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Lord Warner: My Lords, this has been an interesting, stimulating and thoughtful debate. As I come to respond and to think about the future stages of the Bill, I find the attractions of reshuffling extremely attractive.

We have had three very distinguished and lively maiden speeches. Like other noble Lords, I look forward to the future contributions of the noble Baronesses, Lady Neuberger and Lady Murphy, and the noble Lord, Lord Roberts of Llandudno. When listening to the speech of the noble Baroness, Lady Murphy, I was very impressed by the robust way in which she did not don rose-tinted spectacles about the present legislative position and recognised, from her own practical experience, the problems that had to be tackled.

I am also grateful for the many supportive remarks made in this debate about the road that we have travelled in getting this Bill—in my view—in pretty good shape. The debate recognised the importance of the principles on which it is based and, with perhaps one or two dissenting voices, of the need to provide a secure framework, which retains the confidence of the public, for medical and scientific research. I wish to correct a slip of the tongue in my opening remarks. I said that the provision for preservation of organs was in Clause 44; it is in Clause 48. I apologise for that mistake.

I remind the House again of the public concerns aroused by the report of the inquiry on Alder Hey and the Isaacs report. The latter did not just cause concern about organs and tissues from the deceased but has also had an impact on the public perceptions about organs and tissues from the living. We cannot duck out of that. Arguing the distinction between tissue from the deceased and from the living overlooks the fact that the public do not always make that same distinction. People legitimately want to know how, if I may put it this way, bits of their body are to be used by professionals. The public still feel that way, however
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much goodwill they may have towards medical researchers and the benefits of medical research for future generations.

I reiterate the importance of the Government's role of trying to maintain a balance between the needs and feelings of patients and their relatives and those of medical research, bearing in mind the contributions that can be made to future knowledge for the benefit of future generations of patients.

A number of noble Lords have asked why we cover tissue from the living and do not just concentrate on the coroner's area and tissue from deceased people. That assumes that the present arrangements are satisfactory. As I have said, and as a number of noble Lords have said, they are not satisfactory. They are muddled, and they cause concern for many medical researchers. A lot of attention has been given in this debate to the problems that some aspects of this Bill might cause for researchers. The present structure of legislation causes just as much, if not more, concern to researchers because of the uncertainty that it creates in their minds. If we do not bring greater clarity through this Bill and the statutory codes of practice, we will damage research by that failure. Doing nothing is not an option.

Many interesting and important points have been raised, and I will try to deal with as many as I can. I will write to noble Lords before the Committee stage on those issues that I fail to deal with. Noble Lords have raised the need for consent for research to be generic and enduring. We agree; as I tried to make clear in my opening remarks. While research ethics committees may, in individual research projects, sometimes ask for specific consent, as they rightly do at present, the Bill simply establishes the baseline. That clearly allows for consent to be broad and durable.

Many noble Lords have mentioned the issue of research using residual samples where the Bill allows for research without consent, provided ethical approval is given to the use of anonymised samples. The questions are twofold. First, does anonymised mean permanently unlinked? I have already tried to indicate that it does not. The Bill allows samples that are anonymised in ways that will retain their linkage to the clinical record. Secondly, is it in fact necessary for such samples to be anonymised in the first place? We maintain that it is. While we recognise that it is part of the duty of professionals to maintain confidentiality in their handling of patient information, we believe that the use of tissue samples is not an identical issue, especially the use of those samples for research when the patient has not given consent.

Through the consultation that has been taking place, we saw that people were happy for tissue to be used, but they wanted to be involved. They wanted to know what was to be done with that tissue. First and foremost, that means consent as the basis for the use of the tissue. People want knowingly to contribute and to be involved. In the situation, however, where tissue is to be used without consent, without people's knowledge, research ethics committees will represent their interests by ensuring that it is done on an ethically
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acceptable basis. More than that, it is for the protection of the patient as well as the researcher that it should be done on an anonymised basis. The researcher will have their tissue; certain clinical details and other diagnostic information. There is no reason why the researcher should also know the name of the person that the tissue has come from.

I have listened carefully to this debate, and I have heard little evidence that the knowledge of the name itself is essential to research. There may be some practical issues; there may be some systems to be changed and adapted in the way that the research is done, but the critical issue in these circumstances is that without consent, the researcher does not have the name. That will protect the researcher, who should not be put in a position where they might find themselves with tissue, clinical details and identifying names, and then discover new information about the person through their research. There is no need for that to arise. If the researcher is the treating doctor, and such new information might arise, there is no justification for not seeking consent. Again, let us be clear, tissue can be used in research if consent is sought, or if it is ethically approved for anonymised use. That provides a sensible balance.

