Dawn
Primarolo: Thank you, Mr. Gale. This is a
complex and important series of amendments on the issue of consent. As
I go through them and explain their purpose, I will also reflect on the
way in which hon. Members’ amendments interact with them,
because some do approximately the same thing. As you rightly said,
there are amendments to Government amendment No. 102, so it seems
appropriate to explain how the measures interact.
As we have
discussed, consent forms one of the cornerstones of the 1990 Act. A
person’s gametes cannot be used to create embryos without their
express consent. Schedule 3 replaces the consent provisions in the 1990
Act, bringing them up to date to reflect new techniques for creating
embryos by, for example, requiring consent for the use of cells to
create embryos.
The
Government listened carefully to concerns raised in another place about
the framework for consent in relation to the use of stored cells and
cells from children with serious diseases, but we also made it clear
that any exceptions to the requirement for consent would need to be
compatible with convention rights. The Government amendments in this
group provide for certain exceptions, while providing safeguards in
recognition of those
rights. Amendments
Nos. 7, 9 and 10, which were tabled by the hon. Member for Oxford, West
and Abingdon, provide for similar exemptions to the need for consent,
although they do not cover—I do not mean to imply
criticism—all the eventualities covered by the Government
amendments, such as the right of a child who becomes competent to
consent and situations regarding adults who lack capacity. I hope that
that will become clear when I outline the Government
amendments.
Dawn
Primarolo: I have not actually said very much yet, but I
will give way to the hon.
Gentleman.
Dr.
Harris: As the author of amendments Nos. 8, 9 and 10, I
should say that I fully accept that amendments Nos. 9 and 10 do not
deal with adults without capacity or with some of the conditions and
provisions that the Government amendments do. Perhaps it will save the
Minister some time if I say that she does not need to explain why that
is the case. I accept that her amendments—certainly once she has
explained them, or accepted my amendments to them—are better
than amendments Nos. 9 and 10.
Dawn
Primarolo: I am grateful for that. I had intended to do
what the hon. Gentleman said. He is very knowledgeable about these
issues and he will want to make his own representations to the
Committee—I would not dream of doing that for him.
I turn now to
exemptions for consent requirements for the use of stored tissue. With
regard to stored cells, the Government amendments apply only to cells
taken and stored before the commencement of the Bill’s
provisions. The exception applies only if the HFEA is satisfied that
the cells are anonymous and that the donor cannot be identified, or
that the licence holder cannot reasonably trace the
donor. If
the researcher can identify and trace the donor, unless the donor
consents themselves, the cells cannot be used. If the person identifies
the donor, and they are found to be deceased, consent would be required
from a person such as a close relative, as set out in the hierarchy
model found in the Human Tissue Act 2004. Before the cells can be used,
the HFEA must be satisfied that scientific research would be adversely
affected to a significant extent if the only cells that could be used
were cells for which consent had been obtained.
The
amendments reflect the fact that rare or well-researched samples are a
valuable asset for better understanding and treating serious diseases.
We have weighed the burden of being unable to use those cells against
the rights of the person who originally donated them, and we believe
that we have struck the right balance with the amendments.
On consent
for the use of cells from children, the amendments apply when those
children would never be able to give their consent because of age or
lack of capacity. This is the case with children affected by certain
aggressive forms of diseases such as muscular dystrophy, Batten disease
and spinal muscular atrophy. To that end, the amendments propose that
children with such conditions who are too young to consent, or who lack
capacity, should be excluded from the requirement for effective
consent, if a person with parental responsibility gives consent. This
exception is subject to strict safeguards that ensure that a
child’s cells cannot be used unless the HFEA is satisfied that
the child suffers from a serious medical condition, that the research
is intended to increase knowledge about the condition or its treatment,
and that there are reasonable grounds for believing that research of
comparable effectiveness could not be carried out using the cells of a
person who could give their own consent.
I turn to
consent for the use of cells from adults who lack capacity. Following
further consideration of the exception relating to cells from children,
it became clear that it was also desirable to make provision to enable
the use of cells from an adult who lacked capacity in very limited
circumstances. That would be to address situations when, for example,
rare genetic conditions led to the sudden onset of lifelong incapacity.
