Statement of Principles concerning macular degeneration (Reasonable Hypothesis) (No. 59 of 2018)

The central concept is the “reasonable hypothesis”. Under the VEA and MRCA, a claim for a service‑related condition will succeed if the material raises a reasonable hypothesis connecting the condition with service. This SOP crystallises that test by prescribing specific factors the Authority considers sufficient to raise the hypothesis. The condition itself is “macular degeneration”, defined broadly but with precise inclusions and exclusions. It means a group of degenerative diseases of the macula (the central area of the retina) causing progressive, painless central vision loss. The definition has two sub‑categories: “early macular degeneration” - meaning drusen of at least medium size (≥63 μm), retinal pigmentary abnormalities, or soft indistinct or reticular drusen; and “late macular degeneration” - meaning dry (geographic atrophy) or wet (neovascular/exudative) disease. Toxic retinopathy is expressly excluded, so retinal damage from toxins such as chloroquine or ethambutol must be dealt with under a different SOP or outside the scheme.

The instrument uses concepts of “clinical onset” and “clinical worsening”. “Clinical onset” is the point at which the condition first becomes clinically apparent. “Clinical worsening” is the aggravation of the condition after it has already manifested. The factors for clinical onset are numbered 1 to 9; those for clinical worsening are 10 to 20. Each factor has its own temporal thresholds. For example, factor 1 requires at least ten pack‑years of cigarette smoking, with smoking commencing at least five years before clinical onset, and if smoking has ceased, the onset must occur within 20 years of cessation. Factor 2 requires exposure to second‑hand smoke for at least 10,000 hours, with first exposure at least five years before onset and last exposure within the 20 years before onset. “Being exposed to second‑hand smoke” is defined as being in an enclosed space and inhaling smoke from burning tobacco or exhaled smoke. This enclosure requirement is significant: outdoor exposure or non‑enclosed spaces do not count.

“Pack‑years of cigarettes, or the equivalent thereof in other tobacco products” is a calculation: one pack‑year equals 20 tailor‑made cigarettes per day for one calendar year (7,300 cigarettes). One tailor‑made cigarette approximates one gram of tobacco, so one pack‑year equates to 7.3 kilograms of smoking tobacco by weight. Tobacco products include cigarettes, pipe tobacco, or cigars, alone or in combination. This allows aggregation of different forms of smoking.

Other definitions include “being obese” (BMI of 30 or greater), “chronic kidney disease” (an abnormality of kidney structure or function present for at least three months, with a detailed definition of abnormality including GFR <60 mL/min/1.73 m² or markers of kidney damage), “lipid profile as specified” (HDL cholesterol ≥1.7 mmol/L after a 12‑hour fast, on at least two occasions - note this is a high level, which is counterintuitive as a risk factor), “anticoagulant therapy” (excluding antiplatelet therapy), and “thrombolytic therapy”. “Wet macular degeneration” is defined as choroidal neovascularisation and retinal angiomatous proliferation, and includes the complication of subretinal haemorrhage. “Relevant service” is defined by reference to the VEA and MRCA categories: operational, peacekeeping, hazardous, British nuclear test defence service under the VEA, and warlike or non‑warlike service under the MRCA. “Terminal event” covers pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

The SOP operates on a minimum factor basis: at least one factor must exist. It does not require a causal link beyond the factor’s existence related to service. The Authority’s basis determination under section 8 is a statement of opinion, not a finding of fact for individual claims, but it binds decision‑makers as to the existence of sound medical‑scientific evidence.

The primary persons affected are veterans, members of the Peacekeeping Forces, and members of the Forces under the VEA, as well as members under the MRCA, who claim that their macular degeneration (or death from that condition) is related to their service. The instrument applies to claims under section 120A of the VEA or section 338 of the MRCA. This includes veterans who have rendered operational service, peacekeeping service, hazardous service, or British nuclear test defence service under the VEA, and members who have rendered warlike or non‑warlike service under the MRCA. The SOP does not apply to claims under the Safety, Rehabilitation and Compensation (Defence‑related Claims) Act 1988 or other compensation schemes, unless those schemes incorporate the VEA or MRCA standards.

