{"id":"F2020L00502","name":"Statement of Principles concerning malignant neoplasm of the liver (Balance of Probabilities) (No. 32 of 2020)","slug":"statement-of-principles-concerning-malignant-neoplasm-of-the-liver-balance-of-probabilities-no-32-of","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440469,"registerId":"F2020L00502-fast-fetch-1775956077387","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning malignant neoplasm of the liver (Balance of Probabilities) (No. 32 of 2020)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 20.2\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n\n\n \n\nStatement of Principles\n\nconcerning\n\nMALIGNANT NEOPLASM OF THE LIVER (Balance of Probabilities)\n\n(No. 32 of 2020)\n\nThe Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n \n\nDated 24 April 2020\n\n \n\n \n\n \n\n \n\n \n\n| The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of:
|\n| --- |\n| 
Professor Nicholas Saunders AO
Chairperson
|\n\n\n \n\n \n\n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Repeal\n\n5 Application\n\n6 Definitions\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n8 Basis for determining the factors\n\n9 Factors that must exist\n\n10 Relationship to service\n\n11 Factors referring to an injury or disease covered by another Statement of Principles\n\nSchedule 1 - Dictionary\n\n1 Definitions\n\n \n\n\n\n\n1 Name\n\nThis is the Statement of Principles concerning malignant neoplasm of the liver (Balance of Probabilities) (No. 32 of 2020).\n\n2 Commencement\n\n This instrument commences on 25 May 2020.\n\n3 Authority\n\nThis instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n4 Repeal\n\nThe Statement of Principles concerning malignant neoplasm of the liver No. 22 of 2011 (Federal Register of Legislation No. F2011L00502) made under subsections 196B(3) and (8) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 applies.\n\n6 Definitions\n\nThe terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n(1) This Statement of Principles is about malignant neoplasm of the liver and death from malignant neoplasm of the liver.\n\nMeaning of malignant neoplasm of the liver\n\n(2) For the purposes of this Statement of Principles, malignant neoplasm of the liver:\n\n(a) means a primary malignant neoplasm arising from the hepatocytes; and\n\n(b) excludes:\n\n(i) carcinoid tumour;\n\n(ii) Hodgkin's lymphoma;\n\n(iii) malignant neoplasm of the bile duct;\n\n(iv) non-Hodgkin lymphoma; and\n\n(v) soft tissue sarcoma.\n\nNote: Malignant neoplasm of the liver is also known as hepatocellular carcinoma.\n\n(3) While malignant neoplasm of the liver attracts ICD‑10‑AM code C22.0, in applying this Statement of Principles the meaning of malignant neoplasm of the liver is that given in subsection (2).\n\n(4) For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4.\n\nDeath from malignant neoplasm of the liver\n\n(5) For the purposes of this Statement of Principles, malignant neoplasm of the liver, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's malignant neoplasm of the liver.\n\nNote: terminal event is defined in the Schedule 1 – Dictionary.\n\n8 Basis for determining the factors\n\nOn the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that malignant neoplasm of the liver and death from malignant neoplasm of the liver can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA.\n\nNote: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.\n\n9 Factors that must exist\n\nAt least one of the following factors must exist before it can be said that, on the balance of probabilities, malignant neoplasm of the liver or death from malignant neoplasm of the liver is connected with the circumstances of a person's relevant service:\n\n(1) having cirrhosis of the liver before the clinical onset of malignant neoplasm of the liver;\n\n(2) having chronic infection with hepatitis B virus before the clinical onset of malignant neoplasm of the liver;\n\nNote: chronic infection with hepatitis B virus is defined in the Schedule 1 - Dictionary. \n\n(3) having chronic infection with hepatitis C virus before the clinical onset of malignant neoplasm of the liver;\n\nNote 1: In the past, hepatitis C viral infection may have been classified as non-A, non-B hepatitis.