Clause 3 - ''Appropriate consent'': adults
Human Tissue Bill

Mr Alan Hurst (Braintree, Labour)

I remind the Committee that with this we are discussing the following:

Amendment (a) to the proposed amendment, in

line 1, leave out 'paragraph' and insert 'paragraphs 3, 5 and'.

Amendment (b) to the proposed amendment, in

line 2, leave out 'would' and insert 'might'.

Amendment No. 91, in

clause 24, page 15, line 24, after '(ii)', insert '3(2A)'.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

When we adjourned, I was explaining why I think that there is some merit in including further purposes in paragraphs 3 and 5 to enable those who lack capacity to participate in research. If one relies only on best interest, it is difficult to argue that material from such people can be used, because it is harder to prove that that would be in their best interest. The test of whether it is not contrary to their best interest is more valid.

I was about explain briefly that patients with a ruptured aneurysm in their head are usually, but not always, in a pretty bad way and unconscious, and may proceed to acute surgery when samples may be taken. Those samples might be useful for research on the cause and treatment of, as well as the inflammatory response to, such aneurysms.

It is not clear whether such tissue may be stored for the purposes of research to await any recovery of the patient. Sadly, people with such a serious condition sometimes do not recover and there may be a particular interest in looking at the material for research purposes rather than for treatment or diagnosis in such cases. It is likely, but not certain, that there may eventually be benefits for similar patients.

I could give other examples involving more chronic incapacity—it would be sad if the Bill failed to take account of that. The Government may intend to amend the Bill through other legislation covering incapacity. The hon. Member for South

Cambridgeshire (Mr. Lansley) and I may find that satisfactory, but it should be clarified.

My amendment (b) would clarify amendment No. 90. It proposes words that are a little less specific than ''would benefit persons''—we are in the realms of future research—and would to change them to

''might benefit persons with the same or similar conditions''.

It is not against the interests of an incapacitated person for their tissue, with appropriate consent from an appropriate person, to be subject to research when there is a chance, although not a certainty, that that might benefit people with the same or similar conditions.

The same extension could be made for education and training, because it will be difficult to obtain material for clinicians' education and training, which will aid future treatment and cures, if samples from such patients are never available for the purposes of paragraph 3 of schedule 1. I wait with interest to hear the Minister's response.

Ms Rosie Winterton (Minister of State, Department of Health; Doncaster Central, Labour)

I understand the contributions of the hon. Member for South Cambridgeshire, my hon. Friend the Member for Leyton and Wanstead (Harry Cohen)—he made valid comments not only about people with mental incapacity, but about people with mental illness—and the hon. Member for Oxford, West and Abingdon (Dr. Harris).

Perhaps I may say first to my hon. Friend that it is important to be clear that people may have a mental illness, without losing capacity, but be able to make decisions. We are looking particularly at the issue of people who are mentally incapacitated and we must distinguish between the two.

Under common law, nobody can consent to medical procedures on behalf of a mentally incompetent adult, although treatment can be carried out if it is necessary and in the person's best interests. A person without capacity to give consent will not be able to provide the necessary consent for the use of their material for the purposes listed in the Bill, including research. When such a person dies, their relatives will be able to consent to their body, or material from it, being used.

The Mental Incapacity Bill covers questions of consent on behalf of incapacitated persons. The Bill has recently undergone pre-legislative scrutiny, and we will consider any changes that have to be made to the common law position. If changes have to be made to this Bill as a result, they will be made through the relevant channel.

Mr Andrew Lansley (South Cambridgeshire, Conservative)

I am grateful to the Minister for at least making clear what I suppose we had expected, but she does not say what the Government's intentions are. In advance of legislation that covers the whole field, it may be premature to ask them to state their intentions in relation to the important aspect of consent for mentally incapacitated persons, but that means that we will not be able to consider the issue in the context of the Bill.

Although we hope that the Bill will in due course become the Human Tissue Act and that it may be amended, there will be a time during which the review process has clearly failed to complete its course in this significant respect. Those of us who are focusing on the provisions in the Bill may not have the opportunity to give future amendments the same scrutiny.

There is little scope for us to press the Government further, when they consider themselves procedurally, if not constitutionally, constrained from being able to say more. On that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Dr Richard Taylor (Wyre Forest, Independent)

I beg to move amendment No. 51, in

clause 3, page 3, line 41, at beginning insert

'Except where subsection (3A) applies'.

Mr Alan Hurst (Braintree, Labour)

With this it will be convenient to discuss the following amendments:

No. 52, in

clause 3, page 3, line 43, at end insert—

'(3A) Where the person concerned has died and no person in a qualifying relationship can be found or the person cannot be identified, ''appropriate consent'' means the consent of the coroner.'.

No. 73, in

clause 3, page 4, line 23, at end insert—

'(d) if neither paragraph (a) nor paragraph (b) applies and no person who stood in a qualifying relationship to him immediately before he died exists or can be found in a reasonable time, the hospital authority.'.

No. 74, in

clause 3, page 4, line 23, at end insert—

'(5A) Where the person concerned has died and the activity does not involve storage for use, or use, for the purpose of anatomical examination or public display and the person concerned cannot be identified, ''appropriate consent'' means the consent of the coroner.'.

Dr Richard Taylor (Wyre Forest, Independent)

I am afraid that I must start by craving your indulgence, Mr. Hurst. When I was penetrating the tortuous depths of the Bill, to meet the deadline for tabling amendments, I had not reached the striking clarity of clause 56, so I framed amendment No. 51 under the misunderstanding that an anatomical examination implied post mortem examination. With your indulgence, may I ask the Minister to clarify some matters regarding post mortem examination, which are not clear in the Bill?

My problem arises from my experience as a practising physician. A patient, perhaps one whom I had known for years, might die from a rare, puzzling illness, but one would find that they had no relatives. A medical value post mortem—to use the phrase ''medical interest'' would be wrong—was crucial to confirm the diagnosis, see the effect of treatment and demonstrate a unique case for teaching purposes. As far as I can see, the Bill does not contain any provision for a request for a post mortem when no family can be found. The point of the amendment is to find out whether that is the case.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

I rise to speak to amendments Nos. 73 and 74, which probe on an issue separate from but

analogous to the framing of the amendments tabled by the hon. Member for Wyre Forest (Dr. Taylor). They deal with what happens when there are no relatives available from whom consent can be obtained, the subsequent position on organ donation and what happens when a person is unidentifiable.

