Statement of Principles concerning malignant neoplasm of bone and articular cartilage (Balance of Probabilities) (No. 67 of 2020)

Malignant neoplasm of bone and articular cartilage is defined in section 7(2) as a primary malignant neoplasm arising in bone or articular cartilage. It includes three specific subtypes: chondrosarcoma of bone or articular cartilage, Ewing sarcoma, and osteosarcoma. It expressly excludes malignant neoplasms of haematopoietic tissue within bones (such as leukaemia or lymphoma involving bone), metastatic lesions within bone or articular cartilage that arise from other primary malignant neoplasms, and soft tissue sarcoma. The definition attracts ICD-10-AM codes C40 (malignant neoplasm of bone and articular cartilage of limbs) and C41 (malignant neoplasm of bone and articular cartilage of other and unspecified sites). The ICD edition used is the Tenth Edition effective 1 July 2017. The definition also covers death from malignant neoplasm of bone and articular cartilage where death results from a terminal event contributed to by the disease. Terminal event is defined in the dictionary as including pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

Balance of probabilities is the standard of proof required. The Repatriation Medical Authority states in section 8 that, on the sound medical-scientific evidence available, it is “more probable than not” that the disease can be related to relevant service. This standard is lower than the reasonable hypothesis standard that applies to some other claims under the VEA.

Relevant service is a defined term in the Schedule 1 dictionary. It means: (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA.

This definition is crucial because the factor must be related to this service. Operational service, hazardous service, and British nuclear test defence service are excluded from the definition. A claimant with operational service who had a radiation exposure during that service may not be able to rely on this SoP unless the exposure also relates to a different kind of service that qualifies. Note that the instrument itself is made under s 196B(3) of the VEA, which applies to all claims, but the definition of relevant service narrows the relationship test. The instrument also references the MRCA and VEA in the dictionary.

Cumulative equivalent dose is defined in the dictionary as the total dose of ionising radiation received by a particular organ or tissue from external or internal exposure (excluding normal background radiation in Australia), calculated in accordance with the ARPANSA guide as in force on 2 August 2017. Examples given include being present during nuclear weapons testing, diagnostic or therapeutic medical procedures, or aircrew cosmic radiation exposure. The note clarifies that dose is averaged over the mass of the specific tissue or organ, and if multiple sources exist, the dose estimates must be combined.

Clinical onset is not defined in the instrument but is a legal concept that appears in the factors (e.g., “at least five years before the clinical onset”). The instrument does not define it, so common law principles apply. Similarly, “affected region” and “affected site” are not defined, leaving room for interpretation as to the proximity required between the exposure or condition and the location of the tumour.

Other conditions (Paget’s disease, chronic osteomyelitis, giant cell tumour) are not defined in the instrument, so their ordinary medical meaning applies. The factor requires that these conditions exist “at the affected site” before clinical onset.

Anthracycline chemotherapeutic agent is not defined; it is a class of drugs such as doxorubicin, epirubicin, etc. The factor requires taking such an agent at least five years before clinical onset.

Inability to obtain appropriate clinical management is the only factor that applies to aggravation or material contribution, as per section 10(2). Its meaning is not defined; it would require evidence that the person could not access adequate treatment for the malignant neoplasm due to their service circumstances.

The primary class of persons affected are veterans and members of the Forces who render “relevant service” as defined. This includes persons who rendered 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. It does not extend to persons whose service is solely operational, hazardous, or British nuclear test defence service, unless the factor itself can be related to a different qualifying service. This is a significant limitation because many veterans with combat-related exposures may find that their operational service is excluded from the definition. However, the instrument also applies to claims under s 120B of the VEA, which does apply to operational service claims. This creates a potential inconsistency: the SoP is mandatory for operational service claims under s 120B, but the relationship to service must be to “relevant service” as defined - which excludes operational service. The practical effect is that for a veteran with only operational service, the factor must still be related to that service (since s 120B requires it), but the definition of relevant service in this SoP does not include operational service. This is a drafting mismatch that may lead to litigation. In practice, the Repatriation Medical Authority may intend that the factor can be satisfied if the exposure occurred during a period of qualifying service, but the wording is restrictive.

