Human Tissue Bill

Public Bill Committee, 27 January 2004.

Human Tissue Bill

Rosie Winterton (Labour, Doncaster Central)

I beg to move,

That—

(1) during proceedings on the Human Tissue Bill, the Standing Committee, in addition to its first sitting on Tuesday 27th January 2004 at 9.10 a.m., shall meet on that day at 2.30 p.m. and on Thursday 29th January, Tuesday 3rd February and Thursday 5th February at 9.10 a.m. and 2.30 p.m.;

(2) the Committee shall consider the Bill in the following order: Clause 1, Schedule 1, Clauses 2 to 10, Schedule 2, Clauses 11 to 13, Schedule 3, Clauses 14 to 35, Schedule 4, Clauses 36 to 46, Schedule 5, Clauses 47 to 50, Schedule 6, Clauses 51 to 57, New Clauses, New Schedules, Clause 58, Schedule 7, Clause 59, Schedule 8, Clauses 60 to 63 and remaining proceedings on the Bill;

(3) proceedings in the Committee on the Bill shall (so far as not previously concluded) be brought to a conclusion at 5 p.m. on Thursday 5th February 2004.

May I welcome you to the Chair, Mrs. Adams? This is the first Bill that I will have taken through Committee, and it will be wonderful to do so under your guidance.

The Bill is an important measure that seeks to balance the legitimate rights and expectations of families with equally important but broader public health considerations. It will make consent the clear basis for the keeping and use of tissue organs, and will restore confidence so that important health research can proceed with the support of patients, families and the public. It will ensure that events such as those highlighted in the Alder Hey, Bristol and Isaacs inquiry reports will not happen again. It also provides an opportunity to establish a consistent and comprehensive framework, in which principles of consent will apply to all medical uses of human bodies, organs and tissue.

I am sure that members of the Committee will find much common ground, as was the case on Second Reading. It will be good for us to proceed in that spirit. It will be cosy on the Labour Benches in this Room. We recognise the contributions of professional and family groups in delivering the broad consensus that lies behind the proposals in the Bill. I am looking forward to the discussions, and to the assistance of Committee members in delivering what my hon. Friend the Member for Norwich, North (Dr. Gibson) described on Second Reading as

''a landmark Bill, of which we shall all be proud.''—[Official Report, 15 January 2004; Vol. 416, c. 1012.]

Andrew Lansley (Conservative, South Cambridgeshire)

I join the Minister in welcoming you to the Chair, Mrs. Adams. Your reputation for fairness precedes you, and I expect that, as long as we behave ourselves and

maintain order, you will be a benevolent dictator. We on the Conservative Benches will endeavour to keep to that stricture.

I entirely agree with the Minister that proceedings will be cosy; this is not one of the cavernous Committee Rooms with which we are usually provided. If the Minister finds that it becomes too cosy on the Labour Benches, she may make use of space on the Opposition Benches. Indeed, we might reach that stage for other reasons.

The Minister rightly said that this is an important Bill that secured support in principle from all parties, but there are reservations about many of the details. The 46 or so groups of amendments that have been tabled reflect the difficulties that have ensued. I am sure that we will complete our consideration on time, as we are instructed to by the House, but I hope that we use the time productively to amend the Bill to meet many of the concerns raised by various outside interests. I will not bore the Minister or the Committee by repeating this point, but it needs to be made once: the range of amendments and the number of representations made to hon. Members indicate the uncertainty and lack of clarity felt about the Bill, particularly in the medical research community. That concern should have been removed by pre-legislative scrutiny. I called for that in a debate on 29 April 2003, and the then Minister undertook to facilitate it by publishing a draft Bill by the summer recess. Such a Bill was not published, however.

The Bill before us was published in December, and the Committee is debating its provisions in January. We shall also consider the many comments of the medical research community, the pharmaceutical industry, clinicians and pathologists, who are concerned about the practical implications of the legislation. Those groups are by no means comfortable with certain aspects. Indeed, although the intentions and purposes are supported, as far as I can see, their implementation is not attracting the same support across the medical and research community, so we have a job to do.

I am sure that the Programming Sub-Committee was not wrong in setting out a simple programme whereby we go from the start of the Bill and get to the end. Fortunately, this is not one of those Bills for which we must start in the middle, but we should not let the moment pass without being aware that there might have been a better way to consider the detail.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I associate myself with the remarks welcoming you to the Chair, Mrs. Adams, and with those made by the hon. Member for South Cambridgeshire (Mr. Lansley) about the sadness that there was not pre-legislative scrutiny and that we shall have to conduct additional scrutiny in Committee on what are complex matters. There is a lack of clarity about many provisions, and we shall need a lot of your help and guidance to ensure that we get through the Bill and obtain the required clarification as quickly as possible. In that spirit, I shall finish my remarks now.

Question put and agreed to.

The Chairman: I remind the Committee that there is a money resolution and a Ways and Means resolution in connection with the Bill. Copies of the two resolutions are available in the Room. I also remind hon. Members that adequate notice should be given of amendments. As a general rule, my co-Chairman and I do not intend to call starred amendments, including any that may be reached during the afternoon sitting.

Clause 1 - Authorisation of activities for scheduled purposes

Richard Taylor (Independent, Wyre Forest)

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'.

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.'.

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.

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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.

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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?

Andrew Lansley (Conservative, South Cambridgeshire)

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.

Rosie Winterton (Labour, Doncaster Central)

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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?

Rosie Winterton (Labour, Doncaster Central)

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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?

Rosie Winterton (Labour, Doncaster Central)

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.

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?

Rosie Winterton (Labour, Doncaster Central)

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.

Andrew Murrison (Conservative, Westbury)

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

Rosie Winterton (Labour, Doncaster Central)

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.

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.

Rosie Winterton (Labour, Doncaster Central)

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.

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?

Rosie Winterton (Labour, Doncaster Central)

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.

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.

Rosie Winterton (Labour, Doncaster Central)

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.

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''.

Joe Benton (Labour, Bootle)

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

Rosie Winterton (Labour, Doncaster Central)

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.

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.

Rosie Winterton (Labour, Doncaster Central)

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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?

Rosie Winterton (Labour, Doncaster Central)

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.

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.

Rosie Winterton (Labour, Doncaster Central)

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.

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?

Rosie Winterton (Labour, Doncaster Central)

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.

Richard Taylor (Independent, Wyre Forest)

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.

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'.

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).

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.

Richard Taylor (Independent, Wyre Forest)

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.

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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.

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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.

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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.

Andrew Murrison (Conservative, Westbury)

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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.

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?

Andrew Lansley (Conservative, South Cambridgeshire)

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.

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.

Rosie Winterton (Labour, Doncaster Central)

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.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

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.

Rosie Winterton (Labour, Doncaster Central)

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.

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.

Rosie Winterton (Labour, Doncaster Central)

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.

Andrew Lansley (Conservative, South Cambridgeshire)

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.

Rosie Winterton (Labour, Doncaster Central)

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.

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.

Rosie Winterton (Labour, Doncaster Central)

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

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.

Rosie Winterton (Labour, Doncaster Central)

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

Standing Committee G

Clause 1 - Authorisation of activities for scheduled purposes

Irene Adams (Labour, Paisley North)

I remind the Committee that with this we are discussing 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).

Rosie Winterton (Labour, Doncaster Central)

Before lunch, I was dealing with amendments Nos. 47 to 49. Unfortunately the hon. Member for Oxford, West and Abingdon (Dr. Harris) is not here yet, but I shall continue to address the points that he made.

I shall give a practical example of how we feel, in relation to part 2 of schedule 1, that there is a difference between taking tissue or cells from a living person and from one who is deceased. I shall do that by setting out what happens when consent is given to a post mortem. Included in that consent are activities intrinsic to the post mortem, which include tests, controls and information that will have been covered when consent to the post mortem was given. The code of practice will cover that. It is what is currently in the guidance that is issued to people informing them about what will happen in a post mortem.

However, with regard to a deceased person, keeping of tissue for subsequent quality control, clinical audit and so on would require consent. We will not allow tissue to be kept without the knowledge and agreement of the appropriate person. From living patients, we allow part 2 purposes without consent—beyond the consent of the clinical and diagnostic process—because audit quality control is bound up with the

diagnostic and clinical process. In the case of a post mortem, there is no reason not to discuss and agree such matters with the next of kin, and our current code of practice and model consent forms for post mortem illustrate how people would be taken through those points, among others.

I shall give a practical example of clinical audit and quality assurance in relation to a living person by referring to the example of cervical smear tests mentioned by the hon. Member for South Cambridgeshire (Mr. Lansley) this morning. Having taken a smear test, and carried out an initial quality assurance assessment of whether the test has been done properly, it is quite usual to keep the test for some time in case of future developments, or a further need because of what may have happened to a living patient. If there has been a development of the disease we may wish to go back and check that the quality assurance and clinical audit were done properly.

The idea of a post mortem is to find out the cause of death, and any check for quality assurance would be carried out at that time. The implications of keeping tissue, cells or organs from a post mortem for any length of time, would be strongly against the principles of the Bill. It could well aggravate the situation. An example of that would be the public health monitoring of living people, which is allowed without consent. It could be argued that such monitoring for CJD should and would be allowed if the amendments tabled by the hon. Member for Oxford, West and Abingdon were agreed to. That could mean whole brains being taken for future public health monitoring. For obvious reasons that is quite different from what can happen to a living person; it is not possible to perform such a removal of organs from a living person without pretty dire consequences.

Consent must be required for the purposes of part 2 of schedule 1 because the implications are different for someone who is deceased and someone who is alive.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

May I first apologise to you, Mrs. Adams, and to the Minister for losing the first two sentences of the sitting. Carriage Gates were not available to me because of the demonstrations, so I had to run round the other way.

I am grateful to the Minister because she has been very clear about quality assurance, public health monitoring and clinical audit. Does she feel that she has dealt with education and training incidental to the post mortem examination? Does what she has said apply to any slides from histology that are often retained—they might continue to be retained—after the return of the body and the organs to the family? Will those slides be available or will specific consent be required even for their review at a later clinical audit?

Rosie Winterton (Labour, Doncaster Central)

As I have said, clinical audit would be dealt with at the time. On the current post mortem form, the retention of blocks and slides is mentioned, so people understand exactly what is happening and what may be retained. Some people will want absolutely everything returned.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I said it in a rush. Does the Minister feel that education and training incidental to the post mortem examination is covered in part 2 of schedule 1? One might argue that it should be assumed to be taking place when there is a hospital examination and that it should form part and parcel of consent to it.

Rosie Winterton (Labour, Doncaster Central)

I will refer to the hon. Gentleman's amendments later.

Amendments Nos. 63 to 66 would make lawful the storage or use of bodies for purposes under schedule 1 only when the death had been certified and registered under the Births and Deaths Registration Act 1953 or the equivalent order in Northern Ireland. Currently, the Bill provides that before a body can be stored for anatomical examination, which is defined under clause 56 as

''examination by dissection for . . . purposes of teaching or studying, or researching into, morphology''

or anatomy—morphology is the shape of the body and how one bit works compared with the others; I spent a very interesting lunchtime looking up the definition of morphology—the dead must first be certified, and before the body can be used for that purpose the death must be registered. The provision has been lifted from the Anatomy Act 1984, which this Bill repeals and replaces, so that the regulation and licensing of the use of bodies for anatomy teaching can be brought into this wider scheme.

