Preparation of codes

Human Tissue Bill – in a Public Bill Committee at 2:30 pm on 3rd February 2004.

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Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health 2:30 pm, 3rd February 2004

I beg to move amendment No. 85, in

clause 23, page 14, line 13, leave out 'may prepare' and insert

'shall prepare one or more'.

Photo of Joe Benton Joe Benton Labour, Bootle

With this it will be convenient to discuss the following:

Amendment No. 14, in

clause 23, page 14, line 13, after 'prepare', insert 'or approve'.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

We have discussed codes of practice from various viewpoints during previous debates, so I should like to deal with a number of specific issues relating to the preparation of such codes. The amendments are designed to explore two issues.

First, the legislation says:

''The authority may prepare codes of practice''.

I understand that it is the intention that it will produce them. The ''may'' in this context appears because the codes are in the plural, therefore the wording is permissive as to the number of codes that the authority has to prepare. Representatives of a couple of bodies raised with me the concern that they were unclear on how the authority could proceed other than by preparing codes of practice, and that, therefore, it should be specified in the legislation that they shall do so. Of course, if we were to say ''shall prepare'' codes of practice, there would be a question of how many codes the authority was to prepare. Therefore, I have phrased the amendment slightly differently, because

''shall prepare one or more'' codes of practice seems to be consistent with the intention of the Bill and a little clearer.

Amendment No. 14 would permit the authority to adopt codes of practice that have been prepared by other bodies. For example, the Royal College of Pathologists has its own guidelines for the conduct of post mortem examinations, and no doubt there are others of which I am not aware. The range of activities that has to be dealt with under subsection (2) is sufficiently wide that the measure will no doubt impinge on a range of bodies that have been involved in scrutinising and giving guidance.

It might be excessive for the authority not to be able simply to approve existing guidelines in order to issue a code of practice. If it were to do so, the provisions on consultation would have to be complied with in the same way because such guidelines would assume the formal status of a code of practice of the authority. However, it would be transparent that the authority was approving an existing code rather than, necessarily, starting from scratch.

The purpose of amendment No. 14 is to permit the authority to approve codes of practice that are prepared by other bodies. Although that may be done in relation to one or two issues, it does not mean that that will not be extended in future. If, for example, the authority wanted to take a more self-regulatory approach with the professions, it could permit some of the professional bodies to take responsibility for

preparing codes of practice and then, under the legislation, approve them. That possibility—not requirement—might commend itself and, in the spirit of future, flexibility would be advantageous. I hope that both those arguments commend themselves to the Committee.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest

I strongly support the amendments. The Minister was kind enough to provide me with a copy of the code of practice on families and post mortems, which is very recent—it was written in May 2003. It answers many of my questions; to be honest, it answers one question more satisfactorily than she did. It is vital that we have at least the reassurance that existing codes will be taken into account when new ones, if required, are constructed.

The hon. Member for South Cambridgeshire mentioned the Royal College of Pathologists guidelines on autopsy practice. Those came out only in May 2002, and will certainly remove some of the almost ghoulish practice that some of us as young housemen and students were appalled to see carried out in the long-distant past. I strongly support the view that codes of practice introduced by the Human Tissue Authority should be built on some of the very satisfactory existing guidelines.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

I shall start by giving a little background. The Bill empowers the Human Tissue Authority to prepare and publish codes of practice, and sets down the matters with which it must deal through the codes. In bringing all those issues together under the Human Tissue Authority and ensuring that common principles are applied, our aim is to ensure a consistent approach to all matters relating to the keeping and use of human tissue that fall within the broad remit of the authority.

Many of the codes are to be subject to approval by the Secretary of State and are to be laid before Parliament so that the process can be observed and overseen at the appropriate level. As the hon. Member for South Cambridgeshire set out and as the hon. Member for Wyre Forest (Dr. Taylor) remarked, amendment No. 14 envisages the authority receiving and approving codes that have been prepared elsewhere. However, it would be inappropriate for the codes to be approved by the authority and then approved again by the Secretary of State.

