Human Tissue Bill

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

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

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

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

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

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

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

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

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

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

9.45 am

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

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

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

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

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

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

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

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

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

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

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