Human Tissue Act 2004
Human Tissue Act 2004
2004 CHAPTER 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.
[15 November 2004]
B e 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:—
Part 1
Removal, storage and use of human organs and other tissue for scheduled purposes
1 Authorisation of activities for scheduled purposes
(1) The following activities shall be lawful if done with appropriate consent—
(a) the storage of the body of a deceased person for use for a purpose specified in Schedule 1, other than anatomical examination;
(b) the use of the body of a deceased person for a purpose so specified, other than anatomical examination;
(c) the removal from the body of a deceased person, for use for a purpose specified in Schedule 1, of any relevant material of which the body consists or which it contains;
(d) the storage for use for a purpose specified in Part 1 of Schedule 1 of any relevant material which has come from a human body;
(e) the storage for use for a purpose specified in Part 2 of Schedule 1 of any relevant material which has come from the body of a deceased person;
(f) the use for a purpose specified in Part 1 of Schedule 1 of any relevant material which has come from a human body;
(g) the use for a purpose specified in Part 2 of Schedule 1 of any relevant material which has come from the body of a deceased person.
(2) The storage of the body of a deceased person for use for the purpose of anatomical examination shall be lawful if done—
(a) with appropriate consent, and
(b) after the signing of a certificate—
(i) under section 22(1) of the Births and Deaths Registration Act 1953 (c. 20), or
(ii) under Article 25(2) of the Births and Deaths Registration (Northern Ireland) Order 1976 (S.I. 1976/1041 (N.I. 14)),
of the cause of death of the person.
(3) The use of the body of a deceased person for the purpose of anatomical examination shall be lawful if done—
(a) with appropriate consent, and
(b) after the death of the person has been registered—
(i) under section 15 of the Births and Deaths Registration Act 1953, or
(ii) under Article 21 of the Births and Deaths Registration (Northern Ireland) Order 1976.
(4) Subsections (1) to (3) do not apply to an activity of a kind mentioned there if it is done in relation to—
(a) a body to which subsection (5) applies, or
(b) relevant material to which subsection (6) applies.
(5) This subsection applies to a body if—
(a) it has been imported, or
(b) it is the body of a person who died before the day on which this section comes into force and at least one hundred years have elapsed since the date of the person's death.
(6) This subsection applies to relevant material if—
(a) it has been imported,
(b) it has come from a body which has been imported, or
(c) it is material which has come from the body of a person who died before the day on which this section comes into force and at least one hundred years have elapsed since the date of the person's death.
(7) Subsection (1)(d) does not apply to the storage of relevant material for use for the purpose of research in connection with disorders, or the functioning, of the human body if—
(a) the material has come from the body of a living person, and
(b) the research falls within subsection (9).
(8) Subsection (1)(f) does not apply to the use of relevant material for the purpose of research in connection with disorders, or the functioning, of the human body if—
(a) the material has come from the body of a living person, and
(b) the research falls within subsection (9).
(9) Research falls within this subsection if—
(a) it is ethically approved in accordance with regulations made by the Secretary of State, and
(b) it is to be, or is, carried out in circumstances such that the person carrying it out is not in possession, and not likely to come into possession, of information from which the person from whose body the material has come can be identified.
(10) The following activities shall be lawful—
(a) the storage for use for a purpose specified in Part 2 of Schedule 1 of any relevant material which has come from the body of a living person;
(b) the use for such a purpose of any relevant material which has come from the body of a living person;
(c) an activity in relation to which subsection (4), (7) or (8) has effect.
(11) The Secretary of State may by order—
(a) vary or omit any of the purposes specified in Part 1 or 2 of Schedule 1, or
(b) add to the purposes specified in Part 1 or 2 of that Schedule.
(12) Nothing in this section applies to—
(a) the use of relevant material in connection with a device to which Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices applies, where the use falls within the Directive, or
(b) the storage of relevant material for use falling within paragraph (a).
(13) In this section, the references to a body or material which has been imported do not include a body or material which has been imported after having been exported with a view to its subsequently being re-imported.
2 ‘Appropriate consent’: children
(1) This section makes provision for the interpretation of ‘appropriate consent’ in section 1 in relation to an activity involving the body, or material from the body, of a person who is a child or has died a child (‘the child concerned’).
(2) Subject to subsection (3), where the child concerned is alive, ‘appropriate consent’ means his consent.
(3) Where—
(a) the child concerned is alive,
(b) neither a decision of his to consent to the activity, nor a decision of his not to consent to it, is in force, and
(c) either he is not competent to deal with the issue of consent in relation to the activity or, though he is competent to deal with that issue, he fails to do so,
‘appropriate consent’ means the consent of a person who has parental responsibility for him.
(4) Where the child concerned has died and the activity is one to which subsection (5) applies, ‘appropriate consent’ means his consent in writing.
(5) This subsection applies to an activity involving storage for use, or use, for the purpose of—
(a) public display, or
(b) where the subject-matter of the activity is not excepted material, anatomical examination.
(6) Consent in writing for the purposes of subsection (4) is only valid if—
(a) it is signed by the child concerned in the presence of at least one witness who attests the signature, or
(b) it is signed at the direction of the child concerned, in his presence and in the presence of at least one witness who attests the signature.
(7) Where the child concerned has died and the activity is not one to which subsection (5) applies, ‘appropriate consent’ means —
(a) if a decision of his to consent to the activity, or a decision of his not to consent to it, was in force immediately before he died, his consent;
(b) if paragraph (a) does not apply—
(i) the consent of a person who had parental responsibility for him immediately before he died, or
(ii) where no person had parental responsibility for him immediately before he died, the consent of a person who stood in a qualifying relationship to him at that time.
3 ‘Appropriate consent’: adults
(1) This section makes provision for the interpretation of ‘appropriate consent’ in section 1 in relation to an activity involving the body, or material from the body, of a person who is an adult or has died an adult (‘the person concerned’).
(2) Where the person concerned is alive, ‘appropriate consent’ means his consent.
(3) Where the person concerned has died and the activity is one to which subsection (4) applies, ‘appropriate consent’ means his consent in writing.
(4) This subsection applies to an activity involving storage for use, or use, for the purpose of—
(a) public display, or
(b) where the subject-matter of the activity is not excepted material, anatomical examination.
(5) Consent in writing for the purposes of subsection (3) is only valid if—
(a) it is signed by the person concerned in the presence of at least one witness who attests the signature,
(b) it is signed at the direction of the person concerned, in his presence and in the presence of at least one witness who attests the signature, or
(c) it is contained in a will of the person concerned made in accordance with the requirements of—
(i) section 9 of the Wills Act 1837 (c. 26), or
(ii) Article 5 of the Wills and Administration Proceedings (Northern Ireland) Order 1994 (S.I. 1994/1899 (N.I. 13)).
(6) Where the person concerned has died and the activity is not one to which subsection (4) applies, ‘appropriate consent’ means—
(a) if a decision of his to consent to the activity, or a decision of his not to consent to it, was in force immediately before he died, his consent;
(b) if—
(i) paragraph (a) does not apply, and
(ii) he has appointed a person or persons under section 4 to deal after his death with the issue of consent in relation to the activity,
consent given under the appointment;
(c) if neither paragraph (a)...
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