Legalize / United Kingdom / Wales / Act of Senedd Cymru

Human Transplantation (Wales) Act 2013

Type Act of Senedd Cymru

Publication 2013-09-10

State In force

Jurisdiction Wales

Department Statute Law Database

Source legislation.gov.uk

Reform history JSON API

Introduction

Overview

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The main provisions of this Act—

(a) impose a duty on the Welsh Ministers to promote transplantation (section 2);

(b) provide that certain activities done in Wales for the purpose of transplantation are lawful if done with consent (section 3);

(c) set out how consent is given to transplantation activities, including the circumstances in which consent is deemed to be given in the absence of express consent (sections 4 to 9);

(d) make it an offence for transplantation activities to be done in Wales without consent (section 10);

(e) make amendments (sections 15 and 16) to the Human Tissue Act 2004, including in relation to a code of practice issued under that Act which—

(i) gives practical guidance to persons that do transplantation activities, and

(ii) lays down the standards expected in relation to the doing of such activities, including how consent is to be obtained.

Promotion of transplantation

Duty of the Welsh Ministers to promote transplantation

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(1) The Welsh Ministers must—

(a) promote transplantation as a means of improving the health of the people of Wales,

(b) provide information and increase awareness about transplantation,

(c) inform the public of the circumstances in which consent to transplantation activities is deemed to be given in the absence of express consent, and

(d) ensure that the resources available to Local Health Boards include the specialist skills and competencies required for the purposes of this Act.

(2) The duty under subsection (1) includes in particular an obligation on the Welsh Ministers, at least once every 12 months, to promote a campaign for the purpose of informing the public throughout Wales about the circumstances in which consent to transplantation activities is deemed to be given in the absence of express consent.

(3) The Welsh Ministers must, for the first five years after this section comes into force, report annually to the National Assembly for Wales on the steps taken to fulfil their duty under subsection (1).

Lawful transplantation activities

Authorisation of transplantation activities

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(1) Transplantation activities are lawful if done in Wales—

(a) with express consent where that is required (see sections 4 to 7), or

(b) otherwise with deemed consent (see sections 4 and 9).

(2) The following are transplantation activities for the purpose of this Act—

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

(b) removing from the body of a deceased person, for use for that purpose, any relevant material of which the body consists or which it contains;

(d) using for that purpose any relevant material which has come from a human body.

(3) A transplantation activity of the kind mentioned in subsection (2)(c) or (d) is lawful (without the need for consent) where done in Wales if—

(a) the relevant material has been imported into Wales from outside Wales, and

(b) its removal from a person's body took place outside Wales.

Consent

Consent: adults

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(1) This section makes provision about consent for the purposes of section 3 in relation to a transplantation activity involving the body, or relevant material from the body, of a person who is not—

(a) an excepted adult (see section 5), or

(b) a child (see section 6).

(2) Consent is deemed to be given to the activity unless—

(a) the case is one mentioned in the first column of Table 1 in subsection (3); in which case express consent is required, or

(b) the case is not one mentioned in the first column of Table 1 in subsection (3) and subsection (4) applies.

(3) For each case mentioned in the first column of Table 1 the meaning of express consent in relation to an activity is as provided in the second column of the table—

Case	Meaning of express consent
1. The person is alive.	The person's consent.
2. The person has died and a decision of the person to consent, or not to consent, to the activity was in force immediately before his or her death.	The person's consent.
3. The person has died, case 2 does not apply, the person had appointed a person or persons to deal with the issue of consent in relation to the activity and someone is able to give consent under the appointment.	Consent given by the person or persons appointed.
4. The person has died, case 2 does not apply and the person had appointed a person or persons to deal with the issue of consent in relation to the activity, but no one is able to give consent under the appointment.	Consent of a person who stood in a qualifying relationship to the person immediately before death.

(4) This subsection applies if—

(a) a relative or friend of long standing of the deceased objects on the basis of views held by the deceased, and

(b) a reasonable person would conclude that the relative or friend knows that the most recent view of the deceased before death on consent for transplantation activities was that the deceased was opposed to consent being given.

