Transplantation and Anatomy Act 1979

This Act is built around a small set of statutory concepts that structure rights, duties and criminal prohibitions. Precise definitions in s 4 and the related operative provisions determine boundaries of permitted behaviour.

• Tissue and authorised purpose (s 4). “Tissue” is broadly defined to include organs, parts of the human body and substances extracted from a human body (s 4). The Act separates “regenerative tissue” (which regenerates after removal through natural processes) and “non‑regenerative tissue” (s 4). “Authorised purpose” is defined with distinct scope for regenerative and non‑regenerative tissue (s 4): for regenerative tissue the authorisation covers transplantation, other therapeutic uses and medical or scientific uses; for non‑regenerative tissue authorised uses are transplantation or, where the tissue is from a deceased person, scientific purposes.

• Consent and certification (ss 8-11, 10). Consent by an adult donor must be in signed writing, given by a person of sound mind who has received medical advice (s 8(1)). Non‑regenerative tissue consent must specify the time and does not have effect until 24 hours post‑signature (s 8(2)). Section 10 permits a medical practitioner to certify that consent was given in the practitioner’s presence, with explanation of nature and effect, and that the donor was over 18, of sound mind and freely consenting; s 11 makes the presence of such a certificate (or NTCAT decision as permitted under the Health Care Decision Making Act 2023) a precondition for authorised removal by another practitioner.

• Retention (s 4A). Authorisation under the Act also authorises retention of tissue to the extent reasonably necessary for the authorised purpose. That statutory retention permission interacts with storage, disposal and anatomical teaching regimes.

• Revocation (ss 16-17, 16A). A donor may revoke consent at any time by indicating so orally or in writing to prescribed hospital officers or attending medical practitioners/nurses (s 16). Recipients of revocation have an immediate obligation to investigate whether a practitioner plans to rely on the consent and to inform that practitioner if so (s 16A). Instruments of consent and certificates must be returned to donors when revocation is communicated to the person holding them (s 17).

• Senior available next of kin and priority rules (s 4; ss 19-19A). The Act sets a strict, categorical order of priority for who qualifies as the “senior available next of kin” (s 4). That person can authorise particular post-mortem removals (ss 19-19A), subject to checks where there are multiple persons in a priority class and to conditions where the deceased previously expressed wishes (s 19B). The Act expressly conditions next‑of‑kin authority on the absence of evidence that the deceased had objected during life (s 19A(3)).

• Coroner involvement (s 20). If a death is or may be reportable to a coroner, or if no medical practitioner has given a certificate as to cause of death, or if an inquest order exists, a coroner’s consent is required before tissue removal; coroners may give directions releasing this requirement and may attach conditions (s 20).

• Brain death certification for patients with artificial circulation/respiration (s 21). Where circulation and respiration are artificially maintained, two medical practitioners (one a specialist, both with at least five years’ practice) must have carried out clinical examinations and each must certify irreversible cessation of all brain function before tissue may be removed (s 21). The Act specifies the specialties recognised for the specialist requirement (s 21(4)).

• Anatomy authorisation and codes (ss 22A-22D). The Chief Health Officer can authorise and prescribe conditions for anatomy teaching and practice at educational institutions via Gazette notice (s 22B). Codes of practice may regulate operational details (transport, receiving, disposal, inspections) and must be published on the Agency website before they take effect (s 22D(6)-(6A)). Contraventions attract criminal penalties (s 22D(7)).

• Trading prohibition, treatment exceptions and ministerial waiver (ss 22E-22F). Contracts or arrangements for valuable consideration to supply tissue are prohibited (s 22E). The statutory ban is limited where the contract provides only reimbursement of necessary expenses, where it is authorised under s 22F, and where tissue obtained under authorised contracts has been processed and is supplied following a medical practitioner’s directions for therapeutic or scientific purposes (s 22E(2)-(3)). The Minister may authorise otherwise prohibited contracts where “special circumstances” exist and may impose conditions (s 22F).

• Offences, strict liability and liability protection. Several offences carry substantial maximum penalties (up to 400 penalty units or four years imprisonment for removal without authorisation, s 27) and some are strict liability (for example, obligations to make reasonable inquiries under s 18(2) and the requirement in s 16A(4) to inform a practitioner about revocation carry strict liability labels). Simultaneously, s 25 provides a statutory exclusion of liability for persons acting without negligence and in good faith in pursuance of the Act, which establishes a factual test for protection from civil or criminal proceedings.

These concepts jointly create a framework prioritising informed consent and specified authorisation routes, procedural safeguards where death determination is clinically or legally complex, constraints on commercial dealing in human tissue, and administrative oversight via the Chief Health Officer and Minister.

The Act assigns roles, responsibilities and criminal liabilities across a set of identifiable actors. Key affected parties are:

• Donors and prospective donors. Individuals contemplating donation while alive (s 8) or making directions to operate after death (s 19B) are directly affected. The Act sets the form of consent, the capacity threshold, the 24‑hour delay for non‑regenerative tissue (s 8(2)), the revocation mechanics (s 16) and the right to receive instruments and certificates upon revocation (s 17).

