The
Committee consisted of the following
Members:Chairman: †
Mrs.
Janet Dean †
Afriyie,
Adam (Windsor) (Con) †
Austin,
Mr. Ian (Dudley, North)
(Lab) †
Battle,
John (Leeds, West)
(Lab) †
Blunt,
Mr. Crispin (Reigate)
(Con) †
Bone,
Mr. Peter (Wellingborough)
(Con) †
Chapman,
Ben (Wirral, South)
(Lab) †
Gidley,
Sandra (Romsey) (LD) †
Gilroy,
Linda (Plymouth, Sutton)
(Lab/Co-op) †
Goodman,
Helen (Bishop Auckland)
(Lab) †
Irranca-Davies,
Huw (Ogmore) (Lab) †
Michael,
Alun (Cardiff, South and Penarth)
(Lab/Co-op) †
Milton,
Anne (Guildford)
(Con) †
Murrison,
Dr. Andrew (Westbury)
(Con) Webb,
Steve (Northavon)
(LD) †
Winterton,
Ms Rosie (Minister of State, Department of
Health)†
Wood,
Mike (Batley and Spen)
(Lab) †
Wright,
Mr. Iain (Hartlepool)
(Lab) Mark Etherton, Committee
Clerk † attended the
Committee First
Standing Committeeon Delegated
LegislationMonday 19
June
2006[Mrs.
Janet Dean in the
Chair]Draft Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 20064.30
pm
The
Minister of State, Department of Health(Ms Rosie
Winterton): I beg to
move, That the
Committee has considered the draft Human Tissue Act 2004 (Persons who
Lack Capacity to Consent and Transplants) Regulations
2006. It is a pleasure
to serve under your chairmanship, Mrs. Dean. In considering the
regulations we shall return to issues discussed at length in our
interesting debates on the Human Tissue Bill. I am sure that Opposition
Members are aware of the recommendations and findings of the Select
Committee on the Merits of Statutory Instruments, which were mentioned
in the House of Lords debates. I shall address in my opening speech
some of the issues raised, and I hope that that will assist Opposition
members of the
Committee. The
regulations are being made under the Human Tissue Act 2004, one of the
key objectives of which was to rationalise and update a wide range of
legislation and put it together in one Act of Parliament. The law on
the retention and use of organs and tissue was reviewed following
public concern about events at Bristol royal infirmary and the Royal
Liverpool children’s hospital. The review revealed that the law
on tissue retention, both from the living and the deceased, was
inadequate and that the law on anatomical examination and transplants
needed to be updated and brought into a single cohesive
framework. The
regulations deal with two important issues: they cover the storage of
tissue from incapacitated adults and its use in research, including DNA
analysis; and they set out a framework for the approval of the living
donation of organs, bone marrow and peripheral blood stem cells. They
have been subject to the usual consultation and have been laid before
Parliament alongside a further set of regulations and draft codes
prepared by the Human Tissue Authority. The codes and regulations will
complete the implementation of the 2004
Act. I shall first
explain the proposed deemed consent provisions for incapacitated
adults, as set out in regulations 3 to 8, which make up part 2. The
concept of consent is the principle that underpins the 2004 Act. Among
other things, part 1 of that Act sets out a requirement for consent
from those capable of giving it to the storage and use of their tissue
for certain purposes, such as research or transplantation. The
regulations describe circumstances in which there is to be deemed
consent in relation to adults who lack the capacity to consent for
themselves. The 2004 Act dealt
with general issues of consent in part 1, and created separately in
section 45 the new offence of non-consensual analysis of DNA. The
regulations correspondingly provide separately for general issues of
deemed consent, in regulations 3 and 4, and DNA analysis, in
regulations 5 to 7. Those provisions together set out the limited
circumstances in which the tissue of people who do not have capacity to
consent can be kept and used when consent would otherwise have been
required. The
circumstances in which consent will be deemed to have been given were
indicated during the passage of the 2004 Act. They are as follows:
first, and most simply, when it would be in the best interests of the
incapacitated person from whose body the material came. For instance,
let us imagine that an incapacitated person—P, for the purposes
of debate—is cared for by a family member. It might be in that
person’s interests to have their tissue tested for the benefit
of that relative, if it would help to identify a genetic disorder and
if P’s ongoing care depended on the carer’s continued
good health. That type of test would probably involve DNA analysis; the
draft regulations would permit such analysis, which would otherwise
require
consent. Adam
Afriyie (Windsor) (Con): Will the Minister confirm that
there is no route by which somebody’s DNA could find its way on
to the national DNA database via the
regulations?
Ms
Winterton: I do not think that there is any way by which
such DNA could find its way on to the national database, but I shall
seek further clarification. If I am able to confirm that by the end of
the debate, I shall certainly return to it. If not, I shall write to
the hon. Gentleman
afterwards. Secondly,
the regulations will allow tissues to be kept or used for research
where that research is authorised under the Medicines for Human Use
(Clinical Trials) Regulations 2004. Finally, they will allow for
research in circumstances authorised under sections 30 to 33 of the
Mental Capacity Act
2005. The Mental
Capacity Act is not expected to be brought into force fully until 2007,
so the regulations have a transitional provision allowing the storage
and use of tissue for research where the research has ethical approval.
