{"id":"F2020L01083","name":"Statement of Principles concerning pure red cell aplasia (Reasonable Hypothesis) (No. 60 of 2020)","slug":"statement-of-principles-concerning-pure-red-cell-aplasia-reasonable-hypothesis-no-60-of-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440582,"registerId":"F2020L01083-fast-fetch-1775956158003","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 (Reasonable Hypothesis) (No. 60 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 (Reasonable Hypothesis)\n\n(No. 60 of 2020)\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 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 (Reasonable Hypothesis) (No. 60 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(2) of the Veterans' Entitlements Act 1986.\n\n4 Repeal\n\nThe Statement of Principles concerning aplastic anaemia No. 50 of 2012 (Federal Register of Legislation No. F2012L01791) made under subsections 196B(2) and (8) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act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 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\nThe Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that pure red cell aplasia and death from pure red cell aplasia 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 pure red cell aplasia or death from pure red cell aplasia 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 one year 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) taking a non-aspirin, nonsteroidal, anti-inflammatory drug on at least four days per week for a continuous period of at least four weeks, within the one year before the clinical onset of pure red cell aplasia;\n\n(5) being exposed to benzene as specified on at least 30 days within the one year 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(6) having acute hepatitis within the one year before the clinical onset of pure red cell aplasia;\n\n(7) having a liver transplant within the six months before the clinical onset of pure red cell aplasia;\n\n(8) having an autoimmune disease from the specified list of autoimmune disease 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(9) having a haematological malignancy from the specified list of haematological malignancies within the six months before the clinical onset of pure red cell aplasia;\n\nNote: specified list of haematological malignancies is defined in the Schedule 1 - Dictionary.\n\n(10) having a thymoma or thymic carcinoma before the clinical onset of pure red cell aplasia;\n\n(11) having an infection with parvovirus B19 or acute infectious mononucleosis within the six months before the clinical onset of pure red cell aplasia;\n\n(12) being pregnant at the time of the clinical worsening of pure red cell aplasia;\n\n(13) 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(12) and 9(13) 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(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 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) 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 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) coeliac disease;\n\n(c) eosinophilic fasciitis;\n\n(d) graft versus host disease;\n\n(e) hyperimmunoglobulinaemia;\n\n(f) hypoimmunoglobulinaemia; or\n\n(g) systemic lupus erythematosus.\n\n specified list of haematological malignancies means:\n\n(a) chronic lymphocytic leukaemia/small lymphocytic lymphoma;\n\n(b) Hodgkin's lymphoma;\n\n(c) non-Hodgkin lymphoma; or\n\n(d) T-cell large granular lymphocytic leukaemia.\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. chloroquine | 9. clopidogrel |\n| 10. clozapine | 11. dapsone | 12. deferasirox |\n| 13. d-penicillamine | 14. gold | 15. hydantoins |\n| 16. immune checkpoint inhibitors (including nivolumab, pembrolizumab) | 17. interferon alfa-2 and peg-interferon alfa-2 | 18. ipilimumab |\n| 19. isoniazid | 20. lamivudine | 21. lamotrigine |\n| 22. leuprolide | 23. linezolid | 24. methyldopa |\n| 25. mycophenolate | 26. peg-interferon alfa-2 | 27. phenytoin |\n| 28. procainamide | 29. recombinant erythropoietin | 30. ribavirin |\n| 31. rifampicin | 32. sulphonamide antibiotics (including trimethoprim, sulfamethoxazole) and drugs containing sulphonamide antibiotics (including sulfasalazine) | 33. sulphonylureas (including chlorpropamide, tolbutamide) |\n| 34. tacrolimus | 35. ticlopidine | 36. valproic acid |\n| 37. zidovudine | | |\n\n\n \n","sortOrder":0}],"analysis":{"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"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument appears consistent with its original purpose. It replaces a 2012 Statement of Principles concerning aplastic anaemia with a more specific instrument focused on pure red cell aplasia. The scope remains tightly focused on establishing medical connection factors for a specific haematological condition in the veterans' compensation context."