Human Tissue Bill

HL Deb 25 October 2004 vol 665 cc1064-142

3.5 p.m.

Report received.

Clause 1 [Authorisation of activities for scheduled purposes]:

Baroness Neuberger moved Amendment No. 1:

Page 3, line 2, at end insert—

"( ) Subsection (1)(d) does not apply to the storage of relevant material for the purpose of education and training relating to research if—

1. (a) the material has come from the body of a living person, and
2. (b) the education and training relating to research falls within subsection (12).

( ) Subsection (1)(t) does not apply to the use of relevant material for the purpose of education and training relating to research if—

1. (a) the material has come from the body of a living person, and
2. (b) the education and training relating to research falls within subsection (12).

( ) Education and training relating to research falls within this section if it is to be, or is, carried out in circumstances such that the person carrying it out is not in possession, and not likely to come into possession, of information from which the person from whose body the material has come can be identified."

The noble Baroness said: My Lords, in moving this amendment, I shall speak also to Amendments Nos. 6, 8, 9 and 66. The effect of Amendment No. 1 and the spirit of the others would be to deal with the question of education and training relating to research on tissue taken ante mortem. The present drafting requires that consent be obtained for education and training relating to research when it does not require it for other education and training or for tissue taken ante mortem and anonymised to the researcher, where research ethics committee approval has been gained.

This causes real difficulties in the teaching of health professionals. I am not a health professional but I have spent most of my working life around health professionals and am convinced that the requirement to get consent for anonymised tissue for education and training relating to research makes it virtually impossible for clinical teachers to teach students of medicine, nursing and other health professions, and it requires to be changed.

In teaching hospitals, for instance, clinical instructors move freely from education and training relating to human health to education and training relating to research. The reason is that medicine and other health professions are increasingly evidence-based, as we would wish them to be. That evidence must come from research. As those who are teaching explain and demonstrate techniques and theories, they are bound to criss-cross from what is technically now education and training relating to human health to what is technically, or might be argued to be, education and training relating to research. That might be, for instance, looking at a slide, where one might be talking about the specific instance of a slide relating to a particular clinical condition, or how one would construct a research project looking at slides of that kind. We are likely to see among clinical instructors here confusion and considerable worry about whether people are committing a criminal offence. In education and training relating to research, it would not be usual to gain research ethics committee approval any more than one does for any other kind of education and training.

The amendment would allow education and training relating to research to proceed without consent if anonymised to the researcher and ante mortem. The noble Baroness, Lady Murphy, very powerfully made the point in Committee that we are using the concept of consent wrongly in some of the requirements in the Bill. She argued that we were talking about prospective research of the sort that one would be arguing through and testing out in a research ethics committee. This is much more about the kind of education and training that goes between techniques and ways that one might construct a trial. She was absolutely right to say that we are thinking incorrectly about that. I beg to move.

Earl Howe

My Lords, all the amendments in this group fall under the same broad heading but adopt a slightly different approach—a dual approach. Amendment No. 1, so ably moved by the noble Baroness, extends the principle of anonymisation in relation to research, in Clause 1(9), to education and training relating to research. But in so doing it exempts such education and training from the need for patients' consent. Amendment No. 67 does the same thing with regard to education and training relating to research using the results of DNA analysis.

Amendments Nos. 6, 8 and 66 adopt a more radical approach, by proposing that all education and training in these areas should be exempt from the consent requirements. Those are two different approaches, which are not necessarily mutually inconsistent. I will come to what I believe that the Government should do.

I shall not repeat everything that the noble Baroness said, but I will say something about genetics, about which I have been briefed quite extensively. As all of us are aware, genetics is a rapidly advancing science. Because it is advancing so quickly, we frequently find that technological advances are rapidly translated across to service provision. As a result, it is difficult—if not impossible—in that field to distinguish between education and training relating to human health and that relating to research. I put that to the Minister as an additional argument from the real world.

As the noble Baroness said, in every other field, the distinction that the Government are trying to draw is well nigh impossible. What, in practice, is the distinction between training someone for diagnostic work and training someone for research work, when the techniques are the same in both? How can one separate those two types of training in a laboratory? It is meaningless to do so but, apparently, the Government believe that one type of training does not require consent and the other does.

The Government have acknowledged the difficulty and pointlessness of trying to draw rigid dividing lines between the definitions in Schedule 1. They are right about that. The same applies here: one simply does not find situations in educational settings in which only researchers are being trained or only clinicians who diagnose and treat patients. The reality of life is that a lot of people are gathered in one place, listening to the same teacher but learning different skills. Someone studying to be a clinical academic doctor will need clinical, research and teaching skills at the same time to do the job. Those things go together and reinforce each other. Why pretend that convenient dividing lines can be drawn between each activity? If tissue can be used without a patient's consent for education and training in diagnostic work, what harm do the Government perceive will be done to that patient by not obtaining his consent to use the same tissue for education and training in research?

Of the two approaches in the amendments, I can see no case for not embracing the second and more radical, to which the noble Lord, Lord Turnberg, has put his name. The arguments are clear-cut. If, however, the Government are willing to move some distance but not all the way, I, for one, would be willing to compromise by settling for Amendments Nos. 1 and 67 and thus avoid a Division. The practical effect of those amendments, even if it is not the legal effect, would be that any human tissue from living donors used for education and training of any kind would need to be anonymised. If the Minister is willing to compromise on that basis, the House should swallow hard and not pursue the more radical option.

Baroness Finlay of Llandaff

My Lords, I shall not repeat the arguments made so well by the noble Lords who have spoken, but, having put my name to the amendments, I must emphasise that it is important for everyone to understand that today's research technique is tomorrow's routine practice. Without good training in research and research techniques, the clinicians of tomorrow will be far less effective. They will not understand the fundamentals of the practice that they will enact.

We are not talking about taking new or additional specimens; we are talking about using redundant tissue that would otherwise be discarded to allow training in research techniques. That comes down to things such as fixation techniques, staining techniques and refining the ability of clinicians, who can then link their research expertise directly to the clinical scenario. They will probably use such techniques as routine throughout their career and will also have an understanding on which to make further advances in techniques.

It is also the beginning of quality control. The Government have recognised the importance of quality control but, unless we improve the way in which we do things, we will not have better quality in the long term. The quality control of today will, in five years' time, seem ridiculously outdated. We must be able to develop more refined techniques that are more cost-effective and have greater accuracy, so that we decrease false negatives and false positives in results. The development of such techniques comes under the category of research.

It is important to remind the House that all those in higher specialist training are required to have some time in research, the reason being that there has been much evidence over the years that clinicians who are not trained in research techniques are, in the long term, less effective than those who have had adequate training. It is now a statutory part of their training. It is against that background that I strongly support all the amendments.

3.15 p.m.

Lord Jenkin of Roding

My Lords, like my noble friend Lord Howe, I have had a good deal of helpful briefing. I am impressed by the wide range of the organisations that have taken the view that a wholly artificial distinction has been written into the Bill. They include the Academy of Medical Sciences and the Association of Medical Research Charities, which includes such important bodies as the Wellcome Foundation, Cancer Research UK, the Medical Research Council and various others.

I was particularly impressed by a note that I received from the Council of Heads of Medical Schools. It made some strong points, and I shall refer briefly to them. The council simply said that it was impossible, in practice, to separate training for research from training for diagnosis. The council considers the matter from the point of view of the role of the pathologist. Anyone who has watched any of the recent television programmes will appreciate how enormously important pathology is in developing research and training, as well as in chasing murderers.

Pathology is the hidden science at the heart of modern medicine. It is vital to the diagnosis and clinical management of disease. Pathologists are central to the delivery of quality clinical care in the NHS, and their work underlies much of the work that must be done subsequently by surgeons and other specialists.

The council also says something that accords with my experience as a Secretary of State for Health and chairman of a health authority: It is part of every doctor's role to advance medical knowledge through research and this is especially true in pathology. The techniques which pathologists use in the diagnosis of disease are also those which are used in research, and consequently it is simply not possible to make a distinction between training for research and training for diagnosis". The council gave me some examples. I shall not weary the House with them this afternoon, as I am not sure that I understand them entirely. It took the example of cancer treatments. The work that is done to decide the appropriate treatment for a patient's cancer and the work that is done to enable research to go forward into the appropriate treatment for a patient's cancer is, the council says, indivisible. That is why it argues, as I argue, that there is a wholly artificial distinction in the Bill.

When most of the major medical research bodies, including the Medical Research Council, a public body, join forces to say that the Government have got it wrong, the House should take note. Reluctantly, I would go along with my noble friend's suggested compromise. I would like to go the whole way and say that the distinction drawn in the Bill and in the first schedule is quite unrealistic and cannot be sustained, but I will listen to what the Minister has to say.

In Grand Committee, when we had heard the Minister advance his arguments for making this distinction no less than three times, his argument was absolutely no more convincing the third time than it had been on either of the other two. He may do better today but, somehow, I doubt it.

Lord Turnberg

My Lords, in speaking to these amendments, I shall speak also to Amendment No. 8. I am sorry to return to the matter of education and training and to add to the burden of my noble friend the Minister on this issue. But I do so only because this is such a vital issue. I speak here from the point of view not so much of researchers but of the rest of us, whose future health is so dependent on good research being carried out but which is threatened by this part of the Bill.

I declare my interests as vice-president of the Academy of Medical Sciences and, perhaps more importantly, as adviser to the Association of Medical Research Charities whose member charities are largely made up of patients and their carers and cover a wide range of disease categories. I shall not repeat the arguments so ably made by others in Grand Committee and today. But I want to make one of two points that I hope might persuade my noble friend.

I can best illustrate the problem by describing the case of a young pathologist in training being taught how to distinguish various diseases by examining small sections under the microscope and going on to reach a diagnosis. They will also need to train in research techniques—for example, new types of tissue stains or tests that will enhance the understanding of disease—which they are likely to use in their future career. Those novel research techniques are all part of the training for a forward-looking pathologist who will be expected to have an active, inquiring future.

We really cannot afford to have pathologists who will be stuck in the time warp of today's technologies for the next 30 or more years. They must be capable of understanding and applying new research to their future work, to say nothing of those who want to go on to an academic career.

That type of training in research techniques will not necessarily be of direct relevance to the patients with whom they are dealing—even though, inevitably, pathologists in training will know who they are or, more importantly, who they were—because they may be untraceable for one reason or another. For that reason, pathologists in training are very likely to know the identity of the patients from whom tissue has been taken. After all, they have been making the diagnoses.

It is because of that that I have some difficulty with parts of Amendments Nos. 1 and 67 where it is suggested that research trainees should not know the identity of the patients. I fear that that will not be practicable in the circumstances that I have described.

It has been suggested that a line has to be drawn somewhere between research and education and that if training in research is allowable without consent as other training is, that will open the door to others who may want to do research without consent. But that cannot be so. Nowadays, no clinical research can be carried out without ethics committee approval. One cannot get a research grant or publish the results without ethics committee approval. Ethics committees are unlikely to give approval for research without consent or anonymisation.

So the distinction between research and training for research is much clearer than that between training for research and training for professional purposes. I do not accept that that would open this door, but it would remove a high hurdle placed in the way of a pathologist in training—a confused pathologist in training. The effect of such confusion is that he or she would be discouraged from training in pathology at a time when we are desperately short of pathologists and, equally importantly, will inhibit anyone from entering an academic career when we are losing just these academic clinicians we need to take forward the Government's strategy on research and development.

We have more than enough reasons to be worried about the fall in numbers of young doctors willing to enter academic careers without adding an additional unnecessary burden. If it is said, "Oh yes, but we have to protect patients' rights", I agree with that. It is vital that we do so. But I fail to see how putting all education and training, which everyone agrees is essential, into Part 2 of this schedule will in any way conflict with that principle. It just does not make sense.

I hope that I can persuade my noble friend to take this away and consider it further. I know that he has earned admiration and respect for his support for the needs of clinical research. I hope that he will continue to respond to those needs.

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 reexamine 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 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 it' 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 I 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.

3.30 p.m.

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.

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 postmortems 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 postmortem 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 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: Informed consent does not need to be at the expense of medical research … The national health service can no longer assume that the benefits of science, medicine or research are somehow self-evident, regardless of the wishes of patients or their families. The relationship between patients and the service today has to be based on informed consent. That will require changes in practice, policy and medical education". 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, set out a detailed exposition of who could give consent to taking and using tissue and organs in life and after death, for therapeutic purposes, for research and for educational purposes". 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: Retention of human tissue for research or teaching requires consent from the donor or the next of kin of deceased patients or those who cannot speak for themselves. Written consent should be obtained in these circumstances. Q: What type of consent is needed for the use of human tissue for educational purposes? A: Written consent". The Medical Research Council, in its paper Human Tissue and Biological Samples for use in Research, states: Patients should always be informed when material left over following diagnosis or treatment (described as surplus to clinical requirements) might be used for research. Wherever practicable, individual consent should be obtained for the use for research of human material surplus to clinical requirements".

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 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: The special sensitivity of the public with regard to genetics research should always be taken into account". 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.

Lord Jenkin of Roding

My Lords, the Minister quoted the GMC as being in full support of the Bill. All of us support the general thrust of the Bill. On this narrow question of education, the GMC has stated: Finally, the distinction between education or training relating to research (for which consent is required) and other education and training also needs further explanation. It will not be immediately clear whether consent is needed where, for example, tissue is used for both clinical training and training in research techniques". The GMC is as concerned as everyone else about this artificial distinction.

Lord Warner

My Lords, the noble Lord is a little precipitate; he might have listened to the rest of my arguments. My quick answer to his point, as we said many times before in Grand Committee, is that the Bill provides for guidance to be produced by the Human Tissue Authority. I did not hear anything in the noble Lord's quotation which suggested that the GMC is saying that we need to put this on the face of the Bill.

Lord Walton of Detchant

My Lords, is not the Minister overlooking the distinction between the performance of research, on the one hand, and training in research techniques, on the other?

Lord Warner

My Lords, we are not in Committee; we have been through that stage. We have sat patiently and listened to everyone's arguments and it would be useful now to hear the Government's arguments. I shall try to answer the questions during the rest of my remarks.

I was developing the argument that we need to have constraints and safeguards in respect of research, so why then should we offer less protection from frivolous or unwarranted use in training for research activities, or an unnecessary accumulation of stored samples without the patients' knowledge, when the training is not itself capable of producing research results?

We have accepted that training in relation to clinical and diagnostic activities should be possible without consent because they are plainly and directly connected to the procedure to which the patient has actively consented. But they have most likely not consented to the use of residual samples in research, let alone training in research techniques, which is one stage further removed from the purpose for which the tissue was taken. This is a critical point. People give consent for particular purposes. The Bill is framed in terms of the purposes for which consent is required.

In many cases—however difficult it may be for particular researchers on one or two occasions—the people whose tissue it is are not giving consent for education and training and research. They may be giving their consent very often for research itself, but not for a stage which is some way removed from that.

3.45 p.m.

We are not saying that such research-related training should not be carried out. We are all agreed that it is important that our medical, scientific and technical staff are properly and professionally trained; we are all agreed, I hope, that they should be trained in appropriate ways and using material that has been appropriately sourced. Here we come to the nub of the question: what does it mean to be appropriately sourced?

As the Bill stands, people could receive education or training in research, quite legitimately, in a number of ways. A number of noble Lords seem to have lost sight of this in their remarks. The Bill covers tissue where consent for that purpose has already been given, which is the default position under the Bill. It covers where tissue is being used for the diagnostic procedure itself or for training or education in diagnostic techniques. We know that research and clinical activities share most techniques for tissue analysis. It covers where tissue is being used in the course of a research project. This would be on-the-job training in an REC approved project with anonymised tissue. And it covers archived tissue, which is outwith the constraints of Part 1 of the Bill and of which, as we know, there is an abundance. So there is a great deal of scope for people to secure education and training in research in legitimate ways without any further amendment to the Bill.

I accept that the archived mechanism would mean drawing on past collections and may not be a sufficient answer for the future, but, to the extent that other options might not provide all that is needed—although, despite noble Lords' attempts to be persuasive, I am still at a loss to see that there should be a significant problem—we may for the future still need some minor changes in our systems to ensure that we meet today's standards. In the Government's view, that is what some in the profession will have to accept as a part of retaining public consent.

A number of noble Lords have referred to cases where difficulties have been claimed, but there are others who do not claim such difficulties. The bio and pharma industries have no difficulties with the consent provisions as they stand in the Bill. Major collections such as the UK Biobank and the national bloodspot screening programme have no difficulties. They will have training, education and research needs, but they have been set up in ways that accommodate those requirements and, indeed, their standards go beyond the baseline set out in the Bill. We know that many hospital departments work already beyond the requirements set out herein. Indeed, Department of Health officials received a call recently from an NHS laboratory manager asking when the Bill will be passed that will relax the rules—his term—on tissue in use at present.

So it is not the case that there is widespread dissent from the provisions in the Bill as presently drafted. Nevertheless, we have been given examples of how the research training provisions will supposedly create difficulties. Let me respond briefly to them.

The noble Baroness, Lady Finlay, raised a number of issues relating to improving techniques for the future and quality control to secure accuracy. I suggest gently to the noble Baroness, to whose scientific and medical expertise I always give ground, that both examples are totally outside the issue that we are discussing. I recognise that they are important, but research to improve techniques will fall within the research category and be subject to the provisions we have agreed; quality control is already an activity that sits within part 2 of Schedule 1, requiring no consent.

My noble friend Lord Turnberg also raised the issue, in his normal courteous way, and wrote to me about a similar scenario. I cannot agree with him. We do not believe that there is an insuperable difficulty in making the distinction that we are making in the Bill. We believe that anonymity is a critical safeguard and is provided for in the Bill.

The issue has been presented to us as relating principally to NHS pathology laboratories rather than academic or industry settings in which consented tissue is the norm. In NHS laboratories, it is suggested that training in research-related activities such as chromosomal analysis is necessary. I am sure that that is the case, and I am pleased that NHS pathology laboratory staff are engaged in research, but the techniques of tissue analysis are not conducted solely for research. The principal activity in NHS pathology labs is overwhelmingly diagnostic and clinical tests, and it is in that context that training can ordinarily be conducted. We remain unconvinced that a significant problem exists for many professionals in this area.

Your Lordships will be aware of the debates that took place in another place. The Government were, typically, extremely responsive to the concerns expressed by those representing the views of the medical and scientific professions, as my noble friend Lord Turnberg acknowledged. We listened at Second Reading and in Committee, and we sat down with representatives of the professions, and their leaders, including the GMC and many of the other bodies that noble Lords have mentioned. We agreed a package of amendments with those with research interests, who I would gently suggest to the noble Earl, Lord Howe, are people from the real world. We went through the issues with them. The contents of the Bill are a result of the discussions that we had with them and they provided for the arrangements in the Bill, as amended in the other place. Many of the organisations cited by noble Lords were fully tied into the process. We have made significant adjustments to the Bill to meet research concerns. But, like Oliver Twist, a few still seem to want to come back for more.

I have taken a lot of time on this response—more than, I suspect, many noble Lords would want to hear. But it is crucial that noble Lords understand the history of the process, where the Government have come from and our present position. Lines need to be drawn—and these are pragmatic ones that allow for the use of tissue in situations that patients could reasonably expect. At the same time we must guard against accruing stocks of human tissue for unacceptable purposes. We must have some guidance on that area, which will be produced on the basis of this Bill by the Human Tissue Authority.

I do not need to set out my credentials, or those of this Government, in terms of support for medical research and education. But we must recognise the importance of securing the trust, confidence and support of patients and the public. I have tried to set out the Government's position on the area. As we have said repeatedly, we are aiming at finding the right balance. That is an objective that I am sure we all share. I strongly urge noble Lords to recognise that the Bill achieves that balance, and that these amendments, in their various forms, would take matters in the wrong direction.

In conclusion, the Government are unable to accept the amendments, would not be able to accept them in future and would need to seek to reverse them at a later stage if they were passed today.

Baroness Neuberger

My Lords, I am grateful to the Minister for his assurance that the legislation has no intention of damaging education and training for research. However, unless he is prepared to accept at least the spirit, if not necessarily the letter, of some of the amendments, many of us around the House—as we have heard in the course of debate—will have real concerns that nevertheless education and training for research will be seriously compromised. For that reason, I remain convinced that we need to press hard on the amendments.

