Human Tissue (Scotland) Act 2006
Part 1 — Transplantation etc.
General functions of the Scottish Ministers
Duties of the Scottish Ministers as respects transplantation, donation of body parts etc.
1
It is the duty of the Scottish Ministers to—
- (a) promote, support and develop programmes of transplantation;
- (b) promote information and awareness about the donation for transplantation of parts of a human body;
- (c) promote the taking of any necessary measures relating to the quality and safety, storage and use of any such part donated for that purpose.
Assistance and support
2
- (1) The Scottish Ministers may provide assistance and support to any person providing, or proposing to provide, a service relating to transplantation.
- (2) Assistance and support provided under subsection (1) is to be provided on such terms, including terms as to payment, as the Scottish Ministers think fit.
- (3) In this section, “assistance” includes financial assistance.
Use of part of body of deceased person for transplantation, research etc.
Use of part of body of deceased person for transplantation, research etc.
3
- (1) Part of the body of a deceased person may be removed from the body and used, for the purposes of—
- (a) transplantation;
- (b) research;
- (c) education or training;
- (d) audit,
only if the requirements of subsection (2) are satisfied as respects the part.
- (2) The requirements are that—
- (a) the removal and use for the purpose in question are authorised in accordance with section 6, 7, 8, 9 or, as the case may be, 10; and
- (b) the removal is carried out in accordance with section 11.
Disapplication of sections 3, 6 to 11 and 16 in certain circumstances
4
Sections 3, 6 to 11 and 16 do not apply—
- (a) to anything done for the purposes of the functions or under the authority of the procurator fiscal;
- (b) in relation to the removal of any part of the body of a deceased person during a post-mortem examination of the body or the subsequent retention and use of the part or in relation to retention and use of a part of a body to which section 36 applies;
- (c) in relation to retention and use of tissue sample to which section 38 or 47 applies or an organ to which section 40 or 48 applies;
- (d) as respects the removal, retention or use of any part of a body of a deceased person if it is the body of a person who died before the day on which section 3 comes into force and at least 100 years have elapsed since the date of the person's death.
Consent by procurator fiscal to removal of part of body
5
- (1) Where a person knows, or has reason to believe, that an examination of the body of a deceased person is, or may be, required for the purposes of the functions of the procurator fiscal, the person may not, except with the consent of the procurator fiscal, remove from the body any part of it, or authorise such removal, for a purpose referred to in section 3(1).
- (2) For the purposes of subsection (1), consent by the procurator fiscal may be given verbally and if so given is to be confirmed in writing as soon as is reasonably practicable.
Authorisation: adult
6
- (1) An adult may 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).
- (2) Authorisation by virtue of subsection (1)—
- (a) must be—
- (i) in writing; or
- (ii) expressed verbally;
- (b) subject to subsections (3) and (4), may be withdrawn in writing.
- (3) If the adult is blind or unable to write, withdrawal of authorisation by virtue of subsection (2)(b) may be signed by another adult (a signatory) on the adult's behalf and if it is so signed it must be witnessed by one witness.
- (4) Withdrawal of authorisation which is signed by a signatory on behalf of an adult by virtue of subsection (3) must contain a statement signed by both the signatory and the witness in the presence of the adult and of each other that the adult, in the presence of them both, expressed the intention to withdraw the authorisation and requested the signatory to sign the withdrawal on behalf of the adult.
- (5) Nothing in subsection (3) prevents an adult who is blind from withdrawing, in accordance with subsection (2)(b), any authorisation by virtue of subsection (1).
- (6) In subsection (2)(a)(i), “writing” includes, in relation to the requirement there for authorisation to be in writing, representation of a character in visible form.
Authorisation by adult’s nearest relative
7
- (1) If there is in force immediately before an adult's death no authorisation by the adult by virtue of section 6(1) of removal and use of any part of the adult's body for transplantation, the nearest relative of the deceased adult may, subject to subsection (4), authorise the removal and use of any part for one or more of the purposes referred to in section 3(1).
- (2) If—
- (a) there is in force immediately before an adult's death authorisation by the adult by virtue of section 6(1) of removal and use of a part of the adult's body for transplantation;
- (b) the authorisation does not expressly include removal and use of the part for a particular purpose referred to in paragraphs (b) to (d) of section 3(1),
the nearest relative of the deceased adult may, subject to subsection (4), authorise the removal and use of the part for the particular purpose in question which is not included in the authorisation.
- (3) If—
- (a) there is in force immediately before an adult's death authorisation by the adult by virtue of section 6(1) of removal and use of a particular part of the adult's body for transplantation;
- (b) the authorisation does not expressly include removal and use of another particular part,
the nearest relative of the deceased adult may, subject to subsection (4), authorise the removal and use of the other particular part which is not so included for one or more of the purposes referred to in paragraphs (b) to (d) of section 3(1).
