Human Tissue Bill

House of Commons, 28 June 2004.

New Clause 7 — Powers of Court to dispense with need for consent

Rosie Winterton (Labour, Doncaster Central)

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

Michael Martin (Speaker, Glasgow Springburn)

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

Rosie Winterton (Labour, Doncaster Central)

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

Part 1 of the Bill requires consent for the use of tissue for scheduled purposes, including

"Obtaining scientific or medical information . . . which may be relevant to any other person".

Clause 46 will make it an offence to analyse DNA without qualifying consent. In both cases, the consent of a living person will be required for the use of his or her tissue for such a purpose.

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

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

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

Andrew Lansley (Conservative, South Cambridgeshire)

The Minister is talking about when there is a major public health issue, and I acknowledge that it is intended that such a power would be used only in the most exceptional circumstances. If in the circumstances of the kind that she has described the patient had expressly not given consent, the proposed powers would not enable the withdrawal of consent to be overridden. Are there other powers to allow tissue to be retained and tested for public health purposes?

Rosie Winterton (Labour, Doncaster Central)

I am not quite sure that I follow exactly the hon. Gentleman's question. If an infectious disease broke out, consent had not been given by an individual and the relatives could not be found, an application would be made to the High Court to waive the consent requirements. We shall of course be consulting on the exact circumstances when drawing up the detail of the regulations that will stem from that, but the principle is that, where an individual's relative who is known to be alive but cannot be contacted, a waiver of the consent requirements could be sought. Similarly, if in the interests of public health there needs to be research into a new disease, for example, an application could be made.

Andrew Lansley (Conservative, South Cambridgeshire)

I am not disputing the intended purposes of the new clause and the amendments; it is just that they are not designed to override someone's express refusal to give consent to the retention and testing of tissue—even in the case of a public health emergency of the kind that the Minister has described. That may be satisfactory, or powers extant may allow the retention of tissue for public health purposes. I am simply asking for information on that.

Rosie Winterton (Labour, Doncaster Central)

It would be quite unusual for somebody completely to refuse consent for diagnostic purposes. The consent under the Bill is usually that given after an operation or for future use. The hon. Gentleman highlights the case of somebody who has made a general commitment that consent for the use of their tissue for research purposes would never be given. The Bill deals with scheduled purposes, and as I have said, these matters can be considered during the making of regulations.

Andrew Murrison (Conservative, Westbury)

Perhaps I can help the Minister by providing an example. According to the Prime Minister, we are liable to be attacked by terrorists. Some terrorists may be of suicidal intent, having been infected with a virus of the sort that the hon. Lady helpfully described in the letter she sent to hon. Members a few days ago. Such persons would, I suspect, withdraw their consent. What would be the position in those circumstances?

Rosie Winterton (Labour, Doncaster Central)

The hon. Gentleman has highlighted an issue that we will need to consider during consultation on the regulations. The question will be whether the High Court can override that withdrawal of consent. The new clause covers circumstances in which it is not possible to obtain consent. Whether a deceased person had given consent—some cases might not be clear—and whether there is a relative who knows will also have to be considered in relation to the regulations. Those are fair points to be considered during the consultation, although I think that the situation that the hon. Gentleman describes is quite unlikely to arise.

The flu epidemic early in the last century has been mentioned to us in relation to the cases that we have in mind. It might be impossible to find someone who stands in a qualifying relationship to a victim of the disease, but it might become necessary to test material from victims to determine whether the same virus is causing a new epidemic. The order is required to provide a way to deal with unexpected and exceptional situations, which could require the testing of material from living people who are no longer reasonably traceable, or from deceased persons whose next of kin cannot be found, in the interests of public health. We therefore propose to include in the Bill a power for the Secretary of State to make regulations to enable the High Court to waive the need for consent to use tissue for health-related research in cases in which appropriate consent cannot be obtained. It is expected that the regulations will provide for the Court to waive the need for consent only in rare cases and when the public interest justifies doing so.

The new clause introduces the High Court waiver. There are consequential amendments to clauses 53 and 60. Amendments are also needed to schedule 5, so that a High Court waiver may also apply, where necessary, to consent to having a person's tissue with a view to testing its DNA. The provision will also apply in Scotland.

We recognise the need for a mechanism to deal with truly exceptional cases, but we are confident that the requirement that the circumstances be exceptional and the protection provided by the High Court will not allow exploitation of the waiver without proper cause. I shall take on board the points made by the hon. Gentlemen, but I comment the amendments to the House.

Andrew Lansley (Conservative, South Cambridgeshire)

I am grateful to the Minister for her explanation of the purposes of new clause 7 and the related amendments and for her willingness to consider further the questions that my hon. Friend the Member for Westbury (Dr. Murrison) and I raised. We acknowledge that we are dealing only with what we hope are the most exceptional of circumstances, but as our debates on the Bill have demonstrated, there is a need to consider extremely rare events. Unhappily, those described by my hon. Friend might be just such a set of events. If a living person has refused consent to the use of any material, the new clause, as I understand it, would not permit the High Court to make an order requiring that tissue be taken and tested. That set of circumstances begs a question. I know that my colleagues will come back to that, and I hope that the Government will consider the matter.

There is also the question, not least in the research community, of whether, where somebody whose relative has refused consent, for example, for DNA analysis, which could be of benefit to a living relative, a court could make an order for the benefit of that individual contrary to the expressed wishes of a living person. The Government are not proposing that, and on balance I think that they are right not to do so. It is one of those instances where we have trespassed to the minimum extent in circumstances where the expressed wishes of individuals are not to be complied with. That is the principle underlying the Bill, and we want to hold to it as often as we can.

The purposes of the new clause and the related amendments, as the Minister has described them, seem to be acceptable. However, there may be exceptional circumstances where somebody cannot be traced, where relatives cannot be traced and where tissue could be properly analysed in the interests of either a living person or for public health purposes. In such cases we think that it is reasonable for there to be regulations setting out how the High Court could make an order. On that basis, we are happy to accept the new clause and the amendments.

I shall not chide the Minister too often, but I shall do so now and once more later. She will recall that when the Bill was first presented to the House back in December we made it clear that we believed that it would have been in the interests of the Bill's passage if there had been a period—albeit a short period—of pre-legislative scrutiny. The Minister will recall also that I asked for that in a debate in April. It could have been achieved in some form over the summer. I see that the Minister takes the view from a sedentary position that she was not responsible for the matter at that time. She was not, but she enjoys—that being the operative term—collective responsibility for the decisions, or lack of decisions, made by the Government at an earlier stage.

It is clear that had pre-legislative scrutiny been undertaken last summer into the early autumn, it would have been possible to examine many of the issues that have now been raised. It is a great pity that we had to raise many of those issues in Committee, which perhaps is not the best forum designed to secure consensus. The Committee reported six months ago, and I cannot recollect many instances where the passage of time between the conclusion of consideration in Committee and on Report has been as long as six months. No doubt that is a recognition of the range of issues raised in Committee to which there had to be further regard, with substantial consultations being required with outside bodies. Much credit goes to them for working through those issues with officials in the Department.

I do not want to criticise the Government unduly. Broadly speaking, we are arriving at the right conclusions. However, it is a great pity that we have had to do so through a tortuous and less transparent process than was originally recommended by the Opposition.

We shall work our way through the, I think, 100 new clauses and amendments that the Government have tabled on Report.

Andrew Murrison (Conservative, Westbury)

Ninety-nine.

Andrew Lansley (Conservative, South Cambridgeshire)

My hon. Friend tells me that there are 99, which is just under the ton. I hope that we will work through them with the good humour that has characterised our debates so far.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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

I have a question for the Minister on this group of amendments, which I take from a briefing that I received from the Medical Research Council. I do not necessarily agree with the MRC on the issue, but it agrees with the thrust of the Government's approach with respect to the amendments. The MRC states:

"We agree this is an important issue but we agree that the solution is too stringent. Unlike the case described above"—

which is the example that the Minister gave—

"which pertains to diagnosis and treatment, for possible research uses there are research ethics committees".

The MRC suggests that the power that the Minister is seeking to give to the High Court in these circumstances might usefully rest with ethics committees, not with the court, and that as an additional safeguard, research ethics committees might be required to inform the Human Tissue Authority so that the authority could satisfy itself that such waivers were not being over-used.

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

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

The matter is raised by the Medical Research Council, which is why I feel more confident to refer to it than I otherwise would. The MRC states:

"The term 'DNA analysis' is not clearly defined and is of uncertain validity as a concept. There are a number of genetic tests that do not involve analysis of DNA but which yield similar results. Also, DNA is mentioned but there seems no logical reason to omit RNA."

For example, one can use a test of the sequence of proteins. Where DNA is mentioned, it would have been possible to mention RNA. I queried the omission previously and I remember the Government saying that they would respond. I fear I forgot to follow it up, as they forgot to respond. Perhaps during this stage of the Bill, not necessarily immediately, the Government could clarify why they are confident that there is no loophole where the DNA provisions apply across the board.

Rosie Winterton (Labour, Doncaster Central)

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

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

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

I hope that the House will accept the new clause.

Question put and agreed to.

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

New Clause 6 — Interpretation of Part 1

Rosie Winterton (Labour, Doncaster Central)

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

Michael Martin (Speaker, Glasgow Springburn)

With this it will be convenient to discuss Government amendments Nos. 48 to 64.

Rosie Winterton (Labour, Doncaster Central)

In Committee, hon. Members raised a technical point about the scope for misunderstanding in the current definition of anatomical examination given in clause 55, which states:

"'anatomical examination' means examination by dissection for anatomical purposes",

which are for the

"purposes of teaching or studying, or researching into, morphology."

Use and storage of the body of a deceased person or material from it for that purpose requires the advance written consent of the individual concerned, witnessed by another, and is a licensable activity. The scheduled purpose of health-related research, on the other hand, may be consented to after death by relatives and is not licensable under the Bill.

Researchers in particular are concerned that there could be confusion about when research on tissue involving examination by dissection requires advanced consent and licensing and when it does not. Basically, there was concern that the stricter requirements would apply to all bits of tissue used for morphological research.

We therefore propose to clarify the references to anatomical examination by amending clauses 2, 3, 7, 13, 23, 43 and 55. The effect of the amendments to clause 55 is to clarify the definition of anatomical examination so that it is now defined as macroscopic examination by dissection for the purposes of teaching, studying or researching into the gross structure of the human body. That excludes from the definition much of the research about which concerns have been expressed to us.

The effect of the amendments to clauses 2 and 3 is that the prior written and witnessed consent of the individual is required only in relation to anatomical examinations carried out on whole bodies or material that has come from a whole body in the course of use of the body for the purpose of anatomical examination. The amendments to clauses in part 2 impose a licensing requirement only in relation to whole bodies that are used or stored for anatomical examination or material from such bodies that is stored or used for that purpose.

I hope that that is clear. As I said, these are technical amendments dealing with matters that were raised in Committee. I hope that the situation is now clarified.

Andrew Murrison (Conservative, Westbury)

I congratulate the Minister on her eloquent exposition. It is a pity that the description that she gave could not have been given previously. I underscore the remarks of my hon. Friend the Member for South Cambridgeshire (Mr. Lansley) about pre-legislative scrutiny. Although the change is technical, it is also fundamental. The Minister's description is a return to common sense, because she elegantly described the situation, as we understand it, in a dissecting suite in a medical school, which is the measure's intention. Correctly, she has in mind a gross, large-scale examination of parts derived from a dead person that excludes histology—examining specimens under a microscope. I congratulate her on the change, although it is a pity that it was not made earlier.

Question put and agreed to.

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

New Clause 8 — Activities involving material from adults who lack capacity to consent

Rosie Winterton (Labour, Doncaster Central)

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

Michael Martin (Speaker, Glasgow Springburn)

With this it will be convenient to discuss the following amendments: No. 7, in clause 3, page 3, line 40, after 'alive', insert

'and subsection (2A) does not apply'.

No. 8, in page 3, line 40, at end insert—

'(2A) This subsection applies where the person concerned is alive, but lacks the capacity to give consent.

(2B) Where subsection (2A) applies, "appropriate consent" means the consent of a person who stands in a qualifying relationship to him.'.

No. 9, in page 4, line 31, at end insert—

'(8) For the purposes of this section a person lacks capacity to give consent if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of or a disturbance in the functioning of the mind or brain.'.

Government amendments Nos. 99 to 107.

Rosie Winterton (Labour, Doncaster Central)

The Bill was not intended to impact on the common law test of best interests, regarding the activities that can take place in relation to tissue from mentally incapacitated adults. As we have said, such issues—in particular, research—will be dealt with under the forthcoming Mental Capacity Bill. However, we now recognise that, as drafted, the Human Tissue Bill would prevent activities that are currently lawful, where the removal of tissue for a particular purpose—for example, transplantation—is deemed to be in the best interests of the incapacitated individual. The person's best interests would be frustrated, because they cannot give the necessary consent to the subsequent use of the tissue.

The Mental Capacity Bill is unlikely to be enacted before 2007, and the Human Tissue Bill is likely to be enacted in 2005. That gap makes it necessary to amend the Human Tissue Bill, so that it does not have a detrimental effect in the interim on the use of tissue lawfully removed from incapacitated patients. We therefore propose to amend the Bill by taking a power to make regulations setting out what is required before tissue from those who lack capacity can be used for purposes regulated by the Bill. Those purposes will include obtaining information that may be relevant to the diagnosis and treatment of another person, such as a genetic relative, and transplantation. The intention is to use the regulations to provide that, in the case of incapacitated adults, tissue may be used for scheduled purposes, where that would be in the adult's best interests.

The regulations would also allow research using the tissue of incapacitated persons, where participation in the research by the person who lacks capacity is authorised in accordance with the clinical trials regulations, which came into force in May. Such use would be subject to the safeguards set out in those regulations, which include that an ethics committee must approve the research. The regulations will also take account of the outcome of debates on the Mental Capacity Bill later in this Session, and research relating to mentally incapacitated adults will be debated in that context. Indeed, rather than setting down the circumstances in the Bill, regulations are proposed because we do not want to pre-empt the debates that will take place later in the Session.

In due course, the Mental Capacity Bill may replace the regulation-making power by amendment. Similar amendments will be made to the provisions dealing with DNA, so the regulations can say when it is lawful to hold material from an adult who lacks capacity with the intention of analysing the DNA. Those apply also to Scotland, where it will be necessary for the regulations to take account of authority under the Adults with Incapacity (Scotland) Act 2000, whether for research or for any other of the purposes that I outlined.

Tam Dalyell (Labour, Linlithgow)

What is the relationship with the Scottish Department of Health, and which other Departments have been involved in discussions? I am not in any way critical; I should just like to know.

Rosie Winterton (Labour, Doncaster Central)

Particularly with regard to the 2000 Act, the main discussions have taken place with the Department of Health and Community Care in Scotland. I am not entirely sure about the nature of discussions with other Departments.

Because we recognise that allowing the use of tissue from incapacitated persons is a sensitive issue, we have provided that the regulations should be subject to affirmative resolution to allow Parliament to discuss the details. Prior to that, it will be necessary to undertake further discussions with appropriate Departments in Scotland. That will give Parliament the opportunity to discuss details that may not have been debated elsewhere.

I commend the new clause to the House.

Andrew Murrison (Conservative, Westbury)

I am glad that any regulations will be subject to the affirmative resolution procedure, because this area is a minefield. It is a pity that we do not yet have the Mental Capacity Bill; if we did, we would not need to discuss the matter in quite this way. I am deeply worried about Secretaries of State making regulations that affect people in such situations, although I suspect that, mercifully, they would be needed very infrequently. I assume that in drafting the provision, the Minister had specific instances in mind that drove it forward, because she, like me, will have been very cautious about treading in this extremely problematic area.

The Minister referred to the measure's potential interaction with the Medicines for Human Use (Clinical Trials) Regulations 2004. I am not entirely clear about how that will work, and I would be grateful if she expanded on it a little further.

Rosie Winterton (Labour, Doncaster Central)

With regard to the authority that is required before a person who lacks capacity can participate in a clinical trial, the legal representative of that person must give consent to their participation. A legal representative is a person who has a sufficiently close relationship with the person lacking capacity, or, if no such person is available, a doctor or other person nominated by the person's health care provider. The clinical trials regulations set out the detailed information that must be provided and other requirements that must be fulfilled before participation can be authorised. We will look very closely at the requirements under the clinical trials directive to ensure that the regulations fit in with them.

Question put and agreed to.

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

New Clause 9 — Duties in relation to carrying out functions

Rosie Winterton (Labour, Doncaster Central)

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

Michael Martin (Speaker, Glasgow Springburn)

With this it will be convenient to discuss Government new clause 10—Power of Human Tissue Authority to assist other public authorities.

Rosie Winterton (Labour, Doncaster Central)

The new clauses relate to the duties and powers of the Human Tissue Authority. I shall deal first with new clause 9. It is a shame that the hon. Member for South Cambridgeshire (Mr. Lansley) is not here because in Committee, he asked about including a provision that would require the Human Tissue Authority to adhere to best regulatory practice, minimising burdens and costs. He pointed out that other recently established public bodies had such duties written into their legislation. We have agreed to include such an amendment to make it clear that the authority is expected to be lean, effective, accountable and focused.

Steve Pound (Labour, Ealing North)

I was impressed by the word "economically" in the new clause. The guidance notes that my hon. Friend issued refer to a total cost to the new authority of approximately £1.5 million per annum. They also mention additional fees and licences. Is £1.5 million a net figure or will it decrease as income from fees and licences increases?

Rosie Winterton (Labour, Doncaster Central)

My recollection of the discussion in Committee is that the fees and licences would cover the administrative costs of inspection and issuing the licences. Some costs would accrue to the authority over and above those, such as the costs of issuing the codes of practice, administrative support and so on. If I remember correctly, the two sums are separate, but the intention is that the fees and licences will cover the inspection element.

Ian Gibson (Labour, Norwich North)

My hon. Friend talks about a mean, lean organisation. The same was said of the Human Fertilisation and Embryology Authority, which our Select Committee examined. The funding for it was doubled. Could not bodies cross-fertilise under an umbrella organisation? After all, they are considering the same matters, which include interacting with the public. Quangos and similar bodies appear to spring up every six months. Is there not a case for getting them together to consider the ethical and moral issues?

Rosie Winterton (Labour, Doncaster Central)

Let me correct my hon. Friend: I did not say that the authority would be a mean body; I simply said that it would be lean. However, he is right to point out that several arm's-length bodies exist. I am sure that he knows that a review of those bodies is currently being conducted to ascertain whether there is room to achieve the 50 per cent. cut in their number that the Secretary of State wanted.

New clause 10 gives the Human Tissue Authority power to assist public bodies. Clause 37 currently allows the authority to make arrangements with other public authorities so that they can carry out any of the Human Tissue Authority's functions. Again, that is relevant to the point that my hon. Friend the Member for Norwich, North (Dr. Gibson) correctly made. We want to avoid duplication of inspections and reduce bureaucracy. However, under the Bill as it is currently drafted, the authority cannot assist other bodies. It would therefore be sensible to enable it to do that. In particular, we have it in mind that the authority could assist Scottish Ministers in regulating live transplants in Scotland, if asked to do that. In this way, the regulation of live transplants would remain consistent across the UK, and we would avoid the need to set up a separate new body in Scotland, which would be inefficient given the small number of cases involved. The HTA will therefore be able to help to minimise the bureaucratic impact on those regulated, and the power would also give the authority sensible flexibility and allow it to assist any UK body.

I hope that the hon. Member for South Cambridgeshire will be pleased that we have taken up his suggestion, and that the whole House will support the new clauses.

Andrew Murrison (Conservative, Westbury)

I am sure that my hon. Friend the Member for South Cambridgeshire will be extremely pleased. Indeed, looking through the new clauses, I am very pleased to see how much of what we suggested in Committee has been taken up, and how many suggestions from third parties have also been adopted. Best regulatory practice is a welcome addition to the Bill, for example. I am also pleased that the agency will consult and liaise with other bodies. This has prompted me to look again at the Health Protection Agency Bill, which reaches its Committee stage tomorrow. It, too, places an onus on other bodies to co-operate with the agency that it establishes, and I wonder why no reciprocal arrangement is proposed between that agency and the Human Tissue Authority. Perhaps it might be worth considering introducing such an arrangement, to ensure that other such bodies associated and liaised with the HTA. It would be good if the Minister could give me an assurance that they will do so.

Rob Marris (Labour, Wolverhampton South West)

I appreciate that my hon. Friend the Minister wishes, as far as she can, to achieve a consensual approach to the drafting of the Bill. However, if most of my constituents read new clause 9, they would be surprised that Parliament wanted to place on the face of a Bill an exhortation—indeed, a legislative requirement—for an authority to

"carry out its functions effectively, efficiently and economically",

and to follow

"the principles of best regulatory practice".

The implication of the inclusion of those requirements seems to be that some other Government bodies and quangos do not operate effectively, efficiently and economically, and do not follow the principles of best regulatory practice. If that is the case, perhaps the House should turn its attention to those other bodies.

It is surprising to read the proposals in new clause 9, having heard Ministers constantly saying in Committee and on Report—which is somewhat akin to Committee—to Members who have tabled amendments that they are unnecessary because the provision is already implied or exists elsewhere in the Bill. I should have thought that the wording in new clause 9 was, by necessary implication, an exhortation on every Government Department, quango and similar body.

Tam Dalyell (Labour, Linlithgow)

I believe that my hon. Friend the Member for Wolverhampton, South-West (Rob Marris) raised the question of vets in relation to this matter. Did I mishear him?

Rob Marris (Labour, Wolverhampton South West)

I did not raise the question of vets.

Tam Dalyell (Labour, Linlithgow)

Then we shall leave that matter. I should like to ask the Minister about the arrangements with Scotland, as I believe that she has some information about that. I thoroughly approve of these measures being introduced on a UK basis, but it would be nice to have on record the arrangements for transplants in Scotland.

Rosie Winterton (Labour, Doncaster Central)

I would say to my hon. Friend the Member for Wolverhampton, South-West (Rob Marris) that best regulatory practice is included in some legislation. Given that questions had been raised about the duties of the authority and whether there would be duplication, we felt that it was important to make matters clear by placing the best regulatory framework in the Bill.

