Human Tissue (Authorisation) (Scotland) Act 2019

Part 1 — Overview of Act

Overview of Act

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This Act is arranged as follows—

• Part 2 amends the Human Tissue (Scotland) Act 2006 (“the 2006 Act”) to make provision about duties of the Scottish Ministers in relation to transplantation and pre-death procedures and in relation to the register,

• Part 3 amends the 2006 Act to make provision about the authorisation of removal and use of part of the body of a deceased person,

• Part 4 contains general and final provisions.

Part 2 — Duties of the Scottish Ministers

Removal of part of body of deceased person: further requirements

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• (1) In section 1 of the 2006 Act, at the end of paragraph (c), insert

; (d) promote information and awareness about how transplantation may be authorised (including, in particular, how authorisation of transplantation may be deemed to be given); (e) promote information and awareness about the nature of pre-death procedures, when they may be carried out and how they may be authorised

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• (2) The text of section 1 so amended becomes subsection (1).

• (3) After subsection (1) so formed, insert—

(2) The duty under subsection (1)(d) must be carried out at least once in every calendar year. (3) The Scottish Ministers must, in carrying out the duty under subsection (1)(d), have regard to the need to— (a) provide information to the public about— (i) how authorisation of transplantation may be deemed to be given, (ii) how to give an express authorisation or make an opt-out declaration, (b) provide information in health care settings about— (i) how authorisation of transplantation may be deemed to be given, (ii) how to give an express authorisation or make an opt-out declaration. (4) In subsection (3)(b), “health care settings” means any place where a service is provided for or in connection with the prevention, detection or treatment of illness, other than an independent health care service (within the meaning of section 10F of the National Health Service (Scotland) Act 1978).

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Establishment and maintenance of register

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• (1) The 2006 Act is amended as follows.

• (2) After section 2 insert—

(2A) (1) The Scottish Ministers must make arrangements for the establishment and maintenance of a register (referred to in this Part as “the Register”) for the purposes of facilitating— (a) the carrying out of their duty under section 1(a), (b) the removal and use of part of the body of a deceased person for transplantation that is authorised by virtue of section 6, 6D, 6E, 6F, 6G, 8, 8D, 10 or, as the case may be, 10A. (2) The Register must include information relating to— (a) persons who authorise the removal and use of a part of the person's body after the person's death for transplantation, (b) persons who do not authorise the removal and use of a part of the person's body after the person's death for transplantation. (3) The Register is not to be open to public inspection or search. (4) Information may be kept in the Register in any form the Scottish Ministers consider appropriate. (2B) (1) Arrangements made by the Scottish Ministers under section 2A(1) may in particular authorise a person to establish and maintain the Register. (2) In this Part, “register organisation” means— (a) the Scottish Ministers, or (b) where a person is authorised as mentioned in subsection (1), that person. (3) The Scottish Ministers must publish information about arrangements under section 2A(1) so far as they authorise a person as mentioned in subsection (1). (2C) (1) The register organisation may disclose information about a person from the Register to— (a) a person listed in subsection (3) for the purpose of enabling or assisting a person listed in subsection (3) to carry out functions under this Part that relate to the removal and use of a part of the body for transplantation, (b) a person operating outwith Scotland for the purpose of enabling or assisting that person to carry out functions that relate to the removal and use of a part of the body for transplantation. (2) The power to disclose information about a person from the Register conferred by subsection (1) includes the power to disclose that there is no information kept in the Register about the person. (3) The persons are— (a) a registered medical practitioner, (b) a person (or person within a description) authorised under section 11(1)(b), (c) a health worker who is acting in accordance with section 16H or 16I. (4) A person who receives information under subsection (1)(a) may, for the purpose of enabling or assisting a person listed in subsection (3) to carry out functions under this Part that relate to the removal and use of a part of the body for transplantation, disclose that information to a person listed in subsection (3) or (5). (5) The persons are— (a) in relation to a person who at the relevant time is an adult— (i) the adult's nearest relative, (ii) any other person who is consulted under section 16H(2)(d) in relation to the adult, (b) in relation to a person who at the relevant time is a child— (i) a person who has parental rights and parental responsibilities in relation to the child, (ii) a person mentioned in section 10A(4), (iii) any other person who is consulted under section 16I(2)(b) in relation to the child. (2D) (1) The Scottish Ministers may by regulations make provision in relation to the Register. (2) Regulations under subsection (1) may, in particular— (a) modify section 2A(1) to add the purpose of facilitating the removal and use of part of the body of a deceased person for a purpose referred to in paragraphs (b) to (d) of section 3(1), (b) modify the list in section 2A(2), (c) modify the list in section 2C(3) to— (i) add a person (or description of person), (ii) remove, or vary the description of, a person (or description of person), (d) modify the purposes for which information may be disclosed under section 2C.

