HL Deb 11 October 2004 vol 665 cc1-56GC

(Third Day)

Monday, 11 October 2004.

The Committee met at half past three of the clock.

[The Deputy Chairman of Committees (Baroness Gould of Potternewton) in the Chair.]

Clause 27 [Provision with respect to consent]:

Earl Howe moved Amendment No. 69:

Page 18, line 1, at end insert— ( ) carer of longstanding

The noble Earl said: I shall speak also to Amendments Nos. 110 and 111. This is a self-explanatory amendment that would add "carer of longstanding" to the list of qualifying relationships in Clauses 27 and 59. Not only do I think that longstanding carers would be appropriate people to give consent in many instances but, sad to say, they may also in some cases be the only people who have a close knowledge of the dead person. Including carers in the list would further reduce the risk of there being no one available to consent on behalf of the deceased. I beg to move.

The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)

Sadly, I am unable to accept these amendments. They would allow carers in the home or nursing home staff to agree to use in transplantation, research and so on, of the tissues and organs of people who had been in their care, or even of their whole body. There are provisions on somewhat similar lines in the Anatomy Act 1984 and in the Human Tissue Act 1961. They used to allow hospitals, for example, to agree to anatomical examination of the bodies of deceased vagrants, which saved funeral expenses. However, these provisions have not been used for many years and they were deliberately not transferred from the older legislation as being no longer socially acceptable. The point of this Bill is to make it clear that individuals, or those close to them, should decide what happens to their bodies, organs and tissue after death. That is the context of why we have not transferred the provisions of earlier legislation.

Frankly, I do not see the case for a special category for carer of longstanding in the list of qualifying relationships, although I understand where the noble Earl is coming from. The Government recognise the very valuable role played by carers. It is possible that individuals may discuss the kind of issues covered by this Bill with their carer. Indeed, this is all the more likely if the carer also happens to be a relative or a longstanding friend. We have provided for a friend of longstanding, and if a carer has not become a friend over time, I do not think that we need to give that person special rights to agree to the use of a person's remains. Family members are, of course, already covered in the hierarchy of qualifying relationships.

However, if the individual specifically wanted their carer to make decisions on their behalf after death, the Bill already provides for the possibility of appointing a "nominated representative" to act after that person has died, and it would be perfectly possible to appoint a carer in this way. In sum, we have taken the view that the Bill already provides sufficient scope for recognising the relationship which may develop between someone and their carer but leaves this decision to individual choice rather than imposing it automatically in all cases through primary legislation. In those circumstances, we do not think that these amendments are appropriate.

Earl Howe

I am a little disappointed by that answer which I confess I did not expect given the precedents in earlier legislation. The noble Lord is, of course, quite right that a carer may well be a friend or relation of the deceased person and the Bill provides for that eventuality. However, it seems to me that a situation could arise where the status of the carer as being either a friend or not a friend of the deceased was called into question. It would be a pity if the donation of tissue were frustrated on the basis of an argument of fact of that kind and for no other good reason. With regard to whether a particular person is or is not friend of the dead person, I should have thought that there was a case, to avoid the possibility of wrangling, for making it clear that certain categories of carer, if not every type of carer, were included in the list of qualifying relationships in their own right, provided that they had been in that position for a considerable time.

Nevertheless, I note what the Minister has said. I shall reflect on it and, for the time being, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Earl Howe moved Amendment No. 70:

Page 18, line 9, at end insert "unless another of them has explicitly withheld consent. >( ) Where persons accorded equal highest ranking in accordance with subsections (4) and (5) disagree as to the giving of consent, appropriate provision shall be made.

The noble Earl said: Clause 27 covers what should be incorporated in the set of standards to be laid down by the Human Tissue Authority relating to obtaining consent from individuals who are in a qualifying relationship with the dead person. Subsection (7) deals with how to treat people of equal highest ranking in accordance with the ranking order set out in subsection (4). It omits to say what happens if two or more people of equal highest ranking disagree. I do not claim that I have a one-size-fits-all answer to that problem—that would be presumptuous. However, this should be a problem for the HTA to confront and resolve. The HTA should have a duty to think through the issue and come up with a clear set of guidelines which clinicians and others can refer to easily.

I hope that the Minister will be sympathetic to the idea behind the amendment, at least by recognising that there is a genuine issue here. I beg to move.

Lord Warner

We need to jog back a little on this issue. Clause 27 requires the code of practice to provide that where two or more persons are of equal rank in the list of persons qualifying to give consent to the use of tissue from the deceased for scheduled purposes, the consent of one of them will suffice to make the use of a dead person's tissue lawful.

I understand what the noble Earl says about the thought behind the amendment, but as it is framed it would change that position so that if one of several persons of equal rank on the list explicitly refuses consent, this will act as a veto. The amendment would also require the code of practice to make appropriate provision for the case where there is disagreement between persons of equal rank on the list.

This amendment is rather similar to that proposed to Clause 4 which would have allowed one of several nominated individuals appointed jointly and severally to, in effect, veto consent to use tissue. The arguments against Amendment No. 70 are similar to the ones I used earlier.

We do not think it necessary to give a veto to one of several people who may consent. This could create difficulties and uncertainty for those seeking consent, who could feel obliged to ensure that every member of a particular group had had an opportunity to object to a particular activity. Let us take the example of a person who dies leaving a large number of siblings who live in dispersed locations. If the person dies unexpectedly and only one sibling is available to give consent to transplantation, which is required as a matter of urgency, doctors might not want to risk an objection later coming to light from another sibling, and valuable transplant opportunities could be lost. In some cases, we feel that the amendment's approach would hamper, not assist, medical research, which I am sure is not the noble Earl's intention.

The Bill sets down a simple minimum standard for what will be lawful and creates simplicity and certainty for those working with human tissue. Of course, while the consent of one would be sufficient to render the act lawful, it would not render it obligatory. In the knowledge that there was disagreement among siblings, many doctors would presumably hesitate to proceed, and might well decline to do so.

I suggest that the situations that may arise are many and variable and are not amenable to resolution through statute. I am not altogether sure that it would be possible to offload this problem on to the Human Tissue Authority in quite the same way, for many of the same reasons. It is best managed, we think, by those dealing with families sensitively on the ground, supported by such careful guidance as the Human Tissue Authority can produce. But we are trying to provide something practicable for those who have to deal with the circumstances of transplantation, for example, or particular research needs.

Therefore, the Bill provides that the code of practice to be issued by the Human Tissue Authority must give practical guidance, lay down standards in relation to communication with the family of a deceased person and deal with consent. The code will include guidance on how to handle matters when people disagree about whether to consent or to have their loved ones' tissue used. It is appropriate that the authority should consider how to approach that and have the flexibility to respond to a range of difficult circumstances. It is not necessary to spell out precisely what the code should address in that regard and we believe that we must leave it to the Human Tissue authority to provide the appropriate guidance. We do not want to impose, inadvertently or otherwise, an inappropriate right of veto in this area.

Earl Howe

My amendment is not intended to hamper research in any way, nor do I wish to impose an obligation on clinicians to undertake a trawl of possible siblings living half way across the world to guard against the possibility that one might veto what another might have said. That was not in my mind. I can understand why the Minister would object to that idea.

However, as he acknowledged, if siblings openly disagree—for example, a brother and sister are sitting in the same room with diametrically opposing views—that puts a clinician in a difficult position. The Minister says that the clinician could use the agreement of one sibling as a green light to go ahead with whatever the clinician wanted to do. I am slightly alarmed by that because that could store up problems at a later date if the clinician decided to ignore the protestations of the other person. However, it was reassuring to hear the Minister say that, in some measure at least, the HTA's code would address the handling of relations and awkward situations of that kind. I am pleased that the obligation to deal with consent issues, which is written into the Bill, will embrace that area.

It is somewhat disappointing that the Minister has closed the door to an amendment such as this. I shall consider whether it could be reframed in some way, but I am grateful to him for his clarification of the Government's position and I beg leave to withdraw the amendment.

Lord Walton of Detchant

I apologise. Perhaps I may ask a question or has the amendment been withdrawn?

Earl Howe

I am happy not to withdraw the amendment.

Lord Walton of Detchant

Given that a "spouse or partner" has the highest ranking under subsection 4(a), what is the position if a non-married partner of a patient refuses consent but the parent, brother and sister classified in paragraphs (b) and (c) wish to give consent?

Lord Warner

The Bill provides a ranking system.

Lord Walton of Detchant


Lord Warner

However, the point of the amendment tabled by the noble Earl, Lord Howe, was that if there are people of equal rank, should we provide arbitration, either through legislation or through the code, on who is more equal than the other? I was casting doubt on that—not the principle of ranking, but the principle of allowing people of equal rank to make a decision on who was more significant than the other in this area. I believe that that was what the noble Earl was seeking in his amendment.

3.45 p.m.

Lord Walton of Detchant

I appreciate that, but this position means that—

Baroness Andrews

Order. May I invite the noble Lord to stand while he is speaking?

Lord Walton of Detchant

If a person grouped in paragraph (a) in the hierarchy refuses consent, can I clarify whether that cannot be overruled by consent given by the people listed in paragraphs (b), (c) or (d)?

Lord Warner

That is correct.

Lord Jenkin of Roding

The noble Lord, Lord Walton, has raised an important point. Paragraph (a) includes not only a spouse but a partner. However, the people listed in the subsequent order of the hierarchy may well be blood relations of the deceased, whereas the partner is not. If there is a question of a heritable disease or a genetic condition, which may or may not be identified through the use of the tissues for research, on the face of it it would seem a little unfortunate if someone who was not a blood relation could override the wishes of several people—a parent, child, brother or sister—who might be blood relations. My noble friend Lord Howe has raised a point of some substance, and I think that we should come back to it. In the mean time, perhaps the Minister will reflect on what has been said.

Lord Warner

Perhaps I may clarify a point in the hope that it will be helpful to the Committee. Clause 27(4) lists a qualifying set of relationships, and "spouse" and "partner" are equal. A spouse or partner outranks a parent or child. I am dealing with the point raised by the noble Lord, Lord Walton, so that there is no misunderstanding. However, in dealing with some exceptional circumstances, such as were raised by the noble Lord, Lord Jenkin, I have drawn attention to Clause 27(3), which provides for the authority to allow flexibility to deal with exceptional circumstances. I hope that that clarifies the point.

The nub of the Government's position vis à vis the noble Earl's amendment is that, where there are equal-ranking people in the hierarchy of ranks, we do not think it right to give one a power of veto over the other. That is unlikely to be helpful to clinicians and researchers in this area.

Baroness O'Neill of Bengarve

Perhaps I may raise a further question. Does this hierarchy of persons bear any relationship to the way in which the person with a duty to secure a decent disposal of the deceased may fall? I can see that there may be a division of responsibility that is awkward for a family.

Lord Warner

Because we are in Committee, I shall not attempt to respond to that point, although it goes somewhat wider than the amendment that we were discussing, and we need to make progress on the Bill. We have provided for flexibility, and we have provided for guidance to be given through the Human Tissue Authority on the consent arrangements. We debated many of those issues substantively when the noble Baroness was unable to be with us during the earlier sittings of the Committee.

Earl Howe

I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Earl Howe moved Amendment No. 71:

Page 18, line 16, at end insert "or (d) a wish for him not to deal with the issue has been expressed in writing by the person concerned and has not been revoked.

The noble Earl said: This amendment continues the theme of the debate that we had just now. As we are all aware, Clause 27 deals with the standards to be laid down by the HTA covering the consent to be obtained from people in a qualifying relationship with a deceased person. Subsection (8) provides for a limited range of exceptions to what is otherwise an automatic hierarchy of consultees.

It seems to me that there should be another kind of exception to the hierarchy, and that is where the dead person has expressed the wish that he does not want a specific relation or friend to deal with issues surrounding consent following his death Just as Clause 4 allows you to appoint a nominated representative to act on your behalf, equally, it should be possible to exclude someone from ever taking decisions about what happens to your body or body parts when you have died. The automaticity of the process laid down in Clause 27 should not depend only on whether a person in a qualifying relationship is willing, able and available to give consent; it should also depend on the absence of any blackballing by the person who has died. I beg to move.

Lord Warner

I understand where the noble Earl is coming from. I understand what he is saying that the amendment means, but there is ambiguity in the wording. It could be interpreted in a number of ways. One could interpreted it as proposing to leave out from the list of qualifying relationships who can make decisions after a person's death relatives or friends who have themselves expressed a wish in writing not to deal with such decisions that has not been revoked. Or it could be taken to mean that the deceased person can state in writing before he dies that he wants a particular relative to be left out of the list qualifying relationships. I understand where the noble Earl is coming from, but there is a question about the interpretation of the amendment.

If one interprets the amendment in the first way, it would be unnecessary because Clause 27(8)(a) provides for the exclusion from decision making of someone who does not want to deal with the issue of consent after a relative's death. That provision would cover people who made decisions in the past and in writing.

In the second case, the amendment is also unnecessary. If the deceased person had wanted to exclude particular relatives from making decisions about the retention and use of his body and body parts after his death, he could have nominated representatives that he wished to do so. They would take precedence over other relatives. Indeed, if the deceased had developed his views on the question of what should happen after his death, he would also had the option of making his decision known and eliminating the need for relatives to determine the question.

Although I am happy to reflect further on the matter, it seems unnecessarily complicated to provide for individuals to exclude relatives in writing when they could just as easily make a positive choice either of what they wish to happen to their body or of whom to nominate from people who would be willing to take on the task. That, as well as the ambiguity, is the reason for our doubts.

Earl Howe

Although in theory one can lay down rules that make it easy for a person to nominate an individual to represent him after his death, many people will not do that in practice. Although I fully recognise and accept the Minister's technical criticisms of the drafting of the amendment, there ought to be provision that would at least place an onus on the clinician in the case to seek guidance, perhaps from other members of the family or people in the hierarchy of relationships, when it becomes known that the deceased person did not wish a particular person to exercise the choice on his behalf.

We want to avoid putting clinicians in a difficult spot. Let us say that a brother or sister comes forward and says that the deceased person did not wish his child to take a decision on his behalf after his death and that, furthermore, the deceased person had written that down on a piece of paper that had been witnessed. What is the clinician to do then? That situation needs to be addressed. It is not fair to put the doctor in that position, and he ought to be able to turn to a clear set of rules in such circumstances.

Nevertheless, I accept the Minister's invitation to reflect further on the matter, and hope that, equally, he is able to do so before the next stage of the Bill. We are, I am sure, both after a Bill that works smoothly and effectively; that is what lies behind my amendment. In the mean time, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 72 not moved.]

Clause 27 agreed to.

Clauses 28 and 29 agreed to.

Clause 30 [Possession of anatomical specimens away from licensed premises]:

[Amendments Nos. 73 to 75 not moved.]

Clause 30 agreed to.