With regard to Scotland, giving the HTA the power in new clause 10 to assist other bodies, if it is asked to do so, will help Scottish Ministers in terms of regulating live transplants in Scotland. This question involves some continuing discussions, which we have been having with the Scottish Executive, who have been not only working with us, but consulting the public on the issue of the Bill. We will continue to work with them in that way to ensure that we do not duplicate areas in which we could assist.

Question put and agreed to.

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

New Clause 10 — Power of Human Tissue Authority to assist other public authorities

New Clause 1 — Determination of consent for removal, storage and use of organs from Adults for purpose of transplantation

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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

Michael Martin (Speaker, Glasgow Springburn)

With this it will be convenient to discuss the following:

New clause 2—Register of personal decisions about availability of organs for purpose of transplantation—

'(1) It shall be the duty of the Authority to maintain a register of persons deciding to make all their organs, or specified organs—

(a) available, or

(b) unavailable

for removal for the purpose of transplantation.

(2) Any person who decides to make all his organs, or specified organs—

(a) available, or

(b) unavailable

for removal for the purpose of transplantation may inform the Authority in a prescribed manner.

(3) Any person who has informed the Authority of his decision under subsection (2) but then makes another decision may inform the Authority in a prescribed manner.

(4) Upon receipt of information in accordance with subsection (2) or (3) the Authority shall—

(a) confirm to the relevant person in writing that the information has been received, and

(b) ensure that—

(i) an appropriate entry is made in, or removed from, the register, or

(ii) the appropriate entry is amended.

(5) The Secretary of State may by regulations prescribe the ways in which an adult may provide information to the Authority for the purposes of this section, including opportunities to provide such information when a person is—

(a) registering for the receipt of, or receiving, primary medical services,

(b) applying for a driving licence, or

(c) making an application for a passport.

(6) The Authority shall take such steps as it considers appropriate to promote public awareness of the register and of the means by which a person may make an entry in the register.

(7) Where the authority is satisfied that—

(a) a person in relation to whom information is held on the register has died, and

(b) a period of one month has elapsed since his death, the Authority may remove the entry in respect of that person from the register.

(8) Information held by the Authority in accordance with the provisions of this section may only be made available to—

(a) the person in respect of whom the information is held,

(b) a person in a qualifying relationship to the person specified in paragraph (a) when that person is deceased,

(c) a person to whom the duty under section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation] applies, and

(d) such other persons as may be prescribed by regulations.

(9) A person commits an offence if he—

(a) makes information held by the Authority in accordance with the provisions of this section available other than to the persons specified in subsection (8),

(b) does anything which causes an entry—

(i) not to be made in the register after the Authority has been informed in a prescribed manner,

(ii) to be removed without due authorisation, or

(iii) to be false or incomplete.

(10) A person guilty of an offence under subsection (9) shall be liable to—

(a) imprisonment for a term not exceeding 12 months, or

(b) a fine not exceeding the statutory maximum, or

(c) both.'.

New clause 3—Duties to persons who stood in a qualifying relationship in relation to transplantation—

'(1) It shall be the duty of the person to whom the duty under section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation] applies to—

(a) inform the person or persons who stood in a qualifying relationship to the deceased immediately before the death of the deceased of his or their rights under this section, and

(b) to provide him or them with an opportunity to exercise those rights.

(2) Those rights are—

(a) to be informed about the operation of relevant provisions of this Act,

(b) to signify an objection to the removal of a relevant organ for a reason specified in subsections (3) to (5).

(3) The reason specified in this subsection is that the deceased person had made known his decision to make all his organs, or a relevant organ, unavailable for removal for the purpose of transplantation even though he had not informed the Authority for the purpose of the making of an entry in the register.

(4) The reason specified in this subsection is that—

(a) the deceased person had made known his decision to make all his organs, or a relevant organ, unavailable for removal for the purpose of transplantation, and

(b) he had informed the Authority accordingly, but

(c) a relevant entry was not made in the register, or

(d) the appropriate entry in the register was not amended accordingly.

(5) The reason specified in this subsection is that the removal of a relevant organ for the purpose of transplantation would cause significant distress to any person who stood in a qualifying relationship to the deceased immediately before his death.

(6) The person to whom the duty under subsection (1) applies may designate another person to perform activities in relation to that duty.

(7) It shall be the duty of the person to whom the duty under subsection (1) applies to secure that any person designated under subsection (6) to perform activities is a suitable person to participate in the carrying-on of those activities.

(8) The qualifying relationships for the purposes of this section are—

(a) spouse or partner,

(b) parent or child,

(c) brother or sister.

(9) The qualifying relationships shall be ranked in the order given in subsection (8) for the purposes of subsection (1).

(10) Relationships in the same paragraph of subsection (8) shall be accorded equal ranking for those purposes.

(11) The duty under subsection (1) shall apply in relation to the person or persons whose relationship to the person who has died is accorded the highest ranking in accordance with subsections (8) to (10).

(12) If two or more persons are accorded equal ranking in accordance with subsections (8) to (10), the duty under subsection (1) shall apply to all of the persons accorded that ranking.

(13) In applying the principles set out above, a person's relationship shall be left out of account if—

(a) he does not wish to exercise his rights under this section,

(b) he is not able to exercise those rights, or

(c) it is not reasonably practicable to communicate with him within the time available before the organ or organs must be removed.

(14) Nothing in this section affects the general professional obligations of registered medical practitioners in relation to the family of the deceased.'.

New clause 5—Elective ventilation for transplantation—

'(1) This section applies where—

(a) a patient is in a hospital, nursing home or other institution; and

(b) the person having the control and management of the institution reasonably believes that—

(i) consent making removal of part of the body of the patient, after he has died, for transplantation lawful has been, or will be, given,

(ii) part of the body of the patient is or may be suitable for use for transplantation after he has died, and

(iii) elective ventilation would be appropriate.

(2) Where this section applies it shall be lawful for the person having the control and management of the institution to administer elective ventilation.

(3) Authority under subsection (2) shall only extend to the taking of the minimum steps necessary for the purpose mentioned in that provision.

(4) Authority under subsection (2) 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.

(5) Authority under subsection (2) 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.

(6) In this section, "elective ventilation" means the use of artificial ventilation in a comatose patient who is close to death from severe brain damage for the purpose of protecting part of the body of the patient for transplantation after he has died rather than for the benefit of the patient himself.'.

And the following amendment thereto: (a), in line 9, after 'died', insert—

'( ) a decision of the patient to consent to the activity is in force,'.

Amendment No. 10, in page 2, line 45 [Clause 1], at end insert—

'(10) In this section, "use" does not include any activity authorised by or under section 44.'.

Amendment No. 1, in page 4, line 11 [Clause 3], leave out 'or public display' and insert

', public display or transplantation following removal where each of the conditions specified in section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation](2) is met'.

Amendment No. 2, in page 4, line 23, at end insert—

'(5A) Where the person concerned has died and the activity involves any of the matters specified in subsection (5B), "appropriate consent" means consent determined in accordance with the provisions of section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation].

(5B) Those matters are—

(a) the removal of the material specified in subsection (5C) for the purpose of transplantation where each of the conditions specified in section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation](2) is met,

(b) the storage for use for the purpose of transplantation of the material so removed, and

(c) the use for the purpose of transplantation of the material so removed.

(5C) That material is—

(a) an organ,

(b) associated tissue.'.

Amendment No. 3, in page 4, line 31, at end insert—

'(8) In this section "associated tissue" and "organ" have the same meanings as in section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation].'.

Amendment No. 4, in page 4, line 34 [Clause 4], at end insert

'except where consent is determined in accordance with the provisions of section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation]'.

Amendment No. 11, in page 8, line 35 [Clause 11], at end insert—

'(aa) activities authorised by or under section 44;'.

Amendment No. 5, in page 14, line 22 [Clause 23], leave out paragraph (d) and insert—

'(d) the definitions of death for the purposes of this Act, including a definition of death confirmed by brain stem tests for the purpose of section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation];

(da) the procedures to be followed in relation to brain stem tests for the purpose of confirming death;'.

Amendment No. 12, in page 14, line 35, at end insert—

'(ja) activities authorised by or under section 44;'.

Government amendment No. 66.

Amendment No. 13, in page 28, line 7 [Clause 44], at end insert—

'(4A) This section shall not be read as making unlawful anything which is lawful apart from this section.'.

Government amendment No. 47.

Amendment No. 6, in page 33, line 19 [Clause 55], after 'Act', insert

'except section [duties to persons who stood in a qualifying relationship in relation to transplantation]'.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am grateful for the opportunity to raise the question of presumed consent and I am grateful to those hon. Members who have put their name to the amendment for their indication of support. I hope to set out in my opening remarks the current situation with regard to organ transplant, explain the proposed change, briefly explain what each new clause and amendment would do and then set out the reasons for the change. Finally, I shall deal—in advance, if I may, for a further occasion—with some arguments that Ministers, among others, have used against the proposals.

I hope also that the Minister responds to my "prebuttal" of her points, if she feels I have them right, rather than simply repeating them without reference to some facts that we seek to express.

Andrew MacKay (Conservative, Bracknell)

Optimistic.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The right hon. Gentleman claims that that is optimistic, but I know that we want a good debate rather than simply a repeat of what was said on Second Reading, which, like consideration in Committee, provided an opportunity for differences to be aired. I respect the strong views of those on the other side of the discussion, and I know that those who share my view also respect their strong views. We need to have an exchange of views. If there is an area where the Government feel that the proponents of this measure have it wrong, I am keen that we accept that and revise our position.

The current arrangements, which are best described as relatives' consent with opt-in, stem from the Human Tissue Act 1961. Although it has been described, in shorthand, as an opt-in system, it is best described as seeking relatives' consent, often on a guess, as to what the person would have wanted, with an opt-in to guide them. If someone is in such a position that their organs could be used after their death for transplantation purposes—that is, they have died and their death has been confirmed by brain stem testing on a ventilator in the intensive care unit with no medical contraindications to organ donation—doctors may approach relatives to seek permission so to use the organs.

At the moment, relatives, often at the height of their grief—such deaths are often of young people following a road traffic accident or other trauma—are asked to decide whether the organs can be used. In a small minority of cases, the potential donor would have made clear to relatives his or her opposition to donation. That is generally and rightly respected by those relatives, although it need not be if relatives choose not to do so.

In a larger minority of cases, but still a minority, the potential donor will have indicated a wish to donate by telling relatives, carrying a donor card and/or registering on the organ donor register. Relatives still have to give consent, and in a significant minority of those cases relatives withhold their consent: in the potential donor audit, relatives refused in 11 out of 226 cases in which the organ donor register was consulted. That is not a virtual nothing, in terms of that frequency, but a problem with which both systems must deal. We should not think that it is not also present in the current system.

In the majority of cases, as recognised by the potential donor audit carried out by UK Transplant, the wishes of the potential donor are unknown. In those cases, relatives are forced to second-guess the wishes of their loved one. In about half those cases, permission is withheld—again, those data come from UK Transplant's potential donor audit for the first few months of 2003. If we make a comparison with previous research, that proportion has increased in the last 10 years from 30 per cent. to nearly 50 per cent.

Andrew Murrison (Conservative, Westbury)

On a point of clarity, I think that the hon. Gentleman said, as I think that the record will say, that relatives have to give consent. I am not sure whether he meant that. Perhaps he might like to think again about precisely what he meant. In fact, they do give their consent, and it is always sought, and rightly so. We need to be absolutely clear about the letter of the law.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I will repeat what I was seeking to get across: in a larger minority of cases, the potential donor will have indicated a wish to donate, as in the examples that I used, and relatives still have to give consent, or they still have to be consulted for that consent. I will clarify that. As I explained, in a significant minority of cases—each one is significant for the person or people who will die because that organ is not available, so even one case is significant—relatives withhold their consent.

Under the proposed change, the system would be one in which consent by the potential donor was presumed unless he or she had registered or made known an opt-out. The plan would be that after a widespread media and education campaign, which would be prompted by the change in the law but would take place before it came into effect, every adult would be given multiple and continued opportunities to register their objection to their organs being used after their death for transplantation, and to discuss that view with their relatives. As I described previously, were it the case that someone's organs could be used after their death for transplantation purposes, doctors would have a legal duty to check the opt-out register, to see whether the person had registered an objection. If so, no approach other than the explanation that might be required would be made to relatives, and the wishes of the deceased would be respected. If no opt-out had been registered, relatives would be approached and asked whether they knew of any objection of the deceased that had not been registered. If so, organs would not be taken for transplantation, as previously. If no objection had been registered, and if no objection was known by relatives, medical staff would express an intention to use the relevant organs for life-saving or life-transforming transplantation, in line with the presumed or, where relevant, expressed wishes of the potential donor.

At that point—this is the soft opt-out proposed by me, and supported by the British Medical Association and others—if relatives demonstrate that they would suffer significant distress as a result of the use of organs in that way, the organs would not be taken. This veto opportunity for volunteered distress by relatives is called the soft system of presumed consent, as used in Belgium, which is to be contrasted with the harder system, with no such veto, as used in Austria, for example.

Ian Lucas (Labour, Wrexham)

Can the hon. Gentleman clarify who, in those circumstances, would assess whether the distress was significant?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The same people would make that judgment who make the judgment now when there is indecision or a disagreement among the relatives—the doctors who were caring for the deceased person. It would not be, as in other jurisdictions, doctors with a vested interest for the recipient, but doctors and nurses who have invested their time in looking after the deceased and caring, post-bereavement, for the relatives.

David Wilshire (Conservative, Spelthorne)

rose—

Kevan Jones (Labour, North Durham)

rose—

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I give way first to the hon. Member for Spelthorne (Mr. Wilshire), who has a particular interest in this matter.

David Wilshire (Conservative, Spelthorne)

Following the previous intervention, do I understand the hon. Gentleman correctly? Is he telling us that somebody somewhere, even if they were not involved in the particular case, would have the power to overrule relatives who were distressed? How on earth can anybody measure the amount of distress coming from the bereavement as distinct from the amount of distress coming from the request to object to a transplant?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

These are difficult areas. It is done successfully in Belgium, in respect of both providing more organs and meeting public acceptability. Surveys of relatives show that they are pleased to be relieved of the responsibility of taking a difficult decision at the height of their grief. That is how it would be done here. Clearly, the relatives are distressed as it is, and the current system expects them to take a decision, to second-guess the wishes of the deceased at the peak of their grief when brain stem death will just have been declared after what is normally a short illness following a traumatic injury. In those circumstances, the distress of relatives is already present.

This system proposes that relatives are approached to ascertain whether there were any unregistered objections and it gives them the opportunity to volunteer the view that they do not wish the transplant to go ahead. The difference is that they will not be asked for their view, because the view of the deceased will predominate, whether it be expressed or presumed. Nevertheless, if the relatives have a view, after they know that the organs will otherwise be used, they can state that they would suffer distress and the judgment would be made in the same sensitive way as at present.

I hope that the hon. Member for Spelthorne will accept that these are difficult decisions, but that they have to be made. He must remember that there is another set of distressed relatives—those of patients who are literally dying without the transplants. We have to ensure that we weigh up those two interests as sensitively as we can. Other countries have managed it successfully—by the Belgian method, for example, which has been carefully appraised and incorporates taking into account the views of relatives afterwards.

David Wilshire (Conservative, Spelthorne)

I am grateful for that response and if I catch your eye later, Mr. Deputy Speaker, I may comment on the views of other people and third parties. However, would the hon. Gentleman accept that one definition of hell would be to be already deeply upset and passionately opposed to what is about to happen to one's deceased relative and then to be told by someone, "I am sorry, but you are simply not upset enough"? That, for me, is a definition of hell.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

As I say, the problem that the hon. Gentleman seeks to identify is a problem that occurs now in respect of organ donation where the deceased has a donor card, but relatives may well oppose it. Doctors have a very difficult problem when someone has said in life that they wish to donate, but another group of people are dying and their relatives are deeply concerned about it, and a third party—the bereaved relative whose interests must also be respected—expresses another view. These are difficult decisions to take now—they certainly had to be taken by my colleagues when I worked in acute medicine—and those difficulties will always be with us. We have to set out a framework to ensure that due respect is given to the strongly held views of bereaved relatives. The veto outlined in the provision does precisely that and it does so reasonably.

Kevan Jones (Labour, North Durham)

rose—

Tam Dalyell (Labour, Linlithgow)

rose—

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am keen to make progress, but I will take these interventions.

Kevan Jones (Labour, North Durham)

I appreciate that the hon. Gentleman is attempting to give relatives some input or a veto. However, what happens when relatives are not present and the decision to transplant organs has to be taken, but relatives subsequently come forward to dissent? Would that not put doctors in the terrible position of having done something to which relatives subsequently take strong exception?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The hon. Gentleman will be relieved to know that that problem is far more likely to arise under the current arrangements because the Human Tissue Act 1961, which deals with circumstances when a donor card or the organ donor register has been used, does not require doctors to delay transplantation, because people can be kept ventilated after brain stem death only for so long while relatives are found. That is the first problem, and that already happens now when there is an indication of the deceased's wish but relatives are not present. I hope that the hon. Gentleman recognises that. In many such cases, if not in the vast majority, the deaths take place in intensive care following an illness where there is a process of diagnosis of death by brain stem injury, and relatives are invariably there, where they exist. It is not a rapid decision. There are some circumstances, however, in which rapid decisions need to be taken, and clause 44 presumes consent for cold perfusion in those cases. I not believe that the problem identified by the hon. Gentleman would be any greater than in the current circumstances that I described.

Tam Dalyell (Labour, Linlithgow)

Is there not another definition of hell, which is the agony of the relatives of those desperately in need of a transplant and who see matching tissue going up in crematorium incinerators, when it is likely that the relatives of the deceased would have been only too happy to help someone else?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I share that view and I hope that the hon. Gentleman has a chance to catch your eye later, Mr. Deputy Speaker. I know that he has a long history of campaigning on the issue and would be able to develop those points further.

The differences in the current system and the opt-out system reside mainly in the way relatives are approached. It is not that relatives are approached under one system and not approached under the other. In the current system, relatives are asked to make a decision, usually based on guessing their loved one's wishes or on their own feelings. Under a system of presumed consent with opt-out, the absence of an objection is taken as the basis of a presumption of consent by a potential donor who is ordinarily resident, has capacity and is an adult. Relatives are approached only to seek evidence of unregistered objection or opt-out by the deceased, not to make a decision themselves.

Why do the proposers of the new clause want to change the present system? As I have said, if the present system were working well, improving, doing well enough or offered advantages compared to the one proposed, I would not propose a change. However, it is clear that the present system is not working well enough for prospective recipients, prospective donors or the relatives of the deceased. All those who support change support the current system while we have it, and I hope that it is acknowledged that I and others who support change have worked hard to promote the organ donor register and donor cards. However, we have to recognise that the present system is not working effectively for any of the people involved.

In terms of the effect on potential recipients, the number of cadaveric organ donors is falling year on year despite efforts made under the present system. The Minister may claim that last year there was an increase, but there was not an increase in the number of cadaveric organ donors in 2003 compared with 2002, nor in 2002 compared with 2001. That is what we are measuring. At the same time, the number in need of a transplant rises every year. That means, tragically, that more and more people are dying while on a waiting list for a transplant or before even making it to the formal waiting list. Many people do not make it to a waiting list because the criteria are tight—because the prospects for transplantation are so limited.

Potential donors—the deceased whose organs would be used—do not do well out of the present system either. Surveys have shown that 80 to 90 per cent. of people would in principle wish their organs to be used for transplantation after their death, if possible. However, under the present system, only 50 per cent. have their organs used, because of high rates of refusal by relatives. That means that many organs whose owners would have wanted them to be used to save lives are being buried or cremated with the deceased in direct contravention of their wishes—although I accept that those wishes are often unexpressed.

Nor are relatives of the deceased well served by the present system. They are put under pressure to make a decision, often at the height of their grief. There is now research to suggest that half of them make a decision that they later regret. Every time they see the story of a successful transplant in the media, they feel that their decision—at a time of heightened grief—was not the one that they would have made if they had known then what they know now.

Nor is the present system fair on medical staff. Doctors and nurses are asked to approach relatives to make a decision at a very difficult time. Nor does the NHS do well out of the present system. That is not a major consideration, but it has been mentioned by the media. Maintaining thousands of kidney patients on dialysis, instead of treating them with the far more cost-effective option of transplantation, uses up millions of pounds of NHS cash that could be spent on saving or prolonging the lives of others. That is not a key point and it is more ethical than financial, but even the financial arguments are in favour.

The second point is that presumed consent with opt-out works; it saves lives. Many other countries in Europe and the rest of the world use that system successfully. The average donation rate, in donors per million of population, is 25 per cent. higher in countries with opt-out than in countries that have an opt-in system. Scientific evidence and research backs that up. Several analyses published in scientific journals have looked at the effect of changing to presumed consent with opt-out on rates of organ donation and at other outcomes, such as public satisfaction and relatives' views. They all showed that such a change was successful.

Some analyses examined the factors that could be judged to account for a higher rate of organ donation in one country than another. All those studies cited presumed consent with opt-out as one such factor and often the only one that could realistically be changed; for example, the rate of road traffic accidents is a factor but it would be hard to change that—one would certainly not want to. Another factor is the proportion of people with a particular religious view; in Europe, Roman Catholicism is associated with a higher rate of donation. Those factors are hard to change, but the one thing that countries can change—the one thing Parliament can change—is the law.

Ian Gibson (Labour, Norwich North)

In those successful countries, have their Parliaments and local organisations attempted to highlight and publicise the need to donate organs? Is there a correlation between that and their success? Does the hon. Gentleman have figures on that?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

A change in the law might lead to a temporary increase in donations due to heightened awareness. There was an interesting experiment in Belgium. When the law was changed, and everyone was subject to the same education and publicity, one centre kept to the previous system of seeking formal consent from relatives while another centre switched to the new system. At the second centre, there was a significant and sustained increase in organ donation, which continues to be maintained, but at the first centre, with the original system, the rate, which was lower, stayed the same. Those results were published in peer-reviewed medical literature.

It is thus not acceptable for the Government to say, as they did in their press release of 14 January, that there is no evidence that presumed consent with an opt-out works. It is clear that there is such evidence in the scientific literature. Indeed, all the papers published in peer-reviewed journals indicate that the system works. The Government may not be convinced by the evidence and I respect that view, but to say that there is no evidence or that the evidence is on their side is wrong; it is a misrepresentation and I hope that Members on the Treasury Bench will not continue with it.

