Human Tissue Bill

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Dr. Ladyman: To make it easier for me to respond properly to the hon. Gentleman, will he clarify exactly what he means? It seems that he is describing a donor card signed before a person becomes ill. Such an example is not related to the other provisions, but I might have misunderstood his amendment.

Mr. Lansley: The Under-Secretary is right—it is unrelated to the discussion about the other amendments. Amendment No. 88 is in the group

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because it follows on from amendment No. 87, which refers to residual tissue. An organ donor card could be an enduring consent, but we must be clear when we are legislating about a structure of consent and resting on common law consent. The Under-Secretary's understanding is that consent given that is unrelated to subsequent circumstances can be regarded as explicit consent in subsequent circumstances. I think that the hon. Member for Oxford, West and Abingdon has tabled amendments about whether an organ donor card can be regarded as consent for such purposes. My answer is yes, it can and that it can be regarded as enduring consent. However, we must be aware that practice is not as simple as that. Often it is regarded as conditional consent—conditional on the absence of objections from the next of kin.

Dr. Ladyman: Is the hon. Gentleman asking whether the carrying of a donor card gives consent for uses of the person's body beyond that necessary for transplantation? If that is not what the hon. Gentleman is getting at, is he suggesting that, if a person's body were used for transplant purposes, some parts of it may also be considered to be residual tissue from that process? I am struggling with why such matters should be referred to in the clause.

Mr. Lansley: I meant neither of those arguments. It might have been unhelpful of me, but I grouped together in one amendment three standards that the code of practice should cover, so the matter rides on the coat tails of residual tissue, but is unrelated to it as an argument. The amendment is not about the use for scheduled purposes other than transplantation. I want make sure that there is a strengthened understanding that there is a form of consent that is not subject to subsequent changes of circumstances, nor, by implication, to being overridden by the objections of others, because the consent was given in an enduring form.

Dr. Harris: This intriguing group of amendments was moved thoughtfully by the hon. Member for South Cambridgeshire. I hope that he can satisfy me on a couple of issues. Proposed new subsection (8A) in amendment No. 87 is an interesting way in which to deal with the issue that we discussed under the first group of amendments. Before he was pressed by the Under-Secretary to give an example of enduring consent, I thought that he was talking about whether, for example, a consent taken at the time of the taking of cord blood, which is then frozen for a long time, would endure—in other words, there would be no need to return to the patient or the patient's parents for further consent to use that blood for transplantation or, indeed, for the freezing of bone marrow stem cells, which could be stored for a time and not used acutely.

That is what I thought the hon. Gentleman meant. Even if he did not, I should nevertheless like the Under-Secretary, if this is an appropriate time, to say whether the material in question is considered residual tissue—although I notice that the amendment to a certain extent defines residual tissue. Is the hon. Member for South Cambridgeshire saying that,

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under the amendment, subsequent advice from the Human Tissue Authority would cause a donor card to constitute enduring consent, and that the next of kin could not countermand that consent?

Mr. Lansley: Technically, no, that is not my argument. We would entrench into the codes of practice the concept of a form of consent that would be unrelated to subsequent changes of circumstance and which would be distinguished from any other kind of explicit consent. Once that strengthened form of consent had been created, the assumption about the views of the family that the hon. Gentleman described might be written into the codes of practice, but not necessarily so.

Dr. Harris: As we know from the Second Reading debate, that is a contentious issue. However, I am pretty sure that there are amendments to clause 3 that deal with the problem from my perspective, so I shall leave the issue to one side.

I thought that the hon. Gentleman's reference to enduring consent was also an attempt to address conditional consent, whereby, although people have given consent, or their next of kin has given it after death, for their tissue to be used, they want to set conditions on who can receive it. That might be touched on by his question.

The third issue is the one that the hon. Gentleman started with, which is the idea that there need to be standards on the use of residual issue for research purposes. He did not give a ''for instance'', but he might be referring to a group of patients who have had tumours resected: such tissues are often stored for all sorts of reasons, permission for which is usually granted as part of the written consent for the operation. If research is being conducted on those tumours, consent might be sought for work that does not involve anonymisation of the samples, because researchers might want to compare the findings with other characteristics of the patients: for instance, if a certain antibody or antigen is found, one can, on examination of the case records, ask whether it was a factor in the history.

