Human Tissue Bill

Public Bill Committee, 5 February 2004.

Standing Committee G

Clause 30 - Restriction on transplants involving a live donor

Richard Taylor (Independent, Wyre Forest)

I beg to move amendment No. 56, in

clause 30, page 20, line 41, leave out from 'shall' to end of line 45 and add—

'(a) set out the circumstances in which decisions of the Authority in relation to matters which fall to be decided by it under the regulations shall be subject to reconsideration, and

(b) prescribe the procedure to be followed for such reconsideration.'.

I regret that we did not reach this clause on Tuesday because the Ministers were in such a mood of generosity and kindness that I would like to have moved the amendment then. It is simply a drafting amendment. The Under-Secretary talked about darkness descending upon him. Well, every time I look at the wording of the clause, darkness descends on me. I am sure that the Ministers were not responsible for its wording, so I can be very rude about it. The word ''regulations'' is used four times; the phrase ''regulations may provide'' is used twice; and phrases such as ''subject to'' and ''in accordance with'' are also included. Even a child at school would know that the same words and phrases should not be used time and again. Assuming that the hon. Member for Oxford, West and Abingdon (Dr. Harris) and I, and the staff of the House who helped us draft the amendment, have understood the clause correctly—I am still in doubt about that—is not our wording easier to understand and less opaque?

I finish with the advice of a Chinese philosopher, Chang Tzu, writing in 300 BC. I cannot resist reading a bit more than I need because the oriental imagery is so marvellous. He wrote:

''The sage has the sun and moon by his side. He grasps the universe under the arm. He blends everything into a harmonious whole and casts aside whatever is confused or obscured''.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Before the hon. Gentleman sits down, is it not worth reading out subsection (4); otherwise readers of Hansard might not be aware what it is he objects to?

Richard Taylor (Independent, Wyre Forest)

Indeed. Subsection (4) states:

''Regulations under subsection (3) shall include provision for decisions of the Authority in relation to matters which fall to be decided by it under the regulations to be subject, in such circumstances as the regulations may provide, to reconsideration in accordance with such procedure as the regulations may provide.''

Andrew Murrison (Conservative, Westbury)

Interestingly, the guidance notes that are provided for our edification on the more obscure parts of the Bill are completely silent about the clause. Clearly those responsible for drafting the guidance notes felt, as the hon. Member for Wyre Forest (Dr. Taylor) feels, that the clause is completely impenetrable. To that extent I support the thrust of his argument and his amendment. Will the Under-Secretary tell us what situations he can perceive that would bear on the circumstances quoted in the clause and, perhaps, explain why the clause is here in the first place? Might it not be more appropriate to ditch it altogether?

Stephen Ladyman (Labour, South Thanet)

Difficult, certainly, but not impenetrable—that is how I would describe the clause. Biology is complicated, which is why the brightest people become biologists. People who are not quite bright enough to be biologists but are still quite bright become lawyers, and they will help us to unravel the clause.

I understand the general concern that the hon. Member for Wyre Forest, other hon. Members and practising researchers and clinicians will have about the Bill's complexity, but I will give the hon. Gentleman an analogy. I am sure that all his constituents pretty much understand the laws that govern the use of our roads. We do not expect them to understand all the legislation, but we have provided them with the highway code, which they are expected to read, understand and be tested on. The code is a changing document that is revised, moves with the times and is written in plain English.

The people who will have to work under the provisions in the Bill will not be using its wording but following a ''highway code'' on best practice guidance that the Human Tissue Authority will provide. That guidance will be easy to follow and written in plain English, and we will expect people to understand it. People should not get too worked up about the fact that some lines and paragraphs in the Bill will be more understandable to lawyers than to the rest of us. Unfortunately, although the amendment might result in easier reading, it would change the clause's intention and is clearly deficient. On that basis, I ask the hon. Gentleman to withdraw it.

Paragraph (a) of the amendment appears to suggest that provision for reconsideration of decisions by the authority is already required under subsection (3) and that the duty under paragraph (a) is simply to spell out the circumstances in which reconsideration applies and to prescribe the procedures for that. In fact, reconsideration of decisions by the authority is not covered by the power in subsection (3). Subsection (4) states that, if the Secretary of State makes regulations under subsection (3) to say when live transplants may go ahead, they must include provision for reconsideration of decisions made under those regulations. It also provides for powers to set out the circumstances in which reconsideration applies and a power to define the procedure.

Subsection (4) is a carefully drafted provision that ensures that an appropriate mechanism will be available for the reconsideration of decisions that the authority may make under the regulations. It is right to keep that provision, which achieves the right effect. It will inform the drafting of regulations, but it will not be of direct concern to practitioners.

The suggested phrase

''the procedure to be followed for such reconsideration''

implies that the procedure is for the initiation of a reconsideration, whereas we have in mind something more general, which also captures the procedure to be followed in the implementation of the reconsideration.

I mention such points of detail to show that the Bill's provisions are the result of careful consideration and drafting. Although it may appear to some that certain provisions are overly complex, there are good reasons for the wording, which was chosen with great care. Will the hon. Gentleman at least accept my assurance that practitioners will not have to follow the wording, as the authority will provide plain English guidance for them. I hope that he will be comforted and withdraw the amendment.

Richard Taylor (Independent, Wyre Forest)

I am very relieved; I thought that, having said that biologists were the brightest, the Under-Secretary was going to add that doctors were the dullest, but at least he avoided saying that.

I am sad, as such tortuous writing, even in a document meant for lawyers rather than the general public—the gist of the Under Secretary's argument—brings this place into a degree of disrepute. However, the hon. Gentleman has assured us that it is carefully drafted and that our wording does not cover the points exactly, so I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 30 ordered to stand part of the Bill.

Clauses 31 to 34 ordered to stand part of the Bill.

Clause 35 - Remit of Inspectorate of Organ and Tissue for Human Use

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 130, in

clause 35, page 24, line 6, after 'blood', insert 'blood precursors'.

The clause contains an omission, which the Under-Secretary will be keen to correct. ''Relevant material'', referred to in subsection (3), is said to exclude

''blood or anything derived from blood.''

That appears not to take account of bone marrow, and I assume that it would be the hon. Gentleman's intention to include that.

The wording of my amendment is a bit of a nonsense and, as the Under-Secretary commented on how we are all keen on plain English, I shall suggest an amendment to my amendment. My amendment would change the subsection to read: ''In this section, 'relevant material' does not include blood, blood

precursors or anything derived from blood.'' That clearly makes no sense. Of course, I intended it to read: ''In this section, 'relevant material' does not include blood or anything derived from blood or blood precursors'', with specific reference to bone marrow, and I suspect that that is the hon. Gentleman's intention.

Stephen Ladyman (Labour, South Thanet)

The impact of the amendment would be to remove blood stem cells—haematopoietic cells—from the Bill, and that is not our intention. Blood and blood derivatives would not be covered by the constraints of the Bill, but bone marrow should be. Therefore, the wording of the subsection is appropriate.

Blood stem cells are contained in bone marrow, and the amendment would leave bone marrow transplantation out of the regulatory scheme. That would be wholly inconsistent with the general approach to, and structure of, licensing and regulation of tissue under the Bill and in our wider scheme of law.

The Bill's scope extends to all relevant material, and for the purposes of part 1, which deals with consent, that means all material from a human body except material covered by the Human Fertilisation and Embryology Act 1990—sperm, eggs and embryos—and hair and nails. In respect of the need for consent, the Bill therefore includes blood and blood precursor cells.

The remit of the Human Tissue Authority is set out in clause 11. Under subsection (5), the remit excludes

''blood or anything derived from blood''

when used for the purpose of transplantation, which in this case means transfusion. The remit of the inspectorates relates to the authority's general remit. Therefore, the remit of the inspectorate of organ and tissue for human use, as outlined in clause 35, also excludes

''blood or anything derived from blood.''

The reason for that exclusion is that provision is already made for the regulation of blood and blood products for human application under the EU blood directive. We do not wish to duplicate that.

To create a consistent and comprehensive framework, the principle underlying the Bill is to regulate all human cells unless they are regulated elsewhere or do not need to be, as is the case with hair and nails.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Will the Under-Secretary confirm that the inclusion of bone marrow would include autologous transfusion, in which bone marrow is taken from the patient and put back into the patient? Will the same apply to other human tissue for those purposes?

Stephen Ladyman (Labour, South Thanet)

Yes, I believe that I can confirm that, but if I change my mind before I finish speaking, I will let the hon. Gentleman know.

Rosie Winterton (Labour, Doncaster Central)

My hon. Friend will not change his mind.

Stephen Ladyman (Labour, South Thanet)

No, I will not change my mind.

Blood and blood derivatives fall under the consent provisions, but their procurement, storage and use are excluded from regulation, because they will be dealt with by arrangements being set up under the blood directive. A designated competent authority will carry out inspections under legislation following the blood directive.

However, blood precursors—blood stem cells—are not regulated under the blood directive, so the amendment would remove storage and use of blood precursors from regulation by the appropriate inspectorate. That would mean removing bone marrow transplantation from the oversight of the inspectorate, undermining the comprehensive scope of the regulatory regime. That would be inappropriate, as I hope hon. Members will agree.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

According to the Under-Secretary's answer to my previous question, he is saying that the remit of the authority and the inspectorates will include bone marrow or other tissue taken during an operation that is treated intra-operatively—within the operation—and then put back, because it had been taken out of the body, for example, to transfect for gene therapy or something else. Is that really his intention?

Stephen Ladyman (Labour, South Thanet)

That will be within the remit, but not licensable. If I can clarify that further later on, I will certainly do so. With those explanations, I hope that the hon. Member for Westbury (Dr. Murrison) will accept that he should withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

Given the explanation and the assurances, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 35 ordered to stand part of the Bill.

Schedule 4 - Inspectorates: Boards

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 15, in

schedule 4, page 49, line 38, at end insert—

'(3) Subject to sub-paragraph (2) above, the Authority shall exercise its power to appoint at least one member of the Board whom it believes to be representative of the interests of the Royal College of Pathologists.'.

Various learned bodies and groups representing those engaged in medical research or, professionally, in the handling of human material have expressed concern that their experience and expertise will not be adequately reflected in the various bodies created under the Bill. We have to admit that part of that concern is altruistic; there is a genuine desire on the part of those groups to lend their experience and expertise to these bodies. There is also concern for their members and others who work in this sphere, given the potentially quite punitive nature of some of the measures. It is therefore only natural that those groups should seek to influence the bodies that will be created. The public can be assured that they would benefit from their presence and active involvement in

the inspectorates, which many of us are concerned will not be adequately informed, given the complex nature of much of the subject matter.

The amendment would specifically include representatives of the Royal College of Pathologists in the inspectorate of anatomy and pathology. It is reasonable that such people should be included, given the subject matter with which that inspectorate will be dealing. The Bill deals to a large extent with those who will be excluded from the various bodies that will be set up, but it says relatively little about those who will be included and the expertise that the bodies will have. The amendment would give the authority a steer in that respect.

Stephen Ladyman (Labour, South Thanet)

On Tuesday, in debating amendment No. 6, which was tabled by the hon. Member for South Cambridgeshire (Mr. Lansley), we discussed issues similar to those raised by this amendment. He sought to have the Bill specify that members with relevant expertise should be appointed to the authority. My hon. Friend the Minister of State said then that it is important that a range of expertise is reflected in the authority's membership. That will apply equally to the boards of the inspectorates.