\n\nNote 2: chronic infection with hepatitis C virus is defined in the Schedule 1 - Dictionary. \n\n(4) having chronic infection with hepatitis D virus before the clinical onset of malignant neoplasm of the liver;\n\nNote: chronic infection with hepatitis D virus is defined in the Schedule 1 - Dictionary. \n\n(5) having infection with human immunodeficiency virus before the clinical onset of malignant neoplasm of the liver;\n\n(6) having chronic hepatitis before the clinical onset of malignant neoplasm of the liver;\n\nNote: chronic hepatitis is defined in the Schedule 1 - Dictionary. \n\n(7) having diabetes mellitus for at least ten years before the clinical onset of malignant neoplasm of the liver;\n\n(8) being obese for at least ten years within the 20 years before the clinical onset of malignant neoplasm of the liver;\n\nNote: being obese is defined in the Schedule 1 - Dictionary. \n\n(9) for males, consuming at least 150 kilograms of alcohol within any ten year period at least five years before the clinical onset of malignant neoplasm of the liver;\n\nNote: Alcohol is measured by the alcohol consumption calculations utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink.\n\n(10) for females, consuming at least 75 kilograms of alcohol within any ten year period at least five years before the clinical onset of malignant neoplasm of the liver;\n\nNote: Alcohol is measured by the alcohol consumption calculations utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink.\n\n(11) smoking at least 20 pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical onset of malignant neoplasm of the liver, and:\n\n(a) smoking commenced at least five years before the clinical onset of malignant neoplasm of the liver; and\n\n(b) where smoking has ceased, the clinical onset of malignant neoplasm of the liver has occurred within 20 years of cessation;\n\nNote: pack-years of cigarettes, or the equivalent thereof in other tobacco products is defined in the Schedule 1 - Dictionary. \n\n(12) having received a cumulative equivalent dose of at least 0.5 sievert of ionising radiation to the liver at least ten years before the clinical onset of malignant neoplasm of the liver;\n\nNote: cumulative equivalent dose is defined in the Schedule 1 - Dictionary. \n\n(13) being treated with systemic immunosuppressive therapy for solid organ, stem cell or bone marrow transplantation before the clinical onset of malignant neoplasm of the liver;\n\n(14) being exposed to high levels of dietary aflatoxins, on more days than not, for a period of at least ten years within the 20 years before the clinical onset of malignant neoplasm of the liver;\n\nNote: being exposed to high levels of dietary aflatoxins is defined in the Schedule 1 - Dictionary. \n\n(15) inhaling a cumulative dose of at least 2 500 ppm-years of gaseous vinyl chloride at least five years before the clinical onset of malignant neoplasm of the liver;\n\nNote: ppm-years is defined in the Schedule 1 - Dictionary. \n\n(16) inhaling gaseous vinyl chloride for a cumulative period of at least 10 000 hours while working in the production or processing of vinyl chloride monomer or polyvinyl chloride, at least five years before the clinical onset of malignant neoplasm of the liver;\n\n(17) inability to obtain appropriate clinical management for malignant neoplasm of the liver.\n\n10 Relationship to service\n\n(1) The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person.\n\n(2) The factor set out in subsection 9(17) applies only to material contribution to, or aggravation of, malignant neoplasm of the liver where the person's malignant neoplasm of the liver was suffered or contracted before or during (but did not arise out of) the person's relevant service.\n\n11 Factors referring to an injury or disease covered by another Statement of Principles\n\nIn this Statement of Principles:\n\n(1) if a factor referred to in section 9 applies in relation to a person; and\n\n(2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA;\n\nthen the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.\n\n \n\n \n\nSchedule 1 - Dictionary \n\nNote: See Section 6\n\n1 Definitions\n\nIn this instrument:\n\n being exposed to high levels of dietary aflatoxins means living or working in a geographic region or country where food items, particularly grains and nuts, are regularly contaminated with high levels of aflatoxins, and consuming these food items as a major part of the diet. \n\nNote: Geographic regions or countries where food items are regularly contaminated with high levels of aflatoxins include sub-Saharan Africa, Southeast Asia, Eastern Mediterranean and China.\n\n being obese means having a Body Mass Index (BMI) of 30 or greater.\n\nNote: BMI is also defined in the Schedule 1 - Dictionary.