I assure the Minister that many of us in this House—I would argue probably all of us—are as concerned as he is and as the Government are that the whole area of research should be consent based. I declare an interest as I was formerly a member of the GMC and chaired the consent working group for that body. I was also formerly a member of the Medical Research Council and the BMA's ethics committee. I am as concerned as the Minister is that everything should be consent based. But I believe that he mistakes the issue with regard to ordinary education and training in a clinical setting, when people cross over in their techniques in between looking at what happens in terms of human health and what happens in terms of training people, as to what they might do were they to conduct a research project at a later date.

This legislation, as it stands, does not allow us to deal with that matter. It will certainly concern a large number of researchers and clinical instructors who will worry that they might be about to commit a criminal offence. Of course the public values education and training for research. As the noble Baroness, Lady Hayman, so powerfully put it, the issue is not as easy as saying that one lot is research and one lot education and training for human health. The public values what researchers do, as we know from the support that it gives to the various medical and health research charities.

The Minister has not convinced me or, I believe, many of the other noble Lords who have put their names either to this amendment or to the others. We have listened to arguments around the House from people who are themselves clinicians with experience, people from the voluntary sector and patient advocates. I am sorry that he has not accepted the spirit of these amendments and I would now like to test the opinion of the House.

3.55 p.m.

On Question, Whether the said amendment (No. 1) shall be agreed to?

Their Lordships divided: Contents, 148; Not-Contents, 112.

Division No. 1
CONTENTS
Ackner, L.	Elton, L.
Addington, L.	Ezra, L.
Ampthill, L.	Falkner of Margravine, B.
Anelay of St Johns, B.	Fearn, L.
Astor of Hever, L.	Feldman, L.
Attlee, E.	Ferrers, E.
Avebury, L.	Finlay of Llandaff, B.
Beaumont of Whitley, L.	Fowler, L.
Biffen, L.	Garden, L.
Blatch, B.	Gavron, L.
Bledisloe, V.	Goodhart, L.
Bradshaw, L.	Hayman, B.
Brougham and Vaux, L.	Holme of Cheltenham, L.
Buscombe, B.	Hooper, B.
Caithness, E.	Hooson, L.
Campbell of Alloway, L.	Howe, E.
Carnegy of Lour, B.	Howe of Aberavon, L.
Chadlington, L.	Howe of Idlicote, B.
Chan, L.	Howell of Guildford, L.
Chorley, L.	Hunt of Wirral, L.
Condon, L.	Jellicoe, E.
Cope of Berkeley, L.	Jenkin of Roding, L.
Craig of Radley, L.	Jopling, L.
Craigavon, V.	Kalms, L.
Crickhowell, L.	Kimball, L.
Cuckney, L.	Kingsland, L.
Darcy de Knayth, B.	Laing of Dunphail, L.
Dearing, L.	Listowel, E.
Denham, L.	Liverpool, E.
Dholakia, L.	Livsey of Talgarth, L.
Dixon-Smith, L.	Luke, L.
Dundee, E.	Lyell, L.
Dykes, L.	McColl of Dulwich, L.
Eccles of Moulton, B.	MacGregor of Pulham Market, L
Eden of Winton, L.
Elles, B.	Mackie of Benshie, L.
Elliott of Morpeth, L.	McNally, L.

Maddock, B.	St John of Fawsley, L.
Mar, C.	Saltoun of Abernethy, Ly.
Marsh, L.	Sandberg, L.
Mayhew of Twysden, L.	Sandwich, E.
Miller of Hendon, B.	Scott of Needham Market, B.
Monro of Langholm, L.	Seccombe, B. [Teller]
Mowbray and Stourton, L.	Selborne, E.
Murphy, B.	Selsdon, L.
Murton of Lindisfarne, L.	Sharp of Guildford, B.
Naseby, L.	Sharples, B.
Neuberger, B.	Shaw of Northstead, L.
Newby, L.	Skelmersdale, L.
Noakes, B.	Slim, V.
Northesk, E.	Smith of Clifton, L.
Northover, B.	Soulsby of Swaffham Prior, L.
O'Cathain, B.	Strathclyde, L.
O'Neill of Bengarve, B.	Swinfen, L.
Onslow, E.	Tebbit, L.
Oppenheim-Barnes, B.	Thatcher, B.
Oxburgh, L.	Thomas of Gresford, L.
Park of Monmouth, B.	Thomas of Walliswood, B.
Perry of Southwark, B.	Tope, L.
Peterborough, Bp.	Tordoff, L.
Phillips of Sudbury, L.	Trumpington, B.
Plumb, L.	Turnberg, L.
Quinton, L.	Waddington, L.
Rawlings, B.	Wakeham, L.
	Wallace of Saltaire, L.
Rea, L.	Walmsley, B.
Rees-Mogg, L.	Walpole, L.
Rennard, L.	Walton of Detchant, L.
Renton, L.	Warnock, B.
Roberts of Conwy, L.	Watson of Richmond, L.
Roberts of Llandudno, L.	Weatherill, L.
Rodgers of Quarry Bank, L.	Wilcox, B.
Roper, L. [Teller]	Williams of Crosby, B.
Russell-Johnston, L.	Williamson of Horton, L.
St. John of Bletso, L.	Windlesham, L.

NOT-CONTENTS
Acton, L.	Farrington of Ribbleton, B. [Teller]
Alli, L.
Amos, B. (Lord President of the Council)	Faulkner of Worcester, L.
	Filkin, L.
Andrews, B.	Gale, B.
Archer of Sandwell, L.	Gibson of Market Rasen, B.
Ashton of Upholland, B.	Giddens, L.
Barnett, L.	Goldsmith, L.
Bassam of Brighton, L.	Gould of Brookwood, L.
Berkeley, L.	Gould of Potternewton, B.
Bhatia, L.	Graham of Edmonton, L.
Bhattacharyya, L.	Gregson, L.
Borrie, L.	Griffiths of Burry Port, L.
Bragg, L.	Grocott, L. [Teller]
Brooke of Alverthorpe, L.	Harris of Haringey, L.
Brookman, L.	Harrison, L.
Burlison, L.	Hart of Chilton, L.
Carter, L.	Haskel, L.
Chandos, V.	Haworth, L.
Clark of Windermere, L.	Hilton of Eggardon, B.
Clinton-Davis, L.	Hogg of Cumbernauld, L.
Cohen of Pimlico, B.	Hollis of Heigham, B.
Corbett of Castle Vale, L.	Irvine of Lairg, L.
Crawley, B.	Janner of Braunstone, L.
Dahrendorf, L.	Jay of Paddington, B.
Davies of Coity, L.	Jones, L.
Dean of Thornton-le-Fylde, B.	King of West Bromwich, L.
Desai, L.	Layard, L.
Dixon, L.	Lea of Crondall, L.
Drayson, L.	Leitch, L.
Dubs, L.	Lipsey, L.
Eatwell, L.	Lofthouse of Pontefract, L.
Evans of Temple Guiting, L.	Macdonald of Tradeston, L.
Falconer of Thoroton, L. (Lord Chancellor)	McIntosh of Haringey, L.
	McIntosh of Hudnall, B.

MacKenzie of Culkein, L.	Sainsbury of Turville, L.
Mackenzie of Framwellgate, L.	Sawyer, L.
McKenzie of Luton, L.	Sewel, L.
Mason of Barnsley, L.	Sheldon, L.
Maxton, L.	Simon, V.
Merlyn-Rees, L.	Strabolgi, L.
Morgan, L.	Symons of Vernham Dean, B.
Morris of Aberavon, L.	Taylor of Blackburn, L.
Morris of Manchester, L.	Thomas of Macclesfield, L.
Parekh, L.	Thornton, B.
Patel of Blackburn, L.	Tomlinson, L.
Pendry, L.	Triesman, L.
Pitkeathley, B.	Truscott, L.
Plant of Highfield, L.
Ponsonby of Shulbrede, L.	Tunnicliffe, L.
Prosser, B.	Turner of Camden, B.
Prys-Davies, L.	Warner, L.
Ramsay of Cartvale, B.	Wedderburn of Charlton, L.
Rendell of Babergh, B.	Whitty, L.
Roll of Ipsden, L.	Wilkins, B.
Rooker, L.	Williams of Elvel, L.
Rowlands, L.	Woolmer of Leeds, L.
Royall of Blaisdon, B.	Young of Norwood Green, L.

Resolved in the affirmative, and amendment agreed to accordingly.

4.7 p.m.

Earl Howe moved Amendment No. 2:

Page 3, line 2, at end insert—

"( ) Nothing in subsection 9(b) shall prevent a person, for the purpose of carrying out or facilitating research as referred to in subsections (7) and (8), from taking such action in relation to relevant material as may be necessary to ensure that the person from whose body the material has come may not be identified."

The noble Earl said: My Lords, there is concern in certain quarters of the scientific research community that the wording of the Bill as it stands would have an unintended and regrettable consequence. Clause 1(9) sets out the conditions under which research using tissue from living donors may be carried out without consent. The second of those conditions is, to paraphrase subsection (9)(b), that the tissue must be anonymised so that the researcher does not know, and is not likely to find out, whose tissue it is.

The unintended consequence that I mentioned is that under the Bill the process of anonymisation itself would he rendered illegal; that is the concern. To anonymise a piece of human tissue involves starting off with material that has identifiers attached to it—the name of the person, hospital number and so on—and then converting it into material which does not have identifiers on it. The name and other identifiers are removed and replaced with a code to which the researcher does not have access. This is what is normally referred to as "linked anonymisation". Where that process takes place for the purposes of obtaining samples for research, the fear is that it would be caught by Clause 1(9).

There are analogies here with the processing of information as regulated under the Data Protection Act and the Health and Social Care Act. Under the latter Act researchers are required to apply to the Patient Information Advisory Group before anonymising data sets. However, unlike the processing of information, slides and blood samples cannot easily be de-identified outside the laboratory setting, where appropriate facilities for refrigeration of samples are available. For the small-scale research project, the only staff who may be able to undertake that will be those supervised by or under the authority of the person carrying out the research. For the purposes of the clause, the "person carrying it out" surely must mean all members of a research team involved in a particular project.

The practical ways of getting round the problem are all fairly burdensome. One could employ an independent agent off-site, but that poses obvious logistical difficulties. One could set up Chinese walls in the laboratory and appoint someone to carry out the process of de-identification who is not involved in the research in question. However, in a small laboratory there may not be enough people to enable that separation of functions to take place. One could have a system whereby the name of the patient was removed but another kind of patient identifier was retained. Even that would mean that case-series analysis would be unlawful without consent.

How does the Bill as worded not create an impossible trap for those researchers working in a small laboratory who discover that the requirement to anonymise tissue samples prevents them, in practice, carrying out research projects? I beg to move.

Lord Warner

My Lords, I hope that I can give some reassurance that what is sought by the amendment is already allowed for in the Bill. Clause 1(7) to (9) allows tissue taken from the living to be stored or used for research purposes without consent where two safeguards are met. Those are, first, that the research has ethical approval, and secondly, that the research is or is going to be carried out in circumstances such that the researcher does not know and is not likely to find out the identity of the person whose tissue it is.

We have used the shorthand of "anonymisation" when referring to the second of those two safeguards. In practice, it means separating from the tissue any information which links it to an identifiable individual. Non-identifying information, which may be very important for the purposes of the research, may still be kept with the tissue, and it would be possible to seek further non-identifying information relating to a particular sample if necessary during the research, provided that the person's identity remained confidential. As we have said on several occasions, the Bill does not require such tissue to be permanently unlinked from the patient record.

Therefore, it will not be an offence to store or use tissue for research purposes without consent where a researcher doing REC-approved research does not know the person's identity. How the removal of patient identifiers from the tissue is achieved is not regulated by the Bill. A clinician who wants to carry out research using material from his own patients could, prior to commencing the research project, anonymise all or some of the patient's material. Once that was done and REC approval was obtained, he could commence the research.

The clinician would need to be sure, however, that he met the requirement in Clause 1(9)(b) that he was not likely to come into possession of the patient's identity. He would need either to unlink the tissue and identifying information, or to make arrangements for secure holding of the "key" which links the tissue to particular patients. That would apply whether the laboratory or organisation was small, medium or large.

Although the Bill does not prevent a clinician anonymising his own patient records prior to commencing use of them in research, the clinician would need to be satisfied that he would not need to and would not be likely to come into possession of identifying information. As such, he may consider it simpler to involve a third party for the purpose of anonymisation. However, that is not actually required by the Bill. In any event, I can reassure noble Lords that Clause 1(9)(b)—I invite them to undertake a careful reading of it—does not prevent anonymisation activities where they are done prior to commencement of research.

4.15 p.m.

Earl Howe

My Lords, I am grateful to the Minister. I well appreciate that his reply is intended to be helpful, and I am sure that it takes us further forward. However, I confess to being quite puzzled by it. In a small laboratory setting with perhaps a few named samples on the table, it would seem a bit difficult for any researcher, even if he or she carried out the process of anonymisation, not to have some memory recall of the identity of the person to whom each sample related. In those circumstances, the researcher would infringe subsection (9)(b), as he or she could not stand up and say that they were unlikely to come into possession of the knowledge of who the people were.

There may still be an issue here in certain laboratory settings. It has been put to me that it is certainly not enough simply to remove the name of a patient from the tissue sample and believe that one has thereby anonymised it. Quite often one finds that the hospital number remains as an identifier. Certainly in the eyes of many doctors and the GMC, that is not sufficient to preclude the possibility of the person's identity becoming known at some stage in future.

I shall withdraw the amendment; it was in essence a probe. However, the best thing for me to do is to consider the Minister's reply and see whether the matter could not be further clarified at the Bill's final stage. In the mean time, I am grateful to the Minister for putting his reassurance on record. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Earl Howe moved Amendment No. 3:

Page 3, line 9, at end insert "(having consulted such persons as he shall consider appropriate)"

The noble Earl said: My Lords, I tabled a series of amendments for Grand Committee designed to ensure that, before exercising a number of the delegated powers in the Bill, the Secretary of State should consult such persons as he considered appropriate. I obviously had in mind members of the medical and scientific communities. I have not retabled all those amendments. Instead, I have come back to Clause 1(11), because it has particular importance in the context of the Bill as a whole.

We should remind ourselves that the Bill has emerged from a series of very regrettable medical scandals. I am sure that we have before us a carefully drafted set of provisions. We may not all agree on some of their details, but we are all signed up to the main principles on which the Bill rests, as my noble friend Lord Jenkin pointed out earlier. The Government have steadfastly resisted change to the main planks of the Bill. I understand why they have done that, although I do not always agree that they should be so absolutist in their approach.

Despite the Government's firm stance, we find in subsection (11) a delegated power of a potentially far reaching nature. It is so far reaching that it drew comment from the Select Committee on Delegated Powers and Regulatory Reform. The committee commented that, although the delegation contained in the subsection was not in its opinion inappropriate, the House may wish to see the criteria for its exercise, if such criteria can be formulated, set out on the face of the bill".

The Minister did not specifically respond in Grand Committee to those comments. Having thought about this for quite some time, I have some doubts, as the Committee indicated as well, about whether the criteria for the exercise of this power can be formulated in a satisfactory way.

My amendment requiring the Secretary of State to consult comes at the issue from the other direction. It effectively says that the criteria for the exercise of the power should be examined by those whom the power most affects—namely, the medical and scientific communities—at such time as the Secretary of State may wish to change Schedule 1. Let us remind ourselves that Schedule 1 is very much the linchpin upon which the Bill rests. As we are all aware, it contains a list of those activities in Part 1 where consent is normally required and in Part 2 where it is normally not required. Those lists have been drawn up after extensive thought and consultation.

In Grand Committee, the Minister said it would be unthinkable for any Secretary of State to come to either House of Parliament and present an affirmative instrument without having consulted those whom it directly affected. I can see that; it would be a brave Minister who would do that. But to me, that is not the issue. We need to send out the same kind of reassuring messages with this clause as we do with some of the rest of the Bill. The public need to know that proper consultation will take place; the scientific and medical communities need to know that proper consultation will take place. I do not think that placing a requirement of this kind in the Bill is, if I can put it colloquially, any skin off the Government's nose. I would feel very reassured if the Minister felt able to agree to the proposal contained in the amendment. I hope that he will look at it constructively I beg to move.

Baroness Neuberger

My Lords, I support the noble Earl, Lord Howe, in the amendment. I feel, as he does, that the public would be much reassured by seeing on the face of the Bill that the scientific and medical communities as well as patient groups and the voluntary sector had been suitably consulted.

Baroness O'Neill of Bengarve

My Lords, I think there is a great point to this addition. We have to remember that Schedule 1, which, as the noble Earl has said, is the linchpin of the Bill, contains in each of its halves a list of activities to be treated differently—those normally requiring consent and those not normally requiring consent—but that the lists are not exhaustive. There are many gaps, and many things that fall under none of the headings in Schedule 1. It is, as we saw from the debate on Amendment No. 1, not clear that these matters are mutually exclusive. In those circumstances, I think it highly likely that the Minister or his successors will be back with suggestions about variations in Schedule 1.

Lord Warner

My Lords, let me reassure the noble Earl, Lord Howe, that I do not have the bravery to come before the House with amendments of this kind without having gone through an extensive process of consultation.

A similar amendment was proposed in Grand Committee. I sought to reassure noble Lords at that time that the Secretary of State would consult appropriately before exercising his powers to change the scope of the regulated activities. As I said then, it is customary for consultation with relevant stakeholders to take place before substantive changes are made to legislation. We certainly do not plan to do things differently in relation to the Bill.

However, I recognise that there are concerns in your Lordships' House and outside. Having listened to your Lordships' obvious concerns about this matter, I am content to take the point away to reconsider it with colleagues and to come back to it at Third Reading.

Earl Howe

My Lords, that really is a very encouraging reply. I thank the Minister very warmly, and I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Schedule 1 [Scheduled purposes]:

Baroness Neuberger moved Amendment No. 4:

Page 39, line 11, leave out "which may be relevant to any other person" and insert "with the aim of determining whether or how it is relevant to any other particular person"

The noble Baroness said: My Lords, this amendment concerns the concept of intentionality. In the course of some kind of treatment, information could be obtained that could be relevant to somebody else, but that would not necessarily be known at the outset.

The amendment has been supported in principle by the British Medical Association. I know that the Minister has considered this. He said in Committee: I understand that, particularly in genetics, clinicians will often have stored tissue from a relative of their patient which could be used without the knowledge or consent of that relative, in order to assist the diagnosis of genetic disease. The Bill will require that consent be sought from such relatives before their tissue is used for this purpose. That seems right and proper".—[Official Report, 15/9/04; GC438.] I think we would all agree with that. Consent should clearly be sought before tissue from a competent patient is used for the benefit of another person. However, there are other concerns. The Royal College of Pathologists, in particular, has argued that paragraph 4 goes further than this. In the type of scenario it suggests, in the process of undertaking a diagnostic test for the benefit of an individual patient, unforeseen information is obtained which could or might be relevant to another person. Unless specific consent had been obtained for this eventuality—and that would not be known in advance—it would apparently be unlawful under paragraph 4. For that reason, I have tabled this amendment. I beg to move.

Earl Howe

My Lords, I fully endorse the comments of the noble Baroness. She describes the amendment as coming under the broad heading of intentionality. I would give it the slightly different heading of "fortuitous discovery". Let us suppose that during the course of an investigation being carried out for the benefit of a particular patient, a pathologist makes a very fortuitous discovery which is relevant to the health of another person. Where would that pathologist stand in law if consent had not been obtained?

I should like to speak particularly to Amendment No. 83, which is grouped with Amendment No. 4. In Grand Committee, we had quite an extensive debate about the meaning of the terms employed in Schedule 1. Many of us were and are concerned about the lack of clarity in some of those terms, because we fear that unless researchers and clinicians are clear about what the terms mean, they will not want to risk falling foul of the law and, as a result, research will simply not be undertaken.

During our exchanges in Grand Committee, the Minister appeared to make a very important point which, if I understood him correctly, could considerably alleviate those concerns. He appeared to say (at col. GC439 of the Official Report of 15 September) that in a case where a particular activity could be classified as falling under Part 2 of Schedule 1, as well as under Part 1, only the requirements applicable to Part 2 need apply. This amendment is designed to give the Minister an opportunity to put that assurance beyond doubt.

