The purpose of the HT Act is to provide a consistent legislative framework for issues relating to the collection, storage, use and disposal of human tissue (including organs and whole bodies). It applies to England, Wales and Northern Ireland. There is separate legislation in Scotland (Human Tissue Act (Scotland) 2006).
The HT Act allowed for the establishment of the Human Tissue Authority (HTA) in April 2005 as the regulatory and licensing authority and enabled licences to be issued to organisations storing tissue for human application (i.e. the use of human tissue to treat patients, for example, transplantation) from April 2006 and licences for all other activities (i.e. scheduled purposes, such as research) from September 2006.
The HT Act makes consent the fundamental principle underpinning the lawful storage and use of body parts, organs and tissue from the living or the deceased for specified health-related purposes and public display (Scheduled Purposes). It also covers the removal of such material from the deceased.
The HT Act regulates the removal, storage and use of human tissue – defined as material that has come from the human body and consists of, or includes, human cells (Relevant Material). Cell lines that have divided outside the human body are excluded, as is hair and nail from the living. Live gametes and embryos are also excluded as they are covered by regulation under the Human Fertilisation and Embryology Act 2008.
Offences under the HT Act, with penalties ranging from a fine to up to three years’ imprisonment, or both, include:
- removing, storing or using human tissue for Scheduled Purposes without appropriate consent;
- storing or using human tissue donated for a Scheduled Purpose for another purpose;
- trafficking in human tissue for transplantation purposes;
- carrying out licensable activities without holding a licence from the HTA;
- having human tissue, including hair, nail and gametes (i.e. cells connected with sexual reproduction), with the intention of its DNA being analysed, without the consent of the person from whom the tissue came or of those close to them if they have died. Medical diagnosis and treatment, criminal investigations, etc. are excluded.
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