Amendment No. 73 states that

''if neither paragraph (a) nor paragraph (b) applies and no person who stood in a qualifying relationship to him immediately before he died exists or can be found in a reasonable time, the hospital authority''

would be the appropriate body to decide whether organs could be used. Under the Human Tissue Act 1961, those lawfully in possession of the body are able, though not required, of course, to use organs for transplantation if the person consented or if there is no reason to believe that they did not. The debate has long been about who has lawful possession of the body.

The Bill clarifies many matters, but it still does not deal with someone who is identified and is known to have no family, friends or reachable friends who would fit the qualifying relationship. Will the Minister provide clarification on whether hospital authorities can use organs—for transplantation, for example—or absolutely cannot?

Amendment No. 74 would add proposed subsection (5A). I am not certain of the circumstances in which the terms of the amendment would be appropriate. If someone were unidentified, it might be difficult for the purposes of transplantation to be certain that there were not unknown medical contra-indications. It would be useful to clarify the appropriate consent, if any might exist, in those circumstances.

Dr Andrew Murrison (Westbury, Conservative)

I am glad that the hon. Member for Wyre Forest has clarified his intentions, because I was going to condemn him as a resurrectionist, given how his amendment reads. Clearly, he is not one. I am relieved to know that individuals will not be anatomised and dissected in medical schools at the behest of the coroner, because that would be inappropriate.

I understand that, if cause of death cannot be certified, which was a concern of the hon. Gentleman, it would be, de facto, a coroner's case. We would not therefore need the separate permission of the coroner to undertake a hospital post mortem, because establishing the cause of death would proceed as a coroner's case.

If one does not know the cause of death, it is sadly quite likely that the person will not have any friends or relatives. We can all think of cases in which people who have died were of no fixed abode and without friends. One does not know why, and one would like to know more about the death. It would be good to have a hospital post mortem, as, having established the bare facts of the cause of death, one would like to know more.

Tempting though such a proposal may be, we have to resist it, on the basis that it would not be essential to do a hospital post-mortem in that case, because,

presumably, the cause of death would have been established. If it had not, it would be a coroner's case. In such rare instances, we must protect the rights of the individual who has not consented to a post-mortem and has no friends or relatives who could do so under the Bill. Regrettably, therefore, we cannot support the proposal, tempting though I find it as someone who has faced that dilemma professionally.

Amendment No. 73 mirrors the revised amendments No. 51 and 52, tabled by the hon. Member for Wyre Forest. Unless I am very much mistaken, the clarification given by the hon. Member for Oxford, West and Abingdon means that the amendments are similar. I am intrigued by the non-identifiable person referred to in amendment No. 74. Like the hon. Gentleman, I struggle to think of instances where it might apply, but I am sure that he has thought of some. In short, that is enough from me. I look forward to hearing the Minister's clarification of the matters arising.

Ms Rosie Winterton (Minister of State, Department of Health; Doncaster Central, Labour)

We generally agree that, as the hon. Member for Westbury (Dr. Murrison) said, the amendments tabled by the hon. Member for Wyre Forest are related more to post-mortem than to either anatomical examination or public display. There is general consensus that that would not be appropriate.

The amendment tabled by the hon. Member for Oxford, West and Abingdon would give a hospital authority the power to delay transplantation of organs from a person who has far-flung relatives, and it would give the coroner the power to do the same in relation to an unidentified body. The issue, once again, is that the whole Bill is based on the need for informed consent. There must be respect for the rights of the individual. The simple fact that it is impossible to find out what an individual's wishes would have been does not mean that we should override those rights. I agree with the hon. Member for Westbury that it is a question of individual rights.

The policy encapsulated in the Bill was arrived at after public consultation. The key is that consent from the individual or a person close to the deceased must be given if use of their bodies or tissue is to be lawful. As I said, the bodies of the deceased do not belong to the state or the medical profession. We certainly have no intention of allowing third parties, who have no close connection to the deceased, to make decisions about using bodies for education, research or transplantation.

It follows that when a deceased person cannot be identified, or his relatives found, his body and material from it may not be used for the purposes regulated by the Bill. If a person dies and no relatives or close friends can be found, the coroner is be allowed to order a post-mortem to confirm the cause of death, but the principle would apply that any material from that post-mortem would not be used for other purposes because the person's consent had not been given. I hope that I have clearly set out the Government's position. We cannot accept the amendment, and I hope that it will be withdrawn.

Dr Richard Taylor (Wyre Forest, Independent)

The Minister has not quite answered my specific question. I shall try to explain. As a hospital

physician, one gives the death certificate because one perfectly well knows the cause of death. From the point of view of my own learning and experience of teaching student junior doctors, a post-mortem on that patient would be very helpful.

Ms Rosie Winterton (Minister of State, Department of Health; Doncaster Central, Labour)

As I have said, because consent is required from the nearest relative for a post-mortem in those circumstances, one that would not be allowed under the Bill.

Dr Richard Taylor (Wyre Forest, Independent)

I thank the Minister for making that crystal clear. I have no alternative but to beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

I beg to move amendment No. 141, in

clause 3, page 4, line 11, leave out 'or public display' and insert

', public display or transplantation following removal in accordance with the provisions of section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation]'.

Mr Alan Hurst (Braintree, Labour)

With this it will be convenient to discuss the following:

Amendment No. 142, in

clause 3, page 4, line 23, at end insert—

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

Amendment No. 143, in

clause 23, page 14, line 22, 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];

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

Amendment No. 76, in

clause 23, page 14, line 22, leave out paragraph (d).

New clause 3—Determination of consent for removal, storage and use of organs from adults for purpose of transplantation—

'(1) Where part of a body of an adult lying in a hospital or other institution is or may be suitable for use for transplantation, it shall be the duty of the person having the control and management of the institution to ensure that, before any organ is removed from the body, each of the conditions specified in subsection (2) is met.