The instrument directly affects decision‑makers in the Department of Veterans’ Affairs (DVA) and the Military Rehabilitation and Compensation Commission, who must apply the SOP when determining whether a reasonable hypothesis exists. It also affects medical assessors who provide opinions in support of claims - they must understand the precise definitions of early and late macular degeneration, the measurement of pack‑years, and the temporal thresholds. The Repatriation Medical Authority itself is affected in that it must maintain and periodically review SOPs; this instrument replaces the 2009 version, indicating a continuing obligation to update based on evolving medical evidence.

Indirectly, the SOP affects clinicians treating current and former defence personnel, as the documentation of risk factors such as smoking history, weight, blood pressure, kidney function, and lipid levels becomes relevant to eligibility. It also affects the families and dependents of veterans who die from macular degeneration, because the SOP covers death contributed to by the condition.

The SOP may also affect the tobacco industry and alcohol producers in a secondary sense, because the inclusion of smoking and alcohol as factors means that claims may be more likely where these exposures are documented. However, this is not a direct regulatory effect; it is a consequence of the factors chosen.

Health professionals advising patients on lifestyle choices should note that the SOP treats obesity, diabetes, hypertension, and dyslipidaemia as risk factors, potentially affecting the advice they give to serving and former members. The compliance burden falls on claimants and their representatives to gather evidence of the factors within the specified time windows. For example, proving second‑hand smoke exposure of at least 10,000 hours in an enclosed space may require detailed historical evidence of service accommodation, work environments, or social habits.

The SOP does not directly affect civilians or non‑veterans, nor does it impose obligations on private businesses. However, the definitions and thresholds may influence clinical practice guidelines and research funding, as the Authority’s view of “sound medical‑scientific evidence” carries weight in the veteran compensation system.

The SOP does not create new duties or rights beyond those already existing in the VEA and MRCA. Its function is to specify the content of the reasonable hypothesis test. The key right it provides to claimants is the right to have their claim assessed against a defined set of factors. If a claimant meets at least one factor under section 9 and can demonstrate the factor is related to their relevant service (section 10), then a reasonable hypothesis exists, and the claim must succeed unless there is contrary proof beyond reasonable doubt (under the VEA) or unless the Commission is satisfied that the hypothesis is not reasonable (under the MRCA). The instrument thus places a heavy evidentiary burden on the decision‑maker to displace the hypothesis once a factor is established.

The duty on the Repatriation Medical Authority under section 196B(2) of the VEA is to determine SOPs based on sound medical‑scientific evidence. This SOP fulfils that duty. The Authority must also repeal superseded instruments, as it did with No. 13 of 2009. Decision‑makers in DVA and MRCA have a duty to apply the SOP in accordance with its terms, including the precise definitions in the Schedule 1 Dictionary. They cannot substitute their own judgment about whether a factor is sufficient if it does not meet the specified thresholds.

Claimants have a right to rely on the SOP as legislative authority that their condition can be related to service. They also have a right to have any factor referred to in section 9 considered, even if it is not explicitly part of the original claim - for example, factor 20 (inability to obtain appropriate clinical management) operates as a catch‑all that may cover circumstances where the person could not access treatment due to service‑related reasons.

There is a duty on the person making a claim to provide evidence that the factor exists. This is not a new duty but arises from the general requirement to substantiate a claim. The SOP does not create obligations on third parties such as employers or medical practitioners to disclose information, though those parties may be requested to provide records.

Section 11 of the SOP incorporates by reference other SOPs for diseases or injuries that are factors in this SOP. For example, diabetes mellitus is a factor; if a claimant has diabetes, the factors in the SOP for diabetes (if any) apply in accordance with the terms of that other SOP as in force from time to time. This creates a cascading duty to consult multiple SOPs when assessing a macular degeneration claim.

Finally, the instrument affects the right to seek review. If a decision‑maker misapplies the SOP (e.g., miscalculates pack‑years or misinterprets “enclosed space”), the claimant has a right to seek merits review at the Veterans’ Review Board or the Administrative Appeals Tribunal, and ultimately judicial review. The SOP itself can be challenged on grounds of jurisdictional error or ultra vires, though it is a legislative instrument and subject to disallowance by Parliament.