- (4) The nearest relative may not give authorisation under—
- (a) subsection (1) if the relative has actual knowledge that the adult was unwilling for any part of the adult's body, or the part in question, to be used for transplantation;
- (b) subsection (2) if the relative has actual knowledge that the adult was unwilling for the part to be used for the purpose in question;
- (c) subsection (3) if the relative has actual knowledge that the adult was unwilling for any other part of the adult's body or, as the case may be, the other particular part in question, to be used for transplantation.
- (5) For the purposes of—
- (a) subsection (4)(a), the mere fact that there is no authorisation by the adult in force is not to be regarded as unwillingness by the adult referred to in that subsection;
- (b) subsection (4)(b), the mere fact that the authorisation does not include a particular purpose referred to in paragraphs (b) to (d) of section 3(1) is not to be regarded as unwillingness by the adult referred to in that subsection;
- (c) subsection (4)(c), the mere fact that there is no authorisation by the adult in force as respects the removal and use of other parts, or the other particular part in question, for transplantation is not to be regarded as unwillingness by the adult referred to in that subsection.
- (6) Authorisation by virtue of subsection (1), (2) or (3)—
- (a) must be—
- (i) in writing and signed; or
- (ii) expressed verbally,
by the nearest relative;
- (b) subject to subsection (7), may be withdrawn in writing so signed.
- (7) To the extent that authorisation by virtue of subsection (1) is for the purposes of transplantation, it may not be withdrawn.
Authorisation: child 12 years of age or over
8
- (1) A child who is 12 years of age or over may authorise the removal and use of a part of the child's body after the child's death for one or more of the purposes referred to in section 3(1).
- (2) Subject to subsections (3) to (5), authorisation by virtue of subsection (1)—
- (a) must be in writing;
- (b) may be withdrawn in writing.
- (3) If the child is blind or unable to write, authorisation by virtue of subsection (1) and withdrawal of such authorisation may be signed by an adult (a signatory) on the child's behalf and if it is so signed it must be witnessed by one witness.
- (4) Authorisation by virtue of subsection (1), or withdrawal of such authorisation, which is signed by a signatory on behalf of a child by virtue of subsection (3) must contain a statement signed by both the signatory and the witness in the presence of the child and of each other that the child, in the presence of them both, expressed the intention to give the authorisation or, as the case may be, withdraw the authorisation and requested the signatory to sign the authorisation or, as the case may be, the withdrawal on behalf of the child.
- (5) Authorisation by virtue of subsection (1) which is signed by a signatory on behalf of a child by virtue of subsection (3) must contain or be accompanied by—
- (a) certification in writing signed by the signatory that, in the opinion of the signatory;
- (b) certification in writing signed by the witness that, in the opinion of the witness,
the child understands the effect of the authorisation and is not acting under undue influence in giving it.
- (6) Nothing in subsection (3) prevents a child who is blind from giving authorisation by virtue of subsection (1) in accordance with subsection (2)(a) or withdrawing, in accordance with subsection (2)(b), any authorisation by the child by virtue of subsection (1) (including authorisation signed by a signatory in accordance with subsection (3)).
- (7) In subsection (2)(a), “writing” includes, in relation to the requirement there for authorisation to be in writing, but only where the authorisation in writing is not signed by a signatory on behalf of the child, representation of a character in visible form.
Authorisation as respects child who dies 12 years of age or over by person with parental rights and responsibilities
9
- (1) If there is in force immediately before the death of a child who died 12 years of age or over no authorisation by the child by virtue of section 8(1) of removal and use of any part of the child's body for transplantation, a person who, immediately before the death, had parental rights and parental responsibilities in relation to the child (but who is not a local authority) may, subject to subsection (4), authorise removal and use of any part for one or more of the purposes referred to in section 3(1).
- (2) If—
- (a) there is in force immediately before the death of a child who died 12 years of age or over authorisation by the child by virtue of section 8(1) of removal and use of a part of the child's body for transplantation;
- (b) the authorisation does not expressly include removal and use of the part for a particular purpose referred to in paragraphs (b) to (d) of section 3(1),
a person who, immediately before the death, had parental rights and parental responsibilities in relation to the child (but who is not a local authority) may, subject to subsection (4), authorise the removal and use of the part for the particular purpose in question which is not included in the authorisation.
- (3) If—
- (a) there is in force immediately before the child's death authorisation by the child by virtue of section 8(1) of removal and use of a particular part of the child's body for transplantation;
- (b) the authorisation does not expressly include removal and use of another particular part,
a person who, immediately before the death, had parental rights and parental responsibilities in relation to the child (but who is not a local authority) may, subject to subsection (4), authorise the removal and use of the other particular part which is not so included for one or more of the purposes referred to in paragraphs (b) to (d) of section 3(1).
