Human Tissue and Transplant Act 1982 (WA)
Western Australia
Western Australia
Western Australia
Human Tissue and Transplant Act 1982This Act may be cited as the
This Act shall come into operation on 1 March 1983.
(1) In this Act, unless the contrary intention appears —
(a) any substance derived from blood; and
(b) any organ or tissue, including bone marrow and the placenta, of a kind that is suitable as a source from which to derive a constituent of blood for therapeutic use or for the preparation of a substance for therapeutic use;
(a) in relation to a child, means a person referred to in paragraph (a)(i), (ia), (ii), (iii) or (iv) of the definition of “senior available next of kin”; and
(b) in relation to a person other than a child, means a person referred to in paragraph (b)(i), (ia), (ii), (iii), or (iv) of the definition of “senior available next of kin”;
(a) in relation to a child, means the first in order of priority of the following persons who is available at the time —
(i) if the child has both a spouse, and a de facto partner who has attained the age of 18 years, the spouse or de facto partner with whom the child is living as a spouse or de facto partner;
(ia) the spouse, or de facto partner who has attained the age of 18 years, of the child;
(ii) a parent of the child;
(iii) a brother or sister, who has attained the age of 18 years, of the child;
(iv) a guardian of the child;
and
(b) in relation to a person other than a child, means the first in order of priority of the following persons who is available at the time —
(i) if the person has both a spouse, and a de facto partner who has attained the age of 18 years, the spouse or de facto partner with whom the person is living as a spouse or de facto partner;
(ia) the spouse, or de facto partner who has attained the age of 18 years, of the person;
(ii) a son or daughter, who has attained the age of 18 years, of the person;
(iii) a parent of the person;
(iv) a brother or sister, who has attained the age of 18 years, of the person;
(2) For the purposes of this Act —
(3) A reference in this Act to the transplantation of tissue includes a reference to the transplantation of any part of the tissue and to the transplantation of a substance obtained from the tissue.
(4) Where in the case of a particular hospital there is doubt as to which medical practitioner is the chief medical administrator of the hospital, the Chief Health Officer may nominate, either by name or by reference to office, a medical practitioner as the chief medical administrator of that hospital for the purposes of this Act.
(1) The chief medical administrator of a hospital may nominate a medical practitioner as the designated officer of that hospital for the purposes of this Act.
(1A) The nomination must be in writing signed by the chief medical administrator of the hospital.
(2) A nomination under subsection (1) must be submitted to the Chief Health Officer for approval and, upon the grant of approval by the Chief Health Officer, the person nominated is the designated officer for the hospital concerned and may exercise the powers and is subject to the duties conferred and imposed on designated officers by this Act.
(3) The chief medical administrator of a hospital may revoke the nomination of a person as designated officer for the hospital by serving on that person a notice of the revocation signed by the chief medical administrator.
(4) As soon as practicable after revoking the nomination of a person as designated officer for a hospital, the chief medical administrator of the hospital must inform the Chief Health Officer of the revocation.
(4a) If in the case of a particular hospital there is no medical practitioner readily identifiable as the chief medical administrator of the hospital, the Chief Health Officer may nominate a medical practitioner as the designated officer of that hospital for the purposes of this Act.
(4b) A person nominated under subsection (4a) is the designated officer for the hospital concerned and may exercise the powers and is subject to the duties conferred and imposed on designated officers by this Act.
(5) The Chief Health Officer may revoke the approval or nomination of a person as designated officer for a hospital by serving on that person a signed notice of the revocation.
(1) A designated officer may, subject to and in accordance with this section, either generally or as otherwise provided by the instrument of delegation, delegate to 1 or more persons any powers or duties of the designated officer under this Act, other than this power of delegation.
(1A) The delegation must be in writing signed by the designated officer.
(2) A delegation under this section may be made to a specified medical practitioner by name or to a medical practitioner who is the holder for the time being of a specified office at the hospital concerned, being in every case an office relevant to the subject matter of this Act.
(3) A delegation under this section —
(a) may be made subject to such conditions, qualifications, and exceptions as are set out in the instrument of delegation;
(b) has immediate effect, unless the instrument of delegation provides otherwise, and continues in force until revoked by writing signed by the designated officer and given to the delegate.
(4) A designated officer must inform the Chief Health Officer as soon as practicable of every delegation made by the designated officer under this section and where the delegation is to the holder of a specified office, the designated officer must inform the Chief Health Officer as soon as practicable of the name of each successive holder of that office and furnish further information in respect of such persons as the Chief Health Officer may require.
(5) The Chief Health Officer may require the designated officer to revoke a delegation made by the designated officer and the designated officer must immediately comply with the requirement.
(5A) A requirement under subsection (5) must —
(a) be in writing signed by the Chief Health Officer; and
(b) be given to the designated officer.
(6) A designated officer may exercise a power and perform a duty under this Act notwithstanding that the designated officer has delegated its exercise or performance under this section.
(1) The Minister may delegate to a person any power or duty of the Minister under another provision of this Act.
(2) The delegation must be in writing signed by the Minister.
(3) A person to whom a power or duty is delegated under this section cannot delegate that power or duty.
(4) A person exercising or performing a power or duty that has been delegated to the person under this section is taken to do so in accordance with the terms of the delegation unless the contrary is shown.
(5) Nothing in this section limits the ability of the Minister to perform a function through an officer or agent.
