Human Tissue Bill

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Dr. Harris: I seek to help the Minister, which is why I wanted to intervene as soon as possible. There is some confusion, although not in the mind of the hon. Member for Wyre Forest I hasten to add, about controlled non-heart-beating donation and uncontrolled non-heart-beating donation. In many circumstances, death is liable to happen at a planned time and the appropriate steps can be taken. It is only in the uncontrolled situation, with a dead-on-arrival case in A and E, that people other than the transplant staff, such as A and E physicians and surgeons, may be required to take action.

Ms Winterton: The hon. Gentleman is right. I am assured that currently transplant teams, or others who are specifically trained for the purpose of carrying out the procedure, are always available.

Dr. Taylor: I thank the Minister for clarifying that. The phrase ''or others'' is crucial. In Leeds the hospital that does the transplant is different from the hospital that has the A and E department, so it will not be the transplant team who carry out the procedure; it will be done by A and E staff who are trained in the procedure.

Ms Winterton: The important point is that proper training is available and that it co-ordinates with the work of the transplant team so that the person is almost part of that team.

Dr. Harris: I am aware that the Minister had moved on to deal with the point raised by the hon. Member for Wyre Forest, but I want to bring her back to the question of lawfulness. I should have thought that what is required is to make it explicit that the practice is lawful. Clause 1(1)(b) states that without appropriate consent

''the use of the body of a deceased person for a purpose so specified''

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—in other words, transplantation—will not be lawful, and that is why clause 44 is necessary. If the Minister agrees with that, would it be useful—I suspect that she will say it would not be—to make it clear that the paragraph in clause 1 does not apply to the question of preserving organs for transplantation, even though most people would understand that to be the use of a body?

Ms Winterton: I am not quite sure that I completely follow the hon. Gentleman's arguments. The clause clarifies that cold perfusion is lawful, while making it quite clear that consent is required to proceed any further. This is a short procedure. The authority will ensure that it is the least invasive possible but it will make an important contribution to organ donation.

Dr. Murrison rose—

Dr. Harris: I know that the hon. Member for Westbury wants to intervene, but I have to say that I hope that the Minister is not proposing to finish her remarks there. I asked her three specific questions. One concerned the authority that is referred to and who regulates it. The second concerned whether codes of practice would be issued—

Ms Winterton: I answered that.

Dr. Harris: I am sorry if I missed that. Thirdly, I asked whether the Minister accepts that this is to a certain extent an issue of presumed consent, at least up to the point at which consent is required.

Ms Winterton: I answered that as well.

Dr. Harris: I am sorry if the Minister answered that, but I did not hear her deal with those three points.

Ms Winterton: I think that I answered all those points in my remarks. First, I said that the codes of practice issued by the authority would state that the procedure had to be the least invasive. Secondly, I said that this did not involve presumed consent, but the carrying out of a short procedure to ensure that organs do not deteriorate until consent is obtained. Thirdly, the HTA will regulate the practice, but there is also the question of obtaining the authority to go ahead, perhaps from an individual.

10.30 am

Dr. Murrison: I perceived that the Minister was about to conclude her remarks, so I thought that I should intervene briefly. Will she confirm that all she has in mind here is cold perfusion, not ventilation? Will she also say that she will rely on case law as a defence against a charge in the event that someone took exception to cold perfusion having been instituted? We understand that there is no statute law; that is fine. However, there must be case law for the assurance of those who will undertake the procedure. How many cases of cold perfusion have there been in, for example, the past 12 months or so?

Ms Winterton: Cold perfusion has been undertaken as a procedure for the past 10 years. I do not know the exact number of cases, but I can write to the hon.

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Gentleman if he is interested. He asked about case law as a defence in respect of cold perfusion. Obviously, once it is lawful under the Bill, there will be statutory authority to do it. I am not quite clear what the situation would be if someone had indicated beforehand that they did not want the procedure undertaken. As far as I am aware, there have been no objections to it in the past 10 years. Cold perfusion is undertaken after death, and the results last only a certain number of hours before organs start to deteriorate.

