Human Tissue Bill

Public Bill Committee, 29 January 2004.

Standing Committee G

Clause 2 - ''Appropriate consent'': children

Andrew Lansley (Conservative, South Cambridgeshire)

I beg to move, amendment No. 1, in

clause 2, page 3, line 6, at end insert—

'(2A) ''Consent'' for the purposes of this section means consent sought in accordance with the standards expected in relation to the obtaining of consent laid down by the Authority under section 24.'.

Alan Hurst (Labour, Braintree)

With this it will be convenient to discuss the following:

Amendment No. 2, in

clause 3, page 3, line 40, at end insert—

'(2A) ''Consent'' for the purposes of this section means consent sought in accordance with the standards expected in relation to the obtaining of consent laid down by the Authority under section 24.'.

Amendment No. 100, in

clause 23, page 14, line 25, at end insert—

'(ff) the meaning and interpretation of consent under and for the purposes of section 1;'.

Amendment No. 101, in

clause 24, page 15, line 15, after '(g)', insert—

'(aa) section 23(ff),'.

Amendment No. 3, in

clause 24, page 15, line 18, at end insert—

'(1A) The standards laid down under subsection (1) shall include provisions to secure that, wherever practicable, the consent for the retention of organs after death will specify those organs and not be subsumed within a general consent for tissues generally.'.

Amendment No. 4, in

clause 24, page 16, line 4, at end add—

'(10) For the purposes of this section ''organs'' means any part of the human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body.'.

Andrew Lansley (Conservative, South Cambridgeshire)

Good morning, Mr. Hurst. It is a pleasure to welcome you to the Chair. We made good progress on Tuesday and explored some of the issues of importance to the Bill, but I regard no issue as more important than the one that lies at the heart of this group of amendments. It would perhaps be helpful to explain what the group is intended to achieve.

The group has a particular purpose and a general structure fits around it. The purpose is expressed in amendment No. 3, which provides that the standards laid down by the Human Tissue Authority on the giving and obtaining of consent should specify where organs are to be retained and should not subsume such consent within a general or generic consent. We have used various terms. Consent is not defined in the Bill; there is simply consent. The purpose would be that, whenever consent for the use of organs was taken, it

would be separately specified. I shall come back to why that is desirable.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am sorry to interrupt the hon. Gentleman so early, but is he saying that ''consent for the use'' would be separately specified, or does he really mean that the consent should specify each and every organ—''those organs''?

Andrew Lansley (Conservative, South Cambridgeshire)

I am grateful for that question. In case I inadvertently suggested otherwise, I should make it clear that amendment No. 3 would ensure that, in the course of consent being given, if any particular organ was required to be retained, that should be specified in the consent.

Amendment No. 4 is designed to support amendment No. 3 by defining organs in the same terms as those used in the Human Organ Transplants Act 1989. The other amendments are designed to give a structure that allows the Human Tissue Authority to lay down such a standard. For example, amendment No. 100 would insert into clause 23, which deals with the matters that the Human Tissue Authority is concerned with, the provision that the meaning and interpretation of consent can be part of the purposes for which the codes of practice are set down. Amendment No. 101 adds to the matters that can be the subject of standards that are laid down. The amendments set out, first, what can be in the code of practice and, secondly, what can be in the standards, so they would put both consent and the meaning of consent into the codes of practice and the standards.

Amendments Nos. 1 and 2 relate to clauses 2 and 3, which at present define not consent but appropriate consent—in other words, who can give consent. The amendments would mean that consent could be defined in the Bill. At the moment, I presume that its meaning is derived from common law practice. For the purposes of the Bill—obviously the amendments would not have a bearing on the meaning of consent for other purposes—consent would be defined, but not rigidly defined. That takes into account the arguments that we entered into on Tuesday. Just as the meaning of consent has had to develop over time, according to precedent and practice, the Human Tissue Authority could define its meaning through the mechanism of setting down standards in codes of practice. Therefore, best practice at any one time could be reflected. I confess that I do not remember who said that we do not know how best practice might develop in the decades ahead, but they were right to do so. Hopefully, the legislation will last a long time.

To summarise, the Bill should define consent and it should do so by reference to standards set out in codes of practice by the Human Tissue Authority. Amendments Nos. 1 and 2 are intended to allow the Human Tissue Authority to put such standards into its codes of practice.

That brings me to amendment No. 3. In the light of everything else that I have talked about, why do I want to provide that organs, in particular, should be specified in the consent? The reasons relate to my conversations with people in my constituency and beyond it who have been affected by the retention of

organs and tissues. They are aware that, although there were cases—for example, Alder Hey—in which those who retained tissues were trying to evade their responsibilities under the Human Tissue Act 1961, on the great majority of occasions people were not seeking to do so and thought that they were working within the framework of practice.

In our discussions on Tuesday, we rightly emphasised the excessive burdens that would arise if every clinician or member of medical staff who talked to relatives about the retention of tissues and organs had to specify in each case—even for tissue blocks and slides, which involve tiny samples of tissue—all the detailed research. We are starting to talk about the possibility of generic consents. In effect, we are talking about a tick box for scheduled purposes. The Bill sets out how each of the scheduled purposes should be specified, and I hope that by the time we have finished it will do so in more detail.

Even so, if one says to the relatives of somebody who has died, ''We wish to retain tissues from your loved one for the purpose of future research'', those families might expect that the tissues would be sections from a tumour or something of that nature, unless they were told otherwise. On many occasions, people were informed about the retention of tissues in a form that led them to believe that blocks and slides virtually consequent to a post mortem examination and linked to determining the cause of death were retained. Subsequently, they found out that whole organs had been retained, some of which had absolutely no bearing on determining the cause of death, and which clearly were not the subject of the consent that was given. The purpose of amendment No. 3, in effect, is to acknowledge that difference.

It is obvious that there will be major differences in the understanding and emotional response of families and loved ones to the retention of tissues and organs as samples, as compared with whole organs. It is best practice wherever organs are to be retained that specific consent should be given, although it has proved to be one major area of divergence. Given that best practice, good sense would have led people to expect us to be clear about what we expect from the Human Tissue Authority by laying down standards in the codes of practice so that there is no misunderstanding about the matter in future. The HTA would have to be flexible in achieving that.

I hope that I have explained the structure of the amendments by focusing on the issue of substance, although I also hope to commend to the Committee the notion of allowing the HTA to be able to define consent and the question of taking consent more generally. It is not only the issue raised by amendment No. 3 that might be subject to standards in the codes of practice. From my examination of the Bill—the Minister may think that I have misinterpreted it—it is not the intention to allow the HTA to define consent in the codes of practice. It is entirely desirable that the HTA should have that ability.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I thank the hon. Member for South Cambridgeshire (Mr. Lansley) for providing a

valuable service in drawing out the fact that there is a difference between tissues and organs. There is no doubt about that, and people may be misled by the use of the term ''tissues'' where ''organs'' are what is really meant. The current provisions are not acceptable, so I have a great deal of sympathy for the amendments.

My question is whether amendments Nos. 3 and 4 are the best way to deal with the issue. If the amendments were accepted, they would limit the ability of the HTA to come up with its own definitions after wide consultation and deliberation on how best to make it clear that consent should deal with the stated purposes in relation to the range of tissues and organs. There should not be anything misleading, and the danger is that, by specifying that in amendment No. 3, and then defining ''organs'' in the way that amendment No. 4 does, the issue would be closed down when there may be a better way of dealing with it.

I am not certain whether I subscribe to this view, but there is concern that a list of organs that might be retained might be extensive. That could be distressing, even for a family who has no objection to the retention of those organs. It might be argued that a balance has to be found, but I am not necessarily sure that I take that view. I have argued in favour of being much more explicit with patients—even at the risk of upsetting a minority—because of the dangers of being too paternalistic and seeking to protect feelings. Before the issue is decided in statute, it might need more consideration.

Andrew Lansley (Conservative, South Cambridgeshire)

I am grateful to the hon. Gentleman. Of course, we have not yet reached that point in our discussions, but best practice, which should be reflected in the codes of practice, would allow families to state the extent to which they wished to know about what is to be retained. Clearly, that would have to come at an earlier point; there will be some families who do not want to know. That would mean that those who might be distressed in the way that the hon. Gentleman suggests would not necessarily have to go through that ordeal.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

There may be a mechanism that makes the approach that the hon. Gentleman has suggested much more suitable, and if the amendments were accepted, I hope that they would deal with that concern. However, there is still a more general issue that needs to addressed. I am still not sure whether I will support the amendment. I await the Minister's response on whether the definition, which ought to be a matter of consultation, is too narrow, and on whether there is a need to specify individual organs rather than, for example, the amount of tissue that will be retained, which might be more easily understood by the family concerned.

Richard Taylor (Independent, Wyre Forest)

I support this group of amendments because it explores the same matter that I was trying to explore on Tuesday: appropriate consent, as defined, addresses only consent from the appropriate person. I am in the hands of the Minister; I would think that we could address the issue in much more detail under clause 23, which covers the codes of practice. I am not clear whether it is necessary to debate the matter now, but I

am very keen to clarify the definition of the consent required and the way in which it is obtained.

Andrew Lansley (Conservative, South Cambridgeshire)

The extent to which clause 23 covers the meaning of consent is a moot point. It covers the communication with families, but it does not necessarily enable the Human Tissue Authority to define consent, as distinct from the common law definition.

Richard Taylor (Independent, Wyre Forest)

I take that point. I hope that we will have time to study the amendments tabled to clause 23, in which I might try to address it.

Rosie Winterton (Labour, Doncaster Central)

I welcome you to the Chair, Mr. Hurst.

I understand the desire of the hon. Member for South Cambridgeshire in tabling the amendments to reflect some of the concerns that, for example, the Royal College of Pathologists might have about the issue of obtaining consent. I also understand the issues to which he has referred on the stress caused to families due to a lack of clarity about exactly what was being taken—thinking that a small amount of tissue was being taken, whereas whole organs were taken. How to strike the proper balance between the needs of the scientific and medical community and of families is the theme of our debates. I certainly understand that there is an anxiety among some scientists and pathologists, who feel that it is not clear what is meant by ''appropriate consent'' for the purposes, for example, of the criminal offence.

We have established that ''appropriate consent'' relates primarily to the person from whom consent should be sought, rather than to the conditions for obtaining valid consent. However, conditions for obtaining valid consent can be decided only by the person seeking consent, in the circumstances of each individual case, and supported as necessary by guidance. Amendments Nos. 100 and 101 would ensure that the code of practice included interpretation of the meaning of consent. However, it will ultimately be a matter for the courts to determine whether consent has been obtained in any particular case. The code of practice is not the place for that to be spelled out.

That is because failing to obtain appropriate consent is a criminal offence under the Bill. It would not be legally appropriate for a code of practice to define specific legal obligations—breach of which leads directly to criminal liability. The Bill makes that clear in clause 25. On the other hand, it is appropriate for the codes of practice to supplement the provisions of primary legislation.

The code of practice in clause 23 is the right place for guidance on how to obtain consent. It may be expected to reflect the requirements of the common law relating to valid consent for medical treatment, such as the need for sufficient information to be given without coercion. The code of practice will be able to give guidance that allows flexibility in obtaining consent according to different circumstances.

The effect of amendments Nos. 1 and 2 would be to remove that flexibility and undermine the discretion of people seeking consent to determine for themselves what constitutes valid consent. They would be obliged to follow the code of practice in order not to commit a criminal offence, even though valid consent may be obtained without meeting the standards in the code, because of the circumstances of a case. We would expect the person seeking consent to weigh up what information each patient requires before they make a valid decision. If, for example, the code stated that written consent was required to store or use tissue for a particular purpose, and someone who was physically unable to write asked a relative to sign on their behalf, there would be a danger under the amendments of that becoming unlawful.

Andrew Lansley (Conservative, South Cambridgeshire)

I am listening carefully and I understand the point that the Minister is making: amendments Nos. 1 and 2 run the risk of substituting a statutory definition of consent for what is otherwise a common law definition. Is there a problem in that the codes of practice—which, as she has described them, seem to be one way in which guidance can be given on how consent is obtained—do not go beyond communication with the family? Should the codes bear on the question of valid consent in order to guide those who are taking consent?