In this Part, a reference to tissue does not include a reference to fetal tissue, a human embryo, human sperm or a human egg.
Nothing in this Division prevents the removal in accordance with Division 5 of blood from the body of a person.
(1) This section applies to a person who —
(a) has attained the age of 18 years; and
(b) is of sound mind; and
(c) is, in the light of medical advice furnished to the person, prepared to consent as referred to in subsection (1A).
(1A) The person may, by writing signed by the person otherwise than in the presence of any member of the person’s family or any of the person’s friends, consent to the removal from the person’s body of regenerative tissue, other than blood, specified in the consent —
(a) for the purpose of the transplantation of the tissue to the body of another living person; or
(b) for use of the tissue for other therapeutic purposes or for medical or scientific purposes; or
(c) for use of the tissue for the purposes of training, education or quality assurance relating to a use referred to in paragraph (b).
(2) A person who has given a consent referred to in subsection (1A) may, at any time before the removal of the regenerative tissue to which the consent applies, revoke, either orally or in writing, the person’s consent to the removal.
(1) A person who —
(a) has attained the age of 18 years; and
(b) is of sound mind; and
(c) is in the light of medical advice furnished to the person prepared to do so,
may, by writing signed by the person otherwise than in the presence of any member of the person’s family or any of the person’s friends, consent to the removal, after the expiration of a period of 24 hours from the time at which the consent is signed, from the person’s body of non‑regenerative tissue specified in the consent for the purpose of the transplantation of the tissue to the body of another living person.
(2) A person who has given a consent referred to in subsection (1) may, at any time before the removal of the non‑regenerative tissue to which the consent applies, revoke, either orally or in writing, the person’s consent to the removal.
Nothing in this Division prevents the removal in accordance with Division 5 of blood from the body of a child.
In this Division, a reference to the parent of a child does not include a reference to the guardian of a child or to another person standing
(1) It is not lawful, except as provided by this Part, to remove regenerative tissue from the body of a living child for the purpose of the transplantation of the tissue to the body of another living person.
(2) It is not lawful to remove non‑regenerative tissue from the body of a living child for the purpose of the transplantation of the tissue to the body of another living person.
(1) A parent of a child may, in the circumstances specified in subsection (2), consent in writing to the removal from the body of the child of specified regenerative tissue for the purpose of the transplantation of the tissue to the body of another member of the family of the child or to the body of a relative of the child.
(2) The circumstances specified for the purposes of subsection (1) are that —
(a) medical advice has been furnished to the parent and the child regarding the nature and effect of the removal and the nature of the transplantation; and
(b) the child has the mental capacity to understand the nature and effect of the removal and the nature of the transplantation; and
(c) the child has agreed to the removal of the regenerative tissue for the purpose of its transplantation to the body of the person referred to in subsection (1).
14. Revocation of consent
A parent who has given a consent under this Division, or a child who has under this Division agreed to the removal of tissue from the child’s body, may, at any time before the removal of the tissue to which the consent or agreement applies, revoke, either orally or in writing, the consent or agreement, as the case requires, to the removal.
A consent under section 8 is, unless it has been revoked under section 8(2), sufficient authority for a medical practitioner, other than a medical practitioner by whom the medical advice referred to in that section was furnished, to remove the regenerative tissue referred to in the consent —
(a) for the purpose of the transplantation of the tissue to the body of another living person; or
(b) for use for other therapeutic purposes or for medical or scientific purposes; or
(c) for use of the tissue for the purposes of training, education or quality assurance relating to a use referred to in paragraph (b).
A consent under section 9 is, unless it has been revoked under section 9(2), sufficient authority for a medical practitioner, other than a medical practitioner by whom the medical advice referred to in that section was furnished, to remove, after the expiration of a period of 24 hours after the time at which the consent was given, the non‑regenerative tissue referred to in the consent for the purpose of the transplantation of the tissue to the body of another living person.
A consent under section 13 is, unless the parent who gave the consent has revoked the consent or the child has revoked the child’s agreement under section 14, sufficient authority for a medical practitioner, other than a medical practitioner by whom the medical advice referred to in that section was furnished, to remove from the body of the child the regenerative tissue referred to in the consent for the purpose of the transplantation of the tissue to the body of another member of the family of the child or of a relative of the child.
(1) This section applies to a person who —
(a) has attained the age of 18 years; and
(b) is of sound mind.
(2) The person may consent to the removal of blood from the person’s body —
(a) for transfusion of the blood to another person; or
(b) for use of the blood or of any of its constituents for other therapeutic purposes or for medical or scientific purposes; or
(c) for use of the blood or of any of its constituents for the purposes of training, education or quality assurance relating to a use referred to in paragraph (b).
The parent of a child may consent to a removal of blood from the body of the child for a use referred to in section 18(2) if —
(a) a medical practitioner advises that the removal should not be prejudicial to the health of the child; and
(b) the child agrees to the removal.
A consent under this Division is sufficient authority for the removal of blood from the body of the person who has given the consent, or from the body of the child of the person who has given the consent, as the case requires.
(1) A medical practitioner may perform a blood transfusion upon a child without the consent of any person who is legally entitled to authorise the blood transfusion if —
(a) such person —
(i) fails or refuses to so authorise the blood transfusion when requested to do so; or
(ii) cannot be found after such search and enquiry as is reasonably practicable in the circumstances of the case;
and
(b) the medical practitioner and another medical practitioner agree —
(i) as to the condition from which the child is suffering; and
(ii) that the blood transfusion is a reasonable and proper treatment for that condition; and
(iii) that without a blood transfusion the child is likely to die;
and
(c) the medical practitioner who performs the blood transfusion on the child —
(i) has had previous experience in performing blood transfusions; and
(ii) is, before commencing the transfusion, satisfied that the blood to be transfused is suitable for the child.
