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Earl Howe: I am extremely grateful to the Minister for her comprehensive reply, which reassures me to a considerable extent. I am sure that the whole House will be grateful to her for laying out the arguments in such detail. I shall clearly have to read what she said. We agree that a person's prior wishes about the use of their tissue in research should be respected. We agree that there should be provision for deemed consent where a person is mentally incapacitated.
I was fearful of the effect of the wording of the clause, which seemed to create unnecessary and unrealistic barriers in the way of sensible decision-making and effectively pre-empted the provisions of the Mental Capacity Bill. I would not like to put a percentage on it, but I am largely reassured by what the Minister said about the effect of Clause 5. I am persuaded that she is correct that those matters should be debated under the Mental Capacity Bill. I hope that there are no hostages to fortune in the wording of the clause. If there is ever doubt on the matter, I hope that a court will consider what the Minister has helpfully said to reassure itself on the issue. With that, I beg leave to withdraw the amendment.
The Government have tabled this group of amendments to Clause 7 and Schedule 5 to address two issues raised in Committee. First, the amendments provide scope for authority to be granted by the Human Tissue Authority to dispense with consent where people do not respond to requests for consent to use their tissue to inform the healthcare of someone else. Secondly, they take the power to make those types of order from the High Court and give it to the Human Tissue Authority.
The amendments respond, in part, to debate on a related amendment in Grand Committee. That amendment, brought forward by the noble Earl, Lord Howe, would have introduced a court order to allow a refusal of consent to allow tissue to be used for the benefit of a relativefor example, in DNA analysisto be overridden in prescribed circumstances. The Government did not and could not accept such amendments, as I explained at some length, as overriding someone's refusal of consent would cut directly across the basic principle of the Bill, which is that people should be able to decide what happens to their bodily material.
So I cannot accept Amendment No. 75, which would do just that. We must establish systems, especially in the sensitive area of genetics, whereby individuals are asked when their tissue is taken whether they are content for it to be used for purposes such as research or informing their families' care. Indeed, that is an almost routine practice now. We also know that 99 per cent of people will agree, and we have provided scope for a waiver of the need for consent in the case of missing relatives, who are not available.
However, we listened hard to the debate in Grand Committee, which was passionate, and have discussed the issue further with key stakeholders in genetics, including members of the Joint Committee on Medical Genetics. They suggested to us that in reality the need to override refusal is a very infrequent occurrence, and, indeed, some consider that such an order would not be justifiable. So there is clearly no common or universal view across the genetics community. So I argue that we were right to resist the earlier amendment on those grounds.
However, we have been told by geneticists that difficulties can arise more frequently where an individual, although not untraceable, simply refuses to respond, so that they neither give nor refuse consent to the use of their tissue for the benefit of a relative. That arises in connection with requests to test tissue for genetic markers for various forms of familial cancer, for example.
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Bearing in mind that the common law on these issues has been unclear, geneticists anticipate that, once it becomes an offence to analyse human tissue without consent, if individuals do not respond to requests to use their tissue for genetic comparison, their relatives will be refused. The consequence could well not only cause distress to the relatives concerned; it could impede treatment and health prevention measures. So we want to do something about that.
We have addressed that situation by extending the missing relative provision of Clause 7(1) and paragraph 9 of Schedule 5 to these non-responder cases. The amendments therefore provide that in such cases, provided that certain conditions set out in the amendment are met, a direction can be made deeming consent to be in place for obtaining of information to benefit a relative. The conditions for making such a decision include the requirement that reasonable efforts have been made to get the person to consent and that they should have been given notice of the application. That is to make clear that the issue of directions will be the exception rather than the norm, so that the power does not become a mechanism for avoiding the need to ask for consent.
The second effect of this group of amendments is to provide that instead of orders to dispense with the need for consent in the case of missing persons and non-responders being made by the High Court, directions will instead be issued by the Human Tissue Authority. As my noble friend has explained, the intention is that in due course the functions of the Human Tissue Authority, including this one, will be taken over by the regulatory authority for fertility and tissue.
We have made that change not least because we recognise that extending the missing persons order in Clause 7(1) and paragraph 9 of Schedule 5 to non-responders may result in an increase in the number of applications to waive consent to use tissue in such situations. We consider that it should remain an exceptional circumstance, but we want to save any potential burden and cost to the NHS and make it easier both for the professionals and the patients involved. Therefore, we consider it appropriate for applications under Clause 7(1) and the corresponding provision on DNA analysis in Schedule 5 to be made to the HTA rather than the High Court. So I hope that the amendments anticipate and meet the intention of opposition Amendments Nos. 15,17, 20 and 23, albeit using slightly different language.