Rosie Winterton (Labour, Doncaster Central)

The codes of practice will, as has been said, draw on best practice at the time. They will be drawn up in consultation with professional bodies and others. What they will not do is reflect every circumstance.

In a way, that goes back to something that the hon. Gentleman mentioned: the extent to which people will want to know exactly what is happening. Some people may wish to know the minimum about what may be taken from a body. Some relatives may not want to know every detail, while others may. Therefore, the issue, which would be decided by the courts if there were felt to be a breach that constituted a criminal offence, is whether the person had deliberately failed to obtain any consent at all. Although the code of practice can set out certain standards, there will be times when it would not be appropriate necessarily to meet all the standards set, because those standards would refer to absolutely best practice on the assumption that the person wanted the maximum information. If that were not the case, individual judgment might be used. The underlying theme would be the failure to provide information and obtain consent from the relatives of the deceased.

Andrew Lansley (Conservative, South Cambridgeshire)

Let me boil down the question to something slightly different. Is the Minister contending that communication with the family, which is covered by clause 23, is a sufficiently wide expression of what the HTA must include in its guidance? Is there not an argument that, even if the HTA provides guidance on best practice that reflects the decisions of courts when consent has been obtained through them, it must go beyond communication with the family to guide people on what might otherwise be regarded as a criminal offence? Communication with the family is wide, but is it wide enough to enable the

guidance to cover the question of what is and is not lawful?

Rosie Winterton (Labour, Doncaster Central)

That comes back to flexibility and how, in conjunction with others, the guidance can be developed. For example, there is very clear guidance on the different questions that should be tackled when talking through post mortems with families. Flexibility might be required to reflect the needs of families at that time.

Codes can cover best practice on the giving of information and the recording of consent, for example. They illustrate how to address the issue rather than every possible case. Guidance is available on consent to examination and treatment, and it has been very valuable to health professionals. We would not want to enshrine it in statute, because if there is felt to be a breach it might be more restrictive to the approach that individuals need to take with families at a given time.

Although I understand the hon. Gentleman's desire to enshrine in statute through the code of best practice the meaning of consent in individual cases, we need the flexibility of a code that provides guidance but, ultimately, leaves decisions on individual cases to the courts. It is not for us to enshrine in statute the offence of failure to obtain consent. It would be too restrictive to anticipate every circumstance, and it would not be practical or legally appropriate to define every single situation.

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

This is an extremely interesting and important part of our discussion. The Minister has said three times already that the courts will decide. Perfectly valid research and clinical procedures involving clinicians, scientists and medical scientists can be carried out, for reasons that we would all agree are right, and those who carry them out need to know before they embark on them that they have valid consent for what they are about to do. The mention of the courts understandably frightens and upsets many of those who work with human tissue.

Rosie Winterton (Labour, Doncaster Central)

I understand my hon. Friend's comment, but the Bill is intended to make it clear that, because of what has happened in the past, Parliament expects proper consent to be obtained. The difficulty up to now has been that there has not been clarity about what is expected. We are sending out a message that what has happened in some cases is not acceptable and that we are determined to ensure that it will not happen again, but we do not want to be too restrictive and prevent people exercising discretion.

In many cases, we simply want to ensure that there is communication with a family, but we expect high standards in that communication. Where there is best practice at present, that is not impossible, but we must allow for different circumstances. If we try to anticipate such circumstances in the Bill or too tight a code of practice, we will cause enormous difficulties and create too much rigidity. In the case of a criminal offence, a court will take the code of practice into account, but it must make a judgment about the way

in which the person used their discretion in the particular circumstances.

The hon. Member for South Cambridgeshire asked whether the code of practice could lay down standards on obtaining consent as well as simply communicating with the family of the deceased. The answer is yes, because clause 23(1)(b) says that the code may lay down standards in relation to the carrying-on of activities within its remit, which can include standards on obtaining consent to all those activities. However, we must make sure that the Bill does not impose too much rigidity at a sensitive time. There must be discretion to make judgments in individual circumstances.

Andrew Murrison (Conservative, Westbury)

Will the Minister accept that there is a great deal of concern on the part of the medical research community about these grey areas—the areas for discretion? As I understand it, her argument almost invites legal action to flesh out some of the gaps that we are leaving in this proposed legislation, and the concerns of organisations such as the BioIndustry Association will be left unanswered. Organisations such as Cancer Research UK, as I said on Second Reading, are worried that people's fears about going into medical research may influence their decision on whether to pursue clinical research. Those fears will come to fruition and people may worry that they will end up in the law courts as test cases to flesh out this grey area and these areas of discretion. We are doing them no service.

Alan Hurst (Labour, Braintree)

Order. That was a long intervention.

Rosie Winterton (Labour, Doncaster Central)

We were careful when drawing up the legislation to have as much involvement as possible from those involved in scientific and medical research. I want that to continue, which is why we need the sort of flexibility that I am suggesting. We can make a judgment not to have court interference and just hope that we can carry on as before, but I think that we all agree that that is not the way forward. We want a regime that makes it clear that we want properly informed consent. From what I have seen of best practice at the moment, that need not be onerous, but is the right way forward.

I want to ensure that in establishing codes of practice the HTA is able to work with those in the particular community to which the hon. Gentleman referred. We must all pay credit to the valuable work that is done and to the way in which practices have changed in recent years to overcome some of the problems that society recognised. When things were going wrong it was not necessarily because people were deliberately trying to get round what was then best practice and allowed under the law. It was simply lack of clarity, and perhaps that society's expectations had changed. We want to work with those in the scientific and medical research community to ensure that the codes of practice are pragmatic, with flexibility in the system, and that we continue to build on best practice but are able to look at practical implementation also.

Andrew Lansley (Conservative, South Cambridgeshire)

I appreciate that the Minister was responding to my hon. Friend the Member for

Westbury (Dr. Murrison), but I want to explain why he has made an important point. It may have been an offence not to obtain valid consent, but we are creating in the Bill a structure by which those who subsequently use retained tissue and organs are themselves committing an offence if valid consent is not obtained from the families of the deceased person by someone else. That is the heart of the problem because the Bill, for the reasons given by the Minister, does not set out what valid consent means. It is by reference to common law, which will be flexible. However, someone using tissues and organs for research may not be able to satisfy themselves that when consent was obtained it was valid consent. Yet, they could become liable to prosecution.

Rosie Winterton (Labour, Doncaster Central)

I hope that I can give the hon. Gentleman some firm reassurance. That is exactly why the clause that deals with the criminal penalties says ''reasonably believes''. The wording is correct because we want to make absolutely clear that if a person undertaking scientific or medical research reasonably believes that consent has been properly obtained, they would not be committing a criminal offence. That person may have an organ with something attached to it that says, ''Consent has been obtained''. If they imagine that consent has been obtained, it is clear that there is no criminal case to answer.

Andrew Lansley (Conservative, South Cambridgeshire)

In a sense, we have a circular argument. Do we not return to the point where the definition of reasonable belief is simply that the individual understands that consent has been obtained in a way that is consistent with the code of practice? In effect, the question of whether a prosecution might be undertaken becomes a question of whether consent has been obtained in accordance with the code of practice, notwithstanding clause 25.

Rosie Winterton (Labour, Doncaster Central)

If an individual had not been involved in the obtaining of consent, it would be quite reasonable for them to assume, if they have the appropriate documentation—we should remember that the HTA would consider the practices of an establishment to ensure that the means of obtaining consent is correct—

Ian Gibson (Labour, Norwich North)

As I understand it, the local ethics committees would still exist, on which patient organisations, the local reverend and a few professionals from other walks of life sit. So, if somebody wanted to use tissue or perform experimentation, as often happens and will continue to happen, is it not true that they would have to apply through the local ethics committee, and that it could and would insist that consent—through whatever mechanism we end up with—had been obtained? There is a safeguard backing up what the Minister says. We should not forget that those committees are very important, and that they need a little more teeth.

Rosie Winterton (Labour, Doncaster Central)

That is absolutely right. The role of the local ethics committee will be extremely important, particularly when specific projects are being undertaken. I saw a clear example of that when I visited the Royal Brompton laboratory, which was researching cystic fibrosis. Researchers knew that they had to explain to people from whom they might

remove part of a lung that they were using it for research into cystic fibrosis. The medical ethics committee said that it wanted the donor to be sure of the particular research for which the organ was to be used.

The hon. Member for Westbury raised the concern about grey areas, and he asked whether doctors and scientists should be anxious. The Bill will clarify the law, providing a clarity that the current law lacks. The codes will help and guide professionals. Due to developments over recent years, professionals are familiar with working on such a basis.

The research community has expressed fears about ending up in court as test cases, so I will explain how an individual matter would be resolved. Any complaint will usually go through the normal complaints procedure first. If consent were consistent with the codes, it would be unlikely to go any further. As I have said, it is likely to proceed to court only if there were exceptional circumstances that led to a police prosecution.

Let me reassure the hon. Gentleman about the separation between the person undertaking the research and the person obtaining consent. That would be different. There might be incredibly difficult circumstances if somebody had in front of them a form that clearly said, ''I am content for this to be used for a particular bit of research, but I do not want it to be used for another type of research because I have moral objections to particular medical procedures.'' If somebody deliberately ignored that, that would obviously cause difficulties. It is the separation between the two that we must be clear about. It is clear how obtaining consent should be approached. If somebody had no idea that consent was not obtained properly, that would not be considered their fault and they would not be liable under the Bill.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I certainly agree with what the Minister said in response to the worry expressed by the hon. Member for Westbury. Does she agree that whether consent is statutory or common law does not prevent fears that people will end up in court? Sometimes, in our increasingly litigious society, it is one person's word against another. What is required is that clinicians make clear written records of the process that they undertook to demonstrate that correct procedures were followed. I hope that that will be in the code of practice, and perhaps we can debate the matter on clause 23. Record keeping is key in the defence of some allegations.

Rosie Winterton (Labour, Doncaster Central)

That certainly can be the case. We have to be clear that there are clear guidelines and good practice already. We know that that is not impossible.

Of course I understand the natural need for reassurance that is felt by some in the scientific and medical research community. I hope that the message that we send out from this Committee is that we want to clarify the situation. What holds people back at the moment is a lack of clarity about the law.

Amendment Nos. 3 and 4 seek to ensure that relatives are sure about what they are agreeing to when

they are asked to consent to removal and use of tissue and organs. As I have said, the hon. Member for South Cambridgeshire is right to say that there have been misunderstandings about the meaning of ''tissue''. However, distinguishing between tissue and organs in the way that he suggests does not necessarily provide the information that relatives need. Some organs are very small, whereas tissue can mean large amounts of body material, such as part of a limb. The definition proposed by the hon. Gentleman in amendment No. 4 derives from the 1989 Act and has been found to be confusing.

The problem is that defining an organ is difficult. That is one reason why organs are not mentioned in the Bill. We agree that people should have the right type and amount of information before giving consent. Indeed, if they give consent in relation to one piece of material only, it will be an offence to take, store and use any other material.

The appropriate information will be provided in guidance and in consent forms. The current Department of Health code of practice on families and post mortems states:

''The discussion must make clear to the family:

The meaning of the term human tissue; that it includes organs, parts of organs and tissue in various forms, such as frozen sections and samples fixed in paraffin wax.''

The HTA's code of practice guidance on consent can equally be expected to make it clear that families should be fully informed of the nature and size of the specimens that it is proposed to remove or keep. The model consent forms currently provided by the Department for use in obtaining consent to post mortems also differentiate between organs and tissue, and the HTA could provide models on similar lines.

The difficulty again is to define in legislation something that it is more appropriate to define in codes of practice. As I understand it, a cornea is tissue, but to obtain it, the whole eye, which is an organ, must be taken. We want relatives to have the maximum information about the procedure. If a relative said, ''I want to give permission for the corneas to be taken'', we would want somebody to explain what that involved. I understand that the same is true for heart valves. The codes of practice must make it clear that relatives must be informed about everything that is taking place and not simply be given minimum information.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I agree with the Minister. Does she accept that there must be a balance between providing sufficient information and not putting people off by being too gruesome? One way to move that balance towards the provision of more information would be to demystify some of the issues surrounding the human body. In that respect, the ''Bodyworlds'' exhibition and the plans to broadcast operations to consenting adults who wish to see them seem a good way forward and might put an end to the fear and mystery that surround the human body and the yuck factor, which are a barrier to research.