Tam Dalyell (Labour, Linlithgow)

The hon. Gentleman made reference to the attitude of the Roman Catholic Church, which, of course, varies from time to time, according to whom one is talking to. Before I introduced the first of the ten-minute Bills, my colleagues told me to go and see Cardinal Heenan, so I did and there was certainly no objection at that time from the Roman Catholic hierarchy in England.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

None of the major religions opposes either organ donation or switching to a system of presumed consent. There is certainly no evidence of differential take-up for one system or another. We know that ethnic minority populations are less likely to donate organs, yet are more likely to need them—for example, owing to the incidence in the Asian community of diabetes leading to end-organ failure—so we need to increase the supply across the board.

Steve Pound (Labour, Ealing North)

That point has been raised by several people. Does the hon. Gentleman see anything in the Government's proposals that would actually increase the amount of donation, especially among the south Asian community? I am thinking of the work of Dr. Kartan Lalvani, who, for several years, has been trying to increase donation because of the high rate of take-up. Does the hon. Gentleman agree that, almost irrespective of anything else we discuss today, we must concentrate on that aspect? We must increase the amount of those donations.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Absolutely. Regardless of what happens today, we need to support the measures and projects being undertaken by UK Transplant. I welcome much of what the Government have done in respect of the existing system and we also recognise the work being done in those communities by UK Transplant and by the National Kidney Research Fund.

The third point about the scientific basis to believe that opting out would work is that it would tackle the real cause of low donation rates. A comprehensive audit of potential donor experiences in UK intensive care units has been carried out by UK Transplant—a Government-funded body, charged with running the organ donor system. It considered every death on ICU during a published period in 2003, and which of them had the appropriate medical indications where transplantation might be considered, where brain-stem testing was done and where transplantation was considered and relatives were approached. That showed that the reason why organ donation rates are low and falling is specifically the high rate of refusal by relatives—approaching 50 per cent.—not other factors, such as doctors failing to approach relatives. It is often said, "Oh, we should just improve the number of times that doctors approach relatives. They are being lax. They are not tackling the issue because it is so difficult for them to raise." That audit clearly showed that relatives are being approached and that the specific cause of our low donation rates is relatives' refusal. The low rate is not caused by the fact that, for example, organs are not used although permission has been given, which is a factor in other countries that have high wastage rates.

Ian Gibson (Labour, Norwich North)

Does the hon. Gentleman think that there might be a correlation with an anti-science, anti-medical culture that has developed since events such as those at Alder Hey? That might be the underlying reason why people do not entrust organs to the hands of the medical brotherhood and sisterhood.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

There appears to be no temporal association with a drop in organ donation and the events at Alder Hey or Bristol—thank goodness—but there has just been a steady and slow drop, and the only data points that we have for relative refusal is 30 per cent. in 1993, from the Gore study, and approaching 50 per cent. from the potential donor audit, being conducted nationally now. We know from opinion polls that people distinguish between the use of organs for research and the use of organs for transplantation. Those people who are badly affected by what happened Alder Hey and Bristol do not oppose presumed consent or organ donation generally for transplantation. I have had discussions with, for example, NACOR, which confirms that that is the case. The focus is on, first, children, and secondly, informed consent for the use of organs.

David Taylor (Labour/Co-operative, North West Leicestershire)

Do not surveys frequently show that between 70 and 90 per cent. of people have no objection to organ donation? The hon. Gentleman quotes the figure that 50 per cent. of grieving relatives fail to give permission, but that must only be because they are taking a precautionary approach, never having discussed the issue with their loved ones. Is that not a reasonable stance for them to take?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Yes, given that relatives are forced to make a decision, but it is very difficult for them to know what to do. Indeed, the potential donor audit asked relatives why they said no. In the main, they did not say no because the deceased did not want to donate. In 26 cases, the reason given in the audit was:

"Next of kin not sure whether patient would have agreed to donation."

That would be solved by presumed consent, as the relatives would be given a presumption because of the failure to opt out where that occurs. [Interruption.] That is better than guessing. I understand that hon. Members are concerned about that, but relatives must guess at the moment. They are unable to do so; they play safe, so several other people suffer because those organs are not available. However, we know, as the hon. Gentleman said, that 90 per cent. of people support organ donation.

David Taylor (Labour/Co-operative, North West Leicestershire)

I am grateful to the hon. Gentleman for giving way again. I would want to support new clause 1 and I strongly support its spirit, but his argument is, in fact, seriously flawed. Relatives who had no idea whether their loved ones would have wanted to agree to organ donation will not have their fears assuaged by the fact that a default system is somehow at work. The two things are totally separate, are they not?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

No. In fact, that is the key point, as shown by the successful operation of presumed consent in Belgium. First, the opt-out provides the opportunity to discuss such things with the family, so those discussions take place more than when there is an opt-in system with a donor card. We would all wish that those discussions took place more often. Secondly, the fact that someone has applied for a passport or been to the post office and applied for a driving licence and all those other things without registering an opt-out relatively straightforwardly should reassure relatives, as it does in those countries that use such a system, that their loved one did not object, even if, like many people, they did not think about it. That will allow relatives safely to consider such things and to find reassurance in the fact that other people will benefit from their lives being saved by that gift of life.

I am keen to make progress—I know that other people wish to speak—so I shall now deal with some of the ethical issues. I believe, and the British Medical Association believes, that presumed consent with opt-out is ethical; indeed, it is highly ethical, and many ethicists would argue that it is more ethical than the current system, for a number of reasons.

First, it creates a default position that life should be saved rather than a default position that life could be lost. Secondly, as the evidence shows, it saves lives that are currently needlessly being lost; and thirdly, it encourages informed decision making by potential donors during life as opposed to what is inevitably subjective second-guessing by grieving relatives after death. Fourthly, it is more likely, as we have heard, to respect the autonomy and wishes of the deceased, the vast majority of whom would want to donate, while still allowing conscientious objectors to do so while having protection in law for their objections. Finally, it treats relatives more fairly by not imposing life-and-death decision making upon them at a very difficult time.

Presumed consent with opt-out meets the wishes of the deceased for the reasons that I have given, in that the vast majority of people wish to donate. As I have said, presumed consent is fairer to relatives, because we know that many relatives regret making decisions to say no when they realise that they could have saved a life. It is fairer to them because, under the soft system, there are the following benefits. They are not asked to make a de novo presumption or guess about the wishes of their loved one, and they are asked for any knowledge of an unregistered expressed objection by their loved one. That is considered a valid opt-out, so that protection exists. After they are informed of the intention to use organs for transplantation on the basis of expressed or presumed consent, they are given the opportunity to volunteer their own objections. Finally, presumed consent applies only to adults over the age of 16. In the case of children, under our proposals, parental consent would be required as now. That must be made clear.

David Wilshire (Conservative, Spelthorne)

I am doing my level best to follow the hon. Gentleman's ethical arguments, and I can see why he says that there is an element of guesswork as to what the deceased would have thought. However, to argue that presumed consent eliminates any guesswork is not correct. It may well be that the odds of getting it right are greater, but presumed consent will not be right 100 per cent. of the time.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Because presumed consent removes the decision that is often based on a guess from the relatives, it removes the guess. I think that the hon. Gentleman is right that it would meet the wishes of the deceased—I am glad that he accepts this—on the vast majority of occasions. That is not the case at the moment. It also benefits the other group of interested parties: the people who are desperate for the transplantation.

David Wilshire (Conservative, Spelthorne)

rose—

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I know of the hon. Gentleman's particular interest in the subject, so I shall, of course, give way again.

David Wilshire (Conservative, Spelthorne)

I want to ensure that the record is correct. I do not believe that I said that presumed consent would meet the wishes of the deceased; I said that it might meet the wishes of more deceased, but I most certainly did not say all.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I think the hon. Gentleman was saying—this follows logically—that presumed consent is more likely to meet the wishes of the deceased on more occasions than the current situation in which 50 per cent. of people do not have their organs used even though 80 to 90 per cent. of them are not opposed to the use of their organs. That is a big gap, and no system could be worse than that in terms of meeting their needs.

In the final part of my speech, I wish to deal with the rebuttals that have previously been made as that will aid the debate. The Government have said in a press release and elsewhere that there is no evidence that such a system would work, but that is simply not the case. I welcome the fact that the Government say that they want to make evidence-based policy, but they should know that there was a report in The Lancet on 30 May 1998, volume 351, by a group describing the evidence that a shift to opt-out had increased the number of cadaveric donors in Spain, Austria and Belgium. It also showed very low opt-out rates—2 per cent. in Belgium—suggesting, much as polls show, that few people oppose donation. It said:

"In three western countries there is evidence that changing to a contracting out system resulted in an increase in organs."

The Government may say that that was just a group of junior researchers, some fly-by-nights without much credibility. The lead author was Professor Sir Ian Kennedy, who wrote the Kennedy report on the Bristol heart scandal. He is clearly respected sufficiently by the Government to be appointed to head the new health care commission that inspects the NHS.

More sophisticated studies have examined possible confounding factors. Ronald Gimbel, an American, and his group examined the situation throughout Europe and tried to identify specific factors that increased the organ donation rate using a regression analysis. He identified four factors, and said:

"Evidence from this study, and from the studies previously discussed, clearly suggest that the practice of presumed consent (opting-out) legislation has had a significant effect on the number of cadaveric donors per million population. As the gap between the supply and demand for transplant continues to widen, professionals and policymakers should consider revisiting the implications of this legislation, or some hybrid of alternatives, as an effort to expand the 'the gift of life' to those in need."

The study represents peer-reviewed scientific evidence, so the Minister cannot simply repeat the mantra, "There is no evidence." She may not be convinced by the study. Indeed, she may be able to cite a peer-reviewed scientific study that suggests that presumed consent is not a relevant factor, although I have not read one, but she should not say that there is no evidence for my proposals. I could cite other papers, but I shall not do so for reasons of time. The Government's research shows that presumed consent could work because the potential donor audit identified the problem as relatives' refusal.

I accept that it was important for such work to be done before any changes were made to the system. The Government claim that the current system is working, but they need to examine the statistics published on UK Transplant's website, because they show a year-on-year decline in organ donation, including over the past year. Statistics for the year ending 31 December 2003 clearly show that the percentage change for total solid organ transplants between 2002 to 2003 was minus 5 per cent: there were 2,219 such procedures in 2003 and 2,333 in 2002. That represents a fall over the past year, in my book. There was an 8 per cent. drop in the total number of deceased donors, from 770 in 2002 to 710 in 2003. Even if the Government choose four quarters at random, they cannot say that we have turned a corner—sadly. I respect the work of UK Transplant, but we must accept that the current situation is not working.

The Government say that there is a need to consult relatives to identify social factors that might contraindicate transplants, and the Minister repeated that on the radio. I agree, but relatives would be asked that question under the proposed system, as well as being asked whether unregistered objections existed. The Minister cannot claim that the need to consult relatives about a person's social history is an argument against my proposal.

The Minister has cited the case of a child in France, but the measure would not apply to France. Even if the Bill were amended by the new clauses, it would be unlawful for children's organs to be used for transplant without parental consent. France has not changed its law back from a system of presumed consent, as is set out clearly in the Gimbel paper. If the Minister can cite a different paper or argue with the letter than I received from the French Ministry, that is fine. However, she should not say that France has changed its law back to what it was before.

The Minister might argue that Spain uses informed consent in practice, despite the fact that it has provisions on presumed consent in law. I accept that that is the case, but Spain has a culture of presumed consent, so it can use informed consent, or relatives' consent. As the country has a high rate of organ transplants for other reasons, it has less need to push presumed consent as much as possible. The situation in Spain is not an argument against presumed consent, but an argument for changing this country's law.

I have heard that the Government have argued that they have put a Whip on the vote because my proposal represents an expenditure issue. However, that cannot be right, so I think that the hon. Member for Ealing, North (Mr. Pound) spoke for many people when he said that such a suggestion would be ridiculous.

The Government have argued—this may be the view of the Conservative Front Bench—that as the Bill is all about informed consent, we should not move away from that approach. The current system for organ donation is one not of informed consent but of relatives' consent, and that often boils down to relatives making second guesses at a difficult time. Arguing that the provisions should not be included in the Bill is wrong in principle. Given that such Bills come along only once every 40 years, it is little consolation to suggest that another Bill might come along shortly. It should not be suggested that my proposals are not relevant to a Bill that deals with issues surrounding Alder Hey and the use of children's organs for research.

I am grateful to the House for allowing me to set out my arguments at such length. I hope that hon. Members accept that I took interventions to allow people to challenge my views and I look forward to the rest of the debate.

I stress that we support the existing system as far as it goes, but it is not working, there is an alternative, and at the very least the Government should be calling for a public debate. They cannot simply say that we cannot change the law because there has not been a public debate and they are not going to have one. They need to answer to the thousands of people on transplant waiting lists and their relatives, and to those who have been buried or cremated with their organs when they would have wanted them to be used. It is those two groups of people to whom the new clauses speak, and I hope that the Government will listen through us to them.

Tam Dalyell (Labour, Linlithgow)

As the hon. Member for Oxford, West and Abingdon (Dr. Harris) said, I have a long history in this matter, going back to 1970 when I introduced a ten-minute Bill. I do not propose to regurgitate history, because things have moved on, but I say one thing to Conservatives: ten-minute Bills usually empty the House. For the Bill that I presented, the House did as usual and emptied. However, there remained the former Conservative Prime Minister, Ted Heath, and he listened to what I said. In the Corridor shortly afterwards, he said, "I was very sympathetic, but you'll never get this past Keith Joseph and Department of Health officials." I say that because at that time there was considerable sympathy for such a proposal on an all-party basis. I say as an aside that, had there been a Labour Government in 1970, David Ennals and others would almost certainly have introduced a Bill on presumed consent precisely along the lines proposed in the new clauses tabled by the hon. Member for Oxford, West and Abingdon.

That is history, but to move to the present, and as lots of Members want to speak, I shall merely emphasise one point that the hon. Gentleman made most eloquently. It is totally unsatisfactory that decisions have to be made at the point of maximum grief. Of course relatives do not want to have to jump to a decision after a sudden, terrible accident. Furthermore and very importantly, for very understandable human relations reasons, doctors are rather reluctant to put the question. When a doctor is struggling to save some patient at a time of grief, the system fails. How can we expect a doctor to summon up the energy to ask the dreadful question, "Can we have organs?" One cannot blame them, as human beings, for not wanting to do so. I rest the argument for the moment on the point of maximum grief.

Given the history of the matter, is it really necessary to have a three-line Whip? [Interruption.] The former Secretary of State for Health—[Hon. Members: "It was not him."] Ah, it was his neighbour. Nevertheless, the former Secretary of State for Health, my right hon. Friend the Member for Holborn and St. Pancras (Mr. Dobson), had better speak for himself. I ask my hon. Friends on the Front Bench to be tolerant on this matter.

Andrew MacKay (Conservative, Bracknell)

As so often, I agree with a great deal of what the Father of the House said.

May I emphasise, as somebody who at one time was the Government deputy Chief Whip, that I cannot understand why this Government have imposed a three-line Whip on the business before us. This is an immensely sensitive issue and which way each of us should vote is a matter of judgment—often moral judgment. There is no good reason whatever for Government Back Benchers and Front Benchers to be whipped. I commend the Liberal Democrats and my party for allowing a free vote. I put it to those on the Treasury Bench—I notice that there is no Whip present at the moment, but the Minister will no doubt pass on the comments to the Chief Whip—that such behaviour devalues public debate and confidence in the House.

Many issues are party political. Accordingly, and rightly, we are whipped on them. However, there are many issues that attract great interest from outside the House on which the House is not divided along party lines. I suspect that many of my colleagues oppose the new clause, which I support. That is healthy, right and proper. It would have been far better had the debate been completely open and unwhipped. We have harmed public confidence in our House of Commons, and I deeply regret that. I hope that lessons can be learned for the future and that there will be more free votes on issues that are wholly non-party political. That should have been the case today. I strongly endorse the comments made by the Father of the House today and by the hon. Member for Ealing, North (Mr. Pound) last week when he broadcast to the nation in his usual voluble style.

A large number of right hon. and hon. Members wish to speak and I do not wish to delay the House unduly. We are, I hope, united on one point: we all want more organ donors and to reduce the number of people who are suffering while they wait for a donation and who might lose their lives during that period. I am sure that there is common consent throughout the House on that point. The question is how to get that. I strongly believe that opting out of donation rather than opting into it will increase the number of donations. A minority of people, for ethical and other reasons, do not want to donate their organs. I understand that. Their wishes must be respected, and if Parliament accepts the new clause they will have every right to opt out. Among the great majority of people, however, there is not only a general desire to donate their organs, but a degree of complacency or laziness—they never quite get around to getting an organ donor card. The new clause will put that right.

I conclude by gently chiding the Minister, which I do not like doing as I have a lot of time for her. She is not a new Labour clone who is unable to speak her mind; she comes from a far more distinguished background of Labour Ministers and I respect her for that. Perhaps it was because it was early in the morning, or perhaps it was because I had only just woken up, but I thought that one of the hon. Lady's replies on the "Today" programme was uncharacteristically insensitive. She said that, instead of doing as the hon. Member for Oxford, West and Abingdon (Dr. Harris) proposes, we should encourage doctors and nurses to persuade patients and their relatives in hospital that donation would be a good idea. With the greatest respect, let me point out that that means a doctor or nurse, at a most sensitive time, telling someone, "Look, you're probably going to die. Why not fill in this donor form?" or saying the same to a patient's relatives. That is unbelievably callous. I am not suggesting that the Minister is unbelievably callous, but that would be the result of her suggestion.

The ability to opt out of donating one's organs is a much better way forward. I hope that, even at this late hour, the Government have second thoughts and allow the new clause to go a stage further.

Frank Dobson (Labour, Holborn and St Pancras)

As my hon. Friend the Member for Linlithgow (Mr. Dalyell) will confirm, I have opposed the opting-out proposition both from the Opposition Front Bench and as a Minister. However, as I have listened to recent discussions, in particular the speech made by the right hon. and learned Member for Rushcliffe (Mr. Clarke) the last time that we debated the subject and the speech made by the hon. Member for Oxford, West and Abingdon (Dr. Harris) today, I have become more doubtful. We have to recognise that the present system is not working: it does not produce enough organs to meet the needs of people who would be able to live a decent life if they had an organ transplant. I do not think that we can go on as we are, but nor do I think that simply attaching the opting-out proposition to the Bill is the best way forward.

There are a lot of arguments in both directions. It is ridiculous that we have reached a position in which Ministers assert that the French did something and the proposer of the new clause says that that is not the case. The least that the Government can do is to agree to produce a Green Paper or a discussion document setting out the facts of what has happened in those countries that have introduced an opt-out system. My principal concern about such a system is that there might be a terrible, scandalous incident that would be provoked into public hysteria by the news media. There would then be a huge falling off in the willingness of people to have their organs used. However, it should not be beyond the wit of this Parliament to come up with a proposition that would, generally speaking, protect against that.

Tam Dalyell (Labour, Linlithgow)

My right hon. Friend is absolutely right. What scuppered things in the late 1960s and early 1970s was a scandalous incident whereby two patients were moved across my right hon. Friend's city of London to die in the right place, to the advantage of a particular renal surgeon. That was devastating for a cause that was otherwise a sensible one.

Frank Dobson (Labour, Holborn and St Pancras)

I accept that. I recall the point that my hon. Friend is making.

It is wrong for the Government to have a whipped vote this evening, but despite that I will probably be voting with them. That is because I would want from the Government Front Bench an undertaking that we shall have a thorough-going examination of the whole issue.

Gwyneth Dunwoody (Labour, Crewe and Nantwich)

I know that my right hon. Friend is putting forward an informed and sensible proposition. However, does he accept that we have been debating these matters not for 10 years or for 20 years, but for as long as I can remember? Many people are dying now and not in the next 20 years. Does he agree that to ask for a Green Paper is, in House of Commons terms, putting back a very difficult decision that many of us do not want to take but one that we have a special responsibility to take?

Frank Dobson (Labour, Holborn and St Pancras)

I accept all the points that my hon. Friend is making. I accept that it is a difficult decision. There are those on the extreme edges of both arguments who are certain, but there are many in the middle ground who are extremely confused, and who come from both ends of the spectrum. We owe it to them and to the people of this country generally that if we are to change the law, we must get it right. The worst thing that we could do would be to change the law in a way that ended up with a mess. We are not particularly good at making changes to the law on the hoof. We are not too good at making clear and sensible laws at the best of times, but as I have said we are pretty bad at changing things on the hoof. However, there is no reason why, within two or three months, the Government cannot come up with a closely argued proposition, setting out the views of the chief medical officer and others, so that there is thorough-going consideration. Then the Government can introduce a Bill in the next Queen's Speech and get on with things. That is what we should do.

Richard Taylor (Independent, Wyre Forest)

I am so grateful to the Father of the House, the hon. Member for Linlithgow (Mr. Dalyell), for mentioning the doctors' dilemma. I was hesitant about putting forward the tremendous problem that practising doctors face at this fearful time. The hon. Gentleman was right to say that it is the worst time for any family to make a decision. It is the time of maximum grief. The thing that has moved me more than anything as a practising doctor who has had to ask relatives for consent for transplantation at this, the worst time, is that they have, on occasions, said to me afterwards, "Thank you very much. I realise what a terrible job it was for you." That has amazed me. That is the most generous thing anybody could ever say.

I am wholly in favour of the new clause. It would force people to argue among themselves before the moment occurred. At present, relatively few people discuss with their families whether they should fill in an organ donor card, but if there were presumed consent, I believe that many, many more families would talk about it and then, if a disaster happened to a young member of the family, the rest of the family would at least be aware of that member's wishes, and they would expect a doctor to ask at the crucial time. There is no doubt that the new clause would increase the number of organ donations, which are desperately needed by so many people.

Steve Pound (Labour, Ealing North)

I support the grouped clauses moved by the hon. Member for Oxford, West and Abingdon (Dr. Harris).

It does not need to be put on the record but I shall do so anyway, superfluous though it may be, and say that the majority of the Bill is excellent. It is a first-class piece of legislation that does long overdue work and is entirely worthy of support on both sides of the House. Were it not for the area covered by the grouped clauses moved by the hon. Member for Oxford, West and Abingdon, it would be well nigh the most perfect piece of legislation I have seen. The fact that it even approaches that state of perfection is very much to the credit of my hon. Friend the Minister. However, she may have erred by not allowing a conscience vote on this occasion.