The hon. Member for South Cambridgeshire referred to the Royal College of Pathologists guidance on the conduct of post mortems. It would be perfectly acceptable for the royal college to have particular guidance available that it was appropriate to issue to its members. The Human Tissue Authority might use that as a basis for its own code of practice. However, it is not necessarily true that all the objectives would be identical. We would not expect the authority to take on board and approve a document as it stands without a period of consultation, consideration and reflection. However, we would expect it to look at such codes

from a slightly wider perspective. That would not stop the Royal College of Pathologists and other professional bodies considering whether they wish to give additional advice to their members.

The authority should take a common-sense approach. If guidance were available that could form a basis for the codes of practice, the authority would take that into consideration. We want the theme of its work to be consultation with others who are involved. It would be inappropriate for the authority almost to rubber-stamping something that had been put together by perhaps only one group without considering some of the wider implications. At the beginning of the process, we would want the authority to engage in wider consultation. A common-sense approach would obviously be adopted, and where good guidance was available, we would certainly expect it to be taken into consideration.

Amendment No. 85 would make it mandatory for the authority to prepare at least one code of practice, but we do not think that that is necessary. I draw the attention of the Committee to the structure of clause 23. The authority is empowered to prepare codes under subsection (1) and it is required to cover in those codes the matters set out in subsection (2). The authority would be unable to fulfil the statutory requirement in subsection (2) if it were not to prepare codes under subsection (1).

There is an important point to that. If we were to say in subsection (1) that the authority must prepare codes and to specify in subsection (2) what those codes should cover, one might suppose that subsection (2) represented an exhaustive list. Obviously, that is not our intention. We intend that the authority should cover the matters listed in subsection (2) but that it should be able to prepare codes on other matters within its remit as it sees fit. As time moves on—this relates to the discussion that we had this morning—the authority may need to give guidance in circumstances that we cannot anticipate today. In addition, a single code might cover both the storage and use of tissue from living patients, while another free-standing code might cover the conduct of anatomical examinations. As I said, all those matters are covered in subsection (2). Furthermore, to return again to this morning's discussion, the authority might have to give guidance on some aspect of public display or on arrangements for live transplant. Those are just some examples of how things might move on and of how we will need flexibility to deal with such developments.

I understand the intention behind the amendments, but the powers in subsection (1) and the specific requirements in subsection (2) set out the right understanding of what we should expect from the authority. They also send a clear signal that the authority can extend its guidance to cover all the activities that fall within its remit if it considers that appropriate. With that explanation, I hope that the hon. Member for South Cambridgeshire will withdraw the amendment.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health 2:45 pm, 3rd February 2004

I am grateful to the Minister for her explanation. In particular, I am grateful to her for explaining that the discretion in subsection (1) will allow the authority to go beyond the matters with which it is required to deal under subsection (2) and that the amendment might have had the perverse effect of constraining the authority. It is helpful to explain that to the wider community.

On amendment No. 14, the Minister seemed to be talking about pre-existing guidance or guidance volunteered by professional bodies. I am not sure whether she really covered the issue of the authority taking a self-regulatory approach by giving other bodies the responsibility for preparing codes of practice and consulting a wider group of stakeholders, rather than simply resting on its professional expertise. I hope that the Government will consider the issue to ensure that nothing in the Bill will prevent the authority from taking such an approach. There is a risk of that, which would be undesirable because co-regulatory and self-regulatory solutions should be sought wherever possible, particularly when one is dealing with technical, professional matters. With those caveats, however, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest

I beg to move amendment No. 151A, in

clause 23, page 14, line 14, after 'persons', insert 'requesting consent for and'.

I realise that I am returning in a way to a discussion that we had a few days ago, when the hon. Member for Westbury (Dr. Murrison) underlined the fact that those who request consent are just as important, if not more so, than those who carry out the activity. The amendment would require the Human Tissue Authority to have codes for the requesting of consent as well as for the carrying out of activities.

The reason for raising the issue again is the extremely clear letter that I received at the weekend, which I am sure other members of the Committee also received, from Professor Peter Furness, who is a professor of diagnostic histopathology. He puts the points well:

''I am concerned that debate on this Bill is emphasising the relatively small number of post mortem samples'' and does not adequately address the

''many millions of specimens from living patients.''