(2) When a medical practitioner has performed a blood transfusion on a child without the consent of any person legally entitled to authorise it and in respect of that transfusion the requirements and conditions of this section have been complied with, the transfusion is taken for all purposes to have been performed with the authority of a person legally entitled to authorise it.
(3) Where a medical practitioner other than the medical practitioner who is to perform the blood transfusion on the child cannot be found after search or enquiry for such time as the last‑mentioned medical practitioner considers reasonable in the circumstances of the case, having regard to the emergency arising from the condition of the child, it is sufficient compliance with subsection (1)(b) if that last‑mentioned practitioner is satisfied —
(a) as to the condition from which the child is suffering; and
(b) that a blood transfusion is a reasonable and proper treatment for that condition; and
(c) that to delay the blood transfusion until that other medical practitioner can be found and be available for consultation would cause a serious deterioration in the child’s condition; and
(d) that without a blood transfusion the child is likely to die.
(4) In this section —
(5) Nothing in this section relieves a medical practitioner from liability in respect of the administration of a blood transfusion to a child being a liability to which the medical practitioner would have been subject if the transfusion had been administered with the consent of a parent of the child or a person having authority to consent to the administration of the transfusion.
Nothing in this Part applies to the removal of tissue for the purpose of the practice of anatomy under the
(1) A designated officer for a hospital may, subject to and in accordance with this Part, authorise the removal of tissue from the body of a person who has died in hospital or whose dead body has been brought into the hospital —
(a) for the purpose of the transplantation of the tissue to the body of a living person; or
(b) for use of the tissue for other therapeutic purposes or for medical or scientific purposes; or
(c) for use of the tissue for the purposes of training, education or quality assurance relating to a use referred to in paragraph (b).
(2) A designated officer for a hospital may authorise the removal of tissue from the body of a person who has died in the hospital or whose dead body has been brought into the hospital —
(a) where, after making inquiries, the designated officer is satisfied that the deceased person during the person’s lifetime expressed the wish for, or consented to, the removal after death of tissue from the body of the deceased person for the purpose or a use referred to in subsection (1) and had not withdrawn the wish or revoked the consent; or
(b) where, after making inquiries, the designated officer has no reason to believe that the deceased person had expressed an objection to the removal after death of tissue from the body of the deceased person for the purpose or a use referred to in subsection (1) and the designated officer is satisfied that the senior available next of kin consents to the removal of tissue from the body of the deceased person for the purpose or a use referred to in subsection (1).
(3) The authority of a designated officer to authorise the removal of tissue from the body of a deceased person under this section is restricted —
(a) in the case of the circumstances referred to in subsection (2)(a), by the expressed terms of the wishes or consent of the deceased person;
(b) in the case of the circumstances referred to in subsection (2)(b), by the consent of the senior available next of kin,
both as to the tissue which may be removed and as to the purpose or use of the tissue.
(4) The senior available next of kin of a person may make it known to a designated officer at any time when the person is unconscious before death that the senior available next of kin consents to the removal, after the death of the person, of tissue from the body of the person for the purpose or a use referred to in subsection (1), but the designated officer must not act on such an indication if the person recovers consciousness.
(5) Where there are 2 or more persons having a description referred to in a subparagraph of paragraph (a) or (b) of the definition of “senior available next of kin” in section 3, an objection by any one of those persons has effect for the purposes of this section notwithstanding any indication to the contrary by the other or any other of those persons.
(1) If the designated officer for a hospital has reason to believe that the death of a person is or may be a reportable death, the designated officer must not, under and in accordance with section 22, authorise the removal of tissue from the body of the deceased person unless the coroner has given consent to the removal.
(2) A coroner may give a direction either before or after the death of a person that the coroner’s consent to the removal of tissue from the body of the person after the death of the person is not required and, in that event, subsection (1) does not apply to or in relation to the removal of tissue from the body of the person.
(3) A consent or direction by a coroner under this section may be expressed to be subject to such conditions as are specified in the consent or the direction.
(4) A consent or direction may be given orally by a coroner, and if so given, must be confirmed in writing.
(1) In this section —
(a) if subsection (2) applies — a medical practitioner who made a declaration under that subsection relating to the authority; or
(b) the designated officer for the hospital in which the authority was given or a person who has lawfully exercised the designated officer’s powers under section 22;
(a) the purpose of the transplantation of the tissue to the body of a living person; or
(b) use of the tissue for other therapeutic purposes or for medical or scientific purposes; or
(c) use of the tissue for the purposes of training, education or quality assurance relating to a use referred to in paragraph (b).
(1A) Subject to subsection (2), an authority under this Part is sufficient authority for the removal of tissue from the body of the deceased person referred to in the authority, for a permitted purpose or use, by —
(a) if the tissue to be removed is ocular tissue —
(i) a permitted practitioner; or
(ii) a person appointed under section 24A(1) as an authorised person for the purposes of this paragraph;
or
(b) if the tissue to be removed is musculoskeletal tissue —
(i) a permitted practitioner; or
(ii) a person appointed under section 24A(1) as an authorised person for the purposes of this paragraph;
or
(c) if the tissue to be removed is skin —
(i) a permitted practitioner; or
(ii) a person appointed under section 24A(1) as an authorised person for the purposes of this paragraph;
or
(d) in any other case — a permitted practitioner.