(2) Those conditions are—

(a) that the deceased was, immediately before he died, ordinarily resident in England, Wales or Northern Ireland;

(b) that, where the person to whom the duty under subsection (1) applies knows, or has reason to believe, that—

(i) the body of the deceased person, or

(ii) relevant material which has come from the body of a deceased person,

is, or may be, required for purposes of functions of a coroner, the consent of the coroner has been obtained;

(c) that the deceased had not opted to make his organs, or the relevant organ, unavailable for removal for the purpose of transplantation and recorded that view in the register maintained in accordance with the provisions of section [register of persons opting to make organs unavailable for removal for purpose of transplantation]; and

(d) that no person with a right to signify an objection under the provisions of section [duties in relation to persons who stood in a qualifying relationship] has done so.

(3) Where each condition in subsection (2) is met, consent shall have been determined for—

(a) the removal of organs, or the relevant organ, for the purpose of transplantation, and

(b) for the subsequent storage for use, and use, of such organs for the purpose of transplantation.

(4) Where a body is transferred to another institution prior to the removal of any organ, the duty under subsection (1) shall also be transferred to the person having the control and management of the institution to which the body has been transferred.

(5) In dealing under section 23(1) with the matters mentioned in this section and sections [register of persons opting to make organs unavailable for removal for purpose of transplantation] and [duties in relation to persons who stood in a qualifying relationship], the Authority shall, in particular, lay down the standards expected in relation to the performance of the duty imposed by subsection (1).

(6) In this section and sections [register of persons opting to make organs unavailable for removal for purpose of transplantation] and [duties in relation to persons who stood in a qualifying relationship]—

''death'' has the meaning given in accordance with the provisions of section 23(2)(d); and

''organ'' means any part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body.'.

New clause 4—Register of persons opting to make organs unavailable for removal for purpose of transplantation—

'(1) It shall be the duty of the Authority to maintain a register of persons opting to make all their organs, or specified organs, unavailable for removal for the purpose of transplantation.

(2) Any person who opts to make all his organs, or specified organs, unavailable for removal for the purpose of tranplantation may inform the Authority in a prescribed manner.

(3) Any person who has informed the Authority of his decision under subsection (2) but then opts to make all his organs, or specified organs, available for removal for the purpose of transplantation 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) applying for a driving licence,

(b) making an application for a passport, or

(c) providing information relating to the register of parliamentary or local government electors.

(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, and

(b) 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.

(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 5—Duties in relation to persons who stood in a qualifying relationship—

'(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 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, and

(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 expressed his wish 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 expressed his wish 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 had not been made in the register.

(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 qualifying relationships for the purposes of this section are—

(a) spouse or partner;

(b) parent or child;

(c) brother or sister.

(7) The qualifying relationships shall be ranked in the order given in subsection (6) for the purposes of subsection (1).

(8) Relationships in the same paragraph of subsection (6) shall be accorded equal ranking for those purposes.

(9) 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 (6) to (8).

(10) If two or more persons are accorded equal ranking in accordance with subsections (6) to (8), the duty under subsection (1) shall apply to all of the persons accorded that ranking.

(11) In applying the principles set out above for the purposes of subsection (1), 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.'.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

This is a substantial group of amendments, but I am conscious of the pressure of time since I know that we want to make progress—I as much as anyone—which is why I am happy to limit my contribution to about seven minutes. The Minister may well have a lot to say, but perhaps it would be best to debate specific issues through interventions rather than my setting out something that we may wish to repeat at a later date, while other people who support the opt-out of presumed consent are able to put their names to an amendment at a later stage.

To cut things short, I am keen to stress that the amendment is designed to do several things. Using an opt-out system and a presumption of consent for adults where there has not been an opt-out would lead to a greater rate of organ donation with the subsequent downstream effects of a greater prevention of avoidable loss of life, and avoidable morbidity through transplantation. There is strong evidence that that would be the impact.

There has been a series of reviews in the literature, and I have conducted an exhaustive search for published reviews to see whether there are suggestions that such a system does not work. Reviews have shown that there is felt to be a significant impact on the number of organs made available, when controlling for other factors, which is sometimes difficult to do. Given the state of play—increasing waiting lists and significant numbers of people dying while waiting—and, despite the best efforts of the Government, clinicians, UK Transplant and officials, all of whom I fully support, we face a worsening position, especially with regard to cadaveric donors. That is likely to continue for some years to come.

I was surprised that the Department said in a press release that there was no evidence to support the proposition that the process would work, because it has worked in other countries where it has been tried. A review by Professor Kennedy of the European Forum for Transplant Ethics and a recent review by researchers in New York covering the piste of European systems showed that there had been a significant effect. In the interests of speeding things up, I shall not read out the conclusions.

Dr Andrew Murrison (Westbury, Conservative)

To which countries is the hon. Gentleman referring, and which countries, having tried it, maintain the opt-out system that he is describing?

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

I am happy to send the hon. Gentleman the references. I tend to refer to the Belgian model, but many countries were considered. Consideration was given not only to their legislation but to their practice,

and the reviewers concluded that there was a significant impact. In fact, even where a very soft system of presumed consent was practised, it was felt that having the legislation in place had an impact, because it changed the mindset.

It is not sufficient to consider the evidence for beneficial downstream effects, because there are other hurdles to jump. One must demonstrate that the system would be more likely to meet the wishes of the donor, because I agree that the wishes of the donor should be primary. There is increasing evidence that our current system, under which we ask relatives to second-guess the wishes of their loved ones, makes it difficult for those wishes to be acceded to. Opinion poll and survey data consistently show that between 70 and 90 per cent. of people are willing to become donors when they die, but only 50 per cent. of relatives give consent. Some 48 per cent. say no, according to the latest survey, which was carried out by UK Transplant.

That gap is significant. People who are willing to donate are not enabled to do that, because relatives, at the height of their grief, are asked, ''What do you think your loved one would have wanted? And if you haven't a clue, what do you think?'' That is not the best way to ensure that the donor's wishes are primary. Until we get a full opt-in system under which knowledge is available to relatives, we will still have the problem of that gap. We are still a long way away from that system.

Mr Ian Lucas (Wrexham, Labour)

Will the hon. Gentleman clarify a point for me? Is he talking about cases in which the deceased has indicated consent, or cases in which there is no evidence whether the deceased has indicated consent?

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

Under the current system, relatives are sometimes approached in the knowledge that there is a donor card and an indication on the organ donor register. It is hard to tease things out, but, if we take a proportionate approach, about 15 per cent. of people have been on the organ donor register over the past few years. Assuming that the register is checkable and checked, a proportion of relatives will be in the situation referred to. However, we heard earlier that there are cases in which that is not sufficient and relatives say that because of their own objections that they do not want donations to be made. That situation is difficult.