I understand that there are financial implications, but this is a cross-party issue that so affects all parts of the Hose, as evidenced by the list of supporters of the new clauses. It is very seldom that we see the name of the right hon. Member for Bromley and Chislehurst (Mr. Forth) in the same company as the name of the hon. Member for Oxford, West and Abingdon and, on a humbler and far lower stratum, my own name.

Tam Dalyell (Labour, Linlithgow)

One does not wish to shoot one's own troops or one's friends, but my hon. Friend says there are financial implications. Some of us think that the proposed scheme would save money in the medium and long term, rather than cost money.

Steve Pound (Labour, Ealing North)

The Father of the House, as ever, makes an excellent point. It is to his credit that he first raised the issue 33 years ago. I do not think that the measure before us will be weighed in the bankers' scales. I simply understand that there are implications with regard to the infrastructure and that the Government must, rightly and responsibly, pay heed to that matter.

In a gesture that I shall never repeat, I once offered to advise anyone who wished to nominate a Bill to be put before the House of Commons. That was on the "Today" programme last year, after I had been inveigled by the producer, Mr. Kevin Marsh. If the House is the echo chamber of the nation, the "Today" programme approaches that to a certain extent, though I do not in any way mean to compare you, Mr. Deputy Speaker, to the producer of the "Today" programme.

By far the most popular topic suggested from across the country was for a Bill precisely along the lines proposed by the hon. Member for Oxford, West and Abingdon. It was not until that rather unfortunate Christmas eve when we were hijacked by gun nuts from various survivalist magazines ranging from Auckland to Alabama that we lost out. I learned a good deal during that time. Principal among the things I learned was never, ever to do it again. The second thing I learned was what strength and depth of feeling mean.

The Minister referred earlier, as did the hon. Member for South Cambridgeshire (Mr. Lansley), who leads for the Opposition, to the good humour with which business had been conducted today. There was good humour in Committee, as there is on the Floor of the House. I cherish, admire and enjoy that good humour, but for many of our constituents what good humour there is is that of endurance—the bravery that they manage to summon up when they are looking at a very dark future. I mentioned my experience on the "Today" programme. I can also mention Mrs. Foley, a 33-year-old teacher and mother of a seven-year-old child, and a constituent of mine, who has cystic fibrosis and—she will not mind my saying this; she has given me permission to do so—may not live for many more years. She has good humour and immense courage and bravery, but I cannot simply look her and others in the eye and say that in this place, at this time and on this day, I did not do every single thing that I could to try to increase the number of donated organs and consequently the number of transplants, which would make such an enormous difference to people.

I cannot even begin to bring to the table the depth of knowledge and expertise of the hon. Member for Wyre Forest (Dr. Taylor) and various other Members who have spoken, but I spent 10 years working in University College hospital and Middlesex hospital in London. I was the ancillary worker who had to take the relatives into the interview room after their boy had been killed on the A40 or had died in a car crash on Marylebone lane, and who had to stand by, get the tea and be present if the relatives felt faint. I sat in on scores of the very sort of conversations that the hon. Gentleman mentioned. On one or two occasions, yes, the doctor was insulted and called a ghoulish bloodsucker or a Frankenstein, but in the vast majority of cases the reaction was, "We hadn't thought of that; he would really have liked that. He may be gone, but someone else will live." I heard that said over and over again.

One of the arguments against what is proposed—I am not saying that the Government are suggesting this—is that gung-ho consultants in accident and emergency departments may be a little too anxious to record brain stem death. Consultants in A and E departments seem the most unlikely group of people to want frivolously to go through the enormous amount of paperwork that such a transplant would involve unless it was the most serious possible case and death had been confirmed. My hon. Friend the Member for Linlithgow (Mr. Dalyell) spoke about nightmare cases such as the kidney shuffle across east London, which we remember, but I cannot envisage any case in which an A and E consultant, a registrar or anyone in accident and emergency would act prematurely or in breach of their primary Hippocratic oath because of the prospect of gaining an organ for transplant. I simply do not see that happening.

The Government have said—and I support them—that one solution is to increase the number of people carrying donor cards. I agree, and I had a great deal of sympathy with my right hon. Friend the Member for Holborn and St. Pancras (Mr. Dobson) when he called for a Green Paper. The difficulty is that for every France that the Minister raises, I can match it with a Spain and trump it with a Belgium. We can go right around Europe and talk about different cases, interpretations and levels of statistical analysis, but at the end of the day, perhaps, we have to convince the non-experts—the people such as my constituent, my neighbours and, frankly, myself. I simply cannot understand how my constituent would have a better chance of living if she were Belgian rather than British, how we in this country cannot manage what our fellow Europeans can manage so well, and how, as was said earlier, a vitally needed organ can be buried or burned while someone else is dying for it. This seems the most simple and elementary matter of demand and supply. We are simply not maximising the supply, whereas the demand is increasing exponentially.

If we were to place cards in GPs surgeries, as has been suggested, I wonder how high the take-up would be. Nowadays, GPs—there are many in the House, and they can doubtless speak with far more authority than I can—tend to have about eight to 10 minutes to see a patient. Can anyone imagine a GP talking to a patient and saying at the end of the consultation, "Yes, everything is fine; no trouble at all. By the way, have you thought about carrying a donor card?" The patient may wonder about the secret, subliminal message that lies behind that statement. If my hon. Friend the Member for Dartford (Dr. Stoate) were involved, the message would not be subliminal, because he would probably force the patient to take a donor card.

I am a strong proponent of compulsory national identity cards, as are most people who care about the safety and integrity of our nation. We face the prospect of issuing such cards, and that offers the perfect opportunity to link what the hon. Member for Oxford, West and Abingdon refers to as "illiberal legislation" with this liberal legislation. Including an opt-out on ID cards is a remarkably sensible idea.

My hon. Friend the Member for Enfield, North (Joan Ryan) has displayed an extraordinary degree of scientific understanding and great sensitivity in the long conversations in which other people and I have expressed our concerns. I am extremely grateful for her understanding and sensitivity, and I respect and admire her and the Minister for spending so much time on the matter. However, the problem is that the Government are squeamish.

Some hon. Members are simply not prepared to argue the case for a national system of donations, and some are terrified that the tabloid press will come up with stories about Frankenstein, Dracula and Burke and Hare—I genuinely believe that that concern informs much of the language in the explanatory notes. By arguing the case for a national system of donations—I accept that I am moving into uncharted waters—we ask people to recognise that each of us is a member of the same national community, and that we have the opportunity to give as well as to receive. I recognise that the area is difficult, but we must examine it because it lies at the core of the issue.

Tony McWalter (Labour/Co-operative, Hemel Hempstead)

My hon. Friend mentions the prospect of the press taking up the cudgels on the misuse of the new rule in the new clause, but they might also take an interest in other cases. An 18-year-old friend of mine died at Christmas in Papworth hospital, while waiting for someone with a donor card to die, when we all knew that many other people, whose organs would have saved that boy's life, were dying.

Steve Pound (Labour, Ealing North)

I thank my hon. Friend for that comment. Individual cases are one of the hardest points in the debate, and they are one of the factors that make objectivity so difficult—I realise that I have mentioned an individual case myself. Sometimes hon. Members examine the actuarial rather than the actual and the theoretical rather than the real. No hon. Member is untouched by experience of someone dying for the want of a transplant, and we have all met people in that situation in our family lives, our surgeries and our communities. Some of us strive for objectivity, and some of us are more successful than others in achieving it.

I have immense sympathy for the constituent of my hon. Friend the Member for Hemel Hempstead (Mr. McWalter), and I know how the family must have felt. This afternoon, however, we have it in our gift—I use the word "gift" advisedly—to turn back the tide. Imagine sending to the nation the message that we are all our brothers and sisters' keepers, and that we have a mutual responsibility. The tabloids may come up with lurid examples, but, please God, we do not need their permission to legislate.

I ask the Government seriously to consider the new clauses, which have been crafted with great skill and which touch an area of concern right across the country. If they were to reconsider the matter, whether in the form proposed by my right hon. Friend the Member for Holborn and St. Pancras or in any other form, they would not only make friends but save lives, and there can be no higher or finer calling than that.

Tam Dalyell (Labour, Linlithgow)

On a point of order, Mr. Deputy Speaker. I hope that this is in no way taken to be a criticism of, let alone to be offensive to, the Minister or the Government Whip, but from time to time in the House of Commons the tenor of the debate—the cross-party feeling—is that something should be altered and that only a Secretary of State, who is a Cabinet Minister, can make a decision on it. I do not know what he has to do that is more important than to listen to the House of Commons on this matter, but should he not at least be told what is being said, in the light of which he may wish to suggest a relaxation of the Whip?

Michael Lord (Deputy Speaker, Central Suffolk and North Ipswich)

As a very senior and experienced Member of this House, the hon. Gentleman will be aware that that is not a matter for the Chair. Everybody has seen today's Order Paper, and it is entirely for the Government to decide whom they wish to put forward for the Front Bench.

David Wilshire (Conservative, Spelthorne)

It is something of an irony that the speaker who immediately follows that point of order by the Father of the House is an Opposition Whip. I make it clear that I want to state only my own personal views and that although I do not seek to dragoon anybody into voting in any particular way, I hope that my personal arguments might persuade Members on both sides of the House to oppose the new clause. In response to the comments of the hon. Member for Ealing, North (Mr. Pound), nothing that I say will be coloured by what the media may say about me or about anybody or anything else.

On Second Reading, I explained why I feel so involved in this matter and have such strong views about it; I therefore see no need to take up the House's time by repeating those remarks. For the purposes of this debate, suffice it to say that when my daughter died all those years ago, I regret that I was not asked and I was relieved that I was not forced to object. Those two points have always driven my views in these matters.

I entirely accept that the hon. Member for Oxford, West and Abingdon (Dr. Harris) is motivated by finding a way to help other people, as is every other Member who has spoken or will speak in this debate. I want them to understand that those of us who take a different view are not against helping others. If there are ways in which we can improve the number of organs that are available, count me in, provided that we do not go down the route, as I see it, of the ends justifying the means.

I accept that improvements are required, and I will support them, but I will not support this particular proposal. I do not believe that it is selfish to put the deceased or the deceased's family ahead of a third party. To suggest that those of us who take that view are being selfish is unkind and unfair, because we do not see it like that. The hon. Member for Oxford, West and Abingdon made the fair point that on some occasions the deceased leaves the express wish that his or her organs may be used, yet in some circumstances the relatives can object. I would have no difficulty in buying into an amendment that stated that a clearly expressed wish of the deceased stands above all else. I can accept that—I am not opposed to all change. However, I find it difficult to accept the hon. Gentleman's suggestion that we are best guessing. As I said, perhaps we would make fewer mistakes under his arrangements, but we would not eliminate all mistakes. If the hon. Gentleman does not like best guessing, the amendment retains it but in a different form.

The hon. Gentleman justified the new clause by saying that he envisaged many opportunities for people to opt out. If there are to be such opportunities, it follows that there will be many opportunities for people to opt in. I happen to prefer opting in to opting out. He also said that the new clause would take the decision making out of the hands of relatives. Other hon. Members have explained why they believe that that is a kind thing to do, but from my experience, it is not a kind thing to do.

I accept that some people who are faced with the traumatic experience of someone who is dear to them dying will find it almost impossible to cope with such a request. It would genuinely add to their grief. However, others—I have spoken to some over the years—somehow found it helpful in a moment of appalling grief when someone said, in the middle of catastrophe, "Here is something that you could consider doing that would perhaps make the grief more bearable." Although some people would find the request almost impossible to handle, others would find it helpful to be asked.

I am deeply sorry that nobody asked me at the time. However, I think that I know myself well enough to say that if any organs had been removed from my daughter and I could have had the opportunity to object but the matter was taken out of my hands, I would have been outraged for the rest of my life. I appreciate that children are exempt and I shall comment on that shortly.

Let me consider the text of the new clause because some points might help colleagues to form a view. Subsection (1) of new clause 1 refers to

"part of a body of an adult lying in a hospital".

I appreciate that, when I explained what happened to me, I was referring to a 12-year-old daughter. Some debate took place about whether an adult should be considered to be 16 or 18. However, I sense that those who support the new clause hold that it is wrong, insensitive or somehow not right to include children in it, and we now have a definition of children. I gently say to the hon. Member for Oxford, West and Abingdon that everyone is somebody's child. If it is wrong to include a child who is under 18, is it not also wrong to include a 40-year-old child when a mother or father who are still alive could have the same strong views about their child? The child argument does not get us very far.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I did not want to interrupt the hon. Gentleman, but there is a distinction. Law—including the measure—recognises that autonomy and competence to consent come with adulthood. Some pragmatism has been applied in that the measure does not allow a Gillick-competent child to benefit—if I may use that word, given that there would be no benefit to that child—from presumed consent because a line is clearly drawn at the age of 16. Although everyone is someone's child, I urge the hon. Gentleman to consider the recipients of transplants and their relatives. They would not want to die or their relatives to die because of difficulties caused by someone who did not want the organs of their adult child to be removed even if that child did.

David Wilshire (Conservative, Spelthorne)

Of course I understand what the hon. Gentleman is saying and I appreciate that, when dealing with legislation we must, on occasions, take a legalistic view of it. However, the significance of the debate about whether this should be a free vote or a whipped vote is that it flags up the fact that we are in the territory of personal, subjective beliefs and convictions, rather than that of what the lawyers might say. I understand that there have to be legal definitions in this regard, and I am grateful for the fact that the age has now been set at 18, but if we are going to invoke the concept of the child and its parents, I must emphasise that I believe that we are all somebody's child. That is all that I am saying, and it is a subjective point which the hon. Gentleman may or may not set much store by.

New clause 1(2)(e) is at the heart of this proposal, in that it states that unless someone has registered an objection, things can go ahead. I would support the hon. Member for Oxford, West and Abingdon in this if he were to say that this provision involved a required request rather than presumed consent. If we were being asked to legislate that people must be asked, I would be with him. I understand the point made by the hon. Member for Wyre Forest (Dr. Taylor). It is incredibly difficult to approach people at the moment of a bereavement, and I am not sure that it is any easier to say "Please may we?" than "Do you mind if we do?" I would have thought that both were equally difficult. All that I can say is that it would sound so much kinder to be asked, "Do you mind?" rather than, "Do you object?" It would be so much more considerate of the views of the bereaved to ask whether they minded, rather than asking whether they wanted to object. Someone could end up in a much worse position for the rest of their life if they had to say, "I'm against this", as opposed to being able to say, "I'd rather not say yes at the moment." To object could leave a scar, whereas saying yes or no to the question "May we?" might not do so.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Again, I hesitate to interrupt the hon. Gentleman, but I want to make it clear that the proposal would not involve any such question being asked. People are sometimes scarred by having objected because they felt that their relative had suffered enough, for example, or for similar reasons that are often cited, but this measure would remove that possibility because they would be asked whether the deceased had made any objection. If they had, the relative would be notified that the plan was to use the deceased's organs and would be given an opportunity to volunteer an objection. However, they would not be prompted to make an objection, because consent would be presumed if the deceased had made no objection.

David Wilshire (Conservative, Spelthorne)

Again, I understand what the hon. Gentleman is saying, but I come at this from a somewhat different angle. However, the object that we are both trying to achieve is the same.

New clause 3(2)(b) states that people may

"signify an objection to the removal of a relevant organ for a reason specified in subsections (3) to (5)."

I tried to say in an earlier intervention that, if we start getting the law involved in these matters by saying that there has to be "significant distress" involved, I cannot get my mind round how we should deal with such situations. If we are saying that any asking at this moment of maximum grief is wrong, it would simply add insult to injury to try to measure the amount of distress involved. If the hon. Member for Oxford, West and Abingdon is suggesting that there can be reasons for relatives to object, I could begin to go along with him if he also said that all that the relative needed to do was to say no, rather than have us try to measure whether that was reasonable or unreasonable, or whether it was a frivolous "no", a moderately held view or a deeply held view. If we could just settle for a yes or no, that would be the best way of going about it.

Another aspect of new clause 3 that worries me is that a relative can be overruled if

"it is not reasonably practical to communicate with him within the time available".

That seems to be an invitation to lawyers to wrangle over what constitutes a reasonable amount of time, or a reasonable amount of effort to find someone. We would eliminate all that by opting for informed requests, because someone would then have to be asked, and they would have to be given the opportunity to answer. If that is thought to take too long, we return to the argument about whether all this is being done in the interest of the third party whose life could be saved, or of the deceased and their family. I can only say that one has to take one's own view on that.

I have always done my best to argue this case as best I can, but in the end, it is a subjective judgment. All that I can say to the House is that I remain opposed in principle to presumed consent. For me, the way to achieve our objective is through more education and discussion and through encouraging and helping members of the medical profession to make these requests. All of that is kinder and gentler, and it will achieve the same result in the end.

I have raised some practical issues about the implementation of this proposal, and if the House votes to accept the new clause, for whatever reason, and the Government find themselves in another place with this provision in the Bill, will the Minister consider amending it to take some of the sting out of it for those of us who are against it in principle? I am prepared to back change, provided that it helps not only other people but the family involved. In such circumstances, the family comes first. If we work at this, and if we encourage people and explain to them what we want to achieve, I believe that more transplants will become available on the NHS. However, I do not want to see presumed consent or the idea of society taking over the possession of the deceased's body.

Howard Stoate (Labour, Dartford)

I am grateful to have caught your eye, Mr. Deputy Speaker, in this important debate on an extremely sensitive and difficult issue. The House is at its best when it debates difficult issues that affect all our constituents, and I am sure that many, if not most, hon. Members will have had experience of constituents who are on waiting lists for transplantation and are in dire need of help, or who have relatives in that situation.

These are difficult issues for us to grasp, and I am grateful to the hon. Member for Oxford, West and Abingdon (Dr. Harris) for tabling the new clause, because it gives the House a good opportunity to discuss them. People have very strong views on them—we have heard opposing views being expressed here today—and take them seriously. They have clearly thought about them carefully, because they affect us deeply.

As someone who still practises a certain amount of medicine, I come across all sides of the argument. I have spoken to many people about carrying donor cards, which are available in the vast majority of GPs' surgeries, and I am sure that a large number of my GP colleagues discuss the issue with their patients whenever they get the opportunity, and encourage them to carry the cards. I have also spoken to people who have been asked whether they would allow a deceased relative's organs to be used for transplantation, and I have had patients who have benefited from transplantation themselves.

The economic argument is an interesting one. At one time, I had the distinction of being the most expensive GP in the country, because I had a patient who was on an extremely rare and expensive immunosuppressant drug while waiting for a heart-lung transplant, and the cost of it sent someone with a black briefcase down from the Ministry to talk to me about why I was spending so much of Her Majesty's money on this patient. Of course, once that patient had had their successful heart-lung transplant, my drug bill went back to somewhere approaching the mean. So there are economic arguments on both sides, and many interesting ways of looking at the issue.

The public have extremely strong views on this matter, but the problem is that they do not always express them. I have been a doctor for many years, and it has become apparent to me that, although people may have deeply held convictions in this regard, they often do not know how to talk about them or who to talk about them with. Just because someone does not opt out or in does not necessarily mean that they do not have deeply held views on the issue.

I chair the all-party group on men's health, and one issue that comes up time and again is that men in particular find it extremely difficult to seek help when they have a genuine health problem. Often, they simply do not come forward until the disease is well progressed or they present late with very serious illnesses such as heart disease or cancer. When they do present, they often suffer worse outcomes and die younger as a consequence.

Just because somebody does not necessarily express a view on something in public does not mean that they do not hold very strong views about it. That is why I have real problems with a presumed consent clause. I understand all the reasons that were cogently put forward by the hon. Member for Oxford, West and Abingdon, and I have great sympathy with his arguments, but I have real concerns and I shall vote against his new clause, for reasons that I too hold deeply.

Having spoken to many patients—many people who could be donors—I know that people have not a superstition, but a deeply held view about what should be done with their body. They still consider their bodies their property—even after they have died, when it could be argued that the property belongs to nobody as the person has left and the body is a corpse. However, that is not the case in the mind of a large number of people who still feel very strongly. People make elaborate plans for their own funerals and how their remains should be dealt with because they have such deeply held views about what should happen to them even after death.

I listened carefully to the arguments relating to the need to have more organs available. Nevertheless, I must show great respect for people whose unspoken views are often deeply held.

David Taylor (Labour/Co-operative, North West Leicestershire)

Would my hon. Friend care to say why his patients—often men whom he says have deeply held views about their own bodies and what might happen to them after death—in many cases fail to communicate that information either to relatives or via any system for registering their wishes?

Howard Stoate (Labour, Dartford)

That is an interesting question and my hon. Friend has raised an important point. At a recent meeting of the all-party men's health group, a patient was prepared to come forward to talk about his experiences and why he was such a late presenter. This chap had had rectal bleeding for 10 months before plucking up the necessary to go and see his GP to discuss it and get something done about it. It would be quite wrong to say that he did not care about his rectal bleeding, because clearly he did care deeply about it.

This chap kept coming up with all sorts of reasons to put the visit off and not to go, saying, "I'm under stress at work and just having an off day. It's probably piles. It's nothing to worry about." He managed that self-deception for 10 months before admitting it and going to his GP, who said, "Actually, mate, you've got bowel cancer." Fortunately, even though he had waited 10 months, he was able to have a successful operation. As far as anyone can tell, he has been cured. The fact is that men find it exceptionally difficult to talk even to their closest relatives about these deeply personal issues.

We can call that machismo, male pride or anything we like—it is not all that well understood—but there is no doubt that that is the situation. Over the decades, I have had patient after patient after patient who left coming forward to the doctor very late. When they do come, they often do not know what they want to say and it is difficult to coax out of them the real reason for their visit. They will come along to talk about their skin problem, but they really want to talk about their psychosexual difficulties. Getting round to that is very difficult indeed.

My point remains that people have very deeply held views that they cannot, will not or would rather not discuss with their relatives, friends or medical advisers. For that reason, I have real problems with an opt-out scheme that would presume that just because people do not come forward they are implicitly consenting to this process. I shall give an example that Members of the House will well understand.