The requirement that the death be fully certified and registered is a direct consequence of the origins of the Anatomy Act, and lies in the scandal of Burke and Hare in the early 19th century when the provenance of bodies used in medical schools was sometimes rather uncertain, to say the least. The requirement is a practical one in the case of the donation of whole bodies to an anatomy school. In that situation, the donor would be the individual. Should an individual want to donate their body to an anatomy school, the usual practice is to contact the inspector of anatomy and be directed towards an anatomy school, which will usually be informed of what is going to happen. The anatomy school may then be prepared to receive the body. Dissection for teaching purposes is not an activity that needs to begin immediately, so obviously it is not difficult to ensure that the death is registered. That is current practice and we believe it is right that it should continue with such a degree of security.

If such security were to be extended to all schedule purposes, as proposed in amendments Nos. 60 and 61, or even to purposes in part 1 of schedule 1, as proposed in amendments Nos. 62 and 63, it would have detrimental and possibly catastrophic effects. The purposes set out in schedule 1 include carrying out a post mortem, which may be included in several of those purposes, and transplantation. To take the latter as the clearest example, it would simply not be possible to require formal registration of death under the Births and Deaths Registration Act and still use organs for transplantation. Likewise, a post mortem may well be needed to find out the cause of death so that a death certificate can be signed. The timing of such things is crucial.

Richard Taylor (Independent, Wyre Forest)

The Minister has me puzzled on that last point. When I was working, we were always told that one could not hold up the death certificate until the post mortem had been held. If one could not give a death certificate, one had to refer the matter to the coroner.

Rosie Winterton (Labour, Doncaster Central)

Will the hon. Gentleman repeat that?

Richard Taylor (Independent, Wyre Forest)

When a patient dies in hospital, a death certificate has to be given. One cannot wait for the result of a post mortem before giving a death certificate. If a death certificate cannot be given, one has to refer to the coroner. That was my understanding of events before I retired, which was a few years ago.

Rosie Winterton (Labour, Doncaster Central)

My understanding is that there can be a certificate of death—something that a doctor would sign to say that someone had died—but that to get a death certificate the cause of death has to be established. A doctor is perfectly able to say that someone is dead although they do not know why that person has died. If they want a cause of death, a post mortem is required. That is when a death certificate can be issued, which says why someone has died and can then be registered. It is important to remember that we are discussing the formal registration of the death, not just the issue of a death certificate.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

This is an interesting area. I understand the registration issue to which two of the amendments apply. In her earlier remarks, the Minister talked almost solely about registration. I suspect that she did so because, as the hon. Member for Wyre Forest (Dr. Taylor) said, that is not how it would work for a hospital-interest post mortem.

I will repeat what the hon. Member for Wyre Forest said, to check that the Minister's understanding is the same. If one cannot give a death certificate before a hospital post mortem, by definition the matter has to go to the coroner. In fact, hospital-interest post mortems are not for providing a cause of death for the purposes of death certification, but for other purposes. Therefore the first two of the amendments at least pose a legitimate question about why the clause does not extend wider than anatomical examination—for example, to public display, which I mentioned in my earlier remarks.

Irene Adams (Labour, Paisley North)

Order. We are wandering rather far from the subjects at hand. I ask Committee members to keep within the terms of the clauses.

Rosie Winterton (Labour, Doncaster Central)

It is true that if one cannot give a death certificate because the cause of death is unclear, the matter is referred to the coroner. However, it is possible for permission to be given for the hospital post mortem to find out the cause of death. We must distinguish between the formal registration of death under the Births and Deaths Registration Act, which is required for the purposes of donation to an anatomy school, and what would happen in a case of transplantation.

The hon. Member for Oxford, West and Abingdon raised the issue of public display. The Human Tissue

Authority would require the registration of the death certificate and the will in writing because, as the hon. Gentleman will know, for public display a signed and witnessed declaration that the person wishes their body to be publicly displayed is required. Through its licensing procedure, the Human Tissue Authority will be able to ensure that the person has been registered dead and that the proper consent, in a written statement or a will, has been obtained before a public display licence is granted. That is because there has to be a proper, formal registration of death before the will can come into effect.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I will try to stick to the issue. Amendments Nos. 60 and 62 were intended to probe why the clause is limited to anatomical examination. They do not extend to public display, for which it is clearly necessary to have a death certificate. I asked earlier whether that was because the draftsmen of the Bill were doing as little as possible to transpose the Anatomy Act 1984, or whether there was a specific reason why it could be conceived that before public display—not least in relation to the issues raised by the hon. Member for Wyre Forest—a death certificate should not be issued as a statutory requirement. In that sense, the treatment of anatomical examination and public display are similar. The Minister's answer justified the requirement for written consent for public display, which is not the issue before us and is not even controversial between us.

Rosie Winterton (Labour, Doncaster Central)

As I have said, because we now have a licensing procedure the Human Tissue Authority will be able to regulate that by requiring that both the registration of death and written consent are produced. However there needs to be a certain amount of discretion, particularly with regard to the importation of bodies, where the Human Tissue Authority would again have jurisdiction for these purposes. Consequently we have made a straight translation from what was in the previous Anatomy Act and incorporated it into this one.

The next set of amendments, Nos. 64, 69 to 72, 78 and 79, and 48 to 49, would alter the references to the individual's consent to anatomical examination. They would specifically exclude anatomical examinations such as those for the purposes of determining the cause of death, education and training, obtaining scientific and medical information about an individual, and research—that is to say, most of the other purposes set out in schedule 1. This would mean that consent to anatomical examination for those other purposes could be given by a relative after a person's death, and indeed the removal of the definition of ''anatomical examination'' in clause 56, as amendments Nos. 78 and 79 propose, would do just that.

It is difficult to see that these amendments can be necessary, given the way that ''anatomical examination'' is defined in clause 56(1). That reflects the current definition of ''anatomical examination'' in the Anatomy Act, to make possible a clear understanding of what we mean by the term and identify it as the activity that relates directly to anatomy teaching. To introduce these amendments would in fact create confusion. Given the definition in

clause 56, what would be the significance of referring to ''anatomical examination'' as not including certain activities, when those activities are not part of what we mean by ''anatomical examination'' anyway? Activity for purposes such as establishing the cause of death, under paragraph 2 of schedule 1, and establishing after a person's death the efficacy of any drug or other treatment administered to him, in paragraph 4 of schedule 1, are activities that would be part of a post mortem investigation, rather than an anatomical examination.

If one were to consent to a post mortem, either in advance or for a deceased relative, it would be most likely that a person would agree to those further purposes as well, such as research and teaching. The purposes set out in schedule 1 are intended to operate in this way: a person can consent to one, more or all of the purposes. For example, if one agrees to the use of one's body for anatomical examination after one's death, one is likely also to agree to the use of tissue in research. The scheme is flexible where it needs to be.

We do not believe that there is any need to confuse what is meant in the Bill by ''anatomical examination'' as opposed to a post mortem examination. It is also clear that the meaning of ''anatomical examination'' is well established now for those teaching and studying anatomy, and we wish to retain the particularity of that discipline by, as I said, bringing forward the effect of the current Anatomy Act, which has worked well.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I accept everything that the hon. Lady has just said, and indeed I think I conceded it all in my introductory remarks. I only made one substantive point on this group of amendments, which was that simply saying ''anatomical examination'' in schedule 1 is not helpful to anyone who is not an anatomist. I understand that the purpose of the Bill is also to inform the public about what is going on. However, I suggested that the Government might consider describing the schedule 1 purposes as anatomical examination by dissection, or something that makes it clearer what is being talked about. Many people, including those who have written to me, have assumed that anatomical examination is just that and does not have the specific meaning implied in what the Minister said about medical schools and schools of anatomy.

Rosie Winterton (Labour, Doncaster Central)

That is set out in clause 56. We feel that for drafting purposes, that is the best place for it, because there is not only a reference to it, but an explanation. It would be nice if members of the public could feel completely at ease in reading all our legislation, but sometimes it can be a little bit obscure, which we all regret slightly on occasion.

On training and education being incidental to diagnosis and treatment, we cannot accept the amendment tabled by the hon. Member for Oxford, West and Abingdon, not least because it would have an effect that he did not intend. The Bill provides that the use of human tissue for the purposes listed in part 1 of schedule 1 requires appropriate consent from the right person, except, for example, in the case of post mortems required by the coroner. Further exceptions to the consent requirements of the Bill are provided in

part 2 of schedule 1. Those relate to the use of tissue from living patients who have already given consent to the removal of tissue during the course of diagnostic testing or surgery. An exception is made for education and training, which is incidental to medical diagnosis or treatment.

Paragraph 10 of part 2 of schedule 1 would ensure that medical students, trainee pathologists, and technicians could use human tissue from living patients for on-the-job training and education without specific consent, provided that the tissue were removed with consent from the living patient. In practical terms, that means that medical students, trainee pathologists, or technicians can use human material that has come into pathology laboratories for diagnosis for the purpose of their laboratory training and education without further consent being obtained from the patient whose tissue they are using. For obvious reasons, we take the view that that sort of training is intrinsic to the diagnosis and treatment of the patient. However, we have used the term,

''incidental to medical diagnosis or treatment''

so that no one is excluded who may need to take part in laboratory training.

We are trying to establish that the activity should be related to the diagnostic or treatment activity in the clinic or lab. We do not want to be too restrictive, but we do not wish to allow uses that are only remotely connected. The best way to encapsulate that is through the use of the words ''incidental to'', which capture the spirit of our intention. The words ''inherent to medical diagnosis or treatment'' would narrow the field of those who may lawfully take advantage of using tissue without specific consent. That is not what the hon. Member for Oxford, West and Abingdon intended. Although we have considered his amendment, the wording that we have chosen on advice enables others, such as trainee nurses or doctors, to enter a laboratory to see how tests are carried out. The hon. Gentleman's wording is too tight.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am grateful to the Minister for that explanation. I conceded in my introductory remarks that I was more interested in eliciting the justification of the word ''incidental'' than in praising the suggestion of the word ''inherent''. It strikes me that when the schedule states,

''incidental to medical diagnosis or treatment''

it does not mean incidental to a patient's medical diagnosis or treatment. While she is on the subject, can the Minister explain why that is so, and whether it is a significant difference?

Rosie Winterton (Labour, Doncaster Central)

If it relates to a patient, it might be restricted because it does not allow the flexibility of someone else seeing how a process was carried out, as opposed to teaching how a condition was diagnosed. Although the suggestion is interesting, it would be more restrictive on the education and training that we want to provide. I hope that I have been able to reassure the Committee that we have considered those matters carefully.