Under a system of presumed consent, if relatives were to volunteer an objection, the system would work in a similar way to the present system. Under the system that I propose, if relatives volunteer that they would be distressed—they are usually asked specifically, which is a questionable practice—the organs would not be taken. That is what makes it a soft, not a hard, system.

Between September and December 2003, there were 11 cases in which people who were on the organ donor register did not have their organs used. On the assumption that that was down to relatives withholding consent—the reason why the majority of organs are not taken—that suggests that the problem

is somewhat greater than the figure of 1 per cent. would suggest.

Mr Ian Lucas (Wrexham, Labour)

In some of those 11 cases, could the reason not be completely different? Might it be that families would not give consent for removing organs from the deceased. A body may have been HIV-positive, for example.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

That is certainly possible, and we need to tease out the data. In fact, I am on the hon. Gentleman's side. If it is the case that where there is a presumption, whether through an opt-in or an opt-out system, that someone is willing for their organs to be used—the 70 to 90 per cent. of cases—and if it is true that relatives rarely object to or veto the decision, an opt-out system with presumed consent and a relative check is very effective. If the hon. Gentleman and the Minister are right—I hope that they are—that there is no new phenomenon of relatives saying that they will be distressed, despite the presumed or actual consent granted by the patient, the opt-out system will work effectively. Softening the system—I think that that was the term used by the hon. Member for Westbury—would cater for the minority of cases where relatives had specific concerns. The purpose of such a scheme is to ensure that we maximise the number of times that the organ donor's wishes are met—their wishes expressed by not opting out—and clearly there must be adequate opportunities to do that. Research shows that that is optimised.

We must ensure that ethics experts do not deem it unethical to use a system of opt-out and then presume the consent of those who have not opted out. The view across Europe is that it is not unethical. Some countries such as ours have chosen not to go down that path, and others have chosen to do so, but no pan-European organisation has expressed the view that it is unethical. Indeed, the view of many ethical authorities in this country is that it is ethical.

Dr Andrew Murrison (Westbury, Conservative)

I am grateful to the hon. Gentleman for giving way on a similar point to the one that I raised with him earlier, which relates to the countries in Europe that operate the opt-out system. May I press him to tell the Committee in broad terms the number of countries in Europe where the opt-out system operates and the number where it does not? That would be helpful.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

I am keen to get on, and there will be other opportunities to discuss specific country examples. I want talk about the proposal in broad terms, but I shall send the hon. Gentleman the references from the reviews.

A number of ethical authorities in this country believe that, because of the pressing need for organs, it is not only ethical but ethically right to opt out. Many people are dying while waiting for an organ and a number of organs are lost whose donors would have wanted them to be used in such a way. I am more than willing to cite those authorities.

Much in the Bill and our debates has dealt with the way in which we should treat relatives. I need to explain how an opt-out system would work, although it is described in the new clauses. The system would apply only to adults and to people ordinarily resident in this country, so it would not apply to people from overseas who may not know the system. The detail would be determined in any plan, but people would have the opportunity to opt out through post offices, driving licence and passport applications, at GP registration or in communications relating to the electoral roll requirement, although a legislative change may be necessary to maximise that potential. Therefore, there would be multiple opportunities to opt out and plenty of opportunities for people to discuss the issue with their families in a way that, sadly, despite all the efforts of educators and advocates, does not occur at present because so many relatives do not know their loved one's wishes.

Where someone has chosen not to exercise the opt-out—this could run parallel with a donor card system—the presumption would be that they have no objection to their organs being used to save the life of someone else after their death. We propose a soft system of presumed consent, where the relatives are approached in the same way as they are now, asked the necessary questions about medical and social history—to say that that must still be done is not an argument against the system—and informed that no opt-out has been found on the opt-out register. They would then be asked whether they knew of any opt-out that had not been registered—if that had been discussed and the person concerned had said that they did object, but had not got round to opting out. That is critical. If relatives said that such a situation existed, it would be taken as an opt-out.

Furthermore, if at that stage the relatives volunteered that they would suffer significant distress, despite there being no opt-out on the register and no known opt-out from the person—or, indeed, as now, if the person had been quite keen on the idea of donation—organs would still not be taken. That accepts the Minister's point in our earlier debate that, practically, it is not good policy to take organs in those circumstances. I was pleased that I was able to press her on that matter because every one of her answers—she said how important it was that where there was significant distress, organs should not be taken—was acceptable to me, and I was able to cite them in describing the new clauses that would introduce such a system.

Mr Ian Lucas (Wrexham, Labour)

Who assesses significant distress?

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

The same people who assess it at the moment. The problem would not change if we moved from an opt-in to an opt-out system. When there is donor card, for example, doctors must judge without necessarily having to press the relatives whether it would be too distressing to push the point. I have been in that position as a practitioner. I have known situations where patients were dying for want of an organ, and where it was clear that the owner of those organs, whose autonomy we are trying to respect, wanted them to be used. In that case, one makes a judgment about whether the family is significantly

distressed. That could clearly be brought out in a code of practice. There are issues to do with the hierarchy; we have the same problem now about how we deal with disagreements.

If we are to respect the patient's autonomy, the key factor in such an approach, as has been shown in Belgium, is that it is fairer to grieving relatives to ask them about their understanding of their loved one's views, but not to ask them to guess those views or to ask them specifically for their own view. Many patients' relatives do not want to deal with that question, and those who would be distressed by the thought of organ donation have and must be given the opportunity to volunteer that they would be distressed.

Mr Ian Lucas (Wrexham, Labour)

I am grateful for the hon. Gentleman's continuing patience in giving way. I cannot grasp why it is in order for there to be a general presumption that the deceased person would have given consent, but that the family of that person is not allowed to make an assessment of what the deceased person would have liked. Is that not peculiar?

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

I thought that I had made that clear. Exactly what the hon. Gentleman wants would apply. The relatives would be asked whether there was an opt-out—whether the person did not want their organs to be used. The hon. Gentleman is making the point that they are not given an opportunity to guess on the basis of the values of the person concerned, and I accept that that could be an issue. However, if they feel strongly that the person would not have wanted their organs to be used—let us remember that the opt-out would come up all the time, on every trip to the post office and on almost every official form—they would have the opportunity to say that they were distressed because, even though the matter had never been discussed and the person had never taken advantage of the opt-out, they do not think that the person would have wanted to be a donor. That is what happens abroad. There have been a few cases—for example in Belgium—of such reasons being posited, and organs have not been taken. We would be maximising respect for the patient's wishes, but giving scope to meet the stress of relatives as fully as now.