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• (3) In section 59(3) (regulations subject to affirmative procedure), after paragraph (a) insert—

(aa) regulations under section 2D(1);

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Part 3 — Authorisation of removal and use of part of body of deceased person

Chapter 1 — Timing of authorisation

Timing of authorisation

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• (1) The 2006 Act is amended as follows.

• (2) In section 7—

• (a) in subsection (1), for “immediately before an adult's death no authorisation by the” substitute “ at the relevant time no authorisation by an ”,

• (b) in subsections (2) and (3), for “immediately before an adult's death authorisation by the” substitute “ at the relevant time authorisation by an ”,

• (c) in subsections (1), (2) and (3), the word “deceased” is repealed.

• (3) In section 9—

• (a) before subsection (1), insert—

(A1) Subsections (1) to (3) apply in relation to a child who is 12 years of age or over at the relevant time.

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• (b) in subsections (1) and (2), for “immediately before the death of a child who died 12 years of age or over” substitute “ at the relevant time ”,

• (c) in subsections (1), (2) and (3), for “immediately before the death, had” substitute “ at the relevant time, has ”,

• (d) in subsection (3), for “immediately before the child's death” substitute “ at the relevant time ”.

• (4) The title of section 9 becomes “ Authorisation by person with parental rights and responsibilities: child 12 years of age or over ”.

• (5) In section 10—

• (a) before subsection (1), insert—

(A1) Subsection (1) applies in relation to a child who is under 12 years of age at the relevant time.

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• (b) in subsection (1), for “immediately before the death of a child who died under 12 years of age had” substitute “ at the relevant time has ”.

• (6) The title of section 10 becomes “ Authorisation by person with parental rights and responsibilities: child under 12 years of age ”.

• (7) In section 11(5)—

• (a) in paragraphs (d)(iii), (e)(iii), (f)(iii), (g)(iii), (h)(iii) and (i)(iii), the word “deceased” is repealed,

• (b) in paragraphs (l)(i), (m)(i), (n)(i), (o)(i), (p)(i), (q)(i), (r)(i) and (s)(i), for the word “died” substitute “ at the relevant time was ”,

• (c) in paragraphs (l)(iii), (m)(iii), (n)(iii), (o)(iii), (p)(iii), (q)(iii), (r)(iii) and (s)(iii), for “immediately before the child's death” substitute “ at the relevant time ”.

• (8) In section 22—

• (a) in subsection (1), for “immediately before an adult's death authorisation by the” substitute “ at the relevant time authorisation by an ”,

• (b) in subsection (2), for “immediately before the death of a child who died twelve years of age or over authorisation by the” substitute “ at the relevant time authorisation by a ”,

• (c) in subsection (3)—

• (i) in the opening words, for “a deceased” substitute “ an ”,

• (ii) in paragraph (a), for “immediately before the adult's death” substitute “ at the relevant time ”,

• (d) in subsection (4)—

• (i) in the opening words, the word “deceased” is repealed,

• (ii) in paragraph (a), for “immediately before the child's death” substitute “ at the relevant time ”.