Andrew Lansley (Conservative, South Cambridgeshire)

The Minister will recall what I said about cervical smear tests. I have a note from Dr. Herbert, the chairman of the British Society for Clinical Cytology, who said:

''It is usually inappropriate to use cytology slides for these purposes''—

teaching, setting exams, training and continuing education—

''until the final diagnosis has been confirmed by other means, usually a subsequent biopsy''.

To summarise the point, education and training for those purposes comes after the treatment, insofar as it was treatment, and certainly after the diagnosis. How can it be incidental to medical diagnosis and treatment?

Rosie Winterton (Labour, Doncaster Central)

Will the hon. Gentleman go through that again.?

Andrew Lansley (Conservative, South Cambridgeshire)

The point that Dr. Herbert makes is that using cytology slides for teaching, for setting exams and for training would not be appropriate until after the final diagnosis. That is often after subsequent biopsy. If by definition it is after diagnosis, how can it be seen as incidental to diagnosis or treatment?

Rosie Winterton (Labour, Doncaster Central)

The hon. Gentleman is slightly confused. Perhaps I have not made myself clear. We are talking about on-the-job training. Further education and training—for example, taking a general teaching approach—would require further consent. We are talking about something that would probably take place in a pathology laboratory. People would see the process, and see how the diagnosis was made. If we were talking about the wider educational purpose, outside the confines of on-the-job training, the process would be different and further consent would be needed in order to expand the education and training being provided.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

My question is twofold. First, the term ''incidental to'' medical diagnosis or treatment helps the Minister to answer the question raised by the hon. Member for South Cambridgeshire. However, there will need to be careful guidance on the point at which such training becomes not on the job but more general, because histopathologists show slides in all sorts of lecture theatres to all sorts of audiences under the generality of education and training. Indeed, they are encouraged to do so by their employers and their professional organisations.

Secondly, I am keen for the Minister to explain the issue that she said when speaking to other amendments in this group that she would return to. Is she satisfied that there will not have to be two categories of slide kept after post mortem—legitimately kept as part of post mortem? Will there be one category where

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

is allowed and another where, because the box has not been ticked—it has to be a separate box because of the appearance in part 2 for post mortem material—it will not be allowed? I should be grateful if the Minister could clarify that point.

Irene Adams (Labour, Paisley North)

Before we go any further, may I ask you to keep interventions much briefer, Dr. Harris? There should not be speeches in the middle of the Minister's speeches.

Rosie Winterton (Labour, Doncaster Central)

There is already clear guidance on what should be returned after post mortem has been carried out and what may be retained. It is important that in these circumstances we stick to the point of consent.

I hope that I have been able to give some reassurance on the points that were made. I urge members of the Committee to reject the amendments.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The Minister did not tackle amendment No. 67 in her response, but I shall not ask her to go into it because we had an earlier discussion about clinical audit.

I want to try again to make the point about amendment No. 65 that I tried to make a little earlier. It is because there is a separate part 2 for material retained from deceased people after post mortem, which is related to education and training incidental to medical diagnosis or treatment, that it is my understanding that it is lawful to retain slides or blocks and that that will be part of the consent for the post mortem examination. Perhaps there is no other purpose for which they may be retained, but I think that it has been accepted that such slides are generally retained.

Is it the Minister's understanding—she may consider it more appropriate to write to me to clarify the point—that there will therefore be two categories of slides: one where the family have granted separate consent and another where the slides may not be used for education and training, albeit incidental to medical diagnosis or treatment, because there has been a clear decision not to tick the box on the consent form? I want to be sure that my understanding of the significance of having that separate provision is correct, because a number of pathologists—I have heard of some—are concerned that the requirement for separate consent for that incidental education and training will mean a significant change in the way in which they practise, particularly with regard to retained histology slides.

I am grateful to the Minister for her explanation of the reason for a separate group of purposes in part 2, especially with regard to clinical audit, public health monitoring and quality assurance. I shall reflect on what she said. As I said, there is still an issue around education and training, but she explained that that is necessary because the provision implies a retention beyond post mortem examination. That is one issue that we need to deal with in light of events at Alder Hey and Bristol.

I wish to raise one point on amendments Nos. 64, 49, 69 and 72. The Minister said that it does not have to be clearer in schedule 1 that anatomical examination means dissection in schools of anatomy because, apparently, the provision does not exist to make such purposes clear to perusers of the Bill; people will automatically direct themselves to clause 56, where it is all made clear in morphological terms. One purpose of schedules, especially those separated

out such as schedule 1, is to be helpful, and although I heard what the Minister said about her satisfaction with clause 56, I ask her to reflect on whether paragraph 1 of schedule 1 could be more helpful.

Two issues emerged from our discussions on amendments Nos. 60 and 62. The first is that it would be possible to require certification before public display, even though the Government have decided not to do so. I suspect that we will deal with the Minister's explanation on imports later, but the point applies equally to anatomical examination and public display, and why there should not be a statutory requirement for certification and registration for public display has not been clarified. I do not want to prolong matters, but if the Minister could write to satisfy me on that point, I would be happy.

The second, broader issue was raised by the hon. Member for Wyre Forest. It was not made clear in the debate that certification can, and arguably does, take place before post mortem examination for hospital-interest post mortems. Indeed, when there is time, which there usually is for a ventilated patient, it is considered good practice to show a family thinking about transplantation a death certificate before seeking permission for organ donation for transplantation. That helps the family understand that death has occurred, even though there is still a beating heart and lung movement from the ventilator. An explanation should be given for why the Bill does not currently deal with that.

Those issues can be dealt with in correspondence, so I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 16, in

clause 1, page 2, line 14, at end insert

'; or

(iii) the death has been lawfully recorded in accordance with the provisions of the country in which the deceased person died.'.

Irene Adams (Labour, Paisley North)

With this it will be convenient to discuss the following:

Amendment No. 17, in

clause 1, page 2, leave out line 20.

Andrew Murrison (Conservative, Westbury)

I hope that I shall not detain the Committee too long.

I suspect that the Bill's drafting on the impetration of bodies has a lot to do with its providence in the Anatomy Act, and I want to probe the Minister's thinking on the impetration of bodies for anatomy. I am sure that, like Conservative Members, the Minister would want to ensure that we have safeguards for the bodies of foreign nationals that are brought into the country for purposes of dissection. Given the way that we certify and register the cause of death in this country, it is exceptionally difficult to mirror our processes for bodies that are imported.

Will the Minister describe how she believes that statutory best practice could be mirrored in our dealings with bodies that come from abroad? There

seems to be a loophole in that some of our safeguards may be circumvented in importing bodies from abroad. We might later discuss the subject of skeletons, about which from our experience the hon. Member for Wyre Forest and I can get exercised, but this is not the time to do so. A form of certification for bodies coming into the country that mirrors the registration of cause of death that applies here would be appropriate. That will come within the purview of the Human Tissue Authority, but amendments Nos. 16 and 17 are designed to mirror our practice, as far as possible, for bodies that are brought into this country for dissection.

As a supplementary, I should say that there is probably also a health and safety element. For obvious reasons, it would be useful, if not essential, for those who are practising on the bodies to have an idea of cause of death. The Minister might like to consider the amendments as probing amendments, designed to demonstrate that the matter has not been thought through adequately.

Rosie Winterton (Labour, Doncaster Central)

The hon. Gentleman is right to say that it is important that we should be able to expect the same standards to apply in respect of the donation of bodies from within the country and without. However, he will recall that we have stated that the principle of the Bill is that the legislation should set the framework, but that operational detail should be dealt with by the Human Tissue Authority in codes of practice.

I realise that this is a probing amendment, and for that reason it tries to put into the Bill a lot of detail about the importation of whole bodies for dissection. Perhaps I can give some reassurance. We do not expect that whole bodies will commonly be imported for dissection. In fact, at the moment, we are not aware of any shortage in the United Kingdom of bodies donated for medical education.

Andrew Murrison (Conservative, Westbury)

Let me give an example of where this might come into play. A large number of British nationals living abroad might stipulate their wish to donate and thus enter into arrangements with medical schools. With that in mind, would the Minister give us her thoughts?

Rosie Winterton (Labour, Doncaster Central)

I will come to that. We did not want to preclude the importation of bodies donated for education from, for example, Scotland or the Channel Islands. For the purposes of this clause, Scotland is considered to be abroad. Obviously, if a donor dies in Scotland, his or her body might need to cross the border. However, the provisions of the Anatomy Act will still apply in Scotland, so the same death certification is required there as elsewhere in the UK. When similar issues arose previously under the Anatomy Act, it meant that people from the Channel Islands could not donate their bodies for medical education in the UK. By allowing imports, the Bill overcomes that anomaly.

The imported bodies will be subject to a code of practice to be prepared by the authority. That is provided for at clause 23(k)(i). We will expect the code to embrace the principle that human bodies should not

be imported when sufficient ethical sources of suitable bodies are available in the UK. We will also require evidence of death certification in the country where the person who donated his or her body died. Provisions along those lines are already in the Department of Health code of practice on the import and export of body parts. We would also expect the code of practice to require consent to be given in similar terms to that in the standards that we have set for anatomical research.

In addition, the hon. Gentleman made a point about a British national who might have been living abroad. The same would apply, in that the death certificate would be needed for removal from the other country—say, Spain. In terms of the anatomy school taking the body, the same consent conditions would apply or, if the donation was stipulated in a will, the will would become valid once the death had been properly registered.

The hon. Gentleman is right to raise both issues. We are anxious that the Human Tissue Authority will address them, allowing for flexibility in the ways in which death certificates might be issued in different countries. Bodies for anatomical examination will be able to be stored and used only in anatomy schools licensed by the Human Tissue Authority. The authority will have the power to set the licence conditions, which we will expect to state that those schools may receive only bodies with specified evidence of death certification. The authority will have the power to enforce its licence conditions through inspections procedures, and breach of licence conditions may lead the authority to revoke the licence.

I realise that this was a probing amendment, and I hope that I have been able to give the hon. Gentleman the reassurance that he seeks. I urge the Committee to reject the amendment.

Andrew Murrison (Conservative, Westbury)

I am grateful to the Minister for her description of current practice and how it will be transposed under the new arrangements. However, subsection (3) lays out clearly the rules under which people may be anatomised in the United Kingdom, and it would seem reasonable to add the certification arrangements that would be required for people being imported into the UK for the same purpose. Leaving it up to codes of practice would, I suspect, be adequate in practice. On balance, it would be more elegant were the legislation to reflect the fact that people would be imported from time to time, but it seems unreasonable to press the point so I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Richard Taylor (Independent, Wyre Forest)

I beg to move amendment No. 50, in

clause 1, page 2, leave out lines 17 to 29 and insert

'a body or relevant material from a body if—

(a) the body or relevant material has been imported, or

(b) it is the body of, or relevant material from, a person who died before the day on which this section comes into force and at least one hundred years have elapsed since the date of the person's death.'.

I am pleased to move amendment No. 50, because it would simplify the Bill by saying in one short section

what is now said in three. Unless the Minister can tell me that we are missing anything out, I would like to press it strongly.