Some of the purposes set out in Schedule 1 will, in certain day-to-day situations, overlap: for example, public health monitoring and research; drug efficacy testing and clinical audit; public health monitoring and obtaining medical information about a person which may be relevant to another person. Where this occurs, there has to be clarity about what consent requirements apply, if any. The common sense answer is to say that if the activity genuinely falls within the scope of Part 2 of the schedule and consent is therefore not required, it is irrelevant that it may also fall within the scope of Part 1 in the context of the consent provisions.

In common with other noble Lords, I am grateful to the Minister for the letter he sent to many of us on the terminological aspects of Schedule 1. I hope that he will now be able to provide further comfort on these matters.

4.30 p.m.

Lord Warner

My Lords, the amendments in this group are addressed once more at seeking to redefine or clarify the activities covered by Schedule 1. As I said when we discussed these matters in Committee, the structure of the schedule provides for such activities as research and allows for the use of tissue without consent from living patients in the case of Part 2 activities. If an activity can properly be described, for example, as "public health monitoring", then, even though in some cases it may be possible to describe it as research, it would be proper to treat it under Part 2 of Schedule 1, because it is public health monitoring.

Clause 1(10) makes it clear that activities using tissue from the living for the purposes listed in Part 2 of Schedule 1 are lawful. Some of the amendments address precisely that point, and I am happy to give again the reassurance that the Bill accommodates it. As noble Lords who attended Grand Committee will be aware, and, as the noble Earl, Lord Howe, has said, I have written a letter in those terms and have set out in detail the Government's understanding of what is meant by each of the activities listed in Part 2 of Schedule 1. Further HTA guidance will develop this to help ensure that researchers and practitioners understand fully when consent is needed.

I do not believe that there is anything of substance between us. We agree that we are trying to achieve a workable and pragmatic Bill that is based on principle and that practitioners should know how to operate within it. We have described activities that require consent and those which, in respect of tissue from living patients, do not. These amendments do not add anything and they might risk altering the meaning of the scheduled purposes. I should emphasise that we must await HTA guidance on these issues, which will help researchers and allay many of the anxieties that they may have.

I shall return to my first point. Schedule 1 lists purposes—regulation of the activity of removing, storing or using tissue for that purpose. So where an activity is done for one purpose, one could not say that it is also done for another. For example, it has been suggested that there could be confusion between clinical audit and research. We can distinguish between clinical audit and research, and I have set out in my letter what is meant by each, but the purpose of the activity would nevertheless be clear. If, in examining some tissue samples, my purpose is to audit a number of clinical cases, that is clearly different in purpose from examining them for conducting research, even if I use the sample in the same way. The purpose is the determining factor regarding the classification of activities in Schedule 1.

The amendment adds words to the scheduled purposes at paragraphs (4) and (6), which would not be helpful. Amendment No. 4 adds the notion of the aim of establishing the relevance of information that might be derived from examining a tissue sample. That is already implicit in the paragraph, because the schedule deals with purpose the purpose of examining tissue to that end. So the effect of the amendment would be potentially to exclude situations where it is already known, and in what manner, that information will benefit another person. The effect of excluding such cases from the schedule in this way would be that there would be no requirement for consent in cases where it should he obtained. In other words, it would be lawful to use tissue from patient A without his consent if, as part of the treatment and diagnosis of patient B it was desirable to obtain information from A's tissue, when it was known that that would be relevant to B. This is a complicated issue, but if the noble Baroness considers it carefully, and reads Hansard, she might think that this would not be the right outcome.

Amendment No. 5 again adds words that are not necessary. We have cast this paragraph quite widely but also very carefully, so that it does cover the matters which that amendment seeks to address. To extend the paragraph to include, for example, research into the use of the human body, which would be an effect of the amendment, would risk taking us into other fields altogether. Research into the performance of athletes, for example, could be one such use that might be caught under the proposed amendment. As I have said before, we should resist adding unnecessary words, because they might have a tendency to lead us astray. We should await guidance from the HTA regarding this area.

The final amendment in this group seeks to apply a principle of mutual exclusivity to Schedule 2 activities. I am in favour of tidy-mindedness in this area, but I have already explained that Schedule 1 deals with purposes and that if an activity is carried out for one purpose, it is plainly not being carried out for another. In the case of tissue from the deceased, the same requirements apply to all activities in Schedule 1. The distinction between Part 1 and Part 2 purposes is relevant only to tissue from the living—and the distinctions are clear and appropriate. Activities which can be described as being for Part 2 purposes are explicitly lawful without requiring consent.

A particular issue raised by noble Lords is the relationship between research and public health monitoring. I tried to cover that in my letter of 15 October to Members of the Grand Committee, and I should he happy to circulate that more widely, if that is the wish of noble Lords. For the benefit of the House, I shall not read out the whole of that letter, but a small part of it is worth quoting, which, I hope, will provide some reassurance: … the Government does not think it necessary or helpful to define too narrowly the purposes listed in the schedule. Nor is it necessary to provide for mutual exclusivity of definitions. For example, an activity may properly be described as 'public health monitoring', even though it may be possible in some particular case also to describe it as research. If its primary purpose can properly be described as 'public health monitoring' it will fall under Part 2 of Schedule 1, which means that where tissue from living patients is concerned, consent will not be needed. The Human Tissue Authority will provide practical guidance and advice to those carrying on activities within its remit. Its guidance will not be definitive, as ultimately it will be for the courts to decide the scope of the scheduled purposes".

I would suggest that if we moved away from that by trying to provide mutually exclusive definitions, we would be likely to cause more difficulty than we anticipated. That is why we should await HTA guidance, which will be consulted on widely, involving people who have practical experience in such areas.

I hope that with that reassurance, noble Lords will withdraw their amendments.

Baroness Neuberger

My Lords, I thank the Minister for his reassurance and clarification. I am not sure that I completely agree with him, but, meanwhile, I shall read Hansard once again and decide whether I need to come back to this matter at a later stage. For now, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 5 not moved.]

Earl Howe moved Amendment No. 6:

Page 39, line 15, leave out "or education or training relating to such research"

On Question, amendment agreed to.

[Amendment No. 7 had been withdrawn from the Marshalled List.]

Lord Turnberg moved Amendment No. 8:

Page 39, line 20, leave out from "health" to end of line 21.

On Question, amendment agreed to.

Baroness Neuberger moved Amendment No. 9:

Page 39, line 20, leave out from "health" to end of line 21 and insert "or research in connection with disorders, or the functioning, development or use of the whole or any part of the human body."

On Question, amendment agreed to.

Clause 3 ["Appropriate consent": adults]:

Lord Turnberg moved Amendment No. 10:

Page 4, line 20, after "his" insert "general and enduring"

The noble Lord said: My Lords, when this matter was debated in Committee, the Minister was reluctant to include in the Bill the phrase "generic and enduring" in relation to "consent", although he gave some welcome reassurance that that was what the Government meant by "consent". However, that is where the problem lies. My fear is that research ethics committees, which will be examining research proposals, will be left with the difficulty of interpreting what is meant by "consent" when they already have some difficulties with it.

I can perhaps best illustrate the problem by describing the situation of patients who have biopsies taken for diagnostic purposes or who have tumours or other diseased organs removed. Their consent is sought at the time for research to be performed on the removed parts. It is rare for such consent to be withheld and it is usually presumed by the patients at least that they are giving consent for all types of research to be undertaken then and at any time in the future. Some patients may wish to give limited consent; only for certain types of research and only for a limited time. That is entirely reasonable and acceptable. However, most patients could not care less.

Unfortunately, research ethics committees may not interpret the consent that is given in the same way. Whenever they receive a request for permission to undertake a new piece of research on the same tissue at some future date, even if it differs from the original research only marginally, they may demand that further, new consent is required from the patients. That is likely to be the position that the committees adopt as they lean over backwards towards what they see as being their responsibility. However, obtaining renewed consent at that stage may be quite impossible or, at least, impracticable because patients may have moved or died in the interim or be untraceable. Those who can be traced are likely to be surprised by a renewed request for a consent which they felt they had already given.

There seem to be three arguments against inserting "generic" and "enduring" in the Bill. First, some suggest that it would open up an opportunity for malicious research on tissues against the patient's best interests, However, any new research or even minor changes in the original research for which consent was given requires renewed approval by a research ethics committee. Therefore, considerable safeguards are in place, to say nothing of the duties of confidentiality and the penalties for misbehaviour that are envisaged in the Bill.

Secondly, it is suggested that inserting qualifying adjectives in a Bill closes off different interpretations and reduces flexibility. However, the words "generic" and "enduring" do the opposite of narrowing the definition of consent; they broaden its meaning.

Finally, if it is suggested that it is unnecessary to include those words, the clearer guidance that they would give to ethics committees and the HTA would remove an area of confusion that would continue to bedevil them and the researchers who seek their approval. I beg to move.

4.45 p.m.

Baroness Finlay of Llandaff

My Lords, I support the amendment to which I have added my name. Perhaps I may remind the House that the Minister helpfully said in Committee that where a patient has given clear consent for the use of tissue for research purposes, that consent would be continuing and generic and would endure. That is so important that it should be stated in the Bill. It would ensure that case series could be studied; that genetics research could proceed unimpeded by the need to try to trace everyone every time; that clinicians and staff, particularly those with continuing professional education, could carry on with their understanding of research; and importantly, that patients who wished to contribute to the common good could do so without being pestered by requests for different consents on their surgically excised tumour or blood sample. It would also ensure that all healthcare organisations had in place straightforward and failsafe procedures to ensure that, when such consent is not given, the specimen would be discarded after the diagnostic process and the patient knew that he would not be contacted again even if some new information came to light. That is patient choice.

If a patient has given general and enduring consent and then changes his mind, he simply goes back to inform the trust, which has to act. The Minister's letter helpfully clarified some of those matters, but we suggest that the amendment would preserve patient choice and prevent patients and healthcare researchers being burdened with cumbersome re-consenting processes which would simply be time-consuming and maybe burdensome to a patient who says, "I just want to be rid of this tumour. You can do what you like with it. I want it to be used for the common good. I never want to hear about it or be reminded of it again". The amendment would make it clear that the Bill allows patients to do that, but it would also make it clear that if a patient did not wish to consent, the trust must take appropriate action.

Baroness Hayman

My Lords, I have been in the Minister's situation and therefore I know the arguments that are rehearsed against adding to the Bill adjectives of the kind suggested by the amendment of my noble friend Lord Turnberg. However, there are two good arguments for so doing in this case.

As has been said by other noble Lords, the effect of the Bill as it stands is that consent would be generic and enduring. The Minister made that absolutely and helpfully clear in Grand Committee. The difficult question we now face is whether we think that that being recorded in Hansard will be sufficient to obviate the problems not only for research ethics committees, as were outlined by my noble friend, but also, I would suggest, for patients. There is an advantage in patients understanding that giving a single consent relates not only to a small piece of research—perhaps on breast cancer if they have had a breast tumour removed—but could have different applications in future, having been stored in a tissue bank.

Including these words in the Bill would simplify and clarify the situation without acting as a deterrent and requiring people to return on several occasions to give different consent. It would also help the research community and make the nature of the consent more transparent to patients.

Baroness O'Neill of Bengarve

My Lords, I understand the Minister's reservation about adjectives—often they are not helpful—but we are not operating in a vacuum. We are operating in an area in which a number of international conventions or agreements are highly relevant to prospective research. Where specific consent is sought, for example, for a clinical trial which may put people at risk, they must consent to particular intervention.

Here we are discussing retrospective research. The tissue has already been removed and the question is whether the patient shall be bothered again and again for specific consent. At an earlier stage in another place, a misleading degree of emphasis was put on specific consent. I am pleased that the understanding now is that that adjective is not intended and I hope that we can make that clear on the face of the Bill.

Baroness Neuberger

My Lords, we on these Benches support the amendment tabled by the noble Lord, Lord Turnberg, and the noble Baroness, Lady Finlay.

Lord Warner

My Lords, I have a terrible feeling that after listening to me, my noble friend Lady Hayman will feel that Ministers are generic and enduring.

I understand entirely the concern and reasoning behind this amendment, having discussed it in other guises on several previous occasions, and I am aware that assurances on this point have also been given in another place. The point that colleagues in the research community are making is that they should not be bound slavishly to go back to patients for further consent each and every time tissue is used for a new project, or for a novel use which may arise from time to time. I entirely sympathise with that view, provided that the patients in question are equally happy to donate their bodily material on that basis. I repeat that there is nothing in the Bill whatever to prevent tissue being donated on the basis that it can be used for any research project now or in the future.

I suggest to noble Lords that the wording of the initial consent is possibly the key here, bearing in mind also that the Human Tissue Authority will be issuing guidance in this area. Having spent some time looking at the considerable variation between some of the consent forms which are produced and signed, I think that this is an area to which the Human Tissue Authority will need to give attention.

However, I have enough humility to realise that not all researchers will necessarily read my golden words in Hansard or attend debates in your Lordships' House, and therefore they would like to see the matter spelt out on the face of the Bill. But there are very good reasons not to put unnecessary words into the Bill, and the proposed amendment is a good case in point. The effect of the amendment is to make "general and enduring" consent the only sufficient form of consent for the activity in question. Thus, if a person wanted to give a more limited consent—perhaps to research into a particular condition, to partake in a particular project or, more widely, to donate tissue for transplant to a particular person—that could well fall outwith the Bill and therefore be questionable in law. That seems to me to be an undesirable consequence and one which I assume is unintended by my noble friend.

However, the more general point is that, by not qualifying the term "consent" with any adjective—whether it be "general", "generic", "enduring" or "genuine"—all possibilities are left open and can be brought into play, depending on the circumstances. If we mandate that only "general and enduring- consent is permissible, then we shall also need to add in Clause 3 that consent may equally well not be general and enduring and we shall probably also need to list some other possibilities that come to mind.

I suggest that the only sensible way forward is not to qualify the term in statute but to allow flexibility in practice, coupled with the guidance of the Human Tissue Authority. I recognise that I am continuing the traditional ministerial onslaught on adjectives but I suggest that, when researchers stop to consider this issue, they will realise that this proposal may not he in their best interests.

We have been around this issue several times and I believe that the concerns of the research community on this point are entirely met by the Bill as currently worded. The research community would do well to wait patiently for the guidance from the Human Tissue Authority. Tinkering with the word "consent" by adding adjectives to the Bill risks producing outcomes that the research community would not like.

Lord Turnberg

My Lords, I am grateful to the Minister for his response, although naturally I am somewhat disappointed that he is unwilling to put these words on to the face of the Bill. I am moderately encouraged by his suggestion that we wait to see the guidance produced by the HTA. I am not very patient but I am willing to wait. With that, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 5 [Prohibition of activities without consent etc.]:

Earl Howe moved Amendment No. 11:

Page 6, line 43, leave out sub-paragraph (i).

The noble Earl said: My Lords, in moving Amendment No. 11, I shall speak also to all the other amendments in this group. We come to a matter raised in Grand Committee by my noble friend Lord McColl—that is, the issue of criminal penalties. My noble friend argued then that a maximum three-year term of imprisonment for the type of offence that we are considering was inappropriate and disproportionate. Both my noble friend and I still hold to that view. However, the Minister's reply in Grand Committee gave me no cause whatever to think that he was likely to change his mind on that question—quite the reverse. Therefore, I have returned to another feature of this issue with which we on these Benches have, if anything, even greater difficulty.

My noble friend Lord Jenkin underlined very effectively the point that I am about to make. We can agree or not about whether a term of imprisonment is an appropriate penalty for the offences detailed in the Bill and what the maximum term should be. A separate question altogether is whether we should empower a magistrate to pass down a sentence of imprisonment. If the offence with which someone is charged is serious enough to warrant a prison sentence, it seems to me that it should be heard in the High Court.

To try to argue that minor offences under the Bill should attract a prison sentence is, I believe, to lose sight of what is proportionate. No offence in this Bill—absolutely none—concerns physical harm to an individual. The nature of all the offences relates to infringements of privacy, individual autonomy and respect for the person.

I do not suggest for one minute that those are not serious matters, but I do suggest that the kind of minor matter likely to be tried in a magistrates' court under those headings is inherently less serious than some other matters commonly tried in a magistrates' court. For a magistrate to be able to send a doctor, researcher or clinician to prison for an offence that is not of the most serious kind seems to me inappropriate and wrong.

In Grand Committee, the Minister said that the Bill should send out a clear deterrent message. As I said, I disagree with the Minister as to the nature and extent of that deterrent message, but I am no longer arguing that point with him. The deterrent message in the Bill remains unaffected by the amendments.

The degree of seriousness attaching to the most serious offences under the Bill is equally unaffected because those will be heard by the Crown Court. If a magistrate who is called upon to hear a case believes that if the case is proven it is such as to warrant a prison sentence, then he or she is capable of referring it upwards. Therefore, I hope that the Minister will not reject these amendments. I believe that they give a better balance to the Bill and a better balance to the messages that it sends out. I beg to move.

Baroness Finlay of Llandaff

My Lords, we have a national shortage of pathologists. I know that in Committee the Minister said that the penalties are to act as deterrents but I submit that erasure from the register is the greatest deterrent. I am not going to plead that pathologists or clinicians are more special than anyone else, but why does a magistrate have the power to imprison?

By not practising, the public is protected from harm and the pathologist, when suspended, is prevented from repeating a harm, as well as being duly punished. If a major problem arises, of course it will go to the High Court and it is right that the High Court has punitive powers. I suggest that the only deterrence achieved by keeping imprisonment at the behest of a magistrate is the certainty that fewer people will enter the specialty of pathology through fear of being wrongfully convicted and fear of the trauma around that.

We have 50 per cent of the pathology service that we should have and, at this rate, we may have none. Without pathologists, diagnostic accuracy will be almost absent. Do we really want to destroy pathological diagnostic services in the hope of deterring a potential unidentified wrongdoer in the future? Please may we have a sense of proportion and ensure that we attract bright, conscientious doctors to be pathologists and not drive them away by the threat of a magistrate being able to lock them up?

Lord Jenkin of Roding

My Lords, I agree with every single word that has been said by my noble friend Lord Howe on the Front Bench and with what has been said most eloquently by the noble Baroness, Lady Finlay of Llandaff, who has used her expertise throughout the proceedings on this Bill to huge effect.

The only point that I would add, and which I hope the Minister will take on board, is that it is perhaps this provision concerning the possibility of imprisonment from a magistrates' court that has sown the most hostility and suspicion among those who are engaged in medical research and related activities. The Minister would do himself and the purposes of his Bill a considerable service if he were to meet the arguments advanced and agreed strongly and firmly by most noble Lords, and I think that it would improve the Bill if he did so.

Baroness Neuberger

My Lords, from these Benches I support the amendment put forward by the noble Earl, Lord Howe, the noble Lord, Lord McColl, and the noble Baroness, Lady Finlay.

5 p.m.

Lord Warner

My Lords, these amendments repeat a number of amendments proposed at Committee stage to remove the power to impose a penalty of 12 months' imprisonment on summary conviction for offences under the Bill. I know many magistrates and it is mildly fanciful to think that a large number of them are hanging around the country waiting to give custodial sentences to pathologists and so deprive the NHS of them. We need to keep the matter in proportion.

I made it clear in Grand Committee that the Government consider that the offences and penalties in the Bill are there to demonstrate the seriousness with which we view the events that have taken place in the past and to act as a deterrent to any future misuse of human tissue. There would have to be a real wilfulness of intention to bring about a prosecution of the kind provided for in the Bill. In the unlikely event of a prosecution, it would be for the courts to decide the appropriate penalty from the range available. That is how we do business in this country. In the nature of things, an offence would have to be very serious indeed to warrant a custodial sentence. We have to keep that firmly in our minds.

However, I recognise from noble Lords' comments that, notwithstanding our assurances, pathologists and researchers continue to feel vulnerable. I am willing to take away the issue of custodial penalties being available on summary conviction and return to the matter at Third Reading. Perhaps the matter can be left on that basis.

