Human Tissue Bill

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Mr. Lansley: I am grateful to the hon. Gentleman. Of course, we have not yet reached that point in our discussions, but best practice, which should be reflected in the codes of practice, would allow families to state the extent to which they wished to know about what is to be retained. Clearly, that would have to come at an earlier point; there will be some families who do not want to know. That would mean that those who might be distressed in the way that the hon. Gentleman suggests would not necessarily have to go through that ordeal.

Dr. Harris: There may be a mechanism that makes the approach that the hon. Gentleman has suggested much more suitable, and if the amendments were accepted, I hope that they would deal with that concern. However, there is still a more general issue that needs to addressed. I am still not sure whether I will support the amendment. I await the Minister's response on whether the definition, which ought to be a matter of consultation, is too narrow, and on whether there is a need to specify individual organs rather than, for example, the amount of tissue that will be retained, which might be more easily understood by the family concerned.

Dr. Richard Taylor (Wyre Forest) (Ind): I support this group of amendments because it explores the same matter that I was trying to explore on Tuesday: appropriate consent, as defined, addresses only consent from the appropriate person. I am in the hands of the Minister; I would think that we could address the issue in much more detail under clause 23, which covers the codes of practice. I am not clear whether it is necessary to debate the matter now, but I

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am very keen to clarify the definition of the consent required and the way in which it is obtained.

Mr. Lansley: The extent to which clause 23 covers the meaning of consent is a moot point. It covers the communication with families, but it does not necessarily enable the Human Tissue Authority to define consent, as distinct from the common law definition.

Dr. Taylor: I take that point. I hope that we will have time to study the amendments tabled to clause 23, in which I might try to address it.

The Minister of State, Department of Health (Ms Rosie Winterton): I welcome you to the Chair, Mr. Hurst.

I understand the desire of the hon. Member for South Cambridgeshire in tabling the amendments to reflect some of the concerns that, for example, the Royal College of Pathologists might have about the issue of obtaining consent. I also understand the issues to which he has referred on the stress caused to families due to a lack of clarity about exactly what was being taken—thinking that a small amount of tissue was being taken, whereas whole organs were taken. How to strike the proper balance between the needs of the scientific and medical community and of families is the theme of our debates. I certainly understand that there is an anxiety among some scientists and pathologists, who feel that it is not clear what is meant by ''appropriate consent'' for the purposes, for example, of the criminal offence.

We have established that ''appropriate consent'' relates primarily to the person from whom consent should be sought, rather than to the conditions for obtaining valid consent. However, conditions for obtaining valid consent can be decided only by the person seeking consent, in the circumstances of each individual case, and supported as necessary by guidance. Amendments Nos. 100 and 101 would ensure that the code of practice included interpretation of the meaning of consent. However, it will ultimately be a matter for the courts to determine whether consent has been obtained in any particular case. The code of practice is not the place for that to be spelled out.

That is because failing to obtain appropriate consent is a criminal offence under the Bill. It would not be legally appropriate for a code of practice to define specific legal obligations—breach of which leads directly to criminal liability. The Bill makes that clear in clause 25. On the other hand, it is appropriate for the codes of practice to supplement the provisions of primary legislation.

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The code of practice in clause 23 is the right place for guidance on how to obtain consent. It may be expected to reflect the requirements of the common law relating to valid consent for medical treatment, such as the need for sufficient information to be given without coercion. The code of practice will be able to give guidance that allows flexibility in obtaining consent according to different circumstances.

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The effect of amendments Nos. 1 and 2 would be to remove that flexibility and undermine the discretion of people seeking consent to determine for themselves what constitutes valid consent. They would be obliged to follow the code of practice in order not to commit a criminal offence, even though valid consent may be obtained without meeting the standards in the code, because of the circumstances of a case. We would expect the person seeking consent to weigh up what information each patient requires before they make a valid decision. If, for example, the code stated that written consent was required to store or use tissue for a particular purpose, and someone who was physically unable to write asked a relative to sign on their behalf, there would be a danger under the amendments of that becoming unlawful.