It would be inappropriate to identify one particular professional interest that had to be represented on the board of the inspectorate of anatomy and pathology. That is not to say that we do not regard the Royal College of Pathologists as an important body with a legitimate interest in the activities of the inspectorate. However, it is not only pathology that has such an interest, but the anatomy, tissue banking and pharmaceutical communities. In any event, in making appointments to the board, the authority will comply with the standards of the Nolan report, which includes the overriding principle that all appointments should be made on merit. All vacancies will be brought to the attention of those with an interest in the area of the inspectorate's work so that they can apply. The vast majority of public bodies do not have persons who represent particular bodies on their boards, and there is no special case for treating the inspectorate differently.

With that assurance, I hope that the hon. Gentleman will withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

The Under-Secretary seems to be saying that he would expect the bodies to include people who are associated with the various organisations that will be dealt with by the Bill. I hope that that is true and that those bodies will act as a repository of experience and expertise. Given that my interpretation of his comments is correct, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Schedule 4 agreed to.

Clauses 36 to 39 ordered to stand part of the Bill.

Clause 40 - Criminal justice purposes

Harry Cohen (Labour, Leyton and Wanstead)

Subsection (1) describes

''the prevention or detection of crime, or . . . the conduct of a prosecution''

as purposes of examinations and the removal of body parts. As Committee members might know, I spoke on Second Reading about a long-term concern of mine: the removal of brains of criminals and people generally. I am led to understand that the brain is removed in an extremely high percentage of cases when there is a pathologist post-mortem examination. I do not understand why.

Richard Taylor (Independent, Wyre Forest)

I should point out that for an effective post-mortem examination in which the brain has to be examined, it must be removed in toto because it must be fixed before it can be sectioned for examination. Removal of the brain is implicit in a post mortem that requires examination of the brain.

Harry Cohen (Labour, Leyton and Wanstead)

I appreciate that point, and I understand that a relatively high proportion of such post mortems would include brain removal, especially if people had had brain-related deaths. However, my understanding is that the brain is removed in about 45 per cent. of all post mortems. That seems excessively high.

I want to concentrate on the criminal justice aspect. At the time of Ronnie Kray's death, I read a report that his brain was removed and that he was buried without it. That caused a lot of offence to his family. Fred West also had his brain removed. We do not know what has happened in the case of Harold Shipman—I cannot ask because that is all sub judice at present. Fred West and Harold Shipman both hung themselves, so I do not understand why, in those circumstances, their brains should be removed.

I received an answer to my question from the Under-Secretary of State for Constitutional Affairs, the hon. Member for Tottenham (Mr. Lammy), who said:

''Under the Coroners Act 1988 and Coroners Rules 1984, a coroner undertaking a coroner's post mortem examination may remove and retain any organs or tissue that he/she deems relevant to the cause of death on his/her own authority alone. However, any organ or tissue removed in such cases may not be used for any other purpose unless separate authorisation is obtained.''—[Official Report, 4 June 2003; Vol. 406, c. 485W.]

That answer was welcome. However, I wonder whether coroners are qualified to make that decision. It seems that, particularly in the prison system, the process is driven by the pathologists, who want to undertake brain removal. The pathologists seem to be setting the trends.

Andrew Murrison (Conservative, Westbury)

The hon. Gentleman has done the Committee a great service by raising an important point. I suspect that the answer is that the pathologist conducting the coroner's post mortem has a series of tick boxes and that the process is very didactic. I suspect that the removal, weighing, fixing and

examination of the brain are part of that list. A more reasoned approach to the examination of those organs might be appropriate.

Harry Cohen (Labour, Leyton and Wanstead)

The hon. Gentleman has hit the nail on the head—I think that the removal of brains is done automatically, as a matter of routine. That should not be the case. Whether for criminals or members of the public, brains should be removed only if there is proof or suspicion that a brain illness or defect has caused death.

I received an interesting e-mail from Caroline Wheeler of the Sunday Mercury, a Birmingham newspaper. She says:

''I am a journalist from the Sunday Mercury . . . I recently read an article in the Sunday Mirror, where the report claimed that bids were coming in from scientists across both sides of the Atlantic to buy Robert Maudsley's brain after he died.''

Robert Maudsley has not died—he was very ill, but did not die. He was an axe killer who—ironically—threatened to eat someone's brain. Ms Wheeler told me that bids of about £25,000 were submitted for his brain. There is therefore a bit of a market building up in criminal brains.

In an earlier debate, I referred to the notion—it is still very prevalent—of a criminal gene. I understand that that notion has been discredited because there is no evidence for it, but it is still prevalent among some people in criminology and anatomy. We do not want that sort of market to build up.

In Britain, we used to hang, draw and quarter criminals. The criminals whom I have named—as well as many others—were vicious, horrible people, but we do not want to go back to those days. We do not want their brains to be taken out automatically either—perhaps as a sort of punishment. We should have respect for bodies, even those of criminals.

I share the suspicion of the hon. Member for Westbury that the post-mortem process is carried out according to a tick-box system. I ask the Under-Secretary to examine that to see whether we can improve the system so that brains will not be removed automatically if there is no reason to do so. I seek those improvements not just for criminals—their treatment was my main reason for raising the matter—but for members of the public.

Stephen Ladyman (Labour, South Thanet)

I thank my hon. Friend for raising this issue. I assure him and more importantly, Mr. Maudsley, that there is legislation covering the removal of people's brains before they are dead.

Harry Cohen (Labour, Leyton and Wanstead)

But will his brain be sold after his death?

Stephen Ladyman (Labour, South Thanet)

I assure my hon. Friend that it will not be possible to sell organs. There may be good reason in the criminal justice system for it to be appropriate to look at the brain, even when it is clear that the direct cause of death was something else. My hon. Friend mentioned hanging, and it may be clear that the person died as a result of asphyxiation through hanging. However, coroners might legitimately want to ask why the person hanged himself, whether it was as a result of a mental

disorder—which clearly cannot be gauged from a physical examination—or whether he was toxicologically induced into a fit of depression that led him to hang himself. The criminal justice system might need answers to those questions even though, on the face of it, it is clear that the person hanged himself.

One should bear in mind that a coroner's autopsy is for information for the judicial process, and that somebody may be charged with an offence in connection with someone's death. A person has a right to know that somebody will have considered carefully all the facts surrounding his death, and will have all the answers to questions—even questions that did not immediately seem obvious ones to ask. They may well become relevant questions in the context of a defence against an accusation connected with the death.

I understand my hon. Friend's point, and I absolutely agree that people's brains should not be removed for absolutely no reason. Brains can be removed only if doing so is directly relevant to the criminal justice system, or the family has given consent. It should not be done on a routine basis. It certainly should not be done on the basis of anybody offering to purchase parts from people whom they think might have special characteristics.

It is clear that the Act will allow post mortems for the purposes of the criminal justice system only in the circumstances of the exceptions mentioned in the clause. The only exceptions that we have built into the legislation are occasions on which it is necessary for certain procedures to take place outside licensed premises, such as at the scene of a crime. Clearly, scenes of crimes cannot be licensed premises, so that exception has been provided for. I assure my hon. Friend that the Government and the Committee agree with him that we must not allow the routine removal of body parts for purposes outside the criminal justice system or for unnecessary purposes. The Bill will achieve that when it is enacted.

Question put and agreed to.

Clause 40 ordered to stand part of the Bill.

Clause 41 - Religious relics

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 182, in

clause 41, page 26, line 21, after second 'of', insert 'committal or'.

Alan Hurst (Labour, Braintree)

With this it will be convenient to discuss the following:

Amendment No. 183, in

clause 41, page 26, line 31, at end insert

'or the ceremony associated with committal'.

Government amendment No. 109.

Andrew Murrison (Conservative, Westbury)

This is a fascinating clause, on which I have received a lot of correspondence. Perhaps the Government have had a lot of correspondence on the amendments as well. The result of my amendments and of the Government amendment would essentially be the same. The clause deals with religious relics, although it could be interpreted as also including

bodies displayed at funerals for relatives to view, provided that they are religious funerals. I do not think that that is the clause's intention. I think that it was drafted to apply to relics in the generally understood sense of the word: relics that might appear in a church many hundreds of years old, for example. I drafted my amendments to cover non-religious funerals, as it is perverse to allow the display of the dead at religious funerals but not at the increasing number of secular funerals. My amendments and Government amendment No. 109 would allow the display of the deceased at religious or secular funerals so that relatives and mourners can pay their respects.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I declare an interest as an honorary associate of the National Secular Society. I have had correspondence on this matter through the National Secular Society, including from a constituent of the hon. Member for Westbury. I support what he said and ask whether it is necessary, if the Government accept his amendment, to change the title of clause 41 to ensure that people's body parts are not considered as ''religious relics'' if there is no religion associated with the activity involved. Until I saw Government amendment No. 109 and the hon. Gentleman's amendments, I thought that the clause assumed that all burials were carried out in a religious setting. In fact, a significant number are not.

Stephen Ladyman (Labour, South Thanet)

I am glad that the hon. Member for Westbury acknowledges that his amendments and the Government amendment would have the same effect. Of course, the Government amendment does it better, so I hope that he will ultimately agree to accept it.

Andrew Murrison (Conservative, Westbury)

That is a very dangerous thing to say. The Committee will no doubt have observed that my amendments are far less wordy than the Government's. We have talked about the need for plain English and for the Bill to be understood. I strongly submit that my amendments are better than the Government's.

Stephen Ladyman (Labour, South Thanet)

Well, we will have to have an arm-wrestling contest to settle that later.

The hon. Gentleman is right that his amendments would remove places of non-religious burial from the remit of the Human Tissue Authority, from the licensing scheme, and from the remit of the inspectorate of anatomy and pathology. Government amendment No. 56, which we believe resolves the issue of non-religious funeral ceremonies more comprehensibly, will have the same effect by amending a different clause.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The Under-Secretary meant to refer to Government amendment No. 109 to clause 56.

Stephen Ladyman (Labour, South Thanet)

The hon. Gentleman is right. For once he illuminates me rather than clouds my judgment. He is Watson to my Holmes.

Government amendment No. 109 came about because of concerns raised, since the Bill was published in December, about the public display provision. Hon.

Members will know that public display is a scheduled purpose. Storage and use of bodies for that purpose is lawful only if the deceased gave advance, witnessed written consent. That requirement is set out in clauses 2(4) and 3(3). Public display also falls under the remit of the Human Tissue Authority, as outlined in clause 11(1), and is licensable under clause 13(2)(f)—except for display at places of public religious worship of bodies or material connected with such worship, for example religious relics, which is covered by clause 41(2).

After the Bill was published in December, it was pointed out to us that the public display of the body of the deceased before funerals is customary in some ethnic communities and at venues that might not be places of religious worship. An unintended consequence of the Bill would have been to make it unlawful to display a body at a funeral that was open to the general public, unless the deceased had given advance consent in writing. The Bill would have also required such display premises to be licensed if they were not places of religious worship.

Amendment No. 109 will remove from the definition of ''public display'' any display of a body that is connected with a person's funeral or that allows people to pay their last respects to the deceased. The exemption would apply whether or not the funeral is religious. I commend the amendment to the Committee. I hope that, on that basis, the hon. Member for Westbury will agree to withdraw his amendment. If he does so, that will be the end of the bulk of my work in this Committee. I have enjoyed serving under your chairmanship, Mr. Hurst, and that of Mrs. Adams. I hope that Opposition Members do not feel that I have teased them too often and too much. I will buy them alcohol later if they feel that I need to make it up to them.

Andrew Murrison (Conservative, Westbury)

With that tempting prospect, Mr. Hurst, and given that Government amendment No. 109 is very similar to, if rather wordier than, my amendments, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 41 ordered to stand part of the Bill.