• Next of kin and senior available next of kin. The defined hierarchy for “senior available next of kin” (s 4) determines who can authorise post‑mortem removal where the deceased left no effective direction. The Act also addresses conflicts where multiple persons in the same priority class exist (ss 19(3), 19A(4)), and provides that a next of kin’s advice given while a patient is unconscious authorises future removal unless rescinded if the patient regains consciousness (s 19).

• Medical practitioners and clinical teams. Practitioners are central to certification (s 10), to undertaking removal operations under authorisation (s 11, s 22), and to complying with brain‑death certification rules (s 21). The Act imposes duties to act on revocations (s 16A), requires that a certifying practitioner not be the same practitioner who removes tissue in certain cases (s 11(2)(a)), and holds practitioners criminally liable for making misleading statements in certificates (s 27A).

• Hospital designated officers. The person appointed under the Medical Services Act 1982 as “designated officer” has explicit statutory authority to give post‑mortem authorisations for hospital patients (s 18) and may delegate powers to suitably qualified health practitioners (s 29). The designated officer must make reasonable inquiries before authorising removals (s 18(2)) and is repeatedly placed at the procedural centre of hospital‑based consent and revocation processes (ss 16, 16A, 17, 18).

• Educational institutions and authorised schools of anatomy. An “authorised school of anatomy” is created by a Gazette authorisation under s 22B. The governing body (holder) of the authorisation must comply with conditions (s 22C) and codes of practice (s 22D), and breach attracts criminal penalties. The Chief Health Officer controls the supply of authorisations and conditions.

• Chief Health Officer and Minister. The Chief Health Officer has the regulatory power to authorise anatomy schools and make codes of practice (ss 22B, 22D), including setting conditions and procedural requirements. The Minister may authorise, in writing and subject to conditions, otherwise prohibited contracts for valuable consideration under s 22F where “special circumstances” are satisfied (s 22F).

• Coroners and courts. Where a death is reportable or otherwise falls into enumerated categories, the coroner has gatekeeper power to permit or withhold consent to tissue removal and may issue directions to relieve certain coroner consent requirements (s 20). The Act references the Coroners Act 1993 for definitions and interaction (s 4; s 20).

• Researchers, tissue processors and downstream users. The Act permits use of tissue for therapeutic, medical and scientific purposes where obtained under authorised routes. It also permits, in a limited way, supply of processed tissue obtained under an authorised arrangement if it has been subjected to processing and is supplied for therapeutic/scientific use under a medical practitioner’s directions (s 22E(3)). That creates a route for regulated downstream use where initial collection complies with the Act.

• Administrative staff and registrants. Nurses and registered health practitioners are recipients of revocation notifications and given statutory duties to inform designated officers (ss 16, 16A). Bodies responsible for record‑keeping and custodianship of instruments of consent also carry obligations (s 17).

• The public healthcare system and hospitals. Hospitals must maintain systems for documenting consent, processing revocations, complying with coroner directions and performing required medical certifications (ss 10, 16-18, 21). The Act places operational tasks on hospitals that affect resource use and administrative processes.

• Entities considering commercial arrangements. Persons and organisations contemplating contracts involving tissue for valuable consideration are constrained by the prohibition in s 22E and must seek Ministerial authorisation under s 22F where applicable or ensure supplies fall within the processing exception in s 22E(3). The Act also renders any such unauthorised contract void (s 22E(4)).

In short, the statute affects individual bodily autonomy and family decision‑makers, clinicians and hospital administrators who must document and verify consent and revocations, the Chief Health Officer and Minister as regulators, educational institutions conducting anatomy teaching, and any actors contemplating commercial activity with human tissue. The Act intersects with other Territory laws and national registration schemes referenced in the text (for example, Health Practitioner Regulation National Law), which brings national‑system registered practitioners (specialists, nurses) into scope for specified duties and authority (s 21; s 29).

The Act creates several express duties and rights, many of them procedural. Below are the main ones with the statutory references and practical implications.

Donor rights and duties

• Right to give informed consent. An adult of sound mind has the right to give signed consent to removal of tissue for authorised purposes, provided medical advice has been given (s 8(1)). For non‑regenerative tissue, the donor must specify the time of signing and accept that the consent takes effect only after 24 hours (s 8(2)). Notes to the Act signal that advance personal plans and substitute decision processes under the Health Care Decision Making Act 2023 can operate to give or revoke consent for adults lacking capacity (s 8 notes; s 11 note).

• Right to revoke. A donor may revoke consent at any time by indicating revocation to specified persons (s 16). The revocation can be oral or in writing. Upon revocation, the donor has the right to receive the instrument of consent and any certificate held by the custodian once the custodian has been informed (s 17(2)).

Duties on recipients of revocation

• Immediate notification and inquiry duties. A medical practitioner or nurse who is told of a revocation must immediately inform the designated officer for the hospital (s 16A(1)). The designated officer or the medical practitioner who received the revocation (the responsible person) must make reasonable inquiries to discover whether any medical practitioner is proposing to rely on the consent (s 16A(3)). If the responsible person learns a medical practitioner is proposing to rely, they must immediately inform that practitioner of the revocation (s 16A(4)). Failure to inform an intending practitioner is a strict liability offence carrying a maximum penalty of 100 penalty units (s 16A(4)-(6)).

