{"id":"F2024L00488","name":"Statement of Principles concerning malignant neoplasm of the gallbladder (Balance of Probabilities) (No. 37 of 2024)","slug":"statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-balance-of-probabilities-no","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442375,"registerId":"F2024L00488-fast-fetch-1775957396102","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 gallbladder (Balance of Probabilities) (No. 37 of 2024)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\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 GALLBLADDER (Balance of Probabilities)\n\n(No. 37 of 2024)\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 26 April 2024.\n\n \n\n \n\n \n\n \n\n \n\n| |\n| --- |\n|
Professor Terence Campbell AM
Chairperson
by and on behalf of
The Repatriation Medical Authority |\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 gallbladder (Balance of Probabilities) (No. 37 of 2024).\n\n2 Commencement\n\n This instrument commences on 28 May 2024.\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 gallbladder (No. 90 of 2015) (Federal Register of Legislation No. F2015L00922) made under subsections 196B(3) and (8) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act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 gallbladder and death from malignant neoplasm of the gallbladder.\n\nMeaning of malignant neoplasm of the gallbladder\n\n(2) For the purposes of this Statement of Principles, malignant neoplasm of the gallbladder:\n\n(a) means a primary malignant neoplasm arising from the epithelial cells of the gallbladder; and\n\n(b) includes:\n\n(i) adenocarcinoma of the gallbladder;\n\n(ii) adenosquamous carcinoma of the gallbladder;\n\n(iii) carcinoma of the gallbladder;\n\n(iv) clear cell carcinoma of the gallbladder;\n\n(v) poorly cohesive carcinoma of the gallbladder;\n\n(vi) squamous carcinoma of the gallbladder; and\n\n(vii) carcinoma in situ of the gallbladder; and\n\n(c) excludes:\n\n(i) soft tissue sarcoma;\n\n(ii) malignant neoplasm of the bile duct;\n\n(iii) neuroendocrine carcinoma of the gallbladder;\n\n(iv) non-Hodgkin lymphoma; and\n\n(v) Hodgkin lymphoma.\n\n(3) While malignant neoplasm of the gallbladder attracts ICD‑10‑AM code C23, in applying this Statement of Principles the meaning of malignant neoplasm of the gallbladder 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 gallbladder\n\n(5) For the purposes of this Statement of Principles, malignant neoplasm of the gallbladder, 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 gallbladder.\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 gallbladder and death from malignant neoplasm of the gallbladder 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 gallbladder or death from malignant neoplasm of the gallbladder is connected with the circumstances of a person's relevant service:\n\n(1) having cholelithiasis before clinical onset; \n\n(2) having a chronic biliary infection of Salmonella typhi or Salmonella paratyphi detected on at least 2 separate occasions, at least a month apart, and within 2 years before clinical onset;\n\nNote: A biliary infection by Salmonella can be ascertained by detection of specific antibodies in serum or detection of Salmonella sp. in stool samples.\n\n(3) having primary sclerosing cholangitis before clinical onset;\n\nNote: primary sclerosing cholangitis is defined in the Schedule 1 – Dictionary.\n\n(4) having had an intravascular injection of Thorotrast (thorium dioxide) before clinical onset;\n\n(5) being obese for at least 10 years within the 20 years before clinical onset;\n\nNote: being obese is defined in the Schedule 1 – Dictionary.\n\n(6) having diabetes mellitus for at least 10 years before clinical onset;\n\n(7) having chronic infection with hepatitis B or C virus before clinical onset;\n\nNote: chronic infection with hepatitis B or C virus is defined in the Schedule 1 - Dictionary.\n\n(8) inability to obtain appropriate clinical management for malignant neoplasm of the gallbladder before clinical worsening.\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(8) applies only to material contribution to, or aggravation of, malignant neoplasm of the gallbladder where the person's malignant neoplasm of the gallbladder 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 obese means:\n\n(a) having a Body Mass Index (BMI) of 30 or greater; or\n\n(b) for males, having a waist circumference exceeding 102 centimetres; or\n\n(c) for females, having a waist circumference exceeding 88 centimetres.\n\nNote: BMI is defined in the Schedule 1 - Dictionary.\n\n BMI means W/H2 where:\n\n(a) W is the person's weight in kilograms; and\n\n(b) H is the person's height in metres.\n\n chronic infection with hepatitis B or C virus means infection with hepatitis B or C virus resulting in a chronic infection of at least six months duration, and which must be confirmed by laboratory testing for hepatitis B or C serological or nucleic acid markers.\n\n malignant neoplasm of the gallbladder—see subsection 7(2).\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n primary sclerosing cholangitis means an autoimmune disorder characterised by a progressive, inflammatory, sclerosing process in the bile ducts.