Clause 35 - Remit of Inspectorate of Organ and Tissue for Human Use

Human Tissue Bill – in a Public Bill Committee at 9:10 am on 5th February 2004.

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Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health) 9:10 am, 5th February 2004

I beg to move amendment No. 130, in

clause 35, page 24, line 6, after 'blood', insert 'blood precursors'.

The clause contains an omission, which the Under-Secretary will be keen to correct. ''Relevant material'', referred to in subsection (3), is said to exclude

''blood or anything derived from blood.''

That appears not to take account of bone marrow, and I assume that it would be the hon. Gentleman's intention to include that.

The wording of my amendment is a bit of a nonsense and, as the Under-Secretary commented on how we are all keen on plain English, I shall suggest an amendment to my amendment. My amendment would change the subsection to read: ''In this section, 'relevant material' does not include blood, blood

precursors or anything derived from blood.'' That clearly makes no sense. Of course, I intended it to read: ''In this section, 'relevant material' does not include blood or anything derived from blood or blood precursors'', with specific reference to bone marrow, and I suspect that that is the hon. Gentleman's intention.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

Will the Under-Secretary confirm that the inclusion of bone marrow would include autologous transfusion, in which bone marrow is taken from the patient and put back into the patient? Will the same apply to other human tissue for those purposes?

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

Yes, I believe that I can confirm that, but if I change my mind before I finish speaking, I will let the hon. Gentleman know.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

My hon. Friend will not change his mind.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

No, I will not change my mind.

Blood and blood derivatives fall under the consent provisions, but their procurement, storage and use are excluded from regulation, because they will be dealt with by arrangements being set up under the blood directive. A designated competent authority will carry out inspections under legislation following the blood directive.

However, blood precursors—blood stem cells—are not regulated under the blood directive, so the amendment would remove storage and use of blood precursors from regulation by the appropriate inspectorate. That would mean removing bone marrow transplantation from the oversight of the inspectorate, undermining the comprehensive scope of the regulatory regime. That would be inappropriate, as I hope hon. Members will agree.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

According to the Under-Secretary's answer to my previous question, he is saying that the remit of the authority and the inspectorates will include bone marrow or other tissue taken during an operation that is treated intra-operatively—within the operation—and then put back, because it had been taken out of the body, for example, to transfect for gene therapy or something else. Is that really his intention?

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

That will be within the remit, but not licensable. If I can clarify that further later on, I will certainly do so. With those explanations, I hope that the hon. Member for Westbury (Dr. Murrison) will accept that he should withdraw the amendment.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

Given the explanation and the assurances, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 35 ordered to stand part of the Bill.