{"id":"F2018L00192","name":"Statement of Principles concerning toxic retinopathy (Reasonable Hypothesis) (No. 19 of 2018)","slug":"statement-of-principles-concerning-toxic-retinopathy-reasonable-hypothesis-no-19-of-2018","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":439500,"registerId":"F2018L00192-fast-fetch-1775955505927","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning toxic retinopathy (Reasonable Hypothesis) (No. 19 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 (Reasonable Hypothesis)\n\n(No. 19 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 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 (Reasonable Hypothesis) (No. 19 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(2) of the Veterans' Entitlements Act 1986.\n\n4 Revocation\n\nThe Statement of Principles concerning toxic maculopathy No. 39 of 2009 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 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\nThe Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that toxic retinopathy and death from toxic retinopathy 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 toxic retinopathy or death from toxic retinopathy 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 or ganciclovir 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 a phenothiazine from the specified list of phenothiazines for a continuous period of at least the two weeks before the clinical onset of toxic retinopathy;\n\nNote: specified list of phenothiazines is defined in the Schedule 1 - Dictionary.\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 daily topiramate for a continuous period of at least seven days within the 30 days before the clinical onset of toxic retinopathy;\n\n(11) having iron chelating therapy as specified for a continuous period of at least the four weeks before the clinical onset of toxic retinopathy;\n\nNote: iron chelating therapy as specified is defined in the Schedule 1 - Dictionary.\n\n(12) having haematological or biochemical evidence of poisoning with cobalt at the time of the clinical onset of toxic retinopathy;\n\n(13) 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(14) inhaling isopropyl nitrite within the two weeks before the clinical onset of toxic retinopathy;\n\n(15) using an intravenous drug containing talc within the five years before the clinical onset of toxic retinopathy;\n\n(16) 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;\n\n(b) being treated with intravenous paclitaxel or docetaxel within the three months before the clinical onset of toxic retinopathy; or\n\n(c) being treated with the thiazolidinedione drugs rosiglitazone or pioglitazone for a continuous period of at least the four weeks before the clinical onset of toxic retinopathy;\n\nNote: cystoid macular oedema is defined in the Schedule 1 - Dictionary.\n\n(17) for cystoid macular oedema only, in an aphakic or pseudophakic eye only:\n\n(a) being treated with topical adrenaline eye drops, within the three months before the clinical onset of toxic retinopathy; or\n\n(b) being treated with latanoprost 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(18) 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(18) 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(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 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 100 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; or\n\n(e) taking daily quinacrine (mepacrine or Atebrin) for a continuous period of at least six months; or\n\n(f) taking a cumulative dose of quinacrine of at least 20 grams; or\n\n(g) taking a cumulative dose of at least 1000 mg of mefloquine within a 30 day period.\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 iron chelating therapy as specified means:\n\n(a) daily oral deferasirox; or\n\n(b) daily oral deferiprone; or\n\n(c) subcutaneous or intramuscular deferoxamine.\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\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 aminoglycosides means:\n\n(a) amikacin;\n\n(b) gentamicin;\n\n(c) kanamycin;\n\n(d) netilmicin; or\n\n(e) tobramycin.\n\n specified list of phenothiazines means:\n\n(a) chlorpromazine;\n\n(b) thioridazine;\n\n(c) fluphenazine;\n\n(d) trifluoperazine; or\n\n(e) pericyazine.\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 six months; 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":{"kimi_summary":{"content_quality":"ok","complexity_score":5,"scope_assessment":{"changed":true,"description":"The 2018 instrument significantly expanded scope compared to the revoked 2009 Statement of Principles concerning 'toxic maculopathy'. The new version covers 'toxic retinopathy' broadly — including crystalline retinopathy, peripheral retinal degeneration, and chemically induced chronic cystoid macular oedema — not just macular damage. It also added numerous new causal factors (e.g., topiramate, ritonavir, interferon, canthaxanthin, isopropyl nitrite, talc in IV drugs) that were absent from the 2009 version, and introduced sub-type specific factors with additional restrictions."