(5) In this section a reference to the appointment of a person or persons to deal with the issue of consent is a reference to an appointment under section 8.

(6) This section does not apply to consent for a transplantation activity that involves removal of excluded relevant material (for provision in relation to which see section 7).

Consent: excepted adults

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(1) This section makes provision about consent for the purposes of section 3 in relation to a transplantation activity involving the body, or relevant material from the body, of an excepted adult.

(2) In the case of an excepted adult express consent is required.

(3) An “excepted adult” means—

(a) an adult who has died and who had not been ordinarily resident in Wales for a period of at least 12 months immediately before dying, or

(b) an adult who has died and who for a significant period before dying lacked capacity to understand the notion that consent to transplantation activities can be deemed to be given;

and for this purpose 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.

(4) For each case mentioned in the first column of Table 2 the meaning of express consent in relation to an activity is as provided in the second column of the table—

Case	Meaning of express consent
1. A decision of the excepted adult to consent, or not to consent, to the activity was in force immediately before death.	The excepted adult's consent.
2. Case 1 does not apply, the excepted adult had appointed a person or persons to deal with the issue of consent in relation to the activity and someone is able to give consent under the appointment.	Consent given by the person or persons appointed.
3. Case 1 does not apply and the excepted adult had appointed a person or persons to deal with the issue of consent in relation to the activity, but no one is able to give consent under the appointment.	Consent of a person who stood in a qualifying relationship to the excepted adult immediately before death.
4. None of cases 1, 2 or 3 applies in relation to the excepted adult.	Consent of a person who stood in a qualifying relationship to the excepted adult immediately before death.

(5) In this section a reference to the appointment of a person or persons to deal with the issue of consent is a reference to an appointment under section 8.

(6) This section does not apply to consent for a transplantation activity that involves removal of excluded relevant material (for provision in relation to which see section 7).

Consent: children

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(1) This section makes provision about consent for the purposes of section 3 in relation to a transplantation activity involving the body, or relevant material from the body, of a person who is a child or has died a child.

(2) In the case of a person who is a child or has died a child express consent is required.

(3) For each case mentioned in the first column of Table 3 the meaning of express consent in relation to an activity is as provided in the second column of the table—

Case	Meaning of express consent
1. The child is alive and case 2 does not apply.	The child's consent.
2. The child is alive, no decision of the child to consent, or not to consent, to the activity is in force, and either the child is not competent to deal with the issue of consent or is competent to deal with the issue but fails to do so.	Consent of a person who has parental responsibility for the child.
3. The child has died and a decision of the child to consent, or not to consent, to the activity was in force immediately before death.	The child's consent.
4. The child has died, case 3 does not apply, the child had appointed a person or persons to deal with the issue of consent in relation to the activity and someone is able to give consent under the appointment.	Consent given by the person or persons appointed.
5. The child has died, case 3 does not apply and the child had appointed a person or persons to deal with the issue of consent in relation to the activity, but no one is able to give consent under the appointment.	Consent of a person who had parental responsibility for the child immediately before the child died, or where no such person exists, the consent of a person in a qualifying relationship to the child at that time.
6. The child has died and none of cases 3, 4 or 5 applies in relation to the child.	Consent of a person who had parental responsibility for the child immediately before the child died, or where no such person exists, the consent of a person in a qualifying relationship to the child at that time.

(4) In this section a decision or appointment made by a child is only valid if the child was competent to deal with the issue of consent when it was made.

(5) In this section a reference to the appointment of a person or persons to deal with the issue of consent is a reference to an appointment under section 8.

(6) This section does not apply to consent for a transplantation activity that involves removal of excluded relevant material (for provision in relation to which see section 7).

Consent: transplantation activities involving excluded material

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(1) This section makes provision about consent for a transplantation activity that involves the removal of excluded relevant material.

(2) In this Act, “excluded relevant material” means relevant material of a type specified by the Welsh Ministers in regulations.

(3) Examples of the types of relevant material that may be specified are composite tissues and other types of material the removal and use of which is considered to be novel.