Duties and procedural safeguards for medical practitioners

• Certification duty. A medical practitioner may certify that consent was given in their presence, that they explained the nature and effect of the removal, and that the donor was over 18, of sound mind and freely consenting (s 10). A certificate under s 10 is a precondition to authorised removal under s 11 in some cases. The Act criminalises making misleading statements in a certificate given for the Act (s 27A). The Act also precludes a medical practitioner who gave the certificate under s 10 from removing the tissue under certain consents (s 11(2)(a)).

• Certification for brain death. Where respiration and circulation are artificial, two examiners (practitioners with five years’ practice, one a recognised specialist) must conduct examinations and each must certify irreversible cessation of all brain function before tissue may be removed (s 21(1)-(4)). The Act lists recognised specialties for this purpose (s 21(4) table).

Duties on designated officers for hospitals

• Inquiry before authorisation. A designated officer may authorise removal of tissue from a deceased hospital patient (s 18(1)), but must make reasonable inquiries first (s 18(2)). Failure to make the reasonable inquiries is a strict liability offence with a maximum penalty of 100 penalty units (s 18(2)-(3)).

• Delegation. Designated officers may delegate powers under the Act to registered health practitioners within the hospital provided they are satisfied as to suitable qualifications and experience (s 29).

Regulatory duties of the Chief Health Officer and holders of anatomy authorisations

• Issuing authorisations and conditions. The Chief Health Officer may, by Gazette notice, authorise specified anatomy teaching/practice at schools of anatomy and impose conditions which must be stated in the Gazette notice (s 22B(1)-(3)).

• Codes of practice. The Chief Health Officer may make codes of practice (s 22D(1)) dealing with transportation, procedures, returns/records, inspection and disposal (s 22D(2)-(5)). The Chief Health Officer must publish the code on the Agency's website and the code has no effect until published (s 22D(6)-(6A)).

• Duty of holders. Holders of anatomy authorisations must not engage in conduct that contravenes conditions of the authorisation (s 22C) and must comply with codes (s 22D(7)); both contraventions attract criminal sanctions.

Ministerial duty/authority

• Exceptional authorisations. The Minister may authorise, in writing and subject to conditions, a person to enter into otherwise prohibited contracts/arrangements for valuable consideration where satisfied there are “special circumstances” (s 22F). The Act does not define “special circumstances” and leaves scope to the Minister to set conditions in the authorisation.

Confidentiality and disclosure

• Duty to keep information confidential. The Act criminalises deliberate or reckless conduct that results in disclosure of confidential information identifying donors, recipients or persons associated with tissue removal (s 28(1)); exceptions are listed for court orders, hospital administration or bona fide research, consent of the person, and privileged communications (s 28(2)). Maximum penalties apply (s 28(1)).

Liability protection and good faith

• Exclusion of liability. s 25 provides that, subject to the Act, a person is not liable in civil or criminal proceedings for acts done pursuant to a consent or authorisation where the act is done without negligence and in good faith. Subsections (2)(a) and (b) describe circumstances that establish good faith, including honest reasonable belief that required consents were given or no reason to doubt the validity of purported consents.

Specific rights and constraints relating to commerce

• Prohibition on trading in tissue. Contracts for valuable consideration to supply tissue are criminalised (s 22E(1)) and void unless they fall within express exceptions (s 22E(2)-(4)). This creates a bright line against commercial purchase of tissue, with narrowly prescribed statutory exceptions and a ministerial override for special circumstances.

Timing and death determination

• Moment of death. For Territory law purposes, death is treated as occurring when either irreversible cessation of all brain function or irreversible cessation of blood circulation occurs (s 23). This statutory definition interacts with brain‑death certification requirements (s 21) and post‑mortem authorisations.

Duties to document and return instruments

• Custodial duties. Persons in possession of instruments of consent and certificates must return them to the donor on revocation (s 17(2)); failure to do so is an offence (s 17(2)) and an offence of strict liability (s 17(3)) unless a reasonable excuse is established (s 17(4)).

These duties and rights interact: e.g. the donor’s right of revocation creates immediate practical duties for hospital staff and designated officers to investigate and notify, and the medical certification and coroner provisions add procedural gating that affects clinician decision‑making. The Act mixes strict liability obligations (requiring careful administrative compliance) with a good‑faith shield (s 25) that depends on demonstrable honesty and absence of negligence.

The Act establishes an enforcement regime combining criminal offences with variable fault elements, strict liability for specific procedural failures, and an overarching application of Part IIAA of the Criminal Code to determine fault and defences (s 5). Below are the principal sanctions, the applicable fault standards where stated, and enforcement mechanics.

Primary offence categories and maximum penalties

• Removal without authorisation (s 27). It is an offence to intentionally remove tissue where the person is reckless as to whether the removal is authorised. Maximum penalty: 400 penalty units or imprisonment for 4 years. Fault elements are intentionality and recklessness as to authorisation. The Act notes that a medical practitioner performing a coroner‑directed autopsy does not commit an offence under this section (note to s 27).

• Misleading certificates (s 27A). A person must not intentionally make a statement known to be misleading in a certificate given for the Act. Maximum penalty: 400 penalty units or imprisonment for 2 years. Fault elements require intentional false statement, knowledge it is misleading and that the certificate is for this Act.

