Statement of Principles concerning malignant neoplasm of bone and articular cartilage (Reasonable Hypothesis) (No. 66 of 2020)

The central concept is “malignant neoplasm of bone and articular cartilage”, defined in subsection 7(2) as a primary malignant neoplasm arising in bone or articular cartilage. It expressly includes chondrosarcoma of bone or articular cartilage, Ewing sarcoma, and osteosarcoma. It excludes malignant neoplasms of haematopoietic tissue within bones (such as leukaemia or lymphoma involving bone), metastatic lesions from other primary cancers (for example, a prostate cancer deposit in bone), and soft tissue sarcoma. The definition is narrower than the ICD-10-AM codes C40 and C41, which cover a broader range of bone and cartilage neoplasms. The instrument says the meaning given in subsection (2) prevails, so even if an ICD code includes a particular tumour, the SoP may not apply if it falls within the exclusions. “Relevant service” is defined in the dictionary with six categories: operational service, peacekeeping service, hazardous service, and British nuclear test defence service under the VEA; and warlike service and non-warlike service under the MRCA. This definition delimits the type of service that can form the basis of a claim. The SoP applies the “reasonable hypothesis” standard, which is lower than the civil standard of proof (“reasonable satisfaction”) used for some non-operational service claims. The factors in section 9 are the minimum that must exist. They include a cumulative equivalent dose of ionising radiation of at least 0.1 sievert to the affected region at least two years before clinical onset; various pre-existing conditions at the affected site (Paget’s disease, osteonecrosis, chronic osteomyelitis, giant cell tumour); stem cell or bone marrow transplantation; taking growth hormone for at least three months; taking an anthracycline chemotherapeutic agent at least five years before onset; taking denosumab for at least three months, with onset within two years of cessation; and inability to obtain appropriate clinical management. “Cumulative equivalent dose” is defined with reference to a calculation methodology set by the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) as in force on 2 August 2017. The instrument also defines “terminal event” as including pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function, which is relevant because malignant neoplasm of bone and articular cartilage includes death contributed to by the neoplasm.

The SoP directly affects veterans, members of Peacekeeping Forces, and members of the Forces under the VEA, as well as members of the Australian Defence Force under the MRCA, who claim that they suffer from malignant neoplasm of bone and articular cartilage (or have died from it) and that the disease is connected to their relevant service. It also affects the dependants of such persons who claim compensation after death. The instrument applies to a defined subset of the population: those with relevant service as defined (operational, peacekeeping, hazardous, British nuclear test defence, warlike, or non-warlike service). It does not apply to peacetime service under the VEA or to civilian claims. The instrument also heavily affects the decision-makers within the Department of Veterans’ Affairs (DVA), who must apply the factors mechanically when assessing liability. The Repatriation Medical Authority is the body that made the instrument, but it also affects medical professionals who provide evidentiary reports, because they must tailor their assessments to the specific factors listed. For example, a radiation oncologist may need to calculate cumulative equivalent dose using the ARPANSA methodology. The Veterans’ Review Board and the Administrative Appeals Tribunal are affected as review bodies that must follow the SoP. The instrument also affects the legal representatives and advocates who assist claimants, because they must identify which factor is most likely to be satisfied and gather evidence accordingly. The SoP places no direct compliance burden on any private business or market participant, but it does impose a cost on the taxpayer through the compensation system: every successful claim results in a liability on the Commonwealth. Conversely, the narrow definition and exclusion of certain neoplasms reduce the volume of claims that can succeed, which limits fiscal exposure. The existence of a prescribed list of factors also shifts the evidentiary burden onto claimants to prove the existence of one of those factors, which may be difficult for veterans who lack detailed medical records or exposure histories.

