Human Tissue Act 1983 (NSW)

Human Tissue Act 1983 No 164 An Act relating to the donation of tissue by living persons, the removal of tissue from deceased persons, the conduct of post-mortem examinations of deceased persons, and certain other matters. Part 1 Preliminary 1 Name of Act This Act may be cited as the Human Tissue Act 1983. 2 Commencement (1) Sections 1 and 2 shall commence on the date of assent to this Act. (2) Except as provided by subsection (1), this Act shall commence on such day as may be appointed by the Governor in respect thereof and as may be notified by proclamation published in the Gazette. 3 (Repealed) 4 Definitions (1) In this Act, except in so far as the context or subject-matter otherwise indicates or requires— blood product means a product or extract derived or extracted from blood by any process of manufacture. child means a person who has not attained the age of 18 years and who is not married. designated officer means— (a) in relation to a hospital, a person appointed for the time being under section 5 (1) (a) to be a designated officer for the hospital, or (b) in relation to a forensic institution, a person appointed for the time being under section 5 (3) to be a designated officer for the forensic institution. designated specialist, in relation to a hospital, means a person appointed for the time being under section 5 (1) (b) to be a designated specialist for the hospital. donor, in relation to blood, means the person from whom the blood has been removed. exempt supplier— (a) in relation to the supply of blood or a blood product, means— (i) the Australian Red Cross Society, or (ii) the governing body of a hospital, or (iii) any other body declared by the regulations to be an exempt supplier for the purposes of this Act, or (a1) in relation to the supply of blood products that are therapeutic goods within the meaning of the Therapeutic Goods Act 1989 of the Commonwealth and that are registered goods within the meaning of that Act—a body that supplies those goods, or (a2) in relation to the supply of blood products that are therapeutic goods within the meaning of the Therapeutic Goods Act 1989 of the Commonwealth and that are exempt goods for the purposes of Part 3–2 of that Act—a body that supplies those goods in compliance with the conditions (if any) of the relevant exemption. (b) (Repealed) exercise a function includes perform a duty. forensic institution means— (a) an institution that is under the control of a public health organisation (within the meaning of the Health Services Act 1997), or (b) an accredited pathology laboratory under the Health Insurance Act 1973 of the Commonwealth, or (c) an institution that is under the control of the Health Administration Corporation, at which post-mortem examinations of human bodies are carried out, but does not include a hospital. function includes a power, authority or duty. governing body means— (a) in relation to a hospital— (i) in the case of a public hospital that is controlled by a public health organisation within the meaning of the Health Services Act 1997—the public health organisation, or (ii) in the case of a public hospital within the meaning of the Health Services Act 1997 that is controlled by the Crown (including the Minister or the Health Administration Corporation)—the Crown, or (iii) in the case of a private health facility within the meaning of the Private Health Facilities Act 2007—the licensee of the facility, or (b) in relation to a forensic institution— (i) in the case of a forensic institution that is controlled by a public health organisation within the meaning of the Health Services Act 1997—the public health organisation, or (ii) in the case of an accredited pathology laboratory under the Health Insurance Act 1973 of the Commonwealth—the person in charge of the laboratory (however designated), or (iii) in the case of a forensic institution that is controlled by the Health Administration Corporation—the Health Secretary. Health Secretary means the Secretary of the Ministry of Health. hospital means— (a) a public hospital within the meaning of the Health Services Act 1997, or (b) a private health facility within the meaning of the Private Health Facilities Act 2007. inspector means a person appointed as an inspector under Part 7A. medical, dental or surgical treatment means any medical, dental or surgical treatment carried out by, or under the supervision of, a medical practitioner or dentist with respect to a living person in the interests of the health of the person. next of kin means— (aa) in relation to a child who is living—a person referred to in paragraph (aa) of the definition of senior available next of kin, and (a) in relation to a deceased child—a person referred to in paragraph (a) of the definition of senior available next of kin, and (b) in relation to any other deceased person—a person referred to in paragraph (b) of that definition. non-regenerative tissue means tissue other than regenerative tissue. premises includes any means of