as possible to
ensure that the legality of complex reproductive medicine is equally
clear. The clause as it stands ensures clarity around the regulation
and use of single human embryos and immature eggs and sperm, making it
clear that single-cell embryos fall within the authority’s remit
and that immature gametes may be matured in the laboratory and used in
treatment. 11
am If
the amendments were made, clarity would be lost and single-cell embryos
would fall outside regulation. The law would, at best, become uncertain
and, at worst, prohibit the use of immature eggs and sperm in
reproductive therapies. In trying to address what were the difficult
challenges in 1990, the Government have listened very closely to the
evidence presented and to debates about the Bill in another place. We
have proposed the wording as it stands. I assure the hon. Gentleman
that the Government seek to continue to regulate and enforce according
to the principles of the 1990 Act, which I know that he and many of his
hon. Friends support. I hope that he accepts that his probing amendment
has secured comments on the record for clarity and that he will
withdraw it at as suitable
time.
Dr.
Harris: I would be grateful if the Minister would address
herself to the point that I raised about her expectations of the impact
of the new wording on people who are researching eggs, but not putting
them through a process of cloning or fertilisation. In their research,
an egg may start to divide as a consequence of manipulation that is
done for perfectly legitimate scientific reasons—not as the
deliberate end point of the research, but just as a happenstance. The
1990 Act stated: “embryo
means a live human embryo where fertilisation is complete,
and...references to an embryo include an egg in the process of
fertilisation”. I
understand that. It has been transferred to the Bill, but the new Bill
also states that “references to an embryo
include an egg” not just
in the process of fertilisation,
but “undergoing any other
process capable of resulting in an
embryo.” The
Government had the option of stating that references to an embryo would
include an egg that had undergone any other process capable of
resulting in an embryo and, indeed, of considering a one-cell embryo to
be an embryo, thus avoiding the worry about the distinction between
one-cell and two-cell embryos. I accept the Minister’s view that
one-cell embryos have to be included in regulation, but the wording
“has undergone” would enable research that does not
intend to produce an embryo to continue without a licence when it is
looking at the properties of an egg. I wonder whether the Government
considered using the wording, “has undergone any other process
resulting in an embryo”, rather than
“is undergoing any other process
capable of resulting in an
embryo”. The
definition used is going to make things wider. At the moment, there is
no defence for people researching eggs when there might be division.
What is the
Minister’s response to the point I raised originally? Secondly,
did she consider the slightly narrower definition that, I think, would
still tick all the boxes that she quite rightly feels ought to be
ticked to ensure that regulation is
accurate? | 
