{"id":"human-tissue-and-transplant-regulations-2024","name":"Human Tissue and Transplant Regulations 2024","slug":"human-tissue-and-transplant-regulations-2024","collection":"regulation","jurisdiction":"wa","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":176875,"registerId":"wa-human-tissue-and-transplant-regulations-2024-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Human Tissue and Transplant Regulations 2024","content":"![Crest]()Western Australia\n\nHuman Tissue and Transplant Act 1982\n\nHuman Tissue and Transplant Regulations 2024\n\nWestern Australia\n\nHuman Tissue and Transplant Regulations 2024\n\nContents\n\n1. Citation 1\n\n2. Commencement 1\n\n3. Exempt entity (s. 29A(1)) 1\n\n4. TG law provisions (s. 29A(4)(d) and (e)) 1\n\n5. Tissue banks (s. 29B(1)) 3\n\n6. Body of medical practitioners (s. 29E(3)(a)) 3\n\n7. *Human Tissue and Transplant Regulations 2006* repealed 3\n\nNotes\n\nCompilation table 4\n\nDefined terms\n\n  \n\nHuman Tissue and Transplant Act 1982\n\nHuman Tissue and Transplant Regulations 2024\n\n##### 1. Citation\n\n\t\tThese regulations are the *Human Tissue and Transplant Regulations 2024*.\n\n##### 2. Commencement\n\nThese regulations come into operation as follows —\n\n(a) regulations 1 and 2 — on the day on which these regulations are published on the WA legislation website;\n\n(b) the rest of the regulations — on 19 February 2024.\n\n##### 3. Exempt entity (s. 29A(1))\n\nFor the purposes of the definition of ***exempt entity*** in section 29A(1), the Australian Bone Marrow Donor Registry (ACN 096 625 231) is an exempt entity.\n\n##### 4. TG law provisions (s. 29A(4)(d) and (e))\n\n(1) In this regulation —\n\nequivalent rule, in relation to a rule made under the Therapeutic Goods Act, means the rule that —\n\n(a) applies as a law of the State under the *Therapeutic Goods Law Application Act 2024* section 10; and\n\n(b) is equivalent to the rule made under the Therapeutic Goods Act;\n\nequivalent section, in relation to a section of the Therapeutic Goods Act, means the section of the Therapeutic Goods Act that —\n\n(a) applies as a law of the State under the *Therapeutic Goods Law Application Act 2024* section 5; and\n\n(b) is equivalent to the section of the Therapeutic Goods Act;\n\nTGA provision has the meaning given in section 29A(1);\n\nTG law provision has the meaning given in section 29A(1).\n\n(2) For the purposes of section 29A(4)(d), the following TG law provisions are prescribed —\n\n(a) the Therapeutic Goods Act section 19(1);\n\n(b) the Therapeutic Goods Act section 19(5);\n\n(c) a rule made under the Therapeutic Goods Act section 19(7A);\n\n(d) the Therapeutic Goods Act section 32CK(1);\n\n(e) the Therapeutic Goods Act section 32CM(1);\n\n(f) a rule made under the Therapeutic Goods Act section 32CM(7A);\n\n(g) the Therapeutic Goods Act section 41HB(1);\n\n(h) the Therapeutic Goods Act section 41HC(1);\n\n(i) a rule made under the Therapeutic Goods Act section 41HC(6);\n\n(j) the equivalent section of each section of the Therapeutic Goods Act prescribed under paragraphs (a), (b), (d), (e), (g) and (h);\n\n(k) the equivalent rule of each rule made under the Therapeutic Goods Act prescribed under paragraphs (c), (f) and (i).\n\n(3) For the purposes of section 29A(4)(e), the following TGA provisions are prescribed —\n\n(a) a regulation made for the purposes of the Therapeutic Goods Act section 18(1);\n\n(b) the Therapeutic Goods Act section 18A(1);\n\n(c) a regulation made for the purposes of the Therapeutic Goods Act section 32CA(2);\n\n(d) the Therapeutic Goods Act section 32CB(1).\n\n(4) A regulation referred to in subregulation (3)(a) or (c) is not prescribed for the purposes of section 29A(4)(e) to the extent that it applies to a therapeutic good mentioned in the *Therapeutic Goods Regulations 1990* (Commonwealth) Schedule 5 item 10.\n\n[Regulation 4 amended: SL 2024/276 r. 4.]\n\n##### 5. Tissue banks (s. 29B(1))\n\nFor the purposes of the definition of ***tissue bank*** in section 29B(1), the following facilities are tissue banks —\n\n(a) the Perron Rotary Express Milk Bank (PREM Bank);\n\n(b) the branch of Australian Red Cross Lifeblood responsible for donor human milk.\n\n##### 6. Body of medical practitioners (s. 29E(3)(a))\n\nFor the purposes of section 29E(3)(a), the Western Australian Kidney Transplant Society Medical Subcommittee is a body of medical practitioners.\n\n##### 7. *Human Tissue and Transplant Regulations 2006* repealed\n\nThe *Human Tissue and Transplant Regulations 2006* are repealed.