Clause 31 [Possession of former anatomical specimens away from licensed premises]:

[Amendments Nos. 76 to 78 not moved.]

Clause 31 agreed to.

Clause 32 agreed to.

Clause 33 [Restriction on transplants involving a live donor]:

Lord Clement-Jones moved Amendment No. 78A:

Page 23, line 16, leave out "may" and insert "shall"

The noble Lord said: In moving the amendment, I shall also speak to Amendment No. 78B.

The Human Organs Transplant Act 1989 was introduced in direct response to the "kidneys for sale" scandal, which exposed an international trade in human organs. Under the 1989 Act, the making or receiving of payment, except expenses, for the supply or offer of any organ is illegal. That applies to live and dead donors. The legislation also applies restrictions on live donation of non-regenerative organs.

Those who are closely genetically related must provide evidence of the relationship before proceeding. That, of course, applies to kidney donation. For unrelated donors—for so-called "altruistic" donations—the donation may not proceed until approval has been received by a body called the Unrelated Live Transplant Regulatory Authority—or, ULTRA, for short. It is rather a splendid acronym. Although the definition in the Act of a close genetic relation is fairly broad, including uncles and aunts by half-blood, donation between long-term partners, which makes up an increasing number of live donations, requires approval from ULTRA. The authority itself makes the distinction as regards altruistic donations between "altruistic stranger donations" and "paired exchange donations".

Traditionally, attitudes toward living donor kidneys in the UK have been understandably cautious; but evidence from other countries indicates that the procedure is generally very safe, with few risks for the donor and a high chance of success for the recipient. Major complications for the donor are rare, and the mortality rate is about 0.03 per cent. There are clear advantages to the donation of kidneys from healthy living donors; higher success rates have been achieved from related and unrelated donors, compared with "cadaveric donors". I am not familiar with that phrase, but I am sure that the Minister will be.

Any use of healthy living donors must be subject to strict safeguards. Guidance issued by the British Transplantation Society and the Renal Association states that living donor kidney transplantation should be undertaken only when four essential conditions are met. First, the risk to the donor must be low; secondly, the donor must be fully informed; thirdly, the decision to donate must be entirely voluntary and not due to coercion or the offer of an inducement; and, fourthly, the transplant procedure must have a good chance of providing a successful outcome for the recipient.

Before ULTRA approves an application for donation by a living unrelated donor, it must be satisfied that no payment has been made, or is to be made; that the person referring the case for consideration is the doctor with clinical responsibility for the donor; that a doctor has explained to the donor the nature of the procedure and the risks involved in the removal of the organ in question; that the donor's consent was not obtained by coercion or the offer of an inducement; that the donor understands that his or her consent can be withdrawn at any time; and that the donor and recipient have been interviewed separately by a suitably qualified independent person, who is not part of the transplant team. That person must be satisfied that the above conditions have been met.

4 p.m.

Those conditions are equally important whether the donation is from a relative or from an unrelated donor. The current mechanism was established as an immediate response to a scandal about the sale of human kidneys. That fact is reflected in the limited scope of ULTRA. While it may succeed in preventing exploitation caused by financial pressures, its failure to consider other types of pressure appears to be illogical. If such a regulatory body is considered necessary, as we believe that it is, it should have the broader role of protecting all live donors from exploitation and pressure.

All live donations should be subject to the same rigorous assessment, either by ULTRA or by some other mechanism, to ensure that the potential donation is truly voluntary and free from pressure. The remit of ULTRA should broaden out the categories of donation governed by ULTRA. Those are the twin goals of the amendment.

In a meeting last September—I hope that the Minister will clarify its status—people from ULTRA stated that, the Secretariat should seek the approval of Ministers to the approval of such live donations"— meaning altruistic donations— subject to the development of a detailed procedure for clinicians to follow if they wished to seek approval for such transplants. Members recognised that, if there was a problem early on, public and medical opinion could easily turn against such procedures. Members felt that a cautious approach was required and that 'paired exchange donation' should be prioritised in the submission and that 'paired exchange' and 'altruistic stranger' should be dealt with separately". That is absolutely valid.

Clearly, there is movement on the part of ULTRA. The amendments attempt to broaden the scope of the authority, and the Bill appears to be a useful place in which to do that. I beg to move.

Earl Howe

The noble Lord, Lord Clement-Jones, has made a powerful case, which the BMA fully supports. It briefed me earlier today on the subject, saying that at present ULTRA's conditions were required to be met only in the case of unrelated donors. However, that rule ignores the real pressures that could be placed on individuals to donate to a relative. In the BMA's view, there do not appear legitimate grounds for making a distinction between related and unrelated donors. It believes that the conditions are equally important whether the donation is from a relative or an unrelated donor and that the process of assessment should be equally rigorous in either case. I have much sympathy with that view.

Lord Warner

We certainly have some sympathy with the points behind the amendment, and we are certainly supportive of living donation of tissue and organs in appropriate circumstances. Like the noble Lord, we would not want to set up a system in which there was a prospect of undue coercion of people to make donations. I do not believe that anything separates our views in that regard.

My concern about the amendment at this stage is that it rathers force the issue of stranger donation, which is not currently practised, as the noble Lord, Lord Clement-Jones, said, in the UK, although it is being considered by ULTRA. That authority has discussed altruistic/stranger donation and has advised that it should be considered. That has been put to Ministers and officials, who agree that it should be actively considered in the context of establishing regulations under the Human Tissue Bill. That would then give us the opportunity to discuss that in a public fashion before deciding how to proceed.

One effect of the amendment—I hope that the noble Lord, Lord Clement-Jones, will take this remark in the spirit in which it is offered—is that it would tend to limit the scope for future discussion, including parliamentary consideration, of developments in transplantation practice. The amendments seek to ensure that regulations under Clause 33 allow not only organ donation between relatives and people in other close relationships but altruistic organ donation, sometimes known as stranger donation. That slightly jumps the gun before we have had the discussion about the proposals from ULTRA.

I fully acknowledge that we need to make progress in this area, but it needs to be done in a way which has public consent. That raises some difficult issues and there needs to be a parliamentary framework for discussion, which the regulations will provide.

It might be helpful if I explain a little of the background and rationale behind the current draft of the Bill. Clause 33 deals with the transplantation of tissue and organs between living people. It takes the approach that the removal or use of material for transplantation is an offence, other than where it is of a type set out in the regulations that I have mentioned, and the procedure approved, where so specified by the Human Tissue Authority. That allows us to make regulations that are kept up to date with developments in medical technologies that might allow new types of tissue or organ transplantation between living individuals.

Regulations are likely to provide for several types of situation, many of which are already practised. For example, the donation of whole organs, notably kidneys, which the noble Lord mentioned, currently takes place between relatives and close friends or partners. Donations of part organs has recently become possible, as part of the liver can be donated, such that both donated and remaining parts can function adequately. There is also donation of bone marrow or other regenerative tissue that might involve invasive procedures, and donation of other regenerative tissue, such as skin, or of non-regenerative tissue, such as bone, corneas and heart valves. So this is not simply a kidney transplantation issue—the scope is much wider.

In all those cases, the regulations and consequential approval procedures would need to consider questions of relatedness or closeness of donors and recipients. But the social and the technological issues involved are pretty complex, and they are changing—the situation is not static. That is why regulations are appropriate in terms of the manner in which we have designed them under the Bill.

The provisions of Clause 33 repeal, replace and extend those in the current Human Organ Transplants Act 1989. Regulations made under that Act established ULTRA as the body whose approval would be needed for donation of organs between unrelated persons. The donation of organs between related persons is unregulated, as the noble Lord acknowledged, although it is now recognised that the potential for abuse, as he also acknowledged, is no less than between unrelated persons.

No authorisation has yet been given to unrelated transplants between strangers. Clause 33 extends the regulatory mechanism to cover all those situations as well as to tissue other than organs, as tissue donation is increasingly possible, as I have indicated, and can involve highly invasive procedures, such as where bone marrow is concerned.

In making the regulations, the Government will be able to consider new developments, such as part organ donation and stranger organ donation, and make appropriate restrictions or criteria that can be implemented through an HTA approval process. The Bill does not set out the type of procedures that regulations may cover, as those will change as techniques develop, as I have indicated. The only pre-set criterion for live donation is that no reward can have been given, in contravention of Clause 32. The regulations would establish other criteria, including the need to ensure that there was no coercion. That is an extremely important point, and we support the noble Lord, Lord Clement-Jones, on that.

The trouble with Amendments Nos. 78A and 78B is that they would oblige the Secretary of State to make regulations under the clause and would require the regulations to deal with transplants in particular circumstances. I say to the noble Lord that we have had this discussion before. His amendment is starting to look uncommonly like a list. I do not want to go over all the arguments for and against lists, but the amendment is starting to take us down the list path, and we are not sure that, at this point in our knowledge and given the ULTRA consideration, that is the path to go down.

I have tried to set out the context and to be as helpful as I can in explaining what the Government are doing. I hope that the noble Lord will see my response as a constructive one, not as an attempt simply to kick the matter out of court. In those circumstances, we would prefer to leave the Bill as it is, wait for the further public debate that there will have to be on the regulations and not prescribe their style by making the amendments.

Earl Howe

Before the noble Lord, Lord Clement-Jones, responds, I would like to come in in defence of his amendment. In Amendment No. 78B, we have a list, but it is an exclusive list. I would be hard put to it to add to it. As I read it, it covers more or less every eventuality. We are all against lists that can be added to or abbreviated, but I would have thought that this was quite a good list.

Having said that, I must ask the Minister whether he can say when he expects ULTRA to publish its proposals. It would be helpful to have some sort of timetable, however loose.

Lord Warner

I cannot give the noble Earl a timetable off the top of my head, but I will look into the matter and write urgently to him, as with other Members of the Committee.

Lord Clement-Jones

I have a question for the Minister before I withdraw the amendment. My motive in moving the amendment was that it should, in a sense, be the precursor of a full parliamentary debate on the subject. It was a probing amendment, and I thought that the Minister's reply was sympathetic and constructive. Obviously, he has had a good break; perhaps the Labour Party conference engenders feeling of goodwill—who knows?

At this stage, I entirely accept what the Minister had to say. It was helpful, in the sense that a lot of what is happening on the issue is behind the arras—the noble Earl alluded to that. We do not quite know what ULTRA has talked about since September 2003, and we do not quite know what the process is in the department. In a sense, what the Minister said lifts the veil from that a little and was helpful. In effect, what he said, as I understood it, was that the regulations made under the clause would be debated under the affirmative procedure and that this form of live organ donation was bound to be discussed, simply because that is what must be included in the regulations. I welcome that; a public debate will be important.

I can quibble about whether the amendment gives carte blanche for regulations on altruistic stranger donations. I do not think that the amendment quite says that, but I can see why the Minister should imagine so. I certainly do not want to close the moral argument on that; there will be strong views on it. I hope that we are jumping the gun only slightly. The regulations will be debated—fairly soon, I hope. As the Minister said, we need to make progress. The more one looks at the matter, the more one sees that we need to rationalise what was in the 1989 Act, which was passed in some haste. Therefore. I think now must be the time to do that. I certainly do not want to go down a yellow brick road or a list path, if the two are the same, but the Minister has coined a new phrase in succession to his predecessor.

In the mean time, I am encouraged by what the Minister has had to say. I should like him to confirm that the regulations will be debated under the affirmative process before I withdraw the amendment.

4.15 p.m.

Lord Warner

I assure the noble Lord that our spirits were lifted not only by our party conference but by what we observed at the other party conferences. I can give him the assurance that he seeks and will try to give a bit more detail about what is going on behind the arras concerning timescales for material entering the public arena, and so on.

Lord Clement-Jones

I thank the Minister for that reply and very much welcome his clear embracing of competition in the field of party conferences. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 78B not moved.]

Lord Warner moved Amendment No. 79:

Page 23, leave out line 41 and insert "regulations made by the Secretary of State."

The noble Lord said: Government Amendments Nos. 79 and 104 to 106 implement a recommendation made by the Delegated Powers and Regulatory Reform Committee in its 25th report, published on 16 July. The Government are, as ever, grateful for the committee's detailed consideration of the Bill.

As drafted, the Bill deals in Clause 33 with offences relating to transplants involving live donors, and this is essentially carried over from the Human Organ Transplants Act 1989. Clause 33 sets out the offence and penalties related to the removal and transplantation of organs and other material from living donors in circumstances other than those provided for in regulations made under the clause. Those include circumstances where the Human Tissue Authority is satisfied that no reward has been given in relation to the transplant.

As drafted, Clause 33(7) gives the Human Tissue Authority power to define "transplantable material" for the purpose of the clause. That was intended to provide the maximum degree of flexibility in case the definition should need to change in future—the point I was making in debate on the previous set of amendments. However, the Government have accepted that that power should be subject to the same scrutiny as the power in Clause 33(3), which enables the Secretary of State to define exemptions from the relevant offences.

These government amendments therefore make the definition of transplantable material a matter for regulations made by the Secretary of State and subject to affirmative resolution. As with other affirmative powers in the Bill, the Secretary of State must consult the National Assembly for Wales and the relevant Northern Ireland department before acting under those powers. I beg to move.

On Question, amendment agreed to.

Clause 33, as amended, agreed to.

Clause 34 [Information about transplant operations]:

[Amendment No. 80 not moved]

Clause 34 agreed to.

Clause 35 [Inspectorate of Anatomy and Pathology]:

Lord Clement-Jones moved Amendment No. 81:

Page 24, line 18, leave out "Anatomy and Pathology" and insert "Human Tissue"

The noble Lord said: In moving the amendment, I shall also speak to all the other amendments up to Amendment No. 95. The Minister and his team will have noticed that this is a somewhat ingenious probing amendment, which took me some labour to draft, but I hope that it fulfils its purpose.

This rather splendid document reconfigures the department's arm's-length bodies and contains hours of harmless amusement but is dear to the hearts of many of us who have long argued for rationalisation of the regulatory bodies in the Department of Health. It seems extraordinary that we have two inspectorates set up by the Bill—the Inspectorate of Anatomy and Pathology and the Inspectorate of Organ and Tissue for Human Use.

In the face of resounding language in the reconfiguring document, the five key drivers behind the review are "devolution to the front line", "appropriate impact for minimal burden"— that was a good line—the Gershon efficiency review, the Lyons review of public sector relocation and taking an overview of ALBs across the health and social care system. In the face of that heavyweight support for the exercise that the Minister, to his credit, has been taking through—and there are some interesting and largely welcome proposals in the paper—it is extraordinary why it is not beyond the wit of the Bill and the department to have a single inspectorate with two sets of functions.

