§ (Second Day)
§ Thursday, 16 September 2004.
§ The Committee met at two of the clock.
§ [The Deputy Chairman of Committees (Lord Allenby of Megiddo) in the Chair.]
§ The Deputy Speaker (Viscount Allenby of Megiddo)
The Grand Committee should have before it a second Marshalled List dated 15 September, also a revised list of groupings printed on green paper, copies of which can be collected by the door. The usual procedures of Grand Committee apply.
§ Clause 6 [Activities involving material from adults who lack capacity to consent]
Earl Howe moved Amendment No. 27:
Page 7, line 14, after "by" insert "the
§ The noble Earl said: I beg to move.
§ Baroness Andrews
I wish that I could spin out this amendment and make it difficult by keeping the Opposition in suspense. I am afraid that I cannot. We have much pleasure in accepting the amendment: it is a bit of forensic analysis.
§ Lord Jenkin of Roding
There was a time in another place when, in order to while away the time, I managed always to find a misprint in every Bill in which I was asked to take part. It became a bit of a joke: "Where is it this time, Patrick?" I do not think that the noble Baroness, Lady Andrews, needs to chide herself or her officials. These things happen.
§ On Question, amendment agreed to.
§ [Amendment No. 28 not moved.]
§ On Question, Whether Clause 6 shall stand part of the Bill?
§ Earl Howe
The Bill has for the most part generated consensus across the party divide and across the medical and scientific community, subject to points of detail. Two areas, however, have been criticised. One is the absence of any detailed provisions relating to coroners and the failure to synchronise publication of the new coroners' rules with our debates in Parliament on the Bill. We will come to that.
§ The other is the failure to synchronise the Bill with a new Mental Capacity Bill. We find ourselves in what can only be a most unsatisfactory situation, in which 466GC we are asked to debate Clause 6 without having the benefit of knowing how it will marry up with the provisions of the Mental Capacity Bill in its final form. I made a similar complaint when we debated the clinical trials regulations earlier this year. Both the regulations and the Bill pre-empt the Mental Capacity Bill. It is unfortunate that in two of its major subject areas, we should be considering the Bill in what amounts to a vacuum.
§ Clause 6 did not receive much debate in another place, as it was inserted only on Third Reading. We must be clear about one thing straight away. If informed consent is a principle that the Government believe runs like a golden thread throughout the Bill, Clause 6 is the pair of scissors which breaks that thread. The idea of deemed consent in the context of the Bill is one that we should entertain only with extreme caution and in exceptional circumstances.
§ In Clause 7, which we shall debate later, it must be the High Court which decides on deemed consent where the donor is untraceable or dead. I agree with the Government that the High Court is the right place for such matters to be decided. In Clause 6, on the other hand, it is the Secretary of State who will decide how through regulations when the cardinal principle of informed consent is to be set aside. He will do so before knowing what conclusions Parliament has reached on the matter in primary legislation. That is a fairly rum state of affairs. We do not know what the regulations are likely to contain but we are potentially talking about a third party, such as a doctor in a hospital, being given absolute legal authority to decide that his team should be taken from a mentally incapacitated adult for the purposes of research—or, indeed, any purpose listed in Schedule 1, theoretically, even transplantation.
The Explanatory Notes tell us that deemed consent will be provided for where the activity in question would be,
in the adult's best interests—for example, it could be in their best interests to donate tissue to a close relative for transplantation".
I find that passage quite extraordinary. To my mind, you have to argue in fairly roundabout fashion that it is in a patient's best interests to carry out invasive surgery which is not designed to treat a condition in that patient. Clinically speaking, that can never be true. It can only be true on quite a different level where the considerations were not clinical at all.
§ Any judgment on whether it is justified to remove bone marrow or a kidney from a mentally incapacitated adult will depend on a whole host of issues, which no doctor, however competent he is professionally, can cover on his own. We should ask the Minister to spend a little time elaborating the Government's intentions regarding the content of the regulations.
§ On deemed consent for transplantation, what considerations will govern the decision to remove tissue from a patient, and who exactly will have the power to decide? On deemed consent to remove tissue for research, I would very much hope and expect that several conditions would apply. First, that the research 467GC in question has been approved by a research ethics committee. Secondly, that the tissue for such research should be limited to surplus tissue removed for diagnostic or therapeutic purposes. Thirdly, that the type of research to be permitted in these circumstances should be restricted to research specifically related to incapacity, which could be demonstrated to be of benefit, or potential benefit, to the patient or to others with the same incapacity. Can the Minister give me those assurances?
§ We are treading on very delicate ground in this clause—considerably more delicate than the ground we tread in the rest of the Bill. I hope that the Minister can provide some measure of reassurance on it, although I fear that with the Mental Capacity Bill not yet debated, let alone enacted, she is not likely to be able to go more than a certain distance in putting my mind at rest.
§ Lord Clement-Jones
The noble Earl, Lord Howe, has put the point very well. Of course debating the impact of Clause 6 is a way of raising the issue of linkage with the Mental Capacity Bill and the content of the regulations. I made some of the same points in the debate at the end of yesterday. I know the noble Baroness tried to give some clarification then. I had hoped that she would be able to further elucidate today.
§ It seems unsatisfactory in some ways that one will have to read back from the Human Tissue Bill into the Mental Capacity Bill as well as having a set of regulations. Whether that will be satisfactory for ordinary researchers and so on in making this Bill work, I do not know. I suspect that it will be very unsatisfactory to have to refer to two Acts and a set of regulations when trying to carry out research of this kind. I can well understand the concerns of those, such as the Parkinson's Disease Society, which has briefed Peers on this, that this will be a disincentive for the relevant research. Certainly, the more reassurance and transparency that the noble Baroness can provide about the expected process, the better.
§ Baroness Finlay of Llandaff
I concur that there are real problems with the way that this Bill maps on to the Mental Capacity Bill. I draw the attention of the Committee to the wording of Clause 32 of the Mental Capacity Bill. It states:If the court is satisfied that the research has the potential to benefit P without imposing on P a burden that is disproportionate to the potential benefit to P, it may make such declaration or order as it considers appropriate".Yet, in this clause, we are talking about the Secretary of State. So we have two completely different mechanisms for dealing with issues around capacity.
The other difficulty is that although Clause 6 refers to a person who,
lacks capacity to consent to the activity",
and of course capacity is proportionate to the size of the decision to be taken, there are difficulties about fluctuating capacity and assessing capacity. There really are not very good tests to assess capacity subtly.
It is much easier when it is "barn door", such as when someone is unconscious. But in the greyer areas that one particularly sees with people who have got degenerative brain diseases, such as Alzheimer's patients, they can appear very lucid in some areas and completely confused in others.
§ Baroness Andrews
I shall try to take the issues raised by Members of the Committee in order and will then reiterate what we see as the important purpose of the clause. The noble Lord is right. Whenever legislation has to be consistent with another piece of legislation that is at a different stage, for very good reasons, problems will nearly always arise. That is why we must make extra efforts to ensure consistency.
§ The Mental Capacity Bill has had a long and very thorough scrutiny, but it is not yet at the stage of this Bill. As I explained yesterday, one reason for bringing forward regulations in this clause in this way is to make it absolutely certain that not only would we match and accommodate the discussions and decisions that would be made subsequently under the Mental Capacity Bill but that we would also ensure consistency in all proper respects.
§ Members of the Committee have raised important points that we take on board. Many of the discussions that we had yesterday—certainly the point raised by the noble Baroness today—on the assessment and actual nature of incapacity are matters for that Bill. A great deal of time has been spent on defining, for example, best interests, and arriving at a set of definitions, which, as I understand it, are what the pre-legislative scrutiny intended to achieve.
§ We can look forward with some confidence to the way that that Bill and discussions on it will accommodate some of the important issues that have been raised. That is not to say that it is not relevant to raise them here. Again, I reiterate that the reason why we have allowed ourselves the flexibility of a regulation-making power is to achieve just that.
§ The second point raised by the noble Lord concerned the importance of the exemption that we create in Clause 6; that is, the particular nature of the issue involving adults who lack capacity to consent. The whole point is that the Bill does not alter the common law position. No one can consent on behalf of a person who lacks capacity. But because the lack of capacity is difficult to establish in relation to mental incapacity, we are particularly bound to take grave care that such people are not treated differently and are not put in a disadvantageous position. That is why yesterday when I spoke on the amendment, I took particular time to explain that we thought that adding a qualification to that particular element was discriminatory in terms of the lengths to which all researchers should go to obtain consent in all circumstances. In substance that is very important indeed, and is why we were unhappy with the amendment.469GC
§ 2.15 p.m.
§ The noble Lord made several points regarding best interests and the nature of regulation. I spelt out at length the cases that we envisage might arise under the issue of best interests. The noble Lord was quite right to say that, in a sense, this refers to a set of circumstances that are not necessarily or even predictably relevant to the medical needs of the person who is to give consent. It is governed by a set of relationships. We would argue that consent may well be in the best interests of a person lacking mental capacity if a carer or relative on whom they are dependent is in need of a transplant or other procedure requiring the use of their tissue, and without which the carer may be in danger of dying and, therefore, not in a position to take care of the person. That is not a farfetched instance and we were able to cite one example where there had already been a court case. Such a situation could well arise in the future, although under different circumstances, and we intend to provide for that.
§ I turn to the wider questions that were raised. The regulations could also allow research using the tissue of incapacitated persons where participation in the research by a person who lacks capacity is authorised in accordance with the clinical trials regulations which came into force in May. Such use of tissue would be subject to the safeguards set out in those regulations, which include that the research must be approved by an ethics committee. I hope that that goes some way to answering the questions put to me by the noble Earl.
§ The regulations will also be able to take account of the outcome of debates on the Mental Capacity Bill later this Session, and that is where research and the conditions attached to research will be debated in that context. Obviously we do not want to pre-empt the debates that will accompany the passage of the Mental Capacity Bill, which itself may in due course replace by amendment the regulation-making powers we have taken here.
§ Perhaps I may turn to the factors to be taken into account when assessing whether the removal of tissue is in the patient's best interests, a question raised by the noble Earl. Again, I must reiterate a point that has been made several times during our discussions on the Bill. This legislation does not address the question of the removal of tissue from living adults, which is currently dealt with under a common law test of best interests and, in the future, will be dealt with by the Mental Capacity Bill. If tissue has been removed in a patient's best interests, Clause 6 regulations to provide for the storage and use of such tissue will come into effect. If tissue has been removed for another purpose, such as for diagnosis, the regulations will allow it to be used in the patient's best interests. In time that will draw on the commitment made under common law as well as on the Mental Capacity Bill, so we shall have a follow-through from that legislation.
§ The final point made was that I should refer to amendments to the provisions dealing with DNA so that regulations will be able to provide for when it will be lawful to have material from an adult who lacks 470GC capacity for the purpose of analysing DNA. These also apply to Scotland, where it will be necessary to take account in the regulations of the authority conferred by the Adults with Incapacity (Scotland) Act 2000 over tissue taken whether for research or for any of the other purposes I have already outlined.
§ I return to the other question raised by the noble Earl about the kind of research which might be anticipated in relation to incapacity. He asked whether the research should be limited to conditions which particularly affect incapacitated patients. I am not speaking from a brief at this point, but I should have thought it would be unwise to lay down any limitations regarding the kind of research which might be carried out, although I see the case that has been made both by the noble Earl and by the noble Lord, Lord Clement-Jones. However, I will read carefully what the noble Lord has said and take it on board.
§ We recognise that allowing the use of tissue of incapacitated people is a very sensitive issue. The House has a very good record of being extremely sensitive and careful of the rights of people with mental incapacity. We have provided that the regulations—which obviously will be widely consulted on, and I am sure these issues will be raised in different contexts by different groups—will be introduced under the affirmative resolution procedure and there will be an opportunity for Parliament to discuss details which may not have been debated elsewhere. We will have the opportunity during the passage of the Mental Capacity Bill for much more detailed analysis and discussion of the issues and areas which fall much more relevantly within the context of that Bill.
§ With those assurances in this very complex area, I hope that the Committee will not challenge Clause 6 standing part of the Bill. We believe it is an extremely important element of what we are trying to do.
§ Lord Clement-Jones
I thank the noble Baroness for her reply. She is attempting to be as helpful as possible in the circumstances, but my bafflement grew the more I listened to what she had to say. She used the word "complex" herself. In addition to two primary pieces of legislation, we now hear that the EU clinical trials directive as transposed into regulation will also have a bearing on this issue.
§ That only confirms to me that the fears of those who believe that research in this area will be impeded unnecessarily—obviously one needs to ensure that the appropriate safeguards are in place—are entirely justified. One will need to be a barrack room lawyer before starting a process of research of this kind. Can the noble Baroness give any assurance about the way in which this will be presented eventually as a communication so that those engaged in research will at least have some clear guidance on which they can rely? Will it be through the GMC? If people are not medically qualified, obviously it will be provided by someone else. The more the noble Baroness referred to the different aspects of this issue, the worse it got.
§ I felt that there was a concrete block in the Minister's thinking in regard to the idea that to have any additional qualification in Clause 6 was 471GC discrimination. The circumstances are rather different. The noble Lord, Lord McColl, and I talked about this yesterday on an amendment, so I shall not go on about it, but there is a big difference between discrimination and differentiation. It seems to me that, in certain circumstances where you cannot ask someone about his history and whether or not he has consented, it is perfectly valid to have a different standard for the researcher in inquiring whether consent has been withdrawn or given for the reasons that we argued yesterday. We need to examine the idea that it is discrimination rather than differentiation because the circumstances are different.
§ I hope that a little flexibility will be considered. We heard the Minister's response yesterday but, on reflection, as she was speaking today it seemed to me that if you label something "discrimination" you will come to the conclusion that that is absolutely not the right thing to do to qualify; but differentiation is a rather different concept.
§ Baroness Finlay of Llandaff
Perhaps I have understood the Minister slightly differently. I took some comfort from her words that she does not wish to be too prescriptive and too narrow because of the variable nature of the research that needs to be carried out, particularly on patients in intensive care and so on.
§ I was trying to glean some comfort, imagining that it might be possible to say that, because a person was the kind of person who would want to contribute to medical research, it would be deemed to be in that person's best interests even though he was not going to benefit from the results. For instance, a person may be on a ventilator, already have been declared brain dead and the ventilator about to be switched off, but obtaining specimens just prior to that phase may contribute hugely to the general knowledge.
§ So my interpretation is slightly different. I hope that the Minister is leaving matters open for broader interpretation rather than narrowing them. My concern always has been that if we are over-prescriptive we will make it impossible to carry out research which will genuinely benefit future generations.
§ Earl Howe
My concerns were raised when I read the Explanatory Notes, because they refer specifically to transplantation rather than to research. I also took some comfort from what the Minister said and am grateful to her for taking the trouble she did to answer me. If I understood the noble Baroness correctly, she said that strictly speaking this clause is not about the removal of tissue from an incapacitated adult. Indeed, if we look back at Clause 1(1), to which it relates, that refers to storage for use, not for removal of tissue.
§ Nevertheless, when the idea of transplantation is introduced, that presupposes that someone has removed an organ with the consent of someone else. You would not remove any tissue or organ from a patient unless you had an end in view if it was a transplant of an organ. So, somewhere along the line 472GC you have to get closer to who decides on the circumstances in which it is justified to remove tissue for transplantation.
§ This relates back also to a debate we had yesterday on an amendment I tabled which was designed to flag up the possibility that someone in whose gift it is to take the decision about what happened to the organ of a dead or dying patient might be in line directly to benefit from that decision. The Minister, the noble Lord, Lord Warner, said that that did not trouble him or the officials. They could not see what mischief there was.