\n\n BMI means W/H2 where:\n\nW is the person's weight in kilograms; and\n\nH is the person's height in metres.\n\n chronic hepatitis means biochemical evidence of continuing or relapsing hepatocellular necrosis and hepatic inflammation for at least six months.\n\n chronic infection with hepatitis B virus means infection with hepatitis B virus resulting in a chronic infection of at least six months duration, and which must be confirmed by laboratory testing for hepatitis B serological or nucleic acid markers.\n\n chronic infection with hepatitis C virus means infection with hepatitis C virus resulting in a chronic infection of at least six months duration and which must be confirmed by laboratory testing for hepatitis C serological or nucleic acid markers.\n\n chronic infection with hepatitis D virus means infection with hepatitis D virus resulting in a chronic infection of at least six months duration and which must be confirmed by laboratory testing for hepatitis D serological or nucleic acid markers.\n\n cumulative equivalent dose means the total dose of ionising radiation received by the particular organ or tissue from external exposure, internal exposure or both, apart from normal background radiation exposure in Australia, calculated in accordance with the methodology set out in Guide to calculation of 'cumulative equivalent dose' for the purpose of applying ionising radiation factors contained in Statements of Principles determined under Part XIA of the Veterans' Entitlements Act 1986 (Cth), Australian Radiation Protection and Nuclear Safety Agency, as in force on 2 August 2017.\n\nNote 1: Examples of circumstances that might lead to exposure to ionising radiation include being present during or subsequent to the testing or use of nuclear weapons, undergoing diagnostic or therapeutic medical procedures involving ionising radiation, and being a member of an aircrew, leading to increased levels of exposure to cosmic radiation.\n\nNote 2: For the purpose of dose reconstruction, dose is calculated as an average over the mass of a specific tissue or organ. If a tissue is exposed to multiple sources of ionising radiation, the various dose estimates for each type of radiation must be combined.\n\n malignant neoplasm of the liver—see subsection 7(2).\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n pack-years of cigarettes, or the equivalent thereof in other tobacco products means a calculation of consumption where one pack-year of cigarettes equals twenty tailor-made cigarettes per day for a period of one calendar year, or 7 300 cigarettes. One tailor-made cigarette approximates one gram of tobacco or one gram of cigar or pipe tobacco by weight. One pack-year of tailor-made cigarettes equates to 7.3 kilograms of smoking tobacco by weight. Tobacco products mean cigarettes, pipe tobacco or cigars, smoked alone or in any combination.\n\n ppm-years means parts per million multiplied by years of exposure.\n\n relevant service means:\n\n(a) eligible war service (other than operational service) under the VEA;\n\n(b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or\n\n(c) peacetime service under the MRCA.\n\nNote: MRCA and VEA are also defined in the Schedule 1 - Dictionary.\n\n terminal event means the proximate or ultimate cause of death and includes the following:\n\n(a) pneumonia;\n\n(b) respiratory failure;\n\n(c) cardiac arrest;\n\n(d) circulatory failure; or\n\n(e) cessation of brain function.\n\n VEA means the Veterans' Entitlements Act 1986.\n\n \n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":5,"scope_assessment":{"changed":false,"description":"This is a straightforward replacement of a 2011 Statement of Principles with the same scope and purpose. It maintains the established framework for determining service connection for liver cancer under the veterans' compensation scheme, updating medical evidence and definitions but not expanding beyond the original intent of providing medical criteria for this specific condition."