Clauses 42 and 43 ordered to stand part of the Bill.

Clause 44 - Preservation for transplantation

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I beg to move amendment No. 124, in

clause 44, page 27, line 41, leave out from beginning to 'has' and insert

'appropriate consent for the use of the relevant part for the purpose of transplantation in accordance with the provisions of Part 1'.

Alan Hurst (Labour, Braintree)

With this it will be convenient to discuss the following:

Amendment No. 125, in

clause 44, page 27, line 41, leave out 'consent' and insert 'permission'.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The purpose of the amendments is to probe what the Government mean by the word ''consent'' in line 41. We are talking about a non-heart-beating donation where there is a need to preserve organ function, normally of the kidneys, while appropriate consent, if I may use that term, is obtained to remove organs for transplantation. By inserting a canula into the veins in the groin and perfusing the kidneys—not exclusively the kidneys these days—with a cooling fluid, their function can be preserved, even though the heart is not beating and pumping oxygenated blood around, so that they can still be used for transplantation. I wish to have a short debate on clause stand part about that approach.

The clause states that the authority

''(a) to take steps for the purpose of preserving the part for use for transplantation, and

(b) to retain the body for that purpose . . . ceases to apply once it has been established that consent making removal of the part for transplantation lawful has not been, and will not be, given.''

There is no reference to what that consent is in relation to the appropriate consent given under clause 1. Do the Government mean unqualified consent or consent that they do not cross-refer in this part of the Bill, or do they mean permission, as we would understand it, from the appropriate person? Amendment No. 125 would allow them to say that, but if we are to have a consistent Bill, perhaps they should refer back to appropriate consent, such as that given under clause 1.

I am not sure whether such provision is appropriate to the architecture of the Bill. This is one place where consent is unqualified by any adjective and so there may be a question about its nature. Who will give that permission? Without cross-reference to another part of the Bill, the hierarchy of relatives who can give that permission will be in question. I am trying to be helpful with this probing amendment. In order to speed up progress, I will conclude my remarks there.

Andrew Murrison (Conservative, Westbury)

This is a difficult but necessary clause because it will allow organs that are currently lost to be salvaged. It is quite controversial, particularly among those who might be engaged in harvesting such organs, several of whom are concerned about the ethical and legal implications for them. It is important to get the notion of consent clear, so that that category of people can feel comfortable that what they are doing is fair and reasonable.

We have exhaustively defined consent elsewhere in the Bill, and I am not clear about the word ''permission'', which we have not defined, although the hon. Member for Oxford, West and Abingdon implied that there was a common-usage understanding of the word. I would therefore resist an amendment that would substitute the word ''permission'' for ''consent''. I seek your guidance, Mr. Hurst: I assume that we will have a clause stand part debate, in which we may explore other issues.

The Chairman indicated assent.

Andrew Murrison (Conservative, Westbury)

Thank you, Mr. Hurst. With that in mind, I conclude my remarks on the amendment.

Ian Gibson (Labour, Norwich North)

Will my hon. Friend the Minister consider in her reply another aspect of consent, which I do not think we have discussed? I am referring to consent from people with motor neurone disease who can neither write nor speak. However, there are other mechanisms, involving the alphabet and so on, by which they can transmit consent. We must be careful about the giving of consent by people with different types of disease. We do not want to miss any tricks at this stage.

Rosie Winterton (Labour, Doncaster Central)

We will resist the amendments. The hon. Member for Westbury touched on the issue of consent, which we debated quite thoroughly earlier. Although amendment No. 124 is designed to reflect the wording of part 1 of the Bill, it is unnecessary. It is clear from the Bill as a whole that the consent that makes removal of an organ or tissues for transplantation lawful is the appropriate consent required by part 1. On amendment No. 125, we argue that ''permission'' would, as the hon. Gentleman said, be at odds with the wording of the rest of the Bill. The consent to which the clause refers is that which makes the removal for transplantation lawful. We know from part 1 of the Bill that that is appropriate consent as defined in clauses 2 and 3.

My hon. Friend the Member for Norwich, North (Dr. Gibson) made the important point that the Human Tissue Authority will need to consider, and issue guidance to reflect, the different circumstances that people may face. Of course, people with motor neurone disease will face particular difficulties, and it is important that appropriate mechanisms are available to enable them to indicate that they want their organs or a relative's organs to be available for transplantation should they wish to do so. The authority will be able to indicate that in guidance.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The Minister has just said that consent means the consent referred to in part 1, but that is not obvious to someone reading the Bill because it does not say—when it could—that for the purposes of the clause, consent shall mean appropriate consent, and that is not cross-referenced. In tabling these probing amendments, I wanted to ask her why she has specifically not included that cross-reference. That would be an obvious thing to do, because everywhere else that consent is mentioned, a qualifying adjective makes it clear that it is appropriate consent or qualifying consent. Why is only the vague term ''consent'' in this clause?

Rosie Winterton (Labour, Doncaster Central)

The wording in this part covers two things: the appropriate person referred to and the fact that the act of obtaining consent has been carried out. The consent cannot be any other consent; the Bill cannot talk about permission. Throughout, the Bill refers to consent—the appropriate consent in terms of the person from whom consent should be obtained. It also refers to the fact that the Human Tissue Authority will issue guidance to help people to obtain that

consent. To change the wording to ''permission'' would be inappropriate and confusing in this part of the Bill.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Shall we forget amendment No. 125, which refers to ''permission'', and concentrate on the amendment that would change ''consent'' to ''appropriate consent'', or whatever is the appropriate terminology, as defined in part 1? I do not understand why in every other part of the Bill there is a cross-reference to ''appropriate consent'' as defined in clauses 2 and 3 in part 1, but just in this clause, where one would have thought there was a need to be specific, it is left as ''consent''. It might be implied that it is something other than what is in the rest of the Bill. Courts may have difficulty seeing what the Minister sees as obvious when they have to carry out a literal interpretation of the Bill.

Rosie Winterton (Labour, Doncaster Central)

I assure the hon. Gentleman that in drafting this part, we have been careful to ensure that we are not opening up any loopholes. The method that he suggests would cause greater confusion. I realise that he is finding that difficult to accept, but I assure him that we need to consider the thread running through the Bill, especially in this part when we are discussing transplantation. Obviously consent can be made by relatives as well, and we must ensure that we use the appropriate wording. According to our legal advice from parliamentary counsel and others, the Bill's wording is appropriate.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am sorry to press the Minister on this point. She is saying that the wording is correct because she says it is correct and because that is her advice, and I find that hard to accept. I hope that she is saying it is correct because she thinks it is correct and that is her advice, but could she explain why it would be confusing or why loopholes would be created if there were a reference to appropriate consent as defined in part 1? What is being lost? As we shall discuss in the clause stand part debate, this is a controversial issue and people will want reassurance about what the Minister means by consent, versus appropriate consent.

Rosie Winterton (Labour, Doncaster Central)

I draw the hon. Gentleman's attention to clause 1(1)(c); it states that the removal of material from a deceased person is lawful with appropriate consent. The consent referred to in clause 44 cannot, therefore, be anything other than appropriate consent. I assure the hon. Gentleman that we have given thorough consideration to the correct wording to use in this clause. We know that this is the most appropriate way to express the consent to be given for transplantation. Having given the hon. Gentleman that assurance, I hope that he will seek leave to withdraw the amendment.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The Minister has just said that, because clause 44 refers to consent making removal of the part for transplantation lawful, that is all that is required to refer to part 1 of the Bill. However, I am not sure that that is as helpful as the Minister thinks. The Government have included these provisions in part 3 rather than part 1. I could understand it if they were in

the same part as those covering the definition of appropriate consent and the issue of qualifying relatives—that would flow naturally. However, some of the provisions and definitions in the Bill relate solely to a specific part, and repeat definitions cover other parts to clarify what does and does not apply to the rest of the Bill. The Minister has explained that she is confident that because the term ''lawful'' is used, the provision must refer to part 1, but she has not explained why it is not necessary, helpful or consistent to make specific reference to the phrase ''appropriate consent''.

I will not make much more progress at this point, but I hope that further explanations will be forthcoming. I am not trying to be difficult, as I am a strong supporter of the clause, but there is controversy around it, which is why I used amendment No. 124 to probe the Government's thinking. That said, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

Richard Taylor (Independent, Wyre Forest)

I want to raise some ethical concerns about the clause. Its laudable aim is to increase the supply of organs for transplantation, but it has raised troubles in the mind of some of the clinicians who harvest those organs. The concerns are similar to those surrounding the separation of those who ask for consent for a post mortem from those who carry out the examination.

The idea troubles clinicians who work in accident and emergency departments, intensive care units, medical wards and coronary care units. As we understand it, the clause makes legal without consent the measures necessary in a non-heart-beating donor to preserve the organs within the dead body until consent can be obtained. That could involve ventilation and operations on the groin to insert cannulae in the femoral artery and vein to perfuse the organ.

An intensive care consultant from Leeds, Dr. Dominic Bell, who has written about the ethical aspects of non-heart-beating donation in the Journal of Medical Ethics, has written to me:

''Under the terms of Clause 44, elective ventilation could also be incorporated if instituted at the point of death, regardless of debate already existing as to the precise timing of death for the purpose of these interventions. These are not therefore minor undertakings and many staff in the arena would harbour ethical concerns about embarking on these particularly without explicit and detailed prior consent in today's climate.''

He concludes:

''Clinicians working in areas where donor recruitment takes place need not only resolution of the key ethical issues but also highly detailed prior consent before embarking on any manoeuvres that are solely for 3rd party benefit. Aspects within the bill relating to organ procurement need expansion and greater debate and public engagement before simply authorising by legislation.''

I will be grateful to hear the Minister's comments, and if she wants me to, I shall pass her the letter so that she can consider it more deeply.

Andrew Murrison (Conservative, Westbury)

I am mindful of the lateness of the hour and our general intentions.

Andrew Lansley (Conservative, South Cambridgeshire)

My hon. Friend could go on for hours.

Andrew Murrison (Conservative, Westbury)

My hon. Friend seems to be encouraging me to speak at great length, but I understand that he, like the rest of us, would like to finish early. With that in mind, I shall keep my remarks brief.

I am concerned about this clause because it opens up a new legal and ethical area, which is—judging from the remarks of the hon. Member for Wyre Forest—opaque, to say the least. The Minister must understand that people working in intensive care units in hospitals will be asked to do something that they do not currently do. It is important that she gives us a clue about what she understands by terms such as ''least invasive'' and ''minimal''. That is unclear at the moment—although we have a fair idea of what is involved, from the hon. Gentleman's description. It involves putting people on a ventilator, for example, if they are not already on one, to preserve organs prior to harvesting. As I said earlier in the debate on the amendment, that seems entirely reasonable. However, the thread running through the Bill is consent, and we must be clear about permission or consent and the mandate on which practitioners operate before they embark on organ perfusion or de novo ventilation. It really is a minefield. Allowing the clause to stand part of the Bill, and to be dealt with in such a summary fashion, is treading on very dangerous ground.

