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Standing Committee Debates

Code of Practice on Consent (Code 1)

The Committee consisted of the following Members:

Chairman: Miss Anne Begg
Blunt, Mr. Crispin (Reigate) (Con)
Clelland, Mr. David (Tyne Bridge) (Lab)
Devine, Mr. Jim (Livingston) (Lab)
Efford, Clive (Eltham) (Lab)
Harris, Dr. Evan (Oxford, West and Abingdon) (LD)
Irranca-Davies, Huw (Ogmore) (Lab)
Mackinlay, Andrew (Thurrock) (Lab)
Main, Anne (St. Albans) (Con)
Mole, Chris (Ipswich) (Lab)
O'Brien, Mr. Stephen (Eddisbury) (Con)
Penning, Mike (Hemel Hempstead) (Con)
Pugh, Dr. John (Southport) (LD)
Sheridan, Jim (Paisley and Renfrewshire, North) (Lab)
Smith, John (Vale of Glamorgan) (Lab)
Trickett, Jon (Hemsworth) (Lab)
Vara, Mr. Shailesh (North-West Cambridgeshire) (Con)
Winterton, Ms Rosie (Minister of State, Department of Health)
Chris Shaw, Committee Clerk
† attended the Committee

Third Standing Committee on Delegated Legislation

Wednesday 25 October 2006

[Miss Anne Begg in the Chair]

Code of Practice on Consent (Code 1)

