Human Tissue Bill

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Dr. Harris: It is clear; Opposition Members had already reached subsection (3) and seen that. Will the Minister clarify under which schedule a dissection for the purposes of studying the morphology of tissue would be considered to have consent if the tissue were taken from someone in life and were used for that purpose?

Ms Winterton: I think that that is under schedule 1(1). The first paragraph of the schedule relates to anatomical examination.

The post mortem situation addressed in the amendments is even more delicate, and we must be careful in how we approach bereaved relatives as an obligation on them to specify all manner of detail would be wrong. We already have a code of practice on communication with relatives at post mortems and consent forms that help to guide us carefully through that process. Good practice will ensure that those questions are put at the right time and in the right way. There are sometimes circumstances in which such questions should not be asked, and it would be wholly wrong to place obligations on the decision maker.

I am afraid that we cannot accept the amendments, and I urge the Committee to reject them.

<<22>>10.30 am

Dr. Taylor: The debate has been very helpful, particularly to me. I am delighted that the Minister has accepted that such uncertainty exists in the research community and that the situation needs clarification. I was even more pleased with her honesty in admitting her confusion over some of the technical details, because her honest approach augurs well for the progress of the Bill. The last thing that I would want to do is restrict flexibility, so we will return to the codes of practice under the Human Tissue Authority in amendment No. 87.

I welcome the clarification of consent for use of a body for anatomical dissection, because one nightmare for a practising physician is when relatives say that their mother wanted to bequeath her body to medical research. When I was working, the channels for coping with that situation were extraordinarily difficult.

I agree that we must build on current best practice. The Minister made me think hard about making consent a legal responsibility, because when I looked at the consent form from which I quoted, I realised that I would not automatically have asked for consent for medical research and education if I sensed that the family with which I was dealing was already too hurt and damaged. I would not want to remove the right of the attending doctor to decide what consent he should request.

I welcome the discussion and the clarity that it has brought as we have raised and explored the issues, but I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Dr. Harris: I beg to move amendment No. 57, in

    clause 1, page 1, line 11, after 'in', insert 'Part 1 of'.

The Chairman: With this it will be convenient to discuss the following:

Amendment No. 58, in

    clause 1, page 1, line 15, leave out paragraph (e).

Amendment No. 59, in

    clause 1, page 1, line 19, leave out paragraph (g).

Amendment No. 60, in

    clause 1, page 1, line 21, leave out

    'the purpose of anatomical examination'

    and insert

    'any purpose specified in Schedule 1'.

Amendment No. 62, in

    clause 1, page 1, line 21, leave out

    'the purpose of anatomical examination'

    and insert

    'any purpose specified in Part 1 of Schedule 1'.

Amendment No. 61, in

    clause 1, page 2, line 7, leave out

    'the purpose of anatomical examination'

    and insert

    'any purpose specified in Schedule 1'.

Amendment No. 63, in

    clause 1, page 2, line 7, leave out

    'the purpose of anatomical examination'

    and insert

    'any purpose specified in Part 1 of Schedule 1'.

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Amendment No. 48, in

    schedule 1, page 37, line 6, at end insert

    'for purposes which may include—

    (a) determining the cause of death,

    (b) education or training which is inherent in anatomical examination,

    (c) establishing after a person's death the efficacy of any drug or other treatment administered to him,

    (d) clinical audit,

    (e) public health monitoring, or

    (f) quality assurance.'.

Amendment No. 64, in

    schedule 1, page 37, line 6, at end insert

    'other than for the purposes set out in paragraphs 2 to 5 and 7'.

Amendment No. 49, in

    schedule 1, page 37, line 7, at end insert

    'otherwise than by anatomical examination'.

Amendment No. 65, in

    schedule 1, page 37, line 12, leave out 'incidental to' and insert 'inherent in'.

Amendment No. 67, in

    schedule 1, page 37, line 15, at end insert

    'other than activity considered to be clinical audit'.

Amendment No. 66, in

    schedule 1, page 37, line 26, leave out 'incidental to' and insert 'inherent in'.

Amendment No. 69, in

    clause 2, page 3, line 17, after 'examination', insert

    'other than for the purposes of paragraphs 2 to 5 and 7 of Schedule 1'.

Amendment No. 70, in

    clause 2, page 3, line 25, after 'examination', insert

    'other than for the purposes of paragraphs 2 to 5 and 7 of Schedule 1'.

Amendment No. 71, in

    clause 3, page 3, line 42, after 'examination', insert

    'other than for the purposes of paragraphs 2 to 5 and 7 of Schedule 1'.

Amendment No. 72, in

    clause 3, page 4, line 11, after 'examination', insert

    'other than for the purposes of paragraphs 2 to 5 and 7 of Schedule 1'.

Amendment No. 78, in

    clause 56, page 33, leave out lines 12 to 15.

Amendment No. 79, in

    clause 56, page 33, line 29, leave out subsection (2).

Dr. Harris: This large group of amendments can be broken down into five sub-groups. I will first set out how I propose to divide them and what questions I will raise, and then discuss them in more detail.

I would like to help the Committee by suggesting that amendments Nos. 57, 58 and 59 are one distinct sub-group, which deal with the issue of a separate part 2 to schedule 1. My main question is whether it is logical that part 2 exists and that the default position is that of not requiring consent for performing activities such as hospital-interest post mortems on relevant material from deceased persons.