I should encourage the Minister to talk about the terms ''least invasive'' and ''minimal''. We have done the subject of consent to death. I was reassured by some of the remarks of the hon. Member for Wyre Forest, even though the hon. Member for Oxford, West and Abingdon seemed not to be. I should appreciate a description from the Minister of what will happen in practice under the measures outlined in the clause.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

This clause is interesting because it is different from other measures in the Bill. I think that the Minister will say that it is valuable because of the need to increase the number of organs from non-heart-beating donors, which have shown to be very effective. In some studies, they are just as effective—in terms of the length of time that the transplanted organ survives—in saving and transforming life, particularly with the donation and transplantation of kidneys. Many people argue that we will make significant progress in tackling the huge shortfall of organs available for transplantation—and do something about the hundreds of people who die every year while waiting for an organ—only by increasing that form of donation. Although there has been plenty of correspondence on this issue, and it was included in the Government's consultation, it has not been the subject of a huge amount of public debate beyond that.

I would be grateful if the Minister could respond to a number of points. First, what is the origin of the authority? It is necessary to expand on what ''authority'' refers to. In the clause, the word is used as a noun meaning ''authorisation'', rather than ''an authority''. It is not clear who is responsible for ensuring that the people carrying out these activities are competent. Subsection (4) states:

''Authority under subsection (1) shall extend to any person authorised to act under the authority by—

(a) the person on whom the authority is conferred by that subsection, or

(b) a person authorised under this subsection to act under the authority.''

In a sense, that is circular, and it is not clear whether there is an authority in the sense of the Human Tissue Authority which is responsible for dealing with this matter. One assumes, since subsection (1) refers to a

''hospital, nursing home or other institution'',

that those responsible for clinical governance and care standards in hospitals, nursing homes and other institutions will have an interest in it. It is important for the Minister to clarify that because it seems to suggest that such activity might be less well regulated by the Bill than other actions, even though it may be as controversial as, or more controversial than, other activities.

My second point concerns what the ''minimum steps necessary'' are. There has been no explanation of whether those minimum steps will relate only to cannulation of the main vessels in order to perfuse them with cold fluid, or whether elective ventilation of someone who is dead—as confirmed by brain stem death—might happen at the point of death or after death. The Minister should clarify that point, because it is currently recognised that elective ventilation of someone who is alive is not lawful. That has been examined in several cases, because elective ventilation is taking an action on someone that is not for their benefit, and therefore is not covered by the usual defence to a charge of battery. Moreover, as the Minister will be aware, there is a small risk in that process of producing a persistent vegetative state, which leaves the person in limbo. That is in no one's interest.

The correspondent of the hon. Member for Wyre Forest raised that point, among others, and, as the hon. Gentleman said, was concerned that, under clause 44, elective ventilation could also be incorporated if instituted at the point of death. That matter must be clarified, and I am not sure whether the codes of practice that are mentioned throughout the Bill will cover it, because the clause makes no specific reference to codes of practice. I regret that I have not looked through the Bill to see whether the codes of practice and the authority's remit extend to that matter. I suspect that they do not and, if that is the case, it will be necessary for clear regulations and codes of practice to be devised.

Thirdly, I hope that the Government will concede, although I suspect that they may not, that they are, for this purpose, endorsing a presumed consent. The

consent is presumed for this activity to take place, until subsequent checks are made. That is the view of many people who are examining this issue, including the correspondent of the hon. Member for Wyre Forest who says in his note that the clause, despite the protestations of the Minister regarding presumed consent,

''does constitute presumed consent, albeit for preservation techniques, not actual procurement.''

The Minister must acknowledge and deal with the fact that where the need is shown, and a good purpose is intended, it is legitimate to presume consent for an action until further considerations can be taken into account.

I would be grateful if the Minister could respond to the three points that I have raised.

Rosie Winterton (Labour, Doncaster Central)

I am sure that hon. Members will recall the debates about presumed consent on Second Reading and earlier in the Committee proceedings. I gave reassurances that there were provisions in the Bill that would increase the availability of organs for donation; the clause contains such provisions.

I will briefly address some of the main points that have been made. All hon. Members have raised the question of whether the clause extends the law. I want to make it clear that it does not make perfusion lawful; that activity is already lawful. The purpose of the clause is to clarify the current position. The provision allows a hospital or nursing home to authorise a member of staff to agree that preservation can begin after death until the wishes of the deceased, or those close to them, are known. That will not involve elective ventilation, which is and will remain unlawful. The clause will allow only the minimum preservation necessary after death. Elective ventilation can commence before death and would not be lawful under the clause. I understand hon. Members' points about that, but I hope that my explanation clarifies the position.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The Minister said that the clause will not make those activities lawful. Will she clarify on what basis the current practice is lawful? How does current law—statute or common law—restrict what is lawful only to the act of preserving organs for potential transplantation use, and not to other actions taken on a dead body?

Rosie Winterton (Labour, Doncaster Central)

I know that this sounds tortuous, but the current procedure of cold perfusion is lawful because there is no law against it. I realise that that sounds odd, but it is the case. We want to make it clear to people that they can undertake that activity. Just as embalming is lawful, so is cold perfusion.

With regard to the codes of practice issued by the authority, I assure the hon. Gentleman that the authority will ensure that only the least invasive procedures are used. The hon. Members for Wyre Forest and for Westbury raised the issue of intensive care unit staff, but the activity in question is carried out by transplant teams after death. As I have said, we are trying to clarify the law so that people have confidence that they can carry out the procedure, which can add

to the number of organs available for donation. The time in which consent is sought is short simply because organs will deteriorate.

Richard Taylor (Independent, Wyre Forest)

I cannot envisage that it is practicable for perfusion to be carried out by a transplant team. Currently, it is carried out by the staff in the ICU or A and E department. I cannot envisage the transplant team being able to get to the hospital in enough time, unless the team happens to be idle in a major hospital. However, the procedure will be relevant to many people in smaller and district general hospitals without transplant teams. I am sure that the bulk of organs come from such situations and I remember the problems that we had with arranging transport.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Will the Minister give way?

Alan Hurst (Labour, Braintree)

Order. The Minister has not yet replied to Dr. Taylor's intervention.

Rosie Winterton (Labour, Doncaster Central)

I assure the hon. Member for Wyre Forest that we envisage members of the transplant team undertaking that activity because a certain amount of training will be needed.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I seek to help the Minister, which is why I wanted to intervene as soon as possible. There is some confusion, although not in the mind of the hon. Member for Wyre Forest I hasten to add, about controlled non-heart-beating donation and uncontrolled non-heart-beating donation. In many circumstances, death is liable to happen at a planned time and the appropriate steps can be taken. It is only in the uncontrolled situation, with a dead-on-arrival case in A and E, that people other than the transplant staff, such as A and E physicians and surgeons, may be required to take action.

Rosie Winterton (Labour, Doncaster Central)

The hon. Gentleman is right. I am assured that currently transplant teams, or others who are specifically trained for the purpose of carrying out the procedure, are always available.

Richard Taylor (Independent, Wyre Forest)

I thank the Minister for clarifying that. The phrase ''or others'' is crucial. In Leeds the hospital that does the transplant is different from the hospital that has the A and E department, so it will not be the transplant team who carry out the procedure; it will be done by A and E staff who are trained in the procedure.

Rosie Winterton (Labour, Doncaster Central)

The important point is that proper training is available and that it co-ordinates with the work of the transplant team so that the person is almost part of that team.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am aware that the Minister had moved on to deal with the point raised by the hon. Member for Wyre Forest, but I want to bring her back to the question of lawfulness. I should have thought that what is required is to make it explicit that the practice is lawful. Clause 1(1)(b) states that without appropriate consent

''the use of the body of a deceased person for a purpose so specified''

—in other words, transplantation—will not be lawful, and that is why clause 44 is necessary. If the Minister agrees with that, would it be useful—I suspect that she will say it would not be—to make it clear that the paragraph in clause 1 does not apply to the question of preserving organs for transplantation, even though most people would understand that to be the use of a body?

Rosie Winterton (Labour, Doncaster Central)

I am not quite sure that I completely follow the hon. Gentleman's arguments. The clause clarifies that cold perfusion is lawful, while making it quite clear that consent is required to proceed any further. This is a short procedure. The authority will ensure that it is the least invasive possible but it will make an important contribution to organ donation.

Dr. Murrison rose—

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I know that the hon. Member for Westbury wants to intervene, but I have to say that I hope that the Minister is not proposing to finish her remarks there. I asked her three specific questions. One concerned the authority that is referred to and who regulates it. The second concerned whether codes of practice would be issued—

Rosie Winterton (Labour, Doncaster Central)

I answered that.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am sorry if I missed that. Thirdly, I asked whether the Minister accepts that this is to a certain extent an issue of presumed consent, at least up to the point at which consent is required.

Rosie Winterton (Labour, Doncaster Central)

I answered that as well.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am sorry if the Minister answered that, but I did not hear her deal with those three points.

Rosie Winterton (Labour, Doncaster Central)

I think that I answered all those points in my remarks. First, I said that the codes of practice issued by the authority would state that the procedure had to be the least invasive. Secondly, I said that this did not involve presumed consent, but the carrying out of a short procedure to ensure that organs do not deteriorate until consent is obtained. Thirdly, the HTA will regulate the practice, but there is also the question of obtaining the authority to go ahead, perhaps from an individual.

Andrew Murrison (Conservative, Westbury)

I perceived that the Minister was about to conclude her remarks, so I thought that I should intervene briefly. Will she confirm that all she has in mind here is cold perfusion, not ventilation? Will she also say that she will rely on case law as a defence against a charge in the event that someone took exception to cold perfusion having been instituted? We understand that there is no statute law; that is fine. However, there must be case law for the assurance of those who will undertake the procedure. How many cases of cold perfusion have there been in, for example, the past 12 months or so?

Rosie Winterton (Labour, Doncaster Central)

Cold perfusion has been undertaken as a procedure for the past 10 years. I do not know the exact number of cases, but I can write to the hon.

Gentleman if he is interested. He asked about case law as a defence in respect of cold perfusion. Obviously, once it is lawful under the Bill, there will be statutory authority to do it. I am not quite clear what the situation would be if someone had indicated beforehand that they did not want the procedure undertaken. As far as I am aware, there have been no objections to it in the past 10 years. Cold perfusion is undertaken after death, and the results last only a certain number of hours before organs start to deteriorate.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I certainly endorse what the Minister has said. I believe that there was a case in Leicester in which someone sought to prosecute the doctors for undertaking cold perfusion, and there was a worry that the Crown Prosecution Service and the police would act. The clause is therefore welcome. If it turned out that someone had said that they did not want the procedure done to them, although that was not known at the time, the defence would be that the presumption was made that they would permit it, until their wishes were clarified.

Rosie Winterton (Labour, Doncaster Central)

No, a defence would be that the procedure is allowed under statute. It would not be a presumption; it would be what the law says. Having said that, I hope that members of the Committee will agree that the clause is important to ensure that we can assist in obtaining more organs for donation.

Question put and agreed to.

Clause 44 ordered to stand part of the Bill.

Clause 45 - Surplus tissue

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 9, in

clause 45, page 28, line 17, at end insert—

'(3A) Insofar as it would be impracticable to obtain appropriate consent in relation to material to which subsections (2) or (3) apply, it will not be unlawful to make such material available for scheduled purposes.'.

This is a probing amendment. I should be grateful if the Minister would deal with some more definitions. In particular, what does she mean by material ''dealt with as waste''? That question spurred me to table the amendment. Most people, in a utilitarian way, would probably prefer it if surplus material removed from them in the course of a medical procedure could be turned to some good use rather than disposed of. That lies at the heart of the amendment. I hope that the Minister will expound on exactly what the provision means and the circumstances in which it will apply.

I am thinking in particular of procedures such as blood tests, which are carried out many times every hour in the national health service. Parts of the material could be used to good effect for research purposes, even if the primary purpose were investigation. The amendment would allow surplus or waste tissue to be used for other scheduled purposes, with the minimum of bureaucracy and fuss. That would probably be in accordance with the wishes of the vast majority of people in this country.

