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Ms Winterton: Yes, that is the case. There is a clear distinction for education and training on research techniques. They will remain subject to consent, because of the results that may come from them. Members of the academic, teaching and research communities have indicated that they are satisfied that that approach will meet their requirements.

Dr. Harris: The Medical Research Council is still concerned about this matter. The Minister has created three categories: education and training, which do not need consent; research, which does not need consent if the information is anonymised and there is research ethics committee approval; and education and training in research techniques, which always need consent. If research is being conducted on anonymised samples with research ethics committee approval, it should still be possible to carry out education and training on the research techniques involved as long as anonymity remains in place.

Ms Winterton: The carrying out of the research under the Bill as amended is subject to ethics committee
 
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scrutiny where consent is not in place. Using tissue to train people in a research technique, such as the use of particular equipment, is a different matter, and it is not central to providing services. Training researchers while carrying out approved research would be allowed. The authority will elaborate on that point in guidance, but there is a difference between carrying out research that has not been approved by a research ethics committee and training researchers during research that has been approved by such a committee.

The last set of Government amendments in the group consists of amendments Nos. 67 to 70, which deal with the use of residual tissue in relation to testing in-vitro diagnostic medical devices or test kits. The amendment to clause 1 is a technical amendment removing a potential regulatory overlap. Manufacturers of in-vitro diagnostic test kits such as those for pregnancy or HIV use human tissue in order to comply with their duties to evaluate their products before placing them on the market and before batch release. That is regulated by the EC directive on in-vitro diagnostic medical devices, which is implemented in the UK by the Medical Devices Regulations 2002. The directive has its own requirements concerning consent to such use. To be certain that we do not interfere with that established regulatory regime, we propose to amend the Bill to make it explicit that storage and use of tissue for IVD testing covered by the directive are excluded from the scope of the consent provisions.

Mr. Lansley: The amendments that are designed to achieve that aim insert the words "performance assessment" as one of the purposes in part 2 of schedule 1, and there are consequential changes in schedule 5, but I am not entirely sure that I understand by what mechanism that phrase is defined in a way that limits its application to the directive. Is the Minister confident that performance assessment would not be given a wider construction than simply in-vitro diagnostic equipment?

Ms Winterton: I am quite confident that it would not be.

Subject to the specific exclusion to which I have referred, schedules 1 and 5 are amended to clarify that use of human material in IVD kit testing is otherwise within the purposes regulated by the Bill. As I said, that is achieved by adding performance assessment to the purposes listed in part 2 of schedule 1. That will ensure that storage and use for testing done pursuant to the directive is covered by the regulatory regime in part 2 of the Bill. It will also ensure that other IVD kit testing using tissue from living patients may be carried on without consent for that purpose. That will make it clear, for example, that surplus diagnostic tissue can continue to be used to calibrate and assess the comparative performance of medical devices without specific consent. The Medicines and Healthcare Products Regulatory Agency also routinely undertakes or commissions such performance assessment of devices for NHS use.

We regard that activity as a necessary adjunct to the provision of care and diagnostic services in much the
 
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same way as clinical audit and quality assurance. However, the purpose of quality assurance, which is already included in part 2 of schedule 1, was not considered certain to encompass the activities undertaken in testing the devices, so to clarify the position, we are taking the opportunity to add a new purpose to cover the point.

I commend to the House the sensible amendments that I have outlined, which are intended to remove uncertainties and ensure that the points made in Committee are reflected in the Bill.

Mr. Lansley: I think that I had some part in speaking to amendments whose purpose was to raise exactly the points to which the Minister has now responded. I am not sure that I did so exclusively, as other Committee members advanced much the same arguments.

To that extent, I welcome the Government amendments. I do not want to explore them in too much detail, but I want to be clear that there are one or two consequential issues. I mentioned one in an intervention, as I was not entirely sure about it. The Minister's subsequent remarks made it clear that the extent of the medical devices regulations is probably sufficiently wide for us not to have to worry about the point that I raised, but I am not quite sure that performance assessment has been properly or fully defined. Perhaps we could check up on that point at a later stage.

