Human Tissue and Transplant Act 1982

The Act defines several critical concepts that govern its operation. Tissue includes an organ or part of the human body or a substance extracted from, or from a part of, the human body (s 3(1)). This broad definition covers blood, bone marrow, skin, organs and other substances, but Part 2 explicitly excludes fetal tissue, human embryos, human sperm and human eggs from the definition of tissue for that Part (s 6). 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 (s 3(1)). Non‑regenerative tissue is tissue other than regenerative tissue (s 3(1)). The distinction is important because the Act imposes more stringent conditions on the donation of non‑regenerative tissue, including a 24‑hour waiting period after consent (s 9(1)).

Other key definitions include child (a person under 18 years, s 3(1)), medical practitioner (a person registered under the Health Practitioner Regulation National Law (WA) in the medical profession, s 3(1)), and designated officer (a medical practitioner nominated by the chief medical administrator of a hospital and approved by the Chief Health Officer, s 4). The Act also defines senior available next of kin with a hierarchical list. For a child, the order is: spouse or de facto partner with whom the child is living, then spouse or de facto partner who has attained 18 years, then a parent, then a sibling 18 or over, then a guardian (s 3(1)). For an adult, the order is: spouse or de facto partner with whom the person is living, then spouse or de facto partner 18 or over, then a son or daughter 18 or over, then a parent, then a sibling 18 or over (s 3(1)). Note that a spouse and a de facto partner who have both attained 18 years are included, but the definition clarifies priority.

The Act also distinguishes between donations by living persons and donations after death. For living donations, the donor must be of sound mind and give written consent signed away from family or friends (ss 8, 9, 13). For adults, consent to removal of regenerative tissue (other than blood) can be for transplantation, other therapeutic, medical or scientific purposes, or for training, education or quality assurance (s 8(1A)). For non‑regenerative tissue, consent is only for transplantation to another living person (s 9(1)). For children (under 18), regenerative tissue may only be removed for transplantation to a family member or relative, and the child must have the mental capacity to understand and must agree (s 13). Non‑regenerative tissue cannot be removed from a living child at all (s 12(2)).

For deceased donations, the Act operates on two alternative bases. First, if the deceased during life expressed a wish for or consented to removal after death and did not withdraw it, tissue may be removed in accordance with that wish (s 22(2)(a)). Second, if the deceased did not object, the designated officer may act with the consent of the senior available next of kin (s 22(2)(b)). However, where there are two or more persons in the same class (e.g., two siblings), any one objection is effective to prevent removal (s 22(5)). For post‑mortems, similar principles apply under s 25 and s 26.

The Act affects a broad range of persons and entities. Medical practitioners are the primary actors authorised to remove tissue, whether from living donors (ss 15, 16, 17, 20) or deceased persons (s 24). They must comply with the consent and authority requirements and face criminal penalties for unauthorised removal (s 33). Designated officers at hospitals are responsible for authorising the removal of tissue from deceased persons and post‑mortem examinations (ss 22, 25). They may delegate their powers to other medical practitioners, but must inform the Chief Health Officer of delegations and revocations (s 5). Parents of children may consent to removal of regenerative tissue from the child (s 13) and to blood removal (s 19), but only if the child agrees and the child has the mental capacity to understand. Senior available next of kin have a significant role: they can consent to tissue removal from a deceased person (s 22(2)(b)) and can authorise a post‑mortem examination of a body not in hospital (s 26(1)). Their objection blocks removal even if other kin consent (s 22(5); s 25(5)).

The Chief Health Officer has supervisory functions: approving designated officer nominations (s 4(2)), accepting qualifications for brain‑death certification (s 24(2)), issuing codes of practice (s 32A), and receiving delegation notifications (s 5(4)). The Minister can delegate powers (s 5A), appoint authorised persons for removal of ocular, musculoskeletal and skin tissue from deceased persons (s 24A), approve contracts that would otherwise be void under the trading prohibition (s 29E), and make orders exempting or applying the prohibition (s 29D). The Human Tissue Advisory Body, established under s 29F, advises the Minister on recommendations for cost‑recovery by tissue banks and on approval of certain contracts.