\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":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This is a straightforward reissue/replacement of the 2015 Statement of Principles concerning the same condition. It maintains the same structural approach: defining the disease, listing specific causal factors, and requiring connection to service. The scope remains tightly focused on determining liability for gallbladder cancer in the veterans' compensation scheme, which is the original and continuing purpose of Statements of Principles under section 196B(3) of the VEA."},"complexity_factors":["Multiple defined terms in Schedule 1 (10+ definitions including technical medical terms like 'primary sclerosing cholangitis' and 'chronic infection with hepatitis B or C virus')","Cross-references between sections and the Dictionary (e.g., section 6 references Schedule 1, section 7(2) references specific medical subtypes)","Conditional logic in factor 9(2) requiring specific temporal and evidentiary requirements (2 separate detections, at least a month apart, within 2 years)","Nested exclusions in section 7(2)(c) specifying 5 excluded cancer types that don't count as gallbladder cancer under this instrument","Dual application framework covering two different Acts (VEA and MRCA) with different service categories","Specific measurement standards for obesity requiring either BMI calculation or waist circumference thresholds by gender","Factor 9(8) has a limited application scope restricted by section 10(2) to pre-existing conditions only"],"plain_english_summary":"This instrument replaces the 2015 rules for deciding when gallbladder cancer is service‑related for veterans and current/former defence members under the Veterans’ Entitlements Act and MRCA. It sets a Statement of Principles using the balance‑of‑probabilities test: claimants must show their cancer was more likely than not connected to service via one of eight specified medical factors (e.g., gallstones, chronic infections, long‑term obesity/diabetes, certain bile/liver conditions, past thorotrast exposure, or inadequate prior care)."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"This instrument repeals the prior 2015 Statement of Principles (s4) and replaces it with an updated Statement that specifies current factors, definitions and commencement (s2, s6, s7–s11). The repeal and replacement alter the operative text that decision-makers must apply for VEA/MRCA claims."},"complexity_factors":["Multiple clinically specific causal factors with precise timing or duration thresholds (eg. obesity for at least 10 years within 20 years; diabetes for at least 10 years) (s9(5),(6)).","Laboratory and testing requirements for infections and exposures (eg. Salmonella detection on ≥2 occasions at least one month apart within 2 years; chronic hepatitis B/C confirmed by serology or nucleic acid) (s9(2); Schedule).","Inclusion and exclusion of particular histological cancer types and an ICD-10-AM code reference, requiring correct diagnostic classification (s7(2)–(4)).","Cross-reference mechanism to other Statements of Principles where factors overlap, requiring consultation of other instruments (s11).","Requirement to link any listed factor to the person's relevant service—an evidentiary and causation step that engages service records and medical history (s10(1)).","A subjective-sounding but operational factor: 'inability to obtain appropriate clinical management' which applies only in defined circumstances and may be hard to prove (s9(8); s10(2)).","Applicability limited to claims under specific statutory sections (section 120B VEA or section 339 MRCA), so users must verify claim-type before applying criteria (s5).","Evidentiary standard is balance of probabilities, grounded in 'sound medical‑scientific evidence'—legal and medical assessments must be integrated (s8).","Definitions require objective measurement (BMI formula; waist circumference cut-offs) and lab confirmation, creating administrative and medical-evidence burdens on claimants (Schedule).","Instrument is concise but depends on external clinical records, lab reports and other Statements, producing multi-source evidentiary complexity and potential inter-agency coordination."],"plain_english_summary":"This Statement sets the Repatriation Medical Authority’s medical criteria for deciding, on the balance of probabilities, when malignant neoplasm of the gallbladder (or death from it) is connected to a veteran’s or service member’s relevant service under the VEA or MRCA. It lists specific clinical risk factors, exposure types and timing thresholds, and defines measurement rules such as BMI and laboratory confirmation. It matters for veterans and members lodging claims because decision-makers will apply these criteria to determine service connection and entitlement."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-balance-of-probabilities-no","history":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-balance-of-probabilities-no/history","analysis":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-balance-of-probabilities-no/analysis","conflicts":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-balance-of-probabilities-no/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-balance-of-probabilities-no/important-cases","documents":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-balance-of-probabilities-no/documents"}}