Statement of Principles concerning macular degeneration (Balance of Probabilities) (No. 60 of 2018)

The central concept is “macular degeneration”, defined as a group of degenerative diseases of the macula that cause progressive, painless loss of central vision. It expressly includes early macular degeneration (drusen of at least medium size at or above 63 μm, retinal pigmentary abnormalities, or soft indistinct or reticular drusen) and late macular degeneration (dry/geographic atrophy or wet macular degeneration, which includes choroidal neovascularisation and retinal angiomatous proliferation). Toxic retinopathy is excluded. “Death from macular degeneration” includes death contributed to by a terminal event such as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. The instrument defines “relevant service” narrowly: eligible war service (other than operational service) under the VEA, defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA. This means veterans who rendered operational service or hazardous service are not covered by this SoP; they would instead be assessed under the reasonable hypothesis standard in separate instruments. The key causal factors are defined with precise thresholds: smoking at least 15 pack-years of cigarettes or equivalent tobacco products, with timing windows both before clinical onset and after cessation; consumption of at least 20 kilograms of alcohol in a continuous period of two years within the five years before onset or worsening; obesity (BMI of 30 or greater) for at least five years before onset or worsening; chronic kidney disease (abnormality of kidney structure or function present for at least three months) within five years; and for worsening of wet macular degeneration with subretinal haemorrhage only, anticoagulant therapy or thrombolytic therapy within seven days before worsening. The instrument also includes a standalone factor for inability to obtain appropriate clinical management. Each factor must be related to the person’s relevant service. For factors 5 to 10 (those addressing clinical worsening), they apply only where the person’s macular degeneration was suffered or contracted before or during (but did not arise out of) the relevant service, and the factor must materially contribute to or aggravate the disease. The dictionary defines terms such as “pack-years of cigarettes, or the equivalent thereof in other tobacco products” as one pack-year equals 20 tailor-made cigarettes per day for a year (7,300 cigarettes), with one cigarette approximating one gram of tobacco. This volumetric approach standardises evidence but may disadvantage claimants who smoked roll-your-own cigarettes without precise records.

The primary affected group is veterans and members of the Australian Defence Force who have rendered relevant service as defined and who now suffer from macular degeneration or have died from it. The SoP directly impacts their ability to obtain compensation, medical treatment, and other benefits under the VEA or MRCA. Because the instrument applies only to “relevant service” that excludes operational service, hazardous service and British nuclear test defence service, a substantial cohort of veterans who served in combat zones or certain hazardous environments will not have their claims assessed under this SoP. Instead, they fall under separate instruments with a lower threshold of proof. The secondary affected group is the Department of Veterans’ Affairs (DVA), including decision-makers, medical advisers, and review bodies. They must apply the factors strictly, ensuring each condition is met and that the temporal windows are satisfied. Medical practitioners who provide evidence on behalf of claimants or DVA must understand the precise definitions (e.g., the volume of alcohol in Australian standard drinks, the BMI calculation method, the definition of chronic kidney disease). The Repatriation Medical Authority itself is affected in its ongoing role: it must maintain the currency of this SoP and monitor medical evidence to determine whether revision is needed. Private sector ophthalmologists and general practitioners who treat veterans may be asked to provide statements linking smoking, alcohol, obesity or kidney disease to macular degeneration, placing a compliance burden on them to document timelines accurately. The SoP also affects third-party advocates such as the Returned and Services League and legal practitioners who assist with claims, as they must now advise clients on meeting the specific factor thresholds. From an economic standpoint, the instrument concentrates benefits (compensation and medical care) on those who can adduce evidence of the defined factors, while potentially excluding those whose macular degeneration arises from other causes or who lack documentary proof of, say, cumulative alcohol consumption or chronic kidney disease over five years. This creates an incentive for claimants to maximise documentation of lifestyle and health history, which may not always be feasible.