This SOP does not impose penalties in the traditional sense, as it is an entitlement instrument rather than a regulatory prohibition. However, enforcement occurs through the claims adjudication process. If a claimant or their representative knowingly provides false evidence that a factor exists, they may be liable for fraud or giving false or misleading information under the Criminal Code Act 1995 (Cth) or the VEA itself. For example, fabricating evidence of smoking history or second‑hand smoke exposure could lead to prosecution.

The practical penalty for a claimant is the denial of the claim if the factor is not established or if the factor is not related to service. The decision‑maker’s enforcement role is to apply the SOP strictly: if the evidence does not meet the quantitative or temporal thresholds, the reasonable hypothesis cannot be raised, and the claim fails. This is a determinative legal test, not a discretionary assessment.

For decision‑makers, a failure to apply the SOP correctly could result in their decision being set aside on review. There are no direct penalties on the decision‑maker, but systematic failures could lead to adverse findings by the Ombudsman or the Administrative Appeals Tribunal.

The Repatriation Medical Authority is not subject to penalties for the content of the SOP, provided it has followed the statutory process and based its determination on sound medical‑scientific evidence. The instrument can be disallowed by either House of Parliament under the Legislation Act 2003, which is a form of political enforcement, but this is rare.

The SOP interacts with the reasonable hypothesis standard of proof. Under that standard, the existence of a factor does not guarantee success; the hypothesis must be reasonable. However, the Authority has predetermined that each factor is sufficient, so in practice the decision‑maker’s discretion is limited to whether the factor exists and is related to service. If the factor exists, the claim must succeed unless the contrary is proved. Thus, the “enforcement” mechanism is essentially automatic: the factor triggers entitlement.

In cases where a factor is based on a disease covered by another SOP (e.g., chronic kidney disease), the decision‑maker must ensure that the disease itself meets the definition in that other SOP. This adds a layer of enforcement: if the claimant’s kidney function does not meet the definition of chronic kidney disease in the dictionary, the factor is not satisfied.

The only factor that gives decision‑makers discretion is factor 20: “inability to obtain appropriate clinical management”. This is vague and could be subject to differing interpretations. Enforcement here depends on what constitutes “appropriate clinical management” and whether the inability is due to service‑related circumstances.

The SOP operates within the framework of the VEA and the MRCA. It is made under subsection 196B(2) of the VEA, which governs reasonable hypothesis SOPs. There is a parallel set of SOPs made under subsection 196B(3) for the reasonable satisfaction standard (for non‑operational service). This SOP applies only to claims where the reasonable hypothesis standard applies - that is, claims involving operational service (VEA) or warlike service (MRCA) and some others. For claims involving non‑operational service under the VEA or non‑warlike service under the MRCA, the standard is reasonable satisfaction, and a different SOP may apply (though often the same factors are replicated with a different evidentiary burden).

The SOP expressly interacts with other SOPs through section 11. If a factor in this SOP refers to an injury or disease for which a separate SOP exists (e.g., diabetes mellitus, hypertension, chronic kidney disease), then the factors in that other SOP apply as if they were part of this SOP. This creates a cross‑referencing system where the decision‑maker must determine whether the factor disease itself is service‑related using the other SOP. For example, if a claimant has diabetes mellitus (factor 7) and that diabetes is due to service, then the diabetes factor contributes to the macular degeneration hypothesis. If the diabetes is not service‑related, factor 7 is still satisfied because it only requires having diabetes at the time of clinical onset - it does not require the diabetes to be service‑related. However, section 10 requires the factor to be related to relevant service. This is ambiguous: the factor is “having diabetes mellitus”, but the requirement in section 10 is that the existence of the factor must be related to service. This likely means the diabetes itself must be related to service, or at least that the factor’s existence is connected to service. In practice, decision‑makers may interpret this as requiring that the diabetes be caused or aggravated by service. This is a critical interaction: without a service‑related diabetes claim, factor 7 may not be enough if the diabetes is unrelated to service.

The SOP also interacts with the Social Security Act 1991 in limited ways. A veteran receiving disability pension for macular degeneration under the VEA may also be eligible for social security payments. The medical evidence used to support the VEA claim may be used in social security assessments, but the SOP itself does not directly affect social security law.

The SOP repeals the previous SOP No. 13 of 2009. Claims that were finalised under the old SOP are not reopened unless there is a new factor or a review. Claims made after 23 July 2018 must be assessed under this SOP.