Rosie Winterton (Labour, Doncaster Central)

That is an interesting idea. However, we are talking about people in very difficult circumstances. We must adhere to the principle—I know that all hon. Members do—of informed consent and maximum information, but with sensitivity to people's needs. As the hon. Member for South Cambridgeshire said, in some circumstances people may not wish to know all the details. As long as we are sure that somebody has made the decision not to be told them, that is the way forward.

It is an important issue that, for many hon. Members, goes to the heart of the principles in the Bill, but I hope that I have been able to give the reassurance that they sought and that the hon. Gentleman will seek to withdraw the amendment.

Andrew Lansley (Conservative, South Cambridgeshire)

I am grateful to the Minister for taking the trouble to explain in detail why the Government do not support the amendment. There is a substantial difference in structure between the Bill's provisions and what the amendment proposes. In order to define consent in the Bill, we would have to engage in the process of creating a new statutory framework for consent as opposed to a common law definition. There would be dangers in going down the path of carrying out a little bit of statutory definition and trying to mesh that with common law.

I am happy with the argument relating to overall structure. That does, however, place a special burden on codes of practice to deal with the issues of substance so that no one is in any confusion about what is expected in the obtaining of valid consent, even if it does not include a legal definition. That leads us to amendments Nos. 3 and 4. There are difficulties with including a definition, which is why I rested on what was in previous legislation, which was designed for a different purpose. The Bill deals with a range of purposes for which organs and tissues are being retained.

The Minister referred to paragraph 43 of the current code of practice, which states that

''the discussion must make clear to the family the meaning of the term human tissue; that it includes organs, parts of organs and tissue in various forms, such as frozen sections and samples fixed in paraffin wax''.

That is true, but it highlights the problem. One might have a discussion in which one makes it clear to families the meaning of the term ''human tissue'', but when one examines the standard consent forms in the code of practice—I am not saying that the forms are not best practice; they seem to work in the right way—one finds that the forms, such as the one relating to a baby or child, make it clear that there is consent for the post mortem examination, and consent for the donation of organs for medical research, education or audit.

It is curious that there is a distinction in the forms between medical consent for tissues in section 3 of the form and the donation of organs for medical research in section 5(b). I want to make it clear only that codes of practice will not do their job if they do not clearly reflect the distinction that has to be made between tissues, samples and whole organs. We may not include that in the Bill, but we have to be clear—it would be helpful if the Minister were to confirm this—

that the HTA will not do its job if the discussion does not clarify what ''human tissues'' means. It must also deal with the distinction between tissues and organs in relation to the question of retention so that the consent process makes clear the meaning of ''organs'' in that context. Otherwise, the process of families agreeing—or agreeing with exceptions—may be difficult for those families. That discussion is important.

To satisfy me, will the Minister make it absolutely clear—with no qualifications—that the distinction, reflected in the consent form, needs to be there in future and needs to be an explicit part of the discussion with families, which is covered in the codes of practice?

Ian Gibson (Labour, Norwich North)

Will the hon. Gentleman tell me why he thinks that people would care whether they were being asked about an organ, a piece of tissue, a cell, a piece of DNA, a protein or something else? If the sample is for medical research, and there is confidence and trust, is that not enough? We do not have to become inflexible.

Andrew Lansley (Conservative, South Cambridgeshire)

The short answer is no, it is not enough. Experience has shown that families take different views about the retention of different organs. People often feel differently about brains, hearts, and corneas—as the Minister said, that raises its own issues—compared with other organs or tissues. If we are designing a structure that reflects the wishes of families, as I hope we are, we must take into account their emotional responses and views. It is not, in practice, simply a question of whether one trusts the scientific and medical professions. One may do that, but still have valid emotional and instinctive reasons why one does not want to donate whole organs.

Rosie Winterton (Labour, Doncaster Central)

I am happy to give the hon. Gentleman some reassurance. There is an issue about what people understand tissues and organs to mean, which relates to what I was saying earlier. Tissue can be a whole arm, or part of a limb. Organs can be things that people would not necessarily think of and which do not necessarily fit in with the understanding of an organ as a brain, heart, liver or kidney. We would expect the HTA to make it clear in its codes of practice that we have to take into account public perception of what organs and tissue are, and to be sensitive about emotional responses. I return to the example that I gave. If someone said, ''We're going to take some tissue from the eye''—

Alan Hurst (Labour, Braintree)

Order. I appreciate that the Minister is seeking to be helpful, but interventions are becoming rather lengthy.

Andrew Lansley (Conservative, South Cambridgeshire)

I think that the Minister had helpfully said yes, and was explaining that. Her explanation will help families that are concerned that the practice of obtaining generic consent in the past may become the practice in the future. The fact that the definition of valid consent remains the common law definition has its uncertainties, but at the same time it means that the medical research community will be operating broadly within the legal framework that has developed over about 50 years. Just as we have to satisfy the medical research community about that, we can also say to families that the strengthening of enforcement means that valid consent, although not defined, will be guided

by the codes of practice. That will make their position much stronger if there are flagrant breaches of what is understood to be valid consent. Such breaches will, in future, become breaches of the law by definition, because of the way in which the codes of practice are structured.

If the Minister is saying that the HTA will clearly have to reflect the distinctions, I do not want to press the amendment. I am grateful to the Committee for taking the time and trouble to explore the issue in detail. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I beg to move amendment No. 75, in

clause 2, page 3, line 6, at end insert—

'(2A) Where consent is given by a child under subsection (2), that consent shall represent ''appropriate consent'' in respect of the child upon reaching adulthood for the purposes of section 3 unless an indication is given to the contrary.'.

Alan Hurst (Labour, Braintree)

With this it will be convenient to discuss the following:

Amendment No. 149, in

clause 2, page 3, line 15, at end insert—

'(3A) Where consent is given by a person who has parental responsibility under subsection (3), that consent shall represent ''appropriate consent'' in respect of the child upon reaching adulthood for the purposes of section 3 unless an indication is given to the contrary.'.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

These amendments deal with a relatively small point, which the Minister may be able to clarify in a relatively straightforward way. Clause 2 deals with the giving of consent for material to be taken from children's bodies.

On amendment No. 75, I question whether the consent of a child who is competent to give consent—a Gillick-competent child, in the vernacular—endures into the child's adulthood, unless otherwise revoked, and whether the clause is designed to deal with that.

Amendment No. 149 is probably a more relevant question. It deals with subsection (3), which concerns cases in which a child either is not competent to give consent, or is capable but has not done so, and consent has been given on the child's behalf. The question is twofold: will there be an obligation on researchers, for example, to return to the child to seek consent when that child reaches adulthood—where that is possible—or will the consent given on behalf of the child endure? Part of the problem is that the person who had parental responsibility when consent was given will no longer have parental responsibility at that later point. I seek reassurance that that will not be a problem.

What notification procedure should there be? That is an additional point, which is not really covered by the amendment, but which I hope will be dealt with in this debate. Will there be a requirement to notify people who come of age that material is being retained? Much of the Retained Organs Commission's work involves trying to identify people whose organs have been retained and whose tissue is being used, in order to notify them of that, so that they can withdraw their consent should they choose to do

so—as is their right, where it is reasonable and feasible to do so. Will the Minister clarify that point?

If there is no obligation, or best practice, to contact an adult whose material was used when they were a child on the say-so of someone with parental responsibility, will the Minister clarify whether that person, who may have ethical views and opinions, has a right, upon reaching adulthood, to seek information about their tissue? Should they be able to ask for any stored identifiable tissue to be destroyed and no longer used in research? I am not sure whether I have a settled view as to whether that would be right. Will the Minister deal with those three issues in her response?

Andrew Murrison (Conservative, Westbury)

I take it that these are probing amendments that are designed to shed light on what I confess even for me is an unclear area of the Bill. It touches on the consent given by a minor. We have to consider two things: on the one hand, consent for purposes that may happen in the future, given on the minor's behalf by a parent, guardian or other person; and, on the other hand, consent for a procedure that occurred when someone who subsequently attained their majority was a minor. I should be grateful if the Minister could clarify those two points.

Rosie Winterton (Labour, Doncaster Central)

An interesting point has been raised about future notification, and I shall return to that. The amendments as tabled, which reflect the hon. Members' initial concern, are unnecessary, because the Bill makes no distinction between the quality or duration of consent obtained from a competent child, from a parent on behalf of a child, or from an adult. The Bill neither provides that consent under clause 2 ceases on the child's 18th birthday, nor requires that the child should be revisited at that time for the purposes of obtaining a further consent under clause 3.

If a parent gives consent on behalf of an incompetent child, for example to the storage and use of tissue for the purposes set out in paragraph 7 of schedule 1—for research—that consent will be sufficient for the carrying out of that activity. If it is a continuing activity, such as storage, the consent will continue to have effect until it is withdrawn by the parent, or by the child on becoming competent. Consent given by a competent child to a continuing activity will remain valid until it is withdrawn by that child at any age.

In terms of continued storage, and whether an individual child, if they had been incompetent—a terrible phrase—were to be notified—

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Before the Minister moves on to that matter, may I draw her attention to a difficulty posed by line 15, which could have been the subject of another probing amendment? If line 15 were to say that, in the case of a child being incompetent, ''appropriate consent'' meant the consent of a person who ''at that time'' had parental responsibility for him, there would be no doubt that that consent was still valid. Despite the Minister's assertion, there may still be some doubt, because ''appropriate consent'' for

continued storage and use is defined by the person, and that person no longer has parental responsibility.

Rosie Winterton (Labour, Doncaster Central)

We are confident that consent is valid in both instances, unless it is withdrawn by the child on reaching 18 or beyond, and it will therefore be helpful to put that on the record. The consent is valid unless it is withdrawn.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Will the Minister explain why it is stated in lines 14 and 15 that the appropriate consent is the consent of a person ''who has'' parental responsibility—using the present tense—and why it would not be better to insert the words ''at that time''? Her words will be welcome to those who seek to interpret the provision at a later date, but they do not overrule a more literal reading—indeed, the obvious reading—of those lines.

Rosie Winterton (Labour, Doncaster Central)

There is nothing in the Bill that says that consent ceases at the age of 18; nor does the Bill require that the child be revisited at that time for the purpose of obtaining further consent. Having given that reassurance, I hope that the hon. Gentleman will feel able to withdraw the amendment.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I wanted to intervene earlier. I sought to do so before the Minister went on to address in detail the issue of notification, and whether there will be a requirement to notify. I am seeking clarification as to whether, when she said that she would return to the matter, she meant that she would do so during our consideration of this group of amendments or later. I hope that by intervening I did not put her off from continuing to make remarks in response to the other points that I raised. If now is not an appropriate time, perhaps we will have an opportunity to deal with these matters in a brief clause stand part debate. There is a question about whether people who did not give their consent at the time—because it was given on their behalf—but later gain competence, should be notified if there is identifiable material being stored and/or used.

Rosie Winterton (Labour, Doncaster Central)

There is no particular way in which people would be notified unless their parents or doctors had told them that this was the case. If they understood that something had happened to which they objected, they would have the ability to withdraw their consent.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

That is a useful explanation of the Minister's understanding—that where the knowledge exists, people will have the ability to withdraw their consent. The key question asked by many who feel strongly about the issue is whether they would ever know without being able to contact and get an answer from the person who gave consent on their behalf. Again, I accept that that question is not necessarily directly dealt with by the amendments, but it is something that we may wish to think about, to ascertain whether the position is satisfactory. In the light of the Minister's assurance, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I beg to move amendment No. 112, in

clause 2, page 3, line 34, at end add—

'(7) In the case of transplantation, consent shall include evidence of a signed organ donor card or registration on the NHS Organ Donor Register.'.