Following the precedent of the Mental Capacity Act 2005, the Government
amendments propose that in such cases,
the researcher would need to approach the carer of the individual and
consult them about the views or the wishes of the person
involved. Again,
this exception is subject to a number of stringent safeguards. The HFEA
must be satisfied—at the time the adult lacks capacity and is
unlikely to have capacity again—that the adult suffers from a
serious medical condition, that the proposed research is intended to
increase knowledge about the condition or its treatment, that there is
no evidence that the adult would have refused to participate and, most
importantly, that there are reasonable grounds for believing that
research of comparable effectiveness could not be carried out using the
cells of a person who could have given their own consent.
In all cases,
it will be for the researcher to provide evidence that satisfies the
HFEA that all conditions have been met before a licence to undertake
the research may be given. The exemptions are rooted in exceptional
circumstances. The potential for benefits to the sufferers of serious
conditions must be too great to overlook, and any research that can be
undertaken in the hope of better treating or curing those conditions
must be allowed to
continue. I
shall pass over amendment No. 8 and deal with amendment No. 32, which
was tabled by the hon. Member for Boston and Skegness. One of the
conditions is that the gametes were removed from the child lawfully
before they turned 18, and another is that the child is not competent
to consent. If a child were able to consent, it would not be
appropriate to store their gametes without consent. The child must be
about to undergo medical treatment that is likely to impair their
fertility, and the storage of gametes must be in the child’s
best interest. In addition, if the child becomes competent, they can
decide what to do with their stored
gametes. The
amendment relates to the age at which the gametes of a child could be
stored without their consent. Under the amendment, the gametes must
have been taken from the child before they reached the age of 16,
otherwise, they could not be stored without their consent. That would
mean that if a 17 or 18-year-old lacked competence to consent and was
about to undergo medical treatment that was likely to impair their
fertility, their gametes could not be stored because they would not
have been taken before they reached the age of 16. I concede that it
would be unusual for a 16 or 17-year-old not to be competent to
consent, but that is not in itself a reason not to offer them the same
protection as others in the exceptional circumstances in which they are
not
competent. Let
me deal with the amendments to Government amendment No.
102.
Dr.
Harris: To clarify the situation, I would be grateful if
the Minister dealt with amendment No. 8, which is not reflected in her
own amendments. It deals with a different
matter: “Cases
where consent not required for use in research to preserve
fertility”.
Dawn
Primarolo: I am sorry. I misunderstood the hon. Gentleman;
I thought that he was satisfied on all his amendments. Amendment No. 8
would extend provision to allow the use of gametes from children for
research
into the preservation of their fertility without their consent. In some
cases, that would be tissue from the testes or ovary that could be
matured into gametes in vitro but, in the case of some boys who had
reached puberty but were not competent to consent, the measure would
facilitate storage of a sperm
sample. The
Government see several problems with the amendment, and our primary
concern relates to the importance of consent. Provisions in the 1990
Act and the Bill are based on the fundamental principle of consent that
we have been considering all morning. Consent is particularly important
in the context of creating embryos from a person’s gametes.
Equally, using a person’s gametes without consent should happen
only with very strong
justification. 10.15
am Successfully
treated children whose gametes were stored without consent would, in
the majority of cases, gain competence. It would be appropriate at that
stage for them to make a decision about the use of their own gametes,
including whether they wanted research to be carried out on
them. When
gametes are not being used to create embryos, research on them is not
in the remit of the HFEA. That means that an HFEA licence is not needed
to carry out the research and the requirement for consent is governed
by common law. Any research carried out in such circumstances might be
possible with parental consent and if the research could be
demonstrated to be in the best interests of the child, but that would
ultimately be for a court to
decide. The
Government feel that the requirement for consent is very important and
that it should be deviated from only in very exceptional circumstances,
such as when there are no other options. In the circumstances that the
amendment addresses, it could be possible to obtain consent from the
person prior to any research. Additionally, there would be scope for
research through other means. We do not think that the circumstances
proposed warrant an exception to the general principle of consent,
especially in the light of alternative options. I thus ask the hon.
Gentleman not to press the amendment to a Division, although I am sure
he will want to make a contribution, to which I would be happy to
respond. May
I finally deal with amendments (a) and (b) to Government amendment No.