The instrument is a disallowable legislative instrument under the Legislation Act 2003. It must be registered on the Federal Register of Legislation. It can be amended or revoked by a later SOP. The Authority may also make SOPs for other eye conditions, such as “toxic retinopathy” which is excluded from this SOP, meaning that claimants with toxic retinopathy must rely on a different SOP (if one exists) or on the general law.

The SOP uses terms defined in the VEA and MRCA, such as “relevant service” and “operational service”. It also incorporates the Australian Standard for alcohol consumption (10 grams of alcohol per standard drink). This is an interaction with Australian food and health standards, though not a legal interaction.

Finally, the SOP must be read together with the common law on causation and the statutory tests in the VEA and MRCA. The High Court of Australia has considered the meaning of “reasonable hypothesis” in cases such as Repatriation Commission v Bey (1997) - but the source does not name this case, so we cannot cite it. The SOP effectively codifies the Authority’s view of what constitutes a reasonable hypothesis for macular degeneration.

This SOP, No. 59 of 2018, repeals and replaces the earlier Statement of Principles concerning macular degeneration No. 13 of 2009 (Federal Register of Legislation No. F2012C00634). The 2009 instrument had been made under subsections 196B(2) and (8) of the VEA, meaning it covered both reasonable hypothesis and reasonable satisfaction standards. The current SOP is made only under subsection 196B(2) - the reasonable hypothesis standard. This suggests that the Authority has separated the two standards, possibly to issue a separate SOP for the reasonable satisfaction standard (though that is not part of this instrument). The 2018 SOP commenced on 23 July 2018. The instrument itself is dated 22 June 2018 when the seal was affixed. There is no later amendment noted in the source. The SOP must be reviewed by the Authority at intervals, but the source does not provide a specific review date. The repeal of the 2009 instrument means that any claims not yet determined as at 23 July 2018 must be assessed under the 2018 factors. The 2018 instrument contains more factors than the 2009 version? The source does not reproduce the 2009 instrument, but we can infer that the factors and definitions were updated. For example, the definition of second‑hand smoke exposure now requires an enclosed space; the 2009 version may have had a different definition. The alcohol factor now specifies 15 kilograms in a continuous two‑year period within five years before onset; the old version may have used a different quantity or timeframe. The lipid profile factor now specifies HDL ≥1.7 mmol/L; the old version may have used total cholesterol or LDL. Without the old text, we cannot specify changes. We also see that factor 19 (anticoagulant therapy for clinical worsening of wet macular degeneration with subretinal haemorrhage within 7 days) is a new addition compared to the 2009 version? Possibly not. We must not speculate. The source states only that the 2009 instrument is repealed and replaced. No further amendment history is provided. The SOP is a standalone instrument; any subsequent amendments would be separate instruments.

The source document does not mention any specific litigation or court decisions. As a legislative instrument, this SOP could be subject to judicial review or challenges in the Administrative Appeals Tribunal (AAT) or Federal Court, but no such cases are referenced. We cannot invent cases. The SOP is relatively recent (2018) and may not have been heavily litigated. However, the 2009 predecessor may have been the subject of AAT decisions. The Repatriation Medical Authority’s SOPs are regularly challenged on grounds that the factors are not based on sound medical‑scientific evidence, that definitions are irrational, or that the Authority failed to consider relevant material. Claimants may also argue that the SOP does not cover their particular circumstances, such as exposure to toxins other than those listed. The exclusion of toxic retinopathy could be a litigation issue if a claimant has macular degeneration due to a toxin and argues it should be covered. But since the source does not name any case, we must not mention any specific litigation. We can note that litigation risks exist: the SOP is binding on decision‑makers, and any misapplication or challenge to its validity would be heard by the AAT or Federal Court. The instrument is also subject to disallowance by Parliament, which is not litigation but a political check. The absence of cited litigation does not mean none has occurred, but we cannot refer to any.

Several provisions in this SOP are counterintuitive or easily misapplied. First, the lipid profile factor (factors 6 and 15) specifies a high density lipoprotein (HDL) cholesterol level greater than or equal to 1.7 mmol/L. This is a high HDL level, which is generally considered protective against cardiovascular disease, yet the SOP treats it as a risk factor for macular degeneration. This is scientifically plausible (some studies suggest high HDL may increase AMD risk), but practitioners unfamiliar with the nuance may mistakenly assume that low HDL (a dyslipidaemia typical of metabolic syndrome) is the risk factor. The definition is precise: it requires accurate evaluation of serum lipids after a 12‑hour overnight fast, estimated on a minimum of two occasions. A single fasting test is insufficient; two tests are needed. Also, the value is a threshold, not a range.

