Statement of Principles concerning myelodysplastic neoplasm (syndrome) (Balance of Probabilities) (No. 77 of 2024)

The central concept is the definition of myelodysplastic neoplasm (syndrome) itself, which the SoP provides as a clonal haematopoietic stem cell neoplasm characterised by morphologic dysplasia of at least 10% in at least one cell line (erythroid, granulocyte, or megakaryocyte), persistent cytopaenia, progressively ineffective haematopoiesis, and an increased risk of acute myeloid leukaemia. It expressly includes morphologically defined subtypes such as myelodysplastic neoplasm with low blasts, hypoplastic myelodysplastic neoplasm, and myelodysplastic neoplasm with increased blasts. It also includes genetically defined subtypes: myelodysplastic neoplasm with low blasts and 5q deletion, with SF3B1 mutation, and with biallelic TP53 inactivation. The definition excludes leukaemia (including acute myeloid leukaemia), myeloproliferative neoplasms (chronic myeloid leukaemia, chronic neutrophilic leukaemia, chronic eosinophilic leukaemia, polycythaemia vera, essential thrombocythaemia, primary myelofibrosis, juvenile myelomonocytic leukaemia), aplastic anaemia, and myelodysplastic/myeloproliferative neoplasms in the overlap category (including those with neutrophilia, with SF3B1 mutation and thrombocytosis, and not otherwise specified). The SoP notes that the term also covers what were formerly called myelodysplastic syndromes and myelodysplastic disorders. The instrument also defines “death from myelodysplastic neoplasm (syndrome)” to include death from a terminal event contributed to by the disease, with terminal event defined in the dictionary as including pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. The concept of “relevant service” is critical: it means eligible war service (other than operational service), defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA. This means the SoP applies only to non-operational and non-hazardous service claims where the standard of proof is balance of probabilities. The factors themselves incorporate detailed temporal and quantitative thresholds, such as pack-years for smoking (using the formula of cigarettes per day divided by 20, multiplied by years), cumulative equivalent dose of ionising radiation (calculated excluding normal background radiation but including therapeutic, diagnostic, occupational, high-altitude cosmic, and nuclear explosion or accident sources), and two distinct benzene exposure metrics (hours-based and ppm-years) each with their own timing requirements.

This SoP directly affects veterans and members of the Australian Defence Force (or their dependants) who make claims for disability pension or other compensation under the VEA or the MRCA in relation to myelodysplastic neoplasm (syndrome). Because the instrument applies only to claims on the balance of probabilities, it affects those whose relevant service is “eligible war service (other than operational service)”, “defence service (other than hazardous service and British nuclear test defence service)” under the VEA, or “peacetime service” under the MRCA. This excludes persons whose claims are based on operational service or hazardous service, who would be assessed under the reasonable hypothesis standard (using a different SoP). The SoP also indirectly affects medical practitioners and specialists who may be asked to provide evidence on the disease definition, chronology of exposure, and clinical onset. Lawyers and advocates assisting veterans with claims must understand the precise factor definitions and temporal windows to gather the necessary evidence. Decision-makers in the Department of Veterans’ Affairs and the Military Rehabilitation and Compensation Commission are bound to apply this SoP when assessing claims for myelodysplastic neoplasm (syndrome). The instrument does not create duties for private individuals or corporations; its operation is internal to the compensation system. However, employers or insurers who may be liable for occupational diseases might be indirectly affected if a veteran’s condition is linked to service-related exposure to benzene, ionising radiation, or chemotherapy drugs, because the SoP’s acceptance of a factor could shift liability. The definitions of exposure (for benzene: cutaneous contact, ingestion, or inhalation at certain concentrations) could have implications for civilian occupational health standards, but only insofar as the SoP sets evidentiary thresholds for veterans’ claims. The instrument also affects researchers and the Repatriation Medical Authority itself, as it represents the current state of sound medical-scientific evidence regarding causation of myelodysplastic neoplasm (syndrome). The repeal of the 2015 SoP means all pending decisions not yet finalised must apply the new instrument.