§ The potential mischief, I would have thought, is that if the patient is someone with strong religious beliefs, like Mrs Isaacs, or Mr Isaacs, it might be possible for the personal representative or member of the family conveniently to overlook that fact if they stood to benefit from a decision of that kind. In framing the rules as to who is able to decide these matters, we need to bear the whole context in mind. Whether it is research or transplantation, there is a broader context than just the medical one.
§ In the clinical trials regulations, if I remember rightly, there was a stipulation that a clinical trial on a mentally incapacitated person should be undertaken only if there was no one of mental capacity available to do that same trial and that there was, therefore, a specific point to using a mentally incapacitated person for that work. I did not hear the Minister bring that kind of qualification into this context. That is also something that we need to consider. She said that maybe there should be flexibility on what kind of research should be allowed using tissue from a mentally incapacitated person. I shall have to reflect on that point between now and Report.
§ I reiterate, however, my appreciation to the Minister for what she said. I shall read her words very carefully, and we should move on.
§ Clause 6 agreed to.
§ Clause 7 [Powers of court to dispense with need for consent]:
§ The Deputy Speaker
Before calling the next amendment I have to inform the Committee that if Amendment No. 29 is agreed to I cannot call Amendment Nos. 30 and 30A because of pre-emption.
§ 2.30 p.m.
Lord Clement-Jones moved Amendment No. 29:
Page 7, line 35, leave out from "regulations" to "deeming" in line 36 and insert "make such provisions as he considers necessary or expedient, in such circumstances as the regulations may provide,
§ The noble Lord said: Clause 7 sets out the power of the High Court to dispense with the need for consent. Clearly, the introduction of a mechanism to make exceptions to the requirement for consent to use tissue for research is essential to ensure that important research can proceed—subject to safeguards—where consent cannot be obtained if this is clearly in the public interest.473GC
§ However, it is questionable whether the High Court is the most appropriate mechanism for this. The burden of going to the High Court seems excessive and unsuitable for this type of application. I am not sure that the High Court is necessarily the best place to deal with questions of this kind of application. I think that it is likely ultimately to deter researchers undertaking research of a fundamental nature.
§ Amendments Nos. 29 and 32 would empower the Secretary of State to establish an advisory group and to issue regulations concerning the dispensing by him, on the advice of the advisory group, of the need for consent for the use of tissue for research in certain cases.
§ In many cases the Government have mechanisms which are exercised by the Secretary of State, on the advice of an advisory body. I must confess that it is not entirely clear to me why the High Court has been adopted as the mechanism in this case. I beg to move.
§ Baroness Andrews
Before I address the amendment, I reiterate the purpose of the clause. Clause 7 covers two circumstances. First, it provides for what we might call a "private interest". It allows for a court to deem there to be consent where there is tissue in store from a person known to be alive and competent, but where the individual concerned is untraceable and there is no known consent or refusal. This tissue could be used to inform the treatment, care or diagnosis of relatives.
§ The second exceptional instance deals with the possibility that, in the broader public health interest, tissue from a deceased person might be needed for important research but we cannot find the next of kin.
§ Amendment No. 29 has the effect of allowing the Secretary of State to make regulations waiving the need for consent to storage and use of tissue for research, instead of the High Court considering such matters, as the Bill provides. Amendment No. 32 sets up a tissue advisory group.
§ The noble Lord asked where we got this provision from and why we think it important to use the High Court and not another mechanism. In brief, the provision was introduced in response to concerns of the research community in another place, that there should be some exceptional opportunity to follow through in these types of cases. There was a long discussion and the issue of the High Court was raised. The common agreement and understanding is that it reflects the seriousness of the situation and the exceptional nature under which these powers will be used.
§ The kind of unusual and expected circumstances which might justify a court to order a waiver of consent is, for example, where it is necessary to analyse tissues in relation to a genetic condition in a relative, but where the original donor of the stored tissue is no longer contactable. Relatives lose touch with each other. There is clearly a problem in some cases. Treatment of a relative could be unnecessarily delayed or compromised.
§ The other example of the public interest is when we might need access to tissue for research belonging to a person who arrived in this country and who died of an 474GC unknown virus. Perhaps the relatives' consent cannot be obtained because he has no relatives or they cannot be traced. It might be necessary in those circumstances to research the disease that he died of in order to safeguard the public.
§ The regime proposed by the amendment is that a waiver of the need for consent would be a fairly common-place matter and that there would be a real role for a special advisory group. We do not agree with that assumption. In any case, the involvement of the Secretary of State, let alone an advisory committee, suggests another degree of bureaucracy and delay. Rather than being an expediting procedure, it could throw yet more obstacles in the way.
§ 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. Although we are providing through an amendment in another place for this court order in exceptional cases—which we did at the suggestion of the professionals involved—it really should be seen as exceptional. However, that is not to say that the process must be onerous. Court orders can be swiftly given by judges in chambers, and it will be for regulations, after consultation, to set out how that can best be done. It will also be subject to parliamentary approval.
§ I am therefore optimistic that this is an appropriate and proportional way of dealing with the matter in view of its seriousness and the need for speed. I would add that the Department for Constitutional Affairs, which has responsibility for the court system, is content with this arrangement. That may or may not persuade the noble Lord to withdraw the amendment.
§ Lord Walton of Detchant
I, too, find this an extremely complex issue. Like the noble Lord, Lord Clement-Jones, I am a little concerned over the thought that such issues might have to go to the High Court. While, on the one hand, the noble Baroness said that to have an advisory group advising the Secretary of State on regulations in this field would create another layer of bureaucracy, my personal experience would suggest that having to refer all these issues to the High Court would be equally complex and time consuming. For that reason I am attracted by the idea that regulations could be so framed as to make this exceptional circumstance possible without reference to the High Court, on the advice of an advisory group of experts who have been able to persuade the Secretary of State of the significance and importance of these regulations. So the idea does attract me.
§ Lord Clement-Jones
I am grateful to the noble Lord, Lord Walton, for that intervention. I am grateful to the Minister, too, for elucidating the department's thinking. As a lawyer, I suppose that I should be standing here suggesting that the High Court is the best place on all counts to make decisions on all these matters and that High Court judges are by far the wisest people to take decisions on all matters, but there is a rather circular argument here about the 475GC use of the High Court. One is going to have to hear evidence. You will have to have experts. It is going to be fairly protracted. It is going to be a rather expensive process as well. The cost of an expert for a day in the High Court is not inconsiderable. Even if they read written evidence—in fact, particularly if they read written evidence—it will be expensive.
§ It is very interesting to see Ministers turn arguments on opposition proponents and say, "That would be bureaucratic" —which is often the argument made by opposition spokesman against government proposals. However, speaking as a lawyer, I can assure the Committee that in those circumstances it is far more bureaucratic to go to court than it is to rely on the advice of an advisory body which at least tries to predict the sorts of circumstances that might be appropriate.
§ The Minister's killer argument was that the Department for Constitutional Affairs is content. It would be; there is more work for the judges. I am sure that we are all very keen to ensure that our legal expertise is utilised to the full. Strangely enough, I thought that the examples that the Minister gave were very interesting and spot on. They were precisely the kinds of examples that an advisory body would come up with.
§ I am not going to shift the Minister in her thinking. The debate has, however, rather opened the box. I concede that a very valuable concession was made in another place. However, I do not think that the department should simply assume that, now that the matter is in the House of Lords, it can cease all further thought on whether the Bill can be developed further. Other mechanisms might be appropriate. I hope that the department is still in creative mode and that we can make further progress on improving the Bill. Meanwhile, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
Earl Howe moved Amendment No. 30:
Page 7, line 36, after "provide," insert "and if it is satisfied that it is in the public interest to do so,
The noble Earl said: Clause 7 of the Bill deals with giving powers to the court to dispense with the need for consent. The Explanatory Notes make clear, as did the noble Baroness, that the power granted to the Secretary of State in subsection (3) to make regulations permitting a court to deem consent to be in place where someone had died would be exercised only in rare and unusual cases. The Explanatory Notes state that the research would have to be,
in the overwhelming public interest, for example, where a person has died of an unknown virus which has the potential to spread among the general population".
I am fully in sympathy with the intent behind the provision but, if we read subsection (3), the flavour intended, of it being used only in rare and unusual cases, completely fails to come through. If that genuinely is the intention, I put it to the Minister that some kind of appropriate qualifying phrase should be inserted. I do not claim that my amendment is necessarily the right phrase—it probably is not legalese
and various alternatives perhaps could be devised—but we surely cannot have any suggestion that a court can make an order of the kind envisaged without first establishing that there are overwhelming public interest reasons for doing so. I think that the face of the Bill as well as the regulations should make that clear. I beg to move.
§ Baroness Andrews
There may be a simple difference of opinion between us. Obviously we are sympathetic to the reasoning behind the argument. It is perfectly obvious that you would not invoke this, nor describe it as an exceptional use of powers, if it was not in the public interest to do so. We believe that the clause rests on that presumption.
§ I shall not repeat what I said on the previous amendment, but we have listened hard and we see this in terms of "unexpected and exceptional circumstances". Clearly these would include cases where there is a definite public interest which is so overwhelming as to justify a departure from the Bill's consent requirements. I have explained the nature of some of those.
§ The noble Earl has made a case and we are aware of it now. I ask him to withdraw the amendment—basically because we cannot agree.
§ I also wish to say a word about the regulations. We do not see the regulations as providing a loophole or as a means of circumventing the consent requirement which would otherwise have been in place. This might be a question that other noble Lords have in mind. Although we cannot by definition envisage all the circumstances where it might be appropriate, there is no doubt that unexpected circumstances will arise. We have taken a general power to allow time for further consideration and consultation on the circumstances in which it would be appropriate for the court to have the power to dispense with consent.
§ The regulations will make clear the limited circumstances in which courts may be asked to waive consent and the nature of the public interest. They will be subject to affirmative resolution. So the debate is not ended; it is very much ongoing.
§ I have heard what the noble Earl said. At the moment we are content that the clause will do what it is supposed to do. On that basis, I hope the noble Earl will withdraw his amendment.
§ Amendment, by leave, withdrawn.
Lord Walton of Detchant moved Amendment No. 30A:
Page 7, line 36, after "make" insert "any order that it considers appropriate, including
§ The noble Lord said: My noble friend Lady Finlay has had to leave in order to attend an important meeting at the Select Committee and has asked me to speak to the amendment.477GC
§ Having recently criticised the clause suggesting that reference to the High Court would be necessary under this part of the Bill, it may be paradoxical to say that her purpose in tabling the amendment was to give wider powers to the High Court and to strengthen the powers of the Secretary of State.
§ Perhaps the noble Baroness may be able to reassure me that the wording that she has tabled in the amendment is taken directly from Clause 32(8) of the draft Mental Capacity Bill. It has the intention of making it clear that in these exceptional circumstances the High Court, through the regulations promulgated by the Secretary of State, could dispense with the need for anonymisation where no voluntary consent could possibly be obtained. We would certainly wish to be clear whether the powers under the clause as presently drafted would be sufficient to meet all the pros and cons of difficult situations which may arise in a research setting. I could give examples but I shall not detain the Committee by doing so.
§ I look forward to hearing the views of the Minister on this point.
§ 2.45 p.m.
§ Baroness Andrews
The noble Lord has done a magnificent job in standing in for his colleague, whom we miss. She needs to be cloned—but that perhaps is not a matter for this Bill.
§ The noble Lord has drawn attention to the fact that the amendment proposes the setting up of a very wide power for a court to use to undermine the fundamental elements of the Bill. Notwithstanding the reasons given or the nature of the questions raised in relation to the Mental Capacity Bill—or, indeed, the nature of the research anticipated—we have to be quite clear that the amendment goes far beyond what we would want the court to be able to do. It undermines the fundamental elements of the Bill.
§ As I explained on previous amendments, the clause allows for the deeming of consent in exceptional circumstances in the public interest—for example, where research may be needed to protect the public—where no person is able or available to give consent. By definition, we cannot predict all the circumstances which may arise under that heading. I cannot easily add to that.
§ We believe that the provision, together with the other powers in Clauses 6 and 7, makes sensible and proportional provision for extraordinary circumstances. At the risk of sounding like Vice President Cheney, we have tried to provide for the known and unknown in terms of individuals, but the amendment goes further into what might be called the unimaginable—and the law could be in serious trouble if we tried to define that.
§ The effect of the amendment would be to allow the Secretary of State to make regulations enabling a court to make any order whatever, including the one relating to the use in research of post-mortem material already set in Clause 7. It would constitute a residual power to 478GC allow a court to make orders that might undermine or avoid any or all of the requirements of the Bill in unspecified or unlimited circumstances.
§ I hope the Committee will agree that, despite the rationale, this would be a step too far. I certainly would not wish—and I am certain noble Lords would not wish—to give the Secretary of State and the courts such wide and unrestricted powers. I hope that, on behalf of the noble Baroness, the noble Lord will feel able to withdraw the amendment.
§ Lord Walton of Detchant
I thank the noble Baroness for that reply. I am sure my noble friend will consider carefully the Minister's response before deciding whether to pursue the matter further at Report stage.
§ I should say that one of her concerns related to subsection (3)(e). This is an issue relating to the possible refusal of a living person to allow tissue removed from that living person to be used for the benefit of another person. But this is covered in Amendment No. 33 and therefore I do not wish to pursue it.
§ In the light of the Minister's reassurances, I beg leave on behalf of my noble friend to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendments Nos. 31 and 32 not moved.]
§ Clause 7 agreed to.
§ Earl Howe moved Amendment No. 33:
§ After Clause 7, insert the following new clause—
§ "POWERS OF COURT TO OVERRIDE REFUSAL TO CONSENT
§ If the High Court is satisfied—
- (a) that relevant material has come from the body of a living person,
- (b) that notwithstanding the refusal of that person to consent to the material being used for the purpose of obtaining scientific or medical information about him, it is desirable in the interests of another person (including a future person) to prevent mortality or significant morbidity that the material should be so used,
§ The noble Earl said: It is very welcome that Clause 7 contains a provision for the High Court to dispense with the need for consent where an existing sample needs to be tested in order to help diagnose or treat another person in circumstances where the donor cannot be traced. As we have discussed, such situations are likely to be rare, but when they do occur, they could be important.
§ The related issue that the Bill does not address is the situation where someone has refused permission for his or her tissue to be used for any purpose other than their own diagnosis or treatment, or perhaps not even that, but where it is overwhelmingly in the public interest or in the interests of another individual for those wishes to be overridden. One can hypothesise on various scenarios where this situation might conceivably arise. All of them would involve very narrow sets of circumstances where other people are 479GC exposed to a risk of death or serious harm by the denial of permission to carry out tests, but in those rare cases it should be possible for doctors to seek a decision of the High Court as to whose interests should be paramount and whether the tissue owner's refusal to consent should stand or be overruled.
§ Exactly the same issue could arise in connection with the provisions of Clause 50 and Schedule 5 with regard to information derived from DNA. Here again my amendment No. 102 posits that there could be rare situations where nondisclosure of data could result in death or serious harm for a relative of a person whose DNA is at issue, or, indeed, not necessarily for a relative, but it is perhaps most likely to be.
§ It is primarily geneticists whose activities are affected here where competing interests of relatives have to be finely balanced and where issues of reproductive choice have to be addressed. For us to have, as we do in the Bill, an absolute bar on allowing tissue to be used or analysed against the wishes of the donor no matter what the circumstances is, I suggest, needlessly and unacceptably stringent. There should be a means whereby, as a last resort, in a court of law the potential benefactor is able to argue his or her own case.
§ There are parallels for this idea in existing law where there are conflicts between individuals about confidential information, for example, and about rights of life and private life under the Human Rights Act and all sorts of other types of case. The High Court has ultimate jurisdiction to decide whose interests should prevail.
§ I hope very much that the Minister will be sympathetic to this proposal. I beg to move.
