Dawn
Primarolo: I thought that I had made it clear during a
previous debate that the Government see training as an integral part of
research. We do not see the necessity for a licence for training only
and we do not permit that.
With regard
to the point made by the hon. Member for Boston and Skegness, I am not
aware that there has ever been an issue about unsigned consents, so I
cannot specifically reassure him on that point. I suppose that it
is a bit of a reassurance to say that there has never been such an
issue, but I will go back and double check on that
point. Mark
Simmonds: If that is the case—I am sure that the
Minister is correct—it gives rise to a question about the
necessity of adding a signature to a system that is working perfectly
well
already.
Dawn
Primarolo: I am sure that the hon. Gentleman would accept
that if a signature were made explicit, most of us would sign consent
automatically. However, I cannot tell him whether we have ever had a
consent that has not been signed. The point is to make it explicit.
However, in this matter, we would all ensure that we signed it,
particularly bearing in mind that that could have implications for
future research. As my right hon. Friend the Member for Coatbridge,
Chryston and Bellshill said, there might be areas of research to which
we would not want to consent. I will return to the matter, but I am
unable at the moment to give the hon. Gentleman specific details at the
moment.
Dr.
Harris: I raised six points. The Minister has said that
the first one arose due to a misunderstanding of intention and I shall
look at what she has said. I accept that she has dealt with the second
and third points in respect of training
matters. I
asked whether the Minister could give an explanation on the provisions
on lavage, and the hon. Member for Boston and Skegness, who can speak
for himself, indicated that he was also interested in that answer. I
have also raised substantively—twice—the threshold for
the patient being likely to regain capacity in respect of amended
paragraph 10 of schedule 3 to the 1990 Act. I would be grateful if the
Minister could respond to those two issues only, having had her amusing
fun with my asking questions about the
schedule.
Dawn
Primarolo: I have answered the hon. Gentleman’s
questions specifically with regard to consent and to that point. I put
all his points together by explaining how they interact in the
schedule. If the hon. Gentleman is still dissatisfied after reading
Hansard, I will be more than happy to correspond with him
and make sure that the letters are circulated to every member of the
Committee. I am not trying to avoid answering his questions, but if he
wants complex answers about the interaction of a whole range of things
with which he can be satisfied, he could always give me notice. That
would ensure that I understood before he said it, as well as when he
said it, exactly what was his intention so that I would not
misinterpret it.
The hon.
Member for Boston and Skegness raised a point about the amendment to
paragraph 4 of schedule 3 to the 1990 Act concerning whether people who
are physically incapacitated can withdraw consent. Yes, they can.
Provision is made in paragraph 3 of schedule 3 to the Bill, which
amends paragraph 1 of schedule 3 to the 1990 Act. I hope that he will
be able to reflect on that after the Committee, and if he is still not
satisfied, I would, of course, be happy to come back to
him.
Dr.
Harris: The record will show that I made no criticism of
the Minister either in my opening remarks
or in my intervention. I accept that the first point that I raised was
about a complex interaction, and I did not expect her necessarily to be
able to satisfy me on that.
I am grateful
to the Minister for explaining the position with regard to testing,
which was not immediately apparent to me in respect of human admixed
embryos. More importantly, she explained that under this regime,
training was very clearly going to be permitted on human admixed
embryos and that it was part and parcel of the research licence. I am
not the only person who has expressed concerns about this—people
working in the field want clarification—so I am grateful to her
for that.
I did not
think, however, that it was unreasonable to ask for an explanation of
paragraph 10 of the schedule. The explanatory notes merely
say:
“Paragraph
7 of Schedule 3 to the 1990 Act is amended by paragraph 10 of Schedule
3 to the Bill to prohibit the use of an embryo taken from a woman to
create an embryo in vitro or to create a human admixed embryo in
vitro.” I
merely asked whether this was just tidying up, or whether there had
been a problem or a concern expressed and what was the mischief that
this was seeking to amend.
Dawn
Primarolo: And I did answer the hon. Gentleman’s
point. I say again that this relates to the question of consent that is
in the 1990 Act regarding women and lavage. Paragraph 10 simply makes
it clear that that has not been superseded. It makes it clear that the
embryo taken from the woman is tied up with questions of consent, in
general or specifically. It cannot be used to create a human admixed
embryo, so the consent on that issue in the 1990 Act is linked to this
schedule. That is the answer that I gave
him.
Dr.
