Statement of Principles concerning acute myeloid leukaemia (Balance of Probabilities) (No. 22 of 2024)

The instrument defines several critical concepts. Acute myeloid leukaemia (section 7) is a malignant neoplasm of the blood involving clonal proliferation of immature myeloid cells, with an excess of myeloblasts. It includes numerous subtypes listed in subsection 7(2)(b), such as acute myeloid leukaemia with defining genetic abnormalities, acute promyelocytic leukaemia, myeloid sarcoma, and others. It expressly excludes chronic myeloid leukaemia and myelodysplastic syndrome, meaning those conditions are not themselves AML but may be factors that can lead to AML. Death from acute myeloid leukaemia includes death from a terminal event (pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function) contributed to by the AML (section 7(3) read with the dictionary). Relevant service is defined in the dictionary and means eligible war service (other than operational service) or defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA. This is narrower than all service; it excludes the more generous standards that apply to operational or hazardous service. Pack‑year is a measure of tobacco consumption: 20 cigarettes per day for one year, or 7,300 grams of smoking tobacco. The instrument provides a formula for calculation (dictionary). Cumulative equivalent dose of ionising radiation is the total dose to a specific organ or tissue, calculated according to an ARPANSA guide as in force on 2 August 2017, excluding normal Australian background radiation. Ppm‑years means parts per million multiplied by years of exposure. Being obese means a body mass index (BMI) of 30 or greater, with BMI calculated as weight in kilograms divided by height in metres squared. Being exposed to benzene as specified is a three‑part concept: cutaneous contact with liquids containing more than 1% benzene by volume, ingestion of such liquids, or inhalation of benzene vapour where the ambient 8‑hour time‑weighted average concentration exceeds 5 parts per million. The dictionary also defines myelodysplastic/myeloproliferative neoplasm as a category of overlapping disorders including chronic myelomonocytic leukaemia. The instrument uses a clinical onset trigger throughout section 9; most factors require the exposure or condition to exist before clinical onset of AML, and many have latency or recovery windows (e.g. smoking cessation within 10 years of onset). These definitions are legally binding; decision‑makers cannot substitute alternative meanings. The Repatriation Medical Authority has deemed, on sound medical‑scientific evidence, that these factors are more probable than not relevant to AML causation (section 8). That finding is effectively unreviewable on the merits, though a court could review the legal validity of the instrument.

The instrument directly affects three categories of persons. First, veterans and members of the Forces who have eligible war service (non‑operational), defence service (non‑hazardous and non‑British nuclear test), or peacetime service under the MRCA and who have been diagnosed with AML or have died from it. They are the potential claimants seeking to have AML accepted as service‑related, which unlocks entitlements to compensation, medical treatment, and other benefits under the VEA or MRCA. Second, dependants of such veterans or members who claim in respect of death from AML. Section 7(3) makes clear that death from AML includes a terminal event contributed to by the AML, so a dependant can rely on the same factors. Third, decision‑makers within the Department of Veterans’ Affairs, the Military Rehabilitation and Compensation Commission, and the Veterans’ Review Board (and ultimately the Administrative Appeals Tribunal) who must apply this instrument when assessing claims under sections 120B or 339. The instrument removes their discretion to accept AML as service‑related based on other unlisted factors, unless the claim falls under a different standard (operational service). The instrument also affects medical practitioners who provide evidence in support of claims, because they must understand the specific definitions (e.g. cumulative equivalent dose, pack‑year, ppm‑years) to provide useful expert opinions. The Repatriation Medical Authority itself is affected as the maker; it is required to review and update SoPs periodically. The Commonwealth is affected as the respondent in litigation; the instrument shapes the government’s exposure to liability. The instrument also affects other claimants indirectly: because the SoP is binding, it reduces uncertainty and litigation costs, but it also creates rigid gateways that may exclude meritorious claims where causation exists but does not fit the listed factors. The instrument’s repeal of the 2015 SoP means that anyone with a claim lodged but not yet determined before 26 March 2024 will be assessed under this new instrument if the claim is still pending and the instrument applies (section 5). The instrument does not affect those with operational service; they are covered under separate SoPs made under subsection 196B(2) (reasonable hypothesis). However, note that the instrument defines “relevant service” narrowly, so a veteran with mixed service may need to have AML assessed separately for each period.

