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Baroness Andrews: My Lords, we considered similar amendments in Grand Committee. They were not identical, but they also attempted to change the provision in Clause 7(3) and the recourse that it provides through regulations for the High Court to make an order in exceptional circumstances. I am glad that the earlier suggestion for an advisory committee has been replaced by the proposal that the HTA should determine such questions. I am afraid however that our arguments and our response are the same.

Of necessity, I have to repeat some of the arguments previously made in order to answer some of the points raised by noble Lords. I reiterate that the decision to introduce this power in Clause 7(3) in this way in another place was a specific and very sympathetic response to the powerful case that had been made by the research bodies, which were lobbying for this type of exceptional power to be used very much as a last resort in cases that would be extremely rare.

I have to take issue with the noble Lord, Lord Jenkin. There would be nothing relatively normal about the circumstances that would be referred. Indeed, the cases that we can anticipate are so exceptional that we are unable to define them or even speculate about them, which is why the circumstances in which the power is to be available are to be set out in affirmation regulations. As the noble Lord rightly says, there will be an opportunity for Parliament to debate those.

The order-making power concerns the possible need to conduct research where, for example, a person or many persons die of a new and deadly disease—for example, similar to Ebola. Research may be needed for the public interest, but no person is available to consent to the use of tissue from the deceased.

The amendment provides a regulation-making power so that the Secretary of State may provide for a court order to deal with such cases. To reiterate, it is not set out in the Bill because the cases are, by definition, potentially unknowable, and to give Parliament the opportunity to debate the order before it is made. However, I do not believe that this would have a deterrent effect on research. The fact is that situations of this kind will be so exceptional that research would be of the utmost necessity.
 
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By the same token, I would suggest to the noble Baroness that there would have to be full dialogue with the research community before this would happen because it would be of such importance. That is where the analogy made by the noble Earl with the PIAG and the use of data seems to fall down because data protection concerns the use of existing information, but the use of tissue concerns the effort to derive new information. I suggest, therefore, that different criteria would apply.

I should also say that we do not see such orders as being available to provide a fallback position in cases where it is difficult to secure consent; far from it. Rather, they will deal with the exceptional cases I have just mentioned. They are not simply an alternative route to securing unconsented material for research.

Given the support of the professional community and the truly exceptional nature of the situation I have outlined, the effect of the amendments would be to dilute the significance of both the situation and the decision. It would allow the Human Tissue Authority, rather than the High Court, to determine that the tissue could be used in research. However, it is one of the fundamental tenets of the Bill that consent is needed for the use of tissue in research. The removal, retention and use of tissue from the deceased is a matter of the greatest sensitivity so that any departure from the principle of consent must be subject to the closest scrutiny.

We have provided for parliamentary scrutiny before regulations are made, but we believe that High Court scrutiny is needed before any order is made. This is a unique provision covering the only situation in the Bill where there is the potential to take or use tissue from a deceased person without any consent. Only the most extraordinary cases would be considered under this provision, and that is why we believe that they would warrant the examination of the High Court.

As we have said before, High Court procedures need not be time-consuming or onerous. We have provided in the important government amendments just agreed that the HTA is the appropriate body to determine questions about the use of tissue from a living person for the benefit of a missing relative or non-responder, but there are clear and important differences between that and what is being considered in this clause.

To sum up, first, researchers have confirmed in full discussions held with them before we brought this forward, that this is likely to arise only in truly exceptional circumstances. Secondly, it is exceptional because of the unique public importance which may not necessarily benefit an individual patient, but would be of public interest. Thirdly, it uniquely involves the removal and research of tissue from the deceased, and there is no more sensitive issue than this. Noble Lords know full well why we want to guard against opening any gateway that might risk the problems of organ and tissue retention and the scandals of the past.
 
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On those grounds, we remain convinced of the virtue of the scrutiny of the High Court and I hope that noble Lords will be able to agree with me.

Baroness Hayman: My Lords, before my noble friend sits down, I have listened carefully to her words and I have great sympathy with some of what she has said. However, what is of slight concern in the argument is that we need to have regulations, and Parliament will be able to debate those regulations because we cannot yet foresee the exact circumstances in which it might be necessary to secure consent in this way. If we leave the Bill as it is, only the High Court could make the order.

I understand from my noble friend's argument that it may be wrong to pursue the amendment before us to transfer all that responsibility to the Human Tissue Authority, but I am not yet convinced whether, as this develops, we might not feel in the future that some cases would be appropriate for the High Court and some for the Human Tissue Authority—as we did on an earlier amendment. However, as I read it, it would not be possible except by primary legislation for Parliament to change its mind about the relevant authority.

Even worse than a manuscript amendment is the suggestion that a further amendment be considered at a later stage. However, making provision to enable either the Human Tissue Authority or the High Court to participate might provide a little more flexibility in future parliamentary consideration of regulations.

Baroness Andrews: My Lords, matters do evolve, as do government responses. However, given where we are, I have to stick to what we believe is the appropriate route for the way forward in the foreseeable future.

Earl Howe: My Lords, I cannot disguise that that was a very disappointing reply from the Minister. I had not expected the Government to feel compelled to dig their heels in to quite this extent.

The concern I raised and which I am reflecting from the community outside is that the number of applications of the kind we have been discussing will be neither exceptional nor rare. The community believes that many dozens of such cases will arise every year. That is the point. Moreover, I do not agree with the noble Baroness that the experience of the PIAG is irrelevant in this context. I believe it to be directly relevant to the kinds of situations that I have posited. I took time to enumerate quite a number of possible scenarios, but perhaps the one which may arise most often is where the patient has died and it is simply impossible to obtain consent.

I do not believe that we need feel that in approving an amendment of this kind we are diluting the significance of the decision that is to be taken, nor need we worry that it would lessen the scrutiny given to such decisions, if it were the Human Tissue Authority undertaking that scrutiny.
 
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However, I am particularly grateful to the noble Baroness, Lady Hayman, for her late intervention. She may have opened the way for further discussion between now and Third Reading, and I am sure that I am not the only one with various ideas in mind as to how this circle might possibly be squared. I do not propose to test the opinion of the House on this occasion because it is something we need to talk about further. I therefore beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 25 not moved.]

Clause 8 [Restriction of activities in relation to donated material]:

[Amendments Nos. 26 and 27 not moved.]

The Deputy Speaker: My Lords, before I call Amendment No. 28, I should advise noble Lords that it relates to the provisions in Clause 11 rather than Clause 10, as printed on the Marshalled List.

Clause 11 [Coroners]:

Baroness Finlay of Llandaff moved Amendment No. 28:


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