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Baroness Neuberger: My Lords, from these Benches I support the amendment put forward by the noble Earl, Lord Howe, the noble Lord, Lord McColl, and the noble Baroness, Lady Finlay.

Lord Warner: My Lords, these amendments repeat a number of amendments proposed at Committee stage to remove the power to impose a penalty of 12 months' imprisonment on summary conviction for offences under the Bill. I know many magistrates and it is mildly fanciful to think that a large number of them are hanging around the country waiting to give custodial sentences to pathologists and so deprive the NHS of them. We need to keep the matter in proportion.

I made it clear in Grand Committee that the Government consider that the offences and penalties in the Bill are there to demonstrate the seriousness with which we view the events that have taken place in the past and to act as a deterrent to any future misuse of human tissue. There would have to be a real wilfulness of intention to bring about a prosecution of the kind provided for in the Bill. In the unlikely event of a prosecution, it would be for the courts to decide the appropriate penalty from the range available. That is how we do business in this country. In the nature of things, an offence would have to be very serious indeed to warrant a custodial sentence. We have to keep that firmly in our minds.

However, I recognise from noble Lords' comments that, notwithstanding our assurances, pathologists and researchers continue to feel vulnerable. I am willing to take away the issue of custodial penalties
 
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being available on summary conviction and return to the matter at Third Reading. Perhaps the matter can be left on that basis.

Earl Howe: My Lords, once again, I am very grateful to the Minister for listening so constructively to the concerns raised. I look forward to a further debate on this matter at Third Reading. In the mean time, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 12 not moved.]

Clause 6 [Activities involving material from adults who lack capacity to consent]:

Earl Howe moved Amendment No. 13:

The noble Earl said: My Lords, this is a reconfigured version of an amendment debated in Grand Committee. It stems from a real concern that Clause 6 as drafted could have the effect of impeding the conduct of research into medical conditions or treatments associated with emergency and critical care. In our earlier debates on the issue, the noble Baroness, Lady Finlay, gave a very graphic example of how, in certain situations, time is of the absolute essence in carrying out certain procedures. Where such procedures are of their nature experimental, but nevertheless consistent with an approved research protocol, the absolute requirement to find out whether the patient has previously consented or refused to consent to such use of tissue could act against the best interest of that patient and inhibit the research.

What does the clause oblige a researcher to do? Surely it obliges him to conduct an investigation to establish the facts. The requirement is not discretionary. Before the activity proceeds, the person intending to carry it out must find out—yes or no—whether the patient has previously objected to his blood or other tissue being used for research. Sometimes that is practically impossible, but on other occasions it is not.

In her reply to the previous amendment, the Minister indicated that the researcher would always be able to fall back on the defence of reasonable belief. When I thought about it, I found that argument quite extraordinary. The only grounds on which the defence of reasonable belief can apply are either that one does something when one reasonably believes that consent has been given, or that one does something when one reasonably believes that consent is not required. In the case of someone with mental incapacity, the Bill makes it crystal clear that the consent, or the refusal to consent, of such a person, is not only germane but central to whether the activity can legally take place. In fact, the Minister emphasised that in an earlier reply. So one would not be able to claim that one reasonably believed that the consent requirements did not apply, nor could one claim that one reasonably believed that consent had been given unless one had taken active steps to establish whether or not it had been given. That takes us back to where I began.
 
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The Minister was quite categoric. She said that people with mental incapacity are entitled to the same protection—no more, no less—than people with capacity. That, I agree, should be the ideal. But we need to bear in mind that people lacking capacity are different in one major respect from those who have it; namely, they lack capacity. I suggest to the Minister that she cannot apply the same set of rules to each and every situation, because, as the Bill acknowledges, in some circumstances it is necessary for someone other than the mentally incapacitated individual to take a decision as to what should happen to him. If we allow for that, we have to allow for what is reasonable and practicable. The Minister spoke of,

That absolute obligation is precisely the nub of the problem. Yet the Minister seemed to lurch back and forth because almost in the same breath she also maintained that the extent to which a researcher should be obliged to determine whether consent has been given is not something that the Bill should spell out, since it is, in her words,

But this part of the Bill does not mention professional judgment. The Bill says that the activity may go ahead only after establishing the facts. Only with my amendment does the matter become one of professional judgment, having regard to what is reasonable in the circumstances of the case. That is what the Minister says she wants to achieve. That is what I too believe to be right. I hope that there can be a meeting of minds on this issue. I beg to move.

