Clause 1 - Authorisation of activities for scheduled purposes

Human Tissue Bill – in a Public Bill Committee at 9:10 am on 27th January 2004.

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Photo of Richard Taylor Richard Taylor Independent, Wyre Forest 9:10 am, 27th January 2004

I beg to move amendment No. 34, in

clause 1, page 1, line 5, leave out 'appropriate consent' and insert

'consent from the appropriate person and, where applicable, consent appropriate for the intended purpose'.

Photo of Joe Benton Joe Benton Labour, Bootle

With this it will be convenient to discuss the following:

Amendment No. 35, in

clause 1, page 1, line 23, leave out 'appropriate consent' and insert

'consent from the appropriate person and, where applicable, consent appropriate for the intended purpose'.

Amendment No. 36, in

clause 1, page 2, line 9, leave out 'appropriate consent' and insert

'consent from the appropriate person and, where applicable, consent appropriate for the intended purpose'.

Amendment No. 37, in

clause 2, page 3, line 2, leave out 'appropriate consent' and insert

'consent from the appropriate person'.

Amendment No. 38, in

clause 2, page 3, line 5, leave out 'appropriate consent' and insert

'consent from the appropriate person'.

Amendment No. 39, in

clause 2, page 3, line 14, leave out 'appropriate consent' and insert

'consent from the appropriate person'.

Amendment No. 40, in

clause 2, page 3, line 18, leave out 'appropriate consent' and insert

'consent from the appropriate person'.

Amendment No. 41, in

clause 2, page 3, line 26, leave out 'appropriate consent' and insert

'consent from the appropriate person'.

Amendment No. 42, in

clause 3, page 3, line 36, leave out 'appropriate consent' and insert

'consent from the appropriate person'.

Amendment No. 43, in

clause 3, page 3, line 40, leave out 'appropriate consent' and insert

'consent from the appropriate person'.

Amendment No. 44, in

clause 3, page 3, line 43, leave out 'appropriate consent' and insert

'consent from the appropriate person'.

Amendment No. 45, in

clause 3, page 4, line 12, leave out 'appropriate consent' and insert

'consent from the appropriate person'.

Amendment No. 46, in

clause 5, page 5, line 18, leave out 'appropriate consent' and insert

'consent from the appropriate person and, where applicable, consent appropriate for the intended purpose'.

Amendment No. 47, in

clause 5, page 5, line 21, leave out 'appropriate consent' and insert

'consent from the appropriate person and, where applicable, consent appropriate for the intended purpose'.

New clause 1—Consent appropriate for the intended purpose—

'(1) This section makes provision for the interpretation of ''consent appropriate for the intended purpose'' in section 1 in relation to activities specified in this section.

(2) Where the person concerned has died, in giving consent for the purpose of anatomical examination to determine the cause of death, consent appropriate for the intended purpose shall specify whether or not consent is given for the retention of tissue for research and teaching.

(3) Where the person concerned is alive, in giving consent for the purpose of medical treatment, consent appropriate for the intended purpose shall specify whether or not consent is given for the use of any tissue removed for education and research.'.

New clause 2—Consent appropriate for the intended purpose (No.2)—

'(1) This section makes provision for the interpretation of ''consent appropriate for the intended purpose'' in section 1 in relation to activities specified in this section.

(2) Where the person concerned has died, consent appropriate for the intended purpose shall specify whether or not consent is given for each of the purposes specified in Part 1 of Schedule 1.

(3) Where the person concerned is alive, consent appropriate for the intended purpose shall specify whether or not consent is given for each of the purposes specified in paragraphs 1 and 3 to 8 of Schedule 1.'.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest

I, too, crave your indulgence and guidance, Mrs. Adams, as I am new to the job.

Amendment No. 34 stands in my name and that of the hon. Member for Oxford, West and Abingdon (Dr. Harris). I echo the remarks that have been made: this could work out as a cosy sort of Committee, because there is so much agreement on ending up with the right Bill.

There is universal support for the aims of the Bill. The concerns that I have picked up from those who have written to me are largely about its wording. The Royal College of Pathologists states:

''The tortuous wording of the Bill may cause much confusion about what is lawful. It fails to provide the clarity in the law that is one of its stated prime objectives.''

The Pathological Society of Great Britain and Ireland states:

''Even with the Explanatory Notes, the drafting of this Bill is opaque and difficult to understand as presently drafted.''

That is why the amendments press for more clarity.

Consent in the Bill, as I read it, covers very adequately the matter of consent from the appropriate person, which is obviously very important. The Alder Hey disaster, to which we all look back, occurred not only because there was inadequate consent from the right person, but because the details of the consent were hopelessly inadequate. I look back to years of practice in hospital medicine before the Alder Hey disaster, when hospitals were judged on the post mortem rate—the number that they could perform—to justify their training status. That led to a perfunctory application for permission for post mortems; the junior doctors to whom the job was deputed felt that they had to get a yes from the relatives. That in turn led to inadequate practice in obtaining consent.

Amendment No. 34 would clarify ''appropriate consent'' by requiring consent from the appropriate person and detail of the consent needed for different functions. That is vital, and it should be at the beginning of the Bill and give force of law to the use of adequate consent forms, for both post mortems and operations, that specify generically to what the person is giving consent.

On Second Reading, the Minister said:

''The Bill gives statutory effect to the current requirement for consent.''

It is an example of the opacity of the Bill's wording that I am not sure from where she gets that, and I would be grateful for confirmation. The Royal College of Pathologists writes that

''the main weakness of the current version of the Bill is the failure to compel those who remove human tissue from living patients to seek appropriate consent sufficient to cover its subsequent uses.''

Pathologists are worried. They do not request consent; clinicians do that. Therefore, we have the anomalous position of pathologists carrying out an examination and bearing any penalty, which may include a prison sentence, if the consent obtained by someone else is inadequate.

A paediatric pathologist wrote to the Royal College of Pathologists:

''My prediction, based on experience from autopsy practice in recent years, is that pathologists will attempt to 'play safe', and fail to take specimens for microscopy, let alone subject these to a rigorous investigation, because the hazards of reaching an unreliable diagnosis (patient complaint, civil proceedings, GMC referral) are less than the hazards of inadvertently using a specimen for something that contravenes the Human Tissue Act''.

The BioIndustry Association picks up on that point:

''It should be noted that penalising only those who perform an activity that requires consent without penalising those who have stated wrongly that appropriate consent has been obtained for such an activity seems unfair''.

Unless the Minister can explain that that is already covered, the Bill must be amended to contain enough detail to force the use of adequate consent forms that can be passed to the pathologist, who will then know what consent has been given. Indeed, again on Second Reading, the Minister said that

''obtaining consent will reflect current good practice and need not be onerous''.—[Official Report, 15 January 2004; Vol. 416, c. 991.]

Amendments Nos. 35 to 47 would alter the Bill to be consistent with provisions in amendment No. 34. A new clause is also necessary in addition to clauses 2 and 3, which address appropriate consent from the person who gives it. New clause 1 attempts to address the appropriateness of consent for the intended purpose. It also separates consent when the person concerned is dead from consent from a living person. The Royal College of Pathologists believes that

''A clear distinction should be made between tissue removed after death (which has considerable emotional importance in terms of bodily integrity) and tissue removed from living patients as part of a consented therapeutic or investigative procedure (which is regarded by most patients as 'waste').''

Proposed new subsection (2) aims to enforce the use of a post mortem consent form, as is used now, which will cover those points. In my NHS trust, the standard form contains a separate section headed ''Medical research and education'', which allows the person who is asked for consent to describe to what they are consenting in the way of research and education, and to opt out. Proposed new subsection (3) covers the ability of the living patient to give consent to the removal of spare tissue during an operation.

I ask the Committee to consider amendment No. 34 and its consequential amendments, and new clause 1.

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

I am grateful to the hon. Member for Wyre Forest (Dr. Taylor) for his clear exposition of the reasons behind the amendments and for putting on the record quotations from the medical research community and professional groups, so that they do not have to be repeated.

I joined the hon. Gentleman in tabling the amendments and have also tabled a new clause of my own that probes the Government's thinking in a slightly different way. There is concern that the term ''consent'' relates only to the person giving consent and that the primary legislation will not make it sufficiently clear to people who will clearly be at risk if they fall foul of the measures that they must ensure that the consent is both obtained from the appropriate person and appropriate for the intended purpose. They need to be reassured, because many functions will be carried out by people other than those who obtain the consent. We should make that point clear in primary legislation.

