AUTHORISATION OF ACTIVITIES FOR SCHEDULED PURPOSES

HC Deb 28 June 2004 vol 423 cc95-106

Ms Rosie Winterton

I beg to move amendment No. 108, in page 2, line 32, at end insert— '(6A) Subsection (1)(d) does not apply to the storage of relevant material for use for the purpose of research in connection with disorders, or the functioning, of the human body if—

1. (a)the material has come from the body of a living person, and
2. (b)the research falls within subsection (6C).

Subsection (1)(f) does not apply to the use of relevant material for the purpose of research in connection with disorders, or the functioning, of the human body if—

1. (a)the material has come from the body of a living person, and
2. (b)the research falls within subsection (6C).

Research falls within this subsection if—

1. (a)it is ethically approved in accordance with regulations made by the Secretary of State, and
2. (b)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.'.

Madam Deputy Speaker

With this it will be convenient to discuss the following:

Government amendments Nos. 109, 67, 19, 20, 110 to 112, 21.

Amendment No. 17, in page 36, line 8 [schedule 1], after 'training', insert 'to which paragraph l 3 does not apply'.

Amendment No 15, in page 36, line 20, after 'Research', insert 'to which paragraph 13 does not apply'.

Government amendments Nos. 22, 23, 68.

Amendment No. 18, in page 36, line 28, at end insert— '13 Education, training or research with local research ethical committee approval, carried out using relevant material not otherwise needed after completion of treatment or investigation for which the patient's consent was obtained in writing or by tacit consent for the removal of the sample of relevant material.'.

Government amendments Nos. 69, 24, 70, 113.

Ms Winterton

These three sets of amendments are grouped together because they deal with the use of so-called residual or remnant tissue—that is, tissue removed lawfully from living patients in the course of diagnosis or surgical intervention.

I shall speak first to Government amendments Nos. 108 to 113, which deal with research use of residual tissue. We discussed the matter extensively in Committee. Following the Committee stage, the Government received many direct representations from academic researchers. Hon. Members may also have noticed that there was a campaign in the news media by the same stakeholders. The research community said that obtaining consent to use tissue removed for medical treatment and diagnosis from living patients—so-called residual or remnant tissue—would be so onerous and costly that it would stifle research. I met a number of the stakeholders from the research and academic communities and have considered various options for dealing with the matter.

The Government are clear that they do not wish to impose excessive burdens on those who process the many diagnostic and clinical samples of blood, urine and tissue taken in the NHS. Obtaining consent in relation to all such samples to make them available for research would be a disproportionate burden. However, there is a need to maintain scrutiny and control over the research use to which such samples are put. We therefore propose to amend the Bill to allow research using material from living patients to go ahead without consent, but with safeguards.

The first safeguard will be that the research must be ethically approved in accordance with regulations made by the Secretary of State, which we expect will provide for approval by a research ethics committee. The second safeguard is that the researcher must not possess information as to the identity of the person from whom the tissue came; in other words, the research must be anonymised. We believe that these safeguards will maintain the essential principles of the Bill and provide appropriate controls, while allowing medical researchers the access to human tissue that they need.

Dr. Evan Harris

I have raised this issue with the Minister before: does she propose that the anonymisation should be irreversible—in other words, that someone could never find out who the tissue belonged to—or does she propose that a third party, but not the researcher, could if necessary find out where the sample came from? In what circumstances does she believe that the anonymity could be broken, if it could be?

Ms Winterton

Anonymisation does not mean that the patient and the tissue would be permanently unlinked. Further information could be sought from the records, but the researcher should not get identifying information, and the ethics committees would be able to consider what arrangements were appropriate in each case.

Dr. Harris

I understand that point and I am satisfied about it. Further information could be obtained, but not identifying information. But what about the circumstance in which something that might be of interest to the person concerned or to their benefit is found in the research, or perhaps something is found that is prognostically significant but to their disbenefit? Would that information be able to flow back, and if so, is that true anonymisation? Should there be consent for that? Some people may not want to know, and if they are never asked for consent to the use of their anonymised tissue, they may be burdened with information that they never wanted to have.

Ms Winterton

That is an issue that I would expect the research ethics committee to consider before any research started. It is likely that the research ethics committee would say that in order to be able to use any information that came from the research, consent would have to be sought from the individual. Research ethics committees would have to consider the matter when granting permission for research in the first place.

I shall now move on to the set of amendments dealing with the use of residual tissue for medical education and training. In Committee the Government were made aware of similar concerns about the provisions on consent to the use of residual human tissue for education and training. The Bill as drafted provides that the use of tissue from living patients for on-the-job training in pathology laboratories, for example, should not require consent, as it is considered part and parcel of the diagnostic and care process. However, use of tissue from living patients for education in more formal settings does require consent.