Setting up two boards, each with its own board members, chief executive officer, staff, budget and so on, seems extraordinarily illogical in the face of the new and exciting departmental remit to cut back on the number of bodies that bear down on the health profession. One had only to read the newspaper at the weekend—it was either the Observer or the Sunday Times—to realise just how many bodies inspect hospitals. Two inspectorates are proposed here. Would it not be, at a stroke, a marvellous achievement of some of the department's targets to reduce the number of inspections by 50 per cent in such circumstances? That would be much preferable. The case for a reduction to one is incontestable. I have no doubt that my amendment would be grossly inappropriate as a way of achieving that, but it has allowed a fair crack at raising the matter in Committee. I beg to move.

Lord Warner

I pay tribute to the noble Lord's labours in producing this ingenious set of probing amendments, as he said. I am glad that he enjoyed the document on the arm's-length body review. I am not sure that all the arm's-length bodies saw it as a document that gave them hours of pleasure, but perhaps we should pass over that.

I recognise the spirit in which the noble Lord is moving the amendments and I have much sympathy with him. His amendments would not alter one iota the number of inspections that were made. So the number of inspections would not be reduced as a result of the amendments. That may be a sad response for the noble Lord, given the hours of labour that he has put into the amendments.

My first point is that in establishing the Human Tissue Authority we are already rationalising—as the noble Lord has acknowledged—a somewhat fractured current system. We are pulling together a disparate set of regulatory processes and forming a single cohesive framework. We will replace and bring together the Inspectorate of Anatomy, the responsibilities of ULTRA and the inspection and accreditation of tissue banks that is currently carried out by the Medicines and Healthcare Products Regulatory Agency.

To this will be added new functions such as a licensing post-mortem practice. This is already a good step forward in rationalising arrangements as part of the arm's-length body review mentioned by the noble Lord. We will bring together under a single regulatory umbrella the work of the Human Tissue Authority with that of the Human Fertilisation and Embryology Authority. That is the context in which I am responding to the amendment.

Moreover, in designing the arrangements for the HTA, we have put in place measures to facilitate minimal bureaucratic operation. We have provided for the authority to delegate functions such as inspections to other bodies like the Healthcare Commission or MHRA. That is set out in Clause 40. Equally, Clause 47 allows the HTA to assist other authorities in carrying out their functions. That means that we can make sensible joint arrangements where those will help to reduce the regulatory burden. The HTA has a duty to minimise that burden by virtue of Clause 43, by which the authority must act economically and efficiently and in accordance with best regulatory practice. Therefore, there are several restraints on the Human Tissue Authority in terms of growing bureaucracy.

I think that the noble Lord may have missed the point that the Bill is structured for there to be two inspectorates because they have different functions, but that does not mean that they are two separate organisations. They are both part of the Human Tissue Authority but, because the functions are different, the boards enable them to have separate specialist advisers.

The Inspectorate of Anatomy and Pathology will. for example, inspect the ethical and administrative arrangements for tissue banks for research purposes, anatomy schools and some museums. It will monitor the proper conduct of post-mortems and the storage and use of tissue for research, education and public display.

On the other hand, the Inspectorate of Organs and Tissue for Human Use will inspect the regulatory arrangements and the safety and quality procedures for the procurement, storage and distribution of human tissue for transplantation. The role of this inspectorate will be primarily to safeguard public health. Importantly, it is the work of this inspectorate that will constitute our implementation of the EU Tissue and Cells Directive, which demands the licensing of institutions that store material for human application.

But having two inspectorates will not mean that two separate, large bureaucratic structures will come about. That is certainly not intended. The Bill describes two functions and not two structures. Schedule 4, which describes the inspectorate boards, does not make distinctions. The approach that we have taken allows specialist expertise to provide input into the relevant and distinct areas, while allowing a single operational structure.

Organisationally, the inspectorates will operate as branches within the Human Tissue Authority. They will be maintained within a single administrative framework. They do not need, and will not have, different organisational structures. Even if the amendments were agreed to, there would still need to be functional separation in the way that the work was done.

I hope that in the light of those reassurances the noble Lord will see that we have not gone cold on rationalising inspection and bureaucratic structures. But we think that the functional separation makes sense and we would prefer to keep the Bill as it is. We do not believe that the amendments would deliver the rather grand cuts in bureaucracy that the noble Lord is suggesting.

Lord Jenkin of Roding

As I listened to the noble Lord, Lord Clement-Jones, I thought that he made a strong case and, if I may say so, a very much stronger case for the merger of the two authorities to which his amendments refer than the case that has been made so far—at least, so far as I have seen it—for the merger of the Human Tissue Authority and the Human Fertilisation and Embryology Authority. That strikes me as being a very rum marriage indeed. I hope that it is not too late to use this occasion to express the hope that the Government will have a good hard look at this matter again.

I believe that the HFEA has done a perfectly splendid job because it has been able to concentrate on the specific and, indeed, very difficult remit that has been given to it. The HTA is an entirely different kind of body and it seems to me that, in their search for economies in the arm's-length bodies, the Government have gone down a seriously wrong road. I hope that, even now, there may be time for second thoughts on preserving the significance of the entity—the HFEA—and that it will not be muddled up with other matters in this Bill. They are quite different.

4.30 p.m.

Lord Warner

I shall briefly respond to that. This is not the occasion on which to have a debate about the wonders of the arms' length body review but there is a good case for making the merger. The Government do not accept the noble Lord's arguments. It is rather striking that his party wants to cut bureaucracy but when it comes to making the mergers, it becomes a little shy about pursuing the arguments which need to be pursued to achieve that.

As regards the case that we are discussing, I do not diminish the power of the rhetoric and the arguments of the noble Lord, Lord Clement-Jones, but inspectorates are concerned with being fit for purpose. You must have people with appropriate expertise to carry out inspections. Two separate inspectorial functions are set out in the Bill and two different kinds of inspectors will be needed to carry them out. There will de facto be two separate inspectorates. I thought I made the rather persuasive argument that they would be brigaded under a single Human Tissue Authority. There will not be a separate corporate structure for those two inspectorates. However, they will have different functions and will require different expertise. That is why I said that the amendments were unnecessary.

Lord Clement-Jones

Alas, the Minister was not persuasive enough although I appreciate his returning to that point. I am pleased that, thanks to the noble Lord, Lord Jenkin, we have had a small canter around the ALBs, as we must learn to call them. However, I am not convinced by what the Minister said. He said that there was no separate corporate entity. Strictly in law that is probably right, but there are two boards and two chief executives. Those boards are not purely advisory bodies and it appears that they have a semi-corporate existence in terms of the way they are set up under the Bill. If there were scientific or medical advisory bodies that helped to inform the different sets of inspectors within the HTA, that would be a different matter, but that is not how the matter appears in the Bill. Certainly the impression is given that they will have their separate administrative staff, separate chief executives and separate boards. That seems to me an unnecessary amount of bureaucracy.

Obviously, this is not the time to press the amendments, but I have considerable sympathy with what the noble Lord, Lord Jenkin, said; namely, that if we are talking about the "quick hit" in terms of ALBs and rationalising these matters, this is a very obvious way of doing it for these two bodies. I am sure that at his party conference the Minister was urged to adopt greater radicalism. I urge that too. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 82 to 85 not moved.]

Clause 35 agreed to.

Clause 36 [Remit of Inspectorate of Anatomy and Pathology]:

[Amendments Nos. 86 to 89 not moved.]

Clause 36 agreed to.

Clause 37 agreed to.

Clause 38 [Remit of Inspectorate of Organ and Tissue for Human Use]:

[Amendments Nos. 90 to 92 not moved.]

Clause 38 agreed to.

Schedule 4 agreed to.

Clause 39 [Duties in relation to discharge of:functions by Inspectorates]:

[Amendments Nos. 93 to 95 not moved.]

Clause 39 agreed to.

Clauses 40 to 43 agreed to.

Clause 44 [Criminal justice purposes]:

Earl Howe moved Amendment No. 96:

Page 28, line 25, at end insert "or the defence in a criminal case"

The noble Earl said: Clause 44 grants exemption from the licensing requirements to activities related to criminal investigations or the conduct of a prosecution. This exemption, however, does not apply to the carrying out of a post-mortem examination for purposes of functions of a coroner. Since all forensic post-mortems are subject to a coroner's authority, the licensing requirement will apply.

First, I question the rationale for this piece of regulation. The coroner has professional status. He is subject to regulation already. Requiring him to have a licence—and not just one licence but one for each mortuary to which he is called—frankly seems unnecessary. I take it, reading the clause—although I am far from clear about it—that despite the general absence of an exemption for coroners, post-mortems done to assist the prosecution in criminal proceedings will be exempt from the licensing requirement. If that is so, we need to ask whether such an exemption is consistent with natural justice. Not infrequently the defence in a criminal trial wishes to commission a second post-mortem. If a pathologist on whom the defence wished to call did not hold a licence for the particular mortuary, he might not be able to assist. In my submission the resulting restriction on the choice of pathologists available to the defence has the potential to result in miscarriages of justice.

Through these amendments I think we need to hear from the Minister why coroners are to be subject to licensing by the HTA; and why only the conduct of a prosecution, and not the defence, attracts the exemption from the licensing requirement. I beg to move.

Baroness Finlay of Llandaff

I support this amendment. While we are discussing licensing, it is important to cast our minds back to the previous debate on coroners' work and post-mortems. As the noble Earl, Lord Howe, rightly states, there may be a need for a second post-mortem. There may also be a need to re-examine blocks and slides as part of a defence. Therefore, the whole process is not only about the conduct of a prosecution but also concerns the ability to have a defence.

The investigation of death involves not only the anatomic cause of death but also the circumstances of the death, and that material bears on both factors that could be found in an investigation. I give a simple example. If someone walks into the road, is hit by a car and crushed, unless the post-mortem is done in such a way as to detect the fact that the person had cortical blindness, it may not be until a re-examination is conducted in the defence of the driver that the latter's claim that the man walked into the road in front of him, and that therefore the driver was not at fault, could be upheld. In other words, his defence would fail unless it was possible to conduct a re-examination.

It is unusual that information relating to both the cause and the circumstance of death is known at the time that a post-mortem is first held. Much of that information becomes available after the first postmortem is held. First, one has to consider whether this matter contravenes human rights, as the ability to revisit a wrongful conviction and to explore care that is suspected of being suboptimal—should the person die in care—will be lost unless there is an extension for a post-mortem and for re-examination of all the tissues not only for a prosecution but for a defence.

Secondly, I suggest that it might also contravene human rights in a coroner's case if both the postmortem and the material retained cannot be revisited. If a death occurs in circumstances involving a public body, such as a death in prison, and possibly by extension a death in the NHS, Article 2 of the Convention on Human Rights requires there to be an investigation that offers an effective remedy. If that investigation is not supported because revisiting the post-mortem or the material cannot be undertaken, when it is realised that further investigation is necessary, the information is simply not there. Therefore, there is no effective remedy available.

I suppose that the extreme in revisiting a postmortem would be exhumation, but the problem with that is that, when a body has already been interred, the material is not optimal for obtaining samples. The whole process is deeply distressing for everybody—the families and the pathologists and police officers involved. It is a relatively ineffective way of revisiting.

I suggest that the licensing system and the whole process by which coroners' post-mortems and coroners' specimens are dealt with in the Bill warrant revisiting. Of course, the relatives need to know what is being done, and they need access to information. However, it may be that we will need to revisit cases for the conduct of our judicial system.

Baroness Andrews

Clause 44 exempts from the remit of the Human Tissue Authority, the licensing regime and the inspection system anything done for purposes related to the prevention or detection of crime or to the conduct of a prosecution. Amendment No. 96 would extend the exemption to anything done for purposes relating to the defence in a criminal case. The noble Baroness, Lady Finlay of Llandaff, has just explained in some detail why that is important.

I shall set the Committee's minds at rest: the fact that provision has already been made to exempt anything done for the conduct of a prosecution means that the interests of the defence are already protected. The words "conduct of a prosecution" are understood to include the steps taken by the defence on behalf of the accused and reflect the wording in other statutes. No further provision is necessary. The wording is comprehensive, and I am assured that it will cover the circumstances described by the noble Baroness. Extending the wording of this clause to include specific reference to the defence might cast doubt on the wording of the other statutes. We must be careful about that, and the amendment is therefore unnecessary and would be unhelpful.

Amendment No. 97 would remove from subsection (2) the reference to Clause 16(2), which relates to activities that are subject to licensing by the Human Tissue Authority. By leaving out that reference, the amendment would, as the noble Earl said, exclude from the HTA's licensing system post-mortems carried out on behalf of a coroner that were also done for criminal justice purposes.

In that context, the noble Earl asked why we believed that all coroners' post-mortems should be carried out in licensed premises under the oversight of the HTA. I shall give three reasons. The first is a practical point: it may be difficult to establish whether a post-mortem needs to be performed for criminal justice purposes only. It is perfectly possible—I am sure that it happens frequently—for the situation to alter during an investigation. We need the licensing framework to cover that point.

Secondly, there is a logical point. If some non-criminal post-mortems require licensing, there is no logical reason why those that have a criminal element should not be similarly licensed. Thirdly—possibly the most important point with regard to the Bill—we consider that the carrying-on of all post-mortems should be licensed, in order to maintain public confidence in post-mortem practice and procedure. The Committee will not need reminding that most post-mortems are coroners' post-mortems. Many of the dreadful cases of organ retention occurred following a coroner's post-mortem. Removing the reference to Clause 16(2) would undermine the confidence that we seek to rebuild through the Bill by removing from the HTA's oversight a particular type of coroner's post-mortem. We see no public benefit in that.

I hope that, on those grounds, the noble Earl will be able to withdraw the amendment.

4.45 p.m.

Baroness Hayman

Before my noble friend sits down, I apologise for intervening on an issue with which I am not totally familiar. However, having listened to the debate, it seems to me that the noble Baroness, Lady Finlay, was envisaging circumstances in which, some time after the event, it might be possible for concerns to be expressed not in the course of a prosecution. It might, for example, be a civil case concerning negligence in the circumstances of a death that was alleged to be due to lack of care. I wonder whether my noble friend can reassure us. She said that all the circumstances about which people were concerned would be encompassed by the phrase, the conduct of a prosecution". Very clearly, this clause deals with criminal prosecutions but, as I understand the argument being put forward, there may be cases that end up in the civil courts that would be prejudiced in this way.

Baroness Andrews

I can give some more detail in relation to criminal cases which may also be useful. As I said, the defence is protected during the investigation as the term "conduct of a prosecution" includes steps taken by the defence on behalf of the accused. Following conviction. samples used, for example, in the course of a prosecution must be retained for the duration of the sentence. Therefore, if there is a wrongful conviction, there is still the possibility of revisiting the post-mortem issues.

I think that we shall have to take further advice on the questions raised about civil law and come back to the noble Baroness as those points are not strictly covered by what I have in front of me.

Earl Howe

This has been an extremely useful debate. I am particularly grateful to both the noble Baronesses opposite for their contributions. It is also helpful to have on the record the Minister's reply because it was certainly unexpected. I am pleased by it but I did not expect it.

