Human Tissue Bill

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Ms Winterton: The hon. Members for Wyre Forest, for Oxford, West and Abingdon and for South Cambridgeshire raised the issue of whether organisations such as the Royal College of Pathologists feel that the Bill will be over-constraining and onerous on their ability to carry out important research. There is uncertainty about what medical and scientific research can be carried out. That is why the Bill has been brought forward, as well as to address past problems that caused great distress to families. Due to those past events, there has been a climate of hesitancy in the research community about what is and is not lawful. The Bill attempts to clarify that position. We know that, in many instances, if people are properly asked about the use of tissue or organs for medical research, they are likely to accede. Relatives are particularly likely to do so if they know that their loved one made that request. We must provide a proper framework so that that research can take place.

We must also have flexibility in the legislation, so that the Human Tissue Authority can continue to consult all concerned: relevant professional, research and scientific groups as well as groups representing families. That means that when the authority issues guidance and codes of practice, they can not only reflect current situations, but be flexible and pragmatic enough so that they can be given proper practical effect.

The difficulty of trying to specify every circumstance in the Bill would be that it would be almost impossible to change that to reflect any changes in scientific research and in terms of the practicality of the guidance issued. We have to strike that balance, and we are confident that we have done so in the Bill. The difficulty with the amendments is that they would have the unfortunate consequence of bringing undue complexity and even conflicting meanings into part 1 of the Bill. Amendments Nos. 34 to 47 appear to be intended to clarify and help with the process of

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consent, but in fact the consent provisions in part 1 and schedule 1 to the Bill are already straightforward and simple.

Mr. Lansley: The Minister is referring to consent. One thing that I found somewhat surprising when I looked at the Bill was that consent was qualified by the word ''appropriate'' in one set of circumstances and by the word ''qualifying'' in another, but the word ''consent'' is never defined. Is she happy that the meaning of consent will not be defined in either the legislation or the codes of practice and will be defined only by reference to the common law interpretation of that word?

Ms Winterton: We must recognise that consent, as it is defined under common law at the moment, can be given in different ways. Again, it is extremely difficult to see how, in legislative terms, we could provide a definition without it being restrictive. With the Bill, we must put in place a statutory framework to allow the Human Tissue Authority to work both within the common law and within the guidance that is issued, so that that reflects current best practice and can be pragmatic.

Mr. Lansley: Just to be sure, is it the Minister's intention that consent will not be defined either in the legislation or by the Human Tissue Authority, or does she intend that consent should be able to be interpreted and given meaning in this context by the Human Tissue Authority?

Ms Winterton: Let us consider the practicality of that. I think that we are all clear that consent means that someone has been adequately consulted and asked. We may be talking about the removal of tissue or organs for medical research, for example, but let us now take the example of someone who gives blood. One would say that that might be used for the scheduled purposes in terms of clinical audit, on-the-job education and public health monitoring. In that sense, it might be adequate and appropriate for consent to have been seen to have been given by, for example, notices in surgeries or hospital waiting rooms. Consent beyond that, for further medical research, would involve specific consent, perhaps by a tick box like the one used at St. Thomas's hospital. Different types of consent could be used, as defined by the Human Tissue Authority guidance building on current best practice. The Bill contains nothing more than what is current best practice.

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Dr. Harris: With respect, the Minister is trying to explain the word ''appropriate'' rather than the definition of the word ''consent''. In ethical terms, consent is about protecting the autonomy of individuals, so it is hard to see how, strictly speaking, consent applies after death, as there is no autonomy to protect. Particularly in common law, consent is understood to protect someone taking blood, for example, against a charge of battery and assault.

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Again, it is hard to see how that would apply after death. Does the Minister accept that while we can rely on the common law treatment of consent for the living, she may mean ''permission'' for deceased persons?

Ms Winterton: No. In a situation where someone is deceased, we are talking about getting permission from the relatives, which is where consent comes in. There may also be a nominated person, for which we have also provided. There are a number of people from whom consent has to be sought if a person is deceased, and they are carefully defined in the Bill. It is clearly specified that anatomical examinations would require the individual written permission of the person who is deceased. The same applies to public display.

The Bill is clear throughout on who needs to give consent in any circumstances. Ongoing guidance about the means of obtaining consent will have to be developed by the Human Tissue Authority in consultation with professional organisations and other representatives of the scientific communities to ensure that the collection of consent is not onerous.

