{"id":"F2018L00016","name":"Statement of Principles concerning hepatitis C (Reasonable Hypothesis) (No. 13 of 2018)","slug":"statement-of-principles-concerning-hepatitis-c-reasonable-hypothesis-no-13-of-2018","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":439452,"registerId":"F2018L00016-fast-fetch-1775955471926","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning hepatitis C (Reasonable Hypothesis) (No. 13 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\nHEPATITIS C (Reasonable Hypothesis)\n\n(No. 13 of 2018)\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 22 December 2017\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 hepatitis C (Reasonable Hypothesis) (No. 13 of 2018).\n\n2 Commencement\n\n This instrument commences on 29 January 2018.\n\n3 Authority\n\nThis instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.\n\n4 Revocation\n\nThe Statement of Principles concerning hepatitis C No. 54 of 2008, made under subsection 196B(2) of the VEA is revoked.\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 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 hepatitis C and death from hepatitis C.\n\nMeaning of hepatitis C\n\n(2) For the purposes of this Statement of Principles, hepatitis C means infection with the hepatitis C virus resulting in:\n\n(a) an acute, symptomatic, clinical illness characterised by inflammation of the liver, and which is confirmed by laboratory testing for hepatitis C serological or nucleic acid markers; or\n\n(b) a chronic infection of at least six months duration, and which is confirmed by laboratory testing for hepatitis C nucleic acid markers.\n\nNote 1: Acute hepatitis C infection is commonly accompanied by fever, tiredness, loss of appetite, nausea, vomiting, abdominal discomfort and jaundice.\n\nNote 2: Chronic hepatitis C infection may involve both inflammation of the liver and the development of fibrosis in the longer term.\n\n(3) While hepatitis C attracts ICD‑10‑AM code B17.1 or B18.2, in applying this Statement of Principles the meaning of hepatitis C 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 hepatitis C\n\n(5) For the purposes of this Statement of Principles, hepatitis C, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's hepatitis C.\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 hepatitis C and death from hepatitis C 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 hepatitis C or death from hepatitis C with the circumstances of a person's relevant service:\n\n(1) being exposed to the hepatitis C virus at least one week before the clinical onset of hepatitis C;\n\nNote: being exposed to the hepatitis C virus is defined in the Schedule 1 - Dictionary. \n\n(2) being infected with the hepatitis A, hepatitis B, hepatitis D or hepatitis E virus before the clinical worsening of hepatitis C;\n\n(3) for chronic infection only:\n\n(a) being infected with human immunodeficiency virus before the clinical worsening of hepatitis C;\n\n(b) undergoing solid organ, stem cell or bone marrow transplantation before the clinical worsening of hepatitis C;\n\n(c) being treated with rituximab within the one year before the clinical worsening of hepatitis C;\n\n(d) for females only, consuming a total of at least 55 kilograms of alcohol within the ten years before the clinical worsening of hepatitis C;\n\nNote: Alcohol consumption is calculated utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink.\n\n(e) for males only, consuming a total of at least 70 kilograms of alcohol within the ten years before the clinical worsening of hepatitis C;\n\nNote: Alcohol consumption is calculated utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink.\n\n(f) smoking at least 15 pack-years of cigarettes, or the equivalent thereof in other tobacco products, within the 20 years before the clinical worsening of hepatitis C;\n\nNote: pack-years of cigarettes, or the equivalent thereof in other tobacco products is defined in the Schedule 1 - Dictionary. \n\n(g) being obese for at least the five years before the clinical worsening of hepatitis C;\n\nNote: being obese is defined in the Schedule 1 - Dictionary.\n\n(h) having severe hepatic iron overload at the time of the clinical worsening of hepatitis C; or\n\nNote: iron overload is defined in the Schedule 1 - Dictionary. \n\n(i) having evidence of chronic infection with schistosomiasis involving the liver before the clinical worsening of hepatitis C;\n\n(4) inability to obtain appropriate clinical management for hepatitis C.