Earl Howe

My Lords, once again, I am very grateful to the Minister for listening so constructively to the concerns raised. I look forward to a further debate on this matter at Third Reading. In the mean time, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 12 not moved.]

Clause 6 [Activities involving material from adults who lack capacity to consent]:

Earl Howe moved Amendment No. 13:

Page 7, line 10, at beginning insert "to the knowledge of the person carrying out the activity for which consent is required (having made all reasonable enquiry, having regard to the activity in relation to which consent is required)"

The noble Earl said: My Lords, this is a reconfigured version of an amendment debated in Grand Committee. It stems from a real concern that Clause 6 as drafted could have the effect of impeding the conduct of research into medical conditions or treatments associated with emergency and critical care. In our earlier debates on the issue, the noble Baroness, Lady Finlay, gave a very graphic example of how, in certain situations, time is of the absolute essence in carrying out certain procedures. Where such procedures are of their nature experimental, but nevertheless consistent with an approved research protocol, the absolute requirement to find out whether the patient has previously consented or refused to consent to such use of tissue could act against the best interest of that patient and inhibit the research.

What does the clause oblige a researcher to do? Surely it obliges him to conduct an investigation to establish the facts. The requirement is not discretionary. Before the activity proceeds, the person intending to carry it out must find out—yes or no—whether the patient has previously objected to his blood or other tissue being used for research. Sometimes that is practically impossible, but on other occasions it is not.

In her reply to the previous amendment, the Minister indicated that the researcher would always be able to fall back on the defence of reasonable belief. When I thought about it, I found that argument quite extraordinary. The only grounds on which the defence of reasonable belief can apply are either that one does something when one reasonably believes that consent has been given, or that one does something when one reasonably believes that consent is not required. In the case of someone with mental incapacity, the Bill makes it crystal clear that the consent, or the refusal to consent, of such a person, is not only germane but central to whether the activity can legally take place. In fact, the Minister emphasised that in an earlier reply. So one would not be able to claim that one reasonably believed that the consent requirements did not apply, nor could one claim that one reasonably believed that consent had been given unless one had taken active steps to establish whether or not it had been given. That takes us back to where I began.

The Minister was quite categoric. She said that people with mental incapacity are entitled to the same protection—no more, no less—than people with capacity. That, I agree, should be the ideal. But we need to bear in mind that people lacking capacity are different in one major respect from those who have it; namely, they lack capacity. I suggest to the Minister that she cannot apply the same set of rules to each and every situation, because, as the Bill acknowledges, in some circumstances it is necessary for someone other than the mentally incapacitated individual to lake a decision as to what should happen to him. If we allow for that, we have to allow for what is reasonable and practicable. The Minister spoke of, an absolute obligation to ensure that consent is either given or not". That absolute obligation is precisely the nub of the problem. Yet the Minister seemed to lurch back and forth because almost in the same breath she also maintained that the extent to which a researcher should be obliged to determine whether consent has been given is not something that the Bill should spell out, since it is, in her words, a matter for professional judgment".—[Official Report, 15/9/04; col. GC 461.] But this part of the Bill does not mention professional judgment. The Bill says that the activity may go ahead only after establishing the facts. Only with my amendment does the matter become one of professional judgment, having regard to what is reasonable in the circumstances of the case. That is what the Minister says she wants to achieve. That is what I too believe to be right. I hope that there can be a meeting of minds on this issue. I beg to move.

Baroness Finlay of Llandaff

My Lords, determining care for those who lack capacity is fraught with difficulties, yet it faces clinicians daily. In determining best care we must carry out research—that is research into the most delicate, the most fragile frontiers of human existence, such as when someone has had a cardiac arrest or is on a ventilator, precariously balanced between life and death. Without research into conditions that destroy the very essence of a person, such as Parkinson's disease or Alzheimer's disease, nothing will ever improve. That is why we cannot duck the issue. We cannot hope that archived specimens will give us all the answers and we cannot rely on the "ask or anonymise" principle alone.

Without this amendment research ethics committees will be too cautious to allow such vital research to proceed and it will be extremely difficult to define exactly how to deal with consent in a reasonable way. The amendment recognises that one must make inquiries but also that there must be limits on what can be done. It recognises the situation-specific nature of such inquiries.

At a cardiac arrest there are only seconds in which to ask those around whether they know anything about the patient and the patient's wishes, whereas for a patient with Alzheimer's disease, such inquiries can be carried out over days and in greater depth. The amendment tries to clarify the need for being situation specific rather than just inappropriately punitive. There will be a really deleterious rebound if there is no recognition of situation specificity when people lack capacity.

Lord Walton of Detchant

My Lords, on this amendment, the Minister may wish to fall back on the last sentence of Clause 6 which states: there shall for the purposes of this Part be deemed to be consent of his to the activity if it is done in circumstances of a kind specified by regulations made by the Secretary of State". Of course, we have no idea what those regulations will be. For that reason, it seems to me that this amendment is extremely important in strengthening the clause and in no sense does it impair its impact. I strongly support it.

Baroness Neuberger

My Lords, the argument has been made very eloquently by others. Given that reasonable inquiries have to be made—and it is situation specific—I support the amendment.

Baroness Andrews

My Lords, I am grateful to noble Lords for their contributions to the debate. I shall try not to lurch quite so much as I appeared to have done in Committee but I have to use some of the same arguments. Since the amendment is a reconfiguration, I think that my arguments will reconfigure too and refocus on some of the things which emerged in Committee regarding emergency and critical care.

My speech in Committee addressed what was in Clause 2. I would just reiterate for context that Clause 6 allows for regulations to set out the circumstances in which consent to activities regulated by the Bill may be deemed to be in place in the case of a person who lacks capacity. Those circumstances are likely to, include: first, where the activity is in the person's best interests; secondly, where the activity is authorised under the clinical trials regulations; and, thirdly, where the activity is authorised under the Mental Capacity Bill, in particular in relation to research, to which the Bill has a particular and prior regard, and possibly also where a deputy or attorney appointed under that Bill gives consent on the person's behalf. If the person made a decision about use of their material prior to losing capacity, the regulations would not apply.

So the effect of the amendment would be that, even where a prior decision to refuse consent had been made by a person who had lost capacity, the regulations which would deem consent to be in place could still apply, provided that the researcher was not aware of it, having made all reasonable inquiries in the circumstances.

I quite understand that the purpose of this amendment is to ensure that research may proceed in emergency situations. We certainly do not have any wish or intention to inhibit research for the excellent purposes cited in the many examples offered by noble Lords today; that is, in situations where care is critical, but also where research might be conducted for the purpose not of treating the patient, but of using the opportunity potentially to benefit others by taking and using material for research purposes. Of course the Bill is concerned with use and storage rather than removal and research, which comes under mental capacity. The noble Baroness has given us examples on "a loss of capacity" in terms of unconscious situations in strokes and head injury.

Noble Lords took issue with some of the justifications I gave for the clause itself, in terms of the best interests of the patient in what we acknowledge would be in exceptional circumstances. We were also concerned to ensure—and I think it is worth making this point again—that there should not be a lower test of evidence for people with mental incapacity than will be provided for in the Mental Capacity Bill. I take the point made by the noble Lord, Lord Walton, that it is very difficult to discuss two Bills in parallel which overlap to the extent that these Bills do when we do not have the other Bill in front of us at the same stage and we do not have the regulations. Indeed, the rationale for providing for regulations in Clause 6 is precisely to give us the necessary flexibility and opportunity for this Bill and the Mental Capacity Bill to mirror each other.

I am afraid that I cannot accept even the reconfigured amendment for two main reasons. First, the Mental Capacity Bill is the right place for us to have an exhaustive and comprehensive debate on the conditions which apply for people with mental incapacity in research situations. We look forward to those debates. We will be pursuing much the same issues, but in far greater detail and with greater relevance. The second reason is we believe that the Bill provides adequate protection from liability in the context in which we are making the case.

If I may deal with the Bill in principle, I believe that the medical and research communities have nothing to fear from this provision. I can see why fears have been raised, but I believe that the Bill covers these situations. We believe that it offers adequate protection if researchers comply with the standard of making reasonable inquiries, having regard to the circumstances of the case—to the situation-specific nature of the case. If a researcher makes inquiries which are consistent and compatible with that—for example, if he or she used material from a person who lacked capacity in the course of a research project, and took all reasonable steps in the particular circumstances to establish the absence of a prior decision—then he or she would be protected from criminal liability by Clause 5(1)(a).

We cannot pre-define in statute what are reasonable steps for the reason I gave—and I believe the noble Baroness agreed with me—that we do not want to prescribe practitioners' judgment in this field. We do not want to say what we think should be reasonable steps. These are decisions which are taken on a daily basis. We must leave it to the professionals. Again, that will depend on the individual case and the circumstances. A second point I should like to emphasise is that the HTA guidance will be able to assist in these definitions and determinations.

5.15 p.m.

I reiterate that Clause 5(1)(a) provides that a person does not commit an offence under the Bill if he reasonably believes that appropriate consent is in place. That applies in all relevant circumstances, including those that arise in emergency care. What is reasonable will obviously be a matter to be considered in each case. This is not a novel idea. Practitioners should do no less than this already when considering whether an unconscious patient should be entered into a research project. As I have said, the judgment that practitioners make on a regular basis reflects these situations.

To take an example, consider a researcher who wishes to rely on deemed consent in accordance with regulations made under Clause 6 to carry out a research project on people lacking capacity. Assuming that the regulations are applicable, provided the researcher had made all reasonable inquiries as to whether there was a prior decision but had found none, he would be able to say that he reasonably believed that appropriate consent was in place. In the situation now under discussion—emergency situations where a patient might be suitable for an ongoing project—the case remains the same. That is, the researcher need only say that his belief was reasonable.

Let me make it quite clear that the same considerations would arise when considering whether someone had a "reasonable belief" for the purposes of Clause 5(1)(a) as would arise when considering whether someone had made "all reasonable inquiries" in the terms of the amendment. Nothing is gained by adding an additional reasonable belief qualification to Clause 6 itself. So I believe the purpose of the amendment is achieved in the Bill itself. I hope that that, with the HTA guidance, will reassure noble Lords and the research community on that point.

The second fundamental reason we cannot accept the amendment looks to a different logic. The debate we are having today, as I have said, is far from the final word. In all sincerity, as I explained when we debated a similar amendment in Grand Committee, it will be the Mental Capacity Bill and not this Bill which will govern the involvement in research of people with mental incapacity and which will lay down the definitions and the detailed conditions for such research. This Bill will be entirely reliant on the provisions of that Bill in relation to the standards governing research involving those who lack capacity.

Discussions on the Mental Capacity Bill will establish the conditions relating to research. These will be reflected in the regulations we will be making under Clause 6.

Clauses 30 to 33 of the Mental Capacity Bill set out a detailed set of safeguards and procedures which will govern research involving people who, for whatever reason, cannot consent to it. This covers storage and use of material from their bodies, as well as its removal. But because our Bill deals with use and storage we obviously have to make sure that there is compatibility. That overlap is designed to be filled by the regulations.

What links the two Bills together above all, and what must remain indisputable, are the rights of such patients to have their previous wishes respected. Clause 33(2)(b) of the Mental Capacity Bill provides that nothing may be done to, or in relation to, a person who lacks capacity in the course of research which would be contrary to an advance decision of his which has effect. Clause 6 of this Bill is consistent with that provision and the two Bills must work together from the same starting point. That is obviously why we have provided for the regulations.

One regulation will be on precisely where the activity in question is authorised under the Mental Capacity Bill. So it would be pointless in this Bill, as the amendment seeks to do, to set a different qualifying standard because of the need to make the regulations ultimately compatible and cross-referenced.

Let me summarise. First, the protection of the "reasonable belief defence in Clause 5(1)(a) offers equal protection to that which is proposed in the amendment, and is equally adaptable to the circumstances of each case—situations specific—including those where the issue of research arises in emergency situations. To that extent we would argue that the amendment is not needed. Secondly, the Bill must match the Mental Capacity Bill, which also provides that nothing should be done that is contrary to a proper refusal of consent.

I hope that on both grounds I have been able to reassure noble Lords that we have balanced the interests of the research community and of the patient with proper regard for the consent provisions, which we want upheld.

Earl Howe

I am extremely grateful to the Minister for her comprehensive reply, which reassures me to a considerable extent. I am sure that the whole House will he grateful to her for laying out the arguments in such detail. I shall clearly have to read what she said. We agree that a person's prior wishes about the use of their tissue in research should be respected. We agree that there should be provision for deemed consent where a person is mentally incapacitated.

I was fearful of the effect of the wording of the clause, which seemed to create unnecessary and unrealistic barriers in the way of sensible decision-making and effectively pre-empted the provisions of the Mental Capacity Bill. I would not like to put a percentage on it, but I am largely reassured by what the Minister said about the effect of Clause 5. I am persuaded that she is correct that those matters should be debated under the Mental Capacity Bill. I hope that there are no hostages to fortune in the wording of the clause. If there is ever doubt on the matter, I hope that a court will consider what the Minister has helpfully said to reassure itself on the issue. With that, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 7 [Power of court to dispense with need for consent]:

Baroness Andrews moved Amendment No. 14:

Page 7, line 16, leave out "High Court" and insert "Authority"

The noble Baroness said: My Lords, I shall speak also to the other amendments standing in our name on the Marshalled List and to the grouped opposition amendments, if I may.

The Government have tabled this group of amendments to Clause 7 and Schedule 5 to address two issues raised in Committee. First, the amendments provide scope for authority to be granted by the Human Tissue Authority to dispense with consent where people do not respond to requests for consent to use their tissue to inform the healthcare of someone else. Secondly, they take the power to make those types of order from the High Court and give it to the Human Tissue Authority.

The amendments respond, in part, to debate on a related amendment in Grand Committee. That amendment, brought forward by the noble Earl, Lord Howe, would have introduced a court order to allow a refusal of consent to allow tissue to be used for the benefit of a relative—for example, in DNA analysis—to be overridden in prescribed circumstances. The Government did not and could not accept such amendments, as I explained at some length, as overriding someone's refusal of consent would cut directly across the basic principle of the Bill, which is that people should be able to decide what happens to their bodily material.

So I cannot accept Amendment No. 75, which would do just that. We must establish systems, especially in the sensitive area of genetics, whereby individuals are asked when their tissue is taken whether they are content for it to be used for purposes such as research or informing their families' care. Indeed, that is an almost routine practice now. We also know that 99 per cent of people will agree, and we have provided scope for a waiver of the need for consent in the case of missing relatives, who are not available.

However, we listened hard to the debate in Grand Committee, which was passionate, and have discussed the issue further with key stakeholders in genetics, including members of the Joint Committee on Medical Genetics. They suggested to us that in reality the need to override refusal is a very infrequent occurrence, and, indeed, some consider that such an order would not be justifiable. So there is clearly no common or universal view across the genetics community. So I argue that we were right to resist the earlier amendment on those grounds.

However, we have been told by geneticists that difficulties can arise more frequently where an individual, although not untraceable, simply refuses to respond, so that they neither give nor refuse consent to the use of their tissue for the benefit of a relative. That arises in connection with requests to test tissue for genetic markers for various forms of familial cancer, for example.

Bearing in mind that the common law on these issues has been unclear, geneticists anticipate that, once it becomes an offence to analyse human tissue without consent, if individuals do not respond to requests to use their tissue for genetic comparison, their relatives will be refused. The consequence could well not only cause distress to the relatives concerned; it could impede treatment and health prevention measures. So we want to do something about that.

We have addressed that situation by extending the missing relative provision of Clause 7(1) and paragraph 9 of Schedule 5 to these non-responder cases. The amendments therefore provide that in such cases, provided that certain conditions set out in the amendment are met, a direction can be made deeming consent to be in place for obtaining of information to benefit a relative. The conditions for making such a decision include the requirement that reasonable efforts have been made to get the person to consent and that they should have been given notice of the application. That is to make clear that the issue of directions will be the exception rather than the norm, so that the power does not become a mechanism for avoiding the need to ask for consent.

The second effect of this group of amendments is to provide that instead of orders to dispense with the need for consent in the case of missing persons and non-responders being made by the High Court, directions will instead be issued by the Human Tissue Authority. As my noble friend has explained, the intention is that in due course the functions of the Human Tissue Authority, including this one, will be taken over by the regulatory authority for fertility and tissue.

We have made that change not least because we recognise that extending the missing persons order in Clause 7(1) and paragraph 9 of Schedule 5 to non-responders may result in an increase in the number of applications to waive consent to use tissue in such situations. We consider that it should remain an exceptional circumstance, but we want to save any potential burden and cost to the NHS and make it easier both for the professionals and the patients involved. Therefore, we consider it appropriate for applications under Clause 7(1) and the corresponding provision on DNA analysis in Schedule 5 to be made to the HTA rather than the High Court. So I hope that the amendments anticipate and meet the intention of opposition Amendments Nos. 15,17, 20 and 23, albeit using slightly different language.

Amendment No. 31 would add to the general responsibilities of the HTA a duty to advise on Section 7 powers. I can tell the noble Lord that that is already in place under Clause 15(b). So we have taken care of that point.

Noble Lords may note that these amendments will not extend to Scotland as the HTA will have no role there. It will therefore continue to be the Court of Session which makes the relevant orders in relation to DNA analysis in Scotland.

Taken together, this group of amendments means that we have come a considerable way to meet the concerns expressed in Committee. I very much hope that noble Lords feel that too. The government amendments provide a pragmatic solution to a situation which, while not common, could potentially damage the interests of certain patients who should be protected. We have provided for two sets of circumstances where it may not be possible to obtain consent, but I must restate that we cannot countenance overriding a clear refusal of consent. I hope that noble Lords will understand and sympathise with the progress that we have made and the direction in which we have travelled. I beg to move.

Earl Howe

My Lords, I begin by welcoming all the government amendments and thanking the Minister for having responded so constructively to a range of concerns raised in Grand Committee by several noble Lords.

The first concern related to the question of whether the High Court or the Human Tissue Authority is the more appropriate point of reference to decide whether tissue from living donors can be used to obtain vital medical information where the donor cannot be traced. Having initially been of the view that the provisions in the Bill were right and that it should be the High Court, I have now changed my mind, having listened to extensive representation on the subject and I am glad that the Government have been similarly persuaded.

The second concern related to the situation in which a donor is contacted to give his consent for his tissue or DNA analysis to be used but declines to make a decision one way or the other or simply ignores any attempt to contact him about it. I am delighted that the Government are now willing to make provision for that kind of situation; it is important.

5.30 p.m.

The issue that the Government have not addressed in their amendments—and on which, despite what the Minister said, I hope to persuade her once more—is the person who maliciously, perversely or spitefully refuses to allow a DNA analysis from his tissue to be used to benefit another person, even when that person may be seriously ill or at risk. I argued in Grand Committee that, while in normal circumstances, we all accept that a person's decision in relation to his own tissue should be respected, and "No" should mean "No", there were some very exceptional cases in which a court might decide that neither human rights nor the public interest would be best served by clinging unremittingly to the principle of donor consent.

The Minister should note that I am still talking about the court rather than any other body. I fully acknowledge that in this amendment we are dealing with a clear exception to the principle of patient autonomy, on which we are all agreed, and it is appropriate that only a court should be able to hear the relevant arguments. That is my central issue of concern. The Bill is built around the cardinal rule that patient consent and refusal to consent should trump every other consideration. By refusing to budge from that rule, the Government are denying anyone what they would in normal circumstances take for granted: the right to argue their own case in front of a judge in a court of law. I question seriously whether as parliamentarians we should be depriving our fellow citizens of the right to use the courts in that way, especially when the matter concerned is one of life and death. It is those life-and-death situations which my amendment tries to address.

As I said, these situations may turn out to be rare. But we can imagine, let us suppose, a young woman many of whose relatives have suffered from a variety of different cancers, including colorectal, endometrial and gastric cancer. There is a suggestion that the family has a familial cancer pre-disposing syndrome and that the young woman may have inherited it. The only way of finding out is to test an unaffected family member after identifying the gene mutation in a person known to be affected. Let us imagine that the one relative who is still alive and who has previously contracted cancer refuses to give a DNA sample for testing and refuses to allow a sample of tumour tissue to be tested. The young woman is therefore left high and dry. She does not know whether she should undergo the recommended regime of screening. Some screening tests are themselves risky. The refusal of the woman's relative to give consent may be perverse and unreasonable but as the Bill stands there is nothing that she can do. She is denied even the opportunity of presenting her case to a judge.