The SoP does not create new duties or rights but operates within the existing framework of the VEA and MRCA. The key right for a claimant is that if at least one of the ten factors in section 9 exists and is related to relevant service, a reasonable hypothesis must be taken to connect the disease to that service. This means the decision-maker cannot reject the claim on causation grounds unless the hypothesis is otherwise excluded (for example, if there is a contrary medical-scientific evidence that rebuts the hypothesis). The decision-maker has a duty to apply the SoP when special rule it applies: that is, for claims under section 120A of the VEA or section 338 of the MRCA. The factors are exhaustive in the sense that the SoP does not provide for other mechanisms to raise a reasonable hypothesis; the instrument states that “at least one of the following factors must as a minimum exist”. So the decision-maker has both a right and a duty to reject a claim if no factor is present, even if the claimant offers alternative medical theories. The factor in subsection 9(10) (inability to obtain appropriate clinical management) operates differently: subsection 10(2) provides that this factor applies only to material contribution to, or aggravation of, malignant neoplasm of bone and articular cartilage where the disease was suffered or contracted before or during (but did not arise out of) the person’s relevant service. This means it cannot be used to establish original onset as a result of service; it only addresses worsening of a pre-existing condition during service. The other factors apply to both original onset and aggravation (provided the factor is related to service). Each factor carries its own temporal requirements: for example, ionising radiation requires at least two years before clinical onset; anthracyclines require at least five years before onset; denosumab cessation must occur within two years of onset. The claimant has a right to have the claim assessed according to these factors, but the burden of proof lies on the claimant to produce evidence that the factor exists. The SoP also implies a duty on the decision-maker to consider the dictionary definitions, especially “cumulative equivalent dose”, which must be calculated using the ARPANSA guide as in force on 2 August 2017.

This instrument does not contain any penal provisions. It is a legislative instrument that determines evidentiary thresholds for compensation claims, not a regulatory code that imposes fines or sanctions. The enforcement of the SoP occurs through the claims process and review mechanisms. If a decision-maker incorrectly applies the SoP, the claimant can seek internal review and then external review by the Veterans’ Review Board or the Administrative Appeals Tribunal. The Tribunal can set aside the decision and substitute its own, applying the SoP correctly. There are no penalties for a veteran who falsely claims to have a factor, but the general criminal provisions of the Criminal Code would apply to fraudulent conduct, such as providing false or misleading information to the Commonwealth. That is not contained in this instrument. The SoP itself creates no offences. The primary enforcement risk is from the Commonwealth’s perspective: if a decision-maker misapplies the SoP and grants a claim that should have been rejected, the resulting compensation payments may be stopped or recovered under the VEA or MRCA if overpayment occurs, but again that is not within this SoP. The SoP’s design is essentially a gatekeeping mechanism: it prevents claims based on diffuse or unsubstantiated causation theories. In that sense, its enforcement is prophylactic. There is no penalty for the Repatriation Medical Authority if the factors are later found to be outdated; the SoP can be amended or replaced. The only direct consequences for non-compliance with this instrument are that a decision-maker who fails to apply it would have made an error of law, and the decision could be quashed on review. For claimants, there is no penalty for failing to satisfy a factor other than the claim being denied. The instrument does not impose reporting or record-keeping obligations directly on any person; the compliance burden falls on the DVA and the review tribunals to correctly interpret and apply the criteria.

This SoP is made under subsection 196B(2) of the VEA and is part of a broader statutory scheme for compensating veterans and defence members. It interacts with the substantive provisions of the VEA, particularly sections 120, 120A, and 120B, which set out the standard of proof and the role of Statements of Principles. Under section 120A, for claims where the standard is reasonable hypothesis, the decision-maker must determine whether a reasonable hypothesis exists having regard to the relevant SoP. This SoP is that relevant SoP for malignant neoplasm of bone and articular cartilage. It also interacts with the MRCA: section 338 of the MRCA similarly refers to Statements of Principles, and this SoP applies to MRCA claims as stated in section 5. The instrument repeals the previous SoP No. 106 of 2011, which was made under both subsections 196B(2) and (8) (reasonable hypothesis and reasonable satisfaction). The new SoP is only for reasonable hypothesis. Therefore, for claims that require the reasonable satisfaction standard (such as non-operational service claims under the VEA), a different SoP or no SoP may apply, depending on the circumstances. The instrument also interacts with other Statements of Principles via section 11. If a factor in section 9 refers to an injury or disease that itself is covered by another SoP, then that other SoP applies as in force from time to time. For example, factor (2) refers to Paget’s disease of bone: if Paget’s disease itself has a SoP, then that SoP will govern whether Paget’s disease can be related to service. This cross-referencing mechanism ensures consistency across the system. The SoP uses the ICD-10-AM classification as a reference, but the definition in subsection 7(2) overrides any ICD code inconsistency. This may cause tension with diagnostic coding in medical records, but the instrument clarifies that the meaning in the SoP prevails. The instrument also interacts with the common law concept of causation only to the extent that it displaces it for the reasonable hypothesis stage. No separate causation analysis is required beyond satisfaction of a factor. The SoP does not interact with state or territory workers’ compensation schemes or with private insurance, because it is exclusively for Commonwealth military compensation. It also has no direct interaction with the Australian Radiation Protection and Nuclear Safety Act 1998, but it references ARPANSA’s guide for dose calculation, which is a non-legislative document.

