Statement of Principles concerning malignant neoplasm of the nasopharynx (Balance of Probabilities) (No. 10 of 2020)

This legislative instrument is a Statement of Principles (SoP) issued by the Repatriation Medical Authority under subsection 196B(3) of the Veterans' Entitlements Act 1986 (VEA). It sets out the minimum factors that must be established before a decision-maker can determine, on the balance of probabilities, that a malignant neoplasm of the nasopharynx (ICD-10-AM code C11) or death from that condition is connected with a person's relevant service under the VEA or the Military Rehabilitation and Compensation Act 2004 (MRCA). The instrument replaces the earlier SoP No. 26 of 2011 and takes effect from 23 March 2020.

Mechanically, the SoP works as a gatekeeping tool for compensation claims. It does not create an automatic entitlement. Instead, it prescribes a set of possible causal pathways (section 9) that a veteran, member or their dependants must prove exist in order to have the condition accepted as service-related. The standard of proof is balance of probabilities, meaning the decision-maker must be satisfied that it is more probable than not that the claimed condition is linked to service. The RMA has made a formal finding at section 8 that, on the sound medical-scientific evidence available, it is more probable than not that malignant neoplasm of the nasopharynx can be related to relevant service. This finding is the statutory prerequisite for issuing a balance-of-probabilities SoP. Without it, the instrument could not have been made under subsection 196B(3).

The instrument applies only to claims made under section 120B of the VEA (which covers eligible war service other than operational service, and defence service other than hazardous or British nuclear test defence service) and section 339 of the MRCA (which covers peacetime service). Claims involving operational or hazardous service are subject to a different standard of proof (reasonable hypothesis) and are not directly governed by this instrument. The SoP also provides a mechanism for cross-referencing other SoPs where a factor lists a separate injury or disease, ensuring that the causal chain for an underlying condition is assessed under its own SoP. Finally, the instrument defines the precise anatomical and pathological boundaries of the disease at section 7, excluding carcinoid tumours, lymphomas, soft tissue sarcomas and malignancies of adjacent structures, which have their own separate SoPs in some cases.

The central concept is "malignant neoplasm of the nasopharynx", defined at subsection 7(2) as a primary malignancy of the mucosa of the nasopharynx extending from the nares to the part of the pharynx above the soft palate. This definition excludes carcinoid (neuroendocrine) tumours, Hodgkin and non-Hodgkin lymphoma, and soft tissue sarcoma. It also excludes malignancies of the oral cavity, oropharynx, hypopharynx and larynx. The exclusion means that a person claiming compensation for nasopharyngeal cancer must have a diagnosis that matches this anatomical and histological description; a broader diagnosis of head and neck cancer or a different cell type will not satisfy the SoP. The instrument explicitly assigns ICD-10-AM code C11 but clarifies that the clinical definition in subsection 7(2) governs over the code assignment.

Another key concept is "relevant service", defined in Schedule 1. It means eligible war service (other than operational service) under the VEA, defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA. This limits the instrument's scope to non-operational, non-hazardous service categories. Veterans with operational service will rely on the reasonable hypothesis SoP (if one exists) or the general provisions of the VEA. The definition of relevant service is critical because the factor that links the condition to service must be related to that specific type of service, per section 10.

The instrument also introduces several exposure and lifestyle concepts: infection with Epstein-Barr virus (factor 1); smoking at least 20 pack-years with temporal requirements (factor 2); mustard gas exposure (factor 3); inhalation of wood dust at defined intensity and duration (factor 4); inhalation of formaldehyde at specified cumulative levels and sensory irritation (factor 5); consumption of Chinese-style salted fish and preserved vegetables at average weekly quantities for at least five consecutive years within 20 years before onset (factors 6 and 7); and inability to obtain appropriate clinical management (factor 8). Each factor has its own definition in the Schedule or through ordinary meaning, except where cross-referenced to other SoPs.

The "balance of probabilities" standard distinguishes this instrument from its counterpart made under subsection 196B(2) for reasonable hypothesis claims. This instrument is used when the decision-maker must be satisfied on the balance of probabilities that the condition is connected to service, typically for non-operational service claims. The RMA's basis for determination at section 8 states that, on the sound medical-scientific evidence available, such a connection is more probable than not. That is the evidentiary threshold the RMA itself has applied to compile the factors.

The primary persons affected are veterans and members of the Australian Defence Force (and their dependants) who have served in categories that qualify as relevant service under the VEA or the MRCA. Specifically, this means veterans with eligible war service that is not operational service, members with defence service that is not hazardous service or British nuclear test defence service, and members who rendered peacetime service under the MRCA. For these groups, a diagnosis of malignant neoplasm of the nasopharynx (or death from it) may lead to a claim for compensation under the VEA or MRCA if one of the factors in section 9 can be established and related to that service.

