{"id":"F2020L01088","name":"Statement of Principles concerning aplastic anaemia (Balance of Probabilities) (No. 59 of 2020)","slug":"statement-of-principles-concerning-aplastic-anaemia-balance-of-probabilities-no-59-of-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440585,"registerId":"F2020L01088-fast-fetch-1775956160130","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning aplastic anaemia (Balance of Probabilities) (No. 59 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\nAPLASTIC ANAEMIA (Balance of Probabilities)\n\n(No. 59 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 28 August 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 Schedules\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\nSchedule 2 - Drugs\n\n1 Specified Drugs\n\n \n\n\n\n\n1 Name\n\nThis is the Statement of Principles concerning aplastic anaemia (Balance of Probabilities) (No. 59 of 2020).\n\n2 Commencement\n\n This instrument commences on 28 September 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 aplastic anaemia No. 51 of 2012 (Federal Register of Legislation No. F2012L01793) made under subsections 196B(3) and (8) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act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 Schedules\n\nAny item in a Schedule to this Instrument has effect according to its terms.\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n(1) This Statement of Principles is about aplastic anaemia and death from aplastic anaemia.\n\nMeaning of aplastic anaemia\n\n(2) For the purposes of this Statement of Principles, aplastic anaemia:\n\n(a) means bone marrow failure, characterised by:\n\n(i) destruction of haematopoietic stem cells with peripheral blood cytopaenia; and\n\n(ii) hypocellular bone marrow in which normal haematopoietic tissue is replaced by fatty marrow; and\n\n(b) excludes:\n\n(i) inherited bone marrow failure syndromes, including Fanconi anaemia, dyskeratosis congenita, Shwachman-Diamond syndrome and inherited amegakaryocytic thrombocytopaenia;\n\n(ii) isolated leukopaenia and isolated thrombocytopaenia;\n\n(iii) myelodysplastic syndrome;\n\n(iv) paroxysmal nocturnal haemoglobinuria; and\n\n(v) replacement of bone marrow due to fibrosis or an infiltrative neoplastic process.\n\n(3) While aplastic anaemia attracts ICD‑10‑AM code D61.1, D61.2, D61.3 or D61.8, in applying this Statement of Principles the meaning of aplastic anaemia 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 aplastic anaemia\n\n(5) For the purposes of this Statement of Principles, aplastic anaemia, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's aplastic anaemia.\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 aplastic anaemia and death from aplastic anaemia 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, aplastic anaemia or death from aplastic anaemia is connected with the circumstances of a person's relevant service:\n\n(1) being pregnant at the time of the clinical onset of aplastic anaemia;\n\n(2) being treated with a drug specified in the Schedule 2 - Drugs of this Instrument within the six months before the clinical onset of aplastic anaemia;\n\n(3) being treated with a drug which is associated in the individual with:\n\n(a) the development of aplastic anaemia within six months of drug therapy; and\n\n(b) the improvement of aplastic anaemia within six months of discontinuing or tapering drug therapy;\n\n(4) being exposed to benzene as specified on at least 45 days within the six months before the clinical onset of aplastic anaemia;\n\nNote: being exposed to benzene as specified is defined in the Schedule 1 - Dictionary. \n\n(5) inhaling, ingesting or having cutaneous contact with an organophosphate insecticide on at least 45 days within the six months before the clinical onset of aplastic anaemia;\n\n(6) having acute hepatitis within the one year before the clinical onset of aplastic anaemia;\n\n(7) having a liver transplant within the three months before the clinical onset of aplastic anaemia;\n\n(8) having an autoimmune disease from the specified list of autoimmune diseases within the two years before the clinical onset of aplastic anaemia;\n\nNote: specified list of autoimmune diseases is defined in the Schedule 1 - Dictionary. \n\n(9) having chronic lymphocytic leukaemia/small lymphocytic lymphoma or T-cell large granular lymphocytic leukaemia within the six months before the clinical onset of aplastic anaemia;\n\n(10) having a thymoma or thymic carcinoma before the clinical onset of aplastic anaemia;\n\n(11) being pregnant at the time of the clinical worsening of aplastic anaemia;\n\n(12) inability to obtain appropriate clinical management for aplastic anaemia.\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 factors set out in subsections 9(11) and 9(12) apply only to material contribution to, or aggravation of, aplastic anaemia where the person's aplastic anaemia 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 8-hour time-weighted average (TWA) means the averaging of different exposure levels to benzene during an average exposure period equivalent to eight hours.\n\n aplastic anaemia—see subsection 7(2).\n\n being exposed to benzene as specified means:\n\n(a) having cutaneous contact with liquids containing benzene greater than 1% by volume; or\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 (TWA) benzene concentration exceeding five parts per million.\n\nNote: 8-hour time-weighted average (TWA) is also defined in the Schedule 1 - Dictionary.\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\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 list of autoimmune diseases means:\n\n(a) ABO mismatched haematopoietic stem cell transplant;\n\n(b) eosinophilic fasciitis;\n\n(c) graft versus host disease;\n\n(d) hyperimmunoglobulinaemia;\n\n(e) hypoimmunoglobulinaemia; or\n\n(f) systemic lupus erythematosus.