The SoP does not impose duties on individuals in the usual sense; rather, it establishes the legal framework under which a claimant has the right to have their condition recognised as service-related if they meet the specified factors. The primary duty falls on the decision-maker (the Repatriation Commission or the Military Rehabilitation and Compensation Commission) to apply the SoP when determining a claim to which section 120B of the VEA or section 339 of the MRCA applies. The decision-maker must be satisfied that at least one factor in section 9 exists and is related to the person’s relevant service. The claimant has the right to present evidence addressing any of the factors, including medical evidence confirming the diagnosis of myelodysplastic neoplasm (syndrome) as defined, and evidence of smoking history, chemotherapy treatment, radiation exposure, benzene exposure, treatment for a malignant neoplasm, or inability to obtain appropriate clinical management. The SoP gives the claimant a pathway to a favourable finding if they can satisfy the requisite thresholds and temporal relationships. The SoP also confers a right on the Repatriation Medical Authority to determine the instrument and to repeal previous versions. Section 10 requires that the factor must be related to the person’s relevant service; this is a duty on the decision-maker to ensure the connection is made. The note that section 9(7) (inability to obtain appropriate clinical management) applies only to material contribution to or aggravation of the disease where it was suffered or contracted before or during but did not arise out of relevant service , this limits the right to rely on that factor to cases where the disease pre-existed or was contracted during service but was not caused by service. The dictionary definitions, particularly for “being exposed to benzene,” create a duty on the person or their representatives to establish exposure meeting the specific concentration and duration thresholds, including documenting 8-hour time-weighted average concentrations exceeding 5 parts per million or cutaneous/ingestion contact with liquids containing benzene greater than 1% by volume. The instrument also gives the right to rely on other Statements of Principles if a factor refers to an injury or disease covered by another SoP (section 11), meaning the factors in that other SoP apply as in force from time to time.

This instrument contains no penalty provisions. It is a legislative instrument made under the VEA that sets out evidentiary standards. Enforcement is not applicable to the SoP itself; rather, it is used in the administrative decision-making process for compensation claims. The penalties that attach to the underlying legislation (the VEA and MRCA) for fraud or false statements in claims are separate and not mentioned in this instrument. The SoP’s practical enforcement occurs through the review process. If a decision-maker fails to apply the SoP correctly, the claimant may seek review by the Veterans’ Review Board, the Administrative Appeals Tribunal, or the Federal Court. The instrument itself does not create a cause of action. The Repatriation Medical Authority has no enforcement role once the SoP is made. The only consequence of failing to adhere to the SoP is that a decision may be set aside and remitted for reconsideration. The SoP also has no direct interface with criminal law or regulatory penalties. The definitions of exposure and the quantitative thresholds (e.g., 0.05 sievert, 15 pack-years, 2,500 hours of benzene exposure) serve as gateways for entitlement, not as regulatory limits. For example, an employer who exposes a worker to benzene at levels below the SoP’s threshold would not face any penalty under this instrument, since the SoP is not an occupational health and safety standard. It is purely a compensable causation standard. The note that “cumulative equivalent dose excludes doses from normal background radiation” ensures that only above-background exposures count, which avoids penalising claimants for unavoidable ambient exposure. The instrument does not address consequences for non-compliance by claimants; a claimant who fails to satisfy any factor simply has their claim denied under this SoP. The repeal of the 2015 SoP means any prior decisions or opinions based on the old instrument are no longer authoritative for new claims.

The SoP is made under subsection 196B(3) of the Veterans’ Entitlements Act 1986, which specifically authorises the Repatriation Medical Authority to determine such statements for the balance of probabilities standard. It interacts directly with the VEA, particularly sections 120B (which requires the Commission to be satisfied on the balance of probabilities where the SoP exists for claims involving eligible war service other than operational service, or defence service other than hazardous service). Similarly, section 339 of the Military Rehabilitation and Compensation Act 2004 imposes the same requirement for claims under that Act. The SoP is thus a critical link in the statutory chain: it gives content to what “related to service” means for this specific disease. The instrument also interacts with other SoPs through section 11: if a factor in this SoP refers to an injury or disease covered by another SoP (for example, factor 9(6) refers to “completing a course of therapy for malignant neoplasm”), then the factors in that other SoP apply as in force from time to time. This creates a network of interconnected SoPs. The SoP does not operate to override any other Commonwealth, state, or territory legislation outside the compensation context. For example, it does not affect workers’ compensation laws, tort law, or criminal law. It explicitly excludes certain diseases from the definition of myelodysplastic neoplasm (syndrome) (leukaemia, myeloproliferative neoplasms, aplastic anaemia, overlap MDS/MPN), meaning those conditions must be claimed under their own respective SoPs if they exist. The ICD-10-AM codes (D46 and C94.6) are referenced only for identification purposes; the substantive definition in the SoP governs. The instrument also interacts with administrative law: decisions based on the SoP are reviewable under the Administrative Appeals Tribunal Act 1975 and the Federal Court of Australia Act 1976. The SoP itself can be challenged as ultra vires or for legal error, though the RMA’s discretion on what constitutes “sound medical-scientific evidence” is broad. The instrument also interacts with privacy laws insofar as medical and exposure records are required to prove factors. The repeal of the 2015 SoP means that any pending claims not yet decided should be assessed under the new instrument, but claims already determined are not reopened unless the new SoP is more favourable and the legislation allows backdating.

