Ms
Winterton: Let me be clear about the provisions in the
mental health Bill that relate to incapacitated people. They are to do
with the Bournewood safeguards, which relate to a person who is deemed
to be detained or who has their liberty restricted. They are not to do
with research in relation to the Mental Capacity Act or, before that,
the Human Tissue
Act.
John
Battle: As I understood it, the definition of mental
capacity is likely to be changed. That is the question, because the
definition applies to both whether a person is locked up and whether
they can give their organs. Both things depend on the crucial
definition of what it means to be mentally
incapacitated. The issue relates to not just physical but mental health.
I want to tease out from my hon. Friend whether the Government intend
to change the law again and quickly.
Ms
Winterton: It is not a question of that, because the
Mental Capacity Act sets out clearly how capacity can be judged. There
are strict principles about the capacity test. For example, the test
says that some people may be incapacitated at some times and have
capacity at others: people with Alzheimer’s can come in and out
of capacity. The Bournewood proposals are clearly related to what
happens when someone has not got capacity. If they were sectioned under
the Mental Health Act 1983, it would be quite difficult to determine
whether they had given consent, which is part of the reason for
detention; but at the same time, because of their condition, they are
effectively detained. It is about people’s rights in those
situations. Many of the proposals that will come forward relate to the
assessment process that will be undertaken as to how someone is placed
in particular types of care. The crossover involving the Mental Health
Act and the Mental Capacity Act has more to do with certain European
human rights issues.
Adam
Afriyie: We are talking about the crossover between the
Mental Health Act and these regulations, and that Act introduces the
concept of withdrawing treatment from those who are incapacitated. I
accept that that may not be the final form, but we are clearly covering
that area within the Human Tissue Act because we are dealing with
people who are incapacitated. I am concerned about the crossover
between incapacitation here and the use of organs if that person passes
away—if someone looks as though they may be passing away and
does not have a living will stating that they do not want treatment to
be withdrawn, some confusion could be
caused.
Ms
Winterton: I do not think that the Mental Health Act deals
with the issue of withdrawing treatment if someone is about to pass
away. It is the Mental Capacity Act that deals with issues around the
withdrawal of treatment and the process which enables a third person to
take health care decisions on an incapacitated person’s behalf.
We are dealing here with circumstances where there have been no
specific instructions. It is possible under the Mental Capacity Act to
cover some of the issues when someone says that they would like their
body to be used for research or to make their organs available for
transplantation.
Adam
Afriyie: I apologise; I was referring to the legislation
coming up later this year. My area of concerns lies in exactly what the
Minister has been describing. There may be a slightly different
decision-making process in these regulations from that in the
legislation coming later this year. I seek some assurance that there
will be no imbalance between the
two.
Ms
Winterton: I am not quite clear what conflict the hon.
Gentleman is referring to.
Adam
Afriyie: The potential conflict I foresee is that there is
a decision-making process under the Mental Capacity Act as to whether
someone is incapacitated or unable to make a decision, but what happens
in terms of the withdrawal of treatment or life support from such a
person? Those issues seem likely to form part of these regulations in
certain circumstances, and my concern is the crossover between the
two.
Ms
Winterton: I am not clear where there would be a crossover
with decisions that are made here. We are talking here particularly
about regulations that allow tissue to be kept or used for research; we
are defining that. I shall come on to the issue of transplants. Perhaps
the hon. Gentleman will come back during that debate, but the current
issue is quite clearly defined as research or a person’s best
interests. It is not necessarily to do with an individual passing away;
it is about whether the individual has the capacity to give
consent. Let me turn
to part 3 of the regulations, which deals with transplants. Regulation
9 sets out the list of organs whose removal and use for transplantation
must be notified to NHS Blood and Transplant, formerly UK Transplant.
It replaces the list that is currently provided under the Human Organ
Transplants Act 1989, which the Human Tissue Act repeals and
replaces. Regulations
10 to 12 deal with the donation of organs and tissues by living donors.
Currently the Human Organ Transplants Act sets out offences in relation
to organ trafficking and requires approval by the Unrelated Live
Transplant Regulatory Authority of living organ donation between
unrelated persons. In the consultation paper “Human Bodies,
Human Choices” of 2002, and when we presented the Human Tissue
Bill in 2004, we made it clear that this regulatory scheme would be
brought under the Human Tissue Authority, but also that it should be
extended to other forms of live donation. In particular, approval will
be needed for donation of organs between relatives. That is because the
risks of pressure or coercion in such cases is no less than in
donations between unrelated persons.
Adam
Afriyie: Regulation 12(5)(a) refers to an arrangement
whereby “transplantable
material is removed from a donor (“D”) for transplant to
a person who is not genetically related or knownto
D”, and the same is to be
found in paragraph (b). However, everybody on the planet is genetically
related in some way. Can the Minister point us to the definition of
“genetically related”? Humans arose 50,000 years ago
from, probably, two or three human beings. We are all genetically
related; the question is to what extent. Is there a definition of
“genetically related” anywhere in this
legislation?
Ms
Winterton: I am not sure that there is, but in the spirit
of making sensible legislation I would venture to suggest that we know
what is meant.
Adam
Afriyie: Would the Minister consider that the child of a
great- great-great-grandparent is genetically related to a
great-great-great-great-great-great-grandparent, for
example?
Ms
Winterton: Possibly. However—and this is a serious
point—we must be clear about ensuring that approval for living
donations is needed for the donation of organs between relatives. The
point about the possibility of the risks of pressure and coercion is a
serious one and, putting aside the points made by the hon. Member for
Windsor, it is important that we take note of
that.
