New South Wales: 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may be appointed by the Governor in respect thereof and as may be notified by proclamation published in the Gazette. 3 (Repealed) 4 Definitions (1) In this Act, except in so far as the context or subject-matter otherwise indicates or requires— blood product means a product or extract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 (b) (Repealed) exercise a function includes perform a duty.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 certificate in a form prescribed by the regulations. (2) A person must not remove or use a donor's blood for a purpose referred to in section 20C (a) unless the donor has signed a certificate and had the signature witnessed by a person (or a person belonging to a class of persons) (the prescribed witness) prescribed by the regulations. Maximum penalty—100 penalty units. (3) A requirement in this section that a donor sign a certificate is satisfied if— (a) in the case of a donor who is illiterate but not physically incapable of signing—the donor makes his or her mark on the certificate and the prescribed witness certifies on the certificate that, before the mark was made, the nature and effect of the certificate were explained to the donor, or (b) in the case of a donor who is physically incapable of signing—a person authorised to do so by the donor signs the certificate, or (c) in the case of a donor who is a child under the age of 16 years—the child's parent or guardian signs the certificate. (4) (Repealed) 20E False or misleading statements A person must not, for the purposes of this Division, sign a certificate that contains any statement that, to that person's knowledge, is false or misleading in a material particular. Maximum penalty—50 penalty units or imprisonment for one year, or both. 20F Restrictions as to legal proceedings involving infection by a prescribed contaminant involving blood (1) If— (a) a person has become infected with a prescribed contaminant, or a disease that is attributable to a prescribed contaminant, and (b) the contaminant was or may have been transmitted to that person as a result of a transfusion of blood or a blood product or of any other treatment involving the use of blood or a blood product, the provisions of subsection (3), (4) or (5) apply according to the circumstances of the case. (2) The regulations may make provision for or with respect to prescribing defences (in addition to those provided for in subsections (4) and (5)) as defences to proceedings of the kind referred to in subsections (4) and (5). (3) Proceedings for an offence (except an offence against section 20E) or in tort or for a breach of contract arising out of the transmission of a prescribed contaminant as referred to in subsection (1) may not be brought against the donor of the blood concerned in the infection, unless it is proved in the proceedings— (a) that the donor has previously been found guilty of an offence against section 20E or of an offence against a law of another State or a Territory that corresponds to that section, or (b) that the donor would have been found guilty of such an offence had the donor been charged with such an offence. (4) If proceedings for an offence or in tort or for a breach of contract arising out of the transmission of a prescribed contaminant as referred to in subsection (1) are brought against a person (other than the donor) in respect of a supply by that person, or an employee of that person, of blood or a blood product, it is a defence in those proceedings for the defendant to prove that— (a) at the time of supply, the defendant was an exempt supplier or an employee of an exempt supplier, and (b) if the defendant or an employee of the defendant removed the blood or the blood from which the blood product was derived or extracted from the donor—the defendant or that employee had, before supply, ensured that— (i) the donor had signed either a certificate of the kind referred to in section 20D or a similar document as to the medical suitability of the donor to provide blood for a purpose referred to in section 20C (a), and (ii) the blood or the blood from which the blood product was derived or extracted had been subjected to tests of a kind approved by the Minister for the purposes of this section and those tests had indicated that no prescribed contaminant was present in that blood, and (c) if the defendant or an employee of the defendant obtained the blood or blood product from another person—that other person was an exempt supplier or an employee of an exempt supplier, and (d) before the time when the blood or blood product was used for transfusion to, or for otherwise treating, the infected person, the defendant had not become aware that the blood or blood product was or was likely to have been contaminated with the prescribed contaminant concerned or, if before that time the defendant had become aware of that fact, the defendant had taken all reasonably practicable steps to ensure that the blood or blood product was not so used. (5) If proceedings for an offence or in tort or for a breach of contract arising out of the transmission of a prescribed contaminant as referred to in subsection (1) are brought against the person who carried out the transfusion or treatment or the employer or any supervisor of that person, it is a defence in those proceedings for the defendant to prove that— (a) if the defendant or an employee of the defendant removed the blood or the blood from which the blood product was derived or extracted from the donor directly, the defendant or that employee had ensured that— (i) the donor had signed either a certificate of the kind referred to in section 20D or a similar document as to the medical suitability of the donor to provide blood for a purpose referred to in section 20C (a), and (ii) the blood or the blood from which the blood product was derived or extracted had been subjected to tests of a kind approved by the Minister for the purposes of this section and those tests had indicated that no prescribed contaminant was present in that blood, and (b) if the defendant or an employee of the defendant obtained the blood or blood product from another person—that other person was an exempt supplier or an employee of an exempt supplier, and (c) when the transfusion or treatment was carried out, the defendant was not aware that the blood or blood product was or was likely to have been contaminated with the prescribed contaminant concerned. (6) In this section— prescribed contaminant means a contaminant prescribed by the regulations for the purposes of this section. 