vehicular transport. prescribed contaminant means an organism or substance declared by the regulations to be a prescribed contaminant for the purposes of this Act. record includes book, account, deed, writing, document and any other source of information compiled, recorded or stored in written form, or on micro-film, or by electronic process, or in any other manner or by any other means. regenerative tissue means tissue that, after injury or removal, is replaced in the body of a living person by natural processes of growth or repair. regulation means a regulation made under this Act. senior available next of kin, other than in Part 4A, means— (aa) in relation to a child who is living— (i) a parent of the child, or (ii) if no person referred to in subparagraph (i) is available—a person who is a guardian of the child, and (a) in relation to a deceased child— (i) a parent of the child, (ii) where a parent of the child is not available—a brother or sister of the child, being a brother or sister who has attained the age of 18 years, or (iii) where no person referred to in subparagraph (i) or (ii) is available—a person who was a guardian of the child immediately before the death of the child, and (b) in relation to any other deceased person— (i) a person who was a spouse of the deceased person immediately before the deceased person's death, (ii) where the deceased person, immediately before death, had no spouse or where the deceased person had a spouse but the person who was then the deceased person's spouse is not available—a son or daughter (if any) of the deceased person, being a son or daughter who has attained the age of 18 years, (iii) where no person referred to in subparagraph (i) or (ii) is available—a parent of the deceased person, or (iv) where no person referred to in subparagraph (i), (ii) or (iii) is available—a brother or sister of the deceased person, being a brother or sister who has attained the age of 18 years. spouse means— (a) the person to whom a person is legally married (including the husband or wife of a person), or (b) a de facto partner, but where more than one person would so qualify as a spouse, means only the last person so to qualify. Note— "De facto partner" is defined in section 21C of the Interpretation Act 1987. supply means supply by way of sale, exchange or gift, and includes receive, keep or store for the purpose of supply. tissue includes an organ, or part, of a human body and a substance extracted from, or from a part of, the human body. Note— The Interpretation Act 1987 contains definitions and other provisions that affect the interpretation and application of this Act. (1A) The regulations may— (a) prescribe additional bodily materials or classes or types of bodily materials as tissue for the purposes of this Act, and (b) exclude bodily materials or classes or types of bodily materials from being tissue for the purposes of this Act. (2) In this Act— (a) a reference to a parent of a person includes a reference to the following— (i) a step-parent of the person, (ii) an adoptive parent of the person, (iii) the Minister administering the Children and Young Persons (Care and Protection) Act 1998, if the Minister has sole parental responsibility in respect of the person (whether under that Act or otherwise), (b) a reference to a son or daughter of a person includes a reference to any person of whom the person is a parent, (c) a reference to a brother or sister of a person includes a reference to any person who is a son or daughter of a parent of the person, and (d) (Repealed) (2A) In this Act, except in so far as the context or subject-matter otherwise indicates or requires, a reference to tissue includes a reference to— (aa) blood, (a) ova and semen, and (b) foetal tissue. (3) In this Act, a reference to the transplantation of tissue includes a reference to— (a) the transplantation of any part of the tissue, and (b) the transplantation of any substance obtained from the tissue, and, without limiting the generality of the foregoing, includes a reference to the transfusion of blood. (4) In this Act, a reference to the removal of blood (however expressed) for any specified purpose includes a reference to the removal of blood so that a product to be derived or extracted from that blood may be used for that purpose. (5) In this Act, a reference to tissue removed from the body of a living person in the course of medical, dental or surgical treatment includes— (a) tissue expelled from the body of the person in the course of the treatment, and (b) all tissue removed or expelled from the body of the person in the course of the treatment, even if the person dies during the course of the treatment. (6) In this Act, a reference to medical or scientific purposes includes educational purposes connected with medicine or science. (7) For the purposes of this Act, a child is in the care of the State if— (a) a Minister administering the Children and Young Persons (Care and Protection) Act 1998 has sole parental responsibility in respect of the child (whether under that Act or otherwise), or (b) the Secretary under the Children and Young Persons (Care and Protection) Act 1998 has sole parental responsibility in respect of the child (whether under that Act or otherwise). (8) For this Act, the principal care officer, in relation to a child in the care of the State, means the Secretary under the Children and Young Persons (Care and Protection) Act 1998. 