The instrument does not impose duties on private parties; it creates a framework for administrative decision‑making. The key duty lies on the Repatriation Medical Authority: it must determine SoPs based on sound medical‑scientific evidence (section 8) and must ensure the instrument is not inconsistent with the VEA or MRCA. For decision‑makers, the duty is to apply the instrument strictly. If the decision‑maker finds that at least one factor in section 9 exists in the person’s circumstances, and that factor is related to the person’s relevant service, then the decision‑maker is bound to accept that AML is connected with that service on the balance of probabilities. Conversely, if no factor is established, the decision‑maker must find that the disease is not service‑related, unless an exception (e.g. for operational service) applies. The instrument also creates a right for the claimant to have the claim assessed against these factors. That right is enforceable through review mechanisms: internal review, the Veterans’ Review Board, and the Administrative Appeals Tribunal. Claimants have the right to present evidence that a factor existed (e.g. medical records showing myelodysplastic syndrome, radiation dose calculations, smoking history). They also have the right to rely on a terminal event definition to include death from AML. Section 9(13) is a notable factor: inability to obtain appropriate clinical management for AML before clinical worsening. This factor applies only to material contribution to or aggravation of AML (section 10(2)) and only where the AML was suffered or contracted before or during (but did not arise out of) relevant service. That creates a right for a person whose AML existed before service to claim aggravation due to lack of treatment during service. However, the factor is vague: “inability to obtain appropriate clinical management” is not defined, so there is scope for dispute. The instrument also gives the Authority the right to prescribe detailed calculation methods for cumulative equivalent dose (dictionary). It incorporates by reference the ARPANSA guide as in force on 2 August 2017, meaning any future amendment to that guide does not automatically apply. The instrument’s dictionary gives the right to convert between cigarette and other tobacco product quantities for pack‑year calculations (note: 7,300 grams = one pack‑year). There is no right to ignore the defined terms; they are mandatory.

This instrument is not a penal statute. It contains no offence provisions or penalties for non‑compliance. The “penalty” for failing to meet a factor is the rejection of a claim for service‑relatedness of AML. That is a civil administrative consequence, not a criminal sanction. However, enforcement of the instrument occurs through the claims and review process. If a decision‑maker fails to apply the instrument correctly, the claimant can seek review. The Veterans’ Review Board and the Administrative Appeals Tribunal have the power to set aside decisions and substitute new ones that correctly apply the SoP. The instrument can be enforced indirectly through the Administrative Decisions (Judicial Review) Act 1977 or the common law for jurisdictional error. For example, if a decision‑maker misinterprets “cumulative equivalent dose” or “pack‑year”, a court could quash the decision. The instrument also has an internal enforcement mechanism: section 11 requires that if a factor refers to another injury or disease covered by a different SoP (e.g. myelodysplastic syndrome), that other SoP must be complied with. So if the other SoP is later amended, the current instrument’s factor incorporates those amendments as they apply from time to time. That creates a dynamic compliance burden. For practitioners, the risk is not a financial penalty but a lost claim. There is no direct liability for the Commonwealth if the instrument is misapplied, except through the usual compensation framework. The Repatriation Medical Authority is not subject to sanctions for making an instrument that later proves to be flawed, unless the instrument is ultra vires. Given that the Authority is composed of medical experts, challenges to the validity of the instrument on medical‑scientific grounds are unlikely to succeed. The instrument commenced on 26 March 2024 (section 2). From that date, any claims to which it applies must be determined using this SoP. The repealed 2015 SoP is no longer in force, so any prior claim still pending might be decided under the new one if the application provision (section 5) applies. That could disadvantage a claimant who would have met the old factors but not the new ones. There is no transitional provision beyond the repeal; the instrument is silent on pending claims. That is a significant enforcement risk for claimants: they must now satisfy the 2024 factors.