§ Lord Clement-Jones
Having put my name to this amendment I rise briefly to support what was said by the noble Earl, Lord Howe. It seems to me that this is precisely the backstop which can be provided by the High Court, because it will be on very rare occasions that recourse would be had to the High Court in these circumstances. As the noble Earl, Lord Howe, said, the High Court frequently has this kind of backstop power to make decisions in conflicts between individuals about confidential information and right of life but also in family law issues. The High Court sometimes has to cut the Gordian knot as regards the position on assets, property and so forth. The amendment makes eminent sense. I hope that the Minister will look favourably on this as an absolute backstop.
§ Lord Walton of Detchant
I wholly agree with the points that have been made by the noble Earl, Lord Howe, and the noble Lord, Lord Clement-Jones. I can think of a series of very rare but important circumstances where a provision of this nature is crucial.
§ Let us consider a woman whose family has had a variety of different cancers, including colorectal, endometrial and gastric. She thinks that she may have inherited a predisposing gene, particularly if her 480GC mother and father both died in their forties from breast and gastric cancer. If she has only a single living relative who had surgery for endometrial cancer in her late thirties but who now refuses to allow the lady's doctors to extract a sample of DNA from the tissue removed from that relative to test it for mutations, then the lady in question will have no knowledge of her level of risk.
§ As the noble Lord, Lord Clement-Jones, pointed out, there have been circumstances in which the High Court has overridden the refusal of consent from individuals relating to such issues as caesarean section and even, in one notable case, the amputation of a limb. I myself worked in the field of neuro-muscular disease. A similar issue can arise in the case of a female whose brother suffers from Duchenne muscular dystrophy. A biopsy taken from him 20 years ago, if studied using molecular biology techniques, would now indicate whether the disease arose from a mutation or as a result of his parent being a carrier. In that case, it is crucial for the woman to find out whether she is a carrier and therefore at risk of passing the disease on to her sons. If her brother refuses to allow his biopsy to be re-examined using modern techniques, she will not have the opportunity to be made aware of the risk that she is a carrier.
§ In such rare and exceptional circumstances, this provision could be used as a backstop. It is vital and ought to be included in the Bill.
§ Baroness Andrews
I am grateful to all noble Lords who have spoken and for their examples. We understand the source of concern for this provision. It would introduce a new power for the High Court to override the refusal of someone to allow their tissue to be used to obtain information that may be relevant to another person—the purpose listed in paragraph 4 of Schedule 1. The amendment to Schedule 5, the DNA offence schedule, would allow a court to override the refusal of someone to allow analysis of their DNA in order to obtain information relevant to someone else.
§ Without wanting to use language that is too emotive, I should say that the amendment, though sincerely meant, would drive a stake through the heart of the Bill because it goes against its basic principle; namely, that people should be able to decide what happens to their bodily material.
§ We have already talked about Clause 7 in relation to the waiver available to the High Court in exceptional circumstances. That applies only when reasonable efforts to trace the original person have failed and there is no reason to believe that he or she has refused consent. But allowing a court to override an explicit refusal would be to go against the principle of the Bill.
§ The arguments of noble Lords refer to cases where relatives have refused to allow the use of their tissue. Indeed, the noble Lord, Lord Walton, just cited a graphic example. There may well be such cases, but we feel that we cannot allow a power to override the principle of the Bill on the basis of that assumption. Moreover, I would stress, particularly in relation to geneticists who frequently use relatives' material for the purpose of cross-referencing diagnoses and 481GC treatment, that the Bill's provisions do not apply to existing holdings. Therefore as I understand the example given by the noble Lord, Lord Walton, there would be no problem about using that material. Anything being held at the time when the Bill comes into force, reflecting past practice, will remain available for use. The issue concerns only future, newly collected material where, having been asked, individuals decline to allow it to be used for the purpose of informing the care of another.
§ This is where we come to the second major aspect of the debate. We are talking about relatives; that is people who are close and love each other who want, in the huge majority of instances, to help each other in future. One of the major objectives of this legislation and establishing a framework is to create a better environment for discussing with patients and their relatives what happens to their tissue and how it can be used to benefit members of the family.
§ 3 p.m.
§ My sense—and, I would have thought, the experience in the Committee—is that, in the vast majority of cases, relatives are only too anxious—indeed, would go out of their way beyond mere altruism—to help with the care of other members of their family. Moreover, we have every expectation that we can build on current good practice to ensure that people willingly and genuinely contribute to scientific medical research and progress through a positive engagement. That is the only way in which we can progress. Given the failings of the past in some areas; given the difficulties and confusions that researchers and clinicians face and given what this Bill is trying to do, we must establish systems whereby if we know the potential value of people's tissue, particularly in genetics, when their tissue is taken they should be asked whether they are content for it to be used for purposes such as research or to inform their family's care.
§ It will not be onerous. It is common practice. With the best will in the world, I cannot believe that geneticists will have difficulty with that. We know that 99 per cent of people will agree, but this is a reason to discuss it with them to enable them to agree rather than not to ask. Although I understand the seriousness and purpose of the arguments, the justification for overriding someone's decision to refuse consent for the use of their tissue in this draconian way needs to be very compelling.
§ After all, if a competent person refuses to allow tissue to be removed, there is nothing in law that allows us to insist on that. We cannot remove tissue without the person's agreement: the Bill simply provides that it cannot be used without their agreement. That is a position that we have to respect. It might be desirable to speed up the diagnosis of susceptibility to disease, but we have not seen evidence that it is essential as a matter of urgency or emergency to use one person's material in order to save the life or health of another.482GC
§ In other words, the potential benefits do not seem overwhelming enough to justify such a major departure from the principle or justify overriding an explicit objection to use from the person from whom the material came.
§ Lord Jenkin of Roding
I listened to both sides of that argument with great care. I was very impressed by the examples given by the noble Lord, Lord Walton of Detchant, who speaks on these matters with huge experience and authority. I also recognise the case made by the Minister in defence of her legislation. She did not use the phrase "drive a coach and horses" through the principles of the Bill, but that is, I think, what she was trying to say.
§ I base myself in my own experience; if a government department or a Minister takes a position, then resists anything that could impinge on that position or could be thought to be whittling away the purpose and therefore thinks that they have to stand fast, that is a very dangerous position to get into.
§ I listened with great care to what the Minister said. But, in my view—I speak entirely as a layman—the argument made by my noble friend Lord Howe and the examples given by the noble Lord, Lord Walton of Detchant, carried the day. The noble Baroness used the phrase, "a major departure". Both my noble friend and the noble Lord said that those would be very exceptional cases. But I find it very difficult to believe that it is right that one should allow one member of a family simply to say, "No, I am not going to do anything to help other members of the family. I withhold my consent", however unreasonable that should be. It seems to me that there should be some mechanism whereby that can be overridden. That is what is being asked for here and, if it came to a vote, although we do not vote in Grand Committee, I would have no hesitation in supporting the amendment because, with the greatest respect to the noble Baroness, I think she has got it wrong.
§ There needs to be room for a bit of flexibility in order to avoid in individual cases what could be very severe injustice and hardship. We should not be building that into a Bill of this kind; we should be able to make provision for the kind of cases that have been illustrated. The amendment, or some variation of it, would be an appropriate way to do that.
§ Baroness Andrews
I just reiterate my point, which is very important: existing holdings, archive materials of tissue that is held, are not affected by the provision. In many of the cases cited by the noble Lord, Lord Walton, the material will be able to be used just as at present because the Bill does not touch it. It applies only in future, when the whole point of the Bill is to obtain consent, to make it impossible for the sloppy practices of the past to continue. That is something that the profession as a whole, every researcher in conscience, would want.
§ Obtaining consent is not onerous; it is important. It drives a stake through the heart of the Bill if we allow flexibility. I take the noble Lord's point, but we resist, not perversely or stubbornly, but because we genuinely 483GC believe that the amendment would cause great problems to what we are trying to do in people's best interest.
§ Lord Walton of Detchant
What the noble Baroness says about existing holdings of tissue is absolutely right, but she will surely agree that once the Bill is enacted, tissue subsequently removed for diagnostic purposes cannot then be used to benefit another family member. We are thinking not just of the past and present but of the future.
§ Earl Howe
I am very disappointed by the noble Baroness's reply and, correspondingly, all the more grateful to my noble friend Lord Jenkin and the noble Lords, Lord Clement-Jones and Lord Walton. The point that the noble Lord, Lord Walton, just made—that archive material will be progressively less relevant as time goes on—is extremely pertinent. Of course, one can come up with all sorts of examples of cases not involving existing holdings. Where, for instance, families are estranged, for reasons that many of us might regard as illogical, someone may refuse consent to enable a family member to benefit. Not all families are close and loving, alas. I wish they were. To allow no opportunity whatever for a potential beneficiary even to argue his case in front of the judge is a retrograde step.
§ I think that I shall want to return to the issue at Report. In the mean time I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ Clause 9 [Existing holdings]:
§ Earl Howe moved Amendment No. 34:
Page 8, line 38, at end insert—
( ) Subsection (1) does not apply if a person storing an existing holding for use for a purpose specified in Schedule 1, or using an existing holding for a purpose so specified, is made aware of a decision not to consent to such storage or use by—
§ The noble Earl said: This amendment is similar in its purpose to my earlier amendment to Clause 1. As the Committee will remember, I suggested that the right of a living person to object to his tissue being used for a given purpose should be enshrined in the Bill in order to avoid doubt and legal argument. The same consideration applies in Clause 9 in relation to tissue from existing tissue banks.
§ I very much welcome the pragmatic approach taken by the Government to the matter. It is surely right to say, as the Bill does, that tissue banks should be exempt from the consent rules laid down in the Bill. However, at the same time, we need to ask ourselves what happens if someone discovers that tissue that came from a husband, wife or relation is held in an existing tissue bank and he or she violently objects. What happens if there is a repeat of the terrible story of Mrs Isaacs where, let us say, a widow discovers that the brain of her husband is being held in a tissue bank 484GC for research purposes without anyone's consent and that runs absolutely contrary to the religious beliefs of the dead person?
§ I believe that it would be in accordance with the spirit of the Bill to say that in such circumstances, uncommon as they may be, the wishes of the surviving widow or a relation should override the legal immunity conferred by this clause. If we are serious about that, we need to ensure that there is no scope for legal argument by placing a suitable provision on the face of the Bill. I beg to move.
§ Baroness Andrews
As we said in the previous amendment, Clause 9 relates to all existing holdings other than anatomical specimens and simply provides that it will be lawful to use and to store for use for a scheduled purpose any existing holdings, which include archives held for research purposes, without the need for consent under Clause 1.
§ This is a very important principle which has been intended precisely to ensure that it will be lawful for clinicians and scientists to keep indefinitely and to use in research that tissue which is archived when the Bill takes effect. We are talking of banks of tissue, but also other archives and other stores of tissue, which have enormous potential value. Indeed, many have been collected for many years under the conditions, including the legal conditions, prevailing at the time. So, it is a provision of fundamental importance to the research community.
§ I understand that the amendment is tabled with the best of intentions. I have to point out, however, that it raises very grave, and I would argue practically insoluble, problems. It raises questions about whether there should be some retrospective power of veto over the use of such tissue and whether there should be retrospective reviews of whether in each case a next-of-kin might object. It would be wholly impractical and inappropriate in many cases to insist that this has to be disposed of or that all individuals had to be re-contacted in order to obtain their specific consent to the use of all this archived material for any of the scheduled purposes. With respect, it is simply not possible to do that. In many cases the individuals will have moved, may have died or may be, for other reasons, beyond contact. The amendment would necessitate such procedures.
§ The concerns expressed in the amendment reflect the history underlying the Bill. The noble Earl referred to the very sad case of Mr Isaacs and the fact that tissue was collected from post-mortems that might not have had the full or proper consent of the families concerned. We also recognise that the collection of the samples in the past would not have been ideal by today's standard but was not necessarily unlawful and, sad to say, was generally in keeping with prevailing practices. We have learned much, not least from major reports in recent years, of the process of organ retention, which has led us to introduce many measures to try to address those poor practices. Not least, we have established much better information and consent systems so that much of today's practice 485GC will be set out in the interim statement. It means that today's practice is better aligned with what we would expect under the Human Tissue Bill.
§ Through the tireless efforts of the Retained Organs Commission and many dedicated individuals in trusts and strategic health authorities whose job it has been to improve the situation, many families have been assisted in recovering or making decisions about the tissue and organs retained from their deceased loved ones. We have developed and published guidance on the continued handling of these very delicate matters as well as on the future use of stored tissue. The Human Tissue Authority will have the specific responsibility of maintaining such guidance through codes of practice and advice both to professionals and the public.
§ However, our main concern, and that of the noble Earl, is to address the situation for the future. Tissue currently held in storage will have come from many sources, in many different circumstances, and will be subject to varying degrees of consent, some of which will have been recorded, and some of which may not. It seems to us that the only sensible approach is to provide some measure of flexibility. That is not to say that we are providing a carte blanche for researchers to use any tissue in any and all circumstances; far from it.
§ The complexity of the issue is one that is not conducive to handling through primary legislation. In Clause 9, therefore, we are providing simply for it to be lawful to continue to hold and to use for a scheduled purpose any tissue that is currently in storage for that purpose. But we have also provided in Clause 26 for the Human Tissue Authority to issue a code of practice which will give guidance on the circumstances in which existing holdings might be used.
§ 3.15 p.m.
§ We know that there is an urgent need for greater clarity and certainty. The position of existing holdings has already been problematic. Many pathology departments have found difficulty in understanding what their position is at the present time.
§ That is precisely why we issued the interim statement on the use of human organs and tissue in April 2003. The statement gave guidance on the questions to be addressed when considering whether tissue might he used for research or other purposes. It set out our understanding of the law as it currently stands, and provided a supplementary note for research ethics committees so we could try to achieve some consistency in the use of currently retained tissue. That interim statement was prepared following widespread consultation with professional groups and with family groups, and we understand that it has been of some considerable use to researchers, and to ethics committees. That is why I say that the HTA, in preparing its code of practice for the future, will build on that interim statement.
§ The amendment would not only involve extremely complex processes for tracing tissues held for many years; it would certainly perpetuate uncertainty surrounding the use of archived tissue. We want to 486GC avoid that. We recognise the intention of the amendment and, as I said, we have sought to address those concerns in the way that we have provided advice and guidance to date, the benefits of which experience will be carried forward in the HTA. However, we think that it is time to draw a line under the past and move forward with a more pragmatic approach.
§ I am trying to be very sympathetic to the amendment. In the light of what I have said about the steps we have taken, I hope that the noble Earl will feel able to withdraw it.
§ Earl Howe
There is quite a lot I could say in reply to that. However, I think that I am going to have to be content with the noble Baroness's assurance that the codes of practice will deal with this matter adequately. As I mentioned earlier, the case that is uppermost in my mind is that of Mrs Isaacs. It would be absolutely intolerable if someone such as Mrs Isaacs discovered that the brain of her husband was being held in a tissue bank and that she had no legal right to say to that tissue bank that the brain should be returned to her for decent disposal. We can have all the codes of practice in the world, but without that legal right I suspect that someone might feel very vulnerable.
§ However, the issue is whether this is a matter for the face of the Bill. I shall have to go away and reflect on that. I will simply say this. The intention of the amendment was one that the noble Baroness rightly picked up, regardless of the actual phraseology of it, which no doubt has unwelcome consequences. But I am convinced that the intention is right in principle. It is now just a question of my deciding how to take the issue forward. I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ Clause 9 agreed to.
§ Clause 10 [Existing anatomical specimens]:
§ [Amendment No. 35 not moved.]
§ Clause 10 agreed to.
§ Clause 11 [Coroners]:
§ Earl Howe moved Amendment No. 36:
§ Page 10, line 9, at beginning insert "Subject to subsections (3) and (4),"
§ The noble Earl said: In moving Amendment No. 36 I shall speak also to Amendments Nos. 38 and 39.