},"complexity_factors":["17 distinct causal factors with varying temporal requirements (5, 10, or 20 year lookback periods)","14 defined terms in Schedule 1, several requiring mathematical calculations (BMI, pack-years, ppm-years, cumulative equivalent dose)","Cross-references to two separate Acts (VEA and MRCA) and their defined service types","Nested definitions: some defined terms rely on other defined terms (e.g., 'being obese' uses 'BMI' which has its own formula)","Specific measurement methodologies required (Australian Standard for alcohol, ARPANSA guide for radiation dose calculation dated 2 August 2017)","Section 11 creates dynamic incorporation of other Statements of Principles by reference ('as in force from time to time')","Dual application framework — different rules apply depending on which compensation scheme (VEA or MRCA) the claim falls under","Exclusionary definitions in section 7(2) that carve out five specific conditions from coverage"],"plain_english_summary":"This instrument sets medical rules for deciding when hepatocellular carcinoma in Australian current or former Defence Force members is more likely than not related to service, replacing the 2011 version. It establishes a defined list of 17 risk factors that, if present and service-linked, create a presumption of service connection for compensation under veterans’ laws.\n\nIt matters to claimants, the Repatriation Medical Authority, and DVA decision-makers because it standardises causation assessments and exclusions for non-hepatocyte liver cancers."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"This instrument expressly repeals the Statement of Principles concerning malignant neoplasm of the liver No. 22 of 2011 (s4) and comes into force on 25 May 2020 (s2). It re‑states the medical definition, lists specified causal factors and provides definitions and measurement methods (s7–s9, Schedule). The instrument text does not set out a clause‑by‑clause comparison with the repealed instrument, so whether the substantive scope has been widened or narrowed cannot be determined from this instrument alone."},"complexity_factors":["Multiple technical medical criteria and quantitative thresholds in section 9 (e.g. BMI, pack‑years, kilograms of alcohol, sieverts, ppm‑years, cumulative hours), requiring precise measurement and historical evidence (s9).","Temporal and latency requirements across many factors (e.g. exposures or conditions must precede clinical onset by specific intervals: 5, 10 or up to 20 years) increasing evidentiary complexity (s9, Schedule definitions).","Laboratory and clinical confirmation requirements for chronic infections and chronic hepatitis (s9(2)–(4); Schedule definitions), meaning claimants must produce specific test records.","Cross‑references to other Statements of Principles and primary statutes (VEA, MRCA) that can import additional applicable factors and legal tests (s3, s5, s11).","Use of specialist dose‑reconstruction methodology and external technical guidance for ionising radiation (Schedule: cumulative equivalent dose; ARPANSA guidance), imposing technical expertise for proof.","Sex‑differentiated and exposure‑type thresholds (alcohol different for males/females; occupation‑specific vinyl chloride metrics) require detailed consumption/work histories (s9(9)–(10), s9(15)–(16)).","An open‑ended factor—'inability to obtain appropriate clinical management'—creates potential for discretionary assessment about access to care and material contribution/aggravation (s9(17), s10(2)).","Formal repeal and replacement of the earlier 2011 Statement (s4) requires comparing instruments to determine substantive changes to scope or thresholds."],"plain_english_summary":"This Statement of Principles replaces the 2011 instrument and sets the medical criteria the Repatriation Medical Authority uses to decide whether primary liver cancer (hepatocellular carcinoma) is connected to a veteran's or service member's relevant service for VEA and MRCA claims. It lists specific conditions, exposures and quantitative thresholds (for example chronic viral hepatitis, cirrhosis, obesity, alcohol and tobacco use, radiation and certain chemical exposures) that, if proven and service‑related, establish a connection on the balance of probabilities and so affect entitlement."},"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/statement-of-principles-concerning-malignant-neoplasm-of-the-liver-balance-of-probabilities-no-32-of","history":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-liver-balance-of-probabilities-no-32-of/history","analysis":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-liver-balance-of-probabilities-no-32-of/analysis","conflicts":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-liver-balance-of-probabilities-no-32-of/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-liver-balance-of-probabilities-no-32-of/important-cases","documents":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-liver-balance-of-probabilities-no-32-of/documents"}}