Human Tissue Bill

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Dr. Ladyman: This is one of those wonderful occasions when one thinks back to one's schooling and remembers those esoteric lessons that one had to attend, wondering, ''What possible value could knowing this ever have for me?'' I remember as an O-level and A-level biologist having to discuss the theory that hair is excrement, on the grounds that excrement is defined as non-cellular material that has been metabolised and then egested from the body. I wrote long and erudite responses about why hair was different from other cellular material. Finally, after all these years, it is useful to know that.

Let me stress to Opposition Members that the fundamental philosophy behind the Bill is that people should consent to the use of material from their bodies and that they should understand that consent when they give it. Nobody has the right to override that consent or to consider it valueless. I do not accuse any Opposition Member of making that error, because I know that these are probing amendments to allow us to put on the record our understanding of the issues. Were they seriously putting forward the amendments, I would have to accuse them of falling into the trap that led us to need the Bill.

At Alder Hey and other organisations that retained material, pathologists or others either thought the material so valueless that nobody would worry if

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they kept it, or transposed their opinion of the value of the material for that of those who ought to have been consenting to its use. It is because they could see scientific merit in keeping the material that they thought that, on balance, it should be retained and the individuals who ought to have been consulted need not be consulted. In reality, that mindset, benignly held, but with malign impact, caused the problems that we are addressing today. There is a whiff of that to these amendments. Although—

Dr. Harris rose—

Dr. Ladyman: Let me finish, then the hon. Gentleman can get upset with me. Although we might not see a problem in retaining, for example, blood samples—as somebody who has spent much of his life in or around laboratories, I cannot foresee any reason why anybody should want to withhold consent for that—I accept that some people might. Their opinion has to count for more than that of those who think, ''It does not matter, we can retain the material.'' We must remember that the fundamental philosophy that people should consent to the use of all material is the overriding one.

Dr. Harris: I strongly endorse that. I have spent four years on a research ethics committee, and a coach and horses would not make me sign the amendment in the name of the hon. Member for Wyre Forest. I cannot speak for the hon. Member for Westbury; I would not ascribe any motives to another hon. Member. When the Minister uses the terms ''Opposition Members'' and ''these amendments'', he must realise that we are the victims of the grouping of amendments and not necessarily in support of the thinking behind what the hon. Member for Wyre Forest proposes—or, I suspect, wants to probe.

Dr. Ladyman: I did not accuse anybody of falling into the trap, because I acknowledged that all the Opposition amendments were probing. I said that, were Opposition Members to press the amendments, they would be falling into the trap, but I accept that the hon. Gentleman wishes to make his position clear. Let me reiterate that the fundamental principle is that people must consent.

The hon. Member for Wyre Forest asked a specific question about what sort of consent will be needed. Clearly, if somebody is sent by a general practitioner for a blood test, and he goes into the clinic and puts out his arm in order for the blood to be taken, he is consenting to the use of that blood for the purposes of finding out what is wrong and how to make him better. That is what, by implication, he has consented to.

Mr. Peter Kilfoyle (Liverpool, Walton) (Lab): Unlike my hon. Friend, I am not a biologist at any level. However, when he was talking about why people might not want their blood samples to be kept, I thought of constituents who have not wanted their DNA to be kept—they felt, for good reasons or bad, that it might be used at some future point to connect them to crimes. Is there any currency in that line of argument?

Dr. Ladyman: I am absolutely sure that none of my hon. Friend's constituents is suspected of any crime, current or future. I say that because I was brought up

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in his constituency. He makes a valid point—some will hold that concern and they are entitled to do so; we should not impose our views on them.

As I was saying to the hon. Member for Wyre Forest, by holding out one's arm and allowing blood to be taken, one is consenting to the use of that blood for the purposes of finding out what is wrong and making it better and—as my hon. Friend the Minister said earlier—consenting to actions that are an integral part of the process, such as quality assurance. If somebody wants to use that blood for other purposes, including research, an additional consent must be obtained. That can be a very simple process, and we would want it to be as bureaucracy-free as possible. However, if material is to be used for anything other than the purpose for which it was given, consent should be sought.

Dr. Taylor: I am very interested to hear the Under-Secretary talk about the simplicity of gaining consent, but what bothers me is that about 30 million samples are provided every year. I am sure that residual specimens from patients with leukemias and other blood diseases are kept for future use, and I would like to hear the Under-Secretary tell us how consent could be obtained simply from such a number of patients.

Dr. Ladyman: I assure the hon. Gentleman that there is some very good practice in that respect—St. Thomas's hospital is a good example. Consent is routinely sought to make additional use of material, and that can be a very simple process. It is not for me to do the job of the Human Tissue Authority and to establish best practice, but I can envisage several ways in which consent might be sought. For example, people giving blood for a blood test could be read a simple form and asked to sign it if they did not want the material to be retained after the test. The process can be as quick and easy as the human imagination can make it; we have no wish to make it long and drawn out.

Clause 1 and schedule 1 are intended to ensure that no human bodies, body parts, organs or tissue will be taken for research or other specified purposes without the consent of relatives or patients. That is the fundamental principle behind the Bill. As the Bill stands, the term ''relevant material'' refers to all material that contains cells other than hair and nail, which are regarded as disposable, and gametes and embryos, which are covered by separate legislation. The term therefore applies to all material from a human body, including organs and blood. It is intended that such material should require appropriate consent when stored or used for scheduled purposes, such as research or education.

I fully understand the concern that the patient and their relatives must be properly informed and sure that they and the clinicians are talking about the same material when making decisions about the patient's body, and that will be made clear in guidance. It is not necessary to make fine distinctions in primary legislation, which could lead to confusion by defining too closely the issues that we are discussing.

The misunderstandings that have arisen can be resolved through better communication between

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patients and those seeking consent about what will be used and for which purposes. As we shall see, one of the main roles of the Human Tissue Authority will be to set down standards for communication with families, which will have to be met when obtaining consent.

Another of the authority's roles will be to provide the public and persons carrying out activities within its remit with information and advice about the nature and purpose of those activities. That will allow for flexibility when dealing with the many possible situations covered by the Bill's overall framework.

I hope that Opposition Members are reassured by my comments; I am rapidly studying their body language to see whether I need to explain the issue ad nauseam.

Dr. Harris: Can the Minister clarify his understanding of amendment No. 80, which would make the Bill refer to ''a human cell or cells''? Can he assure me that every cell will count? While he is at it, will he address the issue of acellular material, which was raised by the hon. Member for Westbury?

Dr. Ladyman: I give the hon. Gentleman the assurance that one cell will have exactly the same impact as many cells, so there is no issue in that regard.

The hon. Gentleman asked an interesting question about mucus and the fact that it is a disposable material. I shall have to reflect on whether it will be covered by the same criteria as hair and other material. However, given that one would have to provide the mucus, one would know that it was to be used for some purpose. In practice, we may not have to worry about that.

I have been advised that mucus, if it includes cells, is covered by the Bill. However, the hon. Gentleman was making the point that it would not necessarily include cells. Saliva would be another obvious material that includes no cells and may raise some interesting issues. I will reflect on that and provide further information if it comes about. However, the Bill is essentially based on cellular material—whether one cell or multiple cells.

4 pm

Dr. Murrison: I am sure that phlegm and saliva both contain cells; I would be surprised if they did not. The Under-Secretary has not mentioned the acellular materials that I mentioned—plasma and serum. They are in a slightly different category from phlegm and mucus. Perhaps he would like to say why they appear to have been excluded.

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