Authorised persons under s 24A(1) - who cannot be medical practitioners - may remove ocular, musculoskeletal or skin tissue from deceased bodies. Authorised suppliers (persons who supply therapeutic goods that comprise tissue and are registered on the Australian Register of Therapeutic Goods, or who own or control a prescribed tissue bank) may sell or supply tissue for cost‑recovery under s 29B. Authorised schools of anatomy under the Anatomy Act 1930 may recover reasonable costs for supplying donated bodies or prosected specimens (s 29C). All persons are affected by the advertising prohibition in s 30, which makes it an offence to publish or exhibit an advertisement relating to buying human tissue or the right to take tissue from bodies, unless the advertisement is approved by the Minister.

Finally, the Act applies to coroners where a death is or may be a reportable death under the Coroners Act 1996. In such cases, neither tissue removal nor post‑mortem examination may proceed without the coroner’s consent (ss 23, 27). A coroner may give a direction that consent is not required, either before or after death, and may impose conditions.

The Act imposes several duties and confers corresponding rights.

Duty to obtain proper consent before tissue removal. For living adults: consent must be in writing, signed otherwise than in the presence of family or friends (s 8(1A), s 9(1)). For regenerative tissue, the donor must have been furnished with medical advice (s 8(1)(c)). For non‑regenerative tissue, a 24‑hour period must elapse after signing (s 9(1)). For children: a parent may consent to regenerative tissue removal only if medical advice has been given to both parent and child, the child has mental capacity and agrees, and the tissue is for transplantation to a family member or relative (s 13). Revocation may be oral or written at any time before removal (ss 8(2), 9(2), 14).

Rights of donors include the right to revoke consent (ss 8(2), 9(2), 14), and the right to have their wish for post‑mortem removal or examination respected (s 22(2)(a), s 25(2)). The Act also protects donor and recipient identity from public disclosure - it is an offence to disclose information that may make identity publicly known (s 34(1)), with exceptions for court order, hospital administration, bona fide medical research, consent of the person, or privileged circumstances (s 34(2)).

Duty of designated officers to make inquiries before authorising removal or post‑mortem. For deceased tissue removal, the designated officer must be satisfied of the deceased’s expressed wish or that the senior available next of kin consents, and that there is no reason to believe the deceased objected (s 22(2)). For post‑mortems, the officer must make reasonable inquiries to ascertain the deceased’s wishes and the views of next of kin (s 25(2), (3)). Issuing an authority without making required inquiries is an offence (s 33(2)).

Duty of medical practitioners to obtain certification of brain death before removing tissue from a person whose respiration and circulation are artificially maintained. Two medical practitioners, each with at least five years’ practice and one holding specialist qualifications in general medicine, neurology, neurosurgery or other qualifications accepted by the Chief Health Officer, must have clinically examined the person and declared irreversible cessation of all brain function (s 24(2), (3)). The medical practitioner who performed the clinical examination for brain‑death certification cannot be the one who removes the tissue (s 24(1) definition of “permitted practitioner”).

Rights of next of kin include the right to consent to tissue removal (s 22(2)(b)) and to authorise a post‑mortem examination of a body not in hospital (s 26(1)). They may make known their consent at any time when the person is unconscious before death, but the designated officer cannot act on that indication if the person recovers consciousness (s 22(4), s 25(4)). Any one person in the same class of senior available next of kin can block removal or examination by objecting (s 22(5), s 25(5)).

Duty not to trade in tissue. A person who enters into a contract or arrangement for valuable consideration for the sale or supply of tissue, or for post‑mortem or anatomical examination, commits an offence (s 29A(3)). The contract or arrangement is void (s 29A(2)). However, certain contracts are exempt: reimbursement of expenses necessarily incurred (s 29A(4)(a)), sale of blood on the national product price list by entities on that list (s 29A(4)(b)), sale or supply by exempt entities under agreement with the Commonwealth or State (s 29A(4)(c)), therapeutic goods approved under the Therapeutic Goods Act 1989 (Cth) (s 29A(4)(d), (e)), and cost‑recovery sales by authorised suppliers (s 29A(4)(f)). The Minister may also approve a contract in special circumstances (s 29E).