Rosie Winterton (Labour, Doncaster Central)

We return to an issue—the use of human material variously described as ''residual'', ''waste'' or ''surplus''—on which the Committee has had considerable debate. To return to the Bill's principles that we are entitled to determine how material from our bodies should be used and that we should have to consent to the use of that material, we should not assume that any material that is left over from one use can be somehow used for another purpose without consent. If we followed that path, we would undermine the Bill's consent provisions, which are its very foundation. That is not only the Government's view, but is mentioned in the guidance provided by the General Medical Council:

''You must obtain appropriate consent or authorisation before taking or retaining organs, tissues or bodily fluids, from patients or volunteers, for research purposes. This applies whether the material is obtained solely for research purposes or retained following a clinical or surgical treatment.''

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I hope that the Minister will accept that part 2 of schedule 1 makes it clear that that does not apply for public health monitoring purposes. We have had a debate about what that means—although it was not satisfactory and I suspect that we shall return to it. The term ''public health monitoring'' can and will include research, not just public health monitoring. The rubicon has been crossed in that respect. That is why many people find it difficult to understand that, for epidemiological and unleaked and anonymised research, that definition appears to be quite narrow.

Rosie Winterton (Labour, Doncaster Central)

As the hon. Gentleman said, we have discussed this matter and may return to it at a later stage. We cannot accept the amendment because it would take us beyond the Bill's intention and undermine some of its fundamental principles. I hope that the hon. Member for Westbury will feel able to withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I beg to move amendment No. 127, in

clause 45, page 28, line 17, at end insert—

'(3A) Subsections (2) and (3) shall continue to apply after the person from whose body the material has been removed has died.'.

This amendment probes whether the clause covers sufficiently the question of surplus tissue taken during treatment or diagnosis from a patient or a research subject who subsequently dies. What circumstances will apply? Will the procedures that apply to the tissue of a deceased person—where there is a requirement for consent, and the opportunity for the tissue to be reunited with the body for burial—similarly apply? Is the issue dealt with as the clause specifies because when the tissue was taken the person was alive? I hope that I am making the purpose of the amendment clear; it should be clear, and I believe that it is. I hope that the Minister can reassure us on the exact position because a number of people have raised the issue with me in the fear that they might be breaking the law in such circumstances.

Rosie Winterton (Labour, Doncaster Central)

I assure the hon. Gentleman that any consent given during a lifetime persists after death, but the purpose of clause 45 is to make it clear that material taken from a human body during medical treatment, diagnostic testing and research or relevant material that for whatever reason is no longer required for those scheduled purposes may be disposed of as waste. That can apply to material either from the living or the dead; the provisions of the clause are not affected by whether the person from whom the tissue came has subsequently died. The provision is merely a way of enabling tissue that is no longer required to be disposed of and of making it absolutely clear that that activity can be undertaken. I realise that it sounds odd that that has to be clarified, but it is important for the purposes of those undertaking such activities that it is clear that they can dispose of that material unless there has been a particular request to return it if necessary.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

That was the point that I wanted to probe. I understand the purpose of the clause, but let us take the case of someone who has had an operation that involves cutting away tissue—a minor amputation, for example—and dies post-operatively. That tissue has not been taken from a deceased person. Does the Minister envisage that doctors will have a duty to offer the return of that material or will it be up to the family to request it? It is a valid point because issues have been raised in this respect and we would not want them to be raised again in an unplanned way.

Rosie Winterton (Labour, Doncaster Central)

Obviously, the authority will be looking at exactly how that would be made practicable. If a request were made about the return of tissue removed, it would obviously be respected. It is important that if, in giving consent for scheduled purposes, a particular request is made about what should happen to material afterwards, it should be taken into account.

In the light of those assurances, I hope that the hon. Gentleman will ask leave to withdraw the amendment.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Owing to the need for speed, I will not pursue the point except to note that there is a question about what happens when someone who has given consent for research to be carried out dies, and his family want everything that had been given for research, which may still be ongoing, to be returned in time for a burial.

Rosie Winterton (Labour, Doncaster Central)

Let me reassure the hon. Gentleman that if a person gives consent while alive to the use of surgical tissue, it will extend after death. The family would not be able to overturn that consent.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am very grateful to the Minister for putting that on record because it will be necessary to ensure that relatives have realistic expectations of discussions concerning this important Bill. What the Minister said will help in that respect. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I beg to move amendment No. 126, in

clause 45, page 28, line 18, leave out subsection (4).

The purpose of this probing amendment is to give the Minister an opportunity to explain the purpose of clause 45(4), which states:

''This section shall not be read as making unlawful anything which is lawful apart from this section.''

I think that I know what that means, but I am not sure that everyone who reads it will do so, and it is an important part of the clause. Rather than raising the matter in the clause stand part debate, I thought it might be useful to give advance notice that the Minister should take this opportunity, if she would be so willing, to clarify what is meant and what sort of activities are not meant to be caught by the provision.

Rosie Winterton (Labour, Doncaster Central)

I accept that this is a probing amendment. It would remove a subsection that makes it clear that the reference to lawful disposal is not intended to affect the lawfulness or otherwise of other disposals of human material. Subsection (4) simply clarifies that by referring to certain disposals in the clause. We do not intend to cast doubt over the lawfulness of disposals that are not referred to in the clause, such as disposals of tissue that have come from a person's body during the course of cosmetic treatment. We are aware that, in the medical context only, there has been some uncertainty about the status of ''discarded'' tissue. That is why we have taken the opportunity to clarify the issue. However, in doing so, we did not want to create any doubt about the status of other material.

The clause allows for material that has come from a human body during the course of medical treatment, diagnostic testing or participation in research, or is relevant material that is no longer required for scheduled purposes, to be disposed of as waste. However, it does not insist that the material be disposed of as waste, not least because that may be against the person's wishes. For example, we would not intend to criminalise the use of human material for non-scheduled purposes, such as the development of cosmetics, if that is the wish of the tissue donor.

I hope that that clarifies matters for the hon. Gentleman.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 45 ordered to stand part of the Bill.

Clause 46 - Offences relating to non-consensual analysis of DNA

Andrew Lansley (Conservative, South Cambridgeshire)

I beg to move amendment No. 184, in

clause 46, page 28, line 22, leave out paragraph (a) and insert—

'(a) he analyses or procures the analysis of any human DNA in any bodily material without qualifying consent intending—

(i) that the person from whose body the DNA has come be identified as such, and

(ii) that the results of the analysis be used otherwise than for the excepted purposes (see section 47),

unless he reasonably believes that he does the activity with qualifying consent or that what he does is not an activity to which this subsection applies,'.

Alan Hurst (Labour, Braintree)

With this it will be convenient to discuss the following:

Amendment No. 179, in

clause 46, page 28, line 22, after 'material', insert

'not covered under section 7'.

Amendment No. 131, in

clause 46, page 28, line 23, after 'DNA', insert 'or RNA'.

Amendment No. 98, in

clause 46, page 28, line 23, after 'material', insert

'or derived from that material'.

Government amendments Nos. 157 and 158.

Amendment No. 187, in

clause 46, page 28, line 33, at end insert

', or

(c) it has been imported or come from a body which has been imported.'.

Government amendments Nos. 159 to 161.

Amendment No. 188, in

clause 46, page 29, line 5, at end add—

'(6) In this section, references to bodily material which has been imported do not include bodily material which has been imported after having been exported with a view to its subsequently being re-imported.'.

Clause stand part.

Amendment No. 186, in

schedule 5, page 54, line 8, at end insert—

'(1A) The analysis shall be regarded as being the subject of qualifying consent if the analysis of DNA for the listed purpose would be authorised under section 1(1) if the analysis were done in England, Wales or Northern Ireland.'.

Schedule 5 stand part.

Amendment No. 132, in

clause 47, page 29, line 10, at end insert 'and RNA'.

Amendment No. 185, in

clause 47, page 29, line 19, at end insert—

'(g) in England, Wales and Northern Ireland, purposes specified in sections 1(1)(f) and 1(1)(g).'.

Amendment No. 133, in

clause 47, page 29, line 21, at end insert

'providing the material is anonymised'.

Amendment No. 134, in

clause 47, page 30, line 3, leave out subsection (7).

Amendment No. 135, in

clause 47, page 30, line 6, leave out from '(2)' to end of line 7.

Clause 47 stand part.

Government amendments Nos. 163 to 166, Nos. 180 and 181, and Nos. 167 to 175.

Government new schedule 2—Qualifying consent.

Andrew Lansley (Conservative, South Cambridgeshire)

As amendment No. 184 leads the group, I shall speak to that before we hear the Minister explain how the Government intend to remove clause 47 and what was schedule 5, and insert instead new schedule 2. That will help us for a couple of reasons. I hope that she will not feel the need to talk to amendments Nos. 185 and 186 because amendment No. 185 is redundant, as is, I think, amendment No. 186 because it would ensure consistency between Scotland and other parts of the United Kingdom. That consistency has become clearer by virtue of the way in which new schedule 2 is expressed.

Most of our amendments, other than amendments Nos. 184 and 98, are affected by the way in which the Government have rejigged the structure, so they probably lose their immediate effectiveness. However, they were tabled in order to raise issues. Rather than refer at length to amendments and how they work, it is simpler to refer to the subjects they raise and how they arise.

My first question relates to the creation of an offence of intent. Amendment No. 184 is designed to question the nature of the offence that we are creating. When we considered retained organs and tissue generally, we discussed the offence of storing and using materials for which consent had not been received. At no point have we created an offence of an intention to do something. When considering DNA analysis, we should ask why the offence should be constructed around an intention.

Amendment No. 184 would change the clause's structure. The offence would be to undertake or procure the analysis unless it was, for example, consented, identifiable or for an excepted purpose. The idea of intention is questionable in principle and would be difficult to define in practice. The prospect is worrisome, particularly to those engaged in medical research who might feel that they are liable for an offence arising from an intention rather than from undertaking an activity.

My second question arises from amendment No. 98. Clause 46 refers to

''human DNA in the material''

and the question of its analysis. I hope that nobody—especially not the hon. Member for Norwich, North—will ask me how it works. Apparently, it is possible and indeed common to undertake DNA analysis not necessarily on material, but following a procedure known as PRC—

Ian Gibson (Labour, Norwich North)

PCR.

Andrew Lansley (Conservative, South Cambridgeshire)

Oh. PCR. Anyway, it is possible to derive a chemical sequence from the material and then not undertake DNA analysis on that material. I hope that I am correct and the hon. Member for Norwich, North will tell me if I not. From a legal perspective, however, the analysis does not occur on the material but on a sequence derived from the material. Is that issue properly covered?

My third question relates to amendments Nos. 187 and 188 and whether the provisions are consistent with earlier provisions on the importation of bodies or relevant material from bodies, which we have discussed. Amendment No. 132 explored whether RNA should be covered as well as DNA. Again, I would hate to explain it.

Taken together, amendments Nos. 96 and 133 are designed to determine whether it is possible to extend the list of excepted research purposes and ensure that the material is anonymised and cannot be used subsequently to identify anyone. That is important. If the material is anonymised and there are no consequences on the person concerned, considerable benefits for medical research would arise as specific consent would not be needed for every case.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The question of anonymisation is interesting, but we probably will not have enough time or energy to go into it. It is important to note that although something can be anonymised at the point of analysis, the question is whether that anonymisation is irreversible, so that it can never be tracked back to other aspects of the medical record—if not of the person. We need to consider, therefore, whether it would be better irreversibly anonymised and unlinked. That needs more clarification.