4A Notes Notes included in this Act do not form part of this Act. 5 Designated officers and designated specialists (1) The governing body of a hospital may, by instrument in writing— (a) appoint such persons as the governing body considers necessary to be designated officers for the hospital, and (b) except as provided by subsection (2), appoint such persons as the governing body considers necessary to be designated specialists for the hospital. (2) The governing body of a hospital shall not appoint a person to be a designated specialist for the hospital unless the person is a medical practitioner— (a) whose appointment as a designated specialist for the hospital is for the time being approved by the Secretary of the Department of Health, or (b) who is a member of a prescribed class of medical practitioners. (3) The governing body of a forensic institution may, by instrument in writing, appoint such persons as the governing body considers necessary to be designated officers for the forensic institution. 5A Delegation of functions of next of kin (1) A next of kin of a deceased person may from time to time, by instrument in writing, authorise a person to exercise his or her functions under this Act as a next of kin of the deceased person. (2) In such a case, the person so authorised— (a) may exercise the functions of a next of kin of the deceased person under this Act (other than the function conferred by subsection (1)), in the place of the person who authorised him or her, and (b) is taken, for the purposes of this Act, to be a next of kin of the deceased person, and (c) for the purposes of the definition of senior available next of kin in section 4 (1), is taken to be a next of kin of the same order as the person who authorised him or her to exercise the functions of a next of kin. 5B Delegation of functions of principal care officer The Secretary under the Children and Young Persons (Care and Protection) Act 1998 may delegate to a person the Secretary's functions as principal care officer under this Act. Part 2 Donations of tissue by living persons Division 1 Exclusion of certain tissue 6 Definition In this Part, a reference to tissue does not include a reference to ova, semen or foetal tissue. Division 2 Donations by adults 7 Consents to removal of regenerative tissue from adults A person, other than a child, may give consent in writing to the removal from the person's body of specified regenerative tissue for the purpose of— (a) its transplantation to the body of another living person, or (b) its use for other therapeutic purposes or for medical purposes or scientific purposes. 8 Consents to removal of non-regenerative tissue from adults (1) A person, other than a child, may give consent in writing to the removal from the person's body, at any time after the expiration of 24 hours after the consent is given, of specified non-regenerative tissue for the purpose of its transplantation to the body of another living person. (2) A consent given under subsection (1) shall specify the day on which, and the time at which, it is given. 9 Medical practitioners' certificates A medical practitioner may certify in writing— (a) that the consent in writing of a person, the terms of which consent are set out in the certificate, was given in the presence of the medical practitioner, (b) that the medical practitioner explained to the person, before the consent was given, the nature and effect of the removal from the body of that person of the tissue specified in the consent, and (c) that the medical practitioner is satisfied that, at the time the consent was given— (i) the person was not a child, (ii) the person was of sound mind, and (iii) the consent was freely given. Division 3 Donations by children 10 Consents to removal of regenerative tissue from children A parent of a child may give consent in writing to the removal from the child's body of specified regenerative tissue for the purpose of its transplantation to the body of a parent (being a biological parent, step-parent or adoptive parent), brother or sister of the child. Note— A child must understand the nature and effect of the removal of tissue if a medical practitioner's certificate is to be issued under section 11. If a child is not capable of such understanding, a medical practitioner's certificate must be issued under section 11A and only transplantation to the body of a brother or sister is allowed. 