This instrument is a new SoP that repealed and replaced the previous Statement of Principles concerning malignant neoplasm of bone and articular cartilage No. 106 of 2011, which was registered as F2011L01742. The previous SoP was made under both subsections 196B(2) and (8) of the VEA, meaning it covered both the reasonable hypothesis and reasonable satisfaction standards simultaneously. The new instrument is made only under subsection 196B(2) and therefore applies only to the reasonable hypothesis standard. This is a significant change because for claims where the standard of proof is reasonable satisfaction (for example, non-operational service claims that are not subject to the reasonable hypothesis rule), the new SoP does not directly apply. The repeal is effective from 28 September 2020, the commencement date of the new instrument. The previous SoP was made in 2011, so this instrument updated the medical-scientific evidence base after approximately nine years. The instrument itself has not been amended since its commencement; it remains in force as at the date of this analysis. The instrument does not include any transitional provisions, so claims lodged after 28 September 2020 are assessed under the new factors, while claims lodged before but not yet determined may also be assessed under the new SoP if the delegate considers it applies. The instrument uses the ARPANSA guide as in force on 2 August 2017, which may itself be updated over time, but the instrument does not automatically incorporate future amendments to that guide. Any change to the dose calculation methodology would require a new SoP or an amendment. The instrument does not provide a sunset date or review requirement, but the Repatriation Medical Authority has a practice of periodically reviewing and updating SoPs. The amendment history of this particular instrument is minimal, with no changes registered since its enactment. The prior SoP No. 106 of 2011 may itself have been an amendment of an earlier instrument, but that is not disclosed in the source. The instrument is current as of the date of this analysis, but practitioners should verify the current status on the Federal Register of Legislation.

The source itself does not provide any information about litigation history, including any court or tribunal decisions that have considered this specific SoP. As a legislative instrument made in 2020, it is relatively recent, and there may be few publicly reported cases directly construing its terms. However, the broader category of Statements of Principles has been extensively litigated at the High Court, the Federal Court, and the Administrative Appeals Tribunal. In particular, the validity of the Repatriation Medical Authority’s process for determining factors has been challenged in cases such as Repatriation Commission v O’Brien (2006) and others. The calculation of cumulative equivalent dose is likely to be a contested issue, especially the requirement that the dose be to the “affected region”. For primary bone neoplasms, the affected region is the site of the tumour itself. The methodology set out in the ARPANSA guide may be subject to interpretive disputes. The exclusion of metastatic lesions and haematopoietic malignancies could also be litigated if a claimant argues that a particular neoplasm falls within the definition despite being secondary to an undiscovered primary. The factor regarding denosumab (factor 9(9)) introduces a temporal requirement that onset must occur within two years of cessation. The meaning of “permanently ceased” could be disputed. Factor 9(10) (inability to obtain appropriate clinical management) is a common factor in many SoPs and has been the subject of tribunal decisions interpreting what constitutes “inability” and “appropriate clinical management”. However, because the source does not name any specific cases, no case citations can be included. The instrument’s interaction with other SoPs via section 11 could also generate litigation if the reference to “another Statement of Principles” is ambiguous. Overall, the litigation history of this particular instrument is sparse or unreported in the source, but the legal principles governing SoPs generally are well established.