Andrew Lansley (Conservative, South Cambridgeshire)

I think I understand the hon. Gentleman's point. Clearly, if there is scope for material on which DNA analysis is being undertaken subsequently to be identified, almost by definition the criterion of it being anonymous is not being met. He may well be right that practical and technological issues may be associated with whether something is anonymous but if, in practical and technological terms, it is irreversible, the legal point that the amendment tries to establish is that research ought to be able to be conducted in relation to that material.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I do not want to press the point, because it is not the key issue. I understand what the hon. Gentleman says. However, although the material may be anonymous for the purposes of research, that does not necessarily mean that it can never be tracked back. Indeed, research projects on anonymous samples sometimes allow the researchers to go back to the record, without knowing the name, to see what other factors were present and to see whether they can pick up a pattern. For example, they may find a genetic marker in a DNA analysis and want to look in the medical records, without knowing the person's name, to see whether he had a certain form of cancer. It is a complex area and, for the reasons that I have just given, more work needs to be done.

Andrew Lansley (Conservative, South Cambridgeshire)

I am happy to accept the hon. Gentleman's point. It is an interesting one, but I cannot explore it further now. However, we may need to explore it once we have had the benefit of the Minister's response.

Those are the underlying purposes of the amendments. The only general point that I would make is that considerable concern has been expressed about the developing practice in medical genetics. When considering the process of DNA analysis, and the extent to which offences are created in relation to it, we want to know how it will relate to current practice. It seems to me that we have established elsewhere the principles of consent flow into DNA analysis, but it may cause problems for those engaged in medical genetics when linking consents to subsequent treatments for sets of related individuals, even those related on a rather tenuous basis.

Ian Gibson (Labour, Norwich North)

The whole consent business has been handled through the biobank project, under which 500,000 people have consented to give DNA. It seems to be working well. It is controlled through GPs, ethical committees and so on. The procedures are in operation to give medical science the kind of information that it wants.

Andrew Lansley (Conservative, South Cambridgeshire)

The hon. Gentleman makes a good point. It shows that we respect the principles of consent and are trying to find ways to work with them. Indeed, it is my intention not to forgo consent in relation to the undertaking of DNA analysis when a person can be identified. I recognise, however, that some of the relationships between people are indeed tenuous and that people are having to give consent for purposes that stretch a long way from their personal interests in order to assist others. That is fine. If he is right, and if we proceed down that path, we may be able to assist them. However, I hope that we do not make any changes that would make some of those processes more difficult to achieve.

I have raised a number of points and we need to understand how the Minister wants to structure this part of the Bill.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am also keen to hear from the Minister. Amendment No. 179 and others in the group are in my name. I realise that what I want to achieve on existing holdings will probably be better achieved by Government amendment No. 158. On that basis, I do not propose to press amendment No. 179 to a vote. If the Minister is generous with interventions and if I catch your eye, Mr Hurst, it may be possible to speak later.

Rosie Winterton (Labour, Doncaster Central)

As hon. Gentlemen have said, the Government have tabled several linked amendments to clause 46 and introduced a new schedule to address some of the matters that have been brought to our attention by Committee members and other stakeholders. I have written to Committee members to explain our proposals and included a revised version of clause 46 showing how it will look if the amendments are accepted. I hope that the Government amendments will adequately address many of the Opposition amendments.

It was brought to our attention that, as drafted, the Bill would not allow appropriate DNA analysis of existing holdings of human material without falling foul of the offence in clause 46. The use of existing holdings of relevant material for scheduled purposes in England, Wales and Northern Ireland was exempted from the DNA offence. However, the clause currently does not deal adequately with existing holdings of other types of material such as hair, which is covered by the DNA offence. We heard about an example of research carried out by the Natural History museum on hair samples taken over the past 100 years from now extinct tribes. That would not fall within the description of research in schedule 1, and the material used would not be ''relevant material''. We have no desire to prevent such research. The clause also does not apply to existing holdings in Scotland.

To cater for such situations, we have attempted to simplify the DNA provisions. As amended, clause 46 will make it an offence for any bodily material to be held with the intention to analyse the DNA in it unless there is qualifying consent, as defined in part 1 of new schedule 2. There will be no offence if the results of the

analysis were to be used for an excepted purpose, if the material itself is excepted or if the person reasonably believes that to be the case.

The hon. Member for South Cambridgeshire asked about the nature of the offence, and I can reassure him that we have deliberately framed the offence so that it is limited to bodily material held with the intention to carry out unlawful analysis of the DNA in it. We have not planned to make it an offence to carry out the analysis, as the offence is aimed at those who obtain human material with unlawful intentions rather than those who carry out the analysis further down the line. To put it in a real context, we are talking about the newspaper, not the technician. As a result, the whole of clause 47 should be omitted and its provisions transferred to the new schedule. For the purposes of the DNA offence, part 1 of the new schedule sets out what constitutes qualifying consent.

Andrew Lansley (Conservative, South Cambridgeshire)

I am afraid that the Minister has confused me. The changes seem to open up the possibility that if someone obtained material that was subsequently used unlawfully, the person who engaged in the second activity would not be committing an offence. To have it that way round seems odd.

Rosie Winterton (Labour, Doncaster Central)

If the hon. Gentleman lets me work through more of the issues surrounding the offence, I may be able to give him further reassurance.

As I said, such consent can be given by the person from whose body the material came, or by their parents if the person is a child. Once the person has died, consent may be given by anyone who stood in a qualifying relationship with the deceased immediately before they died. Those rules apply to the whole UK, and specific provisions relating to Scotland are set out in paragraph 3 of the new schedule.

The list of excepted purposes in clause 47 will be in part 2 of the new schedule. The purposes listed in paragraph 5 are the same as those that were in the Bill when it was introduced, but they also include criminal justice purposes, national security and so on.

Paragraph 6 provides for an excepted purpose to apply where existing holdings are used for scheduled purposes other than anatomical examination and public display, which are not relevant. That will allow existing holdings of any material, wherever it is held in the UK, and regardless of whether it is relevant material, to be used for such purposes, without an offence being committed under clause 46.

Paragraph 7 reflects the Bill as drafted and provides that it will not be an offence under clause 46 to use any material that has come from the body of a living person, whether that material was held before or after the Bill came into force, for the purposes listed in part 2 of schedule 1.

Paragraph 8 reflects part 1 of the Bill. If there is authority under part 1 to use relevant material in England, Wales or Northern Ireland, the use of that material for DNA analysis will not be an offence under clause 46. That will include cases where appropriate consent is given under part 1, or where there is an

exemption from the requirement for consent to be given because the relevant material has, for example, been imported.

The hon. Member for South Cambridgeshire mentioned importation. We cannot accept automatic authorisation for use of imported bodily material that is not relevant material, such as hair, nails and gametes, or for any material imported into Scotland. That would create a loophole and enable non-consensual DNA testing to be conducted in the UK simply by importing bodily material, or perhaps even by exporting and quickly re-importing it.

The hon. Gentleman also raised the issue of person A who innocently holds material that is then passed to person B, who carries out DNA analysis without consent. In those circumstances, person A, who held the material innocently, would not be subject to the offence, because they had no intention of carrying out an illegal activity. Person B would be liable because they would have held the material before proceeding with the DNA analysis. Therefore, the offence lies with person B, who intends to carry out the unlawful activity.

Paragraph 9 is a new measure, which provides that if there is authority under section 51 of the Adults with Incapacity (Scotland) Act 2000 to use material from incapacitated adults for research, the use of that material for DNA analysis will not be an offence under clause 46.

Paragraph 10 provides a power to amend the references in the new schedule to excepted purposes. In that way, we will be able to reflect any changes that may be made to the purposes listed in schedule 1.

We propose some changes to the categories of excepted material, which are outside the scope of the offence altogether. That includes material from a person who died more than 100 years ago, which is consistent with our approach elsewhere in the Bill, and also includes embryos outside the body, which are covered by the Human Fertilisation and Embryology Act 1990.

An additional type of excepted material proposed by the amendments is that of existing holdings of material for which the identity of the person from whom it came is not known and is not likely to become known. That would mean that DNA analysis of existing anonymised holdings of material would not be an offence, whatever it was used for. That would allow, for example, the Natural History museum research project that I described to continue.

The other amendments are consequential on the changes that I have described, particularly the removal of clause 47, and the fact that the schedule now applies to all of the UK. Hon. Members raised the issue of use of DNA analysis and PCR on sequencing derived from the material. Under part 1 of the Bill, consent would be required to obtain the material to carry out PCR. We are aware that experts have argued that it is illogical to limit the offence to DNA because there are numerous other methods for the analysis of genetic information. We have deliberately chosen not to extend the definition beyond the general concept of analysis of human DNA because there are many

potential ways to infer the make-up of a person's DNA. The Bill is not the correct place to list complex and technical terminology, which constantly changes.

I hope that the Committee will welcome the amendments, which are intended to address the many helpful comments and amendments suggested by Opposition Members and stakeholders outside the House. I commend the Government amendments to the Committee.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am not sure how we are to structure this debate, given that the Minister has finished her remarks. Perhaps you will give us guidance on that, Mr. Hurst. I imagine that I am to speak and—

Alan Hurst (Labour, Braintree)

Order. Not for the encouragement of the Committee, it is open for Members to speak more than once in each debate.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

That is helpful, Mr. Hurst.

A number of points that the Minister raised require further scrutiny. I hope that I will not pre-empt any points that the hon. Member for South Cambridgeshire intends to make. My first question is about DNA and RNA. The Minister said that the offence has deliberately been left general. I would have thought that specifying human DNA rather than genetic or sequenceable material would compound the problem that the she is attempting to solve by keeping the offence general. That needs further exploration and clarification—today, rather than later. Incidentally, I suppose that one could back-sequence from protein as well these days.

Dr. Gibson indicated assent.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The hon. Gentleman is nodding. No doubt he is already thinking about a grant application.

My second point concerns correspondence that I have had on the issue of intention. Will the Minister expand on intentional offences? I am sure that there are intentional offences, but we must be careful before legislating in that area because of the difficulty of proof. I do not suggest that she seeks to create a thought crime that might be too wide, but we know the sort of thing that she is considering. Is there any evidence that the sorts of offences that we are talking about will be caught by the measure? In the scenario that she painted, in which person A has the material innocently and person B carries out the DNA analysis, it is possible that, although the analysis is carried out without consent, no one would be found guilty because the person who committed the offence reasonably believed that the material was accepted and that consent had been given.

We must stress that there is a duty to be careful when carrying out DNA analyses because of the other purposes to which they may be put. The exemption for reasonable belief might—I surprise myself by saying this—allow cases to slip through, and people carrying out DNA analysis might not be required to be careful about ensuring that they have consent. There must be

a requirement that people are not reckless about consent. The default situation should be that gaining consent is carefully done.

The ethics and law surrounding the analysis of a person's DNA for the clinical benefit of someone else have not been raised. Someone might require information about someone else's genetics to find out whether they have a condition and, if so, what is the right treatment available. That might be the case particularly for the advice needed for genetic counselling. I regret that I cannot illustrate a scenario now, but that is why schedule 1 provides for research to be done for the benefit of another individual. If it emerges that information from a dead person might be useful but that he gave no recent consent for DNA analysis, would the person whom it might help have recourse to using it? Schedule 1 refers to:

''Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person''.

Clearly, that normally requires consent. However, in the case of DNA analysis, what are the Government's intentions if the interests of two people sharing genetic information must be considered? That case may not arise, but it is a concern.

