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Mrs. Patsy Calton (Cheadle) (LD): I want to bring to the attention of the House a number of points that have surfaced recently from the cancer research world, on which I seek clarification from the Minister. The concerns relate to material that has been stored previously, such as material stored several years ago. As someone whose material was stored several years ago, I can speak with some authority on the matter. I understand that ethics committees are already refusing permission because of the lack of consent in cases such as that of my own stored material. A number of people in my position would be horrified to think that material that had been lying in a tissue bank for some years could not be used now because of misunderstandings about the intentions of the Bill.

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I understand that Herceptin was discovered because of work that was done with material that had been stored—exactly like my own material—during the last few years. First, I would like the Minister to clarify whether material such as that stored six to eight years ago requires additional consent. Secondly, if consent is required, what form will it take? Will it require more than simply a letter to the last known address? Thirdly, are repeated consents necessary for new research as it arises? I apologise if that does not fit completely with Lords amendment No. 6, but like my hon. Friend the Member for Oxford, West and Abingdon (Dr. Harris), I was not clear whether "another person" referred to a specific person. I thought that the point was broader and would thus be acceptable.

I would be grateful if the Minister would clarify the three points I made about stored material from persons such as myself, who would be horrified to think that such material could not be used because ethics committees were erroneously of the opinion that fresh, modern, up-to-date consents of the type required by the Bill had to be obtained for every item stored in the past.

Ms Rosie Winterton: First, I shall deal with the amendment tabled by the hon. Member for Wyre Forest (Dr. Taylor). I hope that during the course of my opening remarks, I can clarify some points for him. I am sure that he is aware that the effect of his amendment would be to extend the waiving of consent applications for research purposes, which is why we could not accept it. We have said quite clearly that it is not about getting consent for research purposes, but about a link with an individual. To clarify his point, we have used the term "person" because it refers to an individual who wishes to find out information about the effect on themselves, or possibly their children. If someone was making a
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decision about whether to have a baby, for example, and felt that they might pass on a condition that a relative suffered from, it would be possible for consent to be waived in those circumstances. For those reasons, we cannot accept the amendment, but I hope that what I have said clarifies the points raised by his probing amendment.

I shall move on to points made by the hon. Members for Westbury (Dr. Murrison) and for Oxford, West and Abingdon (Dr. Harris). It is absolutely vital that proper efforts are made to locate a person and ensure that although they have received information, they have not in fact responded to it. The question of ascertaining whether someone had died would be covered by the attempt to find out whether they would respond to the information. The provision obviously concerns tissue from the living. If we were talking about someone who had died, the process would revert to getting consent from a relative.

Under the clause, the applicant should show that there is no reason to believe that the person has died. If it was necessary to prove that there was reason to believe that the person had died, those involved would have to revert to obtaining permission from a relative to use the stored material, so reasonable efforts would have to be made. The clause is nothing to do with trying to carry out research without gaining consent, as was suggested by the hon. Member for Oxford, West and Abingdon.

The reason why those issues can be dealt with by the Human Tissue Authority, rather than by the High Court, is that it will be possible to show that efforts have been made to contact the person or there will be clear evidence that the person is missing, so taking such cases to the High Court would be excessive.

Dr. Evan Harris: The Minister may have missed this, but my specific question was how she could be certain in her view, which she gave in answer to my earlier intervention, that an application under Lords amendment No. 6 must come from a person in a clinic who seeks a diagnostic or therapeutic intervention and could not be initiated by a clinician who seeks to use the tissue of someone who cannot be traced or who does not respond for the generic purpose of helping people in the future, even in circumstances that can be defined but are not specified. The Minister said that the application must originate from a person in the clinic. I should be grateful to her if she would say where that is made clear in the Bill.

Ms Winterton: Such things must relate to the interests of another person—an individual—and the application to the Human Tissue Authority must state that that person has asked that an attempt be made to obtain the material from their relative because they believe that they may have a certain condition. It must state that the proof that they have that condition is X and the reason why they want to find that out is Y, because the person may need treatment in between, perhaps to stop the condition developing.

The hon. Member for Cheadle (Mrs. Calton) asked about existing holdings. Existing holdings are exempt from consent provisions, but we will say in the code of practice—we expect research ethics committees to consider this at the moment, as we have said
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previously—that those involved should try to obtain consent from an individual if it is clear from using existing material that they were likely to identify, because they knew from whom the material had come, something that might affect the individual in the future or that might link to another condition.

If research ethics committees anonymise the material, it can be used anyway. Anonymising the material does not necessarily mean that they would not have access to a person's medical records, so they could look at the treatment that the person had received, but they would not know who the person was. However, it is for individual research ethics committees to consider the proposed research and decide whether it would be necessary, if at all possible, to get the person's consent because the research may have a direct effect on them. I hope that that answers the hon. Lady's questions.

Finally, the most appropriate method of getting permission from people who lack capacity is to obtain a relative's consent. The Mental Capacity Bill makes clear the steps that must be undertaken to obtain consent where, for example, research is to be carried out. However, if research is not involved, those involved must ensure that the necessary consultation takes place, while also considering the person's best interests. It could be in a person's best interest to have their tissue used to benefit a relative. As hon. Members may know, there have been some recent examples where a person who is looking after someone without mental capacity has wished to obtain treatment because they can then find out what is affecting them. So there may be a wider best interests test.

With those reassurances, I hope that the House will accept these Lords amendments.

Lords amendment agreed to.

Lords amendments Nos. 5 to 17 agreed to.

Clause 33

Restriction on transplants involving a live donor

Lords amendment: No. 18

Ms Rosie Winterton: I beg to move, That this House agrees with the Lords in the said amendment.

Mr. Deputy Speaker: With this we may discuss Lords amendments Nos. 40, 43 and 47.

Ms Winterton: Lords amendments Nos. 18, 40, 43 and 47, which were moved by the Government, implement a recommendation made by the Delegated Powers and Regulatory Reform Committee in its 25th report, published on 16 July. The Government are grateful, as always, to the Committee for its detailed consideration of the Bill. These Lords amendments put right an anomaly in the Bill that was noted by the Committee.

Clause 33 deals with transplants from living patients. It is brought forward from, and updates, the Human Organ Transplants Act 1989. In effect, it states that live transplants carried out using transplantable material are unlawful unless carried out in circumstances, and in
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accordance with procedures, set out in regulations. Through that approach, we can specify the type of material to which the offence applies, as well as the circumstances in which live transplants may be allowed—for example, where no coercion or payment is involved—and specify how case-by-case approval must be sought from the Human Tissue Authority.

We use the term "transplantable material" because transplants no longer only involve organs—the term can relate to part-organs or different tissue samples—and because it can be updated by regulation, as new procedures are developed.

Under the Bill, the Human Tissue Authority must make the regulations that define the term "transplantable material", while the Secretary of State has the power to make regulations setting out how and when cases would be subject to an approval procedure. The Secretary of State's power is subject to affirmative resolution in both Houses and the HTA's power is subject to no parliamentary scrutiny at all. The Committee pointed out that inconsistency, and the Government have accepted its recommendation.

We accept that both regulation-making powers should be subject to the same level of scrutiny, and the amendments will thus make the definition of transplantable material a matter for regulations subject to the affirmative procedure made by the Secretary of State. As with the other affirmative powers in the Bill, the Secretary of State will have to consult the National Assembly for Wales and the relevant Northern Ireland Department before acting under the powers.

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