},"complexity_factors":["18 distinct causal factors in section 9, many with nested sub-conditions and specific time windows (ranging from 7 days to 5 years)","Multiple defined terms in Schedule 1 (approximately 12 formal definitions), several of which contain their own sub-lists and alternative criteria (e.g., 'being treated with a quinoline-based drug as specified' has 7 separate pathways)","Conditional logic limiting certain factors to specific sub-types of the condition (e.g., factors 16 and 17 apply 'for cystoid macular oedema only', with factor 17 further restricted to 'aphakic or pseudophakic eye only')","Cross-referencing between the main instrument and Schedule 1 definitions, plus external references to the Veterans' Entitlements Act 1986 and Military Rehabilitation and Compensation Act 2004","Dual statutory framework application (VEA and MRCA) with different service categories listed in the definition of 'relevant service'","Specific quantitative thresholds throughout (dose amounts, duration periods, cumulative gram totals) that require precise calculation","Exception clauses in section 7(2)(c) explicitly excluding certain related conditions (toxic optic neuropathy, macular degeneration, etc.)"],"plain_english_summary":"This Statement of Principles determines when veterans, current/former defence members and peacekeepers can claim compensation for toxic retinopathy — retinal damage tied to certain drugs, medical treatments or chemical exposures. It applies under the Veterans' Entitlements Act and MRCA and uses a \"reasonable hypothesis\" test: plausible service‑related exposure before onset is enough to link the condition to service.\n\nThe 2018 version expands the 2009 rule (formerly limited to maculopathy), covering more retinal damage and more risk factors (certain medications, injections/IV treatments, industrial chemicals, inhalants, IV drug talc, or lack of care), potentially widening eligibility."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"This instrument expands and clarifies scope compared with the earlier Statement it revoked (No. 39 of 2009). Conspicuous changes include: (a) a change in focus from \"toxic maculopathy\" to the broader term \"toxic retinopathy\" (section 7), thereby covering additional retinal pathologies (Schedule); (b) explicit inclusion of death where toxic retinopathy contributed (section 7(3)); (c) an updated and longer list of specific causative agents, routes and dose/duration thresholds (section 9 and Schedule 1), including agents and exposures not all contained in the prior 2009 instrument; and (d) an added factor for inability to obtain appropriate clinical management (section 9(18)). Those additions broaden the range of exposures and circumstances that can raise a reasonable hypothesis of service connection compared with the earlier instrument."},"complexity_factors":["Multiple time‑limited exposure windows and dose thresholds across section 9 and Schedule 1 (e.g. varying windows: 7 days, 30 days, 3 months, 5 years, etc.)","Approximately 12–15 defined terms in Schedule 1 with nested sub‑conditions (e.g. \"being treated with a quinoline‑based drug as specified\" has seven sub‑items including dose and duration rules).","Several lists of specific drugs (aminoglycosides, phenothiazines) that must be checked against clinical records (Schedule).","Cross‑references to other Statements of Principles via section 11, which imports other SoPs' criteria and increases interpretative complexity.","Conditional exceptions and special‑case factors (for example, separate sub‑rules for cystoid macular oedema, and aphakic/pseudophakic eyes — section 9(16)–(17) and Schedule).","Revocation of an earlier, related SoP (No. 39 of 2009) which requires comparing old and new texts to see scope changes (section 4).","Interaction with external statutory schemes (VEA and MRCA) — the instrument applies only within those claims frameworks (section 5)."],"plain_english_summary":"**What this instrument does**\n\n- This is a Statement of Principles (SoP) issued by the Repatriation Medical Authority (RMA) about \"toxic retinopathy\" and death from toxic retinopathy. (See sections 1 and 7.)\n- It sets out the medical criteria that, if met, raise a \"reasonable hypothesis\" that the person’s toxic retinopathy is related to their military \"relevant service\" and so may attract entitlements under the Veterans' Entitlements Act 1986 (VEA) or the Military Rehabilitation and Compensation Act 2004 (MRCA). (See sections 5, 7 and 8.)\n- It replaces an earlier Statement about \"toxic maculopathy\" (revoked — section 4) and came into force on 2 April 2018 (section 2).\n\n**Who this affects**\n\n- Veterans, former members of the Australian Defence Force, and other covered service personnel who lodge claims under the VEA or MRCA for toxic retinopathy or for death where toxic retinopathy contributed. (See section 5 and Schedule: definition of \"relevant service\".)\n- Medical practitioners and claims assessors who must identify and document the presence of listed exposures, treatments, or clinical findings when assessing whether the \"reasonable hypothesis\" standard is met. (See section 9 and Schedule 1.)\n\n**How it works, mechanically**\n\n- The RMA states it has medical‑scientific evidence supporting a connection between toxic retinopathy and relevant service (section 8). That is the RMA's basis for publishing this SoP.