I say that because pathologists will carry out much of the work but rarely obtain consent from the relatives or—when the people concerned are alive—the patient. The treating clinician—or, when appropriate, their delegate—usually obtains consent. Both parties—the person obtaining the consent and the person carrying out an activity on the relevant material—must reach an understanding that consent is adequate for its purposes and comes from the appropriate person. I have no doubt that the Minister's response will be that the issue of consent will be clarified by the Human Tissue Authority in its code of practice and standard consent forms.

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

I do not know whether the hon. Gentleman has interpreted the Bill as I have, but it is clear that, among other matters, the Human Tissue Authority will have to deal with communications with the family about the giving of consent. However, the meaning of ''consent'' is not defined in the Bill and is not one of the matters dealt with by the Human Tissue Authority under clause 23. Moreover, it is not one of the matters dealt with by clause 24. Communication with the family is the limit of the matters that are to be dealt with in the standards set out by the Human Tissue Authority. I therefore contend that it might not set out in its standards that every scheduled purpose must be specifically consented to.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon 9:30 am, 27th January 2004

I am grateful to the hon. Gentleman for making that point, particularly in regard to clause 23. I will be interested to hear the Minister's response.

The remit of the Human Tissue Authority is set out in clause 11, which is written in more general terms. However, it would be useful to know whether the Minister believed that the remit of the Human Tissue Authority and what it will cover in the code of practice would be sufficient to cover the question of consent without relying on the Secretary of State to make a post hoc amendment to the legislation.

So far, the Government have not proposed to put the issue of consent, as understood in clinical practice, on a statutory footing, and I understand the reasons for that. Nevertheless, the point that we are making in the group of amendments still stands. There is a danger either that people will be put at risk or that people will feel that they are at risk. There is an exemption in relation to the penalty clauses for those who are carrying out activities in good faith—believing that there was consent—but any area of doubt may cause people to leave the field of such work, or to choose not to go into that area, or to minimise the number of procedures they carry out on such material. One can understand their fears, given the incidents that occurred after the Alder Hey scandal. There is a strong argument for clarifying that area in a Bill that is otherwise not very clear.

The hon. Member for Wyre Forest chose, when seeking to explain the reasons for a paving amendment that mentions

''consent for the appropriate purpose'' to single out education research. That is important, because that area is the one in which there might be the most doubt. If the Government are setting out a series of purposes and uses in schedule 1, it might be more appropriate for the discussion to focus on ensuring that the consent is specific, where appropriate, to each of the purposes set out in schedule 1, rather than singling out education research. The hon. Gentleman and I tabled similar new clauses, but with that difference, in the hope that both would be selected and that we could have this discussion.

New clause 2(2) states:

''Where the person concerned has died, consent appropriate for the intended purpose shall specify whether or not consent is given for each of the purposes specified in Part 1 of Schedule 1.''

There is an argument that that might have read simply schedule 1 or part 2. As will become clear when we discuss the next group of amendments, there is an argument that no distinction should be made between material from the dead and the living in respect of the activities set out in part 2, and that those activities would normally be covered by the consent for removal for the purposes in part 1 of schedule 1, as they are for dealing with live material. That is why I drafted the proposed new clause in that way.

However, if the Government are not minded to agree that consent for part 2 purposes should be included in consent for removal of tissue for the purposes set out in part 1, part 2 will be more important in clarifying that consent is available. The

part 2 activities listed in the schedule are those in which it would be more likely to be assumed that consent had been given by virtue of the consent that had been provided to obtain the material and carry out some of the other activities. Clinical audit,

''education or training which is incidental to medical diagnosis or treatment'' and quality assurance, are part of the everyday work on almost every sample—from both the living and the dead—that comes through a pathology laboratory. If the Government require specific consent for part 2 purposes, there is a stronger argument that those purposes should be specified in any consent, and that that should be made clear in the primary legislation.

In cases in which the person concerned is alive, and in which the Government concede in clause 1 that specific consent is not required for the purposes listed in part 2, the purpose of new clause 2 is to establish whether consent has been given for paragraphs 1 and 3 to 8. Determining the cause of death would not be an appropriate purpose for which to seek consent from a living person prior to an operation, for obvious reasons. One might argue that anatomical examination might be included in that list but, as is made clear in clause 56, that can take place on a part of the body removed from a person who is alive.

I hope that I have set out the reason why we are seeking to table the amendments, and in a way additional to the points made by the hon. Member for Wyre Forest. I look forward to hearing the Minister's response to the point. I understand, from the helpful conversation that I had with someone in her team, the problem that the Government foresee, among others, around this sort of new clause. It would require those seeking consent to go into whether consent was required for all the other purposes, particularly part 1 purposes, when it might be obvious that it would be inappropriate. It is clear that there will be a restricted purpose and it is not worth going through all the other purposes to get the person giving consent to tick all the boxes.

That is not necessarily as strong an argument as it might be, because we need to ensure that in the consent process there is more openness about these issues. It would benefit society if people having operations were not protected from the things that happen in pathology labs; otherwise, we will continue to have this air of ignorance and mystery. It is relatively straightforward sensitively to explain—in written form, supplemented or substituted by verbal explanation where appropriate—the sort of purposes for which material might be used, and the sort of purposes for which the health service and the scientific community might find it helpful to use, and to seek that consent in explicit terms.

There is a worry about forcing or encouraging doctors and patients or relatives to go through some of these purposes, but that is exactly—even in a tick-box sort of way—the sort of position we need to be moving towards if we are going to make these sorts of things more explicit. I hope I am not pre-empting or

misrepresenting some of the arguments the Minister will use, but I thought I should get my rebuttal in first, to save time.

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

I am grateful to the hon. Members for Wyre Forest and for Oxford, West and Abingdon for taking us a little more widely onto the subject of consent. I wished to talk about some of the issues associated with trying to obtain consent. It is remarkably generous of the hon. Member for Oxford, West and Abingdon to present not only his argument but the counter-argument.

The purpose of the two new clauses and the associated amendments is to put into the Bill, in which we are determining what is lawful and what is not, the particular point that specific consent should be given for each scheduled purpose. The hon. Gentlemen were referring to the risks associated with that for medical researchers or for pathologists and physicians who are not associated with the immediate consent. If anything, that raises more risks, because, if one goes down the route of the new clauses, it is not possible subsequently for the Human Tissue Authority to vary the measure according to particular practice. It would be necessary for it to be done in every case where consent is given or else it would not be lawful. That is the difficulty.

We must decide at this early point whether to accept that, for practice to be reflected accurately in law, it is desirable that we set a framework that the Human Tissue Authority subsequently fleshes out in detail, or to specify everything in the Bill. It will be obvious from subsequent debates that I want, wherever possible, to allow the HTA to set out such matters in accordance with, and so as to secure, best practice.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest

I hope that I have not given the impression that I am suggesting that consent should be asked for for every specific item of research. I am looking for the phrase ''generic consent'' for items that come under the headings of research and education.

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

I was specifically referring to new clause 2, which gives rise to those problems. I recognise that the hon. Gentleman's new clause 1 has a slightly different purpose and is more concerned with education and research. There are difficulties with the precise definition of teaching and research in this context—perhaps the Minister will refer to that. The wording does not relate directly to the purposes in schedule 1. If we were to go down that path, we would have to cross-refer new clause 1 to schedule 1 for it to be effective.

To return to my point, many in the medical research community are worried that if matters are not specified in the Bill, they will certainly become liable to criminal proceedings in relation to the compliance or otherwise with the code of practice, which they cannot yet see. I suspect that there is an equal, or even greater danger. By putting something hard and fast in the Bill that does not relate to the practicalities of practice, we run the risk of criminalising a wide range of legitimate

activity that we would later want to permit medical research to undertake. The structure of the measure would force us down a particular path.

I should say to the hon. Member for Oxford, West and Abingdon that his point, which is a counter-argument to the structure of new clause 2, is a valid one. We would require across the NHS—literally, on millions of occasions—that every time consent were taken for any purpose, people would be asked for their consent for each of the scheduled purposes. I do not think that we can do that.

I should draw attention to the fact that there is another approach, although I shall not speak at length about it. Referring to amendments in other groups that we shall discuss later, amendment No. 100 would specify that the interpretation and meaning of consent would be dealt with by the Human Tissue Authority under its codes of practice. Amendment No. 101 would permit standards laid down by the HTA to include the interpretation and meaning of consent.

