{"id":"F2018L00195","name":"Statement of Principles concerning systemic sclerosis (Balance of Probabilities) (No. 26 of 2018)","slug":"statement-of-principles-concerning-systemic-sclerosis-balance-of-probabilities-no-26-of-2018","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":439501,"registerId":"F2018L00195-fast-fetch-1775955505930","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning systemic sclerosis (Balance of Probabilities) (No. 26 of 2018)","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\nSYSTEMIC SCLEROSIS (Balance of Probabilities)\n\n(No. 26 of 2018)\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 2 March 2018\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 Revocation\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 systemic sclerosis (Balance of Probabilities) (No. 26 of 2018).\n\n2 Commencement\n\n This instrument commences on 2 April 2018.\n\n3 Authority\n\nThis instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n4 Revocation\n\nThe Statement of Principles concerning systemic sclerosis No. 65 of 2009 made under subsection 196B(3) of the VEA is revoked.\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 systemic sclerosis and death from systemic sclerosis.\n\nMeaning of systemic sclerosis\n\n(2) For the purposes of this Statement of Principles, systemic sclerosis (also known as scleroderma):\n\n(a) means an autoimmune, fibrosing connective tissue disorder characterised by deposition of collagen in skin and internal organs, and microvascular lesions, especially in the skin, lungs and kidneys; and\n\n(b) excludes localised sclerosis, graft versus host disease with dermal fibrosis, and scleroderma-like conditions (for example, scleromyxoedema and eosinophilic fasciitis).\n\nNote 1: The three main subsets of systemic sclerosis are limited cutaneous systemic sclerosis (previously referred to as CREST syndrome, comprising calcinosis cutis, Raynaud phenomenon, oesophageal dysmotility, sclerodactyly, telangiectasias), diffuse cutaneous systemic sclerosis and systemic sclerosis sine scleroderma.\n\nNote 2: The diagnosis of systemic sclerosis is based on clinical findings, although histopathologic confirmation is sometimes needed to rule out other diseases. Serological markers for systemic sclerosis include elevated levels of anticentromere antibodies and anti-Scl-70 antibodies.\n\n(3) While systemic sclerosis attracts ICD‑10‑AM code M34, in applying this Statement of Principles the meaning of systemic sclerosis 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 systemic sclerosis\n\n(5) For the purposes of this Statement of Principles, systemic sclerosis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's systemic sclerosis.\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 systemic sclerosis and death from systemic sclerosis 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, systemic sclerosis or death from systemic sclerosis is connected with the circumstances of a person's relevant service:\n\n(1) inhaling respirable crystalline silica dust, at the time material containing crystalline silica was being:\n\n(a) produced;\n\n(b) excavated;\n\n(c) drilled, cut or ground; or\n\n(d) used in construction, manufacturing, cleaning or blasting,\n\nfor a cumulative period of at least 5 000 hours before the clinical onset of systemic sclerosis;\n\n(2) being treated with bleomycin at the time of the clinical onset of systemic sclerosis;\n\n(3) inhaling, ingesting or having cutaneous contact with trichloroethylene for a cumulative period of at least 5 000 hours within a period of ten consecutive years, before the clinical onset of systemic sclerosis;\n\n(4) inhaling respirable crystalline silica dust, at the time material containing crystalline silica was being:\n\n(a) produced;\n\n(b) excavated;\n\n(c) drilled, cut or ground; or\n\n(d) used in construction, manufacturing, cleaning or blasting,\n\nfor a cumulative period of at least 5 000 hours before the clinical worsening of systemic sclerosis;\n\n(5) being treated with bleomycin at the time of the clinical worsening of systemic sclerosis;\n\n(6) inhaling, ingesting or having cutaneous contact with trichloroethylene for a cumulative period of at least 5 000 hours within a period of ten consecutive years, before the clinical worsening of systemic sclerosis;\n\n(7) for clinical worsening of systemic sclerosis manifesting as scleroderma renal crisis only, being treated with 15 milligrams or more per day of prednisone, or equivalent oral glucocorticoid therapy, for a period of at least four weeks within the six months before the clinical worsening of systemic sclerosis;\n\nNote: equivalent oral glucocorticoid therapy and scleroderma renal crisis are defined in the Schedule 1 - Dictionary.\n\n(8) inability to obtain appropriate clinical management for systemic sclerosis.\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(4) to 9(8) apply only to material contribution to, or aggravation of, systemic sclerosis where the person's systemic sclerosis 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 equivalent oral glucocorticoid therapy means a glucocorticoid in the following table, at the doses specified in the table, or a therapeutically equivalent dose of another glucocorticoid:\n\n| Glucocorticoid | Minimum average