},"complexity_factors":["Multiple defined terms in Schedule 1 (8-hour TWA, terminal event, relevant service, etc.) requiring cross-reference","Specific drug list of 37 medications in Schedule 2 with varying chemical classes","Time-bound conditions varying by factor (6 months, 1 year, 2 years, or no time limit)","Nested definitions (e.g., 'being exposed to benzene as specified' requires understanding of '8-hour time-weighted average')","Exclusions in the disease definition (congenital Diamond-Blackfan anaemia, myelodysplastic syndrome, paroxysmal nocturnal haemoglobinuria)","Conditional application in section 10(2) where two factors only apply to aggravation of pre-existing conditions","Cross-reference mechanism in section 11 linking to other Statements of Principles","Dual statutory framework application (VEA and MRCA with different service definitions)"],"plain_english_summary":"This instrument sets medical rules for deciding when pure red cell aplasia is service-related for Australian Defence Force members and veterans under the VEA and MRCA. It identifies 13 medical/exposure factors—e.g., specific drugs, benzene exposure, infections (hepatitis, parvovirus B19), autoimmune disorders, certain cancers or thymus tumours, pregnancy, and lack of timely treatment—that create a “reasonable hypothesis” linking the disease to relevant service; if met, the benefit of the doubt favors the veteran."},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":true,"description":"This instrument repeals the earlier Statement of Principles concerning aplastic anaemia No.50 of 2012 (s4) and replaces it with a Statement limited to pure red cell aplasia (PRCA) defined in s7(2)-(4). That change narrows and restates the medical scope (specific exclusions listed), introduces a detailed drug list (Schedule 2), precise exposure thresholds (Schedule 1) and new temporal linkage rules for factors (s9). It applies to claims under section 120A of the VEA and section 338 of the MRCA (s5), and limits application of factors 9(12) and 9(13) to material contribution/aggravation where PRCA existed before or during relevant service (s10(2))."},"complexity_factors":["Narrow clinical definition with specific exclusions (pure red cell aplasia defined and exclusions listed) (s7(2)-(4))","Extensive, named list of implicated drugs in Schedule 2 requiring medical history review (Schedule 2)","Multiple, different exposure and time windows for factors (e.g. 1 year, 6 months, 2 years) increasing evidentiary complexity (s9)","Quantitative benzene exposure threshold and exposure modes (cutaneous, ingestion, inhalation with 8‑hour TWA >5 ppm) requiring occupational/industrial hygiene evidence (Schedule 1)","Cross‑references to other Statements of Principles so overlapping diseases require application of other instruments (s11)","Different legal relationships to service depending on whether condition arose before/during service (material contribution/aggravation rules; s10 and s9(12)-(13))","Replaces earlier aplastic anaemia Statement (repeal) which changes which conditions/claims are governed by this instrument (s4)","Applies specifically to claims covered by particular statutory sections (section 120A VEA and section 338 MRCA), so administrative claim pathways and decision‑makers are specified (s5)","Terminology and medical categories (autoimmune disease list, haematological malignancies, terminal events) require interpretation against schedules and clinical records (Schedule 1)"],"plain_english_summary":"This instrument, made by the Repatriation Medical Authority, sets the medical criteria used to decide when pure red cell aplasia (PRCA) or death from PRCA can be connected to a person's military or peacekeeping service for VEA/MRCA claims. It defines PRCA, excludes certain conditions, and lists specific risk factors (drugs, exposures, infections, illnesses and time windows) that, if present and linked to relevant service, raise a reasonable hypothesis that PRCA is service‑related."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-reasonable-hypothesis-no-60-of-2020","history":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-reasonable-hypothesis-no-60-of-2020/history","analysis":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-reasonable-hypothesis-no-60-of-2020/analysis","conflicts":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-reasonable-hypothesis-no-60-of-2020/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-reasonable-hypothesis-no-60-of-2020/important-cases","documents":"/api/acts/statement-of-principles-concerning-pure-red-cell-aplasia-reasonable-hypothesis-no-60-of-2020/documents"}}