Clause 1 - Authorisation of activities for scheduled purposes

Human Tissue Bill – in a Public Bill Committee on 27th January 2004.

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Amendment proposed [this day]: No. 57, in

clause 1, page 1, line 11, after 'in', insert 'Part 1 of'.—[Dr. Harris.]

Question again proposed, That the amendment be made.

Photo of Mrs Irene Adams Mrs Irene Adams Chair, Scottish Affairs Committee, Chair, Scottish Affairs Committee 2:30 pm, 27th January 2004

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).

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

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.

Photo of Evan Harris 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?

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

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.

Photo of Evan Harris 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.

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

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.

Photo of Richard Taylor 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.

Photo of Richard Taylor 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.

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

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.

Photo of Evan Harris 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.

Photo of Mrs Irene Adams Mrs Irene Adams Chair, Scottish Affairs Committee, Chair, Scottish Affairs Committee 2:45 pm, 27th January 2004

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

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

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.

Photo of Evan Harris 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.

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

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.

Photo of Evan Harris 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.

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

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.

Photo of Evan Harris 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?

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health 3:00 pm, 27th January 2004

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.

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

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?

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

Will the hon. Gentleman go through that again.?

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

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?

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

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.

Photo of Evan Harris 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.

Photo of Mrs Irene Adams Mrs Irene Adams Chair, Scottish Affairs Committee, Chair, Scottish Affairs Committee

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.

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

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.

Photo of Evan Harris 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.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

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.'.

Photo of Mrs Irene Adams Mrs Irene Adams Chair, Scottish Affairs Committee, Chair, Scottish Affairs Committee

With this it will be convenient to discuss the following:

Amendment No. 17, in

clause 1, page 2, leave out line 20.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

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.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health 3:15 pm, 27th January 2004

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.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

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?

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

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.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

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.

Photo of Richard Taylor 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.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

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.

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

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.

Photo of Richard Taylor 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.

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

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.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health 3:30 pm, 27th January 2004

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.

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

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.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.

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

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.

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

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.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.

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

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.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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

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

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.

Photo of Richard Taylor 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.'.

Photo of Mrs Irene Adams Mrs Irene Adams Chair, Scottish Affairs Committee, Chair, Scottish Affairs Committee

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'.

Photo of Richard Taylor 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.

Photo of Evan Harris 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.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health) 3:45 pm, 27th January 2004

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.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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—

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.

Photo of Evan Harris 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.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.

Photo of Peter Kilfoyle 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?

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.

Photo of Richard Taylor 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.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.

Photo of Evan Harris 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?

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health) 4:00 pm, 27th January 2004

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.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.

Photo of Richard Taylor 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.