{"id":"F2022L01127","name":"Statement of Principles concerning malignant neoplasm of the anus and anal canal (Balance of Probabilities) (No. 83 of 2022)","slug":"statement-of-principles-concerning-malignant-neoplasm-of-the-anus-and-anal-canal-balance-of-probabil","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441496,"registerId":"F2022L01127-fast-fetch-1775956780941","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 anus and anal canal (Balance of Probabilities) (No. 83 of 2022)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 22.10.0\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 ANUS AND ANAL CANAL  (Balance of Probabilities)\n\n(No. 83 of 2022)\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 23 August 2022.\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:<br> |\n| --- |\n| <br> <br>Professor Terence Campbell AM<br>Chairperson<br> |\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 anus and anal canal (Balance of Probabilities) (No. 83 of 2022).\n\n2               Commencement\n\n              This instrument commences on 19 September 2022.\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 anus and anal canal No. 52 of 2013 (Federal Register of Legislation No. F2013L01639) made under subsection 196B(3) 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 anus and anal canal and death from malignant neoplasm of the anus and anal canal.\n\nMeaning of malignant neoplasm of the anus and anal canal\n\n(2)          For the purposes of this Statement of Principles, malignant neoplasm of the anus and anal canal:\n\n(a)          means a primary malignant neoplasm arising from the epithelial cells of the anus or anal canal; and\n\n(b)          includes:\n\n(i)            adenocarcinoma;\n\n(ii)         adenocarcinoma in situ;\n\n(iii)       carcinoma in situ;\n\n(iv)        high-grade anal squamous intra-epithelial lesion (HSIL); and\n\n(v)          squamous cell carcinoma; and\n\n(c)          excludes:\n\n(i)            atypical squamous cell histology of undetermined significance in the anal canal;\n\n(ii)         haematolymphoid tumours including Hodgkin's lymphoma and non-Hodgkin lymphoma;\n\n(iii)       low-grade anal squamous intra-epithelial lesion (LSIL);\n\n(iv)        malignant melanoma;\n\n(v)          mesenchymal tumours including soft tissue sarcoma;\n\n(vi)        neoplasms of the perianal skin (anal margin); and\n\n(vii)     neuroendocrine tumours.\n\nNote: Anatomically, the anus and anal canal extends from the anus (anal verge) to the junction of the anal canal with the rectum, including the anorectal transformation zone.\n\n(3)          While malignant neoplasm of the anus and anal canal attracts ICD‑10‑AM codes C21.0, C21.1, C21.2 or D01.3, in applying this Statement of Principles the meaning of malignant neoplasm of the anus and anal canal 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 anus and anal canal\n\n(5)          For the purposes of this Statement of Principles, malignant neoplasm of the anus and anal canal, 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 anus and anal canal.\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 anus and anal canal and death from malignant neoplasm of the anus and anal canal 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 anus and anal canal or death from malignant neoplasm of the anus and anal canal is connected with the circumstances of a person's relevant service:\n\n(1)          having smoked tobacco products:\n\n(a)          in an amount of at least 10 pack-years before the clinical onset of malignant neoplasm of the anus or anal canal; and\n\n(b)          commencing at least 5 years before the clinical onset of malignant neoplasm of the anus or anal canal; and\n\nif smoking has ceased before the clinical onset of malignant neoplasm of the anus or anal canal, then that onset occurred within 20 years of cessation;\n\nNote: one pack-year is defined in the Schedule 1 - Dictionary.             \n\n(2)          having infection of the epithelium of the anal canal with a specified human papillomavirus before the clinical onset of malignant neoplasm of the anus or anal canal;\n\nNote: specified human papillomavirus is defined in the Schedule 1 – Dictionary.\n\n(3)          having receptive anal intercourse at least 2 years before the clinical onset of malignant neoplasm of the anus or anal canal;\n\n(4)          having infection with human immunodeficiency virus before the clinical onset of malignant neoplasm of the anus or anal canal;\n\n(5)          taking an immunosuppressive drug for organ or tissue transplantation for at least the 1 year before the clinical onset of malignant neoplasm of the anus or anal canal;\n\nNote: organ or tissue transplantation is defined in the Schedule 1 - Dictionary.\n\n(6)          having perianal manifestations of Crohn disease for at least the 3 years before the clinical onset of malignant neoplasm of the anus or anal canal;\n\nNote: perianal manifestations of Crohn disease is defined in the Schedule 1 - Dictionary.\n\n(7)          inability to obtain appropriate clinical management for malignant neoplasm of the anus and anal canal.