He continues:

''There seems to be an entirely appropriate consensus that to approach patients for consent long after a sample has been taken is neither practical nor desirable . . . It is also self-evident that clinicians cannot, at the time of sampling, predict which specimens will be valuable for teaching or research within the laboratory.''

Professor Furness goes on to provide evidence that clinical staff are unlikely to request adequate permission to allow pathologists and researchers to use spare, and in some cases, waste samples for the necessary work. I shall not quote his evidence because it is extensive, but it largely concerns the point that has already been raised, which is that the obtaining of consent can be so onerous that clinicians do not have time to go into the detail.

Professor Furness has an answer that may be too broad for the Government to accept, but which would at least solve the problem. He feels that the NHS should record the wishes of patients when they originally book in, which would mean that the many millions of blood samples—the bits that are left over—from patients with rare forms of leukaemia could, if needed, be used for research. The amendment is important and seeks to separate the askers of permission from those carrying out the work, and to require the Human Tissue Authority to bear that in mind when drawing up its codes of practice.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

I am grateful to the hon. Gentleman for raising the issues as he did. The amendment is not necessary in practice because, by definition, not only the activity itself but the consent needed for it will fall within the authority's remit. The giving of practical guidance on consent is already in the provisions.

The hon. Gentleman makes an important point, however, which I have discussed with both Professor Furness and the BMA. Although we have touched on the issue before, it is worth noting that the BMA has shown considerable interest in the question of whether consent can be sought—clearly it can be legally—at non-stressful times. Can one have ethical discussions with patients that are not necessarily related to, as it were, the moment of decision? That could happen with a GP, before undertaking treatment or at the point of out-patient referral. Indeed, there could be a discussion with a GP about a range of possible circumstances. The question arises because the more one focuses on the activity itself, the less people are likely to have the opportunity to consider ethical issues that relate to themselves, their bodies, their willingness to donate material, the purposes for which they might do so and possible exceptions to doing so.

As we have said, as time goes on and we move towards the electronic patient record, the bureaucratic impediments to such a discussion giving rise to consent at particular moments when treatment occurs will progressively be reduced to the extent that the electronic patient record will, in the long term, be available to clinicians when they see or treat a patient.

We should arrive at the stage where such a discussion could enable all clinicians to have some pre-existing indication of a patient's willingness to provide consent at the point at which consent might be taken. They might, as we know, have to supplement that consent by checking with the family of a patient who was unconscious, incapacitated or dead, but the process might be more effective as time goes on. It will certainly be less burdensome to the clinical medical professions when dealing with patients. It may also be much less stressful for patients when they give consent. I have trespassed slightly to make that point again. The point was not confined to Professor Furness, but it has attracted attention. People are not sure that this is the way to go, but I am sure that they would not want the Bill to close off that possibility.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

The hon. Member for Wyre Forest has given us an opportunity to ask the Government how they

believe consent obtained in such a way for surgical specimens will be dealt with. We are faced with a choice between consent forms and the need to recognise that research shows that they are not working in the NHS. The consent form should provide a box for ''any and all uses'' for research within reason, although that would still require a separate box for controversial areas of research so that people can conscientiously object without their tissue being used for all sorts of purposes, some of which they may disagree with on moral grounds.

There are two categories of research. One is a specific research project, such as the breast cancer research unit seeking to obtain normal breast tissue following breast reduction operations, which Professor Furness mentioned in his letter. In my experience of serving on a research ethics committee, the bid for research funding, or at least the protocol, usually involves one of the researchers ensuring that the patient had provided adequate consent and that it is not relied on without a clinician—often named as an investigator—participating in the research and having the responsibility of checking it to ensure that it was good and proper. That is one situation where the onus is on specific researchers to check the consent, although I am not suggesting that consent can be implied in any way.

There is a separate problem, however, in that such tissue may then be stored and might be available for a future research study that is just as valuable, if not more so, than the current one. The question is then whether the consent given at the time for a project will be wide enough. One can handle that difficulty by ensuring that the original consent form covers those options for future research along the same lines.