The instrument also affects decision-makers at the Department of Veterans’ Affairs, the Veterans’ Review Board, and the Administrative Appeals Tribunal, who must apply this SoP when determining claims for malignant neoplasm of bone and articular cartilage. It binds them and cannot be departed from unless the instrument is invalid. Medical practitioners providing evidence for claims must be aware of the specific factors, particularly the dose reconstruction methodology for radiation exposure and the latency requirements. Legal representatives for claimants need to gather evidence addressing each factor and the relationship to the defined relevant service.

The instrument does not affect the general public or civilian workers, except where they might be covered under the MRCA for peacetime defence service. It has no direct effect on state workers’ compensation schemes, though some schemes may consider similar factors by analogy.

Healthcare providers who treat veterans may need to document histories of Paget’s disease, chronic osteomyelitis, giant cell tumour, or anthracycline use, as these may become critical to a future claim. Medical records must note the specific site of any of these pre-existing conditions relative to the later bone cancer.

The instrument creates no duties in the conventional sense. It does not impose obligations on claimants or medical practitioners. Its main legal effect is to establish a set of conditions that, if satisfied, entitle a person to have their malignant neoplasm of bone and articular cartilage accepted as related to their relevant service on the balance of probabilities. This is a right, not a duty. The right arises once at least one factor in section 9 exists and that factor is related to the person’s relevant service as defined. The decision-maker has a duty to apply the SoP: section 120B of the VEA and section 339 of the MRCA require that the Repatriation Medical Authority’s SoP be applied in determining claims. Failure to properly apply the SoP would be an error of law.

A notable right embedded in the SoP is the ability to rely on factor (6) - inability to obtain appropriate clinical management - for aggravation or material contribution where the disease was already present before or during service but did not arise out of service. This is a limited right: it only applies if the disease existed prior to or during service, and the inability to obtain clinical management made a material contribution to the disease or aggravated it. The relationship to service must still be shown: the inability to obtain clinical management must be related to the person’s relevant service. This might cover cases where a person’s service prevented them from accessing timely treatment, e.g., due to posting in a remote location or operational constraints. However, the bar is high because “appropriate clinical management” is not defined and would require evidence of what management was appropriate and why it could not be obtained.

Another important right is the ability to combine factors: section 9 requires at least one factor to exist, but if more than one exist, they can all be considered. The instrument does not require the factor to be the sole cause; it only requires that the factor exists and is related to service.

Section 11 provides a cross-reference mechanism: if a factor in section 9 refers to an injury or disease that is itself covered by another SoP determined under s 196B(3) VEA, then the factors in that other SoP apply in accordance with its terms. For example, factor (2) - Paget’s disease of bone - is a disease for which a separate SoP may exist. If a person has Paget’s disease and also meets the criteria under that SoP, then the presence of Paget’s disease for the purposes of this SoP is established by applying the other SoP. This prevents duplication and ensures consistency.

The instrument does not create any duty to report, notify, or provide information. However, to exercise the right to claim, a person must submit evidence that satisfies the factors. The burden of proof is on the claimant on the balance of probabilities.

This Statement of Principles does not contain penalty provisions or enforcement mechanisms. It is a legislative instrument that sets standards for decision-makers; it is not a regulatory statute imposing fines or sanctions. The only “penalty” that might arise from non-compliance is an adverse outcome for a claimant if a decision-maker fails to apply the SoP correctly, or an error of law that may be corrected on review. There is no provision for civil or criminal liability under this instrument.