Alan Hurst (Labour, Braintree)

With this it will be convenient to discuss the following:

Amendment No. 150, in

clause 2, page 3, line 34, at end add—

'(7) In the case of transplantation, consent shall include an affirmation on any instrument that the Human Tissue Authority may determine.'.

Amendment No. 113, in

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

'(5A) In the case of transplantation, consent shall include evidence of a signed organ donor card or registration on the NHS Organ Donor Register.'.

Amendment No. 151, in

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

'(5A) In the case of transplantation, consent shall include an affirmation on any instrument that the Human Tissue Authority may determine.'.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

This group of amendments—in which there are two analogous amendments; one tabled by me and the other by the hon. Member for South Cambridgeshire—deals with the question of what consent is, both in terms of clause 2, dealing with children, and clause 3, dealing with adults. Perhaps it is easier for our purposes, since they are effectively identical, to deal only with the amendment to clause 2, and the insertion of the proposed subsection (7). It is effectively a probing amendment to clarify whether that is the understanding.

I agree that amendments Nos. 150 and 151 are more relevant in this instance, because I do not think that we would want to place on statute terms that can be transient. Probing amendments should not use such terms where that can be avoided. I am not suggesting that, in tabling his amendment, the hon. Gentleman believes that the opt-in donor card and the NHS organ donor register will not be with us for a long time. However, I recognise that it is better to keep the exact limits of the instrument as vague as is done in amendment No. 150.

The issue of whether consent would include that was raised a number of times on Second Reading. I think that what was really being investigated at that stage was whether—where there is written consent of that nature, and it is deemed to satisfy the requirements of clause 2—that in itself is sufficient to allow donation to take place. The answer appears to be yes and no, because while it is sufficient, it does not require doctors to follow that consent. There may be many reasons why they do not. Even after the time when consent is confirmed—I use that term loosely—by the family, there may be medical or practical contra-indications to consider before transplant. Clearly, consent is not a requirement. The current position is that where consent exists, it is still possible for relatives to withhold their consent. It appears, unpractised, to trump the signed, informed consent of the person seeking to donate.

On Second Reading, the Government said that the question was about not relatives refusing to give consent, but intervening factors, such as distressed

relatives, which means that doctors exercise their discretion not to take the organs even though someone's life might be saved and it is the wish of the person seeking to donate.

Andrew Murrison (Conservative, Westbury)

The hon. Gentleman probably shares my concern about the availability of organs and the possibility that, with consent having been given on a donor card, for example, consent might be overturned on consultation with relatives. He will have noted, as I have, on the website of UK Transplant that such an eventuality is ''virtually unknown'', and that his point is therefore academic.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am not sure that it is so unknown these days. Research that I have seen shows that, in about 1 per cent. of cases in which the person concerned was known to have opted in under the donor card system, relatives have refused consent.

I met representatives of UK Transplant to discuss the matter, who told me of several cases—nine were mentioned—of relatives not giving consent even though the person was on the organ donor register. Nine would be 1 per cent. of 900; clearly nine is not vanishingly rare. It is a live issue, particularly given the publication of the potential donor audit by UK Transplant, which showed that relatives were saying no in 48 per cent. of cases. Although we do not have the exact information, that figure is bound to cover some people who are on the organ donor register. About 17 per cent. are on the register, so it would be bizarre if that 17 per cent. were all included in the other 52 per cent. of cases.

I have read what the Minister said on Second Reading, and I understand that where there is a donor card, written consent as outlined in clause 3 or registration on the organ donor register, she does not plan to allow the taking of organs and the saving of lives where there is no medical contra-indication to doing so but where relatives object. I understand the position, although it is sad. We do not necessarily need to discuss the matter in Committee; it was an issue on Second Reading and it is possibly one for Report and Third Reading.

My organ donor card states not only that I give consent for my organs to be used, but that it is my fervent wish that on no account for non-clinical reasons—where there is no medical contra-indication—should anyone be able to overrule that consent. I am still concerned that—in my case if a relative can be found who is prepared to own up to being such—the danger remains that my valid, written, informed and advance consent would be overruled. I do not know what legislative scope exists to deal with that problem. I hope that we can probe the matter through the amendments.

Andrew Murrison (Conservative, Westbury)

We are in danger of straying into the area of presumed consent, which I am sure he will deal with shortly. Will he comment on the position of the British Medical Association, which takes the view of soft presumed consent, in which the views of relatives will be taken into account? It seems to be contrary to his line.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am certainly not dealing with an opt-out system. I will not answer that specific opt-out question because the two cases are different. Under the opt-in system, which the hon. Gentleman supports, should the wish of the person concerned be overridden when there is valid, written and advance consent for the organs to be used, there is no medical contra-indication and the family have co-operated by giving information about the person's lifestyle that might be relevant to a contra-indication?

On Second Reading, the Minister said that the proposals were all about the fact that we owned our bodies and that the decision should be ours if our autonomy was to be respected after our death. It is inconsistent for the Government not to explain how they can allow consent to be overridden for non-clinical reasons where it has been given in writing in advance, or where, to take a separate issue, with which I would like the Minister to deal, there has been a specific request to respect an autonomous decision and not to take into account the views of third parties, including relatives, be they estranged, distant or otherwise.

We can talk about whether it is necessary in primary legislation to use language such as that in amendments Nos. 150 and 151—I think that it is—or about whether consent should take the form of a specific instrument, such as a donor card or register, but the Minister must tell us in terms other than of clinical contra-indications whether it is right, given that lives are lost when consent is overridden, for there not to be a better way of dealing with the issue under the current opt-in system.

I shall not go into the alternative approach, where there would be a presumption of consent and relatives would have to be asked whether they knew of an undeclared opt-out; that is a question for another debate on another day. However, I hope that the Minister understands that the amendments raise key questions about autonomy, particularly in the two sets of circumstances that I described. I look forward to her response.

Andrew Murrison (Conservative, Westbury)

I hope that the hon. Gentleman did not imagine that I was trying to be unhelpful in my interventions, because we share a great deal of common ground. In particular, it is important for the individual's wishes to be paramount once an affirmation has been made on an organ donor card or in the organ donor register.

Like the hon. Gentleman, I have concerns about the availability of organs, but there is a more important point. UK Transplant tells us that it has a vast number of people on its register. Indeed, it cites an incredible figure, although I would rather check it because I am not too sure about it. None the less, I am concerned about how such figures translate into organs being received by those who need them. The concern of us all is that many hospitals are reluctant to accede to the desires expressed in the register or on organ donor cards. Those wishes are probably overlooked in the heat of the moment, which probably reduces the potential harvest of useable organs. If we are to attempt to save lives, we must address that problem practically and before we start considering the few

cases—UK Transplant notes that they are virtually unknown—where organs are wasted or go by default because relatives object, even though consent has been given on the organ donor card or in the register.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I refer the hon. Gentleman to the potential donor audit published by UK Transplant, and I would be happy to give him a copy. It shows that there were 278 cases of brain stem death where there was no medical contra-indication. The subject of organ donation was considered in 255 of those cases—the vast majority—and relatives were approached in 244 of them. Doctors are therefore seeking relatives' views in the vast majority of cases. However, in 48 per cent. of cases, the relatives say no. According to the audit, that is where the problem is. Some of those cases will involve people who have registered or who have a donor card, so there is a question to address.

Andrew Murrison (Conservative, Westbury)

I am grateful to the hon. Gentleman; that is extremely useful. We are told that the number of people registered by UK Transplant runs into the hundreds of thousands, which is extraordinary. It is difficult to tally that with the figures that the hon. Gentleman cites. Clearly, further work needs to be done. I maintain my impression that there is scope to improve the harvest of useable organs. I do not know, but strongly suspect, that moves in that direction would be more practicable and productive than overriding the wishes of next of kin in cases where people have already registered their wishes on a donor card or on the registry.

As the hon. Gentleman said, his amendments and those in my name and those of my hon. Friends the hon. Members for South Cambridgeshire and for Rayleigh (Mr. Francois) are very similar. We chose to cite the Human Tissue Authority and to give our amendments a broader remit than his because it is important to reflect future developments and the possibility that they might improve the current means of giving consent to the removal of organs.

That touches on the issue of presumed consent, the idea behind which is to increase the harvest of organs. We all want to do that; the question is how best to achieve it. The means of gaining consent for the harvesting of organs may improve in future. We can think, for example, of the electronic patient record, entitlement cards—a possibility that my party is examining—or even a national identity card, which is controversial, but by no means impossible.

Such vehicles would make it far easier to register informed consent to the removal of organs after death, and would not rely on the notion of presumed consent, which is highly controversial. The hon. Gentleman may want to discuss this issue later in our proceedings, but organisations such as the BMA seem to be very keen on such vehicles as a means of increasing the harvest of organs. As I said, we are all in favour of that, but the question is how best to achieve it.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

May I make it clear that I support moving to an opt-out system that involves presumed consent? That does not mean, however, that anyone who supports such a system does not support efforts to maximise the number of people taking advantage of it

while we have an opt-in system. I have been active in that area through the all-party kidney group and others. I have now found the figures. It turns out that in the sample that I mentioned, transplantations from 11 donors on the organ donor register did not proceed, despite the fact that relatives had been asked. That means that 11 or more lives could have been lost, against the wishes of the donor.

On this narrow question of presumed consent, will the hon. Gentleman say how many lost organs he believes to be sufficient to justify the ability of relatives in the opt-in system to countermand the advance written consent given by the donor?

Andrew Murrison (Conservative, Westbury)

It would be invidious to put a figure on that. This is a sensitive area, which we stray into at our peril. The sensitivities of relatives are important, as is the general public's confidence in organ donation. We can all think of test cases in which relatives do not want organs to be removed from their next of kin, and the attendant publicity. I do not know whether our net take of organs would increase substantially if we were to alter the sensitive way in which I believe health professionals operate, but I have my doubts.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I disagree with the hon. Gentleman, but I understand his argument. However, what does he think is the right thing to do when someone has written on a donor card that they do not want their wishes to be overridden, which shows that they have thought about that?

Andrew Murrison (Conservative, Westbury)

It is important to stress that relatives should be taken along every step of the way. There is no current mechanism for doing that on the organ donor card. We all carry them, and they are straightforward, but we must involve relatives in this procedure because it is necessary to ask various questions before proceeding with the removal of organs. I say to the hon. Gentleman that there are far better ways of maximising the take of organs. It requires a great deal of publicity for the general public to be taken along, and considerable damage has been done by the tragedies at Alder Hey and the Bristol royal infirmary.

We must build the general public's confidence in organ transplantation. We know from the figures that that confidence has been dented, and I cannot see how ignoring the sensitivities and the sensibilities of relatives in this procedure will enhance the confidence and good will that the general public have in transplantation. I suspect that this a small point of principle. I tend to agree with the hon. Gentleman: in general, it is axiomatic that the wishes of people expressed before death must have primacy. We do not disagree on that point, or on the need to harvest more organs. On the practical point, my amendments Nos. 150 and 151 would establish the means of maximising the take of organs and improve confidence in the system. They would also set a framework for incorporating future technological developments in improving the take of organs.

Rosie Winterton (Labour, Doncaster Central)

I shall deal first with the amendments. We certainly appreciate what the hon. Member for Oxford, West and Abingdon (Dr. Harris)

intends in amendments Nos. 112 and 113: to make the organ donor card, or entry in the organ donor register a clear legal basis for consent. We also recognise that the alternative amendments Nos. 150 and 152 are similar, but less specific. They would give a power to the Human Tissue Authority to determine what instruments would be appropriate evidence of consent.

Although we accept that the amendments are well intentioned, we do not believe that they would be helpful. The amendments are unnecessary because appropriate consent given under clauses 2(6)(a) and 3(5)(a) would include signed organ donor cards or entry on the UK organ donor register or any other such instrument that might be developed, or even a note carried by the donor. There may be a risk, however well-intentioned the amendments, that they may lead to a more formal approach to the question of evidence of consent than is strictly necessary. For example, there may be confusion that failure to carry a card could be interpreted as a refusal of concern.