A further point is that there is now good research to show that many relatives, who at the height of their grief say no to donation because they cannot deal with the decision—they are asked for their decision and not the wishes of their loved one—come to regret not having given their consent at that acute moment, particularly when they hear stories later on about people whose lives have been saved through donation. Some follow-up has taken place, although it is difficult to do, and those are the findings. Such an opt-out system with presumed consent is of benefit to the relatives in not only the acute stage but down the line.

For those reasons, we have an a priori obligation to consider changing the system, particularly given the terrifying number of people on the waiting list for transplants. The number has risen inexorably from 5,410 in 1993 to 6,507 in 1998, and from 7,072 in 2002 to 7,278 in 2003. That increase occurs almost every year. There is a similar steady rise in the number of people dying while waiting. Despite the great efforts

that have been made, under the current system the number of cadaveric organ donors continues to drop, from 853 in 1993 to 757 in 1998, picking up over four years to 766 in 2002, but dropping in the past full calendar year—2003—to 710. Although one can pick out the financial year of 2002–03 in which there may have been an increase in cadaveric donors, the figures for 2003 are very disappointing.

People are dying while waiting, organs are being lost and the majority view of people who want to donate, which is up from 70 to 90 per cent. is not being considered, because 50 per cent. of relatives who are asked for their opinion say no. Therefore, we urgently need to consider the change, and there is good evidence of public support for it.

Support exists in not only listeners' polls; a survey of 2,000 people carried out by the National Kidney Research Fund in July 2000 showed that 57 per cent. of those questioned would support a system of presumed consent. A telephone poll conducted by ''Watchdog Healthcheck'' in February 2001 attracted some 52,000 people and found that 78 per cent. of respondents supported a shift to presumed consent. Again, they are responsive polls not scientific samples, so we clearly need more information on the matter. The Department of Health's response that there has not been demonstrable public support and no public debate, when it has not initiated a debate or a fair survey of public opinion, makes it difficult to conclude that the question has been settled.

Dr Ian Gibson (Norwich North, Labour)

Could the hon. Gentleman enlighten me? What drives and precipitates the increasing demand in the medical community? Has it become more fashionable to have transplantation departments or has some kind of new immunological understanding of the processes increased the possibility of carrying out more transplants? Why is it more likely to see transplantation used? Could he explain the figures that he has quoted and the drive behind the increase? Is there some reason why the science and the medicine have made it more possible?

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

The reasons that the hon. Gentleman gives have contributed to an increased demand for transplantation. I am not suggesting that changes to the system would close the gap between the number of donors and people waiting for transplants, but it would contribute about 30 per cent. to its closure—based on studies of its impact in other European countries. We must continue with live donations, non-heart-beating donations, which we will discuss later, and the adequate supply of intensive care facilities.

There are fewer and fewer road traffic accidents, fortunately, and the morbidity and mortality associated with strokes is decreasing, so donations may come from a diminishing number of people. However, the fact that the total possible number of cadaveric donors is decreasing does not mean that we should not make every effort—as long as it is ethical, acceptable, fair to relatives and maximises the autonomy of donors—to increase the number of organs available.

The question of public support is, I accept, key. If a fair opinion poll suggested that people did not support the system, then I do not think that it would be viable. I accept that, because the system is something that can be implemented only with public support. However, I do not think that the question asked in May 1999 comparing the status quo and a system of presumed consent was fair, simply because of the way that it was asked and the fact that 50 per cent. supported the status quo. We need to have an informed debate.

Opinion polling since then, including in Scotland, shows that when the two systems are put side by side—rather than presented as involving a shift from the status quo—people do not like the donor card. I do and I am a strong advocate of presumed consent. Only when that is done can we obtain a fair gauge of public support. I am not considering the listeners' poll on Radio 4, or votes on ten-minute Bills by Members, although they are interesting and in support. We need to obtain better judgment of public support, and I hope that by a later stage of the Bill we will be able to do so.

Dr Ian Gibson (Norwich North, Labour)

I want some information about transplantation. Does the hon. Gentleman have a breakdown of the figures comparing the private and public sectors? Not everybody is like George Best, who can get a transplant in the private sector. I wonder whether there is an increase in private sector transplantation, as against the public sector. Where is the demand and increase being met?

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

I understand that the organ donation system, in which one finds an organ available for transplant and looks for a potential recipient, does not distinguish between the private sector and the NHS. Everyone is in the same pool. So I am not sure that I can answer that question.

Dr Ian Gibson (Norwich North, Labour)

Is there data on it?

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

I am not sure that I can answer that question either, and I look to others to do so.

In summary, I know that this is effectively a First Reading debate of the new clause and that the Minister has made it clear that she does not support it, but I thought that the Committee would benefit from the opportunity to air its view. I am sorry to have taken 18 minutes—with interventions—in so doing.

Dr Andrew Murrison (Westbury, Conservative)

The hon. Gentleman mentioned seven minutes at the beginning of his speech and I think that he took 24, but we enjoyed it. It was time well spent.

The issue is a matter of conscience on which individual Members may wish to take a view. I would certainly not wish to represent a corporate view in my remarks. I will put my thoughts on the record and hope that, at least on the Opposition Benches, my comments might be reflected.

On the one hand, the hon. Gentleman's remarks raised practical considerations. I share the concern that we need to harvest more organs for transplantation, although we might part company on how that could best be done. On the other hand, there

was a philosophical strand to what he said. There he and I part company dramatically. It boils down to what we do with the body parts of other people. If I understand his logic correctly, he assumes that it is okay to use the organs of people who have died, unless they have said that they would rather that the state did not use those organs in that way. That seems to be quite a big move to take philosophically. Certainly it does not subscribe to the way that I like to think about how we do things in this country. I am fascinated to hear about the approach taken on the continent. We have heard about Belgium. I look forward to hearing about the other countries that use that system, and also about those that do not and the reason that they have decided not to do so.