Enforcement occurs through the ordinary processes of administrative review. A claimant who believes the decision-maker has not properly applied the SoP can seek review at the Veterans’ Review Board and then the Administrative Appeals Tribunal. At those levels, the instrument is binding and must be interpreted and applied. If a decision-maker incorrectly finds that a factor does not exist, or misapplies the definition of relevant service, the decision can be set aside.

The Repatriation Medical Authority is not itself subject to enforcement under this instrument. The Authority is the maker of the SoP and is not a party to individual claims. The SoP does not impose any obligations on medical practitioners, hospitals, or treating doctors. However, if a medical practitioner provides false or misleading evidence in support of a factor, they may be subject to general laws concerning fraud or perjury, but not specifically under this SoP.

The instrument does not contain any time limits for claims or sunset clauses. It continues in force until repealed or replaced. The only enforcement concern for claimants is the statute of limitations under the VEA or MRCA for making a claim, but that is external to this instrument.

Given the technical nature of the factors, particularly the ionising radiation dose calculation and the latency periods, errors in assessing the factor are likely to be the main area of dispute. There is no penalty for miscalculating a dose; the consequence is simply that the factor is not established. The decision-maker has no power to impose sanctions on a claimant who fails to satisfy the factors.

Overall, the instrument lacks any enforcement teeth. Its purpose is to provide a binding medical-scientific standard, not to regulate conduct.

The SoP is determined under Part XIA of the VEA, specifically subsection 196B(3). It interacts with the VEA and the MRCA at the claim level. The instrument itself states that it applies to claims under section 120B VEA or section 339 MRCA. Section 120B VEA deals with the application of SoPs to claims where the standard of proof is the balance of probabilities, including operational service. Section 339 MRCA does the same for peacetime service claims under that Act.

The instrument does not directly interact with state or territory workers’ compensation legislation, but those jurisdictions may have similar disease-specific provisions or may rely on this SoP as evidence in common law proceedings. However, there is no formal cross-vesting.

A significant interaction is with other Statements of Principles. Section 11 provides that if a factor in section 9 refers to an injury or disease that is the subject of another SoP, then the factors in that other SoP apply. This incorporates that other SoP’s criteria by reference. For example, if a person has giant cell tumour of bone (factor (4)), and there is an SoP concerning giant cell tumour of bone, then the factors of that SoP must be satisfied for the factor to be considered present. This avoids the need for this SoP to re-litigate the causation of pre-existing conditions. The other SoP applies “as in force from time to time”, meaning that if the other SoP is later amended, the current version applies to claims.

The SoP references the ICD-10-AM classification system, but only to clarify the meaning of malignant neoplasm of bone and articular cartilage. The ICD codes are not used to determine factors; they are merely cross-referential. The iteration of ICD-10-AM is fixed to the Tenth Edition effective 1 July 2017. This means that if a later edition changes the coding for bone cancers, this SoP does not automatically update; a new SoP would be needed or the existing definition would remain based on the 2017 edition.

The cumulative equivalent dose factor references a specific ARPANSA guide as in force on 2 August 2017. This external document is incorporated by reference. Any change to that guide after that date does not affect this SoP unless the SoP itself is amended. This is a rigidity point - claimants must use the 2017 methodology regardless of scientific advances.

The VEA and MRCA themselves contain provisions about the standard of proof (s 120, s 120A, s 120B VEA; s 338, s 339 MRCA). This SoP only operates within the balance of probabilities framework. It does not affect claims under the reasonable hypothesis standard (s 120 VEA for operational service) because s 120B requires a SoP to be applied for balance of probabilities claims. However, the SoP itself is made under s 196B(3), which is the general power for both standards. In practice, the instrument’s factor list would be the same for reasonable hypothesis claims (made under s 196B(2)), but this particular SoP is specifically for balance of probabilities.

The SoP does not interact with criminal law, contract law, or tort law directly. It does not create any cause of action.

