The
Chairman: Order. The hon. Gentleman assumes that there
will be a schedule stand part debate. I have yet to decide that, but
the way things are going, the debate is becoming very comprehensive
indeed.
Dr.
Harris: The case that I want to put in that respect is
that there are extensive matters in schedule 3, which is lengthy, that
are not subject to the amendments. I can try to bring those matters
into my remarks,
but—
The
Chairman: Order. The hon. Gentleman is right that there
are matters in the schedule that are not covered by the amendments, but
it is wrong to assume at this stage that there will necessarily be a
stand part debate.
Dr.
Harris: I want to express not an assumption, but a hope.
Otherwise, it will be difficult for me to put my points on this
extensive schedule because they are totally unrelated to the
amendments. I will bow to your discretion at the appropriate time,
Mr.
Gale. I
am very grateful to the Government for tabling amendment No. 102 and
other related amendments. As the Minister will know, several scientific
organisations expressed concern when it appeared that the Bill would
not permit the use of existing cells. She will be aware of the letter
to The Times that was signed by a number of Nobel laureates,
headed by Sir Martin Evans, Sir Paul Nurse and Sir John Sulston. It was
supported by Sir Ian Wilmut, director of the Medical Research Council
centre for regenerative medicine; Sir Richard Sykes, a trustee of the
UK Stem Cell Foundation; Lord May of Oxford, a former chief scientific
adviser to the Government; Professor Bobrow; Dr. Robin Lovell-Badge;
and a number of other leading researchers, all of whom expressed
concern. The
current situation is a tribute to the Government’s general
handling of the issue since consultation began several years ago. We
are now in a position to welcome the fact that they looked into the
issue that was raised, consulted the scientific community and came up
with an amendment that seems to answer almost all its concerns. I
recognise what a job of drafting that was, given the length of the
amendments. I know that the Government’s default position might
not be to spend a huge amount of time on drafting, so that shows that
they recognised that the issue is
important. The
same applies to the provision on children. It was not clear that it
would be permitted, and the Government expressed the importance of
obtaining explicit and specific consent when embryos were created,
because of concerns about people’s autonomy. I understand that,
as do the members of the research community whom I have spoken
to—if I may speak for them—and patients groups. It is
particularly pleasing for the Genetic Interest Group, which worked
extremely hard on the issue and wrote a letter to Professor Lord Darzi
on 25 January, expressing support for the amendment tabled in the other
place and standing in the name of Lord
Patel. It
is welcome that the Government have not only addressed that issue, but
taken the time and made the
effort to ensure that the same issues should apply in questions of
adults without
capacity. I
have tabled two small probing amendments to Government amendment No.
102. Amendment (a) questions the threshold for research to be
permitted, which is set out in proposed new paragraph 15G in amendment
No. 102. Paragraph 15G(1)
states: “A
licence may not authorise the application of paragraph
15F”— which
is to allow the use of existing cell
lines— “unless
the Authority is
satisfied— (a)
that there are reasonable grounds for believing that scientific
research will be adversely affected to a significant extent if the only
human cells that can be used to bring about the creation in
vitro of embryos or human admixed embryos for use for the purposes
of the project of research
are” those
in respect of which there is an effective
consent. My
concern is with the phrase “to a significant extent”, for
two reasons. First, that is a different measure from the one used in
relation to consent for the use of children’s cells, earlier in
the amendment. For example, condition D in proposed new paragraph
15A(5) is expressed in terms
of “reasonable
grounds for believing that research of comparable effectiveness cannot
be carried
out”. That
seems to me to be a very appropriate test. There is a reasonableness
test, which is important and which guides the licensing committee or
the HFEA in deciding whether they are prepared to license the use of
the cells. Also, its reference to comparable effectiveness focuses the
question on the outcome of the research, not the convenience of
researchers.
I totally
accept the Minister’s statement that she would not want a test
that merely enabled existing cell lines to be used simply for
convenience and because the scientific research might be thought to be
“adversely affected”. I understand her concern about
leaving it at that; it would clearly adversely affect researchers to
have to get consent when they could simply buy in cell
lines. I
hope that the Minister accepts that I accept that my amendment on its
own is not adequate, but I urge her to consider whether she might use
wording such as “comparable effectiveness”, which focuses
on outcomes. If that is not done, it will be hard for the HFEA to
interpret “significant extent”, whereas
“reasonable
grounds for believing that research of comparable effectiveness cannot
be carried
out” is
much clearer. It will be hard for scientists to know what the HFEA will
decide counts as “significant
extent”. I
hope that the Minister recognises that there are two ways of doing this
and that there may be a slightly better way than the one she has
proposed. 1.15
pm Amendment
(b) would amend condition B in proposed new paragraph 15G(3). There is
a problem, in that conditions B and C might not capture a frequent
occurrence. A researcher might have reason to believe that P has died
because the cell lines were taken 10 years ago from someone with
cancer, but might not know that P had died, in which case condition C
would not apply.