20G (Repealed) 20H Records The regulations may provide for the keeping of certificates given for the purposes of this Division and for the making and keeping of records in respect of those certificates. Part 3A Regulation of businesses supplying blood and blood products 21 Unauthorised persons prohibited from carrying on a business of supplying blood or blood products (1) A person, other than an exempt supplier, must not carry on a business of supplying homologous blood or blood products. Maximum penalty—100 penalty units. (2) A person must not participate in the management of a business of supplying homologous blood or blood products unless that business is an exempt supplier. Maximum penalty—100 penalty units. (3) In this section, a reference to carrying on a business of supplying homologous blood or blood products is a reference to carrying on a business or undertaking of supplying blood or blood products to medical institutions and other persons— (a) for the purpose of transfusing to persons other than the donor some or all of the blood or blood products, or (b) for the purpose of using some or all of the blood or blood products for other therapeutic purposes, or for medical or scientific purposes, involving the treatment of persons other than the donor. 21A Presumptions in certain legal proceedings If in any legal proceedings relating to an alleged contravention of this Part it is proved that— (a) a person, other than the donor, has supplied blood or blood products on at least 2 occasions to one or more persons for the purpose of transfusion to other persons or for other therapeutic purposes, or for medical or scientific purposes, involving the treatment of persons, or (b) a person, other than the donor, has kept on premises occupied by that person blood or blood products in excess of the prescribed quantity, it is to be presumed for the purposes of those proceedings, unless the contrary is proved, that the person was carrying on a business of supplying homologous blood or blood products within the meaning of section 21. 21B Offences by corporations (1) If a corporation contravenes, whether by act or omission, any provision of this Part or a regulation made for the purposes of this Part, each person who is a director of the corporation or who is concerned in the management of the corporation is taken to have contravened the same provision if the person knowingly authorised or permitted the contravention. (2) A person may be proceeded against under a provision pursuant to subsection (1) whether or not the corporation has been proceeded against under that provision. (3) Nothing in this section affects any liability imposed on a corporation for an offence committed by the corporation against this Part or a regulation made for the purposes of this Part. 21C Injunctions (1) If, on the application of the Health Secretary, the Supreme Court is satisfied that a person has engaged, or is proposing to engage, in conduct that constitutes or would constitute one or more of the following— (a) a contravention of section 21, (b) attempting to contravene section 21, (c) aiding, abetting, counselling or procuring a person to contravene section 21, (d) inducing, or attempting to induce, whether by threats or promises or otherwise, a person to contravene section 21, (e) being, directly or indirectly, knowingly concerned in, or party to, the contravention by a person of section 21, (f) conspiring with others to contravene section 21, the Court may grant an injunction in such terms as the Court determines to be appropriate. (2) If an application is made to the Supreme Court for an injunction under subsection (1), the Court may, if in the opinion of the Court it is desirable to do so before considering the application, grant an interim injunction restraining a person from engaging in conduct of the kind referred to in subsection (1) pending the determination of the application. (3) The Supreme Court may rescind or vary an injunction granted under subsection (1) or (2). (4) If an application is made to the Supreme Court for the grant of an injunction restraining a person from engaging in conduct of a particular kind, the power of the Court to grant the injunction may be exercised— (a) where the Court is satisfied that the person has engaged in conduct of that kind—whether or not it appears to the Court that the person intends to engage again, or to continue to engage, in that conduct, or (b) where it appears to the Court that, in the event of the injunction not being granted, it is likely that the person will engage in conduct of that kind—whether or not the person has previously engaged in conduct of that kind. (5) The Health Secretary is not to be required to give any undertaking as to damages or costs in respect of an application under this section. 21D–21E (Repealed) Part 3B 21F–21V (Repealed) Part 3C Use of tissue removed during medical, dental or surgical treatment 21W Application (1) This Part applies with respect to the use of tissue removed from the body of a living person during medical, dental or surgical treatment carried out in the interests of the health of the person. This Part does not authorise the removal of tissue from the body of a person after that person's death or the use of any tissue so removed. Note— See Parts 4 and 5 in relation to the removal of tissue after a person's death and the use of that tissue. (2) This Part does not apply to or in respect of the following— (a) tissue that is removed in accordance with Part 2, (b) blood that is removed in accordance with Part 3. (c) (Repealed) 21X Authority to use tissue removed from adult (1) The use, for therapeutic, medical or scientific purposes, of tissue removed from the body of a person during medical, dental or surgical treatment, is authorised if— (a) the person has given his or her consent in writing to the use of the tissue for that purpose, and (b) the consent has not been revoked. (2) The authority conferred by subsection (1) is subject to the terms and any conditions of the consent referred to in that subsection. (3) This section does not apply if the person— (a) is a child, or (b) is a patient to whom Part 5 of the Guardianship Act 1987 applies. 