{"id":"F2020L01084","name":"Statement of Principles concerning pure red cell aplasia (Balance of Probabilities) (No. 61 of 2020)","slug":"statement-of-principles-concerning-pure-red-cell-aplasia-balance-of-probabilities-no-61-of-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440581,"registerId":"F2020L01084-fast-fetch-1775956158001","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning pure red cell aplasia (Balance of Probabilities) (No. 61 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\nPURE RED CELL APLASIA (Balance of Probabilities)\n\n(No. 61 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 pure red cell aplasia (Balance of Probabilities) (No. 61 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No. 51 of 2012 (Federal Register of Legislation No. F2012L01793) made under subsections 196B(3) and (8) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act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 pure red cell aplasia and death from pure red cell aplasia.\n\nMeaning of pure red cell aplasia\n\n(2) For the purposes of this Statement of Principles, pure red cell aplasia:\n\n(a) means complete or nearly complete cessation of red cell production in the bone marrow without effects on other haematopoietic cells and characterised by anaemia, reticulocytopaenia and absent or rare erythroid precursor cells in the bone marrow; and\n\n(b) excludes:\n\n(i) congenital Diamond-Blackfan anaemia;\n\n(ii) myelodysplastic syndrome; and\n\n(iii) paroxysmal nocturnal haemoglobinuria.\n\n(3) While pure red cell aplasia attracts ICD‑10‑AM code D60, in applying this Statement of Principles the meaning of pure red cell aplasia 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 pure red cell aplasia\n\n(5) For the purposes of this Statement of Principles, pure red cell aplasia, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's pure red cell aplasia.\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 pure red cell aplasia and death from pure red cell aplasia 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, pure red cell aplasia or death from pure red cell aplasia is connected with the circumstances of a person's relevant service:\n\n(1) being pregnant at the time of the clinical onset of pure red cell aplasia;\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 pure red cell aplasia;\n\n(3) being treated with a drug which is associated in the individual with:\n\n(a) the development of pure red cell aplasia within six months of drug therapy; and\n\n(b) the improvement of pure red cell aplasia 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 pure red cell aplasia;\n\nNote: being exposed to benzene as specified is defined in the Schedule 1 - Dictionary. \n\n(5) having acute hepatitis within the one year before the clinical onset of pure red cell aplasia;\n\n(6) having a liver transplant within the three months before the clinical onset of pure red cell aplasia;\n\n(7) having an autoimmune disease from the specified list of autoimmune diseases within the two years before the clinical onset of pure red cell aplasia;\n\nNote: specified list of autoimmune diseases is defined in the Schedule 1 - Dictionary.\n\n(8) having chronic lymphocytic leukaemia/small lymphocytic lymphoma or T-cell large granular lymphocytic leukaemia within the six months before the clinical onset of pure red cell aplasia;\n\n(9) having a thymoma or thymic carcinoma before the clinical onset of pure red cell aplasia;\n\n(10) having an infection with parvovirus B19 within the six months before the clinical onset of pure red cell aplasia;\n\n(11) being pregnant at the time of the clinical worsening of pure red cell aplasia;\n\n(12) inability to obtain appropriate clinical management for pure red cell aplasia.\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, pure red cell aplasia where the person's pure red cell aplasia 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 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 defined in the Schedule 1 - Dictionary. \n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n pure red cell aplasia—see subsection 7(2).