The hon. Members for Oxford, West and Abingdon and for Westbury semi-acknowledged that we are trying to avoid any specific references in the Bill that could become irrelevant within a few years. For example, we are seeing enormous changes in information technology, particularly the development of the NHS IT strategy. That could make unnecessary the carrying of a donor card, or a specific entry in the organ donor register. In our information strategy, which accompanies the NHS framework for renal services, we have already signalled our intention in this respect. We would like to see consent or otherwise for organ donation become part of the electronic patient record, which would give immediate access. Appropriate health care professionals would then have access to what is almost a virtual organ donor register. Consent or non-consent could easily be recorded by any health care professional with access to the person's electronic medical record, or even by individuals themselves. That came up on Second Reading—a suggestion made by the hon. Member for Spelthorne (Mr. Wilshire).

We are anxious that the amendments would be more restrictive than we would wish. We believe that the proposed changes would, in a sense, overtake the suggestions set out in primary legislation, and might even lead to misinterpretation. Having said that, we are coming on to a wider discussion about presumed consent or otherwise.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am a little confused over whether the Minister is planning to deal now with the two cases that I raised about overruling, or whether she envisages sufficient time to do so in—I hope—a short clause stand part debate on clause 3. I look to you for guidance, Mr. Hurst, on whether I should continue to press the Minister on the points that I have raised?

Alan Hurst (Labour, Braintree)

I will certainly permit a clause stand part debate if the hon. Member wishes to raise matters then. It is for him to decide.

Rosie Winterton (Labour, Doncaster Central)

I can—I hope—quickly deal with the question of overruling by relatives of what is on an organ donor register card. I say to the hon. Member

for Oxford, West and Abingdon, as I have said before, that we can seek to increase the number of people on the organ donor register. The hon. Member for Westbury was right to say that in the vast majority of cases relatives would give the necessary information about recent medical history. They would co-operate with requests about organ donation if there were a clear indication of what the loved one wanted.

We must be practical. We are talking about medical teams in difficult circumstances and about the practicalities for medical screening—the information that may be required from nearest relatives. Consent given by a person cannot be overridden by a relative as a matter of law. However, we cannot compel a medical team to take and use an organ in circumstances where they are facing great distress on the part of relatives. It is impossible to put people in that position. We as legislators sometimes have to recognise the practicalities.

There are many measures that we can take to increase the number of people on the organ donor register. The hon. Member for Westbury said that that ran into the hundreds of thousands. In fact, there are 11 million people on the register. We can do everything that we can to increase that, and we can take the measures that I will come on to in some of the later amendments that the hon. Member for Oxford, West and Abingdon has tabled. However, we must face the practicalities of implementation. When somebody has made a particular statement, but relatives, perhaps in a very distressed state, refuse to give information, it is asking a lot for a medical team completely to go against that. The team can say what the person has done and what the law is, but would have to be sensitive in such circumstances.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I accept to a large extent what the Minister says, but let us deal with the practicalities. I have been in the position of an approaching medical team. Where there is clear advance written consent, is it not best to state that there is consent and ask whether the relatives know of any reason why it has been withdrawn, rather than go fishing for permission from them? It is better not to ask, ''Is it all right with you?'', but to wait for relatives with severe distress—the term that the Minister used—to volunteer the relevant information before taking that into account? There have been so many cases where the practice has become to ask the relatives if they mind. That is different from only responding to severe distress.

Rosie Winterton (Labour, Doncaster Central)

The difficulty is that, for screening purposes, those in the approaching team would have to say that they knew, for example, that the person had been on the organ donor register and carried an organ donor card. The team would have to confirm what the person had wished to do and ask the relatives to give recent social and medical history, so that those matters could be clear for screening purposes. It is difficult to do that without saying what the reason is. It logically follows from that that the relative knows. If that causes great distress to the relative there and then, either they say, ''I'm not going to tell you because I don't want that to happen'' or they tell the team and

only later realise what has happened. If a person feels very strongly, the situation is difficult for those in the medical team. We must understand that.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am not arguing that relatives should not be informed and that information should be concealed. I am saying that the approach should be to say, ''This person is on the organ donor register, we have the donor card and it is our intention to use the organs, so we need to ask you some questions about recent medical and social history. Get the answers.'' In practice, relatives are asked, ''Do you mind?'' regardless of what the person thought, which ought not to happen where there is a clear opt-in. Where a relative says that they mind, organs are not taken and the decision is put down to distress. There is a difference between relatives volunteering the information during a consultation where the intention has been stated and not seeking it owing to distress.

Rosie Winterton (Labour, Doncaster Central)

I understand the hon. Gentleman's point, but I emphasise again that people refuse in less than 1 per cent. of cases where the deceased's wishes are known. In a sense, the hon. Gentleman is missing the point and anticipating situations that have a tiny chance of arising if we get the system right and get more people on to the organ donor register. We are considering other ways for people to carry donor cards, as well as all the other means that I have described. The real issue is about making the approach at the right time. As I said, the situation that the hon. Gentleman anticipates constitutes 1 per cent. of cases. It would be foolish for us to imagine otherwise.

The approach that we have adopted is the right one. We need to ask questions about the person on the organ donor register. To my ears, the phrasing that the hon. Gentleman used to describe the approach—''It is our intention to take these''—does not sound like the most the sensitive. It might have the opposite effect and make people feel that the procedure was being conducted insensitively, thereby making them object. We can argue back and forth about using a different approach, but we must return to the reality that we are talking about only 1 per cent. of cases.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am very disappointed that the Minister should use the words that I chose earlier to suggest that that is how I would recommend that relatives be approached. I was talking about the general approach, the principles of which are that one explains that the relative had a donor card and wished to donate in such circumstances, and that one should ask those questions that are necessary to provide certainty if there is no medical contra-indication. I do not suggest going up to relatives and saying, ''We intend to take the organs.'' If we are going to have a sensible, sensitive debate, we need to separate such issues from the practicalities.

Rosie Winterton (Labour, Doncaster Central)

This boils down to practicalities—the practicalities of approaching relatives to ensure that the wishes of the deceased are made known to them in such a way as to achieve maximum co-operation. We must not give the impression that we think, ''Whatever you say, we have the right to do

this.'' We must have regard to the circumstances of every individual.

Andrew Murrison (Conservative, Westbury)

We are in danger of labouring the point, so perhaps we should focus on what the Bill is about. Its provenance lies in the fact that relatives were not dealt with sensitively and properly at Alder Hey or Bristol royal infirmary. Despite the reassurances, I am not convinced that the formal wording that might come out of any changes that the hon. Member for Oxford, West and Abingdon wishes to make would be commensurate with that. I commend the Minister's robust stance.

Rosie Winterton (Labour, Doncaster Central)

I thank the hon. Gentleman for that intervention. I understand that the hon. Member for Oxford, West and Abingdon is anxious to ensure that we maximise organ donation—we all agree on that—but we are talking about the practicalities of the 1 per cent. of cases in which permission is refused.

Our intention is to ensure that enough people indicate their wishes on the register. If we introduce any feeling of pressure, we might create not only adverse publicity, but a perception that the Bill is about putting people under pressure, not consent. We have to be very sensitive to that. Any system that we introduce must be one that maximises in the most practical way possible the number of organs donated, and is based, as the hon. Member for Westbury said, on the principle of informed consent. It should deal sensitively with particular circumstances and recognise the situations that medical teams face.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

We should all agree that this matter is about three things: maximising organ donation, maximising autonomy in respect of the persons whose organs are being donated and reducing, as far as possible, the stress and distress of relatives who, in almost all circumstances, are at the height of their grief. That applies not only in the short term; we have to bear in mind their long-term interests.

The problem is demonstrated by the evidence. I have one question to ask, and I hope that the Minister will write to me about it. The number of people registering on the organ donor register increases year on year, and I support the campaign for that. All my Christmas cards said, ''Sign one more card this year,'' and gave the number of the organ donor register and the donor card system. However, we have to be aware that as that number goes up, the number of organ donations is going down—the system is not working. Perhaps there will be a sudden turnaround.

Nevertheless, we know from opinion poll evidence that the number of people willing to donate organs has gone up from 70 to 80 per cent. to 80 to 90 per cent. Therefore, in spite of an increasing willingness to donate and increasing numbers opting in on the register, the numbers are coming down. That is a problem we must recognise. If only a small number of relatives are, in practice, overruling the deceased's wishes, that would be fair.

Rosie Winterton (Labour, Doncaster Central)

In the interests of speed, I should say that there are a number of reasons for that, including, for example, the number of people in intensive therapy units. However, I shall write not only to the hon. Gentleman, but to the wider Committee, with some

reasons for refusal. They can be quite detailed, so it may be better to have them in writing.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Data are available on the excellent UK Transplant website, which sets out those figures. Reasons have been given for the dramatic fall in the number of strokes and road traffic accidents in the past two years. Clearly, that is a factor, but the fact that one line is going up while the other, sadly, is still drifting down should be of even greater concern than issues such as ICU beds, which are supposed to be going up, not down.

The point that the Minister used in defence would be fair if the number involved were tiny. I counted four occasions—and one for the hon. Member for Westbury—on which she said that in only 1 per cent. of cases did relatives say no where there was an opt-in on the register or donor card.

Rosie Winterton (Labour, Doncaster Central)

The hon. Gentleman makes assertions about numbers going down. The reality is that the number of donations has gone up by about 6 per cent. Cornea donations have gone up more in some areas—by 12 per cent., I think. I shall write to him with the figures, but following the publication of the framework and the other measures that have been taken there has been an increase.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The 6 per cent. increase was in the annual report for 2002–03. I fell into the trap of using the latest data, not the last data that showed an increase. The latest data presented to me—for 2003–04 to date—showed, at least until June 2003, a 12 per cent. reduction in organ donors. I hope that the data are now available to September 2003. If the Minister is to write to us with the data, which will inform later parts of the debate, it would be helpful if she gave us the most up to date figures.

As the Minister and the hon. Member for Westbury referred to the figure of 1 per cent., I would be grateful if she wrote as soon as possible, giving the basis for it and showing how the latest authoritative data from the excellent potential donor audit support the figure of 1 per cent., because that is not what I have seen. I was presented by UK Transplant with a figure of 11 cases in which the organs of people on the register had not been used—in most cases, if not all—because the relatives refused consent. That does not sound like 1 per cent. of any figure.

I simply ask the Minister to write to me this afternoon to clarify where the 1 per cent. figure comes from. If she can do that, I shall say that the proposal is probably not worth the candle, but I still believe that 11 lives in one section of a year are a significant number that we should be concerned about.

Andrew Murrison (Conservative, Westbury)

I think that the record will show that I did not use the figure of 1 per cent. at any time in my contribution. However, I quoted UK Transplant in saying that this situation was virtually unknown in practice and made a judgment based on the figures that it gave. If UK Transplant says the situation is virtually unknown, we need to take cognisance of that.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I understand. If the Minister can send us information saying that UK Transplant's figures show that the situation is virtually unknown, or involves

1 per cent. or a tiny number of cases, she is right to take her present position on the issue.

Rosie Winterton (Labour, Doncaster Central)

The hon. Gentleman referred to 11 people, and said that the organs of most of them were not used. I suggest that that is quite a low number when the relevant figure is, I think, about 6,000, although I am not certain of that. His figure would not necessarily indicate that the total is so far removed from that.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Then I would be grateful if the Minister provided the data showing that the 11 donors on the organ donor register in whose cases transplantation did not proceed were 11 out of several thousand, not several hundred. If that is the case, she is right in saying that it is probably not worth—[Interruption.] Does the hon. Member for Norwich, North (Dr. Gibson) wish to intervene?

Ian Gibson (Labour, Norwich North)

I dispute the hon. Gentleman's figures. They come from a biased source, but we will unravel this when we obtain the official figures.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I could not hear that sedentary intervention and translate the accent. The hon. Gentleman will have to forgive me, although I am grateful to him for clarifying his point.

All I am saying is that there are figures, which should be made available to the Committee. If they show that the cases involved are a tiny minority, it may be right that we do not push the issue further. In the light of what the Minister said, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Is the Minister able to discuss notification at this point, or is she planning to do that in another way? Should adults who had organs taken as a child with consent from someone else be notified when they come of age so that they can exercise their right under the Bill to withdraw that consent where there is identified stored and used tissue?