Amendment No. 87 cannot be grouped here as it proposes various matters, amongst which it would require that consent given should indicate for what scheduled purpose it has been given. That does not, I hope, suffer from the same detriment as new clause 2 in requiring consent to be sought for every scheduled purpose in order for consent to be given for any individual scheduled purpose. I hope that the Committee will recognise that although I do not dissent from the proposition that specific consent should be given for a specific purpose, amendment No. 87 is designed to deal with that point. It is designed to do so through the mechanism of indicating to the HTA that consent should be included in the code of practice. If those concerned did not comply with the code of practice, they would have to demonstrate that they reasonably believed or had complied with the obligations under clause 1 or that the activity in which they were engaged was not a schedule 1 activity. We would be going down a less risky path from the point of view of subsequent education, teaching and research.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon 9:45 am, 27th January 2004

I am conscious that new clause 2 specifically excludes part 2 purposes for the reason I gave: it is questionable whether a distinction should be made between material from the living and the dead in respect of part 2 purposes. Is it the hon. Gentleman's understanding that his amendment No. 87 will deal adequately with the need to specify whether effectively all material can be used for clinical audit and quality assurance? It is part and parcel of any sensible post mortem examination, or indeed some of the other part 1 purposes, that there has to be some audit and quality assurance in order to inform that process. The process does not end at the point at which the post mortem examination is complete; tissues, slides and blocks need to be retained to be checked against developing knowledge, either about the patient or the condition. Is it the hon. Gentleman's understanding that his amendment to clause 24 will cover the need for all those to be explicit?

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

Unless I am mistaken, amendment No. 87 will not change the part 2 aspects of schedule 1; in so far as clinical audit and quality assurance are desirable purposes, they would not normally require consent. To that extent amendment No. 87 would not be designed to require consent to be attained for those scheduled purposes. Perhaps I have missed something, but I do not think that it impacts on that matter.

At this point we are beginning to consider whether we can ensure that consent meets the objectives of both assuring families and patients that their wishes will be fully respected, while enabling the medical and research communities to secure the resources on which they have to undertake important tasks. One of the risks is that we legislate and assume that everything out there will work in precisely the form in which we legislate.

I am grateful to a senior pathologist who has undertaken research on the subject. He tells me that at a hospital in High Wycombe, tick boxes were put on the histopathology request forms, with separate boxes indicating whether the patient consented or objected to the teaching or research use of any material. After a publicity campaign an audit showed that 68.4 per cent. of request forms were submitted to the laboratory with none of the boxes marked.

In Leeds, an audit showed that only 48 per cent. of specimens received in the laboratory had traceable consent forms. Of those that were found, 40 per cent. did not have the tissue section completed. In Southampton, a new surgical consent form incorporating consent for teaching and research use was implemented in early 2003. Over 10,000 specimens were received in five months, which were audited. Of those, only 40 per cent. had consent forms attached. Of those consent forms, some 24 per cent. did not make any indication of refusal or consent, or indeed withheld consent, for tissue use for teaching or research. Therefore, just over two thirds of the cases or the tissues being accumulated in that Southampton archive would not be available for teaching or research.

Although we believe that we issue best practice, and good practice in consent was issued by the Department in November 2001, it does not automatically follow that because we issue the consent forms and we have a best practice, or indeed even because the human tissue authority has issued its code, that we will necessarily secure the activity on the part of those taking consent.

That raises two questions. First, we have to make sure that the requirements for taking consent are not excessive or onerous. We have subsequently to ensure that those who are charged with taking consent understand that they have that responsibility and that they may become liable if subsequent activity is undertaken on tissues obtained if the proper consent is not taken. Amendment No. 22, which we shall come to later, is designed with that purpose in mind.

We must also carefully consider what consent requirements we impose. If we go down the route of new clause 2 and this amendment, we will overburden consent at the outset. I raise the point at the early stages of the discussion, although we will consider it

later. As the hon. Member for Wyre Forest said, we must think hard about generic consent. We must consider the extent to which we can reconcile our objectives in a mechanism that enables consent to be taken simply, without requiring, as the Under-Secretary said on Second Reading, return to patients or relatives to obtain consent for subsequent activities. It must be possible for a range of activities to be consented to at one time. We should perhaps consider whether patients could agree to an advance directive so that, rather than having to give consent for a range of scheduled purposes every time tissue or a sample is taken, they consent in advance and it stays with them. That would be generic consent not only to a range of purposes, but to the retention of tissues for those purposes over a period, or even over the history of an individual's contact with the national health service.

Most of those points are not covered by the amendment. We will come to them later, but I wanted to raise them at this stage, with your indulgence, Mrs. Adams. When we discuss consent later, we might study the detail instead of considering whether the legislation is consistent with such approaches of generic consent.

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

The hon. Members for Wyre Forest, for Oxford, West and Abingdon and for South Cambridgeshire raised the issue of whether organisations such as the Royal College of Pathologists feel that the Bill will be over-constraining and onerous on their ability to carry out important research. There is uncertainty about what medical and scientific research can be carried out. That is why the Bill has been brought forward, as well as to address past problems that caused great distress to families. Due to those past events, there has been a climate of hesitancy in the research community about what is and is not lawful. The Bill attempts to clarify that position. We know that, in many instances, if people are properly asked about the use of tissue or organs for medical research, they are likely to accede. Relatives are particularly likely to do so if they know that their loved one made that request. We must provide a proper framework so that that research can take place.

We must also have flexibility in the legislation, so that the Human Tissue Authority can continue to consult all concerned: relevant professional, research and scientific groups as well as groups representing families. That means that when the authority issues guidance and codes of practice, they can not only reflect current situations, but be flexible and pragmatic enough so that they can be given proper practical effect.

The difficulty of trying to specify every circumstance in the Bill would be that it would be almost impossible to change that to reflect any changes in scientific research and in terms of the practicality of the guidance issued. We have to strike that balance, and we are confident that we have done so in the Bill. The difficulty with the amendments is that they would have the unfortunate consequence of bringing undue complexity and even conflicting meanings into part 1 of the Bill. Amendments Nos. 34 to 47 appear to be intended to clarify and help with the process of

consent, but in fact the consent provisions in part 1 and schedule 1 to the Bill are already straightforward and simple.

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

The Minister is referring to consent. One thing that I found somewhat surprising when I looked at the Bill was that consent was qualified by the word ''appropriate'' in one set of circumstances and by the word ''qualifying'' in another, but the word ''consent'' is never defined. Is she happy that the meaning of consent will not be defined in either the legislation or the codes of practice and will be defined only by reference to the common law interpretation of that word?

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

We must recognise that consent, as it is defined under common law at the moment, can be given in different ways. Again, it is extremely difficult to see how, in legislative terms, we could provide a definition without it being restrictive. With the Bill, we must put in place a statutory framework to allow the Human Tissue Authority to work both within the common law and within the guidance that is issued, so that that reflects current best practice and can be pragmatic.

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

Just to be sure, is it the Minister's intention that consent will not be defined either in the legislation or by the Human Tissue Authority, or does she intend that consent should be able to be interpreted and given meaning in this context by the Human Tissue Authority?

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health 10:00 am, 27th January 2004

Let us consider the practicality of that. I think that we are all clear that consent means that someone has been adequately consulted and asked. We may be talking about the removal of tissue or organs for medical research, for example, but let us now take the example of someone who gives blood. One would say that that might be used for the scheduled purposes in terms of clinical audit, on-the-job education and public health monitoring. In that sense, it might be adequate and appropriate for consent to have been seen to have been given by, for example, notices in surgeries or hospital waiting rooms. Consent beyond that, for further medical research, would involve specific consent, perhaps by a tick box like the one used at St. Thomas's hospital. Different types of consent could be used, as defined by the Human Tissue Authority guidance building on current best practice. The Bill contains nothing more than what is current best practice.

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

With respect, the Minister is trying to explain the word ''appropriate'' rather than the definition of the word ''consent''. In ethical terms, consent is about protecting the autonomy of individuals, so it is hard to see how, strictly speaking, consent applies after death, as there is no autonomy to protect. Particularly in common law, consent is understood to protect someone taking blood, for example, against a charge of battery and assault.

Again, it is hard to see how that would apply after death. Does the Minister accept that while we can rely on the common law treatment of consent for the living, she may mean ''permission'' for deceased persons?

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

No. In a situation where someone is deceased, we are talking about getting permission from the relatives, which is where consent comes in. There may also be a nominated person, for which we have also provided. There are a number of people from whom consent has to be sought if a person is deceased, and they are carefully defined in the Bill. It is clearly specified that anatomical examinations would require the individual written permission of the person who is deceased. The same applies to public display.