The Act creates multiple criminal offences with escalating penalties.

Offences related to removal of tissue (s 33(1)): removing tissue (other than blood) from a living person without a valid consent or authority under Part 2 Div 4 - fine of $500. Removing blood without a valid consent under Part 2 Div 5 - fine of $500. Removing tissue from a deceased person without authority under Part 3 - fine of $500. Conducting a post‑mortem examination without authority under Part 4 - fine of $500. Removing tissue in the course of a post‑mortem beyond what is necessary - fine of $500. Designated officers who issue an authority without making required inquiries commit an offence with a fine of $1,000 (s 33(2)).

Trading in tissue offences (s 29A): entering into a contract or arrangement for valuable consideration for the sale or supply of tissue, or for post‑mortem or anatomical examination, is an offence punishable by imprisonment for 12 months or a fine of $12,000 (s 29A(3)). The contract or arrangement is void (s 29A(2)). The Minister may by order declare that s 29A(2) does not apply to certain processed products (s 29D(1)) or, conversely, that it applies to a contract that would otherwise be exempt (s 29D(2)).

Advertising offences (s 30): publishing, exhibiting, or depositing an advertisement relating to buying human tissue or the right to take tissue from bodies is punishable by imprisonment for 12 months or a fine of $12,000 (s 30(1)), unless the advertisement is approved by the Minister (s 30(2)).

Use of human embryonic stem cell lines (s 30B): using a human embryonic stem cell line except for a therapeutic use is a crime. On indictment, the penalty is imprisonment for 5 years. On summary conviction, imprisonment for 12 months. “Therapeutic use” is defined broadly to include preventing, diagnosing, curing or alleviating disease, influencing physiological processes, testing susceptibility, contraception, pregnancy testing, replacement or modification of anatomy, and training or research for those purposes (s 30A).

Disclosure of identity (s 34): disclosing information that may make a donor, recipient, or person whose body is subject to a consent or authority publicly known is an offence with a fine of $500. Exceptions apply for court orders, hospital administration, medical research, consent, or privileged circumstances.

Enforcement of codes of practice (s 32B): where the Chief Health Officer believes a person has contravened a direction in a code of practice, the Chief Health Officer may require that person to enter into a written undertaking to discontinue the conduct, follow specified future conduct, and take action to achieve the code’s objects. Failure to enter into an undertaking when requested, or failure to observe an undertaking, is an offence with a fine of $1,000. A prosecution requires the Chief Health Officer’s approval (s 32B(5)). The undertaking is registered in a Register of Undertakings open for public inspection (s 32B(2), (3)). Breach may also be reported to a relevant registration board or licensing authority (s 32B(6)).

Liability protection (s 31): a person is not liable in civil or criminal proceedings for an act done in pursuance of a consent, agreement or authority given or purportedly given under the Act, if the act is done without negligence and in good faith. Good faith is established if the person had an honest and reasonable belief that the required consent or authority had been given, or had no reason to doubt that a purportedly valid consent or authority was given in accordance with the Act.

The Act expressly states that it does not apply to the removal of tissue for the practice of anatomy under the Anatomy Act 1930 (s 21A). The Anatomy Act 1930 governs the receipt and possession of bodies for anatomical study. However, Part 5 of the Human Tissue and Transplant Act does permit an authorised school of anatomy to recover reasonable costs associated with supply of a donated body or portion to another school or to persons covered by the Anatomy Act 1930 s 18 proviso (s 29C).

The Act interacts with the Coroners Act 1996 by requiring that if a death is or may be a reportable death, tissue removal (s 23) and post‑mortem examination (s 27) cannot proceed without the coroner’s consent. A coroner may give a direction that consent is not required, either before or after death, and may impose conditions. The Coroners Act definition of “coroner” and “reportable death” is imported (s 3(1)).

