Clause 13 - Licence requirement

Human Tissue Bill – in a Public Bill Committee at 10:45 am on 3rd February 2004.

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Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health) 10:45 am, 3rd February 2004

I beg to move amendment No. 156, in

clause 13, page 10, line 27, at end insert 'normally requiring consent'.

Photo of Mr Alan Hurst Mr Alan Hurst Labour, Braintree

With this it will be convenient to discuss the following:

Amendment No. 32, in

clause 13, page 10, line 32, leave out subsection (3).

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

We deal now with licence requirements—in the context of amendment No. 156, the licence requirements for the storage of body parts. We have already heard about the need to clarify aspects of the Bill, and my hon. Friends and I feel that some clarification of subsection (2)(e)(ii) is due. Such clarification would be helped by the amendment, which would exclude part 2 of the schedule 1 purposes. At the moment, that is not clear. It would be helpful if it were very clear that the Under-Secretary does not intend those part 2 purposes to require licensing, and our amendment would achieve that.

Amendment No. 32 is simple. I expect that the Under-Secretary will perceive a theme running through our amendments: we seek to clip the powers of the Secretary of State. Amendment No. 32 would do that. Meanwhile, will the Minister comment on the circumstances that would result in the exception referred to in subsection (3)?

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

It is important to restate the principle behind the way in which we have structured the Bill. The Bill intends to provide a strong statutory framework, with as much flexibility as possible in it. That is why we have chosen to do certain things through regulation and best practice guidance, rather than including them in the Bill. I fear that the hon. Gentleman's amendments go against that principle.

For example, amendment No.156 would limit the licensing requirement for tissue storage to storage for part 1 purposes. Storage for use for purposes in part 2 of schedule 1 would not be licensable. Under subsection (2)(e)(ii), the licensing requirement for tissue storage applies to living and post mortem tissue. The hon. Gentleman's amendment would mean that tissue from living patients would not need consent of use for part 2 purposes, and might not need strict regulation. One might argue that point. However, his amendment would also exempt from the licensing requirement the storage of post mortem tissue for part

2 purposes. Such tissue is subject to consent requirements, and for that reason we want it to be subject to the licensing scheme. In many cases, living and post mortem tissue will be kept in the same institutions; it would be impractical to operate separate regimes for different types of tissue.

The Human Tissue Authority will give guidance under clause 23 on the storage for use of all such tissue, and it will establish appropriate licensing and inspection mechanisms for the various activities that fall under subsection (2). Given our approach of maintaining flexibility in the statutory framework, the Human Tissue Authority will be able to apply different approaches in different circumstances, depending on the nature or scale of the activity. For example, it would exercise a more rigorous overview of safety and quality matters in tissue storage for human application than in tissue storage for other uses.

It is important to recognise the significance of human tissue and that, whether it is from living patients or from the deceased, it should be subject to common principles and approaches. For that reason, it is all subject to the appropriate oversight from the Human Tissue Authority. To remove from the licence requirement all tissue for all part 2 purposes would risk lack of oversight in potentially sensitive areas of activity. I hope that, with that explanation, the hon. Gentleman will see fit to withdraw his amendment.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health) 11:00 am, 3rd February 2004

I am very grateful to the Under-Secretary for that reply, but he has not addressed amendment No. 32, and he may want to do so. In respect of amendment No. 156, I am partially reassured. Having earlier accused the Under-Secretary of pedantry, I must turn that on myself, because the part 2 scheduled purposes would almost certainly be covered by a licence that was provided for under part 1.

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

I am sorry that I did not clarify our position on amendment No. 32; I thought that I had explained it in my introductory remarks. We want to achieve the highest possible ethical standards in respect of all of our operations, including those that involve tissue banks. We believe that we can establish those ethical standards, but within a strong statutory framework, and the amendment is unnecessary because it would not allow us flexibility within that framework.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

I am grateful for that clarification, which is fine. The part 2 scheduled purposes would be carried out by licensed persons on licensed premises because they would also be engaged in part 1 scheduled purposes. I think that the Under-Secretary is saying that licensing would not be viewed as addressing part 2 purposes principally, but as addressing part 1 purposes, given that those who are operating under the licence would be participating in part 1 purposes on premises that are principally licensed because of the need to conduct those part 1 purposes. That is a terribly twisted way of putting it, but I am sure that the

Under-Secretary understands me. If that is the case, I am happy to beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 13 ordered to stand part of the Bill.