21Y Authority to use tissue removed from child (1) A senior available next of kin of a child may, by instrument in writing, authorise the use, for therapeutic, medical or scientific purposes, of any tissue removed from the body of the child during medical, dental or surgical treatment. (2) A senior available next of kin must not grant an authority under subsection (1) if it appears to the senior available next of kin, after making such inquiries as are reasonable in the circumstances, that— (a) the child objects to the use of the tissue for the purposes to be authorised, or (b) there is another next of kin of the same or higher order of the classes in paragraph (aa) of the definition of senior available next of kin in section 4 (1) who objects to the use of the tissue for the purposes to be authorised. Maximum penalty—10 penalty units. (3) This section does not apply if the child is deceased. Note— Section 21ZA may apply if the child is deceased. 21Z Authority to use tissue removed from person under guardianship (1) A person responsible for a person who is a patient to whom Part 5 of the Guardianship Act 1987 applies may, by instrument in writing, authorise the use, for therapeutic, medical or scientific purposes, of any tissue removed from the body of the patient during medical, dental or surgical treatment. (2) This section does not apply if— (a) the patient is a child and the 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 patient is a child and 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), or (c) the patient (whether or not a child) is deceased. (3) In this section— person responsible for a person has the meaning given by Part 5 of the Guardianship Act 1987. 21ZA Authority to use tissue removed from deceased person (1) A senior available next of kin of a person who is deceased may, by instrument in writing, authorise the use, for therapeutic, medical or scientific purposes, of any tissue that was removed from the body of the deceased person, before that person's death, during medical, dental or surgical treatment. (2) A senior available next of kin must not grant an authority under subsection (1) if it appears to the senior available next of kin, after making such inquiries as are reasonable in the circumstances, that— (a) the deceased person had, during the person's lifetime, expressed an objection to the use of tissue removed from the person's body for the purposes to be authorised and had not withdrawn that objection, or (b) there is another next of kin of the same or higher order of the classes in paragraph (a) or (b) of the definition of senior available next of kin in section 4 (1) who objects to the use of the tissue for the purposes to be authorised. Maximum penalty—10 penalty units. 21ZB Effect of authority under this Part (1) An authority under this Part is sufficient authority for the use, for therapeutic, medical or scientific purposes, of tissue removed from the body of a person during medical, dental or surgical treatment, if the tissue is used in accordance with the terms and any conditions of the authority. (2) An authority under this Part does not authorise the removal of tissue from the body of a person. Note— Parts 2 and 3 provide authority to remove tissue (including blood) from the body of a living person for purposes such as transplantation and transfusion, and other therapeutic, scientific, and medical purposes. Parts 4 and 5 provide authority to remove tissue from the body of a person who is deceased. In certain cases, an authority under this Act to remove tissue is not required (see section 34 (1) (a)). Part 4 Removal of tissue after death 22 (Repealed) 23 Authority to remove tissue where body of deceased at a hospital (1) If a designated officer for a hospital is satisfied, after making such inquiries as are reasonable in the circumstances in relation to a person who has died in the hospital or whose dead body has been brought into the hospital, that— (a) the person had, during the person's lifetime, given his or her consent in writing to the removal after that person's death of tissue from that person's body for the purpose of— (i) its transplantation to the body of a living person, or (ii) its use for other therapeutic purposes or for medical purposes or scientific purposes, and (b) the consent had not been revoked, the designated officer may, by instrument in writing, authorise the removal of tissue from that person's body in accordance with the terms and any conditions of the consent. (2) An authority under subsection (1) is not to be given in respect of a deceased child. (3) If the designated officer is not satisfied as to the matters referred to in subsection (1), or the deceased person is a deceased child, and the designated officer is satisfied, after making such inquiries as are reasonable in the circumstances in relation to the deceased person, that— (a) the deceased person had not, during the person's lifetime, expressed an objection to the removal of tissue from the person's body after the person's death or, if the person had expressed such an objection, based on the most recent views expressed by the deceased person, the person no longer had an objection to the removal of tissue from the person's body, and (b) a senior available next of kin has given his or her consent in writing, or in any other manner prescribed by the regulations, to the removal of tissue from the person's body, and (c) there is no 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 4 (1) who objects to the removal of tissue from the person's body, the designated officer may, by instrument in writing, authorise the removal of tissue from the deceased person's body in accordance with the terms and any conditions of the consent referred to in paragraph (b). (4) This section does not apply to a deceased child who, immediately before his or her death, was in the care of the State. 