rate (milligrams/day) |\n| --- | --- |\n| cortisone | 75 |\n| hydrocortisone | 60 |\n| prednisone | 15 |\n| prednisolone | 15 |\n\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 scleroderma renal crisis means a disorder characterised by the abrupt onset of marked hypertension, rapidly progressive renal failure due to thrombotic microangiopathy vasospasm, and tissue ischaemia. Up to 10 percent of patients with scleroderma renal crisis are normotensive, although their blood pressure may be increased from baseline values.\n\n systemic sclerosis—see subsection 7(2).\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":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"This 2018 Statement replaces the 2009 Statement (section 4) and primarily updates and clarifies the medical and exposure criteria (for example, explicit 5,000‑hour thresholds for silica and trichloroethylene exposure, inclusion of bleomycin and a defined glucocorticoid threshold for scleroderma renal crisis, and the \"inability to obtain appropriate clinical management\" factor). These are technical refinements and restatements of the original purpose — to specify when systemic sclerosis can be connected to service for compensation law — rather than a material expansion beyond that original statutory purpose. The instrument therefore changes detail and evidentiary thresholds but does not, on its face, broaden the fundamental scope of what the Statement is meant to decide."},"complexity_factors":["Single substantive Part setting out disease definition, causal factors, and application (concise structure)","Approximately 7 defined terms in Schedule 1 (equivalent oral glucocorticoid therapy, MRCA, relevant service, scleroderma renal crisis, systemic sclerosis, terminal event, VEA)","Eight numbered causal factors in section 9 with several numeric thresholds (5,000 hours; 10‑year window; prednisone 15 mg/day; 4‑week/6‑month timing)","Conditional logic linking onset vs clinical worsening and service timing (section 10(2))","Cross‑references to other Statements of Principles (section 11) and to external classification (ICD‑10‑AM) (section 7(3)–(4))","Revocation of an earlier Statement (section 4) — requires comparing prior instrument for full effect","A small equivalence table in the Schedule that sets out specific dose equivalencies (adds technical detail)"],"plain_english_summary":"**What this instrument does (mechanics)\n\n- This is a \"Statement of Principles\" that sets out the medical and exposure conditions under which systemic sclerosis (scleroderma) — and death from it — can be regarded as connected with a person's military or defence service for the purposes of veterans' compensation law. (See sections 3, 5 and 7.)\n\n- It does not itself pay benefits. Instead, decision‑makers who determine claims under the Veterans' Entitlements Act 1986 (VEA) or the Military Rehabilitation and Compensation Act 2004 (MRCA) use these medical findings to decide whether systemic sclerosis was caused by, contributed to, or aggravated by relevant service. (See section 5 and section 8.)\n\n**Who it affects\n\n- Veterans, former members of the Australian Defence Force, or current members whose claims are considered under the VEA or MRCA (section 5). \n- Medical assessors and the Department/agency that decides entitlement and pays benefits (they apply these criteria when deciding claims). \n\n**The legal test and the medical criteria\n\n- The standard of proof the Authority records is the \"balance of probabilities\" (i.e. more likely than not) (title and section 8). \n- A claimant needs at least one of the specific factors listed in section 9 to be present and to be related to the person's relevant service (section 10). Key factors include:\n - Long cumulative exposure to respirable crystalline silica dust (at least 5,000 hours before clinical onset or before clinical worsening) while producing, excavating, drilling/cutting/grinding or using silica‑containing material in work such as construction, manufacturing, cleaning or blasting (section 9(1) and 9(4)).\n - Treatment with the cancer drug bleomycin at the time of clinical onset or clinical worsening (sections 9(2) and 9(5)).\n - Long cumulative exposure (at least 5,000 hours within ten consecutive years) to trichloroethylene by inhalation, ingestion or skin contact, before clinical onset or worsening (sections 9(3) and 9(6)).\n - For clinical worsening that presents as scleroderma renal crisis, prior use of at least 15 mg/day prednisone (or an equivalent glucocorticoid dose) for at least four weeks within the six months before worsening (section 9(7) and the equivalence table in the Schedule).\n - \"Inability to obtain appropriate clinical management\" for systemic sclerosis as a factor for clinical worsening (section 9(8)).\n- Section 10 requires that any listed factor be related to the person's relevant service; subsections 9(4)–9(8) only apply where systemic sclerosis was suffered or contracted before or during (but not as a result of) the person's relevant service (section 10(2)).\n- The instrument also cross‑refers to other Statements of Principles where a listed factor is an injury or disease already covered by another Statement (section 11).\n\n**Definitions and technical detail\n\n- The Schedule provides definitions such as what counts as systemic sclerosis, scleroderma renal crisis, relevant service, and the table of equivalent oral glucocorticoid doses used to set the prednisone threshold (Schedule 1).\n- The Statement replaces (revokes) the prior Statement on systemic sclerosis from 2009 (section 4).\n\n**Why it matters (official claim and practical effects)\n\n- Official claim: the Repatriation Medical Authority records that, based on available medical‑scientific evidence, it is \"more probable than not\" that systemic sclerosis can be related to relevant service (section 8). \n- Practical effect: if a claimant can establish one of the listed causal factors, and link it to their relevant service, the medical presumption in this Statement will make it materially easier for claim decision‑makers to find a service connection when determining entitlement to compensation or liability for medical treatment under the VEA or MRCA (sections 5 and 8).