The Minister criticised my Amendment No. 97 on a number of grounds. I shall go away and think about what she said. I am not sure that exempting coroners from the licensing requirement would have the effect of undermining confidence in coroners. I can see why cosmetically it might he desirable in the Government's eyes to impose licensing requirements on coroners, but I hope that this Bill and the other regulations to which coroners are subject will ensure that the tragedies that we have seen in the past will not recur. The simple requirement to have a licence does not seem to be a very compelling addition to the protection that we all enjoy from the law and from codes of conduct and so on. Therefore, I resist the argument that the Minister put forward. My amendment may not be the right one in any case and that is another question that I shall consider, but in the mean time I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 97 not moved.]

Baroness Finlay of Llandaff moved Amendment No. 97A:

Page 28, line 31, leave out "by a constable"

The noble Baroness said: This is a probing amendment, but I rather hope that the Government will accept it because it is designed to add a little clarity to a situation which I found rather opaque. The more that I read this part of the Bill, the more opaque it became—for two reasons. First, often a body is not found by a constable; it is found by a lay member of the public or an ambulance man, and many unfortunate people have stumbled across bodies in various states of decay, which is absolutely horrible for them. The term "by a constable" is rather misleading, given that the majority of bodies are initially found by someone else and then the police are involved.

The second reason relates to the removal of relevant material from the body because it is not done by a constable. In fact, it is usually done by a forensic pathologist, a forensic scientist or perhaps even another scene-of-crime officer who is not necessarily a constable. In fact, it would be almost dangerous to insist that a constable should remove relevant material. There are some highly specialised techniques which forensic science needs to use for criminal investigations whereby the process of removal of the material is itself part of the investigation. Although I am sure that there are no clumsy constables, if there was a clumsy constable valuable evidence might be destroyed. So I remain confused over the wording of the clause and I have tabled the amendment to delete the words "by a constable". I beg to move.

Baroness Andrews

The noble Baroness says that she is confused by the text of the clause but I do not think I can help her very much. This was a late amendment, upon which we can all agree. We are willing to take this matter away and see if we can make it clearer. If I may reiterate, Clause 44 works by excluding criminal justice activities from regulation by the HTA, except for coroners' post-mortem examinations which would require a licence. It would not be appropriate for any post-mortem examination activities which take place at the site of discovery to have a licence because licences are premises-related, therefore Clause 44(3) ensures that such activities are not subject to regulation.

Clause 44(3) refers to the location where the constable first finds the body and ensures that the exemption applies to the location where the police first attend the remains. As the noble Baroness says, there may be cases where the remains are found by persons other than the police and moved, for whatever reasons. But without this wording, the location at which the police attend remains would not be within the exemption. That is why we need the wording. It also ensures that the exemption takes effect only when the police have attended the location. There are obvious reasons why it would be inappropriate for material to be taken from a body before the proper authorities have become involved.

This matter is technical and clearly tries to stay within the process of law. On the question that the noble Baroness raised regarding the removal of relevant material which is not done by a constable in some instances, it would be carried out by a forensic pathologist on the authority of the coroner. The reference, "by a constable" does not relate to the removal of the material but to the initiation of the police investigation.

Although we cannot support the amendment we appreciate that it is probing and we will consider in conjunction with colleagues in the Home Office whether we can do anything to make the wording clearer.

Lord Jenkin of Roding

As an avid viewer of the television series, "Silent Witness", I thought that the noble Baroness, Lady Finlay of Llandaff, made an extremely strong case and I am pleased that the Minister will take this clause away and look at the matter again.

Baroness Finlay of Llandaff

I am most grateful to the Minister for her reply and for helping already to clarify the matter. I am sure that we can find a form of words that is clear to everyone. In the interim, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 44 agreed to.

Clauses 45 to 47 agreed to.

Clause 48 [Preservation for transplantation]:

Earl Howe moved Amendment No. 98:

Page 30, line 23, at beginning insert "Subject to section 11(2),"

The noble Earl said: This is a straightforward amendment suggested to me by the Royal College of Pathologists. Clause 48 contains some welcome provisions which will make it lawful, subject to consent, to preserve organs in a dead body so that they are kept ready for transplantation. Reading the clause in isolation, one might conclude that clinicians and managers were being granted an unfettered right to retain a dead boy and preserve transplantable organs in it while consent was being sought. That, surely, cannot be so. The clause stipulates that, in order to keep an organ in a fit state for transplant, it is permissible only to take the minimum steps necessary to that end and to use the least invasive procedure. If the least invasive procedure is accompanied by perfusion, that may have implications for the functions of a coroner.

Clause 48 contains no mention of the coroner. I cannot help feeling that that is misleading. Clause 11(2)(a) says that, if someone knows or believes that a body or relevant material from it may be required for purposes of functions of a coroner, he shall not act under the terms of Clause 1, other than with the coroner's consent. The same stipulation should surely apply to clinicians in a hospital who seek to use the organs in a dead body for transplantation.

I expect that the Minister will tell me that the amendment is unnecessary for some reason, but I should be grateful if she would agree, at least, to reflect on it, if only as a means of delivering greater clarity and coherence in the Bill. I beg to move.

Baroness Andrews

I shall start by reiterating the purpose of Clause 48: it provides—for the first time—clear authority to go ahead with cold perfusion or other preservation techniques, while consent to transplantation is sought. As the noble Earl said, it includes no requirement to make sure that the coroner is content before commencing the preservation steps. That position is what the amendment would change, so that, if the death might be of interest to the coroner, it would not be lawful to carry out cold perfusion or other preservation techniques until the coroner gave his consent.

We have given considerable thought to the issue. The amendment raises important challenges. We recognise the need to safeguard the primary interest of the coroner if a death is referred to him, and we had a long debate on that matter. However, we also recognise the fact that the deceased may be a potential organ donor, and we do not want to inhibit or impede either interest. I am sure that we are all agreed on that.

Having considered the matter, we do not think that there need be statutory provision to avoid a conflict of responsibilities. To begin with, we are not aware that we are trying to remedy any existing or identified problem with the notification of coroners. The existing situation seems to work well: clinicians are already and will continue to be legally obliged to refer suspicious, unexpected, violent or unnatural death to the coroner. Although Clause 48 makes it clear that preservation techniques such as cold perfusion are lawful—it is important to have that—it does not make them obligatory and does not interfere with the obligation on the clinician to report deaths to the coroner in the circumstances that I mentioned. We are not aware of any current problem with coroners' cases in that respect.

Providing for the requirements of coroners can be dealt with better in guidance, rather than in the Bill, and in the code of practice to be issued by the Human Tissue Authority. We have discussed the issues with the Home Office and with the Coroners' Society, and neither has raised any objections to that approach. In the code of practice, which is already in preparation, we aim to make it clear that, on occasions on which doctors consider that the coroner may have an interest in the death of a person whose organs are suitable for donation, they should contact his office and, if required, take samples for the coroner's purposes before taking steps to preserve organs that might be donated. That would avoid difficulties if the need for preservation were acute and viable organs might otherwise be lost. I understand that, for example, in the case of a person who dies in an A&E department, preservation for non-heart beating donation would need to be started within 15 minutes.

A statutory obligation to obtain prior agreement from a coroner would, in some cases, risk the loss of precious viable organs for donation. By the same token, we consider that the guidance will allow the clinician to assist the coroner and preserve organs for potential donation.

This is a very delicate question, and I believe that we are all trying to establish the same objective of balancing the needs of the coroner and of proper investigations with not losing opportunities for organ donation. This matter is handled well in practice, with no known problems. We have the best, most flexible and most robust means of dealing with this, through guidance and with the oversight of the Human Tissue Authority. I hope that the noble Earl will agree.

5 p.m.

Lord Walton of Detchant

While I appreciate why the noble Earl has tabled the amendment, I think that the Minister has stated the position very clearly. It is clear that in the case of an individual who has died a violent death, perhaps in a road traffic accident, the coroner must be involved in any decision. But in the case of an individual who dies of natural causes, where the coroner is in no way involved, time is of the essence before removing organs for transplantation. For that reason, there are circumstances, in this very difficult and sensitive situation, in which it may not be necessary to involve the coroner before the decision about the organ is made.

Earl Howe

If that is the effect of my amendment, I readily concede that it is ill drafted. However, I hope that that is not its effect. I was seeking to address the precise circumstances that the noble Baroness very helpfully outlined in which there might be suspicious circumstances surrounding a death. In that situation, the interests of criminal justice should, in my view, prevail over any deemed desirability for transplant of organs.

The noble Baroness spoke of a balance of interests. She is absolutely right—I am quite content with her reply that this matter is best dealt with in guidance. I do not think that there is any difference between us on the substance of the issue. I am much reassured by what she said, and I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 48 agreed to.

Clause 49 agreed to.

Clause 50 [Non-consensual analysis of DNA]:

The Deputy Chairman of Committees (Viscount Simon)

I remind the Committee that if Amendment No. 99 is agreed to, I cannot call Amendment No. 100, due to pre-emption.

Lord Clement-Jones moved Amendment No. 99:

Page 31, line 22, leave out paragraph (a) and insert— (a) he analyses or procures the analyses of any human DNA in any bodily material without qualifying consent intending that the results of the analysis be used otherwise than for an excepted purpose,

The noble Lord said: The DNA analysis offence set out in Clause 50 is not just the offence of analysing DNA without consent. It is an offence of holding material intending to analyse DNA without consent. It is very hard to see how an offence that can be committed purely on the basis of an intention is necessary, appropriate or consistent with ordinary criminal justice principles in this particular case. There are obvious evidential difficulties in terms of mens rea. There is also considerable concern that an offence based solely on a state of mind among researchers and doctors will create a climate of fear among doctors and researchers and deter the collection of tissue samples in the future that may be of value to clinical care and research.

Amendment No. 99 would limit the application of the offence in Clause 50 to analysing or procuring the analysis of DNA rather than intending to do so, as currently proposed. I beg to move.

Earl Howe

I would like to row in behind the noble Lord, Lord Clement-Jones, because I intended to raise this issue under clause stand part. It would appear to fall more easily under this group of amendments.

As the noble Lord said, the clause defines an offence of intent. That, as he said, seems remarkable in itself. We need to hear from the Minister how such an offence can possibly be policed or enforced in the absence of conclusive corroborating evidence, which may well not exist. I say this because of the very large number of excepted purposes for which DNA analysis will be perfectly legal. Those excepted purposes are listed in Schedule 5.

To prove intent is not, I should have thought, a straightforward matter at the best of times. To prove that someone's intent is that DNA should be analysed for an illegal purpose and not for an excepted purpose would have to depend on some fairly clever policing.

I realise that it may be possible to construct a criminal case after the event—that is, once the DNA analysis has taken place and the results applied for an illegal purpose. But one would still have to prove intent. The offence is not the actual carrying out of the analysis for an illegal purpose, but possessing the material with intent to do so. The person deriving benefit from the analysis may never be in possession of the material. The person carrying out the analysis may not be aware of the use to which it will be put or may not have inquired sufficiently about the origins of the material concerned.

I think that the noble Lord's amendment is very much to the point, and I look forward to hearing what the Minister has to say.

Lord Turnberg

I, too, support the amendment. Samples are taken with the intent that, at some future date, DNA may be analysed. Increasingly, research requires some element of DNA analysis to be included. It is at that point that a decision is taken to obtain consent and to get ethical committee approval so that the analysis can be undertaken. But at the time of the intent to make an analysis, that approval may not have been given. This is extraordinarily difficult, because one never knows how DNA will be analysed in the future. It is a very expanding field.

Baroness Finlay of Llandaff

I also support the amendment and the concept behind it. One has to prove intention, but if there was a vexatious litigant against somebody who was involved in research, it might be difficult to prove that there was no such intention. That is an incredibly important point, and could be a major distracter in the delivery of healthcare services.

Unfortunately, there are vexatious complainants out there. In the event of somebody becoming somewhat paranoid and wishing to target, for example, a geneticist or a pathologist and claim that some of his or her DNA had been retained with malintent, it could be a very lengthy procedure. It would be much easier and clearer if the clause contained the wording suggested by the noble Lord, Lord Clement-Jones.

Lord Warner

I note before starting that Amendment No. 101 was also grouped with this, but I did not hear any remarks about it.

Earl Howe

My apologies. I should have said that explicitly. I am grateful to the Minister.

Lord Warner

On Amendment No. 99, it might be helpful if I trudged through the thinking behind Clause 50(1). The offence laid down in Clause 50(1) covers the possession of bodily materials with the intention that any human DNA in the material be analysed without consent. It is our firm view that the offence therefore already covers someone procuring a DNA test on bodily material without valid consent, and which is not to be used for any excepted purpose. This is because a person having the material with the intention of procuring a DNA test on it would come within the scope of the offence.

However, the offence as drafted in the Bill goes deliberately further than the amendment, which restricts the nature of the offence, for the reasons which have been given. The offence covers an individual who has possession of bodily material for the purposes of conducting an analysis or, later, getting another person to perform the analysis of that material without consent, whether or not the analysis is ever carried out. It is deliberately framed in that way. It therefore meets the original concern that was identified by the Human Genetics Commission which, in turn, was prompted by lurid stories of DNA theft from dustbins for purposes of paternity disputes or for media intrusion in a person's private life. We have framed a provision which has a deterrent purpose and deals with intent.

I am no lawyer, and I defer to the legal expertise of the noble Lord, Lord Clement-Jones, but I would say, from my rusty recollection of my time at the Home Office, that there are many offences in which it is difficult to prove mens rea. This is certainly true in many criminal cases. We are not, I suggest, introducing a novel legal concept in this area.

The existing provision is intended to be sufficiently broad to prevent or deter people from obtaining material in the first place, irrespective of whether they later procure the analysis without consent. The Government believe that obtaining a person's bodily material with malicious intent is, in itself, an unwarranted invasion of privacy. That is where we came into this argument, to which the Human Genetics Commission drew a great deal of attention.

On Amendment No. 101, I understand the point behind it. However, we are of the view that the existing formulation already achieves the desired effect. Clause 50(1)(c), which sets out the reasonable belief defence, relates to the classes of bodily material which are excepted from the DNA offence and listed in Clause 50(2). These classes are bodily material that is not from a person who has died more than 100 years ago, is an existing holding from an anonymised source or is a human embryo outside the body. These are the only categories of excepted bodily material envisaged in the Bill, and should not be confused with the list of excepted purposes contained in Schedule 5.

If a person has acted recklessly in considering whether or not the bodily material is from such a source, then he could not be said to have a reasonable belief as to its origins. It would not be reasonable, I suggest, to have a reckless belief. I therefore think that Amendment No. 101 is totally unnecessary, because the reasonable belief defence is sound as it is.