The Act interacts with the Human Reproductive Technology Act 1991. Part 2 (living donations) excludes fetal tissue, human embryos, human sperm and human eggs from its operation (s 6). Part 5 (trading in tissue) explicitly provides that it does not apply to the sale or supply of a human embryo, human sperm or a human egg, which are instead regulated under the Human Reproductive Technology Act 1991 s 53Q (s 29). Part 6 of the Human Tissue and Transplant Act also uses the definition of “excess ART embryo” from Human Reproductive Technology Act 1991 s 53T to define human embryonic stem cell lines.

The Act interacts with Commonwealth legislation, particularly the Therapeutic Goods Act 1989 (Cth). The definition of “therapeutic goods” is borrowed from that Act (s 3(1)). Part 5 exempts from the trading prohibition contracts or arrangements for the sale or supply of therapeutic goods that comprise, contain or are derived from tissue if the sale or supply is in accordance with an approval under a TGA provision prescribed by the regulations (s 29A(4)(d)), or if the goods are exempt under a TGA provision from Part 3.2 or Part 3.2A Div 4 of the Therapeutic Goods Act (s 29A(4)(e)). The National Blood Authority Act 2003 (Cth) is referenced via the national product price list (s 29A(1).)

The Act also references the Public Health Act 2016 for the definition of Chief Health Officer (s 3(1)) and the Health Services Act 2016 to include a health service provider that has the conduct of pathological examinations as an area for which it is established within the definition of hospital (s 3(2)). The Chief Health Officer’s powers under this Act are supplemented by the Interpretation Act 1984 s 41-44, which apply to codes of practice as if they were regulations (s 32A(2)).

The regulations under this Act may adopt a code or subsidiary legislation made under another WA Act or an Act of the Commonwealth or another State or Territory, either wholly or in part, with modifications (s 37). Adoption by reference is permitted, but any amendments to the adopted text after the regulations are made have no legal effect unless specifically adopted later (s 37(4)).

The Act received assent on 8 December 1982 and commenced on 1 March 1983. It has been amended multiple times. Significant amendments include those by the Health Legislation Amendment Act 1984 (No. 28 of 1984), which made changes to definitions and designated officer provisions. The Human Tissue and Transplant Amendment Act 1987 (No. 5 of 1987) amended section 24. The Sentencing (Consequential Provisions) Act 1995 (No. 78 of 1995) updated penalty provisions. The Coroners Act 1996 (No. 2 of 1996) substituted references to coroner and reportable death and amended ss 23, 27, 33. The Human Tissue and Transplant Amendment Act 1997 (No. 25 of 1997) inserted s 32A and s 32B on codes of practice and enforcement undertakings, and amended ss 22, 25, 26, and 28.

The Acts Amendment (Lesbian and Gay Law Reform) Act 2002 (No. 3 of 2002) amended definitions in s 3 to include de facto partners. The Acts Amendment (Prohibition of Human Cloning and Other Practices) Act 2004 (No. 18 of 2004) inserted Part 6 (ss 30A, 30B) restricting use of human embryonic stem cell lines. The Human Tissue and Transplant Amendment Act 2006 (No. 14 of 2006) made further amendments but the text does not specify details. The Medical Practitioners Act 2008 (No. 22 of 2008) and the Health Practitioner Regulation National Law (WA) Act 2010 (No. 35 of 2010) updated references to medical practitioner registration. The Health Services Act 2016 (No. 11 of 2016) and Public Health (Consequential Provisions) Act 2016 (No. 19 of 2016) amended definitions of hospital and Chief Health Officer respectively.

The most substantial recent amendments came via the Human Tissue and Transplant Amendment Act 2022 (No. 41 of 2022), which received assent on 21 November 2022. Part 2 Divisions 1 and 2 commenced the next day. Part 2 Division 3 commenced on 19 February 2024. This amendment rewrote large parts of the Act. It inserted a long title, new Part 5 on trading in tissue (ss 29-29F), replaced Part 2 Div 5 on blood transfusions (new ss 18-20), amended definitions (including “blood” to include bone marrow and placenta as sources for blood constituents), inserted s 21A excluding the Anatomy Act from Part 3, amended s 24 to allow non-medical authorised persons to remove ocular, musculoskeletal and skin tissue, inserted s 24A for appointment of authorised persons, amended Part 4 heading, and made many other changes to simplify language and update references. The Therapeutic Goods Law Application Act 2024 (No. 19 of 2024) further amended s 29A to include references to the applied therapeutic goods law and TGA provisions. The Assisted Reproductive Technology and Surrogacy Act 2025 (No. 19 of 2025) is listed in the uncommenced provisions table and will amend Part 5 when proclaimed.