This instrument (No. 67 of 2020) repeals the previous Statement of Principles concerning malignant neoplasm of bone and articular cartilage No. 107 of 2011, which was made under subsections 196B(3) and (8) of the VEA. The previous instrument was registered on the Federal Register of Legislation as F2011L01740. The current instrument was made on 28 August 2020 and commenced on 28 September 2020.

The text provides no further amendment history. There is no indication of any intermediate amendments between 2011 and 2020. The SoP is a standalone legislative instrument; amendments to SoPs are typically done by remaking the entire instrument rather than by piecemeal amendment. Under section 196B of the VEA, the Repatriation Medical Authority may revoke or amend a SoP. This instrument exercises the power to repeal the earlier one and replace it with a new determination.

The dictionary in Schedule 1 is new compared to the 2011 version? The source does not provide the prior instrument, so we cannot compare. However, the current instrument includes definitions that may have been updated, such as the ARPANSA guide reference (2 August 2017). The previous instrument likely used an older version of the guide. The definition of “cumulative equivalent dose” now explicitly references that guide, whereas the 2011 version may have used a different methodology or incorporated it by reference differently.

The ICD-10-AM reference is also updated to the Tenth Edition effective 1 July 2017. The previous SoP likely referenced an older edition. This ensures consistency with current coding practice.

The disease definition remains substantively the same, but note that the current instrument includes an explicit exclusion for soft tissue sarcoma, which may have been implicit or absent before.

The instrument does not provide a list of changes, but the repeal clause (s 4) is the only amendment history stated. It is likely that the factors themselves have not changed substantially from 2011, as the medical-scientific evidence base is stable. However, the dose threshold for ionising radiation (0.5 sievert) and the latency period (5 years) remain. The inclusion of anthracycline chemotherapeutic agent may have been present in the 2011 version; without that text, we cannot confirm.

Given the lack of detail, the only reliable amendment history is the repeal and replacement.

The instrument does not mention any litigation history. No court or tribunal decisions are cited within its text. This is expected - Statements of Principles are legislative instruments and do not include judicial reasoning. However, SoPs are frequently the subject of litigation in the Administrative Appeals Tribunal and the Federal Court in the context of veterans’ claims. Typical issues include the interpretation of “clinical onset”, “affected region”, and the correct calculation of cumulative equivalent dose under the ARPANSA guide. Cases may also challenge the validity of the SoP itself if the Repatriation Medical Authority is alleged to have acted beyond power or failed to consider relevant medical evidence.

The predecessor SoP (No. 107 of 2011) may have been considered in some decisions. Common areas of dispute include whether a particular dose reconstruction is correct, whether the dose was received at least five years before clinical onset, and whether a specific site of Paget’s disease is the same site as the bone cancer. The factor requiring “at least 0.5 sievert cumulative equivalent dose” is a bright-line test that often leads to expert evidence on dose reconstruction. The definition of “cumulative equivalent dose” averaging over the mass of a specific tissue or organ can be contentious in cases of non-uniform exposure.

Because the instrument itself does not cite any case, we cannot name specific decisions. However, it is known that the Repatriation Medical Authority’s SoPs have been upheld as valid delegated legislation, and the High Court has considered the nature of the Authority’s function in cases such as Repatriation Commission v Smith (though that case is not cited in the instrument). For the purposes of this analysis, we note that the instrument is likely to be litigated in the context of the specific factors, particularly the radiation dose threshold.

Practitioners should be aware that the Federal Court has held that the Authority must base its SoP on sound medical-scientific evidence, and that the factors must be more than mere possibilities. However, no such challenge appears in this specific instrument.

This section highlights traps for unwary practitioners and claimants.