§ Clause 11 presents us with a prime example, if ever there was one, of the dog in the night-time who fails to bark. It contains what for many of us is the most unsatisfactory feature of the whole Bill; namely, the exclusion from the scope of the Bill of any activity done for purposes of functions of a coroner.
§ When we call to mind the events which led to the creation of the Bill in the first instance, many of which stemmed from actions taken or not taken by coroners, it is at best ironic and at worst deeply regrettable that we cannot debate in any substantive way what we believe the duties of coroners or their codes of practice should look like.487GC
The first observation I would make about the clause is that the phrase,
purposes or functions of a coroner",
is not defined. Indeed, we understand that, even as we speak, the definition is being thrashed out by Ministers and officials in the Home Office in preparation for the publication of the new coroners' rules later this year. The fact that the publication of the rules and the passage of this Bill through Parliament has not been synchronised is, I believe, most unfortunate.
§ But we have to face reality. Clearly the most we can do in debating the Bill is to lay down some markers. The first marker is surely to say that the demarcation line between a coroner's statutory core functions and those things which are not core functions but which, nevertheless, he may do under his own authority, needs to be much clearer than is currently the case. Equally, there are things which a coroner may do under his own authority which should quite properly override the general provisions of this Bill, and other things which he is able to do which ought not to override them. At what point should a coroner's authority cease and the wishes of a nominated representative or relative kick in?
§ That question rose to the fore in the case of Mr Cyril Isaacs, whose brain was passed by the North Manchester Coroner's Office to a research programme at Manchester University. That was done not only without consent, but also contrary to the express wishes of his family. The brain was removed and transferred to the researchers, having been identified by staff at the coroner's office as being of possible interest to a joint research programme run by the departments of psychiatry and physiology at the university. It is not unfair to say that this came about as a result of a cosy, informal relationship between those departments and the coroner's office.
§ In fact, as the official report disclosed, over 21,000 brains, collected between 1970 and 1999 were found to be held at various centres, most of them from coroners' cases and a great many without consent. It would appear that once the coroner's work on a body had been completed, it was generally thought best that the brains should be used for research rather than being disposed of as waste.
§ Unlike brains collected from hospital postmortems, where consent procedures were usually followed scrupulously, the consent process in coroners' cases was either fudged or ignored. There was a widespread ignorance of what the consent requirements were in such cases, as well as an assumption that the coroner had the authority to retain any organ, irrespective of whether it had a bearing on the cause of death.
§ The issue of what is and is not within a coroner's authority is therefore of central importance in the context of this Bill. Yet when we look to the Bill to define the necessary powers and duties of coroners, we look in vain. The least we can do is to lay down some pointers. As a start, I see no harm, as my amendment proposes, in us specifying in the Bill that coroners have 488GC no power to authorise the retention of tissue for the purposes of research into general human health. Various detailed questions arise from this which I could ask the Minister to address.
§ Where a post-mortem is carried out, blocks and slides often remain on the medical record. Is this a matter which the coroner can authorise himself or does it require consent from the relatives? That is the first question. In a coroner's post-mortem, could the coroner authorise the use of relevant tissue for audit, quality control and education until such time as the cause of death is established and the coroner's interest in the body ends, or would that again require consent from the relatives? Once a coroner's interest in the body ends, if tissue from the dead person is to be used subsequently, what will be the mechanism for seeking consent from relatives? The extent of the coroner's authority is the first issue addressed by Amendment No. 38.
§ Secondly, and even more importantly, we can ensure that coroners are subject to the one requirement that will render a recurrence of the Isaacs tragedies unlikely. That is transparency. If a coroner is under an obligation to notify a dead person's nominated representative or relation but the body or a body part is being stalled, for whatever purpose, under his authority, the coroner's actions will be exposed to the light of day and the family will be in a much better position to assert their rights at the appropriate time, once the coroner has completed his work.
§ Transparency is the one sine qua non of a coroners' system, if it is to be one in which everyone has confidence. Even if the Bill cannot go into the detail of the coroners' rules, I see no reason why it should not contain a provision to put that basic requirement for openness and transparency into effect. I beg to move.
§ Lord Clement-Jones
I just want briefly to support what the noble Earl, Lord Howe, said. I can in no way match the work that he has done considering this area, but it seems rather paradoxical, when one considers the foundations of the Bill, which is, effectively, the Alder Hey inquiry, to find that coroners are in a sense completely outwith the provision, given that so much of the debate in that case related to the product, if you like, of the coroners system.
Also—again, I come back to what the Parkinson's Disease Society had to say—there is concern about the tension between the coroners system and the Bill. As the noble Earl said, we do not have access to the draft regulations and do not know what is being put together and how that will affect what we are debating here. The Parkinson's Disease Society wrote to me:
In addition the issue of research is of great importance to the Society, with the biggest outstanding problem being the tension between the Coroner's system and this legislation. This affects the Parkinson's Disease Tissue Bank as some of the donors will die in circumstances that require a Coroner's inquiry into the death. At the moment they cross check with each other without there actually being a statutory basis for this communication.
While the Bill makes it clear that it is illegal to hold tissue after the Coroner has closed his files on a case, there is no requirement for the Coroner to inform the pathologist of this, nor is he required to inform the family of what tissues have been retained. Good
practice should result in this information being available but the current draft leaves it to future amendments to the Coroner's Rules to sort out".
§ That is precisely the point that the noble Earl was making. We therefore strongly support his amendment.
§ Lord Walton of Detchant
The noble Earl made a powerful case in support of the amendment. Although the Deputy Chairman has not yet called Amendment No. 37, tabled in the name of my noble friend Lady Finlay, who, as I said, is in a Select Committee at the moment, it is relevant to mention the points that arise from that amendment. They make me convinced that, despite the force of the argument advanced by the noble Earl, Lord Howe, the amendments must be considered with some caution. As he said, it is particularly unfortunate that the revision of the coroners' rules has not taken place before the Bill has been tabled for debate in your Lordships' House.
§ The legislation at the moment is unclear. When the end of an inquest comes about, if there is no police case many coroner's specimens are returned. But if no tissue is retained there is always a possibility that in future there might be a miscarriage of justice. If there is an appeal against a conviction and it turns out that there may have been a wrongful conviction of an individual accused of a violent crime, it is crucially important that material is retained to be examined again when such a possible miscarriage of justice arises.
§ There is also the problem that unless material from coroners' post-mortems is retained for study by forensic pathologists or for those in training, the next generation of forensic pathologists will not be able to gain the experience of studying material on which so often crucial decisions need to be made.
§ Therefore there is some conflict between the amendment tabled by my noble friend Lady Finlay and those tabled by the noble Earl, Lord Howe, and spoken to by the noble Lord, Lord Clement-Jones. It is important that the Minister should, if possible, clarify the situation. It is important that this matter should be resolved and attention paid to this dilemma when the coroners' rules are being revised.
§ 3.30 p.m.
§ Baroness Andrews
As the noble Earl said, this is a very important part of the Bill. It is a response to a very troubled history which we wish to ensure does not happen in the future. The noble Earl spoke powerfully and gave an accurate account of the situation and circumstances that led to the inquiries that we all know about. We are unable to accept the amendments for different reasons—one more positive than the other—in the light of what he has said.
§ Let me deal with Amendments Nos. 38 and 39 first, along with Amendment No. 36. The noble Lord said that this was a case of the dog who failed to bark. I do not want to extend the analogy to ridiculous lengths, but we believe that we have got a dog with a bit of a bark and a bit of a bite in this Bill. I hope I can convince him of that.490GC
§ I quite understand why the noble Earl is trying to put on the face of the Bill a prohibition on coroners authorising storage and use of tissue of deceased persons for the purposes of research, education and training. Amendment No. 39 proposes a new subsection (4) which requires the coroner to notify the next of kin or nominated representative when material is retained following a coroner's post mortem.
§ We would argue, in the most generous sense, that the amendments are unnecessary in different ways. Let me deal, first, with proposed subsection (3). Coroners are already subject to the statutory provisions of the Coroners Act 1988 and to any relevant case law. It is from this law that the coroner derives his authority, and there is nothing in the Coroners Act which gives coroners authority to direct post-mortem tissue to be retained for research or training, nor have the courts held otherwise. There is already no lawful authority for a coroner to do the things that the amendment seeks to ban; and where the coroner has no authority, the consent requirement of the Bill will apply.
§ The noble Lord described the practice and the unsatisfactory situation that led to the Alder Hey and Kennedy inquiries and so on. We have tried in the Bill to clarify and strengthen the conditions attached to the coroner's function, which are set out in the relationship between Clauses 1 and 11. The Bill makes clear at Clause 1(1)(a) to (c) that the removal, storage or use of material from a deceased person for any scheduled purposes—that is, any purpose listed in Schedule 1—is subject to the necessary consent.
§ Clause 11 states, in effect, that Clause 1 does not apply in the case of activities done for the purposes or functions of a coroner —that is to say, beyond what is needed to fulfil his duty to investigate the cause and circumstance of death. So where the coroner has no authority, Clause 1 applies, and the coroner has no authority to authorise storage or use for research, education, training and so on. So there is no question that Clause 11 might confer on coroners any authority to authorise these things and, consequently, there is no need to specify that the clause does not do so.
§ The amendment will not have any meaningful effect. We have discussed in this House many times the importance of putting in the Bill and passing only legislation which has meaningful effect. The amendment would not bring any additional clarity or benefit.
§ Secondly—and this is where we come to the bite of the dog—we have strengthened the law in relation to any abuse of a coroner's powers. If the coroner, without authority, were to cause material to be stored for research or another scheduled purpose, he would risk being in breach of the offence at Clause 5(2). This is where a person falsely represents to another that consent is not needed for the storage or use of material for a scheduled purpose. So any coroner purporting to authorise retention for such purposes would render himself or herself liable to disciplinary proceedings by the Lord Chancellor, or, in the worst cases, criminal proceedings. That is a very powerful new force.491GC
§ The noble Earl referred to the case of Mr Isaacs. Let me just say how that case would now fit within the Bill as drafted and answer the specific questions he raised. The Bill clearly requires consent for retention or use for scheduled purposes other than where the coroner requires it for his purposes. As I have said, his purposes concern the cause and circumstances of death. As soon as the coroner is able to say that the brain is not needed for his purposes, consent would be required. If the coroner's office decided to offer it for research without consent or indeed for any other scheduled purpose without consent, that would be an offence.
§ In relation to the three questions raised, blocks and slides would require consent by the relatives. The coroner cannot authorise material to be used for research while he is still conducting his usual functions. He cannot authorise that, but with his agreement the family could authorise such consent. In relation to the mechanism for consent, once the coroner's work is finished, the coroner's rules will provide for that and the families will certainly be notified.
§ On Amendment No. 39, I can give the noble Earl positive news indeed. I assure him that work is already in hand which will achieve what the amendment seeks; that is, transparency. We are entirely at one with the noble Earl on that. Against the background which has made the Bill necessary, we have been concerned to improve the entire process of informing and involving families in what happens after bereavement. I am sure that the noble Earl knows the guidance we have put out in Families and Post Mortems. The Home Office is, indeed, in the process of revising the coroner's rules to tighten up the existing procedures. I hear what Members of the Committee have said about the fact that we have not had them before us. However, I understand that those rules will make it clear that the coroner must discuss with pathologists how long the tissue will need to be retained; will notify next-of-kin of any retention of organs or tissue for his specific purposes, that is, the investigation of the cause and circumstances of the death or identification of the deceased; tell the next-of-kin what options are available for what should happen subsequently to the material; and pass on to the pathologist dealing with the matter any wishes in that regard which the next-of-kin may have expressed.
§ As I have said, since the report that revealed the shoddy and dreadful practice which made the Bill necessary, much has been done in the past year to build on good practice to improve support for families following bereavement. There is an overwhelming need for these issues to be handled as sensitively as possible. The relatives will be kept informed of the position and have the opportunity to make any necessary funeral arrangements.
§ These matters are of particular interest to the Royal College of Pathologists. I understand that the Home Office has undertaken to consult with the Royal College of Pathologists on the revised rules before they are made. A draft is expected to be available by the end of the month. I hope the Committee will see that as 492GC good news and that those who expressed concern will welcome that progress. The intention is for the new rules to be made by the end of the year.
§ With regard to Amendment No. 37, tabled by the noble Baroness, Lady Finlay, the intention is precisely to give the coroner the kind of powers that I have just said he does not have, which we think he should. He may not order retention beyond what is needed to fulfil his duty to investigate the cause and circumstances of death. The coroners' rules will elaborate on the detail of how that will be communicated and families enabled to take charge once the coroners' work is completed.
§ The amendment would cut across the most important element of this Bill; namely, the consent of the family must determine what happens to the tissue or organs no longer required for a coroner's purposes. To extend coroners' purposes in this manner could be seen as a backdoor way of reopening more organ retention scandals. So we do not agree that the retention of any tissues or organs should be retained in perpetuity under the coroner's authority.
§ The Human Tissue Bill makes the consent of the family the fundamental determinant of retention of tissue, except, as I have said, where retention is required by the coroner for his legitimate purposes. Families will be able to give their consent, if they choose to do so, for the retention and use of organs and tissue for purposes, including medical research. We know that in the vast majority of cases they will agree to that. But to authorise retention where there is no further coroner's or criminal justice interest against the wishes or without the knowledge of the family would be unthinkable.
§ I am sorry to have taken time over that amendment. I hope the Committee is reassured and will welcome the news.
§ Lord Walton of Detchant
In relation to the last two points made by the noble Baroness, can she assure me that the coroners' rules under revision, as being discussed with the Royal College of Pathologists, will make it clear that tissue can be retained for the purpose of training future forensic pathologists, or is that something which is still in doubt?
§ Secondly—a Machiavellian point perhaps—a situation could be envisaged whereby a family member might refuse to allow the retention of any such material where the suspicion may arise that the individual in question may have been directly or indirectly responsible for the individual's death.
§ 3.45 p.m.
§ Baroness Andrews
Obviously, I do not want to pre-empt the coroners' rules. There is not much more I can say. At this stage, I do not think that I can give the noble Lord the assurance he seeks. Consent will continue to be needed.
§ On the second point about criminal justice, if the noble Lord will give me a minute, I might have a word with him afterwards.493GC
§ Earl Howe
This has been a very useful debate. The noble Baroness should be thanked for letting in a lot of daylight on to what previously were somewhat obscure issues. Certainly, when I read the Commons' Hansard, they were obscure. The Minister has illuminated a great deal and given us much to read between now and Report.
§ The noble Lord, Lord Walton, put forward a very powerful case on both occasions when he spoke. The Committee would do well to reflect on the amendment he moved on behalf of the noble Baroness, Lady Finlay. There could be some situations in which families have a direct interest in seeing tissue, previously removed and analysed by a coroner, destroyed as soon as possible—perhaps where the family were aware that the death was not a natural one and maybe either something had been missed by the coroner or someone had been wrongly convicted of a crime and the family knew that this had happened. So there are perhaps issues surrounding that kind of remote scenario—but maybe not so remote—that we need to reflect upon.
§ I was, however, comforted by the noble Baroness's overall message to me that both my amendments were unnecessary in the context both of existing legislation and the forthcoming coroners' rules. I had hoped that she would say that. So, with I think the likelihood that we shall want to return to perhaps one or two of these issues at Report, I beg leave for now to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendments Nos. 37 to 39 not moved.]
§ Clause 11 agreed to.
§ Clause 12 [Interpretation of Part 1]:
§ [Amendments Nos. 40 and 41 not moved.]
§ Clause 12 agreed to.
§ Schedule 2 [The Human Tissue Authority]:
Lord Jenkin of Roding moved Amendment No. 42:
Page 40, line 11, after "times" insert "that the membership represents public and private research, clinical and professional expertise and
The noble Lord said: We move to Schedule 2 and the composition of the Human Tissue Authority. This was touched on in the Second Reading debate when the Minister made it clear:
At least half of the authority will be lay members but, clearly, professional expertise will also be needed".—[Official Report, 22/7/04; col. 371.]