The source text does not refer to any decided cases. The Act has been in force for over forty years, but the compiled legislation provided contains no references to judicial decisions, and the section notes do not list any case annotations. Accordingly, no litigation history can be derived from the source. Readers seeking case law should consult a legal research database.

Several provisions require careful attention. First, the definition of “blood” is extended to include any substance derived from blood and any organ or tissue (including bone marrow and placenta) of a kind suitable as a source from which to derive a constituent of blood for therapeutic use or for preparation of a therapeutic substance (s 3(1)). This means that bone marrow and placenta donations are treated as blood donations for the purposes of Part 2 Div 5, and are therefore removed from the stricter tissue regimes under Div 2 and 3. However, the “tissue” definition in Part 2 excludes fetal tissue, embryos, sperm and eggs (s 6), but not bone marrow or placenta - so the blood classification is a specific override.

Second, the trading prohibition in s 29A is nuanced. It voids any contract or arrangement for valuable consideration for the sale or supply of tissue, or for post‑mortem or anatomical examination. But valuable consideration does not include reimbursement of expenses necessarily incurred (s 29A(4)(a)). An authorised supplier (owner of a prescribed tissue bank or supplier of registered therapeutic goods) may sell tissue for a cost‑recovery amount that covers removal, evaluation, processing, storage, distribution or other prescribed matters (s 29B(3)). However, the supplier must be satisfied after reasonable inquiries that the first sale or supply was not for valuable consideration other than reimbursement (s 29B(3)(b)). This means that the original donor or family cannot receive payment; only the processing entity can recover costs.

Third, the brain‑death certification requirement under s 24(2) applies only where the respiration and circulation of the blood of a person are being maintained by artificial means. If a person has died naturally without artificial support, the certification is not required, and the standard deceased donor provisions under s 22 apply. However, practitioners should note that the two certifying doctors must each have been a medical practitioner for at least five years, one must hold specialist qualifications in general medicine, neurology, neurosurgery or other qualifications accepted by the Chief Health Officer, and each must have clinically examined the person. The certifying doctors cannot be the doctor who removes the tissue (s 24(1) definition of “permitted practitioner”).

Fourth, the senior available next of kin hierarchy can create practical difficulties. For an adult, the first priority is a spouse or de facto partner with whom the person was living. If the person had both a spouse and a de facto partner who has attained 18 years, the one with whom the person is living is the first priority. The definition does not give automatic priority to a spouse over a de facto partner if the person is not living with the spouse. “Available” is not defined and could lead to disputes.

Fifth, the child consent regime under s 13 requires not only parental consent but also the child’s agreement, and the child must have the mental capacity to understand the nature and effect of the removal and transplantation. There is no age threshold beyond 18; a 17‑year‑old capable of understanding must agree. If the child cannot understand, removal is prohibited. Non‑regenerative tissue can never be removed from a living child (s 12(2)).

Sixth, the advertising prohibition under s 30 is absolute except with Ministerial approval. Publishing an advertisement relating to buying human tissue or the right to take tissue includes not only newspapers but broadcasting, television, cinematograph, and “other means whatever”. Even depositing such an advertisement in the area of a house or shop is an offence. This could cover social media posts, online marketplaces, or signs.

Seventh, the disclosure offence under s 34 prohibits any disclosure that may make the identity of a donor, recipient, or person whose body is subject to a consent or authority “publicly known”. It does not require proof of actual public knowledge; “may become” is a lower threshold. Exceptions are limited.

Compliance with the Act requires adherence to several key processes.

For tissue removal from a living adult, obtain written consent signed by the donor away from family or friends (ss 8(1A), 9(1)). For regenerative tissue (other than blood), the donor must have been furnished with medical advice. For non‑regenerative tissue, a 24‑hour period must elapse after the consent is signed. The medical practitioner who removes the tissue must not be the practitioner who provided the medical advice (ss 15, 16). Always verify that the donor has not revoked consent orally or in writing before proceeding.