A series of issues have emerged as a result of the inclusion of criminal justice purposes that do not require consent. There is a civil liberties issue concerning the circumstances under which DNA analysis of such material should be permitted. Would it be permitted if people were charged or detained, or would it be permitted in all cases? How will the provisions relate to criminal justice measures that have either been proposed or enacted? Many people are concerned that their DNA might be used for criminal justice purposes without their knowledge even if they are not in the frame or have not been charged. We must be clear about the circumstances under which DNA analysis is permitted.

There are other significant issues to which we may need to return, but I am conscious of the time so I will leave my remarks at that.

Andrew Lansley (Conservative, South Cambridgeshire)

We may indeed need to return to those other significant issues. I do not begrudge the hon. Member for Oxford, West and Abingdon the opportunity to make his points, and he did so perfectly fairly.

I am not entirely persuaded why it is desirable that the structure of creating an offence around the idea of ''intention'' in relation to the analysis of DNA material should be completely different to the structure of an offence in relation to the retention of organs and tissues. Why is the offence not one of having relevant material with the intention of undertaking activities without appropriate consent, as in the earlier part of the Bill? We have a choice about how to proceed, but the provisions raise all the questions that the hon. Gentleman mentioned about establishing burdens of proof. We may have to return to that.

We will need to work through the issue of medical genetics. Balances are currently struck, in the absence of legislation, in cases in which substantial benefits can flow to given individuals from the analysis of DNA material when consent has not been given. We need to

be sure that there are no circumstances in which it might be more ethical for the analysis of DNA to go ahead because of the overwhelming benefits that would accrue. Obviously, that should not be to the detriment of the individual whose material was being used, even if their consent had not been obtained. We are talking about life-saving or life-changing procedures, for which consent may not have been obtained, and we need to work through that.

I will stop at that point, not least because I want to consider some of those issues and the Minister's response in detail, although I may reserve the option to return to them on Report. On that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

On a point of order, Mr. Hurst. I am not sure whether it is feasible for us to finish in the remaining three minutes, so we seem to be in the worst of all worlds. We have put questions to the Minister on this important subject, but she has not had an opportunity to respond to some of them, although she did, in effect, read out what was, I accept, a very helpful letter. What recourse do we have? Perhaps it is too late to ensure that we have a full debate on some of the issues that the hon. Member for South Cambridgeshire and I raised.

Alan Hurst (Labour, Braintree)

The position is as the hon. Gentleman describes it. Hon. Members have lost the opportunity to discuss those matters because we have just concluded the debate on the group that included

clause stand part. Hon. Members will have to take another opportunity to raise their concerns as the Bill proceeds through its different stages.

Amendments made: No. 157, in

clause 46, page 28, line 25, leave out

'excepted purposes (see section 47)'

and insert 'an excepted purpose'.

No. 158, in

clause 46, page 28, line 32, after 'death,' insert—

'( ) it is an existing holding and the person who has it is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified,'.

No. 159, in

clause 46, page 29, line 1, leave out from 'Schedule' to 'has' in line 2 and insert

'(Section 46: Supplementary) (which makes provision for the interpretation of ''qualifying consent'' and ''use for an excepted purpose'' in subsection (1)(a))'.

No. 160, in

clause 46, page 29, line 3, after 'section', insert

'(and Schedule (Section 46: Supplementary))'.

No. 161, in

clause 46, page 29, line 5, at end add—

'''existing holding'' means bodily material held immediately before the day on which this section comes into force.'.—[Ms Winterton.]

Clause 46, as amended, ordered to stand part of the Bill.

Schedule 5 disagreed to.

Clause 47 disagreed to.

It being twenty-five minutes past Eleven o'clock, The Chairman adjourned the Committee without Question put, pursuant to the Standing Order.

Adjourned till this day at half-past Two o'clock.

Hurst, Mr. Alan ( Chairman)

Cohen, Harry

Davey, Valerie

Ellman, Mrs.

Francois, Mr.

Gibson, Dr.

Harris, Dr. Evan

Ladyman, Dr.

Lansley, Mr.

Lucas, Ian

Murrison, Dr.

Naysmith, Dr.

Ryan, Joan

Taylor, Dr. Richard

Watson, Mr.

Winterton, Ms Rosie

Standing Committee G

Human Tissue Bill

Clause 49 - Power to de-accession human remains

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 128, in

clause 49, page 31, line 4, leave out subsection (5) and insert—

'(5) Schedule [consequential amendments relating to de-accession] shall have effect.'.

Alan Hurst (Labour, Braintree)

With this it will be convenient to discuss the following:

New schedule 1—Consequential Amendments Relating To De-accession—

Imperial War Museum Act 1920.

1 (1) The Imperial War Museum Act 1920 (c.16) is amended as follows.

(2) In section (2) (powers and duties of Board) after subsection (1)(c), there is inserted—

''(cc) dispose of any human remains belonging to the Museum (including things with which the human remains are mixed or bound up) in accordance with the provisions of section 49 of the Human Tissue Act 2004.''

National Maritime Museum Act 1934.

2 (1) The National Maritime Museum Act 1934 (c.43) is amended as follows.

(2) In section 2 (establishment of Board of trustees and duties of the Board) after subsection (3)(b), there is inserted—

''(cc) dispose of any human remains vested in them for the purposes of the Museum (including things with which the human remains are mixed or bound up) in accordance with the provisions of section 49 of the Human Tissue Act 2004.''

British Museum Act 1963.

3 (1) The British Museum Act 1963 (c.24) is amended as follows.

(2) After section 5 there is inserted—

''5A Powers of British Museum Trustees under the Human Tissue Act 2004

The Trustees of the British Museum may dispose of any human remains vested in them and comprised in their collections (including things with which the human remains are mixed or bound up) in accordance with the provisions of section 49 of the Human Tissue Act 2004.''

(3) After section 8 there is inserted—

''8A Powers of National History Trustees under the Human Tissue Act 2004

The Natural History Trustees may dispose of any human remains vested in them and comprised in their collections (including things with which the human remains are mixed or bound up) in accordance with the provisions of section 49 of the Human Tissue Act 2004.''

National Heritage Act 1983.

4 (1) The National Heritage Act 1983 (c.47) is amended as follows.

(2) In section 6(3) (acquisition and disposal of objects by Board of the Victoria and Albert Museum), after paragraph (c), there is inserted—

''(cc) the disposal is an exercise of a power conferred by section 49 of the Human Tissue Act 2004, or''.

(3) In section 14(3) (acquisition and disposal of objects by Board of the Science Museum), after paragraph (c), there is inserted—

''(cc) the disposal is an exercise of a power conferred by section 49 of the Human Tissue Act 2004, or''.

(4) In section 20(3) (acquisition and disposal of objects by Board of the Armouries), after paragraph (c), there is inserted—

''(cc) the disposal is an exercise of a power conferred by section 49 of the Human Tissue Act 2004, or''.

Merseyside Museums and Galleries Order 1986.

5 (1) The Merseyside Museums and Galleries Order 1986 (S.I. 1986/226) is amended as follows.

(2) In Article 6 (acquisition and disposal of works and objects), after paragraph (2)(c), there is inserted—

''(cc) the disposal is an exercise of a power conferred by section 49 of the Human Tissue Act 2004, or''.'.

Andrew Murrison (Conservative, Westbury)

The clause gives powers to bodies to de-accession human remains. My understanding is that its purpose is to allow the remains of indigenous people to be returned to their countries of origin. We welcome this measure, but we are concerned about the drafting. Some of the bodies that are mentioned in the Bill have expressed concerns about the position in which the measure would place their trustees.

The amendment and the new schedule would get round that for all of the bodies that are listed, with the exception of the Museum of London. Under the legislation governing that body, its governors are allowed to de-accession human remains on the authority of a majority of two thirds of the governors, so it is unnecessary to include it in new schedule 1. For the remainder, we propose powers for the trustees of the bodies, all of which are governed by separate Acts. The amendment would make consequential amendments to that legislation to enable the trustees to exercise the powers that we propose to give them.

It is worth pointing out that we are talking about powers, not obligations. I am sure that the Minister will say that it is up to the museums or bodies concerned to de-accession remains; there is no obligation on them. However, we hope very much that they will agree to requests to de-accession and return the remains of indigenous peoples, as that, as I understand it, is the purpose of the clause. I commend the amendment to the Committee and hope that the Minister will accommodate it.

Rosie Winterton (Labour, Doncaster Central)

I am interested in the hon. Gentleman's comments. We are not aware of any representations having been made about that issue arising from the clause by any of the organisations or museums that he mentioned. As he said, new schedule 1 seeks to insert references to clause 49 into the governing legislation of the museums concerned. It and the amendment are unnecessary, because subsection (5) makes it clear that the power given by the clause to each museum is a freestanding power, in

addition to the other powers in the legislation that governs them. The clause is technically correct and it is the appropriate means by which to grant power under the Bill to national museums to de-accession human remains.

I undertake to go back to the organisations that the hon. Gentleman has mentioned, and I will ask the Department of Culture, Media and Sport to check that we have not overlooked any problems. I can assure the hon. Gentleman that we feel that the clause satisfactorily covers the issues that he has raised, but we shall check in case anything has been missed out or the organisations have any concerns that they have not told us about, and if there are such concerns we shall come back. I hope that he will withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

With the assurance that the Minster will make further inquiries on this matter, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 49 ordered to stand part of the Bill.

Clause 50 ordered to stand part of the Bill.

Schedule 6 agreed to.

Clauses 51 to 53 ordered to stand part of the Bill.

Clause 54 - Orders and regulations

Clause 56 - General interpretation

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I rise to raise with the Minister for future consideration the question of definitions. It is not my purpose to reopen the debate on clause 1 and schedule 1, but despite the Under-Secretary putting on the record the term ''public weal'' to explain public health monitoring—we have since determined how he meant that be spelled, and some of us even know what he meant, although I am sure that he did throughout—it is still not clear what such monitoring includes by way of epidemiological examinations. He accepted that there may have been an issue, but said that such examinations would generally be included but would not necessarily mean any research done on samples that were irreversibly anonymised and would always remain unlinked from the patient's record. I do not want to misquote him, but I thought that was his view.

I know that that is not a matter for debate now. However, regardless of whether the Government accept that the drafting needs to be wider than it is, if we are still questioning the issue in Committee it might be worth their thinking about taking the opportunity at a later stage—or putting my mind completely at rest now, which I think would be difficult—to clarify exactly what is covered and what is not. As the issue comes under schedule 1, people may feel deterred from undertaking perfectly legitimate activities. I do not believe that it can be left to codes of practice, since there will be genres of research and research propositions that will evolve more quickly than codes of practice are amended.

I hope that the Minister will accept that thought in the spirit in which it is meant. It might save us time in later stages if we can have further clarification.

Rosie Winterton (Labour, Doncaster Central)

We will look back at the remarks made earlier in the Committee. I note what the hon. Gentleman has said, and I assure him that, if we feel that more can be done to clarify the position, we will return to the matter.

Question put and agreed to.

Clause 56, as amended, ordered to stand part of the Bill.

Clause 57 ordered to stand part of the Bill.

New Clause 6 - Removal of relevant material following death

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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

This is a probing new clause, if there is such a thing—I believe that there is. I am very pleased that it was selected. There were alternative ways of raising the issue, such as an amendment, but by the time the matter became apparent, we had considered the relevant clauses.