(4) In the case of a transplantation activity that involves the removal of excluded relevant material express consent is required, and such consent must be specific to the removal of excluded relevant material.

(5) For an adult, for each case mentioned in the first column of Table 4 the meaning of express consent in relation to an activity is as provided in the second column of the table —

Case	Meaning of express consent
1. The adult is alive.	The adult's consent.
2. The adult has died and a decision of the adult to consent, or not to consent, to the activity was in force immediately before death.	The adult's consent.
3. The adult has died, case 2 does not apply, the adult had appointed a person or persons to deal with the issue of consent in relation to the activity and someone is able to give consent under the appointment.	Consent given by the person or persons appointed.
4. The adult has died, case 2 does not apply and the adult had appointed a person or persons to deal with the issue of consent in relation to the activity, but no one is able to give consent under the appointment.	Consent of a person who stood in a qualifying relationship to the adult immediately before death.
5. The adult has died and none of cases 2, 3 or 4 applies in relation to the adult.	Consent of a person who stood in a qualifying relationship to the adult immediately before death.

(6) For a child, for each case mentioned in the first column of Table 5 the meaning of express consent in relation to an activity is as provided in the second column of the table—

Case	Meaning of express consent
1. The child is alive and case 2 does not apply.	The child's consent.
2. The child is alive, no decision of the child to consent, or not to consent, to the activity is in force, and either the child is not competent to deal with the issue of consent or is competent to deal with the issue but fails to do so.	Consent of a person who has parental responsibility for the child.
3. The child has died and a decision of the child to consent, or not to consent, to the activity was in force immediately before death.	The child's consent.
4. The child has died, case 3 does not apply, the child had appointed a person or persons to deal with the issue of consent in relation to the activity and someone is able to give consent under the appointment.	Consent of the person or persons appointed.
5. The child has died, case 3 does not apply and the child had appointed a person or persons to deal with the issue of consent in relation to the activity, but no one is able to give consent under the appointment.	Consent of a person who had parental responsibility for the child immediately before the child died, or where no such person exists, the consent of a person who stood in a qualifying relationship to the child at that time.
6. The child has died and none of cases 3, 4 or 5 applies in relation to the child.	Consent of a person who had parental responsibility for the child immediately before the child died, or where no such person exists, the consent of a person who stood in a qualifying relationship to the child at that time.

(7) In this section a decision or appointment made by a child is only valid if the child was competent to deal with the issue of consent when it was made.

(8) In this section a reference to the appointment of a person or persons to deal with the issue of consent is a reference to an appointment under section 8.

Appointed representatives

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(1) A person may appoint one or more persons to represent the person after death in relation to express consent for the purposes of section 3.

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

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

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

(5) A written appointment 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 or her 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 section 9 of the Wills Act 1837.

(6) Where a person appoints two or more persons in relation to the same transplantation activity, they are to be regarded as appointed to act jointly and severally unless the appointment provides that they are appointed to act jointly.

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

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

(9) A person appointed may at any time renounce the appointment.

(10) A person may not act under an appointment if the person—

(a) is not an adult, or

(b) is of a description prescribed by regulations made by the Welsh Ministers.

(11) Where a person has appointed a person or persons under section 4 of the Human Tissue Act 2004 to deal after death with the issue of consent in relation to an activity done for the purpose of transplantation, the person is also to be treated as having made an appointment under this section in relation to the activity.

(12) For the purpose of sections 4(3), 5(4), 6(3) and 7 if it is not reasonably practicable to communicate with a person appointed under this section within the time available if consent is to be acted upon, the person is to be treated as being not able to give consent to an activity under the appointment.

Activities involving material from adults who lack capacity to consent

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(1) This section applies where—

(a) a transplantation activity within section 3(2)(c) or (d) (storage or use of relevant material which has come from a human body) done in Wales involves relevant material from the body of a person (“P”) who—

(i) is an adult, and

(ii) lacks capacity to consent to the activity, and

(b) no decision of P's to consent, or not to consent, to the activity is in force.

(2) P's consent to the activity is to be deemed if the activity is done in circumstances of a kind specified by regulations made by the Welsh Ministers.

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