{"id":"F2020L00169","name":"Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020","slug":"australian-organ-and-tissue-donation-and-transplantation-authority-regulations-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":100739,"registerId":"commonwealth-F2020L00169-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  This instrument is the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n  This instrument is made under the Australian Organ and Tissue Donation and Transplantation Authority Act 2008.","sortOrder":1},{"sectionNumber":"5","sectionType":"section","heading":"Definitions","content":"#### 5 Definitions\n\n  In this instrument:\n\n> Act means the Australian Organ and Tissue Donation and Transplantation Authority Act 2008.","sortOrder":2},{"sectionNumber":"6","sectionType":"section","heading":"Substances that are not tissue","content":"#### 6 Substances that are not tissue\n\n  For the purposes of the definition of tissue in section 4 of the Act, the following substances are specified:\n    (a) blood and blood products, including progenitor cells such as those in cord blood or bone marrow;\n    (b) reproductive tissue, including sperm and eggs;\n    (c) foetal tissue;\n    (d) stem cell tissue.","sortOrder":3},{"sectionNumber":"7","sectionType":"section","heading":"Alternative name for Australian Organ and Tissue Donation and Transplantation Authority","content":"#### 7 Alternative name for Australian Organ and Tissue Donation and Transplantation Authority\n\n  The name Organ and Tissue Authority is specified for the purposes of subsection 8(2) of the Act.","sortOrder":4}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This regulation appears to be operating exactly within its intended scope — providing technical specifications and exclusions under the parent Act. There is no evidence of scope creep; it does precisely what regulations are meant to do: fill in specific details (definitions and naming) that the primary legislation left for subordinate instruments."},"complexity_factors":["Extremely short instrument — only 7 sections total, with 4 substantive provisions","Single defined term ('Act') in interpretation section","No cross-references beyond basic references to the parent Act","Simple list structure for excluded substances with no conditional logic or exceptions","Straightforward administrative provision for alternative naming with no procedural requirements"],"plain_english_summary":"This regulation sets out technical details for how Australia's organ and tissue donation system works under the main 2008 Act.\n\n**What it does:**\n- **Defines what counts as \"tissue\"** — importantly, it excludes blood, blood products, reproductive tissue (sperm and eggs), foetal tissue, and stem cells from the definition. This means these substances are regulated under different laws, not this one.\n- **Gives the Authority a shorter name** — the Australian Organ and Tissue Donation and Transplantation Authority can officially use \"Organ and Tissue Authority\" as its alternative name.\n\n**Who it affects:**\n- Medical professionals and hospitals involved in organ donation and transplantation\n- The Organ and Tissue Authority itself (the government agency)\n- Patients and families navigating the donation system (indirectly, by clarifying what is covered)\n\n**Why it matters:**\nThe exclusions are significant. If you're donating blood, bone marrow, or reproductive material, those activities fall under separate regulatory schemes. This regulation draws a clear line between organ/tissue donation (covered here) and other biological donations (covered elsewhere). The naming provision simply makes the Authority's branding more practical for everyday use."},"flash_summary":{"complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument does not expand the Authority’s powers or create new obligations. It narrows and clarifies the Act’s scope for the term “tissue” by specifying that certain substances (blood and blood products, reproductive tissue including sperm and eggs, foetal tissue, and stem cell tissue) are not ‘tissue’ for the purposes of section 4 of the Act (regulation 6), and it prescribes an alternative name for the Authority (regulation 7). The regulation is made under the Act (regulation 3) and operates as a definitional clarification rather than a substantive change to the Act’s delegated powers."},"complexity_factors":["Very short instrument with three operative provisions (name, authority, definitions)","Direct cross-reference to the parent Act (requires reading regulation alongside the Act) — regulation 3 and regulation 5","Legal effect is definitional (specifies exclusions) rather than procedural or licensing, lowering administrative complexity — regulation 6","Uses terms with technical medical meaning (blood products, reproductive tissue, foetal tissue, stem cell tissue) that may require sector expertise to apply in borderline cases — regulation 6","Prescriptive text leaves little administrative discretion, reducing complexity of decision-making but creating possible interaction issues with other regulatory definitions"],"plain_english_summary":"The regulation narrows the Organ and Tissue Donation and Transplantation Authority Act 2008 by specifying that blood and blood products (including progenitor cells), reproductive tissue (sperm, eggs), foetal tissue and stem cell tissue are not “tissue” for the Act’s purposes, and permits the Authority to be called the “Organ and Tissue Authority.” It thus limits the Act’s regulatory scope over those materials, affecting organisations that handle them but creating no new duties, fees or powers."}},"importantCases":[],"_links":{"self":"/api/acts/australian-organ-and-tissue-donation-and-transplantation-authority-regulations-2020","history":"/api/acts/australian-organ-and-tissue-donation-and-transplantation-authority-regulations-2020/history","analysis":"/api/acts/australian-organ-and-tissue-donation-and-transplantation-authority-regulations-2020/analysis","conflicts":"/api/acts/australian-organ-and-tissue-donation-and-transplantation-authority-regulations-2020/conflicts","importantCases":"/api/acts/australian-organ-and-tissue-donation-and-transplantation-authority-regulations-2020/important-cases","documents":"/api/acts/australian-organ-and-tissue-donation-and-transplantation-authority-regulations-2020/documents"}}