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The noble Baroness said: My Lords, this amendment concerns the concept of intentionality. In the course of some kind of treatment, information could be obtained that could be relevant to somebody else, but that would not necessarily be known at the outset.
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"I understand that, particularly in genetics, clinicians will often have stored tissue from a relative of their patient which could be used without the knowledge or consent of that relative, in order to assist the diagnosis of genetic disease. The Bill will require that consent be sought from such relatives before their tissue is used for this purpose. That seems right and proper".[Official Report, 15/9/04; GC438.]
I think we would all agree with that. Consent should clearly be sought before tissue from a competent patient is used for the benefit of another person. However, there are other concerns. The Royal College of Pathologists, in particular, has argued that paragraph 4 goes further than this. In the type of scenario it suggests, in the process of undertaking a diagnostic test for the benefit of an individual patient, unforeseen information is obtained which could or might be relevant to another person. Unless specific consent had been obtained for this eventualityand that would not be known in advanceit would apparently be unlawful under paragraph 4. For that reason, I have tabled this amendment. I beg to move.
Earl Howe: My Lords, I fully endorse the comments of the noble Baroness. She describes the amendment as coming under the broad heading of intentionality. I would give it the slightly different heading of "fortuitous discovery". Let us suppose that during the course of an investigation being carried out for the benefit of a particular patient, a pathologist makes a very fortuitous discovery which is relevant to the health of another person. Where would that pathologist stand in law if consent had not been obtained?
I should like to speak particularly to Amendment No. 83, which is grouped with Amendment No. 4. In Grand Committee, we had quite an extensive debate about the meaning of the terms employed in Schedule 1. Many of us were and are concerned about the lack of clarity in some of those terms, because we fear that unless researchers and clinicians are clear about what the terms mean, they will not want to risk falling foul of the law and, as a result, research will simply not be undertaken.
During our exchanges in Grand Committee, the Minister appeared to make a very important point which, if I understood him correctly, could considerably alleviate those concerns. He appeared to say (at col. GC439 of the Official Report of 15 September) that in a case where a particular activity could be classified as falling under Part 2 of Schedule 1, as well as under Part 1, only the requirements applicable to Part 2 need apply. This amendment is designed to give the Minister an opportunity to put that assurance beyond doubt.
Some of the purposes set out in Schedule 1 will, in certain day-to-day situations, overlap: for example, public health monitoring and research; drug efficacy testing and clinical audit; public health monitoring and obtaining medical information about a person
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which may be relevant to another person. Where this occurs, there has to be clarity about what consent requirements apply, if any. The common sense answer is to say that if the activity genuinely falls within the scope of Part 2 of the schedule and consent is therefore not required, it is irrelevant that it may also fall within the scope of Part 1 in the context of the consent provisions.
In common with other noble Lords, I am grateful to the Minister for the letter he sent to many of us on the terminological aspects of Schedule 1. I hope that he will now be able to provide further comfort on these matters.
Lord Warner: My Lords, the amendments in this group are addressed once more at seeking to redefine or clarify the activities covered by Schedule 1. As I said when we discussed these matters in Committee, the structure of the schedule provides for such activities as research and allows for the use of tissue without consent from living patients in the case of Part 2 activities. If an activity can properly be described, for example, as "public health monitoring", then, even though in some cases it may be possible to describe it as research, it would be proper to treat it under Part 2 of Schedule 1, because it is public health monitoring.
Clause 1(10) makes it clear that activities using tissue from the living for the purposes listed in Part 2 of Schedule 1 are lawful. Some of the amendments address precisely that point, and I am happy to give again the reassurance that the Bill accommodates it. As noble Lords who attended Grand Committee will be aware, and, as the noble Earl, Lord Howe, has said, I have written a letter in those terms and have set out in detail the Government's understanding of what is meant by each of the activities listed in Part 2 of Schedule 1. Further HTA guidance will develop this to help ensure that researchers and practitioners understand fully when consent is needed.