Baroness Finlay of Llandaff: My Lords, determining care for those who lack capacity is fraught with difficulties, yet it faces clinicians daily. In determining best care we must carry out research—that is research into the most delicate, the most fragile frontiers of human existence, such as when someone has had a cardiac arrest or is on a ventilator, precariously balanced between life and death. Without research into conditions that destroy the very essence of a person, such as Parkinson's disease or Alzheimer's disease, nothing will ever improve. That is why we cannot duck the issue. We cannot hope that archived specimens will give us all the answers and we cannot rely on the "ask or anonymise" principle alone.

Without this amendment research ethics committees will be too cautious to allow such vital research to proceed and it will be extremely difficult to define exactly how to deal with consent in a reasonable way. The amendment recognises that one must make inquiries but also that there must be limits on what can be done. It recognises the situation-specific nature of such inquiries.

At a cardiac arrest there are only seconds in which to ask those around whether they know anything about the patient and the patient's wishes, whereas for a patient with Alzheimer's disease, such inquiries can be carried out over days and in greater depth. The amendment tries to clarify the need for being situation
 
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specific rather than just inappropriately punitive. There will be a really deleterious rebound if there is no recognition of situation specificity when people lack capacity.

Lord Walton of Detchant: My Lords, on this amendment, the Minister may wish to fall back on the last sentence of Clause 6 which states:

Of course, we have no idea what those regulations will be. For that reason, it seems to me that this amendment is extremely important in strengthening the clause and in no sense does it impair its impact. I strongly support it.

Baroness Neuberger: My Lords, the argument has been made very eloquently by others. Given that reasonable inquiries have to be made—and it is situation specific—I support the amendment.

Baroness Andrews: My Lords, I am grateful to noble Lords for their contributions to the debate. I shall try not to lurch quite so much as I appeared to have done in Committee but I have to use some of the same arguments. Since the amendment is a reconfiguration, I think that my arguments will reconfigure too and refocus on some of the things which emerged in Committee regarding emergency and critical care.

My speech in Committee addressed what was in Clause 2. I would just reiterate for context that Clause 6 allows for regulations to set out the circumstances in which consent to activities regulated by the Bill may be deemed to be in place in the case of a person who lacks capacity. Those circumstances are likely to, include: first, where the activity is in the person's best interests; secondly, where the activity is authorised under the clinical trials regulations; and, thirdly, where the activity is authorised under the Mental Capacity Bill, in particular in relation to research, to which the Bill has a particular and prior regard, and possibly also where a deputy or attorney appointed under that Bill gives consent on the person's behalf. If the person made a decision about use of their material prior to losing capacity, the regulations would not apply.

So the effect of the amendment would be that, even where a prior decision to refuse consent had been made by a person who had lost capacity, the regulations which would deem consent to be in place could still apply, provided that the researcher was not aware of it, having made all reasonable inquiries in the circumstances.

I quite understand that the purpose of this amendment is to ensure that research may proceed in emergency situations. We certainly do not have any wish or intention to inhibit research for the excellent purposes cited in the many examples offered by noble Lords today; that is, in situations where care is critical, but also where research might be conducted for the purpose not of treating the patient, but of using the opportunity potentially to benefit others by taking and
 
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using material for research purposes. Of course the Bill is concerned with use and storage rather than removal and research, which comes under mental capacity. The noble Baroness has given us examples on "a loss of capacity" in terms of unconscious situations in strokes and head injury.

Noble Lords took issue with some of the justifications I gave for the clause itself, in terms of the best interests of the patient in what we acknowledge would be in exceptional circumstances. We were also concerned to ensure—and I think it is worth making this point again—that there should not be a lower test of evidence for people with mental incapacity than will be provided for in the Mental Capacity Bill. I take the point made by the noble Lord, Lord Walton, that it is very difficult to discuss two Bills in parallel which overlap to the extent that these Bills do when we do not have the other Bill in front of us at the same stage and we do not have the regulations. Indeed, the rationale for providing for regulations in Clause 6 is precisely to give us the necessary flexibility and opportunity for this Bill and the Mental Capacity Bill to mirror each other.

I am afraid that I cannot accept even the reconfigured amendment for two main reasons. First, the Mental Capacity Bill is the right place for us to have an exhaustive and comprehensive debate on the conditions which apply for people with mental incapacity in research situations. We look forward to those debates. We will be pursuing much the same issues, but in far greater detail and with greater relevance. The second reason is we believe that the Bill provides adequate protection from liability in the context in which we are making the case.