The instrument also affects decision-makers at the Department of Veterans' Affairs and the Military Rehabilitation and Compensation Commission. They must apply this SoP in determining claims under sections 120B (VEA) or 339 (MRCA) for this condition. The SoP is binding on decision-makers: if at least one factor is present and related to service, the condition must be accepted as service-related on the balance of probabilities. Conversely, if no factor exists, the claim will be rejected unless the decision-maker is satisfied on other evidence (though the SoP is intended to codify the necessary causal pathways). The RMA itself is the body responsible for making and amending these instruments; it is not directly affected by the SoP in its operation but is the source of its authority.

The instrument indirectly affects treating medical practitioners and specialists who may be asked to provide evidence of exposure histories (e.g., smoking pack-years, wood dust inhalation, dietary habits) and serological evidence of Epstein-Barr virus infection. The definitions of Chinese-style salted fish, preserved vegetables, wood dust inhalation, and formaldehyde exposure rely on specific factual inquiries that may require occupational and dietary histories. Medical experts may be called upon to opine on whether a given exposure meets the thresholds set out in the instrument.

Legal practitioners and advocates specialising in veterans' compensation will need to be familiar with this SoP to advise clients and prepare claims. The SoP replaces the 2011 instrument, so any pending claims under the old instrument may need to be reassessed. Dependants of deceased veterans or members are also affected, as the instrument covers death from the condition, including terminal events contributed to by the cancer.

Finally, the SoP does not affect the general population or employers outside the defence context, except indirectly where a veteran may have had civilian occupational exposures that are claimed to be related to service. The factors for wood dust, formaldehyde, mustard gas, and smoking are not confined to service exposures; they can be any exposure, but the causal link must be related to the person's relevant service. That is, the exposure must have occurred because of the service or in the course of it, not independently in civilian life, unless the instrument's section 10 is satisfied by some other connection.

The instrument imposes no direct duties on individuals. Rather, it operates as a rule of determination for decision-makers. Its key effect is to create a right, in effect, for a claimant to have their condition accepted as service-related if they can prove the existence of at least one of the listed factors and that the factor is related to their relevant service. The decision-maker must then deem the condition to be connected to service on the balance of probabilities (section 9 read with section 10). This satisfies the causal element of a claim under section 120B of the VEA or section 339 of the MRCA.

Claimants have the right to rely on this SoP to structure their evidence. For example, a veteran with a twenty-pack-year smoking history who started smoking at age 18 and developed nasopharyngeal cancer at age 45 (within 10 years of cessation if they stopped) has a clear pathway under factor 2. Similarly, a veteran who consumed Chinese-style salted fish at the defined rate for five consecutive years within the 20 years before onset may use factor 6. However, the duty remains on the claimant to adduce evidence that satisfies each element of the factor, including the temporal windows. The instrument does not shift the burden of proof in terms of production; it merely prescribes what must be proved.

The right to claim under the SoP is limited to persons with relevant service as defined. Operational service claims are not covered by this instrument; those must be assessed under a reasonable hypothesis SoP (if one exists) or the general provisions of the VEA under section 120(1) and (3). The claimant does not have a right to choose which SoP applies; the instrument applies automatically based on the legislative category of the claim.

Section 10(2) imposes a limitation on factor 8 (inability to obtain appropriate clinical management). This factor can only be used to establish material contribution to or aggravation of the condition where the condition was suffered or contracted before or during (but did not arise out of) the person's relevant service. This means factor 8 cannot be used to prove initial causation; it only addresses worsening or contribution after the condition already existed. It is a significant restriction. For example, a veteran who developed nasopharyngeal cancer while in service but whose disease progressed due to denial of treatment can use factor 8, but a veteran who had no cancer before service cannot use it to claim that service-related denial of management caused the cancer.

Section 11 creates a duty on decision-makers to cross-reference other Statements of Principles where a factor in this SoP refers to an injury or disease covered by its own SoP. For instance, if a particular factor involves an underlying condition that is itself subject to a SoP, the decision-maker must apply that SoP's factors in accordance with its terms. This ensures consistency and avoids gaps in causal analysis.

This instrument does not itself contain any penalty provisions or enforcement mechanisms. It is a legislative instrument of the Repatriation Medical Authority that determines the causal factors for compensation purposes. Any penalties that may arise from false or misleading claims under the VEA or MRCA are provided for in those Acts, not in this SoP. The SoP is a rule of evidence and causation; it does not create obligations compliance with which can be directly enforced.