Rosie Winterton (Labour, Doncaster Central)

I hope that I can be of some help. We would expect parents to tell their children that the Bill does not provide for notification. There are some issues about practicality here. People carrying on activities regulated by the Bill are thankfully entitled to assume that consent endures until they have been given notice that it has been withdrawn, even though the right to withdraw may have passed to the child. The point is interesting, but this is a practical issue. It would be difficult to find a method of notification that did not produce undue burdens.

The Human Tissue Authority might be able to emphasise in guidance to parents the fact that if they are making a donation we would expect them to tell children that that had happened so that they had the right to withdraw consent. It would be too burdensome to say that every birthday had to be recorded and that such people had to be informed in writing that their donations were still in storage.

Richard Taylor (Independent, Wyre Forest)

The Minister had the answer herself. That is exactly the sort of thing that could go on to the electronic patient register when it is put in place. When a young person turns 18, as well as the keys to the front door, their electronic patient record can be handed to them so that they know what has happened.

Rosie Winterton (Labour, Doncaster Central)

The hon. Gentleman makes an important point that will be clear in the future. In the meantime, there are too many practicalities, but I hope that the HTA may be able to help.

Question put and agreed to.

Clause 2 ordered to stand part of the Bill.

Clause 3 - ''Appropriate consent'': adults

Andrew Lansley (Conservative, South Cambridgeshire)

I beg to move amendment No. 90, in

clause 3, page 3, line 40, at end insert—

'(2A) In relation to the purposes in paragraph 7 in Schedule 1, where it is not contrary to his interests and would benefit persons with the same or similar conditions, a person who stands in a qualifying relation to him can consent on behalf of an adult who lacks the mental capacity to make decisions on his own behalf.'.

Alan Hurst (Labour, Braintree)

With this it will be convenient to discuss 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)'.

Andrew Lansley (Conservative, South Cambridgeshire)

During the consultation that led to the framing of the Bill, the question of what should happen in circumstances where someone lacks the capacity to give consent was considered. The law does not permit someone to give consent to treatment on behalf of another adult. By extension, therefore, the structure of consent does not allow someone to give consent for the retention of tissues and organs on behalf of another adult.

The consultation went on to consider the question of best interests and non-therapeutic research. Taking it step by step, the best interest criteria include the fact that a clinician dealing with someone who cannot give consent, or who does not have the capacity to do so in relation to therapy, can treat that patient if it is in the patient's best interests. However, something that is not concerned with the treatment of that patient would not necessarily satisfy the definition of best interests.

The consultation also considered the Council of Europe convention on human rights and biomedicine, which recognised the fact that non-therapeutic research on a person not able to consent would be ethical—I think it should have said ''could'' be ethical—if strict safeguards were applied. A document, ''Who Decides? Making Decisions on Behalf of Mentally Incapacitated Adults'', was based on the work of the Law Commission. It considered that question and observed that non-therapeutic research could improve understanding of the

condition from which a patient suffers, and may assist fellow suffers in future.

The consultation pointed to a consensus that non-therapeutic research could be justifiable if it was concerned with the condition from which a person without capacity suffered and if the procedures involved minimal risk and invasiveness. The commission's recommendation was touched upon on Second Reading. If my recollection is correct, the Minister said that that would be dealt with in the draft Mental Incapacity Bill. However, in this Bill we are setting the legislative framework for the retention of organs and tissues.

On the face of it, we were surprised that the issue was not being dealt with in this Bill, given the recommendations of the Law Commission. Amendment No. 90 is designed to achieve that. It would provide for occasions on which an adult who lacked the mental capacity to make a decision needed a person in a qualifying relationship to give the appropriate consent for him. Amendment No. 91 to clause 24 links up with the subsequent definition of qualifying relationship, and is merely consequential.

Amendment No. 90 refers to this process being ''not contrary'' to that person's interests—that is in relation to the ''minimal risk and invasiveness''—and to whether it would

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

A test therefore has to be met, and we propose that it should relate specifically to medical research under paragraph 7 of schedule 1 in connection with disorders of the functioning of the human body, rather than the wider ones proposed separately by the hon. Member for Oxford, West and Abingdon. We decided at that point to try to implement the Law Commission's intentions.

If Ministers and the Committee are not persuaded to include that provision now, we can at least explore Ministers' intentions in relation to the Mental Incapacity Bill, so that in due course people can see the whole framework of legislation.

Harry Cohen (Labour, Leyton and Wanstead)

I appreciate the hon. Member for South Cambridgeshire tabling the amendment. It is right to seek clarification on how people with mental incapacity will be treated under this Bill. I raised that point on Second Reading, as did my hon. Friend the Member for Liverpool, West Derby (Mr. Wareing).

Clause 3 is about appropriate consent for adults and we have just dealt with the clause on appropriate consent for children. However, people with mental incapacity are another issue. Children are clearly vulnerable in many ways and of special interest. In my opinion, people with mental incapacity are similarly vulnerable and need special arrangements.

Other organisations have also asked for clarification. For example, the Royal College of Nursing asked for clarification on procedures for those with learning difficulties or incapacities. The assumption seems to be that people with mental illness

and mental incapacity need to be treated in the same way as every other adult. That may not be appropriate. Whereas many would want to be treated equally and to have the same rules apply to them as to other adults, there is a specific difference. Their judgment may be easily or overly influenced and they may not make the best decision in terms of their own interest. They may not even be fully capable of making such a decision. That needs to be taken into account.

I have raised the issue of criminal brains and I asked questions about that on Second Reading. I am told that there is a market for such brains, because a criminal gene is being looked for. There could also be a search for a mentally ill persons' gene; in future, there could be a demand for the body parts, particularly the brain, of someone with a specific mental illness. That needs to be considered. I ask the Minister for clarification because of that particular vulnerability.

Ian Gibson (Labour, Norwich North)

I am sure that I could offer my brain to the Government Whips, who would probably take it with great alacrity at the moment.

As I understand it, the Mental Incapacity Bill will examine a system of advocacy for patients and how they are supported and helped, recognising the fact that the system is often hard for them to unearth. That will help to meet some of the problems raised by my hon. Friend.

Harry Cohen (Labour, Leyton and Wanstead)

I certainly welcome that and I would support such a system. However, this Bill does not touch on that issue. There should be a code of guidance, or something in the Bill that cross-references it to that system of advocacy. I am glad that the amendment has been tabled, as it means that we can get some clarification from the Minister on that important point.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I support amendments (a) and (b). They probe on the amendment tabled by the hon. Member for South Cambridgeshire. It should be noted that his amendment is about matters that are ''not contrary'' to the interests of people, rather than in their best interests. That is important, because a requirement that related to their best interests might make it difficult to carry out non-therapeutic research. It may not be in the best interests of such a person to carry out non-therapeutic research, but it certainly cannot be contrary to their interest for research to be carried out. That would be the case not only on research, but with regard to the purposes set out in paragraphs 5 and 3 of schedule 1:

''Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person)''

and education and training. If I may give an example of people who, in my experience, are almost always incapacitated—

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

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

Standing Committee G

Clause 3 - ''Appropriate consent'': adults

Alan Hurst (Labour, Braintree)

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)'.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Rosie Winterton (Labour, Doncaster Central)

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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.

Richard Taylor (Independent, Wyre Forest)

I beg to move amendment No. 51, in

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

'Except where subsection (3A) applies'.

Alan Hurst (Labour, Braintree)

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.'.

Richard Taylor (Independent, Wyre Forest)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Andrew Murrison (Conservative, Westbury)

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.

Rosie Winterton (Labour, Doncaster Central)

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.

Richard Taylor (Independent, Wyre Forest)

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.

Rosie Winterton (Labour, Doncaster Central)

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.

Richard Taylor (Independent, Wyre Forest)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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]'.

Alan Hurst (Labour, Braintree)

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.'.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Andrew Murrison (Conservative, Westbury)

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

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Ian Lucas (Labour, Wrexham)

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?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Ian Lucas (Labour, Wrexham)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Andrew Murrison (Conservative, Westbury)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Ian Lucas (Labour, Wrexham)

Who assesses significant distress?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Ian Lucas (Labour, Wrexham)

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?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Ian Gibson (Labour, Norwich North)

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?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Ian Gibson (Labour, Norwich North)

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?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Ian Gibson (Labour, Norwich North)

Is there data on it?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Andrew Murrison (Conservative, Westbury)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Andrew Murrison (Conservative, Westbury)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Andrew Murrison (Conservative, Westbury)

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.

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

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.

Rosie Winterton (Labour, Doncaster Central)

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.''

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Rosie Winterton (Labour, Doncaster Central)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Rosie Winterton (Labour, Doncaster Central)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Rosie Winterton (Labour, Doncaster Central)

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.

Andrew Murrison (Conservative, Westbury)

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?

Rosie Winterton (Labour, Doncaster Central)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Clause 4 - Nominated representatives

Andrew Lansley (Conservative, South Cambridgeshire)

I beg to move amendment No. 10, in

clause 4, page 5, line 10, at end insert—

'(8A) If, in accordance with the requirements of subsections (3) to (5), a person writes to disallow any person from enjoying a qualifying relationship as defined in section 24, then that adverse nomination shall apply in relation to appropriate consent.'.

A provision in clause 4 allows a person, having been nominated, to renounce their appointment. I point that out because amendment No. 10 is designed to explore the question not so much of a nominated representative, but of a person who is in a ''qualifying relationship''.

If an individual has not provided consent and has not nominated anyone as their representative, after their death the provisions in clause 24 would come into effect. However, clause 24 does not permit anyone, by virtue of an instrument of the sort set out in clause 4(3) to (5), to vary in advance who is in a ''qualifying relationship'' with them for the purposes of giving consent.

If I am wrong, I will be pleased to hear why; otherwise, I hope that it might be possible to include the amendment. It is always a sensitive issue, but none of us is without experience of families in which, if they thought about it, some people would be excluded from the ''qualifying relationship'' of others. We should permit it.

Stephen Ladyman (Labour, South Thanet)

I guess that we could call it the amendment to ensure that the annoying relative who gets drunk at family Christmas parties is in no position to dispose of one's body parts after death. Although I have no experience of the hon. Gentleman's family, I can see why in principle he would consider the amendment necessary.

Sufficient safeguards already exist in the Bill, however. Were someone to go to the trouble of identifying another whom they did not want to be nominated to act on their behalf, it would be more simple to do it the other way round by nominating someone to act on their behalf. That is already in the Bill, so we have already adequately covered the amendment. I undertake to consider it further before

Report, but it is an unnecessary amendment and I hope that the hon. Gentleman will withdraw it.

Andrew Lansley (Conservative, South Cambridgeshire)

I am grateful to the Under-Secretary, not least for agreeing to think about this matter. It seems rather a burdensome and unlikely proposition that people will specify their own structure of qualifying relationships prior to death, and more likely that they might specify who was not in a qualifying relationship with them. It is rather like constructing a will—the difficulty being that one does this on the basis of a range of hypothetical circumstances that might accrue before the point of one's death. In practice, it is probably simpler to exclude somebody from a qualifying relationship than to anticipate all the circumstances that might arise before death. If the Under-Secretary is willing to think about it, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 4 ordered to stand part of the Bill.

Clause 5 - Prohibition of activities without consent etc.

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 22, in

clause 5, page 5, line 18, after 'does', insert

'or causes to be done'.

The purpose behind the amendment is fairly clear to anybody who has read the various briefing notes with which medical research organisations—particularly pathologists—have regaled us. They are concerned about the apparently unfair onus that will be placed upon them—given that they are most unlikely to be actively involved in obtaining consent—rather than on clinicians, who would be actively involved. Therefore, there is some fear among the organisations that represent pathologists and medical researchers that they will be unduly affected by the Bill. The focus is very much on them, and not on clinicians, who are really in the front line of the gaining of consent.

Much of the concern has to do with the slightly ambiguous language in the Bill. The Under-Secretary has explained that much of it will be fleshed out in codes of practice, but as we have discussed before, that will not give a great deal of comfort to those organisations that represent pathologists and medical researchers. Indeed, in clause 5(1) we have the words ''reasonably believes''. The word reasonably is something that we could argue about, and no doubt lawyers will argue about it at great length and cost in the law courts. It is that sort of ambiguity that worries many of the organisations to which I have referred, and those concerns are well founded.