One can think of numerous other examples. Duchene muscular dystrophy is a serious inherited disease which usually results in death in early adulthood. A woman planning to have a family may wish to know whether she is a carrier of the condition when another member of her family already has it. Let us suppose that this other person refuses to allow his DNA to be tested. Again, the Bill presents that woman with no option or opportunity to argue her case. It seems that here we are dealing, as so often, with a balance of rights and responsibilities.

I must ask the Minister whether she believes that by blocking all avenues such as those I have imagined, no matter what the circumstances, we are acting in accordance with the best principles of human rights and common humanity. One does not have to be a critic of the Bill—I certainly am not—to believe that we are not doing so. I hope, therefore, that even at this late stage, the Minister might be persuaded to take this matter away and think about it again.

Baroness Finlay of Llandaff

My Lords, I wish to add to the words of the noble Earl, Lord Howe, who has so clearly explained why we need to allow the High Court sometimes to be the final arbiter. The government amendments are tremendously welcome, but there are families who have not spoken to each other for many years. Often in such families it is not a question of refusing consent having had the information to refuse; what often happens is that one side of the family flatly refuses to have anything to do with the other, so they will not even listen to the arguments. The problem is that an independent healthcare representative may visit the relative and ask to talk to them about their refusal, at which point the door will be slammed in their face or a load of expletives will be hurled at them. What can they do? Nothing, except go away. If they put anything in writing, it is simply torn up without being read.

I know that that would not apply to anyone in your Lordships' House, where we all try to talk to our families, even when we disagree with them. But there are families out there who for decades have said, "I have always said that I will never speak to so and so. I never will, and that is that". It does not seem right that somebody, through pure obstinacy and some longstanding vendetta, often over something so trivial that you would not believe it except that it is true, can effectively jeopardise or deny the life of another person. At that point the state must intervene to ensure that the right to life of each of its citizens is potentially upheld and protected. It is through a hearing in the High Court that that could happen. That is why this final provision for the "once in a few years" scenario is so important.

Lord Walton of Detchant

My Lords, I welcome the very helpful government amendment. But, equally, I must express my concern, as have the noble Earl, Lord Howe, and my noble friend Lady Finlay, over the Government's decision not to consider further Amendment No. 75. I stand by the principle of patient autonomy; I favour the principle of informed consent. But there are circumstances, with which we have become very familiar through press reports, when the High Court has overridden the wishes of an individual. I can think of a series of different circumstances—where, for instance, women have been forced to have a Caesarean section, and similar examples—which have hit the press over many years. No one is suggesting that any provision such as that enshrined in Amendment No. 75 should be anything other than a very rare exception.

Let me give another example from my own personal experience. There is a progressively fatal disease called Huntington's chorea which is dominantly inherited. That means that half of an affected individual's offspring of either sex are likely to be affected by the disease. But the problem with Huntington's disease is that the symptoms and signs do not usually appear until the mid-40s or even later, by which time, for example, a woman would have passed through her major reproductive period. In some such families I became familiar with what one might almost call a conspiracy or culture of silence, where the family was simply not prepared to talk about it. If a woman whose father died of Huntington's chorea and is still below the age of onset has a daughter who wishes to know whether she is carrying the gene, it would be very helpful to have tests carried out on her mother in order to determine whether she is a carrier who is likely to pass it on to her son.

There are many other examples. I have been approached by the Genetic Interest Group, a national alliance representing individuals and families affected by genetic disorders. It has more than 130 groups in membership and a smaller number of individual members. It is deeply concerned about this clause and would like to see, as I would, that in exceptional circumstances the High Court might be willing to listen to all the arguments and to override the refusal of consent to DNA analysis given by an individual who is at risk from a genetic disorder and whose relatives may also be at risk.

Lord Turnberg

My Lords, I too am delighted with the government amendments, and I welcome them. However, although I may be accused of looking a gift horse in the mouth, I must say that I support the noble Earl's amendment, largely because it asks simply that an individual in the situation that we heard described can have access to the High Court. We are not asking for anyone to override a person's will, but access to the High Court is not something that we should deny such people.

Baroness Neuberger

My Lords, I too am grateful to the Government and am delighted at the amendments that have been tabled. However, I too support the noble Earl, Lord Howe, on Amendment No. 75.

I shall not go through all the arguments; they have already been well rehearsed around the House. However, with reference to the right reverend Prelates present, I shall draw on some of my pastoral experience as a rabbi. Sometimes, families fall out—one can only describe it as "big time"—often over issues such as money. In such a situation, an estranged member of the family may refuse—partly because they hope that their much-loathed cousin will shortly depart this earth—even though it would be possible to help by, at least, allowing some form of testing to take place. We ought to allow some reference to the High Court.

This is the proper use of the High Court. We are not saying that the High Court must agree, but there should be reference to it in such circumstances. More times than I care to remember, I have experienced circumstances in which families have fallen out and have behaved irresponsibly and horribly. That is why I support the amendment.

Baroness Hayman

My Lords, like others, I welcome the significant shift in the Government's position. Reference to the Human Tissue Authority, rather than to the High Court, will, in the majority of such difficult cases, be a more appropriate way of dealing with the matter. The extension of the circumstances in which that can be done is to be welcomed and shows a real response to the concerns voiced in Committee.

The case that the noble Earl made is persuasive, however. The ability to have access to the High Court for decisions in hugely difficult areas is justified because we are not talking about the principle of consent by the patient overriding on every occasion the interests of the researcher, which is—perhaps I am putting it crudely—the underlying current of the Bill. We are talking about a situation in which the interests of two separate patients or potential patients may conflict.

It would not be a good way forward for there not to be access to some form of conflict resolution in those circumstances because the Bill is absolutist. They would be rare cases, but we see such rare cases before the courts at the moment, involving parents and children and the interests of different patients. The interests involved in court-ordered Caesareans are hugely difficult to determine, but they involve a real clash between the interests of two individuals. As parliamentarians, we cannot lay down in legislation in whose interests such conflicts should be resolved, but it is our responsibility to lay down a process by which they may be resolved.

The Lord Bishop of Peterborough

My Lords, I support many of the comments that have been made. For pastoral and theological reasons, I support the amendment.

Certainly, you may not own my body, but neither totally do I. As John Donne memorably said, none of us is an island; we all belong to each other. There must, therefore, be a mechanism by which issues of the common good can, in very specific circumstances, override informed consent, which is what we all agree with. I hope that the Government will think again about the amendment.

Baroness Andrews

My Lords, the noble Earl has been extremely persuasive. I shall reflect on what he and other noble Lords said. I can give no assurances or commitments because some major issues are involved, not least the fact that the amendment would breach the principle of the Bill. We want to think hard about that.

I understand that in such situations other ways of obtaining the necessary information are sometimes available and that the proposed route is not always the only one. We will want to consider that, as the matters involved are not always matters of life and death. However, we will take the discussion further at a later stage and consider some of the implications on both sides of the argument.

On Question, amendment agreed to.

5.45 p.m.

The Deputy Speaker (Lord Lyell)

My Lords, as Amendment No. 14 has been agreed to, I shall not call Amendment No. 15.

[Amendment No. 15 not moved.]

Baroness Andrews moved Amendment No. 16:

Page 7, line 29, leave out "order" and insert "direct"

On Question, amendment agreed to.

The Deputy Speaker

My Lords, Amendment No. 16 precludes Amendment No. 17.

[Amendment No. 17 not moved.]

Baroness Andrews moved Amendment No. 18:

Page 7, line 30, at end insert—

"(1A) If the Authority is satisfied—

1. (a) that relevant material has come from the body of a living person,
2. (b) that it is desirable in the interests of another person (including a future person) that the material be used for the purpose of obtaining scientific or medical information about the person from whose body the material has come ("the donor"),
3. (c) that reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose,
4. (d) that there is no reason to believe—
1. (i) that the donor has died,
2. (ii) that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or
3. (iii) that the donor lacks capacity to consent to the use of the material for that purpose, and
5. (e) that the donor has been given notice of the application for the exercise of the power conferred by this subsection,

it may direct that subsection (2) apply to the material for the benefit of the other person."

On Question, amendment agreed to.

Baroness Andrews moved Amendment No. 19:

Page 7, line 31, leave out "an order" and insert "a direction"

On Question, amendment agreed to.

The Deputy Speaker

My Lords, Amendment No. 19 precludes Amendment No. 20.

[Amendment No. 20 not moved.]

Baroness Andrews moved Amendments Nos. 21 and 22:

Page 7, line 31, after "(1)" insert "or (1A)"

Page 7, line 34, leave out "order is made" and insert "direction is given"

On Question, amendments agreed to.

[Amendment No. 23 not moved.]

Earl Howe moved Amendment No. 24:

Page 7, line 35, leave out "High Court" and insert "Human Tissue Authority"

The noble Earl said: In moving Amendment No. 24, I shall speak also to the other amendments grouped with it.

I have already warmly welcomed the changes made to subsection (1) and the fact that the Government have reconsidered the question of whether the HTA, rather than the High Court, should be the point of referral in cases in which there is a need to use tissue from living donors for the benefit of another person but the donor cannot be traced. With these amendments, we seek to persuade the Government that they should take the process one stage further to what I believe is a logical conclusion.

If I were to sum up what the Bill says about research on tissue, it would be, "Obtain consent. If you can't obtain consent and the tissue is from a living person, anonymise. If you can't do either of those things, go to the High Court under the provisions of Clause 7(3)". That is a simplified analysis but, I hope, a correct one. The issue in contention is whether, instead of the High Court, the Human Tissue Authority would act as an equally appropriate and capable gatekeeper on research proposals if consent is impossible or, for one reason or another, it is not feasible to anonymise.

I urge the Minister to think again about that. A few minutes ago, I said that since Grand Committee I had changed my mind on the matter of whether it should be the High Court or the Human Tissue Authority. The Minister, who has also changed her mind, gave very convincing reasons why. I have done so for a number of reasons, one being that I have been convinced that the need to use this mechanism will not be rare. If we look at the experience of the Patient Information Advisory Group, in a typical 12-month period—June 2002–03—applications for research where consent could not be obtained or conducted anonymously numbered some 58.

We can imagine several—I suggest quite probable—scenarios. The first is where consent has been obtained from a patient, but it is unclear whether the consent is sufficiently broad to cover the research in question. Another scenario might be where it is unclear whether consent has been obtained, say, because of a failure in record keeping. We can imagine a situation where a patient has died of a rare condition without either giving or withholding consent and has no friends or relatives who might consent on his or her behalf; or, let us suppose, a patient with a rare condition cannot be traced but the inclusion of his or her tissue in a research project is of importance to the development of treatments for that condition and it is impossible to anonymise the tissue because the patient is known to all of the researchers working in the particular field. It might happen that a piece of research is well under way and is being done on anonymised samples. During the course of the research, say, the principal investigator discovers that he recognises some of the tissue samples as belonging to former patients of his. It is impossible to locate those individuals in order to obtain consent, but the research cannot continue without further authority. There may well be justification for allowing the research to continue if the risks to the individual are judged by a suitable third party to be minimal and that confidentiality is assured and the benefits of completing the research are potentially very high.

Against that background, I question whether the High Court is the most appropriate mechanism to deal with those types of application. The burden of going to the High Court seems excessive and unsuitable for that type of application and likely to deter researchers from undertaking research. Even if the applicant does not need to go to a court, he or she will no doubt need legal representation to make an application and, almost certainly, the support of expert evidence—all of which researchers in the academic and public sector are ill-placed to afford. The High Court mechanism will also, by its nature, have a considerable deterrent effect.

I do not believe that the Government have produced a good argument to show why those matters are necessarily best decided by judges rather than by a body of individuals with relevant experience and expertise working alongside lay members. Indeed, one has to ask what the Human Tissue Authority is for if it is not to adjudicate this type of case.

I took note of what the noble Baroness said about the previous group of amendments where she rightly pointed out that it might be overly burdensome to insist that the High Court should be the arbiter in those cases. I agree with that.

So, for all those reasons, I hope that the noble Baroness will reconsider the provisions in Clause 7(3). I am aware that they are the provisions that are of most concern to the research and scientific community in the context of this clause, although I am sure that they will be very grateful for the changes that we have made to the earlier part. I beg to move.

Lord Jenkin of Roding

My Lords, I support my noble friend. This subsection would give the Government power to make regulations either for the High Court or for the Human Tissue Authority—we would prefer the HTA. My point on that is that this is not the final word. When the Government draft their regulations and consult on them, there will be another opportunity, if necessary, to circumscribe the circumstances in which the Human Tissue Authority can give the necessary consent.

As my noble friend has said, if one is setting up a body such as the Human Tissue Authority, it would be desirable that any of these what one might call relatively normal circumstances—they may be infrequent but they are not wholly exceptional—be considered by the authority rather than putting everyone to the expense and trouble of taking a case to the High Court.

Baroness Neuberger

My Lords, the noble Earl, Lord Howe, and the noble Lord, Lord Jenkin, have made a very good and persuasive case. In support of this amendment, it is worth saying that it would be proper here for the Human Tissue Authority to make those decisions, precisely as it was when we were discussing Amendment No. 75. It was the proper use of the High Court when we were talking about a case where we were going against the principle. Here, it seems that the Human Tissue Authority ought to be allowed to be the body that makes those decisions. I support the amendment.

Baroness Finlay of Llandaff

My Lords, one very small point in favour of having the Human Tissue Authority is that the stages before a decision is made when there is potentially a dialogue that may go on between those who want to conduct a study and the authority may be extremely informative in ensuring that the research community really understand how the Bill is to be implemented. The guidance will also be able to evolve with time as different research techniques and scenarios arise.

I am not saying in any way that the authority would water down the Bill. I think quite the converse: it may be very rigorous. But by having a dialogue with the research community, there will be a much better uniformity of standard and better understanding than trying to have local reinterpretation of a one-off High Court judgment by other researchers who are not quite sure what to do. The advantage of the authority, I hope, is that it will be approachable and able to discuss and provide guidance at a stage that perhaps would remove the need for some formal decision to then be taken.

Baroness Andrews

My Lords, we considered similar amendments in Grand Committee. They were not identical, but they also attempted to change the provision in Clause 7(3) and the recourse that it provides through regulations for the High Court to make an order in exceptional circumstances. I am glad that the earlier suggestion for an advisory committee has been replaced by the proposal that the HTA should determine such questions. I am afraid however that our arguments and our response are the same.

Of necessity, I have to repeat some of the arguments previously made in order to answer some of the points raised by noble Lords. I reiterate that the decision to introduce this power in Clause 7(3) in this way in another place was a specific and very sympathetic response to the powerful case that had been made by the research bodies, which were lobbying for this type of exceptional power to be used very much as a last resort in cases that would be extremely rare.

I have to take issue with the noble Lord, Lord Jenkin. There would be nothing relatively normal about the circumstances that would be referred. Indeed, the cases that we can anticipate are so exceptional that we are unable to define them or even speculate about them, which is why the circumstances in which the power is to be available are to be set out in affirmation regulations. As the noble Lord rightly says, there will be an opportunity for Parliament to debate those.

The order-making power concerns the possible need to conduct research where, for example, a person or many persons die of a new and deadly disease—for example, similar to Ebola. Research may be needed for the public interest, but no person is available to consent to the use of tissue from the deceased.

The amendment provides a regulation-making power so that the Secretary of State may provide for a court order to deal with such cases. To reiterate, it is not set out in the Bill because the cases are, by definition, potentially unknowable, and to give Parliament the opportunity to debate the order before it is made. However, I do not believe that this would have a deterrent effect on research. The fact is that situations of this kind will be so exceptional that research would be of the utmost necessity.

By the same token, I would suggest to the noble Baroness that there would have to be full dialogue with the research community before this would happen because it would be of such importance. That is where the analogy made by the noble Earl with the PIAG and the use of data seems to fall down because data protection concerns the use of existing information, but the use of tissue concerns the effort to derive new information. I suggest, therefore, that different criteria would apply.

I should also say that we do not see such orders as being available to provide a fallback position in cases where it is difficult to secure consent; far from it. Rather, they will deal with the exceptional cases I have just mentioned. They are not simply an alternative route to securing unconsented material for research.

6 p.m.

Given the support of the professional community and the truly exceptional nature of the situation I have outlined, the effect of the amendments would be to dilute the significance of both the situation and the decision. It would allow the Human Tissue Authority, rather than the High Court, to determine that the tissue could be used in research. However, it is one of the fundamental tenets of the Bill that consent is needed for the use of tissue in research. The removal, retention and use of tissue from the deceased is a matter of the greatest sensitivity so that any departure from the principle of consent must be subject to the closest scrutiny.

We have provided for parliamentary scrutiny before regulations are made, but we believe that High Court scrutiny is needed before any order is made. This is a unique provision covering the only situation in the Bill where there is the potential to take or use tissue from a deceased person without any consent. Only the most extraordinary cases would be considered under this provision, and that is why we believe that they would warrant the examination of the High Court.

As we have said before, High Court procedures need not be time-consuming or onerous. We have provided in the important government amendments just agreed that the HTA is the appropriate body to determine questions about the use of tissue from a living person for the benefit of a missing relative or non-responder, but there are clear and important differences between that and what is being considered in this clause.

To sum up, first, researchers have confirmed in full discussions held with them before we brought this forward, that this is likely to arise only in truly exceptional circumstances. Secondly, it is exceptional because of the unique public importance which may not necessarily benefit an individual patient, but would be of public interest. Thirdly, it uniquely involves the removal and research of tissue from the deceased, and there is no more sensitive issue than this. Noble Lords know full well why we want to guard against opening any gateway that might risk the problems of organ and tissue retention and the scandals of the past.

On those grounds, we remain convinced of the virtue of the scrutiny of the High Court and I hope that noble Lords will be able to agree with me.

Baroness Hayman

My Lords, before my noble friend sits down, I have listened carefully to her words and I have great sympathy with some of what she has said. However, what is of slight concern in the argument is that we need to have regulations, and Parliament will be able to debate those regulations because we cannot yet foresee the exact circumstances in which it might be necessary to secure consent in this way. If we leave the Bill as it is, only the High Court could make the order.

I understand from my noble friend's argument that it may be wrong to pursue the amendment before us to transfer all that responsibility to the Human Tissue Authority, but I am not yet convinced whether, as this develops, we might not feel in the future that some cases would be appropriate for the High Court and some for the Human Tissue Authority—as we did on an earlier amendment. However, as I read it, it would not be possible except by primary legislation for Parliament to change its mind about the relevant authority.

Even worse than a manuscript amendment is the suggestion that a further amendment be considered at a later stage. However, making provision to enable either the Human Tissue Authority or the High Court to participate might provide a little more flexibility in future parliamentary consideration of regulations.

Baroness Andrews

My Lords, matters do evolve, as do government responses. However, given where we are, I have to stick to what we believe is the appropriate route for the way forward in the foreseeable future.

Earl Howe

My Lords, I cannot disguise that that was a very disappointing reply from the Minister. I had not expected the Government to feel compelled to dig their heels in to quite this extent.

The concern I raised and which I am reflecting from the community outside is that the number of applications of the kind we have been discussing will be neither exceptional nor rare. The community believes that many dozens of such cases will arise every year. That is the point. Moreover, I do not agree with the noble Baroness that the experience of the PIAG is irrelevant in this context. I believe it to be directly relevant to the kinds of situations that I have posited. I took time to enumerate quite a number of possible scenarios, but perhaps the one which may arise most often is where the patient has died and it is simply impossible to obtain consent.

I do not believe that we need feel that in approving an amendment of this kind we are diluting the significance of the decision that is to be taken, nor need we worry that it would lessen the scrutiny given to such decisions, if it were the Human Tissue Authority undertaking that scrutiny.

However, I am particularly grateful to the noble Baroness, Lady Hayman, for her late intervention. She may have opened the way for further discussion between now and Third Reading, and I am sure that I am not the only one with various ideas in mind as to how this circle might possibly be squared. I do not propose to test the opinion of the House on this occasion because it is something we need to talk about further. I therefore beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 25 not moved.]