(1B) An authority under this Part is subject to any restriction that applies in relation to the authority by reason of section 22(3).
(2) Where the respiration and the circulation of the blood of a person are being maintained by artificial means, tissue must not be removed from the body of the person for a permitted purpose or use unless 2 medical practitioners (each of whom has carried out a clinical examination of the person, each of whom has been for a period of not less than 5 years a medical practitioner and one of whom holds specialist qualifications in general medicine, neurology or neurosurgery or has such other qualifications as are accepted by the Chief Health Officer) have declared that irreversible cessation of all function of the brain of the person has occurred.
(3) For the purposes of subsection (2), any period during which a person who is a medical practitioner practised as a medical practitioner, however described, under the law in force in a country outside Australia must be taken into account in calculating the period of 5 years referred to in that subsection.
[(4) deleted]
(1) The Minister may, in writing, appoint a person, or a person in a class of person, to be an authorised person for the purposes of any 1 or more of section 24(1A)(a)(ii), (b)(ii) or (c)(ii).
(2) A person cannot be an authorised person if the person is a medical practitioner.
(3) The Minister may, in writing, revoke an appointment made under subsection (1) if the Minister considers it appropriate to do so.
(4) If, immediately before the day on which the
Human Tissue and Transplant Amendment Act 2022 section 20 comes into operation, a person is an authorised person for the purposes of section 24 —(a) the person is taken to have been appointed under subsection (1) to be an authorised person for the purposes of section 24(1A)(a)(ii); and
(b) for the purposes of subsection (3), the person’s appointment is taken to be an appointment made under subsection (1).
(1) A designated officer for a hospital may, subject to and in accordance with this Part, authorise a post‑mortem examination of the body of a person who has died in the hospital, or whose dead body has been brought into the hospital, for the purpose of —
(a) ascertaining the cause or extent of disease or any pathological condition that may be present in that person; or
(b) ascertaining whether the health of that person was affected by any condition of health that is prescribed for the purposes of this paragraph; or
(c) teaching pathology.
(2) Where the designated officer, after making such inquiries as are reasonable in the circumstances, has reason to believe that the deceased person had, during the person’s lifetime, expressed the wish for, or consented to, a post‑mortem examination of the person’s body and had not withdrawn the wish or revoked the consent, the designated officer may authorise under subsection (1) a post‑mortem examination of the body.
(3) Where the designated officer, after making such inquiries as are reasonable in the circumstances, has no reason to believe that the deceased person during the person’s lifetime —
(a) had expressed the wish for, or consented to, a post‑mortem examination of the person’s body; or
(b) had expressed an objection to the post‑mortem examination of the person’s body,
and after making those inquiries and such further inquiries as are reasonable in the circumstances, the designated officer —
(c) has no reason to believe that the senior available next of kin of the deceased person has an objection to a post‑mortem examination of the body of the deceased person; or
(d) is unable to ascertain the existence or the whereabouts of the next of kin of the deceased person or is unable to ascertain whether any of the next of kin of the deceased person has an objection to a post-mortem examination of the body of the deceased person,
the designated officer may authorise under subsection (1) a post‑mortem examination of the body of the deceased person for the purpose referred to in that subsection.
(4) The senior available next of kin of a person may make it known to a designated officer at any time when the person is unconscious before death that the senior available next of kin has no objection to a post‑mortem examination of the body of the person, but the designated officer must not act on such an indication if the person recovers consciousness.
(5) Where there are 2 or more persons having a description referred to in a subparagraph of paragraph (a) or (b) of the definition of “senior available next of kin” in section 3, an objection by any one of those persons has effect for the purposes of this section notwithstanding any indication to the contrary by the other or any other of those persons.
(1) Where the body of a deceased person is in a place other than a hospital, the senior available next of kin of the deceased person may, subject to and in accordance with this Part, authorise a post‑mortem examination of the body of the deceased person for the purpose of —
(a) ascertaining the cause or extent of disease or any pathological condition that may be present in that person; or
(b) ascertaining whether the health of that person was affected by any condition of health that is prescribed for the purposes of this paragraph; or
(c) teaching pathology.
(2) Subsection (1) does not apply where the senior available next of kin of the deceased person has reason to believe that —
(a) the deceased person had, during the person’s lifetime, expressed an objection to a post‑mortem examination of the person’s body and had not withdrawn the objection; or
(b) another next of kin of the same or a higher order of the classes in paragraph (a) or (b) of the definition of “senior available next of kin” in section 3 has an objection to the post‑mortem examination of the body of the deceased person.
(3) Where a deceased person, during the person’s lifetime, expressed the wish for, or consented to, a post‑mortem examination of the person’s body and the wish had not been withdrawn or the consent revoked, a post‑mortem examination of the body of the deceased person in accordance with the wish or consent is, by force of this subsection, authorised.
(1) If the designated officer for a hospital or, in a case to which section 26 applies, the senior available next of kin, has reason to believe that the death of a person is or may be a reportable death, the designated officer or the senior available next of kin, as the case may be, must not authorise a post‑mortem examination of the body of the deceased person unless the coroner has given consent to the examination.
