I beg to move amendment No. 9, in
clause 45, page 28, line 17, at end insert—
'(3A) Insofar as it would be impracticable to obtain appropriate consent in relation to material to which subsections (2) or (3) apply, it will not be unlawful to make such material available for scheduled purposes.'.
This is a probing amendment. I should be grateful if the Minister would deal with some more definitions. In particular, what does she mean by material ''dealt with as waste''? That question spurred me to table the amendment. Most people, in a utilitarian way, would probably prefer it if surplus material removed from them in the course of a medical procedure could be turned to some good use rather than disposed of. That lies at the heart of the amendment. I hope that the Minister will expound on exactly what the provision means and the circumstances in which it will apply.
I am thinking in particular of procedures such as blood tests, which are carried out many times every hour in the national health service. Parts of the material could be used to good effect for research purposes, even if the primary purpose were investigation. The amendment would allow surplus or waste tissue to be used for other scheduled purposes, with the minimum of bureaucracy and fuss. That would probably be in accordance with the wishes of the vast majority of people in this country.
We return to an issue—the use of human material variously described as ''residual'', ''waste'' or ''surplus''—on which the Committee has had considerable debate. To return to the Bill's principles that we are entitled to determine how material from our bodies should be used and that we should have to consent to the use of that material, we should not assume that any material that is left over from one use can be somehow used for another purpose without consent. If we followed that path, we would undermine the Bill's consent provisions, which are its very foundation. That is not only the Government's view, but is mentioned in the guidance provided by the General Medical Council:
''You must obtain appropriate consent or authorisation before taking or retaining organs, tissues or bodily fluids, from patients or volunteers, for research purposes. This applies whether the material is obtained solely for research purposes or retained following a clinical or surgical treatment.''
I hope that the Minister will accept that part 2 of schedule 1 makes it clear that that does not apply for public health monitoring purposes. We have had a debate about what that means—although it was not satisfactory and I suspect that we shall return to it. The term ''public health monitoring'' can and will include research, not just public health monitoring. The rubicon has been crossed in that respect. That is why many people find it difficult to understand that, for epidemiological and unleaked and anonymised research, that definition appears to be quite narrow.
As the hon. Gentleman said, we have discussed this matter and may return to it at a later stage. We cannot accept the amendment because it would take us beyond the Bill's intention and undermine some of its fundamental principles. I hope that the hon. Member for Westbury will feel able to withdraw the amendment.
I beg to move amendment No. 127, in
clause 45, page 28, line 17, at end insert—
'(3A) Subsections (2) and (3) shall continue to apply after the person from whose body the material has been removed has died.'.
This amendment probes whether the clause covers sufficiently the question of surplus tissue taken during treatment or diagnosis from a patient or a research subject who subsequently dies. What circumstances will apply? Will the procedures that apply to the tissue of a deceased person—where there is a requirement for consent, and the opportunity for the tissue to be reunited with the body for burial—similarly apply? Is the issue dealt with as the clause specifies because when the tissue was taken the person was alive? I hope that I am making the purpose of the amendment clear; it should be clear, and I believe that it is. I hope that the Minister can reassure us on the exact position because a number of people have raised the issue with me in the fear that they might be breaking the law in such circumstances.
I assure the hon. Gentleman that any consent given during a lifetime persists after death, but the purpose of clause 45 is to make it clear that material taken from a human body during medical treatment, diagnostic testing and research or relevant material that for whatever reason is no longer required for those scheduled purposes may be disposed of as waste. That can apply to material either from the living or the dead; the provisions of the clause are not affected by whether the person from whom the tissue came has subsequently died. The provision is merely a way of enabling tissue that is no longer required to be disposed of and of making it absolutely clear that that activity can be undertaken. I realise that it sounds odd that that has to be clarified, but it is important for the purposes of those undertaking such activities that it is clear that they can dispose of that material unless there has been a particular request to return it if necessary.
That was the point that I wanted to probe. I understand the purpose of the clause, but let us take the case of someone who has had an operation that involves cutting away tissue—a minor amputation, for example—and dies post-operatively. That tissue has not been taken from a deceased person. Does the Minister envisage that doctors will have a duty to offer the return of that material or will it be up to the family to request it? It is a valid point because issues have been raised in this respect and we would not want them to be raised again in an unplanned way.
Obviously, the authority will be looking at exactly how that would be made practicable. If a request were made about the return of tissue removed, it would obviously be respected. It is important that if, in giving consent for scheduled purposes, a particular request is made about what should happen to material afterwards, it should be taken into account.
In the light of those assurances, I hope that the hon. Gentleman will ask leave to withdraw the amendment.
Owing to the need for speed, I will not pursue the point except to note that there is a question about what happens when someone who has given consent for research to be carried out dies, and his family want everything that had been given for research, which may still be ongoing, to be returned in time for a burial.
Let me reassure the hon. Gentleman that if a person gives consent while alive to the use of surgical tissue, it will extend after death. The family would not be able to overturn that consent.
I am very grateful to the Minister for putting that on record because it will be necessary to ensure that relatives have realistic expectations of discussions concerning this important Bill. What the Minister said will help in that respect. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
I beg to move amendment No. 126, in
clause 45, page 28, line 18, leave out subsection (4).
The purpose of this probing amendment is to give the Minister an opportunity to explain the purpose of clause 45(4), which states:
''This section shall not be read as making unlawful anything which is lawful apart from this section.''
I think that I know what that means, but I am not sure that everyone who reads it will do so, and it is an important part of the clause. Rather than raising the matter in the clause stand part debate, I thought it might be useful to give advance notice that the Minister should take this opportunity, if she would be so willing, to clarify what is meant and what sort of activities are not meant to be caught by the provision.
I accept that this is a probing amendment. It would remove a subsection that makes it clear that the reference to lawful disposal is not intended to affect the lawfulness or otherwise of other disposals of human material. Subsection (4) simply clarifies that by referring to certain disposals in the clause. We do not intend to cast doubt over the lawfulness of disposals that are not referred to in the clause, such as disposals of tissue that have come from a person's body during the course of cosmetic treatment. We are aware that, in the medical context only, there has been some uncertainty about the status of ''discarded'' tissue. That is why we have taken the opportunity to clarify the issue. However, in doing so, we did not want to create any doubt about the status of other material.
The clause allows for material that has come from a human body during the course of medical treatment, diagnostic testing or participation in research, or is relevant material that is no longer required for scheduled purposes, to be disposed of as waste. However, it does not insist that the material be disposed of as waste, not least because that may be against the person's wishes. For example, we would not intend to criminalise the use of human material for non-scheduled purposes, such as the development of cosmetics, if that is the wish of the tissue donor.
I hope that that clarifies matters for the hon. Gentleman.