{"id":"F2021L00616","name":"Statement of Principles concerning porphyria cutanea tarda (Balance of Probabilities) (No. 70 of 2021)","slug":"statement-of-principles-concerning-porphyria-cutanea-tarda-balance-of-probabilities-no-70-of-2021","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440863,"registerId":"F2021L00616-fast-fetch-1775956337810","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning porphyria cutanea tarda (Balance of Probabilities) (No. 70 of 2021)","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\nPORPHYRIA CUTANEA TARDA (Balance of Probabilities)\n\n(No. 70 of 2021)\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 21 May 2021\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 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 porphyria cutanea tarda (Balance of Probabilities) (No. 70 of 2021).\n\n2 Commencement\n\n This instrument commences on 21 June 2021.\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 porphyria cutanea tarda No. 44 of 2012 (Federal Register of Legislation No. F2012L01358) made under subsection 196B(3) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act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 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 porphyria cutanea tarda and death from porphyria cutanea tarda.\n\nMeaning of porphyria cutanea tarda\n\n(2) For the purposes of this Statement of Principles, porphyria cutanea tarda means a skin disorder resulting from decreased activity of the enzyme uroporphyrinogen decarboxylase in the liver and accumulation of porphyrins in the circulation.\n\nNote: Typical clinical manifestations of porphyria cutanea tarda include blistering of the skin in sun-exposed areas, hyperpigmentation and facial hypertrichosis.\n\n(3) While porphyria cutanea tarda attracts ICD‑10‑AM code E80.1, in applying this Statement of Principles the meaning of porphyria cutanea tarda 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 porphyria cutanea tarda\n\n(5) For the purposes of this Statement of Principles, porphyria cutanea tarda, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's porphyria cutanea tarda.\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 porphyria cutanea tarda and death from porphyria cutanea tarda 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, porphyria cutanea tarda or death from porphyria cutanea tarda is connected with the circumstances of a person's relevant service:\n\n(1) for males, consuming a total of at least 100 kilograms of alcohol within the 10 years before the clinical onset of porphyria cutanea tarda;\n\nNote: Alcohol consumption is calculated utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink. \n\n(2) for females, consuming a total of at least 50 kilograms of alcohol within the 10 years before the clinical onset of porphyria cutanea tarda;\n\nNote: Alcohol consumption is calculated utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink. \n\n(3) having alcohol use disorder at the time of the clinical onset of porphyria cutanea tarda;\n\n(4) having cirrhosis of the liver or alcoholic steatohepatitis at the time of the clinical onset of porphyria cutanea tarda;\n\n(5) having chronic renal failure at the time of the clinical onset of porphyria cutanea tarda;\n\nNote: chronic renal failure is defined in the Schedule 1 - Dictionary.\n\n(6) having hepatic iron overload at the time of the clinical onset of porphyria cutanea tarda;\n\nNote: iron overload is defined in the Schedule 1 - Dictionary.\n\n(7) having a viral infection from the specified list of viral infections at the time of the clinical onset of porphyria cutanea tarda;\n\nNote: specified list of viral infections is defined in the Schedule 1 - Dictionary. \n\n(8) taking a drug from the specified list of drugs within the 30 days before the clinical onset of porphyria cutanea tarda;\n\nNote: specified list of drugs is defined in the Schedule 1 - Dictionary.\n\n(9) taking a drug which is associated in the individual with the clinical onset of porphyria cutanea tarda during drug therapy and either:\n\n(a) the improvement of porphyria cutanea tarda within 2 months of discontinuing or tapering drug therapy; or \n\n(b) the redevelopment of porphyria cutanea tarda on rechallenge with the same drug; and\n\nwhere taking the drug continued for at least the 7 days before the clinical onset of porphyria cutanea tarda;\n\n(10) ingesting food contaminated with hexachlorobenzene within the 1 year before the clinical onset of porphyria cutanea tarda;\n\n(11) for males, consuming a total of at least 100 kilograms of alcohol within the 10 years before the clinical worsening of porphyria cutanea tarda;\n\nNote: Alcohol consumption is calculated utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink. \n\n(12) for females, consuming a total of at least 50 kilograms of alcohol within the 10 years before the clinical worsening of porphyria cutanea tarda;\n\nNote: Alcohol consumption is calculated utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink. \n\n(13) having alcohol use disorder at the time of the clinical worsening of porphyria cutanea tarda;\n\n(14) having cirrhosis of the liver or alcoholic steatohepatitis at the time of the clinical worsening of porphyria cutanea tarda;\n\n(15) having chronic renal failure at the time of the clinical worsening of porphyria cutanea tarda;\n\nNote: chronic renal failure is defined in the Schedule 1 - Dictionary.\n\n(16) having hepatic iron overload at the time of the clinical worsening of porphyria cutanea tarda;\n\nNote: iron overload is defined in the Schedule 1 - Dictionary.\n\n(17) having a viral infection from the specified list of viral infections at the time of the clinical worsening of porphyria cutanea tarda;\n\nNote: specified list of viral infections is defined in the Schedule 1 - Dictionary. \n\n(18) taking a drug from the specified list of drugs within the 30 days before the clinical worsening of porphyria cutanea tarda;\n\nNote: specified list of drugs is defined in the Schedule 1 - Dictionary.