11 Medical practitioners' certificates A medical practitioner may certify in writing— (a) that the consent in writing of a parent of a child, the terms of which consent are set out in the certificate, was given in the presence of the medical practitioner, (b) that the medical practitioner explained to the parent and to the child, before the consent was given, the nature and effect of the removal from the child's body of the tissue specified in the consent and the intended effect of its proposed transplantation, and (c) that the medical practitioner is satisfied that, at the time the consent was given— (i) the parent and the child were each of sound mind, (ii) the parent and the child each understood the nature and effect of the removal of the tissue and the intended effect of its proposed transplantation, (iii) the consent was freely given, and (iv) the child was in agreement with the proposed removal and transplantation of the tissue. 11A Medical practitioners' certificate—child not capable of understanding (1) A medical practitioner who is of the opinion that a child is not, by reason of his or her age, capable of understanding the nature and effect of the removal of tissue from his or her body and the intended effect of its proposed transplantation, may certify in writing that— (a) the consent in writing of a parent of a child, the terms of which consent are set out in the certificate, was given in the presence of the medical practitioner, and (b) the medical practitioner explained to the parent, before the consent was given, the nature and effect of the removal from the child's body of the tissue specified in the consent and the intended effect of its proposed transplantation, and (c) the medical practitioner is satisfied that— (i) at the time the consent was given, the parent was of sound mind, and (ii) at the time the consent was given, the parent understood the nature and effect of the removal of the tissue and the intended effect of its proposed transplantation, and (iii) the consent was freely given, and (d) the medical practitioner is of the opinion that the following conditions (the pre-conditions for child tissue donation) are satisfied— (i) the child, by reason of his or her age, is not capable of understanding the nature and effect of the removal of the tissue and the intended effect of its proposed transplantation, (ii) the brother or sister of the child is likely to die or suffer serious and irreversible damage to his or her health unless the tissue intended to be removed from the child is used in the treatment of that brother or sister, (iii) any risk to the child's health (including psychological and emotional health) caused by the removal of the tissue is minimal. (2) A certificate by a medical practitioner to the effect that the pre-conditions for child tissue donation are satisfied is effective only if a second medical practitioner, who is a specialist in paediatric medicine or paediatric transplants, also certifies in the certificate that— (a) he or she is of the opinion that those pre-conditions are satisfied, and (b) he or she provides that opinion as an independent medical practitioner, being a medical practitioner— (i) whose primary role in providing an opinion in the case is to ensure the health of the child from whom the tissue is to be removed, and (ii) who is not responsible for the care of the brother or sister in whose treatment the tissue is to be used. Division 4 Effect of consent 12 Effect of consent under section 7 Except as provided by section 15, a document that purports to be a consent given in accordance with section 7 is, where a certificate has been given in accordance with section 9 in relation to that consent, sufficient authority for a medical practitioner (other than the medical practitioner who gave the certificate) to remove the regenerative tissue specified in the consent for the purpose or purposes specified in the consent. 13 Effect of consent under section 8 Except as provided by section 15, a document that purports to be a consent given in accordance with section 8 is, where a certificate has been given in accordance with section 9 in relation to that consent, sufficient authority for a medical practitioner (other than the medical practitioner who gave the certificate) to remove (at any time after the expiration of 24 hours after the date and time specified in the consent to be the date on which, and the time at which, the consent was given) the non-regenerative tissue specified in the consent for the purpose specified in the consent. 14 Effect of consent under section 10 (1) Except as provided by section 15, a document that purports to be a consent given in accordance with section 10 is, where a certificate has been given in accordance with section 11 in relation to that consent, sufficient authority for a medical practitioner (other than the medical practitioner who gave the certificate) to remove the regenerative tissue specified in the consent for the purpose specified in the consent. (2) Except as provided by section 15, a document that purports to be a consent given in accordance with section 10 is, where a certificate has been given in accordance with section 11A in relation to that consent, sufficient authority for a medical practitioner (other than either of the medical practitioners who gave the certificate) to remove the regenerative tissue specified in the consent for the purpose specified in the consent. 