The instrument does not impose duties on private persons in the regulatory sense; rather, it creates a structured decision-making framework for the Commonwealth. The primary duty is on the Repatriation Medical Authority to have determined this SoP on the basis of sound medical-scientific evidence (as stated in section 8). Once in force, the DVA has a duty to apply the factors set out in section 9 when determining whether macular degeneration is connected to a person’s relevant service. The decision-maker must find that at least one factor existed and that it is related to service; if so, the condition is taken to be service-related unless positive evidence proves otherwise. Claimants have the right to rely on the existence of any one of the factors to establish the connection. They also have the right to adduce evidence that they satisfy a factor even if the Department does not raise it. The SoP does not create a right to automatic acceptance; it merely sets out the evidentiary hurdles. If a claimant satisfies a factor but the Department disputes that the factor is related to service (for example, the smoking occurred entirely after discharge but the onset of macular degeneration was during service), the burden falls on the claimant to show the linkage. Importantly, factor 10 (inability to obtain appropriate clinical management) can operate as a safety net where none of the lifestyle or disease factors apply. However, this factor requires evidence that clinical management was unavailable or inaccessible, which may be difficult to prove, particularly for peacetime service where medical care was generally provided. Claimants also have the right to seek review of decisions through the Veterans’ Review Board, the Administrative Appeals Tribunal, and the Federal Court. The instrument itself does not confer a right to appeal; that arises under the parent Acts. The practical right that matters is the ability to have a claim assessed under the balance of probabilities standard rather than the reasonable hypothesis standard, which applies to operational service claims. This means that for veterans covered by this SoP, the evidentiary burden is higher, requiring proven factors rather than merely plausible ones.

Strictly speaking, this instrument carries no direct penalties. It is not a penal statute; it is a delegated legislative instrument that defines the causation framework for veteran entitlements. However, the enforceability of the SoP arises through the claims process. If a decision-maker fails to apply the factors correctly, a claimant can challenge the decision and have it set aside. The primary enforcement mechanism is judicial or administrative review. The Repatriation Medical Authority itself does not enforce the SoP; it merely issues it. The Department must comply with it as a binding legislative instrument; failure to do so would be an error of law. There is no fine or sanction for non-compliance, but an incorrect decision may be reversed on review, and the decision-maker may be required to reassess the claim. The instrument also interacts with the general penalties under the VEA for fraud: a person who knowingly provides false information to satisfy one of the factors (e.g., false statements about smoking history) could face prosecution under the Criminal Code or the VEA. However, that is not unique to this SoP. The SoP itself imposes no additional penalty beyond the legal consequences of making false statements. From an economic perspective, the absence of penalties for the Department if it misapplies the factors means that the cost of erroneous denials falls on the claimant, who must bear the time and expense of review. The SoP thus structures incentives: claimants have a strong incentive to document factors thoroughly, while the Department has a weaker incentive to apply the factors generously because erroneous acceptance only shifts the cost to the public purse, whereas erroneous denial may be corrected later. The instrument’s focus on objective thresholds (pack-years, kilograms of alcohol, BMI) reduces the discretion of decision-makers, which limits both arbitrary denials and arbitrary grants, but also reduces flexibility to consider individual circumstances that fall outside the defined thresholds.

This SoP is made under subsection 196B(3) of the VEA, which confers power on the Repatriation Medical Authority to determine statements of principles for the balance of probabilities standard. It directly interacts with sections 120B of the VEA and 339 of the MRCA, which require that the Commission or MRCC be satisfied that a disease is connected to service on the balance of probabilities. The SoP provides the mandatory criteria for that satisfaction. It also interacts with other SoPs through section 11: if a factor in section 9 refers to an injury or disease that is itself covered by another Statement of Principles (e.g., chronic kidney disease or obesity), then the factors from that other SoP apply as in force from time to time. This creates a cascading effect: to prove factor 4 (chronic kidney disease) for macular degeneration, the claimant must also satisfy the SoP for chronic kidney disease. That means the evidentiary burden can be layered, increasing compliance costs. The SoP also interacts with the general law of evidence and administrative law. The Administrative Appeals Tribunal and courts may consider whether the SoP was correctly applied. The instrument repeals the earlier SoP No. 14 of 2009, meaning that any claim decided after commencement must be assessed under the new factors. Claimants who previously had their claims rejected under the old SoP may be able to reapply if the new factors differ (though the instrument does not specify this). The SoP also interacts with medical practice standards: the definitions of chronic kidney disease, anticoagulant therapy, and thrombolytic therapy use clinical criteria that align with Australian medical guidelines, but they are not necessarily identical to all clinical definitions. For example, “anticoagulant therapy” excludes antiplatelet therapy such as aspirin and clopidogrel, which may mean that a claimant taking those drugs for heart disease cannot rely on factor 9. The instrument also interacts with privacy laws: claimants must authorise the release of their medical records to prove factors such as kidney function or alcohol consumption. There is no direct interaction with workers’ compensation or motor vehicle accident insurance, but a veteran who also has a separate claim under another scheme may need to coordinate evidence. The Instrument is silent on how it interacts with state or territory health laws.