Mr. Lansley: I am listening carefully and I understand the point that the Minister is making: amendments Nos. 1 and 2 run the risk of substituting a statutory definition of consent for what is otherwise a common law definition. Is there a problem in that the codes of practice—which, as she has described them, seem to be one way in which guidance can be given on how consent is obtained—do not go beyond communication with the family? Should the codes bear on the question of valid consent in order to guide those who are taking consent?

Ms Winterton: The codes of practice will, as has been said, draw on best practice at the time. They will be drawn up in consultation with professional bodies and others. What they will not do is reflect every circumstance.

In a way, that goes back to something that the hon. Gentleman mentioned: the extent to which people will want to know exactly what is happening. Some people may wish to know the minimum about what may be taken from a body. Some relatives may not want to know every detail, while others may. Therefore, the issue, which would be decided by the courts if there were felt to be a breach that constituted a criminal offence, is whether the person had deliberately failed to obtain any consent at all. Although the code of practice can set out certain standards, there will be times when it would not be appropriate necessarily to meet all the standards set, because those standards would refer to absolutely best practice on the assumption that the person wanted the maximum information. If that were not the case, individual judgment might be used. The underlying theme would be the failure to provide information and obtain consent from the relatives of the deceased.

Mr. Lansley: Let me boil down the question to something slightly different. Is the Minister contending that communication with the family, which is covered by clause 23, is a sufficiently wide expression of what the HTA must include in its guidance? Is there not an argument that, even if the HTA provides guidance on best practice that reflects the decisions of courts when consent has been obtained through them, it must go beyond communication with the family to guide people on what might otherwise be regarded as a criminal offence? Communication with the family is wide, but is it wide enough to enable the

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guidance to cover the question of what is and is not lawful?

Ms Winterton: That comes back to flexibility and how, in conjunction with others, the guidance can be developed. For example, there is very clear guidance on the different questions that should be tackled when talking through post mortems with families. Flexibility might be required to reflect the needs of families at that time.

Codes can cover best practice on the giving of information and the recording of consent, for example. They illustrate how to address the issue rather than every possible case. Guidance is available on consent to examination and treatment, and it has been very valuable to health professionals. We would not want to enshrine it in statute, because if there is felt to be a breach it might be more restrictive to the approach that individuals need to take with families at a given time.

Although I understand the hon. Gentleman's desire to enshrine in statute through the code of best practice the meaning of consent in individual cases, we need the flexibility of a code that provides guidance but, ultimately, leaves decisions on individual cases to the courts. It is not for us to enshrine in statute the offence of failure to obtain consent. It would be too restrictive to anticipate every circumstance, and it would not be practical or legally appropriate to define every single situation.

Dr. Doug Naysmith (Bristol, North-West) (Lab/Co-op): This is an extremely interesting and important part of our discussion. The Minister has said three times already that the courts will decide. Perfectly valid research and clinical procedures involving clinicians, scientists and medical scientists can be carried out, for reasons that we would all agree are right, and those who carry them out need to know before they embark on them that they have valid consent for what they are about to do. The mention of the courts understandably frightens and upsets many of those who work with human tissue.

Ms Winterton: I understand my hon. Friend's comment, but the Bill is intended to make it clear that, because of what has happened in the past, Parliament expects proper consent to be obtained. The difficulty up to now has been that there has not been clarity about what is expected. We are sending out a message that what has happened in some cases is not acceptable and that we are determined to ensure that it will not happen again, but we do not want to be too restrictive and prevent people exercising discretion.

In many cases, we simply want to ensure that there is communication with a family, but we expect high standards in that communication. Where there is best practice at present, that is not impossible, but we must allow for different circumstances. If we try to anticipate such circumstances in the Bill or too tight a code of practice, we will cause enormous difficulties and create too much rigidity. In the case of a criminal offence, a court will take the code of practice into account, but it must make a judgment about the way

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in which the person used their discretion in the particular circumstances.

The hon. Member for South Cambridgeshire asked whether the code of practice could lay down standards on obtaining consent as well as simply communicating with the family of the deceased. The answer is yes, because clause 23(1)(b) says that the code may lay down standards in relation to the carrying-on of activities within its remit, which can include standards on obtaining consent to all those activities. However, we must make sure that the Bill does not impose too much rigidity at a sensitive time. There must be discretion to make judgments in individual circumstances.

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