15 Written consent not to be sufficient authority in certain circumstances A document that purports to be a consent given in accordance with section 7, 8 or 10 is not sufficient authority for a medical practitioner to remove tissue if the medical practitioner knows or has reasonable grounds for suspecting— (a) that the consent is revoked, or (b) that the certificate given for the purposes of section 9, 11 or 11A, as the case may be, in relation to that document contains a statement which is false or misleading in a material particular, or (c) if a certificate was given for the purposes of section 11—that the child is no longer in agreement with the proposed removal and transplantation of the tissue, or (d) if a certificate was given for the purposes of section 11A—that the child has at least some understanding of the procedures involved in the removal of tissue from his or her body and has repeatedly and consistently expressed an unwillingness to undergo any such procedure. Division 5 Revocation of consent or agreement 16 Revocation of consent (1) A reference in this section, in relation to a consent given in accordance with a provision of this Act, to the donor— (a) in a case in which the consent is given in respect of a child—is a reference to the child, and (b) in any other case—is a reference to the person who gave the consent. (2) Where a medical practitioner has given a certificate in accordance with section 9, 11 or 11A and the person by whom the consent the subject of the certificate was given indicates— (a) if the donor is a patient in a hospital— (i) to a designated officer for the hospital, (ii) to a medical practitioner who is attending the donor in a professional capacity, or (iii) to a nurse employed at the hospital, or (b) if the donor is not a patient in a hospital—to a medical practitioner who is attending the donor in a professional capacity, that the consent is revoked, subsections (3), (4) and (5) have effect. (3) Where— (a) the donor is a patient in a hospital, and (b) the person who gave the consent for the purposes of this Act indicates to a person referred to in subsection (2) (a) (ii) or (iii) that the consent is revoked, the person to whom the indication is given shall forthwith inform a designated officer for the hospital of the revocation of the consent. Maximum penalty—40 penalty units or imprisonment for 6 months, or both. (4) The designated officer for the hospital or, where the donor is not a patient in a hospital, the medical practitioner who is attending the donor in a professional capacity shall, if it appears to the designated officer or medical practitioner, as the case may be, after making such inquiries (if any) as are reasonable in the circumstances, that any other medical practitioner is proposing to remove tissue from the body of the donor pursuant to the consent, inform that other medical practitioner forthwith that the consent is revoked. Maximum penalty—40 penalty units or imprisonment for 6 months, or both. (5) A medical practitioner who has possession of— (a) an instrument of consent, or (b) a certificate given in accordance with section 9, 11 or 11A in relation to the consent, or both, shall, as soon as practicable after becoming aware that the consent is revoked, furnish the instrument or certificate, or both, as the case may be, to the person who gave the consent. Maximum penalty—40 penalty units or imprisonment for 6 months, or both. 17 Child no longer in agreement with removal or transplantation (1) Where a medical practitioner has given a certificate in accordance with section 11 and the child in relation to whom the certificate has been given indicates— (a) if the child is a patient in a hospital— (i) to a designated officer for the hospital, (ii) to a medical practitioner who is attending the child in a professional capacity, or (iii) to a nurse employed at the hospital, or (b) if the child is not a patient in a hospital—to a medical practitioner who is attending the child in a professional capacity, that the child is no longer in agreement with the proposed removal and transplantation of tissue, subsections (2), (3) and (4) have effect. (2) Where— (a) the child is a patient in a hospital, and (b) the child indicates to a person referred to in subsection (1) (a) (ii) or (iii) that the child is no longer in agreement with the proposed removal and transplantation of tissue, the person to whom the indication is given shall forthwith inform a designated officer for the hospital that the child is no longer in agreement with the proposed removal and transplantation of tissue. Maximum penalty—40 penalty units or imprisonment for 6 months, or both. (3) The designated officer for the hospital or, where the child is not a patient in a hospital, the medical practitioner who is attending the