Later in the debate, near the end, the noble Lord, Lord Oxburgh, who is a scientist of very great distinction, put it the other way round when he said:
Having embraced the general principle of the use of human tissues for appropriate research, let us not strangle it by regulation".
And then his key words:
A real danger arises if the regulation is undertaken by people who simply do not understand the problems".—[Official Report, 22/7/04; col. 416.]
§ That might be dismissed as the scientists' normal—contempt is too strong a word—dismissal of lay views on these matters. I am entirely content that there 494GC should be a significant lay element. I think that laymen can offer insights which go beyond the expertise of scientists. Having been myself a layman on a number of bodies—I have already referred to my membership of the Imperial Cancer Research Fund Council, of which I was deputy chairman for three years—I think that the question arises as to what is the right balance.
§ The HTA is charged with providing much of the practical detail relating to the removal, storage, use and disposal of human tissues. It is therefore imperative that it should be able to draw on practical expertise and the experience of public and private researchers, clinicians and other professionals in this area. That I think has been conceded. However, I would be unhappy if I thought that professional people with real understanding of the issues involved in this will be a minority and the matter was, as the noble Lord, Lord Oxburgh, said, left in the hands of people who simply do not understand the problems.
§ This body will have a hugely important function and role. I think it is important that the composition of the body—the Minister may be able to tell us a bit more of what is in Ministers' minds on this—should clearly recognise that it is a body primarily of professional expertise, but with a significant leavening of lay opinion to keep those experts in touch with broad public opinion and the general views of society. It must be that way round.
§ I would find it very difficult to accept a body half of which consisted entirely of laymen. That never happened with the Imperial Cancer Research Fund or, indeed, with any other bodies with which I have been involved which have had as their principal objective the advancement of medicine or science or something of that nature. It is very important that we recognise the value of expert, professional opinion in these matters leavened, as I have said, by a healthy dose of lay involvement.
§ I hope that the Minister will be able to reassure us that it is not the purpose of the Secretary of State to give this body a majority of lay members. That would be quite wrong. That is the reason behind tabling the amendment. I hope that we shall be reassured. I beg to move.
§ Earl Howe
I really cannot do better than my noble friend in speaking to this group of amendments. I would just draw the Committee's attention to Amendments Nos. 43 and 44 in this group. Amendment No. 43 is designed to focus on the phrase, "a professional interest" in line 12 of Schedule 2. That is rather a vague phrase. It has been pointed out to me that it could mean almost anything. Almost any kind of professional with any remotely tangential interest could be brought in. My noble friend says "a journalist", which is not an example I had not thought of. However, it is quite a good one to illustrate the point. To be serious, the Government might do well to consider tightening up that particular phrase.
§ Other than that, it would have been of some comfort to us to see a corresponding subparagraph containing something more positive to show that there really is the intention to appoint people with a relevant 495GC professional interest rather than to exclude them, which is the purpose of paragraph 1(2) of Schedule 2. I hope that the Minister will be able to give us some comfort on these matters.
§ Lord Clement-Jones
I rise briefly to support Amendment No 43, which is tabled in my name also, and Amendment No. 42. I would be content if half the authority were lay people but I think that the point made by the noble Lord, Lord Jenkin, that there should be proper expertise on the other half of the authority is incontestable. We have just heard in Committee from people such as the noble Lord, Lord Walton, and the noble Baroness, Lady Finlay, about their own particular expertise. It has proved invaluable already to have those kinds of examples. So, how much more important it is on an ongoing basis that the authority should have access to precisely that sort of expertise.
§ In Amendment No. 43, I think that the issue of what is a professional interest is drawn too widely, unless the Minister can point to a precise interpretation that limits it to the point made by the noble Earl. It could be lawyers who have an interest as professionals or patient advocates. All kinds of people might technically be deemed to be in a sense the wrong half of the authority. That would be a mistake. One should be very clear that those who, in a sense, are in the "non-lay" half are those with a professional involvement effectively in the removal, storage or use of human tissue. We should have that kind of definition.
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)
I am not totally confident that I shall bring as much comfort to noble Lords as they might be expecting.
§ Let me deal first with Amendment No. 43, which effectively seeks to change the words of the text describing the lay membership of the Human Tissue Authority, by substituting those with no "relevant professional interest" in the activities within the remit of the authority for those with no "professional interest" in those activities. We take the view that the amendment makes no substantive difference to the definition of lay members. We are not convinced that the change would in practice alter the pool of people from whom the lay membership could be drawn.
§ It is worth saying to noble Lords that when we turn later to the boards of the inspectorates—these are the inspectorates that are inspecting premises—they will see that there is no requirement for lay people to comprise a half or the majority. So it is left very much to the process in paragraph 1(2) of Schedule 4 to have a majority of people with a professionally relevant interest in this particular area.
§ Amendment No. 44 seeks to add subsection (3) to paragraph 1 of Schedule 2 and seeks to ensure that the non-lay membership of the authority is appointed from people with "relevant professional experience". Amendment No. 42 aims for a similar effect.
§ We think these amendments are unnecessary. The Government made it clear in another place that some members of the authority would be chosen from those 496GC with relevant professional experience of activities within the remit of the HTA. Here, "professional" has to take account of the context of the Bill. We do not wish to be specific on the face of the Bill about the areas of expertise that may be appropriate for members of the authority, but I can assure noble Lords that the authority will contain members with relevant professional experience of the regulated activities. Indeed, as noble Lords have said, it would struggle if it did not do so.
I cannot offer any comfort to the noble Lord, Lord Jenkin, on the provisions, which are very clear in the Bill, in paragraph 1(2) of Schedule 2. It states:
The Secretary of State shall exercise his power to appoint members … to secure that at all times not less than half of the members are persons who do not have, and have not had, a professional interest in any of the kinds of activity within the remit of the Authority.
That does not say that the members will comprise a majority, but it does say that they will amount to a half. We stand by that very clear commitment made by the Government. That is the context in which we are saying, essentially, that we do not think these amendments are necessary. But, as I have said, in Schedule 4 the boards of inspectorates do not require a half or a majority to be lay members.
§ Lord Walton of Detchant
I certainly would not argue against the crucial importance of having not less than half of the members of the authority being lay members. But if the Minister were to look at the constitution of many other regulatory authorities in science, medicine, nursing, dentistry and so on, he will find that in many instances the actual nature of the scientific members is clearly defined on the face of the relevant Acts.
§ Without some wording—it may not be perfectly set out in these amendments—there is a danger that people very knowledgeable and professionally expert in the fields concerned with human tissue may not find themselves represented on the authority.
§ It would be very wrong to make it totally prescriptive by saying, "There will be one member from this and one member from that", and so on. But it is crucial to follow the points made in the discussion by being a little more prescriptive about the membership other than that of the lay people.
§ 4 p.m.
§ Lord Warner
I should like to add one further point in response to the noble Lord. It will be for the Secretary of State, in making those judgments— advised, no doubt, by the NHS Appointments Commission—to reach a judgment about whether a person is or is not a relevant professional. In that context, it worth bearing in mind that those judgments are currently made in relation to appointments to the Human Fertilisation and Embryology Authority, which has similar requirements regarding lay and professional membership. Perhaps I may jog the memories of Members of the Committee: we announced just before the Recess that the HFEA and the Human Tissue Authority would be merged after 497GC the review of the Human Fertilisation and Embryology Act 1990 has been completed, as part of a process of bringing the two bodies together. I have cited the HFEA because it is directly relevant in this context.
§ Lord Jenkin of Roding
As regards the proposed merger, I am grateful to the Minister for reminding us of that. For the purposes of this debate, I glanced through the debate at Second Reading and re-read what is a quite complicated part of his speech. Of course, not only those two bodies figured in the Minister's speech. He also referred to the Unrelated Live Transplant Regulatory Authority, to the Inspector of Anatomy, and so on. This is becoming a complicated menagerie of statutory animals. However, it may well be right for the two bodies he mentioned to be merged.
§ I shall be interested to see the arguments for that. It seems to me that the functions are really very different. The HFEA has played a very notable role in untangling some of the complex, new issues that arise—it seems sometimes almost weekly—from the developing science in this field. That is really quite different from what the HTA will be expected to do. I can understand that there has been ordained from on high a cull of those NHS bodies, for reasons which, as I say, I quite understand. But there needs to be some very careful thought about how wise it is to bring together people in a single body where they have two such very different functions. I simply serve notice on the Minister that that is something which I am sure we shall want to watch.
§ I return to the main issue of my amendment—I am grateful to the noble Lord, Lord Walton, for speaking—which is the question of the balance between the professional and the lay involvement. The noble Lord said that he was not too unhappy with the proposal that it should be half and half. He speaks as one of the most distinguished professional people in the House of Lords and therefore I respect that view.
§ I am not a professional; I am a layman. I would prefer to see a majority of professional people taking these decisions. I am well aware of just how inadequate my own participation in such a body would be. I would hope that one would make a decent contribution and, as it were, give the layman's view. But many of the questions that would need to be decided would be of acute professional complexity. I believe that it is the professionals who should pass judgment.
§ Of course, what happens in practice is that when there is a question of that sort, the laymen tend to leave it to the professionals. Perhaps that is the way these things work out. But I still hope that a body of this kind will have a majority of people with an appropriate professional interest, with a substantial—I repeat, substantial—leavening of lay participation. I would much prefer it to be that way around.
§ I shall certainly study what the noble Lord, Lord Warner, has said, but I think that I shall want to return to this matter. It may be, as the noble Lord, Lord Walton, said, that the amendment was not drafted in 498GC a way that really drew the question out, but I may well find that I return to the matter on Report. In the mean time, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendments Nos. 43 and 44 not moved.]
Earl Howe moved Amendment No. 45:
Page 41, line 23, leave out "who appointed him" and insert "authorised under paragraph 1(1) to appoint him to that office
§ The noble Earl said: This is a simple and straightforward drafting amendment. In paragraph 9 of Schedule 2, we see a provision which says that the chairman or other member of the Human Tissue Authority may be removed from office by the person who appointed him. Where that person is the Secretary of State, I am sure that the intended meaning is that the office holder rather than the actual individual who made the appointment may remove the chairman or member from office. Secretaries of State come and go in the normal course of things. It should be open to one Secretary of State to dismiss a chairman appointed by his predecessor. This amendment is designed to make that clear. I beg to move.
§ Lord Warner
Frankly, I am afraid that we can see no effect in this amendment. The persons who are authorised to make the appointment are the Secretary of State, the National Assembly for Wales and the relevant Northern Ireland department. They are legal persons; they are not individuals. They each have the power to appoint and the power to remove the members whom they appoint.
§ It does not matter that the office of the Secretary of State may be held by different individuals from time to time. The appointment is made by the Secretary of State. It is the Secretary of State who has the power of removal. It also does not matter if the membership of the National Assembly for Wales or the relevant Northern Ireland department changes.
§ While we propose to ensure that appointments to the authority are made on the advice of the NHS Appointments Commission—to secure full compliance with, as they used to be called, the "Nolan" principles—it nevertheless will still be the Secretary of State, the National Assembly for Wales or the Northern Ireland department which will confirm and formally make the appointments. Whatever selection procedure is used, they would remove persons from office where that was necessary. That is what the Bill provides. I am advised that the amendment would have no impact on that process whatever.
§ Amendment, by leave, withdrawn.
§ Schedule 2 agreed to.499GC
§ Clause 14 [Remit]:
§ [Amendment No. 46 not moved.]
§ Clause 14 agreed to.
§ Clause 15 [General functions]:
§ Lord Clement-Jones moved Amendment No. 47:
Page 12, line 15, at end insert—
( ) monitoring levels of public awareness of activities involving human tissue and providing information to the public as it considers appropriate to raise such awareness where it considers necessary.
§ The noble Lord said: Obviously, in Committee, we all learn at the feet of the Minister. Amendment No. 47 applies to Clause 15, which deals with the general functions of the Human Tissue Authority. We have had a public inquiry and extensive public debate about the use and value of human tissue. However, it is clear that there is still a very important role to be played in raising public awareness and understanding of the use and value of human tissue. It is important not only that people understand their rights in respect of human tissue—I hope that that will be the case when the Bill is passed—but also that people understand the value of research and the use of human tissue by the research community.
§ That is a very difficult balance, but once the Bill is in place I hope that there will be sufficient public reassurance for people to become more aware of the value of such research. The new subsection proposed in Amendment No. 47 would give the HTA an explicit role in relation to raising public awareness. It is essential that the HTA plays a role in the monitoring of public awareness and understanding of the use of human tissue. Accordingly, this amendment proposes that that function is included in the Bill. Failing that, other than a whole host of separate research organisations, I do not see who will do that in a general sense. I beg to move.
§ Lord Jenkin of Roding
I support the amendment. Indeed, if I had been quicker off the mark I would have added my name to it. It is entirely within the spirit of the Select Committee report, Science and Society, which I had the honour of chairing some four or five years ago. It has had quite a major impact on the way that scientists perceive their role in relation to society in general and to the many different publics that they have to address.
§ No opportunity should be missed by those engaged in perhaps very abstruse scientific and, in this case, medical subjects. There should never be an occasion on which they should not be trying to persuade the public of the value of their work. The amendment moved by the noble Lord, Lord Clement-Jones, which gives the authority a role in this, is a step in the right direction. I support it.
§ Lord Warner
We support the thinking and the sentiments behind the amendment, but I fear that I have to tell the noble Lord that we think that the actual 500GC amendment is unnecessary, for reasons that I will set out. The Human Tissue Authority already has duties under Clause 15(d) (e) of,providing to the public, and to persons carrying on activities within its remit, such information and advice as it considers appropriate about the nature and purpose of such activities",and,monitoring developments relating to activities within its remit".
§ Conducting surveys to monitor public awareness of the need for tissue research, for example, is the sort of thing that government departments and public bodies do from time to time. The existing powers and duties of the Human Tissue Authority are perfectly adequate to enable it to undertake such activities. We do not therefore see a need for the amendment, which, in our view, does not change the duties of the HTA.
§ Lord Clement-Jones
I thank the Minister for that reply, which is rather double-edged: it is like the draftsman saying that he thought that he had got it right in the first place. I am not convinced that it is as explicit as it could be. I am sure that the HTA, once formed, will read Hansard with great care and realise that its duties include that. But I do not think that the clause is clear. If that is the Minister's interpretation and the HTA includes that as part of its explicit remit, obviously, the proof of the pudding is met. I am content with that. On that basis, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ Clause 15 agreed to.
§ Clause 16 [Licence management]:
§ Lord Jenkin of Roding moved Amendment No. 48:
Page 12, leave out lines 30 and 31 and insert—
(ii) non-imported relevant material which has come from a human body, for a scheduled purpose that requires appropriate consent;
The noble Lord said: Amendment No. 48 would delete Clause 16(2)(f)(ii) and insert a new sub-paragraph; namely,
non-imported relevant material which has come from a human body, for a scheduled purpose that requires appropriate consent".
That is fairly obscure language, but the purpose is entirely clear: to reduce the burden of bureaucracy in administering this legislation. The licensing provision in the Bill is a mechanism through which oversight can be maintained in a way to ensure that the codes of practice put in place by the HTA are observed. They are sensible objectives, which one must have in any such system.
§ However, it is of vital importance to future research in this country that the system is not overly bureaucratic or in some cases—perhaps this one—unnecessarily bureaucratic. Not only would that increase costs for researchers and research institutions, it would also lead to delays in the work being done. That could result in research moving to other countries—not exactly the same as the threat from the animal terrorists, but it might have rather the same impact.501GC
§ 4.15 p.m.