There are
three possible situations. The first is that the patient has died, in
which case condition C would
apply, so that is straightforward. Another is that the researcher has no
decent reason to believe that the person has died, such as when the
cell lines are taken from the biopsy of a healthy person, an umbilical
cord or whatever. A third scenario is that the researcher has reason to
believe that the person is dead, but does not know. I understand fully
the Minister’s point that researchers must take reasonable steps
to ensure that they can identify a relative if the person has died. It
would not be good enough for the researcher to take the view, “I
don’t know if the person’s died, so I’m going to
treat them as simply uncontactable, not worry about contacting a
relative and press on.” I accept that she made a valid
point. The
first aspect of condition B specifies that the researcher must
have “taken
all reasonable steps to contact the
person”. It
could be possible to resolve the problem that I have identified by
adding a further provision that the researcher must also have taken
reasonable steps to establish whether the person has died. If they had
done both those things, it would be reasonable for the researcher, even
if they had a reason to believe that the person may have died, to treat
the person as uncontactable, not necessarily dead. I hope that the
Minister will accept that that is a concern in the research community,
and I hope that she will deal with it in her response, if not
now. I
want to draw the Committee’s attention to a couple of other
aspects of the amendments. One of them specifies the condition that the
person must be likely to regain capacity, but I want to probe whether
that is the appropriate test. There may be a situation—I am
talking about an adult, not a child who is likely to gain the capacity
to consent at some point—in which someone has a clinical
condition that makes it possible that they might regain capacity, but
difficult to argue that it is likely that they will. I do not want to
spend the Committee’s time identifying specific cases, but it
would be useful if the Minister considered whether there would be a
better test that would enable the provision not to be quite so
tight. I
turn to amendment No. 8, which I tabled. Unlike amendments Nos. 9 and
10, its purpose is not dealt with by the Government amendments. Under
the Bill as it stands, it will be possible to store the gametes of
children who are about to undergo chemotherapy or some other medical
research that threatens their future fertility. Under the quite
reasonable provision in paragraph 12 of schedule 3, the tissue could be
stored without the explicit specific consent of the person on the basis
of that person’s best interests.
That all
makes sense. The problem is, however, that for this to be effective, it
is important that the storage techniques are correct. The basis of new
paragraph 9 is that the gametes are lawfully taken and that their
storage is in the best interests of the child. It is hard to meet that
test—or certainly more difficult—if the storage procedure
that is used fails to meet the requirements of that test. Let us take
the example of a biopsy of testicular tissue taken from a child without
the capacity to consent, such as a prepubertal boy. If that storage is
not done correctly, the procedure is not going to work, even if the
clear intention is to provide something that will help the child retain
his fertility and thus meet the best interests of that child.
As I
understand it, freezing such gonadal tissue is a tricky business.
Amendment No. 8 would provide grounds whereby it would be
possible—again, under the same best-interest tests—to use
part of the tissue that had been taken, frozen and stored to test
whether the freezing technique successfully met the purpose for which
the tissue was taken: preserving
fertility.
I think the
Minister understood that that was the intention of the amendment. She
made the very fair point that this really ought to be a last resort and
that when there was a decent alternative, one would not need to do
this. She said that the alternative would be to wait for the child to
gain capacity, when he could consent to the use of stored gametes to
test the freezing. The problem is that we might be in a position in
which it would take some years for that situation to arise.
For example,
if the tissue that was frozen was taken from a six-year-old boy with
the hope of preserving fertility and, at the age of 14, the child
acquired capacity—essentially, competence to consent to research
being done, including testing, albeit only for the purpose of research,
the fertilisation ability of the sperm, which would not be allowed at
present—one could test whether the storage of the
six-year-old’s sperm was being carried out correctly. That,
however, would be some way done the line, and if it turned out that the
storage was done incorrectly, nothing could be done to help either that
person—whose tissue had been taken but was not going to be
useful—or any other child whose gametes were stored and frozen
under the same procedures in the intervening eight
years. There
might be a small gap in which some provision is needed to allow this to
take place. If, under Government amendment No. 102, it is legitimate,
in the best interests of the child, for a child’s cells to be
used to create an embryo for research into a disease from which the
child and other people are suffering, is there a significant difference
between that and using another cell—a gamete cell—to
create an embryo by fertilisation for research under the 14-day rule,
also in the best interests of that child, even though one could
probably do it eventually in a number of years time when the child
gained capacity? I would be grateful if the Minister would consider
that question.