child in a professional capacity shall, if it appears to the designated officer or the medical practitioner, as the case may be, after making such inquiries (if any) as are reasonable in the circumstances, that any other medical practitioner is proposing to remove tissue from the body of the child pursuant to the consent, inform that other medical practitioner forthwith that the child is no longer in agreement with the proposed removal and transplantation of tissue. Maximum penalty—40 penalty units or imprisonment for 6 months, or both. (4) A medical practitioner who has possession of— (a) an instrument of consent, or (b) a certificate given in accordance with section 11 in relation to the consent, or both, shall, as soon as practicable after becoming aware that the child to whom the consent relates is no longer in agreement with the proposed removal and transplantation of tissue, furnish the instrument or certificate, or both, as the case may be, to the person who gave the consent. Maximum penalty—40 penalty units or imprisonment for 6 months, or both. Part 3 Blood donations Division 1 Preliminary 18 Objects of Part The objects of this Part are— (a) to provide for appropriate consents for the removal of blood, and (b) to minimise the risks to the public that may arise from the receipt of blood and blood products, and (c) to ensure the continued viability of the blood supply. 18A Application of Part (1) This Part applies to the removal of blood from the body of a person for the purposes of— (a) its transfusion into another person, or (b) its use, or the use of any of its constituents, for other therapeutic purposes or for medical or scientific purposes, other than for the purpose of the treatment of the person from whom the blood is removed. (2) This Part does not apply to the removal of blood from a person for the purpose of using the blood in the treatment of that person. (3) Part 2 does not apply to or in respect of the removal of blood from the body of a person in accordance with this Part. Division 2 Consent to removal of blood 19 Consent to removal of blood from persons 16 years and over A person, other than a child who is under the age of 16 years, may consent in writing to the removal of blood from the person's body for the purpose of— (a) its transfusion to another person, or (b) its use, or the use of any of its constituents, for other therapeutic purposes or for medical or scientific purposes, other than for the purpose of the treatment of the person from whom the blood is removed. 20 Consent to removal of blood from persons under 16 years A parent or guardian of a child who is under the age of 16 years may consent in writing to the removal of blood from the child's body for a purpose referred to in section 19 (a) or (b), but that consent is only effective if at the time the consent is given— (a) the child is in agreement with the removal of the blood from the child's body, and (b) a medical practitioner advises the parent or guardian that any risk to the child's health (including psychological and emotional health) caused by the removal of the blood is minimal. 20A Consent to removal of blood from child if child unable to agree A parent or guardian of a child who is under the age of 16 years may consent in writing to the removal of blood from the child's body without the consent of the child for the purpose of using the blood in the treatment of the child's parent (being the biological parent, step-parent or adoptive parent), brother or sister, but that consent is only effective if— (a) a medical practitioner (other than the medical practitioner responsible for treating the child's parent, brother or sister) certifies in writing that, in the opinion of the medical practitioner— (i) the child is unable to understand the nature and effect of the removal of blood from the child's body, and (ii) any risk to the child's health (including psychological and emotional health) caused by the removal of the blood is minimal, and (b) a medical practitioner certifies in writing that the parent, brother or sister is likely to die or suffer serious damage to his or her health unless blood removed from the child is used in the treatment. 20B Effect of consent under Division An effective consent under section 19, 20 or 20A 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 to whom the consent relates, as the case may be. Division 3 Special provisions concerning donors 20C Application of Division This Division applies— (a) to blood that is removed from a donor's body for the purpose of— (i) its transfusion to another person, or (ii) its use, or the use of any of its constituents, for other therapeutic purposes or for medical or scientific purposes involving the treatment of a person other than the donor, and (b) to blood products derived or extracted from blood of the kind referred to in paragraph (a). (c) (Repealed) 20D Certificates by donors (1) In this section— certificate means a certificate relating to the medical suitability of the donor, being a ce