{"id":"F2018L00193","name":"Statement of Principles concerning toxic retinopathy (Balance of Probabilities) (No. 20 of 2018)","slug":"statement-of-principles-concerning-toxic-retinopathy-balance-of-probabilities-no-20-of-2018","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":439502,"registerId":"F2018L00193-fast-fetch-1775955505929","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning toxic retinopathy (Balance of Probabilities) (No. 20 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\nTOXIC RETINOPATHY (Balance of Probabilities)\n\n(No. 20 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 toxic retinopathy (Balance of Probabilities) (No. 20 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 toxic maculopathy No. 40 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 toxic retinopathy and death from toxic retinopathy.\n\nMeaning of toxic retinopathy\n\n(2) For the purposes of this Statement of Principles, toxic retinopathy:\n\n(a) means pathological changes in the cells of the retina of the eye, in the presence of:\n\n(i) sustained vision impairment; and\n\n(ii) evidence from the history, physical examination, or diagnostic testing that the pathological changes are caused by a chemical agent; and\n\n(b) includes chemically induced chronic cystoid macular oedema, crystalline retinopathy, toxic maculopathy, and peripheral retinal degeneration that does not involve the macula; and\n\n(c) excludes toxic optic neuropathy, zonal occult outer retinopathy, macular degeneration, retinal detachment and breaks, and retinal photodamage.\n\nDeath from toxic retinopathy\n\n(3) For the purposes of this Statement of Principles, toxic retinopathy, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's toxic retinopathy.\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 toxic retinopathy and death from toxic retinopathy 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, toxic retinopathy or death from toxic retinopathy is connected with the circumstances of a person's relevant service:\n\n(1) being treated with a quinoline-based drug as specified, before the clinical onset of toxic retinopathy;\n\nNote: being treated with a quinoline-based drug as specified is defined in the Schedule 1 - Dictionary. \n\n(2) being treated with tamoxifen as specified within the one year before the clinical onset of toxic retinopathy;\n\nNote: being treated with tamoxifen as specified is defined in the Schedule 1 - Dictionary. \n\n(3) being treated with an intravitreal or subconjunctival aminoglycoside from the specified list of aminoglycosides, within the seven days before the clinical onset of toxic retinopathy;\n\nNote: specified list of aminoglycosides is defined in the Schedule 1 - Dictionary.\n\n(4) being treated with intravitreal fomivirsen within the 30 days before the clinical onset of toxic retinopathy;\n\n(5) being treated with intravenous deferoxamine within the seven days before the clinical onset of toxic retinopathy;\n\n(6) being treated with the phenothiazine drugs chlorpromazine or thioridazine for a continuous period of at least the two weeks before the clinical onset of toxic retinopathy;\n\n(7) being treated with daily clofazimine, at an average dose of at least 100 milligrams per day, for a continuous period of at least the three months before the clinical onset of toxic retinopathy;\n\n(8) being treated with ritonavir for a continuous period of at least the three months before the clinical onset of toxic retinopathy;\n\n(9) being treated with interferon for a continuous period of at least four weeks, within the three months before the clinical onset of toxic retinopathy;\n\n(10) being treated with subcutaneous or intramuscular deferoxamine for a continuous period of at least the four weeks before the clinical onset of toxic retinopathy;\n\n(11) taking oral canthaxanthin supplements or tablets as specified within the five years before the clinical onset of toxic retinopathy;\n\nNote: taking oral canthaxanthin supplements or tablets as specified is defined in the Schedule 1 - Dictionary.\n\n(12) inhaling isopropyl nitrite within the two weeks before the clinical onset of toxic retinopathy;\n\n(13) using an intravenous drug containing talc within the two years before the clinical onset of toxic retinopathy;\n\n(14) for cystoid macular oedema only:\n\n(a) being treated with daily niacin for a continuous period of at least two weeks, at an average dose of at least 1.5 grams per day, within the three months before the clinical onset of toxic retinopathy; or\n\n(b) being treated with intravenous paclitaxel or docetaxel within the three months before the clinical onset of toxic retinopathy;\n\nNote: cystoid macular oedema is defined in the Schedule 1 - Dictionary.\n\n(15) for cystoid macular oedema only, in an aphakic or pseudophakic eye only, being treated with topical adrenaline eye drops, within the three months before the clinical onset of toxic retinopathy;\n\nNote: cystoid macular oedema and aphakic or pseudophakic eye are defined in the Schedule 1 - Dictionary.