• Unauthorised contracts and arrangements for valuable consideration (s 22E). Entering into, offering, holding out to enter into, or inquiring about such contracts is an offence if done intentionally. Maximum penalty: 400 penalty units or imprisonment for 2 years. Contracts or arrangements of this kind are void unless authorised under s 22F or limited to expense reimbursement (s 22E(4)).

• Anatomy teaching offences (s 22A). Using a body or part of a body for teaching, study or practice of anatomy otherwise than at an authorised school is an offence where the actor intentionally uses the body and is reckless as to whether it is used at an authorised school. Maximum penalty: 200 penalty units or imprisonment for 2 years.

• Contravention of conditions of an anatomy authorisation (s 22C). The holder who intentionally engages in conduct that is reckless as to whether it contravenes a condition faces a maximum penalty of 200 penalty units.

• Contravention of a code of practice (s 22D(7)). The person who intentionally engages in conduct that is reckless as to whether it contravenes the code is liable to 200 penalty units or imprisonment for 2 years.

• Unlawful disclosure of confidential information (s 28). A person who intentionally engages in conduct that is reckless as to whether it results in disclosure of confidential information and is reckless as to whether the information is confidential faces a maximum penalty of 200 penalty units or imprisonment for 2 years. Exceptions are listed (court orders, hospital administration and bona fide research, consent of the person, or privilege) (s 28(2)).

• Failure to act on revocation (s 16A(4)). The responsible person who learns a practitioner proposes to rely on a consent and fails to inform them immediately commits an offence of strict liability with maximum 100 penalty units. The provision creates strict liability for the notification duty (s 16A(5)-(6)).

• Failure to make reasonable inquiries before authorising removal (s 18(2)). The designated officer must make reasonable inquiries before giving an authorisation; failure to do so is a strict liability offence with maximum 100 penalty units (s 18(2)-(3)).

• Failure to return instrument/certificate after revocation (s 17(2)). The person in possession of the instrument must give it to the donor; breach is strict liability and carries a maximum penalty of 100 penalty units (s 17(2)-(3)).

Enforcement mechanisms and fault standards

• Criminal Code overlay. Part IIAA of the Criminal Code applies to offences under the Act (s 5). That Part sets out general principles of criminal responsibility, defences, and burden of proof. The Act separately specifies fault elements for many offences (intentionality and recklessness are frequent). The Act explicitly identifies which offences are strict liability (for example s 16A(5), s 18(3), s 17(3)).

• Strict liability and defences. For designated strict liability offences, the Act often preserves a defence based on reasonable excuse (e.g. s 16A(6) and s 17(4)), requiring the defendant to establish the excuse.

• Civil liability exclusion and good‑faith protection. s 25 excludes civil or criminal liability for acts done in pursuit of consents or authorisations under the Act where the acts are done without negligence and in good faith. The statute provides guidance on what counts as good faith, including an honest reasonable belief that required consents were given (s 25(2)(a)) or no reason to doubt a purported consent (s 25(2)(b)). This operates as a statutory protective mechanism for practitioners and others acting on consents, but it is fact specific and will be tested against negligence standards.

• Administrative enforcement. The Chief Health Officer’s powers to issue Gazette authorisations, impose conditions for anatomy schools and publish codes (ss 22B-22D) establish administrative enforcement levers. Contraventions of conditions and codes attract criminal penalties independent of broader criminal enforcement.

• Void contracts. The Act renders unauthorised commercial contracts in this space void (s 22E(4)). That civil consequence interacts with the criminal sanction for entering into or holding out such contracts (s 22E(1)). The Minister’s power to authorise exceptional contracts (s 22F) is the statutory avenue to avoid automatic voidness subject to conditions.

Implementation risks and practical enforcement implications

• Evidence and proof. Several offences require proof of intent and recklessness, which anchors prosecutions to evidentiary records and contemporaneous documentation (certificates, notices, inquiries). The s 25 good‑faith shield also shifts enforcement focus to whether acts were negligent or unreasonable.

• Administrative burden and strict liability traps. Strict liability offences tied to procedural steps (making reasonable inquiries, providing notifications, returning instruments) create compliance traps where honest administrative failures can attract penalties unless a reasonable excuse is shown.

• Coroner interaction. Coroner consent requirements (s 20) can delay or block intended removals; failing to secure coroner consent where required exposes actors to criminal liability under s 27 for unauthorised removal.

• Confidentiality enforcement. s 28 criminalises disclosures that are at times necessary for hospital administration or bona fide research, but the statute lists those permitted disclosures explicitly. Implementers must align records systems and staff training accordingly.

In summary, enforcement relies on evidence of compliance with documentary and procedural obligations, with substantial penalties for unauthorised removals and misleading certification. The mix of strict liability procedural offences and a statutory good‑faith exclusion of liability produces an enforcement landscape where good record keeping, prompt notification and documented inquiries materially reduce legal risk.

The Act is not stand‑alone; it explicitly cross‑references Territory and national schemes and leaves some functions to be determined by subordinate instruments. The key statutory interactions and their practical implications follow.