2.30 pm
Dr. John Pugh (Southport) (LD): I beg to move,
That the Committee has considered the Code of Practice on Consent (Code 1).
The Chairman: With this it will be convenient to consider the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006(S.I. 2006, No. 1260).
Dr. Pugh: I apologise for the fact that my hon. Friend the Member for Oxford, West and Abingdon (Dr. Harris) is not here. As members of the Committee will see from the parliamentary monitor, he is otherwise engaged. He has his finger in many pies and, although he is enormously talented, he has not yet mastered bifurcation. I must also apologise in advance for what I am about to say. I have had to mug up on my hon. Friend’s brief pretty quickly, and he has followed such measures far more carefully and with greater scrutiny than I have hitherto.
The regulations follow a prolonged debate and extensive consultation on the legislation. The Government thought long and hard to reach a balance to deal sensitively with a difficult subject, where, in fact, many varying interests clash, such as medical research, patient autonomy and welfare, and the public benefit that can come through transplants and research. We must bear in mind that some primeval feelings about respect for the body, the deceased and so on are deep-rooted, sensitive and important to people. There are the interests of the bereaved to consider in connection with such issues as well as cultural sensitivities in different parts of our society about the body and body parts.
There is a need for a balance. I accept that it is difficult to achieve, but somehow or other we must reflect society’s view of where it can be found because, at times, we can get matters spectacularly wrong. The example of Alder Hey leaps readily to mind. The whole history of anatomy is full of the most disgraceful episodes of one sort or another, such as the recent furore over the exhibition of cadavers as a form of entertainment.
We need to have regulations that are practical and reflect a balance with which we are happy and comfortable. We have before us two documents, one that is legally complex and impenetrable and one that is clear and therefore far more questionable. Let us first consider the impenetrable document. It mainly concerns exemptions from requirements of licensing for those who hold tissue. The medical fraternity has tried to draw a distinction between end users and storers, which have definite licensing requirements to meet.
At the back of the second document is an explanation of storage, but it is a glib one-line definition. It has been suggested by medical opinion that we need to be absolutely certain that we know what is meant by storage. That is accepted by some of the medical fraternity, but there are occasions when, because research is ongoing, information needs to be retained over a certain period, and that raises the question whether that itself constitutes storage. Holding samples as part of a batch before sending them back to storage takes place prominently in research communities and is an issue that needs to be clarified before we can happily accept the regulations. It is certainly an issue that has been raised within the British Medical Association. I shall make no further comment about the impenetrable document.
I turn now to the more accessible document, the code of practice. It raises two worries. Some concern general clarity while others are residual worries that have been expressed by the BMA. However, all of them are fundamentally about consent, what it means and how it can best be defined. I shall take them in the order set out in the code of practice and explain where I and those who are far more expert than me perceive difficulties. I doubt whether any of us here have day-to-day experience of being involved in such affairs. I have actually witnessed a post-mortem, but that is the limit of my experience.
Most members of the Committee will find one difference manifestly clear—the difference in the code of practice between the living and the dead. The regulations that apply to organ removal and retention of samples are different in each case. The BMA has cited a situation that is worthy of consideration, however, because there are two categories of material that may be obtained from deceased people: material from a living person who has subsequently died, and material removed at death. The question is which set of regulations should be applied in that context.
There is also a distinction within the regulations between research and clinical audit—they are differentiated in relation to the regulations that apply to them. Again, however, a question that has been asked is whether that difference is manifest to people who work in a day-to-day medical capacity. Some aspects of clinical audit are partly research. Indeed, public health monitoring, which is differentiated from research and which has a different set of applicable rules, can in part seem to be an aspect of research. I raise that issue because the BMA will itself raise it in its response to the consultation, and I should welcome the Minister’s comments.
One factor that emerges straight away when such issues are raised is that of anonymised and non-anonymised tissue. We are far more comfortable with the existence of samples and data about us if they are anonymised, but can be examined by anyone who wants to do appropriate research. The general view is that when samples are anonymised, we can be far more relaxed about what happens to them, because they cannot be identified with a particular person at a particular time. The legislation proposes a Chinese wall—a firewall—so that when anonymised data are used for research purposes, it is impossible for any and every researcher to identify the source of samples, even though the data may not be completely unlinked to identity.
I have been asked—and I pass the question on to the Minister—whether that procedure of ensuring anonymity and of different treatment of allegedly anonymous samples, which does not completely remove the link, necessarily involves a third party who simply hands on the samples and says, “We are not telling you where they are coming from”? Alternatively, does it simply mean that the pathologist or researcher removes any identifying tags in the context of the research? Either may be practical, but practitioners need to know which is the case, so that they can be comfortable about being on the right side of the law.
The BMA has also raised the question of relatively minor clinical matters. It is suggested that it is generally a good idea, whatever a sample is and whenever it is being used, to seek consent if it can possibly be obtained. My problem with that is not general, but it is genuine. If the code of practice is supposed to do what its name suggests, and it says that something may be done, but need not be, so that there will still be good practice in either event, what will practitioners do? Will they feel obliged scrupulously to seek consent if obtaining it is remotely plausible, or should they decide to obtain consent in some contexts but not others, depending on their judgment of the circumstances? The guidance is not particularly clear.
There is another problem: that of data and samples that are not collected directly for research purposes but which are kept with the ongoing patient records. As we know, patient records can be voluminous and can be kept for some time—I am referring to medical blocks and slides and so on. Do all the scruples and regulations apply in that case, or is that area one where a more relaxed regime applies, or where the regulations have no purchase?
There are two more issues before I conclude on BMA matters. I believe that during the passage of the Act it was made clear that signing the organ donor register constituted legal consent. It does not matter how long ago signing took place, as long as one is walking around with a card that was signed at some point, and there is an audit trail to indicate permission. The BMA suggests that the regulations do not actually specify that in precise terms. One can say plausibly that none the less they imply it, but the BMA suggests that it would be helpful to make that absolutely and completely explicit.
The BMA makes another point that is worth debate if not a second view. The regulations say that if as part of the surgery there is any possibility that tissue samples might be removed and subsequently used for research purposes, consent for that should be part and parcel of the consent given during the operation process. The BMA suggests that it is desirable for those two things to be separate—that it is one thing to consent to the operation and another thing to consent to what might befall as a result of it or what people might want to do with the bits taken from it. Perhaps the Minister will respond to that point.
In its representations, the BMA also touches on the sensitive issue of minors and what happens to children, who if very young often lack the capacity for consent in any meaningful sense. In consequence of the events at Alder Hey and so on, the BMA recognises that it is pretty undesirable for anything to be done with the bodies of young children when consent is not evident and thoroughly explicit. It thinks that as a general rule of thumb, that ought not to be a territory that people should investigate too hard without all the ramifications of detailed consent.