I have a
number of other related points that are specific problems with the
schedule. They are not substantial issues, but I would like to save
them for a stand part debate, as I have focused all my remarks on this
group of amendments. However, if it is your understanding that there
will not be a stand part debate, Mr. Gale, I will try and
deal with them in the next
group.
The
Chairman: Let me clarify the position. If I have caused
the confusion, I will resolve it. There are issues contained in
schedule 3 that are not covered by amendments. If any hon. Member
wishes to raise those issues, they may of course do so. What we cannot
do is find ourselves in a situation in which we have thoroughly debated
acres of text that we will then debate again during a stand part
debate. The hon. Gentleman referred to specific amendments and said
that he wanted to discuss them later. I think that that is what he
said, but if I misunderstood him, I freely apologise. By the time that
we get to the stand part debate, we cannot go back over ground that we
have already covered. I think we all understand
that.
Dr.
Brian Iddon (Bolton, South-East) (Lab): I wish to seek a
small assurance from the Minister regarding the Government amendment
No. 102, which is complicated. Proposed new paragraph 15D(2) will
require a researcher to
“take reasonable
steps to identify a person
who” is
caring for
P “otherwise
than in a professional capacity or for remuneration”.
I am particularly
concerned about the phrase “or for remuneration”, because
a very close person could be caring for P who was receiving
remuneration from a number of sources. For example, the remuneration
could be compensation for an accident. I am particularly concerned
about what would happen if the carer of P was receiving benefits. Would
that regarded under this amendment as
remuneration? Mr.
Tom Clarke (Coatbridge, Chryston and Bellshill) (Lab): I
shall try, Mr. Gale—as we all will—to stick to
your guidelines and be specific, but some of the points that I want to
raise follow from the point made that my hon. Friend the Member for
Bolton, South-East, as well as some of the points raised by the hon.
Members for Boston and Skegness and for Oxford, West and Abingdon,
although perhaps I will make them from a different
perspective.
May I begin
by posing the question that the hon. Member for Boston and Skegness
asked about Scotland? I am a little confused about that one, and I
cannot quite understand why, with some of the issues that we are now
addressing, we start at 16 in Scotland. Perhaps the Minister will
clarify that.
On Government
amendment No. 65, may I concentrate for just a moment on proposed
sub-paragraph (2)(a)? I am slightly puzzled by the Minister’s
use of the word “storage”. It seems to me that this
particular provision reaches well beyond that. It is assumed that,
after we die, the cells can be used for various purposes unless we
state otherwise. This seems to me to be presumed consent. For the sake
of posterity and those who read Hansard closely, may I say for
the record that I would not wish my cells to be used for such research
after I am gone? It is wrong for all of us to assume that our
constituents take the same view on the matter. I would be interested to
hear, for example, how the British Medical Association has advised the
Minister on this issue?
I thought
that the rules on consent in the Bill—I recognise that consent
is the essence of what we are discussing—were very tight and
that they formed one part of the Bill that was pretty secure. However,
Government amendment No. 102 seems to widen things
considerably—frankly, beyond what I had anticipated. To go from
the tight, robust provisions in the original Bill to around 260 lines
on “Cases
where human cells etc. can be used without the consent of person
providing
them” seems
to me to be changing the ball game
somewhat.
1.30
pm Again,
to draw on something specific, proposed new paragraph 15D in amendment
No. 102 refers to how R—the researcher—can nominate
someone who only has to fill the criteria of
having “no
connection with the
project”. That
is a massive loophole. Conceivably, a researcher could appoint a
different researcher on a different project to speak as an advocate for
the person who has died. If
that is not the case, I would welcome clarification from my right hon.
Friend. If that is the case, we all know what the consultation will
lead
to. As
the Minister knows, I am committed to advocacy, as I was at the time
that I was fortunate enough to steer a Bill on disabled persons through
the House. Advocacy is of the utmost importance when we consider all
Government Bills. However, it is essential to remember that the
advocate is not speaking for himself or herself, but for the person. It
is not for the advocate to express a view, which might not necessarily
be that of the person, and I would like my right hon. Friend to
underline that
point. Let
me put a specific question in that context. Does the Minister recognise
that there seems to be a clear conflict of interest in having the
licence holder for the research project nominating the person under
proposed new paragraph 15D(3) who is to be consulted on behalf of the
person lacking capacity? There is no indication that the person to be
consulted on behalf of the person lacking capacity has even to see the
person lacking capacity. A lot of clarification is called
for. Before
I conclude, I remind Labour Members about the letter dated 25 March
that we all received from the Prime Minister. He
wrote: “we
will have a free vote on the three new ethical issues on which the
house has not previously taken a view”
If the Government
amendments are accepted, which I anticipate will happen, we will have a
new profound ethical issue to discuss. I hope that the provisions will
receive close scrutiny on Report and that my right hon. Friend the
Minister will agree that they, too, would thus be the subject of a free
vote.
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