Clause 8 [Restriction of activities in relation to donated material]:

[Amendments Nos. 26 and 27 not moved.]

The Deputy Speaker

My Lords, before I call Amendment No. 28, I should advise noble Lords that it relates to the provisions in Clause 11 rather than Clause 10, as printed on the Marshalled List.

Clause 11 [Coroners]:

Baroness Finlay of Llandaff moved Amendment No. 28:

Page 10, line 9, after "for" insert "current or future"

The noble Baroness said: My Lords, my noble friend Lord Walton spoke most eloquently on this issue in Committee on my behalf, and I am most grateful to him. Having read carefully those proceedings in Hansard, I have returned to the issue because it is one of fundamental human rights.

In Committee it was made clear that the Coroners' Rules are being rewritten and should clarify the extent of the authority of the coroner. However, we do not have those rules before us, and when they are introduced, the statutory instrument will not be amendable. Therefore we must ensure that the clause complies with human rights.

The Bill as written makes illegal the retention of any blocks and slides after completion of the coroner's inquest or after six months beyond the end of a sentence if a criminal conviction were brought. In discussion with the Bill team, I have been told that blocks and slides would be available to the family, who would be asked to consent to some of them being retained. The Minister stated in Committee that it was felt that almost all families would agree to this. If that is the case, why subject them to this distress, because those who refuse must de facto be the cause of suspicion, leading to reinvestigation which in turn would cause more distress?

No one would think that any specimens could or should be used for research without the family's consent, and no one would think that the family should not be entitled to know which slides and blocks were being retained. But if the obligation of the state under Article 2 of the European Convention on Human Rights is to be complied with, there must be an ability to revisit some blocks and slides as part of the clinical record.

If there has been a wrong conviction, there must be the ability to revisit. First, let us take the example of a father who works in the chemical industry and is sexually abusing his daughter. When he realises that she is about to spill the beans, in a fit of panic he poisons her. However, her death occurs when she is out clubbing with her boyfriend—a bit of a bad lad who has convictions for joy riding and possession of cannabis. He is convicted of her murder but did not supply her with any drugs that night. He will find it difficult to prove his innocence. The father, who is desperate for all evidence to be destroyed, encourages all blocks and slides to be returned to him and the girl's mother and appears grief stricken. I do not have to remind your Lordships of Soham and Huntley's public display of grief.

Secondly, and crucially, Article 2 requires that deaths in hospital can be and are properly reviewed; the process must be transparent. Under Article 2, sudden and unexpected deaths, whether medical or surgical, within the NHS place procedural obligations on the public authority to investigate adequately.

When a death occurs within 24 hours of admission or of surgery, it is reported to a coroner. Other unexpected deaths may be reported but the decision often depends very much on junior medical staff. In Middleton v West Somerset Coroner, the noble and learned Lord, Lord Bingham, described the procedural obligation to investigate, and Glass v UK has established that a hospital trust is indeed a public body. The procedural obligation outlined in Jordan v UK makes clear that it cannot be left to the initiative of the next of kin to either lodge a formal complaint or to take responsibility for the conduct of any investigative procedures. Indeed, it is financially impossible, and often crippling, for most to be able to do so. Amin v Home Secretary established the principles underpinning such an investigation.

The positive obligations that the state has to protect life under Article 2 of the Convention extends to requiring hospitals to have regulations to protect life and to investigate failures, whether systemic or due to individual negligence. Make no mistake, the fact that a post-mortem has taken place does not mean that there will be an inquest; there are wide variations in coroners' practices across the UK. The recent case of Mellar v Sheffield demonstrated that failure occurs when specimens are not taken at post-mortem and retained beyond the time the coroner is involved.

So where a death has been referred to the coroner and a post-mortem undertaken, blocks and slides must be retained so that they can be revisited. The state body, the NHS, must be held accountable. Serial systemic failures will be apparent only after a series of deaths. The families of victims must be informed of the investigation and its conduct must be transparent. But bereaved relatives cannot be shouldered with the responsibility of determining, when grieving, whether or not a future investigation will require a revisiting of blocks and slides as part of the clinical record. This is consistent with the Luce review recommendations. Now that the national confidential inquiry into perioperative deaths has been disbanded, this becomes even more pressing.

The Government's own publication, An Organisation with a Memory: Learning from Adverse Events in the NHS, explored deficits and a recent BMJ editorial argued that each surgical death should be subject to detailed forensic and statistical analysis. The state has a responsibility to its citizens. It is because of that that I have tabled the amendment. I beg to move.

6.15 p.m.

Earl Howe

My Lords, I support the case so ably made by the noble Baroness. There is a real issue here. I suspect that the Minister will tell us that this is outwith the scope of the Bill. If so, we are in a real bind. There is absolutely no way in which this House can affect the way in which the Coroners' Rules will eventually look because when they come in front of us we will not be able to amend them.

The noble Baroness has made an extremely important point. I hope that the Government will take it fully on board.

Baroness Neuberger

My Lords, I support the noble Baroness, Lady Finlay, and the noble Earl, Lord Howe, on this issue. I, too, am very worried because we have not received the Coroners' Rules and we need to look at them. I am extremely concerned that we are getting ourselves into a mess here. I support the amendment.

Baroness Andrews

My Lords, I am grateful to the noble Baroness for moving the amendment. It is reminiscent of an amendment tabled in Committee which, as I suggested then, goes to the heart of the Bill and the fundamental principles on which it is based—that is, that individuals or those who were close to a person who has died should have the right to determine the uses to which bodily material is put.

It has become evident—indeed, we are debating a Bill which reflects this—that existing practices are no longer acceptable and have lost the confidence of the public. We should keep in mind as we debate this serious subject that the centrepiece of the Bill is a requirement for consent for a range of medical and other related purposes. In relation to the deceased, consent will be required for those purposes set out in Schedule 1 to the Bill, with the exception of where the activity is required by the coroner.

Let me be quite clear, the Bill does not constrain the power exercised by coroners to retain tissue for their legitimate purposes. The Bill clearly ensures that the coroner's authority to retain human tissue for his purposes is unaffected, and this obviously includes any cases where there is the slightest suspicion of foul play. In the case, for example, of possible miscarriages of justice, we know that samples used in the course of a prosecution must be retained until after the end of any resultant prison sentence. However, material which is no longer required by the coroner will then fall within the consent provisions of the Bill, and consent will therefore be required for subsequent retention and use for scheduled purposes.

I am aware of the view—this was discussed in Committee—that forensic techniques may be developed in the future that could establish nefarious involvement in cases where this cannot currently be detected. I have previously written on this point to those Members of your Lordships' House who attended Grand Committee. The amendment suggests that even where the coroner has concluded his inquiries and is satisfied, tissue should be retained in case suspicion should arise at some time in the future. The problem is: where do we draw the line? Technically, one could argue that any case involving sudden heart failure might lend itself to this requirement.

We have to be very careful because, logically, this implies the retention of all tissue from the deceased in all cases, or in some subjectively selected subset of cases, regardless of suspicion at the time. I do not believe that that is a sensible or proportionate route to take.

The Government take the view that where the coroner and criminal justice authorities do not require retention for their respective purposes, retention of tissue for scheduled purposes cannot be justified without appropriate consent. Indeed, in other cases where no proceedings are to take place, evidence of other kinds is routinely returned to the owner by the police authorities.

The effect of the amendment would be to give the coroner precisely the kinds of powers that he does not and should not have. He may not order retention beyond what is needed to fulfil his duty to investigate the cause and circumstances of death. The Coroners' Rules will elaborate on the detail of how that will be communicated and families enabled to take charge once the coroner's work is complete.

As noble Lords may know, limited consultation is in progress until the end of the month in order to enable the rules to be prepared as quickly as possible. The consultation includes the Royal College of Pathologists and the Coroners' Society.

The noble Baroness made a broad and powerful case based on human rights, and I shall address the points that she made in relation to the European Court. The convention balances different rights. In considering the convention in the context of retention of material from the deceased, it is important to bear in mind Article 8, dealing with the rights of surviving families and loved ones. A provision that allows wholesale retention of material without families' consent in all cases, or cases when there is some unproven suspicion about the death, might risk infringing those rights.

On the other hand, I am not in a position to reply in detail to the case that the noble Baroness raised about Article 2. I should be happy to consider her particular concerns about Article 2 inquiries and write to her with more detailed views. I hope that on that basis, in order to take the argument further, she will allow us to do that.

Lord Walton of Detchant

My Lords, surely the amendment does nothing other than to support the existing authority and rules of the coroner and takes account of what changes may occur when the coroner's rules are amended. I did not think that it carried the implications that the Minister suggests it may.

Baroness Andrews

My Lords, the noble Lord is right. Indeed, the case I have made is that the coroner can do only what he has to do for the purpose of his function. The argument raised by the noble Baroness is that, essentially, we should consider whether in the context of the Bill we should give the coroner additional powers, in the sort of circumstances that she raises. We shall certainly continue the debate in the context of the coroners' rules. I am addressing in particular the European point in relation to the argument that the noble Baroness made on Article 2.

Baroness O'Neill of Bengarve

My Lords, I believe that one cannot really appeal here to the basic principle of consent, which we all agree is fundamental to the Bill. We all also agree that that principle is, and must be, limited by, in this case, public purposes—and hence, the powers of the coroner. This is an argument about the exact boundary to be drawn to those powers. Therefore, one cannot argue directly from consent to a particular solution. It is important to remember that tissues taken from all of us when we are alive are retained post mortem, and that is taken to be entirely acceptable. I am not certain why we should expect the coroner to be able to determine a limit to the retention confined to the process of his investigation, particularly when there may be very difficult questions to be answered about the circumstances of a death.

Baroness Andrews

My Lords, we are indeed talking about the boundaries of the coroner's power to retain, in this instance, blocks and slides. Our argument is that he has the power to do that in all appropriate circumstances. The case made by the noble Baroness, Lady Finlay, is that there will be instances, such as a case of sudden heart failure, that might put people within the category in which blocks and slides must be retained. That drives a bit of a coach and horses through the notion of the family's right to decide what to do with the body.

Having made the offer, as I did, to the noble Baroness, Lady Finlay, we do believe that the amendment cuts across important aspects of the Bill—namely, the consent of the family. We are sensitive to the situation that we are trying to address in the Bill as a whole. Therefore, I am reluctant to do anything that might compromise the consent principle in this context.

Baroness Finlay of Llandaff

My Lords, I am grateful to the Minister for her reply and for having listened to the point that I made about Article 2. I should point out that sometimes the coroner does not even have a hearing. After a death is reported, a post mortem may be held and the case may be opened and closed without a hearing or inquest.

The criticism made specifically in relation to a cardiac death was that no specimens were taken from the coronary arteries. If they had been taken, the lack of care—when there was 95 per cent stenosis—would have been evident. It was much more difficult to prove inadequacies in care later on. The issue does not involve wholesale collections of specimens, as referred to in Article 8. The issue is one of some blocks and slides and specimens often no bigger than a fingernail clipping, which can be held in an archive so that they can be revisited later.

It is important that we recognise that the state has a responsibility to its citizens. When people in the care of the NHS die unexpectedly, there must be an ability to revisit blocks and slides as part of an investigation into systemic failures. When in custody, there must be an ability to prove wrongful conviction. The state must be able to revisit the complete record, including blocks and slides, if wrongful acquittal or failure to investigate is suspected. That is different from returning pieces of clothing, spectacles or other pieces accumulated by the police as evidence in a police investigation. We are talking about major failures here.

I can understand that the Government will wish to appease those who were wronged in Alder Hey and Bristol, but in this Bill they will leave future victims unprotected. This is a fundamental human rights issue: if the Bill passes as drafted, we will be allowing a breach of Article 2.

I was going to test the opinion of the House tonight, but in the light of the Minister's final comments I shall go away and have further discussions. However, I want to register now that I intend to return to the matter. If we do not ensure that we are compliant with human rights legislation, future generations will more than curse us for the inability to prove that they have been wrongfully handled by criminal justice or the healthcare system to which they entrusted their lives. With that caveat, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Schedule 2 [The Human Tissue Authority]:

Lord Jenkin of Roding moved Amendment No. 29:

Page 40, line 11, after "times" insert "that the membership represents public and private research, clinical and professional expertise and"

The noble Lord said: My Lords, the amendment stands in my name and in that of my noble friend Lord Howe. In Grand Committee we addressed the composition of the Human Tissue Authority. At that stage I was in favour of there being a majority of the appropriate professional people and a minority of the lay membership. Our amendments reflected that. I was entirely in support of there being a substantial lay membership but, at that stage, I believed that it should be in a minority. However, having heard the argument at that stage, particularly the arguments made by the noble Lord, Lord Walton of Detchant, and the Minister, I accept that the Minister's proposal is that there should be about half and half professional and lay members. From that point of view, I have abandoned part of the original proposal.

Since we debated the matter, however, I have seen a copy of the advertisement that has been published by the NHS Appointments Commission for the chair and up to 14 members of the Human Tissue Authority. I would not dream of reading the whole thing, as most of it is irrelevant to my argument. However, the paragraph relating to members states: The membership of the HTA will bring their personal credibility and experience to benefit the work of the Authority. The members will be drawn from both professional and lay backgrounds; the successful candidates will be able to demonstrate knowledge and experience from one or more of the following areas". After that, there are two columns, the first of which is headed "Lay members" and includes such subjects as "Ethics", "Legal", "Family representation". "Patient representation", "Media", "Finance" and so on. I have not read them all out.

6.30 p.m.

The second column comprising professional members constitutes a somewhat surprising list. It reads: Pathologist, Coroner, Anatomist, Surgeon, Researcher, Pharmacologist". I consider that a pretty rum list. It requires giving a very wide meaning to the word "researcher". I find it strange that it includes, for instance, a surgeon and a pathologist but it does not include someone who is a physician or any other specialties in the health service.

Therefore, the amendment is intended to reflect my wish that there should be a representation on the Human Tissue Authority of the professions as fairly widely drawn. I suspect that unless you give a very wide meaning to "researcher", this list is not as widely drawn as I would want it to be. In particular there is absolutely nothing to indicate that it should cover both the public and the private sectors.

On a day when the newspapers are carrying reports of the welcome growth of research by private sector companies it is noteworthy that by far the largest element in that is by the pharmaceutical industry in this country. I would regard it as strange indeed if the HTA were not to include someone from the private sector pharmaceutical industry. Pharmacologists are included in the list, but that is a very specific profession. I should have thought it ought to be made perfectly clear that both the public and private sectors are covered.

I have one other point only that I think is worth making. In justifying his "half and half" argument the Minister said: It is worth saying to noble Lords that when we turn later to the boards of the inspectorates…they will see that there is no requirement for lay people to comprise a half or the majority. So it is left very much to the process in paragraph 1(2) of Schedule 4 to have a majority of people with a professionally relevant interest in this particular area".—[Official Report, 16/9/04; col. GC 495.] However, the inspectorates will shortly be removed from the Bill under the amendments proposed by the Government. It is therefore even more important that the authority itself should comprise a broad membership of the professional category of people as well as the half who will be lay people. I hope that the Minister can give us a very strong reassurance that that is, indeed, the Government's intention. I beg to move.

Lord Walton of Detchant

My Lords, I have not seen the advertisement to which the noble Lord, Lord Jenkin, referred, but I agree with him that the list of professional individuals seems somewhat curious and rather selective. However, in Grand Committee I pointed out that following the reorganisation of many of the regulatory authorities in the healthcare field, these now have in general approximately half lay and half professional members. I believe that what the noble Lord said supports that view. I agree entirely with his opinion that the kind of specification set out in this amendment would ensure that there was a proper representation of the professional interest alongside the lay members of the authority. I therefore support the amendment.

Lord Warner

My Lords, I shall not be drawn on the subject of the subsequent amendment on the inspectorates which we shall discuss other than gently to remind the noble Lord that he and the Front Bench of the Conservative Party supported the removal of the inspectorates in Grand Committee. However, we shall come to that in a moment.

We have given assurances, and I am happy to repeat them, that members of the authority will be chosen from those with relevant professional experience of the activities that lie within the remit of, and are to be regulated by, the Human Tissue Authority. It is difficult to specify on the face of the Bill particular areas that should be covered as we would inevitably seem to favour those above others. The amendment refers to research and clinical and professional expertise, but what about patient and family representation as part of the lay group of members? We certainly would expect to see those elements as well as, for example, ethical and legal expertise, tissue banking, archaeology, anatomy and coroners.

I can not only assure noble Lords that the authority will contain members with relevant professional experience of regulated activities—which is the term used in the Bill—but I can also demonstrate that this is already in hand. The noble Lord tried to use the advertisement against us. However, the department has set up a working group to assist in drawing together the relevant information and guidance that will inform the codes of practice to be published by the Human Tissue Authority. This group already includes members from research backgrounds, including the private sector, together with clinical and professional groups as well as others. But more specifically, advertisements for the chair and members of the authority were published last week, as the noble Lord said. I note that he has read them. These called for applications from lay and professional people with many areas of expertise including, as the noble Lord said, ethics, law, family and patient interests, finance, pathology, anatomy, research and pharmacology. There are also others such as archaeology, media, coroner and surgeon, but it is important to note that this is not an exhaustive or exclusive list. Applicants may come from many varied areas and sometimes individuals from less obvious areas of interest may have much to contribute. Therefore, while we wish to secure input from the areas set out in this amendment, it is itself somewhat restrictive. We have made clear our determination to have people from a wide range of backgrounds and expertise on the authority.

I still do not consider that such a limited set of areas as the amendment proposes should be specified on the face of the Bill. Members of all medical colleges and the private sector pharmaceutical industry have been alerted to the advertisements for membership of the Human Tissue Authority and we expect applications from a wide range of professions. I hope that that reassures the noble Lord and that he feels able to withdraw his amendment.

Lord Jenkin of Roding

My Lords, before the noble Lord sits down, I listened with care to what he said, but does he consider that the wording of the advertisement might with advantage be amended to make it clear that the list is not exclusive? It could refer to, knowledge and experience of one or more of the following areas but there may be others". The list appears rather exclusive.

Lord Warner

My Lords, I believe that it is meant to be an illustrative list but I shall take that point away, investigate the matter and write to the noble Lord.

Lord Jenkin of Roding

My Lords, with that assurance I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Lord Warner moved Amendment No. 30:

Page 43, line 33, at end insert—

"The Authority may delegate any of its functions (to such extent as it may determine)—

1. (a) to any member of the Authority,
2. (b) to any member of the staff of the Authority, or
3. (c) to a committee consisting of persons each of whom is—
1. (i) a member of the Authority, or
2. (ii) a member of the staff of the Authority."

The noble Lord said: My Lords, the structure of the Human Tissue Authority was drawn up so as to allow expertise in the different areas which fall within its remit to be brought in to inform the two inspectorates in their different tasks. One inspectorate was to inspect and license anatomy and pathology activities, and the other was to inspect and license activities related to tissues and organs for human transplantation.

That structure was devised for good reasons before the Government instituted their review of health arm's length bodies. As a result of that review I announced in July that the Human Tissue Authority would merge its activities with those of the Human Fertilisation and Embryology Authority when the current review of the Human Fertilisation and Embryology Act 1990 is complete. The merger is likely to be in a few years, however.

At that time, both the HTA and the HFEA will be subsumed into a new organisation called the Regulatory Authority for Fertility and Tissue. Noble Lords may recall that the noble Lord, Lord Clement-Jones, with support from those on the Conservative Benches, proposed amendments in Grand Committee that would have reduced the number of inspectorates in the structure of the Human Tissue Authority from two to one. We have reconsidered the position since then, and have concluded that it would be helpful to the Human Tissue Authority to have maximum flexibility as it organises its activities alongside those of the HFEA and prepares for eventual merger.

I want to put on record that I am grateful to the noble Lord for provoking us a little on the issue. He has gone out in a blaze of glory in the area. We therefore propose this large group of amendments, which removes the inspectorate of anatomy and pathology and the inspectorate of organ and tissue for human use from the structure of the Human Tissue Authority altogether. The amendments also allow the HTA to delegate its inspection and licensing functions to any of its members and staff, or to a committee composed of members and staff.

The authority will still be able to call on the advice of experts in the various areas that it regulates, but it will be able to operate in as streamlined a way as possible. It will remain possible for the HTA to hear appeals against decisions taken by those to whom it delegates certain functions, such as committees formed to deal with licensing decisions. I beg to move.