The second sub-group contains amendments Nos. 60, 62, 61 and 63. They are probing amendments on the requirement for death certification. I understand

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that that is carried over from previous Acts, such as the Anatomy Act 1984. It would be helpful if the Minister could explain that, and also why ''public display'' is not included in the same provision.

The third sub-group to which I shall speak includes amendments Nos. 64 and 49 and, by extension, in clauses 2 and 3, amendments Nos. 69, 70, 71 and 72. We have already dealt with some of those matters and my remaining questions will be brief. They probe the definition of ''anatomical examination'' and consider—for those not intimately acquainted with the Anatomy Act—whether that definition could be clearer in the Bill.

The fourth sub-group is amendment No. 65 alone. It asks whether the words ''incidental to'' education and training are right. Finally, amendment No. 67 is another probing amendment on the distinction between clinical audit and the purpose in the schedule. Amendments Nos. 78 and 79 go with the third sub-group of amendments, together with amendments Nos. 64 and 49, because they examine the definition of ''anatomical examination'' that we have already covered.

Amendments Nos. 57, 58 and 59 would, while not removing part 2, have the effect of not differentiating, for the purposes of schedule 2, between consent sought for material from living persons and from deceased persons. Subsection (1)(c) would therefore have to do with

    ''the removal from the body of a deceased person, for use for a purpose specified in''

part 1 of schedule 1 of any relevant material that the body consists of or contains.

Amendments Nos. 58 and 59 would delete paragraphs (e) and (g) of subsection (1), which relate only to purposes specified in part 2. There is a problem for pathology labs and relatives, as those purposes are not already provided for within the consent for schedule 1. Unless the Minister proposes that they can be stand-alone issues, and that relatives will be asked to provide permission for material from a deceased body for part 2 purposes, not as a consequence of another purpose in part 1, that would create problems. Is it logical to require specific consent, for example, for quality assurance or clinical audit in a pathology lab dealing with post mortem examinations?

Would not it be better for the code of practice and the consent form to make clear that giving consent for a hospital post mortem—not a coroner's post mortem—for the purpose of determining the cause of death, or establishing after a person's death the efficacy of any drug or other treatment administered to them, may require clinical audit and quality assurance, and would particularly entail some education and training incidental to the medical diagnosis and treatment? The default position would otherwise be that those boxes were not ticked. We have heard from the hon. Member for South Cambridgeshire and the Minister that on many occasions boxes are not ticked as a consequence of the fact that we are dealing with a difficult area and often the minimum consent is that which is obtained.

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If that is the case, it seems reasonable for education and training incidental to medical diagnosis or treatment to be part and parcel. Otherwise, it will be difficult for pathology labs to ask people who might be watching a post mortem examination or part of it to leave the laboratory because there is not permission for that education or training which is inherent in NHS best practice and is required for continued best practice. I am finding it difficult to understand why one cannot deal with these areas in the same way.

Perhaps Ministers were tempted to require consent for part 2 purposes for samples from living people but decided that the volume of such samples would be too great and would create problems because of the frequency with which implied consent is given for the removal of some samples such as blood samples or cytological specimens; therefore, there would not be anything in writing to determine. That is a pragmatic approach that I support, but I think that the same should apply to the purposes set out in part 2 for permission for using relevant material from deceased persons.

The impact on relatives of having to explain clinical audit quality assurance and education or training incidental to medical training or diagnosis is disproportionate to the additional autonomy that it gives families in those circumstances. I have not heard any concern raised by those representing the people who were so badly treated in the Alder Hey scandal. The problem was that clinical audit, incidental education or training, public health monitoring or quality assurance was being carried out without specific consent. This is not a proportionate response to those incidents. I would be grateful if the Minister would explain that.

The impact on the service could be significant. If clinical audit is to mean anything, it has to be on a reasonable sample of material. If paperwork has to be gone through to identify those 30 per cent. of samples where explicit permission was given for clinical audit, we are undermining the point of clinical audit. It becomes unrepresentative, and the same applies to quality assurance. It is vital that quality assurance tackles the whole range of work carried out in a pathology lab. There will be questions over whether it will be possible for the service to maintain quality in those circumstances.

One argument might be that the impact on deceased persons and their families will be greater for part 2 purposes than the impact on living people when part 2 purposes are carried out, and that therefore one needs specific consent. If anything, partly because the person concerned is deceased and therefore there will be no direct implications for them of the results of public health monitoring, the impact on those individuals is less than that as a result of public health monitoring, which does not specify that it is anonymised and therefore might not take place on people who are alive. We will come to the question of public health monitoring when we deal with the schedule later, and it is tangential to what I am saying, but I use it as an example of the impact on the individual. The default position should be that those part 2 purposes are

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permitted when consent is given for one of the other schedule purposes using material from a deceased person. I would be grateful for the Minister's response.

Amendments Nos. 60, 62, 61 and 63 are probing amendments. I was seeking to give the Minister the opportunity to clarify why a death certificate is required only for

    ''The storage of a body of a deceased person for use for the purpose of anatomical examination''

and not for anything else. The hon. Member for Wyre Forest may want to intervene at this point, because he would certainly have some knowledge of whether that requirement is also necessary for some other purposes. It may not be necessary to set it out in such a way.

10.45 am

 
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