Clause 35 - Remit of Inspectorate of Organ and Tissue for Human Use
Human Tissue Bill
9:10 am
Dr Stephen Ladyman (Parliamentary Under-Secretary, Department of Health; South Thanet, Labour)
The impact of the amendment would be to remove blood stem cells—haematopoietic cells—from the Bill, and that is not our intention. Blood and blood derivatives would not be covered by the constraints of the Bill, but bone marrow should be. Therefore, the wording of the subsection is appropriate.
Blood stem cells are contained in bone marrow, and the amendment would leave bone marrow transplantation out of the regulatory scheme. That would be wholly inconsistent with the general approach to, and structure of, licensing and regulation of tissue under the Bill and in our wider scheme of law.
The Bill's scope extends to all relevant material, and for the purposes of part 1, which deals with consent, that means all material from a human body except material covered by the Human Fertilisation and Embryology Act 1990—sperm, eggs and embryos—and hair and nails. In respect of the need for consent, the Bill therefore includes blood and blood precursor cells.
The remit of the Human Tissue Authority is set out in clause 11. Under subsection (5), the remit excludes
''blood or anything derived from blood''
when used for the purpose of transplantation, which in this case means transfusion. The remit of the inspectorates relates to the authority's general remit. Therefore, the remit of the inspectorate of organ and tissue for human use, as outlined in clause 35, also excludes
''blood or anything derived from blood.''
The reason for that exclusion is that provision is already made for the regulation of blood and blood products for human application under the EU blood directive. We do not wish to duplicate that.
To create a consistent and comprehensive framework, the principle underlying the Bill is to regulate all human cells unless they are regulated elsewhere or do not need to be, as is the case with hair and nails.