Put simply, “ethical approval” means approval under
existing research ethics review systems. The transitional arrangement
will ensure that legitimate research activities do not fall foul of one
piece of legislation, pending implementation of the
other.
Adam
Afriyie: The Minister mentioned research ethics
authorities. Regulation 8
states: “Research
is ethically approved within the meaning of this regulation if approval
is given by a research ethics
authority”. What are
those research ethics authorities? What bodies are
they?
Ms
Winterton: The research ethics bodies can vary. Sometimes
they will be local; clinicians will have to apply to the local ethics
committee to use such material. At other times, committees of experts
on certain conditions such as cystic fibrosis would look at
the extent of research into that field—I visited somewhere
carrying out such research not long ago. Ethics committees ensure that
legislation is complied with, that research requirements are met and
that our knowledge of conditions such as cystic fibrosis
benefits.
Adam
Afriyie: I would like clarification on a final point. The
Minister mentioned local research ethics authorities. Is she suggesting
that a local body, such as the one that she mentioned—the cystic
fibrosis group—will have jurisdiction and be able to approve
research, on the basis of which it could go
ahead?
Ms
Winterton: As I have said, the ethics committees tend to
ensure that legislation is complied with—for example, when using
or storing tissue. They must also be satisfied that proper procedures
are in place in order to obtain consent when it is needed. If such
consent is not needed—perhaps because that person is
incapacitated—they must ensure that the appropriate all-round
consent has been obtained before any such research is carried out. That
is a safeguard at both local and national level for projects that look
into particular conditions.
Sandra
Gidley (Romsey) (LD): Will the Minister clarify who will
oversee the ethics committees? I dealt with a case a couple of years
ago where there was a problem in the ethics committee, as a member of
the committee pushed forward some problematic research. Obviously, I do
not want to go into the details today. What will stop a very keen
doctor who wants material to further his research from trying to push
something before an ethics committee that might be inappropriate to the
best interests of a patient if they had
capacity?
Ms
Winterton: The overall system is finally accountable to
Ministers. Reviews of the work of ethics committees have been carried
out. Obviously, if people think that the wrong decision has been
reached or that the proper research has not been properly passed by the
ethics committee, complaints can be made. The process involves a group
of individuals with a specific task and if a researcher proposed
something that people thought was wrong, the ethics committee would
consider that in the round. People do not always like the work that is
carried out, for various reasons, but the strategic health authorities
always have oversight if people think that there is a problem. Clinical
trials are accredited by the UK Ethics Committee Authority. So the
ethics committees are overseen in a number of ways, eventually leading
right up to the Secretary of State.
Mr.
Peter Bone (Wellingborough) (Con): So that I can
understand, I shall give a practical example. My wife was very poorly
with liver cancer, and the NHS did a wonderful job and she recovered.
She was asked before her operation whether some of her liver could go
towards research, and she consented, although she easily could not have
done so. Are we saying that in such a situation, if the patient was
incapacitated, it automatically would be said that that piece of liver
could go for research?
Ms
Winterton: No, we are saying that if the research is in
the person’s best interests—such as in my example of an
individual’s carer and research such as a DNA test from the
incapacitated person—consent can be deemed to have been given.
In general, and under the terms of the Mental Capacity Act, in cases
such as that of the hon. Gentleman’s wife the ethics committee
will stress that as far as possible research material should be taken
from those with the capacity to consent. There are some instances in
which an ethics committee might say that research could be carried out
on people without capacity, but there are clear safeguards about that.
Often such instances will be associated with an individual’s
condition. Some of the examples that we discussed during consideration
of the Act were about what might be appropriate social activities for a
person with Alzheimer’s to undertake. There are strict rules on
invasive procedures, which should be as minimal as possible. For
example, if the person found the taking of blood uncomfortable, it
should stop. These
areas can of course be controversial. We received many representations
during consideration of the legislation. However, it was obvious that a
lot of important research could be done into particular conditions, as
long as there were clear rules guiding ethics committees considering
how samples were to be taken for research purposes. Those rules should
be adhered to on the understanding that the research is necessary and
that any tissue would be obtained in the most appropriate
way. John
Battle (Leeds, West) (Lab): I generally welcome this
legislation because, after what happened, safeguards need to be
introduced to make sure that there is no abuse and also that people do
not turn against transplants. That is a big issue, which could go the
other way, with people saying that they do not want to know about the
whole business. My
question is about the process and this particular legislation. My hon.
Friend said that it is a transitional and interim piece of legislation,
not least because the Human Tissue Act 2004 comes into force before the
Mental Capacity Act 2005. The Mental Capacity Act will not come into
play until 2007. However, there were plans to have a mental health Bill
that would change the Mental Capacity Act, and I am told that that
might be brought forward before the summer recess in July. Will my hon.
Friend confirm that that is the case? Or will we need to do this all
again to redefine the Mental Capacity Act? If so, this will be a very
transitional measure.
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