In local elections, it is common for only 25 or 30 per cent. of people to turn out to vote. Does that mean that the other 70 per cent. have no view? Clearly it does not. Any Members who have been on the doorstep and talked to people as they go round their constituency will know that people have exceptionally deeply held views, but they do not necessarily think that voting is the way to express them. If the House were to say, "If 70 per cent. don't vote, we must presume that they entirely agree with Government policy because they have not voted against it," that might be nice in that it would provide a warm glow and allow me to think that my constituents like me more than they probably do, but we would not be doing ourselves justice in making such an assumption.

Gwyneth Dunwoody (Labour, Crewe and Nantwich)

I am listening with great care to this argument and I hope my hon. Friend will forgive me if I say that I find it mildly patronising. Many people find it difficult to articulate their views, but if they are asked about something as important as looking after their health they find the words. They may not find the right ones and they may not use the words that he and his profession would recognise, but most manage to say what concerns them.

If my hon. Friend really is saying that because there is a problem with communication, we cannot allow such legislation to go forward, I say to him that there is a major difference between voting in an election—whatever happens, people get an interesting House of Commons whether they vote or not—and the issue we are discussing, which is rather more significant.

Howard Stoate (Labour, Dartford)

My hon. Friend makes an important point. I always respect what she has to say as she holds strong views on these issues, and I welcome her intervention, but I do not agree. Having been a doctor for a long time, I know that, unfortunately, people do not find the words even when they know themselves to be severely ill. Any doctor in the House would, I am sure, be able to echo that. The experience is that many patients do not present with life-threatening illness often until it is too late. For all sorts of reasons that I have already outlined, that is the case. People do not express their views to their friends, their family or their doctor when they would perhaps otherwise like to do so. For those reasons, I feel strongly about this.

Having said that, we all want more organs to be available for transplantation as it is grossly unacceptable that so many people should be suffering, and even dying on a waiting list, because of a lack of available organs. That is a tragedy. It is the duty of the Government and the House to do all they can to increase the number of organs that are available for transplantation, but I happen to think that this would be the wrong way to do it.

We need a far more sophisticated education programme and we need to make it far more of a duty for doctors, nurses, health professionals, ambulance crews, those responsible for public information campaigns and those who supply information through the media to talk up the reason why people should be donors. An example is the blood transfusion service, which, through a combination of clever advertising and public awareness campaigns, generally manages to ensure a sufficient supply of blood freely given to save the lives of others. The same could be done with a carefully worded public awareness campaign on this issue.

Paul Burstow (Liberal Democrat, Sutton and Cheam)

Back in April 2000, the hon. Member for Broxtowe (Dr. Palmer) introduced a ten-minute Bill on presumed consent for organ transplants and the hon. Gentleman was a sponsor of it. It is entirely valid for a Member to reach a different conclusion at a later stage on the basis of evidence, but I have not heard that evidence so far. I wonder why he has changed his position.

Howard Stoate (Labour, Dartford)

That is an interesting point and I am grateful to the hon. Gentleman for bringing it up. I supported my hon. Friend's Bill because I think that such things should be debated in the House. I was keen for his Bill to be discussed, even though it was only a ten- minute Bill, because we should have the opportunity, albeit for a mere 10 minutes, to raise the issue so that it can be flagged up and the public can be aware of it.

David Taylor (Labour/Co-operative, North West Leicestershire)

My hon. Friend is most generous in giving way yet again. Is he saying that, with more imaginative and innovative approaches—for example, ones similar to those that organisations such as the National Blood Service tend to use—to promoting actual consent, he would be confident that sufficient had been done to reduce the large and widening gap in respect of the number of people waiting for an organ transplant, which has grown by more than a third in 10 years?

Howard Stoate (Labour, Dartford)

That is the question. I do not know that that would bridge the gap, but it should be tried. We do not do enough to promote the benefits of carrying organ donor cards. We have failed to some extent, as a Government and as a House, in not doing what we could to promote the scheme. I would like everything possible to be done to ensure that people are aware of it and are encouraged to carry cards.

Julian Lewis (Conservative, New Forest East)

I have been listening to what the hon. Gentleman has been saying with a lot of sympathy. Over the years, I have carried various donor cards, which became increasingly dog-eared and were eventually discarded. Also, at various times, I have signed various forms. Why, in the 21st century, when we know so much about network databases, does it still seem unclear to at least one Member of Parliament whether there is a national database, which, if people signed up to just once to give their organs, could put an end to the matter and save an awful lot of distressing questions and answers?

Howard Stoate (Labour, Dartford)

The hon. Gentleman raises an interesting point: there is a national database, which I gather is based in Bristol, but it is not well publicised. That is the problem—the public do not know of its existence.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The hon. Gentleman is being uncharacteristically unfair on the Government, who have introduced a number of new initiatives to promote the organ donor register and the donor card. The fact is that those are not working well enough. People sign the register in ever-increasing numbers, but the number of donors is going down. Does he accept that that is probably why Elizabeth Ward, who was the inventor of the kidney donor card, and founder of the British Kidney Patient Association, supports these new clauses—she knows that an opt-in scheme could never work well enough to save as many lives as we could under a presumed consent scheme?

Howard Stoate (Labour, Dartford)

That matter should be tested, and we need to do more. The fact remains that we are not doing enough at the moment to promote the scheme, and I am sure that we could do a lot more.

I will not detain the House further. I agree entirely with increasing the number of organs available for transplant, and I know that patients of mine would benefit from readier availability. I am sure that everyone in the House would welcome that. The question is: how should it be done? My view is that an opt-out scheme is a step too far, and that public opinion would oppose it.

Desmond Swayne (Conservative, New Forest West)

I congratulate the hon. Member for Oxford, West and Abingdon (Dr. Harris) on his new clause, and on the powerful argument that he used when he moved it. He is assured of my support in the Lobby tonight.

I wish to speak to new clause 5, which stands in my name, and to which the hon. Member for Oxford, West and Abingdon has tabled an amendment, which, I accept, very much improves it. I see new clause 5 as complementary to new clause 1 or any other means by which we could secure a greater number of potential donors, be it an increase in the use of donor cards or whatever. That is because increasing the number of donors does not necessarily mean an increase in the number of usable organs. That is the key point. Members have referred to the experience of Belgium, which has seen a 30 per cent. increase in the number of successful transplant operations, and which has a system in place akin to that proposed in new clause 1. I do not doubt that it would not have achieved that success had it not also had a system of elected ventilation in place.

Elected ventilation is the subject of new clause 5. Members will be aware of precisely what elected ventilation means, as they will all have received a letter from Mr. Charles Curry, about six weeks ago, explaining it. It is the procedure by which someone is put on a ventilator not to make them better or in the hope that they will recover but purely to preserve their organs for transplantation. It now turns out that in this country, that is unlawful. Some four years ago, Mr. Jetmund Engeset, the surgeon responsible for transplant operations in Aberdeen, came down to meet Members and assured us that, were elected ventilation available to him, he could increase the number of successful transplant operations in Aberdeen by 100 per cent. I was also impressed when Professor Terry Feest came to the House to discuss elected ventilation, because, until 1994, he used it at Exeter and doubled the number of successful transplants carried out. Only when he published his results in The Lancet and a discussion about elected ventilation ensued was it discovered, on advice from the Department of Health, that it was unlawful.

As I understand it, common law requires that a procedure can only be carried out on a patient if it is for his benefit. Clearly, if someone is ventilated purely to preserve their organs for transplant, that is not for their benefit but for someone else's. It therefore falls foul of the law. Elected ventilation was therefore discontinued, with a consequent reduction in the number of successful transplants and organs that became available.

It seems to me that we have an opportunity to correct that situation. We are told, however, that it is not as important as it once was: because of the increasing number of what are called non heart-beating donors, as technology has moved on, we can afford to take the organs out of the cadaver and use them—we do not need to keep people ventilated to have the organs fresh, if I might use that term, from a heart-beating donor. That is an overstatement, however: we are now able to get a certain number of kidneys and livers from cadavers, but overwhelmingly, it is much better to have them from heart-beating donors. At the moment, there is no prospect of getting lungs and hearts from non heart-beating donors. Are we to write those off, and say that we do not need the procedure? I would suggest not.

Incidentally, there was a discussion some three weeks ago, and a great deal of media coverage, about the shortage of transplant surgeons that now arises because of the antisocial hours associated with that branch of the profession. Organs become available at a time of night or day that is not suited to anyone's convenience. Nevertheless, it seems to me that the precipitate decline in the number of surgeons, which is consequent on the unpredictability of that profession, would be assuaged at least to some extent by reintroducing the practice of elected ventilation.

There are disadvantages to elected ventilation. One of the arguments made against it is that it makes use of desperately needed intensive care beds. That argument will continue, although many will argue that it does not require intensive care beds, and that what it requires is less than the high-intensity care bed. We as parliamentarians, however, should not intrude on that argument. It is for clinicians to argue about what is the best use of a particular bed at a particular time, and it is not for us to frame laws and prevent people from doing things as a consequence.

There is also some disquiet among members of the BMA that elected ventilation can in certain circumstances give rise to the persistent vegetative state. Again, clinicians can argue about that and reach conclusions among themselves. It is not a matter for Parliament in framing the law.

We had an effective way of increasing the number of successful transplants. When it was in use, it doubled the number of effective transplants.

Julian Lewis (Conservative, New Forest East)

Before my hon. Friend finishes his speech, may I say that if there is a Division on new clause 1, he and I will find ourselves in opposing Lobbies for the first time in the seven years that we have both been in the House? There is no reason, however, why someone with my views cannot totally support what he says about new clause 5. The question of keeping organs in a fit state to be transplanted, once the necessary consents have been obtained, is entirely separate from the question of presumed consent. I assume that he would accept that.

Desmond Swayne (Conservative, New Forest West)

My hon. Friend is right that I differ from his judgment on anything only rarely. We will certainly be in different Lobbies tonight, but I entirely accept what he said in his words of support for new clause 5.

Christopher Chope (Conservative, Christchurch)

Before my hon. Friend finishes, will he comment on why the Government seem to have been so reluctant to accept this proposal? Does he share the frustration of Mr. Curry that the Government have not answered the questions that he raised in correspondence with them?

Desmond Swayne (Conservative, New Forest West)

My hon. Friend is right. I have raised the issue on several occasions over the last five years both from the Front Bench as a Conservative health spokesman and from the Back Benches as I do now, but I have never had a satisfactory answer. Ministers have tended to say that it will become unnecessary, if it is not already unnecessary, because of the advances in science and the ability to gain organs from non heart-beating donors, but I simply do not believe that. I accept that there is some opposition on grounds of the competition for respirators, for example, in hospital intensive care units. However, I believe that that is a matter for clinicians, not Ministers.

In summary, we had a system that doubled the number of transplants when it was used. An interpretation of the common law brought about circumstances in which it had to be discontinued. It seems to me that we have a perfect opportunity to put that right tonight and I cannot imagine why we should not take it.

Ian Lucas (Labour, Wrexham)

We all accept that this is an extremely difficult and contentious issue. We have had an illuminating debate about it, but the balance of contributions has focused on the rights of those who are awaiting treatment. We all accept that they are in an invidious position and we all want to do as much as possible to assist them. I have to say that if, two years ago, I had been asked to vote on this particular issue, I might well have voted differently from how I intend to vote this evening.

I believe that we have not concentrated enough on the rights of those who are left behind. I want to say a few words about the relatives of those who may lose people very close to them. It is important to consider the backcloth to the legislation. In respect of the new clause, we have not considered it enough. The Human Tissue Bill was introduced in response to the Alder Hey and Bristol royal infirmary cases, which involved individual rights being ignored by people in authority. The Bill is fundamentally about ensuring that those terrible events do not recur. When we vote this evening, we need to reflect on the fact that we are operating against a backcloth of enhancing individual rights against abuse.

Some constituents who came to see me to talk about the Bill particularly influenced me. They were bereaved some 30 years ago, but were no less bereaved on account of the length of time that had passed. They had never been to see their MP before, but they told me about their children. I accept the fact that the Bill does not relate specifically to children, but my constituents' views are relevant to our debate. They told me how their rights had been disregarded and their views overridden by people in authority who had not listened to what they had to say. I cannot accept that the introduction of a doctrine of presumed consent sits correctly with the backcloth that I have described.

David Taylor (Labour/Co-operative, North West Leicestershire)

I am very sympathetic to my hon. Friend's position, having been a bereaved parent myself some 27 years ago, but is it not the case that the new clause introduces presumed consent for transplantation use, not retention for research? Surely there is a huge difference between the two.

Ian Lucas (Labour, Wrexham)

That was not a difference that my constituents raised with me. They were suspicious of authority and of people with authority. I believe that they have the right to be so suspicious because of the way in which individuals in authority had treated them.

What disturbs me most is the provision in new clause 3(5), according to which someone in authority has the power to make a judgment about individuals who have just been bereaved. The person in authority has the right to assess whether a particular individual is suffering "significant distress"—not "distress", but "significant distress". With the best will in the world, how can it be right and proper for any doctor—or, indeed, anyone—to make an assessment that the distress caused by bereavement is not "significant" enough to allow the bereaved relatives to prevent organs from being used?

Julian Lewis (Conservative, New Forest East)

Does the hon. Gentleman accept that there are further complications on that point? What if people have religious objections to their relatives' organs being used in that way? Would such objections be regarded as "significant distress"? What about the Muslim community, Jehovah's Witnesses or people who belong to minority groups, for example? Would the distress caused by offending religious beliefs be "significant" enough to overrule people's views?

Ian Lucas (Labour, Wrexham)

The hon. Gentleman makes a valid point. As a lawyer, the words "significant distress" immediately rang my alarm bells. I can see applications for injunctions being made, and litigation becoming rampant in this field. Judges could be called out of bed at all hours to take life-or-death decisions, which would make the process of bereavement even more painful than it is now.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

If anyone were at the point of calling lawyers, it would be accepted under the regulations as evidence of people reacting under "significant distress". [Interruption.] It is quite clear what significant distress is, and that is above the threshold. In the case of Jehovah's Witnesses, there are several safeguards. There is the opportunity for the individual to opt out; there is the opportunity to tell relatives that someone is a Jehovah's Witness; and if someone is not a Jehovah's Witness, relatives who are Jehovah's Witnesses still have the opportunity to make the point that they would be significantly distressed, even though doing so would deny a recipient who is not a Jehovah's Witness the opportunity of receiving the organ from someone else who may not be a Jehovah's Witness. Nevertheless, that is the safeguard in the new clause. It should, I hope, meet the hon. Gentleman's concerns.

Ian Lucas (Labour, Wrexham)

I am afraid that it does not meet my concerns at all. In my view, the phrase "significant distress" can create the invidious position whereby someone in a position of authority overrides the rights of people who have to cope with bereavement for the rest of their lives. I say again that the legislation should be about protecting individuals against people who abuse their position. The new clause is not an appropriate way of amending the Bill.

Rob Marris (Labour, Wolverhampton South West)

Peter Cox died in 1989. He was aged 24. He had a brain tumour. His parents, my constituents Rosemary and John Cox, have tirelessly campaigned on this issue since. I have met them many times and discussed the issue with them. I have little doubt that they will be watching our debate today with interest.

The hon. Member for New Forest, East (Dr. Lewis) asked whether there was a national register of some sort. One of the reasons the NHS organ donor register exists is the work of Rosemary and John Cox. In the five years after their son died, they campaigned for such a register. When Peter died, they found that there was a register of those waiting for organ transplants, but no national register of those who had opted into organ donation. It took five years to get one set up, which is a relatively short time in today's society. The register was set up in 1994 and is based in Bristol, as my hon. Friend the Member for Dartford (Dr. Stoate) said. I pay tribute to the work of Rosemary and John Cox, but I suspect that I will disappoint them today by the way in which I vote or abstain on the new clauses.

This debate has addressed a difficult moral issue. I do not have a pager, so I do not know if it is true that the Government will subject Labour Back Benchers to a three-line Whip on the issue. If that is the case, I will need some convincing arguments from my hon. Friend the Minister. I see that my right hon. Friend the Secretary of State for Health has joined us. I would be interested to hear the Government's arguments on why the vote should be subject to a three-line Whip.

John Reid (Labour, Hamilton North and Bellshill)

The answer is simple. It is because the decision about one's own body should be for the conscience of individual citizens. It is not for this Parliament, by free vote or otherwise, to impose on individuals a requisition of their bodies after death for the use of the state. That is why there is no free vote. We are giving the freedom of conscience to the people of this country, and we are not prepared to work on the assumption that Parliament should dictate to them that their bodies belong to the state after death.

Rob Marris (Labour, Wolverhampton South West)

I am grateful to my right hon. Friend for clarifying that point. I found his intervention very helpful, and we may achieve more clarity as the debate continues. I started the debate broadly in favour of new clauses 1, 2 and 3. As the debate has continued, I have changed my position somewhat, partly because of such points as the one succinctly made just now by my right hon. Friend. The debate evokes difficult moral dilemmas for many people and, in that sense, it is a moral decision, not a political decision. I get the feeling that expediency is taking over: we have to change the regime because we cannot get enough organs. I am not entirely convinced that that is the right way to proceed morally, nor that it would work in practice.

I spoke to John Cox over the weekend and he put the argument, forcefully and cogently, in terms of cost. Other hon. Members have adverted to the cost comparison between a kidney transplant and the need for immunosuppressants thereafter, and the continuation of dialysis. Those are interesting arguments, but they are ones of practicality and expediency. They are brought in to try to sway the moral balance, but that is mixing apples and oranges.

We need to consider what has happened to the national organ donor register. By the end of 1995, 2.25 million people had joined the register. By the end of 1999, four years later, that figure had roughly tripled, to 7.5 million. By November 2002, the figure had passed 10 million and now, a year and a half later, it has passed 11 million. The number is increasing and I agree with my hon. Friend the Member for Dartford, who practises medicine, about what we—as a Government and a society—should do to encourage further increases.

David Taylor (Labour/Co-operative, North West Leicestershire)

The trend of increases is encouraging, but we have some 45 million adults in the United Kingdom. The number on the register is only some 25 per cent., which suggests that 75 per cent. of potential donors are untouched by the scheme. How might we increase the numbers signing up to the register?

Rob Marris (Labour, Wolverhampton South West)

We could do more, although I do not want to sound like a hand-wringing politician who says, "Something must be done". I also question my hon. Friend's assumption that the 75 per cent. who have not signed up to the register would wish to do so. That assumption may be unwarranted. It is possible—although, I concede, unlikely—that that 75 per cent. have considered the issue seriously and decided not to opt in and have their organs taken. The hon. Member for Oxford, West and Abingdon (Dr. Harris) mentioned surveys on that point, but we must be careful not to jump to conclusions about who might wish to participate in the scheme.

We cannot assume that people who have not signed an organ donor card—I first did so in 1974, when the card applied to kidney transplants—simply do not know about the scheme. We have used the distribution mechanism of the DVLA and doctors' surgeries, so many people know about the scheme and have decided not to participate.

Kevan Jones (Labour, North Durham)

Publicity is widespread and most people know about the scheme, but it takes a conscious effort to contemplate one's own mortality and opt into the scheme. Does my hon. Friend agree that the ultimate point is that it is down to the individual what happens to their body after they die?

Rob Marris (Labour, Wolverhampton South West)

My hon. Friend makes a powerful point. Just as the hon. Member for New Forest, East was not aware that there was a national register, I did not know that it existed until I met my constituent, John Cox, some four years ago, and I had carried a donor card for nigh on 30 years. I think of myself as a reasonably educated person, and there are probably many such people who still need to be reached by the scheme. I got a driving licence 30 years ago, so I had never been told about the scheme by the DVLA.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The hon. Gentleman rightly rejoices that the number of people on the organ donor register has increased from some 2 million in 1995 to 11 million now. Does he accept that, despite that increase, in the same period the number of cadaveric solid organ donors has fallen from 875 to 710 a year? That is one of the reasons why John Cox and his daughter, Christine Cox, wrote to me to say—as they confirmed in the Sunday Express—that they support the new clause. They do not think that the organ donor register for which they campaigned is doing the job well enough.

Rob Marris (Labour, Wolverhampton South West)

The hon. Gentleman is more qualified than I to interrogate the cadaveric figures. Does the NHS have the infrastructure to deal with potential donations of organs? The problem may be bottlenecks in the NHS that extra Government resources will address. I do not know whether that is the case, and perhaps the hon. Gentleman can tell me.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The most likely reason for the decrease is the relative refusal rate, which has gone up from 30 per cent.—shown in Sheila Gore's study in 1993—to nearly 50 per cent., shown in the UK Transplant potential donor audit. That is why the figures have gone down despite the organ donor register. It is also why we need to recognise that the present system is not working and to change to the new system.

Rob Marris (Labour, Wolverhampton South West)

That is an interesting intervention. If the rate of relative refusal is increasing, it suggests that increasing numbers of people are concerned about organ donation. The new clauses would therefore go against that trend.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I understand the point that the hon. Gentleman makes, but at the same time surveys of public opinion show that between 80 and 90 per cent. of people are willing for their organs to be used. What has changed is the response of grieving relatives, not the wishes of individuals, which—as the hon. Member for North Durham (Mr. Jones) pointed out—should be paramount in the case of their own organs.

Rob Marris (Labour, Wolverhampton South West)

It is difficult to tell from survey evidence, as we know from opinion polls in elections. When relatives are asked, the trend is in the opposite direction to that which the hon. Gentleman wants to see.

John Reid (Labour, Hamilton North and Bellshill)

It is worth checking when the decline in relative refusal rates started. I think that it is recent, and one of the reasons may be the shock and horror felt about what happened at Alder Hey. If the increase is the result of something that was imposed on people against their will, it is another reason why we should be very careful about the decision we make tonight.

Rob Marris (Labour, Wolverhampton South West)

I thank my right hon. Friend for that intervention. When the Government respond to the debate, will they give us reassurance, which my right hon. Friend the Member for Holborn and St. Pancras (Mr. Dobson) sought earlier, about what they are doing in two spheres? What will they do further to promote the current system and to initiate public debate on the issue? The Government may say that they will do nothing and, from what my right hon. Friend said earlier, I suspect that may be the case. However, I should like to know what they would do to promote public debate, as one of the reasons why I shall not vote for the new clause is that I have sat through the whole debate on this group, which has focused on new clauses 1, 2 and 3—[Interruption.] I estimate that the debate will be over by 7.30, but that is a matter for the House and for you, Madam Deputy Speaker. Were the debate to end at 7.30, the House of Commons would have spent three hours debating the issue—only three hours.

