{"id":"sr:human-tissue-regulations-2025","name":"Human Tissue Regulations 2025","slug":"human-tissue-regulations-2025","collection":"regulation","jurisdiction":"vic","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":183585,"registerId":"vic-sr:human-tissue-regulations-2025-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Human Tissue Regulations 2025","content":"Version No. 001\n\n**Human Tissue Regulations 2025**\n\n**S.R. No. 139/2025**\n\nVersion as at  \n21 December 2025\n\n**TABLE OF PROVISIONS**\n\n*Regulation Page*\n\n1 Objective 1\n\n2 Authorising provision 1\n\n3 Commencement 1\n\n4 Revocation 1\n\n5 Definition 1\n\n6 Prescribed classes of persons 1\n\n7 Prescribed institutions 2\n\n8 Prescribed tissue banks 2\n\n═════════════\n\nEndnotes 4\n\n1 General information 4\n\n2 Table of Amendments 6\n\n3 Explanatory details 7\n\n**Version No.** **001**\n\n**Human Tissue Regulations 2025**\n\n**S.R. No. 139/2025**\n\nVersion as at  \n21 December 2025\n\n\t1 Objective\n\nThe objective of these Regulations is to prescribe matters that are authorised or required to be prescribed for carrying out or giving effect to the **Human Tissue Act 1982**.  \n\n\t2 Authorising provision\n\nThese Regulations are made under section 46 of the **Human Tissue Act 1982**.\n\n\t3 Commencement\n\nThese Regulations come into operation on 21 December 2025.\n\n\t4 Revocation\n\nThe Human Tissue Regulations 2015[[1]](#endnote-1) are **revoked**.\n\n\t5 Definition\n\nIn these Regulations—\n\n***the Act*** means the **Human Tissue Act 1982**.\n\n\t6 Prescribed classes of persons\n\nFor the purposes of section 25(b) of the Act, the following classes of persons are prescribed—\n\n(a) in relation to the removal of ocular tissue, a person—\n\n(i) who is employed by, or performs work for, the Centre for Eye Research Australia Limited (ACN 076 481 984) as an eye donor coordinator as part of the Lions Eye Donation Service; and\n\n(ii) whose duties include the removal of ocular tissue from the bodies of deceased persons;\n\n(b) in relation to the removal of tissue of any kind, a person—\n\n(i) who is employed by, or performs work for, the Victorian Institute of Forensic Medicine or a hospital as a forensic technician (including a forensic technical officer), a mortuary technician or a scientist; and\n\n(ii) whose duties include the removal of tissue of any kind from the bodies of deceased persons.\n\n\t7 Prescribed institutions\n\nFor the purposes of Part VII of the Act, the following institutions are prescribed—\n\n(a) La Trobe University;\n\n(b) Monash University;\n\n(c) Royal Melbourne Institute of Technology;\n\n(d) University of Melbourne.\n\n\t8 Prescribed tissue banks\n\nFor the purposes of section 39A(1) of the Act, the following tissue banks are prescribed—\n\n(a) Austin Health Tissue Bank;\n\n(b) Barwon Health Bone Bank;\n\n(c) Donor Tissue Bank of Victoria;\n\n(d) kConFab (Kathleen Cuningham Foundation Consortium for Research into Familial Breast Cancer) Tissue Bank;\n\n(e) Lions Eye Donation Service;\n\n(f) Melbourne Health Tissue Bank;\n\n(g) Monash Health Tissue Bank;\n\n(h) Peter MacCallum Cancer Centre Tissue Bank;\n\n(i) Victorian Brain Bank.\n\n═════════════\n\nEndnotes\n\n1 General information\n\nSee [www.legislation.vic.gov.au](http://www.legislation.vic.gov.au) for Victorian Bills, Acts and current Versions of legislation and up-to-date legislative information.\n\nThe Human Tissue Regulations 2025, S.R. No. 139/2025 were made on 9 December 2025 by the Governor in Council under section 46 of the **Human Tissue Act 1982**, No. 9860/1982 and came into operation on 21 December 2025: regulation 3.\n\nThe Human Tissue Regulations 2025 will sunset 10 years after the day of making on 9 December 2035 (see section 5 of the **Subordinate Legislation Act 1994**).\n\nINTERPRETATION OF LEGISLATION ACT 1984 (ILA)\n\nStyle changes\n\nSection 54A of the ILA authorises the making of the style changes set out in Schedule 1 to that Act.\n\nReferences to ILA s. 39B\n\nSidenotes which cite ILA s. 39B refer to section 39B of the ILA which provides that where an undivided regulation, rule or clause of a Schedule is amended by the insertion of one or more subregulations, subrules or subclauses the original regulation, rule or clause becomes subregulation, subrule or subclause (1) and is amended by the insertion of the expression \"(1)\" at the beginning of the original regulation, rule or clause.