Baroness Hayman

I wonder whether my noble friend could help me. I share a concern about intent being the only factor that determines guilt under the clause. It is possible, as my noble friend outlined, to have malicious intent, which we can all recognise. But this is a very complicated Bill and when it comes to knowing what is excepted material and what are excepted purposes—as my noble friend said, excepted purposes for this clause are different from those for other provisions dealing with tissue—someone could have the mistaken belief that their intent to carry out DNA analysis on some material was lawful under the Bill. However, closer analysis of the legal situation could show that they were not entitled to deal with material in that way and that their intent was mistaken.

Can my noble friend confirm whether that is correct and, if it is, whether it is a matter of some concern for us? Perhaps his formulation of malicious intent might be added, with some purpose, to the Bill.

5.15 p.m.

Lord Warner

Of course, people have different forms of malicious intent. I shall not repeat what I said, but the forms of malicious intent that I referred to occurred when action was clearly taken which invaded the privacy of the particular person whose DNA was obtained by illicit means of one kind or another. There is malicious intent in that.

I understand from the points that have been made that some Members of the Committee are concerned about the possibility of a vexatious litigant targeting a doctor or researcher; they claimed that the vexatious litigant had, in effect, ill intent. I suggest that the legitimate researcher is protected by the fact that, if consent is gained, there is no difficulty. The offence does not apply in the case of the excepted purposes that I outlined previously and which are set out in the Bill, including all the activities dealt with under Part 1. In carrying out their usual business, I would suggest that researchers cannot be at risk, even if someone tried to claim that they were of ill intent. Even if someone did claim that, the police would have to accumulate evidence from that person and would have to convince a CPS prosecutor to charge and prosecute the case. All those things are safeguards.

I can see that it might be slightly unpleasant for the researcher if there was a vexatious litigant, but that is no different from now. All sorts of vexatious people complain about doctors and nurses. My noble friend has seen some of the correspondence that one gets in the Department of Health. Vexatious complainers are not new in this world and will be with us for some time to come, whatever legislation we may or may not pass. I suggest that the Bill has safeguards for the researcher, doctor and scientist when there is a vexatious charge. There are plenty of safeguards with the requirements on the police to have a case and convince a prosecutor that there is a case that can be taken before the courts.

Baroness O'Neill of Bengarve

I share the Minister's concern about the cases in which people obtain DNA with the purpose of having it analysed without consent. A number of very sad television programmes have emphasised those cases. I noticed that, in both his last replies, the Minister did not use the phrase "has bodily material intending"; he said, "obtains bodily material intending". One of our difficulties is that the focus on mere possession seems to put all the evidential weight on the judgment of the intention, because there is no action that is also related to the intention. If the person were to commit an offence by obtaining bodily material, intending to analyse it without consent, there would be a good deal more focus to this supposed offence.

Baroness Hayman

I should like to return to the helpful remarks made by my noble friend the Minister. He referred many times to vexatious complaints, but we are dealing with the creation of a criminal offence. I found more reassuring the issues about prosecution and the prosecution authorities.

We are entering an area in which an absolute offence is being created of holding and being in possession of material, when that material might be held with an intent for a research purpose not permitted under this legislation—not for any of the purposes that all of us deplore. The provision creates an atmosphere and another barrier to the culture that many of us have been trying to engender in medical research, of more clinicians being involved, more researchers taking action and encouraging activity in research. It may not end with prosecutions being undertaken in cases that are self-evidently against common sense—but will my noble friend the Minister consider whether the general purpose to which he is clearly committed and which Members of the Committee all support about the avoidance of invasion of privacy for malicious purposes and the use of DNA analysis to carry that out could be fulfilled without such a draconian clause as we are faced with now?

Lord Warner

I am certainly happy to reconsider the wording of the clause in the light of the concerns expressed by Members of the Committee. I would not like to hold out an excessive amount of hope in this area, because we have to hang on to the fact that we must protect people's privacy. The situation is not hypothetical: we have examples of this kind of malicious invasion of privacy, in which DNA material has been used. We must protect people from that kind of invasion—sometimes, regrettably, as a result of actions by the tabloid media.

The clause provides that protection. I am happy to look at it, to see whether it can be narrowed, but we must hang on to the fact that not only researchers are concerned but the general public as well.

Lord Clement-Jones

I am happy that even if the Minister does not hold out a great deal of hope, he accepts the fact that the noble Earl and the noble Baroness who raised this issue—as well as myself—are not all barking up the wrong tree. There is a serious issue here.

I accept a lot of what the Minister said about the deterrent purpose and the original motive for stating the provision in this way. Of course, there are a lot of offences of intent in the criminal law; mens rea needs to be proved by circumstances, corroboration and so on; but not in this particular area. What the noble Baroness, Lady Hayman, said about the general atmosphere created by the clause is important.

What the Minister said about malicious intent is also absolutely vital. Some of the problems arise out of the way in which subsection (1)(a)(i) is drafted. Does the phrase "without qualifying consent" effectively refer to a malicious intent? Does it mean deliberately without qualifying consent, or does it mean by peradventure? There is a clear exemption under subsection (1)(c): he does not reasonably believe the material to be of a kind so excepted". Therefore, if a researcher gets it wrong, there is clearly a defence in those circumstances.

There is no defence when researchers reasonably believe that there is a qualifying consent but it is not there in those circumstances. One could argue that if they deliberately set out to analyse the material and do it absolutely purposefully without consent, that is what the Minister might define as malicious intent. I fully accept that that should be included in this clause—but I do not think that that is quite the case. Because there is room for debate on that and because that definition is not entirely clear, we have quite reasonably raised the matter by debating this amendment.

I do not believe that it is necessary to refer to vexatious litigants or implacable prosecutions, or even to "clever policing". I would say that it would have to be ubiquitous policing to catch the average researcher under the clause. Therefore, perhaps one could say that the clause is supernumerary except for those researchers who are going out to raid people's dustbins for bodily material, which is a pretty macabre thought.

Be that as it may, I welcome what the Minister said about looking at the clause again. There is a serious point of wording that could be examined. In the mean time, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Lord McColl of Dulwich moved Amendment No. 100:

Page 31, line 23, after "DNA" insert "or RNA"

The noble Lord said: Members of this House and Members in another place were puzzled that RNA was not included in the Bill because it is of course possible to gather DNA information from RNA. However, the Minister's explanation in his letter of 23 August has clarified the situation, giving more detail about the scope of the offence of non-consensual testing of DNA and its interpretation. The Minister pointed out that the offence laid down in Clause 50(1), which is the possession of bodily material with the intention that human DNA in the material be analysed without consent, applies to any process carried out on the bodily material that is intended to provide information about DNA in that material and which is not covered by valid consent.

That would include direct analysis of the DNA—for example sequencing of the genetic code—detection of DNA patterns or visualisation of the chromosomes such as karyotyping. It would also include methods of indirect analysis such as that of specific RNA sequences or protein products or other indirect markers such as metabolites or antigens, provided that the intention was to examine the DNA in the sample by deriving information about it by these means.

The Minister went on to say that if an analysis were made of the presence of a specific RNA molecule that did not intend to provide information about the DNA but could be so used, it would not automatically be an offence. He also emphasised that the offence applied to human DNA, so the use of indirect techniques for the detection of viruses or other pathogens would not be an offence as the intention is not to analyse the human DNA. I should like to thank the Minister for the trouble he has taken in clarifying that point. I beg to move.

Baroness Finlay of Llandaff

I support the amendment, to which I have added my name. It is important to remember that the Bill needs to look forward as well as at the current state. It therefore needs to look at the current frontiers of research.

Research suggests that it will soon be possible, using epidemiological studies to use plasma. From that one would be able to identify substrates, protein products and enzymes that would indicate the identity of a person's DNA. Sections of hair and nail taken from the living are excluded by Clause 58 (2)(b), but there does not seem to be a similar exception in Clause 55, which defines body material for DNA analysis. If the Bill is to look forward and cope with research which is possibly just around the corner, it needs different wording. Although the letter from the Minister was extremely helpful—it may be that simply adding RNA here is insufficient—perhaps we should all think about whether some other form of wording is needed to cover every future eventuality.

Lord Turnberg

I wish to comment on the proposal that DNA includes a wider definition—those matters that can help one define DNA indirectly. We can do that easily in relation to a number of diseases simply by testing for high serum cholesterol. For example, if very high levels are genetically determined, they run in the family and give a good idea of what is going on with DNA. Similarly blood sugar in a young person also gives some indication of DNA. Phenylketonuria detected in samples of blood also give an indirect assessment of DNA in the child. Increasingly, there will be indirect markers; they already exist. A definition of DNA as anything that will give us an idea of the DNA of a person is, perhaps, not entirely acceptable.

5.30 p.m.

Lord Warner

I am certainly not going to trade scientific knowledge with the noble Baroness, Lady Finlay of Llandaff. I know my limitations, and they are considerable in the area that she was getting into.

I am grateful to the noble Lord, Lord McColl of Dulwich, for putting on the record the points that were in my letter. Ultimately, the offence—that is what we are concerned about—claid down in Clause 50(1) relates to the analysis of DNA, by whatever method, and its use without consent or for an excepted purpose. The way in which the material is analysed is, in a sense, irrelevant to the framing of the Bill. The terminology of the Bill enables us to deal with the matter whether the analysis is done by RNA or some other clever new technical form. I suggest that it does not matter.

I shall consult those in the field who are more expert than I am to see whether there are flaws in the drafting. I do not think that there are, and I do not think that legitimate researchers are in any way threatened by the Bill. However, I shall check with those with greater expertise and write to noble Lords before Report.

Lord McColl of Dulwich

I thank the Minister for that helpful reply. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 101 not moved.]

Clause 50 agreed to.

Schedule 5 [Section 50: Supplementary]:

Baroness Finlay of Llandaff moved Amendment No. 101A:

Page 56, line 9, leave out from beginning to "that" and insert "Human Tissue Authority may determine"

The noble Baroness said: The amendment concerns the role of the High Court in dispensing with the need for consent in research. The matter has already been discussed in part with regard to Amendments Nos. 29 to 32.

The Secretary of State is empowered to issue regulations specifying the circumstances in which the High Court or Court of Session can treat the results of a DNA analysis for research as an excepted purpose. That provision was inserted into the Bill following Committee stage in another place and is analogous to Clause 7(3), which concerns the power of the Secretary of State to make regulations enabling the High Court to make an order deeming that there be appropriate consent for the use of human material for research.

Some practical problems arise in making an application to the High Court—a matter that has been brought to my attention by the genetics community. The burden of having to go to the High Court is excessive and may not be suitable in all circumstances. It is costly and time-consuming and may be quite bureaucratic. In other health-related legislation and under common law, recourse to the High Court is required only where exceptional issues of life or liberty fall to be determined, such as sterilisation or discontinuance of artificial hydration and nutrition in a mentally incompetent adult.

Nevertheless, safeguards are important, and it is suggested that the Human Tissue Authority should oversee the working of the paragraph. The authority, rather than the High Court, could be empowered to advise the Secretary of State or could have delegated to it the power to adjudicate the circumstances in which research was justified.

The Human Tissue Authority will have the necessary expertise to make determinations without the need for expert witnesses and the expense of proceeding to court. No researcher, least of all researchers in the NHS, can afford the cost of the solicitors, barristers and so on that would be involved in going to the High Court. The Human Tissue Authority will be statutory. It will develop expertise and could make generic rules to increase clarity and decrease expense.

In Amendment No. 32, the noble Lord, Lord Clement-Jones, suggested a tissue research advisory group. If we allowed the Human Tissue Authority to examine research and allowed it to dispense with the need for consent, the authority's expertise would rapidly increase. It would not incur the huge expenditure of the High Court processes and would allow epidemiological research to continue. It would also be able to address the difficult areas where anonymisation is not possible, such as where the clinician is the researcher and in case series analyses.

The work of PIAG may give some indication of the potential workload simply by extrapolating information from its first year when it had 101 applications, of which 12 concerned linking data sets. So perhaps it would be possible to estimate that there could be about 100 applications per year in the first instance, which is far greater than I believe the Minister envisaged in his reply to previous amendments.

Under the Human Tissue Authority, the process would be far more open, transparent and facilitatory, facilitating research rather than preventing it. The process would not be delayed going to the High Court through lack of funds. It would be less restrictive and would ensure that the audit and public health components of a study were able to proceed as well as the research component. The danger with not having a process that is easy for researchers to consult is that the audit and public health parts of a study only will proceed and the broader research remit will be lost because of the difficulty of proceeding to the High Court where anonymisation is not possible. I beg to move.

Lord Clement-Jones

I support the amendment, which, as the noble Baroness pointed out, is analogous to a previous amendment—Amendment No. 32—relating to Clause 7(3). The issue arises again as to which is the most appropriate body to determine matters under this clause. is it the High Court or the Court of Session? However, as we pointed out earlier, that is a bureaucratic way of going about the matter. I believe that it would be far preferable for it to be dealt with by the Human Tissue Authority. That body could draw up generic rules to increase clarity and reduce the expense of going to the High Court. If that was not thought appropriate, an expert body such as the tissue research advisory group, as previously mentioned, would be another way of dealing with the matter.

I suspect (this is very much in line with the Minister's reply) that the issue is whether this matter is so exceptional that this kind of very large sledgehammer is appropriate or whether there may well he instances—more frequent instances than the Government imagine—where a body, whichever body it is, needs to intervene. The case made by the research community, particularly in this area, is that epidemiological research where tissue or DNA samples are linked to data sets is much more common than perhaps the Government imagine and therefore this matter will become a necessary mechanism which will be used more frequently. Therefore, a body that can respond more flexibly will be more appropriate.

Lord Warner

I fear that I am going to bring further disappointment. This power was put in on Report in the other place in order to provide a last resort in cases where there was an overriding public health interest in doing research and it was not possible to obtain consent, particularly in relation to tissue from the deceased. We listened to the concerns of the medical and scientific community on this. The kind of circumstances envisaged were, for example, where a person with an unknown disease landed at Heathrow and died and no relatives could be contacted to consent to the use of the tissue in research.

We believe that the amendment is unacceptable for a number of good reasons. First, one has to acknowledge that its underlying purpose is clearly to make it easier for researchers to obtain a waiver of the requirement for consent to use tissue in research by effectively reducing the legal hurdle. In this way it is probably hoped, I suspect, that the waiver will be granted not just in the last resort but whenever researchers can persuade the authority to do so.

It is important to realise that in the other place the Government made the waiver subject to the approval of the High Court precisely so that it would be a procedure of last resort to be used only in the most exceptional circumstances. Such a waiver might be needed in unexpected cases where the potential benefit to the health of the public of undertaking the research outweighs the risk of harm to the rights of the individuals concerned. In the other place, we made it clear that we expected the regulations to provide for the court to waive the need for consent only in rare cases where the public interest justified it.

If the noble Baroness will send me her calculations, I shall be happy to look at them, but at present our view is that we cannot accept her numbers. I need many more "further and better particulars", as they say, before simply accepting her numbers.

