 House of Commons |
Session 2005 - 06 Publications on the internet Standing Committee Debates |
Code of Practice on Consent (Code 1) |
The Committee consisted of the following Members:Chris
Shaw, Committee
Clerk †
attended the Committee Third Standing Committee on Delegated LegislationWednesday 25 October 2006[Miss Anne Begg in the Chair]Code of Practice on Consent (Code 1)2.30
pm That the
Committee has considered the Code of Practice on Consent (Code
1).
The
Chairman: With this it will be convenient to consider the
Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and
Supply of Information about Transplants) Regulations 2006(S.I.
2006, No.
1260).
Dr.
Pugh: I apologise for the fact that my hon. Friend the
Member for Oxford, West and Abingdon (Dr. Harris) is not here. As
members of the Committee will see from the parliamentary monitor, he is
otherwise engaged. He has his finger in many pies and, although he is
enormously talented, he has not yet mastered bifurcation. I must also
apologise in advance for what I am about to say. I have had to mug up
on my hon. Friend’s brief pretty quickly, and he has followed
such measures far more carefully and with greater scrutiny than I have
hitherto. The
regulations follow a prolonged debate and extensive consultation on the
legislation. The Government thought long and hard to reach a balance to
deal sensitively with a difficult subject, where, in fact, many varying
interests clash, such as medical research, patient autonomy and
welfare, and the public benefit that can come through transplants and
research. We must bear in mind that some primeval feelings about
respect for the body, the deceased and so on are deep-rooted, sensitive
and important to people. There are the interests of the bereaved to
consider in connection with such issues as well as cultural
sensitivities in different parts of our society about the body and body
parts. There
is a need for a balance. I accept that it is difficult to achieve, but
somehow or other we must reflect society’s view of where it can
be found because, at times, we can get matters spectacularly wrong. The
example of Alder Hey leaps readily to mind. The whole history of
anatomy is full of the most disgraceful episodes of one sort or
another, such as the recent furore over the exhibition of cadavers as a
form of
entertainment. We
need to have regulations that are practical and reflect a balance with
which we are happy and comfortable. We have before us two documents,
one that is legally complex and impenetrable and one that is clear and
therefore far more questionable. Let us first consider the impenetrable
document. It mainly concerns exemptions from requirements of licensing
for those who hold tissue. The medical fraternity has tried to draw a
distinction between end users and storers, which have definite
licensing requirements to meet.
At the back of
the second document is an explanation of storage, but it is a glib
one-line definition. It has been suggested by medical opinion that we
need to be absolutely certain that we know what is meant by storage.
That is accepted by some of the medical fraternity, but there are
occasions when, because research is ongoing, information needs to be
retained over a certain period, and that raises the question whether
that itself constitutes storage. Holding samples as part of a batch
before sending them back to storage takes place prominently in research
communities and is an issue that needs to be clarified before we can
happily accept the regulations. It is certainly an issue that has been
raised within the British Medical Association. I shall make no further
comment about the impenetrable
document. I turn now
to the more accessible document, the code of practice. It raises two
worries. Some concern general clarity while others are residual worries
that have been expressed by the BMA. However, all of them are
fundamentally about consent, what it means and how it can best be
defined. I shall take them in the order set out in the code of practice
and explain where I and those who are far more expert than me perceive
difficulties. I doubt whether any of us here have day-to-day experience
of being involved in such affairs. I have actually witnessed a
post-mortem, but that is the limit of my
experience. Most
members of the Committee will find one difference manifestly
clear—the difference in the code of practice between the living
and the dead. The regulations that apply to organ removal and retention
of samples are different in each case. The BMA has cited a situation
that is worthy of consideration, however, because there are two
categories of material that may be obtained from deceased people:
material from a living person who has subsequently died, and material
removed at death. The question is which set of regulations should be
applied in that
context. There is also
a distinction within the regulations between research and clinical
audit—they are differentiated in relation to the regulations
that apply to them. Again, however, a question that has been asked is
whether that difference is manifest to people who work in a day-to-day
medical capacity. Some aspects of clinical audit are partly research.