\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(7) applies only to material contribution to, or aggravation of, malignant neoplasm of the anus and anal canal where the person's malignant neoplasm of the anus and anal canal 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                               malignant neoplasm of the anus and anal canal—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                               organ or tissue transplantation means the transplantation of:\n\n(a)          all or part of an organ or tissue; or\n\n(b)          a substance obtained from an organ or tissue.\n\n                               perianal manifestations of Crohn disease means the presence of perianal fistula, perianal abscess, anal canal fissures or anal canal strictures associated with Crohn disease.\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                               specified human papillomavirus means human papilloma virus type 16, 18, 31, 33, 35, 45, 51, 52, 58 or 68.\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 (SOP) that maintains the established scope of determining medical eligibility for veteran compensation claims. It updates the 2013 version with current medical evidence but does not expand beyond the original purpose of establishing causal factors for anal cancer in the veterans' compensation context."},"complexity_factors":["Multiple nested conditions within factors (e.g., factor 9(1) has three sub-conditions for smoking: pack-year threshold, commencement timing, and cessation timing)","Cross-referencing between the main instrument and Schedule 1 Dictionary for 8 defined terms","Anatomical and medical terminology requiring specialist knowledge (ICD-10-AM codes, specific HPV types, perianal manifestations)","Exclusion clauses in the definition that require careful parsing (7 specific exclusions from the definition)","Conditional application of factor 9(7) restricted to pre-existing conditions not arising from service","Incorporation by reference of other Statements of Principles through section 11"],"plain_english_summary":"This instrument sets the medical rules for linking anal cancer to Australian defence service, replacing the 2013 version. It defines which forms of anal cancer qualify and the medical factors (such as smoking, HPV, immunosuppression, HIV, certain anal conditions, or delayed/absent care) that can establish a service connection on the balance of probabilities.\n\nIt affects veterans and current/former defence members claiming under the VEA or MRCA and determines entitlement to pensions, treatment, and other benefits."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"This instrument expressly repeals the 2013 Statement and replaces it. It now governs claims under section 120B of the VEA and section 339 of the MRCA and specifies particular risk factors, thresholds, definitions and exclusions that determine when the condition is treated as connected with relevant service. As a result, the previous Statement no longer applies and future decisions must follow the criteria set out here."},"complexity_factors":["Interplay of legal and medical criteria: statutory basis under subsection 196B(3) and application to VEA and MRCA claims (sections 3 and 5).","Detailed clinical definitions and exclusions for the condition (section 7(2)–(4) and Schedule 1).","Multiple temporal and quantitative thresholds (pack‑years, smoking cessation window, minimum latency periods) in factor 9(1) and elsewhere.","Specified infectious agents/types (enumerated HPV types in Schedule 1) requiring lab/clinical evidence.","Several heterogeneous causal factors (behavioural, infectious, immunological, inflammatory, treatment‑related and access‑to‑care) listed in section 9.","Requirement that any listed factor be 'related to the relevant service'—creates an evidentiary link between service and factor (section 10).","Cross‑reference to other Statements of Principles where an identified factor is itself covered (section 11), adding dependency on separate instruments.","Inclusion of death via terminal event or condition (section 7(5)) which broadens adjudicative scope.","Repeal and replacement of an earlier Statement (section 4)—administrative transition risk for ongoing claims."],"plain_english_summary":"This instrument sets the medical criteria the Repatriation Medical Authority uses to decide whether malignant neoplasm of the anus and anal canal (and death from it) is connected to a veteran's service for VEA or MRCA compensation claims. It lists required risk factors (smoking with pack‑year and timing thresholds; specified HPV infection; receptive anal intercourse; HIV; transplant immunosuppression; perianal Crohn disease; or inability to obtain appropriate clinical management), defines technical terms, and requires the factor be related to the person's relevant service."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-anus-and-anal-canal-balance-of-probabil","history":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-anus-and-anal-canal-balance-of-probabil/history","analysis":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-anus-and-anal-canal-balance-of-probabil/analysis","conflicts":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-anus-and-anal-canal-balance-of-probabil/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-anus-and-anal-canal-balance-of-probabil/important-cases","documents":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-anus-and-anal-canal-balance-of-probabil/documents"}}