\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\n\nSchedule 2 - Drugs\n\nNote: See Section 6, Subsection 9(2)\n\n1 Specified Drugs\n\n \n\n| alkylating agents (including temozolomide, busulfan, dacarbazine, cyclophosphamide, melphalan hydrochloride and nitrogen mustard) | 2. allopurinol | 3. antimetabolite agents (including 6-mercaptopurine, fludarabine, fluouracil, methotrexate and pemetrexed) |\n| --- | --- | --- |\n| 4. arsenic | 5. azathioprine | 6. bismuth |\n| 7. carbamazepine | 8. carbimazole | 9. carbonic anhydrase inhibitors (including acetazolamide and methazolamide) |\n| 10. chloramphenicol | 11. chlordiazepoxide | 12. chloroquine |\n| 13. chlorpheniramine | 14. chlorthalidone | 15. cimetidine |\n| 16. dapsone | 17. daunorubicin | 18. d-penicillamine |\n| 19. ethosuximide | 20. felbamate | 21. fluoxetine |\n| 22. ganoderma | 23. gold | 24. hydantoins |\n| 25. imatinib | 26. immune checkpoint inhibitors (including nivolumab and pembrolizumab) | 27. indapamide |\n| 28. lamivudine | 29. leflunomide | 30. lenalidomide |\n| 31. linezolid | 32. mepacrine | 33. mercury |\n| 34. mesalamine | 35. methimazole, | 36. mycophenolate |\n| 37. nifedipine | 38. nizatidine | 39. osimertinib |\n| 40. phenytoin | 41. procainamide | 42. proguanil |\n| 43. propylthiouracil | 44. quinacrine | 45. sulphonamide antibiotics (including trimethoprim and sulfamethoxazole) and drugs containing sulphonamide antibiotics (including sulfasalazine) |\n| 46. sulphonylureas (including chlorpropamide and tolbutamide) | 47. thiazide diuretics | 48. ticlopidine |\n| 49. tocainide | 50. valganciclovir | 51. valproic acid |\n| 52. zidovudine | | |\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 instrument maintains the standard SOP structure and purpose established under the Veterans' Entitlements Act 1986. It replaces the 2012 version (No. 51 of 2012) with updated medical evidence but does not expand beyond the original scope of determining service connection for a specific disease. The 52 listed drugs and refined benzene exposure definitions reflect updated medical science rather than scope creep."},"complexity_factors":["Multiple cross-references to defined terms in Schedule 1 (8 defined terms including nested definitions like '8-hour time-weighted average' being used within 'being exposed to benzene as specified')","52 specified drugs listed in Schedule 2 requiring tabular presentation","Temporal requirements vary across factors (6 months, 1 year, 2 years, 3 months, or no time limit)","Exclusion clauses in the disease definition (5 specific exclusions in section 7(2))","Conditional logic in section 10(2) restricting application of two factors to aggravation cases only","Reference to external classification system (ICD-10-AM Tenth Edition) with specific ISBN and effective date","Incorporation by reference of other Statements of Principles for linked conditions (section 11)"],"plain_english_summary":"This Statement of Principles sets the medical test DVA uses to decide if aplastic anaemia in veterans and current/former defence members is linked to service. Replacing the 2012 SOP, it updates medical science and applies a \"balance of probabilities\" standard, identifying a set of medical and exposure-related factors that can establish service connection.\n\nNotably, pregnancy and lack of appropriate medical care can only help if the anaemia existed before or during service; inherited conditions are excluded."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"The instrument continues the same core function—setting medical criteria to determine whether aplastic anaemia or death from it is connected to relevant service for VEA/MRCA claims. It repeals the 2012 Statement (section 4) and updates specific factors, thresholds and lists (notably Schedule 2 and Schedule 1 definitions), but does not broaden or narrow the fundamental scope of establishing service‑connection under the Acts (sections 5 and 7)."},"complexity_factors":["Technical medical definition and exclusions for aplastic anaemia (section 7(2)): requires clinical, pathological specificity.","Multiple temporal windows and timing requirements for different factors (section 9: ranges from 3 months to 2 years for various items).","Detailed exposure thresholds for benzene (Schedule 1: >1% liquids; inhalation 8‑hour TWA >5 ppm) and minimum exposure duration (45 days) which require industrial/occupational measurement evidence.","Extensive, enumerated list of specified drugs that may trigger causation findings (Schedule 2), creating large pharmaceutical-evidence burden.","Interplay with other Statements of Principles where factors refer to other injuries/diseases (section 11) increases cross-referencing complexity.","Requirement that any identified factor be related to the person’s defined relevant service (section 10), imposing evidentiary linkage to service records.","Inclusion of non‑medical system factors (e.g. inability to obtain appropriate clinical management) as possible contributors (section 9(12)), introducing social/administrative evidence issues.","Repeal and replacement of a prior instrument (section 4) means differences must be checked against the earlier text for claim evolution.","Use of statutory definitions (Schedule 1) and references to external standards (ICD‑10‑AM in section 7(4)) necessitate reference to other documents and codes."],"plain_english_summary":"This Statement of Principles sets the medical rules the Repatriation Medical Authority uses to decide whether aplastic anaemia (or death from it) is connected to a veteran’s or service member’s relevant service for entitlement claims. It replaces the earlier 2012 Statement and applies to claims under the VEA and MRCA.\n\nIt lists specific clinical and exposure factors (for example pregnancy at onset, certain drugs, benzene/organophosphate exposure, infections, autoimmune conditions, transplants and some cancers) and requires at least one such factor to be linked to the person’s relevant service, creating defined evidentiary and timing requirements for claimants and medical assessors."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-aplastic-anaemia-balance-of-probabilities-no-59-of-2020","history":"/api/acts/statement-of-principles-concerning-aplastic-anaemia-balance-of-probabilities-no-59-of-2020/history","analysis":"/api/acts/statement-of-principles-concerning-aplastic-anaemia-balance-of-probabilities-no-59-of-2020/analysis","conflicts":"/api/acts/statement-of-principles-concerning-aplastic-anaemia-balance-of-probabilities-no-59-of-2020/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-aplastic-anaemia-balance-of-probabilities-no-59-of-2020/important-cases","documents":"/api/acts/statement-of-principles-concerning-aplastic-anaemia-balance-of-probabilities-no-59-of-2020/documents"}}