We discussed a variety of ways in which we might increase the harvest of organs for transplantation. That would build on the evident success of UK Transplant. It is reasonable to point out, in a non-partisan way of course, that in 1993 the right hon. Member for South-West Surrey (Virginia Bottomley), who is a member of the Committee although sadly not here this afternoon, instituted the organ register, and it has gone from strength to strength. In 1995, 2.25 million people registered with that organisation. That number rose to 5 million by the turn of the century and now rests at something over 11 million, which is extraordinary. When I looked at UK Transplant's website, I was staggered by that—so much so that I hesitated to use those figures earlier because I thought that they might be incorrect. I now understand that they are spot on. That is a lot of people, so we can assume that UK Transplant will go from strength to strength.

I said earlier that I was concerned that hospitals were not utilising the huge pool of potential donors correctly, which remains my view. From my experience in practice over a number of years, it seems that for perfectly understandable reasons there were a number of missed opportunities in hospital practice. By and large, practitioners are focused on the individual whom they are treating and might not have a wider view of how they can add to the sum total of human happiness by using organs from that person when, sadly, their efforts on that person's behalf are unsuccessful. There are lots of ways we can achieve the aim that the hon. Member for Oxford, West and Abingdon and I want to work towards—increasing the number of organs available for donation—without going down the route he described.

I was reassured slightly by the hon. Gentleman's remarks because it seemed that the presumed consent is not only soft, but even softer than that the British Medical Association is advocating. Perhaps we are moving semantically to the same kind of position. I am still concerned, however, about the presumption that it is all right for the state to take the organs of a citizen without that citizen having explicitly said that that is what they want to happen after their death.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

The hon. Gentleman accepts that that is what happens now. Let us be clear: we are not substituting the presumed consent in the most part for the explicit consent of the person pre-death. We are substituting presumed consent of the donor, who has

had the opportunity to opt out, for the consent of relatives—the second-guessing of relatives in most cases. In the vast majority of those cases we are taking organs without the explicit consent of the donor.

Dr Andrew Murrison (Westbury, Conservative)

I think that I follow that. We dealt with the sensitivities and practicalities in dealing with the consent of relatives this morning. The Minister and I came to the conclusion that it would throw up more problems than it would solve to set aside some of the sensibilities of relatives in the process.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

The hon. Gentleman said earlier that it is a leap to move from the current situation, as he put it, of taking organs only with the explicit consent of the persons whose organs they are. I am saying that we should not do that at the moment, except in a small minority of cases where there is a donor card or register. We rely on either the guess of the person's wishes by the relatives, or their own consent, but at the moment in the vast majority of cases we do not rely explicitly on the consent of the owner of those organs.

Dr Andrew Murrison (Westbury, Conservative)

With transplantation, we are talking about an organ donor card, registration on the register set up for that purpose or the consent of relatives. I agree with the hon. Gentleman's earlier remarks, and we have almost entered the realm of semantics. We are proposing to put into statute a presumed consent—the possibility that the state can take the organs from an individual without them having stated that they wished for that to happen, or indeed their relatives saying that on their behalf. We agree about that.

I would like to move on and say why the system might be unfair. It would work in favour of those who were aware of the opt-out, such as those who have driving licences in the way that the hon. Gentleman described, who read material that comes through their door, and who are engaged in what is going on. The group it would disadvantage, of course, are those who are one step removed from that—those who are not articulate or indigenous, or those who are less well-off. I am not sure whether the hon. Gentleman had considered that, but I suggest to him that it would certainly be easier in practice for those who are articulate or well educated to opt out, and less easy for those who do not have those qualities or attributes. [Interruption.] Does the hon. Member for Norwich, North (Dr. Gibson) wish to intervene to put his remarks on record? I would be very happy for him to do so, but I see that he does not.

The hon. Member for Oxford, West and Abingdon needs to consider that his proposals contain a degree of tacit coercion, although I welcome the way that he has described them because that waters down my original understanding of his intentions. If there were not an element of coercion, there would be little point in his making the proposals in the first place. Presumption means that there is a degree, however subtle, of coercion.

The hon. Gentleman is trying to build into the way that we look at transplantation the assumption that one will donate one's organs when one dies. I am not sure about that. He has quoted many figures from opinion polls and the like, flawed and otherwise—some of them quite badly flawed, I suspect—to suggest

that the public will go along with that, but I am not convinced that rigorous studies would reveal that people would be entirely comfortable with the idea. We tread on difficult ground if we try to lead opinion rather than mirror what people feel and want. I am, therefore, concerned at the coercive nature of his proposals, although after he has described them so well and at such length, I accept that the coercion is rather less than I had originally anticipated.

Personally, I reject his amendments. It is a matter of conscience, and I am sure that, if the matter came to a vote on the Floor of the House, hon. Members on both sides of the House would take contrary views. My personal views are now on record—I suspect that I am not alone in holding them. I am sorry that the hon. Gentleman has moved the amendments, which, in my view, are distinctly illiberal.

Dr Doug Naysmith (Bristol North West, Labour/Co-operative)

I promise that I shall speak for no more than a minute, unlike some other people.

I want to put my position on record. As I said on Second Reading, I have been in favour of some system of presumed consent—certainly soft presumed consent—for quite a long time. It would be very helpful in the kind of situation that the hon. Member for Oxford, West and Abingdon has described. I agree with many of the things he has said. However, in this Bill we are considering trying to reverse something that happened at Alder Hey and in Bristol. In those cases, criticisms were made of the medical profession over the way in which organs were taken, and the purposes for which they were taken led to criticisms of medical and scientific research.

I believe that this Bill will move towards restoring some of the faith in the medical profession and medical scientists that was lost following those happenings. This Bill is not the vehicle for presumed consent. I agree that we need much more discussion on the matter, and I am grateful to the hon. Gentleman for the way in which he has clearly explained the different kinds of presumed consent, but if the amendment were pushed to a vote, I would not support it.

Ms Rosie Winterton (Minister of State, Department of Health; Doncaster Central, Labour)

The debate has highlighted some of the major principles around any decision that would be taken to introduce presumed consent in this country. We must consider public opinion. The hon. Member for Oxford, West and Abingdon referred to the paper by Ian Kennedy, who said:

''Clearly, from a moral standpoint, the social context in which any law is to operate and any medical action that arises from it must be a significant consideration in determining policy. Before any such law''—

that is presumed consent law—

''is promulgated, there will have to be an informed public debate and a clear demonstration that it would be morally acceptable to most people.''