The Bill is clear throughout on who needs to give consent in any circumstances. Ongoing guidance about the means of obtaining consent will have to be developed by the Human Tissue Authority in consultation with professional organisations and other representatives of the scientific communities to ensure that the collection of consent is not onerous.

Clause 1(1) sets out the circumstances in which consent is required for scheduled purposes. The purposes, defined in schedule 1, are the matters with which we are concerned in the Bill. Broadly speaking, they are the use of human bodies or tissue in medical contexts such as education, training and research; the teaching of anatomy; carrying out post mortems; transplantation; finding out medical and scientific information; and related activities such as audit and quality control. We also address the question of public display, the position of which is uncertain under the Anatomy Act 1984.

The Bill sets out whose consent, if any, is needed for each scheduled purpose. That might mean my consent, that of my nominated representative or that of a person in a qualifying relationship, where consent may be needed after my death. That deals with the point raised by the hon. Member for Oxford, West and Abingdon. The setting out of who should give consent is straightforward and that is what is meant by appropriate consent—the person whose consent is needed. At the same time, the Bill sets out that only my consent can authorise anatomical examination, where my whole body is donated to an anatomy school for the purpose of teaching through dissection or public display after my death.

The hon. Member for Oxford, West and Abingdon asked whether anatomical examination could take place on a part removed from a living person. That is not so, because clause 56(2) specifically states that an anatomical examination relates to deceased persons and parts removed from deceased persons.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

Will the Minister clarify that it also means parts from a living person who has subsequently died?

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

The whole purpose of the anatomical examination is that the whole body can be handed over, but that requires pre-written consent for anatomical examination by the individual. A death certificate is also required before the body can be released. I am not completely clear whether that would

be allowed if a part had been removed and the person has subsequently died if that person had given pre-permission for an anatomical examination. Presumably the part may go with the body, but I will get clarification on that particular issue.

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

You are being very liberal, Mrs. Adams, because there are amendments in the next group that explore this. It may help if I use what the Minister has very helpfully said already to frame questions around some of the amendments in the next group.

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

There is a clear principle that for an anatomical examination the person must be deceased. Parts removed from a living person would not go for anatomical examination. The person must be deceased. If parts were removed and the person subsequently died, it may well be that the parts that were removed before the person died could go, but I will get clarification, as that is a technical point. I have to admit that my officials will have to look at exactly what would take place.

In terms of appropriate consent, the Bill sets out who should be consulted in order to obtain consent, which is provided for precisely in clauses 2 and 3. The problem we have with the amendments is that to seek to refer instead to gaining consent from the appropriate person adds nothing to the Bill. However, new clause 1 and 2 are more difficult and would be rather more damaging. New clause 1 would require that whenever any post mortem activity was considered and the consent of an individual or their relatives was being sought, the person giving consent would be obliged to state whether they also consented to research and teaching in order for their consent to the post mortem to be valid.

Equally, the new clause would require that whenever living patients are receiving medical treatment, they must specify whether they consent to the use of tissue for education or research. It seems sensible to be clear in all cases what consent there is and to what activities it extends. However, the approach taken in the new clause goes against the principles on which this part of the Bill is based. The new clause would place obligations on the patient or relative to say whether they consented to a particular group of activities if their consent to the primary activity is to be lawful. It would place blanket requirements on the specification of consent, and there are several difficulties with that.

First, it is not our business to place statutory obligations on parents and bereaved relatives. The Bill sets out when the use of tissue would be lawful. It is not for us to tell individuals that they must give an answer to a question that they may not have wanted to be asked. Secondly, we would in effect be placing a responsibility on the health professionals always to address those questions to the patient or relative. For example, when a person gives blood for diagnosis, the new clause would mean that the person had to specify whether they wished that blood to be used for education or research, and the attending doctor or

nurse would have to ask, even when they knew that the sample would be disposed of immediately after the test was conducted.

Moreover, if a person receiving medical treatment had to specify whether tissue could be used for education or research, what would the position be if they failed or declined to consent to those further purposes? Would we refuse them the treatment if they had failed to answer the question? That would lead to many more problems than it would solve. Indeed, we do not believe that it would solve any problems at all.

New clause 2 takes a slightly different approach, but suffers from similar difficulties. In consenting to a post mortem, for example, the bereaved relative would be obliged to state whether they also consented to the use of the body or tissue for anatomical examination—dissection—or education and training, research, transplantation and public display. Frankly, it is unthinkable that consent would have to be obtained for all those purposes in such circumstances.

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

I am happy to accept the Minister's point and I do not intend to press new clause 2. However, I should like the Minister to consider the case that I cited. I accept that that case is not in new clause 2, but if it were to include part 2 issues only, a post mortem would be required to state whether relatives saw any problem with quality assurance, clinical audit or education and training that were incidental to the medical treatment and diagnosis. If the new clause were to include part 2, rather than part 1, would the Minister revise her thinking?

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

There has to be flexibility in the approach taken by the person dealing with bereaved relatives at any particular time. If there were no clear, prior guidance from the patient, it would not be appropriate to move on to ask for consent. We feel that it is right for those who are dealing with bereaved relatives to be able to make a judgment on what it is possible to ask at a particular time.

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

I understand and have accepted that point in respect of everything in this group except the issue of part 2 purposes such as clinical audit and quality assurance, which I maintain are part and parcel of port mortem examinations. Clause 1 states that the default position, if permission were given only for establishing the cause of death, is that the material cannot be used for clinical audit or quality assurance purposes; nor can any medical students or junior doctors watch the examination because specific consent is needed for those part 2 purposes.

Does the Minister think that under the relatively narrow circumstances of hospital post mortem requests, it might be worth while asking that question and ensuring that it is always asked? Otherwise, pathology laboratories will never know, or they will have half their specimens based on the data provided for by the hon. Member for South Cambridgeshire, on which they cannot carry out full work.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health 10:15 am, 27th January 2004

The point is that clinical audit, for example, does not require consent. Schedule 1 sets out that those are areas for which consent is not normally required in the same sense as public health monitoring or on-the-job training. It is set out clearly that consent is not required for those purposes.

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

That is except in clause 1(1)(e) and (g), which refer to storage and use

''for a purpose specified in Part 2 of Schedule 1 of any relevant material which has come from the body of a deceased person''.

Photo of Joe Benton Joe Benton Labour, Bootle

Order. We are into the next debate. If we stick to this one, we will get to that matter next.

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

We will return to that matter. The obvious difference is what can be used in terms of clinical audit for living patients and from the deceased. There is an issue about the need for consent where someone is deceased. If the material had been taken before they died, it would be possible for it to be used; if it were taken from a deceased person, there would be restrictions on its use.

The hon. Gentlemen may be trying to tease out an assurance that issues of the use of tissue and organs for research and transplantation will be addressed on every possible occasion so that the opportunities for donation are maximised. That is a laudable aim, but this is not the way to achieve it. The consequence of that approach would be that both patients and bereaved relatives were obliged to specify all manner of detail that they might not wish to consider. Doctors would have to ask whether they thought that appropriate. Those approaching bereaved relatives have to be aware of the difficulties that people face in some of those circumstances.

One of the main purposes of the Bill and of the consent provisions is to ensure a proper and positive engagement between medicine, science, patients and the public. We want to ensure that the use of tissue is based squarely on consent. We know that patients, as I have said, overwhelmingly will consent to the use of tissue for research. That is why it is right that they should be asked; current GMC guidelines state that we must not place obligations on patients. We must work with the trust and confidence that we build. It is by means of good practice, not statute, that we should consider when and how we seek such consent.

The hon. Member for South Cambridgeshire asked about generic consent; for example, if blood were taken and an individual stated that they were happy for research to be carried out, that sample could be kept for a length of time. We must distinguish between research that will lead, in general terms, to a particular scientific development and research that will affect an individual. For example, research might lead to the discovery that an individual has a particular disorder that might occur later in life. The use of samples for those purposes is a different scenario. That must be considered in the context of medical ethics committees, which look closely at what research is undertaken and how research material should be collected.

Photo of Doug Naysmith Doug Naysmith Labour/Co-operative, Bristol North West

I know of an archive that is kept for ovarian cancer purposes, which goes back 50 years. Permission for that was given for generic research purposes. How will what the Minister is saying affect the use of tissues that were given over a long period? There are now research purposes that were not thought of 50 years ago, through which useful information can be gained. How will the new proposals affect that? As a result of the Bill's preparation, people have been jumpy recently about what can and cannot be done with, for example, cell lines or tissue samples.

