Human Tissue Act 2004
Part 1
Removal, storage and use of human organs and other tissue for scheduled purposes
1
Authorisation of activities for scheduled purposes
2
“Appropriate consent”: children
3
“Appropriate consent”: adults
4
Nominated representatives
5
Prohibition of activities without consent etc.
6
Activities involving material from adults who lack capacity to consent
7
Powers to dispense with need for consent
8
Restriction of activities in relation to donated material
9
Existing holdings
10
Existing anatomical specimens
11
Coroners
12
Interpretation of Part 1
Part 2
Regulation of activities involving human tissue
The Human Tissue Authority
13
The Human Tissue Authority
14
Remit
15
General functions
Licensing
16
Licence requirement
17
Persons to whom licence applies
18
Duty of the designated individual
19
Right to reconsideration of licensing decisions
20
Appeals committees
21
Procedure on reconsideration
22
Appeal on point of law
23
Conduct of licensed activities
24
Changes of licence circumstance
25
Breach of licence requirement
Codes of practice
26
Preparation of codes
27
Provision with respect to consent
28
Effect of codes
29
Approval of codes
Anatomy
30
Possession of anatomical specimens away from licensed premises
31
Possession of former anatomical specimens away from licensed premises
Trafficking
32
Prohibition of commercial dealings in human material for transplantation
32A
Offences under section 32 committed outside UK
Transplants
33
Restriction on transplants involving a live donor
34
Information about transplant operations
General
35
Agency arrangements and provision of services
36
Annual report
37
Directions
38
Duties in relation to carrying out functions
Exceptions
39
Criminal justice purposes
40
Religious relics
Supplementary
41
Interpretation of Part 2
Part 3
Miscellaneous and general
Miscellaneous
42
Power of Human Tissue Authority to assist other public authorities
43
Preservation for transplantation
44
Surplus tissue
45
Non-consensual analysis of DNA
46
Power to give effect to EU obligations
47
Power to de-accession human remains
General
48
Powers of inspection, entry, search and seizure
49
Offences by bodies corporate
50
Prosecutions
51
Offences: Northern Ireland
52
Orders and regulations
53
“Relevant material”
54
General interpretation
55
Financial provisions
56
Consequential amendments
57
Repeals and revocations
58
Transition
59
Extent
60
Commencement
61
Short title
SCHEDULES
SCHEDULE 1
Scheduled purposes
Part 1
Purposes requiring consent: general
1
Anatomical examination.
2
Determining the cause of death.
3
Establishing after a person’s death the efficacy of any drug...
4
Obtaining scientific or medical information about a living or deceased...
5
Public display.
6
Research in connection with disorders, or the functioning, of the...
7
Transplantation.
Part 2
Purposes requiring consent: deceased persons
8
Clinical audit.
9
Education or training relating to human health.
10
Performance assessment.
11
Public health monitoring.
12
Quality assurance.
SCHEDULE 2
The human tissue authority
Membership
1
(1) The Authority shall consist of— (a) a chairman appointed...
Disqualification
2
A person is disqualified for being appointed as chairman of...
3
(1) A person is disqualified for being appointed as chairman...
Tenure of office
4
Subject to the following provisions of this Schedule, the chairman...
5
(1) The terms of appointment of the chairman and other...
6
Previous service as chairman or other member of the Authority...
7
A person holding office as chairman or other member of...
8
A person holding office as chairman or other member of...
9
A person may be removed from office as chairman or...
9A
The appointing authority may suspend a person from office as...
9B
(1) This paragraph applies where the appointing authority decides to...
9C
(1) This paragraph applies where a person is suspended from...
Remuneration and pensions of members
10
(1) The Authority may pay to the chairman or any...
Staff
11
The Authority may appoint such staff as it considers appropriate,...
Proceedings
12
Subject to any provision of this Act, the Authority may...
13
The validity of any proceedings of the Authority shall not...
Members' interests
14
(1) The Authority shall establish and maintain a system for...
Finance
15
The Secretary of State may out of money provided by...
Accounts and audit
16
(1) The Authority shall keep proper accounts and proper records...
Instruments
17
The application of the seal of the Authority shall be...
18
A document purporting— (a) to be duly executed under the...
Status
19
(1) The Authority is not to be regarded as the...
Supplementary powers
20
The Authority may do anything which is calculated to facilitate,...
21
The Authority may delegate any of its functions (to such...
Application of Statutory Instruments Act 1946
22
The Statutory Instruments Act 1946 (c. 36) shall apply to...
Public records
23
In Schedule 1 to the Public Records Act 1958 (c....
Investigation by Parliamentary Commissioner
24
In Schedule 2 to the Parliamentary Commissioner Act 1967 (c....