The BMA suggests—I throw it open for consideration by the Minister—that the regulation might need to differentiate minors depending on their recognition of what they are consenting to. There is an enormous difference between a 3-year-old and a 13-year-old. I have no particular view on that; I simply pass it on as a representation.
A couple of issues concern me, one of which involves those who lack the capacity to give consent on their own behalf. I was drawn to paragraph 38 of the code of practice on consent, which says:
“The ability of adults with learning difficulties, or with limited capacity to understand, should not be underestimated. Where appropriate, someone who knows the individual well, such as a family member or carer, should be consulted as s/he may be able to advise or assist with communication.”
Off the top of my head, I cannot think of a better phrase than “where appropriate”, but it seems to leave things a little bit loose, to the extent that a medical practitioner could decide that it was not appropriate to consult a family member or carer and that action could be taken where no proper consultation had taken place. Who is the judge of where and when it is appropriate?
I read on to paragraph 40, which I hoped would give me some comfort on that point, but it says that the
“storage and use of relevant material for certain scheduled purposes”
can be allowed
“by a person who is acting in what s/he reasonably believes to be in the best interests of the person lacking capacity”.
Which person are we talking about? In this context, could we be talking about a medical practitioner—the person who wishes to withdraw the sample or has some use for it—or are we talking about somebody who is acting in a parental capacity or as an advocate on the person’s behalf? That made me a little concerned that we have not made enough provision to ensure that those people with learning difficulties or whatever who are incapable of expressing themselves particularly well will be treated ethically and reasonably.
There is a view that on the decease of a patient, the relatives may legitimately be asked questions about what might happen to the patient’s body or bodily parts. There is a set of reasonable requirements to be met, but they are subject to the right person being found at the right time. Paragraph 57 says:
“In applying the principles set out above, a person’s relationship shall be left out of account if... having regard to the activity in relation to which consent is sought, it is not reasonably practicable to communicate with that person within the time available if consent in relation to the activity is to be acted on.”
That basically says that the requirements do not apply if there is insufficient time or if it would be difficult to find the person who ought to give consent. I could be wrong, but that seems to be too open a situation. I think of the situation of people who have no known relatives who can be sought out, but who none the less might have tissue, transplant material or whatever that is of value or use—perhaps just the cornea of the eye or whatever. Such people are in a markedly more vulnerable position.
I totally accept that there will be circumstances in which clinicians will wish to intervene, but where there will be no capacity whatever to get in touch with the relevant people. However, for some people there are no obvious relevant people with whom to get in touch. I would be comforted if the physician was told that he was blocked off and could not do anything if he came across a person who was completely destitute and without any relatives, friends or anybody to advocate on his behalf. However, I am not convinced that that is what the regulations say, although I would be markedly assured if I found that that was the case.
I am not sure that I have adequately reflected all the concerns of the BMA. The issues under consideration are worth the Committee’s careful attention. I hope that the Minister can respond appropriately to some of the concerns that I have raised.
2.47 pm
Mr. Stephen O'Brien (Eddisbury) (Con): I am slightly surprised that we are here at all today, as most of the issues have been fully aired and a pretty broad consensus has been reached.
Given that we have this opportunity to discuss the issues, it is important to lay out some of the background and ensure that we are clear about what the regulations aim to achieve. However, given that the hon. Member for Southport (Dr. Pugh) is standing in for the hon. Member for Oxford, West and Abingdon, on whose behalf he has apologised to the Committee, it is worth adding as a preamble that when a prayer is laid against a statutory instrument we should be given some indication as to the purpose of doing so. A similar incident occurred just a week ago on the Floor of the House, when there was a Liberal prayer against a statutory instrument but the Member concerned chose not to speak to it, so it will be taken tomorrow. There is an issue concerning the potential cost to the taxpayer of this Committee’s convening today. I hope that the Minister can give us some guidance to ensure that we use the time that we are allotted in the House sensibly. That is the procedural point, which is important.
The background to the instrument is probably pretty well known, but I shall state it for the record. Before the Human Tissue Act 2004, the statutory framework on the removal, storage and use of organs was governed by the Human Tissue Act 1961, the Anatomy Act 1984 and associated regulations. The framework was based on a lack of objection, rather than on informed consent. The 2004 Act arose from concerns raised by events at the Bristol royal infirmary and Alder Hey, the Liverpool children’s hospital, the respective Kennedy and Redfern inquiries, and the illegal removal and retention of organs of mentally ill people that was highlighted by the Isaacs inquiry. For the sake of probity, I should declare that in the past 18 months one of my children had an NHS operation at Alder Hey. It was an enormous success and I wish to pay tribute on behalf of my family to the care and professionalism that we experienced on that occasion.
I am glad that a correction to the statutory instrument has been issued. As somebody who has an apostrophe in their surname, I am obsessed with punctuation and spelling. I am glad that “license” has been correctly spelled throughout the document.
There are no thanks in politics for saying, “I told you so,” but would we be here if the Government had listened to the early representations, including from Her Majesty’s loyal Opposition, when the Bill was published in late 2003? We asked and were given an assurance that the Bill would be published before the summer recess 2003 to allow proper pre-legislative scrutiny. However, it was not published until December that year. The then Minister, the right hon. Member for Salford (Hazel Blears), gave my colleague, the then shadow Secretary of State, the hon. Member for South Cambridgeshire (Mr. Lansley),
“the undertaking that we hope to publish the draft Bill for parliamentary scrutiny before the summer recess”.—[Official Report, 29 April 2003; Vol. 404, c. 276.]
Despite the six-month delay, the Bill, as it was fairly well acknowledged in the end, was not the most graciously drafted document. On 6 June 2004, The Observer reported that, as a result of the intense pressure exerted on the Government by third parties,
“Ministers are expected to water down the Bill when it comes back to Parliament.”
That was endorsed by the hon. Member for Norwich, North (Dr. Gibson), who, as Chairman of the Select Committee on Science and Technology, said:
“All we have been hearing from the scientific circuit is, ‘this Bill is dreadful’...At last they—
the Government—
“have got their act together. The idea that each time you take a urine sample you should be asking for consent—how anybody thought that could happen I don’t know”.
The Government introduced a Bill with 99 amendments, including five new clauses. We went through the procedure, with all the additional clauses, but broadly speaking despite the somewhat tortuous process we arrived at the right conclusions. However, the Bill specifically did not provide details on how and when consent should be obtained; it left the Human Tissue Authority to lay down codes of practice, hence our presence here today—although given that we have already discussed this issue, perhaps our presence was not needed. I think that I have talked about that point more than enough.
The important thing is that the further lack of draft codes of practice to accompany the Bill have made scrutinising it less successful for patient and professional groups. That is why there have been a number of representations. We have reached the right conclusion.
Although the hon. Member for Oxford, West and Abingdon is not here, for reasons that I fully understand, he would not have put the case quite as it has been presented by the hon. Member for Southport. The hon. Member for Oxford, West and Abingdon would have argued that the organ donation system in this country should go from being opt-in to opt-out, and that it should presume consent.
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Prepared 26 October 2006