For tissue removal from a living child, ensure that the tissue is regenerative (non‑regenerative is prohibited entirely, s 12(2)). The removal must be for transplantation to a family member or relative. Obtain written consent from a parent (as defined in s 11, which excludes guardians or persons in loco parentis - only a biological or adoptive parent counts). Confirm that medical advice has been given to both parent and child, that the child has the mental capacity to understand, and that the child agrees (s 13). The child or parent may revoke at any time before removal (s 14). The removal must be performed by a medical practitioner other than the one who gave the medical advice (s 17).

For blood removal from a child, the parent may consent if a medical practitioner advises the removal is not prejudicial to the child’s health and the child agrees (s 19). For emergency blood transfusion on a child without parental consent, follow s 21 strictly: (a) the person legally entitled to authorise fails or refuses, or cannot be found after reasonable search; (b) the treating medical practitioner and another medical practitioner agree on the condition, that transfusion is reasonable and proper treatment, and that without it the child is likely to die; (c) the treating practitioner has experience in blood transfusions and is satisfied the blood is suitable. If the second practitioner cannot be found, the treating practitioner may act alone if satisfied on the same points and that delay would cause serious deterioration (s 21(3)). Despite this authority, the medical practitioner is not relieved from liability for negligence (s 21(5)).

For tissue removal after death, the hospital’s designated officer must make inquiries to determine whether the deceased expressed a wish to donate or objected. If there is an expressed wish, act on it (s 22(2)(a)). If no objection, obtain consent from the senior available next of kin (s 22(2)(b)). If the death is or may be reportable to the coroner, obtain the coroner’s consent first (s 23). Keep written records of all inquiries and consents. Where respiration and circulation are artificially maintained, obtain brain‑death certification from two medical practitioners (each 5+ years, one with specialist qualifications or acceptable by Chief Health Officer) who have clinically examined the person (s 24(2)). The certifiers cannot be the doctor who removes the tissue.

For post‑mortem examinations, follow a similar process. In a hospital, the designated officer authorises after reasonable inquiries: either the deceased wished it or did not object and next of kin do not object (s 25). For bodies not in hospital, the senior available next of kin may authorise (s 26). Again, coroner’s consent is required if the death is reportable (s 27).

For trading in tissue, never enter into a contract or arrangement for valuable consideration for the sale or supply of tissue or for post‑mortem/anatomical examination. The only exceptions are: reimbursement of expenses necessarily incurred (s 29A(4)(a)); sale of blood on the national product price list by listed entities (s 29A(4)(b)); sale or supply by an exempt entity under agreement with the Commonwealth or State (s 29A(4)(c)); sale of therapeutic goods under TGA approvals (s 29A(4)(d), (e)); and cost‑recovery sales by authorised suppliers (s 29A(4)(f)). Authorised suppliers must ensure the original supply was not for value and only charge cost‑recovery amounts complying with any regulations (s 29B). Schools of anatomy may recover reasonable costs for donated bodies (s 29C). If in doubt, seek Ministerial approval under s 29E, which requires a recommendation from either a prescribed body of medical practitioners (for non‑regenerative tissue for transplant) or the Human Tissue Advisory Body (for all other cases).

For advertisements, do not publish or exhibit any advertisement relating to buying human tissue or the right to take tissue unless it has been approved in writing by the Minister or belongs to an approved class (s 30).

For embryonic stem cell lines, only use a human embryonic stem cell line for a therapeutic use as defined (ss 30A, 30B). Any other use is a crime with a maximum penalty of five years’ imprisonment.

For codes of practice, comply with any directions issued by the Chief Health Officer with Ministerial approval (s 32A). If the Chief Health Officer asks you to enter into an undertaking for a contravention, do so, and then comply with it, as failure is an offence (s 32B). The Register of Undertakings is public.

Finally, maintain confidentiality of donor and recipient identity (s 34). Only disclose information when required by law, for hospital administration, for bona fide medical research, with the person’s consent, or when privileged.