23A Authority to remove tissue where body of deceased child in care of State at a hospital If a designated officer for a hospital is satisfied, after making such inquiries as are reasonable in the circumstances in relation to a child in the care of the State who has died in the hospital or whose dead body has been brought into the hospital, that— (a) the deceased child had not, during the child's lifetime, expressed an objection to the removal of tissue from the child's body for the purpose of its transplantation to the body of a living person, and (b) the principal care officer for the child has given his or her consent in writing, or in any other manner prescribed by the regulations, to the removal of tissue from the child's body for the purpose of its transplantation to the body of a living person, the designated officer may, by instrument in writing, authorise the removal of tissue from the deceased child's body for the purpose of its transplantation to the body of a living person in accordance with the terms and any conditions of the consent referred to in paragraph (b). 24 Authority to remove tissue where body of deceased not at a hospital (1) If the body of a deceased person (other than a deceased child) is at a place other than a hospital, the removal of tissue from the body of the deceased person for the purpose of its transplantation to the body of a living person, or its use for other therapeutic purposes or for medical purposes or scientific purposes, is authorised if— (a) the deceased person had, during the person's lifetime, given his or her consent in writing to the removal of tissue from the person's body for that purpose, and (b) the consent had not been revoked. (2) The authority conferred by subsection (1) is subject to the terms and any conditions of the consent referred to in that subsection. (3) If the body of a deceased person is at a place other than a hospital, a senior available next of kin of the person may, by instrument in writing or in any other manner prescribed by the regulations, authorise the removal of tissue from the deceased person's body for the purpose of its transplantation to the body of a living person, or its use for other therapeutic purposes or for medical purposes or scientific purposes. (4) A senior available next of kin must not grant an authority under subsection (3) if it appears to the senior available next of kin, after making such inquiries as are reasonable in the circumstances, that— (a) the deceased person had, during the person's lifetime, expressed an objection to the removal of tissue from the person's body after the person's death unless, based on the most recent views expressed by the deceased person, it appears that the person no longer had an objection to the removal of tissue from the person's body, or (b) another next of kin of the same or higher order of the classes in paragraph (a) or (b) of the definition of senior available next of kin in section 4 (1) objects to the removal of tissue from the person's body. Maximum penalty—10 penalty units. (5) This section does not apply to a deceased child who, immediately before his or her death, was in the care of the State. 24A Authority to remove tissue where body of deceased child in care of State not at a hospital If the body of a deceased child who, immediately before his or her death, was in the care of the State, is at a place other than a hospital, the principal care officer for the child may, by instrument in writing or in any other manner prescribed by the regulations, authorise the removal of tissue from the deceased child's body for the purpose of its transplantation to the body of a living person. 24B Consent and authorisation of principal care officer (1) The principal care officer must not give consent under section 23A or grant an authority under section 24A if— (a) it appears to the officer, after making such inquiries as are reasonable in the circumstances, that the deceased child had, during the child's lifetime, expressed an objection to the removal of tissue from the child's body and had not withdrawn that objection, or (b) the officer has not undertaken the consultation and obtained the approvals required by the following subsections. (2) Before determining whether or not to give consent under section 23A or grant an authority under section 24A, the principal care officer is to use reasonable efforts to consult with such persons as the officer considers might be appropriate. (3) If any of the persons consulted is a person whose approval the principal care officer considers should be obtained before consent is given or an authority is granted, the officer must not give consent or grant an authority unless that person approves. (4) The principal care officer may determine that more than one person's approval is required under subsection (3). 25 Consent by coroner (1) If a coroner has jurisdiction to hold an inquest under the Coroners Act 2009 in respect of the death of a person, a designated officer for a hospital, a senior available next of kin or the principal care officer must not authorise the removal of tissue from the person's body unless a coroner has given consent to the removal of the tissue. Maximum penalty—40 penalty units or imprisonment for 6 months, or both. (2) A consent by a coroner under this section may be given before a person's death if the coroner reasonably believes the coroner will have jurisdiction to hold an inquest under the Coroners Act 2009 in respect of the person's death. (2A) A consent by a coroner under this section may be withdrawn by the coroner at any time. (3) If a coroner has jurisdiction to hold an inquest under the Coroners Act 2009 in respect of the death of a person to whom section 24(1) applies, the removal of tissue from the body of the person is not authorised unless a coroner has given consent to the removal of the tissue. (4) A consent by a coroner under this section may be expressed to be subject to such conditions as are specified in the consent. (5) A consent by a coroner under this section may be given orally and, if so given, is to be confirmed in writing as soon as practicable. (6) A coroner shall, in determining the conditions (if any) to which a consent shall be subject, have regard only to the effect which the removal of tissue from the body of the person to whom the consent relates may have in relation to the conduct of any inquest which a coroner has jurisdiction to hold in respect of that person's death. 