Human Tissue Bill

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Dr. Ladyman: I do not think that I would.

Disposability is an issue here. Hair is obviously a disposable material, which I think most people would say is under a different ethical standard from material that has been collected that may have included cells at some time, even though those cells may have been removed for the purpose of storage. A different process is involved. I will certainly consider the matters that have been raised. Acellular materials are not themselves within the scope of the Bill, but the

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control of cells from which they come is within the scope of consent.

We are now delving into the issues on which 18-year-olds will have to write learned essays for years to come. They involve a degree of complexity that is not of any concern to us. I do not think that the measure will have the practical impact suggested by Opposition Members. The fundamental principle that we must apply to interpreting the Bill is that material provided by people from their own body is theirs to control, and they must consent to how it is used in the future.

Dr. Taylor: I am glad to have drawn attention to the problem. We have had a clear reply from the Under-Secretary. I am not altogether satisfied about the ease of implementation, but I am sure that we will return to this matter when we discuss the Human Tissue Authority. I will not press the matter to a Division, so I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

The Chairman, being of the opinion that the principle of the clause and any matters arising thereon had been adequately discussed in the course of debate on the amendments proposed thereto, forthwith put the Question, pursuant to Standing Orders Nos. 68 and 89, That the clause stand part of the Bill.

Question agreed to.

Clause 1 ordered to stand part of the Bill.

Schedule 1

Scheduled purposes

Mr. Lansley: I beg to move amendment No. 92, in

    schedule 1, page 37, line 13, at end insert

    'or conducted using residual tissue'.

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

Amendment No. 93, in

    schedule 1, page 37, line 21, at end insert

    'other than such research conducted using residual tissue'.

Amendment No. 94, in

    schedule 1, page 37, line 26, at end insert 'or using residual tissue'.

Amendment No. 95, in

    schedule 1, page 37, line 28, at end add—

    '13 Research in connection with disorders, or the functioning, of the human body using residual tissues'.

Amendment No. 86, in

    clause 24, page 15, line 20, leave out '(8)' and insert '(8C)'.

Amendment No. 99, in

    clause 24, page 15, line 23, at end insert—

    '(3A) The Standards required to be laid down by subsection (1) may include provision that the use of residual tissue not normally requiring consent for purposes under part 2 of Schedule 1 may require the approval of an appropriately constituted research ethics committee.'.

Amendment No. 87, in

    clause 24, page 16, line 3, at end insert—

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    '(8A) The standards required to be laid down by subsection (1) shall include provision to secure that consent indicates for which scheduled purposes consent has been obtained.

    (8B) The standards required to be laid down by subsection (1) may provide that residual tissue may be retained for scheduled purposes under paragraphs 3, 5 or 7 of Schedule 1 without consent or pursuant to a consent to treatment entered into by the person concerned.

    (8C) The standards required to be laid down by subsection (1) may provide that consent for the scheduled purpose of transplantation may be given by means of an enduring consent.'.

Amendment No. 88, in

    clause 24, page 16, line 3, at end insert—

    '(8D) For the purposes of this Act—

    ''residual tissue'' means relevant material obtained, in the course of, and consequent upon, a course of diagnosis or treatment, following consent of the person concerned to treatment; and

    ''enduring consent'' means a consent given by the person concerned which is obtained prior to any treatment and which is not specific to the circumstances of any diagnosis or course of treatment of that person while he is alive, or to the circumstances of his death.'.

Amendment No. 96, in

    clause 47, page 29, line 26, at end insert—

    '(e) purposes of research in connection with disorders, or the functioning, of the human body using residual tissues.'.

Mr. Lansley: Some of the amendments in the group have slightly different purposes to amendment No. 92, which I will explain. The purpose of amendments Nos. 92, 93, 94 and 95 is to transfer activity using residual tissue in relation to two schedule purposes in part 1, education and training, and research, to part 2. We tabled those four amendments because part 1 deals with education and training other than that conducted using residual tissue, and research other than research conducted using residual tissue; by extension we have added the use of residual tissue to paragraph 10, and we have added a new paragraph 13 to provide that research using residual tissue would not normally require consent.

We want to debate this point because it is clear to many in the medical research and scientific community that, following the tragedies at Alder Hey and Bristol, the issues that have given rise to some of the strongest concerns about the current legislation have arisen in relation to the retention of organs and tissues of those who have died. That is not to say that concern has not been expressed about tissues retained from living persons, but they have tended to be of a lesser nature.