\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(2) to 9(4) apply only to material contribution to, or aggravation of, hepatitis C where the person's hepatitis C 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 being exposed to the hepatitis C virus means:\n\n(a) having percutaneous exposure (intravenous, intramuscular, subcutaneous or intradermal) or permucosal exposure to a specified body substance which is derived from a person infected with the hepatitis C virus; or\n\n(b) having a tissue or organ transplant, where the tissue or organ is derived from a person infected with the hepatitis C virus.\n\nNote: specified body substance is also defined in the Schedule 1 - Dictionary.\n\n being obese means having a Body Mass Index (BMI) of 30 or greater.\n\n Note: BMI is also defined in the Schedule 1 - Dictionary.\n\n BMI means W/H2 where:\n\nW is the person's weight in kilograms; and\n\nH is the person's height in metres.\n\n hepatitis C—see subsection 7(2).\n\n iron overload means an accumulation of excess iron in tissues and organs which has been confirmed by elevated ferritin or transferrin saturation levels. \n\nNote: Causes include haemochromatosis or blood transfusions.\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n pack-years of cigarettes, or the equivalent thereof in other tobacco products means a calculation of consumption where one pack-year of cigarettes equals 20 tailor-made cigarettes per day for a period of one calendar year, or 7 300 cigarettes. One tailor-made cigarette approximates one gram of tobacco or one gram of cigar or pipe tobacco by weight. One pack-year of tailor-made cigarettes equates to 7.3 kilograms of smoking tobacco by weight. Tobacco products mean cigarettes, pipe tobacco or cigars, smoked alone or in any combination.\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 body substance means:\n\n(a) blood, blood products or any body fluid containing blood; or\n\n(b) semen or vaginal secretions.\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 \n\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"},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"This 2018 Statement of Principles replaces the 2008 SOP and refines the medical and evidentiary criteria. Compared with a generic 2008 standard, this version introduces or clarifies several specific, measurable contributors (HIV co‑infection, prior organ/stem cell/bone marrow transplantation, rituximab within 1 year, quantified alcohol thresholds by sex, quantified smoking pack‑years, BMI threshold for obesity, defined iron overload, and inability to obtain appropriate clinical management). It also restates laboratory confirmation requirements and ties definitions to a specific ICD‑10‑AM edition. Those additions increase the instrument’s technical specificity and evidentiary demands, so the scope has shifted from a broader/less-specified test to a more granular, quantitatively‑expressed set of factors and timing rules (see sections 7, 9 and the Schedule)."},"complexity_factors":["Single disease focus (hepatitis C) limiting subject-matter complexity but with several medical sub-conditions (acute vs chronic)","11 defined or specially-used terms in Schedule 1 (e.g. being exposed to the hepatitis C virus, BMI, pack‑years, iron overload, terminal event, relevant service)","Several conditional branches in section 9: primary exposure factor (9(1)); co-infection factor (9(2)); multiple sub-factors for chronic infection (9(3) with 9 subclauses a–i); and a non-biological factor (9(4))","Cross-references to other instruments and statutes (VEA, MRCA, prior SOPs and other SOPs) — see sections 3, 4, 5 and 11","Quantified thresholds and objective measures (alcohol in kg, pack‑years, BMI ≥30, duration criteria such as 6 months for chronic infection) that require numerical calculations and historical data","Timing-based requirements (exposure at least one week before onset; chronic infection duration; contributors present before clinical worsening) creating evidentiary complexity","Limited but meaningful dependency on external medical standards/codes (ICD‑10‑AM reference) — section 7(3)","Layering risk where factors refer to other SOPs, requiring adjudicators to consult multiple Statements and reconcile criteria (section 11)"],"plain_english_summary":"**What this instrument does (mechanics)**\n\n- This is a Statement of Principles (SOP) made by the Repatriation Medical Authority (RMA) that sets out the factual and medical criteria that must be met before a \"reasonable hypothesis\" can be raised that hepatitis C (or death from hepatitis C) is connected to a veteran’s or serving member’s relevant service. (See sections 7, 8 and 9.)\n\n- If at least one of the listed medical or exposure factors is present and it can be related to the person’s relevant service, decision-makers may accept that the condition is plausibly connected to service for the purposes of veterans’ entitlements and compensation legislation. (See sections 9 and 10.)