I do not believe that there is anything of substance between us. We agree that we are trying to achieve a workable and pragmatic Bill that is based on principle and that practitioners should know how to operate within it. We have described activities that require consent and those which, in respect of tissue from living patients, do not. These amendments do not add anything and they might risk altering the meaning of the scheduled purposes. I should emphasise that we must await HTA guidance on these issues, which will help researchers and allay many of the anxieties that they may have.
I shall return to my first point. Schedule 1 lists purposesregulation of the activity of removing, storing or using tissue for that purpose. So where an activity is done for one purpose, one could not say that it is also done for another. For example, it has been suggested that there could be confusion between clinical audit and research. We can distinguish between clinical audit and research, and I have set out in my letter what is meant by each, but the purpose of the activity would nevertheless be clear. If, in
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examining some tissue samples, my purpose is to audit a number of clinical cases, that is clearly different in purpose from examining them for conducting research, even if I use the sample in the same way. The purpose is the determining factor regarding the classification of activities in Schedule 1.
The amendment adds words to the scheduled purposes at paragraphs (4) and (6), which would not be helpful. Amendment No. 4 adds the notion of the aim of establishing the relevance of information that might be derived from examining a tissue sample. That is already implicit in the paragraph, because the schedule deals with purposethe purpose of examining tissue to that end. So the effect of the amendment would be potentially to exclude situations where it is already known, and in what manner, that information will benefit another person. The effect of excluding such cases from the schedule in this way would be that there would be no requirement for consent in cases where it should be obtained. In other words, it would be lawful to use tissue from patient A without his consent if, as part of the treatment and diagnosis of patient B it was desirable to obtain information from A's tissue, when it was known that that would be relevant to B. This is a complicated issue, but if the noble Baroness considers it carefully, and reads Hansard, she might think that this would not be the right outcome.
Amendment No. 5 again adds words that are not necessary. We have cast this paragraph quite widely but also very carefully, so that it does cover the matters which that amendment seeks to address. To extend the paragraph to include, for example, research into the use of the human body, which would be an effect of the amendment, would risk taking us into other fields altogether. Research into the performance of athletes, for example, could be one such use that might be caught under the proposed amendment. As I have said before, we should resist adding unnecessary words, because they might have a tendency to lead us astray. We should await guidance from the HTA regarding this area.
The final amendment in this group seeks to apply a principle of mutual exclusivity to Schedule 2 activities. I am in favour of tidy-mindedness in this area, but I have already explained that Schedule 1 deals with purposes and that if an activity is carried out for one purpose, it is plainly not being carried out for another. In the case of tissue from the deceased, the same requirements apply to all activities in Schedule 1. The distinction between Part 1 and Part 2 purposes is relevant only to tissue from the livingand the distinctions are clear and appropriate. Activities which can be described as being for Part 2 purposes are explicitly lawful without requiring consent.
A particular issue raised by noble Lords is the relationship between research and public health monitoring. I tried to cover that in my letter of 15 October to Members of the Grand Committee, and I should be happy to circulate that more widely, if that is the wish of noble Lords. For the benefit of the House, I
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shall not read out the whole of that letter, but a small part of it is worth quoting, which, I hope, will provide some reassurance:
". . . the Government does not think it necessary or helpful to define too narrowly the purposes listed in the schedule. Nor is it necessary to provide for mutual exclusivity of definitions. For example, an activity may properly be described as 'public health monitoring', even though it may be possible in some particular case also to describe it as research. If its primary purpose can properly be described as 'public health monitoring' it will fall under Part 2 of Schedule 1, which means that where tissue from living patients is concerned, consent will not be needed.
"The Human Tissue Authority will provide practical guidance and advice to those carrying on activities within its remit. Its guidance will not be definitive, as ultimately it will be for the courts to decide the scope of the scheduled purposes".
I would suggest that if we moved away from that by trying to provide mutually exclusive definitions, we would be likely to cause more difficulty than we anticipated. That is why we should await HTA guidance, which will be consulted on widely, involving people who have practical experience in such areas.
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