The letter describes how so many consent forms were not done properly. That was regrettable, but I do not believe that it will be a general problem. There is, however, the broader problem of samples, taken generally during operations, which may be useful to a research project. I have always believed that patients should have the opportunity to give consent for blood samples, for example, to be taken. However, it is clear from the examples already given and from my experience as a busy junior doctor in a hospital that tick boxes are often not ticked if they are not vital to the clinical issue at hand. There is also the problem of the consent form not being sent with the specimen—a problem that is not solved by an enduring consent on an electronic patient record. That is a fundamental problem, regardless of where the consent is recorded. If the consent does not follow the specimen, the pathologist and the researchers are put in a difficult position.

I wonder to what extent the Minister, subject to consulting the Human Tissue Authority and its codes of practice, envisages implied consent being provided for in such a way. She has mentioned the assumption that placing posters in surgeries where blood is taken would be sufficient for implied consent; it could be

said, ''Your blood may be used for NHS research purposes. Please let the doctor, nurse or phlebotomist know if you object to that.''

I am not sure that that is the right way to proceed, given the need for proper, informed consent for research activities. However, it would be helpful if the Minister would take the opportunity to respond. In many cases, there is implied consent for research uses. We also need to discuss, not necessarily in the context of the Bill, how to use clinical governance to improve the appalling return rates for consent forms, which poses a genuine threat to research.

There is one final area: tissue taken in an emergency. Again, I do not think that the fact that it is an emergency is an excuse for not providing for consent to be obtained, because that consent can be sought from the patient after the emergency. We have also discussed what happens when patients do not regain competence after being seen in an emergency. Significant issues are raised by the amendment, and by the question of how to obtain consent for research samples. I shall be interested to hear the Minister's response.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health 3:00 pm, 3rd February 2004

The points that have been raised reflect some of our earlier discussions, not only in Committee but on Second Reading. This legislation will clarify what people can do in given circumstances. As has been said repeatedly, the difficulties that have been experienced in deciding whether particular tissue can be used have arisen from hesitancy and lack of clarity. The Bill is aimed at sorting that hat out.

I return to the core of the issue: we expect—current General Medical Council and BMA guidelines are clear and are followed in the vast majority of cases—that consent should be obtained, as the hon. Member for Oxford, West and Abingdon said. It is not acceptable to extend the boundaries of the type of material or the things that tissue can be used for, and this Committee should not attempt to do so. It is for us to set a clear framework and for the Human Tissue Authority in its codes of practice to consider the issues and give guidance on communication with families, in the case of a deceased person, and with individuals if the tissue is from a living person.

Schedule 1, part 2 allows for activities that can be undertaken without specific consent. However, we do not envisage introducing a category of implied consent. That would be very difficult for us to do, and quite wrong. It would be stretching the boundaries of what we have already laid out in the Bill as to what is and is not acceptable. We have to be quite firm, and that is certainly the view that the Government will take.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

Does the Minister agree that offering information about implied consent in the way described by the hon. Member for Oxford, West and Abingdon, through leaflets in GPs' surgeries and so on, is acceptable only to certain people? It would disadvantage those for whom that form of information was not available.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

Yes. A lot of the distress and controversy that has been caused arose because there was an assumption that it was okay to do x, y and z, and people did not feel that it was right. We must be quite clear that there is a balance that medical ethics committees require when particular research is carried out. I certainly understand the BMA's interest in whether consent gained during a non-treatment discussion could be effective for future uses of tissue collected then or subsequently. That goes back to the point made by the hon. Member for Westbury: consent should be taken when the individual has sufficient information about what will be done with the tissue. It is important that the authority looks when considering its codes of practice at the different ways in which consent can be obtained. We cannot say that it will always be appropriate in every case.

In terms of the codes of practice considered in clause 23, conditions for obtaining valid consent will vary considerably according to the circumstances of each individual case. It is our clear intention that the codes should include guidance on the many and various aspects of consent that will be relevant to activities within the remit of the authority. The amendment before us does not assist us in making that possible.