Coroners Act 1993

• Section 20 ties the Act to the Coroners Act 1993. Where a death is reportable to a coroner or where no medical certificate as to cause of death exists, removal of tissue is contingent on the coroner’s consent (s 20(1)-(3)). Coroners may give directions relieving the need for consent or may attach conditions, and coroner consent may be given orally and must be confirmed in writing (s 20(4)-(6)). Practically, hospital staff and designated officers must screen deaths for coroner reportability before authorising removals, and non‑compliance risks obstruction of coronial processes and criminal liability under s 27.

Health Care Decision Making Act 2023

• The Act incorporates the Health Care Decision Making Act 2023 in multiple places via notes and express cross‑references. The notes to s 8 and provisions in s 11 indicate that decisions by a health care decision maker or NTCAT under the Health Care Decision Making Act can operate as consent or as the donor’s consent where the donor lacks capacity. Section 11(1)(b) expressly recognises consent given by NTCAT under the Health Care Decision Making Act 2023. This integration creates a delegated consent architecture where substitute decision mechanisms under the separate Act have legal effect for tissue removal in specified circumstances.

Health Practitioner Regulation National Law and national registration

• The specialist certification and experience requirements in s 21 rely on national registration under the Health Practitioner Regulation National Law to identify who counts as a “medical specialist” and who is registered to practise in a health profession (s 21(4); s 29 definition). Delegation of designated officer powers to health practitioners (s 29) also expressly requires those delegates to be registered under the National Law.

Interpretation Act 1978 and Gazette processes

• The Chief Health Officer’s authority to authorise anatomy schools by Gazette notice (s 22B) is linked to s 42 of the Interpretation Act 1978 (noted as empowering limitation by specified activities). Codes of practice have formal publication requirements (s 22D(6)-(6A)) and are only effective once published on the Agency’s website, tying regulatory instruments to administrative processes under the Interpretation Act and government publication norms.

Criminal Code

• Part IIAA of the Criminal Code applies to offences under this Act (s 5). That means general principles like fault element definitions, excuses and defences in the Criminal Code apply to prosecutions under the Act and will shape judicial interpretation of intent, recklessness and strict liability where the Act is silent.

Burial and Cremation Act 2022 and funeral/embalming practice

• The Act expressly does not prevent embalming and preparation of a deceased body for burial or disposal (s 26(c)-(d)), which interacts with the Burial and Cremation Act 2022 and related regulation of funeral practices. Practically, anatomy or tissue removal must be coordinated with post‑mortem preparation and disposal regulated elsewhere.

Health Legislation Amendment Act 2021 and codes

• Part 9(40) preserves codes of practice made under s 22D before amendments made by the Health Legislation Amendment Act 2021, indicating continuity and an express link between those amending statutes and the code‑making power.

Other Territory statutes and administrative law

• Designated officers are defined with reference to appointment under the Medical Services Act 1982 (s 4). The Act’s exemption clauses for particular medical procedures reference the Health Care Decision Making Act 2023 (s 26(a)(ii)). Administrative decisions such as the Minister’s exercise of s 22F will be subject to general administrative law principles and judicial review if challenged, although the Act does not expressly provide appeal or merits review mechanisms for ministerial authorisations.

Interactional implications

• Timing and sequencing: The act of removal often triggers obligations under other laws , a coroner’s jurisdiction, the need for brain‑death certification by specified practitioners, or funeral arrangements , creating multi‑agency coordination requirements and potential procedural delays that may affect clinical outcomes (for example, in transplantation).

• Delegation and national registration: Reliance on the Health Practitioner Regulation National Law means specialists and registered practitioners are the units through which compliance and certification are operationalised, linking Territory rules to national professional regulation.

• Substitute decision‑making: Use of the Health Care Decision Making Act 2023 to authorise removal when donors lack capacity centralises substituted decision‑making within a separate statutory regime, with NTCAT decisions treated as consents for the purposes of the Act (s 11(1)(b)).

• Administrative discretion and judicial review: The Minister’s undefined “special circumstances” gateway (s 22F) and the Chief Health Officer’s power to impose conditions on anatomy authorisations (s 22B) create discretionary administrative decisions that are likely reviewable under general administrative law but are otherwise under the executive's control.

In sum, the Act is embedded in a network of Territory and national laws affecting coronial functions, substitute decision‑making, professional registration, administrative decision‑making, funeral practices and criminal liability.

The Act has been subject to multiple amendments since its enactment in 1979. The endnotes supplied within the statute text set out the principal amending instruments and the substantive insertions or re‑enactments. The following summary restricts itself to the material explicitly reflected in the Act’s endnotes and list of amendments.

Foundational Act

• Human Tissue Transplant Act 1979 (Act No. 121, 1979). Assent 15 October 1979; commenced 1 December 1979.

Key amendments and re‑enactments reflected in the text

• Human Tissue Transplant Amendment Act 1989 (Act No. 50, 1989). Amended s 21 (medical certificate requirements) and commenced 20 September 1989 (listed in endnotes).

• 1990s-2000s statutory housekeeping. The Act received a series of statutory revisions and technical amendments via Statute Law Revision Acts in 1995, 1997, 1999, 2005 and other consequential amendments referenced in the endnotes (e.g. De Facto Relationships (Miscellaneous Amendments) Act 1991; Medical (Consequential Amendments) Act 1995).

