Schedule 1 - Scheduled purposes
Human Tissue Bill
4:00 pm
Mr Andrew Lansley (South Cambridgeshire, Conservative)
Some of the amendments in the group have slightly different purposes to amendment No. 92, which I will explain. The purpose of amendments Nos. 92, 93, 94 and 95 is to transfer activity using residual tissue in relation to two schedule purposes in part 1, education and training, and research, to part 2. We tabled those four amendments because part 1 deals with education and training other than that conducted using residual tissue, and research other than research conducted using residual tissue; by extension we have added the use of residual tissue to paragraph 10, and we have added a new paragraph 13 to provide that research using residual tissue would not normally require consent.
We want to debate this point because it is clear to many in the medical research and scientific community that, following the tragedies at Alder Hey and Bristol, the issues that have given rise to some of the strongest concerns about the current legislation have arisen in relation to the retention of organs and tissues of those who have died. That is not to say that concern has not been expressed about tissues retained from living persons, but they have tended to be of a lesser nature.
The question that has emerged from the medical research community, which it is proper for us to discuss, is whether, although there are differences between living persons and deceased persons, the balance of the Bill is wrong, in that, as we heard in our debate on the previous group of amendments, so many tissue samples are being, or will be, retained from living persons in the course of treatment that if consent were required it would be excessive and burdensome to the research community.
The amendments are designed to explore that issue in relation to the two purposes of research and education and training—not to the general purposes of part 1. There are safeguards in the amendments, because although consent would not normally be required, amendment No. 86, a technical amendment,
would allow standards laid down to be included in the code of practice. Amendment No. 87, to clause 24, would add a range of standards that need to be laid down, one of which relates to residual tissues. It would require, in proposed new subsection (8B):
''The standards required to be laid down by subsection (1)''—
the standards in the codes of practice of the Human Tissue Authority—
''may provide that residual tissue may be retained for scheduled purposes under paragraphs 3, 5 or 7 of Schedule 1 without consent or pursuant to a consent to treatment entered into by the person concerned.''
Clause 24(3) allows the authority to set out the exceptions to those standards. Amendment No. 99 would provide that the standards will also require that the use of residual tissue, which would not normally require consent, may none the less
''require the approval of an appropriately constituted research ethics committee.''
I shall summarise the structure that we are suggesting. Residual tissue can be used for education, training and research purposes, and for the obtaining of scientific information. Residual tissue is defined in amendment No. 88 as
''relevant material obtained, in the course of, and consequent upon, a course of diagnosis or treatment, following consent of the person concerned to treatment''.
It clearly relates to a living person consenting to treatment. It does not impact on deceased persons, other than where they have died subsequent to that consent. The tissue can be used for specific purposes, but can be used only with the consent of a properly constituted research ethics committee. I think we are getting to the point where we shall at least have a structure—which could be put into legislation—designed to reflect some good practice now.