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

The Bill makes it clear that it will be lawful to use existing holdings. There is guidance on the circumstances in which some of those holdings should be used and whether, in some cases, they should be returned. The subject is delicate because some existing holdings are traceable to individuals and any dealings must be sensitive. We are aware that existing holdings contain a lot of valuable archive evidence that can be used for research. We want to clarify that that evidence can be used where appropriate and right, as long as it would not cause distress.

It is important to distinguish between the two areas that I was outlining. A person can specify that they are happy for blood, for example, to be used and stored for medical research. However, we must be aware that if research has an effect on an individual, medical research committees and those that commission research must ensure that people are fully aware of the use to which the research might be put.

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

The Minister agrees with the points made by Opposition Members; it is important, when consent is given, to be clear about the particular scheduled purpose for which that consent has been obtained. She is referring to the difference between paragraph 7 of schedule 1, which refers to research

''in connection with disorders, or the functioning, of the human body'', and paragraph 5, which refers to obtaining

''scientific or medical information about a living or deceased person which may be relevant to any other person''.

There is a significant difference between the idea of being part of an anonymised research programme, and information that might be relevant to an individual.

Clearly, we must be able to distinguish between those purposes. To return to the Bill, if it is the Minister's intention that that should be so, and given that it is not required to be the case in the Bill—one could, in theory, give consent for all scheduled purposes in one ticked box, without distinguishing between the purposes—how does she propose that it should be done? Will it be done through codes of practice from the Human Tissue Authority—I do not think that the codes of practice allow that—or through the general principles that have been set out in relation to the remit of the authority? Which is it to be?

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

It will be a mixture of the two. We are building on what is already in guidance regarding how consent should be obtained. We are not altering the position as it stands in respect of what is allowed under best practice. In certain areas, it will be important to

make a distinction. What is, in effect, generic consent can be used in relation to medical research, but there is not always complete anonymity.

In respect of public health monitoring, something might be anonymised. Particular types of research might relate to the individual but not necessarily affect the individual if something was found out from a sample that could have an effect on their life. Knowing the condition of the person, one would wonder whether they should be informed of it. There is a distinction, and the ethics committees will be brought in to ensure that any research follows the most relevant way of gathering the materials.

Photo of Doug Naysmith Doug Naysmith Labour/Co-operative, Bristol North West

What my hon. Friend the Minister is saying makes a lot of sense. There is the question of best practice and in many hospital laboratories and so on best practice is followed well. What really needs to be answered is how that best practice is to be promulgated after the Bill has been put into effect. At the moment, there are problems with certain ethics committees perhaps interpreting their role too rigorously or not rigorously enough. We must ensure that best practice, if that is what we are to depend on, is promulgated and that we know what it means.

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

My hon. Friend is right, and we would expect the Human Tissue Authority to take action on that issue.

Under clause 56(1) to (3), ''anatomical examination'' refers only to examination by dissection of bodies or parts removed from a body after death. Parts of a body removed during life may well be examined or used after the person dies. That could be done under other scheduled purposes, but it would not be defined under the Bill as anatomical examination. I hope that that clarifies the position for hon. Members.

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

It is clear; Opposition Members had already reached subsection (3) and seen that. Will the Minister clarify under which schedule a dissection for the purposes of studying the morphology of tissue would be considered to have consent if the tissue were taken from someone in life and were used for that purpose?

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

I think that that is under schedule 1(1). The first paragraph of the schedule relates to anatomical examination.

The post mortem situation addressed in the amendments is even more delicate, and we must be careful in how we approach bereaved relatives as an obligation on them to specify all manner of detail would be wrong. We already have a code of practice on communication with relatives at post mortems and consent forms that help to guide us carefully through that process. Good practice will ensure that those questions are put at the right time and in the right way. There are sometimes circumstances in which such questions should not be asked, and it would be wholly wrong to place obligations on the decision maker.

I am afraid that we cannot accept the amendments, and I urge the Committee to reject them.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest 10:30 am, 27th January 2004

The debate has been very helpful, particularly to me. I am delighted that the Minister has accepted that such uncertainty exists in the research community and that the situation needs clarification. I was even more pleased with her honesty in admitting her confusion over some of the technical details, because her honest approach augurs well for the progress of the Bill. The last thing that I would want to do is restrict flexibility, so we will return to the codes of practice under the Human Tissue Authority in amendment No. 87.

I welcome the clarification of consent for use of a body for anatomical dissection, because one nightmare for a practising physician is when relatives say that their mother wanted to bequeath her body to medical research. When I was working, the channels for coping with that situation were extraordinarily difficult.

I agree that we must build on current best practice. The Minister made me think hard about making consent a legal responsibility, because when I looked at the consent form from which I quoted, I realised that I would not automatically have asked for consent for medical research and education if I sensed that the family with which I was dealing was already too hurt and damaged. I would not want to remove the right of the attending doctor to decide what consent he should request.

I welcome the discussion and the clarity that it has brought as we have raised and explored the issues, but I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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

I beg to move amendment No. 57, in

clause 1, page 1, line 11, after 'in', insert 'Part 1 of'.

Photo of Joe Benton Joe Benton Labour, Bootle

With this it will be convenient to discuss the following:

Amendment No. 58, in

clause 1, page 1, line 15, leave out paragraph (e).

Amendment No. 59, in

clause 1, page 1, line 19, leave out paragraph (g).

Amendment No. 60, in

clause 1, page 1, line 21, leave out

'the purpose of anatomical examination'

and insert

'any purpose specified in Schedule 1'.

Amendment No. 62, in

clause 1, page 1, line 21, leave out

'the purpose of anatomical examination'

and insert

'any purpose specified in Part 1 of Schedule 1'.

Amendment No. 61, in

clause 1, page 2, line 7, leave out

'the purpose of anatomical examination'

and insert

'any purpose specified in Schedule 1'.

Amendment No. 63, in

clause 1, page 2, line 7, leave out

'the purpose of anatomical examination'

and insert

'any purpose specified in Part 1 of Schedule 1'.

Amendment No. 48, in

schedule 1, page 37, line 6, at end insert

'for purposes which may include—

(a) determining the cause of death,

(b) education or training which is inherent in anatomical examination,

(c) establishing after a person's death the efficacy of any drug or other treatment administered to him,

(d) clinical audit,

(e) public health monitoring, or

(f) quality assurance.'.

Amendment No. 64, in

schedule 1, page 37, line 6, at end insert

'other than for the purposes set out in paragraphs 2 to 5 and 7'.

Amendment No. 49, in

schedule 1, page 37, line 7, at end insert

'otherwise than by anatomical examination'.

Amendment No. 65, in

schedule 1, page 37, line 12, leave out 'incidental to' and insert 'inherent in'.

Amendment No. 67, in

schedule 1, page 37, line 15, at end insert

'other than activity considered to be clinical audit'.

Amendment No. 66, in

schedule 1, page 37, line 26, leave out 'incidental to' and insert 'inherent in'.

Amendment No. 69, in

clause 2, page 3, line 17, after 'examination', insert

'other than for the purposes of paragraphs 2 to 5 and 7 of Schedule 1'.

Amendment No. 70, in

clause 2, page 3, line 25, after 'examination', insert

'other than for the purposes of paragraphs 2 to 5 and 7 of Schedule 1'.

Amendment No. 71, in

clause 3, page 3, line 42, after 'examination', insert

'other than for the purposes of paragraphs 2 to 5 and 7 of Schedule 1'.

Amendment No. 72, in

clause 3, page 4, line 11, after 'examination', insert

'other than for the purposes of paragraphs 2 to 5 and 7 of Schedule 1'.

Amendment No. 78, in

clause 56, page 33, leave out lines 12 to 15.

Amendment No. 79, in

clause 56, page 33, line 29, leave out subsection (2).

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

This large group of amendments can be broken down into five sub-groups. I will first set out how I propose to divide them and what questions I will raise, and then discuss them in more detail.

I would like to help the Committee by suggesting that amendments Nos. 57, 58 and 59 are one distinct sub-group, which deal with the issue of a separate part 2 to schedule 1. My main question is whether it is logical that part 2 exists and that the default position is that of not requiring consent for performing activities such as hospital-interest post mortems on relevant material from deceased persons.