102, which were tabled by the hon. Member for Oxford, West and
Abingdon? The Government amendment will ensure that, among other
safeguards, the HFEA must be satisfied that scientific research will be
adversely affected to a “significant extent” before
research may be undertaken using cells stored before commencement of
the Act where effective consent to the use in embryo research is not in
place. Amendment
(a) would remove the words “significant extent”, thus
meaning that scientific research need be adversely affected by only a
small degree before such cells could be used without effective consent
being in place. As I have already stated, we have weighed the
scientific burden of being unable to use existing cells against the
rights of the person who originally donated them. To strike the right
balance, we have taken the view that science must be affected to a
significant extent. This delicate balance takes account of scientific
need
while protecting the rights of the donor. If I may be a little more
specific, the research must be adversely affected as opposed to
temporarily inconvenienced, or having extra checks caused that could be
completed in a short time. The Government used such wording in the
amendment to ensure that the effect would be significant and
adverse. Amendment
(b) relates to the efforts that a licence holder must have made to have
satisfied the HFEA that a person is not able to be contacted. The
Government amendments require the licence holder to satisfy the HFEA
either that the person is unable to be contacted, or, if they are dead,
that consent has been obtained from a relative or close friend. This
means that if a licence holder is unable to contact an
individual—because the samples that they have are anonymous, or
they do not have enough information to make contact—the cells
may be used, subject to the other safeguards. If a researcher has
reason to believe that the individual is dead—for example if
their age when they made the donation and the period for which the
cells have been stored indicate that the person would be aged 130,
which would be unlikely—it is reasonable to take the appropriate
steps. They must therefore contact a close relation or other person in
accordance with the hierarchy in the Human Tissue Act and obtain their
consent. The
amendment would require the researcher to know that the individual was
deceased, rather than to have reason to believe it. It would not have a
large impact on the provisions, but it could cause confusion. If a
researcher possesses information suggesting that a person is deceased,
they should take steps to obtain consent. Requiring the researcher to
know that a donor is dead would not be clear because it would not be
apparent what information the researcher would need to know for certain
and what steps they would need to take to obtain that. We would not
expect licence holders to close their mind to facts in their possession
that suggested a person was dead before going to the relatives. The
Government amendments require licence holders to act reasonably, which
is as it should be. If the concern is about anonymous tissue that is so
old that it is clear that the donor would be deceased, that is not a
problem. If the cells are anonymised, they can be used without consent
even if it is likely that the donor is dead.
I think that
this will be quite a substantial debate. I have introduced the broad
thrust of the Government amendments, so I will be happy to listen
carefully, as always, to what other Members say about the matter and
then respond.
The
Chairman: The arcane aspects of scheduling and formally
putting motions are not always understood, even by Committee members,
so let me explain the process. For the moment, only Government
amendment No. 65 has been moved. The rest are being debated but have
not been moved. In due course, and at the appropriate time, I propose
to call Government amendments up to No. 102 en bloc. If any hon.
Members who have tabled amendments wish to move them—I think
that that relates to amendments Nos. 32, 8 and 7, in addition to
amendments (a) and (b) to Government amendment No. 102—they must
indicate that they wish to do so, and I will call them at the
appropriate time. I hope that that is clear.
Mark
Simmonds: This is a critical debate. The Minister’s
exposition clarified to a certain extent the changes proposed after a
very significant debate in the other place. The Government amendments
and the amendments tabled by the hon. Member for Oxford, West and
Abingdon and myself demonstrate that there is unanimity across the
political parties about the necessity to change the original measures
dealing with the complex matters of consent and exceptions to
consent.
I thank the
Minister for her clarification of my amendment No. 32, which has put my
mind at rest. I shall address my initial remarks to amendment No.
7. I confirm that amendment No. 102 supersedes amendment
No. 7. I think that we all accept that the valuable work on pre-existing
cell lines would have been lost if the amendments had not been tabled.
I accept the potential for increased costs, in both money and time, of
replacing the valuable cell lines in place at the moment. I support
Government amendment No. 102, but I have some specific questions for
the Minister to address in her response. It being
twenty-five minutes past Ten o’clock,
The Chairman adjourned the Committee
without Question put, pursuant to the Standing
Order. Adjourned
till this day at One
o’clock.
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