Definition of “relevant service” excludes operational service. The most significant gotcha. The instrument’s dictionary defines “relevant service” as eligible war service (other than operational service), defence service (other than hazardous service and British nuclear test defence service), and peacetime service under the MRCA. Yet the instrument applies to claims under s 120B VEA, which covers operational service claims. This creates a catch-22: a veteran with only operational service cannot satisfy the relationship requirement because the factor must be related to “relevant service” as defined. For example, a Vietnam veteran who developed osteosarcoma and had radiation exposure from Agent Orange spraying (ionising radiation from nuclear weapons? unlikely) or from diagnostic X-rays during service would not have that exposure related to “relevant service” if his service was only operational. The only way around this is if the veteran also rendered some qualifying service (e.g., non-operational eligible war service) to which the factor could be related. The instrument does not clarify this inconsistency. Until clarified by a court, decision-makers may find that the factor cannot be related to service if it arises from operational service alone.

Latency periods are strictly five years. The ionising radiation factor and the anthracycline factor both require “at least five years before the clinical onset”. If the exposure occurred 4 years and 11 months before the first symptoms, the factor is not satisfied. Claimants must gather precise dates. The instrument does not allow any discretion to lower the latency period even if the medical evidence supports a shorter induction period.

Fixed ARPANSA guide version. The cumulative equivalent dose calculation must be in accordance with the ARPANSA guide as in force on 2 August 2017. Any later scientific developments or improved calculation methods cannot be used. This may disadvantage claimants if the 2017 guide is more conservative or less precise than later versions.

Dose threshold of 0.5 sievert. This is a high threshold. For comparison, a typical chest CT scan delivers about 0.01 Sv. A whole-body dose of 0.5 Sv from occupational or environmental exposure is rare. Many veterans with medical radiation exposures may fall short.

“Affected region” and “affected site” ambiguity. The radiation factor requires dose to the “affected region”. The Paget’s, osteomyelitis, and giant cell tumour factors require that the condition be “at the affected site”. Neither “affected region” nor “affected site” is defined. Does “region” mean the same anatomical part as the tumour, or a larger area? Does “site” require the exact same bone? This lack of definition invites inconsistent decisions.

Inability to obtain appropriate clinical management (factor 6) is limited. It applies only to material contribution or aggravation where the disease already existed before or during service but did not arise out of service. So it cannot be used as a primary cause factor. It also requires the inability to be related to relevant service, which again must be the defined relevant service (excluding operational). This factor is narrow and difficult to prove.

No provision for multiple primary bone cancers. The definition says “a primary malignant neoplasm arising in bone or articular cartilage”. If a person has two separate primary bone cancers, each would need to be considered separately under the factors. The instrument does not address this.

Terminal event definition is exhaustive. The dictionary defines terminal event to mean only pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. If a person dies from a different cause contributed to by the bone cancer (e.g., sepsis from tumour infection), it may not be covered unless it falls within these five categories. The definition does not include “sepsis” or “multi-organ failure”. This could lead to denial of claims where death is caused by the disease but not by a listed terminal event.

Cross-reference to other SoPs may complicate claims. If a factor refer to a disease that has its own SoP (e.g., Paget’s disease), the claimant must also satisfy that SoP’s factors to establish the existence of the disease. This creates an additional evidentiary burden.

For legal practitioners, compliance means building a robust claim that addresses each relevant factor and the relationship to relevant service. The following steps are essential.

Identify the relevant service. Confirm that the veteran or member rendered service that falls within the definition of “relevant service” in Schedule 1 - that is, eligible war service other than operational service, defence service other than hazardous and British nuclear test defence service, or peacetime service under the MRCA. If the person has only operational service, consider whether there is any other period of qualifying service. If not, the claim may not succeed unless an alternative factor that does not require service-related exposure (such as factor 6) can be used, but even that must be related to relevant service.

Obtain accurate medical diagnosis. Ensure the malignant neoplasm is a primary bone or articular cartilage cancer and not a metastasis, haematopoietic malignancy, or soft tissue sarcoma. The diagnosis should be confirmed by histopathology and recorded with the appropriate ICD-10-AM code (C40 or C41). If the disease is chondrosarcoma, Ewing sarcoma, or osteosarcoma, note that these are included.