\n\nInterpretation\n\nAs from 1 January 2001, amendments to section 36 of the ILA have the following effects:\n\n• Headings\n\nAll headings included in a Statutory Rule which is made on or after  \n1 January 2001 form part of that Statutory Rule. Any heading inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.  \nThis includes headings to Parts, Divisions or Subdivisions in a Schedule; Orders; Parts into which an Order is divided; clauses; regulations; rules; items; tables; columns; examples; diagrams; notes or forms.  \nSee section 36(1A)(2A)(2B).\n\n• Examples, diagrams or notes\n\nAll examples, diagrams or notes included in a Statutory Rule which is made on or after 1 January 2001 form part of that Statutory Rule. Any examples, diagrams or notes inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, form part of that Statutory Rule. See section 36(3A).\n\n• Punctuation\n\nAll punctuation included in a Statutory Rule which is made on or after  \n1 January 2001 forms part of that Statutory Rule. Any punctuation inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.  \nSee section 36(3B).\n\n• Provision numbers\n\nAll provision numbers included in a Statutory Rule form part of that Statutory Rule, whether inserted in the Statutory Rule before, on or after  \n1 January 2001. Provision numbers include regulation numbers, rule numbers, subregulation numbers, subrule numbers, paragraphs and subparagraphs. See section 36(3C).\n\n• Location of \"legislative items\"\n\nA \"legislative item\" is a penalty, an example or a note. As from 13 October 2004, a legislative item relating to a provision of a Statutory Rule is taken to be at the foot of that provision even if it is preceded or followed by another legislative item that relates to that provision. For example, if a penalty at the foot of a provision is followed by a note, both of these legislative items will be regarded as being at the foot of that provision. See section 36B.\n\n• Other material\n\nAny explanatory memorandum, table of provisions, endnotes, index and other material printed after the Endnotes does not form part of a Statutory Rule. See section 36(3)(3D)(3E).\n\n2 Table of Amendments\n\nThere are no amendments made to the Human Tissue Regulations 2025 by statutory rules, subordinate instruments and Acts.\n\n3 Explanatory details\n\n1. Reg. 4: S.R. No. 171/2015. [↑](#endnote-ref-1)","sortOrder":0}],"analysis":{"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"},"summary":{"complexity_score":2,"scope_assessment":{"changed":false,"description":"Unable to assess whether the scope changed from the original intent — no substantive regulatory content, explanatory memorandum, or amendment history is present in the provided document. Only version metadata is visible."},"complexity_factors":["Insufficient legislative text provided to assess true complexity — document appears to contain only metadata and version history information","Human tissue legislation in Australia is inherently complex due to ethical, medical, and jurisdictional considerations, but none of that content is visible here","The interplay between Commonwealth and State/Territory laws on human tissue adds layering that cannot be evaluated without the actual text","As a statutory rule (delegated legislation), it operates subordinate to a parent Act, adding interpretive dependency that cannot be traced without the full text"],"plain_english_summary":"These regulations are intended to set rules governing the collection, storage, use, and transplantation of human tissue and biological material, affecting hospitals, clinicians, donors, families, and research institutions. They matter because they aim to protect donors and recipients, ensure ethical consent and handling, and allocate authority over tissue use.\n\nImportant caveat: the provided document contains almost no substantive text—this summary is based on the title and legal context, not on actual regulatory provisions."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This is a straightforward remake of the 2015 regulations with updated institutional names and modernised structure. It maintains the same limited scope: prescribing specific persons, institutions, and tissue banks for the Human Tissue Act 1982. There is no expansion beyond the original purpose of providing the detailed lists required by the parent Act."