UK Act of Parliament 2004 United Kingdom

Human Tissue Act 2004

An Act to make provision with respect to activities involving human tissue; to make provision about the transfer of human remains from certain museum collections; and for connected purposes.

Read the Act on legislation.gov.uk (opens in a new tab)
Enforced by
HFEA, HTA
Status
Amended (in force with amendments)
Penalty ceiling
Imprisonment 7 of 18 obligations carry imprisonment (3 years). 5 carry different penalties and 6 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Any Person12 Trader1 Director or Officer1

Plus 4 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Any Person — also bound by 2340 other Acts
Trader — also bound by 825 other Acts
Companies Act 2006 243 duties
Companies Act 1985 85 duties
Director or Officer — also bound by 429 other Acts
Companies Act 2006 126 duties

What it requires

Sections creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

Part 1

Removal, storage and use of human organs and other tissue for scheduled purposes

2 of 12 sections shown
s.005 Prohibition of activities without consent etc. (opens in a new tab) Imprisonment
  • Carry out activity on human tissue without appropriate consentAny Person
s.008 Restriction of activities in relation to donated material (opens in a new tab) Imprisonment
  • Use or store donated human tissue for non‑qualifying purposeAny Person
10 other sections in this Part — procedural and definitional
s.001 Authorisation of activities for scheduled purposes (opens in a new tab)
s.002 “Appropriate consent”: children (opens in a new tab)
s.003 “Appropriate consent”: adults (opens in a new tab)
s.004 Nominated representatives (opens in a new tab)
s.006 Activities involving material from adults who lack capacity to consent (opens in a new tab)
s.007 Powers to dispense with need for consent (opens in a new tab)
s.009 Existing holdings (opens in a new tab)
s.010 Existing anatomical specimens (opens in a new tab)
s.011 Coroners (opens in a new tab)
s.012 Interpretation of Part 1 (opens in a new tab)
Part 2

Regulation of activities involving human tissue

13 of 30 sections shown
s.015 General functions (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • HTA must oversee and provide guidance on human tissue activitiesStatutory regulator
s.018 Duty of the designated individual (opens in a new tab) Regulated
  • Designated individual must oversee licensed activitiesTrader
s.020 Appeals committees (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • HTA and HFEA must maintain appeals committees for licensing decisionsStatutory regulator
s.023 Conduct of licensed activities (opens in a new tab) Regulated
  • Comply with HTA directions regarding licensed activitiesAny Person
s.025 Breach of licence requirement (opens in a new tab) Imprisonment
  • Breach of licence requirement for human tissue activitiesAny Person
s.030 Possession of anatomical specimens away from licensed premises (opens in a new tab) Imprisonment
  • Possess anatomical specimen off‑licensed premisesAny Person
s.031 Possession of former anatomical specimens away from licensed premises (opens in a new tab) Imprisonment
  • Possess former anatomical specimen away from licensed premisesAny Person
s.032 Prohibition of commercial dealings in human material for transplantation (opens in a new tab) Imprisonment
  • Commercial dealing in human tissue for transplantationAny Person
s.032 Offences under section 32 committed outside UK Prosecution
  • Commercial dealing with human organs overseasAny Person

Unlimited fine

s.033 Restriction on transplants involving a live donor (opens in a new tab) Imprisonment
  • Remove or use transplant material from a living donor unlawfullyAny Person
s.034 Information about transplant operations (opens in a new tab) Prosecution
  • Fail to comply with transplant information regulationsAny Person