Andrew Murrison (Conservative, Westbury)

I have little more to add. I thought that the hon. Member for Wyre Forest was going to wax more lyrical than he has done. However, the gist is that his amendment would simplify this section of the legislation. Unless the Minister can tell the Committee what would be missed out were the changes to be made, we are minded to support it.

Rosie Winterton (Labour, Doncaster Central)

I completely understand the desire for a more streamlined version of subsections (4), (5) and (6). That would be attractive. However, the amended version does not clearly cover the conditions for using relevant material that has been removed from bodies after they have been imported. That is provided for in subsection (6)(b) of our draft, and we believe that it is preferable to keep the comprehensive published version, which makes it clear that imported bodies, imported material and material that is removed from bodies after import are not subject to the requirements of the Bill.

Subsections (4), (5) and (6) provide for the continued import of bodies and tissue from bodies for research, notwithstanding the fact that the procurement of such bodies or human material may not have been subject to a similar consent regime to that which we are introducing. We have had representations from scientists who are concerned that tissue that has been lawfully collected without consent in, for example, the US might be prohibited from use in England, Wales and Northern Ireland. We do not want that to happen, and the Bill expressly provides for such use.

A further exception from the consent provisions is made for bodies of persons who died more than 100 years before the consent provisions take effect. That will exclude archaeological specimens, wherever they come from, from the consent provisions, and no bar will be placed on continued acquisition or on research involving such specimens.

I can assure the hon. Member for Wyre Forest that we have carefully considered the issue. Contrary to appearances, we do not deliberately set out to have long and difficult clauses, but, in this case, we feel that one is necessary.

Richard Taylor (Independent, Wyre Forest)

I thank the Minister for that explanation. I am not sure that I fully accept it, but I will not press the amendment to a Division. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Andrew Lansley (Conservative, South Cambridgeshire)

I beg to move amendment No. 89, in

clause 1, page 2, line 35, at end insert—

'(7A) ''Storage for use'' under subsection (1) includes storage for use for an intended purpose regardless of whether the purpose in question has been defined or is planned.'.

At a number of points in clause 1, the term ''storage for use'' is used to reflect the fact that material may not be used for some time for the purpose for which consent was obtained, and I would welcome the Under-Secretary's comments on circumstances in which consent was obtained for a specific purpose.

Let us assume that consent has been obtained for scientific research into disorders affecting the human body. What will be the legal position if consent is given for a particular research purpose, but the tissues are then archived, and a subsequent purpose arises? It might be covered by paragraph 7 of schedule 1 and might be

''in connection with disorders, or the functioning ,of the human body'',

but it might not have been contemplated when consent was given. I confess that I cannot explain what the precise uses of such tissues might be, or how the process might work, but the issue was raised with me in relation to tests for vCJD on tissue that was acquired much earlier for a quite different scientific purpose, albeit one that would be covered by paragraph 7.

My difficulty is that the term ''explicit consent'' as it has developed in common law is intended to reflect the fact that someone had a particular purpose in mind when giving consent. Unless it is clear that storage for use for a purpose might mean adaptation to meet other purposes, which could not have been contemplated when consent was given, there is a risk that one may have to return to the original donor to satisfy the consent requirements. That could be very onerous.

I hope that the amendment is unnecessary, but I have to explain the point so that the Under-Secretary can understand.

Stephen Ladyman (Labour, South Thanet)

I hope to be able to give my hon. Friend the Minister a bit of a rest. She deserves one, after a marathon one and a half sittings in which she has ably taken us through the complexities of clause 1. I also hope to be able to give the hon. Gentleman the assurance that he needs, although he and the scientists who have expressed concern over the issue may have read more into the Bill than is there.

The intention is that if one has obtained consent for a schedule 1 purpose, it need not be defined more broadly. If another use, which falls within the same broad definition in schedule 1, arises later, further consent will not be required.

Confusion has arisen because some local medical ethical committees require more detailed consent. While the Bill specifies a baseline—the minimum standard that must be met—some committees might occasionally go further and require more detailed consent. However, that is a matter for them, not the Bill.

I can give the hon. Gentleman the assurance that he seeks on the amendment. As long as one has sought consent under the broad definition in schedule 1, and the future use remains within that definition, further consent will not be needed.

Andrew Lansley (Conservative, South Cambridgeshire)

I am encouraged by what the Under-Secretary has to say. Out of interest, if consent were

obtained not for a broad purpose under schedule 1 but, at the instigation of a research ethics committee, for something a step further on—for a more explicit purpose—would the subsequent use of that tissue be constrained? I suspect that it would. We must therefore be clear that consent will tend to be sought under the general headings in the Bill, not on a more specific basis.

Stephen Ladyman (Labour, South Thanet)

The principle underpinning the Bill is that consent should be given for any action that is to take place. If one narrows the definition of the purpose for which one is seeking consent, one is accepting that the uses to which material can be put will be much narrower in the future. Scientists who do not want to restrict the use of material may stick to the broad definitions in the Bill, for the reason given by the hon. Gentleman. Having said that, scientists may occasionally want to encourage people to donate material more freely than they might have done if there were only a general definition of what it could be used for. They might narrow the definition of the purpose to research into a particular condition, because that might encourage more people to donate material.

The principle that the hon. Gentleman describes is right: material will be used according to the definition that is applied when consent is sought. If broad consent, as defined in schedule 1, is given, further consent will not be needed. I hope that that is the assurance that he needs and that he will withdraw the amendment. If not, I will advise the Committee to resist it.

Andrew Lansley (Conservative, South Cambridgeshire)

I shall not put the Under-Secretary through the stress of having to invite his colleagues to resist the amendment; things are as we had hoped. However, the hon. Gentleman's explanation points up some interesting issues. For example, if one were to start using examples of the purposes for which consent is given, there is a risk that it would stray into limiting the nature of that consent. One has to be careful about the nature of consent forms; but that might militate against the contrary intention, which is to give the maximum possible information to patients and families about the nature of the research that might be undertaken. That might create a tension, but it cannot be reconciled in the Bill. It needs to be taken into account in the codes of practice, which we shall debate later in more detail. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Andrew Lansley (Conservative, South Cambridgeshire)

I beg to move amendment No. 18, in

clause 1, page 2, line 37, leave out 'or omit'.

As you will be aware, Mrs. Adams, as all Bills do, this Bill contains a number of instances in which Ministers seek a power to vary aspects of the Bill by statutory instrument. It is always a matter of judgment as to how far that should go. My hon. Friend the Member for Westbury (Dr. Murrison) and I had a discussion about that. As the purposes set out in schedule 1 are of considerable importance to the structure of the Bill, we wondered whether it should include the power to change schedule 1 purposes without primary legislation.

We came to the conclusion that the power was probably excessive, but we were particularly exercised about whether it should be possible to omit purposes from schedule 1, because if they disappear from the Bill they will disappear from the remit of the Human Tissue Authority. We were somewhat disturbed about that, as distinct from adding to the schedule's purposes. Loopholes in expressions may be found, and one can well understand that varying the schedule purposes may be necessary as a result of the boundary distinctions and definitional issues that we have been discussing. However, we could not see circumstances in which omitting schedule purposes would be desirable without new legislation.

Stephen Ladyman (Labour, South Thanet)

I understand the hon. Gentleman's concern; he will not be astounded to hear that I do not share it. I am not a lawyer, but I am advised that the word ''omit'' is part of a standard legal formula that is often incorporated into such measures. I would not justify leaving it in only on legalistic grounds. It is my view that although the Secretary of State will not require to review the list, and the Government certainly have no intention of reviewing the list in the near future, attitudes to such matters can change dramatically, as we have seen over the past century.

My hon. Friend the Minister mentioned Burke and Hare earlier. It occurred to me then that it would be fascinating to read Hansard for the debate that followed those events, to see the different ethical framework under which Members debated those issues. As time goes by, it may be that the ethical framework, never mind the scientific framework, will change as people's attitudes and society's attitudes change. Flexibility will be needed under such circumstances to allow for significant variation of the schedule.

I can assure the hon. Gentleman that it cannot happen willy-nilly at the whim of a future Secretary of State—an assurance that he frequently seeks. It would require the affirmative resolution procedure. It would have to be debated in the House, were the Secretary of State ever to take the power to omit anything from the schedule. I hope that the hon. Gentleman will withdraw the amendment.

Andrew Lansley (Conservative, South Cambridgeshire)

The Under-Secretary has set out the argument that I anticipated, but it does not answer the point because there is something unusual about using ''omit'' in this context. His arguments were fair on the power to vary the scheduled purposes, but to omit any of them would not be simply to respond to circumstances. The implication is that the legislative remit of the Human Tissue Authority will disappear in relation to the retention of tissues for scheduled purposes. The purposes will not be switched from normally needing consent to not normally needing consent or subjected to an additional code of practice; they will be simply omitted.

The Under-Secretary will tell me whether I am wrong in my understanding that there is no intention to omit any of the scheduled purposes.

Stephen Ladyman (Labour, South Thanet)

For the record, I can give the hon. Gentleman that assurance.

Andrew Lansley (Conservative, South Cambridgeshire)

Therefore, if the issue arises, I hope that it will arise way beyond our parliamentary lifetimes. On that understanding, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Richard Taylor (Independent, Wyre Forest)

I beg to move amendment No. 53, in

clause 1, page 2, line 42, at end add—

'(10) In this section and sections 7 and 9, ''relevant material'' means material, other than gametes, blood and cytological specimens, which consists of or includes human cells.'.

Irene Adams (Labour, Paisley North)

With this it will be convenient to discuss the following:

Amendment No. 54, in

clause 55, page 33, line 4, after 'Act', insert

'(other than sections 1, 7 and 9)'.

Amendment No. 80, in

clause 55, page 33, line 5, after 'includes', insert 'a human cell or'.

Amendment No. 81, in

clause 55, page 33, line 8, leave out 'hair and'.

Richard Taylor (Independent, Wyre Forest)

I will speak to amendments Nos. 53 and 54, which relate to clauses 1 and 55. They are probing amendments to obtain a little more detail about the definition of ''relevant material''. Clause 55 says:

''In this Act, 'relevant material' means material, other than gametes, which consists of or includes human cells.''

Tissues such as blood and cytological smear specimens are not excluded. Will the Under-Secretary respond to pathologists' concerns that that means that consent may be needed for the retention for teaching and education, of spare blood from blood samples and cytological specimens?

On Second Reading, the Minister said that

''consent from patients will be needed for further uses of tissue, by which we mean all material that contains cells—except hair and nail . . . for research, education and transplantation.''—[Official Report, 15 January 2004; Vol. 416, c. 990.]

Giving blood for transfusion obviously implies consent to the use of the blood. Is verbal consent or holding out the arm adequate for the further use of blood samples? A lady consents implicitly in having a smear test, but does that carry adequate consent for the subsequent use of spare blood or cytological slides for education and research? If not, it will be a huge load. The Royal College of Pathologists estimates that at least 30 million blood samples are taken each year, so consent would be impractical.