Indeed, public health monitoring, which is differentiated from research
and which has a different set of applicable rules, can in part seem to
be an aspect of research. I raise that issue because the BMA will
itself raise it in its response to the consultation, and I should
welcome the Minister’s
comments. One factor
that emerges straight away when such issues are raised is that of
anonymised and non-anonymised tissue. We are far more comfortable with
the existence of samples and data about us if they are anonymised, but
can be examined by anyone who wants to do appropriate research. The
general view is that when samples are anonymised, we can be far more
relaxed about what happens to them, because they cannot be identified
with a particular person at a particular time. The legislation proposes
a Chinese wall—a firewall—so that when anonymised data
are used for research purposes, it is impossible for any and every
researcher to identify the source of samples, even though the data may
not be completely unlinked to identity.
I have been asked—and I
pass the question on to the Minister—whether that procedure of
ensuring anonymity and of different treatment of allegedly anonymous
samples, which does not completely remove the link, necessarily
involves a third party who simply hands on the samples and says,
“We are not telling you where they are coming from”?
Alternatively, does it simply mean that the pathologist or researcher
removes any identifying tags in the context of the research? Either may
be practical, but practitioners need to know which is the case, so that
they can be comfortable about being on the right side of the
law. The BMA has also
raised the question of relatively minor clinical matters. It is
suggested that it is generally a good idea, whatever a sample is and
whenever it is being used, to seek consent if it can possibly be
obtained. My problem with that is not general, but it is genuine. If
the code of practice is supposed to do what its name suggests, and it
says that something may be done, but need not be, so that there will
still be good practice in either event, what will practitioners do?
Will they feel obliged scrupulously to seek consent if obtaining it is
remotely plausible, or should they decide to obtain consent in some
contexts but not others, depending on their judgment of the
circumstances? The guidance is not particularly
clear. There
is another problem: that of data and samples that are not collected
directly for research purposes but which are kept with the ongoing
patient records. As we know, patient records can be voluminous and can
be kept for some time—I am referring to medical blocks and
slides and so on. Do all the scruples and regulations apply in that
case, or is that area one where a more relaxed regime applies, or where
the regulations have no
purchase? There are
two more issues before I conclude on BMA matters. I believe that during
the passage of the Act it was made clear that signing the organ donor
register constituted legal consent. It does not matter how long ago
signing took place, as long as one is walking around with a card that
was signed at some point, and there is an audit trail to indicate
permission. The BMA suggests that the regulations do not actually
specify that in precise terms. One can say plausibly that none the less
they imply it, but the BMA suggests that it would be helpful to make
that absolutely and completely
explicit. The BMA
makes another point that is worth debate if not a second view. The
regulations say that if as part of the surgery there is any possibility
that tissue samples might be removed and subsequently used for research
purposes, consent for that should be part and parcel of the consent
given during the operation process. The BMA suggests that it is
desirable for those two things to be separate—that it is one
thing to consent to the operation and another thing to consent to what
might befall as a result of it or what people might want to do with the
bits taken from it. Perhaps the Minister will respond to that
point. In
its representations, the BMA also touches on the sensitive issue of
minors and what happens to children, who if very young often lack the
capacity for consent in any meaningful sense. In consequence of the
events at Alder Hey and so on, the BMA recognises that it is pretty
undesirable for anything to be done with the bodies of young children
when consent is not evident
and thoroughly explicit. It thinks that as a general rule of thumb, that
ought not to be a territory that people should investigate too hard
without all the ramifications of detailed consent.
The BMA suggests—I throw
it open for consideration by the Minister—that the regulation
might need to differentiate minors depending on their recognition of
what they are consenting to. There is an enormous difference between a
3-year-old and a 13-year-old. I have no particular view on that; I
simply pass it on as a representation.