Clause 1(1) sets out the circumstances in which consent is required for scheduled purposes. The purposes, defined in schedule 1, are the matters with which we are concerned in the Bill. Broadly speaking, they are the use of human bodies or tissue in medical contexts such as education, training and research; the teaching of anatomy; carrying out post mortems; transplantation; finding out medical and scientific information; and related activities such as audit and quality control. We also address the question of public display, the position of which is uncertain under the Anatomy Act 1984.

The Bill sets out whose consent, if any, is needed for each scheduled purpose. That might mean my consent, that of my nominated representative or that of a person in a qualifying relationship, where consent may be needed after my death. That deals with the point raised by the hon. Member for Oxford, West and Abingdon. The setting out of who should give consent is straightforward and that is what is meant by appropriate consent—the person whose consent is needed. At the same time, the Bill sets out that only my consent can authorise anatomical examination, where my whole body is donated to an anatomy school for the purpose of teaching through dissection or public display after my death.

The hon. Member for Oxford, West and Abingdon asked whether anatomical examination could take place on a part removed from a living person. That is not so, because clause 56(2) specifically states that an anatomical examination relates to deceased persons and parts removed from deceased persons.

Dr. Andrew Murrison (Westbury) (Con): Will the Minister clarify that it also means parts from a living person who has subsequently died?

Ms Winterton: The whole purpose of the anatomical examination is that the whole body can be handed over, but that requires pre-written consent for anatomical examination by the individual. A death certificate is also required before the body can be released. I am not completely clear whether that would

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be allowed if a part had been removed and the person has subsequently died if that person had given pre-permission for an anatomical examination. Presumably the part may go with the body, but I will get clarification on that particular issue.

Dr. Harris: You are being very liberal, Mrs. Adams, because there are amendments in the next group that explore this. It may help if I use what the Minister has very helpfully said already to frame questions around some of the amendments in the next group.

Ms Winterton: There is a clear principle that for an anatomical examination the person must be deceased. Parts removed from a living person would not go for anatomical examination. The person must be deceased. If parts were removed and the person subsequently died, it may well be that the parts that were removed before the person died could go, but I will get clarification, as that is a technical point. I have to admit that my officials will have to look at exactly what would take place.

In terms of appropriate consent, the Bill sets out who should be consulted in order to obtain consent, which is provided for precisely in clauses 2 and 3. The problem we have with the amendments is that to seek to refer instead to gaining consent from the appropriate person adds nothing to the Bill. However, new clause 1 and 2 are more difficult and would be rather more damaging. New clause 1 would require that whenever any post mortem activity was considered and the consent of an individual or their relatives was being sought, the person giving consent would be obliged to state whether they also consented to research and teaching in order for their consent to the post mortem to be valid.

Equally, the new clause would require that whenever living patients are receiving medical treatment, they must specify whether they consent to the use of tissue for education or research. It seems sensible to be clear in all cases what consent there is and to what activities it extends. However, the approach taken in the new clause goes against the principles on which this part of the Bill is based. The new clause would place obligations on the patient or relative to say whether they consented to a particular group of activities if their consent to the primary activity is to be lawful. It would place blanket requirements on the specification of consent, and there are several difficulties with that.

First, it is not our business to place statutory obligations on parents and bereaved relatives. The Bill sets out when the use of tissue would be lawful. It is not for us to tell individuals that they must give an answer to a question that they may not have wanted to be asked. Secondly, we would in effect be placing a responsibility on the health professionals always to address those questions to the patient or relative. For example, when a person gives blood for diagnosis, the new clause would mean that the person had to specify whether they wished that blood to be used for education or research, and the attending doctor or

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nurse would have to ask, even when they knew that the sample would be disposed of immediately after the test was conducted.

Moreover, if a person receiving medical treatment had to specify whether tissue could be used for education or research, what would the position be if they failed or declined to consent to those further purposes? Would we refuse them the treatment if they had failed to answer the question? That would lead to many more problems than it would solve. Indeed, we do not believe that it would solve any problems at all.

New clause 2 takes a slightly different approach, but suffers from similar difficulties. In consenting to a post mortem, for example, the bereaved relative would be obliged to state whether they also consented to the use of the body or tissue for anatomical examination—dissection—or education and training, research, transplantation and public display. Frankly, it is unthinkable that consent would have to be obtained for all those purposes in such circumstances.

 
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