Statement of Principles concerning aplastic anaemia (Balance of Probabilities) (No. 59 of 2020)

The central concept is aplastic anaemia as defined in subsection 7(2). It means bone marrow failure characterised by (i) destruction of haematopoietic stem cells with peripheral blood cytopaenia and (ii) hypocellular bone marrow in which normal haematopoietic tissue is replaced by fatty marrow. This definition excludes inherited bone marrow failure syndromes (Fanconi anaemia, dyskeratosis congenita, Shwachman-Diamond syndrome, inherited amegakaryocytic thrombocytopaenia), isolated leukopaenia or thrombocytopaenia, myelodysplastic syndrome, paroxysmal nocturnal haemoglobinuria, and replacement of bone marrow due to fibrosis or infiltrative neoplasm. The ICD-10-AM codes D61.1, D61.2, D61.3 or D61.8 are referenced but the definition controls over the codes. This matters because a claimant may have an ICD code that matches but still not meet the definition if an exclusion applies, or conversely may meet the definition with a different code.

Balance of probabilities is the standard of proof under which this SoP operates. Unlike the reasonable hypothesis standard used for operational service, the claimant must prove it is more probable than not that at least one factor existed and relates to service. This is a lower threshold than beyond reasonable doubt but higher than reasonable hypothesis.

Relevant service is defined narrowly in the Schedule 1 dictionary: 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 with operational service or hazardous service are not covered by this SoP; they would be assessed under the reasonable hypothesis SoP (if one exists) or directly under the VEA reverse onus provisions. The distinction is critical because it determines what evidence the claimant must produce.

Being exposed to benzene as specified is a defined term requiring cutaneous contact with liquids containing benzene greater than 1 per cent by volume, ingesting such liquids, or inhaling benzene vapour at an ambient 8-hour time-weighted average concentration exceeding five parts per million. The definition uses an 8-hour TWA averaging method, not a peak concentration. This sets a high threshold for inhalational exposure, potentially excluding veterans exposed at lower levels for shorter periods.

The specified list of autoimmune diseases includes ABO mismatched haematopoietic stem cell transplant, eosinophilic fasciitis, graft versus host disease, hyperimmunoglobulinaemia, hypoimmunoglobulinaemia, and systemic lupus erythematosus. This list is exclusive; other autoimmune diseases are not accepted factors under 9(8) even if they might plausibly cause aplastic anaemia.

Terminal event is defined for death from aplastic anaemia: pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. This broadens the connection: death does not need to be from aplastic anaemia per se but can be from a terminal event that was contributed to by the anaemia.

The factors themselves in section 9 also introduce the concept of clinical onset versus clinical worsening. Factors 9(1) to (10) relate to clinical onset; factors 9(11) and (12) relate to clinical worsening and apply only to material contribution or aggravation where the aplastic anaemia was suffered or contracted before or during (but did not arise out of) relevant service. That is a significant limitation for aggravation claims.

Schedule 2 lists 52 specified drugs, from alkylating agents through to zidovudine, including common drugs like fluoxetine, carbamazepine, and allopurinol, as well as less common ones like ganoderma (a fungus extract). The drug factor (9(2)) requires treatment within the six months before clinical onset. There is also factor 9(3) for drug therapy where the individual develops aplastic anaemia within six months and it improves within six months of discontinuing or tapering; this factor does not require the drug to be listed in Schedule 2, but only that there is an individual association.

The primary group affected is veterans and members of the Defence Force who have rendered relevant service as defined: eligible war service (non-operational), defence service (non-hazardous), or peacetime service under the MRCA. Those with operational service or hazardous service are not subject to this SoP; they are covered by other provisions in the VEA that may apply a lower evidentiary standard. For veterans with peacetime service, this SoP is often the central tool for determining whether aplastic anaemia is service-related.

The instrument also affects dependents of such veterans or members who make claims for compensation after death from aplastic anaemia. The definition of death includes terminal event contributed to by aplastic anaemia, so dependents must demonstrate the causal chain via the factors.