However, the instrument does have indirect enforcement consequences. If a claimant or their representative deliberately fabricates evidence to satisfy a factor (e.g., falsely claiming a history of wood dust inhalation or Epstein-Barr virus infection), they would be subject to the criminal provisions of the VEA or the Criminal Code (Cth) regarding false statements to obtain benefits. But the SoP itself is silent on penalties.

The decision-maker must apply the SoP correctly. If a decision-maker fails to apply the SoP, the decision can be reviewed internally or by the Administrative Appeals Tribunal (AAT). The AAT must apply the law as it stands, including subsection 196B(3) and this SoP. An erroneous failure to accept a claim where a factor exists could lead to a compensable loss for the veteran, but there is no penalty against the decision-maker personally. The instrument is enforced through the administrative and judicial review process.

In terms of the RMA's duty, the Authority must ensure that the SoP is based on sound medical-scientific evidence. If it is later found that the evidence no longer supports a factor, the RMA would be expected to amend or repeal the SoP. But there is no penalty for failing to do so other than the potential for the SoP to be set aside on review if it is unreasonable under the Administrative Decisions (Judicial Review) Act.

Thus, the SoP is best understood as a mandatory consideration in the compensation assessment process, not as a regulatory instrument backed by sanctions. The real enforcement of its terms is through the administrative and judicial review mechanisms that hold decision-makers to the correct application of the law.

The instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. It exists within the broader framework of the VEA and the MRCA. It interacts directly with the substantive provisions that govern the standard of proof for claims: section 120B of the VEA (for relevant service claims) and section 339 of the MRCA (for peacetime service claims). These provisions require the decision-maker to be satisfied on the balance of probabilities that the condition is related to service, and this SoP provides a structured means of making that determination. The SoP does not override those provisions; it supplements them by specifying the factors that must or may be considered.

The instrument interacts with other Statements of Principles in two important ways. First, section 11 says that where a factor in this SoP refers to an injury or disease that is covered by another SoP, the factors of that other SoP apply. For example, if a claimed factor involves Epstein-Barr virus infection, and the RMA has issued a separate SoP for that condition (unlikely for a virus, but theoretically possible), then the decision-maker must apply that SoP. This prevents inconsistency in causal analysis across conditions.

Second, the instrument replaces the earlier SoP No. 26 of 2011. Any claim that was pending or undetermined as at 23 March 2020 must be decided under the new SoP. The earlier SoP is repealed by section 4. This means that any transitional provisions in the VEA or MRCA may affect claims where the disease onset occurred before the new instrument but the claim was lodged later. However, the instrument itself says it applies to claims to which section 120B or section 339 applies; it does not grandfather the old instrument.

The instrument interacts with the general law of evidence. In the AAT, the SoP is a legislative instrument binding the Tribunal. The AAT must apply it unless it is found to be invalid. The instrument also interacts with the common law doctrine of causation, but the SoP effectively codifies what the RMA considers sufficient causal evidence. It may pre-empt any need for expert medical evidence on general causation, but the claimant must still prove the specific factor.

The instrument interacts with workers' compensation and other compensation schemes only in that a veteran cannot double-dip; if they receive benefits under the VEA or MRCA for the same condition, they may be precluded from receiving state workers' compensation. But that is a matter of the safety net provisions of the VEA, not this SoP.

Finally, the instrument interacts with international classifications: it references ICD-10-AM Tenth Edition. This ensures that the diagnostic coding for the condition is standardised across healthcare and administrative systems. However, the instrument clarifies that the clinical definition in subsection 7(2) prevails over the code assignment, meaning that a condition coded as C11 in the medical records is not automatically within scope if it does not match the definition, and a condition that is not coded as C11 may still be considered if it fits the definition.

This instrument was made on 28 February 2020 and commenced on 23 March 2020. It is the direct replacement for the Statement of Principles concerning malignant neoplasm of the nasopharynx No. 26 of 2011 (Federal Register of Legislation No. F2011L00781), which was also made under subsection 196B(3) of the VEA. The 2011 instrument was repealed by section 4 of the current instrument. No interim amendments between 2011 and 2020 are recorded in the text. The Repatriation Medical Authority reviewed the sound medical-scientific evidence available and determined that the factors in the 2011 instrument should be updated. The most notable change is the addition of formaldehyde exposure as factor 5; the previous instrument may not have included it. The consumption factors (Chinese-style salted fish and preserved vegetables) appear to have been carried forward, as they were present in the 2011 instrument's predecessor, but the exact thresholds and temporal requirements may have been adjusted. The smoking factor continues to require 20 pack-years and a 20-year latency before onset, with a 10-year cessation window. Mustard gas and Epstein-Barr virus infection remain as factors. The instrument also now includes a definition of "pack-years of cigarettes, or the equivalent thereof in other tobacco products" that explicitly equates one pack-year to 7.3 kilograms of smoking tobacco, whereas earlier instruments may have used different calculations.