\n\n**Implementation, evidence and administrative consequences (costs, incentives, trade‑offs)\n\n- Who pays: if a claim succeeds, compensation and treatment liabilities are met by the Commonwealth through the responsible veterans' schemes; this instrument affects how those liabilities are assessed (sections 5 and 8).\n- Who decides: the Repatriation Medical Authority issues the Statement (section 3); claims are decided by the appropriate decision‑maker under the VEA or MRCA using these criteria (section 5). \n- Evidence burden and compliance costs: several factors require documentary proof that can be hard to assemble — e.g. proving a cumulative 5,000 hours of exposure to silica or trichloroethylene, or exact timing of clinical onset or clinical worsening (section 9). This raises administrative workload for claimants and for decision‑makers, and increases the chance of disputes about facts (dates, exposure amounts, treatment records). \n- Bureaucratic discretion and interpretive gaps: some terms are precise (5,000‑hour thresholds, drug dose levels), reducing medical discretion; other items — notably \"inability to obtain appropriate clinical management\" — are less defined and will require evaluative judgement by decision‑makers, producing room for argument and variable outcomes (section 9(8) and Schedule definitions). \n- Cross‑claims and overlap: section 11 requires application of other Statements of Principles where exposures intersect with other covered diseases, so claimants and decision‑makers must check for overlap and apply the most relevant Statement. \n- Trade‑offs: the Statement trades off broader medical discretion for more explicit, evidence‑based thresholds (which can both streamline some decisions and impose stricter documentary requirements). It both narrows some routes to entitlement (by requiring specific exposures/timings) and clarifies others (by listing them explicitly). \n\n**Concrete behavioural effects\n\n- Claimants are incentivised to document past occupational exposures, dates of symptom onset/worsening, and treatment histories. \n- Decision‑makers are directed to apply the specified factors; where a factor is met, the Statement makes a service connection more probable on the balance of probabilities. \n- Medical practitioners and record‑holders may face more requests for precise documentation of exposures and medication histories.\n\n**Source citations (key provisions):** authority and application (sections 3–5); disease definition and exclusions (section 7); evidentiary basis (section 8); factors and thresholds (section 9); relation to service (section 10); cross‑reference to other Statements (section 11); Schedule definitions and glucocorticoid equivalence (Schedule 1)."},"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 maintains the established scope of Repatriation Medical Authority Statements of Principles. It updates the 2009 version with current medical evidence and revised ICD-10-AM coding references, but does not expand beyond the traditional function of determining service connection for specific diseases under veterans' compensation legislation. The structure — covering both onset and aggravation factors with defined exposure thresholds — follows the standard template for such instruments."},"complexity_factors":["Moderate cross-referencing between the main instrument and Schedule 1 (Dictionary)","Precise quantitative thresholds requiring calculation (5,000 hours cumulative exposure, 10-year windows, 15mg/day steroid dosing, 4-week and 6-month timeframes)","Dual application structure — factors apply differently to 'clinical onset' versus 'clinical worsening' with specific exclusions in section 10(2)","Nested conditional logic in section 9(7) limiting application to specific disease manifestation (scleroderma renal crisis only)","Technical medical terminology requiring definition (e.g., 'trichloroethylene', 'bleomycin', 'glucocorticoid equivalency')","Incorporation by reference to ICD-10-AM Tenth Edition with specific ISBN and effective date","Interplay with other Statements of Principles via section 11 (dynamic referencing 'as in force from time to time')","Specific exclusion of related conditions in the definition (localized sclerosis, graft versus host disease, scleromyxoedema, eosinophilic fasciitis)"],"plain_english_summary":"This Statement of Principles sets the medical and exposure criteria used to decide, on the balance of probabilities, whether systemic sclerosis (scleroderma) in Australian veterans and defence personnel is connected to their service. It updates prior guidance and applies to new claims and to worsening of an existing condition.\n\nIt matters because the Department of Veterans’ Affairs and tribunals use it to determine entitlement: if a veteran’s service included implicated exposures or treatment and a clinician links those to the disease, they may gain compensation or support."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-systemic-sclerosis-balance-of-probabilities-no-26-of-2018","history":"/api/acts/statement-of-principles-concerning-systemic-sclerosis-balance-of-probabilities-no-26-of-2018/history","analysis":"/api/acts/statement-of-principles-concerning-systemic-sclerosis-balance-of-probabilities-no-26-of-2018/analysis","conflicts":"/api/acts/statement-of-principles-concerning-systemic-sclerosis-balance-of-probabilities-no-26-of-2018/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-systemic-sclerosis-balance-of-probabilities-no-26-of-2018/important-cases","documents":"/api/acts/statement-of-principles-concerning-systemic-sclerosis-balance-of-probabilities-no-26-of-2018/documents"}}