{"id":"F2024L00487","name":"Statement of Principles concerning malignant neoplasm of the gallbladder (Reasonable Hypothesis) (No. 36 of 2024)","slug":"statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-reasonable-hypothesis-no-36","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442378,"registerId":"F2024L00487-fast-fetch-1775957396107","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 (Reasonable Hypothesis) (No. 36 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![RMA Australian Government Coat of Arms](image.001.jpeg)\n\n \n\nStatement of Principles\n\nconcerning\n\nMALIGNANT NEOPLASM OF THE GALLBLADDER  (Reasonable Hypothesis)\n\n(No. 36 of 2024)\n\nThe Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) 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 \n\n \n\nProfessor Terence Campbell AM\n\nChairperson\n\nby and on behalf of                                                         \n\nThe Repatriation Medical Authority\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 (Reasonable Hypothesis) (No. 36 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(2) of the Veterans' Entitlements Act 1986.\n\n4               Repeal\n\nThe Statement of Principles concerning malignant neoplasm of the gallbladder (No. 89 of 2015) (Federal Register of Legislation No. F2015L00921) made under subsections 196B(2) and (8) of the VEA is repealed.\n\n5               Application\n\nThis instrument applies to a claim to which section 120A of the VEA or section 338 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 cell 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\nThe Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that malignant neoplasm of the gallbladder and death from malignant neoplasm of the gallbladder can be related to relevant service rendered by veterans, members of Peacekeeping Forces, 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 as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting malignant neoplasm of the gallbladder or death from malignant neoplasm of the gallbladder 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)          having porcelain gallbladder before clinical onset;\n\nNote: porcelain gallbladder is defined in the Schedule 1 – Dictionary.\n\n(6)          being obese for at least 5 years within the 20 years before clinical onset;\n\nNote: being obese is defined in the Schedule 1 – Dictionary.\n\n(7)          being overweight for at least 5 years within the 20 years before clinical onset;\n\nNote: being overweight is defined in the Schedule 1 – Dictionary.\n\n(8)          having diabetes mellitus for at least 5 years before clinical onset;\n\n(9)          smoking at least 20 pack-years of cigarettes, or the equivalent thereof in other tobacco products, before clinical onset, and:\n\n(a)          smoking commenced at least 5 years before clinical onset; and\n\n(b)          where smoking has ceased,  clinical onset has occurred within 20 years of cessation;\n\nNote: one pack-year is defined in the Schedule 1 - Dictionary.\n\n(10)      having non-alcoholic fatty liver disease for at least 5 years within the 20 years before clinical onset;\n\n(11)      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(12)      being exposed to high levels of dietary aflatoxins, on more days than not, for a period of at least 5 years within the 30 years before clinical onset;\n\nNote: being exposed to high levels of dietary aflatoxins is defined in the Schedule 1 – Dictionary.\n\n(13)      inability to obtain appropriate clinical management of 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 subsections 9(13) 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(2) 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:\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                               being overweight means having a Body Mass Index (BMI) of 25 or greater.\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                               one pack-year means the amount of tobacco consumed in smoking 20 cigarettes per day for a period of 1 year, or an equivalent amount of tobacco products.\n\nNote 1: An equivalent amount of tobacco products is 7,300 grams of smoking tobacco by weight, either in cigarettes, pipe tobacco or cigars, or a combination of same. For pipe tobacco, cigars or combinations of multiple tobacco types, 1 gram of tobacco is considered to be equal to one cigarette.\n\nNote 2: Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 and multiplying this number by the number of years the person has smoked. For example, smoking 10 cigarettes per day for 10 years is equal to 5 pack-years, and smoking 40 cigarettes per day for 10 years is equal to 20 pack-years.\n\n                               porcelain gallbladder means intramural calcification of the gallbladder commonly associated with chronic cholecystitis.