My hon. Friend the Member for Crewe and Nantwich (Mrs. Dunwoody) said that the subject had been debated endlessly and, yes, it has been debated a lot and has been the subject of private Members' Bills and so on. However, at every general election the composition of the Chamber changes: new Members enter Parliament. The House of Commons has not held a full debate on an issue that Members on both sides of the House accept is very difficult, in terms of both the moral and the practical questions. To tie the matter up by three new clauses—although they seem well drafted—in three hours of debate does not do it justice and it is not the right way for Parliament to proceed. When my hon. Friend the Member for Ealing, North (Mr. Pound) was talking about the new clauses, he twice referred to new clauses 1, 2 and 3 as a Bill. He is right; they should be a separate Bill, not tagged on to the Human Tissue Bill, which came about owing to all the horror of Alder Hey and so on. The two should not be mixed, which is exactly the discussion I had about three months ago with my constituent, John Cox, at the time of Second Reading.

Tam Dalyell (Labour, Linlithgow)

A crucial difference between the 1970s and now is that the British Medical Association has changed its mind on presumed consent.

Rob Marris (Labour, Wolverhampton South West)

I am aware that the BMA has changed its mind. The hon. Member for Oxford, West and Abingdon referred to that point when he was moving the new clause. It is important to take it into account but it should not be a determinant of the debate, nor—even though the supporters of the new clauses have the best of motives—should we be bounced into putting a Bill on organ donation and consent relating thereto into the Human Tissue Bill. We are mixing up those two things and we should not do so.

Andrew Murrison (Conservative, Westbury)

The debate on this group has been far ranging. I begin by pointing out that the new clause will be the subject of a free vote for Conservative Members. I was interested to hear the Secretary of State's comment that he was taking a collective view for his party. However, we feel that the judgment must be made individually, according to conscience, which is why we shall have a free vote. I understand that the minor parties will do likewise.

Gwyneth Dunwoody (Labour, Crewe and Nantwich)

I am sure that the hon. Gentleman will like to know that Labour party rules say clearly that on a matter of conscience Labour Members may vote as they wish.

Andrew Murrison (Conservative, Westbury)

It is not for me to intrude on private grief. That matter is for the Labour party, which is not the subject of our debate today.

I want to address new clause 5, which was very well introduced by my hon. Friend the Member for New Forest, West (Mr. Swayne). He brought to the attention of the House a procedure that he believes could increase the harvest of organs for donation—that of elective ventilation. We heard earlier that the BMA had changed its mind about presumed consent; it appears that it has also changed its mind on elective ventilation. The procedure no longer has the support of the BMA, but I understand that the association welcomes debate of the issue—as should we all—and I congratulate my hon. Friend for bringing it to our attention.

Elective ventilation is an invasive procedure and is carried out purely to allow for the development of brain stem death and consequent organ removal. Although it was the subject of fairly positive guidance from the Department of Health in the mid-1990s, it was subsequently deemed illegal as it would be battery and could thus not be in the interests of the patient. How could it be?

The procedure introduces the possibility of harm to patients and my hon. Friend touched on that in relation to persistent vegetative state. Elective ventilation carries the possibility not of the development to which the procedure is geared but of persistent vegetative state, which is of course not in the patient's interest. Indeed, encouraging such a development is not in the interest of any of us. However, it is a risk of elective ventilation and we should bear that in mind.

We should also bear in mind the pressure that the procedure would put on ITU beds and the emotional pressures for the staff of those units. ITU staff are very much geared towards curing people and the procedure would obviously not cure the person who was principally concerned—the person being electively ventilated. The procedure involves a certain mind shift for the people who staff ITU so well, and I do not think that it would attract universal acceptance from them.

My hon. Friend the Member for New Forest, West commented on the Exeter study carried out in the mid-1990s. Over the weekend, I went to the trouble of looking up the old papers on that. I looked at the report and the extensive correspondence that followed, which was not universally appreciative of the procedure. At that time, there was much controversy about its value and acceptability.

One problem is the definition of the point of apnoea—a person's last gasp—which is necessary in order to determine exactly when one institutes elective ventilation. The definition is not as straightforward as Members might suppose; it can be difficult at times to assess when that point has occurred.

Tam Dalyell (Labour, Linlithgow)

In previous legislation, that problem was addressed by putting the decision in the hands of two clinicians, once clinical death had been established, neither of whom was a renal surgeon and likely to benefit. Is not that a satisfactory definition?

Andrew Murrison (Conservative, Westbury)

But at what point does one define death? Is it the point at which somebody's heart stops, as is usually the case, or should brain stem death be the definition? Many of the problems relating to the studies in the mid-1990s arose from Exeter's attempt to redefine the point of death. From my experience, I know that sometimes it is extremely difficult to do that. People do not usually take a dramatic last gasp; it is far slower than that and the point of apnoea—as other medically qualified Members will know—is actually the point of asystole, when one can no longer detect a pulse.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I agree with the hon. Gentleman's analysis. The BMA ethics committee certainly opposes elective ventilation in the circumstances set out under the new clause, but what if the patient had given an advance directive permitting elective ventilation, knowing of the possible risk and that their best interests might not be served, so that their wish to donate organs could best be met? That question is addressed in our amendment to new clause 5 and it is probably worth further consideration.

Andrew Murrison (Conservative, Westbury)

I am grateful to the hon. Gentleman for that intervention and I welcome his amendment. It makes a flawed measure a little bit better. Of course, such an advanced declaration would at least allow the professionals involved the confidence that they were acceding to an individual's wishes, but that is not quite the same as the specific consent that we are talking about generally in this group of new clauses and amendments.

People would need to know specifically whether they were consenting to such a procedure, because it is quite separate from the sort of things that they might envisage or expect under the consent procedures that we are debating more generally. However, with respect to the hon. Member for Oxford, West and Abingdon (Dr. Harris), amendment (a) does not necessarily address some of the other difficulties that I have raised, although I accept that—with respect to my hon. Friend the Member for New Forest, West—it would make new clause 5, which is flawed, a little better.

The more general debate relates to presumed consent and new clauses 1 to 3. The most telling remarks that I read on that issue come from James Kennedy, who is director of the Royal College of Nursing in Scotland. He said:

"The tragedy of the recent organ retention scandals has made it absolutely clear that it is entirely wrong for healthcare professionals to ever presume consent."

Working through the Bill, as my hon. Friend the Member for South Cambridgeshire (Mr. Lansley) and I have done these past few months, it has been clear that consent is central to the measure. Indeed, the Bill is all to do with consent, as was pointed out by the hon. Member for Wrexham (Ian Lucas). Consent is the common thread that runs through the Bill. Indeed, there is no point in it if we do not address consent and put it at the very heart of what we are debating. The events at the BRI and Alder Hey and the Isaacs inquiry all lead to the Bill, and they all address problems to do with consent, yet we are dealing with a group of new clauses and amendments that—with respect to the hon. Member for Oxford, West and Abingdon, whose intentions are entirely sound and accord with my own—would cut across the general direction of travel that relates to informed consent.

I shall now move on to deal with some of the specifics of my disquiet about the measure. The hon. Member for Oxford, West and Abingdon referred to a number of international comparators. My word, there are a lot of them and they bear close scrutiny, but they do not all point in one direction. We could perhaps consider Sweden, which has the sort of system that he recommends, yet its organ donor rate is no greater than our own. We could consider Brazil, which has a big population, and note that it went down the route of presumed consent, but that it rescinded that measure some time later after popular pressure. We could consider the marked regional variations that occur in countries with certain systems—our own and those that have an opt-out system. We must ask why that is, and I suspect that it is because of differing practices in those countries, thus suggesting that more needs to be done to consider why certain areas have a better harvest rate than others. Clearly, the differing rates are not to do with the overall system that applies in those countries.

The system of required request—a clumsy term, but nevertheless perhaps a useful procedure that applies in the United States—might deserve a look. It is defined thus:

"That it shall be illegal, as well as irresponsible and immoral to disconnect a ventilator from an individual who is declared dead following brain stem testing without first making proper enquiry as to the possibility of that individual's tissues and organs being used for the purposes of transplantation."

In other words, the onus is put on those involved to ask the question and establish whether a person is suitable to participate in transplantation.

My suspicion—it is more than a suspicion, as it comes from personal experience—is that, in the heat of the moment, the last thing that a busy practitioner wishes to be involved in is the difficulty of approaching bereaved relatives with such a difficult situation. We have discussed whether more or less distress may be caused to all involved by opting in or opting out, but at the end of the day such things are deeply distressing both for relatives and for practitioners. However, we must press the issue as far as it relates to those who are employed by the NHS. It may very well be that a required request formalises what I know is best practice throughout the NHS in considering whether individuals might be suitable for transplants.

I am also against the measure because the people who opt out will be a skewed population. We know that the articulate, the middle class and those from certain sectors of our society are keen on taking affirmative action of one sort or another. It is likely that those who perhaps do not find it easy to articulate a view or, indeed, whose lives are chaotic in a way that would make such issues a lower priority for them might be disadvantaged as a result. We should remember that silence may also indicate a lack of understanding, rather than agreement with a certain policy. That is important to bear in mind. We also need to bear in mind, of course, the fact that the UK transplant community is pretty well split on the issue.

Of course, we need to bear in mind the views of UK Transplant itself, which is not in favour of presumed consent and offers other mechanisms as a way to increase our harvest of organs. One can think of non-heart-beating donors or living donors. It may be worth while considering the electronic patient record in due course, as a way to increase our harvest of organs where appropriate. Although I applaud the intentions of the hon. Member for Oxford, West and Abingdon—of course, all hon. Members share them—I fear that he has failed to take account of the broad spectrum of organisations involved in such procedures in tabling his series of new clauses and amendments.

My hon. Friend the Member for Spelthorne (Mr. Wilshire) put a particularly telling argument. We all bring certain things to the House and our experiences are very important in what we bring to the House, and his experience is this respect is extremely important. This is an extremely subjective matter. Fortunately, most of us have not had first-hand experience of it.

It is important to bear in mind the fact that significant distress is very much a subjective matter. Indeed, it is culturally and ethnically informed in respect of the giver of the distress, the owner of that distress and the interpreter of that distress. The concept of significant distress would be extremely difficult in the context in which the hon. Member for Oxford, West and Abingdon suggested that it should be used.

In short, I cannot recommend the new clause to my colleagues, although it is for them to make up their minds, but I will leave them with the thought that presumed consent is no consent at all.

Rosie Winterton (Labour, Doncaster Central)

This has been a very thoughtful and considered debate, and hon. Members on both sides of the House agree that we must increase the number of organ donations made in this country. The debate has been about how we achieve that. The new clause and amendments proposed by the hon. Member for Oxford, West and Abingdon (Dr. Harris) would introduce a system of presumed consent. However, I have to tell right hon. and hon. Members that that would undermine the Bill's fundamental principles. We strongly believe that if we want people to donate organs, whether for research or for transplantation, we should ask them for their permission. As my right hon. Friend the Secretary of State has said, the state does not own our bodies and neither do researchers nor clinicians.

Organ donation is a gift from an individual that helps to save the life of another individual. It is also a gift to society. We believe very strongly that we should not assume that someone wants to make that gift. The fundamental principle that runs through the Bill is that consent, and informed consent, lies at the heart of the decisions that individuals take. My hon. Friend the Member for Dartford (Dr. Stoate) has direct experience of this issue and, as he said, people come at it from different directions and with different principles to govern their decisions. As I say, we are talking about people making a gift to society, and we must make sure that we enable that gift to be made without presuming that everybody wants to make it.

As my hon. Friend the Member for Wrexham (Ian Lucas) pointed out, the background to the Bill is the tragedies that occurred at Alder Hey and Bristol. I know that no Member of the House could fail to be moved by the distress that was caused to families at that time. They suffered not only bereavement, but then discovered that organs from their children had been removed without their knowledge. The Alder Hey, Bristol and Isaacs inquiries showed that that had become widespread practice and related not just to children, but to adults as well. Proper consent had not been given.

That is why the Bill came into being. We cannot take one part away from it—the part relating to transplants—and say that we will apply a different set of principles to that. That would not only undermine the Bill's principles, but would run counter to everything that we have been told by parents, families and the public. That would undermine the undertakings that we gave as a result of those reports—that we would make sure that such situations never happened again.

In preparing the Bill we consulted extensively, but we found no evidence that the public would give overwhelming support to a system of presumed consent. Believe me, to get a system of presumed consent, it is necessary to obtain overwhelming public support. We found that the great majority of people do not feel that the state should determine what happens to their bodies after death. What we allow to be done to our bodies is a personal matter for individuals and for the people closest to them.

Alder Hey, Bristol and the Isaacs inquiry revealed a breakdown of trust between the medical profession, researchers and the public. We said that the Bill would rebuild that trust and would provide a secure system whereby what happened when consent was not sought could not happen again.

David Taylor (Labour/Co-operative, North West Leicestershire)

Will my hon. Friend explain in a little more detail how new clauses 1, 2 and 3 undermine the assurances rightly given to parents of children whose organs were retained at Alder Hey and elsewhere? The new legislation rightly deals with that problem, but children are not covered by the proposals on organ transplantation. Is that not an entirely separate issue?

Rosie Winterton (Labour, Doncaster Central)

As hon. Members pointed out earlier—in particular, the hon. Member for Spelthorne (Mr. Wilshire)—even if someone is over 18, there will still be situations in which a parent may have to make a decision about their child. It would take only one case in which somebody did not realise that, under this system, they actually had to opt out of giving consent to their organs being removed, for there to be the kind of public outcry that would completely undermine the work that we have tried to do in recent years to rebuild trust so that people feel confident about coming forward and donating their organs for transplantation or research. We cannot take one part out of the equation. Bereaved parents or people from different religions might suffer great distress and find it unacceptable if they had not realised what they had to do. It would be extremely difficult to devise a system in which one could be assured that everybody knew that they had to opt out if they did not want their organs to be removed. That is why we cannot support the new clauses.

Many hon. Members have cited evidence based on experience in other countries that has appeared in different journals in support of presumed consent. However, I challenge some of the assertions that have been made. For example, the increase in the number of organ donations in Belgium followed, it is true, the introduction of its first-ever transplant law. That made organ donation legal in statute. However, there is no evidence that the law on presumed consent led to the increase. In the north of Belgium, where they have always operated a system of informed consent, the rates stayed the same.

In Austria, the passing of a presumed consent law failed to increase donation rates. The increase actually followed a change to the organ retrieval arrangements that were implemented three years later.

In Spain, the presumed consent law has never been used. The Spanish take pride in the fact that relatives are always asked, but they have a low refusal rate. Spain has the highest rate of organ donation in the world, and it is based not on presumed consent but on a model of organ donation devised by Dr. Rafael Matesanz, who said:

"Most of the Spanish people are in favour of organ donation but they want to be consulted."

The Expert Transplant Committee of the Council of Europe has made its advice clear in a document called "Meeting the Organ Shortage". It states that

"presumed consent laws, when fully accepted, seem to benefit donation but, in practice, are often not applied mainly because of reluctance within the medical and legal communities to enforce donation".

In fact, out of 29 European countries surveyed, 19 have presumed consent, but only seven use it.

My right hon. Friend the Member for Holborn and St. Pancras (Mr. Dobson) asked whether we could produce some of the arguments in a little more detail. I confirm that the chief medical officer still holds the opinion that he held when we published "Human Bodies, Human Choices", and I am happy to give the undertaking that we will publish some of the detailed research and the response to it.

I assure the House that we have used the evidence from the United Kingdom and countries such as Spain to develop our transplant framework "Saving Lives, Valuing Donors" that I launched in July last year. That strategy's aim is to maximise all forms of organ donation by involving the public, the wider NHS and the transplant services. We want 16 million people to be on the organ donor register by 2010, and we also want to increase the number of living organ donors and develop the use of non-heartbeating donors. We have already employed 35 donor liaison nurses to work with staff in critical care units to help to identify potential donors and ensure that relatives are approached by people with appropriate training and given proper support at a critical time.

Although I thank the right hon. Member for Bracknell (Mr. Mackay) for his initial kind comments, he accused me of being rather callous when I talked about approaching relatives. All the evidence from other countries shows that the important factor is the system in place to ensure that people are able to make the right approach to relatives at the relevant moment. The hon. Member for Spelthorne was as eloquent as ever when he illustrated how a different approach could be more callous. If an approach was made with the implication of saying, "We have the right to take these organs from your loved one; do you have any objections?", it would be more callous than the current approach. Many people who suffer bereavement are comforted by knowing that they will be able to help to save other people's lives. The situation that I outlined was not meant to be callous. The approach works effectively in other countries and is one of the reasons why organ donation rates are higher there.

Tam Dalyell (Labour, Linlithgow)

No one imagines that my hon. Friend or anyone else who shares her opinion is callous. However, a problem has been raised several times during the debate: is it sensible and rational to put such an awful question at a time of maximum grief when relatives are least able to give the kind of decision that they might give 24 or 48 hours later? It is the point of maximum grief that is unsatisfactory.

Rosie Winterton (Labour, Doncaster Central)

Under the new clause, relatives would still have to be asked whether they objected.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

May I clarify the situation, even though I thought that I had done so earlier? If no opt-out were recorded, relatives would be asked whether they knew of an unregistered opt-out. If they did not, it would be explained that the intention would be to use the organs for transplantation. Relatives would have the opportunity to raise their objections, but they would not be sought specifically. If they raised objections and said that the procedure would cause them to suffer significant distress, doctors would have the right not to take the organs, as is the case under the current system. Relatives would be asked only the question of whether there was an unregistered opt-out, but they would receive information and have the opportunity to offer their views.

Rosie Winterton (Labour, Doncaster Central)

The hon. Gentleman's comments give rise to two points. We know that relatives are always asked at the moment whether anything in the potential donor's recent history would mean that a disease such as AIDS might be passed on to a recipient. He also knows that if relatives object at that time and do not want to co-operate because they are upset by the situation, the donation will not go ahead, even if the potential donor would have consented.

I tell my hon. Friend the Member for Linlithgow (Mr. Dalyell) that in both situations, an approach would be made to relatives during which they would be asked a question. However, an approach made with the implication that relatives will be told, "We're going to take the organs anyway", would be more callous than the alternative approach. People exercise their judgment in such situations, which is why I question the point made by the hon. Member for Westbury (Dr. Murrison) about required request. We should leave things up to professionals in difficult circumstances rather than providing that requests must be made in every situation, because that requirement would put an enormous burden on staff and I am not sure that they would co-operate in difficult circumstances.

Andrew Murrison (Conservative, Westbury)

May I correct the Minister's inference? The system of required request, or required referral, ensures that professionals ask the question in general circumstances, but allows them to decide whether it is appropriate to broach the matter with relatives in specific circumstances.

Rosie Winterton (Labour, Doncaster Central)

I accept that point, but people clearly need proper training before making such requests—we would certainly want to ensure that they were not made inappropriately.

In addition to the measures that I outlined earlier, we have employed 23 living donor co-ordinators to work with families considering live donation. We have funded 12 programmes to increase the number of organs donated by non-heartbeating donors. Several hon. Members have noted those important programmes because they enable people other than those dying in intensive care units to donate their organs. We have appointed additional transplant co-ordinators to ensure that there is a minimum of one co-ordinator per million people in all regions. We have backed up those programmes with some £7 million investment in the NHS through UK Transplant.

Several hon. Members asked about the results of our initiatives. Between 1 April 2003 and 31 March 2004, the UK saw the highest number of organ transplants ever recorded—2,863 were carried out. There was a 20 per cent. increase in non-heartbeating donation, and 860,000 people added their names to the NHS organ donor register, bringing the total number to more than 11 million. I join my hon. Friend the Member for Wolverhampton, South-West (Rob Marris) in thanking Rosemary and John Cox for everything that they have done to make that happen.

I assure hon. Members that we will continue to do everything that we can to get more people on to the NHS organ donor register. I recently held meetings with representatives from the National Union of Students because it is important for us to use every opportunity to get young people on the register. We have agreed a scheme to go around freshers' fairs in the autumn, and examined programmes through which people may tick a box to sign on to the register when they reapply for new driving licences. There are many schemes that we can consider and, as I am sure that every Member of the House of Commons will want to play their part in doing that, we are examining ways in which they may do so.

The statistics show that our strategy is beginning to work. We have seen a sustained increase in organ donation rates for the first time in seven years. As I said, Spain does not have a system of presumed consent, yet has one of the highest rates of organ donation. Following the kind of changes that we have made, it took Spain 10 years to reach its current level of organ donation. We hope to achieve such a level more quickly.

I reassure my hon. Friend the Member for Ealing, North (Mr. Pound) that we will look at issues such as health space—the electronic patient record, which the hon. Member for Westbury also mentioned. I assure my hon. Friend that there is nothing in our conclusion on presumed consent that is in any way connected to finance. That is not something we have considered at all. Our argument is about the principle of the Bill.

The Bill contains measures that will improve the current situation still further by clarifying two critical issues for transplantees. First, the uncertainties in the Human Tissue Act 1961 will be removed. The Bill makes it clear, not just to clinical teams but to families and those close to potential donors, who can consent and how. Secondly, the Bill makes it clear that preserving organ function after death is lawful. Again, there was uncertainty about that.

We have tabled some amendments on the issue of cold perfusion. I understand that the hon. Member for Oxford, West and Abingdon has withdrawn his amendments on that matter. After discussion in Committee, we reflected further on the issue. The amendments are intended to ensure that preservation does not fall foul of the consent requirements of the Bill, and therefore defeat the purpose for which clause 44 is drafted. The effect of Government amendment No. 66 is to ensure that, where a body is retained under the authority conferred by clause 44, the objective of the clause is not defeated by requirement for consent under clause 1.

The Government oppose new clause 5 tabled by the hon. Member for New Forest, West (Mr. Swayne) because we believe that the practice of elective ventilation remains ethically unacceptable and unlawful, and is in any case unnecessary nowadays. By putting a dying patient on a ventilator shortly before death, there is a risk of prolonging the dying process, and in a few cases of causing the patient to enter a persistent vegetative state. They could then remain in a coma for years. Obviously, such outcomes are not in the best interests of the patient, and in our view that is ethically unacceptable.

Steve Pound (Labour, Ealing North)

I was trying to find an appropriate pause when I could intervene. I apologise if this intervention is inconvenient or inappropriate. My hon. Friend has reassured me that finance is not an issue—that infrastructure costs are not the issue. Why, then, is this matter not subject to a free vote?