(2) Section 26(3) does not operate in a case where the death of a person is or may be a reportable death unless a coroner has given consent to the post‑mortem examination.
(3) A coroner may give a direction either before or after the death of a person that the coroner’s consent to a post‑mortem examination of the body of the person is not required and, in that event, subsection (1) does not apply to or in relation to a post‑mortem examination of the body of the deceased person.
(4) A consent or direction by a coroner under this section may be expressed to be subject to such conditions as are specified in the consent or the direction.
(5) A consent or direction may be given orally by a coroner, and if so given, must be confirmed in writing.
(1) An authority under this Part is sufficient authority for a medical practitioner (other than, in a case to which section 25 applies, the designated officer for the hospital or a person who has lawfully exercised the powers of the designated officer under that section) —
(a) to conduct such examination of the body of the deceased person as is necessary for a purpose referred to in section 25(1) or 26(1); and
(b) to remove from the body of the person such tissue as is necessary for the purpose of the post‑mortem examination.
(2) An authority under this Part is authority for the use of tissue removed from the body of the deceased person as part of the post‑mortem examination for the following purposes —
(a) therapeutic, medical, teaching or scientific purposes;
(b) training, education or quality assurance relating to a use referred to in paragraph (a).
This Part does not apply to or in relation to the sale or supply of a human embryo, human sperm or a human egg.
Note for this section:
The
(1) In this section —
(a) a TGA provision; or
(b) a provision or portion of the applied therapeutic goods law as defined in the
Therapeutic Goods Law Application Act 2024 section 3(1).(2) Subject to subsection (4) and sections 29C, 29D(1) and 29E, a contract or arrangement is void if, under the contract or arrangement, a person agrees, for valuable consideration, whether given or to be given to that person or to another person —
(a) to the sale or supply of tissue from that person’s body or from the body of another person, whether before or after that person’s death or the death of the other person, as the case may be; or
(b) to the post‑mortem examination or anatomical examination of that person’s body after death or of the body of another person after the death of the other person.
(3) A person who enters into a contract or arrangement of the kind referred to in subsection (2) and to which that subsection applies commits an offence.
Penalty for this subsection: imprisonment for 12 months or a fine of $12 000.
(4) Except as provided in section 29D(2), subsection (2) does not apply to or in relation to the following contracts or arrangements —
(a) a contract or arrangement providing only for the reimbursement of any expenses necessarily incurred by a person in relation to the removal of tissue in accordance with this Act;
(b) a contract or arrangement providing for the sale or supply of blood or any of its constituents included on the national product price list if the sale or supply is carried out by or with —
(i) an entity mentioned in the national product price list; or
(ii) the Commonwealth for the benefit of an entity mentioned in the national product price list;
(c) a contract or arrangement providing for the sale or supply of tissue if —
(i) the sale or supply is carried out by or with an exempt entity or the Commonwealth for the benefit of an exempt entity; and
(ii) the tissue is the subject of an agreement between the exempt entity and the Commonwealth or the State;
(d) a contract or arrangement providing for the sale or supply of therapeutic goods that comprise, contain or are derived from tissue if —
(i) the sale or supply is in accordance with an approval or authority given under a TG law provision; and
(ii) the TG law provision is prescribed by the regulations for the purposes of this paragraph;
(e) a contract or arrangement providing for the sale or supply of therapeutic goods that comprise, contain or are derived from tissue if —
(i) the therapeutic goods are exempt under a TGA provision from the operation of Part 3.2 or Part 3.2A Division 4 of the Therapeutic Goods Act; and
(ii) the sale or supply does not breach a condition of the exemption; and
(iii) the TGA provision is prescribed for the purposes of this paragraph;
(f) a contract or arrangement providing for the sale or supply of tissue where the sale or supply of the tissue meets the requirements set out in section 29B(3).
(5) Nothing in this section renders inoperative a consent or authority given or purporting to have been given under this Act in relation to tissue from the body of a person or in relation to the body of a person if a person acting in pursuance of the consent or authority did not know and had no reason to know that the tissue or the body was the subject matter of an unauthorised contract or arrangement.
(1) In this section —
(a) a person who supplies therapeutic goods that —
(i) comprise, contain or are derived from tissue; and
(ii) are included in the Register under the Therapeutic Goods Act or are registered goods under that Act;
or
(b) a person who owns or controls a tissue bank;
(a) established for the purposes of the removal, evaluation, processing, storage and distribution of tissue, or any of those purposes; and
(b) prescribed by the regulations.
(2) Regulations prescribing a facility as a tissue bank cannot be made unless —
(a) the Human Tissue Advisory Body has recommended the making of the regulations; and
(b) the Minister has approved the recommendation.
(3) For the purposes of section 29A(4)(f), the requirements for the sale or supply of the tissue are as follows —
(a) the person selling or supplying the tissue must be an authorised supplier of the tissue;
(b) the authorised supplier must be satisfied, after making reasonable enquiries, that the first sale or supply of the tissue was not for valuable consideration other than reimbursement of any expenses necessarily incurred in relation to the removal of the tissue;
(c) the tissue must have been subjected to processing or treatment;
(d) the sale or supply of the tissue must be for the purpose of enabling the tissue to be used —
(i) for therapeutic, medical or scientific purposes; or
(ii) for the purposes of training, education or quality assurance relating to a use referred to in subparagraph (i);
(e) the consideration given to the authorised supplier for the sale or supply of the tissue must consist only of an amount (a
cost‑recovery amount ) that —(i) is necessarily incurred by the authorised supplier in relation to the removal, evaluation, processing, storage or distribution of the tissue or in relation to any other matter prescribed by the regulations; and
(ii) complies with regulations (if any) made for the purposes of subsection (4).