The question that has emerged from the medical research community, which it is proper for us to discuss, is whether, although there are differences between living persons and deceased persons, the balance of the Bill is wrong, in that, as we heard in our debate on the previous group of amendments, so many tissue samples are being, or will be, retained from living persons in the course of treatment that if consent were required it would be excessive and burdensome to the research community.

The amendments are designed to explore that issue in relation to the two purposes of research and education and training—not to the general purposes of part 1. There are safeguards in the amendments, because although consent would not normally be required, amendment No. 86, a technical amendment,

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would allow standards laid down to be included in the code of practice. Amendment No. 87, to clause 24, would add a range of standards that need to be laid down, one of which relates to residual tissues. It would require, in proposed new subsection (8B):

    ''The standards required to be laid down by subsection (1)''—

the standards in the codes of practice of the Human Tissue Authority—

    ''may provide that residual tissue may be retained for scheduled purposes under paragraphs 3, 5 or 7 of Schedule 1 without consent or pursuant to a consent to treatment entered into by the person concerned.''

Clause 24(3) allows the authority to set out the exceptions to those standards. Amendment No. 99 would provide that the standards will also require that the use of residual tissue, which would not normally require consent, may none the less

    ''require the approval of an appropriately constituted research ethics committee.''

I shall summarise the structure that we are suggesting. Residual tissue can be used for education, training and research purposes, and for the obtaining of scientific information. Residual tissue is defined in amendment No. 88 as

    ''relevant material obtained, in the course of, and consequent upon, a course of diagnosis or treatment, following consent of the person concerned to treatment''.

It clearly relates to a living person consenting to treatment. It does not impact on deceased persons, other than where they have died subsequent to that consent. The tissue can be used for specific purposes, but can be used only with the consent of a properly constituted research ethics committee. I think we are getting to the point where we shall at least have a structure—which could be put into legislation—designed to reflect some good practice now.

Dr. Harris: I would have thought that this sort of use would require the permission of a research ethics committee, and what the hon. Gentleman is doing in amendment No. 99 is saying that ''Standards . . . may include provision'', and those in turn may require the approval of a research ethics committee. If use of this sort of material requires the permission of a research ethics committee—perhaps he would consider circumstances where it would not, and where consent would not be sought, because it was not research envisaged at the outset of the treatment—is that really necessary, and might it actually put in statute a rather weaker provision?

Mr. Lansley: I do not think that the provision would be weaker, because the whole structure of the codes of practice is permissive, in the sense that they allow the Human Tissue Authority to determine what the practice should be. The codes of practice will state that, under some circumstances, the use of residual tissue will require consent, so it would not necessarily follow that the codes of practice would therefore require the approval of a research ethics committee, although that would probably happen under those circumstances as well.

There is a structure here. There is a point of principle here—are we committed to explicit consent as a basis for the use of residual tissues arising from

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treatment? The research community is saying that that is a very burdensome requirement. We have to weigh up whether the demands of consent from living persons following treatment are such that we are not willing to consider that there may be a place for residual tissue—with the consent of research ethics committees—being treated as an exception to that principle. It is a question that we need to consider. I am not saying that we should necessarily reach that conclusion, but we should show the research community that we have considered it. I freely confess that there may be technical problems with the amendments, but the issue needs to be thought about—whether residual tissues arising from treatment, particularly if they are small amounts and directly consequent upon that treatment, should be, necessarily, the subject of explicit consent.

That is the first question that I do not want us to lose sight of, but there are others, and amendments Nos. 87 and 88 are not confined to that question. I ask the Committee to think about those two amendments separately. We discussed earlier, on the first group of amendments, the extent to which consent should be taken for specific, scheduled purposes. Amendment No. 87 would introduce a further standard to be laid down in the codes of practice by the Human Tissue Authority, to the effect that provision to secure consent

    ''should indicate for which scheduled purposes consent has been obtained.''

That is less rigid than putting the structure into the Bill, but clearly directs the Human Tissue Authority towards avoiding generic consent for a range of purposes without spelling out which purposes are intended.

Amendments Nos. 87 and 88 also add a further question—it is merely a question. Can consent for the purpose of transplantation be given by means of ''an enduring consent''? An enduring consent is defined under amendment No. 88 as

    ''a consent given by the person concerned which is obtained prior to any treatment and which is not specific to the circumstances of any diagnosis or course of treatment of that person while he is alive, or to the circumstances of his death.''

Can we be assured that, if explicit consent is required, consent for the purposes of transplantation will not be dependent on any of the circumstances giving rise to the person's death or any of the treatments or diagnoses that he might have received before his death? Will consent at an early stage, unrelated to subsequent events, be regarded as consent that carries through to the scheduled purpose being implemented after death?

4.15 pm

 
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