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UK Act of Parliament
2004
United Kingdom
Human Tissue Act 2004
At a glance
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Any Person 12
- Trader 1
- Director or Officer 1
Plus 4 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
Step-by-step journeys using this legislation
Walkthroughs that take you from a real business situation to compliance.
Relevant guidance
Practical guides for businesses affected by this Act, ordered by how closely they engage with it.
Direct — cites this Act
1 guidesSupporting — topic alignment
3 guidesOther Acts binding the same actors
For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.
Any Person also bound by 2338 other Acts (top 5 shown)
- Human Medicines Regulations 2012 2012 169 duties
- Merchant Shipping Act 1995 1995 144 duties
- Insolvency (England and Wales) Rules 2016 2016 101 duties
- Road Traffic Act 1988 1988 95 duties
- Air Navigation Order 2016 2016 95 duties
Traders also bound by 826 other Acts (top 5 shown)
- Value Added Tax Regulations 1995 1995 413 duties
- Companies Act 2006 2006 243 duties
- The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 2008 114 duties
- Insolvency (England and Wales) Rules 2016 2016 62 duties
- Building Societies Act 1986 1986 56 duties
Directors and Officers also bound by 425 other Acts (top 5 shown)
- Insolvency (England and Wales) Rules 2016 2016 161 duties
- Companies Act 2006 2006 108 duties
- Insolvency Act 1986 1986 72 duties
- The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 2008 55 duties
- The Housing Administration (England and Wales) Rules 2018 2018 26 duties
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
Prohibition of activities without consent etc.
3 years imprisonment- Carry out activity on human tissue without appropriate consent Any Person
Restriction of activities in relation to donated material
3 years imprisonment- Use or store donated human tissue for non‑qualifying purpose Any Person
Browse 10 other sections in this Part — procedural / definitional / commencement
Authorisation of activities for scheduled purposes
“Appropriate consent”: children
“Appropriate consent”: adults
Nominated representatives
Activities involving material from adults who lack capacity to consent
Powers to dispense with need for consent
Existing holdings
Existing anatomical specimens
Coroners
Interpretation of Part 1
Part 2 — Regulation of activities involving human tissue
General functions
Other duties (1) — Crown / regulator
- HTA must oversee and provide guidance on human tissue activities Statutory regulator
Duty of the designated individual
- Designated individual must oversee licensed activities Trader
Appeals committees
Other duties (1) — Crown / regulator
- HTA and HFEA must maintain appeals committees for licensing decisions Statutory regulator
Conduct of licensed activities
- Comply with HTA or HFEA directions regarding licensed activities Any Person
Breach of licence requirement
3 years imprisonment- Breach of licence requirement for human tissue activities Any Person
Possession of anatomical specimens away from licensed premises
3 years imprisonment- Possess anatomical specimen off‑licensed premises Any Person
Possession of former anatomical specimens away from licensed premises
3 years imprisonment- Possess former anatomical specimen away from licensed premises Any Person
Prohibition of commercial dealings in human material for transplantation
3 years imprisonment- Commercial dealing in human tissue for transplantation Any Person
Offences under section 32 committed outside UK
Unlimited fine- Commercial dealing with human organs overseas Any Person
Restriction on transplants involving a live donor
51 weeks imprisonment- Remove or use transplant material from a living donor unlawfully Any Person
Information about transplant operations
Unlimited fine- Fail to comply with transplant information regulations Any Person
Annual report
Other duties (1) — Crown / regulator
- HTA and HFEA must produce and publish annual activity reports Statutory regulator
Duties in relation to carrying out functions
Other duties (1) — Crown / regulator
- HTA and HFEA must operate effectively and follow best regulatory practice Statutory regulator
Browse 17 other sections in this Part — procedural / definitional / commencement
The Human Tissue Authority
Remit
Licence requirement
Persons to whom licence applies
Right to reconsideration of licensing decisions
Procedure on reconsideration
Appeal on point of law
Changes of licence circumstance
Preparation of codes
Provision with respect to consent
Effect of codes
Approval of codes
Agency arrangements and provision of services
Directions
Criminal justice purposes
Religious relics
Interpretation of Part 2
Part 3 — Miscellaneous and general
Non-consensual analysis of DNA
3 years imprisonment- Conduct DNA analysis without consent Any Person
Offences by bodies corporate
- Corporate liability for Human Tissue Act offences Director or Officer
Browse 18 other sections in this Part — procedural / definitional / commencement
Power of Human Tissue Authority to assist other public authorities
Preservation for transplantation
Surplus tissue
Power to give effect to EU obligations
Power to de-accession human remains
Powers of inspection, entry, search and seizure
Prosecutions
Offences: Northern Ireland
Orders and regulations
“Relevant material”
General interpretation
Financial provisions
Consequential amendments
Repeals and revocations
Transition
Extent
Commencement
Short title
Schedules
Powers of inspection, entry, search and seizure
Unlimited fine- Fail to comply with inspection requirements or obstruct inspection Any Person
Browse 90 other Schedules — structural / supplementary
The human tissue authority
Licences for the purposes of section 16
Section 45: supplementary
Consequential amendments
Repeals and revocations
Scheduled purposes
Anatomical examination.
