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Standing Committee G
Thursday 29 January 2004
[Mr. Alan Hurst in the Chair]
''Appropriate consent'': children
Mr. Andrew Lansley (South Cambridgeshire) (Con): I beg to move, amendment No. 1, in
The Chairman: With this it will be convenient to discuss the following:
Amendment No. 2, in
Amendment No. 100, in
Amendment No. 101, in
clause 24, page 15, line 15, after '(g)', insert—
'(aa) section 23(ff),'.
Amendment No. 3, in
clause 24, page 15, line 18, at end insert—
'(1A) The standards laid down under subsection (1) shall include provisions to secure that, wherever practicable, the consent for the retention of organs after death will specify those organs and not be subsumed within a general consent for tissues generally.'.
Amendment No. 4, in
Mr. Lansley: Good morning, Mr. Hurst. It is a pleasure to welcome you to the Chair. We made good progress on Tuesday and explored some of the issues of importance to the Bill, but I regard no issue as more important than the one that lies at the heart of this group of amendments. It would perhaps be helpful to explain what the group is intended to achieve.
The group has a particular purpose and a general structure fits around it. The purpose is expressed in amendment No. 3, which provides that the standards laid down by the Human Tissue Authority on the giving and obtaining of consent should specify where organs are to be retained and should not subsume such consent within a general or generic consent. We have used various terms. Consent is not defined in the Bill; there is simply consent. The purpose would be that, whenever consent for the use of organs was taken, it
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would be separately specified. I shall come back to why that is desirable.
Dr. Evan Harris (Oxford, West and Abingdon) (LD): I am sorry to interrupt the hon. Gentleman so early, but is he saying that ''consent for the use'' would be separately specified, or does he really mean that the consent should specify each and every organ—''those organs''?
Mr. Lansley: I am grateful for that question. In case I inadvertently suggested otherwise, I should make it clear that amendment No. 3 would ensure that, in the course of consent being given, if any particular organ was required to be retained, that should be specified in the consent.
Amendment No. 4 is designed to support amendment No. 3 by defining organs in the same terms as those used in the Human Organ Transplants Act 1989. The other amendments are designed to give a structure that allows the Human Tissue Authority to lay down such a standard. For example, amendment No. 100 would insert into clause 23, which deals with the matters that the Human Tissue Authority is concerned with, the provision that the meaning and interpretation of consent can be part of the purposes for which the codes of practice are set down. Amendment No. 101 adds to the matters that can be the subject of standards that are laid down. The amendments set out, first, what can be in the code of practice and, secondly, what can be in the standards, so they would put both consent and the meaning of consent into the codes of practice and the standards.
Amendments Nos. 1 and 2 relate to clauses 2 and 3, which at present define not consent but appropriate consent—in other words, who can give consent. The amendments would mean that consent could be defined in the Bill. At the moment, I presume that its meaning is derived from common law practice. For the purposes of the Bill—obviously the amendments would not have a bearing on the meaning of consent for other purposes—consent would be defined, but not rigidly defined. That takes into account the arguments that we entered into on Tuesday. Just as the meaning of consent has had to develop over time, according to precedent and practice, the Human Tissue Authority could define its meaning through the mechanism of setting down standards in codes of practice. Therefore, best practice at any one time could be reflected. I confess that I do not remember who said that we do not know how best practice might develop in the decades ahead, but they were right to do so. Hopefully, the legislation will last a long time.
To summarise, the Bill should define consent and it should do so by reference to standards set out in codes of practice by the Human Tissue Authority. Amendments Nos. 1 and 2 are intended to allow the Human Tissue Authority to put such standards into its codes of practice.
That brings me to amendment No. 3. In the light of everything else that I have talked about, why do I want to provide that organs, in particular, should be specified in the consent? The reasons relate to my conversations with people in my constituency and beyond it who have been affected by the retention of
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organs and tissues. They are aware that, although there were cases—for example, Alder Hey—in which those who retained tissues were trying to evade their responsibilities under the Human Tissue Act 1961, on the great majority of occasions people were not seeking to do so and thought that they were working within the framework of practice.
In our discussions on Tuesday, we rightly emphasised the excessive burdens that would arise if every clinician or member of medical staff who talked to relatives about the retention of tissues and organs had to specify in each case—even for tissue blocks and slides, which involve tiny samples of tissue—all the detailed research. We are starting to talk about the possibility of generic consents. In effect, we are talking about a tick box for scheduled purposes. The Bill sets out how each of the scheduled purposes should be specified, and I hope that by the time we have finished it will do so in more detail.
Even so, if one says to the relatives of somebody who has died, ''We wish to retain tissues from your loved one for the purpose of future research'', those families might expect that the tissues would be sections from a tumour or something of that nature, unless they were told otherwise. On many occasions, people were informed about the retention of tissues in a form that led them to believe that blocks and slides virtually consequent to a post mortem examination and linked to determining the cause of death were retained. Subsequently, they found out that whole organs had been retained, some of which had absolutely no bearing on determining the cause of death, and which clearly were not the subject of the consent that was given. The purpose of amendment No. 3, in effect, is to acknowledge that difference.
It is obvious that there will be major differences in the understanding and emotional response of families and loved ones to the retention of tissues and organs as samples, as compared with whole organs. It is best practice wherever organs are to be retained that specific consent should be given, although it has proved to be one major area of divergence. Given that best practice, good sense would have led people to expect us to be clear about what we expect from the Human Tissue Authority by laying down standards in the codes of practice so that there is no misunderstanding about the matter in future. The HTA would have to be flexible in achieving that.
I hope that I have explained the structure of the amendments by focusing on the issue of substance, although I also hope to commend to the Committee the notion of allowing the HTA to be able to define consent and the question of taking consent more generally. It is not only the issue raised by amendment No. 3 that might be subject to standards in the codes of practice. From my examination of the Bill—the Minister may think that I have misinterpreted it—it is not the intention to allow the HTA to define consent in the codes of practice. It is entirely desirable that the HTA should have that ability.
Dr. Harris: I thank the hon. Member for South Cambridgeshire (Mr. Lansley) for providing a
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valuable service in drawing out the fact that there is a difference between tissues and organs. There is no doubt about that, and people may be misled by the use of the term ''tissues'' where ''organs'' are what is really meant. The current provisions are not acceptable, so I have a great deal of sympathy for the amendments.
My question is whether amendments Nos. 3 and 4 are the best way to deal with the issue. If the amendments were accepted, they would limit the ability of the HTA to come up with its own definitions after wide consultation and deliberation on how best to make it clear that consent should deal with the stated purposes in relation to the range of tissues and organs. There should not be anything misleading, and the danger is that, by specifying that in amendment No. 3, and then defining ''organs'' in the way that amendment No. 4 does, the issue would be closed down when there may be a better way of dealing with it.
I am not certain whether I subscribe to this view, but there is concern that a list of organs that might be retained might be extensive. That could be distressing, even for a family who has no objection to the retention of those organs. It might be argued that a balance has to be found, but I am not necessarily sure that I take that view. I have argued in favour of being much more explicit with patients—even at the risk of upsetting a minority—because of the dangers of being too paternalistic and seeking to protect feelings. Before the issue is decided in statute, it might need more consideration.