If I may deal with the Bill in principle, I believe that the medical and research communities have nothing to fear from this provision. I can see why fears have been raised, but I believe that the Bill covers these situations. We believe that it offers adequate protection if researchers comply with the standard of making reasonable inquiries, having regard to the circumstances of the case—to the situation-specific nature of the case. If a researcher makes inquiries which are consistent and compatible with that—for example, if he or she used material from a person who lacked capacity in the course of a research project, and took all reasonable steps in the particular circumstances to establish the absence of a prior decision—then he or she would be protected from criminal liability by Clause 5(1)(a).

We cannot pre-define in statute what are reasonable steps for the reason I gave—and I believe the noble Baroness agreed with me—that we do not want to prescribe practitioners' judgment in this field. We do not want to say what we think should be reasonable steps. These are decisions which are taken on a daily basis. We must leave it to the professionals. Again, that will depend on the individual case and the circumstances. A second point I should like to emphasise is that the HTA guidance will be able to assist in these definitions and determinations.
 
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5.15 p.m.

I reiterate that Clause 5(1)(a) provides that a person does not commit an offence under the Bill if he reasonably believes that appropriate consent is in place. That applies in all relevant circumstances, including those that arise in emergency care. What is reasonable will obviously be a matter to be considered in each case. This is not a novel idea. Practitioners should do no less than this already when considering whether an unconscious patient should be entered into a research project. As I have said, the judgment that practitioners make on a regular basis reflects these situations.

To take an example, consider a researcher who wishes to rely on deemed consent in accordance with regulations made under Clause 6 to carry out a research project on people lacking capacity. Assuming that the regulations are applicable, provided the researcher had made all reasonable inquiries as to whether there was a prior decision but had found none, he would be able to say that he reasonably believed that appropriate consent was in place. In the situation now under discussion—emergency situations where a patient might be suitable for an ongoing project—the case remains the same. That is, the researcher need only say that his belief was reasonable.

Let me make it quite clear that the same considerations would arise when considering whether someone had a "reasonable belief" for the purposes of Clause 5(1)(a) as would arise when considering whether someone had made "all reasonable inquiries" in the terms of the amendment. Nothing is gained by adding an additional reasonable belief qualification to Clause 6 itself. So I believe the purpose of the amendment is achieved in the Bill itself. I hope that that, with the HTA guidance, will reassure noble Lords and the research community on that point.

The second fundamental reason we cannot accept the amendment looks to a different logic. The debate we are having today, as I have said, is far from the final word. In all sincerity, as I explained when we debated a similar amendment in Grand Committee, it will be the Mental Capacity Bill and not this Bill which will govern the involvement in research of people with mental incapacity and which will lay down the definitions and the detailed conditions for such research. This Bill will be entirely reliant on the provisions of that Bill in relation to the standards governing research involving those who lack capacity.

Discussions on the Mental Capacity Bill will establish the conditions relating to research. These will be reflected in the regulations we will be making under Clause 6.

Clauses 30 to 33 of the Mental Capacity Bill set out a detailed set of safeguards and procedures which will govern research involving people who, for whatever reason, cannot consent to it. This covers storage and use of material from their bodies, as well as its removal. But because our Bill deals with use and storage we obviously have to make sure that there is compatibility. That overlap is designed to be filled by the regulations.
 
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What links the two Bills together above all, and what must remain indisputable, are the rights of such patients to have their previous wishes respected. Clause 33(2)(b) of the Mental Capacity Bill provides that nothing may be done to, or in relation to, a person who lacks capacity in the course of research which would be contrary to an advance decision of his which has effect. Clause 6 of this Bill is consistent with that provision and the two Bills must work together from the same starting point. That is obviously why we have provided for the regulations.

One regulation will be on precisely where the activity in question is authorised under the Mental Capacity Bill. So it would be pointless in this Bill, as the amendment seeks to do, to set a different qualifying standard because of the need to make the regulations ultimately compatible and cross-referenced.

Let me summarise. First, the protection of the "reasonable belief" defence in Clause 5(1)(a) offers equal protection to that which is proposed in the amendment, and is equally adaptable to the circumstances of each case—situations specific—including those where the issue of research arises in emergency situations. To that extent we would argue that the amendment is not needed. Secondly, the Bill must match the Mental Capacity Bill, which also provides that nothing should be done that is contrary to a proper refusal of consent.

I hope that on both grounds I have been able to reassure noble Lords that we have balanced the interests of the research community and of the patient with proper regard for the consent provisions, which we want upheld.


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