Amendment No. 31 would add to the general responsibilities of the HTA a duty to advise on Section 7 powers. I can tell the noble Lord that that is already in place under Clause 15(b). So we have taken care of that point.
Noble Lords may note that these amendments will not extend to Scotland as the HTA will have no role there. It will therefore continue to be the Court of Session which makes the relevant orders in relation to DNA analysis in Scotland.
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Taken together, this group of amendments means that we have come a considerable way to meet the concerns expressed in Committee. I very much hope that noble Lords feel that too. The government amendments provide a pragmatic solution to a situation which, while not common, could potentially damage the interests of certain patients who should be protected. We have provided for two sets of circumstances where it may not be possible to obtain consent, but I must restate that we cannot countenance overriding a clear refusal of consent. I hope that noble Lords will understand and sympathise with the progress that we have made and the direction in which we have travelled. I beg to move.
Earl Howe: My Lords, I begin by welcoming all the government amendments and thanking the Minister for having responded so constructively to a range of concerns raised in Grand Committee by several noble Lords.
The first concern related to the question of whether the High Court or the Human Tissue Authority is the more appropriate point of reference to decide whether tissue from living donors can be used to obtain vital medical information where the donor cannot be traced. Having initially been of the view that the provisions in the Bill were right and that it should be the High Court, I have now changed my mind, having listened to extensive representation on the subject and I am glad that the Government have been similarly persuaded.
The second concern related to the situation in which a donor is contacted to give his consent for his tissue or DNA analysis to be used but declines to make a decision one way or the other or simply ignores any attempt to contact him about it. I am delighted that the Government are now willing to make provision for that kind of situation; it is important.
The issue that the Government have not addressed in their amendmentsand on which, despite what the Minister said, I hope to persuade her once moreis the person who maliciously, perversely or spitefully refuses to allow a DNA analysis from his tissue to be used to benefit another person, even when that person may be seriously ill or at risk. I argued in Grand Committee that, while in normal circumstances, we all accept that a person's decision in relation to his own tissue should be respected, and "No" should mean "No", there were some very exceptional cases in which a court might decide that neither human rights nor the public interest would be best served by clinging unremittingly to the principle of donor consent.
The Minister should note that I am still talking about the court rather than any other body. I fully acknowledge that in this amendment we are dealing with a clear exception to the principle of patient autonomy, on which we are all agreed, and it is appropriate that only a court should be able to hear the relevant arguments. That is my central issue of concern. The Bill is built around the cardinal rule that
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patient consent and refusal to consent should trump every other consideration. By refusing to budge from that rule, the Government are denying anyone what they would in normal circumstances take for granted: the right to argue their own case in front of a judge in a court of law. I question seriously whether as parliamentarians we should be depriving our fellow citizens of the right to use the courts in that way, especially when the matter concerned is one of life and death. It is those life-and-death situations which my amendment tries to address.
As I said, these situations may turn out to be rare. But we can imagine, let us suppose, a young woman many of whose relatives have suffered from a variety of different cancers, including colorectal, endometrial and gastric cancer. There is a suggestion that the family has a familial cancer pre-disposing syndrome and that the young woman may have inherited it. The only way of finding out is to test an unaffected family member after identifying the gene mutation in a person known to be affected. Let us imagine that the one relative who is still alive and who has previously contracted cancer refuses to give a DNA sample for testing and refuses to allow a sample of tumour tissue to be tested. The young woman is therefore left high and dry. She does not know whether she should undergo the recommended regime of screening. Some screening tests are themselves risky. The refusal of the woman's relative to give consent may be perverse and unreasonable but as the Bill stands there is nothing that she can do. She is denied even the opportunity of presenting her case to a judge.
One can think of numerous other examples. Duchene muscular dystrophy is a serious inherited disease which usually results in death in early adulthood. A woman planning to have a family may wish to know whether she is a carrier of the condition when another member of her family already has it. Let us suppose that this other person refuses to allow his DNA to be tested. Again, the Bill presents that woman with no option or opportunity to argue her case. It seems that here we are dealing, as so often, with a balance of rights and responsibilities.
I must ask the Minister whether she believes that by blocking all avenues such as those I have imagined, no matter what the circumstances, we are acting in accordance with the best principles of human rights and common humanity. One does not have to be a critic of the BillI certainly am notto believe that we are not doing so. I hope, therefore, that even at this late stage, the Minister might be persuaded to take this matter away and think about it again.
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