Harris: If that is the case, I am grateful to the Minister
for reiterating that and I will go away and study
that. Finally,
I have raised three times now the position of a patient likely to
regain capacity and whether we have the correct threshold. I do not
think that this is a question of interaction or of how the consent
arrangements fall. There is a specific provision. I wish to ask whether
there will be patients in certain conditions in which it will be very
difficult to judge whether “likely” is the right test. I
think that that will create problems, and it struck me that it might be
possible, before the Bill completes its passage, to provide clarity on
that. Question
put and agreed to.
Schedule
3, as amended, agreed
to.
Schedule
4Schedule
inserted in the 1990 Act as Schedule
3ZA Question
proposed, That the schedule be the Fourth schedule to the
Bill.
Mark
Simmonds: I have one or two questions for the Minister
about counselling and the circumstances in which it should be offered.
I certainly do not believe that counselling should be mandatory, but it
should be offered and it should be effective. It is important that
counselling is provided by skilled professionals who are experienced in
such matters, so I have some questions.
Do
counsellors working in this field have specialised training or
expertise, or are they counsellors in other
areas as well? Is there a division between counsellors who work with
people undergoing treatment and counsellors who work with those who
have donated gametes? Are they different kinds of counsellors who
require different training, or do they come from the same generic group
of individuals? Is there any charge for the counselling service? If so,
is it merely a charge to recoup the costs, or is it a
revenue-generating exercise as well? Finally, are the guidelines set by
the HFEA, or is it up to each individual clinic to set its own
guidelines? Dawn
Primarolo: On the question of the fee, the cost of
counselling is covered in the cost of the treatment services—it
is all wrapped up. On the question of who sets the guidelines, a code
of practice is set as guidance for clinics on how to offer counselling.
The code states specifically that patients need to be aware of the
offer, that it needs to be routine, that it should include written
information and that it should give the names of qualified counsellors
in the area, who may also have wider qualifications. The
counsellor’s role needs to be explained, as well as when they
are available and how to access the service. Obviously, there should be
no pressure to accept counselling, but sufficient time should be given
to consider the
offer. I
am afraid that I do not know the answer to the hon. Gentleman’s
question about the division of counsellors’ roles, so I will
have to write to him. The HFEA sets the code of practice, counselling
is included within the cost of treatment, and counsellors need to be
specialised. I will respond to his last point as soon as I
can. Question
put and agreed to.
Schedule 4
agreed
to.
Clause
15Conditions
of storage
licences
Mark
Simmonds: I beg to move amendment No. 5, in
clause 15, page 11, line 47, leave
out ‘ten’ and insert
‘seven’.
The
Chairman: With this it will be convenient to discuss
amendment No. 34, in
clause 15, page 12, line 3, leave
out ‘ten’ and insert
‘seven’.
Mark
Simmonds: Amendment No. 34 is a consequential
amendment to amendment No. 5, so I shall concentrate on the latter. It
is, I acknowledge, a further probing amendment, which relates to how
long gametes and embryos can be kept in storage. At the moment, embryos
can be kept for five years, and then for five years beyond that, if the
couple chooses. Will the Minister put on record what evidence exists
that embryos and gametes are of sufficient quality after and up to 10
years? For how long afterwards does she believe that embryos can be
kept in storage without deteriorating, if there is indeed evidence to
support
that? Is
the Minister concerned that removing the five-year break will result in
fewer couples giving their embryos for research as they will not
necessarily be reminded of the possibility after the five years? As the
1990 Act
lasted for 18 years, I think that the general view in the Committee is
that we wish this Bill, after it becomes an Act, to last similarly
long. Is it possible to change the time period under regulation if
future techniques allow longer storage? I
think that a recent case forms the basis of an amendment that has been
tabled by the hon. Member for Oxford, West and Abingdon. A young girl,
because of treatment she has received, will not be able to have
children later on in life. However, she is of such a young age that
even if her mother donates an egg for her now, after the 10-year period
has elapsed, she will still not be old enough to have a child.
Regulations might allow that situation to be changed as scientific
techniques develop and, again, it could be amended by new
clause 2, which was tabled by the hon.
Gentleman.
2.45
pm
Dawn
Primarolo: I recognise that limits on the storage of
gametes and embryos can cause some concern. The length of storage needs
to ensure fairness, while also taking into account the safety of
freezing. I believe that the statutory 10-year period for gametes, with
extended storage for medical reasons, remains appropriate. I also
consider that the same limits should be applied to embryos. Therefore,
the Bill brings storage limits into line with each
other. The
Warnock report proposed a 10-year period. I suppose that the hon.
