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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
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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.
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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 for Wyre 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"
"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:
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"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
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