{"id":"F2024L01326","name":"Statement of Principles concerning myelodysplastic neoplasm (syndrome) (Balance of Probabilities) (No. 77 of 2024)","slug":"statement-of-principles-concerning-myelodysplastic-neoplasm-syndrome-balance-of-probabilities-no-77-","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442613,"registerId":"F2024L01326-fast-fetch-1775957583543","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning myelodysplastic neoplasm (syndrome) (Balance of Probabilities) (No. 77 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\nMYELODYSPLASTIC NEOPLASM (SYNDROME)  (Balance of Probabilities)\n\n(No. 77 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 18 October 2024.\n\n \n\n \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   \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\n\n\n1.                Name\n\n\nThis is the Statement of Principles concerning myelodysplastic neoplasm (syndrome) (Balance of Probabilities) (No. 77 of 2024).\n\n1.                Commencement\n\n\n              This instrument commences on 19 November 2024.\n\n1.                Authority\n\n\nThis instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n1.                Repeal\n\n\nThe Statement of Principles concerning myelodysplastic syndrome (No. 74 of 2015) (Federal Register of Legislation No. F2015L00906) made under subsection 196B(3) and (8) of the VEA is repealed.\n\n1.                Application\n\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\n1.                Definitions\n\n\nThe terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.\n\n1.                Kind of injury, disease or death to which this Statement of Principles relates\n  1.           This Statement of Principles is about myelodysplastic neoplasm (syndrome) and death from myelodysplastic neoplasm (syndrome).\n\n\nMeaning of myelodysplastic neoplasm (syndrome)\n\n1.           For the purposes of this Statement of Principles, myelodysplastic neoplasm (syndrome):\n  1.           means a clonal haematopoietic stem cell neoplasm characterised by morphologic dysplasia ≥10% in at least one cell line of erythroid, granulocyte, or megakaryocyte lines; persistent cytopaenia; progressively ineffective haematopoiesis; and increased risk of acute myeloid leukaemia; and\n  2.           includes:\n    1.             morphologically defined myelodysplastic neoplasm including myelodysplastic neoplasm with low blasts; hypoplastic myelodysplastic neoplasm; and myelodysplastic neoplasm with increased blasts; and\n    2.          myelodysplastic neoplasms with defined genetic abnormalities including myelodysplastic neoplasm with low blasts and 5q deletion; myelodysplastic neoplasm with low blasts and SF3B1 mutation; myelodysplastic neoplasm with biallelic TP53 inactivation; and\n  3.           excludes:\n    1.             leukaemia including acute myeloid leukaemia;\n    2.          myeloproliferative neoplasms including chronic myeloid leukaemia, chronic neutrophilic leukaemia, chronic eosinophilic leukaemia, polycythaemia vera, essential thromobocythaemia, primary myelofibrosis, and juvenile myelomonocytic leukaemia;\n    3.        aplastic anaemia; and\n    4.         Myelodysplastic/myeloproliferative neoplasms in the overlap category, including myelodysplastic/myeloproliferative neoplasm with neutrophilia; and myelodysplastic/myeloproliferative neoplasm with SF3B1 mutation and thrombocytosis; and myelodysplastic/myeloproliferative neoplasm not otherwise specified.\n\n\nNote: Myelodysplastic neoplasms are also called myelodysplastic syndromes and myelodysplastic disorders\n\n1.           While myelodysplastic neoplasm (syndrome) attracts ICD‑10‑AM codes D46 and C94.6, in applying this Statement of Principles the meaning of myelodysplastic neoplasm (syndrome) is that given in subsection (2).\n2.           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\n\nDeath from myelodysplastic neoplasm (syndrome)\n\n1.           For the purposes of this Statement of Principles, myelodysplastic neoplasm (syndrome), in relation to a person, includes death from a terminal event or condition that was contributed to by the person's myelodysplastic neoplasm (syndrome).\n\n\nNote: terminal event is defined in the Schedule 1 – Dictionary.\n\n1.                Basis for determining the factors\n\n\nOn the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that myelodysplastic neoplasm (syndrome) and death from myelodysplastic neoplasm (syndrome) 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\n1.                Factors that must exist\n\n\nAt least one of the following factors must exist before it can be said that, on the balance of probabilities, myelodysplastic neoplasm (syndrome) or death from myelodysplastic neoplasm (syndrome) is connected with the circumstances of a person's relevant service:\n\n1.           smoking at least 15 pack-years of cigarettes, or the equivalent thereof in other tobacco products, before clinical onset, and:\n  1.           smoking commenced at least 10 years before clinical onset; and\n  2.           