Human Tissue Bill

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Dr. Andrew Murrison (Westbury) (Con): Will the Minister accept that there is a great deal of concern on the part of the medical research community about these grey areas—the areas for discretion? As I understand it, her argument almost invites legal action to flesh out some of the gaps that we are leaving in this proposed legislation, and the concerns of organisations such as the BioIndustry Association will be left unanswered. Organisations such as Cancer Research UK, as I said on Second Reading, are worried that people's fears about going into medical research may influence their decision on whether to pursue clinical research. Those fears will come to fruition and people may worry that they will end up in the law courts as test cases to flesh out this grey area and these areas of discretion. We are doing them no service.

The Chairman: Order. That was a long intervention.

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Ms Winterton: We were careful when drawing up the legislation to have as much involvement as possible from those involved in scientific and medical research. I want that to continue, which is why we need the sort of flexibility that I am suggesting. We can make a judgment not to have court interference and just hope that we can carry on as before, but I think that we all agree that that is not the way forward. We want a regime that makes it clear that we want properly informed consent. From what I have seen of best practice at the moment, that need not be onerous, but is the right way forward.

I want to ensure that in establishing codes of practice the HTA is able to work with those in the particular community to which the hon. Gentleman referred. We must all pay credit to the valuable work that is done and to the way in which practices have changed in recent years to overcome some of the problems that society recognised. When things were going wrong it was not necessarily because people were deliberately trying to get round what was then best practice and allowed under the law. It was simply lack of clarity, and perhaps that society's expectations had changed. We want to work with those in the scientific and medical research community to ensure that the codes of practice are pragmatic, with flexibility in the system, and that we continue to build on best practice but are able to look at practical implementation also.

Mr. Lansley: I appreciate that the Minister was responding to my hon. Friend the Member for

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Westbury (Dr. Murrison), but I want to explain why he has made an important point. It may have been an offence not to obtain valid consent, but we are creating in the Bill a structure by which those who subsequently use retained tissue and organs are themselves committing an offence if valid consent is not obtained from the families of the deceased person by someone else. That is the heart of the problem because the Bill, for the reasons given by the Minister, does not set out what valid consent means. It is by reference to common law, which will be flexible. However, someone using tissues and organs for research may not be able to satisfy themselves that when consent was obtained it was valid consent. Yet, they could become liable to prosecution.

Ms Winterton: I hope that I can give the hon. Gentleman some firm reassurance. That is exactly why the clause that deals with the criminal penalties says ''reasonably believes''. The wording is correct because we want to make absolutely clear that if a person undertaking scientific or medical research reasonably believes that consent has been properly obtained, they would not be committing a criminal offence. That person may have an organ with something attached to it that says, ''Consent has been obtained''. If they imagine that consent has been obtained, it is clear that there is no criminal case to answer.

Mr. Lansley: In a sense, we have a circular argument. Do we not return to the point where the definition of reasonable belief is simply that the individual understands that consent has been obtained in a way that is consistent with the code of practice? In effect, the question of whether a prosecution might be undertaken becomes a question of whether consent has been obtained in accordance with the code of practice, notwithstanding clause 25.

Ms Winterton: If an individual had not been involved in the obtaining of consent, it would be quite reasonable for them to assume, if they have the appropriate documentation—we should remember that the HTA would consider the practices of an establishment to ensure that the means of obtaining consent is correct—

Dr. Ian Gibson (Norwich, North) (Lab): As I understand it, the local ethics committees would still exist, on which patient organisations, the local reverend and a few professionals from other walks of life sit. So, if somebody wanted to use tissue or perform experimentation, as often happens and will continue to happen, is it not true that they would have to apply through the local ethics committee, and that it could and would insist that consent—through whatever mechanism we end up with—had been obtained? There is a safeguard backing up what the Minister says. We should not forget that those committees are very important, and that they need a little more teeth.