That brings me to my second point. The power to allow a court order waiver is the only provision in the Bill which would permit the use of tissue from a person who has died without the consent of the people close to him or her. Given the background of the Bill, I suggest that we recognise that this is an extremely sensitive issue. At this stage, the Government are unwilling to consider lowering the barrier to obtain a waiver of consent in order to use tissue from the deceased.

My third point is that the amendment would be effective for DNA analysis but not for storage and the use of tissue for other kinds of research. In fact, the DNA provisions would then be out of kilter with the rest of the Bill and we do not see much point in creating anomalies. Since the Human Tissue Authority will have no role to play in Scotland, that would be a further anomaly.

However, perhaps I may give a little comfort to the Committee. I suggest that the procedure for obtaining a court order does not necessarily need to be as onerous or as unduly expensive as has been suggested. As a department, we shall be in discussion with the Department for Constitutional Affairs when the regulations are prepared, and in the public health interest we shall seek a procedure that can produce swift results. We understand the importance of speed in this area and we understand the importance of not having a cumbersome process. Therefore, we shall be working with colleagues in other departments to see whether we can find a speedy way to deal with this matter.

However, I must re-emphasise that this provision relates to a small number of cases in exceptional circumstances. We think that, given the background to the Bill, this provision—this high legal hurdle—is justified in terms of public confidence.

Baroness Finlay of Llandaff

The Minister's reply did not really surprise me. I did not expect him to give me much comfort, although I hope that the process of going to court will be less onerous and less expensive. However, I feel that I must defend researchers. They want to be responsible and they want to ensure that they work completely within the law. I think that, when they are in doubt, it will be extremely important for them to be able to take their queries to a body which, over time, is definitively accruing the experience of handling different issues.

There are interfaces between audit and research and between public health and research, and there are circumstances in which it is extremely difficult to anonymise and to ask everyone in a database about consent for their tissue, sample or whatever to be used. Therefore, I have great sympathy with the research community. I also fear that, in wanting to be extremely responsible and not to break the law, researchers will simply feel that they can no longer pursue avenues of research which may be for the common good.

I accept that public confidence is being extremely severely dented by the actions of a few who behave absolutely appallingly. But it will be rather sad if a secondary, unwanted effect of legislation is that we decrease the amount of ground-breaking research in the UK. However, I thank the Minister for his reply and for having considered the amendment to the extent that he has. It will be interesting to see how the procedure goes ahead. I shall also try to explain to him how the extrapolated figures were derived. It is difficult to forward-guess when a piece of legislation is not already in place and the queries are not already coming in. In the light of the Minister's reply, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

5.45 p.m.

Baroness Finlay of Llandaff moved Amendment No. 101B:

Page 56, line 37, leave out from "health" to end of line 38.

The noble Baroness said: This amendment goes back to the thorny issue of the definition of education, training and research. Again, this amendment was suggested by the genetics community, which is particularly concerned with research and acquiring consent to be obtained from living donors for the results of DNA analysis to be used for education or training relating to research.

Genetics is a rapidly advancing field, with technological advances quickly incorporated into service provision. The distinction between education and training relating to human health and that relating to research is particularly difficult for those working in this field to apply. An example of such an anomaly is when medically qualified diagnostic pathologists want to use samples from their patients as comparators or control, without their consent, for the diagnostic assessment of another patient. It seems legally and ethically coherent to treat all education and training as not requiring consent. That would seem to be consistent with European legislation as well.

By removing the exception, the amendment would suggest that all types of education and training relating to human health, including that relating to research, should not require consent. The reason this needs to be looked at again is because everyone involved in education and training for research is subject to confidentiality. So it is not the process that is undertaken that is the problem, it is what is done with the information that is obtained as an end result of the process. It seems completely reasonable that everyone involved in education, training and research must be subject to the rules of confidentiality, as indeed they are.

The thought behind the amendment was to revisit the difficulty that we have already had in trying to distinguish between education and training for clinical use and education and training for research, when often they are integrally bound up and are almost one and the same. I beg to move.

Lord Clement-Jones

I support the noble Baroness on the amendment. We heard what the Minister had to say when we debated this issue under Schedule 1. The case is, if anything, stronger regarding this area. The points that the noble Baroness made about the governing duty of confidentiality must surely be persuasive in these cases. By separating out education and training relating to research on human health from that relating to other forms of health seems to create distinctions that will cause huge problems in practice in the research community. Even if the Government maintained the distinction in Schedule 1, it would be perfectly possible to alter that in Schedule 5 and make a good deal more sense for the purposes of the Bill.

Lord Walton of Detchant

As the noble Baroness said, all healthcare professionals working in this field owe a duty of confidentiality. I find it extremely difficult to see how the provisions in Clause 8—in which bodily material from a living person can be used for clinical audit, for performance assessment, for public health monitoring and for quality assurance—could differ when it comes to the use of similar material for research. It seems entirely reasonable that research in connection with disorders or the functioning of the human body should be subject to the same controls as that relating to clinical audit and the other items in paragraphs (a), (c), (d) and (e) in this part of the Bill. Therefore, I strongly support the amendment.

Lord Warner

The proposals in the amendment, in the context of the DNA provisions in the Bill, seem to rerun many of the arguments that we debated at length in Committee on 15 September. I can only say and—this will not surprise Members of the Committee; whatever else they may accuse me of, I am consistent on this matter—that I shall not rerun all the arguments, but I emphasise that the arguments are essentially the same.

As I said earlier, we are aware that pathologists and researchers say that it is difficult in practice to differentiate between research and training for research. Some will say that they do not wish to do so; some will say that they will find it impractical to ask for consent. However, I remind Members of the Committee once again of the principles of the Bill: we are using the Bill to promote a consent-based environment. It seems to us that research-related activities are not part of what people would expect when their tissue is taken for diagnostic or treatment purposes. That is how we came at this issue.

Schedule 1 contains a clear categorisation of particular exempted and non-exempted activities. That does not mean that all research training is impossible unless there is consent for the purpose. Clearly, when a trainee is observing a research procedure, there is no great difficulty; equally, if a post graduate student had a research proposal approved by an ethics committee, the learning would be part of the research, and that would proceed in the usual way. But if tissue samples are to be used solely—and the emphasis is on the word "solely"—to teach someone how to use a piece of equipment, for example, that is a totally different matter and one in which consent should be required.

We do not wish to create an environment in which all residual tissue can be used for all training and education irrespective of how far removed that is from the original purpose for which the tissue was taken. We know that is not a view shared by everyone in the research community—but I suggest that we would create a serious anomaly if residual tissue could be used for research training without consent, while consent or safeguards would be required to use the same tissue in the research itself. We would create a strange balance in the Bill if that was allowed, which is effectively what the amendment would do.

The amendment would also distinguish between research training issues in the context of DNA analysis and other research training activities, which would produce another anomaly.

We do not like the principles underpinning the amendment, for the reasons we gave at length at Second Reading and in earlier debates, and which I suspect I will give again at Report and Third Reading. However, our position is clear and is not one on which we feel that we can change. There are other anomalies that this amendment would introduce.

Lord Jenkin of Roding

Before the noble Baroness withdraws her amendment, I must tell the Minister that his arguments are no more convincing the second or third time round than they were the first time. I find the arguments about drawing the distinction between training and education for research entirely unreal. I hope that my noble friends on the Front Bench will join noble Lords in other parts of the House on Report, and that we may be able to return to the matter and persuade the Minister to change his mind—if not by our arguments then perhaps by our votes.

Baroness Finlay of Llandaff

I thank the Minister for his reply. I did not want him to spend time going over the same points again, and indeed he made a précis of them for us.

I am really concerned that the wish to promote a consent-based environment, which I believe everybody would support—I do not believe that anyone is against doing that—may as a secondary effect inadvertently seriously decrease the position of academic research, and therefore of clinical benefit, in this country. I personally am concerned that our inability to present the case adequately to the Government may have that result. It may represent a failure of those of us who have tried to amend the Bill in this direction, as much as anything, to help the Government to see the complexities of the issue. Education and training for research and education and training and doing research are still being seen as two separate components, as opposed to being integrally linked.

Academic medicine is certainly in crisis; there are a lot of articles about that around at the moment. I worry that a rigid approach is going to be another nail in the coffin of academic medicine, at the end of the day, because people will have to take the most defensive line at all times—particularly those at the beginning of their careers who do not have experience and a degree of precedent behind them. With that rather gloomy view of the Minister's response, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 102 not moved.]

Baroness Finlay of Llandaff moved Amendment No. 102A:

Page 57, line 41, at beginning insert "either— (i)

The noble Baroness said: Clause 1 recognises that in most situations citizens do not need to be consulted prior to participation in research if their tissue is fully anonymised. Anonymisation protects their privacy and autonomy; that matches codes that have been set out in other legislation, such as the Data Protection Act, within the common law of confidentiality and in the Health Service (Control of Patient Information) Regulations, which are overseen by PIAG. It also matches the NHS code of confidentiality. It is also compatible with the guidance from groups such as the MRC and the GMC. All those codes require that the user must not use sensitive material or information unless he can either ask for consent, anonymise or demonstrate that it is not reasonably practicable to do either of those, but that it is necessary in the public interest and proportionate to proceed. It is the latter possibility that the Human Tissue Bill does not allow.

Several practical problems arise. If tissue is not already anonymised, researchers will need consent to make it anonymous. If a project links a pathology collection of tissue samples with a database, for epidemiological monitoring, for example, which is not purely public health monitoring, the researcher would need consent from every person whose sample was in the collection and every person on the database. Similarly, if the collection of tissue was to be linked to postcode data, that would require consent from each and every person, to the extent that it becomes completely impractical to proceed.

For both database links, if information were being linked alone, that would fall under PIAG; but if the tissue becomes the source of information, without the information from it, the tissue is no use. So I suggest that the requirement of confidentially should trump everything, as it is the ultimate patient protection. Indeed, a piece of tissue per se is of absolutely no use unless it is analysed; but the information might be incredibly important and would certainly warrant protection.

The data from tissue should, of course, be treated with the same respect and dignity as the tissue itself and that should be afforded to a patient. Tissue samples are finite; they are unique and infinitely varied; they are more difficult to anonymise than data. So a researcher would have to contact everyone on the database whose tissue is in a collection before being able to proceed, whereas to anonymise data is a much easier process.

This amendment puts a stress on confidentiality. It provides for the patient protection that the Government seek, and yet allows the work to proceed. I am aware that the Minister may feel that I am trying to hit at the same old nut with yet another hammer, but confidentiality, respect and dignity should be the key to our approach to these issues. All the problems have arisen where there was no respect for individuals' dignity. I beg to move.

6 p.m.

Lord Walton of Detchant

I raised a relevant and, perhaps, related issue previously, when I pointed out that if one is, for example, looking at a large series of slides of human tissue for research purposes relating to a particular disease or disease process, even if one is totally unaware of the individual names of people from whom those slides have been derived, one may well suddenly come across a particular slide that one remembers clearly as having been taken from a named individual. If you recognise that you have seen that slide before in research, are you then guilty of a criminal offence?

In the same way, molecular biologists become skilled at looking at databases of DNA taken from individuals. Suppose that an individual molecular biologist is researching DNA patterns in a certain disease. They may then suddenly find that they recognise the pattern of DNA as having come from an individual about whom they knew some time ago. Would they then, in carrying out that research, be guilty of a criminal offence?

Lord Clement-Jones

Briefly, I support the amendment. The Minister will be relieved to hear that, although I am armed with examples of why the amendment is necessary, I will not recite them. The cogent examples given by the noble Baroness, Lady Finlay, and the noble Lord, Lord Walton, should be quite enough to raise doubt in the Minister's mind in this area. I very much hope that a little more work in the area will be done before Report because concrete examples have been clearly displayed that make the Bill's current provisions in this area, as earlier, impracticable.

Baroness Murphy

We return to something that is the nub of the Bill. I greatly regret my absence on earlier days in Committee. I have read Hansard very carefully and wish that I could have been there.

Again and again, we see an attempt to apply a conception of consent requirements that was inserted into the international codes—in particular, of course, the declaration of Helsinki of 2002—entirely with an eye to prospective research, where subjects are recruited to participate in research and where consent can be sought in a specific, explicit way. We are now discussing a range of issues that are to do not with prospective research but databases for epidemiological research and population studies. Every one of us in this room has had his or her medical treatment based on retrospective study of what has actually happened with different treatments to different categories of patients. We cannot run those sorts of studies with a model of consent process designed for prospective research.

I am sure that we will return to these issues on Report, so I shall say no more now, but there is a fundamental conceptual problem in the way that these clauses have been drafted.

Lord Warner

In rising to respond to these amendments, I feel somewhat like an ageing rock star about to reprise my greatest hits—or not, as the case may be. We have been over this ground many times. I made clear during our first day in Committee the reasons why the Government arrived at the formulation that unconsented use of tissue in research should be subject to the protections of ROC approval and anonymisation. I will not repeat all the words that I said then, but I refer the Committee to cols. GC424–26 in Committee on 15 September.

I emphasise one especially important point. I am conscious that when I speak on these issues, I speak for the Government and it sometimes appears that the Government are wilfully not listening to the medical science community. However, I remind the Committee that the amendments made in the other place followed extensive discussion with some of the most eminent medical scientists in this country. We listened to what they said; we listened to their advice on the issue; and the agreement made was that consent, ROC approval and anonymisation where there was no consent were the requirements on which the system needed to be based.

We did not invent that in Richmond House; we produced that conclusion and discussed the drafting with a large number and wide range of eminent scientists. I need to put that on record yet again to bring home to people that we have had a long engagement with the medical science community on this issue. That is sometimes overlooked as amendments are proposed. I do not want to go over all the ground again, but I emphasise that purpose.

I can well see that it may be difficult and inconvenient on some occasions that researchers must deal with anonymised samples, but there is a reason for that, which is to protect people's privacy where necessary. There are clearly cases in which it would not only be appropriate to ask the patient for his consent but astonishing, if he had a very rare condition and could be easily identified, if he was not identified. The noble Lord, Lord Walton, raised the issue of looking at a large number of slides. I thought that I answered that case when we discussed the question earlier in Committee. In relation to DNA, it is clearly the case that the researcher lacks the intent needed for the offence to apply. So we have dealt with that issue.

Where those activities are part of public health monitoring, which keeps cropping up, they are exempt. It is clear in the Bill that that is an exempted area. I must emphasise yet again that confidentiality is not the issue; the issue is about fairness in treating people. The noble Baroness, Lady Hayman, is not here, but I was struck when she told us of some personal experiences on Second Reading: Anyone who works in a hospital sees terrible breaches of confidentiality all the time".—[Official Report, 22/7/04; col. 409.] That comes from an experienced ex-Minister and chair of a health authority. So resting on confidentiality alone is not sufficiently reassuring to the public interest.