where smoking has ceased, clinical onset has occurred within 10 years of cessation;\n\n\nNote: one pack-year is defined in the Schedule 1 – Dictionary.\n\n1.           being treated with one of the following drugs:\n  1.           a topoisomerase II inhibitor, including etoposide, and doxorubicin; or\n  2.           an alkylating agent including cyclophosphamide, chlorambucil, mechlorethamine, melphalan, nitrosoureas, cisplatin, carboplatin; or\n  3.           taxanes including paclitaxel, and docetaxel;\n\n\nbefore clinical onset, where treatment commenced at least 6 months before clinical onset, and where the treatment has ceased, within 20 years of cessation;\n\n1.           having received a cumulative equivalent dose of at least 0.05 sievert of ionising radiation to the bone marrow at least 2 years before clinical onset;\n\n\nNote: cumulative equivalent dose is defined in the Schedule 1 – Dictionary\n\n1.           being exposed to benzene:\n  1.           for a cumulative total of at least 2,500 hours within a continuous period of ten years before clinical onset; and\n  2.           where the first exposure in that period occurred at least ten years before clinical onset;\n  3.           where the last exposure in that period occurred within the 30 years before clinical onset;\n\n\nNote: being exposed to benzene is defined in the Schedule 1 - Dictionary.\n\n1.           receiving greater than 10 ppm-years of cumulative exposure to benzene before clinical onset and;\n  1.           where the first exposure occurred at least 10 years before clinical onset and:\n  2.           where the last exposure occurred within the 30 years before  clinical onset;\n\n\nNote: ppm-years is defined in the Schedule 1 - Dictionary.\n\n1.           completing a course of therapy for malignant neoplasm before clinical onset, where the first exposure occurred at least 6 months before  clinical onset, and where that therapy has ceased, clinical onset occurred within 10 years of cessation;\n2.           inability to obtain appropriate clinical management for myelodysplastic neoplasm (syndrome) before clinical worsening.\n\n\n1.            Relationship to service\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  2.           The factor set out in subsection 9(7) applies only to material contribution to, or aggravation of, myelodysplastic neoplasm (syndrome) where the person's myelodysplastic neoplasm (syndrome) was suffered or contracted before or during (but did not arise out of) the person's relevant service.\n2.            Factors referring to an injury or disease covered by another Statement of Principles\n\n\nIn this Statement of Principles:\n\n1.           if a factor referred to in section 9 applies in relation to a person; and\n2.           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\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                               8-hour time-weighted average means the averaging of different exposure levels to benzene during an average exposure period equivalent to eight hours.\n\n                               being exposed to benzene means:\n\n(a)          having cutaneous contact with liquids containing benzene greater than 1% by volume;\n\n(b)          ingesting liquids containing benzene greater than 1% by volume; or\n\n(c)          inhaling benzene vapour where such exposure occurs at an ambient 8-hour time-weighted average benzene concentration exceeding five parts per million.\n\nNote: 8-hour time-weighted average is defined in the Schedule 1 - Dictionary.\n\n                               cumulative equivalent dose means the total dose of ionising radiation received by the particular organ or tissue. The formula used to calculate the cumulative equivalent dose allows doses from multiple types of ionising radiation to be combined, by accounting for their differing biological effect.\n\nThe unit of equivalent dose is the sievert. For the purposes of this Statement of Principles, the calculation of cumulative equivalent dose excludes doses received from normal background radiation, but includes therapeutic radiation, diagnostic radiation, cosmic radiation at high altitude, radiation from occupation-related sources and radiation from nuclear explosions or accidents.\n\n                             MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n                             myelodysplastic neoplasm (syndrome)—see subsection 7(2).\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                               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 standard Statement of Principles (SOP) replacement under the Veterans' Entitlements Act framework. It updates the 2015 version to reflect current WHO classification terminology (changing 'syndrome' to 'neoplasm' to align with modern medical taxonomy) and refines exposure criteria. The scope remains tightly focused on establishing causation criteria for a single disease in the veterans' compensation context, which is the original and continuing purpose of SOPs under section 196B."