\n- To meet the SoP's threshold (a \"reasonable hypothesis\"), at least one of the specific factors in section 9 must be shown to have existed before the clinical onset of toxic retinopathy. Examples include: exposure to particular drugs or chemicals, specified routes of administration, minimum doses or treatment durations, certain laboratory evidence (e.g. cobalt poisoning), or inability to obtain appropriate clinical management. (See section 9 and Schedule 1 definitions.)\n- Many factors are time‑limited and dose‑specific. For example: taking daily hydroxychloroquine for at least five years or a cumulative hydroxychloroquine dose of at least 400 g; tamoxifen for six months or 100 g cumulative; intravitreal aminoglycosides within seven days prior to onset; and others. (See section 9 and the Schedule entries for \"being treated with a quinoline‑based drug as specified\", \"being treated with tamoxifen as specified\", specified drug lists, and time windows.)\n- If a factor listed in section 9 refers to an injury/disease already covered by another SoP, the other SoP's factors apply according to that SoP (section 11). This creates cross‑application between Statements.\n- The SoP also includes death from toxic retinopathy (section 7(3)); death is treated as including death from a terminal event or condition to which toxic retinopathy contributed (Schedule definition of \"terminal event\").\n\n**Why this matters (stated purpose and practical implications)**\n\n- The RMA's stated purpose is to define the medical factors which, if present, support a reasonable hypothesis that toxic retinopathy is related to service (section 8). This matters because meeting the reasonable‑hypothesis threshold is a key legal step that allows a claimant to obtain further benefits consideration under the VEA or MRCA.\n\n- Practical consequences and administrative mechanics:\n - Who pays: if a claim proceeds and is accepted under the VEA or MRCA rules, relevant benefits are paid from the veterans' entitlements schemes (the instrument applies to claims under those Acts — section 5).\n - Who decides: the RMA issues the technical SoP (sections 1–3, 8); claim acceptance remains an administrative decision under the VEA/MRCA framework by the Department/decision‑maker applying the SoP to the claimant’s evidence.\n - Evidence and behaviour changes: claimants must show the exposure/treatment and meet dose/time thresholds (section 9; Schedule). This increases the evidentiary and record‑keeping burden on claimants and treating clinicians (medical records, pharmacy records, laboratory tests such as cobalt levels — section 9(12) and Schedule). Clinicians documenting exposures and dosing histories will materially affect claims outcomes.\n\n**Testing RMA's stated basis against implementation considerations**\n\n- Costs and who bears them: the immediate fiscal cost falls on the veterans' entitlements schemes if claims satisfying the SoP lead to accepted claims. Administrative costs include gathering historical treatment records and specialist assessments.\n- Compliance burden: many factors require specific dosage or duration proof (e.g. multiple cumulative dose thresholds in the Schedule). For older exposures this can be burdensome or impossible to prove, increasing evidentiary burden on claimants (see Schedule entries for drug dose/duration thresholds).\n- Bureaucratic discretion and cross‑reference risk: section 11 links this SoP to other Statements where exposures overlap. That creates interpretative dependence on other SoPs, increasing adjudicator discretion and potential inconsistency across claims.\n- Implementation risk: precise time windows (days, weeks, months, years) and the need for laboratory or documented evidence (e.g. cobalt poisoning, IV drug use containing talc) create risks of disputes about timing, causation, and quality of evidence (see section 9 and Schedule).\n- Effects on private choice and clinical practice: the SoP identifies many commonly used medicines (e.g. chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, ritonavir, interferon, topiramate, clofazimine). That may encourage more detailed clinician documentation of indications, dosing and monitoring; it may also affect retrospective risk assessment by clinicians and patients when considering long‑term treatment risks.\n- Concentrated benefits, diffuse costs: benefits (potential acceptance of claims) are concentrated to claimants able to meet specific criteria; costs are borne by the public scheme and by claimants who must assemble historical evidence.\n\n**Key sections to consult**\n- Application and authority: sections 3–5.\n- Definition and scope of \"toxic retinopathy\": section 7 (and Schedule definitions).\n- The list of qualifying factors and required timing/dosing: section 9 and Schedule 1.\n- Cross‑reference to other Statements: section 11.\n\n"},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-reasonable-hypothesis-no-19-of-2018","history":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-reasonable-hypothesis-no-19-of-2018/history","analysis":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-reasonable-hypothesis-no-19-of-2018/analysis","conflicts":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-reasonable-hypothesis-no-19-of-2018/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-reasonable-hypothesis-no-19-of-2018/important-cases","documents":"/api/acts/statement-of-principles-concerning-toxic-retinopathy-reasonable-hypothesis-no-19-of-2018/documents"}}