Medical practitioners who provide evidence in support of claims must understand the definitions and thresholds. For example, they may need to attest to the specific type of bone marrow failure, exclude inherited syndromes, quantify benzene exposure, or confirm the temporal relationship between drug therapy and onset. The definition of aplastic anaemia excludes many conditions that might be clinically similar, so a misdiagnosis could lead to a failed claim.

The Repatriation Commission and the Military Rehabilitation and Compensation Commission are bound by this SoP when assessing claims. Their decision-makers must apply the factors strictly; if a claimant does not meet at least one factor, the claim must be rejected even if the medical evidence suggests a possible causal link. The SoP reduces discretion, which benefits consistency but may produce harsh results where the scientific evidence does not fit the listed factors.

Veterans' advocates and legal practitioners must navigate the specific requirements, especially the exposure thresholds and drug list. The 45-day requirement for benzene and organophosphates means that sporadic exposure may be insufficient even if the total dose is significant. The drug list includes many commonly prescribed medications, so a claimant who took cimetidine or fluoxetine may have a straightforward factor, but the six-month window must be met.

The Repatriation Medical Authority itself is the maker of the SoP. Its members are medical experts who must base the factors on sound medical-scientific evidence. They must decide which exposures and associations are sufficiently proven to warrant inclusion. Their choices have direct financial and personal consequences for claimants.

Other government agencies that rely on the VEA or MRCA, such as the Department of Veterans' Affairs Appeals teams and the Veterans' Review Board, use this SoP as authoritative. The Administrative Appeals Tribunal also applies it on review.

Economically, the SoP determines the probability of a successful claim, which affects the cost of the veterans' compensation system. By narrowing or widening the accepted factors, the RMA effectively budgets for future claims. Claimants have an incentive to produce evidence that matches the factors, which may drive them to seek specific medical opinions or exposure assessments, increasing transaction costs.

The SoP itself does not create duties that private actors must perform, but it imposes duties on decision-makers. The Repatriation Commission and the Military Rehabilitation and Compensation Commission have a duty to apply section 120B of the VEA or section 339 of the MRCA by using the SoP as the standard for determining whether aplastic anaemia is related to service. They must consider the factors in section 9 and determine whether at least one is satisfied on the balance of probabilities. If satisfied, they must find that the condition is related to service unless there is contrary evidence that displaces the presumption. The Commission also has a duty under section 196B to apply the current SoP; using an outdated one would be an error of law.

The RMA has the duty under section 196B(2) and (3) to determine SoPs based on the sound medical-scientific evidence available. This duty is ongoing; they must review and revoke or replace SoPs if the evidence changes. The repeal of the 2012 SoP and commencement of this 2020 SoP represents the exercise of that duty.

Claimants have the right to have their claim assessed under this SoP if they meet the definition of relevant service. They do not have a right to a different standard; the SoP is binding. However, they have a right to present evidence that satisfies one of the factors. If the Commission rejects their claim, they have a right to seek review by the Veterans' Review Board or the Administrative Appeals Tribunal, and ultimately judicial review in the Federal Court.

Claimants also have a duty to provide sufficient evidence to establish a factor. This is not an evidentiary burden created by the SoP itself but by the general provisions of the VEA. The practical effect is that a claimant diagnosed with aplastic anaemia must produce medical records confirming the definition excludes inherited syndromes, must provide evidence of the timing of onset relative to service, and must show exposure or treatment meeting the specifications. The benzene threshold requires detailed exposure history, potentially including industrial hygiene reports.

The right to benefit from factor 9(3) is noteworthy: it allows a claimant whose aplastic anaemia was linked to any drug (not just those in Schedule 2) if the individual temporal relationship is established. This gives some flexibility for novel drugs not listed. However, the duty to prove both development within six months and improvement within six months of discontinuation is stringent; in practice, such evidence may only be available if the drug was stopped and the condition remitted, which does not always happen.

Section 11 provides that if a factor refers to an injury or disease covered by another SoP (e.g., chronic lymphocytic leukaemia under factor 9(9)), the factors in that other SoP apply. This cross-reference imposes a duty on the claimant to also satisfy the SoP for the referenced condition. It prevents a claimant from relying on a diagnosis that is itself not linked to service.