We must hang on to that point. We have tried to strike a balance in the Bill. The Government consider that that balance has been struck after full discussion with the medical scientific community and have responded to its concerns in the requirements and safeguards put in place when consent cannot be obtained. So I must say that we will continue to resist amendments in this area at later stages.

Baroness Finlay of Llandaff

I thank the Minister for his reply and am also grateful to Members of the Committee who have spoken in support of all the amendments that I have tabled with this one. The Government have certainly listened when we compare the Bill with how it was when it first appeared. The Government have listened: I have been present at some of the discussions and felt privileged to be so. I am most grateful to the Minister for having facilitated them. It should also go on the record that the Minister himself has introduced information from the research community in to the Bill's drafting and should take credit for that. Much of the research community has been composed of people who have been undertaking clinical trials and major funded studies. The reason that I wanted to consider the matter again was because of the much smaller studies, which are not fully funded or have no funding at all but which are under way from very respectable units. In my defence, I would say that I tabled the amendments because I was requested to do so by the researchers working in the field in some of the most well known and well respected research units in the country.

I certainly accept that, although privacy is protected by confidentiality, there are breaches of it. That is lamentable. There should be standards for treating people. I am grateful to the Minister for having considered that and for his reply, and I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 102B and 103 not moved.]

Baroness Finlay of Llandaff moved Amendment No. 103ZA:

Page 58, line 23, at end insert— ( ) For the purposes of this Schedule, the use of the results of an analysis of DNA carried out for a purpose in paragraph 8 shall not be regarded as carried out for any other purpose

The noble Baroness said: I shall try to be very brief in speaking to the amendment. It has the same purpose as that of Amendment No. 112, to which my name is appended, and the reasons behind it are the same. However, the issue is that Schedule 5 applies to Scotland—the only part of the Bill that does. Again, I have been alerted to that by the genetics community, which feels that the same terms should govern their practice for the sake of clarity, whether researchers, workers and clinicians are north or south of the Border.

I accept that the clarification of overlap in use between research and health issues is something that we have already gone over quite a lot and I do not want to revisit all those arguments. The Minister may say that this is something for the Scottish Parliament to determine and that it has the powers to determine the point at which overlap between public health monitoring and research, or between education and research and so on, occurs. But that is why the amendment was tabled. I beg to move.

Lord Warner

I was quietly preparing myself for a later amendment. I must apologise to the Committee because I had this amendment marked up for my noble friend. Therefore, although I am not quite making this up on the hoof, it may sound a little as though I am.

As I understand it, the amendment is a re-run of Amendment No. 112, which we debated on 15 September in a group of amendments led by Amendment No. 110. Those were all aimed at clarifying, defining or refining the definitions for scheduled purposes. At the end of that debate, I said that I would write to colleagues with further information about the definitions that the Department of Health had in mind when drafting Parts 1 and 2. That letter is ready for dispatch but, as the amendment is on the same topic, I shall expand on some of the points here.

As I said then, the Government do not think it necessary or helpful to define too narrowly the purposes listed in the schedule, nor is it necessary to provide for mutual exclusivity of definitions. For example, an activity may properly be described as public health monitoring even though it may be possible in some cases also to describe it as research. If its primary purpose can properly be described as public health monitoring, it will fall under paragraph 2 of Schedule 1, which means that where tissue from living patients is concerned, consent will not be needed. The Human Tissue Authority will provide practical guidance and advice for those carrying out activities within its remit. Its guidance will not be definitive as ultimately it will be for the courts to decide the scope of the scheduled purposes. However, the kinds of activity which the Government had in mind when drawing up the list of purposes in Schedule 1 will be described in the letter which I am about to send. Those have been arrived at following discussion between various colleagues across the department and arm's-length bodies and outside organisations. I shall not go into the definitions now as very shortly colleagues will be receiving from me a long letter which deals with the interface between Part 1 and Part 2 purposes.

Returning to the detail of Amendment No. 103ZA, I also regard it as unnecessary because there will be no need to obtain consent from living persons where the purpose for which the DNA is analysed can probably be said to fall within paragraph 8 of Schedule 5. It would also be unacceptable to create an anomaly by including the amendment for analysis of DNA when the Committee previously agreed that it was not necessary in relation to Schedule 1. In the light of those reassurances, which I have managed to give rather creatively, I hope that the noble Baroness will be able to withdraw her amendment.

6.15 p.m.

Baroness Finlay of Llandaff

I am most grateful to the Minister for giving me some reassurances, although I hate to do this—I was concerned that Schedule 5 was the only part of the Bill that related to Scotland and I did not detect the word "Scotland" in the Minister's reply. Perhaps, at this stage, it would be better if this matter were discussed outside the Committee.

It was helpful to hear about the contents of the letter that we are about to receive but a little heart-sinking to hear that it will be a very long letter, although that may be helpful because it will clarify issues. I hope that we shall be able to discuss whether this is a matter that needs to refer to Scotland but, at this stage, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Schedule 5 agreed to.

Clause 51 agreed to.

Clause 52 [Power to de-accession human remains]:

Lord Redesdale moved Amendment No. 103ZB:

Page 33, line 3, after "not" insert— (a)

The noble Lord said: This amendment also stands in the name of the noble Lord, Lord Powell of Bayswater. I start by declaring an interest, although I am not sure whether it is pertinent. I am a member of the All-Party Parliamentary Group on the British Museum, and it is probably at the instigation of the British Museum that this amendment has been tabled.

The purpose of the amendment is not to go against the spirit of the Bill but to clarify an area that is causing some difficulty. The problem brought about by the Bill is that a clash appears to arise between some of the collections of the different national museums. Each museum has a different specialisation. Therefore, while an agreement has been reached between the Prime Minister and the Australian Prime Minister that the Australasian remains in the collection at the Natural History Museum should be returned and we utterly accept that that is appropriate, other aspects of the Bill mean that Egyptian artefacts in the British Museum would also be covered by this portion of the Bill. I do not believe that that was the purpose of the Bill and I think that it would cause problems.

This issue has already raised its head. The legal battles in America over ancient Native Americans have gone on for some time. Native American Indian groups are claiming that any remains discovered are their property. Of course, it is impossible to make such a claim in respect of pre-historic remains which go back several thousands of years. People claim them as relatives but that may not be the case at all.

I suspect that the Government will not accept the amendment at this point. I have never managed to persuade a Minister to accept an amendment on the spot. However, I believe that this amendment has merit and I hope that at a later stage the Minister will be able to come back with a government amendment which takes this area into account. The issue of 500 years is important. Although with hindsight it is very easy to ask why not 400 or 600 years, the term of 500 years would tackle a problem faced by the Museum of London which has a large number of bones that it would like to de-accession. The museum has a vast quantity of bones from the plague pits of the 1660s to 1700. The museum has a large number of bones that have no scientific merit and therefore should be laid to rest. I beg to move.

Baroness Kennedy of The Shaws

I endorse what has just been said. I declare an interest in that I am a trustee of the British Museum. We are concerned that the clause as it stands is insufficient because it is too broad in its temporal scope. The clause encompasses human remains of any age, as it currently stands. We know and understand that the reason for the inclusion of this clause was to do with the agreement between our Prime Minister and the Prime Minister of Australia on a very sensitive issue regarding claims from Australian Aborigines. However, the clause encompasses not just human remains but also human remains bound up with other materials. It automatically indicates to us that items such as ancient Egyptian mummies will fall within the remit of the proposed legislation.

We believe that the clause can sensibly be narrowed in its temporal scope to human remains younger than 500 years, as has been suggested. The Working Group on Human Remains was set up by the Department for Culture, Media and Sport in 2001. It states unequivocally that it believes it is reasonable to take account of the age of human remains in considering the treatment and destination of such remains. Specifically, it argues that the identity of human remains as ancient remains—that is, those dating from before I 500—may be particularly key. We support that very strongly.

We are not trying to close down the debate surrounding the return of human remains in particular circumstances. What we seek to say here is that, first, one would not want to see our museums exposed to huge numbers of claims. Further, it takes us back to the argument that I hope all of us would endorse; namely, that the British Museum is not just a resource for our nation, it is a world resource and a world museum. It holds artefacts and antiquities for human kind. To start the piecemeal taking apart of that could have very serious implications for our world.

This matter has been raised with the Department for Culture, Media and Sport. I understand that it may have discussed the matter with the Minister. I do not know whether the Minister has had the opportunity to have that discussion. We ask that there should be a limitation on the scope of Clause 52 so that human remains younger than 500 years—when the Bill comes into force—should be included but not those which are older. I strongly urge that upon the Minister.

Baroness Andrews

I am very grateful for the explanations that have been offered for the amendment and for the eloquence with which both the noble Lord and the noble Baroness championed the cause of narrowing the scope of the clause.

This is a complex situation. Different museums respond to problems in different ways according to different circumstances. Having said that, we are surprised that the issue is being raised only now, given that there has been such a lot of consultation and discussion between the museum authorities and the Government during the past year. The directors of all the museums named in Clause 52 were frequently consulted on this clause both before and after the Bill was introduced and to my knowledge no one said that they were unhappy with it. Indeed, after concerns were raised about the form of the power in Committee in another place, the DCMS wrote to all the museums concerned, specifically asking them whether they were happy with the power, and no comments were received to the contrary.

Having said that, and having listened to what the noble Lord has said, we understand the British Museum's concerns in the context in which they have been raised, in relation to the mummies—these are bound up with other things—and the need for them not to be subject to vexatious or gratuitous claims for de-accessioning. As the noble Lord, Lord Redesdale, said, the clause was originally put in the Bill to fulfil an undertaking by the Prime Minister to increase efforts to repatriate human remains to Australian indigenous communities. We have to see these collections as legacies of our colonial past, and we feel it is proper that museums should be able to respond positively to claims for repatriation, if they want to do so. That will not be imperilled by the amendment, because most of the collections are from the 18th and 19th centuries.

I am afraid that I shall not be breaking the noble Lord's record on this occasion and accepting the amendment forthwith, but we will take it away for consideration. We will talk to the museum sector and to the museums which the amendment would affect. We shall return to the matter on Report. On that basis, I hope that the noble Lord will feel able to withdraw the amendment.

Lord Redesdale

I thank the Minister for that reply. I quite understand her point about the 11th hour, especially as I received a phone call about the amendment only on Friday afternoon, when I was on a train to York. That shows a deficiency in the process; it also shows the great joy that legislation can bring in focusing the mind at the right time. It is better that we discuss this now rather than later.

I take on board the point about the Australasian remains. I was shocked to find out that they were being deposited as recently as the 1920s—we are talking about remains from our grandfathers' generation. I take on board what the Minister says and hope we can make some progress on this issue. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 103ZC not moved.]

Lord Redesdale moved Amendment No. 103A:

Page 33. line 6, at end insert— ( ) The Secretary of State may by Order issue guidance on the operation of this section.

The noble Lord said: I feel rather guilty about raising this, as I usually attempt to stop any form of secondary legislation on this basis. However, I think that the amendment would be a useful backstop for the clause. One of the problems I have with Clause 52 is that although it is quite clear in what it sets out to do—and I have no difficulty with that—it is slightly open-ended with regard to the means by which that would be achieved.

The Egyptian artefacts in the British Museum could be a particular issue. Under the Bill, it would be not be impossible for a Minister of State in 'Egypt to find DNA evidence linking those remains to somebody living in Egypt now and therefore making a family claim on those remains. I do not think that that was the purpose of the Bill.

The amendment would also give some degree of guidance over somewhat more contentious issues in this country. A particular issue about Stonehenge came to my attention recently. The Amesbury archer was dug up recently in the environs of Stonehenge and is a fantastic find. Associated finds with it contained gold. Therefore, not only was the gold claimed by the British Museum under the Treasure Act 1996, but so was everything that went with it. So the Amesbury archer, in its entirety, was claimed by the British Museum and became part of its collection. I believe that it might stay in the area of Stonehenge, but that is to be considered.

There is the growing movement of the pagan faith and druids who claim that these remains are part of their religion and therefore part of their cultural family, although I do not think they are claiming direct lineal descent. Therefore, claims might be put on the British Museum over whether these should be de-accessions—whether the British Museum has a right to these artefacts. This matter could cause smiles. However, one could be on the receiving end of a contentious and litigious group of people who wanted to prove a point. The Elgin Marbles show how deeply divisive certain issues can be. Therefore, I hope that the Government will look kindly on setting out clear and concise guidance that would be open-ended, so that certain issues that might cause major problems against the spirit of the Bill could be dealt with. I hope that the Minister will take that on board and I beg to move.

6.30 p.m.

Baroness Kennedy of The Shaws

I do not intend to delay the Committee, except to say that when one applies one's mind to the possibilities here—which I shall not list because it might stimulate the juices of many groups who may see possibilities if I were to do that—there are many items in the British Museum, and, I suspect in other museums, that could end up being the subject of lengthy and difficult litigation at great cost to the nation.

Baroness Andrews

This has been an interesting short debate on an interesting aspect of the Bill. As the noble Lord, Lord Redesdale, understands, because he has been involved for a long time in the preparation of the Bill, the intention behind Clause 52 is to remove the statutory bar on the listed national museums which currently prevents them from decommissioning human remains. Clause 52 aligns the power of those museums with the powers of all other museums in terms of their ability to respond to claims for restitution.

By making this matter uniform we are responding precisely to the recommendation of the Working Group on Human Remains; but the power of all museums to relinquish human remains should be made uniform. If the amendment was carried it would cut across the original intention and our response to what we understood was what museums wanted. It would mean that a separate regime would apply to those museums, as distinct from the rest of the museum community. So we have a problem with the amendment and we consider that it would be more appropriate for any guidance issued in relation to the power of museums to de-accession human remains to apply to all museums equally. The noble Lord has asked that that guidance should be clear and concise. I should like to give him that assurance.

We understand that the desire expressed in the amendment for guidance on the exercise of power given by Clause 52 should be linked to the possibility, the real fear, that museums may face legal challenges regarding the decisions over the return of human remains. But we should stress that we do not intend to leave the museums listed in Clause 52 without guidance on the exercise of those powers. The DCMS consultation, "Care of historic human remains", was launched on 28 July. Among other questions, it asked whether there should be a code of practice relating to the care and use of human remains by museums, what the content of the code should be and who should issue the code. We envisage that the consultation will lead to a code of practice for museums that will set out the factors that museums would be expected to take into account in deciding how to respond to a claim for restitution—including guidance on how to assess, for example, the standing of a claimant in relation to the remains in question and how to assess the relative merits of rival claims.

The existence of a code which would be generated with the involvement of the whole museum community and the adoption of such a code by that whole community, including the museums listed in Clause 52, would help individual museums reduce the risks of successful legal challenges to decisions over the return of human remains. I should like to stress this point. The Government will bring Clause 52 into force only when such a code of practice is in place, after all the consultation to which I have referred. This will ensure that the museums named in the Bill are not left without guidance on how to exercise the power in Clause 52. We are doing that while maintaining the need to keep the uniformity of approach in Clause 52. I trust that with that reassurance the noble Lord will feel able to withdraw his amendment.