The instrument is made under subsection 196B(3) of the Veterans’ Entitlements Act 1986, which is a specific power to determine SoPs for claims on the balance of probabilities. It does not purport to override or amend any other legislation. Its interaction with other laws is primarily through its operation within the VEA and MRCA claims systems. Section 10 of the instrument requires that the factor itself be related to the person’s relevant service - that is a connection requirement derived from the VEA itself. The instrument does not replace the ordinary causation principles in the VEA; rather, it fills them with specific medical content. Section 11 of the instrument is crucial: it states that if a factor refers to an injury or disease covered by another SoP determined under subsection 196B(3), then the factors in that other SoP apply in accordance with its terms as in force from time to time. This means that, for example, factor 9(2) lists myelodysplastic syndrome as a haematological disorder. That disease (myelodysplastic syndrome) itself has its own SoP. To rely on factor 9(2), the claimant must not only prove they had myelodysplastic syndrome at the time of AML onset, but also that the myelodysplastic syndrome itself is related to their service under its own SoP. This creates a cascading interaction. Similarly, factor 9(4) refers to treatment with alkylating agents, topoisomerase II inhibitors, etc. Those treatments may themselves be consequences of other service‑related conditions, so the interaction with other SoPs is indirect. The instrument also interacts with the definitions in the VEA: “relevant service” is defined in the instrument’s dictionary with reference to concepts in the VEA (eligible war service, defence service) and MRCA (peacetime service). Those definitions are not repeated; the user must cross‑refer. The instrument interacts with the ARPANSA guide for cumulative equivalent dose (dictionary). That guide is not a legislative instrument but is incorporated by reference as in force on 2 August 2017. Any later revision of the guide does not automatically apply, so the instrument is static in that respect. The instrument also interacts with the general law of evidence and administrative law. It does not override the rules of natural justice, but it effectively prescribes what the Authority considers to be the only allowable medical causation pathways. That may conflict with a claimant’s argument that their AML was caused by an unlisted factor (e.g. another chemical). In such a case, the decision‑maker cannot accept that factor because the SoP is binding. The instrument interacts with the judicial review framework; a court could find that the instrument is unreasonable in a Wednesbury sense, but given the Authority’s expertise, that is unlikely. For operational service claims, separate SoPs under subsection 196B(2) exist; this instrument does not affect them. The instrument also interacts with the Military Rehabilitation and Compensation Act 2004 through section 339 of that Act, which picks up the same SoP for peacetime service. This creates consistency across the two compensation schemes for non‑operational/non‑hazardous service.

The instrument itself is a legislative instrument made on 22 February 2024 and commencing on 26 March 2024. It repeals the previous Statement of Principles concerning acute myeloid leukaemia No. 72 of 2015 (Federal Register of Legislation No. F2015L00904). That 2015 instrument was also made under subsection 196B(3) of the VEA. The 2015 instrument had its own set of factors; the 2024 instrument supersedes it entirely. The instrument does not provide a detailed explanation of what has changed; however, a comparison with the 2015 version would be necessary to identify specific changes in factor thresholds (e.g. pack‑year requirements, latency windows, inclusion or exclusion of certain drugs or conditions). The instrument does not mention any transitional provisions; it simply states it applies to claims to which sections 120B or 339 apply. The application provision (section 5) is the same as the previous SoP. The instrument does not amend any other legislation; it is a standalone determination. The definition of acute myeloid leukaemia has been updated to include specific genetic subtypes and the current WHO classification terminology (e.g. acute myeloid leukaemia with myelodysplasia‑related genetic abnormalities, acute panmyelosis with myelofibrosis). The 2015 version likely had different language. The instrument also includes new factors: factor 9(9) (benzene inhalation/ingestion/contact in amounts greater than 10 ppm‑years) appears to be new or refined. Factor 9(10) (obesity for at least 5 years within 20 years before clinical onset) may also be new. Factor 9(12) (autoimmune diseases) is a list of eight specific conditions. The instrument now includes a specific note for topoisomerase II inhibitors, platinum agents, and PARP inhibitors with examples. The cumulative equivalent dose factor (9(5)) has been retained but the threshold of 0.05 sievert and the 2‑year latency remain. The radioactive iodine factor (9(6)) and radioactive phosphorus factor (9(7)) are new additions compared to the 2015 version? We cannot say with certainty without the 2015 text, but the instrument represents the current authoritative statement. The instrument also clarifies that myelodysplastic syndrome is excluded from the definition of AML (7(2)(c)(ii)) but then appears as a factor (9(2)(a)) - that is consistent with medical knowledge that MDS can progress to AML. The instrument has one unique factor: 9(13) inability to obtain appropriate clinical management. That factor is presumably a response to cases where a person’s AML worsened during service due to lack of treatment. The amendment history is minimal; the instrument is a complete replacement.

