HC Deb 28 June 2004 vol 423 cc26-32

  1. (1)If the High Court is satisfied—
    1. (a)that relevant material has come from the body of a living person,
    2. (b)that it is not reasonably possible to trace the person from whose body the material has come ("the donor"),
    3. (c)that it is desirable in the interests of another person (including a future person) that the material be used for the purpose of obtaining scientific or medical information about the donor, and
    4. (d)that there is no reason to believe—
      1. (i)that the donor has died,
      2. (ii)that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or
      3. (iii)that the donor lacks capacity to consent to the use of the material for that purpose,
    it may order that subsection (2) apply to the material for the benefit of the other person.
  2. (2)Where material is the subject of an order under subsection (1), there shall for the purposes of this Part be deemed to be consent of the donor to the use of the material for the purpose of obtaining scientific or medical information about him which may be relevant to the person for whose benefit the order is made.
  3. (3)The Secretary of State may by regulations enable the High Court, in such circumstances as the regulations may provide, to make an order deeming there for the purposes of this Part to be appropriate consent to an activity consisting of—
    1. (a)the storage of the body of a deceased person for use for the purpose of research in connection with disorders, or the functioning, of the human body,
    2. (b)the use of the body of a deceased person for that purpose,
    3. (c)the removal from the body of a deceased person, for use for that purpose, of any relevant material of which the body consists or which it contains,
    4. (d)the storage for use for that purpose of any relevant material which has come from a human body, or
    5. (e)the use for that purpose of any relevant material which has come from a human body.'.—[Ms Rosie Winterton.]
Brought up, and read the First time.

3.41 pm
The Minister of State, Department of Health (Ms Rosie Winterton)

I beg to move, That the clause be read a Second time.

Mr. Speaker

With this it will be convenient to discuss Government amendments Nos. 85 to 98.

Ms Winterton

The intention of the new clause and the amendments is to ensure that there will, in the last resort, be a way to gain access to human tissue without consent if that is really needed in the interest of individuals whose health might benefit thereby or the health of the general public. We listened to discussions in Committee on the matter and the concerns of the medical and scientific community. Following further consideration, we propose to provide that the High Court may dispense with the consent requirement in certain exceptional circumstances.

Part 1 of the Bill requires consent for the use of tissue for scheduled purposes, including Obtaining scientific or medical information… which may be relevant to any other person". Clause 46 will make it an offence to analyse DNA without qualifying consent. In both cases, the consent of a living person will be required for the use of his or her tissue for such a purpose.

Geneticists, in particular, have raised concerns with Ministers about situations—albeit infrequent ones—in which individuals are untraceable, but the analysis of their tissue samples is necessary to predict the likelihood of a relative having a genetic condition or to help to diagnose and treat a relative. If the original provider of tissue were alive and contactable, consent could be sought. However, if the original person were not contactable because relatives had lost touch, for one reason or another, a problem would clearly arise. We appreciate that in such a situation, the treatment of the relative could be unnecessarily delayed or compromised, so we propose to amend the Bill to allow a court order to be sought so that the need for consent could be waived in the circumstances that I have described.

Such a situation would arise if an existing stored sample needed to be tested to help to diagnose or treat a relative, but when consent for the sample to be used in such a way was neither given nor refused and efforts to trace the original person had failed. The original person would also, as far as was known, have to be alive and competent to give consent.

Members of the medical research community have also drawn attention to the need for a mechanism to waive the requirement for consent to use tissue from living or deceased persons in exceptional cases when that is in the public interest. The reason for needing such a waiver would be to enable consent to be dispensed with in unexpected and exceptional cases where the potential benefit to the health of the public of undertaking some research without consent outweighs the risk of harm to the rights of the individuals concerned. That might be needed, for example, where a person has died as a result of a new virus and relatives who may be asked for permission to take tissue for testing cannot be found. In the event of some new highly infectious disease similar to Ebola, for example, it would be necessary to do research using samples taken from those who had died from the disease. Their relatives may not be available to give consent.

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 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 tissue—even 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 -Morrison (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 consent—some cases might not be clear—and 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.

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.

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 period—albeit a short period—of 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 enjoys—that being the operative term—collective 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.

Dr. Murrison

Ninety-nine.

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.

4 pm

Dr. Evan Harris (Oxford, West and Abingdon) (LD)

I associate myself with the content of the remarks of the hon. Member for South Cambridgeshire (Mr. Lansley) and their tone, which was well judged.

I have a question for the Minister on this group of amendments, which I take from a briefing that I received from the Medical Research Council. I do not necessarily agree with the MRC on the issue, but it agrees with the thrust of the Government's approach with respect to the amendments. The MRC states: We agree this is an important issue but we agree that the solution is too stringent. Unlike the case described above"— which is the example that the Minister gave— which pertains to diagnosis and treatment, for possible research uses there are research ethics committees". The MRC suggests that the power that the Minister is seeking to give to the High Court in these circumstances might usefully rest with ethics committees, not with the court, and that as an additional safeguard, research ethics committees might be required to inform the Human Tissue Authority so that the authority could satisfy itself that such waivers were not being over-used.

Clearly, the Government do not support that approach and I do not necessarily support it, but I should be grateful if the Minister could clarify why the Government decided not to go down that path in cases where someone who is alive is not traceable or the relatives of a dead person are not traceable, and where valuable research could be done that could not be done in any other way. Is that just one of the things that the medical research community will just have to accept, or was there some other reason for the Government's decision?

My second point applies to several groups of amendments and relates to the DNA provisions, which were added late to the Bill in Committee—so late that it was not possible for them to be subjected to scrutiny. One issue that was raised in Committee was why, where DNA is mentioned, such as in this group of amendments, RNA is not mentioned also. Identifying information can be obtained from RNA, if I remember my molecular biology, which in general terms I do not, but in this respect I do.

The matter is raised by the Medical Research Council, which is why I feel more confident to refer to it than I otherwise would. The MRC states: The term 'DNA analysis' is not clearly defined and is of uncertain validity as a concept. There are a number of genetic tests that do not involve analysis of DNA but which yield similar results. Also, DNA is mentioned but there seems no logical reason to omit RNA. For example, one can use a test of the sequence of proteins. Where DNA is mentioned, it would have been possible to mention RNA. I queried the omission previously and I remember the Government saying that they would respond. I fear I forgot to follow it up, as they forgot to respond. Perhaps during this stage of the Bill, not necessarily immediately, the Government could clarify why they are confident that there is no loophole where the DNA provisions apply across the board.

Ms Rosie Winterton

I thank the hon. Member for South Cambridgeshire (Mr. Lansley) for pointing out with what good humour the Bill was considered in Committee. He was wrong to say that that was not the proper forum in which to undertake detailed scrutiny. The Bill is much better for the scrutiny that it underwent at that stage. I hope that by the end of the afternoon the hon. Gentleman will agree that the amendments reflect the consensus that we achieved in Committee.

With regard to the comments of the Medical Research Council, the Bill and the amendments deal with extremely rare circumstances. In a sense, we are overriding the need to obtain consent, which, as the hon. Member for Oxford, West and Abingdon (Dr. Harris) knows, is one of the fundamental principles of the Bill. We therefore feel that the High Court, with the high level of scrutiny that it provides, is the right place for these cases to be dealt with, and not ethics committees at local level. When information about an individual, who may still be alive, is needed, but there is no consent, or when there is a public health interest, it is important that the matter goes to the High Court.

With regard to the RNA question, we need further technical advice, and we will come back with further information.

I hope that the House will accept the new clause.

Question put and agreed to. Clause read a Second time, and added to the Bill.

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