\n\n- The instrument replaces the earlier SOP for hepatitis C (revokes the 2008 instrument) and applies to claims under the Veterans’ Entitlements Act and the Military Rehabilitation and Compensation Act. (See sections 3–5 and 4.)\n\n\n**Who is affected**\n\n- Veterans, former and current members of the Australian Defence Force, and members of Peacekeeping Forces who lodge claims under the relevant veterans’ or military compensation provisions (those covered by the VEA or the MRCA). (See section 5 and the definition of \"relevant service\" in the Schedule.)\n\n- Medical practitioners and decision-makers within the Department of Veterans’ Affairs and claims-assessment bodies who must apply this SOP when assessing whether hepatitis C is related to service. (See sections 8–11.)\n\n\n**Key medical and factual requirements (how it works in practice)**\n\n- The SOP defines \"hepatitis C\" for claims purposes as either an acute laboratory‑confirmed clinical illness or a laboratory‑confirmed chronic infection of at least six months. (See section 7(2).)\n\n- At least one of the factors in section 9 must be present to raise the reasonable hypothesis. The principal factors include:\n - Documented exposure to hepatitis C virus at least one week before clinical onset (percutaneous or permucosal exposure, or an infected donor organ/tissue). (Section 9(1) and Schedule definitions.)\n - Co‑infection with other hepatitis viruses (A, B, D or E) before clinical worsening. (Section 9(2).)\n - For chronic infections, specified medical or behavioural contributors to clinical worsening: HIV co‑infection, prior organ/stem cell/bone marrow transplant, treatment with rituximab within 1 year, defined thresholds of alcohol use (female ≥55 kg of alcohol over 10 years; male ≥70 kg over 10 years), smoking ≥15 pack‑years in the prior 20 years, obesity (BMI ≥30) for at least 5 years, severe hepatic iron overload, or chronic schistosomiasis involving the liver. (Section 9(3).)\n - Failure or inability to obtain appropriate clinical management for hepatitis C. (Section 9(4).)\n\n- The factor(s) relied on must be related to the person’s relevant service (i.e., the exposure or contributor must have a connection to the service). For factors at subsections 9(2)–9(4), they apply only where the person’s hepatitis C was suffered or contracted before or during (but did not arise out of) the relevant service and are limited to material contribution or aggravation. (See section 10.)\n\n- If a factor refers to another injury/disease that already has an SOP, the other SOP’s factors also apply as they are in force. (See section 11.)\n\n\n**Why it matters (stated purpose and practical effect)**\n\n- The RMA states it has relied on medical‑scientific evidence to determine that hepatitis C can be related to relevant service. That is the stated legal basis for setting these factors. (Section 8.)\n\n- Practically, the SOP provides a tested checklist for claims assessors and medical panels: if the laboratory diagnosis plus at least one listed factor (and a link to service) are present, the threshold for a \"reasonable hypothesis\" that the condition is connected to service is met. Meeting that threshold allows claimants to proceed in the statutory compensation/entitlement process; failing to meet it means the claim will generally be rejected at that threshold.\n\n\n**Who pays, who decides, and what behaviour changes**\n\n- Who decides: the RMA sets the SOP; adjudicators (Department of Veterans’ Affairs and associated decision bodies) use it when assessing claims under the VEA and MRCA. (Sections 3, 5, 8–11.)\n\n- Who pays: if the SOP leads to a finding that the condition is service–connected under the VEA or MRCA, veterans’ or military compensation schemes (public funds administered under those Acts) will meet the entitlements/compensation as provided in those Acts. The SOP itself does not set payment rules — it supplies the medical test for connection.\n\n- Behaviour changes and compliance effects: claimants will generally need laboratory evidence of hepatitis C and evidence of the exposure or contributing factor(s) listed (medical records, treatment history, documented exposures). Medical practitioners may need to supply or record the specific tests and histories that map onto the SOP definitions (e.g. nucleic acid testing, ferritin/transferrin saturation for iron overload, BMI history, quantified alcohol/smoking histories). Decision-makers may shift resources toward obtaining these quantified data where previously a more qualitative assessment was used.