House of Commons Disqualification
25
In Part 2 of Schedule 1 to the House of...
Northern Ireland Assembly Disqualification
26
In Part 2 of Schedule 1 to the Northern Ireland...
Freedom of information
27
In Part 6 of Schedule 1 to the Freedom of...
SCHEDULE 3
Licences for the purposes of section 16
Power to grant licence
1
The Authority may on application grant a licence for the...
Characteristics of licence
2
(1) A licence shall not authorise the carrying-on of more...
3
(1) This paragraph applies to a licence authorising the storage...
4
(1) This paragraph applies to a licence authorising the activity...
Power to impose conditions
5
The Authority may grant a licence subject to such further...
Pre-conditions to grant of licence
6
(1) The Authority may not grant a licence in pursuance...
Power to revoke licence
7
(1) The Authority may revoke a licence on application by—...
Power to vary licence
8
(1) The Authority may on application by the holder of...
Power to suspend licence
9
(1) Where the Authority— (a) has reasonable grounds to suspect...
Procedure in relation to licensing decisions
10
(1) Before making a decision— (a) to refuse an application...
Notification of licensing decisions
11
(1) In the case of a decision to grant a...
Permission for the purposes of the licence condition required by paragraph 3(2)
12
(1) This paragraph applies to a licence authorising the storage...
Applications under this Schedule
13
(1) The Authority may by regulations make provision about applications...
SCHEDULE 4
Section 45: supplementary
Part 1
Qualifying consent
Introductory
1
This Part of this Schedule makes provision for the interpretation...
Qualifying consent
2
(1) In relation to analysis of DNA manufactured by the...
Application to Scotland
3
(1) In its application to Scotland, paragraph 2 has effect...
Part 2
Use for an excepted purpose
Introductory
4
This Part of this Schedule makes provision for the interpretation...
Purposes of general application
5
(1) Use of the results of an analysis of DNA...
Purpose of research in connection with disorders, or functioning, of the human body
6
(1) Use of the results of an analysis of DNA...
Purposes relating to existing holdings
7
Use of the results of an analysis of DNA for...
Purposes relating to material from body of a living person
8
Use of the results of an analysis of DNA for...
9
(1) Use of the results of an analysis of DNA...
10
Use of the results of an analysis of DNA for...
Purpose authorised under section 1
11
Use of the results of an analysis of DNA for...
Purposes relating to DNA of adults who lack capacity to consent
12
(1) Use of the results of an analysis of DNA...
Power to amend paragraphs 5, 7 and 8
13
The Secretary of State may by order amend paragraph 5,...
SCHEDULE 5
Powers of inspection, entry, search and seizure
Inspection of statutory records
1
(1) A duly authorised person may require a person to...
Entry and inspection of licensed premises
2
(1) A duly authorised person may at any reasonable time...
Entry and search in connection with suspected offence
3
(1) If a justice of the peace is satisfied on...
Execution of warrants
4
(1) Entry and search under a warrant under paragraph 3...
Seizure in the course of inspection or search
5
(1) A duly authorised person entering and inspecting premises under...
Powers: supplementary
6
(1) Power under this Schedule to enter and inspect or...
7
(1) A person’s right to exercise a power under this...
Enforcement
8
(1) A person commits an offence if—
Interpretation
9
In this Schedule, “duly authorised person”, in the context of...
SCHEDULE 6
Consequential amendments
Wills Act 1837 (c. 26)
1
In section 1 of the Wills Act 1837, in the...
Anatomy Act 1984 (c. 14)
2
In section 4 of the Anatomy Act 1984 (lawful examinations),...
Coroners Act 1988 (c. 13)
3
(1) The Coroners Act 1988 is amended as follows.
Human Organ Transplants Act 1989 (c. 31)
4
In section 1(1)(a) of the Human Organ Transplants Act 1989,...
Criminal Justice and Police Act 2001 (c. 16)
5
(1) Part 2 of the Criminal Justice and Police Act...
Enterprise Act 2002 (c. 40)
6
(1) Paragraph 3(1)(b), (2) and (3) of Schedule 2 shall...
Asylum and Immigration (Treatment of Claimants, etc.) Act 2004
7
In section 4 of the Asylum and Immigration (Treatment of...
SCHEDULE 7
Repeals and revocations
Part 1
Repeals
Part 2
Revocations

Human Tissue Act 2004
2004 c. 30
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.
[15th November 2004]
Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and consent of the Lords Spiritual and Temporal, and Commons, in this present Parliament assembled, and by the authority of the same, as follows:—
s, 14 extended (Scotland) (with modications) (27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), reg. 1(2)(3)7(1)(a)