Human Tissue Bill

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Dr. Harris: I beg to move amendment No. 77, in

    schedule 1, page 37, line 22, at beginning insert

    'Organ or tissue donation for the purpose of'.

This is a minor amendment, designed to probe the use of the word ''transplantation'' in the list of purposes in schedule 1. I have discussed the amendment with others since I tabled it, and I can foresee some of the Under-Secretary's arguments. It is important to note that, at the time of consent, although transplantation may be intended, it will not necessarily take place. If the word ''transplantation'' is used, there may be an expectation that if tissues—or, more likely, organs—are taken, transplantation should take place. There may be disappointment and a feeling that something that was expected to happen has not done so.

The question of the purpose of transplantation covers everything that must be done on the way, but there is an argument for making schedule 1 more explicit to aid those who are considering the issue. We are talking about what consent is required for organ or tissue donation for the purpose of transplantation and not as the end point. Another question concerns how much of what is covered by ''transplantation'' will be part of the remit of the Human Tissue Authority, which we can deal with later.

Dr. Murrison: We are struggling with some definitions. We struggled with the terms ''inherent'' and ''incidental'', and I would now like some clarification of the term ''transplantation''. There is some confusion about the involvement of the Human Tissue Authority in that regard. Clause 56, which deals with general interpretation, includes transfusion in the definition of transplantation, but clause 11(5) excludes it from the authority's remit. That seems to be a bit of a disconnect, and I seek the Under-Secretary's clarification.

Dr. Ladyman: I am grateful to the hon. Member for Oxford, West and Abingdon for clarifying the purpose behind the amendment, but I am not persuaded that it is necessary.

The term ''transplantation'' is defined in clause 56(4). It is used to describe the process involved in fulfilling a purpose, rather than a specific action that is carried out as part of that process. Transplantation means removing the organ from the donor body—with all the activity that that requires—transporting the organ, storing it during transportation and re-implanting it into the body that receives it. That is a whole process.

Someone who consented to a loved one's organs being used to save someone else's life, only to find that they could not be used for that purpose, may well be very upset. The clinicians would have to be aware of such emotionally difficult situations and would have to give appropriate counselling and advice. It needs to be made clear in the guidance and in the way in which people are consulted when their consent is sought for transplantation that something might go wrong during the process and that the final act might not take place. However, we do not need to deal with that in the Bill, because we clearly define transplantation as a process,

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or a series of steps, rather than as a single act that must be carried out.

I hope that that is sufficient clarification and that the hon. Gentleman will withdraw the amendment.

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

Amendment, by leave, withdrawn.

Mr. Lansley: I beg to move amendment No. 97, in

    schedule 1, page 37, line 27, at end insert 'and epidemiological research'.

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

Amendment No. 82, in

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

    '13 Research activities where relevant material is anonymised and untraceable.'.

Mr. Lansley: We can be brief. I would be hard put to distinguish between public health monitoring and epidemiological research, but I suspect that it is possible to do so. One might say that monitoring relates to the current prevalence of disease in the population, whereas epidemiological research relates to the likely effects on the population of future and communicable diseases. The two things are highly complementary and might, indeed, overlap to an enormous extent, but, in some cases, monitoring may not constitute research. It was certainly the Under-Secretary's intention to include epidemiological studies in paragraph 11, on scheduled purposes.

The purpose of the amendment is to explore, for the sake of completeness, whether the lack of reference to epidemiological studies is really an omission.

Dr. Harris: I am delighted that amendment No. 82 was selected with amendment No. 97; they go together in seeking to probe whether the purposes set out in paragraph 11 to schedule 1 are clear and sufficiently wide.

Public health monitoring is not the same as research for the purposes of supporting or improving public health. Public health monitoring means monitoring of the health of the public or of public health issues, but it can be argued that other approaches could be taken. For instance, such monitoring might not monitor public health directly but instead monitor the prevalence of a pathogen or an underlying condition that may not be apparent in a diagnosis; it may have an impact on public health but not be directly related to public health. It may help to hear how the Under-Secretary defends the existing wording, as I would not need to give exemplars.

Of more relevance is the question of whether public health monitoring is being used as a shorthand for research that is epidemiological and involves either anonymised and unlinkable or anonymised and potentially linkable samples. Some of the paperwork that I have seen on the Bill implies that paragraph 11 would allow prevalence testing on anonymised samples. It is not clear whether that can be done without consent on tissues from the living because it is

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anonymised, or because someone has deemed it to be related to public health.

It could be argued that in respect of tissues from living people—we would not have to deal with the question of whether consent was required—it might be satisfactory to state that if the testing were anonymised and not linkable to the originator of the material, it could have no impact on the individual who had donated it. So long as it was deemed by a research ethics committee to be worth doing—doing so may even be pressing, and not only for reasons of public health—it would not otherwise require consent.

I am not sure that I agree with that, for the same reasons that I gave for agreeing strongly with the Under-Secretary that people have a right over what is done to tissue from their bodies. However, by restricting the provision to public health monitoring, he appears to be of the view that in some circumstances testing can be done when it is monitoring to do with the public health. That is not necessarily specified under paragraph 11, and I would be grateful if he would clarify his thinking. Such practice would not be traceable under certain circumstances. I imagine that his view is that, perhaps when needed to protect the public health, the source of the material may need to be traced, either for the person's own benefit or for the benefit of others. We need clarification.

Let us consider tissue that comes from the living; one example is that of tumours. A treatment may become available that requires the collection of tissue as soon as possible—prospectively, the information might not be so helpful—in order to determine whether there is an antigen on the surface of the tumour. That could be done from de-linked, anonymised tissue that is otherwise available. One would hope that there are two circumstances. One is that there is specific consent for research under paragraph 7 of part 1. I would be grateful if the Under-Secretary said that, where such consent does not exist, someone wishing to do such anonymised and unlinked research would not be allowed to do so, and that that is the intention of the Bill. A number of us have received representations to the effect that, if that is the case, it should be made clear now, so that people are aware of it and researchers can be aware of it when thinking how they will handle the introduction of this measure.

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Dr. Ladyman: Epidemiology is the study of the causes, distribution and control of disease in populations. The Government's view is that public health monitoring is a sufficiently wide definition to include use for epidemiological purposes. Therefore, the amendment tabled by the hon. Member for South Cambridgeshire is unnecessary. We would include in that definition the study of material for things such as the spread of HIV, CJD, severe acute respiratory syndrome—SARS—and so on.

As far as the amendment tabled by the hon. Member for Oxford, West and Abingdon is concerned, the fact that the material is subsequently anonymised does not mean that it was anonymised

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when it was collected from somebody in the first place. The golden thread—that people are entitled to be consulted about what the material that they are providing should be used for—again applies. People should be consulted about the fact that material might be used for the sorts of purposes that he outlined. Even if it is subsequently anonymised, it would not be appropriate to use it for a purpose beyond those set out in part 2 of schedule 1—those not requiring consent.

Dr. Harris: The Under-Secretary said that he considers public health monitoring to include epidemiological studies. There may be one such study that seeks to examine tissue typing on those sorts of samples. That is similar to the sort of research that I described as that usually carried out on so-called residual tissues that are anonymised and unlinked. If he is saying that public health monitoring includes epidemiology, he is running the risk of going further than he would wish to—judged on his strong view, which I share, about the need to ensure that people have control over the type of research that is done with their material, even if it is anonymised.

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