• Human Tissue Transplant Amendment Act 2006 (Act No. 26, 2006). Inserted changes to s 14 (consent to blood removal) commenced 19 September 2006.

• Health Practitioner (National Uniform Legislation) Implementation Act 2010 (Act No. 18, 2010). Commenced 1 July 2010 and amended relevant provisions to implement uniform national registration (listed in endnotes).

• Human Tissue Transplant Amendment Act 2010 (Act No. 46, 2010). This amending Act is repeatedly referenced in the endnotes as re‑enacting major parts: it re‑enacted part headings, substituted and inserted numerous sections (including ss 18-19 re‑enactment and inserting new ss 19A-19B, inserting s 4A). It also appears to have added Part 4 and Part 5 headings and introduced the anatomy authorisation and trading prohibition provisions (ss 22A-22F) as ins No. 46, 2010, s 16. Many amendments and re‑enactments in the list cite No. 46, 2010; the Act’s current structure reflects these rewrites.

• Health Practitioner Regulation (National Uniform Legislation) and Other Legislation Amendment Act 2018 (Act No. 28, 2018). Amended s 16 and related provisions, and the Health Practitioner Regulation national framework references (assent 30 November 2018; commenced 1 December 2018).

• Advance Personal Planning (Consequential Amendments) Act 2013 (Act No. 36, 2013). Amended consent mechanics and references to advance personal plans in respect of donor consent and revocation (assent 19 December 2013; relevant sections commenced 5 February 2014 or other specified dates). The Act’s notes to s 8 and to s 14 reference advance personal plans.

• Health Legislation Amendment Act 2021 (Act No. 20, 2021). Amended code‑making powers and preserved codes of practice via Part 9 s 40; the Act’s list of amendments cites No. 20, 2021 for s 22D amendments and Part 9 transitional arrangements concerning codes.

• Burial and Cremation Act 2022 (Act No. 16, 2022). Amended s 26 to clarify that embalming and preparation for burial/disposal are not prevented by this Act.

• Health Care Decision Making Act 2023 (Act No. 19, 2023). Amended the Act to incorporate the substitute decision‑making mechanisms and NTCAT references; the commencement of that Act is noted as 1 July 2024 (Gaz G13, 20 June 2024). Several sections were amended or annotated to reflect the 2023 Act’s operation (see list of amendments: s 8, s 10, s 11, s 13, s 14, s 16 and others).

Specific insertions and structural changes

• The 2010 amending Act (No. 46, 2010) appears to have restructured Part 3 (donation after death), inserted the anatomy authorisation regime and trading prohibition provisions (ss 22A-22F), introduced s 4A (authorisation of retention of tissue), and generally modernised the Act’s structure.

Transitional provisions

• The Act contains transitional parts (Parts 8 and 9) preserving existing consents, certificates and authorisations given under previous versions of the Act at the time of re‑enactment or amendments (ss 31-39 and s 40). These transitional clauses indicate continuity of prior lawful instruments and reflect the Government’s intention to avoid retrospective disruption.

Overall, the amendment history shows an initial 1979 Act progressively updated to incorporate modern consent mechanics, coronial interaction, national practitioner registration frameworks, substitute decision‑making (post‑2023), and an explicit prohibition on trading with narrowly defined exceptions introduced in the 2010 reforms. The endnotes and list of amendments are the source for this history; the Act text must be read together with those endnotes for precise amendment timing and the scope of re‑enacted provisions.

The statute text and the accompanying endnotes do not supply any judicial decisions or litigation history arising under the Act. The Act’s notes refer to statutory interactions (for example, s 22A’s note that coroner‑directed autopsies are not caught, pointing to s 43BE of the Criminal Code), but no cases are named or summarised in the provided material.

Practically, the enforcement and interpretation of the Act will be shaped by:

• how courts apply Part IIAA of the Criminal Code to the Act’s fault elements; and

• how administrative law principles are used to review discretionary decisions taken under s 22B (Chief Health Officer conditions) and s 22F (Ministerial authorisations).

Absent reported decisions in the supplied text, one should assume that litigated questions likely to arise include the meaning of “reasonable inquiries” in ss 18 and 16A(3), the standard for “special circumstances” under s 22F, the application of the s 25 good‑faith shield, and the boundary between permitted disclosures under s 28(2) and unlawful disclosure under s 28(1). The Act leaves these as factually-dependent and legally contestable points which would be resolved by court or tribunal decisions not provided here.

If you require identification of any Territory or higher‑court decisions that interpreted this Act, the next step is to commission targeted legal research in the NT judicial and coronial databases and national reporters, because the legislative text supplied does not list any cases.

The Act contains several provisions and interactions that are operationally significant but may not be obvious at first reading. These “gotchas” are compliance and implementation traps that frequently produce risk in clinical, administrative and commercial contexts.

1. 24‑hour delay for non‑regenerative tissue (s 8(2))

• A consent for non‑regenerative tissue must specify the time of signing and does not take effect until 24 hours after signature. Failure to observe that delay can convert an otherwise authorised removal into an offence under s 27. Practically, time stamping and record keeping are mandatory.