In economic terms, the rights are a form of contingent entitlement. The SoP converts medical-scientific uncertainty into a fixed list of factors. This reduces transaction costs for the Commission but increases the risk for claimants whose exposure pattern falls just outside the thresholds. The duty to provide precise exposure data may be costly for individuals who lack documentation.

This SoP does not itself impose penalties. It is not a penal instrument; it is a legislative rule for decision-making in the veterans' compensation system. However, the provisions of the VEA and MRCA that incorporate the SoP contain penalties for fraud and false statements. For example, making a false or misleading statement in a claim for compensation can lead to prosecution under section 135 of the VEA (general offences) or under the Criminal Code. A person who claims a factor based on fabricated evidence would risk penalties including imprisonment or repayment of compensation.

The enforcement of the SoP occurs through the claim decision process. If a claimant fails to satisfy any factor, the claim is rejected. If the Commission incorrectly applies the SoP, the claimant can seek review. The Veterans' Review Board and the Administrative Appeals Tribunal (AAT) have the power to set aside the Commission's decision and substitute a new one based on the correct application of the SoP. The AAT can also consider whether the SoP itself is validly made, though such challenges are rare. The Federal Court can judicially review a decision if there is an error of law, including a failure to properly apply the SoP.

The RMA does not enforce the SoP directly. Its role is limited to making and revoking SoPs. There are no penalties against the RMA for a defective SoP; any challenge would be through judicial review of a decision that relied on it.

Notably, factor 9(12) is "inability to obtain appropriate clinical management for aplastic anaemia." This factor applies only to clinical worsening under section 10(2). It is not a penalty but a factor that, if proved, can establish a connection for aggravation. There is no penalty for a failure to provide clinical management; rather, the factor acknowledges that worsening due to lack of management can be service-related.

The drug list in Schedule 2 does not prohibit any drug use; it only specifies drugs that may cause aplastic anaemia for the purpose of the SoP. There is no penalty for doctors prescribing these drugs. The list is purely causal.

Because the SoP is a balance of probabilities standard, the evidentiary threshold is proof on the balance of probabilities. A claimant who cannot prove at least one factor will have the claim rejected, which is the practical enforcement consequence. The SoP does not provide for any waiver or discretion. The system enforces itself through the denial of claims that do not match the criteria.

This SoP operates within a complex statutory framework. Its primary interaction is with the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004. Specifically, section 120B of the VEA requires that for claims relating to non-operational service, the Commission must determine whether an injury or disease is related to service by applying the relevant SoP made under subsection 196B(3). That subsection is exactly the authority for this SoP. Similarly, section 339 of the MRCA requires the use of SoPs for peacetime service claims. Therefore, this SoP supersedes any general consideration of causation for aplastic anaemia; decision-makers cannot rely on medical evidence alone if it does not match a factor.

The SoP also interacts with other SoPs through section 11. If a factor in this SoP refers to an injury or disease covered by another SoP, the factors in that other SoP apply. For example, factor 9(8) requires having an autoimmune disease from the specified list. If the claimant has systemic lupus erythematosus (SLE), and there is a SoP for SLE, then the factors for SLE must also be satisfied. This creates a chain of causation: the claimant must first link SLE to service via its own SoP before the SLE can serve as a factor for aplastic anaemia. This prevents gaming by using an intermediate condition that itself is not service-related.

The SoP interacts with the general standard of proof in the VEA. Section 120 of the VEA provides different standards for operational service (reasonable hypothesis) and non-operational service (balance of probabilities). This SoP applies only to the latter. If a veteran had both operational and non-operational service, the claim might be assessed under different standards for different periods. The SoP does not affect operational service claims for aplastic anaemia; those would be under the reasonable hypothesis SoP if one exists, or under the reverse onus provisions of section 120(3).