Lord Roper

My Lords, in the absence of my noble friend Lord Clement-Jones—he is on his way to China at the moment and much regrets that he cannot be with us for this stage of the Bill, but will certainly be back for Third Reading—I place on record our gratitude to the Government for having listened to the important debate in Grand Committee and tabled this group of amendments.

Earl Howe

My Lords, I echo those sentiments fully from these Benches.

Lord Jenkin of Roding

My Lords, I want to make a brief point. In Grand Committee, I questioned the wisdom of the proposed merger of two very different regulators, the HTA and the HFEA. As I pointed out then, they have two widely differing functions, and I was not at all sure that it made sense for the two bodies to be merged into RAFT. I was struck by the fact that almost every other Member of the Committee present nodded in assent to what I said.

I want, first, to express the hope that the Government will have second thoughts about the proposed merger, and, secondly, to ask whether there will be any opportunity for Parliament to debate it and some of the other mergers that have been put forward in the cull of arm's-length bodies that the Minister described to us on an earlier occasion. To have such a major change in the regulatory structure with no debate in Parliament at all would be absurd. The Minister may not be able to commit himself firmly, but it would be good to know that the department recognised that there may be considerable demand for a debate on what seems to many of us to be a very rum mésalliance indeed.

Lord Warner

My Lords, that is outside the scope of the Bill. Perhaps it would help the House if I simply said that, as I thought that I had made clear, the changes will not take place until there is a review of the HFE Act. There will almost certainly be a response to the Health Committee, which has reported on the subject, and there will be an opportunity for Parliament to debate those issues. The merger itself will require primary legislation, which will give Parliament an opportunity to scrutinise the area. I hope that that helps the noble Lord.

On Question, amendment agreed to.

Clause 15 [General functions]:

[Amendment No. 31 not moved.]

6.45 p.m.

Clause 16 [Licence requirement]:

Earl Howe moved Amendment No. 32:

Page 13, line 11, at end insert— (c) "relevant material", in relation to use for the scheduled purpose of research, does not include material obtained during the conduct of clinical trials on medicinal products for human use.

The noble Earl said: My Lords, we come to an issue debated in general terms in Committee, but not by way of this amendment, which is new. Clause 16 sets out the activities relating to human tissue for which a licence will be required. It also makes provision for exceptions from the licensing requirement and, in subsection (7) specifies two particular exclusions.

My amendment is prompted by a concern about the bureaucratic burden which the clause places on researchers, and in particular on those who undertake clinical research on medical products. Clinical trials are already regulated under the clinical trials directive—implemented under Statutory Instrument No. 1031 of this year—which includes requirements for there to be informed consent and ethics committee approval in place. It also provides for inspection of documents, facilities and records, and sets out quality assurance arrangements and penalties.

Given those existing regulations, it seems difficult to justify imposing additional licensing provisions for blood and other tissue obtained during clinical research on medical products. If we look at Clause 16(7)(b), we see that there is an exclusion from the licensing provisions in respect of blood and blood products for transplantation. The reason for that is that those are covered by other regulations. Exactly the same principle should apply to blood and other tissue obtained during the conduct of clinical research on medical products.

This is an instance of unnecessary overregulation in the Bill. I hope that the Minister will agree to consider the amendment in a constructive way. I beg to move.

Baroness Neuberger

My Lords, we support the noble Earl on the amendment.

Lord Warner

My Lords, I have some sympathy with the case of the pharmaceutical industry, which in this country has a very good record regarding obtaining the proper consent to use tissue in its research. The industry has long been subject to regulation of one sort or another relating to clinical trials of medicines, and is expert at risk management. However, the activities regulated by the recent clinical trials regulations are not identical to those regulated under the Bill. The clinical trials regulations monitor the safe and proper conduct of clinical trials for medicinal products, while the Bill regulates the storage and use of tissue for scheduled purposes, among them research. That includes blood stored and used for research. As the noble Earl said, it is blood for transplantation that is excluded from the Bill on the grounds that it will be separately regulated under the blood directive.

That said, the Government certainly have no desire to burden industry with unnecessary regulation. Research itself is not licensable under the Bill, and the Secretary of State has the scope at Clause 16(3) to exclude from licensing storage for research in circumstances to be specified in regulations. The circumstances of clinical trials undertaken by pharmaceutical companies can be examined in the context of those regulations, which will be made in time to coincide with the effective date of the Bill's implementation.

As I have said before, there is no intention to license—if I can put it this way—every pot on a laboratory bench. I draw your Lordships' attention to Clause 43(2), which requires the HTA to have regard to the principles of best regulatory practice, which includes targeting regulatory activities only at cases in which action is needed. It is intended that the Human Tissue Authority will take a pragmatic approach, using a light touch where appropriate.

We have met representatives of the industry since Grand Committee, and my understanding is that they were reassured by what we said. I hope that, with the assurance that we have every intention of avoiding unnecessary bureaucracy, the noble Earl will be able to withdraw his amendment.

Earl Howe

My Lords, that was a very helpful reply. I noted that the Minister was careful not to make any specific pledges. Nevertheless, the spirit and drift of his remarks were encouraging. I hope very much that these matters will be borne in mind when the regulations come to be drawn up. I am much reassured and I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 25 [Breach of licence requirement]:

[Amendments Nos. 33 and 34 not moved.]

Clause 30 [Possession of anatomical specimens away from licensed premises]:

[Amendments Nos. 35 and 36 not moved.]

Clause 31 [Possession of former anatomical specimens away from licensed premises]:

[Amendments Nos. 37 and 38 not moved.]

Clause 32 [Prohibition of commercial dealings in human material for transplantation]:

[Amendments Nos. 39 and 40 not moved.]

Viscount Chandos moved Amendment No. 41:

Before Clause 33, insert the following new clause—

"Promotion of transplants and the giving and recording of appropriate consents

(1) The Secretary of State may make regulations for the purposes of promoting or securing—

1. (a) an increase in the number of transplants that are carried out using transplantable material removed from a human body or of such transplants of a particular description,
2. (b) an increase in the number of appropriate consents given for such transplants or for such transplants of a particular description, or
3. (c) the recording of such consents in a manner that enables it to be determined whether consent for such transplants or for such transplants of a particular description has been given by a particular person within a period which enables any transplant for which he has given consent to be carried out with a reasonable prospect of success.

(2) Regulations under this section may make such modifications of this Act or any other enactment or any provision made under any enactment as the Secretary of State thinks appropriate for the purposes of the regulations.

(3) In this section "transplantable material" has the same meaning as in section 33."

The noble Viscount said: My Lords, I should like to speak to Amendment No. 41, standing in the name of my noble friend Lord Hughes of Woodside. With the permission of the House, I shall also speak to Amendment No. 42.

The amendments relate specifically to organ donation for the purpose of transplantation. They have been tabled in response to concern about the current system of consent for donation and to raise awareness of the opportunity this Bill presents to improve the rate of organ donation in this country. I declare an interest in this area as president of the National Kidney Research Fund, the UK's leading charity funding research into kidney disease and helping to improve patient care. The fund is committed to helping to improve the organ donation rate and to increasing the number of patients who can be treated with viable transplant.

Transplantation provides patients who have end-stage renal failure with their best chance of rehabilitation. Without a transplant, patients with end-stage renal failure require either haemodialysis or peritoneal dialysis if they are not to die.

My interest in renal treatment is based on my father's 15 years on haemodialysis, starting as one of the first recipients in this country of such treatment in 1965. While he and other dialysis patients, including, in this House, the noble Lord, Lord Biffen, have demonstrated what a full life can still be led with such treatment, that should not obscure the extent to which a considerably higher quality of life is generally attributable to a patient in receipt of a transplant. Nor should it obscure the heavy, continuing cost to the NHS of long-term dialysis treatment, compared with a transplant.

The purpose of these amendments is to allow the Secretary of State to move from the current system of informed consent for organ donation to a system of presumed consent with opt-out. We have opted for an enabling clause, with the attendant difficulties, I admit, in the belief that this may represent the best way to allow the Secretary of State to move forward in this direction at a time when the appropriate measures can best be implemented and public support can best be mobilised. This system would be based on the presumption that an individual's organs would be available for donation unless he or she registers their desire to opt out. It would still ensure that relatives were approached and informed before any organs were made available, so that any objection to donation on their part could be made.

We believe that a system of presumed consent with opt-out, alongside other measures to tackle the shortage of organs, would increase significantly the level of organ donation in this country. Other European countries that have adopted and continue to practise a system of presumed consent have organ donation rates that are almost twice as high as that in the UK. For example, figures for 2003 showed that the UK had around 12 cadaveric donors per million of the population compared with, say, 23 in Austria and 24 in Belgium.

Presumed consent would work best as part of a package of measures to increase organ availability. Under the current system, if a person has failed to register their consent to donate in the appropriate way, their relatives are put under very great pressure, having to second-guess their wishes after their death. At times of great stress, if relatives are unsure of their loved one's wishes, they tend to resort to the default position and refuse donation. Research has shown that this uncertainty is the principal reason behind the 40 per cent refusal rate by relatives in this country.

Moving to a system of consent, where it was accepted that organs would be made available unless relatives objected, would help to alleviate some of the pressure on relatives to make this difficult decision.

I am acutely conscious that the primary purpose of the Bill is to help restore public confidence after the tragedies at Bristol and Alder Hey in the overall practice of organ removal. Against this particular background, I recognise the difficulty and sensitivity of incorporating a measure which may, rightly or wrongly, raise fears of the sort that the Bill has been designed precisely to allay. However, I believe confidently that, particularly with the huge improvement in information technology and the progressive implementation of electronic patient records, a system of presumed consent can now offer the very security and confidence that the public desire. Even 10 years ago, I recognise that that might have been much more difficult to assert.

It is never easy to approach relatives about organ donation at a time of great sadness, particularly if the law states that organs are not available for donation unless appropriate consent has been given. It is right that the wishes of the deceased are paramount in this situation and that relatives are fully consulted ahead of any decision. However, the current system does little to encourage health professionals to make the approach in the first place, and organs are lost as a result of a failure to request donation. Many bereaved people have in fact expressed regret at not being asked at the time whether they would consent to donating their loved one's organs.

A system of presumed consent with opt-out would place a positive emphasis on the importance that organ donation can make to the lives of those waiting for a transplant. It would also reassure healthcare professionals that it was acceptable to request donation, and would therefore encourage them to approach relatives more routinely.

It is for these reasons that I hope the Minister will seriously consider these amendments and recognise the opportunity that the Bill presents to make a real commitment to improve the rate of organ donation in this country.

Lord Brooke of Sutton Mandeville

My Lords, like the noble Viscount, Lord Chandos, I appreciate that these amendments are controversial, against the background of the tragedies and scandals of Alder Hey and Bristol. But I think that your Lordships' House should be grateful to the noble Viscount for having brought forward these amendments so that we may discuss these matters.

On Second Reading in the other place on 15 January, my right honourable friend, Mr Kenneth Clarke—speaking, incidentally, as an ex-Secretary of State for Health—described the introduction of his Transplant of Human Organs Bill of 2001, in which he won seventh place in the ballot, seventh place being inadequate to take a Private Member's Bill through if its subject were controversial. He appreciated the Government's reply that they were waiting for a comprehensive survey of all the legislation on which they would then embark. He applauded the arrival of the Human Tissue Bill as sooner than might have been expected. But he felt that the Government had missed an opportunity to do something positive regarding a continuing shortage of donor organs. The issue is sensitive, so of course it is understood why the Government are cautious, but opportunities for legislation are rare and therefore important.

The bulk of the public recognise the value of having donor organs, especially hearts and kidneys. Several hundred die each year awaiting a transplant, but the quality of life while waiting can also be awesome. Nearly 6,000 people were waiting on the list in November of last year. Donors are, I believe, declining and of course I acknowledge that legislation itself is not the determinant solution.

I may have got my author wrong, but under the lines of Lovelace: Stone walls do not a prison make, Nor iron bars a cage a prisoner had written the graffiti, "But they sure do help". Legislation, likewise, would help in this instance—mutatis mutandis.

I welcome what the Government are doing and the tidying up of the law, but the critical issue, as the noble Viscount said, is consent.

7 p.m.

The assumptions of the public are that once one has secured a donor card, the issue is decided. But it may be only the trigger for the process of persuading sorrowing relatives that that consent should be implemented. If the Minister in the Commons originally could not answer a question about the status of donor cards, what chance has Joe Public—or even, to coin a phrase, "Lord Private"—to understand that status? Mr Tam Dalyell, during research for his 1971 Bill, found a significant number of relatives, as the noble Viscount alluded, who, when they dwelt on the matter, greatly regretted having refused their consent at the time it was asked for. The process itself can put people off. On the chessboard the queen's move, the king's move, the bishop's move, the rook's move and the pawn's move are easy even for a child to understand. But the knight's move is more difficult—and there is an element of the knight's move regarding the process that is involved in this case. The other place devoted some significant time to the new clause moved on this subject—in slightly different terms—by Dr Evan Harris on Report on 28 June, cols. 39 to 94 of Commons Hansard. That was a large proportion of the time devoted to the Bill on Report in the other place—about 60 per cent of the total Report stage, which took up cols. 26 to 115. Those supporting the new clause were overwhelmed fivefold in the Division Lobbies, but it is worth recording as an index of all-party support, that 19 Labour, 18 Conservative, 22 Liberal Democrat, two Plaid Cymru and one independent Members backed it.

The noble Viscount has given comparative statistics that relate to Austria and Belgium. This country's figure is only two-thirds of France's and barely more than a third of Spain's. If registered donors are only just over a fifth of those who support the principle of organ donation, happily three times that proportion in 2000 supported presumed consent with opt-out. That descending spread to three-fifths and one-fifth is a lively index of the present confusion and potential ignorance of the public at large. As the noble Viscount said, Belgium and Austria's organ donation rates are nearly twice that of this country.

Of course I recognise that a system of presumed consent with opt-out would ideally require extra infrastructure, a dedicated transplant co-ordinator in every hospital and proper training for care unit staff and other professionals in approaching patients and relatives for donation. That would mirror the production of Spain's remarkable figures. I recognise the Government's pause for caution, but I hope that the Government also recognise that those supporting the new clause also support a step-by-step process. When crossing a Rubicon one should always ensure that each step will carry one's weight before proceeding to the next.

In conclusion, like Mr Dalyell's contacts, who, in 1971, later regretted not consenting when they were asked to, I hope that we shall not regret a missed opportunity in the Bill.

Lord Biffen

My Lords, I have an interest as a patron of the National Kidney Research Fund and, in his closely argued introduction to this new clause, the noble Viscount, Lord Chandos, referred to my own problems of renal failure.

I am very much in favour of this new clause, and I realise that it is part of a campaign to obtain greater recognition of the move away from "informed consent" to "presumed consent" for transplants, with an opt-out. One has to reflect only that such a doyen of lobbyists, Tam Dalyell, has been campaigning on this subject for so long, with such modest success, to realise that to obtain the changes that one desires is a pretty Herculean task. Yet, the challenge is there in that all western European countries have higher performances in that respect than ourselves. Therefore, it is reasonable to make such requests to the Minister, realising that it is not a matter of delivery tomorrow or in the immediate future. But when the number of transplants substantially increases, all the pressures will be to supply the hospital facilities, the nursing staff and everything that will bring to this country, for those suffering from renal failure, an alleviation which would otherwise be unlikely to occur.

Therefore, although the argument is being made for a gradualist approach, none the less I hope that it will bring an approach with a clear destination.

Baroness O'Neill of Bengarve

My Lords, I have much sympathy with the intention of noble Lords who have put their names to this amendment. I am not sure whether they will have complete sympathy with my comment—which is that they have burdened the amendment with the label of advocating presumed consent. When I read the amendment, I do not think that that is what they wish to propose. They propose to take seriously the consent of the deceased and I would put to the Minister the question of whether the present situation is not one in which systematically the consent of relatives is allowed to override the actual, rather than the presumed, consent of the deceased.

Baroness Finlay of Llandaff

My Lords, I am grateful to my noble friend Lady O'Neill of Bengarve for pointing that out. We are talking not only about kidneys, but also about hearts and lungs. When there has been a sudden death, it is incredibly difficult to go to relatives and even raise the issue of transplants. I have done that. You feel absolutely terrible. But you know that you have also seen someone, perhaps that week, who has been told that they are going on the transplant waiting list and you know that they will die before they ever receive a transplant. That is the problem. We are talking about organs from someone who has died. We are not talking about any change in clinical practice. It is a difficult question to ask—and during that time when the relatives are completely distraught because the death is almost always sudden and unexpected, they desperately clutch at any indication of what the person might have wished for.

But the default mechanism at the moment is always, "if in doubt, don't". I hope that an amendment such as this might help such families tip towards, "if in doubt, do", but still allow for them to say, categorically, that although that person did not carry a card to say that they did not wish to he a donor, one would know that they had said that they did not wish to be. That would be it; end of story. The way that relatives currently wrack themselves in trying to determine the best course of action, and then have regrets later, is a matter that we must take seriously.

I undertook my own study through the Compassionate Friends, which was published in the British Medical Journal under the title, "Your child is dead". Years later those parents whose children had died were drawing comfort from the fact that an organ had been used for transplant. I should like to end by quoting a child who, on the anniversary of her father's death, said: At least when dad was dead four other people were able to carry on living". She was referring to two kidneys, a liver and a heart/lung. But, as she said, they would only have been burned with his body anyway. That is what we are talking about. This matter is very different from the main context of the Bill and the way that we have been debating it. This is an opportunistic way of including this matter, because we are dealing with transplants. But I do not think that simply ignoring the amendment would allow the issue to go away. We must return to it if the amendment is not accepted.

We really must look at better alternatives to young people dying while they wait for messages on their pagers to tell them that a heart, lung, kidney or a liver has been found for them. This issue is not about the George Bests of this world; it is about young people, often under the age of 25, who can do incredibly well and who are very compliant with all their medication. They really could live and contribute to our society if they were freed up by a transplant.

Lord Turnberg

My Lords, I rise briefly to make only one point. I strongly support the amendment. It is likely to be popular with the public at large. If the public were educated about what is really meant by presumed consent with an opt-out, it would be widely accepted. We should move that agenda along.

Lord Rea

My Lords, as a former clinician, I am acutely aware of the huge price in terms of inconvenience and subjective discomfort which patients with kidney failure have to pay as they hold on to life in their need for frequent, intermittent dialysis on a kidney machine. As the noble Baroness, Lady Finlay, has just said, many of those patients die prematurely before they receive a transplant and many do not get that far. It is also labour-intensive and costly for the NHS to keep renal units functioning.

Renal transplantation frees those patients to lead a relatively normal life, although the immunosuppressive drugs that they need may make them more susceptible to infections. I restrict my remarks to kidney failure and renal transplant. My noble friend Lord Chandos has indicated that other organs are equally in demand, but perhaps not quite to the extent of kidneys. Kidneys are the great success story of organ transplants.

The BMA and the great majority of the medical profession believe that presumed consent would considerably increase the supply of donated organs. As other noble Lords have clearly pointed out, there is evidence of that from other countries.

In terms of this country, I can provide slightly different figures from those which have already been given. In December 2003, 7,278 people were on the renal transplant waiting list. That list has grown by 34 per cent in the past 10 years. In 2002, 401 people died prematurely while waiting for transplants. Like the BMA and many others, I feel that the Bill is a suitable vehicle for introducing presumed consent legislation. I understand the Government's reluctance to do so as the tenor of the Bill is obtaining consent wherever possible for procedures involving human tissue. However, evidence shows that the majority of the population—90 per cent in one study—would be willing to donate their organs after death. Opting out rather than opting in does not mean that consent would not be sought. The opt-out could continue, the difference being that where there was any doubt or where relatives could not be located, the organ would be donated rather than cremated or buried.

I am sorry that the movers of the amendment judge that the time is not ripe to press for presumed consent legislation, but I thoroughly support my noble friend and his colleagues in putting the subject high on the agenda for further government consideration.