It is important for organisations such as the BioIndustry Association and others that have corresponded with us that the focus is shifted slightly away from them, and on to those who are involved with the garnering of informed consent—in practice, that tends to mean clinicians. All that the insertion of ''causes to be done'' will do is shift that burden slightly closer to the clinician who is involved with the patient. I think that that is a reasonable small addition to the

Bill, and will address some of the concerns of the likes of the BioIndustry Association and those organisations representing workers in medical research and in pathology. I hope that the Under-Secretary will consider accepting that amendment and keeping those organisations happy.

Stephen Ladyman (Labour, South Thanet)

Again, I understand what the hon. Gentleman is getting at, and it bears repeating that we greatly respect the work that pathologists and others do, and we recognise the difficulties that they face and the worries that they have in this regard. I hope that I am able to clarify that our belief that the existing wording of the Bill is an adequate protection for them. It makes it clear that a reasonable belief that consent had been obtained would be a perfectly good defence were anyone to face sanctions under the legislation. If they were being asked to do something when they knew that consent had not been obtained, the criminal liability in the Human Organ Transplants Act 1989 would be a perfectly legitimate reason for them to refuse to do it. Both of those purposes are covered.

We also believe that were someone required by another person to do something that went against the provisions of the 1989 Act, the Bill would cover it. That person would in effect be committing a criminal activity. For example, if a supervisor in a laboratory required his PhD students to carry out work knowing that consent had not been properly obtained, the supervisor would face the criminal sanction. We believe that the wording in the Act is sufficient to guarantee protection for people in such circumstances.

Andrew Murrison (Conservative, Westbury)

I think the Under-Secretary has answered my principal concern, but just for clarification I would like to exemplify my concerns. A clinician on a ward has a patient, on whom he wants a pathologist to undertake an examination. The clinician says to the pathologist, ''Consent has been gained.'' The pathologist takes that in good faith, and his defence would be that he reasonably believed that consent had been gained. Where would the blame lie if that consent had not been obtained, and who would be in the frame?

Stephen Ladyman (Labour, South Thanet)

The pathologist would have a good defence by claiming that he had reasonable belief that consent had been obtained. It is my view that in those circumstances the clinician—especially if he were aware that consent had not been obtained when he gave that guidance—would be liable. I shall certainly undertake to reflect further on that point before Report, but those points are covered by the wording in the 1989 Act, and the Bill will sufficiently cover the hon. Gentleman's points. On that basis, I hope that he is prepared to withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

Given the Under-Secretary's assurances and the fact that he will think about the matter, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Andrew Lansley (Conservative, South Cambridgeshire)

I beg to move amendment No. 138, in

clause 5, page 6, line 7, leave out '12' and insert '3'.

Alan Hurst (Labour, Braintree)

With this it will be convenient to discuss the following:

Amendment No. 139, in

clause 5, page 6, line 8, leave out 'the statutory maximum' and insert

'level 5 on the standard scale'.

Amendment No. 140, in

clause 5, page 6, line 11, leave out '3 years' and insert '12 months'.

Andrew Lansley (Conservative, South Cambridgeshire)

We turn to the question of associated penalties. I am sure that Committee members will be aware of the concerns that have been raised about the introduction of penalties and the views expressed in certain places that they seem harsh. I was aware that the consultation contemplated the introduction of penalties, and although there were divergent views as to the appropriate severity of those penalties, there was broadly a consensus that enforcement and penalties were required.

When I read the Bill, I was slightly surprised at the severity of penalties because I had anticipated that they would be in line with the existing penalties under the Human Organ Transplants Act 1989. I do not necessarily seek to substitute my view for the Government's, but the amendment is in line with the 1989 Act. The penalties in the clause are substantially in excess of that, and at the time of consultation the Government's consultation document stated that they were not aware of any concerns about the suitability of the provisions relating to penalties.

I was surprised at the general application of the penalties to a range of offences, many of which are similar to those that related to commercial dealings in human material in the past. We are talking about an offence of similar severity, so why has there been a shift?

From the point of view of those who are affected by the legislation, and to whom such penalties might be applied, imprisonment seems to me a sufficiently severe penalty in itself. A fine at level 5 might be exactly the same as the standard statutory maximum—it is certainly not far off it. The provision for 12 months' imprisonment on summary conviction, or three years on indictment, seems excessive. I would be interested to hear the reasoning behind the Government's decision to increase the penalties.

Stephen Ladyman (Labour, South Thanet)

As always, these things are judgment calls. The hon. Gentleman has clearly spoken to some people who think that the penalties are too severe; I assure him that we have spoken to people who do not think that they are severe enough. We have come to a judgment. We can debate its merits, but it is our judgment.

We hope that the penalties in the clause will never have to be imposed, or will be imposed only rarely. We hope that the legislation is clear enough and that the willingness of clinicians and researchers to co-operate with it will be such that it will never be necessary to bring any cases to trial. If a case does come to trial, we think that we have the judgment right. We consulted the Home Office on the appropriate level of penalties for the offences. There is provision for penalties to vary depending on the seriousness of the offence and whether it is dealt with on summary conviction or on indictment. No person may be prosecuted for an offence under the clause without the consent of the

Director of Public Prosecutions. Subsections (1) and (4) also make it clear that it will be a defence if a person ''reasonably believes'' that he has consent, or that the activity that he is undertaking does not require consent.

I made those points when we debated the previous amendment. May I correct something that I said in that debate? In the example that the hon. Member for Westbury gave, I think I said that the clinician would be liable under the Bill. It is my understanding, in fact, that neither the clinician nor the pathologist would be liable in those circumstances. The clinician is not carrying out a licensable activity, and so the penalties would not be imposed on him or her. I hope that I have clarified that.

Andrew Murrison (Conservative, Westbury)

Oh!

Stephen Ladyman (Labour, South Thanet)

I can tell from the hon. Gentleman's furrowed brow and his exclamation that the Opposition are probably already writing amendments for consideration on Report.

Andrew Murrison (Conservative, Westbury)

That is quite something. My word! I asked who would be in the frame, because when something goes wrong, people naturally want a culprit—

Andrew Lansley (Conservative, South Cambridgeshire)

Ours is rather a good amendment.

Andrew Murrison (Conservative, Westbury)

Indeed. I wonder whether, in the light of the information from the Under-Secretary's civil servants, he will retrospectively consider the amendment that I withdrew.

Stephen Ladyman (Labour, South Thanet)

I understand the hon. Gentleman's concerns. We probably all need to think about the clause before Report. My understanding is that if somebody were deliberately flouting the proposed legislation, there would be penalties that could be used. However, we certainly need to reflect on these matters. The hon. Gentleman is right to say that in such circumstances somebody should be held responsible. We must ensure that that is covered in the Bill. I believe that it is, but if it turns out not be, he can rest assured that we will address that.

Amendment No. 139 would change the wording of the clause so that instead of referring to the ''statutory maximum'' it referred to

''level 5 on the standard scale''.

That would have no effect, because both amounts would be £5,000. Since the offence is triable either way, the correct term to use when the offence is tried summarily is the ''statutory maximum''. It is only for summary offences that the standard scale is used. I hope that, with that explanation, the hon. Gentleman will withdraw his amendment.

Andrew Lansley (Conservative, South Cambridgeshire)

I half suspected that that was true in relation to amendment No. 139, but it does not change the point in relation to amendment No. 138. As I understand it, the Human Organ Transplants Act 1989 includes a penalty not for conviction on indictment but only on summary conviction, and that was for three months. As the Under-Secretary said, it is a matter of judgment. My judgment is that 12 months is excessive and that, in particular, no justification has been

presented to move from what was a penalty in relation to commercial dealings in human organs. That seems to me to be a serious offence, and there is no evidence that that penalty has been seen to be insufficient in relation to that offence in the past to warrant this shift to a more severe penalty now.

Stephen Ladyman (Labour, South Thanet)

To return to the phrase that I used during discussion of earlier amendments, the golden thread that runs through the Bill is that people must have consented to the use of their own bodies. It is sacrosanct that we control our own bodies. We are discussing an offence where someone wilfully ignores the wishes of an individual, either by not seeking to ascertain what those wishes are or by ignoring them when they know about them. That is a serious matter and the serious penalties that we are suggesting in the Bill might, in certain circumstances, be entirely appropriate and should be at the disposal of the courts.

Andrew Lansley (Conservative, South Cambridgeshire)

We can differ on this, but I cannot change how I propose to proceed. I shall not press the amendment now but that is not because I agree with the Under-Secretary.

I was trying to ascertain whether there was a clear process by which the Government had arrived at their judgment. It seems to me that it is based on the views that have been expressed to the Department. I am not aware that those views were canvassed specifically in the consultation. I am not persuaded, but we will go away and ask for views between now and Report from those who may be affected and families who, quite rightly, want to see enforcement and penalties that seem to them to be commensurate with the seriousness of the offence. In the light of those views, we shall take a view on the appropriateness of seeking to raise the matter again on Report. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 5 ordered to stand part of the Bill.

Clause 6 - Restriction of activities in relation to

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I beg to move amendment No. 144, in

clause 6, page 6, line 35, leave out 'decent' and insert 'safe and lawful'.

Alan Hurst (Labour, Braintree)

With this it will be convenient to discuss the following:

Amendment No. 147, in

schedule 3, page 44, line 28, leave out 'decent' and insert 'safe and lawful'.

Amendment No. 145, in

clause 28, page 18, line 18, leave out 'decent' and insert 'safe and lawful'.

Amendment No. 146, in

clause 56, page 33, line 41, leave out 'decent' and insert 'safe and lawful'.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I would be grateful if the Under-Secretary could explain how ''decent disposal'' is defined and why that is a better term, defined or otherwise, than ''safe and lawful disposal'', which is

proposed in the amendment to this clause and the other clauses in which it appears.

Richard Taylor (Independent, Wyre Forest)

To give the Under-Secretary a moment more, may I remind him of the words in the code of practice for families and post mortems? I, too, am worried about the word ''decent''. Does that cover the words in the code of practice:

''Tissue and organs should be handled respectfully at all times . . . The method of disposal must be legal''?

With the hon. Member for Oxford, West and Abingdon, I am a little concerned that the word ''decent'' is not quite strong enough or adequate enough to cover the method of disposal.

Stephen Ladyman (Labour, South Thanet)

The amendments would change both the wording and the sense of the clauses, which, as the hon. Member for Oxford, West and Abingdon said, refer to the disposal of bodies and body parts. He suggested the alternative wording ''safe and lawful'', but that does not convey the important idea that the disposal of human bodies or material should be accorded respect appropriate to them, which is what we are trying to achieve.

''Decent disposal'' in relation to whole bodies is a familiar term from the Anatomy Act 1984. It is not the Government's wish to provide exemptions from the offences in clauses 6 and 28 covering the disposal of bodies in any way other than a decent one.

I hope that it would be helpful if I paraphrase the relevant part of the regulations under the 1984 Act. The Anatomy Regulations 1988 state that disposal of a body after anatomical examination shall, so far as is practicable, be in accordance with any wishes expressed by the deceased or any surviving spouse or surviving relative, and separated parts of the body shall, so far as is practicable, be disposed of with the body from which they were removed.

We recognise that disposal of parts of bodies, particularly small parts, is different from the disposal of whole bodies. For that reason, clause 56(5) provides that decent disposal, in relation to material that has come from a body, includes disposal as waste. It is not necessarily the size of the material that should determine the manner of its disposal. There may be enormous differences in how even relatively small amounts of tissue should be disposed of, the obvious example being foetal tissue. For that reason, the Government believe that it is appropriate to put in legislation the concept of decent disposal, but also to deal with the vast range and complexity of the situation to which it applies through the guidance.

Clause 23(2)(1) provides that the Human Tissue Authority's code of practice must deal with the disposal of relevant material, and that that will provide adequate insurance that disposal will be safe and lawful. I hope that that is the assurance that the hon. Members for Oxford, West and Abingdon and for Wyre Forest are seeking, and that the hon. Member for Oxford, West will withdraw his amendment.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

It does, indeed, appear to be the assurance that we sought. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 6 ordered to stand part of the Bill.