In Committee hon. Members raised the issue of the practical difficulty for teachers of distinguishing between those two types of education and training. That led us to reconsider the issue. In the second set of amendments we now propose to allow all education and training using tissue from living patients that relates to human health and to disorders and functioning of the human body to be carried out without consent. That means that references to education and training would be moved from part 1 to part 2 of schedule 1. Consequential amendments relate to clause 8 and schedule 5.

Use of residual human tissue for education and training in research techniques, which is a more easily distinguished topic, will remain subject to consent. Members of the academic, teaching and research communities have indicated that they are satisfied that this approach will allow them access to the tissue that they need for research and education.

Dr. Harris

Perhaps I have not understood the architecture of the Bill, as amended. If the education and training in research techniques were done on anonymised tissue, subject to the approval of a research ethics committee, would it be exempt from the requirement for consent, as the research is, or does the wording mean that while doing the research on anonymised tissue, one could not teach post-doctoral or postgraduate students how to do that research, because that would constitute a part 1, schedule 1 purpose?

8 pm

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 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 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 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.

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.

Dr. Evan Harris

I concur with much of what has been said. I shall raise three issues with Minister, two of which I have already raised in interventions in order to give her prior notice.

My first point, which the hon. Member for South Cambridgeshire (Mr. Lansley) also raised, concerns the flow of further information, where research is conducted on anonymised samples under ethics committee approval. The Minister explained, quite reasonably, that researchers could ask for further clinical data if it helps their research, and, again, that could be subject to research ethics committee oversight. I served on an ethics committee for a number of years, and we used to consider such requests regularly.

My question concerns research that could impact on a patient, who might have an interest in either knowing or not knowing about it. It is probably best to use an example: let us say that many appendixes are used anonymously for research, and a new technique is developed to enable one to see whether Creutzfeldt-Jakob disease infection is present in those tissues. Some patients might want to know if a bit of their tissue, albeit one researched on anonymously without their consent, contains CJD, if that data were useful to them in prognostic terms, especially if a treatment were available to prevent the onset of symptoms.

Although that example is hypothetical, the ethics committee on which I served considered many similar cases. Alternatively, a patient might not want to know that they had such a condition, because, for example, no treatment were available or because the treatment would not enable them to obtain life insurance. Will that be possible, subject to ethics committee approval, or does the Minister expect those insights to be understandable at the outset, in which case the ethics committee would not have allowed the provision of anonymous research samples?

Ms Winterton

indicated assent.

Dr. Harris

What will happen when such insights come as a surprise and are not forecast? Such occasions will not be rare, because we expect science to move on. Collections of remnant tissue may well become useful in research and new techniques, which is why so much fuss is made about them. I want the Minister to guide me on whether we should be careful about allowing research to be done on anonymised tissues, in order not to get into that situation in the first place. What would we do if 1,500 appendixes were needed quickly to test a CJD detection technique? Those questions are not straightforward, but if we are creating a new legislative framework, we must consider them before the Bill leaves both Houses. Even if the Minister cannot give a definitive answer now, I hope that that point will be considered at a later date.

My second point concerns education and training in research techniques. The Minister suggested that the situation will lie in the extremes: either such education and training will not require consent, irrespective of whether it is beyond the treatment and diagnostic phase—that is the position that we discussed in Committee and from which the Government have retreated—or it can be done only with consent and therefore cannot involve anonymised samples. In fact, a great deal of education and training takes place on the correct preparation of slides and their presentation in respect of cervical smears, on blood testing and on the fixing and analysis of surgical remnant samples of the kind that are likely to be anonymised and therefore not to require consent. I hope that the Minister is not saying that it will not be possible to teach people how to prepare slides and to teach cytology techniques on those sorts of sample, which are the majority. That would mean having to try to identify a sub-group in the community from whom to get consent—from patients who probably do not want to be reminded that they had a blood test or smear. I would be grateful for the Minister's clarification on that, because it is possible that an error is being made.

I raised my third point in a meeting with the Minister in which she explained how she thinks that the regulations will work in relation to not requiring consent for anonymised samples. She said that samples that are anonymised and have ethics committee approval will not require consent. However, I got the impression from earlier conversations that there will still be a question on a consent form for an operation which would be, "Are you happy for your tissue to be used on an anonymised basis?" I question whether that is sensible, because even if the answer was no it would not be unlawful for that tissue to be used. When one gets 60 surgical samples back, and the piece of paper does not go with 10 of them—say, elective tumour resections—an error could be made. However, it would not be an error in law because there is no bar on using anonymised samples for a study that has ethics committee approval.