\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)          operational service under the VEA;\n\n(b)          peacekeeping service under the VEA;\n\n(c)          hazardous service under the VEA;\n\n(d)          British nuclear test defence service under the VEA;\n\n(e)          warlike service under the MRCA; or\n\n(f)           non-warlike service under the MRCA.\n\nNote: MRCA and VEA are 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 standard replacement Statement of Principles updating the 2015 version. It maintains the same scope—establishing service connection criteria for a specific cancer in veterans. The structure and purpose remain consistent with the Repatriation Medical Authority's ongoing function under the VEA."},"complexity_factors":["13 distinct medical factors with specific temporal requirements (e.g., 'at least 5 years within the 20 years before clinical onset')","Nested definitions requiring cross-reference to Schedule 1 (e.g., 'being obese' defined via BMI formula and waist circumference thresholds)","Mathematical calculation required for pack-years of smoking with conversion rules for different tobacco products","Exclusion clauses in the disease definition (7(2)(c)) that carve out 5 specific cancer types","Conditional logic in section 9(9) requiring three cumulative elements for smoking (quantity, commencement timing, and cessation window)","Dual statutory framework application (VEA and MRCA) with defined service categories","Incorporation by reference of external medical classification (ICD-10-AM Tenth Edition)","Specific evidentiary requirements for Salmonella detection (2 separate occasions, month apart, within 2 years)"],"plain_english_summary":"This instrument sets the medical test for deciding whether gallbladder cancer in veterans and current/former Australian defence members is service-related, replacing the 2015 version. It identifies specific medical factors that, if present and connected to service, create a “reasonable hypothesis” that the cancer was caused by service.\n\nThat finding determines access to pensions, treatment and other benefits under the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"This instrument repeals the 2015 Statement (s4) and establishes the current, operative list of risk factors, exposure thresholds and diagnostic definitions used to assess whether malignant neoplasm of the gallbladder is reasonably connected to relevant service for VEA and MRCA claims (s5, s9, Schedule 1). It also creates cross-referencing obligations with other Statements of Principles (s11) and narrows the covered pathology through explicit inclusions and exclusions (s7)."},"complexity_factors":["Multiple medical and exposure criteria with precise time and duration thresholds that must be satisfied to raise a reasonable hypothesis (section 9).","Detailed biometric and exposure definitions (BMI, waist circumference, pack‑year calculus, aflatoxin exposure geography) in Schedule 1 affecting evidentiary assessment.","Diagnostic standards for infections and chronicity (eg. serology or nucleic acid confirmation; repeated Salmonella detection criteria) that set proof requirements (section 9(2), Schedule 1).","A special evidentiary route for 'inability to obtain appropriate clinical management' that applies only in limited temporal circumstances (sections 9(13), 10(2)).","Cross-references to other Statements of Principles where factors overlap, requiring claimants and decision-makers to reconcile multiple instruments (section 11).","Explicit exclusions of other tumour types and an ICD-10-AM coding note that constrain scope of the condition covered (section 7(2)(c), 7(3)–(4)).","Statutory interaction with two different claims regimes (VEA and MRCA) and the defined concept of 'relevant service' that determines who is affected (section 5, Schedule 1).","Repeal and replacement of a prior instrument, requiring transitions in case law and administrative practice (section 4)."],"plain_english_summary":"This instrument tells decision-makers which medical facts will, as a minimum, establish a \"reasonable hypothesis\" that a veteran’s gallbladder cancer (or death from it) is connected to their service. It lists specific diagnoses, exposures, durations and diagnostic thresholds (for example cholelithiasis, chronic infections, obesity/overweight by BMI, tobacco pack‑years, aflatoxin exposure and others) that must be related to relevant service for an entitlement claim under the VEA or MRCA. It replaces the earlier 2015 Statement of Principles."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-reasonable-hypothesis-no-36","history":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-reasonable-hypothesis-no-36/history","analysis":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-reasonable-hypothesis-no-36/analysis","conflicts":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-reasonable-hypothesis-no-36/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-reasonable-hypothesis-no-36/important-cases","documents":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-gallbladder-reasonable-hypothesis-no-36/documents"}}