The amendments are designed to obtain the answer to those questions and probe how we can exclude such tissues.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I shall speak to two amendments in the group. Amendment No. 80 is designed to clarify whether in clause 55(1) the phrase

''consists of or includes human cells''

covers something that consists of only one human cell, which may be all that is required for a purpose that requires consent. As I understand it, such a provision works the other way round, but the fact that the amendment was selected suggests that it is a question worth asking.

Amendment No. 81 gives the Under-Secretary the opportunity to clarify the distinction between ''relevant material'' in clause 55 and ''bodily material'' relating to DNA in clause 46. As cellular material is associated with the hair follicle, clause 46 uses the phrase ''bodily material'', so am I right in thinking that it is satisfactory to use the term ''relevant material'' to exclude hair and nail from the provisions? Things can be done with hair, but it is impractical to include it as one of the samples. Now seems to be a good time to ask at what point certain cellular materials coming from the body, such as mucus secretions and phlegm, count as relevant material for the purposes of this part of the Bill.

Andrew Murrison (Conservative, Westbury)

This is an interesting group of amendments. They seek to probe the Minister on which tissues should be included. I seek advice with regard, for example, to plasma and serum, which the hon. Member for Oxford, West and Abingdon might have added to his list of cellular elements, although most people would think of them as body material, possibly more so than phlegm and mucus.

I understand that the amendments tabled by the hon. Member for Wyre Forest would exclude further materials such as cytology specimens and blood. I assume that the answer will be something to do with codes of practice. I am keen to know the Under-Secretary's feelings about acellular materials, particular in view of the remarks of the hon. Member for Oxford, West and Abingdon and of amendments that focus heavily on cells, which, of course, acellular materials such as plasma and serum are not.

Stephen Ladyman (Labour, South Thanet)

This is one of those wonderful occasions when one thinks back to one's schooling and remembers those esoteric lessons that one had to attend, wondering, ''What possible value could knowing this ever have for me?'' I remember as an O-level and A-level biologist having to discuss the theory that hair is excrement, on the grounds that excrement is defined as non-cellular material that has been metabolised and then egested from the body. I wrote long and erudite responses about why hair was different from other cellular material. Finally, after all these years, it is useful to know that.

Let me stress to Opposition Members that the fundamental philosophy behind the Bill is that people should consent to the use of material from their bodies and that they should understand that consent when they give it. Nobody has the right to override that consent or to consider it valueless. I do not accuse any Opposition Member of making that error, because I know that these are probing amendments to allow us to put on the record our understanding of the issues. Were they seriously putting forward the amendments, I would have to accuse them of falling into the trap that led us to need the Bill.

At Alder Hey and other organisations that retained material, pathologists or others either thought the material so valueless that nobody would worry if

they kept it, or transposed their opinion of the value of the material for that of those who ought to have been consenting to its use. It is because they could see scientific merit in keeping the material that they thought that, on balance, it should be retained and the individuals who ought to have been consulted need not be consulted. In reality, that mindset, benignly held, but with malign impact, caused the problems that we are addressing today. There is a whiff of that to these amendments. Although—

Dr. Harris rose—

Stephen Ladyman (Labour, South Thanet)

Let me finish, then the hon. Gentleman can get upset with me. Although we might not see a problem in retaining, for example, blood samples—as somebody who has spent much of his life in or around laboratories, I cannot foresee any reason why anybody should want to withhold consent for that—I accept that some people might. Their opinion has to count for more than that of those who think, ''It does not matter, we can retain the material.'' We must remember that the fundamental philosophy that people should consent to the use of all material is the overriding one.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I strongly endorse that. I have spent four years on a research ethics committee, and a coach and horses would not make me sign the amendment in the name of the hon. Member for Wyre Forest. I cannot speak for the hon. Member for Westbury; I would not ascribe any motives to another hon. Member. When the Minister uses the terms ''Opposition Members'' and ''these amendments'', he must realise that we are the victims of the grouping of amendments and not necessarily in support of the thinking behind what the hon. Member for Wyre Forest proposes—or, I suspect, wants to probe.

Stephen Ladyman (Labour, South Thanet)

I did not accuse anybody of falling into the trap, because I acknowledged that all the Opposition amendments were probing. I said that, were Opposition Members to press the amendments, they would be falling into the trap, but I accept that the hon. Gentleman wishes to make his position clear. Let me reiterate that the fundamental principle is that people must consent.

The hon. Member for Wyre Forest asked a specific question about what sort of consent will be needed. Clearly, if somebody is sent by a general practitioner for a blood test, and he goes into the clinic and puts out his arm in order for the blood to be taken, he is consenting to the use of that blood for the purposes of finding out what is wrong and how to make him better. That is what, by implication, he has consented to.

Peter Kilfoyle (Labour, Liverpool, Walton)

Unlike my hon. Friend, I am not a biologist at any level. However, when he was talking about why people might not want their blood samples to be kept, I thought of constituents who have not wanted their DNA to be kept—they felt, for good reasons or bad, that it might be used at some future point to connect them to crimes. Is there any currency in that line of argument?

Stephen Ladyman (Labour, South Thanet)

I am absolutely sure that none of my hon. Friend's constituents is suspected of any crime, current or future. I say that because I was brought up

in his constituency. He makes a valid point—some will hold that concern and they are entitled to do so; we should not impose our views on them.

As I was saying to the hon. Member for Wyre Forest, by holding out one's arm and allowing blood to be taken, one is consenting to the use of that blood for the purposes of finding out what is wrong and making it better and—as my hon. Friend the Minister said earlier—consenting to actions that are an integral part of the process, such as quality assurance. If somebody wants to use that blood for other purposes, including research, an additional consent must be obtained. That can be a very simple process, and we would want it to be as bureaucracy-free as possible. However, if material is to be used for anything other than the purpose for which it was given, consent should be sought.

Richard Taylor (Independent, Wyre Forest)

I am very interested to hear the Under-Secretary talk about the simplicity of gaining consent, but what bothers me is that about 30 million samples are provided every year. I am sure that residual specimens from patients with leukemias and other blood diseases are kept for future use, and I would like to hear the Under-Secretary tell us how consent could be obtained simply from such a number of patients.

Stephen Ladyman (Labour, South Thanet)

I assure the hon. Gentleman that there is some very good practice in that respect—St. Thomas's hospital is a good example. Consent is routinely sought to make additional use of material, and that can be a very simple process. It is not for me to do the job of the Human Tissue Authority and to establish best practice, but I can envisage several ways in which consent might be sought. For example, people giving blood for a blood test could be read a simple form and asked to sign it if they did not want the material to be retained after the test. The process can be as quick and easy as the human imagination can make it; we have no wish to make it long and drawn out.

Clause 1 and schedule 1 are 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. That is the fundamental principle behind the Bill. As the Bill stands, the term ''relevant material'' refers to all material that contains cells other than hair and nail, which are regarded as disposable, and gametes and embryos, which are covered by separate legislation. The term therefore applies to all material from a human body, including organs and blood. It is intended that such material should require appropriate consent when stored or used for scheduled purposes, such as research or education.

I fully understand the concern that the patient and their relatives must be properly informed and sure that they and the clinicians are talking about the same material when making decisions about the patient's body, and that will be made clear in guidance. It is not necessary to make fine distinctions in primary legislation, which could lead to confusion by defining too closely the issues that we are discussing.

The misunderstandings that have arisen can be resolved through better communication between

patients and those seeking consent about what will be used and for which purposes. As we shall see, one of the main roles of the Human Tissue Authority will be to set down standards for communication with families, which will have to be met when obtaining consent.

Another of the authority's roles will be to provide the public and persons carrying out activities within its remit with information and advice about the nature and purpose of those activities. That will allow for flexibility when dealing with the many possible situations covered by the Bill's overall framework.

I hope that Opposition Members are reassured by my comments; I am rapidly studying their body language to see whether I need to explain the issue ad nauseam.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Can the Minister clarify his understanding of amendment No. 80, which would make the Bill refer to ''a human cell or cells''? Can he assure me that every cell will count? While he is at it, will he address the issue of acellular material, which was raised by the hon. Member for Westbury?

Stephen Ladyman (Labour, South Thanet)

I give the hon. Gentleman the assurance that one cell will have exactly the same impact as many cells, so there is no issue in that regard.

The hon. Gentleman asked an interesting question about mucus and the fact that it is a disposable material. I shall have to reflect on whether it will be covered by the same criteria as hair and other material. However, given that one would have to provide the mucus, one would know that it was to be used for some purpose. In practice, we may not have to worry about that.

I have been advised that mucus, if it includes cells, is covered by the Bill. However, the hon. Gentleman was making the point that it would not necessarily include cells. Saliva would be another obvious material that includes no cells and may raise some interesting issues. I will reflect on that and provide further information if it comes about. However, the Bill is essentially based on cellular material—whether one cell or multiple cells.

Andrew Murrison (Conservative, Westbury)

I am sure that phlegm and saliva both contain cells; I would be surprised if they did not. The Under-Secretary has not mentioned the acellular materials that I mentioned—plasma and serum. They are in a slightly different category from phlegm and mucus. Perhaps he would like to say why they appear to have been excluded.

Stephen Ladyman (Labour, South Thanet)

I do not think that I would.

Disposability is an issue here. Hair is obviously a disposable material, which I think most people would say is under a different ethical standard from material that has been collected that may have included cells at some time, even though those cells may have been removed for the purpose of storage. A different process is involved. I will certainly consider the matters that have been raised. Acellular materials are not themselves within the scope of the Bill, but the

control of cells from which they come is within the scope of consent.

We are now delving into the issues on which 18-year-olds will have to write learned essays for years to come. They involve a degree of complexity that is not of any concern to us. I do not think that the measure will have the practical impact suggested by Opposition Members. The fundamental principle that we must apply to interpreting the Bill is that material provided by people from their own body is theirs to control, and they must consent to how it is used in the future.

Richard Taylor (Independent, Wyre Forest)

I am glad to have drawn attention to the problem. We have had a clear reply from the Under-Secretary. I am not altogether satisfied about the ease of implementation, but I am sure that we will return to this matter when we discuss the Human Tissue Authority. I will not press the matter to a Division, so I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

The Chairman, being of the opinion that the principle of the clause and any matters arising thereon had been adequately discussed in the course of debate on the amendments proposed thereto, forthwith put the Question, pursuant to Standing Orders Nos. 68 and 89, That the clause stand part of the Bill.

Question agreed to.

Clause 1 ordered to stand part of the Bill.

Schedule 1 - Scheduled purposes

Andrew Lansley (Conservative, South Cambridgeshire)

I beg to move amendment No. 92, in

schedule 1, page 37, line 13, at end insert

'or conducted using residual tissue'.

Irene Adams (Labour, Paisley North)

With this it will be convenient to discuss the following:

Amendment No. 93, in

schedule 1, page 37, line 21, at end insert

'other than such research conducted using residual tissue'.

Amendment No. 94, in

schedule 1, page 37, line 26, at end insert 'or using residual tissue'.