(4) The regulations may set out the components of a cost‑recovery amount for a matter or otherwise regulate the charging of the cost‑recovery amount.
(1) In this section —
(2) An authorised school of anatomy may charge an amount to recover the reasonable costs associated with supply of a donated body (including a prosected donated body) or portion or specimen part of a donated body —
(a) to another authorised school of anatomy; or
(b) to a person to whom the proviso to the
Anatomy Act 1930 section 18 applies; or(c) for the purposes of the
Anatomy Act 1930 section 10A.
(3) For the purposes of subsection (2),
reasonable costs associated with supply include reasonable costs for the following —(a) administration in respect of the supply;
(b) the preparation, handling, transfer, receival, embalming, plastination, storage, maintenance and disposal of the body or portion or specimen part of the body;
(c) security in respect of the body or portion or specimen part of the body.
(4) Section 29A(2) does not apply to a contract or arrangement entered into for the purposes of subsection (2).
(1) The Minister may, by order published in the
Gazette , declare that section 29A(2) does not apply to or in relation to the sale or supply in accordance with the order of a specified class or classes of product derived from tissue that has been subjected to processing or treatment.(2) The Minister may, by order published in the
Gazette , declare that section 29A(2) applies to a specified contract or arrangement, or a contract or arrangement of a specified class, to which section 29A(4) would otherwise apply.(3) An order published under subsection (1) or (2) is subject to the conditions, if any, specified in the order.
(4) The Minister may, by order published in the
Gazette , amend or revoke an order published under subsection (1) or (2).(5) An order in effect under section 29(4) as in force immediately before the day on which the
Human Tissue and Transplant Amendment Act 2022 section 31 comes into operation has effect as if it were an order published by the Minister under subsection (1) of this section, and subsection (4) applies accordingly.
(1) The Minister may, if the Minister considers it desirable by reason of special circumstances, approve in writing the entering into of a contract or arrangement that would, but for the approval, be void under section 29A(2).
(2) Nothing in section 29A(2) or (3) applies to or in relation to a contract or arrangement entered into in accordance with an approval under subsection (1).
(3) The Minister must not give an approval under subsection (1) unless —
(a) in the case of a contract or arrangement in relation to non‑regenerative tissue for the purposes of transplantation to the body of a living person —
(i) the entering into of the contract or arrangement has been recommended by a body of medical practitioners prescribed by the regulations for the purposes of this paragraph; and
(ii) the Minister is reasonably satisfied that no monetary payment or reward will be made, given or received for or in consideration of the contract or arrangement;
or
(b) in the case of any other contract or arrangement (irrespective of whether any monetary payment or reward will be made, given or received for or in consideration of the contract or arrangement) — the entering into of the contract or arrangement has been recommended by the Human Tissue Advisory Body.
(1) The Minister must, by instrument signed by the Minister, establish the Human Tissue Advisory Body to provide advice and recommendations to the Minister for the purposes of sections 29B(2)(a) and 29E(3)(b).
(2) The instrument establishing the Human Tissue Advisory Body must —
(a) identify the members of the Advisory Body or provide for the manner of appointing members of the Advisory Body; and
(b) provide for the length and conditions of appointment; and
(c) set out the duties and responsibilities of the Advisory Body and its members; and
(d) set out any other matters in relation to the constitution, operation and procedures of the Advisory Body that the Minister considers appropriate.
(3) The Minister may, by instrument signed by the Minister, amend or revoke the instrument establishing the Human Tissue Advisory Body.
(4) Except to the extent that its procedures are set out in an instrument under subsection (2), the Advisory Body may determine its own procedures.
(5) The members of the Advisory Body are entitled to any remuneration and allowances that the Minister may determine on the recommendation of the Public Sector Commissioner.
(1) A person must not —
(a) publish or disseminate by newspaper, book, broadcasting, television, cinematograph or other means whatever; or
(b) exhibit to public view in a house, shop or place; or
(c) deposit in the area, yard, garden or enclosure of a house, shop or place,
an advertisement relating to the buying in Australia of human tissue or of the right to take tissue from the bodies of persons.
Penalty for this subsection: imprisonment for 12 months or a fine of $12 000.
(2) Subsection (1) does not apply in relation to an advertisement if the advertisement —
(a) has been approved in writing by the Minister and contains a statement to that effect; or
(b) belongs to a class of advertisement approved in writing by the Minister for the purposes of this section.
In this Part —
(a) its use in, or in connection with —
(i) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or
(ii) influencing, inhibiting or modifying a physiological process in persons; or
(iii) testing the susceptibility of persons to a disease or ailment; or
(iv) influencing, controlling or preventing conception in persons; or
(v) testing for pregnancy in persons; or
(vi) the replacement or modification of parts of the anatomy of persons;
or
(b) a use of it that is prescribed in the regulations and is not inconsistent with a use referred to in paragraph (a); or
(c) its use in training or research for the purposes of a use referred to in paragraph (a) or (b).
A person who uses a human embryonic stem cell line except for a therapeutic use commits a crime.
Penalty: Imprisonment for 5 years.
