요약
The Human Tissue Act 2004 was enacted in the wake of the Alder Hey and Bristol organ-retention scandals, in which children's organs had been removed and retained without their parents' knowledge. It makes consent the fundamental principle governing the removal, storage, and use of human tissue ('relevant material') from the living and the deceased for 'scheduled purposes' such as transplantation, research, and education (s.1). It established the Human Tissue Authority (s.13) to license and regulate establishments that store and use human tissue, prohibits commercial dealings in organs for transplantation (s.32), and creates criminal offences including the non-consensual analysis of DNA (s.45). The consent model was later supplemented by an opt-out ('deemed consent') system for organ donation in England.
핵심 포인트
- Appropriate consent is the fundamental principle for storage and use of human tissue for scheduled purposes (s.1)
- Human Tissue Authority (HTA) established as the regulator (s.13)
- Licensing system for establishments that remove, store, or use human tissue
- Prohibition of commercial dealings in human material for transplantation (s.32)
- Non-consensual analysis of DNA is a criminal offence (s.45)
- Organ donation moved to an opt-out 'deemed consent' system in England (2019 amendment)
편과 조
개정 이력
2019 — Organ Donation (Deemed Consent) Act 2019
Introduced the opt-out 'deemed consent' system for organ and tissue donation in England (Max and Keira's Law).