A couple of issues concern me,
one of which involves those who lack the capacity to give consent on
their own behalf. I was drawn to paragraph 38 of the code of practice
on consent, which
says: “The
ability of adults with learning difficulties, or with limited capacity
to understand, should not be underestimated. Where appropriate, someone
who knows the individual well, such as a family member or carer, should
be consulted as s/he may be able to advise or assist with
communication.” Off the
top of my head, I cannot think of a better phrase than “where
appropriate”, but it seems to leave things a little bit loose,
to the extent that a medical practitioner could decide that it was not
appropriate to consult a family member or carer and that action could
be taken where no proper consultation had taken place. Who is the judge
of where and when it is
appropriate? I read on
to paragraph 40, which I hoped would give me some comfort on that
point, but it says that
the “storage and use of
relevant material for certain scheduled
purposes” can be
allowed “by a person who
is acting in what s/he reasonably believes to be in the best interests
of the person lacking
capacity”. Which person
are we talking about? In this context, could we be talking about a
medical practitioner—the person who wishes to withdraw the
sample or has some use for it—or are we talking about somebody
who is acting in a parental capacity or as an advocate on the
person’s behalf? That made me a little concerned that we have
not made enough provision to ensure that those people with learning
difficulties or whatever who are incapable of expressing themselves
particularly well will be treated ethically and
reasonably. There is a
view that on the decease of a patient, the relatives may legitimately
be asked questions about what might happen to the patient’s body
or bodily parts. There is a set of reasonable requirements to be met,
but they are subject to the right person being found at the right time.
Paragraph 57
says: “In
applying the principles set out above, a person’s relationship
shall be left out of account if... having regard to the activity
in relation to which consent is sought, it is not reasonably
practicable to communicate with that person within the time available
if consent in relation to the activity is to be acted
on.” That basically says
that the requirements do not apply if there is insufficient time or if
it would be difficult to find the person who ought to give consent. I
could be wrong, but that seems to be too open a situation. I think of
the situation of people who have no known relatives who can be sought
out, but who none the less might have tissue, transplant material or
whatever that is of value or use—perhaps just the cornea of the
eye or whatever. Such people are in a markedly more vulnerable
position.
I totally accept that there will
be circumstances in which clinicians will wish to intervene, but where
there will be no capacity whatever to get in touch with the relevant
people. However, for some people there are no obvious relevant people
with whom to get in touch. I would be comforted if the physician was
told that he was blocked off and could not do anything if he came
across a person who was completely destitute and without any relatives,
friends or anybody to advocate on his behalf. However, I am not
convinced that that is what the regulations say, although I would be
markedly assured if I found that that was the case.
I am not sure that I have
adequately reflected all the concerns of the BMA. The issues under
consideration are worth the Committee’s careful attention. I
hope that the Minister can respond appropriately to some of the
concerns that I have
raised.
2.47
pm Mr.
Stephen O'Brien (Eddisbury) (Con): I am slightly surprised
that we are here at all today, as most of the issues have been fully
aired and a pretty broad consensus has been reached.
Given that we have this
opportunity to discuss the issues, it is important to lay out some of
the background and ensure that we are clear about what the regulations
aim to achieve. However, given that the hon. Member for Southport (Dr.