Clause 7 - Existing holdings

Stephen Ladyman (Labour, South Thanet)

I beg to move amendment No. 33, in

clause 7, page 7, line 7, at end insert—

'( ) Section 5(1) shall have effect as if the activities mentioned in subsection (1) were not activities to which section 1(1) applies.'.

The amendment corrects a drafting error in clause 7, proving that, very occasionally, even the Government make mistakes. The effect of clause 7, as drafted, is that it would be an offence under clause 5(1) to use existing holdings without appropriate consent. Clause 7(1) provides that clause 1(1) applies to existing holdings without the requirement for appropriate consent. That means that it is lawful to use existing holdings for scheduled purposes without needing to go back and obtain consent.

Clause 5, however, makes it an offence to undertake the activities to which clause 1(1) applies without obtaining appropriate consent. Such activities include storing and using relevant material for scheduled purposes. Clearly, the intention of clause 7 would be defeated if clause 5 made it an offence to continue to store and use existing holdings without appropriate consent. So, the amendment corrects that by providing that clause 5(1) is to be read as though the storage and use of existing holdings were not activities to which clause 1(1) applies. I hope that that is clear to all hon. Members and that they will accept the Government's amendment.

Amendment agreed to.

Richard Taylor (Independent, Wyre Forest)

I beg to move amendment No. 55, in

clause 7, page 7, line 12, at end add

'or that has been used for a purpose specified in Schedule 1'.

I have to declare a personal interest. My local newspaper has written reports saying that many Members have imaginary skeletons in their cupboards. I have a real one, as many doctors of my vintage do. I am concerned that, as the Bill is written, I am not lawfully allowed to have that. I cannot, as the hon. Member for Westbury did some years ago, dispose of mine because that is not covered either. So, the purpose of the words that I seek to add to the Bill is to try to make it legal to have possession of something that was used at one time. However, if the Under-Secretary can reassure me and many other doctors of my sort of age that I am not liable to 51 weeks in prison, or whatever the punishment is, I shall certainly seek leave to withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

I, too, was once the owner of a skeleton—I confess that I am no longer in possession of it. It is a serious point, because there is a considerable number of medical students, and potentially this loophole could criminalise them, which would be terrible. Things have moved on somewhat since the hon. Member for Wyre Forest qualified—in this day and age, a medical student usually has a half-skeleton. Traditionally, those skeletons are sold on to oncoming medical students by those who have qualified. That seems to me to be

perfectly legitimate, and I doubt that there is any profit involved. It means that those skeletons are recycled, and I am sure that most of us would say that that is a good thing. The Under-Secretary may wish to reflect on that rather peculiar situation, and perhaps on whether the amendment put forward by the hon. Member for Wyre Forest is a good one to include in the Bill to close this loophole.

Stephen Ladyman (Labour, South Thanet)

Seldom have I heard Members admitting to such debauched acts. I was going to give the hon. Gentlemen the assurances that they seek, but the thought of banging them away for three years each is intriguing me. Having said that, I can give them and other holders of skeletons the assurance that they want.

The consent provisions of clause 1 do not apply to use of material held for scheduled purposes at the time the Bill comes into force, or to imported bodies and material, or to bodies and material which have come from a person who died more than 100 years before Bill comes into force. It will be lawful to continue to keep and use human material already retained in archives when the Bill takes effect, where these are held for scheduled purposes. The Human Tissue Authority will have the role of advising on how currently stored tissue and organs should be dealt with. The Authority will issue a statutory code of practice setting standards and giving guidance about existing holdings. This will follow on from the existing guidance issued by the Department in April 2003, ''An Interim Statement on the Use of Human Organs and Tissue''.

The intention behind clause 7 is to ensure that it is lawful to continue to store and use existing holdings for scheduled purposes without needing appropriate consent, once the Bill comes into force, subject to guidance. This applies, however, only to material that is still held for scheduled purposes, and not to material that is no longer required, even though it may have been used in the past for scheduled purposes. Such material should be disposed of.

The Bill does not prevent existing holdings of material that have already been used for scheduled purposes being used again for the same purpose, or even for other scheduled purposes, subject to the guidance to be issued by the Human Tissue Authority. The Bill is clear, however, that in future, where consent is given to the use of material for a particular scheduled purpose, the tissue may not be subsequently used for a different scheduled purpose without consent for that purpose. Skeletons currently in the possession of medical students and former medical students may continue to be kept and used for purposes listed in schedule 1 as they are existing holdings under clause 7. Future use of existing holdings will be subject to guidance given in the statutory code of practice, as stated in clause 23. Skeletons may be imported from abroad, but will be the subject of the HTA's code of practice on import and export, and will fall within the regulatory scheme in the same way as any other tissue. The code of practice will ensure that appropriate ethical standards have been applied abroad.

Andrew Lansley (Conservative, South Cambridgeshire)

May we therefore conclude that in the case of a former medical student who has retained his

skeleton, but who has no scheduled purpose in mind, it would no longer be lawful to retain that holding, and in particular to hold it at home, or elsewhere not on licensed premises, or, further to that, to sell it?

Stephen Ladyman (Labour, South Thanet)

My understanding is that private use would be acceptable under the circumstances, but the holder could not sell it. So in the coming years some skeletons may need to be donated to future medical students. They can be passed on but they cannot be sold.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am intrigued by the idea of private use. Does that mean, for instance, that if the hon. Member for Wyre Forest sits at home with his skeleton, stroking it in a loving manner—but no more—that is private use? I do not understand what private use is in that respect as distinct from other uses.

Stephen Ladyman (Labour, South Thanet)

Public display would not be lawful, but private use—presumably the hon. Member for Wyre Forest would be using the skeleton for his personal education, which was why he initially obtained it—would be acceptable. I hope that with those assurances, and as long as Opposition Members do not have any more skeletons in their cupboards, the hon. Gentleman will withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

I am not entirely clear on this matter, and it is an interesting and important point. Is the Under-Secretary saying that medical students will no longer be able to sell their skeletons to each other?

Stephen Ladyman (Labour, South Thanet)

That is correct. I have concluded my comments and I hope that the amendment will be withdrawn.

Richard Taylor (Independent, Wyre Forest)

The first part of the Under-Secretary's contribution was rather above me, but I understood the last part absolutely. If medical students can currently afford to buy a half skeleton, which, going by the rate of inflation, costs as much as £240, and they are not allowed to—

Stephen Ladyman (Labour, South Thanet)

I should point out that we will be providing them with much more generous student loans.

Richard Taylor (Independent, Wyre Forest)

As I am reassured, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Harry Cohen (Leyton and Wanstead) (Lab) rose—

Alan Hurst (Labour, Braintree)

Order. The hon. Gentleman is too late.

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

Harry Cohen (Labour, Leyton and Wanstead)

I want to pick up on the point about students being unable to sell a skeleton that they own to another student. The Under-Secretary said that it would not be allowed under the terms of the Bill. I cannot see why, under those restricted circumstances, selling would be unreasonable. The Under-Secretary should consider that and enable a student who has finished using his skeleton to sell it to another student for the same purpose.

Stephen Ladyman (Labour, South Thanet)

I will consider that. The important point is that the student cannot make a profit. They

could exchange it for the same price, but I suspect that there will be an increased use of plastic skeletons in future.

Question put and agreed to.

Clause 7, as amended, ordered to stand part of the Bill.

Clause 8 - Existing anatomical specimens

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 24, in

clause 8, page 8, line 14, leave out subsection (9).

I cannot promise that the amendment will be anything like as entertaining as the previous one; indeed, I can promise that it will be extremely dull.

The Under-Secretary will appreciate the concerns of many hon. Members about the powers that the Secretary of State might have under the Bill. The purpose of the amendment is to tease out a description of what is meant by amending subsection (8) and the qualifying purposes therein.

Stephen Ladyman (Labour, South Thanet)

I am not sure that I can give the hon. Gentleman the entertaining explanation that he is looking for. It would be unfortunate to remove the order-making power because it necessarily reflects the order-making power in clause 1(8).

The activities that are authorised to be carried out with former anatomical specimens are set out in clause 8(8) by reference to the purposes in schedule 1, in common with the Bill's theme to deal with those purposes. The purposes listed in schedule 1 can be altered by order under clause 1(8). If the proposed power were to be exercised, it could make a nonsense of clause 8(8). We therefore need an order-making power to ensure that any order under clause 1(8) can be accompanied by the necessary consequential amendments to clause 8(8). With that, I hope that the hon. Gentleman will withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

The Under-Secretary was quite right: that was a very dull explanation. Nevertheless, the hour is late, so I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 8 ordered to stand part of the Bill.

Clause 9 - Coroners

Andrew Lansley (Conservative, South Cambridgeshire)

I beg to move amendment No. 13, in

clause 9, page 8, line 17, leave out 'or' and insert 'and'.

Alan Hurst (Labour, Braintree)

With this we may discuss Amendment No. 25, in

clause 9, page 8, line 22, leave out 'with the consent' and insert 'under the authority'.

Andrew Lansley (Conservative, South Cambridgeshire)

The amendments deal essentially with the same point. The clause relates to the coroner's powers. As we understand the position, we are not legislating to interfere with their existing practices, which is fine. Indeed, subsection (1) states:

''Nothing in this Part applies to anything done for purposes of functions of a coroner or under the authority of a coroner.''

What is done under the authority of a coroner that is not for the purposes of their functions? Why does the clause say:

''or under the authority of a coroner'',

rather than ''and under the authority of a coroner''? An action would then have to be both for the coroner's purposes and with his authority.

Amendment No. 25 relates to subsection (2)(b), which specifies that people who deal with material that should be in the hands of the coroner for the purposes of the coroner cannot act on the authority available under clause 1. However, the end of subsection (2) adds the words:

''except with the consent of the coroner.''

Like the ''or'' in subsection (1), that suggests that we are dealing with activities that go beyond the purposes of the functions of a coroner, but which coroners may authorise in lieu of consent. I am not at all sure that we intend them to act in that way. As it happens, amendment No. 26 makes the same point on requiring an activity that is no longer for the purposes of the functions of a coroner to be undertaken with appropriate or qualifying consent, depending on whether it is a scheduled purpose or DNA analysis.

The question at the heart of the amendments is, therefore, whether the Government permit activities that go beyond the functions of a coroner, on the authority of a coroner who is acting in lieu of consent. That was not our understanding of the purpose of clause 9.

Stephen Ladyman (Labour, South Thanet)

The intention is certainly that the Bill should not interfere with the powers and duties of coroners. I think that we all understand that. However, coroners have a duty to act in different circumstances, and we would not want a nominated representative to interfere with those duties. I am sure that there would be no dispute between us over the fact that the coroner's powers should be protected if he suspected, for example, that something had to be investigated. However, coroners have other, wider duties under case law. For example, they may wish to order the storage and retention of bodies for the purposes of a defendant who needs the material to mount a defence in a case in which they are accused of having acted improperly. The coroner therefore has a wide range of responsibilities, which we must ensure are protected.

Amendment No. 13 would constrain a coroner from giving, in the interest of justice, a lawful direction to retain a body or human remains. If a coroner were able only to authorise retention or use in connection with his statutory functions, the nominated representative or person in a qualifying relationship would be able to prevent further examination of the remains on behalf of a person charged with connection of the death. That could result in failure to convict the guilty or acquit the innocent.

Andrew Lansley (Conservative, South Cambridgeshire)

I do not understand that. Would that not be covered by the exceptions under clause 40?

Stephen Ladyman (Labour, South Thanet)

As the Bill stands, the coroner's interest is protected, but we are discussing the impact of the hon. Gentleman's amendment on the Bill. I believe that he can be reassured.

Andrew Lansley (Conservative, South Cambridgeshire)

Let me explain to the Under-Secretary. Even if he were right about the impact of our amendment—I do not concede that he is—the example he is using is drawn from the conduct of a prosecution, but the conduct of a prosecution is specifically exempted from the impact of clauses relating to consent by the terms of clause 40(1)(b).

The rest of the debate is in Hansard.