\n\n![]()\n\nNotes\n\nThis is a compilation of the *Human Tissue and Transplant Regulations 2024* and includes amendments made by other written laws. For provisions that have come into operation see the compilation table.\n\nCompilation table\n\n| **Citation** | **Published** | **Commencement** |\n| --- | --- | --- |\n| *Human Tissue and Transplant Regulations 2024* | SL 2024/10 9 Feb 2024 | r. 1 and 2: 9 Feb 2024 (see r. 2(a));   Regulations other than r. 1 and 2: 19 Feb 2024 (see r. 2(b)) |\n| *Human Tissue and Transplant Amendment Regulations 2024* | SL 2024/276 18 Dec 2024 | r. 1 and 2: 18 Dec 2024 (see r. 2(a));   Regulations other than r. 1 and 2: 19 Dec 2024 (see r. 2(b)) |\n\n\nDefined terms\n\n*[This is a list of terms defined and the provisions where they are defined. The list is not part of the law.]*\n\n**Defined term Provision(s)**\n\nequivalent rule 4(1)\n\nequivalent section 4(1)\n\nTGA provision 4(1)\n\nTG law provision 4(1)\n\n© State of Western Australia 2024.\n\nThis work is licensed under a Creative Commons Attribution 4.0 International Licence (CC BY 4.0). To view relevant information and for a link to a copy of the licence, visit www.legislation.wa.gov.au.\n\nAttribute work as: © State of Western Australia 2024.\n\nBy Authority: GEOFF O. LAWN, Government Printer\n","sortOrder":0}],"analysis":{"issue_detection":{"absurdities":[],"contradictions":[]},"summary":{"complexity_score":1,"scope_assessment":{"changed":false,"description":"No assessment of scope change is possible. The document provided contains no legislative content — it is a 404-style error page from the Western Australian legislation website indicating the page has been moved or removed during a system upgrade. No comparison between original intent and final form can be made."},"complexity_factors":["No legislative text was provided — only a website error page was supplied for analysis","Unable to assess actual complexity of the regulations without access to the document","Score of 1 reflects the trivial nature of what was actually provided, not an assessment of the underlying law"],"plain_english_summary":"The Human Tissue and Transplant Regulations 2024 would set rules for donation, storage and use of human tissue and organs in Western Australia. They govern who can consent, how hospitals and tissue banks must handle material, and include safeguards and penalties to prevent misuse. This affects donors and families, clinicians, transplant services, tissue banks and researchers — essential for safe, lawful transplantation and research."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"These regulations alter scope by (a) naming an exempt entity (Australian Bone Marrow Donor Registry) (reg 3), (b) prescribing which Therapeutic Goods Act sections and rules apply as TG law provisions in WA and defining equivalence to Commonwealth provisions (reg 4(1)–(4)), (c) identifying two recognised tissue banks (reg 5) and a medical subcommittee (reg 6), and (d) repealing the prior 2006 regulations (reg 7). Collectively these changes clarify and narrow or redirect who and what is covered under the Act by specifying named organisations and mapped Commonwealth provisions."},"complexity_factors":["Direct, limited scope: short list of concrete changes (naming an exempt entity, prescribing TG provisions, listing tissue banks and a medical body, repealing earlier regulations) — regs 3, 4, 5, 6, 7.","Cross‑jurisdictional legal mapping: defines ‘equivalent section’ and ‘equivalent rule’ to map Commonwealth Therapeutic Goods Act provisions into State law (introduces external legal references and reliance on the Therapeutic Goods Law Application Act 2024) — reg 4(1) and reg 4(3).","Prescription of specific Commonwealth provisions: enumerates particular Therapeutic Goods Act sections and rules that will be treated as TG law provisions in the State, requiring readers to trace and apply those Commonwealth provisions — reg 4(2) and 4(3).","Targeted compliance impact: named entities (Australian Bone Marrow Donor Registry; Perron Rotary Express Milk Bank; Australian Red Cross Lifeblood branch) are explicitly affected and must align with the Act as interpreted by these regs — regs 3 and 5 (compliance burden concentrated on listed bodies).","Limited administrative discretion: the instrument itself fixes designations rather than creating broad delegations, so practical discretion is mainly in how agencies and affected bodies apply the prescribed TG provisions (less procedural complexity but operational alignment required) — regs 