• (9) In section 50—

• (a) in subsections (1) and (2), for “sections 7 and 30” substitute “ Part 1 and section 30 ”,

• (b) in subsection (1)—

• (i) in the opening words, for “is the person who immediately before the adult's death was” substitute “ in relation to an adult is the person who, at the time mentioned in subsection (1A), is ”,

• (ii) in paragraph (b), for “was in hospital immediately before death” substitute “ is in hospital at the time mentioned in subsection (1A) ”,

• (c) after subsection (1), insert—

(1A) The time is— (a) in relation to Part 1, the relevant time, and (b) in relation to section 30, immediately before the adult's death.

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Chapter 2 — Authorisation by or on behalf of adult

Express authorisation by adult

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• (1) The 2006 Act is amended as follows.

• (2) In section 6—

• (a) in subsection (1), after “section 3(1)” insert “ (an “express authorisation”) ”,

• (b) after subsection (1), insert—

(1A) An express authorisation must— (a) if it is for transplantation, be— (i) in writing, or (ii) given to the register organisation orally or in writing, (b) if it is for a purpose referred to in paragraphs (b) to (d) of section 3(1), be in writing.

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• (c) subsection (2) is repealed.

• (3) The title of section 6 becomes “ Express authorisation: adult ”.

• (4) After section 6 insert—

(6A) (1) An express authorisation may be withdrawn by the adult— (a) in writing, or (b) if the express authorisation was given to the register organisation, by giving the withdrawal to the register organisation orally or in writing. (2) Subsection (3) applies if— (a) there is in force an express authorisation by an adult of removal and use of a part of the adult's body for a purpose referred to in section 3(1), and (b) the adult makes an opt-out declaration as respects removal and use of the part for that purpose. (3) The express authorisation— (a) is treated as withdrawn by the adult to the extent that it relates to removal and use of the part for that purpose, and (b) otherwise remains in force. (4) Subsection (5) applies if— (a) there is in force at the relevant time an express authorisation by an adult of removal and use of a part of the adult's body for a purpose referred to in section 3(1), and (b) a person provides evidence to a health worker that would lead a reasonable person to conclude that— (i) the adult's most recent view was that the adult was unwilling for the part to be removed and used for that purpose, or (ii) if the adult were capable of making a decision about removal and use of the part, the adult would be unwilling in the circumstances for the part to be removed and used for that purpose. (5) The express authorisation— (a) is treated as withdrawn by the adult to the extent that it relates to removal and use of the part for that purpose, (b) otherwise remains in force, and (c) to the extent that it remains in force, is treated as being in force at the relevant time for the purposes of— (i) section 6D(1)(a), (ii) section 6E(1)(a)(i), (iii) section 6F(1)(a)(i), (iv) section 6H(1)(a)(i), (v) section 16F(1)(d), (vi) section 16H(2)(a)(i), (vii) section 16H(3)(a).

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Opt-out declaration by adult

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After section 6A of the 2006 Act insert—