Amendment No. 95, in

schedule 1, page 37, line 28, at end add—

'13 Research in connection with disorders, or the functioning, of the human body using residual tissues'.

Amendment No. 86, in

clause 24, page 15, line 20, leave out '(8)' and insert '(8C)'.

Amendment No. 99, in

clause 24, page 15, line 23, at end insert—

'(3A) The Standards required to be laid down by subsection (1) may include provision that the use of residual tissue not normally requiring consent for purposes under part 2 of Schedule 1 may require the approval of an appropriately constituted research ethics committee.'.

Amendment No. 87, in

clause 24, page 16, line 3, at end insert—

'(8A) The standards required to be laid down by subsection (1) shall include provision to secure that consent indicates for which scheduled purposes consent has been obtained.

(8B) The standards required to be laid down by subsection (1) may provide that residual tissue may be retained for scheduled purposes under paragraphs 3, 5 or 7 of Schedule 1 without consent or pursuant to a consent to treatment entered into by the person concerned.

(8C) The standards required to be laid down by subsection (1) may provide that consent for the scheduled purpose of transplantation may be given by means of an enduring consent.'.

Amendment No. 88, in

clause 24, page 16, line 3, at end insert—

'(8D) For the purposes of this Act—

''residual tissue'' means relevant material obtained, in the course of, and consequent upon, a course of diagnosis or treatment, following consent of the person concerned to treatment; and

''enduring consent'' means a consent given by the person concerned which is obtained prior to any treatment and which is not specific to the circumstances of any diagnosis or course of treatment of that person while he is alive, or to the circumstances of his death.'.

Amendment No. 96, in

clause 47, page 29, line 26, at end insert—

'(e) purposes of research in connection with disorders, or the functioning, of the human body using residual tissues.'.

Andrew Lansley (Conservative, South Cambridgeshire)

Some of the amendments in the group have slightly different purposes to amendment No. 92, which I will explain. The purpose of amendments Nos. 92, 93, 94 and 95 is to transfer activity using residual tissue in relation to two schedule purposes in part 1, education and training, and research, to part 2. We tabled those four amendments because part 1 deals with education and training other than that conducted using residual tissue, and research other than research conducted using residual tissue; by extension we have added the use of residual tissue to paragraph 10, and we have added a new paragraph 13 to provide that research using residual tissue would not normally require consent.

We want to debate this point because it is clear to many in the medical research and scientific community that, following the tragedies at Alder Hey and Bristol, the issues that have given rise to some of the strongest concerns about the current legislation have arisen in relation to the retention of organs and tissues of those who have died. That is not to say that concern has not been expressed about tissues retained from living persons, but they have tended to be of a lesser nature.

The question that has emerged from the medical research community, which it is proper for us to discuss, is whether, although there are differences between living persons and deceased persons, the balance of the Bill is wrong, in that, as we heard in our debate on the previous group of amendments, so many tissue samples are being, or will be, retained from living persons in the course of treatment that if consent were required it would be excessive and burdensome to the research community.

The amendments are designed to explore that issue in relation to the two purposes of research and education and training—not to the general purposes of part 1. There are safeguards in the amendments, because although consent would not normally be required, amendment No. 86, a technical amendment,

would allow standards laid down to be included in the code of practice. Amendment No. 87, to clause 24, would add a range of standards that need to be laid down, one of which relates to residual tissues. It would require, in proposed new subsection (8B):

''The standards required to be laid down by subsection (1)''—

the standards in the codes of practice of the Human Tissue Authority—

''may provide that residual tissue may be retained for scheduled purposes under paragraphs 3, 5 or 7 of Schedule 1 without consent or pursuant to a consent to treatment entered into by the person concerned.''

Clause 24(3) allows the authority to set out the exceptions to those standards. Amendment No. 99 would provide that the standards will also require that the use of residual tissue, which would not normally require consent, may none the less

''require the approval of an appropriately constituted research ethics committee.''

I shall summarise the structure that we are suggesting. Residual tissue can be used for education, training and research purposes, and for the obtaining of scientific information. Residual tissue is defined in amendment No. 88 as

''relevant material obtained, in the course of, and consequent upon, a course of diagnosis or treatment, following consent of the person concerned to treatment''.

It clearly relates to a living person consenting to treatment. It does not impact on deceased persons, other than where they have died subsequent to that consent. The tissue can be used for specific purposes, but can be used only with the consent of a properly constituted research ethics committee. I think we are getting to the point where we shall at least have a structure—which could be put into legislation—designed to reflect some good practice now.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I would have thought that this sort of use would require the permission of a research ethics committee, and what the hon. Gentleman is doing in amendment No. 99 is saying that ''Standards . . . may include provision'', and those in turn may require the approval of a research ethics committee. If use of this sort of material requires the permission of a research ethics committee—perhaps he would consider circumstances where it would not, and where consent would not be sought, because it was not research envisaged at the outset of the treatment—is that really necessary, and might it actually put in statute a rather weaker provision?

Andrew Lansley (Conservative, South Cambridgeshire)

I do not think that the provision would be weaker, because the whole structure of the codes of practice is permissive, in the sense that they allow the Human Tissue Authority to determine what the practice should be. The codes of practice will state that, under some circumstances, the use of residual tissue will require consent, so it would not necessarily follow that the codes of practice would therefore require the approval of a research ethics committee, although that would probably happen under those circumstances as well.

There is a structure here. There is a point of principle here—are we committed to explicit consent as a basis for the use of residual tissues arising from

treatment? The research community is saying that that is a very burdensome requirement. We have to weigh up whether the demands of consent from living persons following treatment are such that we are not willing to consider that there may be a place for residual tissue—with the consent of research ethics committees—being treated as an exception to that principle. It is a question that we need to consider. I am not saying that we should necessarily reach that conclusion, but we should show the research community that we have considered it. I freely confess that there may be technical problems with the amendments, but the issue needs to be thought about—whether residual tissues arising from treatment, particularly if they are small amounts and directly consequent upon that treatment, should be, necessarily, the subject of explicit consent.

That is the first question that I do not want us to lose sight of, but there are others, and amendments Nos. 87 and 88 are not confined to that question. I ask the Committee to think about those two amendments separately. We discussed earlier, on the first group of amendments, the extent to which consent should be taken for specific, scheduled purposes. Amendment No. 87 would introduce a further standard to be laid down in the codes of practice by the Human Tissue Authority, to the effect that provision to secure consent

''should indicate for which scheduled purposes consent has been obtained.''

That is less rigid than putting the structure into the Bill, but clearly directs the Human Tissue Authority towards avoiding generic consent for a range of purposes without spelling out which purposes are intended.

Amendments Nos. 87 and 88 also add a further question—it is merely a question. Can consent for the purpose of transplantation be given by means of ''an enduring consent''? An enduring consent is defined under amendment No. 88 as

''a consent given by the person concerned which is obtained prior to any treatment and which is not specific to the circumstances of any diagnosis or course of treatment of that person while he is alive, or to the circumstances of his death.''

Can we be assured that, if explicit consent is required, consent for the purposes of transplantation will not be dependent on any of the circumstances giving rise to the person's death or any of the treatments or diagnoses that he might have received before his death? Will consent at an early stage, unrelated to subsequent events, be regarded as consent that carries through to the scheduled purpose being implemented after death?

Stephen Ladyman (Labour, South Thanet)

To make it easier for me to respond properly to the hon. Gentleman, will he clarify exactly what he means? It seems that he is describing a donor card signed before a person becomes ill. Such an example is not related to the other provisions, but I might have misunderstood his amendment.

Andrew Lansley (Conservative, South Cambridgeshire)

The Under-Secretary is right—it is unrelated to the discussion about the other amendments. Amendment No. 88 is in the group

because it follows on from amendment No. 87, which refers to residual tissue. An organ donor card could be an enduring consent, but we must be clear when we are legislating about a structure of consent and resting on common law consent. The Under-Secretary's understanding is that consent given that is unrelated to subsequent circumstances can be regarded as explicit consent in subsequent circumstances. I think that the hon. Member for Oxford, West and Abingdon has tabled amendments about whether an organ donor card can be regarded as consent for such purposes. My answer is yes, it can and that it can be regarded as enduring consent. However, we must be aware that practice is not as simple as that. Often it is regarded as conditional consent—conditional on the absence of objections from the next of kin.

Stephen Ladyman (Labour, South Thanet)

Is the hon. Gentleman asking whether the carrying of a donor card gives consent for uses of the person's body beyond that necessary for transplantation? If that is not what the hon. Gentleman is getting at, is he suggesting that, if a person's body were used for transplant purposes, some parts of it may also be considered to be residual tissue from that process? I am struggling with why such matters should be referred to in the clause.

Andrew Lansley (Conservative, South Cambridgeshire)

I meant neither of those arguments. It might have been unhelpful of me, but I grouped together in one amendment three standards that the code of practice should cover, so the matter rides on the coat tails of residual tissue, but is unrelated to it as an argument. The amendment is not about the use for scheduled purposes other than transplantation. I want make sure that there is a strengthened understanding that there is a form of consent that is not subject to subsequent changes of circumstances, nor, by implication, to being overridden by the objections of others, because the consent was given in an enduring form.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

This intriguing group of amendments was moved thoughtfully by the hon. Member for South Cambridgeshire. I hope that he can satisfy me on a couple of issues. Proposed new subsection (8A) in amendment No. 87 is an interesting way in which to deal with the issue that we discussed under the first group of amendments. Before he was pressed by the Under-Secretary to give an example of enduring consent, I thought that he was talking about whether, for example, a consent taken at the time of the taking of cord blood, which is then frozen for a long time, would endure—in other words, there would be no need to return to the patient or the patient's parents for further consent to use that blood for transplantation or, indeed, for the freezing of bone marrow stem cells, which could be stored for a time and not used acutely.

That is what I thought the hon. Gentleman meant. Even if he did not, I should nevertheless like the Under-Secretary, if this is an appropriate time, to say whether the material in question is considered residual tissue—although I notice that the amendment to a certain extent defines residual tissue. Is the hon. Member for South Cambridgeshire saying that,

under the amendment, subsequent advice from the Human Tissue Authority would cause a donor card to constitute enduring consent, and that the next of kin could not countermand that consent?

Andrew Lansley (Conservative, South Cambridgeshire)

Technically, no, that is not my argument. We would entrench into the codes of practice the concept of a form of consent that would be unrelated to subsequent changes of circumstance and which would be distinguished from any other kind of explicit consent. Once that strengthened form of consent had been created, the assumption about the views of the family that the hon. Gentleman described might be written into the codes of practice, but not necessarily so.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

As we know from the Second Reading debate, that is a contentious issue. However, I am pretty sure that there are amendments to clause 3 that deal with the problem from my perspective, so I shall leave the issue to one side.

I thought that the hon. Gentleman's reference to enduring consent was also an attempt to address conditional consent, whereby, although people have given consent, or their next of kin has given it after death, for their tissue to be used, they want to set conditions on who can receive it. That might be touched on by his question.

