Human Tissue Act 2004

Human Tissue Act 2004

2004 CHAPTER 30

Commentary on Sections

Part 2 - Regulation of Activities Involving Human Tissue

Licensing

Section 16: Licence Requirements

33. Subsection (1) prohibits the carrying on of activities to which the section applies without a licence.  Subsection (2) sets out the activities to which the licence requirement applies.  Subsection (3) provides that the Secretary of State may by regulations specify circumstances in which storage of relevant material by a person who intends to use it for a scheduled purpose is excepted from the licence requirement.  This will allow distinction to be made between tissue banks, for example, and individuals using tissue in research projects, who will not then require to be licensed.  Subsection (4) excludes from the licensing requirement activities done in relation to material from bodies, or bodies, where the person died before the Act comes into force and has been dead for at least 100 years.  Subsection (5) provides that the Secretary of State may by regulations add, remove or alter the description of an activity listed in the section.Subsection (7) excludes from the licence requirement storage incidental to transportation.  It also excludes use of blood or blood products for transplantation, and storage of blood or blood products for use for that purpose.  Schedule 3 contains the detailed procedures for granting, varying, revoking and suspending licences.  Licensing functions under the Schedule are conferred on the HTA.