Lord Walton of Detchant

My Lords, like other noble Lords who have spoken—in particular, my noble friend Lady O'Neill—I am not certain that the amendment, as drafted, would have the outcome that the noble Lords who have proposed it are seeking. Nevertheless, during the past 15 years, there has been a sea change in the attitude of the medical and other caring professions toward the acceptance of the principle of presumed consent. I venture to suggest that even if the amendment were not accepted by the Government tonight, presumed consent will become law in this country and I hope that it will do so sooner rather than later.

7.15 p.m.

Lord Chan

My Lords, I, too, support presumed consent, whether the amendment is accepted or not. Its advantage is that it overcomes the inertia of the large majority of the population who do not hold organ donor cards.

Presumed consent would also be an advantage among ethnic minority groups, where organ donation is even less common than it is among the general population, and would certainly reduce, if not eliminate, the illegal practice, referred to in Clause 33, of going abroad and buying an organ. That would be of great advantage to our population.

Lord Warner

My Lords, first, I pay tribute to the National Kidney Research Fund for all its work in this area and to my noble friend Lord Chandos for what he is doing to improve knowledge and understanding.

The Government's document, Saving Lives, Valuing Donors—A Transplant Framework for England, was published in July 2003. It set out the direction for organ and tissue transplantation in England over the next 10 years and encouraged the NHS, commercial and voluntary organisations and the general public to play their parts to optimise the number of potential organ and tissue donors and increase transplant rates to save lives.

Our aims are simple. They are to encourage 16 million people to register on the Organ Donor Register by 2010; and to build a patient and donor-centred service which achieves standards of excellence built on a genuine partnership between the public, charities, the NHS and commercial organisations—a true partnership between those in need and those who can help.

Last year, the Government provided £3.6 million via UK Transplant to support initiatives in hospitals and specific publicity campaigns to increase transplantation rates and raise the profile of organ donation. I am delighted to say that as a result of this investment, the dedication of staff in the NHS and UK Transplant and the generosity of donors, 2003–04 was a record year. Perhaps I may give your Lordships a few statistics. The highest number of organ transplants ever was recorded; the highest number of patients for 14 years received a kidney-only transplant; a further 2,365 people had their sight restored through a cornea transplant, the highest number for seven years; we saw a 20 per cent increase in non-heart-beating donation, which meant that more people than ever received a transplant from these donors; 147 people received a lung-only transplant, the highest number ever; and more than 800,000 people added their names to the NHS Organ Donor Register, bringing the total number registered to well over 11.5 million.

However, I accept that, great as these successes are, we cannot be complacent. As well as continuing to support existing hospital-based programmes such as donor liaison nurses, live donor and non-heart-beating donation units, we are providing funding via UK Transplant to provide a wide range of new initiatives, ensuring that donation rates continue to rise and more people can benefit from a transplant.

These include a year-long publicity programme to celebrate the 10th anniversary of the Organ Donor Register, with the aim of encouraging an additional 1 million to add their names to the register by October 2005. People can already sign up to the Organ Donor Register electronically. As part of the National Programme for IT, we are building an Electronic Patient Register which in time will also enable people to record their wishes on organ donation on their own patient records.

It has been argued that a move to presumed consent would further help increase organ donation rates. That is, unless someone has registered their unwillingness to be a donor, their organs could be taken and used. I say to the noble Lord, Lord Brooke, that possession of a donation card would be treated as presumed consent under the Human Tissue Bill.

When considering presumed consent, we looked closely at the experience of other countries. It is important to note that the practice in most countries is still to ask relatives for their permission before organ donation goes ahead. If they object and permission is not given, the donation will not proceed.

By far and away the most successful organ donation country is Spain, which, although it has a presumed consent law, has never used it. The architect of the "Spanish model" has repeatedly stated that the legal basis of consent is irrelevant to organ donation. What is critical is the organ donation and retrieval system—in particular, ensuring that only healthcare professionals with appropriate training approach relatives to discuss donation.

Learning from the experience and success of Spain and other countries, UK Transplant is holding, in conjunction with trainers from outside this country who are skilled in approaching families, training sessions for transplant co-ordinators on how to approach and discuss organ donation with relatives and friends. Although these are early days, those have proved helpful.

The French also had a presumed consent law, but that was modified in 1996 following an outcry from relatives who had not been informed about a corneal donation. A change in the law was made so that relatives had to be informed before organ removal, thus giving them the opportunity to object. Donation rates have increased by 30 per cent since the law was changed back to consent rather than presumed consent. I was in French hospitals on Thursday and Friday and saw that notices clearly identify the need for doctors and nurses to secure consent from relatives in relation to the donation of organs.

It is important that any measure aimed at increasing donation commands public and professional confidence. In the responses to our consultation document, Human Bodies, Human Choices, of those who responded on the subject of presumed consent, two-thirds were against a system of presumed consent. I also believe that the medical profession is largely content with the Bill and with the need to frame consent provisions in statute.

In conclusion, I have a great deal of sympathy with some of the ideas expressed, but we believe that this particular route is not the way forward. We need to pursue the path of education and consent with donors. I say gently to the noble Viscount, Lord Chandos, that if subsection (2) of the proposed new clause in his Amendment No. 41 were applied to other parts of the Bill, I would be very surprised.

Viscount Chandos

My Lords, I thank the Minister for his answer and I also thank all noble Lords who have spoken unanimously in support of the amendment or the principle behind it. The Minister said that we cannot be complacent, and I should like to take that as his strongest message rather than enter a debate about some of the statistics. As in most areas of life, one seems to be able to find eminently respectable and well researched statistics which are diametrically opposed in what they suggest.

I would have hoped that the practice in countries such as Spain of essentially checking with relatives would be seen by the Government as a reassurance that presumed consent does not open the floodgates to exploitation from which public concern flows. Therefore, it seems to me that the precedence abroad should encourage us that presumed consent would create an environment in which substantially higher rates of organ donation could be achieved.

That said, although I was pleased to hear my noble friend Lord Rea say that he regretted that I had indicated that I would not press this amendment, I would have loved to have found a way of harnessing the enthusiasm and commitment of all noble Lords who have spoken. I recognise that the Bill sets out to address perhaps a more specialist area of human tissues. I hope that the lack of complacency of which the Minister has assured us will become visible in the near future and that every opportunity will be taken to find a Bill and a moment when this area can be addressed. With that, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 42 not moved.]

Clause 33 [Restriction on transplants involving a live donor]:

[Amendments Nos. 43 and 44 not moved.]

Clause 35 [Inspectorate of Anatomy and Pathology]:

Lord Warner moved Amendment No. 45:

Leave out Clause 35.

On Question, amendment agreed to.

Clause 36 [Remit of Inspectorate of Anatomy and Pathology]:

Lord Warner moved Amendment No. 46:

Leave out Clause 36.

On Question, amendment agreed to.

Clause 37 [Inspectorate of Organ and Tissue for Human Use]:

Lord Warner moved Amendment No. 47:

Leave out Clause 37.

On Question, amendment agreed to.

Clause 38 [Remit of Inspectorate of Organ and Tissue for Human Use]:

Lord Warner moved Amendment No. 48:

Leave out Clause 38.

On Question, amendment agreed to.

Schedule 4 [Inspectorates: Boards]:

Lord Warner moved Amendment No. 49:

Leave out Schedule 4.

On Question, amendment agreed to.

Clause 39 [Duties in relation to discharge of fimctions by Inspectorates]:

Lord Warner moved Amendment No. 50:

Leave out Clause 39.

On Question, amendment agreed to.

Clause 41 [Annual report]:

Lord Warner moved Amendment No. 51:

Page 27, line 20, leave out "and the Inspectorates"

On Question, amendment agreed to.

Clause 44 [Criminal justice purposes]:

Lord Warner moved Amendments Nos. 52 to 55:

Page 28, line 22, after "14(1)" insert "or"

Page 28, line 22, leave out "or 36(1)"

Page 28, line 26, after "14(1)" insert "or"

Page 28, line 26, leave out "or 36(1)"

On Question, amendments agreed to.

Baroness Finlay of Llandaff moved Amendment No. 56:

Page 28, line 29, after "removal" insert "for the purposes of a coroner"

The noble Baroness said: My Lords, I hope that it will not take very long to deal with this and my other amendments in this grouping. I was delighted to see that the Government have also tabled an amendment in this grouping in order to correct some wording. I was rather hoping that they might have added their name to my amendment, but no such luck.

The reason that I used the words, for the purposes of a coroner", is that everyone who removes tissue must ultimately be answerable to a coroner's purposes, which are to determine the nature and cause of a death. Often those are not immediately apparent.

I hope that when, as I am sure he will do, the Minister rejects my amendment in favour of those tabled by the Government, he will give me the reassurance that all the police officers who might first attend where a body has been found can be classified as "constables". In my mind, the word "constable" has a slightly narrower definition, but I hope that every member of the police force who might be present can be called a "constable". If that is the case, I shall be only too happy to withdraw my amendment and accept those of the Minister. I beg to move.

Baroness Andrews

My Lords, I shall take the invitation offered by the noble Baroness to speak to the government amendments and shall deal with her amendment at the same time.

Clause 44 is designed to ensure that activities done for scheduled purposes which are also done for criminal justice purposes are excluded from regulation by the Human Tissue Authority. During Grand Committee, the noble Baroness made a valiant attempt to introduce more clarity into the provision by proposing an amendment to Clause 44(3) to delete the words "by a constable" from the subsection. In debate on the amendment, it emerged that there was some uncertainty about the interpretation of subsection (3), which is intended to ensure that coroners' post-mortem activities which take place "at the scene" do not require a licence from the HTA.

There was confusion about whether the mention of the constable—I can assure the noble Baroness that "constable" covers everyone to whom she referred, including chief constables—referred to the police first removing tissue from the body or whether the provision applied only to bodies found by the police as opposed to passers-by. The noble Baroness gave us a very graphic description of passers-by who had, indeed, found bodies.

Therefore, in order to remove ambiguity and to respond to the noble Baroness's Amendment No. 59, the Government agreed to look again at the text of the clause in order to clarify it. The usual expression "at the scene" was previously expressed as, at the place where the body or part is first found by a constable". I think that some of the confusion expressed in Committee concerning the clause relates to the word "found" as much as to the phrase "by a constable". As the noble Baroness, Lady Finlay, emphasised, the majority of bodies are more likely to be found by other people rather than by the police. To avoid ambiguity, these amendments propose to change the description of these "at the scene" post-mortem activities from being at, the place where the body or part is first found by a constable", to being at, the first place where the body or part is situated to be attended by a constable". The wording may not be very elegant but it now says what it means. The formulation expresses clearly the purpose of the provision, which is that the exemption from licensing should apply only to the place where the police first arrive on the scene, even if other people have arrived before them. So the exemption applies to the place where the constable first attends.

There are obvious reasons why it would be inappropriate for material to be taken from a body before the proper authorities have become involved, but we do want to allow proper investigation to proceed unhindered. This clause ensures that that will happen. I hope that the noble Baroness is content with those changes and with that explanation.

On Amendment No. 56, I know that this is very difficult conceptually because we are dealing with a non-inclusion in an exemption from an exception, which is hard to follow. The amendment would insert the words, for the purposes of a coroner", in subsection (3) of Clause 44. However, subsection (3) operates by reference to subsection (2) which already contains the phrase, for the purposes of … a coroner". Subsection (3), therefore, cannot be any wider than subsection (2) and must be limited to removals for coroners' purposes. In other words, the Human Tissue Authority's remit and licensing requirements do not apply in the particular circumstances described in subsection (3) where they are undertaken for coroners' purposes. In the interests of brevity, it would be preferable—I suggest it is redundant—not to repeat the phrase unnecessarily. On those grounds I hope that the noble Baroness will feel able to withdraw her amendment.

7.30 p.m.

Baroness Finlay of Llandaff

My Lords, I am absolutely delighted to accept the Minister's explanation. I shall have to read Hansard to learn the last piece off by heart because it is so complicated. I appreciate the trouble to which the Government have gone to clarify the wording on this. I beg leave to withdraw my amendment.

Amendment, by leave, withdrawn.

Lord Warner moved Amendments Nos. 57 and 58:

Page 28, line 30, at end insert "first".

Page 28, line 31, leave out "first found" and insert "situated to be attended"

On Question, amendments agreed to.

[Amendment No. 59 not moved.]

Clause 45 [Religious relics]:

Lord Warner moved Amendments Nos. 60 and 61:

Page 29, line 21, after "14(1)" insert "and"

Page 29, line 22, leave out "and 36(1)"

On Question, amendments agreed to.

Clause 46 [Interpretation of Part 2]:

Lord Warner moved Amendment No. 62:

Page 30, leave out lines 1 and 2.

On Question, amendment agreed to.

Schedule 5 [Section 50: Supplementary]:

[Amendments Nos. 63 to 65 not moved.]

Earl Howe moved Amendments Nos. 66 and 67:

Page 56, line 37, leave out from "health" to the end of line 38.

Page 56, line 38, at end insert "except where it is to be, or is, carried out in circumstances such that the person carrying it out is not in possession, and not likely to come into possession, of information from which the person from whose body the material has come can be identified"

On Question, amendments agreed to.

Lord Warner moved Amendments Nos. 68 to 74:

Page 57, line 1, after "or' insert "a direction under subparagraph (2) or (2A) or"

Page 57, line 2, leave out "(2) or"

Page 57, line 2, after "(3)" insert "or (3A)"

Page 57, line 3, at end insert "direction is given or"

Page 57, line 5, leave out "High Court" and insert "Authority"

Page 57, line 18, leave out "order" and insert "direct"

Page 57, line 19, at end insert—

"(2A) If the Authority is satisfied—

1. (a) that bodily material has come from the body of a living person,
2. (b) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the person from whose body the material has come ("the donor"),
3. (c) that reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose,
4. (d) that there is no reason to believe—
1. (i) that the donor has died,
2. (ii) that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or
3. (iii) that the donor lacks capacity to consent to the use of the material for that purpose, and
5. (e) that the donor has been given notice of the application for the exercise of the power conferred by this subparagraph,

it may direct that this paragraph apply to the material for the benefit of the other person."

On Question, amendments agreed to.

[Amendment No. 75 not moved.]

Lord Warner moved Amendment No. 76:

Page 57, line 34, at end insert—

"(3A) If the Court of Session is satisfied—

1. (a) that bodily material has come from the body of a living person,
2. (b) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the person from whose body the material has come ("the donor"),
3. (c) that reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose,
1140
4. (d) that there is no reason to believe)—
1. (i) that the donor has died,
2. (ii) that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or
3. (iii) that the donor is an incapable adult within the meaning of the Adults with Incapacity (Scotland) Act 2000 (asp 4), and
5. (e) that the donor has been given notice of the application for the exercise of the power conferred by this subparagraph,

it may order that this paragraph apply to the material for the benefit of the other person."

On Question, amendment agreed to.

Clause 52 [Power to de-accession human remains]:

Baroness Andrews moved Amendment No. 77:

Page 32, line 37, after "remains" insert "which they reasonably believe to be remains of a person who died less than one thousand years before the day on which this section comes into force"

The noble Baroness said: My Lords, this amendment is a direct response to the representations made in Grand Committee by the noble Lord, Lord Redesdale, and by the noble Baroness, Lady Kennedy of The Shaws. In Committee, noble Lords were very concerned to ensure that the de-accessioning power did not make the collections held by the museums listed in Clause 52 vulnerable to gratuitous claims for de-accessioning. I know that they were particularly concerned about the ancient collections of human remains in the British Museum. The amendment we have brought forward responds to that concern by ensuring that the remains of people who died more than 1,000 years before the clause comes into force are outside the scope of this power.

While this amendment is in keeping with the spirit of the amendment brought forward in Committee, which we undertook to consider, it clearly differs in substance on a number of points. This reflects discussions between DCMS and the museums named in Clause 52, and particularly with the British Museum, the Museum of London, and the Natural History Museum, all of which have agreed to the amendment in this form.

First, specifying a cut-off point of 1,000 years, instead of 500 years, will allow the Museum of London to make use of this power in de-accessioning the substantial number of medieval remains which it has within its collection, something which the 500 year cutoff would not have permitted. Secondly, the Government's formulation also allows for professional judgment to be exercised on the part of museum curators, archaeologists and other experts regarding the dating of human remains. This is appropriate as there are a number of ways in which human remains can be dated. These include radiocarbon dating, examination of the circumstances in which the remains were found and of the artefacts with which they may have been buried.

None of those methods will necessarily pinpoint the date of death to a precise year. We have, therefore, formulated this amendment so that it will be sufficient that the remains are "reasonably believed" to be those of people who died less than 1,000 years before the clause comes into force in order for them to fall within the scope of the de-accessioning power. I hope that noble Lords will agree that we have met their concerns, and will understand why this amendment is in this form. I beg to move.

Baroness Neuberger

My Lords, on behalf of my noble friend Lord Redesdale, I thank the Minister for this concession, which we support.

On Question, amendment agreed to.

Clause 57 [Orders and regulations]:

Lord Warner moved Amendments Nos. 78 to 82:

Page 34, line 13, leave out "36(4), 38(2)"

Page 34, line 17, leave out "36(4), 38(2)"

Page 34, line 23, after "14(4)" insert "or"

Page 34, line 23, leave out "or 36(4)"

Page 34, line 43, leave out from beginning to end of line 1 on page 35.

On Question, amendments agreed to.

Clause 59 [General interpretation]:

[Amendment No. 83 not moved.]

Schedule 7 [Consequential amendments]:

Lord Warner moved Amendments Nos. 84 and 85:

Page 62, leave out line 37.

Page 62, line 38, leave out from "2" to "shall" in line 40.

On Question, amendments agreed to.

Clause 64 [Extent]:

Lord Warner moved Amendments Nos. 86 and 87:

Page 37, line 32, leave out "and (3)" and insert ", (2A), (3) and (3A)"

Page 37, line 36, after "9(3)" insert "and (3A)"

On Question, amendments agreed to.

Clause 65 [Commencement]:

Lord Jenkin of Roding moved Amendment No. 88:

Page 38, line 27, leave out "The remaining" and insert "Subject to subsection (6), the other"

The noble Lord said: My Lords, at the end of the Grand Committee stage we raised the question of whether it could possibly be right that researchers should be liable to criminal penalties in advance of the publication of the codes of practice for which the Bill makes provision. Although the noble Lord, Lord Warner, said, we do not think it necessary to stipulate in the Bill a three-month delay"—[Official Report, 11/10/04; col. GC 55.], I am delighted to see that he has had second thoughts, for which he should be commended. The amendment tabled by the Government has met my case exactly. I beg to move.

Lord Warner

My Lords, this is a listening and a reflective government. The effect of the Government's amendment is similar, as the noble Lord, Lord Jenkin, said, to that proposed by him and others. It puts a three-month gap between the publication of the codes of practice relating to consent and the implementation of the penalties relating to consent in Clauses 5 and 8. That will enable practitioners to prepare to meet the necessary standards so as to eliminate any risk that they may inadvertently commit offences during the transition period.

We recognise the importance of allowing people the opportunity to become familiar with the implications of the new legislation, including the provision of codes of practice that will help to support the standards that are required. Consultation during the process of drafting the codes of practice will, in any event, keep stakeholders in the picture about what they will say, and the three-month delay introduced by these amendments will allow everyone to be confident that they are compliant with any new standards before the offences take effect. I hope that this will provide reassurance to practitioners outside this House and to noble Lords. I beg to move.

Lord Jenkin of Roding

My Lords, having heard the noble Lord, I beg leave to withdraw my amendment.

Amendment, by leave, withdrawn.

Lord Warner moved Amendment No. 89:

Page 38, line 38, at end insert—

"(6) No day may be appointed under subsection (2) for the coming into force of section 5 or 8 which is earlier than the end of the period of three months beginning with the day on which the Authority first issues a code of practice dealing with the matters mentioned in section 26(2)(h) and (i).

(7) If the Authority first issues a code of practice dealing with one of the matters mentioned in subsection (6) before it first issues a code of practice dealing with the other, that subsection shall have effect as if the three month period were one beginning with the later of—

1. (a) the day on which the Authority first issues a code of practice dealing with the matter mentioned in section 26(2)(h), and
2. (b) the day on which the Authority first issues a code of practice dealing with the matter mentioned in section 26(2)(i)."

On Question, amendment agreed to.

[Amendment No. 90 not moved.]