The provision at subsection (1) gives the authority power to prepare codes; subsection (2) states what those codes must cover. The amendment adds only to the aspect that empowers the authority to make codes; it does not bring any new obligation on the authority. It is clear that the codes will deal with matters of consent because the codes must provide for guidance on the removal, storage and use of tissue. Consent is the key element of the requirement of the Bill.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

I am glad that the Minister made that last remark. Although the hon. Member for South Cambridgeshire said that he felt that clause 11 or clause 23(2) tackled the issue of obtaining consent, it is only explicitly mentioned in the reference to

''communication with the family of the deceased'' in clause 23(2)(g) and (2)(e). Therefore, is the amendment valid? It draws out what the Minister has just said: the activities involved must include gaining consent.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

The hon. Gentleman is right. That point relates to clause 24(1), which refers to the obtaining of consent and the standards expected to be laid down for obtaining consent for the purposes of section 1. Effectively, that means that clause 24 deals with specific aspects of consent in relation to post mortem consent. The reason why that has been addressed in clause 24 is that the clause goes through the processes and the qualifying persons to whom the consent applies. As we have said, appropriate consent under the Bill applies to the appropriate person who can give consent.

We certainly expect the codes of practice to address the obtaining of consent from those who are living and tissue that has been taken. That theme runs through the Bill as a whole. I accept to a certain extent what hon. Gentlemen are saying about the reference to obtaining consent in relation to a deceased person—

the relevant wording is in clause 24. Given the provisions set out in clause 23, codes of practice will be issued by the authority on what will be appropriate in different circumstances. However, I am prepared to consider how the provisions may be interpreted to the effect that the authority would not issue codes of practice in the circumstances that have been described. That is certainly not what we expect, as it would be impossible for the authority to fulfil its duties, particularly given the references in paragraphs (h) and (i) to the removal of a sample from a human body and the storage of that sample, for example. It is difficult to see how any of those duties could be carried out without the authority issuing guidance on how to obtain consent in such circumstances.

The point is interesting and we shall consider whether it might be necessary to make specific references. However, we do not want to limit the authority or divide the different codes of practice, which would make it difficult to see the connections between them or the theme of obtaining consent that runs throughout. I shall consider the issue because I accept that the expectation that guidance on living patients would be issued might have been aroused by the fact that the Bill also deals with obtaining consent when a person is deceased. With that assurance, I hope that the hon. Member for Wyre Forest will withdraw the amendment.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest

After that, it would be churlish to do anything but withdraw the amendment. I am pleased that the Minister has responded so willingly and is prepared to take my comments on board. The problem is real: I can recall crossing out awkward bits on post mortem consent forms just for speed. However, given the Minister's response, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health 3:15 pm, 3rd February 2004

I beg to move amendment No. 7, in

clause 23, page 15, line 12, at end add—

'(7) In preparing a code of practice, the Authority shall have regard to any guidance published by the Better Regulation Task Force in relation to the best practice in conducting a consultation.'.

In responding to a previous debate, the Minister said that the authority would have regard to guidance from the Better Regulation Task Force. However, as I said earlier, the authority is under no obligation to have regard to such guidance. The amendment would require guidance derived from the work of the Better Regulation Task Force to be considered when undertaking consultation. In some instances, the Cabinet Office may issue such guidance.

To give one example, in all but urgent cases one would clearly want the authority to respect the 12-week injunction on time for consultation, which is derived from the work of the Better Regulation Task Force. If the Government will not adopt the amendment—such provisions are not unknown in legislation covering other regulators—I would like them at least to clarify the mechanism by which the

authority will be required to have regard to best practice on consultation. I therefore hope that the Minister can expand a little on what is in the Bill.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

Although I cannot accept the amendment, I hope that I can clarify the position on following guidance, particularly from the Cabinet Office. As members of the Committee will understand, it is Government policy that consultation should follow Cabinet Office guidance on best practice, and we expect all arm's-length bodies to comply with that policy. However, it is not necessary to provide for such things in statute. Indeed, to take a simple example, we cannot be absolutely sure that the taskforce will last for ever, although it may, so it would be risky to mention it in statute.