Adam
Afriyie: I raised the point because I consider it
incredibly important whether two individuals are genetically related.
Genetics is not necessarily about who one’s parents or
grandparents are, but about the percentage of genetic correlation
between people. That is why I raised that point, which has serious
health
implications.
Ms
Winterton: Perhaps I can reassure the hon. Gentleman. The
regulations do not define “genetically related”. As I
said, we are talking about the phrase’s ordinary meaning, which
is defined in paragraph 94 of the relevant code of practice as
“a close relation”. I think we all understand what that
means. I am aware that
some people, including those on the Merits Committee, are concerned
that the regulations might increase the level of regulation and delay
treatments. In fact, however, the regulations propose a system of
approval much simpler than the current one for unrelated organ
donors. Furthermore,
the new framework will allow for the consideration of new procedures
such as pooled, paired and non-directed altruistic donations. For the
first time, under the regulations, those types of donation will be able
to take place. For example, a wife might wish to donate a kidney to her
husband, but might not be compatible for a direct donation. Through the
system before us, the Human Tissue Authority could permit her to pair
up with and donate to someone else so that her husband can receive a
kidney from, for example, the partner of the other donor. The
provisions should therefore enable a greater number of live donations
to take place. Two or
more couples might be involved—we can imagine a situation in
which there might potentially be a group of four or five donors and
partners. That would be regarded as a pooled arrangement. Although that
might not be common, it could nevertheless be an important option for
some people, if tissue matches are
difficult. Dr.
Andrew Murrison (Westbury) (Con): Does the Minister not
understand the level of coercion that could be involved in that
process? Although it might be expedient to welcome it, what safeguards
will she put in place to ensure that one part of that chain—if I
can put it like that—is not coerced into doing something that
they would rather
not?
Ms
Winterton: That is exactly why we have retained the need
for regulation. As I said, under the new system
the process will have to be properly approved. Some people said that
that was overregulation, but we felt that it was important that proper
approval be required, for the reasons raised by the hon. Member for
Windsor (Adam
Afriyie). Under the
regulations, the regulatory framework also addresses the donation of
bone marrow by children and adults who are unable to consent. Again,
that is another area where the Merits Committee questioned the need for
regulation. However, I can tell right hon. and hon. Members that the
donation of bone marrow, or of peripheral blood stem cells, is not a
trivial matter; nor is it free from risk. Bone marrow donation requires
a general anaesthetic and is a highly invasive procedure; it is painful
and uncomfortable.
PBSC donation involves the
administration of drugs to stimulate the production of PBSCs into the
bloodstream, from where they are extracted. Clearly, risks are
associated with that procedure. So far, frankly, there has not been
sufficient experience to quantify those risks, but we do feel it is
important to make it clear that there may be risks involved. That
healthy adults put themselves through these procedures in order to
donate is admirable. Where people are able to make their own decisions
about the risks they are willing to undertake, we certainly do not wish
or need to regulate. The question is different when the intervention is
on a young, healthy child or on an adult who is unable to understand or
consent to the procedure. Those are the most vulnerable people and we
believe that protection for them is needed. The matter involves
difficult decisions where the parent of the potential donor is also the
parent of the child who would be the recipient. Likewise, the medical
team will be looking after both children. The difficulties inherent in
that situation are obvious.
That that is a fraught
situation is already widely understood. The Council of Europe’s
convention on human rights and biomedicine addresses it clearly. It
states that regenerative tissue should be taken from those unable to
consent only if the procedure has been approved by a competent
authority. In the HTA, which is establishing the approval conduct
processes for living donation, we have such an authority. It has
procedures prepared, as described in the draft code of practice that is
before Parliament. In the case of bone marrow and PBSC donation by
children, the code describes good practice, which could not be
contentious, and establishes a simple and rapid process for HTA
approval for the 30 to 50 cases per year that are anticipated. That
process will not impede or delay
treatment. It has been
suggested that those procedures can be regulated through the HTA
licensing scheme, but in fact the procedures are not licensable.
Although some of the units that carry them out may hold HTA licences
for other activities, many will not hold such a licence. In that case,
the codes would constitute no more than general guidance, with no HTA
power to enforce. The codes therefore supplement and describe the
scheme that we propose. They do not duplicate it and could not
adequately replace it. So, although we noted the points made by the
Merits Committee, we think that in the circumstances it is important to
make sure that the procedures are adequately
approved.
Adam
Afriyie: We are all concerned about the integrity of the
HTA and of the other authorities that were mentioned. Is there anything
in the guidelines to stipulate that if a case were to come before a
member of one of those authorities that related to someone they knew,
or a relative, that member would not be able to be involved in the
decision-making process? Can the Minister assure us on that
point?
Ms
Winterton: Regulations 13 and 14 provide for the
reconsideration of decisions made by the authority under the
regulations. That is, effectively, an appeal system. It would also
obviously be possible during the course of a decision for relatives who
felt that there was something wrong with the procedure to explain why
they felt it should not happen.
Mr.
Bone: On bone marrow transplants, I understand clearly the
situation in which two parents have two children, one of whom
desperately needs a bone marrow transplant, the best chance for which
is from the other child. There is protection there in case carrying out
the transplant is the wrong thing to do. I cannot see how it could be
the wrong thing to do. Will the Minister assure me that in the
situation in which one child needs the bone marrow and the other is the
best match, but the parents do not want the child to have a bone marrow
transplant, their decision could not be overruled by the
authority?
Ms
Winterton: No, it could not be. The idea is that people
will apply to the HTA for bone marrow to be extracted, so a case would
not come before the authority unless someone had
applied.
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