This SoP No. 60 of 2018 commenced on 23 July 2018 and replaced the earlier Statement of Principles concerning macular degeneration (Balance of Probabilities) No. 14 of 2009 (registered on the Federal Register of Legislation as F2009L01581). The 2009 SoP was repealed in its entirety by section 4 of this instrument. The user’s source text does not include the text of the 2009 SoP, so the precise differences between the two cannot be detailed without speculation. However, it is reasonable to infer that the Repatriation Medical Authority reviewed the medical evidence between 2009 and 2018 and considered that the factor thresholds (such as the 15 pack-years, the 20-kilogram alcohol threshold, the obesity duration) remained sound. The current instrument added the note that alcohol consumption is calculated utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink, which may have been clarified relative to the 2009 version. The definition of “chronic kidney disease” now includes a requirement that the abnormality be present for at least three months, whereas the 2009 SoP may have used a different timeframe or definition. The inclusion of factor 9 for anticoagulant or thrombolytic therapy causing clinical worsening of wet macular degeneration with subretinal haemorrhage may be new, as it is absent from the list of factors 1-8 which mirror the structure of earlier SoPs. The instrument also now explicitly refers to the MRCA in several places, reflecting legislative changes since 2009. The application provision (section 5) refers to both section 120B of the VEA and section 339 of the MRCA, whereas the 2009 SoP may only have referenced the VEA. This suggests an expansion of coverage. There is no sunset clause; the SoP remains in force indefinitely until repealed or amended. The amendment history outside the source would include any subsequent amendments (if any) up to the present, but the source only shows the original 2018 determination. Future amendments could adjust the factor thresholds or add new medical risk factors as evidence evolves.

The source text does not recite any case law. However, the Statement of Principles regime has generated significant litigation in the Administrative Appeals Tribunal and federal courts. While no specific cases are cited, it is well known that decisions applying SoPs are subject to review. Claims under this instrument could be challenged on the basis that the Repatriation Medical Authority did not have sound medical-scientific evidence for a particular factor, or that the decision-maker misapplied the temporal window (e.g., whether smoking commenced at least five years before clinical onset). The instrument itself does not create a right to sue; it merely provides the criteria for decision. The AAT has often considered whether the factors in an SoP have been met, and whether the relationship to service exists. For instance, the definition of “pack-years” might be contested where a claimant smoked roll-your-own cigarettes with irregular tobacco content. The exclusion of toxic retinopathy from the definition of macular degeneration could also be litigated if a claimant’s condition results from drug toxicity rather than degenerative disease. The catch-all factor of inability to obtain appropriate clinical management (factor 10) is a potential source of dispute: what constitutes “inability” and what is “appropriate clinical management”? There is no case law in the source, but in practice, the AAT has interpreted these phrases restrictively, requiring evidence of actual unavailability or refusal of treatment, not mere inconvenience. The instrument’s application only to “relevant service” (excluding operational service) means that veterans who served in combat may seek to characterise their service as operational to escape this SoP and access the lower threshold. Thus, there may be litigation over whether a veteran’s service qualifies as relevant service for the purpose of this SoP. The instrument’s repeal of the 2009 SoP and its prospective operation might also lead to arguments about whether the new factors should be applied to claims that were lodged before commencement but not yet decided. The instrument is silent on transitional provisions, so the general rule that delegated legislation applies from commencement would likely apply. This could cause unfairness if a claimant had arranged evidence under the old SoP.