The substantive purposes of the amendments are significant. Let us cast our minds back to when the Bill was being constructed. It was constructed around a range of unhappy and tragic circumstances, but those circumstances often related principally to organs and tissues from people who had died. To that extent, although we had regard to the principle of informed consent throughout our consideration of the Bill, we were conscious that in remedying the many mischiefs that had been exposed after the events at Alder Hey and the Bristol royal infirmary, as well as in other places across the country, we wanted not to damage research and the functioning of the NHS.

It was striking that the research community, pathologists and those representing the families who had lost loved ones and been affected by unauthorised organ and tissue retention tended to take the view that the Bill had gone too far. I am grateful that the Minister has recognised that the Bill has gone too far, but it is important that, as we carefully draw that line again, we do not run the risk of trespassing on the sense that families and patients need to have—the sense that what is done will be done with their consent or will have proper safeguards built around it if it does not require such consent. We need to achieve that in precisely the way that the Minister described.

One of the most important distinctions is built in by Government amendments Nos. 21, 22 and 23, whose purpose is to remove from part 1 of schedule 1, which deals with purposes normally requiring consent, the structure of education and training, as set out in paragraph 3, and to divide it into two parts. There will
 
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now be education and training that relate to human health, which goes beyond the previous reference to

"incidental to medical diagnosis or treatment",

which is distinguished from education and training relating to longer-term research.

The 5.5 million cervical smears were used in Committee as an example to illustrate what is meant by "relating to human health". As I understand it, it is impossible to determine which smears are relevant for the purposes of education and training until beyond the point at which it would be incidental to medical diagnosis or treatment to identify them. Under the Bill as drafted, in order to use smears for education and training, which is vital in establishing what biomedical scientists are looking for, one would automatically have to return to a subset of those 5.5 million women to obtain their specific consent, and, sensibly, no one in Committee regarded that as the right path down which to go. In that example, the need to make the provision wider than

"incidental to medical diagnosis or treatment"

is clear.

Difficulties will inevitably arise in distinguishing between research and education and training, but, if I understand how things work in the NHS, a clear distinction exists on whether one is engaged in education and training or whether one is engaged in research. By definition, if one is engaged in research, one has secured ethical approval for it, and the requirement for consent should flow from that approval, even in relation to education and training.

Unless my hon. Friend the Member for Westbury (Dr. Murrison) pulls me back, we are happy with the changes to schedule 1. We must be careful on schedule 1, because it lies at the heart of the Bill, and if we were to include a provision that goes a step too far, we would undermine the Bill's whole purpose.

Government amendment No. 108 and its related consequential amendments disapply the requirement for appropriate consent for particular purposes, before those purposes become lawful. If ethically approved research is undertaken in accordance with regulations and is carried out in a way in which information is effectively anonymised, Government amendment No. 108 ensures that such research does not require appropriate consent to become lawful. It is important to make it clear that the provision relates to material taken from a living person's body.

Those representing families affected by those issues have made it clear in conversation that they are prepared for such a change, because the legislation's structure clearly distinguishes between organs and tissues taken from living persons, where, as amendment No. 18 tabled by the hon. Member for Wyre Forest (Dr. Taylor) puts it, "tacit consent" has been given for the donation of tissue. Those families take the view that it is reasonable to go down that path. As in the case of the changes to schedule 1, the boundary between education and training for human health and education and training for research is important.
 
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8.15 pm

We must understand what "anonymised" means in those circumstances, and the hon. Member for Oxford, West and Abingdon (Dr. Harris) asked some typically penetrating questions, which are beyond my ken, on that matter. I discussed that issue with staff at the Sir Magdi Yacoub centre at Harefield hospital, who explained that they separate data concerned with research projects conducted by Imperial college from data concerned with the clinical care of the patients from whom the tissues were derived. The dividing line is between data that links tissues to individuals and data that is part of the clinical record.

The answer to the question asked by the hon. Member for Oxford, West and Abingdon is that it is possible for the research team to ask the clinical team questions, and for the clinical team to provide answers. It is possible to ask such questions, but the answers should not allow the research team to identify the patients concerned. The robustness of the approval and the separation of clinical databases and research databases are important in that context.

I did not make any of those points in order to object to the amendments, which remedy what the medical research community feared would be serious adverse consequences arising from the Bill, and I hope that the House accepts them.

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