The Act
8.The Act will repeal and replace the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they relate to England and Wales. It will also repeal and replace the Human Tissue Act (Northern Ireland) 1962, the Human Organ Transplants (Northern Ireland) Order 1989 and the Anatomy (Northern Ireland) Order 1992.
9.The Act is in three parts and has seven schedules:
Part 1 is about consent. It sets out the requirement to obtain appropriate consent to carry out activities regulated under the Act: storage and use of whole bodies, removal, storage and use of human material (organs, tissues and cells) from the bodies of deceased persons, and storage and use of material from living people, for purposes set out in Schedule 1. It defines appropriate consent by reference to who may give it, and provides for a 'nominated representative' who may make decisions about regulated activities after a person’s death. Part 1 makes it an offence to carry out regulated activities without appropriate consent, makes it unlawful to use bodies or human material, once donated, for purposes other than those set out in Schedule 1 and establishes penalties. Part 1 also sets out what should happen to 'existing holdings' of human material obtained before the consent provisions take effect. This Part also exempts coroners from the requirements of Part 1 of the Act, and allows storage and use of human material, obtained from living persons, for specified purposes without consent.
Part 1 does not apply to the removal (as opposed to the storage and use) of human material from living persons. The current law will continue to apply to that. Nor does Part 1 affect the existing law on storage and use of human material for purposes other than those mentioned in Part 1.
Part 2is about the regulatory system to be established to make sure that regulated activities are carried out in a proper manner. It sets up the Human Tissue Authority (HTA) with a remit covering removal, storage, use and disposal of human material. It also sets out the range of activities for which a licence from the HTA is required. It prohibits the conduct of those activities without a licence and establishes penalties for so doing. This Part also sets out who will be responsible for a licence, their duties under a licence and related procedures. It provides for the HTA to issue codes of practice concerning the proper conduct of activities within its remit, to issue directions and make reports. Part 2 brings the regulation of transplants between living persons under the HTA and prohibits commercial dealing in human material.
Part 3deals with various important supplementary issues and general provisions. Section 43 makes it clear that it is lawful for hospital authorities to take the minimum steps to preserve the organs of deceased persons whilst appropriate consent to transplantation is sought. Section 44 provides for disposal of human material which is no longer to be kept. Section 45 makes it an offence, with specified exceptions, for a person to have human material with a view to analysing its DNA without consent. Section 47 creates a power for certain national museums to transfer human remains out of their collections if they think it appropriate to do so. This Part also contains general provisions including powers of inspection, entry, search and seizure, the power to make regulations and orders by way of statutory instruments, interpretation and consequential changes to existing statutes.