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

I wonder whether the Minister is able to complete the quotation, because I believe it goes on to say:

''Much of the objection to change would be mitigated by appropriate public education.

We feel that this debate should now take place and, unless there is a majority view against change, the contracting out system of organ donation''—

that is the opting-out system—

''should be introduced.''

Ian Kennedy wrote that back in 1998 and he is still waiting for the Department of Health to follow his urgings and start that public debate. Perhaps the Minister is willing to do so now, even at this late stage.

Ms Rosie Winterton (Minister of State, Department of Health; Doncaster Central, Labour)

I shall certainly address that point, particularly in relation to the Bill, but in a minute.

In an article on Belgium's experience of presumed consent, Paul Michielson wrote:

''No transplantation law can operate efficiently without acceptance by the public.''

That is exactly my point with regard to the Bill. Following events at Alder Hey and Bristol, and the Isaacs inquiry, we consulted widely for ''Human Bodies, Human Choices''. The majority of the public were happy to donate organs and tissues for a wide variety of purposes, but they wished to be consulted. They wanted to be sure that they knew exactly what would be taken and what it would be used for. The fundamental premise of the Bill is that consent must be obtained to use human organs and tissue, whether from the living or after death. We had an extensive consultation process after the 1998 article with patients, doctors and research groups, and found little support for presumed consent. Therefore, the premise of the Bill is that informed consent should govern our actions.

As my hon. Friend the Member for Bristol, North-West (Mr. Naysmith) said, different arguments can be made about presumed consent but, following the tragic experience of thousands of families, we are considering how to deal with informed, as opposed to presumed, consent. The hon. Gentleman seems to be saying that there should be informed consent for the use of organs for medical or research purposes, but presumed consent in the case of transplantation of a deceased person's organs. That would mean two completely different approaches in one Bill.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

The Minister's analysis is correct. I am suggesting that there should be two different processes for different purposes—research and transplantation. I do so because they are different. One has a direct benefit for people whose lives are in danger. It is commonly the practice in Europe to use a system of presumed consent for transplantation and a different system for other purposes. The current system involves relatives' consent in the majority of cases, rather than informed consent of the person concerned.

Ms Rosie Winterton (Minister of State, Department of Health; Doncaster Central, Labour)

I shall come on to some of the practical difficulties with the system that the hon. Gentleman proposes. First, I want to deal with the figures that he used this morning, about which I promised to write to Committee members. I hope he will agree, however, that it is more effective to address them now and put my response on the record.

We discussed the 1 per cent. refusal rate, which came from a MORI poll commissioned by the United Kingdom Transplant Coordinators Association and the British Association of Critical Care Nurses in 1994. The survey has not been repeated, but the UKTCA confirms that family refusals when the wishes of the deceased are known remain rare. Neither recent anecdotal evidence nor any recent data suggests otherwise.

The report about the 11 people on the organ donor register who did not become donors comes from an analysis of calls to the duty office of UK Transplant. The analysis was performed from October to December 2003. Some 226 calls were made by health care professionals to check whether a person was on the organ donor register. During the same quarter, all actual organ and tissue donors were checked against the register so that their entry could be removed.

Of the 226 calls, 38 were found to be on the register. Of those 38, 10 became solid organ donors, 16 became tissue donors and 11 were non-donors. The reasons for non-donation are not known, but they could include medical contra-indications—they are not necessarily family refusals—which brings us to back to the 1 per cent. rate of family refusal. Of the other 188 inquiries about people who were not on the register, 37 became solid organ donors, 26 tissue-only donors and 128 did not donate.

Results from the first three months—April to June 2003—of the potential organ donor audit show that of 495 potential organ donors, 277 were confirmed as suitable. Of those 277, donation was not discussed with 33 families, a figure that we want to improve, and 119 refused, so 125 became solid organ donors. The results show the necessity to ensure that families are approached only by a properly trained health care professional. As witnessed in Spain, that approach could cut refusals to as low as 20 per cent., which is why it is a key plank of our investment in UK Transplant and the transplant framework.

The hon. Gentleman also asked about the fluctuation in organ donation rates. Rates were up 6 per cent. in 2002–03. UK Transplant reported that, for the first quarter of 2003–04, cadaveric donation rates were down by 10 per cent. However, quarterly rates regularly fluctuate between fewer than 165 donors and more than 230 donors. The figure for the lowest quarter since 2001 is 163 and the figure for the highest is 236. That is well in excess of that 10 per cent. variation. It is difficult to use any individual quarter to project the annual rate.

The hon. Gentleman has obviously made valid points about the need to increase organ donation and he proposed an alternative system, which he suggests would be more effective in increasing the organ donation rate. However, I refer him to the point that I made earlier. Spain does have the highest rate of organ donation in the world, but although it has a presumed consent law, it is not operated in practice. The Spanish transplant organisation takes a positive pride in the fact that the consent of those closest to the donor is always sought.

Dr. Rafael Matesanz, who has made no secret of his views, publicly stated a number of times, including at a symposium at the Royal College of Physicians in 2001 organised by the National Kidney Research Fund, that the legal basis of consent for donation is not the relevant factor in increasing donation rates. In his presentation, he said:

''In 1989, when the National Transplants Organisation was created, there were many people in Spain who believed that the main solution to solving the organ shortage was to change the legislation and apply strict presumed consent laws. However, we found little evidence to suggest that the style of legislation influences the organ donor, because regardless of how the donor might become available, relatives are always consulted, as in most European countries, and their wishes are always respected. In Spain, despite the very large increase in organ donation, over 20 per cent. of families refuse to allow organ donation to take place. This has fallen from 30 per cent. in the early 1990s but is still high.''

So there is the practical point that nowadays it is absolutely necessary to carry out the screening process to which I referred, which gives people the opportunity not to co-operate if they do not wish to do so. There is also the fact that, even where presumed consent operates—in France the system changed because it was felt to be unacceptable—consent is always sought.

Personally, I found the arguments used by the hon. Member for Spelthorne (Mr. Wilshire) on Second Reading very persuasive. I am aware that the proposal does not include children, but similar pressures would apply. Hon. Members will recall that he said that he had not been approached and always regretted that because he would have consented in the circumstances. However, he also said, ''I feel that if it had been presumed that I would give my consent, I would have felt guilty in not doing so, even if I had not wanted to.''

