Human Tissue Bill

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Dr. Taylor: 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.

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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').''

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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.

Dr. Harris: 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.

Mr. Lansley: 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.

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Dr. Harris: 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

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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

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

 

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Prepared 27 January 2004