Rosie Winterton (Labour, Doncaster Central)

I had hoped that I had explained that the whole basis of the Bill is informed consent. As I have said, to remove one part of that—the bit referring to transplantation—would go against everything that we have said in response to the inquiries at Alder Hey and Bristol, and to the Isaacs report, and the undertakings that we have given to patients and families. That is why the Government feel that that is the principle of the Bill and that it should not be removed or undermined.

To return briefly to the issue of elective ventilation, there are also practical arguments that make any such procedure unnecessary. As we set out in "Saving Lives, Valuing Donors", the results of using organs from non-heartbeating donors are, for kidneys and probably livers, as good as those from heartbeating donors. So, I am afraid that the Government cannot accept the new clause.

Amendment No. 47 is in this group because it relates to transplantation. We became aware that the definition of transplantation in clause 55 does not include skin transplants, which are possible nowadays. So, a minor textual adjustment allows transplantation to include material applied to the body as well as material placed in the human body.

To sum up, the fundamental principle of the Human Tissue Bill is that it is for us as individuals to decide for what purposes our bodies and bodily material should be used. If we have not ourselves made our wishes clear, consent must be obtained from someone we have nominated or from those closest to us. Appropriate consent must be obtained to use human organs and tissues whether from the living or after death. I reiterate that that has governed our approach to the Bill from the very beginning. We have given very clear commitments to patients, families and staff in the NHS that that was the principle to which we would stick. We have based our approach on the issue of presumed consent on evidence from other countries. As I hope I have been able to illustrate, it is not having the legal basis of presumed consent that makes the difference. It is the system of organ donation in practice that makes the difference. We are investing more than £7 million in a system to maximise organ donation, and we are seeing the results of that.

Following what happened at Bristol and Alder Hey, trust was undermined between patients and the public and the medical profession and researchers about the system of removing organs without consent. We cannot accept an amendment that would set us back years in terms of the trust that we have been able to build up. We believe that our approach is the right one for patients; that it is the right one for relatives; and that it is the one that the public endorse. I therefore urge my right hon. and hon. Friends to reject the new clause.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

This has been an excellent and good-natured debate. I do not think that anyone doubts the sincerity of the views held by Members on either side of the House on this issue, although I am sure there is much doubting of sincerity in other debates. We have benefited from being able to have an open debate on the subject.

I am a member of the BMA medical ethics committee and a co-chairman of the all-party kidney group, but my main interest in the issue comes from my years as a senior house officer in renal medicine and in acute medicine, where I saw organ donations from both sides. That is why I think something has to be done. I recognise that I come rather late to the debate, given that the hon. Member for Linlithgow (Mr. Dalyell), who spoke in this debate, introduced a private Member's Bill on the subject some years ago, as have the hon. Members for Nottingham, East (Mr. Heppell), who is now a Government Whip, for Broxtowe (Dr. Palmer), for West Bromwich, East (Mr. Watson), for Mitcham and Morden (Siobhain McDonagh) and the right hon. and learned Member for Rushcliffe (Mr. Clarke)—as well as my own Bill.

When the Bill introduced by the hon. Member for Broxtowe was pressed to a Division on First Reading, it was passed by 113 votes to 25, and 88 Labour Members voted in favour of presumed consent and only five against it. That perhaps explains why the Government have imposed a three-line Whip tonight. There will be a free vote for those on the Liberal Democrat Benches—and on the Conservative Benches—despite the fact that it is Liberal Democrat policy to support presumed consent. I know that some of my hon. Friends will not vote with me, and that is their right, because it is a matter of conscience.

John Reid (Labour, Hamilton North and Bellshill)

I have already explained to the hon. Gentleman why there is no free vote on this issue. It is nothing to do with those figures; it is to do with the simple fact that the conscience that has to be exercised as regards one's own body is one's own conscience, and it is not the role of this Parliament to remove from individuals the right to exercise their own choice. That is the sole reason why there is not a free vote. By allowing for a free vote, we would not be extending the power of people to exercise their conscience. We would be taking that power off them by assuming their consent.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

On that basis, the right hon. Gentleman would not allow a free vote even on a private Member's Bill because he does not think that Parliament has any legislative role in this respect. Yet Parliament is indeed legislating today to remove autonomy from individuals and transfer it to their grieving relatives. That is what current legislation and the Bill do. Parliament is therefore entitled to express a view on the issue. It is sad that the Secretary of State will not trust Members of Parliament to represent the views of the country and will not allow a free vote. It may well be that we would not win the vote, but it should at least be free.

The hon. Member for Westbury (Dr. Murrison) opposes presumed consent. He quoted anecdotes drawn from the experience of Sweden. Those anecdotes may well be correct; the problem is that there is anecdote to support both sides of the argument. That is why I urge hon. Members, when considering whether presumed consent with opt-out would work, to look to the published review literature in peer-reviewed scientific journals that attempts to adjust for local factors, such as the fact that countries have different rates of road traffic accidents.During the debate, no one has disputed the two reviews that I quoted that show that, on balance, this legislative proposal does have an impact.

The hon. Gentleman said that the transplant community is split. I hardly think that that is the case, given that the British Transplantation Society voted 80 per cent. to 20 per cent. in favour of a change in the law to presumed consent with opt-out, having previously taking a different view. That society represents doctors, nurses, technicians and transplant co-ordinators involved in the field. He argued that UK Transplant opposes presumed consent, but that is a Government body. I doubt that he has asked the individuals who work within UK Transplant for their individual views, as I have. If he did, I suspect that he would hear a different opinion.

Andrew Murrison (Conservative, Westbury)

The hon. Gentleman disparages UK Transplant. He should know that it represents the views of a raft of bodies and individuals engaged in transplantation. He should be guided by such an august body.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

UK Transplant's job is to implement Government policy, and I think that it does so rather well. The Government are making a big effort using the existing system. The fact that it does not work is not the fault of the Government or of UK Transplant.

The hon. Gentleman argued for required consent—that is, forcing doctors to raise the issue with relatives, based on the presumption that not doing so is why we are not getting the organ donations we need. However, the Government's own study, the potential donor audit carried out by UK Transplant, shows that in 255 of the 278 cases of people in intensive care units between April and June 2003 who were suitable for potential donation the subject was considered, and in only 23 cases was it not. A record of conversations with the relatives appears in the case notes of 244 of those 255 cases; only in 11 cases is there no such record, although that is likely to be because relatives' views were already known. Even if it were appropriate—the Minister said it is not—the hon. Gentleman's would be a fruitless approach.

The Minister said that we should not presume that all wish to donate. That is not the effect of the new clause. The new clause provides for an opt-out of which those who do not wish to donate can avail themselves. The hon. Lady should not misrepresent the proposal.

The Minister's main argument was that the new clause represented a different approach from that taken in the rest of the Bill—that the common thread of the rest of the Bill is what she describes as informed consent. I hope that I accurately reflect her argument. However, I question whether the rest of the Bill is about informed consent in relation to transplantation so much as it is about relatives' consent, which is not the informed consent of the individual, but often a guess at what that individual would have wanted. In any case, the Bill does not always refer to informed consent: the Government have had to table an amendment to clause 44, which deals with cold perfusion, to make it clear that it does not follow the main thrust of the Bill, in that people are presumed to consent to cannulation of their renal artery for preservation of renal function while further inquiries are made. Presumed consent therefore already appears in the Bill. It is right to have it for the purpose of transplantation, and the Minister would be right to extend the principle.

The hon. Lady says that there is no evidence of overwhelming public support for presumed consent. That may be so, but neither is there evidence of lack of public support for it. As the right hon. Member for Holborn and St. Pancras (Mr. Dobson) suggested, there should be a consultation specifically on the issue. He suggested a Green Paper; I ask that the Government conduct some form of exercise to establish the level of public support. If there were no public support for the new clause, I would withdraw it. Opinion polls have shown that there is public support; the Minister has not shown that there is none. That is why I think we can go ahead.

We can debate what the Belgian and the Spanish experience show. The Minister is not convinced by the evidence, but I am glad that, today, she retreated from her original position, which was that there was no evidence to support the assertion that presumed consent may well work. We can and should have that debate. I hope that, at the very least, we shall have the chance to have it.

Rob Marris (Labour, Wolverhampton South West)

The hon. Gentleman talks about having further debate. I invite him to withdraw the motion in view of the fact that this debate has lasted three hours and four minutes and, judging by the notes in his hand, is likely to take, at most, about five minutes more. Does he really think that such a major change in UK law is best achieved after less than three hours, 10 minutes of debate? I do not think that it is.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I draw the hon. Gentleman's attention—[Interruption.]

Sylvia Heal (Deputy Speaker, Halesowen and Rowley Regis)

Order. We are nearing the end of an important debate and the volume of conversation is too high.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I draw the hon. Gentleman's attention to the fact that there have been private Members' Bills on this subject. Another may well be needed. Furthermore, there is another House, which has not yet considered the matter—another House that contains a considerable amount of expertise. If the new clause is accepted, there will be further opportunities both in that House and when the Bill is sent back to this place to consider the matter further. The hon. Gentleman should therefore be reassured.

The Secretary of State made two interventions. We thank him for having come to the Chamber to participate in the debate—I think it was the hon. Member for Linlithgow who suggested that he did so. The right hon. Gentleman said that the decline under the present system might be due to what happened at Alder Hey. That is a common fear, but the figures that I handed to him in graphic form, to make it absolutely clear, suggest that the decline has been a steady one over 10 years. The present system is not working. The Minister of State might have been able to announce today that the figures for the last 12 months—not a calendar year—which were not on the UK Transplant website last week, show an improvement. I hope that that improvement can be sustained, but we have had false dawns before. The current system is not working. That is why the Coxes, who invented the organ donor register, and Elizabeth Ward, who invented the kidney donor card, all support the new clauses. They know that what it proposes would be more effective.

The Secretary of State's main point was that my proposal represented a nationalisation of organs. It does not. It would return to ourselves autonomy in determining what happens to our organs. Yes, the vast majority of people want to donate, but under my scheme, they would have the opportunity to opt out if they did not. Instead of allowing 50 per cent. of grieving relatives at the height of their grief to make a decision that many later regret and that goes against the wishes of the person whose organs they are, presumed consent with opt-out maximises the autonomy and the right of decision of the persons whose organs they are.

We need a fair test of the House. With a three-line Whip in operation on the Government Benches, I do not think that we will have a fair test. I hope that we will have an opportunity to test the views of the nation through some form of deliberation or consultation. The best we can do today is to divide the House and show that many hon. Members on both sides feel that we owe it to people on the transplant waiting list to do more for them, we owe it to relatives to reduce the stress that they face when asked to make donation decisions, and we owe it to people whose organs they are to restore their autonomy.

Clause 1 — Authorisation of activities for scheduled purposes

Rosie Winterton (Labour, Doncaster Central)

I beg to move amendment No. 108, in page 2, line 32, at end insert—

'(6A) Subsection (1)(d) does not apply to the storage of relevant material for use for the purpose of research in connection with disorders, or the functioning, of the human body if—

(a) the material has come from the body of a living person, and

(b) the research falls within subsection (6C).

(6B) Subsection (1)(f) does not apply to the use of relevant material for the purpose of research in connection with disorders, or the functioning, of the human body if—

(a) the material has come from the body of a living person, and

(b) the research falls within subsection (6C).

(6C) Research falls within this subsection if—

(a) it is ethically approved in accordance with regulations made by the Secretary of State, and

(b) it is to be, or is, carried out in circumstances such that the person carrying it out is not in possession, and not likely to come into possession, of information from which the person from whose body the material has come can be identified.'.

Sylvia Heal (Deputy Speaker, Halesowen and Rowley Regis)

With this it will be convenient to discuss the following:

Government amendments Nos. 109, 67, 19, 20, 110 to 112, 21.

Amendment No. 17, in page 36, line 8 [schedule 1], after 'training', insert

'to which paragraph 13 does not apply'.

Amendment No. 15, in page 36, line 20, after 'Research', insert

'to which paragraph 13 does not apply'.

Government amendments Nos. 22, 23, 68.

Amendment No. 18, in page 36, line 28, at end insert—

'13 Education, training or research with local research ethical committee approval, carried out using relevant material not otherwise needed after completion of treatment or investigation for which the patient's consent was obtained in writing or by tacit consent for the removal of the sample of relevant material.'.

Government amendments Nos. 69, 24, 70, 113.

Rosie Winterton (Labour, Doncaster Central)

These three sets of amendments are grouped together because they deal with the use of so-called residual or remnant tissue—that is, tissue removed lawfully from living patients in the course of diagnosis or surgical intervention.

I shall speak first to Government amendments Nos. 108 to 113, which deal with research use of residual tissue.We discussed the matter extensively in Committee. Following the Committee stage, the Government received many direct representations from academic researchers. Hon. Members may also have noticed that there was a campaign in the news media by the same stakeholders. The research community said that obtaining consent to use tissue removed for medical treatment and diagnosis from living patients—so-called residual or remnant tissue—would be so onerous and costly that it would stifle research. I met a number of the stakeholders from the research and academic communities and have considered various options for dealing with the matter.

The Government are clear that they do not wish to impose excessive burdens on those who process the many diagnostic and clinical samples of blood, urine and tissue taken in the NHS. Obtaining consent in relation to all such samples to make them available for research would be a disproportionate burden. However, there is a need to maintain scrutiny and control over the research use to which such samples are put. We therefore propose to amend the Bill to allow research using material from living patients to go ahead without consent, but with safeguards.

The first safeguard will be that the research must be ethically approved in accordance with regulations made by the Secretary of State, which we expect will provide for approval by a research ethics committee. The second safeguard is that the researcher must not possess information as to the identity of the person from whom the tissue came; in other words, the research must be anonymised. We believe that these safeguards will maintain the essential principles of the Bill and provide appropriate controls, while allowing medical researchers the access to human tissue that they need.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I have raised this issue with the Minister before: does she propose that the anonymisation should be irreversible—in other words, that someone could never find out who the tissue belonged to—or does she propose that a third party, but not the researcher, could if necessary find out where the sample came from? In what circumstances does she believe that the anonymity could be broken, if it could be?

Rosie Winterton (Labour, Doncaster Central)

Anonymisation does not mean that the patient and the tissue would be permanently unlinked. Further information could be sought from the records, but the researcher should not get identifying information, and the ethics committees would be able to consider what arrangements were appropriate in each case.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I understand that point and I am satisfied about it. Further information could be obtained, but not identifying information. But what about the circumstance in which something that might be of interest to the person concerned or to their benefit is found in the research, or perhaps something is found that is prognostically significant but to their disbenefit? Would that information be able to flow back, and if so, is that true anonymisation? Should there be consent for that? Some people may not want to know, and if they are never asked for consent to the use of their anonymised tissue, they may be burdened with information that they never wanted to have.

Rosie Winterton (Labour, Doncaster Central)

That is an issue that I would expect the research ethics committee to consider before any research started. It is likely that the research ethics committee would say that in order to be able to use any information that came from the research, consent would have to be sought from the individual. Research ethics committees would have to consider the matter when granting permission for research in the first place.

I shall now move on to the set of amendments dealing with the use of residual tissue for medical education and training. In Committee the Government were made aware of similar concerns about the provisions on consent to the use of residual human tissue for education and training. The Bill as drafted provides that the use of tissue from living patients for on-the-job training in pathology laboratories, for example, should not require consent, as it is considered part and parcel of the diagnostic and care process. However, use of tissue from living patients for education in more formal settings does require consent.

In Committee hon. Members raised the issue of the practical difficulty for teachers of distinguishing between those two types of education and training. That led us to reconsider the issue. In the second set of amendments we now propose to allow all education and training using tissue from living patients that relates to human health and to disorders and functioning of the human body to be carried out without consent. That means that references to education and training would be moved from part 1 to part 2 of schedule 1. Consequential amendments relate to clause 8 and schedule 5.

Use of residual human tissue for education and training in research techniques, which is a more easily distinguished topic, will remain subject to consent. Members of the academic, teaching and research communities have indicated that they are satisfied that this approach will allow them access to the tissue that they need for research and education.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Perhaps I have not understood the architecture of the Bill, as amended. If the education and training in research techniques were done on anonymised tissue, subject to the approval of a research ethics committee, would it be exempt from the requirement for consent, as the research is, or does the wording mean that while doing the research on anonymised tissue, one could not teach post-doctoral or postgraduate students how to do that research, because that would constitute a part 1, schedule 1 purpose?

Rosie Winterton (Labour, Doncaster Central)

Yes, that is the case. There is a clear distinction for education and training on research techniques. They will remain subject to consent, because of the results that may come from them. Members of the academic, teaching and research communities have indicated that they are satisfied that that approach will meet their requirements.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The Medical Research Council is still concerned about this matter. The Minister has created three categories: education and training, which do not need consent; research, which does not need consent if the information is anonymised and there is research ethics committee approval; and education and training in research techniques, which always need consent. If research is being conducted on anonymised samples with research ethics committee approval, it should still be possible to carry out education and training on the research techniques involved as long as anonymity remains in place.

Rosie Winterton (Labour, Doncaster Central)

The carrying out of the research under the Bill as amended is subject to ethics committee scrutiny where consent is not in place. Using tissue to train people in a research technique, such as the use of particular equipment, is a different matter, and it is not central to providing services. Training researchers while carrying out approved research would be allowed. The authority will elaborate on that point in guidance, but there is a difference between carrying out research that has not been approved by a research ethics committee and training researchers during research that has been approved by such a committee.

The last set of Government amendments in the group consists of amendments Nos. 67 to 70, which deal with the use of residual tissue in relation to testing in-vitro diagnostic medical devices or test kits. The amendment to clause 1 is a technical amendment removing a potential regulatory overlap. Manufacturers of in-vitro diagnostic test kits such as those for pregnancy or HIV use human tissue in order to comply with their duties to evaluate their products before placing them on the market and before batch release. That is regulated by the EC directive on in-vitro diagnostic medical devices, which is implemented in the UK by the Medical Devices Regulations 2002. The directive has its own requirements concerning consent to such use. To be certain that we do not interfere with that established regulatory regime, we propose to amend the Bill to make it explicit that storage and use of tissue for IVD testing covered by the directive are excluded from the scope of the consent provisions.

Andrew Lansley (Conservative, South Cambridgeshire)

The amendments that are designed to achieve that aim insert the words "performance assessment" as one of the purposes in part 2 of schedule 1, and there are consequential changes in schedule 5, but I am not entirely sure that I understand by what mechanism that phrase is defined in a way that limits its application to the directive. Is the Minister confident that performance assessment would not be given a wider construction than simply in-vitro diagnostic equipment?

Rosie Winterton (Labour, Doncaster Central)

I am quite confident that it would not be.

Subject to the specific exclusion to which I have referred, schedules 1 and 5 are amended to clarify that use of human material in IVD kit testing is otherwise within the purposes regulated by the Bill. As I said, that is achieved by adding performance assessment to the purposes listed in part 2 of schedule 1. That will ensure that storage and use for testing done pursuant to the directive is covered by the regulatory regime in part 2 of the Bill. It will also ensure that other IVD kit testing using tissue from living patients may be carried on without consent for that purpose. That will make it clear, for example, that surplus diagnostic tissue can continue to be used to calibrate and assess the comparative performance of medical devices without specific consent. The Medicines and Healthcare Products Regulatory Agency also routinely undertakes or commissions such performance assessment of devices for NHS use.

We regard that activity as a necessary adjunct to the provision of care and diagnostic services in much the same way as clinical audit and quality assurance. However, the purpose of quality assurance, which is already included in part 2 of schedule 1, was not considered certain to encompass the activities undertaken in testing the devices, so to clarify the position, we are taking the opportunity to add a new purpose to cover the point.

I commend to the House the sensible amendments that I have outlined, which are intended to remove uncertainties and ensure that the points made in Committee are reflected in the Bill.

Andrew Lansley (Conservative, South Cambridgeshire)

I think that I had some part in speaking to amendments whose purpose was to raise exactly the points to which the Minister has now responded. I am not sure that I did so exclusively, as other Committee members advanced much the same arguments.

To that extent, I welcome the Government amendments. I do not want to explore them in too much detail, but I want to be clear that there are one or two consequential issues. I mentioned one in an intervention, as I was not entirely sure about it. The Minister's subsequent remarks made it clear that the extent of the medical devices regulations is probably sufficiently wide for us not to have to worry about the point that I raised, but I am not quite sure that performance assessment has been properly or fully defined. Perhaps we could check up on that point at a later stage.

The substantive purposes of the amendments are significant. Let us cast our minds back to when the Bill was being constructed. It was constructed around a range of unhappy and tragic circumstances, but those circumstances often related principally to organs and tissues from people who had died. To that extent, although we had regard to the principle of informed consent throughout our consideration of the Bill, we were conscious that in remedying the many mischiefs that had been exposed after the events at Alder Hey and the Bristol royal infirmary, as well as in other places across the country, we wanted not to damage research and the functioning of the NHS.

It was striking that the research community, pathologists and those representing the families who had lost loved ones and been affected by unauthorised organ and tissue retention tended to take the view that the Bill had gone too far. I am grateful that the Minister has recognised that the Bill has gone too far, but it is important that, as we carefully draw that line again, we do not run the risk of trespassing on the sense that families and patients need to have—the sense that what is done will be done with their consent or will have proper safeguards built around it if it does not require such consent. We need to achieve that in precisely the way that the Minister described.

One of the most important distinctions is built in by Government amendments Nos. 21, 22 and 23, whose purpose is to remove from part 1 of schedule 1, which deals with purposes normally requiring consent, the structure of education and training, as set out in paragraph 3, and to divide it into two parts. There will now be education and training that relate to human health, which goes beyond the previous reference to

"incidental to medical diagnosis or treatment",

which is distinguished from education and training relating to longer-term research.

The 5.5 million cervical smears were used in Committee as an example to illustrate what is meant by "relating to human health". As I understand it, it is impossible to determine which smears are relevant for the purposes of education and training until beyond the point at which it would be incidental to medical diagnosis or treatment to identify them. Under the Bill as drafted, in order to use smears for education and training, which is vital in establishing what biomedical scientists are looking for, one would automatically have to return to a subset of those 5.5 million women to obtain their specific consent, and, sensibly, no one in Committee regarded that as the right path down which to go. In that example, the need to make the provision wider than

"incidental to medical diagnosis or treatment"

is clear.