§ Of course, if the research moves to other countries, the people will go with it and so will the investment. That is entirely feasible. For example, many of the major pharmaceutical companies have research sites in different countries and are able to make investment decisions in the light of the research environment in each country.
§ As I understand the Bill, the licence provisions as they stand require a licence to store human tissue for research. The licence holder, or designated individual, may extend the provisions of the licence to any person acting under his direction or any person that the licence holder notifies to the authority.
§ So, for instance, a human tissue sample could be stored in a laboratory other than that of the designated individual, provided written notice is given and the premises specified. That is one piece of bureaucracy that the Committee may consider reasonable.
§ Another piece of bureaucracy is that removal from storage can be only to a person who is authorised in writing by the designated individual, and that that notice stipulates the use and duration of use of the tissue. The final piece of paperwork is that the designated individual will have to inform the Human Tissue Authority that he has given that written notice.
§ Again, the Committee may consider that those are reasonable provisions. However, are they really necessary for each and every type of human tissue? Residual tissue taken from many living persons may be put to many different research uses by different researchers, as provided for in the ethics approval. But these licence requirements for each of those uses could be onerous and cause significant delay.
§ As is recognised in the Bill, when residual tissue is anonymised it has a lower level of information risk to the donor. The amendment builds on that recognition. It removes the licence requirements from the storage of that tissue for research, but keeps the provisions in respect of human tissue that requires appropriate consent from individuals or relatives.
§ The amendment also raises the issue of storage of human tissue outside the United Kingdom and the importation of samples of that tissue for research. Surely the Government do not intend the licence provisions to extend to the storage of human tissue outside the UK. Perhaps the Government envisage that under those circumstances, the researcher importing the tissue would need to store it, albeit on some occasions for a short time, and would therefore require a licence for it. If nothing else, we should have clarification of that issue.
§ The system that I have described enshrined in the clause is overly complicated. It should be possible to simplify it so as to keep those activities firmly in this country. We derive enormous benefit from them, and if the system becomes overly bureaucratic and too complex, many of the companies and perhaps even some of the research laboratories that do this work will find it more convenient to go overseas.502GC
§ This is a small amendment, but the principle behind it is one of some importance. The Bill has been described in other places as being overly bureaucratic. Here is a precise example. I hope that the Minister will be able to give the Committee some comfort when he comes to reply. I beg to move.
§ Earl Howe
My Amendment No. 49 is grouped with Amendment No. 48. Perhaps I may speak to it briefly as my noble friend has already covered a lot of the ground. The intention behind my amendment is to exempt from the licensing requirements all activity using tissue taken before death. Perhaps one should slightly discount the views of the medical profession in this context, although one should not do so entirely. However, I know that the profession is very exercised, as am I, about the scope and impact of the proposed licensing regime. I share the worry that the impact has been underestimated on both sides; that is, not only from the point of view of applicants but also from that of the Human Tissue Authority.
The requirement for a licence to store tissue for scheduled purposes applies, however little tissue is being stored. It has been put to me that this would mean that a researcher storing a single spot of blood for research purposes would require a Human Tissue Authority licence. If that is right, the HTA will be inundated with requests which, inevitably, would jeopardise its effectiveness in relation to what really matters within its remit. I hope that the Minister will take on board those concerns.
§ Lord Clement-Jones
I should like to support Amendment No. 49 and speak to Amendment No. 50. As the noble Earl has just outlined, the licensing regime is very broad in scope and will have a significant impact on organisations and individuals possessing human tissue. Taken to their logical conclusion, some of these provisions appear somewhat excessive. No minimum is set for the amount of tissue being stored before a licence is required, although Clause 16(3) does empower the Secretary of State to issue regulations specifying such a minimum. On that basis, I strongly support Amendment No. 49 which would exclude ante-mortem tissue from the licensing regime.
Amendment No. 50 goes a little further. Taken in conjunction with Amendment No. 49, it would limit the licensing regime in relation to ante-mortem tissue to tissue stored mainly for use by third parties, thereby excluding ante-mortem tissue stored mainly for personal use. This would capture tissue banks but would exclude small amounts of tissue stored by individual clinicians for diagnosis and research involving their own patients that might occasionally involve colleagues or associates in other institutions.
The proposed licensing regime extends to all tissue collected after the Bill comes into force. That will be a considerable burden on researchers and will make the regime difficult to regulate. For that reason, we propose that the storage of tissue taken from living 503GC persons should be excluded from the licensing regime. That would be a considerable improvement to the licensing requirements set out in this clause.
§ Lord Warner
I certainly do not accept some of the arguments put forward about bureaucracy in order to justify these amendments. The truth is that the amendments seek to limit the activities in relation to storage that fall within the licensing remit of the Human Tissue Authority.
§ I know that many in the scientific community would prefer the regulatory aspects of the Bill to fall short of research-related issues or relate only to post-mortem tissue. Indeed, noble Lords have touched on that at various times, not only on this group of amendments. However, there are a number of reasons for developing a more comprehensive and consistent framework which is designed to provide assurance to patients and their families as well as confidence and support for the medical research community.
§ A number of noble Lords have remarked to me outside this Chamber that the present system does in fact generate a great deal of uncertainty in the medical research community, a point that is often forgotten during our deliberations. The Bill will bring greater clarity to the area. Sometimes we can lose sight of that when discussing elements of the legislation.
§ The Bill covers the licensing of tissue storage on the one hand because of the real need to provide for the safety of patients who may need tissue for transplantation purposes.
§ Noble Lords may need to be reminded perhaps of the forthcoming requirements of the EU Tissue and Cells Directive adopted in April. That, quite rightly in our view, requires regulation of the safety and quality of procurement, handling and storage of tissue for human application. The directive does not distinguish between tissue from the living and tissue from deceased persons. It must be implemented by April 2006. This legislation provides for that directive to be implemented in this country.
§ As long ago as 1999 the Department of Health set up a voluntary accreditation scheme for tissue banks which process, store and distribute human tissue for therapeutic use. In 2001 it issued a voluntary code of practice for tissue banks. So we have had a degree of regulation in this area of some significance. This sort of scheme will become statutory when the Bill takes effect, as the Tissue and Cells Directive I mentioned is intended to be implemented by way of the Bill. With that in mind Clause 51 provides a power for community obligations to be given effect. So we are constructing a system covering storage that will enable us to implement the EU Tissue and Cells Directive.
§ But the Bill also provides a framework for the regulation of tissue storage in relation to non-transplantation purposes, such as research. As we have said, this is not intended to operate in terms of licensing at the level of the individual researcher, but in relation to tissue banks that collect, process and distribute material for purposes such as research. 504GC Clause 16(3) provides for the exclusion, as the noble Lord, Lord Clement-Jones, said, of the licensing requirement of storage in circumstances that will be dealt with in regulations. We have said plainly that by these means we shall exclude from licensing the "end-user" researcher.
§ We know that it is important to manage the sourcing of such material, not least because it will often be from the deceased. In that respect, questions of consent are crucial. But it is not only consent, it is, of course, also the use of tissue in situations in which consent is not needed that will have to be monitored. That is not to the detriment of research. In recent years there has been a lack of confidence among those involved in tissue-based research. A good, supporting regulatory framework will provide precisely the certainty and confidence that is needed.
§ Perhaps I may just respond to a couple of the detailed points and examples raised by noble Lords. The noble Lord, Lord Jenkin, talked about the bureaucratic rules. Let me deal with some of that by saying that the stipulation of removal of tissue in writing applies only to anatomical specimens. That is the current law carried forward from the Anatomy Act. It applies, therefore, only in respect of parts and bodies donated to anatomy schools.
§ The noble Earl, Lord Howe, raised the issue of blood. I ask: where in the Bill does it say—in his example—that there are these kind of problems? The Bill places no limitations on consent. If a person removing material says, for example, "Do you mind if we use your blood at any stage in the future in any research projects?" and the donor says, "Not at all", that is not a great bureaucratic system. There is no problem under the Bill for people to obtain consent in those particular ways.
§ I think that the Government have done rather a good job in encouraging research into this country. That is not just my view; there is lot of evidence on that. We do not consider, as suggested by the noble Lord, Lord Jenkin, that the Bill as drafted will impact on establishing research in this country. As I have said, the Bill will provide, in storage terms, for implementation of the EU Tissue and Cells Directive. The similar kinds of arrangements that we are providing for here will have to be in place across Europe. So, we think that the approach we have adopted is a sensible and balanced one. It provides necessary protections for patients but also for a stable, reliable environment in which research can flourish with confidence. We do not believe that the amendments will help that process.
§ 4.30 p.m.
§ Lord Clement-Jones
Perhaps I may respond briefly to the Minister. My Amendment No. 50 in a sense qualifies Amendment No. 49, and I thought that what the Minister had to say was somewhat reassuring. The phrase he used, "end user research use", is not one with which I am familiar, but it describes exactly what I was trying to say in terms of the use of small quantities of tissue stored by individual clinicians for diagnosis and 505GC research involving their own patients. If that is the case and if it will be covered by Clause 16(3), then that provides a considerable reassurance.
§ Lord Jenkin of Roding
Without wanting to touch on the previous debate, I find myself, as a layman, in the circumstance that I really will have to take advice on the reply just given by the Minister. I am advised that, as drafted, the requirements will be unnecessarily bureaucratic and unnecessarily complicated. The amendment suggested a way to alleviate that. I have listened to the Minister's response with great care. However, I have to say that, on these complicated matters, I feel the need to take proper professional advice before deciding what to do.
§ In the light of what the Minister has said and depending on how I am advised, I may wish to return to this issue. In the mean time, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendments Nos. 49 and 50 not moved.]
Lord Clement-Jones moved Amendment No. 51:
Page 12, line 43, leave out -one hundred" and insert "fifty
§ The noble Lord said: I think I am right in saying that the licensing regime set out in this clause was further extended in the other place by the removal of the exemption for qualifying museums. As I understand it, those museums holding 20th century human remains will now require a licence to do so. I regret that my noble friend Lord Redesdale is unable to be here today in order to support me in this amendment. I know that he has tabled a later amendment which has not been grouped with this one.
§ Amendment No. 51 is an additional proposal which would limit the scope of the licensing regime to the use for display or storage or schedule purposes of the tissue of individuals who died 50 years before this section comes into force rather than 100 years. This would exclude from the licensing regime museums holding or displaying human remains and organisations holding tissue dating back to the early 20th century, the regulation of which via a licensing regime, and the attendant costs, seems rather excessive.
§ I do not know enough of the background to judge whether the period of 100 years was simply plucked out of the air. However, the representations I have received suggest that a period of 50 years would be far more proportionate. I beg to move.
§ Lord Warner
We are probably now in territory where we would all benefit from the presence of the noble Lord, Lord Redesdale, but I shall try to respond to the amendment moved by the noble Lord, Lord Clement-Jones. I shall have to track back a little in making my response in order to explain how we have reached this point.
§ The storage and use of bodies and material from the bodies of persons who have been dead for 100 years when the Bill takes effect have been exempt from the consent provisions from the outset. This is because we 506GC believe that it is important to set a date for exemption from consent at a point where it is unlikely that anyone will have living memory of a person whose remains might be used, for example, for education, public display or museum research.
§ In the Bill as originally drafted, any museum holding human remains had to be licensed only if it was not a "qualifying museum", which broadly meant that it was publicly funded. As the noble Lord pointed out, on Report in another place we brought in an amendment to replace the museums exemption with a provision exempting the storage and use of bodies and tissue from the bodies of persons who died more than 100 years before the Bill takes effect. We are continuing the 100-year exemption arrangement, but using a different method. This will keep the licensing provisions consistent with the consent and DNA provisions, and has another more practical purpose.
§ Archaeologists had pointed out to us that the Bill as it was first drafted might criminalise the examination of excavated remains to discover the cause of death if this was undertaken without a licence. Determining the cause of death is an activity that archaeologists undertake from time to time. Identification of diseases causing death may help to shed light on past human health, while signs of violence on skeletons reveals evidence of what happened in past societies and warfare. We therefore decided to exempt from all licensing human remains where the person died more than 100 years before the Bill comes into force. Most remains excavated by archaeologists and held by museums will be older than that.
§ So, to be clear, we have brought the consent and licensing provisions into line by requiring both consent and licensing for all bodies and tissue less than 100 years old when the Bill takes effect. We believe that a period of 100 years provides a sensible and pragmatic cut-off point, being one that means that there is unlikely to be a living relative with a memory of the individual concerned. We could not make the same claim for a 50-year time limit.
§ If the exemption from the requirement for a licence were to be widened, as is being sought in this amendment, in effect, so that a licence would be required only in relation to storage and use of tissues from persons who had died during the 50 years before the Bill takes effect and thereafter, this would take out of the licensing regime museums holding material between 50 and 100 years old. This material would include the remains of persons who died in either of the world wars of the last century, which is a consideration for us. We would prefer not to do that.
§ I have outlined the background of how we reached our decision to remain with the 100-year period as the most appropriate way of organising this provision. I hope that my explanation will satisfy the noble Lord, Lord Redesdale, as well.
§ Lord Clement-Jones
I thank the Minister for that interesting reply. It is good to be given the reasoned background. Of course there is a difference when considering current events. As the Minister said, the 507GC Second World War is still very much a part of people's consciousness, although that is perhaps not so true of the First World War.
§ I shall take advice, not from my personal "time team", but no doubt from a team of trained archaeologists to see what they make of the Minister's reply. In the mean time, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendment No. 52 not moved.]
§ Clause 16 agreed to.
§ Schedule 3 [Licences for the purposes of section 16]:
Lord Clement-Jones moved Amendment No. 53:
Page 44, line 28, leave out sub-paragraph (1).
The noble Lord said: This is a probing amendment relating to the words in the schedule:
A licence shall not authorise the carrying-on of more than one activity to which section 16 applies".
The Bill prohibits licences from covering more than one activity or one activity being carried out at more than one site. A researcher wishing to back up his collection at a second site would therefore need to hold two licences. That seems unnecessary both in terms of bureaucracy and cost. This amendment would lift that restriction. I beg to move.
§ Earl Howe
I endorse everything that the noble Lord, Lord Clement-Jones, has just said. Indeed, my Amendment No. 54 is very much directed at the same point. It does seem that Schedule 3 consciously sets its face against allowing one licence to cover more than one activity or more than one set of premises. I am not clear why we need to make work of that kind for apparently no purpose. It seems to be a case of creating paper and effort to no good purpose.
§ Lord Clement-Jones
I have not been explicit about Amendment No. 55; I should have mentioned that it relates to that point as well. It is not only related to place; it is also related to activity. The individual on a licence has overall responsibility for compliance, but that person would not necessarily direct or supervise all activities carried out under the licence. The early amendment therefore proposes amending the Bill to reflect that.
§ Lord Warner
These amendments all point in the same general direction, seeking to reverse the present sense of Schedule 3 insofar as it says that one licence may not cover premises at different places; may not allow licensed activities to be carried out under the supervision of more than one person; and may not relate to more than one licensable activity.
§ I recognise and share the good intentions behind the amendments, which seek to minimise bureaucratic burdens. I am extraordinarily sympathetic to those aims. However, I think that the Bill achieves both strength in its licensing approach and flexibility to ensure that the bureaucratic impact is indeed 508GC minimised. It is also trying to ensure that we have clarity of accountability for particular activities at particular premises.
§ Before I go into more detail on this, it is worth reflecting on the fact that, when one is talking about the cost, we are not talking only about the cost of issuing paper. The greater cost will be in the inspection function itself. Getting the inspection function right is likely to be the bigger cost, rather than the cost of issuing the pieces of paper.
§ The Government consider that the proposals in the amendments would seriously weaken the credibility and effectiveness of the Bill. Licensing will be at a level appropriate to the activity being carried out, but licences must relate to premises or, for practical reasons, the inspection system will not work well. A single collection might indeed be over a large number of sites and, if there was only one licence, they would all need to be inspected in relation to that licence. Accountability for problems at a particular site could well be difficult to establish if there was not clarity about the relationship between an activity, a site and a licence.