Is the hon. Gentleman suggesting that consent would generally have to be sought if, for example, samples that were patient-identified were to be used for new research conducted years after they had been taken? That is a reasonable question and I hope that the Under-Secretary can clarify the issue. I assume that a research ethics committee would be involved in such work—indeed, one would have to be. If so, I question the need for the extra protection that the hon. Gentleman proposes. Perhaps the understanding is that, for a new research project years later, there would be no need to obtain further consent from those patients, who may not still be alive. That is an interesting area to pursue, since we are dealing with tissue from living sources. Will the Under-Secretary clarify that?

These are not my amendments, but I ask the Under-Secretary to expand on what he believes the role of research ethics committees to be. They are otherwise not mentioned in the Bill; perhaps he regards them as temporary bodies. However, overlaps with research

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ethics committees may become relevant as we discuss other elements of the Bill, particularly those referring to the Human Tissue Authority. Early guidance on the role of research ethics committees would be appreciated.

Dr. Ladyman: Let me first deal with enduring consent for transplants. I shall deal with the topic briefly because I am sure that we will return to it in detail later. I confirm what I said on Second Reading: that the carrying of a donor card, or other indication of one's views, is an enduring consent to organs being used in transplantation. That consent applies either until it is withdrawn by the person who gave it, or until the consent is put into effect on death.

However, nothing in life is that simple. As my hon. Friend the Minister explained extensively on Second Reading, even if someone has expressed their wishes and clearly consented to their organs being used for transplantation, it is necessary to consult relatives when the organs have to be collected—for example, when screening the donor's recent behaviour to ensure that no diseases have been contracted that may pass to the recipient of an organ. If relatives are not prepared to give that information, it may not be possible to use the organs even though the person has given their consent.

Clinicians involved in such decisions are encouraged to be sensitive to the needs of everybody affected by the tragedy of a death. Therefore, if a close relative is deeply distressed by the idea of organs being used for transplantation, even though the individual had consented, the clinician may not feel it appropriate to use those organs. That said, one's donor card is a clear indication of one's views, and would, under the terms of the Act, be considered an enduring consent for organs to be used for transplantation. Someone would not be able to override that consent on technical grounds or because they wanted to impose their moral position; one's expressed wish would have to be clearly dominant in the minds of clinicians. I hope that we do not need to discuss the issue in further detail now, because we will do so later.

Let me deal with the concept of residual tissue. I understand why people working in laboratories and scientists carrying out diagnostic procedures might regard leftover material as waste and of no value to the person who donated it, and why they might therefore believe that they are entitled to impose their view of what it is used for ahead of what might be the view of the individual who provided the material. However, to do that would be fundamentally wrong and against the principles of the Bill. The principles of the Bill are that we all own our bodies, we are entitled to determine how material from our bodies is used, and we should have consented to the use made of that material. If we consented to the use of material from our bodies for diagnostic purposes, it should be used for those purposes, and it should not be assumed that the bit that is left over may be used for any other purpose.

That requires people to be careful when seeking consent for the use of material. If we think that residual material, as it is called in the amendments, may be used for purposes other than diagnostic procedures, it is necessary to consult the person

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providing the material and to ask them to consent to its use for that purpose. What that means should be explained to the person.

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Depending on the type of material, how much material is involved and the likelihood of its being used, the giving of consent may need to be a more detailed process or may be a fairly routine, simple process. A line may simply have to be added to the form that people have to sign to consent to the diagnostic procedure, saying, ''I also consent to any residual material being used for research or education purposes.'' So long as people know that that line is there when they sign the form and they understand what it means, that is perfectly acceptable, but the principle must be that they will know and be consulted. The fact that a bit too much material has been taken by accident is not an excuse for not seeking consent in the first place, and this group of amendments would fly in the face of that principle.

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