Pugh) is standing in for the hon. Member for Oxford, West and Abingdon,
on whose behalf he has apologised to the Committee, it is worth adding
as a preamble that when a prayer is laid against a statutory instrument
we should be given some indication as to the purpose of doing so. A
similar incident occurred just a week ago on the Floor of the House,
when there was a Liberal prayer against a statutory instrument but the
Member concerned chose not to speak to it, so it will be taken
tomorrow. There is an issue concerning the potential cost to the
taxpayer of this Committee’s convening today. I hope that the
Minister can give us some guidance to ensure that we use the time that
we are allotted in the House sensibly. That is the procedural point,
which is
important. The
background to the instrument is probably pretty well known, but I shall
state it for the record. Before the Human Tissue Act 2004, the
statutory framework on the removal, storage and use of organs was
governed by the Human Tissue Act 1961, the Anatomy Act 1984 and
associated regulations. The framework was based on a lack of objection,
rather than on informed consent. The 2004 Act arose from concerns
raised by events at the Bristol royal infirmary and Alder Hey, the
Liverpool children’s hospital, the respective Kennedy and
Redfern inquiries, and the illegal removal and retention of organs of
mentally ill people that was highlighted by the Isaacs inquiry. For the
sake of probity, I should declare that in the past 18 months
one of my children had an NHS operation at Alder Hey. It was an
enormous success and I wish to pay tribute on behalf of my family to
the care and professionalism that we experienced on that
occasion. As I said,
the Opposition support the regulations, but we need to be clear about
how we have come to discuss regulations that were made on 25 April and
laid
before Parliament on 10 May and have been in force since 1 September.
There is a question about process, but perhaps when the Minister is
dealing with my important point on parliamentary procedure and the
costs of today’s Committee, he will also think about what would
be the consequence of our voting against this statutory instrument
today, in the light of its already being in force since 1 September. I
hope that, as a result of this discussion, there will be some
reflection on why we are
here. I am glad that a
correction to the statutory instrument has been issued. As somebody who
has an apostrophe in their surname, I am obsessed with punctuation and
spelling. I am glad that “license” has been correctly
spelled throughout the
document. There are no
thanks in politics for saying, “I told you so,” but would
we be here if the Government had listened to the early representations,
including from Her Majesty’s loyal Opposition, when the Bill was
published in late 2003? We asked and were given an assurance that the
Bill would be published before the summer recess 2003 to allow proper
pre-legislative scrutiny. However, it was not published until December
that year. The then Minister, the right hon. Member for Salford (Hazel
Blears), gave my colleague, the then shadow Secretary of State, the
hon. Member for South Cambridgeshire (Mr.
Lansley), “the
undertaking that we hope to publish the draft Bill for parliamentary
scrutiny before the summer recess”.—[Official
Report, 29 April 2003; Vol. 404, c.
276.] Despite the six-month
delay, the Bill, as it was fairly well acknowledged in the end, was not
the most graciously drafted document. On 6 June 2004, The
Observer reported that, as a result of the intense pressure exerted
on the Government by third
parties, “Ministers
are expected to water down the Bill when it comes back to
Parliament.” That was
endorsed by the hon. Member for Norwich, North (Dr. Gibson), who, as
Chairman of the Select Committee on Science and Technology,
said: “All we
have been hearing from the scientific circuit is, ‘this Bill is
dreadful’...At last
they— the
Government— “have
got their act together. The idea that each time you take a urine sample
you should be asking for consent—how anybody thought that could
happen I don’t
know”. The
Government introduced a Bill with 99 amendments, including five new
clauses. We went through the procedure, with all the additional
clauses, but broadly speaking despite the somewhat tortuous process we
arrived at the right conclusions. However, the Bill specifically did
not provide details on how and when consent should be obtained; it left
the Human Tissue Authority to lay down codes of practice, hence our
presence here today—although given that we have already
discussed this issue, perhaps our presence was not needed. I think that
I have talked about that point more than
enough. The
important thing is that the further lack of draft codes of practice to
accompany the Bill have made scrutinising it less successful for
patient and professional groups. That is why there have been a number
of representations. We have reached the right
conclusion.
Although the hon. Member for
Oxford, West and Abingdon is not here, for reasons that I fully
understand, he would not have put the case quite as it has been
presented by the hon. Member for Southport. The hon. Member for Oxford,
West and Abingdon would have argued that the organ donation system in
this country should go from being opt-in to opt-out, and that it should
presume
consent.
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