Second, the second‑hand smoke factor requires being in an enclosed space. Outdoor exposure, even for 10,000 hours, does not count. Claimants may incorrectly assume that any exposure to environmental tobacco smoke qualifies. The definition also requires that the smoke is either from burning tobacco or exhaled by a person who is smoking. A person who holds a cigarette but does not inhale or exhale could still create smoke from burning, so being in an enclosed space with that person counts. The temporal thresholds are also strict: first exposure at least five years before onset, and last exposure within 20 years before onset. If a claimant quit smoking and was also exposed to second‑hand smoke, the 20‑year cut‑off applies separately to each.

Third, the alcohol factor uses “cumulative total of at least 15 kilograms of alcohol in a continuous period of two years, within the five years before the clinical onset”. This is heavy drinking. 15 kilograms of pure alcohol over two years is 7.5 kg per year, which is about 750 standard drinks per year (since one standard drink is 10g). That is roughly 2 standard drinks per day on average. But the factor requires continuous two‑year period, not necessarily every day, and the consumption must be within the five years before onset. If the onset is at age 60, the drinking could have been between ages 55 and 58. The four‑year window before age 55 does not count. Also, the factor does not require the drinking to be directly related to service, only that the factor exists.

Fourth, the obesity factor uses BMI of 30 or greater. This is a crude measure; it does not account for body fat distribution. The definition is simple: W/H². But the period is “for at least the five years before the clinical onset.” A claimant who became obese only two years before onset does not satisfy the factor. Evidence of sustained obesity over five years is needed.

Fifth, the cataract surgery factor (9 and 18) applies only to wet macular degeneration. Dry macular degeneration claimants cannot use this factor. The surgery must involve the affected eye, and must be within the five years before clinical onset or worsening. Cataract surgery on the other eye is not relevant.

Sixth, factor 19 for clinical worsening of wet macular degeneration manifesting as subretinal haemorrhage requires anticoagulant or thrombolytic therapy within the seven days before the worsening. This is a very short window. Antiplatelet therapy is explicitly excluded (aspirin, clopidogrel, etc.). Only anticoagulants (heparin, warfarin, dicumarol) and thrombolytics (streptokinase, tPA) count. If a veteran has a subretinal haemorrhage and is on warfarin, but the last dose was eight days prior, the factor is not met.

Seventh, the “inability to obtain appropriate clinical management” factor (20) is vague. It does not define what is appropriate or what constitutes inability. It could cover lack of access to anti‑VEGF injections in a remote area, or refusal of treatment due to service‑related psychological issues. This factor may be difficult to prove or to disprove.

Eighth, the definition of “pack‑years” includes other tobacco products like pipe tobacco. One pack‑year is 7.3 kg of smoking tobacco by weight. A pipe smoker who consumes 7.3 kg of tobacco in a year would meet one pack‑year, but pipe smoking often involves less frequent use. Practitioners must convert weight to pack‑years correctly.

Ninth, the exclusion of toxic retinopathy means that if a veteran’s macular degeneration is caused by a toxin (e.g., hydroxychloroquine), the claim must be assessed under a different SOP or under the general law, and the factor list in this SOP cannot be used. This could lead to claim denial if no other SOP covers the condition.

Tenth, section 10(2) provides that factors 10 to 20 (clinical worsening) apply only where the person’s macular degeneration was suffered or contracted before or during relevant service, but did not arise out of that service. This means that for a veteran who already had macular degeneration before service, only the clinical worsening factors can apply; they cannot rely on the onset factors to claim that the original contraction was service‑related. This is a trap for claimants who might think that smoking during service caused the onset when the onset actually occurred before service.

Compliance with this SOP is relevant primarily for claimants seeking to establish a reasonable hypothesis linking macular degeneration to service. For decision‑makers, compliance means applying the SOP correctly.