3–6.","Transitional/legal housekeeping: repeal of the 2006 regulations and specific commencement dates requires stakeholders to track timing of obligations and any transitional effects — reg 2 and reg 7."],"plain_english_summary":"These regulations update how Western Australia’s Human Tissue and Transplant law applies by naming specific exempt organisations, prescribing which Commonwealth Therapeutic Goods provisions operate in the State, formally recognising two donor human milk banks and a kidney-transplant medical subcommittee, and repealing the 2006 regulations. They affect the named organisations, operators of tissue banks, and parties subject to therapeutic-goods rules by clarifying which laws apply and which bodies are recognised, changing who must comply and what legal standards are referenced."},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The regulations appear consistent with their original intent as machinery provisions supporting the Human Tissue and Transplant Act 1982. They perform the typical function of regulations under this Act: naming specific entities, prescribing external laws for application, and identifying tissue banks. There is no evidence of scope creep beyond the Act's original purpose of regulating human tissue and transplants."},"complexity_factors":["Heavy reliance on external legislation: The regulations constantly reference the Therapeutic Goods Act (Commonwealth) and Therapeutic Goods Law Application Act 2024 (WA), requiring readers to cross-reference multiple statutes","Nested definitions: Regulation 4 contains definitions ('equivalent rule', 'equivalent section') that refer to other definitions, which then refer to external statutory provisions","Prescriptive lists with conditional exclusions: Regulation 4(4) creates an exception to the prescribed regulations (excluding donor human milk provisions in specific circumstances)","Technical terminology: Uses specialised terms like 'TG law provision', 'TGA provision', and 'equivalent section' without plain English alternatives in the operative provisions","Short length but dense referencing: Only 7 regulations, but most simply point to external statutory sections rather than creating standalone rules"],"plain_english_summary":"These regulations support Western Australia's main law on human tissue and transplants (the Human Tissue and Transplant Act 1982). They do four main things:\n\n**1. Exempts the Australian Bone Marrow Donor Registry from certain requirements**\n- This national registry (which matches bone marrow donors with patients) is declared an \"exempt entity,\" meaning it doesn't have to follow some rules that apply to other tissue-related organisations.\n\n**2. Lists which Commonwealth therapeutic goods laws apply in WA**\n- The regulations specify which parts of the federal Therapeutic Goods Act (and related rules) are \"prescribed\" (officially listed) as applying in Western Australia. This covers rules about importing, exporting, and manufacturing therapeutic goods like blood products and tissues.\n- There's a carve-out: regulations about \"donor human milk\" don't apply if they relate to specific therapeutic goods listed in Commonwealth regulations.\n\n**3. Names specific tissue banks**\n- Two facilities are officially declared \"tissue banks\":\n  - The Perron Rotary Express Milk Bank (PREM Bank) — a breast milk bank for babies\n  - The Australian Red Cross Lifeblood's donor human milk branch\n\n**4. Names a specialist medical body**\n- The Western Australian Kidney Transplant Society Medical Subcommittee is recognised as an official \"body of medical practitioners\" for kidney transplant matters.\n\n**5. Repeals old regulations**\n- These new regulations replace the Human Tissue and Transplant Regulations 2006.\n\n**Why this matters:** These rules ensure that life-saving tissue and transplant services (like bone marrow matching, breast milk banking, and kidney transplants) operate under clear legal frameworks, while aligning WA law with national therapeutic goods standards."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/human-tissue-and-transplant-regulations-2024","history":"/api/acts/human-tissue-and-transplant-regulations-2024/history","analysis":"/api/acts/human-tissue-and-transplant-regulations-2024/analysis","conflicts":"/api/acts/human-tissue-and-transplant-regulations-2024/conflicts","importantCases":"/api/acts/human-tissue-and-transplant-regulations-2024/important-cases","documents":"/api/acts/human-tissue-and-transplant-regulations-2024/documents"}}