},"complexity_factors":["Extremely short: only 8 regulations spanning 2 pages of substantive content","Single defined term ('the Act')","No conditional logic, exceptions, or nested provisions","Straightforward lists without cross-referencing between provisions","Purely prescriptive (naming specific people/institutions) rather than creating rules with tests or standards","No penalty provisions, offence sections, or enforcement mechanisms"],"plain_english_summary":"This is a short, technical piece of Victorian subordinate legislation (regulations) that updates the rules for handling human tissue in Victoria. It replaces the 2015 regulations and does three main things:\n\n**1. Authorises specific people to remove tissue from deceased bodies**\n- **Eye donor coordinators** working for the Centre for Eye Research Australia (as part of the Lions Eye Donation Service) can remove eye tissue from dead bodies.\n- **Forensic technicians, mortuary technicians and scientists** working for the Victorian Institute of Forensic Medicine or hospitals can remove any type of tissue from dead bodies.\n\n**2. Lists approved universities for anatomical purposes**\nFour institutions are officially approved for Part VII of the Human Tissue Act 1982 (which deals with anatomical examinations and post-mortems): La Trobe University, Monash University, RMIT, and the University of Melbourne.\n\n**3. Names approved tissue banks**\nNine specific tissue banks are officially recognised under the Act, including major hospitals (Austin Health, Barwon Health, Melbourne Health, Monash Health, Peter MacCallum Cancer Centre), the Donor Tissue Bank of Victoria, the Lions Eye Donation Service, a breast cancer research tissue bank (kConFab), and the Victorian Brain Bank.\n\n**Why it matters:** These regulations are essential for organ and tissue donation, medical research, and forensic pathology to operate legally in Victoria. Without these prescriptions, the people and institutions doing this work wouldn't have clear legal authority."},"issue_detection":{"absurdities":[],"contradictions":[]},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"The Regulations replace the earlier 2015 instrument (reg 4) and explicitly prescribe which classes of persons may remove tissue and which institutions and tissue banks are recognised under the Act (regs 6–8). That moves scope from a potentially broader or differently framed set of arrangements to a set defined by named organisations and roles, shifting who is authorised and who bears compliance duties; the instrument also includes a 10‑year sunset (Endnotes 1)."},"complexity_factors":["Named, prescriptive lists of individuals and organisations require administrative identification and upkeep (regs 6–8).","Numerous cross‑references to the Human Tissue Act 1982 mean interpretation depends on the primary Act’s definitions and duties (regs 1–2, 6–8).","Revocation of the 2015 Regulations alters existing compliance baselines and may require affected bodies to change practices (reg 4).","Minimal in‑instrument definitions — core terms and processes are left to the Act, increasing reliance on external text (reg 5).","Temporal limit via the 10‑year sunset in the endnotes creates a known expiry/renewal obligation for regulators (Endnotes 1).","Operational maintenance risk from naming specific entities (including an ACN) — changes in corporate structures or names will require regulatory updates (reg 6(a)(i), reg 8)."],"plain_english_summary":"These Regulations revoke the 2015 Regulations and mechanically list who is authorised to remove human tissue and which institutions and tissue banks are recognised under the Human Tissue Act 1982 (regs 4, 6–8). They affect hospitals, forensic services, eye‑donation coordinators, four universities and nine named tissue banks. The change clarifies compliance obligations by naming the persons and entities that may lawfully remove or hold human tissue and therefore identifies who must meet the Act’s procedural and recordkeeping duties."}},"importantCases":[],"_links":{"self":"/api/acts/human-tissue-regulations-2025","history":"/api/acts/human-tissue-regulations-2025/history","analysis":"/api/acts/human-tissue-regulations-2025/analysis","conflicts":"/api/acts/human-tissue-regulations-2025/conflicts","importantCases":"/api/acts/human-tissue-regulations-2025/important-cases","documents":"/api/acts/human-tissue-regulations-2025/documents"}}