(6B) (1) An adult may make a declaration that the adult does not authorise the removal and use of a part of the adult's body after the adult's death for one or more of the purposes referred to in section 3(1) (an “opt-out declaration”). (2) If there is in force an opt-out declaration by an adult as respects removal and use of a part of the adult's body for a purpose referred to in section 3(1), the part must not be removed and used for that purpose. (3) An opt-out declaration must— (a) if it is as respects transplantation, be— (i) in writing, or (ii) made to the register organisation orally or in writing, (b) if it is as respects a purpose referred to in paragraphs (b) to (d) of section 3(1), be in writing. (6C) (1) An opt-out declaration may be withdrawn by the adult— (a) in writing, or (b) if the opt-out declaration was made to the register organisation, by giving the withdrawal to the register organisation orally or in writing. (2) Subsection (3) applies if— (a) there is in force an opt-out declaration by an adult as respects removal and use of a part of the adult's body for a purpose referred to in section 3(1), and (b) the adult gives an express authorisation of removal and use of the part for that purpose. (3) The opt-out declaration— (a) is treated as withdrawn by the adult to the extent that it relates to removal and use of the part for that purpose, and (b) otherwise remains in force. (4) Subsections (5) to (7) apply if— (a) there is in force at the relevant time an opt-out declaration by an adult as respects removal and use of a part of the adult's body for a purpose referred to in section 3(1), and (b) a person provides evidence to a health worker that would lead a reasonable person to conclude that— (i) the adult's most recent view was that the adult was willing for the part to be removed and used for that purpose, or (ii) if the adult were capable of making a decision about removal and use of the part, the adult would be willing in the circumstances for the part to be removed and used for that purpose. (5) The opt-out declaration— (a) is treated as withdrawn by the adult to the extent that it relates to removal and use of the part for that purpose, (b) otherwise remains in force, and (c) to the extent that it remains in force, is treated as being in force at the relevant time for the purposes of— (i) section 6D(1)(b), (ii) section 6E(1)(a)(ii), (iii) section 6F(1)(a)(ii), (iv) section 6G(2)(a), (v) section 6H(1)(a)(ii) and (iii), (vi) section 16H(2)(a)(ii), (vii) section 16H(3)(b). (6) The adult is treated as having given an express authorisation by virtue of section 6(1) of removal and use of the part for that purpose. (7) The authorisation referred to in subsection (6) is treated as being in force at the relevant time for the purposes of— (a) section 6D(1)(a), (b) section 6E(1)(a)(i), (c) section 6F(1)(a)(i), (d) section 6H(1)(a)(i), (e) section 16F(1)(d), (f) section 16H(2)(a)(i), (g) section 16H(3)(a).

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Deemed authorisation for transplantation as respects adult

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• (1) The 2006 Act is amended as follows.

• (2) After section 6C insert—

(6D) (1) An adult is deemed to have authorised the removal and use of a part of the adult's body after the adult's death for transplantation where there is in force at the relevant time— (a) no express authorisation by the adult of removal and use of any part of the adult's body for transplantation, and (b) no opt-out declaration by the adult as respects removal and use of the part of the adult's body for transplantation. (2) Subsection (1) does not apply in relation to— (a) a person who was not ordinarily resident in Scotland for a period of at least 12 months ending immediately before the relevant time (a “non-resident adult”), (b) an adult who is incapable of understanding the nature and consequences of deemed authorisation, (c) an excepted body part, (d) a part of the adult's body (that is not an excepted body part), if a person provides evidence to a health worker that would lead a reasonable person to conclude that— (i) the adult's most recent view was that the adult was unwilling for the part to be used for transplantation, or (ii) if the adult were capable of making a decision about removal and use of the part, the adult would be unwilling in the circumstances for the part to be used for transplantation. (3) In this Part, an adult is incapable of understanding the nature and consequences of deemed authorisation if, over a significant period ending immediately before the relevant time, the person was incapable of understanding— (a) that an adult may be deemed to have authorised removal and use of a part of the adult's body after the adult's death for transplantation, and (b) that if authorisation is so deemed, after the adult's death part of the adult's body may be removed from the body and used for transplantation. (4) An example of when an adult is to be considered “incapable of understanding the nature and consequences of deemed authorisation” is if there is evidence available to a health worker, including any evidence referred to in section 16H(4), that would lead a reasonable person to conclude that the adult is so incapable. (5) An “excepted body part” is a part of the body specified in regulations made by the Scottish Ministers. (6) Before laying draft regulations under subsection (5) before the Scottish Parliament, the Scottish Ministers must consult such persons as they consider appropriate.

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• (3) In section 59(3) (regulations subject to affirmative procedure), after paragraph (aa) insert—

(ab) regulations under section 6D(5);

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Non-resident adult: authorisation for transplantation by nearest relative

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After section 6D of the 2006 Act insert—