The third issue is the one that the hon. Gentleman started with, which is the idea that there need to be standards on the use of residual issue for research purposes. He did not give a ''for instance'', but he might be referring to a group of patients who have had tumours resected: such tissues are often stored for all sorts of reasons, permission for which is usually granted as part of the written consent for the operation. If research is being conducted on those tumours, consent might be sought for work that does not involve anonymisation of the samples, because researchers might want to compare the findings with other characteristics of the patients: for instance, if a certain antibody or antigen is found, one can, on examination of the case records, ask whether it was a factor in the history.

Is the hon. Gentleman suggesting that consent would generally have to be sought if, for example, samples that were patient-identified were to be used for new research conducted years after they had been taken? That is a reasonable question and I hope that the Under-Secretary can clarify the issue. I assume that a research ethics committee would be involved in such work—indeed, one would have to be. If so, I question the need for the extra protection that the hon. Gentleman proposes. Perhaps the understanding is that, for a new research project years later, there would be no need to obtain further consent from those patients, who may not still be alive. That is an interesting area to pursue, since we are dealing with tissue from living sources. Will the Under-Secretary clarify that?

These are not my amendments, but I ask the Under-Secretary to expand on what he believes the role of research ethics committees to be. They are otherwise not mentioned in the Bill; perhaps he regards them as temporary bodies. However, overlaps with research

ethics committees may become relevant as we discuss other elements of the Bill, particularly those referring to the Human Tissue Authority. Early guidance on the role of research ethics committees would be appreciated.

Stephen Ladyman (Labour, South Thanet)

Let me first deal with enduring consent for transplants. I shall deal with the topic briefly because I am sure that we will return to it in detail later. I confirm what I said on Second Reading: that the carrying of a donor card, or other indication of one's views, is an enduring consent to organs being used in transplantation. That consent applies either until it is withdrawn by the person who gave it, or until the consent is put into effect on death.

However, nothing in life is that simple. As my hon. Friend the Minister explained extensively on Second Reading, even if someone has expressed their wishes and clearly consented to their organs being used for transplantation, it is necessary to consult relatives when the organs have to be collected—for example, when screening the donor's recent behaviour to ensure that no diseases have been contracted that may pass to the recipient of an organ. If relatives are not prepared to give that information, it may not be possible to use the organs even though the person has given their consent.

Clinicians involved in such decisions are encouraged to be sensitive to the needs of everybody affected by the tragedy of a death. Therefore, if a close relative is deeply distressed by the idea of organs being used for transplantation, even though the individual had consented, the clinician may not feel it appropriate to use those organs. That said, one's donor card is a clear indication of one's views, and would, under the terms of the Act, be considered an enduring consent for organs to be used for transplantation. Someone would not be able to override that consent on technical grounds or because they wanted to impose their moral position; one's expressed wish would have to be clearly dominant in the minds of clinicians. I hope that we do not need to discuss the issue in further detail now, because we will do so later.

Let me deal with the concept of residual tissue. I understand why people working in laboratories and scientists carrying out diagnostic procedures might regard leftover material as waste and of no value to the person who donated it, and why they might therefore believe that they are entitled to impose their view of what it is used for ahead of what might be the view of the individual who provided the material. However, to do that would be fundamentally wrong and against the principles of the Bill. The principles of the Bill are that we all own our bodies, we are entitled to determine how material from our bodies is used, and we should have consented to the use made of that material. If we consented to the use of material from our bodies for diagnostic purposes, it should be used for those purposes, and it should not be assumed that the bit that is left over may be used for any other purpose.

That requires people to be careful when seeking consent for the use of material. If we think that residual material, as it is called in the amendments, may be used for purposes other than diagnostic procedures, it is necessary to consult the person

providing the material and to ask them to consent to its use for that purpose. What that means should be explained to the person.

Depending on the type of material, how much material is involved and the likelihood of its being used, the giving of consent may need to be a more detailed process or may be a fairly routine, simple process. A line may simply have to be added to the form that people have to sign to consent to the diagnostic procedure, saying, ''I also consent to any residual material being used for research or education purposes.'' So long as people know that that line is there when they sign the form and they understand what it means, that is perfectly acceptable, but the principle must be that they will know and be consulted. The fact that a bit too much material has been taken by accident is not an excuse for not seeking consent in the first place, and this group of amendments would fly in the face of that principle.

Andrew Murrison (Conservative, Westbury)

This is a useful discussion. It is important to get such matters on the record by way of exploring the issues, as my hon. Friend the Member for South Cambridgeshire said. Does the Under-Secretary agree that, although the fact that the tragedies at Alder Hey led to the Bill should be a thread running through it, there is a big difference between what went on at Alder Hey and what might go on in an operation, for example, in which material would be regarded by most people as residual, as waste? The two need to be clearly distinguished. Many of the representations made to us have been along the lines of, ''We as academics are not clear that politicians have clearly distinguished the two.''

Stephen Ladyman (Labour, South Thanet)

I entirely agree that there is a different order of magnitude in the bigger picture, but I put to the hon. Gentleman that those involved in many of the tragedies that have occurred, including Alder Hey, did not think that they were behaving badly. The tragedies occurred because people thought that they were working within the guidelines and, indeed, that what they were doing was for the best. However, it is not acceptable to have benign intentions if one's actions turn out to be malign.

I agree that there is a difference in the order of magnitude between the use of a bit of residual material that was taken for diagnostic purposes anyway, and the retention of organs. I keep that in proportion in my mind, and I am speaking not only as a Member of Parliament but as a scientist who has done such work. There is a difference, but the principle remains the same. If we are to have a Bill based on the firm principle that people must have consented or understood why the material was collected and what it would be used for, that principle must run through the entire legislation—as a golden thread that is not broken at any point.

The amendments would break that golden thread. The hon. Member for South Cambridgeshire introduced them by saying, ''The research community believes that''. That was also implicit in what the hon. Member for Westbury said. In fact, whereas the research community is alive to the

practical issues and the difference in the order of magnitude between events that happened in the past and what we are talking about now, I believe that, when it discusses the ethics of these principles, it does not disagree with what is in the Bill.

I shall highlight the view of the General Medical Council as an example. Page 12 of its guidance, which is entitled ''Research: the Role and Responsibilities of Doctors'', states:

''Samples of body fluids, tissues and organs can form a valuable archive for research purposes. You must obtain appropriate consent or authorisation before taking or retaining organs, tissues or body fluids, from patients or volunteers, for research purposes. This applies whether the material is obtained solely for research purposes or retained following a clinical or surgical treatment.''

The General Medical Council believes that the extra material that is collected should not be treated outwith the needs agreed to when consent for its use was given.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I do not disagree with the Under-Secretary. Consent must be very clear, and I have come to that conclusion from my work on research ethics committees. However, there is a question over whether the GMC is more representative of the research community than the Medical Research Council, which says in its briefing that the terms, by which it means appropriate consent,

''should be sufficiently broad to allow for use of tissue for new and unforeseen projects, with ethical approval, without having to trouble patients or relatives again for further consent.''

Even if I agree with the Under-Secretary, he still has more persuading to do with what is perhaps the elite body of the medical research community.

Stephen Ladyman (Labour, South Thanet)

I am not entirely sure I agree with the hon. Gentleman. It is not necessary to trouble the family of the deceased again if initial consent is sought in broad enough terms. If there were some purpose for retaining residual material, it would be necessary to obtain the family's consent only for one or more uses of the material as defined in schedule 1. Thereafter, it would not be necessary to return for more specific consent.

The GMC guidelines are not the only template; the position on consent is also set out in the Department of Health's reference guide and in the British Medical Association's guidelines. The BMA, the GMC and other research groups, including the National Translational Cancer Research Network, have clearly stated that they support the Bill's clarification of the position on consent and that best practice will rest on clear statutory advice.

I entirely understand why the hon. Gentleman has tabled the amendments; it is so that we can debate the matter and clearly state the position on the record. I would be surprised if he wished to pursue them any further. When considering the Bill we must maintain the fundamental principle that people are entitled to consultation about the use of materials, and that scientists—no matter how well meaning, and no matter how difficult it may appear to them to overcome the practicalities of the issue—accept the principle.

The vast majority of scientists accept and understand why we believe that the best way forward is to create a statutory framework in the Bill and for the Human Tissue Authority to establish best-practice guidelines that can change as ethical and moral positions change and science changes, so that actions can be refined. That is better than trying to spell out everything in detail in the legislation. The right way forward is a statutory framework with a golden thread running through it stating that people have the right to be consulted about the use of material from their own bodies, which is backed up by best-practice guidelines established in co-operation with the professionals.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I do not necessarily disagree with the Under-Secretary, but is he satisfied that that will provide the autonomy that people need to be able to decide what sort of research they are prepared their tissue to be used for? Some people may have ethical objections to certain types of research, and he should give some thought to what a consent form should look like if he is relying on generic research to reassure the likes of the MRC.

Stephen Ladyman (Labour, South Thanet)

The hon. Gentleman is tempting me into trying to write the best-practice guidance. The whole point of what we are trying to do is not to write that guidance, which will follow as a result of the involvement of professionals who will do their best to help to put it together. We are here today because we are trying to rebuild the public's confidence in the collection of material for medical purposes. Many people no longer quite trust clinicians to do what they say that are going to do with material. Many people who will be consulted about the use of material from their loved ones or from their own bodies are unsure about giving the go-ahead in case their child's organs end up in a bottle on a shelf to be used by someone for undisclosed purposes in a year's time. We are trying to rebuild people's confidence in the system, but we will not do so if we undermine the Bill's principle that they should be consulted.

Members of the research community may foresee practical difficulties with consultation, but they must come to terms with the fact that if they want the public's trust and confidence, and if they want to be able to obtain material freely, they must put more effort into ensuring that everyone has the confidence in the system that we want them to have, so that organs and material are freely donated. I should add that best practice is already well defined and that people are working well.

I hope that Opposition Members accept my arguments and that the hon. Member for South Cambridgeshire is prepared to withdraw the amendment.

Andrew Lansley (Conservative, South Cambridgeshire)

On the subject of enduring consent, we will have an opportunity to discuss just how effective the consent proceedings for transplantation can be made. From what the Under-Secretary has said, there seems to be no value in trying to intrude a further definition of consent rather than considering at a later stage the issues relating to the organ donor card or the registry. I therefore entirely accept what the Under-Secretary has had to say, and will move on.

On the subject of residual tissue, the Under-Secretary is right that there is quite a strong acceptance of the principle of consent among members of the research community—certainly those to whom I have spoken. They are, however, very worried about the practicalities, and we will have to try to deal with that worry in the codes of practice. The Under-Secretary is right to say that we are trying to rebuild confidence in the system, but the reason why some of availability of material has been prejudiced is only partly to do with a reduction in relatives' consent. It probably has more to do with the concerns when encountering patients of people in the research community and clinicians about expanded consent procedures and the practical difficulties of obtaining consent, especially for very large numbers of tissue samples.