The instrument commenced on 26 March 2024. As of the date of this analysis, there is no reported litigation specifically concerning this instrument. However, there is likely to be case law on the predecessor 2015 SoP, which was repealed. That litigation might have interpreted key terms such as “pack‑year”, “cumulative equivalent dose”, “clinical onset”, and the definition of AML. Such case law would be persuasive but not binding on the new instrument, because the new instrument has different wording in some respects. For example, the Administrative Appeals Tribunal often considers SoPs, and there may be decisions on whether a particular factor was related to service. Under the previous SoP, there were likely disputes over benzene exposure calculations, smoking history reconstruction, and radiation dose assessment. The new instrument’s inclusion of explicit examples for drugs (e.g. PARP inhibitors) may reduce interpretive litigation. The factor on autoimmune diseases (9(12)) is likely to generate disputes about whether a particular condition was truly present before clinical onset and whether it is service‑related. The obesity factor (9(10)) may also be contested, especially regarding the 5‑year duration within the 20‑year period. The instrument does not define “clinical onset” but that term has been judicially considered in other VEA contexts; it generally means the time when the person first sought medical attention or when symptoms became such that a reasonable person would seek diagnosis. There is also likely to be litigation about the application of section 11 - whether a factor that refers to another disease (like myelodysplastic syndrome) requires the claimant to satisfy the other SoP separately. The instrument’s note to section 9(2) states that myelodysplastic syndrome is also known as myelodysplastic neoplasm, but that is merely clarificatory. The terminal event definition in the dictionary may also be litigated: the list includes pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. The inclusion of “circulatory failure” is broad; a claimant may argue that any haemodynamic collapse qualifies. The instrument does not say “terminal event” must be the immediate cause; it says the death must be “contributed to by the person’s acute myeloid leukaemia”. That could generate disputes over contribution thresholds. No litigant has yet challenged the validity of the instrument itself on jurisdictional grounds, but that is always possible. The instrument is made under a specific statutory power; a challenge would need to argue that the Authority misapplied the “sound medical‑scientific evidence” test or that the factors are not based on evidence. Given the Authority’s composition, such a challenge is difficult but not impossible.

Several traps are worth noting. First, the definition of relevant service in the dictionary is critical and narrow. It excludes operational service, hazardous service, and British nuclear test defence service. A veteran with operational service cannot use this instrument; they must rely on the reasonable‑hypothesis SoP. If a claim is mistakenly assessed under this instrument when it should be under the reasonable hypothesis standard, the decision may be invalid. Second, the instrument excludes myelodysplastic syndrome (MDS) from the definition of AML (section 7(2)(c)(ii)), yet factor 9(2)(a) includes MDS as a haematological disorder that can be a factor. That means a person who initially had MDS and later developed AML cannot claim that the MDS itself is part of the AML; they must rely on factor 9(2). But to satisfy factor 9(2), they must have had MDS “at the time of clinical onset” of AML. That is a narrow temporal window. Third, the smoking factor (9(1)) requires at least 15 pack‑years, with smoking commencement at least 10 years before onset, and if smoking ceased, onset must be within 10 years of cessation. A claimant who quit smoking 11 years before onset of AML will miss the window even if they had 30 pack‑years. Fourth, the benzene factor 9(8) requires a cumulative total of at least 2,500 hours within a continuous period of 5 years, with first exposure at least 5 years before onset and last exposure within 30 years. That is a high threshold; many occupational exposures may not reach 2,500 hours. The alternative benzene factor 9(9) uses a cumulative dose of more than 10 ppm‑years, but the definition of ppm‑years is not elaborated: it says “parts per million multiplied by years of exposure” but does not specify averaging or whether it is an 8‑hour TWA. That could cause disputes. Fifth, the obesity factor (9(10)) requires being obese (BMI ≥ 30) for at least 5 years within the 20 years before clinical onset. This is a relatively new factor; it may be difficult to prove obesity for a continuous 5‑year period without regular weight records. Sixth, the autoimmune disease factor (9(12)) lists eight specific diseases; it does not include other autoimmune conditions such as multiple sclerosis or type 1 diabetes. Only those listed count. Seventh, factor 9(13) - inability to obtain appropriate clinical management - only applies to aggravation or material contribution, not to original causation, and only if AML was suffered or contracted before or during (but did not arise out of) service. That is a narrow pathway. Eighth, the instrument’s definition of “terminal event” includes “cessation of brain function” which is effectively brain death; that could be argued even if other causes are listed. Ninth, note that the cumulative equivalent dose factor (9(5)) requires a dose of at least 0.05 sievert to the bone marrow. That is a relatively low dose (50 mSv), but the calculation must exclude normal Australian background radiation. The ARPANSA guide may be complex to apply. Tenth, all factors must be related to the person’s relevant service. Even if a factor exists (e.g. obesity), the claimant must show that the obesity itself is connected to service. That may be difficult for non‑service‑acquired obesity.