The place to set out our policy on the Human Tissue Authority will be the management statement, which will be drawn up by the authority and the Department of Health, and used to hold the authority accountable to Parliament through the Secretary of State. I can therefore reassure the hon. Gentleman that we will expect the authority to follow Cabinet Office guidance on consultation and that that will be made clear in the management statement. With that explanation, I hope that the hon. Gentleman will withdraw the amendment.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

I am grateful to the Minister for that; she has made an interesting point about how the proposals will work. I was not aware that that was the mechanism; indeed, schedule 2 does not refer to the management statement as distinct from the authority's financial arrangements, and it would be interesting, in due course, to hear a little more about how the arrangements will work.

As far as I can see, the authority is not only at arm's length but statutorily free of obligations, unless they are set out in statute. Clearly, the management statement is an extra statutory provision, and I would be interested to hear whether it would be enforceable in relation to the authority.

I simply wanted to flag up those questions, to which we may return later. They have elicited at least one useful piece of information, and, on that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

I want to ask one or two questions for the record. There is obviously a substantial relationship between the codes of practice and the activity of the NHS. Ministers will understand that point, not least because the explanatory notes set out some of the public sector financial and manpower consequences that flow from the Bill. The explanatory notes give a figure of about £2.7 million for resources and £300,000 for a central training budget. I am sure that many in the NHS are concerned to ensure that the resources for implementation and training will reflect

requirements not only once the Bill is enacted. There are one-off costs even now that are associated with implementing the interim statement and introducing consent forms. It would be useful if the Minister could say something about how the Human Tissue Authority, in framing codes of practice, will reflect its understanding of the resource implications of the codes' requirements.

Will the Minister state that the Department understands that implementation and training need to be properly resourced? There is, in addition, the issue of the extent to which the NHS complies. I would be the last to add to the burden of inspection and control, and the Bill is clearly designed to place a set of obligations directly on the trusts and on those who receive consent and undertake regulated activities.

There are many variables, such as the extent to which existing consent forms have been adopted in the NHS; that to which those who work with consent forms secure the appropriate consent at the appropriate time; and that to which, in line with the interim statement, bereavement counsellors are appointed in accident and emergency units. There will be concern in the NHS if its procedures are not in accordance with the Bill at the point at which the Bill comes into force. In theory, criminal penalties or severe consequences would flow from a failure to take proper procedures into account. Equally, if patients and their families feel that obligations are set out in the Bill but are not being complied with in practice in the NHS, they will suspect that some of our objectives have been undermined.

Many of our concerns are to do with the relationship between the codes of practice and NHS management activity. It is unfair for us to legislate—to impose codes of practice—and for the authority to promulgate codes based on the gold standard, if everybody in the NHS is then to discover that they have no resources, time or bereavement counsellors; they have not been given the consent forms in the appropriate manner; they have not had any opportunity to train, and so on. We cannot allow the strain of trying to reconcile such matters to fall wholly on a junior hospital doctor or NHS clinician who is trying to manage such things in the midst of addressing a range of other priorities.

I hope that the Minister can say something about the mechanisms. We have not previously discussed the matter, but we should do so, possibly on Third Reading. When we legislate, we must be clear about the processes by which activities will be managed, so that they will be acceptable in practice to the staff who have to live with them.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

I was interested to hear the hon. Gentleman's closing words, because I have identified some issues that we could well leave until Third Reading. We have both been requested by the Academy of Medical Sciences and others to raise the question, perhaps under the commencement clause or now of the time lag between the promulgation of the codes of practice—in order that people get to know them—and the implementation of criminal sanctions. If the Minister can pre-empt that, it would be

appreciated by both of us, and by others who are concerned that there might be a big bang that will scare people and cause paralysis.

The major concern about codes of practice is how they will impact on research using retained samples following surgery. I am raising the matter under clause stand part because of subsection (2)(d), which deals with

''the definition of death for the purposes of this Act''.

I thought that I had tabled a probing amendment on the issue; perhaps it was subsumed in our discussion on the new clause.