Unlimited fine

s.036 Annual report (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • HTA must produce and publish annual activity reportsStatutory regulator
s.038 Duties in relation to carrying out functions (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • HTA must operate effectively and follow best regulatory practiceStatutory regulator
17 other sections in this Part — procedural and definitional
s.013 The Human Tissue Authority (opens in a new tab)
s.014 Remit (opens in a new tab)
s.016 Licence requirement (opens in a new tab)
s.017 Persons to whom licence applies (opens in a new tab)
s.019 Right to reconsideration of licensing decisions (opens in a new tab)
s.021 Procedure on reconsideration (opens in a new tab)
s.022 Appeal on point of law (opens in a new tab)
s.024 Changes of licence circumstance (opens in a new tab)
s.026 Preparation of codes (opens in a new tab)
s.027 Provision with respect to consent (opens in a new tab)
s.028 Effect of codes (opens in a new tab)
s.029 Approval of codes (opens in a new tab)
s.035 Agency arrangements and provision of services (opens in a new tab)
s.037 Directions (opens in a new tab)
s.039 Criminal justice purposes (opens in a new tab)
s.040 Religious relics (opens in a new tab)
s.041 Interpretation of Part 2 (opens in a new tab)
Part 3

Miscellaneous and general

2 of 20 sections shown
s.045 Non-consensual analysis of DNA (opens in a new tab) Imprisonment
  • Conduct DNA analysis without consentAny Person
s.049 Offences by bodies corporate (opens in a new tab) Regulated
  • Corporate liability for Human Tissue Act offencesDirector or Officer
18 other sections in this Part — procedural and definitional
s.042 Power of Human Tissue Authority to assist other public authorities (opens in a new tab)
s.043 Preservation for transplantation (opens in a new tab)
s.044 Surplus tissue (opens in a new tab)
s.046 Power to give effect to EU obligations (opens in a new tab)
s.047 Power to de-accession human remains (opens in a new tab)
s.048 Powers of inspection, entry, search and seizure (opens in a new tab)
s.050 Prosecutions (opens in a new tab)
s.051 Offences: Northern Ireland (opens in a new tab)
s.052 Orders and regulations (opens in a new tab)
s.053 “Relevant material” (opens in a new tab)
s.054 General interpretation (opens in a new tab)
s.055 Financial provisions (opens in a new tab)
s.056 Consequential amendments (opens in a new tab)
s.057 Repeals and revocations (opens in a new tab)
s.058 Transition (opens in a new tab)
s.059 Extent (opens in a new tab)
s.060 Commencement (opens in a new tab)
s.061 Short title (opens in a new tab)
Schedules

Schedules

1 of 91 shown
s.005 Powers of inspection, entry, search and seizure (opens in a new tab) Prosecution
  • Fail to comply with inspection requirements or obstruct inspectionAny Person