2. Certifier cannot be the remover in certain cases (s 11(2)(a))

• Where a s 10 certificate is used, the consent authorises removal only by a medical practitioner other than the certifying practitioner. If the certifying practitioner then proceeds to remove tissue, they risk falling foul of s 11. This separation of roles must be observed in staffing and procedural allocation.

3. Strict liability procedural offences (ss 16A(4)-(6), 17(3)-(4), 18(2)-(3))

• Designated strict liability offences attach to notification and inquiry duties. Administrative slips , failing to inform a practitioner about revocation, failing to make reasonable inquiries before authorising removal, or failing to return instruments after revocation , attract penalties unless the defendant proves a reasonable excuse. These are classic operational compliance risk points.

4. Coroner consent and oral directions (s 20)

• Coroners can give consent or directions orally and confirm them in writing later (s 20(6)). Hospital staff must be alert to coroner processes and obtain written confirmation as soon as possible. A misstep here can interrupt organ retrieval timelines and create legal exposure.

5. Brain‑death certification requirements (s 21)

• For patients on artificial circulation/respiration, two practitioners (one a specialist) with at least five years’ practice must certify irreversible cessation of all brain function. The specialist list is narrow and specifically enumerated in s 21(4). Delays or lack of available qualified examiners can prevent lawful removal in time‑critical clinical settings.

6. Next‑of‑kin priority rules and conflicts (s 4 definition; ss 19-19A)

• The Act’s strict hierarchy for “senior available next of kin” can produce practical disagreements. If more than one person fits a priority class, an objection by any one of them defeats the authorisation in some contexts (s 19(3), s 19A(4)). Hospitals must have procedures to resolve who is “senior available” at the relevant time and to record efforts to locate or consult other kin.

7. Market prohibition with narrow exception (ss 22E-22F)

• The Act’s blanket prohibition on contracts for valuable consideration is strict (s 22E(1)), and parties cannot contract around it except where the Minister authorises (s 22F) or where only expense reimbursement is involved. A contract that purports to be commercial is void (s 22E(4)). Entities involved in tissue processing need to ensure the procurement chain began under an authorised arrangement and processing meets s 22E(3) conditions.

8. Retention authorised only to extent reasonably necessary (s 4A)

• While the Act authorises retention to the extent reasonably necessary, it does not define “reasonable”. That ambiguity affects policies on storage duration, consent for research reuse and disposal. Holders of anatomy authorisations must adopt defensible retention protocols and document necessity.

9. Codes of practice and publication timing (s 22D(6)-(6A))

• Codes do not take effect until published on the Agency website. Implementers must confirm publication dates; acting on an unpublished draft may expose actors to compliance gaps. Conversely, rapid publication of stringent codes can impose new obligations that require operational changes.

10. Good‑faith shield is fact‑sensitive (s 25)

• s 25 protects actors acting without negligence and in good faith, but these are contested legal standards. Documentation proving honest reasonable belief and absence of negligence is essential. Reliance on this shield is not a substitute for procedural compliance.

11. Ministerial discretion is undefined (s 22F)

• The Minister may authorise exceptions where “special circumstances” exist, but the Act contains no statutory guidance on the meaning of that phrase. This uncertainty creates transactional risk for commercial actors seeking authorisation; proactive consultation with the Minister’s office and detailed justification will be necessary.

12. Multiple cross‑legislative triggers

• Interactions with coronial law, national registration, and the Health Care Decision Making Act 2023 mean that compliance requires multi‑system checks. For example, an NTCAT decision under the separate Act is treated as consent for this Act (s 11(1)(b)), which places evidentiary obligations on hospital records to show the source of authority.

13. Confidentiality exceptions are narrow and context‑dependent (s 28)

• s 28 permits disclosures in limited circumstances; otherwise, disclosure is a criminal offence. Institutions must map internal information flows and classify permissible disclosures (e.g. for bona fide research) to avoid s 28 breaches.

14. Timing mismatch between clinical urgency and administrative duties

• Many provisions (reasonable inquiries; coroner consent; multiple next‑of‑kin checks) can create delays that are clinically significant for transplantation. Hospitals must design rapid decision pathways and documentation practices to reconcile clinical urgency with statutory obligations.

These “gotchas” emphasise the need for clear, well‑documented institutional processes, staff training, defined escalation pathways for coroner issues, and early engagement with the Minister or Chief Health Officer where commercial or unusual arrangements are contemplated.

To operationalise compliance the following practical checklist maps statutory duties to concrete administrative steps. The focus is on hospitals and designated officers, medical practitioners, anatomy schools, and potential commercial actors.

For hospitals and designated officers

• Document roles and delegations. Record the designated officer appointment and any delegations under s 29. Ensure delegated health practitioners meet the registration and experience standards the designated officer relied upon when delegating.

• Policies for consent collection. Implement standard consent forms that capture the time of signing (mandatory for non‑regenerative tissue, s 8(2)) and that are capable of being certified under s 10. Ensure medical practitioners providing the s 10 certificate document they explained nature and effects, age, sound mind and voluntariness.

