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Earl Howe: My Lords, this has been a debate of remarkable quality, enhanced, I need hardly say, by three very distinguished maiden speeches from the noble Baronesses, Lady Neuberger and Lady Murphy, and the noble Lord, Lord Roberts. We hope that all three will play a full part in our further deliberations both in Committee and on Report. I congratulate them very warmly.
As many noble Lords remarked, the Bill is born of real and widespread human distress. It is of small comfort only that the distress was wholly unintended but in seeking to ensure that the mistakes that caused it should never happen again, we need to cleave to some basic principles. Every speaker today has articulated those principles well. They are: respect for the individual; the wider good of society; and clarity in the law. In looking for what has gone wrong over the past 30 or 40 yearsthings have gone very wrongnevertheless, we do not need to overstate the case. In particular, we should not be over-critical of the medical profession. Post-mortem practice has developed over a period of years within a legal framework that in the early 1960s appeared adequate but with hindsight today looks woefully imprecise.
The good of society, as exemplified by the ever-widening body of medical knowledge, has never been a goal to be pursued regardless of ethical principle or at all costs. Yet the imperative of furthering clinical research, as a means to that public good, has given rise to unthinking routines which have served to overshadow something equally important and precious; namely, the right of every individual to regard his body as his own, to do with as he wants.
The Bill before us seeks to achieve an appropriate balance between society's good and the rights of the individual; and in so doing it aims to restore what Alder Hey, Bristol and the Isaacs inquiry erodedtrust between medical practitioners and the public.
In subscribing fully to those aims, I have no hesitation in welcoming the Bill; and I welcome in particular its emphasis on informed consent and on unambiguous regulation of the uses of human tissue across the entire spectrum of research, transplantation and teaching. I welcome the pragmatic approach which the Government have adopted to existing tissue banks, which, as many noble Lords have remarked, are of incalculable value for research in the field of public health in particular.
The amendments made in another place have without doubt corrected a number of features in the first version of the Bill, which, with the benefit of reflection, appeared unnecessarily restrictive, especially those relating to the use of residual tissue from living people for research and training purposes.
The Government are to be congratulated on listening to the concerns voiced by MPs of all parties; but at the same time one cannot help thinking that the
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five-month delay between Committee and Report stages in another place might have been avoided had the Bill been the subject of pre-legislative scrutiny. That scrutiny need not have taken very long, but it would have enabled the major players in the scientific community to make considered comments on the Bill, as opposed to commenting on a consultation document. In that way I suspect that the unintended anomalies, such as the original provisions on residual tissue and tissue trafficking, might have been identified and dealt with earlier and more rapidly.
Having said all that, and despite the very welcome improvements made to the Bill, it will not have escaped the Minister's notice that the prevailing view emerging from the debate is that we are not there yet. From the speeches made today, I think we can single out four or five principal issues which are likely to raise their heads in Committee.
The first issue relates to research carried out on tissue from living people without consent. We need to look at whether in these situations the requirement for anonymity contained in the Bill is either necessary or desirable. There is a good deal of researchas we heard from the noble Lord, Lord Walton, in particularparticularly epidemiological and genetic-related research, which requires clinical information to be correlated with data obtained from tissue specimens. Indeed, there is a real sense in which the value of the tissue falls to negligible levels unless some sort of linkage can be maintained with the donor.
The noble Baroness, Lady Hayman, made the very telling point that medical confidentiality, rather than complete anonymity, may be all that most people would wish to see preserved in circumstances of this nature. I think we need to look at that and, in particular, whether it would be beneficial for the avoidance of doubt that the ministerial assurances given both here and in another place about reversible anonymity should be translated on to the face of the Bill.
Equally, the requirement for anonymity should also be questioned in relation to doctors who wish to carry out research on their own patients. The Bill at present would appear to prohibit that, and that is surely a serious concern. It is a concern that chimes in with a theme of a number of speeches, which is that, in several important respects, the measures in the Bill appear disproportionate to the mischief that they purport to address.
In that vein, we shall also need to examine whether the definition of appropriate consent needs to be refined. When consent is obtained for the use of human tissue in research, it is not possible to state in advance the precise purpose for which the tissue may have future use. The noble Lord, Lord Turnberg, made that point. To revisit the patient or his family to obtain updated consent is simply impractical.
The Minister gave some reassurances on that point. My view is that the Bill should make it explicit that generic and enduring consent, although not mandatory, should nevertheless be legal in appropriate circumstances.
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As the Bill stands, consent is required when education or training involving human tissue relates to research techniques. On the other hand, when the education or training relates to disorders of the human body, no consent is needed. We should closely consider whether the distinction between the two sorts of education and training serves a useful purpose. In fact, the relevant wording in Schedule 1 runs rather wider than education and training in research techniques. It appears to cover training in the methodology of research, such as the use and evaluation of statistical tests. I cannot believe that that is what is intended but, if it is, we should pay heed to the warnings sounded by the noble Baroness, Lady Neuberger, and my noble friend Lady Cumberlege about the risk that researchers might be criminalised unwittingly as a result of a narrow definitional distinction. I am worried about that and about where it might lead.
The last main area of contention concerns coroners. There are two problems with Clause 11. One is that it ducks the whole issue of retained organs as it relates to coroners. We are simply asked by Ministers to await publication of the new coroners' rules sometime around the end of the year. That is not at all satisfactory.
is too vague. The obvious question is: how far does a coroner's legal protection extend? Does it extend only to a coroner's core functions, which are the investigation of the circumstances and causes of a death, or does it extend more widely to anything at all done by the coroner within the ambit of the coroners' rules?
My view is that, beyond the coroner's statutory, core functions there is no reason why the rules and provisions of the Bill should not apply, especially in relation to the obtaining of consent from families for tissue to be retained in tissue banks for research purposes, after a post-mortem has been completed. I hope that it will be possible to build some meaningful provisions in to the Bill on rules for coroners. However, at the very least, families should be entitled to be informed if tissue from a dead person is retained following a coroner's post-mortem, and they should have a right to know the reasons.
Openness and informed consent should be the principles that guide us as we debate the Bill. I freely concede that if we are tempted to add to the exceptions already agreed to the consent principle, we should do so with care. That is why I cannot personally reconcile myself to the concept of presumed consent in the context of organ transplantation, despite the sincere and committed speech of the noble Lord, Lord Hughes. It is surely difficult for us to countenance the risk of repeating the errors of Alder Hey and Bristol, where it was precisely the presumption of consent that led to the distress of many thousands of families.
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We cannot say that we believe in the principle of consent as the bedrock of the Bill and, in the same breath, say that we do not need consent in that very sensitive and important area of activity. No doubt we will debate the matter further in Committee. But if confidence in the medical profession is to be as we would wish it, we cannot afford to take further risks, and this would be a big one.
One of the principal tests of the Bill's success will be whether, when it is in force, we see a better understanding on the part of patients and the public of why human tissue is of such value to medical research; why such research is for the good of us all; what pathology is; and how ethical standards are upheld and safeguarded. Those are the ways in which the consent of patients and families to donate tissue and organs for transplantation and research will become increasingly forthcoming. If that can be achieved alongside a new sense of confidence within the wider research community, this Bill will have done its job well. In common with all noble Lords, I very much hope that we can complete that virtuous circle.
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