Several aspects of this SoP could trap unwary claimants, advocates, or decision-makers. First, the definition of malignant neoplasm of bone and articular cartilage in subsection 7(2) is not coextensive with the ICD-10-AM codes C40 and C41. The SoP explicitly excludes malignant neoplasms of haematopoietic tissue within bones, metastatic lesions from other primary neoplasms, and soft tissue sarcoma. A veteran diagnosed with a plasmacytoma within bone (a haematopoietic malignancy) or a bone metastasis from a lung primary cannot use this SoP. Second, the factors are exhaustive. If a plausible medical theory exists that does not match any factor, it cannot raise a reasonable hypothesis under this SoP. That means a veteran whose bone cancer occurred only a year after an ionising radiation exposure cannot rely on factor 9(1), which requires at least two years. Third, the cumulative equivalent dose must be calculated using the ARPANSA guide as in force on 2 August 2017. Any dose estimate that uses a different methodology (such as newer dosimetry models) may be rejected unless it can be mapped to the guide. The definition also excludes “normal background radiation exposure in Australia”. This could create disputes over what constitutes “normal” in different regions (e.g., high radon areas). Fourth, factor 9(9) regarding denosumab includes a cessation window: if the person stops taking denosumab, onset must occur within two years of cessation. If the onset occurs more than two years after cessation, this factor does not apply even if denosumab was a likely cause. Fifth, factor 9(2) requires Paget’s disease of bone “at the affected site”. A veteran with Paget’s disease at a different skeletal site cannot use this factor. Sixth, factor 9(10) (inability to obtain appropriate clinical management) applies only to material contribution to, or aggravation of, a pre-existing condition that was suffered before or during service but not arising out of service. It cannot be used to establish original onset due to service. Seventh, the SoP only applies to claims under the reasonable hypothesis standard, not to claims where the standard is reasonable satisfaction. A decision-maker must check which standard applies to the specific claim before invoking this SoP. Eighth, the instrument does not incorporate future amendments to the ARPANSA guide; if the guide changes, the SoP still refers to the 2017 version, which may become outdated. Ninth, the definition of “terminal event” includes only five listed causes of death. If a person dies from a cause not listed (such as sepsis or pulmonary embolism) and that cause was contributed to by the bone cancer, the death may not be considered from the disease under the SoP unless the terminal event fits one of the categories. Tenth, the cross-referencing in section 11 means that if a factor refers to another disease (e.g., Paget’s disease), the SoP for that disease must be satisfied separately. A veteran cannot simply prove Paget’s disease exists; they must also show that the Paget’s disease is related to service under its own SoP. This adds a layer of complexity and potential grounds for denial.

For the Department of Veterans’ Affairs, compliance with this SoP requires that every claim for malignant neoplasm of bone and articular cartilage under the reasonable hypothesis standard be considered against the ten factors. The decision-maker must obtain medical evidence establishing whether any factor exists and whether it is related to the veteran’s relevant service. The decision-maker must also ensure that the disease falls within the definition in section 7(2), excluding haematopoietic, metastatic, and soft tissue sarcomas. For each factor, the required temporal relationship must be checked: for example, radiation exposure must be at least two years before clinical onset, and anthracyclines must be at least five years before. Medical records, service records, and specialist reports should be gathered. If the veteran has a factor that refers to another disease covered by a different SoP, the delegate must also apply that SoP to determine whether the factor itself is service-related. For the veteran or their representative, compliance means providing evidence to satisfy at least one factor. This may involve obtaining a diagnosis of Paget’s disease or osteonecrosis at the same site as the bone neoplasm, or obtaining a dosimetry report from ARPANSA or a qualified health physicist to calculate cumulative equivalent dose. The veteran should also document any history of growth hormone therapy, stem cell transplant, or use of denosumab or anthracyclines. For factor 9(10) (inability to obtain appropriate clinical management), the veteran must demonstrate that they could not access appropriate treatment for the bone cancer and that this worsened the condition. Legal practitioners should ensure that the claim is made under the correct standard (reasonable hypothesis) and that the SoP is cited in submissions. The DVA should also maintain record-keeping systems that flag the existence of this SoP for claims involving ICD-10-AM codes C40 and C41. Because the instrument is a legislative instrument, it has force of law, and the DVA must publish its delegate guidelines consistent with the SoP. The Department should also train decision-makers on the specific exclusions and temporal requirements. The Repatriation Medical Authority updates SoPs periodically, so compliance also requires monitoring the Federal Register of Legislation for any future amendment or replacement. In summary, compliance is a matter of following the checklist of factors and ensuring all definitions are correctly applied, with no room for extraneous causal reasoning.