That pressure also applies to relatives, whether the deceased was a child or another close relative. That is what I shall bear in mind when I consider the presumed consent that the hon. Member for Oxford, West and Abingdon is proposing. Our evidence shows that it is extremely persuasive if relatives are told that it was the positive wish of the deceased to donate his or her organs. If there has not been a positive decision to opt out—this goes back to the point made by the hon. Member for Westbury—I suggest that it would be up to the relatives to decide, because, under the system proposed by the hon. Member for Oxford, West and Abingdon, there would still be a requirement to return to the relatives, who would have to make a judgment. If they do not have the positive indication that our system would provide, I suggest that it would be more difficult for them make up their mind. Under our system, there would be a positive indication in favour of donation as opposed to a positive indication against it. I suggest that that is far more persuasive for a relative. We must persuade people to make a positive opting-in proposal because all the evidence shows that only 1 per cent. of people would go against those wishes.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

At the moment, there has been no opt-in in 80 per cent. of cases and relatives are asked to decide. We know that about 20 per cent. of people carry donor cards. If someone has not chosen to carry

a donor card to mention their intentions, or to opt in on the register, relatives might be more likely to assume that the deceased's wish was not to donate because they had not opted in. That is contrary to the general position shown by people's wishes. I think that the argument works the other way from that suggested by the Minister.

Ms Rosie Winterton (Minister of State, Department of Health; Doncaster Central, Labour)

That is arguable. There are two scenarios. From the figures that we have, it seems that about one third of people said that organ donation could go ahead, although there was no indication of what their relative wanted. Over and above that, we know that when there has been a positive indication, only 1 per cent. of relatives refuse. A more positive approach is to increase the number of people on the organ donor register, and we must consider ways of doing so—for example, with an electronic patient record. The hon. Member for Oxford, West and Abingdon referred to driving licences and that system is having an increased effect, having reached more than 6 million people. The single most important measure is that people in intensive care units are able to approach relatives in the correct way.

We already have 35 donor liaison nurses in place. We want every hospital intensive care unit to have a properly trained person who can approach relatives and make the appropriate inquiries. If they are armed with that positive opt-in to the system, there is likely to be a refusal in only 1 per cent. of cases. I know that the hon. Gentleman is keen to increase the amount of organ donation carried out, but I emphasise to him that all the evidence shows that increasing the number of people on the organ donor register is likely to be the most effective way of increasing organ donation. That also fits in with the principles of the Bill. Given the discussion that has taken place about the background to the Bill—the debate that took place about presumed consent when we conducted our consultation—we feel that that is the way forward, and we will continue to do everything that we can to encourage that.

Dr Andrew Murrison (Westbury, Conservative)

I am grateful to the Minister and am sure that she consulted the Royal College of Nursing as part of her consultation exercise. It is important to put on record the strong feeling of the RCN against presumed consent. The findings of its conference suggested that more resources might be dedicated towards nurses, who tend to be at the front line in discussion of sensitive issues with the bereaved. Would she agree that that is likely to increase the harvest of organs and that the RCN is right to oppose presumed consent?

Ms Rosie Winterton (Minister of State, Department of Health; Doncaster Central, Labour)

I am grateful to the hon. Gentleman for reminding the Committee of the views of the RCN. The same view is held by UK Transplant, which feels strongly that individuals should have the opportunity to decide whether to donate after death. The fear of UK Transplant was that an opt-out system would mean that people would fail to register an objection, there would be undue distress to families and that what might happen is, to an extent, the experience of France where the system fell into disrepute.

We do not want to take that approach. We want to take a positive opt-in approach. We will continue to take measures to make that as easy as possible. I say to

the hon. Member for Oxford, West and Abingdon that, particularly in the light of this legislation and the discussions and consultation that went with it, we feel that that is the best way forward. I am afraid that his amendment would go against some of the fundamental principles set out in the Bill. Therefore, I urge him to withdraw the amendment.

Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)

I am grateful to the Minister and other hon. Members that we have been able to have a debate on the issue and for the manner in which the debate was held.

I, along with many others who support the measure, would not be proposing a change if the system were working and if we had 80 per cent. of people on the organ donor register, and therefore less than 48 per cent. of relatives were not disagreeing to organ donation. We are not in that position.

Although I hope that I am wrong, the trends are not encouraging. We now have the figures for the first three quarters of the year 2003–04. In the calendar year 2003, there were 710 cadaveric donors. That takes the figures from the last quarter of 2002–03 and from the first three quarters of 2003–04. The number for the calendar year 2002 was 766 such donors. That is a drop of 7.3 per cent. calendar year to calendar year at a time when the number of people registering on the organ donor register has been increasing thanks to the work of the Minister, her officials and UK Transplant. The signs are not good. I hope that I am wrong and that there will be a sudden turnaround, but it does not look good.

If the hon. Lady is arguing that the problem is that people approaching relatives are not yet sufficiently trained, and that she has a programme of training, she must explain why the rejection rate by relatives of donors, which was only 30 per cent. in 1993, according to the Sheila Gore study, has increased to 48 per cent. That was the previous study, and was the only one that we could examine before we had the donor audit. People have not become less trained in the past 10 years; if anything, they have become more experienced. There has been a particular drive in that area thanks to the resources allocated in recent years by the Government, so I ask the Minister to reflect on whether she can rely on that defence.

The evidence from abroad clearly shows that presumed consent would work. Gimble et al conclude:

''Evidence from this study, and from the studies previously discussed''—

those are the other reviews—

''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 organs 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 'gift of life' to those in need.''

There is a pressing urgency. The evidence, rather than the anecdotes and the opinion of Mr. Matesanz, who I am sure is well respected in Spain, suggests that it would work.

Before we revisit the matter, we must consider the figures on public acceptability that the Minister has provided. In seeking the leave of the Committee to withdraw the amendments, I thank her for setting out some of the hurdles that those of us who support the measure will have to cross. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

The Chairman, being of the opinion that the principle of the clause and any matters arising thereon had been adequately discussed in the course of the debate on the amendments proposed thereto, forthwith put the Question, pursuant to Standing Orders Nos. 68 and 69, That the clause stand part of the Bill.

Question agreed to.

Clause 3 ordered to stand part of the Bill.