This SoP (No. 77 of 2024) is the immediate successor to the Statement of Principles concerning myelodysplastic syndrome (No. 74 of 2015), which was made under subsection 196B(3) and (8) of the VEA and registered as F2015L00906. The 2015 SoP is repealed effective 19 November 2024, the commencement date of the new instrument. The SoP itself does not detail the reasons for the repeal, but the Repatriation Medical Authority reviews SoPs periodically based on developments in medical-scientific evidence. The instrument was made on 18 October 2024 and commences on 19 November 2024, providing a 32-day gap between making and commencement. There is no stated transitional provision; the instrument applies to claims to which section 120B or section 339 applies, so claims lodged before commencement but decided after will be governed by the new SoP. The earlier SoP may have had different factor thresholds or temporal windows; practitioners would need to compare the two versions. The instrument does not reference any earlier SoPs before 2015, but the 2015 SoP itself would have replaced an even earlier version. The Amendment history of the VEA and MRCA is not directly relevant, but note that section 196B has been amended over time to give the RMA its current powers. The SoP also refers to the ICD-10-AM Tenth Edition (effective 1 July 2017), which itself may be updated in future editions, but the SoP locks in that edition for coding purposes while preserving its own substantive definition. The instrument is silent on its own sunsetting or review date; however, as a legislative instrument, it may be subject to automatic repeal under the Legislation Act 2003 if not remade. The fact that the RMA has determined a new SoP suggests they had sufficient new evidence to warrant change. No explanatory statement or accompanying material is included with the instrument, so the precise rationale for changes (e.g., the inclusion of taxanes in factor 9(2)(c), or the new benzene ppm-years option) is not recorded in the source.

This instrument does not cite any litigation. As a newly made SoP that commenced on 19 November 2024, it has not yet been subject to judicial consideration. However, previous SoPs for myelodysplastic syndrome (the 2015 version) and other conditions have been frequently litigated in the Administrative Appeals Tribunal and the Federal Court. Historically, claimants have challenged the RMA’s determination of factors on grounds including jurisdictional error (e.g., whether the RMA considered all sound medical-scientific evidence), failure to provide adequate reasons, or misinterpretation of factor requirements. Courts have generally given the RMA wide latitude in assessing medical evidence. The absence of cited cases in this instrument is typical; SoPs are legislative instruments that set evidentiary standards and do not themselves report case law. Nevertheless, the interpretation of specific terms like “sound medical-scientific evidence,” “clinical onset,” and “inability to obtain appropriate clinical management” has been the subject of extensive case law. For example, the phrase “inability to obtain appropriate clinical management” in factor 9(7) has been considered in previous decisions concerning other SoPs, with tribunals clarifying that it requires an objective inability, not merely a failure to seek treatment. The note in section 10(2) that this factor applies only to aggravation may reflect prior litigation distinguishing between causation and aggravation. The instrument’s definition of “being exposed to benzene” with its three limbs (cutaneous, ingestion, inhalation at >5 ppm TWA) is likely a response to earlier cases where disputes arose over what constituted sufficient exposure. The conversion of smoking pack-years (including the note that 1 gram of tobacco equals one cigarette) reflects standardisation after earlier appeals over inconsistent calculations. Practitioners should be alert that the new SoP may generate test cases concerning the novel factors, particularly the taxane drug category and the ppm-years alternative for benzene, as well as the ten-year cessation window for malignant neoplasm therapy.

