Clause 13 - Licence requirement
Human Tissue Bill
10:45 am
Dr Stephen Ladyman (Parliamentary Under-Secretary, Department of Health; South Thanet, Labour)
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.