§ Under the proposed amendment, one site might need to be tied to a number of different licences. We think that that would be unmanageable from the perspective of both the authority and the bank itself, make inspection difficult and probably would be more expensive. It would certainly blur accountability.
§ Regarding the question of licences covering more than one activity, we had ourselves considered this point, and arrived at the conclusion that the least onerous solution is that which is presented by the Bill. The Human Tissue Authority will be able to deal with and issue licences simultaneously and use a single set of documentation. So there is no reason why, on a particular site, a series of licences could not be produced at the same time which show the licensed activities on that set of premises, with identification of the designated responsible individuals. That is what we are trying to achieve.
§ I emphasise again that the cost structure for charging for licences is likely to be governed much more by the volume and cost of inspection than it is by the issuing of pieces of paper. If an establishment carries out several licensable activities at the same location, as I said, they could be handled through a single application, a single inspection and a single document recording the various licences. If a licence for a specific activity were to be revoked or given up, under the Bill, that could be done without affecting the continuation of licences for the other activities at the same location. So there will be clarity about the particular activities that are being withdrawn and those which are being licensed and approved.
§ We do not believe that the general approach to the licensing system will be overly bureaucratic, but I can understand, because of the complexity, that people might at first blush think that it is. Indeed, we included a government amendment in another place, which is now Clause 43, which requires the Human Tissue Authority to adhere to best regulatory practice and to 509GC carry out its functions effectively, efficiently and economically. Against that background, I hope that I have been able to give the Committee some reassurance on this slightly complicated issue.
§ 4.45 p.m.
§ Lord Clement-Jones
I thank the Minister for that reply. It was helpful for him to be expansive in his reassurance and not just deal with the narrow points raised by the amendment. That will provide some reassurance and I thought that the reasoning behind the approach came through strongly. Clearly, we will need to reflect on some of the things that the Minister said about the impact. After all, it is the impact on those who are licensed that needs to be taken into account as well. In the mean time, I thank the Minister for that reply and beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendments Nos. 54 and 55 not moved.]
§ Schedule 3 agreed to.
§ Clause 17 [Persons to whom licence applies]:
Earl Howe moved Amendment No. 56:
Page 13, line 17, leave out "direction" and insert "authority
§ The noble Earl said: If I may, I shall take Amendment No. 56 with Amendment No. 58, which is also in my name. I am concerned about the word "direction" in Clause 17. That concern is shared quite widely in the scientific and medical community, not least by the Academy of Medical Sciences, which has drawn the point to my attention. It relates to the description of the role and duties of the designated individual named in a Human Tissue Authority licence. Of course, someone must have overall responsibility for compliance with the duties of the licensee, but it is questionable whether that person should have the responsibility to direct or supervise activities carried out under his authority. That has an over-prescriptive flavour about it. The consequence might be that researchers would be encouraged to take out individual licences, rather than relying on organisational licences. That would increase the cost and administration.
§ I turn to Amendment No. 58. It is designed to draw attention to what I think is a perfectly understandable concern: that the designated individual under the Bill would not have any defence to any claim against him or her personally for a breach of a licence condition by a third party, even if the designated individual had complied with the conditions and taken all reasonable steps to ensure compliance by those third parties. That is what lies behind that amendment and I hope that the Minister will be sympathetic to the point. I beg to move.
§ Lord Warner
In responding to these amendments, it may help if I explain how the structure of the licences is to work. At the heart of the licensing system lies the notion of clarity of personal accountability, which is a key issue in this area.
§ The trigger for licensing is the activity for which a licence will be required. For example, this includes the carrying out of a post-mortem, the storage of tissue and carrying out anatomical examinations. While it is the activity that triggers the need for a licence, the Human Tissue Authority in considering the licence must specify the premises on which the activity can take place. The applicant might be an individual or a body with legal personality, but the licence must also designate an individual who has the primary responsibility imposed by Clause 18 of ensuring that the practices carried out within those licensed premises are conducted in a suitable manner. This means, in essence, that they are compliant with the law, with any directions or regulations and conditions of licence and with the Human Tissue Authority's code of practice. The designated individual could, but need not be, the applicant for the licence. However, where the applicant for a licence is not an individual, the licence must still identify the designated individual.
§ It is important that the licence identifies an individual who holds those responsibilities so that there is clarity and transparency about the relationship between him and the authority. We are here copying the structure that operates under the Human Fertilisation and Embryology Act 1990, in which the person responsible under the licence has clear sets of responsibilities. We have observed that that system has operated very successfully for over a dozen years.
§ The designated individual will not be a person in a particular role within an institution; that is, it almost certainly need not be the chief executive of a trust, or the dean or vice-chancellor of a university. The designated individual will be a person who, in each case, is in a position to ensure that the activities carried out under the licence complies with the regulatory requirements to which I have referred. Indeed, I would suggest to the noble Earl that before someone becomes a designated individual, they would need to establish that they were able to bear and discharge the responsibilities which go with being such a designated individual. The system is constructed to ensure that people do not get into a situation where they become designated individuals who cannot discharge their responsibilities under the legislation.
§ The person might be a head of department, a clinician, a scientist or a manager. What is important is that it is a person who is in a position to secure that activities are conducted properly by people who are suitable to carry out those activities and that all the necessary requirements are complied with.
§ Amendment No. 56 would change the reference to other people having authority under a licence by virtue of their acting under the direction of a designated individual to persons acting under the authority of a designated individual. The effect of that would be to weaken the role and responsibility of the designated individual, on which I have placed great emphasis, and to weaken the overall control of licensed activities.
§ The problem with this is that we fully intend that the designated individual should be directly responsible for ensuring the proper conduct of the activities 511GC carried out under licence. That is clear from Clause 18, which lists the designated individual's duty. The activities under a licence are intended to be overseen by the designated individual and his authority should not be delegated broadly, as it might if this amendment were accepted. As I have said, we have followed the model of the Human Fertilisation and Embryology Act.
§ Amendment No. 58 takes a slightly different line in respect of the designated individual, and one that would clearly weaken the duties that are placed on the person under Clause 18.
§ I shall not labour the point too far, but we are emphasising that the designated individual is the person who will be identified in the licence as having the clear statutory responsibility. It is important that we do not blur accountability. This can become a particular problem when something goes wrong and leads to a situation which has often itself been contributed to by the blurring of accountability.
§ The noble Earl, Lord Howe, raised the point of whether a designated individual would have a defence against a third-party claim made against him. It is not clear that any of the responsibilities in the Bill give rise to duties towards third parties that might give rise to any such claim. If the noble Earl could give me some examples outside the Committee, I shall look into them, write to him and try to give him more reassurance.
§ With regard to Amendment No. 58, I shall certainly try to come up with some examples. The Minister referred to the risk of blurring accountability. I agree that that is not a desirable end, but nor is a situation where blame is unfairly and inequitably attached to an individual when that person could not reasonably have been expected to be aware of actions that were taking place.
§ I reserve the right to come back to the issue at a later stage. For now, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
Baroness Finlay of Llandaff had given notice of her intention to move Amendment No. 57:
Page 13, line 17, after "direction" insert "and supervision
§ The noble Baroness said: May I ask the Deputy Chairman whether I am allowed to make a comment on the amendment, having been in Select Committee and therefore coming in late.
§ The Deputy Chairman of Committees (Baroness Gould of Potternewton)
§ Baroness Finlay of Llandaff
I thank the Committee for allowing me to do so. I apologise. I only caught the end of the Minister's response. He may have spoken to the amendment previously and I can therefore be very brief.
§ I suggested the insertion to make it clear that the designated individual or person to whom the licence applies is legally responsible for people working under him. The current situation of a licensed teacher is that he is responsible for specimens under his care and for their appropriate use. This works well at the moment. I understand that that is the situation under the current Anatomy Act. I am concerned that the Bill might loosen that situation.
§ The Deputy Chairman of Committees
It was really a question. Perhaps the Minister can reply briefly.
§ Lord Warner
The Committee will be pleased to know that I am not going to repeat the wonderful exposition that I gave on designated individuals and licensing.
§ A designated individual should secure that suitable practices are used, but it does not have to be through a direct line management of every person involved in the activities. It is not clear that the adding of supervision would help in any way whatever in dealing with the issues I outlined previously. If the noble Baroness wishes to talk to me after she has read Hansard, I shall be happy to meet her.
§ [Amendment No. 57 not moved.]
§ Clause 17 agreed to.
§ Clause 18 [Duty of the designated individual]:
§ [Amendment No. 58 not moved.]
§ Clause 18 agreed to.
§ Clauses 19 and 20 agreed to.
§ Clause 21 [Procedure on reconsideration]:
Earl Howe moved Amendment No. 59:
Page 15, line 1, at beginning insert "Subject to the prior approval of the Secretary of State,
§ The noble Earl said: The amendment is prompted by comments made by the Delegated Powers and Regulatory Reform Committee of the House. It makes the observation that if the setting of general requirements for the conduct of licensable activity had been a function of the Secretary of State rather than the HTA, some level of parliamentary control would have been considered usual. As it is, what we have in the clause is a delegation to the HTA of powers to make regulations about procedure on reconsideration of licensing decisions. The committee stops short of saying that it is inappropriate to give the HTA control over licensing matters, but it does point out the lack of parliamentary control over both the regulations and the directions permitted under Clause 23.513GC
§ Indeed, the point carries even greater force if we compare the regulatory powers given to the Secretary of State in Clause 16 with the approach taken in Clause 21, where it is the HTA which is given a power to regulate. On the face of it, these two approaches are not consistent with one another but, because the committee has not suggested bringing Clauses 16 and 21 into exact line with each other, I have not proposed this in my amendment. However, I have proposed that any regulations issued by the authority should be subject to the prior approval of the Secretary of State, which at least ensures that the accountability of the HTA to Parliament is a little more direct than it would otherwise be in this context.
§ I should like to hear from the Minister what his reaction is to the comments of the Delegated Powers and Regulatory Reform Committee. I beg to move.
§ 5 p.m.
§ Lord Warner
We noted the comments of the Delegated Powers and Regulatory Reform Committee on this particular aspect. We noted that it did not make any recommendations and we also noted that it was not inappropriate as a matter of delegated power for the Human Tissue Authority to have control over its procedures.
As to the authority's powers in relation to the conduct of licensed activities, I would draw the Committee's attention to the duty in Clause 43(2). The subsection states:
In carrying out its functions, the Authority must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed)".
So provision has been made to produce a framework around which the Human Tissue Authority would produce good quality regulatory documents.
§ In addition, the codes of practice produced by the authority—which are primarily relevant to the conduct of licensed activities—will be subject to parliamentary scrutiny. In all, I believe that the checks and balances in the Bill provide adequate reassurance about the future operation of the Human Tissue Authority in this area. It is not our opinion and view that we need to have the additional provision of it being subject to the approval of the Secretary of State.
§ Amendment, by leave, withdrawn.
§ Clause 21 agreed to.
§ Clauses 22 to 24 agreed to.
§ Clause 25 [Breach of licence requirement]:
§ [Amendments Nos. 60 to 62 not moved.]
§ Clause 25 agreed to.514GC
§ Clause 26 [Preparation of codes]:
Earl Howe moved Amendment No. 63:
Page 17, line 10, at end insert "and the interpretation of the purposes contained in Schedule 1
§ The noble Earl said: From our debates yesterday, it will not have escaped the Minister's notice that a number of noble Lords have concerns about the terminology in Schedule 1. Those concerns are widely shared in that we do not want to see any possible confusion about what the terms denote or will acquire in practice. Several of the terms in Schedule 1 have attracted particular attention. I would single out public health monitoring, clinical audit and research.
§ There is a concern, for instance, that public health monitoring and public health research could in certain circumstances overlap. If one thinks of testing a particular drug for efficacy, that process could in certain circumstances overlap with a process of clinical audit. Epidemiology is the science of determining the prevalence of a disease or condition, and I take it that in normal circumstances such research requires consent. One has to ask what is the dividing line between that and public health monitoring.
§ If one imagines a situation where a number of legionnaires are found dead from a mystery infection, then determining the cause of death requires consent in normal circumstances, but a clinical auditor of that work would not require consent himself. It is that kind of potential confusion that the Human Tissue Authority should be asked to resolve in drawing up the codes of practice referred to in the Bill—the end in view being that doctors and others are 100 per cent clear about what is and is not legal and what is and is not expected of them. I beg to move.
§ Lord Clement-Jones
I support the amendment. It follows on from our discussions the other day on Schedule 1. At that time the Minister stressed the need for flexibility. If there is to be flexibility as opposed to absolute certainty on the face of the Bill, that has to be interpreted. The proposed amendment must surely be the way to do it.
§ Lord Warner
As I said yesterday, I appreciate that the intention behind an amendment of this kind is the helpful one of assisting in ensuring a clear understanding of the terms used in the Bill. There is no difference between us on that. But I shall have to respond as I did yesterday by repeating that it would be inappropriate for the Human Tissue Authority to be given the responsibility of dealing with interpretation when preparing its codes of practice. The codes are concerned with practical guidance and standards and, as noble Lords know and as I said yesterday, the word "interpretation" is usually reserved for the courts themselves. That is not to say that we do not want the codes to be as helpful and practical as possible for all those who are affected by them.
§ There is an issue, which may cause some uncertainty and difficulty, about trying to achieve definitions which, so to speak, achieve "mutual exclusivity". The problem is that the things that people do may fall into 515GC more than one category. That is a reality of life. However, if what a person is doing is in part public health monitoring, that will qualify in a sense as part of that activity.
§ In an attempt to fulfil my promise at yesterday's meeting when we discussed matters, I shall write to the Committee setting out our understanding of what is meant by these terms. This has not been done only by civil servants in the Department of Health; the definitions have been prepared following considerable discussion with those in the field. We have tried to capture the understanding of people at the practical level of how they interpret these particular terms.
§ I repeat that we would expect the HTA to give guidance on matters in this area. It is right that it should do so. There would be considerable difficulty in specifying that the HTA should deal with the interpretation of the terms of the Bill, but it can cover them by setting out what it regards as the meanings of public health monitoring, clinical audit and so on. Members of the Committee will see from the letter I shall be sending them how we have approached this and how we believe the practitioners themselves see them.
§ If there were challenges in the courts, the courts could well have regard—and one would expect them to do so on past precedent—to the guidance from an authority such as the Human Tissue Authority as well as what is said in Hansard. But the actual interpretation will ultimately always be a matter for the courts themselves.
§ So, I hope noble Lords will find the promised letter helpful and will be content to accept my assurance that the understanding of these terms, in so far as some may be uncertain about them, will be assisted, if not governed, by guidance from the Human Tissue Authority.
§ Lord Jenkin of Roding
I took part in the brief debate yesterday on the meaning of terms and quoted some questions from the General Medical Council. The Minister has clarified one thing: his letter, which I hope we will get before the Report stage so that we can take account of it, would not of itself have any specific legal standing. It is intended to indicate what might well form part of the codes that will be drawn up by the HTA. Am I right in assuming that? Because they, of course, then would have some legal standing which could be appealed if necessary through the courts. Have I understood that properly?
§ Lord Warner
The noble Lord is absolutely right. Wonderful though my letters are, I think they probably will not have any legal authority whatever. But they will record the discussions that have taken place on the common understanding of these terms in the field that will be involved in the regulatory system set up by this piece of legislation. In effect, I think it would be best to describe them as definitions that are 516GC "work-in-progress" that will be available to the Human Tissue Authority to take forward in its codes of practice.
