Human Tissue Bill

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Dr. Taylor: 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.

Dr. Harris: 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

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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

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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.

Mr. Lansley: 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?

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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.

Dr. Harris: 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.

11 am

Mr. Lansley: 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.

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Prepared 27 January 2004