Frankly—I say this in the most helpful way that I can—the research community needs to reflect very carefully on how it will appear to the public if it pushes too far for legislative amendments in this area. That would simply give the public the impression that they are to be bypassed in terms of obtaining consent about how tissue will be used.

Lord Winston: My Lords, I am very grateful to my noble friend the Minister for giving way. Perhaps he can clarify one issue for me. Supposing, during the course of research on a number of samples, one discovers a risk of cancer in certain patients. One might need to recall one's own patients to re-examine their smears or take another biopsy. How does that fit with the notion of anonymisation? I do not understand that and would be grateful for clarity.

Lord Warner: My Lords, I am prepared to write to my noble friend about that matter, but we are in areas of great detail that are Committee stage issues. Perhaps I may be allowed to use the time available to respond to the points that were made in the debate, which is what I was trying to do, and to set out the Government's position as clearly as possible. I should be grateful if I could be allowed to deploy those arguments as I have listened extremely patiently to the points made by noble Lords.

A number of noble Lords raised issues around the codes of practice. We should be clear that the codes of practice will be consulted on and can be debated in Parliament before they are introduced. Certainly, some of those codes will be subject to affirmative resolution, which must happen before the legislation is brought into operation. There are considerable opportunities for the detail of the consent and other arrangements to be subject to parliamentary scrutiny
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and public consultation. That will cover many of the concerns and points alluded to by my noble friend Lord Winston.

The noble Baroness, Lady O'Neill, raised the issue of the HTA's code of practice and whether it will define the limits of criminal offences in the Bill. That is not the case. Human Tissue Authority codes of practice will give practical guidance on matters within its remit and will set down the standards that it expects to be followed. Clause 28 makes it clear that failure to follow the code does not render a person liable to criminal proceedings.

Noble Lords asked whether research ethics committees will be able to manage the workload indicated by the processes involved. The research projects to be covered by research ethics committees are not different from those that are already being conducted and are already subject to REC approval. There should be no significant increase in case load. Indeed, RECs should benefit from the availability of clear and consistent guidance in that area.

A number of noble Lords raised the issue of retaining material following coroners' post-mortems, noting that it can be extremely important to retain that material for future research or diagnosis in the family. We agree entirely, but we must add that if the tissue is no longer required in respect of the coroner's needs—investigation of the cause or circumstances of death—the retention for scheduled purposes must be subject to the consent of the family. The Bill provides for that.

Noble Lords will be aware that Ministers at the Home Office have confirmed that amendments to the Coroners' Rules will be forthcoming this year. They will make clear that the coroner should inform the pathologist of what material is to be retained and for what period under his authority. The rules will also make clear that the family must be informed of any such retention. But where there is no requirement on the part of the coroner, consent is required.

The noble Baroness, Lady O'Neill, asked why the Bill is coming before the coroners' legislation. We are working closely with colleagues in the Home Office on that. As I said, the revised Coroners' Rules will be brought forward. I assure noble Lords that we will ensure that those new rules are wholly consistent with the Bill.

Noble Lords have raised a wide variety of issues and I shall try to address as many as possible in the time available. The noble Lord, Lord Clement-Jones, raised the subject of the costs of implementation. We have made provision for implementing the Bill and I think that the details are set out in paragraph 83 onwards of the Explanatory Notes. He also asked whether the Bill would affect the tracking of infectious diseases. It will not because it provides specifically for the use of tissue from the living or residual samples for use in public health monitoring, which includes epidemiological studies to track the prevalence and spread of disease.
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A number of noble Lords asked why RNA has not been linked in with DNA in the relevant provisions of the Bill. What we are most concerned about here is the kind of case where unscrupulous people obtain a tissue sample with a view to testing it for paternity, for example, without consent. While the direct testing of DNA is within the scope of the offence, so too would be the use of RNA in its scope if it is used as the means of analysing the person's DNA. However, I shall write in more detail to noble Lords about this rather complex issue.

My noble friend Lord Winston asked a number of questions about foetal tissue and the position with regard to photographs. Foetal tissue is treated in the Bill as tissue from the woman from whom it came. Her consent will be required, which must be right as a matter of law. In practice, guidance may ask that the genetic father's view may be sought when possible, but as a point of lawfulness it must be a matter for the consent of the woman. The Bill does not deal with photographs, but with the material itself and its uses for scheduled purposes. Photography is subject to professional GMC guidance, but we are concerned here with the lawful use of the tissue itself.

