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Lord Walton of Detchant: My Lords, my comments will be extremely brief, but I speak from personal experience. As part of my professional training I undertook a formal period of training in neuropathology. I examined brain specimens taken from living patients with various forms of brain tumour.

What is the purpose of research in medicine? The purpose of research is, first, to try to elucidate disease processes in order that the management of those diseases can be improved. But a second and most important aspect of research is to improve diagnostic accuracy. As new and sophisticated techniques of examination of tissue specimens continue to emerge, diagnosis becomes infinitely more precise.

If we had not used certain pathological techniques in examining samples taken from the brains of people suspected of suffering from Creutzfeldt-Jakob disease and subsequently been in a position to store and re-examine them, we would not have developed the techniques that later resulted in the identification of that damaging variant of the disease called new variant CJD.

But I speak more particularly from my experience in patients suffering from muscular dystrophy and other neuromuscular disorders. We used to use a technique of muscle biopsy—obtaining a sample of muscle from a patient—in order to confirm the diagnosis and to identify people who had a progressive muscular dystrophy and to distinguish them from those who might have an inflammatory disorder of muscles, such as polymyositis, which could be effectively treated.

As time went by, recognising the inaccuracy of the biopsy technique and the methods of staining then available, we discovered not only that the gene identified as the cause of the most severe form of muscular dystrophy could be recognised, but also that the missing gene product could be recognised by examining such tissue with a completely new technique.

I am simply making those particular points to demonstrate exactly what the noble Lord, Lord Jenkin of Roding, said earlier. It is absolutely impossible to distinguish training and education of individuals working in all branches of pathology—from training them on the one hand to be good diagnosticians and on the other hand to be able to identify and use research techniques involving such tissue in the future. For that reason alone, I strongly support this whole group of amendments.

Baroness Hayman: My Lords, I, too, add my voice to the chorus asking my noble friend to respond positively to this group of amendments. The evidence before us from organisations outside this House—I remind the House of my interest as chairman of
 
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Cancer Research UK—and the speeches that we have heard today make it crystal clear that drawing that distinction poses a problem for researchers, trainers and academic clinicians. We cannot deny that there is a problem in drawing the distinction for them.

We therefore have to ask ourselves whether there is a problem in not drawing the distinction for patients. I have to say that I find it very hard to understand what that problem is and what the evil against which we are guarding ourselves is by putting training for research into a different category from other forms of training. Part of that relates to the fact that this Bill is often caricatured as a sort of balance between the interests of patients and those of researchers. However, that is a false understanding of the vast majority of medical research in this country and of the right approach to take in the interests of patients.

It is of supreme interest to patients to have clinicians who are well trained in research techniques. Patients will be treated better if the majority of clinicians, even if they do not themselves pursue an academic or research career, have had some training in research techniques. To suggest that there is a group of pointy-headed scientists on one side carrying out research in their own interests and a group of wonderful, caring clinicians looking after patients who therefore should be exempt from certain strictures in the Bill on the other side is to make an absolutely false distinction. It is in the interests of patients as well as those of researchers and trainers not to have this difficult distinction in the Bill. I hope that my noble friend will be able to respond positively.

Baroness O'Neill of Bengarve: My Lords, I shall say very little because so much has been said and well said already. However, I should like to remind noble Lords that this Bill was introduced primarily to establish certainty about what is lawful and what is not lawful. A division of training and education between the two parts of Schedule 1 would make it impossible to say that certainty is produced. On the contrary, people would be left constantly uncertain about whether a particular bit of teaching is being done for one or the other purpose.

The Parliamentary Under-Secretary of State, Department of Health (Lord Warner): My Lords, first, I welcome the noble Baroness, Lady Neuberger, to her Front Bench responsibilities. I am sure that we shall have many interesting discussions in the months ahead. The noble Lord, Lord Jenkin, drew attention to the fact that I failed on several occasions in Committee to convince him with regard to this issue. All I can say to the noble Lord is that when I worked as a civil servant for him, I think that I failed to convince him on a number of occasions then as well. However, I shall do my best to convince noble Lords, although I think that I start the task with an uphill struggle.
 