Performance assessment.
Public health monitoring.
Quality assurance.
Determining the cause of death.
Establishing after a person’s death the efficacy of any drug...
Obtaining scientific or medical information about a living or deceased...
Public display.
Research in connection with disorders, or the functioning, of the...
Transplantation.
Clinical audit.
Education or training relating to human health.
(1) The Authority shall consist of— (a) a chairman appointed...
(1) The Authority may pay to the chairman or any...
The Authority may appoint such staff as it considers appropriate,...
Subject to any provision of this Act, the Authority may...
The validity of any proceedings of the Authority shall not...
(1) The Authority shall establish and maintain a system for...
The Secretary of State may out of money provided by...
(1) The Authority shall keep proper accounts and proper records...
The application of the seal of the Authority shall be...
A document purporting— (a) to be duly executed under the...
(1) The Authority is not to be regarded as the...
A person is disqualified for being appointed as chairman of...
The Authority may do anything which is calculated to facilitate,...
The Authority may delegate any of its functions (to such...
The Statutory Instruments Act 1946 (c. 36) shall apply to...
In Schedule 1 to the Public Records Act 1958 (c....
In Schedule 2 to the Parliamentary Commissioner Act 1967 (c....
In Part 2 of Schedule 1 to the House of...
In Part 2 of Schedule 1 to the Northern Ireland...
In Part 6 of Schedule 1 to the Freedom of...
(1) A person is disqualified for being appointed as chairman...
Subject to the following provisions of this Schedule, the chairman...
(1) The terms of appointment of the chairman and other...
Previous service as chairman or other member of the Authority...
A person holding office as chairman or other member of...
A person holding office as chairman or other member of...
A person may be removed from office as chairman or...
The appointing authority may suspend a person from office as...
(1) This paragraph applies where the appointing authority decides to...
(1) This paragraph applies where a person is suspended from...
The Authority may on application grant a licence for the...
(1) Before making a decision— (a) to refuse an application...
(1) In the case of a decision to grant a...
(1) This paragraph applies to a licence authorising the storage...
(1) The Authority may by regulations make provision about applications...
(1) A licence shall not authorise the carrying-on of more...
(1) This paragraph applies to a licence authorising the storage...
(1) This paragraph applies to a licence authorising the activity...
The Authority may grant a licence subject to such further...
(1) The Authority may not grant a licence in pursuance...
(1) The Authority may revoke a licence on application by—...
(1) The Authority may on application by the holder of...
(1) Where the Authority— (a) has reasonable grounds to suspect...
This Part of this Schedule makes provision for the interpretation...
Use of the results of an analysis of DNA for...
Use of the results of an analysis of DNA for...
(1) Use of the results of an analysis of DNA...
The Secretary of State may by order amend paragraph 5,...
(1) In relation to analysis of DNA manufactured by the...
(1) In its application to Scotland, paragraph 2 has effect...
This Part of this Schedule makes provision for the interpretation...
(1) Use of the results of an analysis of DNA...
(1) Use of the results of an analysis of DNA...
Use of the results of an analysis of DNA for...
Use of the results of an analysis of DNA for...
(1) Use of the results of an analysis of DNA...
(1) A duly authorised person may require a person to...
(1) A duly authorised person may at any reasonable time...
(1) If a justice of the peace is satisfied on...
(1) Entry and search under a warrant under paragraph 3...
(1) A duly authorised person entering and inspecting premises under...
(1) Power under this Schedule to enter and inspect or...
(1) A person’s right to exercise a power under this...
(1) A person commits an offence if—
In this Schedule, “duly authorised person”, in the context of...
In section 1 of the Wills Act 1837, in the...
In section 4 of the Anatomy Act 1984 (lawful examinations),...
(1) The Coroners Act 1988 is amended as follows.
In section 1(1)(a) of the Human Organ Transplants Act 1989,...
(1) Part 2 of the Criminal Justice and Police Act...
(1) Paragraph 3(1)(b), (2) and (3) of Schedule 2 shall...
In section 4 of the Asylum and Immigration (Treatment of...
Official guidance
Authoritative sources published by regulators or government explaining this legislation.
- Coroners' post-mortem examination FAQs | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Organ donation and transplantation: the legal framework | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Types of living organ donation | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Roles of the HTA and NHSBT | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Living organ donation matching websites and social media | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- The Independent Assessment process | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Living organ donation | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Deceased organ and tissue donation for transplants | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Bone marrow and peripheral blood stem cell (PBSC) donation | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Body donation | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- ... and 69 more
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
HFEA
PrimaryHuman Fertilisation and Embryology Authority
Licences and monitors fertility clinics and research centres in the UK. Regulates the creation, storage, and use of human embryos and gametes.
Human Tissue Authority
Statutory regulator for activities involving human tissue and organs. Licenses establishments that store and use human tissue for purposes including research, transplantation, …
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Browse legislation
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Regulators
Learn more about the bodies that enforce this legislation.