That is misleading to patients and creates an extra burden of bureaucracy in elective cases. In the case of a big lump of tissue such as a heart, which perhaps should not be used for research, even anonymised, because the person undergoing the heart transplant operation might not expect it, the ethics committee would prevent it. We should leave it to the committee to do that instead of requiring the insertion of a question about anonymised tissue on consent forms. The quality of the consent is the same when it is implied by holding one's arm out as it is when one ticks a box for a straightforward operation. The same information should be required; the fact that one consent is in writing does not mean that it is any more of a consent than the other. Does the Minister still think that there will be the extra complication that she envisaged?

Other than that, I welcome the fact that the Government have made changes to this part of the Bill. Some of the amendments are similar to those that the hon. Members forWyre Forest (Dr. Taylor) and for South Cambridgeshire and I tabled in Committee. At that time, they received rather less than long shrift, and I am glad that the Minister has thought again.

Dr. Richard Taylor

I wish to speak to amendments Nos. 15, 17 and 18, which stand in my name. I tabled them at the beginning of May in the hope of reminding the Minister of the points that she said she would reconsider in Standing Committee. That approach seems to have borne fruit.

I recently received a letter from the chairman of the British Society for Clinical Cytology which emphasised the crucial nature of these amendments. She said: During the last few months I have attended two international conferences in South America—at the first one I was too embarrassed to mention the Human Tissue Bill, but at the second its possible implications were well known around the world. It is quite clear that the latest Department of Health guidelines, without the backing of law, have already put the UK way behind in research and development. Lets hope to goodness that the amended law will allow some ground to be made up. That is typical of the concern with which people regarded the unamended Bill. I therefore congratulate the Government on their amendments, which will correct the situation and add the protection of anonymity.

I remain puzzled as to what caused that seismic change in Government thinking. In Committee, hon. Members argued long and hard for such changes to the Bill because we had all received letters from pathologists of different sub-specialties and from their professional organisations. The hon. Member for South Cambridgeshire (Mr. Lansley) hit the nail on the head when he said that a Standing Committee is not the best forum to obtain consensus. I realised that when I served on one for the first time and found that there was always a Government Whip there to make absolutely sure that nothing went through against the Government's wishes.

I hope that you will allow me to digress for two minutes, Mr. Deputy Speaker. During our proceedings on the Asylum and Immigration Bill, the hon. Member for Cannock Chase (Tony Wright) said: As I see it, there is no way that legislation this fundamental will be accepted by the other place, so the Bill will presumably return to this House in a form that the Government think that they can get through, which will involve its amendment."—[Official Report, 1 March 2004; Vol. 418, c. 674.] In an Opposition Day debate that the Liberal Democrats introduced on young people and democracy, we considered things that put people off politics. I referred to the practice of sending an unamended measure to the House of Lords so that there would be room for amendment when it came back, and I likened the Government to a second-hand car salesman.

I wonder whether such comments made the Government change their mind. Whatever has led to that, I am delighted. I hope that Standing Committees may become better forums for changing views, even when they contradict that of the Government. I am convinced that the Government's amendments do all that is necessary, and I shall therefore not press the amendments that I tabled.

8.30 pm

Ms Rosie Winterton

I thank the hon. Member for Wyre Forest (Dr. Taylor) for not pressing his amendment. I am delighted that he is delighted about what happened in Committee.

The hon. Member for Oxford, West and Abingdon (Dr. Harris) asked about consent forms when tissue is intended for research purposes. The Human Tissue Authority will consider that in guidance but I hope that, if an individual says that they do not want their residual tissue to be used for research, it will not happen. I acknowledge that discussions must take place about the way in which that will work. However, I hope that respect will be shown.

The hon. Gentleman also asked about training in research procedures. I believe that I answered that question previously, but I emphasise that training in diagnostic and care procedures and in medical education must be regarded as part of the package of providing diagnostic and care services. We recognise that training is essential for protecting future services. However, we also acknowledge that research is different from care and we therefore have different specific consent requirements for research.

Training in research techniques should be aligned with the research provisions. Clearly, when a trainee is observing a research procedure, there is no difficulty. If a postgraduate student has a research proposal that a research ethics committee approves, the learning would be part of the research, which would proceed in the usual way. However, it is different if tissue samples—and we could be considering sizeable lumps—are to be used solely to teach someone how to use a piece of equipment. In that case, consent would be needed.

In the case of unexpected information being found during research, I hope that the research ethics committees would generally be able to tell whether such information would be discovered and rule accordingly. By and large, they would ask for consent if they believed that such information was likely to emerge. However, we need to leave such matters to the Human Tissue Authority and the management of the research ethics committees so that they can introduce some flexibility within the general parameters.

Amendment agreed to.

Amendments made: No. 109, in page 2, line 38, after '(4)', insert', (6A) or (6B)'.

No. 67, in page 2, line 42, at end insert— '() Nothing in this section applies to—

1. (a)the use of relevant material in connection with a device to which Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices applies, where the use falls within the Directive, or
2. (b)the storage of relevant material for use falling within paragraph (a).'.—[Derek Twigg.]