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Ms Winterton: I know it was hoped that time would be found for the publication of a draft Bill, but unfortunately that was not possible. That is why we published our broad legislative proposals in September, and held a further round of meetings. The organisations referred to by the hon. Gentleman, such as family support groups, want us to get on with establishing a legislative framework. The House will have an opportunity to debate the proposals, and they will be scrutinised in Committee. Given the broad consensus that emerged during extensive consultations, we decided that this was the best way of making our proposals law as quickly as possible. As a result of that work, we are proposing the Bill today.
Part 1 deals with consent. We propose a comprehensive framework in which principles of consent will apply to all medical uses of human bodies, organs and tissue and to public display. We can therefore move forward in the knowledge that proper legal and ethical standards will apply to all circumstances in which tissue can be kept and used for the public benefit. The same principles will apply to the removal, keeping and use of tissue following post-mortem, and to the keeping and use of tissue from living patients. Except to the extent necessary to maintain the integrity of the coroner's investigation or the criminal justice system, the decision will lie first and foremost with the individual.
The role of the family or person closest to the deceased, where the individual's wishes were not given before his or her death, will be made clear and explicit, and there will be offences for keeping or using tissue or organs without consent.
Clause 1 provides that consent will be needed for carrying out a hospital post-mortem, and that it will be needed for the subsequent keeping or use of tissue or organs for transplantation, research, education and training. For certain particularly sensitive purposes—the donation of the whole body to a medical school teaching anatomy for anatomical examination or for public display, as in Professor von Hagens' "Bodyworlds" exhibition—the prior personal consent of the individual will always be required. The Bill will not interfere with the coroner's authority to order a post-mortem for his purposes, related to establishing the cause of death, or with his power to ask for tissues or organs to be retained, should they be needed, for his purposes. That is made clear in clause 9.
Harry Cohen (Leyton and Wanstead) (Lab): I saw the exhibition to which the Minister refers, as did many thousands of other people. It was informative, interesting and could be viewed in some respects as an exhibition of art—however gruesome some people might consider it. Do the Minister's comments mean that the exhibition would have been banned in this country?
Ms Winterton: Such an exhibition would be allowed to go ahead if it had been properly licensed and if the prior consent of each deceased person had been properly obtained.
Where tissue is taken from living patients, some purposes are so bound up with general diagnostic and clinical care that the consent that the patient gives to the procedure itself can be regarded as consent to those other purposes. These are set out in part 2 of schedule 1 and include clinical audit, quality control and on-the-job training in the laboratory. Separate consent will not be needed in those cases or for public health monitoring where tissue taken from living patients is used—unlinked and anonymised—for epidemiological studies. Those issues were discussed extensively with representatives of the medical and research communities as the proposals for the Bill developed.
Although consent will not be needed for those particular uses, it will be good practice nevertheless to ensure that patients are aware that such uses might be made of their tissue or samples. That could include, for example, notices in waiting rooms or leaflets from out-patients, as set out in Department of Health guidance. However, consent from patients will be needed for further uses of tissue, by which we mean all material that contains cells—except hair and nail, which are regarded as disposable—such as for research, education and transplantation.
My hon. Friend the Member for Leyton and Wanstead (Harry Cohen) asked about consent. Appropriate consent identifies whose consent is relevant in the circumstances, not what is needed by way of consent. It can come from an individual, nominated representative or next of kin, as I shall explain more fully later.
Failing to obtain consent—whether from patients themselves or, in the case of the deceased, from other appropriate people—may be a criminal offence and subject to penalty. I say "may" because there will be safeguards to ensure that people cannot commit an offence inadvertently. For example, it is not intended that individual researchers be subject to the licensing requirements and they will not, in fact, themselves retrieve the tissue from patients. They will probably receive it from others, perhaps a tissue bank. In those circumstances, the researcher could quite reasonably rely on the regulated system to deliver tissue that has the appropriate consent for the purpose.
Mr. Lansley : I am grateful to the Minister for being so generous in giving way. I wish to be clear about the question posed by the hon. Member for Bolton, South-East (Dr. Iddon). The Bill defines appropriate consent and therefore qualifies what consent means, but the definition of consent is effectively left to the code set out by the Human Tissue Authority. If the House wants to qualify the consent process to make it acceptable , it will need to do more with the Bill to make that happen.
Ms Winterton: As the hon. Gentleman says, the Human Tissue Authority will issue further guidance on that matter. It is true that the Bill does not set out precisely what form consent should take in any particular situation. The Bill gives statutory effect to the current requirement for consent. It would be unrealistic to imagine that we could set all that out in primary legislation. Consent to treatment, for example, is a current common law requirement, which is subject to quite extensive guidance from the Department of Health, the General Medical Council, the British Medical Association and the Medical Research Council, which also deal with the need for consent before taking tissue for research purposes. The regulatory body established by the Bill will issue a code of practice on obtaining consent. Clearly, that will have to be pragmatic.
In some cases—for example, where tissue might be kept for some time—the fact that consent has been given needs to be recorded for future reference; and in many cases, as when blood samples are given, consent may be verbal or even a gesture such as holding out an arm. For surgical procedures, however, consent is likely to be recorded on a signed form. In all cases, consent will need to meet the general requirement that it is properly informed and freely given.
The process of seeking and obtaining consent will reflect current good practice and need not be onerous, even where consent for research use is being considered. We know that people overwhelmingly support the use of surplus tissue for research. We are, in effect, setting out in the Bill what is already current good practice—for example, in the GMC guidelines. Moreover, as at present, research ethics committees will continue to have a role in considering whether legal and ethical standards have been met in the context of the specific projects that they consider.
Dr. Evan Harris: On the question of authorised consent for transplantation, it is clear from clause 3 that
pre-morbid consent by the individual constitutes the consent and that—quite rightly, in my view—it is inappropriate for relatives to be allowed to veto it. Is it the Minister's understanding that the current donor card represents written and "appropriate consent", and that the current practice of relatives being allowed to veto that donor card request should therefore be discontinued as a matter of course, even in a minority of cases?
Ms Winterton: I am not familiar with the wording on my donor card, but I shall certainly look into the issue to see whether any changes need to be made.
Nick Harvey (North Devon) (LD): Perhaps I can help the Minister. I have my donor card with me, which states,
- "Please let your relatives know your wishes, and keep this card with you at all times."
Dr. Iddon: My hon. Friend is being very patient in giving way. Researchers are extremely worried about future research that they may need to conduct. Will she assure them that they will have access to such tissue through the "appropriate consent" form, which was signed by the individual in question, or their relatives, way back in history? Researchers are concerned that they may be about to commit a criminal act by examining tissue for research, when consent was not gained for such a research application.
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