Gentleman is quite right about which years one picks—it is
arbitrary. Five years was the decision of Parliament. In the 24 years
since the report was published, there has been no body of evidence to
suggest that using embryos that have been frozen for 10 years endangers
a mother or child. There is a possibility of change—the hon.
Gentleman pointed to the regulating power—enabling an extension
beyond 10 years in specific circumstances, but that is something that
would need to be considered later. At this point, because we can see
that there is an application to go further, it seems sensible to go for
10 years. I suppose that his guess might be as good as anyone
else’s. That is the reason for settling at 10 years, but
allowing variation under specific circumstances and having the
regulatory power in place, if it is necessary to extend it further in
the
future.
Mark
Simmonds: I am grateful to the Minister for that
explanation and for the confirmation that there are regulatory powers
for changing what is in the Bill, if scientific advancement allows. In
that context, I beg to ask leave to withdraw the
amendment. Amendment,
by leave,
withdrawn. Question
proposed, That the clause stand part of the
Bill.
The
Chairman: With this it will be convenient to discuss new
clause 2— Extension of statutory storage period for treatment
of blood relatives ‘(1) The
Human Fertilisation and Embryology (Statutory Storage Period)
Regulations (S.I. 1991/1540) are amended as
follows. (2) In regulation 2(1)
for “paragraph (2)” substitute “paragraphs (2) and
(2A)”. (3) After
regulation 2(2)
insert— “(2A) The
circumstances referred to in paragraph (1) are that the gametes were
provided by a person who has given written consent for them to be used
by another person—
(a) who is a blood relative of the person providing
the gametes, (b) whose
fertility was, in the written opinion of a registered medical
practitioner, significantly impaired on the date on which the gametes
were provided, and (c) who was
aged under 45 on the date on which the gametes were
provided.”.’.
Dr.
Harris: I wanted to draw attention to something that has
already been touched upon: a problem with not only the current storage
legislation, but the regulations. The Minister will be aware of the
case that I am going to cite on behalf of my hon. Friend the Member for
Hazel Grove (Andrew Stunell), who has been assiduously pursuing the
issue for one of his constituents. He raised it on Second Reading and
wrote to the Minister on 14 May to set out the problems. I
thought that it would be useful to summarise the situation and to quote
from that letter, with the permission of my hon.
Friend. The
problem is that the regulations for storing gametes were set by the
Human Fertilisation and Embryology (Statutory Storage Periods)
Regulations 1991, which could, in theory, be amended under the current
Bill. In this case, there is a woman whose daughter suffers from Turner
syndrome. That is not life-threatening—a relatively normal life
can be led with treatment—but one of its features is
infertility. In this case, the mother wishes to donate her own eggs so
that her daughter will be able to have children by IVF treatment in the
future. The problem is that the time limit for storing gametes is set
at 10 years. Regulations state that gametes must be donated before the
donor reaches the age of 36, which creates a problem in this family
and, presumably, others. If the mother donated before the age of 36,
the 10 years would expire when her daughter was still only 18 and
therefore extremely unlikely to be ready to use the eggs.
The Committee
will be aware that the current regulations provide for an exception if
the gametes are stored for the use of the donor. However, according to
a letter received by my hon. Friend the Member for Hazel Grove from the
HFEA, the reason for the 10-year limit is that it is best if clinics
are not overburdened by the number of samples in storage. I accept that
there is a regulatory issue, so the question is whether there could be
exceptional circumstances in which samples might be permitted to be
stored for longer than 10 years, for example if donated eggs are
intended for another family member who is infertile, which is the case
that my hon. Friend has made in a number of forums. Would new clause 2
achieve that? If not, might an amended
version? There
is discretion on retrieving eggs after the age of 36. In exceptional
circumstances, clinics can use eggs from women over the age of 36, but
I think that everyone is aware—the Minister is, of
course—that fertility and thus the efficacy of the treatment
diminishes rapidly after that
point. Even
if the drafting of new clause 2 is not perfect—if there are
imperfections, it is through no fault of my hon. Friend—I hope
that its intention is clear. It states that an exception can be made
when a person
“has given
written consent for them to be used by another person...(a) who is
a blood relative of the person providing the gametes...(b) whose
fertility was, in the written opinion of a registered medical
practitioner, significantly impaired on the date on which the gametes
were provided, and...(c) who was aged under 45 on the date on
which the gametes were provided.”
This is not a
unique case—I am conscious of the fact that we should not
legislate to provide for an individual case—and I wonder whether
an amendment could be made. Obviously, we do not need primary
legislation, so I would understand if the Minister said that the
Government wished to consider the matter themselves and introduce their
own regulations to allow for an
exception.
| 