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I shall set out in detail and unequivocally the Government's position on this issue. Let me begin by saying that it is not our intention, in any part of this Bill, to undermine or in any way damage research or education in any area of healthcare, and we do not believe that we have done that in the Bill as it now reads. We accept totally the importance of our pathologists, to whom my noble friend Lord Turnberg drew attention. It is our real and clear intention to support research in this Bill, along with the necessary education and training, by placing them in a framework that brings confidence to the medical and research community and to the public alike. The way to achieve this is to work with a consent-based system, one with a sensible and pragmatic approach to the variety of situations in which tissue is quite properly used. It is public consent for a new and, with due respect, we believe a clearer system that will bring certainty and clarity to researchers, whether pathologists or otherwise.

It is of tremendous importance that we carry with us a public that sees the value of research, education and training; is happy to contribute to those activities; and perhaps most important, is convinced by the process by which we provide the material for research and other purposes. I would suggest that this is a forward-looking Bill that sets out the framework by which that will be achieved. It does not ask for widespread changes in practice because for the most part current practice is ethical, effective and appropriate.

But that is not to say that there will be no changes, because clarification is needed in some respects. Patients and the public are increasingly concerned about the use of tissue, whether it is from post-mortems or, for example, tissue used in genetics research. There are anxieties, and we must face up to them rather than pretend otherwise, just because Alder Hey and other incidents are now fading a little into the past. We need to protect the professional environment and standards by reassuring people that the rules are clear, appropriate and respected by professionals.

I know that the use of residual samples is not the same as what happened at Alder Hey. But, first, it was not just at Alder Hey, as we saw from Bristol and the Isaacs report. Unconsented removal and the use of tissue and organs was widespread. But the impact of the whole episode went far wider. It has affected the use of tissue in research, as we have seen, since pathology laboratories, RECs and tissue banks have been uncertain about whether and when they can release samples. Under the Bill, this will become clear and confidence can return. But that must be accompanied by a change in the way in which some parts of the research and clinical professions regard these questions. It is not just a question of post-mortem tissue, but of all elements of professional medical and research practice. To say, "Trust me because I am a doctor", is not good enough in today's world.

I will return to the specific question of the amendments in a moment, but let me illustrate further the background to the Bill which is critical to
 
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understanding the length of time over which we have engaged with all the professions about these issues. As long ago as January 2001 the then Secretary of State announced the review. As he said then:

That statement was made four years ago. In his report of January 2001 recommending a review of the law, the Chief Medical Officer said that new legislation should,

This Bill is not just a reaction to Alder Hey. We are not positing a false divide between patients, doctors and researchers. It is part of a whole process of developing a patient-focused approach to health, research and education. But as my right honourable friend Alan Milburn said four years ago, patient-centred consent-based practice is not at odds with research and education. On the contrary, it will be to our advantage that we develop and encourage the engagement of patients with these vital activities that support our healthcare system.

That the professions as a whole agree with these sentiments cannot be in doubt. Indeed, it is worth bearing in mind that it is enshrined in current guidance. Let me quote a few examples from current professional guidance in the area. The General Medical Council, in its document, Research: the Role and Responsibilities of Doctors, states:

    "Samples of body fluids, tissues and organs can form a valuable archive for research purposes. You must obtain appropriate consent or authorisation before taking or retaining organs, tissue or bodily fluids from patients or volunteers for research purposes. This applies whether the material is obtained solely for research purposes or retained following a clinical or surgical treatment".

The British Medical Association, in its "Consent Toolkit", states:

The Medical Research Council, in its paper Human Tissue and Biological Samples for use in Research, states:

I acknowledge that these do not all go to the precise question of training in research techniques, but they do illustrate the established views of these professional
 
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bodies and are supportive of the present consent-based approach in the Bill, which includes research and teaching.

We know, too, that people are anxious about the use of material in research, especially in genetics. To quote the MRC once more:

It is because we recognise that research using patients' tissue samples should not be carried out without constraint that we require either consent for research or REC approval and anonymisation. This is the protection that we offer in the case of research and there is little dispute now about the fact that independent scrutiny is needed before tissue is used for research without consent.


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