Summary conviction penalty: Imprisonment for 12 months.
(1) Subject to this Act, a person is not liable in any proceedings, whether civil or criminal, for any act done in pursuance of, by reason of, or as a result of, a consent, agreement or authority given, or purporting to have been given, in pursuance of this Act where the act is done without negligence and in good faith.
(2) Without limiting the generality of the expression “in good faith”, a person is regarded as having done an act referred to in subsection (1) in good faith if the person establishes that —
(a) the person had an honest and reasonable belief that a consent, agreement or authority required by this Act for the doing of the act had been given; or
(b) the person had no reason to doubt that a consent, agreement or authority purporting to have been given in accordance with this Act for the doing of the act was a consent, agreement or authority given in accordance with this Act.
(1) Nothing in this Act applies to or in relation to —
(a) the removal of tissue from the body of a living person in the course of a procedure or operation carried out, in the interests of the health of the person, by a medical practitioner with the consent, express or implied, given by or on behalf of the person or in circumstances necessary for the preservation of the life of the person; or
(b) the use of tissue so removed; or
(c) the embalming of the body of a deceased person; or
(d) the preparation, including the restoration of any disfigurement or mutilation, of the body of a deceased person for the purpose of interment or cremation.
(2) In this section,
tissue has the same meaning as in Part 2.
(1) The Chief Health Officer may, with the approval of the Minister, issue codes of practice setting out directions and guidelines for the purposes of facilitating the operation of any of the provisions of this Act.
(2) Sections 41, 42, 43 and 44 of the
Interpretation Act 1984 apply to a code of practice as if it were a regulation.( 3) A code of practice may adopt, wholly or partly, any standard, rule, requirement or other provision contained in a text specified in the code but published by some other person or body —
(a) subject to any modification specified in the code; and
(b) as in force at the time of adoption or as amended from time to time, as may be specified in the code.
(4) A code of practice has effect —
(a) as if a text adopted under subsection (3), identified by reference to the person or body responsible for its original publication and modified by any modification specified in the code, had been set out in full in the code; and
(b) where a text adopted is to be applied as from time to time amended, as if any modification specified in the code at the time the text was adopted prevailed (subject to any amendment of that modification itself under this Act) over any subsequent amendment to that text made by the originating person or body that is inconsistent with that modification.
(1) Where it appears to the Chief Health Officer that a person has by act or omission contravened a direction contained in a code of practice the Chief Health Officer may require the person to enter into a written undertaking —
(a) to discontinue the conduct giving rise to the contravention; and
(b) as to the person’s future conduct; and
(c) regarding the action the person will be required to take to ensure that the objects of the code of practice are attained.
(2) Where a person enters into a written undertaking under subsection (1) the Chief Health Officer must —
(a) retain a copy of the document evidencing the undertaking; and
(b) give a copy of that document to the person who executed it; and
(c) register the document in a Register of Undertakings, to contain the prescribed particulars and to be kept in a prescribed manner and place.
(3) The Register of Undertakings may, at any reasonable time, be inspected by any person free of charge.
(4) A person who fails —
(a) to enter into a written undertaking when requested under this section to do so by the Chief Health Officer; or
(b) to observe such an undertaking entered into by that person,
commits an offence.
Penalty for this subsection: a fine of $1 000.
(5) A prosecution for an offence under subsection (4) must not be commenced without the approval of the Chief Health Officer.
(6) The Chief Health Officer may, whether or not a person has been convicted of an offence under subsection (4), report a breach of any undertaking given under subsection (1) to any relevant registration board or licensing authority and that registration board or licensing authority may take into account the report of the breach when performing its functions.
(1) A person must not —
(a) remove tissue other than blood from the body of a living person for use for a purpose specified in sections 8, 9 or 13 except in pursuance of a consent or authority that is under Part 2 Division 4 sufficient authority for the person to remove the tissue for use for that purpose; or
(b) remove blood from the body of a living person for transfusion or a use specified in section 18(2) except in pursuance of a consent that is under Part 2 Division 5 sufficient authority for the removal of the blood; or
(c) remove tissue from the body of a deceased person for a purpose or use referred to in section 22(1) except in pursuance of an authority that is under Part 3 sufficient authority for the person to remove the tissue for that purpose or use; or
(d) conduct a post‑mortem examination of the body of a deceased person unless the post‑mortem examination is made in pursuance of an authority that is under Part 4 sufficient authority for the person to conduct the post‑mortem examination; or
(e) except as authorised under Part 4, in conducting a post‑mortem examination of the body of a deceased person, remove tissue from the body of a person unless the removal is necessary as part of the post‑mortem examination.
Penalty for this subsection: a fine of $500.
(2) A designated officer for a hospital or a person to whom a designated officer has lawfully delegated any of the designated officer’s powers or duties under this Act who issues an authority under this Act —
(a) without having made any of the inquiries that a designated officer is required to make under this Act; or
(b) without making such inquiries as are reasonable in the circumstance of the case,
is guilty of an offence.
Penalty for this subsection: a fine of $1 000.
(3) Nothing in subsection (1) applies to or in relation to the following —
(a) any act for which a person is not, by reason of section 31, criminally liable;
(b) anything done in pursuance of an order by a coroner under the
Coroners Act 1996 ;(ba) anything done under the
Anatomy Act 1930 ;(c) any other act authorised by law.