I declare an interest as a member of the BMA medical ethics committee. One thing that it has been concerned about has been the public's understanding of the definition of death, particularly because the terms ''brain death'' and ''brain-stem death'' are unhelpful. I hope that the Minister will agree that we need people to understand that death is death and that the death that we are talking about for the purposes of transplantation—when there is a beating-heart donation—is death confirmed by brain-stem tests. That is not death by observation of a non-beating heart and lack of respiration as well as pupilary fixed dilatation. Does the Minister consider that the reference pre-empts a code of practice that will serve as a way of educating everyone in the health service, particularly patients and relatives, that just because a heart is beating on a ventilator, death is death when confirmed by brain-stem testing?

Photo of Ian Gibson Ian Gibson Labour, Norwich North

Will the hon. Gentleman define how many ways we can record death? Do all doctors have different methods of recording death? Does a histopathologist have a different method from others? How many mechanisms of defining death are there?

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

I look to my consultant colleague for correction on the matter, but generally when patients die in hospital, the junior doctor is called to verify—not certify—death by observation and examination of the body that demonstrates that life has expired. That will include monitoring the respiration and cardiac activity as well as the pupilary reflex.

In the specific case of death while on a ventilator, death is verified by brain-stem testing. Sometimes that it difficult for people to understand and there have been some controversies about whether people whose death is confirmed by brain-stem testing are, in fact, dead. That can be damaging to the business and duty of the NHS to ensure that there is a transplantation service. Anything that can be done to make that point clearly, during this debate but mainly in a code of practice issued under subsection (2)(d), will be welcomed by those working in the service and by the BMA, which is particularly concerned about public understanding of the issue.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest

So that members of the Committee do not become worried, I wish to confirm that there are real safeguards in the rules for brain-stem death and particular exclusions in cases of people who have taken overdoses, when even some of the reflexes can be removed. I do not want people to be worried. As the

hon. Member for Norwich, North (Dr. Gibson) said, it is left to pathologists to make the diagnosis, although I hope that physicians are good enough to make it before then.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

As for the points made by the hon. Member for South Cambridgeshire and the relationship between the Human Tissue Authority, the implementation that will be required by the NHS and those who work in it, we need to bear in mind a few issues. Over the next year, the shadow authority will be drawing up codes of practice in two ways. It will first build on best practice. The hon. Gentleman referred to gold standard. In many areas, that will conform with GMC and BMA guidelines. I do not believe therefore that, because the Bill and the codes of practice will bring such policies together and build on them, they will be new to most people in the NHS and those who work on the front line.

At the same time, a common-sense approach will be taken. Before the penalties come into force, it will be important to have wide consultation as well as to build on best practice. Although the hon. Gentleman raises an important point, we must make sure that strings are not attached to the service.

In a sense, the safeguard is that the health service can implement what the authority draws up while it is in shadow form and puts into practice when it comes into being. Otherwise, we would be back where we were before, with a lack of public confidence in the system. Therefore, it is vital that the authority issues code of practice that can be implemented.

The hon. Gentleman asked about bereavement and other services. Funding has been included in allocations already made, so such services can be offered. As I have said, there will be consultation on the draft codes, and people will have ample opportunity to comment and contribute, and to prepare for the time when the authority comes into being.

With regard to the definition of death under subsection (2)(d), I hope that hon. Members will forgive me if I do not enter into the technicalities, as others are far more capable than I am. The hon. Member for Oxford, West and Abingdon was right that the amendment gives me an opportunity to clarify some extremely important aspects of transplantation, so that people understand the difference between heart-beating donations and those when there is no heart beat. The provision sets out the means by which the fact of death is determined. The chief medical officer has already asked the Academy of Medical Royal Colleges to review the current code, and the Human Tissue Authority will pursue the matter further when it is established in shadow form.

I hope that I have shown the Committee that the clause can be implemented in a way that does not shock those in the health service who currently implement guidance from the GMC and the BMA.

However, they will have an opportunity to comment on and contribute to the draft code of practice that the shadow authority will draw up.

Question put and agreed to.

Clause 23 ordered to stand part of the Bill.