It also interacts with the Administrative Appeals Tribunal Act 1975 for review. The AAT applies the same SoP as the Commission. The AAT may consider whether the SoP has been correctly interpreted. The AAT is not bound by the SoP itself being correct as a matter of science, but it is bound to apply it as a legislative instrument.

The SoP interacts with the Safety, Rehabilitation and Compensation (Defence-related Claims) Act 1988 (SRCA) for some defence members? No; the MRCA covers most post-2004 peacetime service. The SRCA may still cover some pre-2004 members, but the VEA SoPs are not automatically imported into the SRCA. However, the SRCA has its own provisions. This SoP is specific to VEA and MRCA.

The drug list in Schedule 2 does not create any regulatory obligations under the Therapeutic Goods Act 1989. It is purely for compensation causation.

Finally, the SoP interacts with state workers' compensation laws only if a veteran also makes a claim outside the federal system, but under the VEA, state compensation is generally excluded. The SoP does not interact with private insurance policies; those have their own definitions.

This instrument, No. 59 of 2020, repeals and replaces the Statement of Principles concerning aplastic anaemia No. 51 of 2012 (Federal Register of Legislation No. F2012L01793). The 2012 SoP was made under both subsections 196B(3) and (8) of the VEA, meaning it covered both balance of probabilities and reasonable hypothesis standards. The new SoP is made only under subsection 196B(3) and thus applies only to the balance of probabilities standard. This suggests that the RMA may have separated the two standards into separate instruments, or that a separate reasonable hypothesis SoP was made or considered. The instrument text does not give the full background.

The 2012 SoP had been in force for eight years before repeal. The RMA reviews SoPs periodically based on new medical evidence. The commencement date is 28 September 2020, allowing a transition period from the date of determination (28 August 2020). Claims lodged before that date would have been assessed under the 2012 SoP; claims after that date use the new SoP.

The source does not list any amendments between 2012 and 2020. There may have been non-substantive amendments or corrections, but they are not referenced. The instrument itself has not been amended since commencement; it is the original version.

The operational history of SoPs is that they are amended when the RMA considers that the medical evidence has changed sufficiently. Common reasons for amendment include new epidemiological studies linking a drug to aplastic anaemia, new evidence on benzene exposure thresholds, or removal of a factor that is no longer supported. The inclusion of immune checkpoint inhibitors (nivolumab and pembrolizumab) in the drug list reflects relatively recent oncology practice. Similarly, the inclusion of drugs like osimertinib and valganciclovir indicates updates.

The repeal provision (section 4) explicitly states that the earlier SoP is repealed. The RMA has the power under section 196B(6) to revoke an SoP. The new SoP therefore represents the current state of medical-scientific evidence on aplastic anaemia causation for balance of probabilities claims.

For researchers, comparing the 2012 and 2020 SoPs would reveal which factors were added, removed, or modified. Without the old text, I cannot detail those changes. The key structural change is the separation from the reasonable hypothesis standard, which may indicate that the RMA now treats the two standards with distinct factor sets. This adds complexity but also clarity.

The instrument is made under the Legislation Act 2003 and is registered on the Federal Register of Legislation. Any future amendments will be similarly registered.

The instrument itself does not cite any case law. It is a legislative instrument, not a court judgment. However, Statements of Principles under the VEA have been the subject of extensive litigation in the Federal Court and High Court, though not tied to this specific SoP. The interpretation of factor requirements, the meaning of "sound medical-scientific evidence", and the standard of proof have all been litigated. The case of Repatriation Commission v Gosewinkel [2007] FCA 378 is a well-known example concerning SoPs generally, but it is not mentioned in the source and therefore cannot be used here.

The source does reference a prior SoP No. 51 of 2012, which may have been considered in proceedings. The repeal suggests that any claims relying on the 2012 SoP will be determined under it if lodged before commencement, but any ongoing litigation about the validity of the old SoP would likely become moot or continue based on the law at the time.

The Federal Court has held that the RMA must base SoPs on sound medical-scientific evidence, and that the factors must be capable of being satisfied. A challenge to this SoP could argue that a factor is not supported by the evidence, but that would require fresh evidence not present in the instrument. The AAT regularly hears disputes about whether a particular exposure satisfied the benzene definition or whether a drug was taken within six months of onset.