Difficulties will inevitably arise in distinguishing between research and education and training, but, if I understand how things work in the NHS, a clear distinction exists on whether one is engaged in education and training or whether one is engaged in research. By definition, if one is engaged in research, one has secured ethical approval for it, and the requirement for consent should flow from that approval, even in relation to education and training.

Unless my hon. Friend the Member for Westbury (Dr. Murrison) pulls me back, we are happy with the changes to schedule 1. We must be careful on schedule 1, because it lies at the heart of the Bill, and if we were to include a provision that goes a step too far, we would undermine the Bill's whole purpose.

Government amendment No. 108 and its related consequential amendments disapply the requirement for appropriate consent for particular purposes, before those purposes become lawful. If ethically approved research is undertaken in accordance with regulations and is carried out in a way in which information is effectively anonymised, Government amendment No. 108 ensures that such research does not require appropriate consent to become lawful. It is important to make it clear that the provision relates to material taken from a living person's body.

Those representing families affected by those issues have made it clear in conversation that they are prepared for such a change, because the legislation's structure clearly distinguishes between organs and tissues taken from living persons, where, as amendment No. 18 tabled by the hon. Member for Wyre Forest (Dr. Taylor) puts it, "tacit consent" has been given for the donation of tissue. Those families take the view that it is reasonable to go down that path. As in the case of the changes to schedule 1, the boundary between education and training for human health and education and training for research is important.

We must understand what "anonymised" means in those circumstances, and the hon. Member for Oxford, West and Abingdon (Dr. Harris) asked some typically penetrating questions, which are beyond my ken, on that matter. I discussed that issue with staff at the Sir Magdi Yacoub centre at Harefield hospital, who explained that they separate data concerned with research projects conducted by Imperial college from data concerned with the clinical care of the patients from whom the tissues were derived. The dividing line is between data that links tissues to individuals and data that is part of the clinical record.

The answer to the question asked by the hon. Member for Oxford, West and Abingdon is that it is possible for the research team to ask the clinical team questions, and for the clinical team to provide answers. It is possible to ask such questions, but the answers should not allow the research team to identify the patients concerned. The robustness of the approval and the separation of clinical databases and research databases are important in that context.

I did not make any of those points in order to object to the amendments, which remedy what the medical research community feared would be serious adverse consequences arising from the Bill, and I hope that the House accepts them.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I concur with much of what has been said. I shall raise three issues with Minister, two of which I have already raised in interventions in order to give her prior notice.

My first point, which the hon. Member for South Cambridgeshire (Mr. Lansley) also raised, concerns the flow of further information, where research is conducted on anonymised samples under ethics committee approval. The Minister explained, quite reasonably, that researchers could ask for further clinical data if it helps their research, and, again, that could be subject to research ethics committee oversight. I served on an ethics committee for a number of years, and we used to consider such requests regularly.

My question concerns research that could impact on a patient, who might have an interest in either knowing or not knowing about it. It is probably best to use an example: let us say that many appendixes are used anonymously for research, and a new technique is developed to enable one to see whether Creutzfeldt-Jakob disease infection is present in those tissues. Some patients might want to know if a bit of their tissue, albeit one researched on anonymously without their consent, contains CJD, if that data were useful to them in prognostic terms, especially if a treatment were available to prevent the onset of symptoms.

Although that example is hypothetical, the ethics committee on which I served considered many similar cases. Alternatively, a patient might not want to know that they had such a condition, because, for example, no treatment were available or because the treatment would not enable them to obtain life insurance. Will that be possible, subject to ethics committee approval, or does the Minister expect those insights to be understandable at the outset, in which case the ethics committee would not have allowed the provision of anonymous research samples?

Rosie Winterton (Labour, Doncaster Central)

indicated assent.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

What will happen when such insights come as a surprise and are not forecast? Such occasions will not be rare, because we expect science to move on. Collections of remnant tissue may well become useful in research and new techniques, which is why so much fuss is made about them. I want the Minister to guide me on whether we should be careful about allowing research to be done on anonymised tissues, in order not to get into that situation in the first place. What would we do if 1,500 appendixes were needed quickly to test a CJD detection technique? Those questions are not straightforward, but if we are creating a new legislative framework, we must consider them before the Bill leaves both Houses. Even if the Minister cannot give a definitive answer now, I hope that that point will be considered at a later date.

My second point concerns education and training in research techniques. The Minister suggested that the situation will lie in the extremes: either such education and training will not require consent, irrespective of whether it is beyond the treatment and diagnostic phase—that is the position that we discussed in Committee and from which the Government have retreated—or it can be done only with consent and therefore cannot involve anonymised samples. In fact, a great deal of education and training takes place on the correct preparation of slides and their presentation in respect of cervical smears, on blood testing and on the fixing and analysis of surgical remnant samples of the kind that are likely to be anonymised and therefore not to require consent. I hope that the Minister is not saying that it will not be possible to teach people how to prepare slides and to teach cytology techniques on those sorts of sample, which are the majority. That would mean having to try to identify a sub-group in the community from whom to get consent—from patients who probably do not want to be reminded that they had a blood test or smear. I would be grateful for the Minister's clarification on that, because it is possible that an error is being made.

I raised my third point in a meeting with the Minister in which she explained how she thinks that the regulations will work in relation to not requiring consent for anonymised samples. She said that samples that are anonymised and have ethics committee approval will not require consent. However, I got the impression from earlier conversations that there will still be a question on a consent form for an operation which would be, "Are you happy for your tissue to be used on an anonymised basis?" I question whether that is sensible, because even if the answer was no it would not be unlawful for that tissue to be used. When one gets 60 surgical samples back, and the piece of paper does not go with 10 of them—say, elective tumour resections—an error could be made. However, it would not be an error in law because there is no bar on using anonymised samples for a study that has ethics committee approval.

That is misleading to patients and creates an extra burden of bureaucracy in elective cases. In the case of a big lump of tissue such as a heart, which perhaps should not be used for research, even anonymised, because the person undergoing the heart transplant operation might not expect it, the ethics committee would prevent it. We should leave it to the committee to do that instead of requiring the insertion of a question about anonymised tissue on consent forms. The quality of the consent is the same when it is implied by holding one's arm out as it is when one ticks a box for a straightforward operation. The same information should be required; the fact that one consent is in writing does not mean that it is any more of a consent than the other. Does the Minister still think that there will be the extra complication that she envisaged?

Other than that, I welcome the fact that the Government have made changes to this part of the Bill. Some of the amendments are similar to those that the hon. Members for Wyre Forest (Dr. Taylor) and for South Cambridgeshire and I tabled in Committee. At that time, they received rather less than long shrift, and I am glad that the Minister has thought again.

Richard Taylor (Independent, Wyre Forest)

I wish to speak to amendments Nos. 15, 17 and 18, which stand in my name. I tabled them at the beginning of May in the hope of reminding the Minister of the points that she said she would reconsider in Standing Committee. That approach seems to have borne fruit.

I recently received a letter from the chairman of the British Society for Clinical Cytology which emphasised the crucial nature of these amendments. She said:

"During the last few months I have attended two international conferences in South America—at the first one I was too embarrassed to mention the"

Human Tissue Bill,

"but at the second its possible implications were well known around the world. It is quite clear that the latest Department of Health guidelines, without the backing of law, have already put the UK way behind in research and development. Lets hope to goodness that the amended law will allow some ground to be made up."

That is typical of the concern with which people regarded the unamended Bill. I therefore congratulate the Government on their amendments, which will correct the situation and add the protection of anonymity.

I remain puzzled as to what caused that seismic change in Government thinking. In Committee, hon. Members argued long and hard for such changes to the Bill because we had all received letters from pathologists of different sub-specialties and from their professional organisations. The hon. Member for South Cambridgeshire (Mr. Lansley) hit the nail on the head when he said that a Standing Committee is not the best forum to obtain consensus. I realised that when I served on one for the first time and found that there was always a Government Whip there to make absolutely sure that nothing went through against the Government's wishes.

I hope that you will allow me to digress for two minutes, Mr. Deputy Speaker. During our proceedings on the Asylum and Immigration Bill, the hon. Member for Cannock Chase (Tony Wright) said:

"As I see it, there is no way that legislation this fundamental will be accepted by the other place, so the Bill will presumably return to this House in a form that the Government think that they can get through, which will involve its amendment."—[Official Report, 1 March 2004; Vol. 418, c. 674.]

In an Opposition Day debate that the Liberal Democrats introduced on young people and democracy, we considered things that put people off politics. I referred to the practice of sending an unamended measure to the House of Lords so that there would be room for amendment when it came back, and I likened the Government to a second-hand car salesman.

I wonder whether such comments made the Government change their mind. Whatever has led to that, I am delighted. I hope that Standing Committees may become better forums for changing views, even when they contradict that of the Government. I am convinced that the Government's amendments do all that is necessary, and I shall therefore not press the amendments that I tabled.

Rosie Winterton (Labour, Doncaster Central)

I thank the hon. Member for Wyre Forest (Dr. Taylor) for not pressing his amendment. I am delighted that he is delighted about what happened in Committee.

The hon. Member for Oxford, West and Abingdon (Dr. Harris) asked about consent forms when tissue is intended for research purposes. The Human Tissue Authority will consider that in guidance but I hope that, if an individual says that they do not want their residual tissue to be used for research, it will not happen. I acknowledge that discussions must take place about the way in which that will work. However, I hope that respect will be shown.

The hon. Gentleman also asked about training in research procedures. I believe that I answered that question previously, but I emphasise that training in diagnostic and care procedures and in medical education must be regarded as part of the package of providing diagnostic and care services. We recognise that training is essential for protecting future services. However, we also acknowledge that research is different from care and we therefore have different specific consent requirements for research.

Training in research techniques should be aligned with the research provisions. Clearly, when a trainee is observing a research procedure, there is no difficulty. If a postgraduate student has a research proposal that a research ethics committee approves, the learning would be part of the research, which would proceed in the usual way. However, it is different if tissue samples—and we could be considering sizeable lumps—are to be used solely to teach someone how to use a piece of equipment. In that case, consent would be needed.

In the case of unexpected information being found during research, I hope that the research ethics committees would generally be able to tell whether such information would be discovered and rule accordingly. By and large, they would ask for consent if they believed that such information was likely to emerge. However, we need to leave such matters to the Human Tissue Authority and the management of the research ethics committees so that they can introduce some flexibility within the general parameters.

Amendment agreed to.

Amendments made: No. 109, in page 2, line 38, after '(4)', insert ', (6A) or (6B)'.

No. 67, in page 2, line 42, at end insert—

'( ) Nothing in this section applies to—

(a) the use of relevant material in connection with a device to which Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices applies, where the use falls within the Directive, or

(b) the storage of relevant material for use falling within paragraph (a).'.—[Derek Twigg.]

Clause 2 — "Appropriate consent": children

Clause 3 — "Appropriate consent": adults

Clause 5 — Prohibition of activities without consent etc.

Rosie Winterton (Labour, Doncaster Central)

I beg to move amendment No. 29, in page 5, line 22, at end insert—

'(1A) A person commits an offence if—

(a) he falsely represents to a person whom he knows or believes is going to, or may, do an activity to which subsection (1), (2) or (3) of section 1 applies—

(i) that there is appropriate consent to the doing of the activity, or

(ii) that the activity is not one to which the subsection applies, and

(b) he knows that the representation is false or does not believe it to be true.'.

Michael Lord (Deputy Speaker, Central Suffolk and North Ipswich)

With this, it will be convenient to discuss Government amendment No. 30.

Rosie Winterton (Labour, Doncaster Central)

On Second Reading and in Committee, several hon. Members argued that the Bill as drafted fails to deal with a position whereby a person knowingly and deliberately deceives a colleague into believing that consent has been given for the use of tissue or organs for research. That is because the criminal offences in the Bill are directed only at the person who stores and uses the material without consent. I gave an undertaking that we would reconsider that issue, which has been of concern to pathologists. They consider it unreasonable that they will be in the frame for the criminal penalties that relate to consent when they may be acting in good faith, whereas a clinician who knowingly misleads them by saying that consent has been granted when it has not, will not commit an offence under the Bill.

Similarly, a coroner—or a coroner's officer or technician—who claims that consent was not necessary because there was authority from a coroner to perform the activity in question would also be outside the scope of the offences. In a case in which a clinician, technician or coroner deliberately and falsely said that appropriate consent or a coroner's authority was in place, and another person stored or used the tissue believing this to be true, this latter person might be able to use the reasonable belief defence against any charge. But in that case, nobody would be liable under the Bill, which we recognise would defeat the purpose of regulation.

After consideration, we propose that an amendment be made to extend the criminal offence, which currently applies to people who carry out an activity without appropriate consent, so that it also applies to people falsely claiming that the necessary consent has been given or is not needed. Amendment No. 29 sets out the new offence. Amendment No. 30 is consequential on this, removing use of existing holdings of human tissue from the scope of the offence, in keeping with our general approach to existing holdings of issue.

We hope that these offences will merely be a backstop to be put in place to demonstrate the seriousness with which we view the issue of consent. We believe that general standards of good practice will be more than sufficient to ensure that there should be no need to invoke the offences.

Andrew Murrison (Conservative, Westbury)

I am grateful to the Minister, and her last comment that she hopes that the offences will be hypothetical was important, because I seriously believe that no charges under this provision will ever be brought. Indeed, members of the research community feel slightly threatened by the possibility of being criminalised in this way, and they need reassurance. It is also important, hypothetically, that those who seek redress should have access to the individual who is to blame. It would be wrong to make a law under which a complainant did not have someone to put the finger on, but this provision makes that possible. The Bill previously failed to do so, because there would have been a defence if a researcher had not been correctly informed as to whether consent had been obtained, and nobody would have been able to be "nailed" for the offence, so to speak. The amendment will remedy that. With that in mind, I support the amendment and its consequential amendment.

Amendment agreed to.

Clause 7 — Existing holdings

Clause 8 — Existing anatomical specimens

Clause 11 — Remit

Rosie Winterton (Labour, Doncaster Central)

I beg to move amendment No. 71, in page 9, line 30, leave out from 'if' to end of line 31 and insert—

'(a) it relates to the body of a person who died before the day on which this section comes into force or to material which has come from the body of such a person, and

(b) at least one hundred years have elapsed since the date of the person's death.'.

Michael Lord (Deputy Speaker, Central Suffolk and North Ipswich)

With this it will be convenient to discuss Government amendments Nos. 72, 73 and 74.

Rosie Winterton (Labour, Doncaster Central)

These amendments fall within the policy area of the Department for Culture, Media and Sport. Nevertheless, I am delighted to present them. In the present draft of the Bill, "qualifying museums" are excluded from the remit of the Human Tissue Authority and from the licensing regime, as it is not our policy intention to regulate museums holding human remains in the same way as tissue banks. Since we discussed the Bill in Committee, however, the archaeological community has pointed out that the Bill as drafted might criminalise the examination of excavated remains to discover the cause of death, if this were undertaken without a licence, and not for the purposes of a "qualifying museum".

Determining the cause of death is an activity that archaeologists undertake occasionally, and not all archaeologists' work would necessarily be connected with the purposes of a "qualifying museum". The identification of diseases causing death may help to shed light on past human health, and the examination of fatal wounds sometimes seen on skeletons may be undertaken to shed light on warfare and violence in past societies. Under the Bill as drafted, this activity might fall within the remit of the Human Tissue Authority and the licensing regime, which could result in its coming within the scope of the offence set out in clause 22, which carries a potential prison term of up to three years if the activity is undertaken without a licence.

It was obviously not the Government's intention that the archeological community should be subject to the regulatory regime imposed by the Bill. The Government are therefore proposing amendments that will except human remains from the licensing provisions where those remains come from an individual who dies before the new regime comes into force and where there is a gap of more than 100 years between the date of death and the undertaking of a regulated activity.

For example, public display of a prehistoric skeleton will be unregulated whereas display of remains from a person who died six months after the relevant provisions come into force will be regulated. That includes Gunther von Hagens' plastinates. This will align the remit of the Human Tissue Authority and the licensing system with the consent requirements in part 1 and the DNA provisions in part 3.

In the light of that, the Government are also proposing to remove the qualifying museum exemption. As we said in Committee, the vast majority of remains in museums date from before 1900. That was the basis for the qualifying museum exemption. However, if the licensing regime is restricted to activities in relation to remains of people who have been dead for fewer than 100 years, as the vast majority of the human remains in museums are older than that, the Government see no need for the qualifying museum exemption.

Additionally, the removal of the exemption responds to representations made by hon. Members on Second Reading and in Committee that we should ensure that the display of more modern remains, and other activities undertaken in relation to such remains, should be regulated irrespective of where that takes place.

All those amendments will impose very few extra burdens on the museum sector and will avoid the unintended imposition of regulatory burdens on activities such as archaeology. It is anticipated that the cost to licensed institutions will be proportionate to the number of remains held by them that fall within the remit of the Human Tissue Authority and the licensing regime. As museums hold few remains that are likely to fall into that category, the impact on the museum sector will therefore be very small. Licensing will be imposed only in respect of modern remains, which the Government believe should be licensed.

We therefore propose that amendments to clauses 11, 13 and 33 be made to achieve that effect and that clause 42, which provides the exemption for qualifying museums, be omitted. I commend the amendments to the House.

Andrew Murrison (Conservative, Westbury)

We broadly welcome the amendments. We have all seen on our television screens the delightful archaeological programmes that deal with, among other things, debate on cause of death, usually related to mediaeval remains. In that context I am a little dubious, I suppose, about the 100 years that the Minister cites. Most remains in which we have an interest relating to cause of death, mortality and morbidity are probably a great deal older. Indeed, 100 years is not a long period in terms of people's knowledge of antecedents and so forth. So, 100 years seems a strange cut-off point and I would be interested in the Minister's explanation of how it came to pass.

Government amendment No. 74 is also welcome, although I do not know whether it is bad form to construct a clause and then delete it entirely at this stage. It seems very strange, but I nevertheless welcome the removal of the special exemption given to so-called qualifying museums. Several of us discussed in Committee our unhappiness with various displays that we have seen recently, in particular those of Professor Gunther von Hagens involving his plastinates. At best, we can say that those offended the sensibilities of a number of our constituents. Had they looked into this matter, many of them would have been rather surprised had such displays been exempted from a measure of this sort. I am glad that that is no longer the case and that qualifying museums will be subject to the rigour of the Human Tissue Authority. That is to be warmly welcomed.

I wonder a bit about the costs of licensing for museums. The Minister says that they will be small, but I can think of museums with reasonably extensive remains of more than 100 years old. I suspect that they are less than reassured by her comments and will be wondering what cost they will have to face, given that in many cases their budgets are not large. It would be good to have a more precise estimation of what sort of financial burden licensing will be for them.

Rosie Winterton (Labour, Doncaster Central)

At this point, I cannot give the hon. Gentleman such an estimate of the cost to museums. Clearly, however, officials in the Department for Culture, Media and Sport have been liaising closely with museums, and have made it clear that there will be very little burden on the museum sector. As I said, the cost to licensed institutions will be proportionate to the number of remains held by them within the remit of the Human Tissue Authority.

With regard to the point about 100 years, the issue is that that is in uniformity with the clauses on DNA and consent, which were designed so that there would be no living memory of patients. I hope that the House will support the amendments.

Amendment agreed to.

Clause 13 — Licence requirement

Clause 23 — Preparation of codes

Rosie Winterton (Labour, Doncaster Central)

I beg to move amendment No. 75, in page 14, line 13, after 'prepare', insert 'and issue'.

Michael Lord (Deputy Speaker, Central Suffolk and North Ipswich)

With this it will be convenient to discuss the following: Government amendment No. 25.

Government amendment No. 26 and the following amendment thereto: (a), in line 2, after '(2)', insert '(e), (g),'.

Government amendments Nos. 76 and 77, 27, 78 to 84 and 28.

Rosie Winterton (Labour, Doncaster Central)

First, I will deal with Government amendments Nos. 75 to 84 regarding approval of the codes of practice.

Most of the codes of practice required under the Bill are currently subject to the Secretary of State's approval and must be laid before Parliament, but there is no procedure for their scrutiny. In Committee, Members raised the issue of making those important codes subject to a process of parliamentary scrutiny, to allow an opportunity for their contents to be considered.

We have taken note of those representations and, on further reflection, we consider that where the codes may have a significant role in the regulation of licensed activities, parliamentary scrutiny would be appropriate. We now propose amendments to provide that the codes approved by the Secretary of State should be laid before Parliament and subject to approval by the negative resolution procedure before they may be issued by the Human Tissue Authority. To achieve that, amendments are proposed to clause 23, and provision for the negative resolution procedure is introduced in clause 26.

Government amendments Nos. 25 to 27 deal with the need for a code of practice on obtaining consent from living patients. We know from debate on Second Reading and in Committee that pathologists and researchers are anxious about what constitutes consent under the Bill, as a criminal penalty attaches to carrying on many activities without consent. Provision for the Human Tissue Authority to lay down the standards expected in relation to obtaining consent to store or use tissue from deceased persons is explicit in clause 24. The reason for that is that it is necessary to set out in the Bill that those standards must include advice on the hierarchy of qualifying relationships when consent is to be given after a person's death.

Hon. Members may recall that amendments were tabled in Committee and that considerable debate took place about the need to make explicit the fact that the Human Tissue Authority would also provide a code of practice giving guidance on obtaining consent from living patients. As presently drafted, the authority would be able to issue such a code on consent and we would expect it to do so, but we recognise the value of providing reassurance to those who are concerned about consent. We therefore propose that the Bill should make it explicit that the authority will issue a code of practice on obtaining consent from living patients.

The amendments will achieve that, placing a new duty on the Human Tissue Authority to deal with consent in its codes of practice in clause 23, and clause 24 then sets out the particular matters that such a code must deal with in respect of the hierarchy of qualifying relations that are relevant to obtaining consent from those close to a deceased person.

The Government are not persuaded of the need for amendment (a) to Government amendment No. 26, which was proposed by the hon. Member for Oxford, West and Abingdon (Dr. Harris). We believe that it is unnecessary because the authority can—[Interruption.] Is the hon. Gentleman not intending to press the amendment?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I was saying to the Minister that it was a probing amendment in the hope that she would explain, as she is now, why she removed the reference to clause 23(2)(e) and (g).

The rest of the debate is in Hansard.