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.'.
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.
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''?
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.
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.
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.
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.
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.
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.
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?
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.
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?
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.
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.
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.
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.
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.
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.
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.
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.
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—
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.
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.
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.
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.
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.
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.
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?
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.
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.
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''—
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.
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.'.
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.'.
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?
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.
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—
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.
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.
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.
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.
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.
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.
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
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.'.
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.
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.
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.
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.
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.
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.
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.
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.
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?
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.
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?
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.
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.
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?
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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?
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.
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?
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.
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.