Because the SoP is made under the VEA, any appeal from a decision applying it goes to the AAT and then the Federal Court. The court may consider whether the decision-maker correctly interpreted the SoP. For example, the definition of "being exposed to benzene as specified" requires an 8-hour TWA exceeding five parts per million. A decision-maker who misapplies the averaging period would make an error of law. Similarly, the exclusion of inherited syndromes in the definition of aplastic anaemia could be litigated if a claimant has an undiagnosed inherited condition.

The specific list of autoimmune diseases in the Schedule could also be challenged if new evidence links a different autoimmune disease to aplastic anaemia. But the power of the RMA to define the list is broad.

No known High Court appeal has directly concerned aplastic anaemia SoPs. The litigation history for this particular condition is likely limited to AAT matters.

Several features of this SoP can trap the unwary claimant or practitioner.

1. Definition exclusions (section 7(2)(b)). The definition of aplastic anaemia excludes inherited bone marrow failure syndromes, myelodysplastic syndrome, paroxysmal nocturnal haemoglobinuria, and others. A claimant diagnosed clinically with aplastic anaemia may later be rediagnosed with MDS, and the SoP would not apply. The ICD-10-AM codes may not match the definition. A claimant with code D61.3 (acute aplastic anaemia) could still be excluded if they have a paroxysmal nocturnal haemoglobinuria clone.

2. Relevant service limitation. The SoP only applies to non-operational service (eligible war service other than operational, defence service other than hazardous, peacetime service). A veteran with operational service will be assessed under the reasonable hypothesis standard, which uses a different SoP (if one exists) or the reverse onus provisions. Mistaking which SoP applies can lead to filing the wrong evidence.

3. Benzene inhalation threshold. Factor 9(4) requires exposure at an ambient 8-hour TWA exceeding 5 parts per million. Brief exposure to high concentrations does not meet this threshold if the 8-hour average is below 5 ppm. The definition uses "ambient" concentration, not personal exposure. A claimant who worked near benzene but did not have personal monitoring may struggle to prove the threshold.

4. 45-day requirement. Both benzene (factor 9(4)) and organophosphate (factor 9(5)) require exposure on at least 45 days within the six months before clinical onset. That means daily or near-daily exposure for about one and a half months. Less frequent but high-dose exposure does not count. This is a high bar that may exclude many claimants.

5. Drug factor 9(3) individual association. This factor requires that the drug is associated in the individual with development within six months AND improvement within six months of discontinuation. If the aplastic anaemia does not improve when the drug is stopped (e.g., because irreversible damage has been done), this factor cannot be satisfied. It is a narrow backstop for drugs not in Schedule 2.

6. Pregnancy factor. Factor 9(1) applies to clinical onset but factor 9(11) to worsening. Both require that the pregnancy be concurrent with the event. A claimant whose aplastic anaemia developed after a miscarriage or stillbirth may need to prove the pregnancy existed at the time of onset.

7. Autoimmune disease list is exclusive. Only six conditions are listed. Common autoimmune diseases like rheumatoid arthritis, multiple sclerosis, or Sjogren's syndrome are not included. A claimant with those conditions cannot use factor 9(8) even if there is a plausible link.

8. Factor 9(9) requires haematological malignancies. Chronic lymphocytic leukaemia (CLL) and T-cell large granular lymphocytic leukaemia are specified. Other haematological cancers are not listed.

9. Clinical worsening factors only apply to aggravation. Section 10(2) limits factors 9(11) (pregnancy) and 9(12) (inability to obtain appropriate clinical management) to cases where aplastic anaemia was suffered or contracted before or during (but did not arise out of) relevant service. That means they cannot be used for initial onset claims.

10. Terminal event definition. Death must be contributed to by aplastic anaemia via one of five listed events. If the cause of death is something else not listed, such as sepsis (not listed) or haemorrhage (not listed), the claim may fail even if aplastic anaemia was contributory.