The second sub-group contains amendments Nos. 60, 62, 61 and 63. They are probing amendments on the requirement for death certification. I understand

that that is carried over from previous Acts, such as the Anatomy Act 1984. It would be helpful if the Minister could explain that, and also why ''public display'' is not included in the same provision.

The third sub-group to which I shall speak includes amendments Nos. 64 and 49 and, by extension, in clauses 2 and 3, amendments Nos. 69, 70, 71 and 72. We have already dealt with some of those matters and my remaining questions will be brief. They probe the definition of ''anatomical examination'' and consider—for those not intimately acquainted with the Anatomy Act—whether that definition could be clearer in the Bill.

The fourth sub-group is amendment No. 65 alone. It asks whether the words ''incidental to'' education and training are right. Finally, amendment No. 67 is another probing amendment on the distinction between clinical audit and the purpose in the schedule. Amendments Nos. 78 and 79 go with the third sub-group of amendments, together with amendments Nos. 64 and 49, because they examine the definition of ''anatomical examination'' that we have already covered.

Amendments Nos. 57, 58 and 59 would, while not removing part 2, have the effect of not differentiating, for the purposes of schedule 2, between consent sought for material from living persons and from deceased persons. Subsection (1)(c) would therefore have to do with

''the removal from the body of a deceased person, for use for a purpose specified in'' part 1 of schedule 1 of any relevant material that the body consists of or contains.

Amendments Nos. 58 and 59 would delete paragraphs (e) and (g) of subsection (1), which relate only to purposes specified in part 2. There is a problem for pathology labs and relatives, as those purposes are not already provided for within the consent for schedule 1. Unless the Minister proposes that they can be stand-alone issues, and that relatives will be asked to provide permission for material from a deceased body for part 2 purposes, not as a consequence of another purpose in part 1, that would create problems. Is it logical to require specific consent, for example, for quality assurance or clinical audit in a pathology lab dealing with post mortem examinations?

Would not it be better for the code of practice and the consent form to make clear that giving consent for a hospital post mortem—not a coroner's post mortem—for the purpose of determining the cause of death, or establishing after a person's death the efficacy of any drug or other treatment administered to them, may require clinical audit and quality assurance, and would particularly entail some education and training incidental to the medical diagnosis and treatment? The default position would otherwise be that those boxes were not ticked. We have heard from the hon. Member for South Cambridgeshire and the Minister that on many occasions boxes are not ticked as a consequence of the fact that we are dealing with a difficult area and often the minimum consent is that which is obtained.

If that is the case, it seems reasonable for education and training incidental to medical diagnosis or treatment to be part and parcel. Otherwise, it will be difficult for pathology labs to ask people who might be watching a post mortem examination or part of it to leave the laboratory because there is not permission for that education or training which is inherent in NHS best practice and is required for continued best practice. I am finding it difficult to understand why one cannot deal with these areas in the same way.

Perhaps Ministers were tempted to require consent for part 2 purposes for samples from living people but decided that the volume of such samples would be too great and would create problems because of the frequency with which implied consent is given for the removal of some samples such as blood samples or cytological specimens; therefore, there would not be anything in writing to determine. That is a pragmatic approach that I support, but I think that the same should apply to the purposes set out in part 2 for permission for using relevant material from deceased persons.

The impact on relatives of having to explain clinical audit quality assurance and education or training incidental to medical training or diagnosis is disproportionate to the additional autonomy that it gives families in those circumstances. I have not heard any concern raised by those representing the people who were so badly treated in the Alder Hey scandal. The problem was that clinical audit, incidental education or training, public health monitoring or quality assurance was being carried out without specific consent. This is not a proportionate response to those incidents. I would be grateful if the Minister would explain that.

The impact on the service could be significant. If clinical audit is to mean anything, it has to be on a reasonable sample of material. If paperwork has to be gone through to identify those 30 per cent. of samples where explicit permission was given for clinical audit, we are undermining the point of clinical audit. It becomes unrepresentative, and the same applies to quality assurance. It is vital that quality assurance tackles the whole range of work carried out in a pathology lab. There will be questions over whether it will be possible for the service to maintain quality in those circumstances.

One argument might be that the impact on deceased persons and their families will be greater for part 2 purposes than the impact on living people when part 2 purposes are carried out, and that therefore one needs specific consent. If anything, partly because the person concerned is deceased and therefore there will be no direct implications for them of the results of public health monitoring, the impact on those individuals is less than that as a result of public health monitoring, which does not specify that it is anonymised and therefore might not take place on people who are alive. We will come to the question of public health monitoring when we deal with the schedule later, and it is tangential to what I am saying, but I use it as an example of the impact on the individual. The default position should be that those part 2 purposes are

permitted when consent is given for one of the other schedule purposes using material from a deceased person. I would be grateful for the Minister's response.

Amendments Nos. 60, 62, 61 and 63 are probing amendments. I was seeking to give the Minister the opportunity to clarify why a death certificate is required only for

''The storage of a body of a deceased person for use for the purpose of anatomical examination'' and not for anything else. The hon. Member for Wyre Forest may want to intervene at this point, because he would certainly have some knowledge of whether that requirement is also necessary for some other purposes. It may not be necessary to set it out in such a way.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest 10:45 am, 27th January 2004

It is an example of the confusion. There must be a death certificate before a post mortem, even if the cause of death is unknown. That is where my confusion arises, and I hope that the Minister will be able to explain the matter more.

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

I hope that that is so. I think that the hon. Gentleman is saying that there might be other circumstances with hospital interest post mortems for which a death certificate is required. The Minister is creating under subsection (2) a statutory requirement for a death certificate, and under subsection (3) a requirement for that death to have been registered.

The same thing might usefully apply in respect of public display, for reasons that were made clear when debating consent. Although that is not the specific subject of the amendments, it may be better to deal with it now, rather than under some separate clause stand part debate. Reading across from the Anatomy Act, I wonder whether subsections (2) and (3) catch up with the issue of public display, as the Minister says she was keen to do. In that respect, I am seeking to be helpful.

Amendments Nos. 64, 49, 69, 70 to 72, 78 and 79 to clause 56 probe the definition of anatomical examination. In our previous debate, the Minister clarified that anatomical examination is of either the body or parts of the body that were taken once the person was dead. Therefore, dissection for purposes of teaching or studying, or research into morphology, which might be done on a diseased kidney removed from someone alive, for example, are not considered anatomical examination. The distinction drawn when the Minister replied in rapid order to my question might be covered not by schedule 1(1), but perhaps by paragraph 7. Perhaps the Minister will clarify that when she responds.

Have the Government given any thought to or consulted on whether the definition of anatomical examination should be updated? The definition in the Bill is a read-across from previous Acts. Part of the problem with the schedule is that anyone reading it who was not acquainted with the legislation might not understand that an anatomical examination is as defined in clause 56; it does not imply dissection or anatomical examination by deception. The purpose of schedule 1 is to help communicate to the public what is going on, so there should be specific reference in

clause 56 to anatomical examinations in schools of anatomy. That is not obvious unless one is already aware that that is the case. I am prepared to confess that many of my initial amendments were tabled when that was not entirely clear to me or to those who were advising me.

Amendment No. 65 tackles the question of the words ''incidental to''. The issue is not whether ''inherent in'', which I suggest would be better—I suspect that it might not be—but whether that is the best terminology. Schedule 1 refers to

''education and training which is incidental to medical diagnosis or treatment.''

That means the presence of trainees or medical students, or students of other health care professions, being taught at post mortem examinations—including the use of slides and tissue blocks for microscopy and histopathology—while diagnosis is proceeding and cause of death being determined, or while other scheduled purposes are being undertaken. I am not sure that ''incidental to'' communicates that particularly well. I would argue for wording that might clarify the matter, such as ''connected with'' or ''related to''. It was clearly in the minds of those who drafted the Bill that education and training at the time of those other activities should be separate from later education and training. A problem in histopathology is that slides and blocks are routinely taken with consent and then used for teaching purposes. It is not clear whether that would be considered to be ''incidental to'' medical diagnosis or treatment, or whether it would require specific consent under paragraph 3 of schedule 1. That refers to

''Education or training relating to—

(a) human health, or

(b) research in connection with disorders, or the functioning, of the human body''.

If the default position is that using those slides for teaching the next generation of histopathologists will not be possible, that might be a problem unless the definition of

''incidental to medical diagnosis or treatment''

Is widened. I am not necessarily arguing for that, because I think that consent is important in this area, but I am questioning whether ''incidental to'' is the right language, and is wide enough to cover a sufficient proportion of the teaching and training that takes place in pathology laboratories.