26 Certificates required in certain situations (1) Where— (a) a person has died in a hospital or the body of a deceased person has been brought into a hospital, and (b) at the time when the person died or at any time thereafter the person's respiration or the circulation of the person's blood was being maintained by artificial means, a designated officer for the hospital shall not give an authority under this Part in respect of the person unless each of 2 medical practitioners (not including the designated officer) has certified in writing— (c) that the medical practitioner carried out a clinical examination of the person while the person's respiration or the circulation of the person's blood was being maintained by artificial means, and (d) that, at the time of that examination, irreversible cessation of all function of the person's brain had, in the opinion of the medical practitioner, already occurred. Maximum penalty—40 penalty units or imprisonment for 6 months, or both. (1A) The 2 medical practitioners referred to in subsection (1) must not include— (a) any medical practitioner who is responsible for, or involved in, the removal of tissue from the person's body for the purpose of its transplantation to the body of another person, or (b) any medical practitioner who is responsible for the care of the person who is the intended recipient of the tissue. (2) At the time when the clinical examination referred to in subsection (1) is carried out— (a) each of the 2 medical practitioners referred to in that subsection shall have practised medicine for a period or periods totalling not less than 5 years during the 8 years immediately preceding that time, and (b) at least one of those medical practitioners shall be a designated specialist for the hospital referred to in that subsection. (3) For the purposes of subsection (2) (a), any period during which a person has practised medicine in a place outside New South Wales in accordance with the law in force in that place shall be taken into account in calculating the period of 5 years referred to in that paragraph. 27 Effect of authority under this Part (1) An authority under this Part is sufficient authority for a medical practitioner other than— (a) a medical practitioner referred to in section 26 (1), or (b) where the authority was given by a medical practitioner, the medical practitioner by whom the authority was given, to remove tissue from the body of the deceased person referred to in the authority for the purpose or purposes specified in the authority. (1A) Without limiting subsection (1), an authority under this Part which authorises the removal of tissue for one or more of the following purposes (whether or not it authorises the removal of tissue for any other purpose) is sufficient authority for a person other than a medical practitioner to remove tissue from the body of the deceased person referred to in the authority for that purpose if the person removing the tissue is appointed, in writing, by the Health Secretary to remove tissue under this section for that purpose and is not the person by whom the authority was given— (a) corneal transplantation, (b) skin transplantation, (c) the transplantation of cardiovascular tissue, (d) the transplantation of musculoskeletal tissue, (e) any other purpose prescribed by the regulations. (1B) Despite subsection (1A), an authority under this Part which authorises the removal of tissue for the purpose of the transplantation of cardiovascular tissue is not sufficient authority for a person other than a medical practitioner to remove the whole of a heart for the purpose of a heart transplant. (2) A contravention by a designated officer of section 26 (1) in relation to the giving of an authority does not affect the validity of the authority. (3) An authority under this Part does not authorise the use, for therapeutic, medical or scientific purposes, of any tissue removed from the body of a deceased person— (a) in the course of the medical, dental or surgical treatment performed while the person was still living, or (b) for the purposes of a post-mortem examination. Note— An authority under Part 3C may be given to authorise the use, for therapeutic, medical or scientific purposes, of any tissue removed in the course of medical, dental or surgical treatment while the person was still living. An authority under Division 2 of Part 5 may be given to authorise the use, for therapeutic, medical or scientific purposes, of any tissue removed for the purposes of a post-mortem examination. 27A Guidelines for removal of tissue after death The Health Secretary may issue guidelines relating to the removal of tissue after death, including in relation to recording reasons for not proceeding with the removal of tissue from the body of a deceased person, where the deceased person has given consent but the family has objected. Part 4A Ante-mortem procedures for donation of tissue after death 27B Definitions In this part— ante-mortem procedure means the following medical procedures, other than normothermic regional perfusion, carried out to determine, maintain or improve the viability of tissue for a relevant purpose— (a) the administration of medication, (b) the removal of blood and tissue for testing, (c) medical imaging and other diagnostic procedures, (d) blood transfusions for