\n\n(16) inability to obtain appropriate clinical management for toxic retinopathy.\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 factor set out in subsection 9(16) applies only to material contribution to, or aggravation of, toxic retinopathy where the person's toxic retinopathy 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 aphakic or pseudophakic eye means an eye without a natural lens, or an eye containing an intraocular lens implant.\n\n being treated with a quinoline-based drug as specified means:\n\n(a) taking daily chloroquine for a continuous period of at least six months; or\n\n(b) taking a cumulative dose of chloroquine of at least 200 grams; or\n\n(c) taking daily hydroxychloroquine for a continuous period of at least five years; or\n\n(d) taking a cumulative dose of hydroxychloroquine of at least 400 grams.\n\n being treated with tamoxifen as specified means:\n\n(a) taking daily tamoxifen for a continuous period of at least six months; or\n\n(b) taking a cumulative dose of tamoxifen of at least 100 grams.\n\n cystoid macular oedema means a painless disorder of the macula, in which disruption of the normal blood-retinal barrier causes the accumulation of fluid within the intracellular spaces of the retina, primarily in the outer plexiform layer.\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 specified list of aminoglycosides means:\n\n(a) amikacin; or\n\n(b) gentamicin.\n\n taking oral canthaxanthin supplements or tablets as specified means:\n\n(a) daily oral canthaxanthin supplements or tablets for a continuous period of at least one year; or\n\n(b) having a cumulative dose of at least 15 grams of canthaxanthin.\n\nNote: Canthaxanthin used as a colour additive in foods or drugs is excluded.\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 toxic retinopathy—see subsection 7(2).\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 replaces the earlier \"toxic maculopathy\" Statement (revoked by section 4) and broadens and clarifies scope in several ways: it uses the wider category \"toxic retinopathy\" (explicitly including chemically induced chronic cystoid macular oedema, crystalline retinopathy, toxic maculopathy and peripheral retinal degeneration) rather than the narrower earlier title; it adds a more detailed list of causative agents, specific dose and duration thresholds (Schedule 1), time windows for exposure-effect relationships, and an inability-to-obtain-care factor (section 9(16)) with a limited application (section 10(2)). Those changes expand the conditions and specific exposure pathways covered compared with a simple update of \"toxic maculopathy,\" so the scope has materially broadened from the prior instrument."},"complexity_factors":["16 alternative causation factors in section 9, several with distinct timing windows and dose/duration thresholds","Schedule 1 contains multiple specific defined thresholds (e.g. hydroxychloroquine: 5 years continuous OR 400 g cumulative)","Cross-reference mechanism to other Statements of Principles (section 11) that can require reading multiple instruments","Limited, conditional application of factor 9(16) (inability to obtain clinical management) via section 10(2) introduces a second‑order exception","Clear, narrow definitional exclusions in the toxic retinopathy definition (section 7(2)(c)) which must be checked","Relatively few defined terms (Schedule 1) but many conditional tests combining timing, dose and route of administration","Practical ambiguity zones: terms like 'clinical onset' and 'related to the relevant service' require fact-specific medical/legal judgment"],"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 the medical rules used to decide whether \"toxic retinopathy\" (and death from it) is connected to a veteran's or serving member's relevant service for the purposes of claims under the Veterans' Entitlements Act 1986 (VEA) or the Military Rehabilitation and Compensation Act 2004 (MRCA) (see sections 3 and 5). \n\n- It defines what is meant by \"toxic retinopathy\" (section 7(2)) and lists the specific exposures, drug treatments, dose and time thresholds that, if present, are treated as sufficient on the balance of probabilities to link the eye condition to service (section 9 and Schedule 1). \n\n- The instrument revokes an earlier related Statement (toxic maculopathy No. 40 of 2009) and commenced operation on 2 April 2018 (sections 2 and 4).\n\nWho this affects\n\n- Primary: veterans and former or current members of the Australian Defence Force who lodge claims under the VEA or MRCA for toxic retinopathy or death from toxic retinopathy (section 5). \n\n- Secondary: medical practitioners, claims assessors at the Department of Veterans' Affairs (DVA) and decision makers who must apply this SoP when determining causation for claims; any tribunal or review body that applies the SoP; and record-keepers (hospitals, prescribers) because exposure/dose history is a factual input for decisions.