The new clause consists of the terminology used in an earlier Act that will be repealed by the Bill. I accept that it is clearly ridiculous to suggest that a registered medical practitioner should be the only one to remove organs. The Minister does not even need to put on the record the fact that that is now out of date. I want to find out whether it is the Government's intention to drop the requirement that there should be a personal examination of the body by someone, presumably a registered medical practitioner, before such acts are carried out. If that is their intention, why is the requirement being dropped? That was a requirement in earlier legislation, however imperfect, and it has not been translated into the Bill. If I am wrong, I will accept that, and I hope that the Minister will have mercy on me, given that we are near the end of our proceedings.

Andrew Murrison (Conservative, Westbury)

I was about to launch into an attack on the hon. Gentleman for holding medical practitioners up as the only profession that could remove organs. He will be aware that a number of professions can do that. I was going to ask him why he had omitted teeth, because dentists are pre-eminently adept at removing teeth—

Stephen Ladyman (Labour, South Thanet)

Like the tooth fairy.

Andrew Murrison (Conservative, Westbury)

The Under-Secretary is reflecting on his moment of glory in an earlier sitting.

Dental practitioners would also be included, but quite apart from the medical and dental professions, vast numbers of people are trained and competent to be involved in the procedure. However, the hon. Member for Oxford, West and Abingdon (Dr. Harris) has reassured me by explaining that this is a probing motion, and I look forward to hearing the Minister's response.

Rosie Winterton (Labour, Doncaster Central)

What the new clause does and what the hon. Member for Oxford, West and Abingdon is trying to get at seem to be two different things. Let me give some background information about the Human

Tissue Act 1961, on which the measure is based. That Act was introduced to made it possible for tissue and organs to be removed for transplantation; it also authorised the removal of tissue for other purposes. As the hon. Gentleman said, the Act originally provided that only doctors could remove the tissue. However, in 1986, an exception was made for eyes, when approval was given, as the hon. Member for Westbury (Dr. Murrison) said, for less qualified technicians to undertake the removal of eyes to retrieve corneas. As has been said, although that is to be done under the supervision of a medical practitioner, the measure builds on experience in other countries which shows that properly trained technicians can retrieve a wide range of tissue, such as bone, tendons and heart valves.

The Bill works differently from the 1961 Act. It does not specify exactly who must do what. Removal of human tissue from the deceased for transplantation will fall within the remit of the Human Tissue Authority, which will have a duty to prepare codes of practice on the definition of death and on removal of tissue from the deceased for scheduled purposes, including transplantation. Those will set out the standards of training and experience, and the practices to be followed by persons undertaking such activities. It is clearly preferable—and I feel that this is what the hon. Member for Oxford, West and Abingdon was getting at—for retrieval of organs, tissues or cells to be undertaken by people who are specifically trained for the purpose, whether or not they are medical practitioners.

I was asked why it need not be a doctor who confirms death before tissue can be removed. The general requirement regarding death certification remains unaffected; it has to be done by a doctor. However, the Bill is about the removal of tissue after death. Removal before death without consent and where it is not in the person's best interests is an offence. No further provision is, therefore, needed with regard to that matter.

To an extent, the hon. Gentleman and I are approaching the matter from the same angle. I hope that I have clarified it and that he feels able to withdraw the motion.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Yes, I beg to ask leave to withdraw the motion.

Motion and clause, by leave, withdrawn.

New Schedule 2 - 'Section 46: Supplementary

Clause 61 - Extent

Clause 62 - Commencement

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I signalled earlier that I might raise a minor issue at this time. I give the Committee advance notice that I have no comments to make on clause 63—the short title.

We touched earlier on the fact that the BioIndustry Association is concerned that, before the Bill's criminalising provisions come into force, adequate time needs to be given for the codes of practice to be fully understood and taught, not simply published. I wish to probe the Government's intention on what sort of gap they want to allow between publication of the final codes of practice—the Minister told us that the draft codes will be sent out for consultation and so forth—and their commencement, as people will need to be taught about them and made aware of their provisions.

Those important provisions will criminalise activity—it is not necessarily of a controversial kind, but it is still unsatisfactory—that has been going and may still be going on in respect of research activities on cells. Will the gap will be sufficient to ensure that people involved in such activity are not caught, or at least that enough planning materials are made available to industry and academia to ensure that

everyone involved in clinical governance has the time in a crowded NHS agenda to make sure that it is done properly? That is my only question.

Rosie Winterton (Labour, Doncaster Central)

Obviously, there will be various stages in the implementation of the proposals. Going back to basics, as we have said before, the Bill builds on best practice. We already have a lot of guidance in the public domain, which is within reach for those working on the front line. Once the shadow authority is set up, there will be consultation on the codes of practice and on any necessary training. Following that, in the many instances when licences will be required, the very process of putting together and making an application will itself be an educative process.

I hope that by the time the final codes of practice are published, people will have a clear understanding of what is expected. At the same time, common sense will be exercised to ensure that the NHS and others are ready for implementation. Once again, I emphasise that the Bill is meant to improve confidence in the system, and ensure that those who undertake medical and scientific research are clear about what is expected of them. Failing to take the approach that I have outlined will go against the way in which we consulted on the Bill and the fact that we will continue to involve people in the decision-making process.

Question put and agreed to.

Clause 62 ordered to stand part of the Bill.

Clause 63 ordered to stand part of the Bill.

Question proposed, That the Chairman do report the Bill, as amended, to the House.

Rosie Winterton (Labour, Doncaster Central)

I would like to take this opportunity to thank Mrs. Adams and you, Mr. Hurst, for your understanding and wise chairmanship. I also thank the Clerk and the other officials who presided over the Committee with such efficiency, understanding and co-operation.

I particularly thank the Under-Secretary of State for Health, my hon. Friend the Member for South Thanet (Dr. Ladyman), who has brought his own expertise and incisiveness to the Committee. I know that he feels that certain hon. Members have sometimes brought darkness over him, but he has only ever enlightened us.

I also thank my hon. Friend the Member for Enfield, North (Joan Ryan) for her support as the Government Whip. She has been exemplary and has kept our proceedings well under control, as I always knew she would. My hon. Friend the Member for South Dorset (Jim Knight) has done a marvellous job as my Parliamentary Private Secretary, which is nothing less than we would expect.

I commend Labour Members on the Committee on their efforts and interventions and on their enthusiasm and commitment.

I thank my officials for their hard work. They have shown a good understanding of the needs of all hon. Members and have tried to give assistance where they could.

I also thank Opposition Members for their constructive opposition; it is a triumph of consensus that there have been no Divisions. The Committee has been overwhelmed by expertise on both sides, which has greatly helped our deliberations. I have been astonished at times by the way in which some Opposition Members have thrown caution and their reputations to the wind by revealing the skeletons in their cupboards.

Ian Gibson (Labour, Norwich North)

You might end up in the Cabinet if you don't watch out.

Rosie Winterton (Labour, Doncaster Central)

Yes, exactly.

Our scrutiny of the Bill has been very productive. The Government have undertaken to consider several of the points that were raised, and we will continue the dialogue over the coming weeks. As my hon. Friend the Member for Norwich, North (Dr. Gibson) said, the Bill will be a landmark. It will balance the need for medical and scientific research and for transplantation with our need, as legislators, to ensure that the tragic events that caused such distress to so many families never happen again.

Andrew Murrison (Conservative, Westbury)

My hon. Friend the Member for South Cambridgeshire (Mr. Lansley) sends his apologies to the Committee. He would have been delighted to have attended this final sitting, but he is absent on duty. However, I know that he wants to be associated with the remarks that I shall make.

It has truly been a pleasure to serve on this Committee. Others will have observed that I am non-confrontational by nature, and this has been a consensual Committee, as one would expect. There has been no disagreement in principle with anything that we have discussed during our eight sittings. Our proceedings have been laced with a degree of levity; the Minister mentioned the skeletons. However, that should not disguise the seriousness of the issues.

I feel personally involved because I began my medical career at the Bristol royal infirmary where, of course, all this began. It is important to reflect on the sombre nature of our deliberations as well as on the lighter moments that accompanied them. As I said on Second Reading, this Bill is a good measure. I hope that we have made it better, that it will go from strength to strength and that, when it is finally enacted, it will be a piece of work in which the public will have confidence and with which the industry, medical researchers and health professionals will be comfortable.

I thank you, Mr. Hurst, and Mrs. Adams for chairing our meetings so well. I thank the Clerk and his Department for their expertise, and the civil servants who have done such a good job, particularly bearing in mind the lack of pre-legislative scrutiny, which we shall continue to highlight. They have navigated this complicated area expertly. I should like also to thank the servants of the House and the police for keeping us in order. I am happy to observe that yesterday's events

in the Chamber have not been mirrored in our proceedings. We and our public, who have been impressively numerous, have been kept well in order. I wish the Bill Godspeed.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I echo the words of the Minister and of the hon. Member for Westbury in thanking you, Mr. Hurst, and Mrs. Adams for having presided over the proceedings so efficiently and fairly. I pass on my thanks to the staff of the Public Bill Office who have been very helpful to Opposition Members by giving us advice on amendments, although I take responsibility for all flaws. I should also like to thank the Minister's Bill team. It would be invidious and possibly injurious to name those whom I found particularly obliging, but it has been the sort of Bill for which it has been necessary to get information directly, and they have been extremely helpful in Committee, in conferences and outside the House.

I thank the Minister and the Under-Secretary for the way in which they have conducted proceedings. I hold no malice against the Under-Secretary, although I hope that his former bosses will overlook his stated opinion that he wanted them banged up, by which I assume he meant locked up—one never knows these days. I hope that they will not look too harshly on him when I send those remarks to them.

Stephen Ladyman (Labour, South Thanet)

I would point out that two of them took me to River Cafe for lunch yesterday. When I worked for them, they never showed any signs of wanting to do that.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I presume that that was before they had seen the Under-Secretary's remarks, otherwise he might have been invited as a food taster. I also thank other Opposition Members for the spirit in which they have conducted themselves. I would particularly like to thank the hon. Member for Wyre Forest (Dr. Taylor) for his sage advice—as my consultant, as I would put it—and to congratulate the Liberal Democrat Members on a 100 per cent. turnout.

The Bill is a good Bill. There are remarks that we can save for Third Reading, but although there have, of course, been differences of opinion, it is pleasing that we have had no Divisions. I hope that there will be no significant disagreements during the Bill's remaining stages. The Bill is important, although I hope that it would have been introduced even if the tragedies had not occurred. As with many things in clinical practice, legislation is clearly required, even if we do not recognise that at the time. Parliamentary timetables being what they are, it is a sad fact of life that it takes some incidents and the reports that come from them to bring us to such a point. Nevertheless, it is good that the Bill has progressed so well and—I look at the Government Whip—in such good time in Committee.

Richard Taylor (Independent, Wyre Forest)

It has all been said, except from my perspective of—still—an amateur MP. I thank you, Mr. Hurst, and Mrs. Adams for your kindness and guidance, and also the Ministers, for their unfailing affability. There have been no attempts to put Opposition Members down—in certain larger arenas I have felt that some Ministers

were definitely trying to put me in my place. I have enjoyed this Committee much more than the other Standing Committee on which I served because it has been non-confrontational and largely consensual. I am also so pleased that the Minister is to reconsider at least one of the issues that I raised.

Alan Hurst (Labour, Braintree)

On behalf of my co-Chairman, I should like to thank hon. Members for their kind remarks and for their conduct during the Bill's passage

in Committee. The only improvement from the point of view of the person in the Chair would have been if all hon. Members had received an honorary doctorate for the duration of proceedings, which would have made things more straightforward.

Question put and agreed to.

Bill, as amended, to be reported.

Committee rose at seven minutes past Three o'clock.