Determine the clinical onset date. The factors require a latency period of at least five years. Obtain a medical report that specifies the date of first symptoms or diagnosis. The instrument does not define clinical onset, so use the common law meaning - the time when the disease first becomes manifest. Gather evidence such as symptom diaries, GP records, and referral letters.

Evaluate each factor systematically.

Ionising radiation (factor 1): Obtain a dose reconstruction from a qualified health physicist using the ARPANSA guide dated 2 August 2017. The dose must be a cumulative equivalent dose of at least 0.5 Sv to the affected region. The affected region is the anatomical area where the tumour later arose. The dose must be received at least five years before clinical onset. Document all exposures during relevant service, including but not limited to medical X-rays, nuclear medicine scans, occupational exposure, environmental exposure (if from service-related activities), or being present at nuclear weapons tests. Exclude normal background radiation. If the dose is borderline, obtain expert evidence.

Paget’s disease (factor 2): Obtain radiological or histological evidence of Paget’s disease of bone at the exact site where the bone cancer developed. The Paget’s must pre-date the clinical onset of the cancer. Note that Paget’s disease itself may have its own SoP; if so, the criteria of that SoP may need to be satisfied to establish the presence of Paget’s disease. Ensure the pre-existing condition is documented before the cancer diagnosis.

Chronic osteomyelitis (factor 3): Similar to Paget’s - require evidence of chronic osteomyelitis at the affected site prior to cancer onset. The osteomyelitis must be chronic, not acute. Medical records should show a history of long-standing infection in that bone.

Giant cell tumour of bone (factor 4): Must have a documented giant cell tumour at the affected site before the cancer develops. Giant cell tumour is itself a bone tumour, and its treatment (including radiation) may increase the risk of subsequent malignancy. Ensure that the giant cell tumour is distinct from the malignant neoplasm.

Anthracycline chemotherapeutic agent (factor 5): Document that the person took a drug in the anthracycline class (e.g., doxorubicin, epirubicin, daunorubicin) at least five years before clinical onset. This factor is relevant for persons who had prior cancer treated with chemotherapy. The anthracycline exposure must have occurred during the course of the person’s service, which may be unusual but possible if a serving member received cancer treatment.

Inability to obtain appropriate clinical management (factor 6): This is the only factor that can support aggravation or material contribution. It requires that the person already suffered from malignant neoplasm of bone and articular cartilage before or during service (but not arising out of service) and that due to their service circumstances they could not obtain appropriate clinical management, leading to aggravation or material contribution. This factor is unlikely to succeed in most cases. Gather evidence of what management was appropriate and why it was inaccessible, e.g., remote posting, lack of specialist care, or operational constraints.

Cross-reference to other SoPs. If a factor refers to a disease that has its own SoP (Paget’s, chronic osteomyelitis, giant cell tumour), ensure that the criteria of that SoP are also met. Alternatively, if the disease is not covered by an SoP, rely on the ordinary medical meaning.

Compile the relationship to service. Show how each factor is related to the person’s relevant service. For radiation, demonstrate that the exposure occurred during qualifying service. For Paget’s, if the Paget’s was caused by service (e.g., due to an injury or infection), establish that link. For the anthracycline factor, show the chemotherapy was received while the person was still serving.

Draft the claim submission. Include a comprehensive analysis of each factor, supported by medical and service records. Use the language of the SoP: “cumulative equivalent dose”, “affected region”, “at least five years before clinical onset”. Address the relevant service definition explicitly.

Be prepared for review. If the decision-maker rejects the claim, the errors are likely to be factual or interpretive. Common errors include misunderstanding the service definition, miscalculating dose, or rejecting a factor because of an inconsistent definition of “affected region”. Prepare to challenge these at the Veterans’ Review Board or Administrative Appeals Tribunal.