11. Drug list cautions. Many drugs are common: fluoxetine (antidepressant), allopurinol (gout), carbamazepine (epilepsy/neuralgia), and thiazide diuretics (hypertension). Claimants should review their medication history carefully. The list also includes herbal products like ganoderma, which is used as a supplement.

Compliance with this SoP is not about obeying a prohibition but about successfully navigating a compensation claim. For a claimant with aplastic anaemia, the following steps are necessary.

First, confirm the diagnosis meets the definition. Obtain a hematologist report that states the condition is acquired aplastic anaemia with destruction of haematopoietic stem cells, peripheral blood cytopaenia, and hypocellular marrow without fatty replacement from other causes. Exclude inherited syndromes, MDS, PNH, and infiltrative processes. Genetic testing may be required to rule out Fanconi anaemia or dyskeratosis congenita.

Second, identify the applicable service type. Determine whether the veteran rendered relevant service as defined (eligible war service non-operational, defence service non-hazardous, peacetime service). If operational service, this SoP is not the correct one; the claim should be under the reasonable hypothesis SoP for aplastic anaemia if one exists, or under the VEA section 120(3) reverse onus.

Third, compile a timeline of clinical onset and all potential exposures. Onset is the time when the condition first becomes clinically apparent. All factors require a specified temporal relationship. For drug factors, obtain records of all medications taken in the six months before onset. Cross-check against Schedule 2. If a drug is listed, factor 9(2) is potentially satisfied. If not listed, consider factor 9(3) but require evidence of improvement on discontinuation.

Fourth, for benzene exposure, gather evidence of frequency and concentration. This may require industrial hygiene assessments, payroll records showing days worked, and air sampling data. If no monitoring data exists, modelling or expert opinion may be used, but the 8-hour TWA threshold must be proven on balance of probabilities. Similarly for organophosphates.

Fifth, for hepatitis factor 9(6), obtain records of acute hepatitis within one year before onset. The hepatitis need not be serologically confirmed but should meet clinical criteria.

Sixth, for autoimmune disease factor 9(8), the claimant must have one of the specified six conditions diagnosed within two years before onset. The diagnosis must be documented. For ABO mismatched stem cell transplant or graft versus host disease, that will be clear from transplant records.

Seventh, for lymphocytic leukaemia or thymoma, obtain pathology reports confirming the diagnosis and timing relative to onset. For factor 9(10), any prior thymoma or thymic carcinoma qualifies, even if years earlier.

Eighth, ensure the factor is related to service. Section 10(1) requires the factor to be related to the relevant service. This is often straightforward for service-related drug treatment or exposure during service, but for factors like pregnancy or autoimmune disease, the relation must be shown. For example, if the pregnancy occurred during peacetime service, that would be related; if it occurred after discharge, it would not.

**Ninth, for clinical worsening claims (factors 11 and 12), note that section 10(2) restricts these to aggravation of pre-existing aplastic anaemia. The worsening must be a material contribution due to pregnancy during service or inability to obtain appropriate clinical management related to service. The latter would require evidence that the Department of Veterans' Affairs failed to provide necessary treatment.

Tenth, maintain thorough documentation. All evidence should be presented in a form that the Repatriation Commission can evaluate. Medical specialists should be asked to address the specific factor criteria in their reports. The more directly the evidence matches the SoP language, the higher the chance of success.

For decision-makers, compliance means applying the SoP strictly. They must not insert their own opinions about causation if the factor is not listed. They must correctly interpret definitions, especially the benzene exposure standard and the list of excluded conditions. They should also ensure that if a factor refers to another disease with its own SoP, that SoP is also applied.

For practitioners advising clients, strategic decisions include whether to pursue a factor that is weak or to argue that a new exposure not listed is nonetheless causal under the general provisions (though the SoP is binding). The only flexibility is factor 9(3) for drugs not in Schedule 2, or the possibility of arguing that the SoP is invalid for some reason.

In summary, compliance is a deterministic exercise: find a factor, prove it relates to service, and the claim succeeds. If no factor can be proved, the claim fails regardless of clinical plausibility.