\n\nWhy it matters (the RMA's stated medical basis and the legal effect)\n\n- The RMA states (section 8) that, on the medical‑scientific evidence available, it is \"more probable than not\" that toxic retinopathy and death from it can be related to relevant service. That is the evidentiary claim that justifies setting these exposure-based rules. \n\n- Legally, if a claimant both (a) meets one of the listed exposure/treatment factors (section 9) and (b) the factor is related to the person's relevant service (section 10(1)), then the condition may be accepted as connected to service on the balance of probabilities for VEA/MRCA claims. The SoP therefore provides a presumptive causal pathway to benefit entitlement decisions.\n\nKey substantive rules and examples (how causation is assessed under this SoP)\n\n- The SoP lists 16 alternative exposure-based factors (section 9). Only one needs to be met for the SoP to operate as a link between condition and service. Examples include: \n - Treatment with certain quinoline drugs (chloroquine or hydroxychloroquine) meeting continuous use or cumulative dose thresholds (Schedule 1); \n - Use of tamoxifen with specified duration or cumulative dose; \n - Intravitreal or subconjunctival aminoglycosides (amikacin, gentamicin) within 7 days of clinical onset; \n - Intravenous deferoxamine, intravitreal fomivirsen, certain psychiatric phenothiazines (chlorpromazine, thioridazine), ritonavir, interferon, clofazimine, canthaxanthin, inhaled isopropyl nitrite, IV drugs containing talc, and specified chemotherapy agents in time windows stated in section 9 and Schedule 1. \n - For cystoid macular oedema (a specific retinal disorder), additional drug exposures (e.g. niacin at defined dose/duration, paclitaxel/docetaxel, topical adrenaline in aphakic/pseudophakic eyes) are listed (section 9(14)–(15)). \n - A separate factor is inability to obtain appropriate clinical management for toxic retinopathy (section 9(16)), but that factor has limited application (see section 10(2)).\n\n- Definitions in Schedule 1 set dose and timing thresholds that matter mechanically (for example hydroxychloroquine: continuous daily use for at least five years OR cumulative dose of at least 400 grams; chloroquine: at least six months continuous or cumulative dose of 200 grams). These thresholds are the factual tests a claimant must meet for that exposure factor.\n\nHow service link is handled and limits\n\n- The SoP requires that the exposure factor be \"related to the relevant service\" (section 10(1)). \"Relevant service\" is defined in Schedule 1 and covers specified categories of service under the VEA and MRCA. \n\n- The inability-to-obtain-care factor (section 9(16)) applies only where toxic retinopathy pre‑existed or was suffered or contracted before or during service but was materially contributed to or aggravated by service (section 10(2)). It does not apply where the condition arose out of service.\n\nCross-reference to other Statements\n\n- If an exposure factor refers to an injury or disease already covered by another RMA Statement, the rules in that other Statement apply as they stand (section 11). This creates an explicit link for overlapping conditions.\n\nStated purpose and a practical test of trade-offs, incentives and implementation issues\n\n- Stated purpose: the RMA asserts a medical‑scientific basis for linking specific chemical/drug exposures to toxic retinopathy so that causation decisions for veterans' claims can be consistent and evidence-based (section 8). \n\n- Who pays: monetary liability for accepted claims is met by the Commonwealth through DVA/entitlements schemes; the SoP influences which claims are accepted and therefore affects public expenditure. \n\n- Who decides: the RMA sets the SoP (this instrument); individual claims are decided by DVA decision makers and review bodies who apply the SoP's tests to the claimant's medical and treatment history. Medical opinion (records, expert reports) provides the factual input. \n\n- Behavioural effects and incentives: claimants and their advisers will be incentivised to obtain and present detailed treatment records (drug names, doses, dates, cumulative doses); medical practitioners and record-holders will face increased demand to provide documentation; prescribers may be mindful of record-keeping but the SoP does not directly regulate prescribing. \n\n- Compliance and evidentiary burden: the SoP shifts the legal question of causation onto relatively objective factual tests (drug exposures, dose/duration, timing). This reduces some diagnostic uncertainty but creates administrative burden where historical records are incomplete (e.g. proving cumulative dose or exact timing). \n\n- Implementation risk and discretion: applying the SoP requires clinical interpretation of \"clinical onset\" and whether an exposure is \"related to the relevant service\"; decision-makers and clinicians exercise judgment on those points. Cross-references to other SoPs can add complexity where multiple instruments interact. \n\n- Market / private-party effects: the SoP does not impose regulation on pharmaceutical manufacturers or private healthcare beyond the indirect effect that their products are listed as possible causal factors. It does not change private contract rights or commercial prices.