Lord Redesdale

The purpose of the amendment was probing; there was never an intention to press it. I hope that the Minister will take on board, along with those drawing up the guidelines, that the area is a minefield and may well throw up some surprises in future. On that basis, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 52 agreed to.

Clause 53 agreed to.

Schedule 6 agreed to.

Clauses 54 to 56 agreed to.

Clause 57 [Orders and regulations]:

Lord Warner moved Amendments Nos. 104 and 105:

Page 34, line 13, after "33(3)" insert "and (7)"

Page 34, line 19, after "33(3)" insert "or (7)"

On Question, amendments agreed to.

[Amendment No. 105A not moved.]

Lord Warner moved Amendment No. 106:

Page 34, line 41, after "33(3)" insert "and (7)"

On Question, amendment agreed to.

Clause 57, as amended, agreed to.

Clause 58 agreed to.

Clause 59 [General interpretation]:

Lord Clement-Jones moved Amendment No. 107:

Page 35, line 26, leave out "18" and insert "16"

The noble Lord said: This very innocuous-looking amendment could be said to challenge the whole architecture of Clauses 2 and 3. However, I hasten to reassure the Minister that it is designed as a probing amendment. Indeed, I am not sure in my own mind in which direction it would be appropriate to travel, but it would be useful to know the underlying reasoning for the adoption of the definition of a child as being under 18, rather than 16. As is well known, English law is very mixed in its treatment of those who are 16 or 18. The age of consent for sexual purposes is 16; the age of minority is 18 for other forms of legal consent. The Government's reasoning for choosing 18 rather than 16 in this case is very important, and should be set out on the record.

The particular effect of a person aged 17 being caught by Clause 2 as opposed to Clause 3 relates to the whole issue of parental consent and the particular additional requirements set out in Clause 2, on which I shall not go into great detail. The Government clearly felt that a 17 year-old should have that particular additional consent rather than be treated as an independent person for the purposes of Clause 3.

The area merits some consideration because of the importance of consent in these circumstances, when often young people are not living with their parents and are not necessarily under parental guidance or control. It may therefore be appropriate that they are treated as adults for this purpose. I look forward to hearing what the Minister has to say. I beg to move.

Baroness Finlay of Llandaff

In one sentence, I support the amendment. The noble Lord, Lord Clement-Jones, pointed out how many youngsters of 16 or 17 live independently. Indeed, they are competent to take decisions and therefore to give consent. It takes almost a backward step to recognise that in all practical circumstances, 16 and 17 year-olds are living as adults in our society today.

Lord Walton of Detchant

I do not want to pursue the matter too far, but I am sure that the Minister will be fully aware that some of us in the medical profession had considerable discussion about the whole issue of consent in minors many years ago and the Family Law Reform Act stated explicitly that consent given by a young person of 16 shall be as valid as if that individual was of full age. Surely that should be taken account of in the clause.

Lord Warner

I am happy to try to set out the Government's thinking as to how the Bill is framed in his area. The Bill treats everyone under the age of 18 as a child. We chose the age of 18 as being the general age of majority, but Clause 2 deals with consent for children and makes a distinction between competent and, if I may put it this way, incompetent children.

Competence in relation to children, as the noble Lord, Lord Walton, I think implies, is a well understood concept. If the child is competent and makes the decision to allow the use of his material for scheduled purposes, the Bill does not allow that decision to be overridden by a parent. The Bill therefore allows specifically for the competent child, whether 17, 16 or, indeed, younger, to make decisions and for those decisions to be respected. However, in relation to medical treatment, which is where I think the noble Lord, Lord Walton, comes in, statute gives 16 and 17 year-olds a right to consent that relates only to consent to medical treatment, not refusal. A competent child's refusal can be overridden in exceptional circumstances by the parent or by a court.

It would not be appropriate to replicate that scheme for the storage and usage of tissue for scheduled purposes, because refusing medical treatment has far more serious potential consequences for the child than a refusal to allow use of tissue for scheduled purposes. Therefore, although we have followed the broad scheme of consent for medical treatment, we have good reason, as I have explained, for not replicating it exactly in that area. That is the basis of our thinking. We believe that it is consistent with the other arrangements for consent by young people.

Lord Clement-Jones

I thank the Minister for that reply. He drew his analogy purely with medical treatment. I am not sure that he has drawn his analogy broadly enough by looking across the piece for other forms of consent. I will study his reply carefully, but one would need also to consider consent for purposes of data protection and a variety of other analogous situations to see whether one is drawing the line too fiercely at 18 rather than 16. I understand why the focus is on medical treatment and why that analogy has been used, but I am not sure whether that is absolutely the best analogy in the circumstances. Be that as it may, I am grateful for the Minister's reply, although we may seek a much fuller explanation for the total context in which this is placed. In the mean time, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

6.45 p.m.

Lord Clement-Jones moved Amendment No. 108:

Page 35, line 36, at end insert— "storage" means keeping under controlled conditions until distribution for use.

The noble Lord said: It is always a great pleasure to try to persuade the Minister. No doubt he will have to seek guidance from the parliamentary draftsman on whether there is a lacuna in the Bill—perish the thought!

It appears that the word "storage" is used throughout the Bill and we have probably used it on a number of occasions. But it is not defined and it appears that it means something rather different from simply having or possessing. However, its meaning is not entirely clear.

I know that the Minister places great faith in the High Court and in the judges and so on. No doubt in due course he will tell me what will happen with proper interpretation. However, as is the case with a number of other definitions in the Bill, it seems that it would be helpful for the research community to have a definition, broad though it may be. The amendment would clarify the meaning of "storage" and, of course, the scope of offences that are dependent on it. That is the key. If there is an offence, it is helpful to have a definition of the word "storage". I beg to move.

Lord Warner

The search for truth is a very beguiling approach often taken by the noble Lord. It is certainly true that there is no definition of "storage" in the Bill and we own up to that, but we have taken the word to have its natural meaning. For example, the Oxford English Dictionary meaning is, keeping or accumulating for future use". The effect of defining the word "storage" in the way proposed in Amendment No. 108 would be to reduce the scope of regulation under the Bill to the storage of human bodies or tissue in tissue banks where the material is for distribution to end users.

The intention of the Bill has always been to regulate the storage of human tissue in general terms and not to restrict the scope of the Bill to particular kinds of storage. The amendment would mean that storage of tissue which was simply kept in-house in a laboratory or an archive and not distributed elsewhere would be unregulated. That would not be acceptable, particularly in the light of the history which has led to the introduction of the Bill.

At Clause 16(3) the Bill provides a regulatory power which will enable the Secretary of State to specify circumstances in which the storage of human tissue by a person intending to use it for a scheduled purpose can be exempted from licensing. The intention is that this power will be used to exempt from licensing the small amounts of tissue that researchers may have in their laboratories for their own use. We think that this flexible approach is preferable to trying to limit the definition of "storage" in the Bill. I hope that that reassures the noble Lord that the scope of licensing will not extend to, if I may express it in this way, every pot of tissue on a laboratory bench.

Lord Clement-Jones

I thank the Minister for that reply. When he is in full flexibility flight, who am I not to accept what he says? I agree that the amendment is rather defective as it limits and does not simply describe. But I shall read what he said more broadly about the impact of his flexible approach, and it is possible that we shall consider the matter again on Report. In the mean time, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Earl Howe moved Amendment No. 109:

Page 36, line 16, leave out "family"

The noble Earl said: Subsection (8) of Clause 59 defines the term "partner" for the purposes of the Bill. A person is someone's partner if the two of them, whether of different sexes or the same sex, live as partners in an enduring family relationship. I do not object in the slightest to the intention underlying this definition; what I question is the inclusion in the definition of the word "family". It is very difficult to see what value is added by that word. Taken in its ordinary meaning, "partner" means sexual partner. A family is normally understood to mean more than just two people. I think that it would be odd to refer to a cohabiting man and woman, or two homosexuals living together, as a family. The key to the meaning of "partner" is surely the word "enduring". Two people cannot be described as partners if they have been living together for just a couple of weeks.

Equally, the word "family" carries connotations which I am not sure the Government intend. When the Civil Partnership Bill was going through the House, Ministers made it absolutely clear that they rejected the idea of spinster sisters or of brother and sister or of two friends living together in an asexual relationship as being on an equal footing to a same-sex couple in a sexual relationship. Indeed, there was a fundamental falling out between the Government and other noble Lords on this very question. I am not going to go into the rights and wrongs of that debate except to say that the Government's concept of a partner for the purposes of that Bill was much narrower than that entertained by a number of other Peers. I take it that the same approach applies here yet by introducing the word "family" it seems to me that the Government are openly inviting the alternative interpretation of the word "partner" so as to include brothers and sisters living together, or two cousins living together non-sexually, or an aunt and niece living together.

Perhaps in this instance Ministers are perfectly relaxed about such an interpretation but I would be slightly surprised if they were. Brothers and sisters and other relations are catered for elsewhere in the hierarchy of qualifying relationships. Unless there is an intention to include cohabiting cousins or aunts and nieces who are clearly of the same family, the word "family" would seem to me redundant. It would be helpful to hear from the Minister whether he agrees with me that, all things considered, it is a word that is misleading in this context and it might be better taken out. I beg to move.

Lord Clement-Jones

This is the sting in the tail of the amendments that the noble Earl, Lord Howe, proposes to the Bill. In general I agree with him but I wish to put on record that I very much disagree with him in this particular case. The definition of "family" should be broad and inclusive, not narrow and exclusive in the way that he has described. The hour is late and we are at the very end of the Committee stage of this Bill. I am sure that we can have a very useful debate at greater length on another occasion, but suffice it to say that on this occasion I entirely agree with the way in which the Bill is drafted.

Lord Warner

I am not sure how to respond to that. The words of the definition of "partner" in Clause 59 have been chosen with great care, and the definition is based on examples in other recent statutes, for example, the Adoption and Children Act 2002, the Sexual Offences Act 2003 and the Anti-social Behaviour Act 2003.

The fact that two people live together as partners in an "enduring family relationship" does not imply that the relationship is part of some larger family. It is just that the relationship between them as partners must be of the same character in terms of mutual affection and support as that which is typical of such a relationship in the family context.

If the word "family" were to be omitted, it would not be clear what kind of enduring relationship was in view. It might, for example, mean that two people who happen to live together and who have been long-term partners for commercial purposes were brought within the definition, when this is not the intention. We do not believe that the amendment is helpful and it could cause some uncertainty, particularly given the framing of this terminology in recent legislation.

Earl Howe

I shall go away and think about that. I am sorry that the noble Lord, Lord Clement-Jones, came down so firmly in the other camp. He did not explain why that was the case, but nevertheless I am sure that he would associate himself with the arguments put forward by the Minister—arguments which I shall have to dwell upon at greater length in the interim between now and Report. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 110 to 112 not moved.]

Clause 59 agreed to.

Clauses 60 and 61 agreed to.

Schedule 7 agreed to.

Clause 62 agreed to.

Schedule 8 agreed to.

Clauses 63 and 64 agreed to.

Clause 65 [Commencement]:

Lord Jenkin of Roding moved Amendment No. 113:

Page 38, line 27, leave out "The remaining provisions" and insert "Subject to subsection (6), the other provisions"

The noble Lord said: In discussing the amendment, I suggest that we also discuss Amendment No. 114.

It is always pleasant when one comes to the end of a long race such as this and I feel privileged to move the last two amendments. Noble Lords will have recognised my considerable reticence over the past three and a half hours, which was in order that we should be able to finish the Grand Committee stage today. We look like achieving that, and I shall be very brief.

On Second Reading, the noble Baroness, Lady Warwick of Undercliffe, who speaks on university matters with great authority, said: The legislation has significant implications for a wide range of staff, and there is a need to consider the role of those no directly involved in clinical research. Non-research clinicians are a vital link in the chain of medical research, due to the role which they play in securing consent to obtain human tissue for future research purposes". Then comes the key sentence in the paragraph. The noble Baroness said: We therefore need to ensure that the appropriate provision is made for advising such staff on all relevant aspects of the consent process".—[Official Report, 22/7/04; col. 398.]

Throughout the debates on the Bill so far, the Minister has laid great stress on the role to be played by the codes of practice that are to be introduced. Also, we have been conscious of the wide range of regulation-making powers which the Government are taking in the Bill. My purpose in moving these amendments, which relate to the commencement of the Bill, derives from the fact that these codes and regulations must be in place before those provisions of the Bill come into force that could impose criminal penalties. If that is not done, there is a risk of very great unfairness to staff, who may do things in complete trust that they are acting lawfully, only to find when the regulations are made that it is unlawful, or when the codes are published that they really should not have done it in that way at all.

Research cannot stand still while awaiting clarification of these matters. Of course, no one wants to embark on a path that might inadvertently lead to a law-breaking situation, due to a lack of clarity. Therefore, it seems to me and to some of those who have been advising me that it is essential that the codes of best practice should be visible and in place as soon as possible, and that they should pre-date the commencement of the parts of the Bill where criminal panalties apply. I am advised that the amendments would achieve that purpose, and I hope that that will attract the sympathy of the Government. We are seeking fairness for the people who will actually have to carry out the provisions of the Bill. I beg to move.

7 p.m.

Earl Howe

I hope that the Minister has some words of comfort for my noble friend in the very cogent case that he has put.

Lord Warner

I certainly pay tribute to the noble Lord's reticence today. I am grateful for his contribution to speeding up progress on the Bill. I think that in Amendment No. 114 he may have meant Clauses 5 and 8 rather than 5 and 6. In my ever-helpful way, I thought that I would draw that to his attention.

Lord Jenkin of Roding

That may well be so.

Lord Warner

Our starting point is that we do not think it necessary to stipulate in the Bill a three-month delay between publication of the codes of practice and the offences coming into force. Clause 65 already allows for implementation of different parts of the Bill to take place at different times. We share the noble Lord's concern that there would be little point in introducing codes of practice out of the blue when people were not aware of what was in them.

The codes will be subject to a huge amount of public consultation and consultation with particular interests. It is therefore highly unlikely that people will be caught unawares. However, in the spirit of constructive consideration, and given the concern which the noble Lord is expressing on behalf of people who work in this area, I will take the issue away and see if we can do something to meet his concerns about Clauses 5 and 8.

Lord Jenkin of Roding

As we come to the final hurdle, we have made some progress. I am most grateful to the Minister for those remarks and for his readiness in understanding the difficulties that people would face. I apologise if Amendment No. 114 was not properly worded, but I think that he got the sense of it. We want to ensure that the regulations and the codes should be in force, available and visible before there is any risk of criminal proceedings under the Bill. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 114 not moved.]

Clause 65 agreed to.

Clause 66 agreed to.

Bill reported with amendments.

The Committee adjourned at four minutes past seven o'clock.