Dr. Harris: I certainly endorse what the Minister has said. I believe that there was a case in Leicester in which someone sought to prosecute the doctors for undertaking cold perfusion, and there was a worry that the Crown Prosecution Service and the police would act. The clause is therefore welcome. If it turned out that someone had said that they did not want the procedure done to them, although that was not known at the time, the defence would be that the presumption was made that they would permit it, until their wishes were clarified.

Ms Winterton: No, a defence would be that the procedure is allowed under statute. It would not be a presumption; it would be what the law says. Having said that, I hope that members of the Committee will agree that the clause is important to ensure that we can assist in obtaining more organs for donation.

Question put and agreed to.

Clause 44 ordered to stand part of the Bill.

Clause 45

Surplus tissue

Dr. Murrison: I beg to move amendment No. 9, in

clause 45, page 28, line 17, at end insert—

'(3A) Insofar as it would be impracticable to obtain appropriate consent in relation to material to which subsections (2) or (3) apply, it will not be unlawful to make such material available for scheduled purposes.'.

This is a probing amendment. I should be grateful if the Minister would deal with some more definitions. In particular, what does she mean by material ''dealt with as waste''? That question spurred me to table the amendment. Most people, in a utilitarian way, would probably prefer it if surplus material removed from them in the course of a medical procedure could be turned to some good use rather than disposed of. That lies at the heart of the amendment. I hope that the Minister will expound on exactly what the provision means and the circumstances in which it will apply.

I am thinking in particular of procedures such as blood tests, which are carried out many times every hour in the national health service. Parts of the material could be used to good effect for research purposes, even if the primary purpose were investigation. The amendment would allow surplus or waste tissue to be used for other scheduled purposes, with the minimum of bureaucracy and fuss. That would probably be in accordance with the wishes of the vast majority of people in this country.

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Ms Winterton: We return to an issue—the use of human material variously described as ''residual'', ''waste'' or ''surplus''—on which the Committee has had considerable debate. To return to the Bill's principles that we are entitled to determine how material from our bodies should be used and that we should have to consent to the use of that material, we should not assume that any material that is left over from one use can be somehow used for another purpose without consent. If we followed that path, we would undermine the Bill's consent provisions, which are its very foundation. That is not only the Government's view, but is mentioned in the guidance provided by the General Medical Council:

''You must obtain appropriate consent or authorisation before taking or retaining organs, tissues or bodily fluids, from patients or volunteers, for research purposes. This applies whether the material is obtained solely for research purposes or retained following a clinical or surgical treatment.''

Dr. Harris: I hope that the Minister will accept that part 2 of schedule 1 makes it clear that that does not apply for public health monitoring purposes. We have had a debate about what that means—although it was not satisfactory and I suspect that we shall return to it. The term ''public health monitoring'' can and will include research, not just public health monitoring. The rubicon has been crossed in that respect. That is why many people find it difficult to understand that, for epidemiological and unleaked and anonymised research, that definition appears to be quite narrow.

Ms Winterton: As the hon. Gentleman said, we have discussed this matter and may return to it at a later stage. We cannot accept the amendment because it would take us beyond the Bill's intention and undermine some of its fundamental principles. I hope that the hon. Member for Westbury will feel able to withdraw the amendment.

Dr. Murrison: I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Dr. Harris: I beg to move amendment No. 127, in

clause 45, page 28, line 17, at end insert—

'(3A) Subsections (2) and (3) shall continue to apply after the person from whose body the material has been removed has died.'.

This amendment probes whether the clause covers sufficiently the question of surplus tissue taken during treatment or diagnosis from a patient or a research subject who subsequently dies. What circumstances will apply? Will the procedures that apply to the tissue of a deceased person—where there is a requirement for consent, and the opportunity for the tissue to be reunited with the body for burial—similarly apply? Is the issue dealt with as the clause specifies because when the tissue was taken the person was alive? I hope that I am making the purpose of the amendment clear; it should be clear, and I believe that it is. I hope that the Minister can reassure us on the exact position because a number of people have raised the issue with me in the fear that they might be breaking the law in such circumstances.

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Prepared 5 February 2004