Clause 3 - ''Appropriate consent'': adults
Human Tissue Bill
11:15 am
Mr Andrew Lansley (South Cambridgeshire, Conservative)
During the consultation that led to the framing of the Bill, the question of what should happen in circumstances where someone lacks the capacity to give consent was considered. The law does not permit someone to give consent to treatment on behalf of another adult. By extension, therefore, the structure of consent does not allow someone to give consent for the retention of tissues and organs on behalf of another adult.
The consultation went on to consider the question of best interests and non-therapeutic research. Taking it step by step, the best interest criteria include the fact that a clinician dealing with someone who cannot give consent, or who does not have the capacity to do so in relation to therapy, can treat that patient if it is in the patient's best interests. However, something that is not concerned with the treatment of that patient would not necessarily satisfy the definition of best interests.
The consultation also considered the Council of Europe convention on human rights and biomedicine, which recognised the fact that non-therapeutic research on a person not able to consent would be ethical—I think it should have said ''could'' be ethical—if strict safeguards were applied. A document, ''Who Decides? Making Decisions on Behalf of Mentally Incapacitated Adults'', was based on the work of the Law Commission. It considered that question and observed that non-therapeutic research could improve understanding of the
condition from which a patient suffers, and may assist fellow suffers in future.
The consultation pointed to a consensus that non-therapeutic research could be justifiable if it was concerned with the condition from which a person without capacity suffered and if the procedures involved minimal risk and invasiveness. The commission's recommendation was touched upon on Second Reading. If my recollection is correct, the Minister said that that would be dealt with in the draft Mental Incapacity Bill. However, in this Bill we are setting the legislative framework for the retention of organs and tissues.
On the face of it, we were surprised that the issue was not being dealt with in this Bill, given the recommendations of the Law Commission. Amendment No. 90 is designed to achieve that. It would provide for occasions on which an adult who lacked the mental capacity to make a decision needed a person in a qualifying relationship to give the appropriate consent for him. Amendment No. 91 to clause 24 links up with the subsequent definition of qualifying relationship, and is merely consequential.
Amendment No. 90 refers to this process being ''not contrary'' to that person's interests—that is in relation to the ''minimal risk and invasiveness''—and to whether it would
''benefit persons with the same or similar conditions''.
A test therefore has to be met, and we propose that it should relate specifically to medical research under paragraph 7 of schedule 1 in connection with disorders of the functioning of the human body, rather than the wider ones proposed separately by the hon. Member for Oxford, West and Abingdon. We decided at that point to try to implement the Law Commission's intentions.
If Ministers and the Committee are not persuaded to include that provision now, we can at least explore Ministers' intentions in relation to the Mental Incapacity Bill, so that in due course people can see the whole framework of legislation.