\n\n\n**Implementation considerations, trade-offs and risks**\n\n- Evidence burden: the SOP sets objective thresholds (e.g. alcohol and smoking quantities, BMI, laboratory confirmation). This reduces discretion but increases the evidentiary burden on claimants and clinicians to document those thresholds (Sections 7, 9 and Schedule definitions).\n\n- Timing and medical complexity: the SOP distinguishes acute vs chronic infection, and for some factors requires the contributor to exist prior to clinical worsening. Determining the timing of infection, clinical onset, and worsening can be medically complex and may require retrospective interpretation of tests and records (Sections 7 and 9(2)–(3)).\n\n- Discrete, quantified thresholds: the inclusion of specific numerical thresholds (e.g. alcohol kilograms, pack‑years) makes the test more predictable but can exclude borderline cases; it also creates incentives to document or contest historical consumption estimates.\n\n- Administrative interaction with other SOPs: where a listed factor is itself an injury/disease covered by another SOP, adjudicators must apply that SOP too — creating potential layering of criteria and cross-referencing (Section 11). That increases interdependence between Statements of Principles.\n\n- Access to treatment considered: \"inability to obtain appropriate clinical management\" is accepted as a factor raising a reasonable hypothesis (Section 9(4)). This introduces a non‑biological criterion that requires adjudicators to assess access to care, which may depend on historical, geographic or systemic factors.\n\n\n**Concise practical takeaway**\n\nIf a claimant has laboratory‑confirmed hepatitis C (acute or chronic) and can show at least one of the specific exposure or contributing factors in section 9, and that factor can be connected to their relevant service, this SOP establishes a medical basis for raising a reasonable hypothesis that the condition is related to service. The instrument standardises what evidence decision-makers should look for, but it increases the need for quantified and time‑specific medical and exposure documentation."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument appears to maintain its original scope as a specific medical determination for hepatitis C under the veterans' compensation scheme. It replaces a 2008 version (No. 54 of 2008) with updated medical evidence and definitions, but does not expand beyond its purpose of establishing service connection factors for this specific disease."},"complexity_factors":["Multiple nested conditions: Factor 9(3) contains 9 sub-factors (a through i) that only apply to 'chronic infection only', creating a conditional structure within a conditional structure","Cross-referencing between instruments: Section 11 requires readers to consult other Statements of Principles if factors refer to diseases covered elsewhere, creating interdependence between documents","Gender-specific thresholds: Different alcohol consumption thresholds for males (70kg) and females (55kg) require careful parsing","Technical medical definitions: 12 defined terms in Schedule 1 including precise calculations (BMI formula, pack-year calculations with specific gram conversions)","Temporal requirements: Multiple time-bound conditions ('at least one week before', 'within the one year before', 'within the ten years before', 'at least the five years before') that must be tracked separately","Dual legislative framework application: Instrument applies to claims under both VEA and MRCA with different service categories listed in the definition of 'relevant service'"],"plain_english_summary":"This instrument from the Repatriation Medical Authority sets the medical criteria for when Australian veterans, current/former defence members and their families can reasonably link hepatitis C (or death from it) to military service for VEA and MRCA claims. It establishes a lower “reasonable hypothesis” test based on service-related blood exposure or on service making pre‑existing hepatitis C significantly worse. That finding determines access to pensions, treatment and other veteran benefits."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-hepatitis-c-reasonable-hypothesis-no-13-of-2018","history":"/api/acts/statement-of-principles-concerning-hepatitis-c-reasonable-hypothesis-no-13-of-2018/history","analysis":"/api/acts/statement-of-principles-concerning-hepatitis-c-reasonable-hypothesis-no-13-of-2018/analysis","conflicts":"/api/acts/statement-of-principles-concerning-hepatitis-c-reasonable-hypothesis-no-13-of-2018/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-hepatitis-c-reasonable-hypothesis-no-13-of-2018/important-cases","documents":"/api/acts/statement-of-principles-concerning-hepatitis-c-reasonable-hypothesis-no-13-of-2018/documents"}}