Several aspects of this SoP can trip up advocates and decision-makers. First, the definition of myelodysplastic neoplasm (syndrome) is expansive but explicitly excludes leukaemia and myeloproliferative neoplasms. A diagnosis that later evolves into acute myeloid leukaemia may split the claim: the MDS period and the leukaemia period are treated separately under different SoPs. The ICD-10-AM codes D46 and C94.6 are only references; the substantive definition governs, so even if a different code is assigned, the patient must still meet the definition in subsection 7(2). The smoking factor requires at least 15 pack-years before clinical onset, with smoking commencing at least 10 years before onset, and if smoking ceased, onset must occur within 10 years of cessation. This window is narrow: a veteran who smoked 15 pack-years but quit 11 years before diagnosis is excluded. The definition of “one pack-year” uses 20 cigarettes per day as the base; a person smoking 10 cigarettes per day for 30 years has only 15 pack-years (10/20 x 30), not 30 pack-years. The equivalent in grams of tobacco (7,300 grams per pack-year) means that someone mixing pipe and cigarettes must carefully quantify weight. The chemotherapy drug factors (9(2)(a)-(c)) include taxanes, which may not be traditionally thought of as strongly leukaemogenic, but the SoP includes them. The threshold for ionising radiation is 0.05 sievert cumulative equivalent dose to bone marrow, which is relatively low , about 50 mSv. This could be reached by multiple CT scans or radiotherapy. However, the exclusion of normal background radiation means only above-background doses count, and the calculation method for cumulative equivalent dose must account for different radiation types using the sievert unit. The note that it includes cosmic radiation at high altitude could catch aircrew or frequent flyers. The benzene exposures are particularly intricate. The instrument defines “being exposed to benzene” via three routes, each with thresholds: cutaneous contact with >1% by volume benzene in liquids, ingestion of such liquids, or inhalation at ambient 8-hour TWA exceeding 5 ppm. Then two alternative cumulative measures exist: (a) 2,500 hours within a continuous period of 10 years before onset, with first exposure at least 10 years and last within 30 years before onset; or (b) greater than 10 ppm-years cumulative, with the same timing. The ppm-years method multiplies concentration (ppm) by years of exposure, so a worker exposed to 1 ppm for 10 years would have 10 ppm-years , exactly the threshold, not exceeding it. The “greater than” language requires strictly more than 10. The hours-based method demands a continuous 10-year period, not necessarily all at once; the 2,500 hours must accumulate within that period. The last exposure must be within 30 years before clinical onset , a long lookback. The inability-to-obtain-appropriate-clinical-management factor (9(7)) only applies to aggravation of a pre-existing or intercurrent disease, not initial causation. The dictionary definition of “terminal event” is non-exhaustive and includes five named conditions but does not limit to them. Section 11 cross-references other SoPs for factors referring to other diseases, such as “malignant neoplasm” , that factor triggers application of the relevant cancer SoP, which may have its own complex criteria. Finally, the instrument applies only to claims under sections 120B of the VEA and 339 of the MRCA; it does not apply to operational service or hazardous service claims (those use reasonable hypothesis SoPs), so practitioners must confirm the correct SoP for the type of service.

Compliance with this SoP is not about following rules in a regulatory sense; rather, it is about gathering and presenting evidence that satisfies at least one of the seven factors for a claimant. For veterans’ representatives, the first step is to obtain a confirmed diagnosis of myelodysplastic neoplasm (syndrome) that matches the definition in section 7(2). The diagnosis should specify the subtype and confirm morphologic dysplasia, cytopaenia, and exclusion of leukaemia and myeloproliferative neoplasms. Medical notes, bone marrow biopsy reports, and genetic testing results (e.g., for 5q deletion, SF3B1 mutation, TP53 inactivation) help establish the definition. Next, identify the relevant service and confirm it falls within the definition of “relevant service” (eligible war service other than operational, defence service other than hazardous/British nuclear test, or peacetime service under MRCA). Then review each factor for potential application. For smoking, obtain a detailed smoking history: start and cease dates, average cigarettes per day, product type, and calculate pack-years (cigarettes per day divided by 20, multiplied by years). Ensure the smoking commenced at least 10 years before clinical onset and that if smoking ceased, the clinical onset was within 10 years of cessation. For chemotherapy drugs, obtain records of treatment for any condition (particularly cancer) listing drugs such as etoposide, doxorubicin, cyclophosphamide, chlorambucil, mechlorethamine, melphalan, nitrosoureas, cisplatin, carboplatin, paclitaxel, or docetaxel. Confirm treatment began at least 6 months before onset and, if ceased, within 20 years of onset. For ionising radiation, gather records of therapeutic radiation (field and dose), diagnostic scans (CT, nuclear medicine, X-ray), occupational exposure (e.g., uranium mining, radiology), and any high-altitude cosmic exposure (e.g., aircrew). Engage a medical physicist or dosimetrist to calculate cumulative equivalent dose to bone marrow, excluding normal background, and ensure it exceeds 0.05 sievert. For benzene exposure, document the nature of exposure (cutaneous, ingestion, inhalation) and measure or estimate ambient benzene concentrations (8-hour TWA >5 ppm) or use job exposure matrices. Two alternative paths: either establish at least 2,500 hours cumulative exposure within a continuous 10-year period, with first exposure 10+ years before onset and last within 30 years; or demonstrate cumulative exposure exceeding 10 ppm-years with the same timing. For malignant neoplasm therapy, obtain records of any cancer treatment that was completed (not necessarily chemotherapy drugs listed separately) and show first exposure at least 6 months before onset and if ceased, onset within 10 years. For inability to obtain appropriate clinical management, this factor only operates for aggravation; gather evidence that the claimant was unable to access appropriate monitoring or treatment (e.g., due to location, cost, or service restrictions) and that this led to clinical worsening. In all cases, the factor must be related to the person’s relevant service , meaning the exposure or event occurred during the period of service or was caused by service-related circumstances. Document the service connection. Keep detailed records including medical reports, exposure histories, and calculations. If a factor references another disease (e.g., malignant neoplasm), ensure you also comply with the relevant SoP for that disease under section 11. Finally, submit the claim with all supporting evidence to the Department of Veterans’ Affairs or the Military Rehabilitation and Compensation Commission, citing the applicable factor and calculations.