\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, nitrogen mustard) | 2. allopurinol | 3. antimetabolite agents (including 6-mercaptopurine, fludarabine, fluouracil, methotrexate, pemetrexed) |\n| --- | --- | --- |\n| 4. azathioprine | 5. carbamazepine | 6. carbonic anhydrase inhibitors (including acetazolamide, methazolamide) |\n| 7. chloramphenicol | 8. dapsone | 9. d-penicillamine |\n| 10. gold | 11. hydantoins | 12. immune checkpoint inhibitors (including nivolumab, pembrolizumab) |\n| 13. isoniazid | 14. lamivudine | 15. linezolid |\n| 16. mycophenolate | 17. phenytoin | 18. procainamide |\n| 19. recombinant erythropoietin | 20. sulphonamide antibiotics (including trimethoprim, sulfamethoxazole) and drugs containing sulphonamide antibiotics (including sulfasalazine) | 21. sulphonylureas (including chlorpropamide, tolbutamide) |\n| 22. valproic acid | 23. zidovudine | |\n\n\n \n\n \n\n \n\n \n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument maintains the standard scope of Repatriation Medical Authority Statements of Principles. It replaces a 2012 instrument concerning aplastic anaemia with a more specific focus on pure red cell aplasia, reflecting updated medical understanding rather than scope creep. The structure follows the standard template for RMA Statements of Principles with definitions, factors, schedules, and application provisions consistent with the legislative framework under section 196B(3) of the Veterans' Entitlements Act 1986."},"complexity_factors":["Moderate cross-referencing between sections (e.g., section 9 factors reference Schedule 1 definitions and Schedule 2 drug lists)","12 distinct causal factors with varying time windows (ranging from 3 months to 2 years before clinical onset)","Nested definitions requiring lookup (e.g., 'being exposed to benzene as specified' requires checking Schedule 1 for technical exposure thresholds)","Specific technical medical terminology throughout (ICD-10-AM codes, haematopoietic cells, reticulocytopaenia)","Conditional logic in section 10 distinguishing between causation vs aggravation of pre-existing conditions","23 specified drugs listed in tabular format in Schedule 2 with some grouped by class (e.g., 'alkylating agents') and others individual","Exclusion clauses in the disease definition (subsection 7(2)(b)) excluding congenital and related conditions"],"plain_english_summary":"This instrument sets the medical rules the Repatriation Medical Authority uses to decide, on the balance of probabilities, whether pure red cell aplasia (or death from it) is connected to military service. It replaces a prior statement and specifies 12 medical connecting factors (e.g. certain drugs, benzene exposure, infections, cancers, pregnancy, inadequate treatment).\n\nIt affects veterans and Defence members claiming under veterans’ compensation law and functions as the gatekeeper for entitlement to benefits."},"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"},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"Yes. The instrument repeals the earlier Statement of Principles concerning aplastic anaemia No. 51 of 2012 (s4) and replaces it with a Statement confined to 'pure red cell aplasia' as narrowly defined with specific exclusions (s7(2)-(3)). This narrows diagnostic scope compared with the repealed instrument and clarifies the list of service‑related factors claimants must show; it applies only to claims under the VEA or MRCA (s5)."},"complexity_factors":["Precise medical definition and explicit exclusions for PRCA (s7(2)-(3))","Multiple temporally‑limited causal factors each with different time windows (s9)","Long, heterogeneous list of specified drugs requiring clinical linkage (Schedule 2; s9(2))","Technical benzene‑exposure threshold and measurement method (Schedule 1 definitions; s9(4))","Cross‑references to other Statements of Principles where overlap exists (s11)","Replacement of an earlier instrument changing diagnostic scope (s4)","Limited application to claims under VEA s120B and MRCA s339, affecting claimant pool (s5)","Standard of proof set as 'more probable than not' based on medical‑scientific evidence (s8)","Different treatment of factors for pre‑existing conditions (material contribution/aggravation) (s10(2))"],"plain_english_summary":"This instrument sets the medical criteria used to decide, on the balance of probabilities, whether pure red cell aplasia (PRCA) or death from PRCA is connected to a veteran's or service member's relevant service. It lists required factors (medical conditions, specified drugs, benzene exposure, infections, pregnancy) with specific time windows, and repeals the prior aplastic anaemia statement.\n\nIt affects people claiming under the VEA or MRCA because meeting one listed factor tied to service determines entitlement decisions and sets the evidentiary timing required."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-balance-of-probabilities-no-61-of-2020","history":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-balance-of-probabilities-no-61-of-2020/history","analysis":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-balance-of-probabilities-no-61-of-2020/analysis","conflicts":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-balance-of-probabilities-no-61-of-2020/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-balance-of-probabilities-no-61-of-2020/important-cases","documents":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-balance-of-probabilities-no-61-of-2020/documents"}}