Human Tissue Act 2004

1 Authorisation of activities for scheduled purposes E+W+N.I.

(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.

F1 (1A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The storage of the body of a deceased person for use for the purpose of anatomical examination shall be lawful [F2 if done with the appropriate consent and after—

(a) the confirmation of the cause of death by a medical examiner in accordance with regulations under section 20(1)(f)(i) of the Coroners and Justice Act 2009 or the issue by a medical examiner of a certificate of the cause of death in accordance with regulations under section 20(1)(h)(i) of that Act, or

(b) the signing of a certificate under Article 25(2) of the Births and Deaths Registration (Northern Ireland) Order 1976 of the cause of the person's death.]

(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.

[F3 (9A) Subsection (1)(f) does not apply to the use of relevant material for the purpose of research where the use of the material requires consent under paragraph 6(1) or 12(1) of Schedule 3 to the Human Fertilisation and Embryology Act 1990 (use of human cells to create an embryo or a human admixed embryo) or would require such consent but for paragraphs 16 and 20 of that Schedule.]

[F4 (9B) Subsection (1) does not apply in relation to—

(a) transplantation activities done in Wales; or

(b) transplantation activities done outside Wales in relation to relevant material that was removed from a human body in Wales.]

[F5 (9C) Subsection (1) does not apply in relation to the following activities done in Northern Ireland in relation to relevant material that was removed from a human body in England—

(a) the storage for use for the purpose of transplantation of the relevant material;

(b) the use for the purpose of transplantation of the relevant material.]

(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) [F6 , (8) [F7 , (9B)(b) or (9C)]] has effect.

[F8 (10A) In the case of an activity in relation to which subsection (8) has effect, subsection (10)(c) is to be read subject to any requirements imposed by Schedule 3 to the Human Fertilisation and Embryology Act 1990 in relation to the activity.]

(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—

[F9 (a) the use of relevant material to the extent that such use is regulated by—

(i) the Medical Devices Regulations 2002 (S.I. 2002/618),

(ii) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, or

(iii) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, 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.

[F10 (14) In this section “ transplantation activities ” has the same meaning as in the Human Transplantation (Wales) Act 2013 (which makes provision in relation to consent for transplantation activities done in Wales). ]

Textual Amendments

F1 S. 1(1A) inserted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(2)(a), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e); and omitted (1.12.2015) by virtue of The Human Transplantation (Wales) Act 2013 (Consequential Provision) Order 2015 (S.I. 2015/865), arts. 1(2), 2(2)(a)

F2 Words in s. 1(2) substituted (9.9.2024) by Coroners and Justice Act 2009 (c. 25), s. 182(4)(e), Sch. 21 para. 48 (with s. 180)

F3 S. 1(9A) inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 22(a); S.I. 2009/2232, art. 2(y)

F4 S. 1(9B) inserted (1.12.2015 coming into force in accordance with art. 1(2)) by The Human Transplantation (Wales) Act 2013 (Consequential Provision) Order 2015 (S.I. 2015/865), arts. 1(2), 2(2)(b)

F5 S. 1(9C) inserted (20.5.2020) by Organ Donation (Deemed Consent) Act 2019 (c. 7), ss. 2(2), 3(3); S.I. 2020/520, reg. 2(b)

F6 Words in s. 1(10)(c) substituted (1.12.2015 coming into force in accordance with art. 1(2)) by The Human Transplantation (Wales) Act 2013 (Consequential Provision) Order 2015 (S.I. 2015/865), arts. 1(2), 2(2)(c)

F7 Words in s. 1(10)(c) substituted (20.5.2020) by Organ Donation (Deemed Consent) Act 2019 (c. 7), ss. 2(3), 3(3); S.I. 2020/520, reg. 2(b)

F8 S. 1(10A) inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 22(b); S.I. 2009/2232, art. 2(y)

F9 S. 1(12)(a) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 3

F10 S. 1(14) inserted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(2)(b), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e)

Commencement Information

I1 S. 1 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)

I2 S. 1 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)