Unlimited fine

90 other schedules
s.002 The human tissue authority (opens in a new tab)
s.003 Licences for the purposes of section 16 (opens in a new tab)
s.004 Section 45: supplementary (opens in a new tab)
s.006 Consequential amendments (opens in a new tab)
s.007 Repeals and revocations (opens in a new tab)
s.sch001 Scheduled purposes (opens in a new tab)
s.sch001 Anatomical examination.
s.sch001 Performance assessment.
s.sch001 Public health monitoring.
s.sch001 Quality assurance.
s.sch001 Determining the cause of death.
s.sch001 Establishing after a person’s death the efficacy of any drug...
s.sch001 Obtaining scientific or medical information about a living or deceased...
s.sch001 Public display.
s.sch001 Research in connection with disorders, or the functioning, of the...
s.sch001 Transplantation.
s.sch001 Clinical audit.
s.sch001 Education or training relating to human health.
s.sch002 (1) The Authority shall consist of— (a) a chairman appointed...
s.sch002 (1) The Authority may pay to the chairman or any...
s.sch002 The Authority may appoint such staff as it considers appropriate,...
s.sch002 Subject to any provision of this Act, the Authority may...
s.sch002 The validity of any proceedings of the Authority shall not...
s.sch002 (1) The Authority shall establish and maintain a system for...
s.sch002 The Secretary of State may out of money provided by...
s.sch002 (1) The Authority shall keep proper accounts and proper records...
s.sch002 The application of the seal of the Authority shall be...
s.sch002 A document purporting— (a) to be duly executed under the...
s.sch002 (1) The Authority is not to be regarded as the...
s.sch002 A person is disqualified for being appointed as chairman of...
s.sch002 The Authority may do anything which is calculated to facilitate,...
s.sch002 The Authority may delegate any of its functions (to such...
s.sch002 The Statutory Instruments Act 1946 (c. 36) shall apply to...
s.sch002 In Schedule 1 to the Public Records Act 1958 (c....
s.sch002 In Schedule 2 to the Parliamentary Commissioner Act 1967 (c....
s.sch002 In Part 2 of Schedule 1 to the House of...
s.sch002 In Part 2 of Schedule 1 to the Northern Ireland...
s.sch002 In Part 6 of Schedule 1 to the Freedom of...
s.sch002 (1) A person is disqualified for being appointed as chairman...
s.sch002 Subject to the following provisions of this Schedule, the chairman...
s.sch002 (1) The terms of appointment of the chairman and other...
s.sch002 Previous service as chairman or other member of the Authority...
s.sch002 A person holding office as chairman or other member of...
s.sch002 A person holding office as chairman or other member of...
s.sch002 A person may be removed from office as chairman or...
s.sch002 The appointing authority may suspend a person from office as...
s.sch002 (1) This paragraph applies where the appointing authority decides to...
s.sch002 (1) This paragraph applies where a person is suspended from...
s.sch003 The Authority may on application grant a licence for the...
s.sch003 (1) Before making a decision— (a) to refuse an application...
s.sch003 (1) In the case of a decision to grant a...
s.sch003 (1) This paragraph applies to a licence authorising the storage...
s.sch003 (1) The Authority may by regulations make provision about applications...
s.sch003 (1) A licence shall not authorise the carrying-on of more...
s.sch003 (1) This paragraph applies to a licence authorising the storage...
s.sch003 (1) This paragraph applies to a licence authorising the activity...
s.sch003 The Authority may grant a licence subject to such further...
s.sch003 (1) The Authority may not grant a licence in pursuance...
s.sch003 (1) The Authority may revoke a licence on application by—...
s.sch003 (1) The Authority may on application by the holder of...
s.sch003 (1) Where the Authority— (a) has reasonable grounds to suspect...
s.sch004 This Part of this Schedule makes provision for the interpretation...
s.sch004 Use of the results of an analysis of DNA for...
s.sch004 Use of the results of an analysis of DNA for...
s.sch004 (1) Use of the results of an analysis of DNA...
s.sch004 The Secretary of State may by order amend paragraph 5,...
s.sch004 (1) In relation to analysis of DNA manufactured by the...
s.sch004 (1) In its application to Scotland, paragraph 2 has effect...
s.sch004 This Part of this Schedule makes provision for the interpretation...
s.sch004 (1) Use of the results of an analysis of DNA...
s.sch004 (1) Use of the results of an analysis of DNA...
s.sch004 Use of the results of an analysis of DNA for...
s.sch004 Use of the results of an analysis of DNA for...
s.sch004 (1) Use of the results of an analysis of DNA...
s.sch005 (1) A duly authorised person may require a person to...
s.sch005 (1) A duly authorised person may at any reasonable time...
s.sch005 (1) If a justice of the peace is satisfied on...
s.sch005 (1) Entry and search under a warrant under paragraph 3...
s.sch005 (1) A duly authorised person entering and inspecting premises under...
s.sch005 (1) Power under this Schedule to enter and inspect or...
s.sch005 (1) A person’s right to exercise a power under this...
s.sch005 (1) A person commits an offence if—
s.sch005 In this Schedule, “duly authorised person”, in the context of...
s.sch006 In section 1 of the Wills Act 1837, in the...
s.sch006 In section 4 of the Anatomy Act 1984 (lawful examinations),...
s.sch006 (1) The Coroners Act 1988 is amended as follows.
s.sch006 In section 1(1)(a) of the Human Organ Transplants Act 1989,...
s.sch006 (1) Part 2 of the Criminal Justice and Police Act...
s.sch006 (1) Paragraph 3(1)(b), (2) and (3) of Schedule 2 shall...
s.sch006 In section 4 of the Asylum and Immigration (Treatment of...

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