- (4) A person may not give authorisation under—
- (a) subsection (1) if the person has actual knowledge that the child was unwilling for any part of the child's body, or the part in question, to be used for transplantation;
- (b) subsection (2) if the person has actual knowledge that the child was unwilling for the part to be used for the purpose in question;
- (c) subsection (3) if the person has actual knowledge that the child was unwilling for any other part of the child's body or, as the case may be, the other particular part in question, to be used for transplantation.
- (5) For the purposes of—
- (a) subsection (4)(a), the mere fact that there is no authorisation by the child in force is not to be regarded as unwillingness by the child referred to in that subsection;
- (b) subsection (4)(b), the mere fact that the authorisation by the child does not include a particular purpose referred to in paragraphs (b) to (d) of section 3(1) is not to be regarded as unwillingness by the child referred to in that subsection;
- (c) subsection (4)(c), the mere fact that there is no authorisation by the child in force as respects the removal and use of other parts, or the other particular part in question, for transplantation is not to be regarded as unwillingness by the child as referred to in that subsection.
- (6) Authorisation by virtue of subsection (1), (2) or (3)—
- (a) must be—
- (i) in writing and signed; or
- (ii) expressed verbally,
by the person who gives the authorisation in accordance with that subsection;
- (b) subject to subsection (7), may be withdrawn in writing signed by the person.
- (7) To the extent that authorisation by virtue of subsection (1) is for the purposes of transplantation, it may not be withdrawn.
Authorisation as respects child who dies under 12 years of age
10
- (1) A person who immediately before the death of a child who died under 12 years of age had parental rights and parental responsibilities in relation to the child (but who is not a local authority) may authorise removal and use of a part of the body of the child for one or more of the purposes referred to in section 3(1).
- (2) Authorisation by virtue of subsection (1)—
- (a) must be—
- (i) in writing and signed; or
- (ii) expressed verbally,
by the person who gives the authorisation in accordance with that subsection;
- (b) subject to subsection (3), may be withdrawn in writing signed by the person.
- (3) To the extent that authorisation by virtue of subsection (1) is for the purposes of transplantation, it may not be withdrawn.
Removal of part of body of deceased person: further requirements
11
- (1) The removal of a part of the body of a deceased person for any of the purposes referred to in section 3(1) may be carried out only by—
- (a) a registered medical practitioner; or
- (b) a person authorised to do so in accordance with regulations made by the Scottish Ministers.
- (2) Regulations under subsection (1)(b) may in particular provide for a registered medical practitioner to authorise the carrying out of the removal by a person who is not such a practitioner.
- (3) The removal of part of the body of a deceased person may not be—
- (a) carried out for any of the purposes referred to in section 3(1) unless the person who proposes to carry it out, before doing so, complies with the requirements specified in subsection (4);
- (b) authorised, by virtue of regulations under subsection (1)(b), unless the registered medical practitioner who proposes to authorise it, before doing so, complies with those requirements.
- (4) The requirements are that the person (and, where a registered medical practitioner proposes to authorise the carrying out of the removal by virtue of regulations under subsection (1)(b), the practitioner) must be satisfied—
- (a) either—
- (i) by personal examination of the body, that life is extinct; or
- (ii) that another registered medical practitioner, by such personal examination, is so satisfied;
- (b) that, if the consent of the procurator fiscal to the carrying out of the removal is required by section 5(1), the consent has been given; and
- (c) that the removal is authorised in accordance with section 6, 7, 8, 9 or, as the case may be, 10.
- (5) For the purposes of subsection (4)(c), the person or, as the case may be, the registered medical practitioner is entitled to be satisfied that the removal is authorised in accordance with the section in question if—
- (a) the person or, as the case may be, the practitioner has no reason to believe that the authorisation was not so given or (in a case where by virtue of this Act it may be withdrawn) that it was subsequently withdrawn;
- (b) in the case of authorisation by virtue of section 6(1) which is in writing, it bears—
- (i) to be as respects the deceased adult;
- (ii) to authorise removal of the part for the purpose in question;
- (iii) to be by the adult;
- (c) in the case of authorisation by virtue of section 6(1) which is expressed verbally, there is what the person or, as the case may be, the medical practitioner considers to be an appropriate record of the authorisation and the authorisation bears from the record—
- (i) to be as respects the deceased adult;
- (ii) to authorise removal of the part for the purpose in question;
- (iii) to have been expressed verbally by the adult;
- (d) in the case of authorisation by virtue of section 7(1) which is in writing, it bears—
- (i) to be as respects the deceased adult;
- (ii) to authorise removal of the part for the purpose in question;
- (iii) to be by, and signed by, the nearest relative of the deceased adult;
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