The noble Lord, Lord Jenkin of Roding, raised a number of points. I have to say that I refute his suggestion that the Bill represents an over-reaction. We have consulted extensively on this legislation with stakeholder communities and, as I said, there will be continuing consultation on codes, regulations and licensing procedures. We believe that the Bill strikes a reasonable balance and is not an over-reaction to the very serious concerns that have been expressed.

The noble Lord, Lord Patel, asked about the definition of "child" used in the Bill and whether it was inconsistent with the definition set out in the Family Law Reform Act 1987. We believe that there is no inconsistency. Clause 2 provides for competent children to be able to give consent to the use of their tissue. However, unlike in the case of medical treatment, the Bill does not contemplate a competent child's refusal to the use of tissue being overridden by their parents or a court. We believe that the Bill is consistent with the rules in place in relation to medical treatment, but does not replicate them exactly.

The noble Baroness, Lady Cumberlege, raised a number of issues, including the need to retain brains at post-mortem for research purposes and whether the Bill will safeguard future studies where data are needed. The Bill will support researchers who need organs for research purposes by making clear the consent process that will be needed and by enabling them to work within a clear framework. The Bill does not affect matters covered by the Data Protection Act. As I said, the Bill provides that research can proceed wherever consent is given or where research ethics committee approval is given for the use of anonymised samples.

On the subject of swipe cards, we certainly envisage that once electronic patient records are introduced, mechanisms can be used to record each patient's
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consent on that record so that it will be clear and available to all health professionals with access to it.

The noble Baroness also asked about the teaching of cytology and whether that will require consent. Clinical education and training using tissue from living patients does not require consent under the Bill.

The noble Lord, Lord Walton, raised a number of issues. On occasion I found myself grappling to understand the technology involved. However, I shall certainly better my education on these matters and write to the noble Lord. He asked whether consent to use post-mortem tissue should be obtained wherever feasible. The Bill does not inhibit any use of the research that the noble Lord described; indeed, it supports such research. Cell lines are excluded from the Bill—a point raised by him and a number of noble Lords—because it applies only to human cells coming directly from a human body. That does not include bacteria or viruses.

My noble friend Lady Hayman made a number of points. However, her confession about some of the confidentiality breaches in her personal experience did not help her case; certainly it would suggest that we need to take very great care to ensure that tissue does not get into the wrong hands or is used without proper consent.

I have a great deal of sympathy with the concerns raised by my noble friend Lord Hughes about securing improvements in organ donation. Despite those sympathies, however, I cannot accept that the Government will take the issue forward in this Bill. My right honourable friend the Secretary of State, John Reid, made it clear in another place that the Government believe that it is not the role of Parliament to remove from individuals the right to exercise their own choice about donation, or to impose on individuals a requisition of their bodies after death.

The noble Lord, Lord Oxburgh, raised a number of issues. We recognise the need to maintain a link between samples and medical records and the Bill does not inhibit this. He referred to the UK BioBank, which is an important development with enormous potential. Samples for the BioBank are collected only with consent and its processes are highly consistent with what is proposed in the Bill.

I enjoyed greatly the speech of the noble Lord, Lord Alderdice, who raised the issue of criminal sanctions. Ultimately, there has to be some sanction in this area which inspires public confidence.

In conclusion, and after listening to the debate, I believe that we are still right that a fresh, coherent approach to the law in this area is needed if we are to give confidence to the public and to the professions. We will achieve this with the Bill as it deals comprehensively with the keeping and use of human tissue and organs, from the living and from those who have died. In the Government's view it does not jeopardise research; indeed, it strengthens the framework within which research can be conducted with confidence.
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I shall study carefully in Hansard all the comments that have been made in the debate and consider the documents to which reference has been made. I hope to do so on a sun lounger. We shall need to scrutinise the Bill carefully in Committee but, when we do so, we must recognise that much of the detail referred to today will rightly appear only in regulations and codes; it should not, I suggest, be written onto the face of the Bill. In its urge to scrutinise, the House can sometimes slip a little over the line by trying to put excessive detail into the legislation itself. No doubt we will have many spirited debates on the issue, but I thought that I should lay out my position right at the beginning.

I believe that the Bill will bring renewed confidence in the contribution of medicine and science to society and in our own contributions to that endeavour.

On Question, Bill read a second time, and committed to a Grand Committee.

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