Legalize / United Kingdom / Public General Act

Human Tissue Act 2004

Type Public General Act

Publication 2004-11-15

State In force

Department Statute Law Database

Source legislation.gov.uk

Reform history JSON API

Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes

Power of Human Tissue Authority to assist other public authorities

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(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.

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

(2) The storage of the body of a deceased person for use for the purpose of anatomical examination shall be lawful 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.

(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.

(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.

(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;

(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—

(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.

(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).

“Appropriate consent”: children

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(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.

“Appropriate consent”: adults

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(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

(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;

(ba) if neither paragraph (a) nor paragraph (b) applies and the activity is one to which subsection (6A) or (6AA) applies, the deemed consent of the person concerned;

(c) if neither paragraph (a) nor paragraph (b) applies and the activity is not one to which subsection (6A) or (6AA) applies, the consent of a person who stood in a qualifying relationship to him immediately before he died.

(6A) This subsection applies to the following activities done in England unless the body is the body of an excepted adult—

(a) the storage of the body of a deceased person for use for the purpose of transplantation;

(b) the removal from the body of a deceased person, for use for the purpose of transplantation, of any permitted material of which the body consists or which it contains;

(d) the use for the purpose of transplantation of any permitted material which has come from a human body.

(6AA) This subsection applies to the following activities done in Northern Ireland unless the body is the body of an excepted adult—

(a) the storage of the body of a deceased person for use for the purpose of transplantation;

(b) the removal from the body of a deceased person, for use for the purpose of transplantation, of any permitted material of which the body consists or which it contains;

(d) the use for the purpose of transplantation of any permitted material which has come from a human body.

(6B) The person concerned is to be deemed, for the purposes of subsection (6)(ba), to have consented to the activity unless a person who stood in a qualifying relationship to the person concerned immediately before death provides information that would lead a reasonable person to conclude that the person concerned would not have consented.

(7) Where the person concerned has appointed a person or persons under section 4 to deal after his death with the issue of consent in relation to the activity, the appointment shall be disregarded for the purposes of subsection (6) if no one is able to give consent under it.

(8) If it is not reasonably practicable to communicate with a person appointed under section 4 within the time available if consent in relation to the activity is to be acted on, he shall be treated for the purposes of subsection (7) as not able to give consent under the appointment in relation to it.

(9) In subsection (6A)—

“excepted adult” means—an adult who has died and who had not been ordinarily resident in England for a period of at least 12 months immediately before dying, oran adult who has died and who for a significant period before dying lacked capacity to understand the effect of subsection (6)(ba);

“permitted material” means relevant material other than relevant material of a type specified in regulations made by the Secretary of State.

(9A) In subsection (6AA)—

“excepted adult” means—an adult who has died and who had not been ordinarily resident in Northern Ireland for a period of at least 12 months immediately before dying, oran adult who has died and who for a significant period before dying lacked capacity to understand the effect of subsection (6)(ba);

“permitted material” means relevant material of a type specified in regulations made by the Department of Health in Northern Ireland, but the regulations may not make provision dealing with a matter falling within a description specified in Schedule 3 to the Northern Ireland Act 1998 (reserved matters).

(10) For the purposes of the definition of “excepted adult” in subsection (9) or (9A) a significant period means a sufficiently long period as to lead a reasonable person to conclude that it would be inappropriate for consent to be deemed to be given under subsection (6)(ba).

Nominated representatives

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(1) An adult may appoint one or more persons to represent him after his death in relation to consent for the purposes of section 1.

(2) An appointment under this section may be general or limited to consent in relation to such one or more activities as may be specified in the appointment.

(3) An appointment under this section may be made orally or in writing.

(4) An oral appointment under this section is only valid if made in the presence of at least two witnesses present at the same time.

(5) A written appointment under this section is only valid if—

(a) it is signed by the person making it in the presence of at least one witness who attests the signature,

(b) it is signed at the direction of the person making it, 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 making it, being a will which is 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 a person appoints two or more persons under this section in relation to the same activity, they shall be regarded as appointed to act jointly and severally unless the appointment provides that they are appointed to act jointly.

(7) An appointment under this section may be revoked at any time.

(8) Subsections (3) to (5) apply to the revocation of an appointment under this section as they apply to the making of such an appointment.

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