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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:

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
 
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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.

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
 
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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
 
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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.


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