},"complexity_factors":["Multiple nested conditions within each factor (e.g., factor 9(1) has 3 sub-conditions; factor 9(4) has 3 timing requirements)","Technical medical terminology requiring definitions (clonal haematopoietic stem cell neoplasm, morphologic dysplasia, cytopaenia)","Two alternative calculation methods for benzene exposure (hours-based vs. concentration-based ppm-years)","Cross-references to external classification systems (ICD-10-AM Tenth Edition)","Conditional logic for cessation of exposure/treatment with specific lookback windows (10 years, 20 years, 30 years, 6 months, 2 years)","Specific exclusion list of 4 related conditions that are NOT covered","Inclusion of 6 sub-types of MDS plus 4 genetic variants in the definition","Dual legislative framework application (VEA and MRCA with different service definitions)","Special rule in section 10(2) limiting factor 9(7) to pre-existing conditions only"],"plain_english_summary":"This instrument updates medical criteria for veterans and current/former defence members to claim compensation for myelodysplastic neoplasm (MDS), replacing the 2015 rules and applying the \"balance of probabilities\" test. It covers peacetime and non‑operational war service and lists specific, evidence‑based risk factors (exposures, prior treatments, smoking, or service‑related lack of care) that, if proven, link MDS to service. It’s the gatekeeper for claims; cases not meeting these criteria will likely be denied. Exclusions apply for other marrow cancers and acute leukaemia."},"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"},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"This instrument repeals the prior Statement (No. 74 of 2015) (s4) and restates the condition definition with explicit inclusions and exclusions (s7(2)), plus detailed, quantified exposure and timing thresholds for causation (s9 and Schedule 1). Those explicit numerical criteria and the clarified death/terminal event definition potentially alter which cases meet the Statement’s test and so change the practical scope of application for entitlement claims (s5, s7(3), s9)."},"complexity_factors":["Technical medical definition and exclusions for the condition (precise morphological and genetic criteria) (s7(2)).","Multiple, numerically expressed exposure and timing thresholds that must be proved (e.g. ≥15 pack‑years; smoking start ≥10 years before clinical onset; smoking cessation window) (s9(1)).","Specific drug classes with temporal limits (topoisomerase II inhibitors, alkylating agents, taxanes; treatment start ≥6 months before onset; cessation within 20 years) (s9(2)).","Radiation metric requiring calculation of cumulative equivalent dose to bone marrow in sieverts, with exclusions for background radiation and inclusion of varied sources (s9(3); Schedule 1 cumulative equivalent dose).","Benzene exposure rules expressed both as hours (≥2,500 hours within a continuous 10‑year period, with first/last exposure timing limits) and as cumulative ppm‑years (>10 ppm‑years) (s9(4)–(5); Schedule 1 definitions).","Cross‑referencing to other Statements of Principles where factors overlap, creating dependency on other instruments (s11).","Requirement that any qualifying factor be related to the person's relevant service, including a special application for aggravation where disease pre‑existed (s10(1)–(2)), raising evidentiary and causal-link burdens for claimants.","Reliance on technical calculations and occupational/medical records (e.g. dose calculation, pack‑year computation, benzene concentration time‑weighting) increases administrative and evidentiary burden on claimants and decision makers (Schedule 1; s9).","Repeal and replacement of a prior Statement (No. 74 of 2015) requires stakeholders to map old findings and claims to the new criteria (s4)."],"plain_english_summary":"This Statement of Principles defines the medical definition and the specific exposure, treatment and timing criteria used to decide whether myelodysplastic neoplasm (syndrome) — or death from it — is connected with a person’s military or defence service for claims under the Veterans' Entitlements Act and the Military Rehabilitation and Compensation Act. It replaces the 2015 statement and sets concrete thresholds (smoking, certain chemotherapy drugs, radiation dose, benzene exposure, prior cancer therapy, and clinical-management gaps) that claimants must meet to establish connection on the balance of probabilities."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-myelodysplastic-neoplasm-syndrome-balance-of-probabilities-no-77-","history":"/api/acts/statement-of-principles-concerning-myelodysplastic-neoplasm-syndrome-balance-of-probabilities-no-77-/history","analysis":"/api/acts/statement-of-principles-concerning-myelodysplastic-neoplasm-syndrome-balance-of-probabilities-no-77-/analysis","conflicts":"/api/acts/statement-of-principles-concerning-myelodysplastic-neoplasm-syndrome-balance-of-probabilities-no-77-/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-myelodysplastic-neoplasm-syndrome-balance-of-probabilities-no-77-/important-cases","documents":"/api/acts/statement-of-principles-concerning-myelodysplastic-neoplasm-syndrome-balance-of-probabilities-no-77-/documents"}}