\n\n(19) taking a drug which is associated in the individual with:\n\n(a) the clinical worsening of porphyria cutanea tarda during drug therapy; and\n\n(b) the improvement of porphyria cutanea tarda within 2 months of discontinuing or tapering drug therapy; and\n\nwhere taking the drug continued for at least the 7 days before the clinical worsening of porphyria cutanea tarda;\n\n(20) ingesting food contaminated with hexachlorobenzene within the 1 year before the clinical worsening of porphyria cutanea tarda;\n\n(21) inability to obtain appropriate clinical management for porphyria cutanea tarda.\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) to 9(21) apply only to material contribution to, or aggravation of, porphyria cutanea tarda where the person's porphyria cutanea tarda 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 chronic renal failure means:\n\n(a) having a glomerular filtration rate of less than 15 mL/min/1.73 m2 for a period of at least 3 months; or\n\n(b) a need for renal replacement therapy (dialysis or transplantation) for treatment of complications of decreased glomerular filtration rate which would otherwise increase the risk of morbidity and mortality; or\n\n(c) undergoing chronic dialysis.\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: Common causes of hepatic iron overload are haemochromatosis and blood transfusions.\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n porphyria cutanea tarda—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 drugs means:\n\n(a) carbamazepine;\n\n(b) chloroquine;\n\n(c) cyclophosphamide;\n\n(d) highly active antiretroviral therapy;\n\n(e) hydroxychloroquine;\n\n(f) imatinib;\n\n(g) interferon alpha;\n\n(h) iron supplements;\n\n(i) oral estrogens;\n\n(j) phenobarbital;\n\n(k) phenytoin;\n\n(l) rifampicin;\n\n(m) sulfonylureas; or\n\n(n) tamoxifen.\n\n specified list of viral infections means:\n\n(a) hepatitis B virus;\n\n(b) hepatitis C virus; or\n\n(c) human immunodeficiency virus.\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":true,"description":"This instrument repeals the 2012 Statement of Principles (section 4) and replaces it with updated criteria. It retains application to VEA and MRCA claims but changes the enumerated risk factors, thresholds, temporal windows and definitions that determine when porphyria cutanea tarda (or death from it) is accepted as related to relevant service, thereby altering evidentiary and entitlement outcomes for claimants."},"complexity_factors":["Multiple discrete causal factors with differing thresholds (e.g. gendered alcohol consumption limits measured in kilograms over 10 years)","Different temporal windows for onset versus worsening (clinical onset vs clinical worsening)","Numerous clinically defined conditions and lab criteria cross‑referenced to the Schedule (e.g. chronic renal failure, iron overload)","Specified lists that require medical verification (drugs, viral infections) and defined exposure periods (30 days, 1 year)","Interaction with other Statements of Principles where factors overlap, requiring cross‑application of other instruments","Legal standard is balance of probabilities, requiring claimants to present medical evidence to meet specified factor tests"],"plain_english_summary":"This Statement of Principles updates how porphyria cutanea tarda (PCT) and death from it are legally linked to a person’s relevant service for claims under the VEA and MRCA. It specifies medical risk factors and exposure windows which, if present on the balance of probabilities at clinical onset or worsening, establish a service connection for compensation. It affects veterans and service members making claims, shifts the evidentiary focus to proving those factors, and determines when the Department must accept PCT as service‑related."},"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":"The legislation maintains its original narrow purpose: establishing specific medical criteria for linking porphyria cutanea tarda to military service. The 2021 version updates medical evidence and replaces the 2012 version but does not expand beyond the original scope of determining compensation eligibility for this specific rare condition."},"complexity_factors":["21 distinct factors with specific temporal requirements (e.g., 'within 10 years before', 'within 30 days before', 'at least 7 days before')","Gender-specific thresholds for alcohol consumption (100kg for males, 50kg for females)","Cross-references to external medical classification systems (ICD-10-AM Tenth Edition)","Nested conditional logic in factor 9 (drug rechallenge and improvement requirements)","Dual application structure distinguishing between 'clinical onset' (factors 1-10) and 'clinical worsening' (factors 11-21)","8 defined terms in Schedule 1, including technical medical definitions (glomerular filtration rate, ferritin levels)","Incorporation by reference of other Statements of Principles for comorbid conditions (section 11)","Specific drug list of 14 named pharmaceuticals and 3 named viruses requiring precise identification"],"plain_english_summary":"This instrument updates the medical rules for deciding whether veterans and current/former ADF members can get compensation for porphyria cutanea tarda (PCT), replacing the 2012 version and applying to claims under the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004.\n\nPCT is compensable only if at least one specified medical factor (e.g. heavy alcohol use, liver or kidney disease, certain infections, drugs, toxin exposure) is present and that factor is shown to be related to the person’s military service."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-porphyria-cutanea-tarda-balance-of-probabilities-no-70-of-2021","history":"/api/acts/statement-of-principles-concerning-porphyria-cutanea-tarda-balance-of-probabilities-no-70-of-2021/history","analysis":"/api/acts/statement-of-principles-concerning-porphyria-cutanea-tarda-balance-of-probabilities-no-70-of-2021/analysis","conflicts":"/api/acts/statement-of-principles-concerning-porphyria-cutanea-tarda-balance-of-probabilities-no-70-of-2021/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-porphyria-cutanea-tarda-balance-of-probabilities-no-70-of-2021/important-cases","documents":"/api/acts/statement-of-principles-concerning-porphyria-cutanea-tarda-balance-of-probabilities-no-70-of-2021/documents"}}