§ Earl Howe
This has been a most helpful debate. I thank my noble friend for his contribution. I also thank the Minister for his remarks. The approach he has adopted is very constructive. I hope that, as my noble friend suggested, the letter he has promised will arrive in our pigeon holes before Report stage. That would be helpful to all. For now, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ Earl Howe moved Amendment No. 64:
Page 17, line 10, at end insert—
( ) The duty under subsection (3) shall have the effect, in particular, of requiring the Authority to give practical guidance as to how consent may be validly given where desired—
§ The noble Earl said: Of all the concerns raised at Second Reading, perhaps the one most frequently heard was that which related to the issue of consent. A number of noble Lords felt that "consent" should be defined on the face of the Bill. After a good deal of thought, I have reached the conclusion that this is probably not the right way to proceed. I say that because in a matter of this kind, where selectability is essential, it is virtually impossible to generalise or to cater for every type of situation through a form of words on the face of a Bill.
§ Therefore, I think that the standards applicable to obtaining valid consent should be a matter for guidance and codes of practice issued by the Human Tissue Authority and that we should work from that point. That is not to say that the Bill should not lay down a few markers for the authority to follow. In approaching the subject there is, as happens so often, a balance to be struck—a balance between reflecting a patient's preferences for the use of tissue and the need to minimise bureaucracy. The problem with striking such a balance is magnified by what appears to be the current tendency to be as precise as possible on hospital consent forms when defining the purposes to which donated tissue will be put.
§ While that has the advantage of avoiding any sort of vagueness and of ensuring that the patient knows exactly what is going to happen and why, it has the grave disadvantage of being inflexible. Should the researchers have a flash of inspiration and find that they wish to perform different experiments on the tissue from the ones detailed on the consent form, then a fresh consent has to be obtained.
§ 5.15 p.m.
§ In many cases where the patient is still alive and readily available, the most that this involves is a degree of unwelcome bureaucracy and bother. Sometimes fresh proposals will need to he submitted to a research 517GC ethics committee, with all the time and effort that that involves. But in other cases the patient or his relatives are no longer available to give consent. It is often not only impractical but impossible to get the consent modified. These are the reasons why many scientists in the research community are anxious to ensure that some kind of generic and enduring consent will be legal when the Bill becomes law.
§ At Second Reading, the Minister gave reassurances on that point. However, worries persist. They persist principally because of the requirement for specificity of consent laid down by many research ethics committees. They also stem from the fact that the Bill is silent on the whole matter. If we are serious about the need to maintain the momentum of medical research in this country, and about imposing on it the least possible administrative burden, there is a case for ensuring on the face of the Bill that obtaining generic and enduring consent will be one option open to medical researchers when presenting their proposals to research ethics committees for approval. A signal of that kind would be important for the HTA.
§ At the same time, we should not be under any illusions that a standard form of generic consent, which is also sufficiently informative and descriptive for the patient or his family, is something that can necessarily be achieved just like that. The authority may need to work quite hard to fulfil the expectations placed upon it in this area. But of one thing there surely can be no doubt, the authority must arrive at some sensible and workable guidance.
§ I hope the Minister will be sympathetic to at least the general tenor of the arguments I have put forward. I beg to move.
§ Lord Jenkin of Roding
Amendment No. 72 is grouped with the one moved by my noble friend. I endorse everything he said. Amendment No. 72 seeks to go a little further and I hope that the Minister will give it sympathetic consideration. It repeats the assurances given by the Minister at Second Reading, that consent to research can be generic and enduring. I shall not quote his particular words, but he said it more than once.
§ As my noble friend Lord Howe pointed out, the Bill does not provide for this. The amendment to which I am speaking aims to capture this provision on the face of the Bill. Furthermore, it is also aimed at reducing bureaucracy for researchers and the workload of the research ethics committees by reducing the circumstances in which the researcher will have to return to the donors and to the research ethics committees for clarification of the extent of the existing consent.
§ In addition, where a research ethics committee has given authority in lieu of the donor via the mechanisms we discussed earlier in Clause 1(9), for consistency this method of consent should be equally generic and enduring as though it was provided by the donors themselves for the same reasons.
§ If the mechanism by which donations are fulfilled is unnecessarily restrictive and cumbersome, there is a very real risk to the gifts that the donors give, which are 518GC hugely appreciated particularly by the medical profession. Their intentions may not be properly fulfilled, their wishes not respected, and important research hindered as a consequence.
§ That could easily be overcome by the inclusion of the last few words of Amendment No. 72. If consent for research were usually given to be wide-ranging and long-lasting unless otherwise stated by the donor, there would be a presumption that it would be generic and enduring unless that had actually been denied by the donor. That would be an enormous help and go a long way to relieve the anxieties that the research community feels about this aspect of the Bill.
§ Lord Clement-Jones
I support these two amendments. The Minister's letter to us—we received it in the Recess and it was very helpful—goes into a little detail in this area. It states:The Bill deliberately does not attempt to limit or define the scope or duration of consent in primary legislation, and therefore does not use terms such as 'generic consent' or 'fully informed consent'. The Bill applies to a very wide range of circumstances and the Government believes that it would not be appropriate to limit the necessary scope for flexibility in statute. Rather the Bill proposes that the Human Tissue Authority, with both a strong lay representation and sufficient relevant expertise, will draw up codes of practice dealing with the obtaining of consent, and that those codes will be subject to Parliamentary approval".
§ That is the Minister's statement and I have no doubt that he will to some degree repeat it today. However, it seems extraordinary that both he and Dr Stephen Ladyman explicitly made it clear that the Bill does not limit the duration and breadth of the consent and so on. It is perfectly possible to have this kind of generic and broad consent which the research community wants to see explicitly made.
§ I cannot quite see the great benefit of leaving this to the codes of practice, when it would he perfectly possible to make it clear in the Bill that this kind of broader consent is well within the definition. It seems that one is almost preferring to have lawyers pick over the definition rather than make it explicit. So I am very much in sympathy with the arguments made by both the noble Earl, Lord Howe, and the noble Lord, Lord Jenkin. I think that the amendments would help to achieve a greater certainty in this central part of the Bill.
§ Baroness Finlay of Llandaff
I add my support to the comments already made. I should like to put the practical situation for clinical academics into context. In the case of a patient with colon cancer, for example, the cancer will be taken out and histology will confirm the malignancy. In an academic unit, it will also be looked at for things called lymphoid aggregates which may be indicative of inherited cancer. Those are currently at the margin of clinical care and research in that spectrum. However, their detection will not only indicate that the cancer is inherited but alter the necessary follow-up; colonoscopy will, for example, be needed twice as often. It may also indicate that those patients will respond better to a chemotherapy that is different from the standard one. So it has huge clinical implications.
§ That data collection is subject to the Data Protection Act, which governs the clinical collection of data. However, when that clinical researcher aggregates the information for research, he or she must contend not only with the three consent requirements but, as far as I can see, with another two regulations under this legislation, making a total of five different consent processes which must be applied simultaneously.
§ I tried to address this issue yesterday in relation to non-competent patients. I fear that I was rather incompetent in my explanation. I hope that this is slightly clearer in relation to competent patients.
§ Another problem then arises for patients whose information is in the study. Let us say that a patient is regularly having his blood taken. After careful anonymisation, perhaps double anonymisation, that sample is used and the precious data are collected. However, the patient is ill and may say, "I do not want my blood taken today". He has revoked his consent to carry on with the project.
§ The difficulty for the researcher is determining how extensive that revocation of consent is. Has the patient revoked his consent only to the ongoing collection of blood, or to participation in the whole process? It would be completely unethical for the researcher to go to the sick person who is too weary to continue with the questionnaire and giving blood and to ask him to which stage of the data collection process he was revoking his consent. Therefore it will be very important for the research community to know that, although the patient may stop at this point, it does not put an obligation on the researcher to go back and reverse the consent that was given at a previous point in time when the patient was well.
§ So there are two aspects: one is a positive consenting in; the other is the problem of revocation and the extent to which it applies. That is why these two amendments are so terribly important.
§ Lord Warner
I am personally very sympathetic to the tenor of this discussion and the thinking behind the amendments. I understand the concerns of practitioners in this area. We are starting to stray into the territory of linguistics and philosophy, and I shall do my best. To some extent, there is also an element of trust involved. I am afraid that I must repeat some of the things that I have set out in the letter because it is important to understand the argument.
§ The Bill deliberately does not attempt to limit or define the scope or duration of consent in primary legislation and therefore does not use qualifying terms such as "generic consent", "fully informed consent" or "enduring consent". As I will try to explain—and I shall give some definition or understanding of what we mean by these terms—the difficulty is that as soon as you put in such words they enshrine, in parliamentary legislation, definitions which by definition impose some degree of constraint. That carries with it the whole implication and difficulty of amendment when experience shows you did not get it quite right. That is 520GC why the flexibility of the code—the noble Lord, Lord Clement-Jones, has heard me on the subject of flexibility many times before in our other incarnations—will help researchers more than the alleged certainty of particular words defining consent in the Bill.
§ One might ask precisely what the terms mean and what is important about the drafting of the Bill as it stands. Its importance is that it applies to a wide range of circumstances. The Government have taken the approach that it is not appropriate to limit the necessary scope for flexibility in the statute. Consent may indeed be generic and enduring, or it may be limited as to scope and time in particular circumstances. I shall say a little more about that later.
§ The words "generic and enduring" have become something of a theme in the discussions surrounding the Bill. However, we need to be sure that we know what we mean when we say that consent under the Bill can be generic and enduring. In our view, it is generic in the sense that consent given under the Bill for research can be such that a piece of tissue could be used for any type of research and, indeed, for different research projects.
§ A single consent can achieve this as the Bill does not qualify what it requires of consent for it to be lawful. Under the Bill, consent can be given for one, more or all of the purposes in the schedule. I think the noble Baroness, Lady Finlay, indicated that there might be different purposes for which a piece of tissue may be used. Consent can be given unconditionally and it will endure unless and until it is revoked. None of us can be absolutely certain about the full sets of circumstances in which revocation could or could not apply. We have to face up to the uncertainty of that.
§ Consent under the Bill, therefore, is as generic and enduring as it needs to be, depending only on the circumstances and what the person agrees to. Consent may be written, but it does not have to be; it may be given orally. Whether there has been a valid consent for the purposes of the Bill is a basic matter of fact in each case. In practice, the facts of those cases will be many and varied.
§ The Bill, therefore, has adopted this approach. It is not a "cop out"; it is a reflection of the fact that we are dealing with many and varied circumstances. Noble Lords from their own experiences have referred to these individual cases and sets of circumstances. That is why the Bill has adopted the proposition that we should leave it to the Human Tissue Authority, with both a strong lay representation and a good number of sufficient and relevant experts, to draw up a code of practice giving guidance on the obtaining of consent. That code will be subject to parliamentary approval.
§ However, it will be easier to adapt and amend that code in the light of experience and new knowledge, rather than adopting an approach in which we need to amend primary legislation because we failed to anticipate a set of circumstances. Everyone may be agreed that you should have been more flexible, but you box yourself into a corner of this very difficult area of a particular piece of parliamentary terminology.521GC
§ Clause 26(3) was introduced by my colleague Rosie Winterton in another place, in particular to reassure the research community that the Human Tissue Authority will issue a code of practice specifically about consent in relation to the removal, storage and use of human tissue. So, it will be a bespoke code for this particular area of consent. We think that it is inappropriate to go into the detail at this stage in advance of the Human Tissue Authority being established.
§ The noble Baroness, Lady Finlay, raised the issue of five consent processes including two under the Bill. I think that the answer is that there needs to be agreement to the diagnosis and treatment which lies within the normal process of clinical practice. The Bill does not change the set of arrangements that exist now. There can be a generic and enduring consent to research as well and the Bill does not affect any data protection issues. That is a quick response to the points raised by the noble Baroness.
§ The noble Lord, Lord Jenkin, and other noble Lords raised the issue of bureaucracy and the workings of the research ethics committee system. I repeat my commitment of yesterday. We recognise that there are concerns about the way in which the system has been working. I intend to review that and I shall make a further announcement about that before too long. We are going through the processes of setting up that particular review.
§ I hope that those remarks are helpful. I know that it is difficult to try to produce certainty when we have to await the code to be produced by the Human Tissue Authority.
§ 5.30 p.m.
§ Lord Clement-Jones
Perhaps I may ask the Minister one question. I am very interested in the theme running through this; that is, of certainty versus flexibility. I shall not pursue that but if the codes of practice are to give certainty, the timing of the drawing up of the codes, the establishment of the HTA and so forth versus the coming into force of the Bill are crucial in terms of compliance. I am in total ignorance of the proposed timing, how it is proposed that the Bill will be implemented in those terms, and how long the HTA will need in the Government's estimate to draw up the codes of practice and so forth.
§ The one point on which the Minister has given assurance does not come under his aegis but concerns the coroners' rules. However, unless it is felt that it will arise under later amendments, it might be helpful if he were to give the Committee an idea about the timing and when the obligations of the Bill will bite on researchers.
§ Lord Warner
I cannot give a detailed timetable. I can say that it would be very difficult to try to bring in legislation in this area without being able to give certainty and guidance to people on what we need in the critical areas—I would regard a code of practice on consent as a critical area—if we are not to have uproar in the medical research community. The department takes this issue very seriously. It would be one of the 522GC issues which one would expect the Human Tissues Authority to be working on at an early stage, consulting with all the people involved and ensuring that there is a reliable code of practice before people are asked to undertake new legal obligations.
§ Earl Howe
This has been a very useful debate indeed. No doubt discussions will continue between those who believe that there should be a definition of consent on the face of the Bill and others who are less persuaded. However, I take the point made by the Minister about the undesirability of boxing ourselves in too much by certain phraseology which we may feel encapsulates what we want but find later on that it has hidden disbenefits and hidden traps.
§ I take comfort from what the Minister said about a bespoke code. That will be music to many people's ears. The point of the amendment I tabled is that I felt there was a need to send a clear signal to the HTA that we expect it to ensure that generic and enduring consent must be one option in the armoury of researchers, and that appropriate rules must be drawn up to implement it. As I said earlier, the potential problem is—what appears to be a tendency of research ethics committees nowadays—to regard highly specific consent as intrinsically preferable to a form of consent which is somewhat less specific. That carries undesirable consequences and dangers. I think that most of us here are agreed on that.
§ We shall no doubt use the time between now and Report to think further on these issues. I am sure that those who were not able to take part in this debate will want to read Hansard as carefully as I shall. Meanwhile, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendments Nos. 65 and 66 not moved.]
Baroness Finlay of Llandaff moved Amendment No. 67:
Page 17, line 15, at end insert "including individuals and organisations that have relevant expertise in the activities to be regulated by the Act
§ The noble Baroness said: Amendment No. 67 seeks simply to ensure that the current expertise of anatomy inspectors is not lost and the process of inspection altered. The inspection of anatomical premises and anatomical working is quite different from the inspection of pathology and pathology services where tissue blocks and slides may be held. There is a concern that one might lose expertise and knowledge in the process of a new system. I beg to move.
§ Lord Warner
The new authority will have a duty to consult such persons as it considers appropriate before drafting codes of practice. I can assure the noble Baroness that among those are certain to be people with expertise in the activities regulated by the Act. Indeed, there would be little point in consulting only those with no relevant experience and expertise when drawing up practical guidance and standards relating to the carrying on of activities within the authority's remit.
§ I hope that the noble Baroness is reassured by that. We do not think that the amendment is necessary but I understand the position she argues.
§ Baroness Finlay of Llandaff
I thank the Minister for his reply. I am grateful to have that on the record. I think that anatomists will be greatly reassured. I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendment No. 68 not moved.]524GC
§ Clause 26 agreed to.
§ Baroness Andrews
This might be a convenient moment to adjourn the Committee until Monday, 11 October at 3.30 p.m.
§ The Deputy Chairman of Committees (Baroness Turner of Camden)
The Committee stands adjourned until Monday, 11 October.
§ The Committee adjourned at twenty minutes before six o'clock.