Ms Winterton: That is absolutely right. The role of the local ethics committee will be extremely important, particularly when specific projects are being undertaken. I saw a clear example of that when I visited the Royal Brompton laboratory, which was researching cystic fibrosis. Researchers knew that they had to explain to people from whom they might

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remove part of a lung that they were using it for research into cystic fibrosis. The medical ethics committee said that it wanted the donor to be sure of the particular research for which the organ was to be used.

The hon. Member for Westbury raised the concern about grey areas, and he asked whether doctors and scientists should be anxious. The Bill will clarify the law, providing a clarity that the current law lacks. The codes will help and guide professionals. Due to developments over recent years, professionals are familiar with working on such a basis.

The research community has expressed fears about ending up in court as test cases, so I will explain how an individual matter would be resolved. Any complaint will usually go through the normal complaints procedure first. If consent were consistent with the codes, it would be unlikely to go any further. As I have said, it is likely to proceed to court only if there were exceptional circumstances that led to a police prosecution.

Let me reassure the hon. Gentleman about the separation between the person undertaking the research and the person obtaining consent. That would be different. There might be incredibly difficult circumstances if somebody had in front of them a form that clearly said, ''I am content for this to be used for a particular bit of research, but I do not want it to be used for another type of research because I have moral objections to particular medical procedures.'' If somebody deliberately ignored that, that would obviously cause difficulties. It is the separation between the two that we must be clear about. It is clear how obtaining consent should be approached. If somebody had no idea that consent was not obtained properly, that would not be considered their fault and they would not be liable under the Bill.

Dr. Harris: I certainly agree with what the Minister said in response to the worry expressed by the hon. Member for Westbury. Does she agree that whether consent is statutory or common law does not prevent fears that people will end up in court? Sometimes, in our increasingly litigious society, it is one person's word against another. What is required is that clinicians make clear written records of the process that they undertook to demonstrate that correct procedures were followed. I hope that that will be in the code of practice, and perhaps we can debate the matter on clause 23. Record keeping is key in the defence of some allegations.

Ms Winterton: That certainly can be the case. We have to be clear that there are clear guidelines and good practice already. We know that that is not impossible.

Of course I understand the natural need for reassurance that is felt by some in the scientific and medical research community. I hope that the message that we send out from this Committee is that we want to clarify the situation. What holds people back at the moment is a lack of clarity about the law.

Amendment Nos. 3 and 4 seek to ensure that relatives are sure about what they are agreeing to when

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they are asked to consent to removal and use of tissue and organs. As I have said, the hon. Member for South Cambridgeshire is right to say that there have been misunderstandings about the meaning of ''tissue''. However, distinguishing between tissue and organs in the way that he suggests does not necessarily provide the information that relatives need. Some organs are very small, whereas tissue can mean large amounts of body material, such as part of a limb. The definition proposed by the hon. Gentleman in amendment No. 4 derives from the 1989 Act and has been found to be confusing.

The problem is that defining an organ is difficult. That is one reason why organs are not mentioned in the Bill. We agree that people should have the right type and amount of information before giving consent. Indeed, if they give consent in relation to one piece of material only, it will be an offence to take, store and use any other material.

The appropriate information will be provided in guidance and in consent forms. The current Department of Health code of practice on families and post mortems states:

    ''The discussion must make clear to the family:

    The meaning of the term human tissue; that it includes organs, parts of organs and tissue in various forms, such as frozen sections and samples fixed in paraffin wax.''

The HTA's code of practice guidance on consent can equally be expected to make it clear that families should be fully informed of the nature and size of the specimens that it is proposed to remove or keep. The model consent forms currently provided by the Department for use in obtaining consent to post mortems also differentiate between organs and tissue, and the HTA could provide models on similar lines.

The difficulty again is to define in legislation something that it is more appropriate to define in codes of practice. As I understand it, a cornea is tissue, but to obtain it, the whole eye, which is an organ, must be taken. We want relatives to have the maximum information about the procedure. If a relative said, ''I want to give permission for the corneas to be taken'', we would want somebody to explain what that involved. I understand that the same is true for heart valves. The codes of practice must make it clear that relatives must be informed about everything that is taking place and not simply be given minimum information.

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