Several subtle points in the instrument can trip up both claimants and decision-makers. First, the smoking factor requires not only 15 pack-years but also that smoking commenced at least five years before clinical onset. A claimant who started smoking two years before diagnosis cannot rely on that factor, even if they smoked heavily for decades before onset. Furthermore, if smoking ceased, the onset must occur within 20 years of cessation. This means an ex-smoker who stopped 25 years ago is excluded, even though the 15 pack-years may have been accumulated earlier. The alcohol factor requires a cumulative total of 20 kilograms of alcohol (2,000 standard drinks) in a continuous period of two years within the five years before onset. That is a very high threshold: roughly 27 standard drinks per week every week for two years. Many people who drink heavily but irregularly (e.g., binge drinkers) may not meet the “continuous period of two years” test, as the definition requires a continuous two-year block, not just a cumulative total over five years. The obesity factor requires being obese (BMI >= 30) for at least five years before onset. BMI is defined as weight in kilograms divided by the square of height in metres. The instrument does not specify how to determine the “starting point” of the five-year period; claimants will need medical records showing weight and height over time. Chronic kidney disease must be present for at least the three months before diagnosis, and must have existed within the five years before onset. Factor 9 applies only to clinical worsening of wet macular degeneration manifesting as subretinal haemorrhage only. If the worsening involves other complications such as exudation or fibrosis without haemorrhage, factor 9 does not apply. Also, factor 9 only applies to anticoagulant or thrombolytic therapy within seven days before the worsening. Antiplatelet drugs (e.g., aspirin, clopidogrel) are expressly excluded. A claimant on aspirin for heart disease cannot rely on this factor. Factor 10 (inability to obtain appropriate clinical management) is a last resort, but the claimant must prove that the inability existed and that it contributed to the worsening. For peacetime service where full medical cover was provided, this may be very hard to establish. The relationship to service requirement (section 10) means that even if a factor exists, it must be related to the person’s service. For example, smoking that occurred wholly after discharge is unlikely to be related to service unless the smoking habit was caused or exacerbated by service-related stress. The instrument does not define “related to service” further, leaving room for factual disputes. Finally, the instrument applies only to “relevant service” as defined. Claimants who served on operational service or hazardous service cannot use this SoP at all; they are assessed under a different standard, which may have different factors. A common mistake is to assume this SoP covers all veterans.

For a veteran or defence member seeking to establish that macular degeneration is connected to service, compliance means gathering documentary evidence that satisfies at least one factor under section 9. The easiest factor to prove may be smoking history, if the claimant has clear records of daily cigarette consumption over a period equivalent to 15 pack-years. Ideally, the evidence should include statements from the claimant, corroboration from partners or medical records documenting smoking habits, and evidence of the date of clinical onset of macular degeneration (from an optometrist or ophthalmologist report). The timing windows must be checked: the smoking must have started at least five years before onset, and if ceased, the onset must be within 20 years. For alcohol consumption, the claimant must produce evidence of at least 20 kg of alcohol over a continuous two-year period within the five years before onset. This could be shown by hospital records documenting alcohol-related admissions, self-reports corroborated by family, or attendance at alcohol treatment programs. The Australian Standard of 10g alcohol per drink applies. For obesity, the claimant needs medical records showing BMI of 30 or greater for at least five years continuously before onset. Annual health checks are useful. For chronic kidney disease, the claimant must have evidence of an abnormality of kidney structure or function (e.g., eGFR <60 mL/min/1.73 m2, or kidney damage markers) that has been present for at least three months, and within five years before onset. For factor 9, the claimant must show that the worsening of wet macular degeneration manifesting as subretinal haemorrhage occurred within seven days of receiving anticoagulant or thrombolytic therapy. The medical records must specify the drug administered and the date. For factor 10, the claimant must show that appropriate clinical management for macular degeneration (such as anti-VEGF injections) was unavailable or inaccessible, and that this inability contributed to the worsening. The Department’s decision-maker must comply by ensuring that each claimed factor is verified against the instrument’s definitions. They must check the temporal relationships (the factor must exist before the clinical event) and the relationship to service. If a factor refers to another disease (e.g., chronic kidney disease), the decision-maker must apply the SoP for that disease as in force. Claimants and advisors should keep a checklist: (1) confirm that the person rendered relevant service; (2) establish date of clinical onset and/or date of clinical worsening; (3) identify whether the claim is for onset or worsening; (4) for worsening, confirm that the disease was suffered before or during service and did not arise out of service; (5) gather evidence for at least one factor, including the required timeframe; (6) ensure the factor is related to service (e.g., smoking during service, or obesity caused by service-related injury). Documentation should be compiled in a service treatment record review. Legal advisers should be alert to the possibility that no factor applies: in that case, the claim will likely fail unless the SoP can be challenged as invalid.