(1) Subject to this section, a person must not disclose or give to any other person any information or document whereby the identity of a person —
(a) from whose body tissue has been removed for the purpose of transplantation or for use for other therapeutic purposes or for medical, teaching or scientific purposes; or
(b) with respect to whom or with respect to whose body a consent or authority has been given under this Act; or
(c) into whose body tissue has been, is being, or may be, transplanted,
may become publicly known.
Penalty for this subsection: a fine of $500.
(2) Subsection (1) does not apply to or in relation to any information disclosed —
(a) in pursuance of an order of a Court or when otherwise required by law; or
(b) for the purposes of hospital administration or
bona fide medical research; or(c) with the consent of the person to whom the information relates; or
(d) when the circumstances in which the disclosure is made are such that the disclosure is or would be privileged.
The Governor may make regulations prescribing all matters that are required or permitted to be prescribed by this Act or are necessary or convenient to be prescribed for carrying out or giving effect to this Act.
(1) In this section —
(2) Regulations may adopt, either wholly or in part or with modifications —
(a) any code; or
(b) any subsidiary legislation made, determined or issued under any other Act or under any Act of the Commonwealth, another State or a Territory.
(3) The adoption may be by —
(a) incorporating the code or subsidiary legislation in the regulations; or
(b) incorporating the code or subsidiary legislation by reference.
(4) If the regulations adopt a code or subsidiary legislation by reference, then, unless the regulations specify that a particular text is adopted —
(a) the code or subsidiary legislation is adopted as existing or in force when the regulations are made; and
(b) any amendments made to the code or subsidiary legislation after the regulations are made have no legal effect as part of the regulations unless they are specifically adopted by later regulations or a later amendment to the regulations.
(5) Particulars of any code or subsidiary legislation adopted by reference must be published on, or accessible through, the website of the department principally assisting in the administration of this Act.
This is a compilation of the
116 of 1982 | 8 Dec 1982 | 1 Mar 1983 (see s. 2) | |
28 of 1984 | 31 May 1984 | 1 Jul 1984 (see s. 2 and | |
5 of 1987 | 29 May 1987 | 29 May 1987 (see s. 2) | |
78 of 1995 | 16 Jan 1996 | 4 Nov 1996 (see s. 2 and | |
2 of 1996 | 24 May 1996 | 7 Apr 1997 (see s. 2 and | |
25 of 1997 | 24 Sep 1997 | 24 Sep 1997 (see s. 2) | |
3 of 2002 | 17 Apr 2002 | 21 Sep 2002 (see s. 2 and | |
18 of 2004 | 16 Jul 2004 | 1 Dec 2004 (see s. 2 and | |
14 of 2006 | 11 May 2006 | 11 May 2006 (see s. 2) | |
22 of 2008 | 27 May 2008 | 1 Dec 2008 (see s. 2 and | |
35 of 2010 | 30 Aug 2010 | 18 Oct 2010 (see s. 2(b) and | |
11 of 2016 | 26 May 2016 | 1 Jul 2016 (see s. 2(b) and | |
19 of 2016 | 25 Jul 2016 | 24 Jan 2017 (see s. 2(1)(c) and | |
41 of 2022 | 21 Nov 2022 | Pt. 2 Div. 1 and 2: 22 Nov 2022 (see s. 2(b)); Pt. 2 Div. 3: 19 Feb 2024 (see s. 2(c) and SL 2024/11 cl. 2) | |
19 of 2024 | 14 May 2024 | 30 Aug 2024 (see s. 2(b) and SL 2024/177 cl. 2) | |
authorised school of anatomy.............................................................................. 29C(1)
authorised supplier................................................................................................ 29B(1)
blood.............................................................................................................................. 3(1)
blood transfusion...................................................................................................... 21(4)
Chief Health Officer .................................................................................................. 3(1)
child................................................................................................................... 3(1), 21(4)
code............................................................................................................................. 37(1)
coroner.......................................................................................................................... 3(1)
cost-recovery amount............................................................................................ 29B(3)
designated officer........................................................................................................ 3(1)
Division........................................................................................................................ 3(1)
donated body.......................................................................................................... 29C(1)
exempt entity.......................................................................................................... 29A(1)
hospital.......................................................................................................................... 3(2)
human egg.................................................................................................................... 3(1)
human embryo............................................................................................................. 3(1)
human embryonic stem cell line.............................................................................. 30A
human sperm................................................................................................................ 3(1)
Human Tissue Advisory Body................................................................................. 3(1)
medical practitioner.................................................................................................... 3(1)
national product price list..................................................................................... 29A(1)
next of kin.................................................................................................................... 3(1)
non-regenerative tissue.............................................................................................. 3(1)
permitted practitioner............................................................................................... 24(1)
permitted purpose or use......................................................................................... 24(1)
reasonable costs associated with supply............................................................ 29C(3)
regenerative tissue...................................................................................................... 3(1)
reportable death........................................................................................................... 3(1)
section........................................................................................................................... 3(1)
senior available next of kin....................................................................................... 3(1)
subsection..................................................................................................................... 3(1)
subsidiary legislation............................................................................................... 37(1)
TGA provision....................................................................................................... 29A(1)
TG law provision................................................................................................... 29A(1)
therapeutic goods........................................................................................................ 3(1)
Therapeutic Goods Act.............................................................................................. 3(1)
therapeutic use............................................................................................................ 30A
tissue.................................................................................................................. 3(1), 32(2)
tissue bank.............................................................................................................. 29B(1)
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