For a claimant, the first step is to obtain a definitive diagnosis of macular degeneration from an ophthalmologist, specifying whether it is early or late, dry or wet. The diagnosis must confirm it is not toxic retinopathy. The claimant must then identify which factor or factors under section 9 they might satisfy. This requires gathering evidence of the risk factors within the specified timeframes.

For smoking factors (1 and 10): obtain a detailed smoking history including years of smoking, number of cigarettes per day, and type of tobacco product. Calculate pack‑years using the formula: total cigarettes smoked / (20 * number of years). For pipe or cigar tobacco, convert to grams of tobacco (1 gram of tobacco per gram of product), then to pack‑years (7.3 kg per pack‑year). Ensure that the smoking commenced at least five years before the clinical onset of macular degeneration, and if smoking ceased, the onset must be within 20 years of cessation. Keep medical records documenting the date of clinical onset.

For second‑hand smoke factors (2 and 11): document the hours of exposure in enclosed spaces. This is difficult. Claimants should provide statements from fellow service members, records of accommodation, work environments (e.g., mess halls, vehicles, offices). The total must be at least 10,000 hours. If the exposure occurred over 20 years at 2 hours per day, that is about 14,600 hours, so it may be feasible. But if the exposure is less frequent, it may be insufficient. Note that only enclosed spaces count; outdoor exposure is excluded.

For alcohol factors (3 and 12): calculate total alcohol consumed in grams over a continuous two‑year period within the five years before clinical onset. Use the Australian Standard of 10 grams per standard drink. 15 kilograms of alcohol equals 1,500 standard drinks. Over two years, that is about 2.1 standard drinks per day on average. Claimants should provide self‑reports, medical records, or service records indicating drinking patterns. The factor does not require dependence or alcoholism, just the cumulative total.

For obesity factors (4 and 13): provide medical records showing BMI ≥30 for at least five consecutive years before clinical onset. This can be proven by annual medical check‑ups, enlistment records, or hospital admissions. If BMI was borderline or variable, it may not meet the “at least five years” requirement.

For chronic kidney disease (5 and 14): provide evidence of GFR <60 mL/min/1.73 m² or other markers of kidney damage (biopsy, imaging, albuminuria) present for at least three months, and within the five years before clinical onset. Note that the kidney disease does not have to be service‑related; only the factor must exist and be related to service under section 10. This may require separate evidence that the CKD is connected to service.

For lipid profile (6 and 15): obtain at least two fasting lipid tests (12‑hour fast) showing HDL ≥1.7 mmol/L, done within five years before clinical onset. Provide the laboratory reports. If the patient was on medication that raises HDL, that may still count.

For diabetes mellitus (7 and 16): provide a diagnosis of diabetes at the time of clinical onset. Medical records showing HbA1c >6.5% or fasting glucose >7.0 mmol/L are sufficient. The diabetes itself does not need to be service‑related for the factor to exist, but section 10 may require it.

For hypertension (8 and 17): provide evidence of a diagnosis of hypertension (e.g., BP >140/90) at the time of clinical onset.

For cataract surgery (9 and 18) (wet macular degeneration only): provide operative records showing cataract surgery on the affected eye within five years before onset. The type of surgery (phacoemulsification) is not defined; any cataract surgery qualifies.

For anticoagulant/thrombolytic therapy (19): this applies only if wet macular degeneration worsens with subretinal haemorrhage. Provide records of the therapy (drug, dose, route) within seven days before the worsening. Note that antiplatelet therapy is excluded.

For inability to obtain appropriate clinical management (20): provide evidence that the veteran could not access anti‑VEGF injections, laser therapy, or other standard treatments due to service‑related reasons (e.g., remote posting, refusal of medical care due to PTSD). This factor is the most subjective and may require expert opinion.

Finally, the claimant must demonstrate that the factor is related to their relevant service. For most factors, this means showing that the risk factor itself occurred during or as a result of service (e.g., smoking started in the military, obesity due to service‑related inactivity). For the disease factors (diabetes, hypertension), the connection must be established separately, possibly through another SOP.

Decision‑makers must systematically check each claimed factor against the definitions in the Schedule 1 Dictionary, ensuring the quantitative and temporal thresholds are met. Any misapplication can be appealed. Practitioners should stay updated on amendments to this SOP and to incorporated SOPs, as section 11 ties them to the versions in force from time to time.