Amendment No. 67 would add the words

''other than activity considered to be clinical audit'' to paragraph 4 of schedule 1, which currently reads:

''Establishing after a person's death the efficacy of any drug or other treatment administered to him''.

It is reasonable for the amendment to be considered with this group here because it concerns whether separate consent is required for clinical audit. Of course, establishing

''after a person's death the efficacy of any drug or other treatment administered to him'' is a key component of many clinical audits. Indeed, if we are concerned with the unintended and/or adverse effects of drug treatment, we need rather more clinical

audits. If those who drafted the Bill intended that such activities would be covered under clinical audit in paragraph 9, I should be interested to know what purposes under paragraph 4 would be considered by the Minister that could not be covered elsewhere. Where appropriate permission for taking the tissue in an operation has been given by a living person, does such clinical audit require specific consent? What happens if, for example, someone going in for a major operation gives consent for a tumour to be removed but then subsequently dies? If the hospital wanted to measure the concentration of the chemotherapeutic agent in the tissue, would that be covered by ''clinical audit'' in paragraph 9 or, because it comes after someone's death, by paragraph 4, which covers

''the efficacy of any drug or treatment administered''?

That may seem a minor point, but several clinicians have asked me to seek clarification.

I hope that breaking down the amendments into those five groups has been helpful, and I look forward to hearing the Minister's response.

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

It was helpful for the hon. Gentleman to take the group of amendments apart to address their purposes. I will work backwards in my contribution, as I will probably remember the arguments better.

The hon. Gentleman will agree that some of the amendments are designed to elicit answers rather than improve the Bill. On amendment No. 67, I am not sure whether we need to include the phrase

''other than activity considered to be clinical audit'' in paragraph 4. That is not necessary, as if the primary purpose is clinical audit rather than establishing the efficacy of drugs or other treatment, it would fall under part 2 of the schedule.

The question of what constitutes a clinical audit is a fair one, however, and a pathologist raised a useful example with me, which concerns cervical smears. As I understand it, in the testing of cervical smears, the point of diagnosis is the same as the point at which one knows whether a particular sample could be valuable for subsequent teaching and testing. How will that situation be dealt with? There are 5.5 million smear tests a year, a significant proportion of which might subsequently be needed for education and training or clinical audit. Will clinical audit suffice as an answer to the question? Such smears are not covered by the provision for

''Education and training which is incidental to medical diagnosis or treatment'', as the diagnosis is completed at the point at which a proportion of them is valid for education or training.

The smear tests are used either to show other technicians what a tissue should look like or, with other tests, to establish overall quality. The latter use is clearly covered by clinical audit, but the question of education and training that is not incidental to medical diagnosis raises a real problem. Will we have to return after diagnosis to the large number of women who have consented to treatment to ask for further consent, or will we consent 5.5 million people routinely for education and training?

I was not persuaded by what the hon. Member for Oxford, West and Abingdon said about the phrase ''incidental to'' and ensuring a sufficient range of activity for education and training. Replacing it with ''inherent in'' would restrict the range of activities, rather than widen it, as ''incidental'' is about as wide a term as possible. It seems that the amendment would have the opposite effect from its purpose.

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

I could have tabled a series of amendments with different words. I said at the outset that the purpose of the amendment was to probe the question of whether the word ''incidental'' was too narrow or wide.

On cervical smears, the hon. Gentleman said that the consent that would be applied and implied by the inclusion in part 2 of the provision on

''Education or training which is incidental to medical diagnosis or treatment'', for which consent is not needed if the tissue comes from a living person, is not wide enough to cover the education and training that he thought would be done on a large scale using the samples that he described. I should be grateful if he would clarify whether he agrees that there is a problem—if not with the words, with the intention.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health 11:00 am, 27th January 2004

The point that I am making is that there may be a problem and that it will not be solved by moving clinical audits in. If it is a quality assurance operation or a clinical audit operation, it is clearly a part 2 purpose. However, in relation to education and training, the subset of smear tests that is diagnosed subsequently and clearly illustrates particular aspects of what a technician is looking for would not be ''incidental to'' diagnosis or treatment because it is after diagnosis. That particular instance raises the question of whether ''incidental to'' has wide enough scope. That may be quite a practical, large-scale illustration of how the language suggests that in order for subsequent education and training to be carried out on such smears, it must be consented to. However, it would not be practical to go back and obtain the consent of large numbers of people, and therefore we would have to gain the consent of 5.5 million people at the outset, which should not be our aim. It raises the question of whether

''Education or training which is incidental to medical diagnosis or treatment'' is the right language in this instance, and whether it would give rise to a problem when diagnosis is complete.

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

The hon. Gentleman accepts my point. Neither he nor I accept that my amendment is better. Perhaps it would have been better if we had both tabled further amendments, such as one that said ''incidental to or further to'' medical diagnosis or treatment, or ''connected to'' that medical diagnosis or treatment. There would then have been no question of using cytological specimens from smears for a purpose

other than education and training relating to that diagnosis or treatment—for a genetic study, for example.

It is not our direct responsibility to come up with alternative wording—the Bill will go through further stages—but it would help if we could discuss some substantive examples. I regret that my amendment did not provide a good enough example for us to work on directly.

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

We can leave that question because our discussion illustrated the point. The Minister can ponder on it and respond to it.

As the hon. Gentleman suggested, the definitions of ''anatomical examination'' have been transferred unchanged into clause 56 from the Anatomy Act. We debated earlier what that means in practice; the definitions are well set out in clause 56. However, in the Anatomy Act, it was defined in relation to a specific process confined to anatomical examination. In the Bill, we are using that definition alongside a range of other purposes, and people will inevitably start to examine that and try to decide which is which. Although there has not been some mischief in the past, and we are not trying to remedy a definitional problem under the Anatomy Act, we must be sure that a definitional problem is not likely to arise in future. That would not necessarily be the case; the definition mainly rests on the question of dissection, but it might also rest on the definition of morphology. However, I do not think that I will go down that path.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

My hon. Friend's reference to morphology has woken me from my musings on other things. The point about morphology has been raised by a number of people who have corresponded with us about the Bill. There is particular concern about the definition of morphology. I believe that the meaning in the Bill is that of gross morphology—the structure, consistency and size of solid objects—but morphology means a great deal more than that. It can also concern cells, for example. My hon. Friend is right to query the meaning of morphology in the Bill; it would be nice to have that clarified.

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

I am grateful to my hon. Friend. One reasons why I did not wish to pursue that subject further was that I thought that he would do it better than me.

It seems to me that it is possible that other scheduled purposes in part 1 could be pursued by way of dissection and study, including the study of the morphology of an organ or tissue. It is therefore conceivable that people might be unclear as to what is required to be treated as anatomical examination and what is not. The conclusion one should come to is that if there is any uncertainty, one must examine the activity and if it consists of dissection and is for the purposes of morphology, it must be anatomical examination and the relevant constraints must apply. It is not possible to say that something that equates to anatomical examination is a different scheduled purpose and so should escape the relevant constraints. If I am wrong, the Minister will tell me. However, if

that is the case, there will not be many boundary problems because anything that appears to stray over the boundary is anatomical examination.

I am unsure of the intention of the hon. Member for Oxford, West and Abingdon in trying to shift the requirement for consent so that it must be given for living persons, as for deceased persons, for the purposes laid out in part 2 as well as part 1 of schedule 1. The hon. Gentleman missed the point that living people consent to treatment. He mentioned the question of implied consent, but we must judge what is implied by consent for treatment. Currently, clinical audit, education incidental to medical diagnosis or treatment, and certain aspects of quality assurance are regarded as enmeshed with the process of treatment. Therefore, it would be difficult to obtain consent for them separately without running the risk of prejudicing the treatment of someone who does not consent. The fact that they are enmeshed means that consent to treatment also implies consent to those purposes.

Part 2 of schedule 1 contains other purposes, such as the proverbial junior doctors or medical students standing round one's bed, which might be incidental to medical diagnosis or treatment but does not have to be consented to. Certain quality assurance processes or public health monitoring purposes would not automatically flow from treatment. Under those circumstances, although consent is not normally required for those purposes in general, patients should be able to withhold consent. We must be sure that the codes of practice permit the Human Tissue Authority to make clear that there are specific instances in which, although the activity may come under the scheduled purposes, patients should be able to withhold consent because it would not prejudice their treatment.