\n\nConcentrated benefits and diffuse costs (who gains, who bears cost)\n\n- Concentrated benefits: claimants with documented qualifying exposures (e.g. long‑term hydroxychloroquine users) obtain a clearer path to acceptance. \n- Diffuse costs: public budgetary cost of additional accepted claims and administrative costs for DVA and healthcare providers to assemble evidence. \n\nKey legal thresholds and practical proof points (where disputes are likely)\n\n- Whether the claimant can satisfy one of the exposure factors in section 9 according to the dose/duration/time limits in Schedule 1. \n- Whether the exposure is \"related to the relevant service\" (section 10(1)). \n- Interpretation of \"clinical onset\" timing in relation to the exposure windows. \n- Interaction with other SoPs where a factor is covered elsewhere (section 11).\n\nPractical takeaways\n\n- If you are a veteran or adviser making a claim: collect medical records that show specific drug names, dates, doses and any ophthalmic diagnoses; note which eye (aphakic/pseudophakic) if relevant to cystoid macular oedema examples. \n- If you are a clinician or records manager: be prepared to provide cumulative dose calculations and time-stamped treatment histories for patients with possible service connections. \n\nSource‑oriented note: the instrument is a technical, exposure-based set of causation rules. The RMA frames them as being founded on available medical‑scientific evidence (section 8). My explanatory points above identify the administrative costs, evidentiary incentives, points of decision-maker discretion and likely areas where factual proof will be contested when the SoP is applied.\n"},"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":5,"scope_assessment":{"changed":true,"description":"The original 2009 instrument covered only 'toxic maculopathy' (damage to the central part of the retina). This 2018 version expands scope to 'toxic retinopathy' — covering the entire retina including peripheral retinal degeneration, crystalline retinopathy, and chemically induced chronic cystoid macular oedema. While broader in anatomical coverage, it maintains the same fundamental purpose: establishing service connection for chemical/drug-induced eye damage in veterans."},"complexity_factors":["16 distinct causal factors with varying timeframes (7 days to 5 years before clinical onset)","Nested conditional logic: factors 14 and 15 apply only to 'cystoid macular oedema only' and factor 15 adds 'aphakic or pseudophakic eye only' restriction","7 defined terms in Schedule 1, several with multi-part definitions (e.g., quinoline-based drug has 4 alternative thresholds)","Cross-referencing structure: section 11 incorporates other Statements of Principles by reference if factors refer to other injuries/diseases","Dual legislative framework application (VEA and MRCA) with different service definitions","Specific dosage and duration thresholds requiring precise calculation (e.g., 'average dose of at least 100 milligrams per day' for clofazimine)","Exclusion clauses in the definition of toxic retinopathy that require distinguishing from similar conditions"],"plain_english_summary":"This instrument sets the medical rules for deciding if Australian veterans and defence members can get compensation for toxic retinopathy — retinal damage from certain chemicals or drugs. It defines the condition, lists 16 risk factors and time limits linking exposures in non-warlike “relevant service” to the injury, and replaces a 2009 maculopathy-only instrument with broader retinal coverage.\n\nIt’s a compensation gateway: proving a listed factor on the balance of probabilities establishes service-relatedness for pensions and treatment."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-balance-of-probabilities-no-20-of-2018","history":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-balance-of-probabilities-no-20-of-2018/history","analysis":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-balance-of-probabilities-no-20-of-2018/analysis","conflicts":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-balance-of-probabilities-no-20-of-2018/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-balance-of-probabilities-no-20-of-2018/important-cases","documents":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-balance-of-probabilities-no-20-of-2018/documents"}}