For claimants, compliance means establishing a clear evidentiary pathway under one or more of the 13 factors. The first step is to obtain a confirmed diagnosis of acute myeloid leukaemia from a qualified haematologist, ensuring it meets the definition in section 7 (including proper exclusion of CML and MDS). The diagnosis must specify the subtype if possible, as some factors relate to genetic abnormalities. The second step is to obtain a complete service history to confirm that the person has relevant service as defined (eligible war service other than operational, defence service other than hazardous, or peacetime service). If the person has operational service, this SoP does not apply; separate advice is needed. The third step is to gather evidence for each potentially applicable factor. For smoking (9(1)), obtain a detailed smoking history in pack‑years, including start and stop dates. Use the formula in the dictionary: divide cigarettes per day by 20 and multiply by years. If pipe or cigar, convert grams to cigarettes (7,300 grams = one pack‑year). Ensure the smoking commenced at least 10 years before clinical onset and, if ceased, that onset was within 10 years of cessation. For haematological disorders (9(2)), obtain medical records showing a diagnosis of myelodysplastic syndrome, MDS/MPN, aplastic anaemia, or paroxysmal nocturnal haemoglobinuria at the time of AML onset. That diagnosis itself may need to be service‑related under its own SoP. For myeloproliferative neoplasms (9(3)), similar approach. For chemotherapy exposure (9(4)), gather records of any treatment with alkylating agents, topoisomerase II inhibitors, azathioprine, platinum agents, or PARP inhibitors at least 6 months before onset, with a 20‑year window after cessation. The note lists examples, but the factor is not limited to those. For ionising radiation (9(5)), calculate cumulative equivalent dose to bone marrow according to the ARPANSA guide. This may require expert evidence from a radiation physicist. For radioactive iodine or phosphorus treatments (9(6), (9(7)), document the treatment and ensure first exposure at least 2 years before onset. For benzene (9(8) and 9(9)), occupational or environmental history must be detailed. For the hours‑based factor (9(8)), prove at least 2,500 hours of specified exposure (cutaneous contact with >1% benzene liquids, ingestion, or inhalation >5 ppm 8‑hour TWA) within a continuous 5‑year period. For the ppm‑years factor (9(9)), calculate using exposure levels and duration (ppm multiplied by years). First exposure at least 5 years before onset, last exposure within 30 years. For obesity (9(10)), gather medical records showing BMI ≥ 30 for at least 5 years within the 20 years before onset. For organ or stem cell transplant (9(11)), obtain records of the transplant (excluding corneal). For autoimmune diseases (9(12)), obtain medical records of one of the eight listed conditions before AML onset. For inability to obtain clinical management (9(13)), this is complex: show that the AML existed before or during service (but not arising out of service) and that during service the person could not obtain appropriate management, leading to worsening. That requires medical records both before service and during service, and evidence that management was denied or unavailable. For all factors, the person must also prove that the factor is related to their relevant service (section 10(1)). That may be straightforward for service‑acquired smoking habits or occupational benzene exposure during service, but more difficult for obesity or autoimmune diseases that may have pre‑existed service. Practitioners should prepare a comprehensive written submission mapping each factor to the evidence, with cross‑references to the instrument’s dictionary. If a factor refers to another disease covered by another SoP, that other SoP must be complied with separately (section 11). The instrument does not allow a claimant to rely on a combination of sub‑threshold factors; at least one full factor must be met. There is no “catch‑all” provision. Therefore, if none of the factors is established, the claim will fail. The best strategy is to identify the strongest factor early and gather all required evidence before lodging. The instrument’s technical definitions (e.g. cumulative equivalent dose, ppm‑years) require expert involvement. The cost of compliance may be significant, particularly for radiation and benzene calculations. Veterans and members should seek assistance from ex‑service organisations or legal aid to navigate the process.