Again, we must be clear, as must the research community, about what consent means for the purposes of the schedule. It needs to be explained to people that different uses may be made over time of the residual material for education, training and research. They can support future research if they consent to it, but the process must be quick and easy. If it is not, we may have many audits of the sort that I illustrated this morning from reports that were sent to me. As those audits demonstrated, a large proportion of samples may simply not have their boxes ticked, which may severely prejudice their representative nature and the archives that otherwise might be established. That is because clinicians who have contact with patients do not see the point of the process and they have a consent procedure that they regard as excessive.

We have fixed on debating residual tissue because, as previously discussed, we are dealing not with the absence of consent, but with consent to treatment and what that implies. The Under-Secretary is right, in the formal sense, that if one looks at any issue, it always seems unreasonable to say that one has a research purpose or further training or educational opportunity in mind and that consent should not be taken in that instance for such a purpose. It is possible for consent to be taken in any of those instances, and it should be taken, but a problem arises when the aggregate number of required consents so overwhelms the front-line GPs and hospital junior doctors that they simply stop having the conversations. Evidence from the audits is that as many as two thirds of cases are returned without the conversation having taken place. There is no answer to that problem, other than to establish the principle in the legislation and to be aware that there must be scope for sensitivity in the codes of practice.

This is an important discussion, to which we may return, but I do not want to depart from the principle to which the Under-Secretary adhered, as it is the basis on which we have supported the Bill. I want to encourage us to continue to consider precisely how the codes of practice will enable consent to be given in a practical way for the benefit of research. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I beg to move amendment No. 77, in

schedule 1, page 37, line 22, at beginning insert

'Organ or tissue donation for the purpose of'.

This is a minor amendment, designed to probe the use of the word ''transplantation'' in the list of purposes in schedule 1. I have discussed the amendment with others since I tabled it, and I can foresee some of the Under-Secretary's arguments. It is important to note that, at the time of consent, although transplantation may be intended, it will not necessarily take place. If the word ''transplantation'' is used, there may be an expectation that if tissues—or, more likely, organs—are taken, transplantation should take place. There may be disappointment and a feeling that something that was expected to happen has not done so.

The question of the purpose of transplantation covers everything that must be done on the way, but there is an argument for making schedule 1 more explicit to aid those who are considering the issue. We are talking about what consent is required for organ or tissue donation for the purpose of transplantation and not as the end point. Another question concerns how much of what is covered by ''transplantation'' will be part of the remit of the Human Tissue Authority, which we can deal with later.

Andrew Murrison (Conservative, Westbury)

We are struggling with some definitions. We struggled with the terms ''inherent'' and ''incidental'', and I would now like some clarification of the term ''transplantation''. There is some confusion about the involvement of the Human Tissue Authority in that regard. Clause 56, which deals with general interpretation, includes transfusion in the definition of transplantation, but clause 11(5) excludes it from the authority's remit. That seems to be a bit of a disconnect, and I seek the Under-Secretary's clarification.

Stephen Ladyman (Labour, South Thanet)

I am grateful to the hon. Member for Oxford, West and Abingdon for clarifying the purpose behind the amendment, but I am not persuaded that it is necessary.

The term ''transplantation'' is defined in clause 56(4). It is used to describe the process involved in fulfilling a purpose, rather than a specific action that is carried out as part of that process. Transplantation means removing the organ from the donor body—with all the activity that that requires—transporting the organ, storing it during transportation and re-implanting it into the body that receives it. That is a whole process.

Someone who consented to a loved one's organs being used to save someone else's life, only to find that they could not be used for that purpose, may well be very upset. The clinicians would have to be aware of such emotionally difficult situations and would have to give appropriate counselling and advice. It needs to be made clear in the guidance and in the way in which people are consulted when their consent is sought for transplantation that something might go wrong during the process and that the final act might not take place. However, we do not need to deal with that in the Bill, because we clearly define transplantation as a process,

or a series of steps, rather than as a single act that must be carried out.

I hope that that is sufficient clarification and that the hon. Gentleman will withdraw the amendment.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Andrew Lansley (Conservative, South Cambridgeshire)

I beg to move amendment No. 97, in

schedule 1, page 37, line 27, at end insert 'and epidemiological research'.

Irene Adams (Labour, Paisley North)

With this it will be convenient to discuss the following:

Amendment No. 82, in

schedule 1, page 37, line 28, at end add—

'13 Research activities where relevant material is anonymised and untraceable.'.

Andrew Lansley (Conservative, South Cambridgeshire)

We can be brief. I would be hard put to distinguish between public health monitoring and epidemiological research, but I suspect that it is possible to do so. One might say that monitoring relates to the current prevalence of disease in the population, whereas epidemiological research relates to the likely effects on the population of future and communicable diseases. The two things are highly complementary and might, indeed, overlap to an enormous extent, but, in some cases, monitoring may not constitute research. It was certainly the Under-Secretary's intention to include epidemiological studies in paragraph 11, on scheduled purposes.

The purpose of the amendment is to explore, for the sake of completeness, whether the lack of reference to epidemiological studies is really an omission.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am delighted that amendment No. 82 was selected with amendment No. 97; they go together in seeking to probe whether the purposes set out in paragraph 11 to schedule 1 are clear and sufficiently wide.

Public health monitoring is not the same as research for the purposes of supporting or improving public health. Public health monitoring means monitoring of the health of the public or of public health issues, but it can be argued that other approaches could be taken. For instance, such monitoring might not monitor public health directly but instead monitor the prevalence of a pathogen or an underlying condition that may not be apparent in a diagnosis; it may have an impact on public health but not be directly related to public health. It may help to hear how the Under-Secretary defends the existing wording, as I would not need to give exemplars.

Of more relevance is the question of whether public health monitoring is being used as a shorthand for research that is epidemiological and involves either anonymised and unlinkable or anonymised and potentially linkable samples. Some of the paperwork that I have seen on the Bill implies that paragraph 11 would allow prevalence testing on anonymised samples. It is not clear whether that can be done without consent on tissues from the living because it is

anonymised, or because someone has deemed it to be related to public health.

It could be argued that in respect of tissues from living people—we would not have to deal with the question of whether consent was required—it might be satisfactory to state that if the testing were anonymised and not linkable to the originator of the material, it could have no impact on the individual who had donated it. So long as it was deemed by a research ethics committee to be worth doing—doing so may even be pressing, and not only for reasons of public health—it would not otherwise require consent.

I am not sure that I agree with that, for the same reasons that I gave for agreeing strongly with the Under-Secretary that people have a right over what is done to tissue from their bodies. However, by restricting the provision to public health monitoring, he appears to be of the view that in some circumstances testing can be done when it is monitoring to do with the public health. That is not necessarily specified under paragraph 11, and I would be grateful if he would clarify his thinking. Such practice would not be traceable under certain circumstances. I imagine that his view is that, perhaps when needed to protect the public health, the source of the material may need to be traced, either for the person's own benefit or for the benefit of others. We need clarification.

Let us consider tissue that comes from the living; one example is that of tumours. A treatment may become available that requires the collection of tissue as soon as possible—prospectively, the information might not be so helpful—in order to determine whether there is an antigen on the surface of the tumour. That could be done from de-linked, anonymised tissue that is otherwise available. One would hope that there are two circumstances. One is that there is specific consent for research under paragraph 7 of part 1. I would be grateful if the Under-Secretary said that, where such consent does not exist, someone wishing to do such anonymised and unlinked research would not be allowed to do so, and that that is the intention of the Bill. A number of us have received representations to the effect that, if that is the case, it should be made clear now, so that people are aware of it and researchers can be aware of it when thinking how they will handle the introduction of this measure.

Stephen Ladyman (Labour, South Thanet)

Epidemiology is the study of the causes, distribution and control of disease in populations. The Government's view is that public health monitoring is a sufficiently wide definition to include use for epidemiological purposes. Therefore, the amendment tabled by the hon. Member for South Cambridgeshire is unnecessary. We would include in that definition the study of material for things such as the spread of HIV, CJD, severe acute respiratory syndrome—SARS—and so on.

As far as the amendment tabled by the hon. Member for Oxford, West and Abingdon is concerned, the fact that the material is subsequently anonymised does not mean that it was anonymised

when it was collected from somebody in the first place. The golden thread—that people are entitled to be consulted about what the material that they are providing should be used for—again applies. People should be consulted about the fact that material might be used for the sorts of purposes that he outlined. Even if it is subsequently anonymised, it would not be appropriate to use it for a purpose beyond those set out in part 2 of schedule 1—those not requiring consent.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The Under-Secretary said that he considers public health monitoring to include epidemiological studies. There may be one such study that seeks to examine tissue typing on those sorts of samples. That is similar to the sort of research that I described as that usually carried out on so-called residual tissues that are anonymised and unlinked. If he is saying that public health monitoring includes epidemiology, he is running the risk of going further than he would wish to—judged on his strong view, which I share, about the need to ensure that people have control over the type of research that is done with their material, even if it is anonymised.

Stephen Ladyman (Labour, South Thanet)

The answer to the hon. Gentleman's question is this: part 2 sets outs the purposes for which consent is not normally required, and they include public health monitoring. Within public health monitoring, we include epidemiological activities. Therefore, if material is being used for that purpose—specifically for the public weal—it will not require an additional consent. If the proposed research goes beyond that, clearly it should have had consent in the first place. The fact that the material has subsequently been anonymised is irrelevant to the process. I hope that that is a sufficient explanation for the hon. Gentleman.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

We can explore the issue later; it is not something that we need to tackle now. I want to take advice on whether the Under-Secretary's definition of epidemiology might be considered by people who take his and my view on research to be too wide. There is a series of studies that might be described as epidemiological that are not related to public health but are carried out in respect of what he called the

public weal. Ultimately, a huge number of research projects might come under that category. However, he has been as clear as he can be at the moment, and I am prepared to think about the matter at a later stage.

Andrew Lansley (Conservative, South Cambridgeshire)

The hon. Member for Oxford, West and Abingdon has teased out an interesting issue, but one on which it might be wise to reflect rather than debate further at this point. Nevertheless, there is clearly a danger of epidemiological research stretching widely into categories of research that ought to come under part 1 rather than part 2. We need to see where the boundaries between the two might lie. We may have an opportunity later to discuss that in relation to the codes of practice. I am happy that the Under-Secretary intends that public health monitoring should include the epidemiological studies that we have in mind. On that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That this schedule be the First schedule to the Bill.

Harry Cohen (Labour, Leyton and Wanstead)

I should like to ask one brief question about ''purposes normally requiring consent''. The second purpose listed is ''Determining the cause of death''. My understanding is that a coroner could require, without consent, to determine the cause of death. I want to be sure that that part of the schedule would not override what the coroner can ask.

Stephen Ladyman (Labour, South Thanet)

A coroner certainly can so require; the Bill does not interfere with the rights of coroners. The schedule is to do with examples such as hospital post mortems, which would not normally require a coroner's intervention.

Question put and agreed to.

Schedule 1 agreed to.

Further consideration adjourned.—[Joan Ryan.]

Adjourned accordingly at six minutes past Five o'clock till Thursday 29 January at ten past Nine o'clock.