Last amended by Organ Donation (Deemed Consent) Act 2019 in 2019. Introduced the opt-out 'deemed consent' system for organ and tissue donation in England (Max and Keira's Law).
Independent editorial summary — not the official statute text. Read the official version on legislation.gov.uk.
Summary
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.
Key Points
- 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)
Parts & Sections
Amendments History
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).
Frequently asked questions
- Why was the Human Tissue Act 2004 created?
- The Human Tissue Act 2004 was enacted following the Alder Hey and Bristol organ-retention scandals, where children's organs were kept without parental knowledge. It establishes consent as the fundamental principle for removing, storing, and using human tissue for scheduled purposes like transplantation, research, and education. The Act also created the Human Tissue Authority to regulate these activities.
- Who regulates the storage and use of human tissue in the UK?
- The Human Tissue Authority (HTA) is the regulatory body established by the Act. It is responsible for licensing and regulating establishments that remove, store, or use human tissue. It is unlawful to carry out licensable activities, such as storing human tissue, without holding a valid HTA licence.
- Is it legal to sell or buy organs for transplantation?
- Yes, it is a criminal offence to give or receive a reward for supplying human material for transplantation. The Act also prohibits brokering such commercial dealings. This ensures that organ and tissue donation remains a voluntary, non-commercial process.
- How does the opt-out system for organ donation work in England?
- In England, organ and tissue donation operates under an opt-out 'deemed consent' system, introduced by the Organ Donation (Deemed Consent) Act 2019. This means individuals are considered to have consented to donation unless they have explicitly recorded a decision not to donate. This system supplements the general consent model for other tissue uses.
- Can someone be prosecuted for analysing my DNA without my permission?
- Yes, the Act creates a criminal offence for holding bodily material with the intent to analyse its DNA without qualifying consent. This provision is designed to protect individuals from non-consensual genetic testing, subject to specific excepted purposes.