• Separation of certification and removal roles. Maintain rotas and procedural checklists to ensure the practitioner who signs a s 10 certificate does not authorise or perform the removal where the Act bars that (s 11(2)(a)).

• Revocation procedure. Create immediate‑action protocols for revocation (s 16). Train staff to whom revocations may be made (designated officer, attending practitioner, registered nurses) to notify the designated officer immediately (s 16A(1)) and to document all communications.

• Inquiry and notification checklist. For s 16A(3) and s 18(2), implement a documented inquiry checklist: log attempted contacts with next of kin, check donor records for prior wishes, record coroner file checks, and log time, person making inquiries and responses. If a practitioner is proposing to rely on consent, the responsible person must immediately inform them (s 16A(4)); record the notification.

• Coroner screening. Insert a coroner‑screening step into post‑mortem authorisation workflows. If coroner consent is required (s 20), do not proceed until coroner consent or direction is obtained in writing; if oral consent is provided, obtain written confirmation as soon as practicable (s 20(6)).

• Brain‑death procedures. Maintain a list of practitioners who meet s 21(2) requirements and protocols for obtaining two independent neurological assessments, with one qualified specialist as listed in s 21(4). Record certificates in the patient file.

• Records management and instruments custody. Keep instruments of consent and certificates in a retrievable, secure form and return instruments to donors promptly after revocation is communicated (s 17(2)). Use time‑stamped electronic systems where possible.

• Confidentiality safeguards. Classify information that identifies donors, recipients and persons to whom consents or authorisations relate. Limit access, implement audit logging and ensure disclosures only occur within the s 28(2) exceptions or under court order. Train staff on criminal sanctions for unlawful disclosure.

For medical practitioners and clinical teams

• Use standardised s 10 certificates and explain consents fully to donors. Keep copies and contemporaneous notes to support any reliance on the s 25 good‑faith defence.

• Where a donor lacks capacity, verify whether the Health Care Decision Making Act 2023 provides for a substitute decision and if NTCAT has authorised the consent (s 11(1)(b)). Document the chain of authority.

• Before removal, confirm that no revocation has been indicated and that the designated officer has been notified in hospital cases (s 16A). If in doubt, contact the designated officer directly and document the communication.

• Recordkeeping to defend prosecutions. Given the intent/recklessness fault standards for major offences and the strict liability procedural offences, contemporaneous records of inquiries, notifications, certificates, and coroner communications are essential.

For holders of anatomy authorisations (educational institutions)

• Seek formal authorisation from the Chief Health Officer by Gazette notice for activities to be undertaken at the school of anatomy (s 22B(1)). Review and accept any conditions and ensure they are implementable.

• Adopt and publish internal procedures consistent with any code of practice issued under s 22D; verify the code has been published on the Agency website before relying on it (s 22D(6)-(6A)).

• Maintain processes for transport, receipt, storage and disposal of bodies or parts to align with codes (s 22D(2)(a),(d),(f)). Be aware contraventions of codes and of authorisation conditions carry criminal penalties (ss 22C, 22D(7)).

• Retention policy. Adopt a retention and disposal policy that can be justified as “reasonably necessary” for authorised purposes in light of s 4A. Record rationales for retaining tissue and for disposal decisions.

For entities considering commercial activity or processing

• Avoid entering into contracts that provide valuable consideration for supply of tissue unless the contract fits a statutory exception (expense reimbursement, s 22E(2)) or you have a Ministerial authorisation under s 22F. A contravening contract is void (s 22E(4)) and criminal liability attaches to entering into certain contracts (s 22E(1)).

• If the business model relies on downstream supply of processed tissue, document the entire chain: initial authorised collection under the Act, evidence of processing/treatment, and an explicit controlling medical practitioner direction for therapeutic/scientific use consistent with s 22E(3).

• Engage early with the Minister or Chief Health Officer for any non‑standard arrangements. Because s 22F is discretionary and undefined in scope, the administrative process will require a robust justification of “special circumstances.”

Cross‑cutting organisational measures

• Training and SOPs. Develop standard operating procedures, staff training on consent, revocation, coroner procedures, records management and confidentiality, and run regular audits.

• Documentation and audit trails. Use time‑stamped electronic records for all consents, revocations, certifications, inquiries, coroner communications and Ministerial/Chief Health Officer authorisations. The s 25 good‑faith defence and the need to establish a “reasonable excuse” for strict liability offences place evidence at the centre of compliance.

• Legal and risk escalation. Create rapid legal escalation channels for coroner interactions, disputed next‑of‑kin scenarios, or requests for ministerial authorisation. Maintain relationships with local coroners’ offices and the Chief Health Officer’s office to streamline necessary communications.

• Policy alignment across statutes. Ensure institutional policies are harmonised with the Health Care Decision Making Act 2023, the Coroners Act 1993, the Health Practitioner Regulation National Law, and Burial and Cremation Act 2022. Map authority flows so staff can identify whether authority derives from the donor, next of kin, NTCAT, coroner or ministerial/Chief Health Officer authorisation.

Following these measures will not eliminate legal risk but will materially reduce exposure to the statutory offences, ensure compliance with procedural obligations the Act places on staff and institutions, and preserve the factual record needed to rely on statutory defences such as s 25’s good‑faith protection.