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Mr. Andrew Lansley (South Cambridgeshire) (Con):
The Minister is talking about when there is a major public health issue, and I acknowledge that it is intended that such a power would be used only in the most exceptional circumstances. If in the circumstances of the kind that she has described the patient had expressly not given consent, the proposed powers would not enable
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the withdrawal of consent to be overridden. Are there other powers to allow tissue to be retained and tested for public health purposes?
Ms Winterton: I am not quite sure that I follow exactly the hon. Gentleman's question. If an infectious disease broke out, consent had not been given by an individual and the relatives could not be found, an application would be made to the High Court to waive the consent requirements. We shall of course be consulting on the exact circumstances when drawing up the detail of the regulations that will stem from that, but the principle is that, where an individual's relative who is known to be alive but cannot be contacted, a waiver of the consent requirements could be sought. Similarly, if in the interests of public health there needs to be research into a new disease, for example, an application could be made.
Mr. Lansley: I am not disputing the intended purposes of the new clause and the amendments; it is just that they are not designed to override someone's express refusal to give consent to the retention and testing of tissueeven in the case of a public health emergency of the kind that the Minister has described. That may be satisfactory, or powers extant may allow the retention of tissue for public health purposes. I am simply asking for information on that.
Ms Winterton: It would be quite unusual for somebody completely to refuse consent for diagnostic purposes. The consent under the Bill is usually that given after an operation or for future use. The hon. Gentleman highlights the case of somebody who has made a general commitment that consent for the use of their tissue for research purposes would never be given. The Bill deals with scheduled purposes, and as I have said, these matters can be considered during the making of regulations.
Dr. Andrew Murrison (Westbury) (Con): Perhaps I can help the Minister by providing an example. According to the Prime Minister, we are liable to be attacked by terrorists. Some terrorists may be of suicidal intent, having been infected with a virus of the sort that the hon. Lady helpfully described in the letter she sent to hon. Members a few days ago. Such persons would, I suspect, withdraw their consent. What would be the position in those circumstances?
Ms Winterton:
The hon. Gentleman has highlighted an issue that we will need to consider during consultation on the regulations. The question will be whether the High Court can override that withdrawal of consent. The new clause covers circumstances in which it is not possible to obtain consent. Whether a deceased person had given consentsome cases might not be clearand whether there is a relative who knows will also have to be considered in relation to the regulations. Those are fair points to be considered during the consultation, although I think that the situation that the hon. Gentleman describes is quite unlikely to arise.
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The flu epidemic early in the last century has been mentioned to us in relation to the cases that we have in mind. It might be impossible to find someone who stands in a qualifying relationship to a victim of the disease, but it might become necessary to test material from victims to determine whether the same virus is causing a new epidemic. The order is required to provide a way to deal with unexpected and exceptional situations, which could require the testing of material from living people who are no longer reasonably traceable, or from deceased persons whose next of kin cannot be found, in the interests of public health. We therefore propose to include in the Bill a power for the Secretary of State to make regulations to enable the High Court to waive the need for consent to use tissue for health-related research in cases in which appropriate consent cannot be obtained. It is expected that the regulations will provide for the Court to waive the need for consent only in rare cases and when the public interest justifies doing so.
The new clause introduces the High Court waiver. There are consequential amendments to clauses 53 and 60. Amendments are also needed to schedule 5, so that a High Court waiver may also apply, where necessary, to consent to having a person's tissue with a view to testing its DNA. The provision will also apply in Scotland.
We recognise the need for a mechanism to deal with truly exceptional cases, but we are confident that the requirement that the circumstances be exceptional and the protection provided by the High Court will not allow exploitation of the waiver without proper cause. I shall take on board the points made by the hon. Gentlemen, but I comment the amendments to the House.
Mr. Lansley: I am grateful to the Minister for her explanation of the purposes of new clause 7 and the related amendments and for her willingness to consider further the questions that my hon. Friend the Member for Westbury (Dr. Murrison) and I raised. We acknowledge that we are dealing only with what we hope are the most exceptional of circumstances, but as our debates on the Bill have demonstrated, there is a need to consider extremely rare events. Unhappily, those described by my hon. Friend might be just such a set of events. If a living person has refused consent to the use of any material, the new clause, as I understand it, would not permit the High Court to make an order requiring that tissue be taken and tested. That set of circumstances begs a question. I know that my colleagues will come back to that, and I hope that the Government will consider the matter.
There is also the question, not least in the research community, of whether, where somebody whose relative has refused consent, for example, for DNA analysis, which could be of benefit to a living relative, a court could make an order for the benefit of that individual contrary to the expressed wishes of a living person. The Government are not proposing that, and on balance I think that they are right not to do so. It is one of those instances where we have trespassed to the minimum extent in circumstances where the expressed wishes of individuals are not to be complied with. That is the principle underlying the Bill, and we want to hold to it as often as we can.
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The purposes of the new clause and the related amendments, as the Minister has described them, seem to be acceptable. However, there may be exceptional circumstances where somebody cannot be traced, where relatives cannot be traced and where tissue could be properly analysed in the interests of either a living person or for public health purposes. In such cases we think that it is reasonable for there to be regulations setting out how the High Court could make an order. On that basis, we are happy to accept the new clause and the amendments.
I shall not chide the Minister too often, but I shall do so now and once more later. She will recall that when the Bill was first presented to the House back in December we made it clear that we believed that it would have been in the interests of the Bill's passage if there had been a periodalbeit a short periodof pre-legislative scrutiny. The Minister will recall also that I asked for that in a debate in April. It could have been achieved in some form over the summer. I see that the Minister takes the view from a sedentary position that she was not responsible for the matter at that time. She was not, but she enjoysthat being the operative termcollective responsibility for the decisions, or lack of decisions, made by the Government at an earlier stage.
It is clear that had pre-legislative scrutiny been undertaken last summer into the early autumn, it would have been possible to examine many of the issues that have now been raised. It is a great pity that we had to raise many of those issues in Committee, which perhaps is not the best forum designed to secure consensus. The Committee reported six months ago, and I cannot recollect many instances where the passage of time between the conclusion of consideration in Committee and on Report has been as long as six months. No doubt that is a recognition of the range of issues raised in Committee to which there had to be further regard, with substantial consultations being required with outside bodies. Much credit goes to them for working through those issues with officials in the Department.
I do not want to criticise the Government unduly. Broadly speaking, we are arriving at the right conclusions. However, it is a great pity that we have had to do so through a tortuous and less transparent process than was originally recommended by the Opposition.
We shall work our way through the, I think, 100 new clauses and amendments that the Government have tabled on Report.
Mr. Lansley: My hon. Friend tells me that there are 99, which is just under the ton. I hope that we will work through them with the good humour that has characterised our debates so far.
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