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

I am a little troubled. We are talking only about tissue; the Bill does not address the issue of whether medical students should be allowed to gather around patients' beds. That issue will be dealt with under common law; people have the right to say, ''No, thank you'', and there are questions about whether best practice should be always to ask. I am sorry if I was not clear, but I was trying to ascertain whether there should be a distinction between the need for definite consent to use material from a deceased person for those purposes, when the Bill makes clear that there is no need for consent to use the relevant material from a living person. Is that distinction justified?

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

I understand the hon. Gentleman's point. I thought that he was coming from a different direction but, if he turns his point around, the same arguments apply. For the relevant purposes, with some exceptions, consent is implied in the consent to treatment, because the activity is enmeshed with the treatment. For a deceased person, there is obviously no longer a consent to treatment, so no limitation on the extent of the retention of organs and tissues can arise from it.

It is therefore necessary for consent to be explicit on the retention or use of a deceased person's organs and tissues. That is the distinction between living and deceased persons that we must bear in mind. We must always remember that underlying the Bill is the common law of consent to treatment of living people, which rightly gives rise to differences to the way that the Bill treats living and deceased people.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest

I have to admit that I put my name to amendments Nos. 48 and 49 because of a lack of understanding. To me, even considering clause 56, the term ''anatomical examination'' covers a post mortem. The hon. Member for South Cambridgeshire has also mentioned his confusion on that point. Schedule 1 needs clarification, and I am not sure of the basis of the difference between parts 1 and 2. Clinical audit can easily require the use of human tissue, but schedule 1 does not state that we have to have permission to do that.

Unfortunately too late to table an amendment, I realised that the Royal College of Pathologists had suggested alterations to schedule 1. Its suggestion would solve the problem by including a part 3 to cover purposes not normally requiring consent

''in accordance with codes of practice produced or endorsed by the Human Tissue Authority and provided that the bodily material has been lawfully removed.''

That would remove my objection.

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

As has been touched on, the combined effect of amendments Nos. 57 to 59 would be contrary to the main intention of the Bill. As has been said many times, the Bill arose from the distress, grief and anger felt by families when they discovered that the organs of their deceased loved ones had been removed and retained without their consent. The Bill's aim is to ensure that that does not happen again.

The requirements for appropriate consent set out in clause 1, for the purposes listed in schedule 1, give effect to the universally accepted principle that the mistakes of the past are not repeated. Clause 1 is intended to ensure that no human bodies, body parts, organs or tissue will be taken for research or other specified purposes without the consent of relatives or patients.

The amendments would have the effect of allowing the removal, storage and use of all relevant material, including organs, from the bodies of deceased persons without any form of consent from the person themselves or from their relatives or loved ones. It may be argued that the Bill allows the storage and use of tissues and organs for certain limited purposes without specific consent. The Bill allows activities for the purposes in part 2 of schedule 1 to be carried out without explicit consent for those purposes from living patients. However, that is entirely different from the situation that would result from the amendments proposed by the hon. Member for Oxford, West and Abingdon.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon 11:15 am, 27th January 2004

I am grateful to have the opportunity to make it clear that my intention was not to allow the removal, use or storage of organs without permission in any circumstances. I argue that the wording of amendments Nos. 57 to 59 would not do that, because the deletion of paragraphs (e) and (g) would mean that one could obtain the material only by reference to paragraphs (d) and (f) respectively. One would still have to have a scheduled purpose and the appropriate consent relating to that. One would not be able to carry out activities for part 2 purposes without already having lawful consent that was predicated on a part 1 purpose.

Similarly, the amendment in paragraph (c) to include part 1 would mean only that someone would need to have a part 1 purpose before being able to act for part 2 purposes. It would not mean that no consent was needed to remove the organs concerned. I want to make that clear and to have it explained to me why I am wrong in that respect, before the allegation is repeated.

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

The hon. Gentleman argued that because, with a living patient, consent for the purposes in part 2—purposes not normally requiring consent—will be deemed to have been given, the activities should be able to go ahead anyway if the person is deceased, for the purposes of clinical audit, education or training, public health monitoring and quality assurance.

The Government expect best practice to mean that if tissue, blood and so on is taken and the samples are to be used for the purposes in paragraphs 9 to 12 of schedule 1, information will still be given that that may happen. Best practice involves, for example, putting leaflets in waiting rooms to say that if a blood sample is given, it may be used for certain purposes. That means that if people have an objection, they can register it.

If someone has died, the circumstances are quite different. Unlike with living patients, there is no common law requirement to obtain consent for the removal of tissue, so under the amendments, no consent would be necessary to remove, store and use material for part 2 purposes from a person who had died. If a person had given permission before they died for medical research and so on to be carried out on them, that would go ahead anyway. If relatives consented, for example, to a post mortem, it is quite likely that they would give consent for the purposes in part 2, which include clinical audit.

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

I hope that the Minister and I are not being distracted by the fact that there is no amendment in the group to delete part 2 of the schedule. I hope that, for the purposes of making the narrow point that I am seeking to make, we can ignore the fact that there is a part 2, but I would still argue that before any tissue can be removed from a dead person, the activity would be lawful only if carried out with appropriate consent and when stored for the use or purpose specified in part 1—or what is left of the schedule—of any relevant material that has come from the human body. There

will be no question for the purposes of clinical audit or education and training incidental to medical diagnosis of organs being taken without that needing to be done lawfully ''with appropriate consent'' under paragraphs (c), (d) and (f) of clause 1.

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

That is not the effect of the amendments. It is clear that the result of the hon. Gentleman's amendments would be that consent was not necessary to remove, store and use materials for the purposes of part 2 of schedule 1. Amendment No. 57 would remove the requirement for consent to removal for part 2 purposes.

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

The Minister is broadly right, but not specifically by reference to removal. The amendments would still make it lawful only for the removal of relevant material from a deceased person for a scheduled purpose if it were done with appropriate consent, because the amendment tabled by the hon. Member for Oxford, West and Abingdon does not remove subsection (1)(c). Subsequent storage or use of part 2 purposes could take place without consent because the effect of the amendment is to remove the requirement for consent with regard to a deceased person in relation to part 2 purposes.

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

It is difficult to see how one would store and use material if it were not removed in the first place. That is the point.

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

Perhaps it might help the debate if we considered that part 2 did not exist or that an amendment in this group deleted part 2. It has clearly been necessary to make this point. Will the Minister consider the three amendments in the context of there not being any more of part 2 so that there are no other scheduled purposes for which it might be lawful to store or use material? We are stuck with paragraphs (c), (d) and (f), which refer to part 1 of schedule 1. I am hoping that, for the purposes of debate and so that we do not miss the opportunity to raise the point—it is important for the reasons that I gave earlier—the Minister can deal with the arguments that do not assume that there is a part 2 present hanging in the air that might be used as an excuse to remove tissue.

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

I do not quite understand what the hon. Gentleman means by there not being a part 2 present.

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

Let me make it even more explicit. In the light of what the Minister says—I am not saying that I accept it, but let us say for argument's purposes that I do—a more consistent group of amendments would be Nos. 57 to 59 and an extra one to delete part 2. Therefore, it would never be lawful to remove organs from a deceased person for any scheduled purpose except where a schedule was specified in the old part 1, and that would be the only part of the schedule that applies in my amended clause 1(1)(c), (d) and (f). On that basis, the concern that she raises—that because there is a part 2 for which consent is not required and

one can remove material for a scheduled purpose—need not apply for the sake of the argument. If I accept that point, I would argue that she should imagine a situation where there was no part 2 left.

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

That is an interesting concept. However, we have to work with the practicalities. It is important that for living patients we distinguish between purposes not normally requiring consent as set out in part 2 and purposes normally requiring

consent. The logic of the hon. Gentleman's argument is that, for the purposes of the deceased, those two are rolled together. I believe that that is what he is saying. There would therefore be a completely separate schedule 1 for those who are deceased, as opposed to living patients. However, if that were the case, it would still revert to the current position: consent would have to be asked for. The position at the moment is—

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

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

Mrs. Irene Adams (Chairman)

Cohen, Harry

Davey, Valerie

Ellman, Mrs.

Francois, Mr.

Gibson, Dr.

Harris, Dr. Evan

Kilfoyle, Mr.

Knight, Jim

Ladyman, Dr.

Lansley, Mr.

Lucas, Ian

Murrison, Dr.

Naysmith, Dr.

Ryan, Joan

Taylor, Dr. Richard

Watson, Mr.

Winterton, Ms Rosie