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Standing Committee G
Thursday 5 February 2004
(Morning)
[Mr. Alan Hurst in the Chair]
Clause 30
Restriction on transplants involving a live donor
9.10 am
Dr. Richard Taylor (Wyre Forest) (Ind): I beg to move amendment No. 56, in
clause 30, page 20, line 41, leave out from 'shall' to end of line 45 and add—
'(a) set out the circumstances in which decisions of the Authority in relation to matters which fall to be decided by it under the regulations shall be subject to reconsideration, and
(b) prescribe the procedure to be followed for such reconsideration.'.
I regret that we did not reach this clause on Tuesday because the Ministers were in such a mood of generosity and kindness that I would like to have moved the amendment then. It is simply a drafting amendment. The Under-Secretary talked about darkness descending upon him. Well, every time I look at the wording of the clause, darkness descends on me. I am sure that the Ministers were not responsible for its wording, so I can be very rude about it. The word ''regulations'' is used four times; the phrase ''regulations may provide'' is used twice; and phrases such as ''subject to'' and ''in accordance with'' are also included. Even a child at school would know that the same words and phrases should not be used time and again. Assuming that the hon. Member for Oxford, West and Abingdon (Dr. Harris) and I, and the staff of the House who helped us draft the amendment, have understood the clause correctly—I am still in doubt about that—is not our wording easier to understand and less opaque?
I finish with the advice of a Chinese philosopher, Chang Tzu, writing in 300 BC. I cannot resist reading a bit more than I need because the oriental imagery is so marvellous. He wrote:
''The sage has the sun and moon by his side. He grasps the universe under the arm. He blends everything into a harmonious whole and casts aside whatever is confused or obscured''.
Dr. Evan Harris (Oxford, West and Abingdon) (LD): Before the hon. Gentleman sits down, is it not worth reading out subsection (4); otherwise readers of Hansard might not be aware what it is he objects to?
Dr. Taylor: Indeed. Subsection (4) states:
''Regulations under subsection (3) shall include provision for decisions of the Authority in relation to matters which fall to be decided by it under the regulations to be subject, in such circumstances as the regulations may provide, to reconsideration in accordance with such procedure as the regulations may provide.''
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Dr. Andrew Murrison (Westbury) (Con): Interestingly, the guidance notes that are provided for our edification on the more obscure parts of the Bill are completely silent about the clause. Clearly those responsible for drafting the guidance notes felt, as the hon. Member for Wyre Forest (Dr. Taylor) feels, that the clause is completely impenetrable. To that extent I support the thrust of his argument and his amendment. Will the Under-Secretary tell us what situations he can perceive that would bear on the circumstances quoted in the clause and, perhaps, explain why the clause is here in the first place? Might it not be more appropriate to ditch it altogether?
The Parliamentary Under-Secretary of State for Health (Dr. Stephen Ladyman): Difficult, certainly, but not impenetrable—that is how I would describe the clause. Biology is complicated, which is why the brightest people become biologists. People who are not quite bright enough to be biologists but are still quite bright become lawyers, and they will help us to unravel the clause.
I understand the general concern that the hon. Member for Wyre Forest, other hon. Members and practising researchers and clinicians will have about the Bill's complexity, but I will give the hon. Gentleman an analogy. I am sure that all his constituents pretty much understand the laws that govern the use of our roads. We do not expect them to understand all the legislation, but we have provided them with the highway code, which they are expected to read, understand and be tested on. The code is a changing document that is revised, moves with the times and is written in plain English.
The people who will have to work under the provisions in the Bill will not be using its wording but following a ''highway code'' on best practice guidance that the Human Tissue Authority will provide. That guidance will be easy to follow and written in plain English, and we will expect people to understand it. People should not get too worked up about the fact that some lines and paragraphs in the Bill will be more understandable to lawyers than to the rest of us. Unfortunately, although the amendment might result in easier reading, it would change the clause's intention and is clearly deficient. On that basis, I ask the hon. Gentleman to withdraw it.
Paragraph (a) of the amendment appears to suggest that provision for reconsideration of decisions by the authority is already required under subsection (3) and that the duty under paragraph (a) is simply to spell out the circumstances in which reconsideration applies and to prescribe the procedures for that. In fact, reconsideration of decisions by the authority is not covered by the power in subsection (3). Subsection (4) states that, if the Secretary of State makes regulations under subsection (3) to say when live transplants may go ahead, they must include provision for reconsideration of decisions made under those regulations. It also provides for powers to set out the circumstances in which reconsideration applies and a power to define the procedure.
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Subsection (4) is a carefully drafted provision that ensures that an appropriate mechanism will be available for the reconsideration of decisions that the authority may make under the regulations. It is right to keep that provision, which achieves the right effect. It will inform the drafting of regulations, but it will not be of direct concern to practitioners.
The suggested phrase
''the procedure to be followed for such reconsideration''
implies that the procedure is for the initiation of a reconsideration, whereas we have in mind something more general, which also captures the procedure to be followed in the implementation of the reconsideration.
I mention such points of detail to show that the Bill's provisions are the result of careful consideration and drafting. Although it may appear to some that certain provisions are overly complex, there are good reasons for the wording, which was chosen with great care. Will the hon. Gentleman at least accept my assurance that practitioners will not have to follow the wording, as the authority will provide plain English guidance for them. I hope that he will be comforted and withdraw the amendment.
Dr. Taylor: I am very relieved; I thought that, having said that biologists were the brightest, the Under-Secretary was going to add that doctors were the dullest, but at least he avoided saying that.
I am sad, as such tortuous writing, even in a document meant for lawyers rather than the general public—the gist of the Under Secretary's argument—brings this place into a degree of disrepute. However, the hon. Gentleman has assured us that it is carefully drafted and that our wording does not cover the points exactly, so I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 30 ordered to stand part of the Bill.
Clauses 31 to 34 ordered to stand part of the Bill.
Clause 35
Remit of Inspectorate of Organ and Tissue for Human Use
Dr. Murrison: 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
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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.
Dr. Ladyman: 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.
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