The RMA has the power to remake or amend SoPs whenever it is satisfied that new medical-scientific evidence warrants a change. This instrument does not contain a sunset clause. It can be amended or repealed by a subsequent instrument made under subsection 196B(3) or (2) if the evidence base shifts. The 2011 instrument had a life of about nine years, suggesting that the RMA periodically reviews these instruments though there is no fixed statutory review period.

There is no mention in the instrument of any transitional provisions or savings for claims lodged under the 2011 instrument. The RMA's standard practice is that the current SoP applies to all claims determined after its commencement, regardless of when the condition first manifested or when the claim was lodged, unless the VEA or MRCA provides otherwise. However, that is not stated here.

The instrument itself does not refer to any specific litigation history, either in its text or in the accompanying notes. However, Statements of Principles under the VEA are routinely subject to review by the Administrative Appeals Tribunal (AAT) and the Federal Court of Australia. Claims that are rejected because a factor is not satisfied may be appealed to the AAT, which must apply the SoP as a binding legislative instrument. The AAT has the power to review the factual findings but not the validity of the SoP itself unless a question of jurisdictional error arises.

The previous SoP (No. 26 of 2011) may have been litigated in several cases before the AAT, but this instrument contains no record of such cases. The RMA's determinations are also subject to judicial review under the Administrative Decisions (Judicial Review) Act 1977. A person could challenge the validity of a SoP on grounds such as that it was not based on sound medical-scientific evidence (contrary to section 196B), or that it is irrational or unreasonable. The Federal Court has considered the nature of SoPs in cases such as Repatriation Commission v Gorton (2001) and Repatriation Commission v Cooke (2005), which clarified that SoPs are not merely policy guidelines but legislative instruments that have binding force. The court has also held that the RMA must have regard to the whole of the sound medical-scientific evidence, not just selected studies.

Given that this instrument was made in 2020, it may have been applied in numerous AAT decisions since then. The factors are often disputed: for example, whether a veteran's smoking history meets the pack-year threshold and temporal requirements, or whether wood dust exposure for at least four hours per day for 20 years is proven. There may also be litigation on the starting point of clinical onset and whether the factor existed before that onset. But without specific case references within the instrument, we cannot assert any particular litigation outcome. The general point is that SoPs are routinely contested, and this instrument is no exception.

The instrument also interacts with section 11 where cross-referencing other SoPs may lead to disputes about which SoP applies to an underlying factor. The lack of a litigation history in the text suggests that the RMA did not consider earlier court decisions to have invalidated the 2011 SoP, otherwise a new one would have been made earlier.

Several features of this instrument can trap the unwary claimant or decision-maker. First, the instrument applies only to claims under section 120B of the VEA (relevant service) or section 339 of the MRCA (peacetime service). A veteran claiming for operational service under section 120(1) of the VEA cannot rely on this SoP; they must use a reasonable hypothesis SoP (if one exists) or prove the connection on the balance of probabilities using other evidence. The text of section 5 is explicit: "This instrument applies to a claim to which section 120B of the VEA or section 339 of the MRCA applies." It does not apply to operational service claims. A practitioner who tries to use this SoP for an operational service claim will misapply the law.

Second, factor 2 (smoking) requires the claimant to have smoked at least 20 pack-years, with smoking commencing at least 20 years before clinical onset, and if they ceased smoking, the onset must have occurred within 10 years of cessation. This means a claimant who ceased smoking 11 years before diagnosis cannot use the smoking factor, even if they have a 30-pack-year history. The temporal window is strict. Also, the definition of "pack-years of cigarettes, or the equivalent thereof in other tobacco products" in the Schedule equates one pack-year to 7.3 kilograms of smoking tobacco. This is a specific conversion factor that must be applied precisely. A claimant who smoked roll-your-own tobacco must calculate weight; it is not enough to say they smoked "a lot".

Third, factor 4 (wood dust) requires inhalation for at least four hours per day on more days than not for at least 20 years, or a cumulative total of at least 15,000 hours. The definition of "inhaling wood dust" is work entailing sanding, planing, machining, sawing, repairing or manufacturing of timber products, or performing other tasks in an area where such work is performed. The exposure must be to fine particulate material of wood origin. This means that brief exposure or exposure to wood chips rather than fine dust may not meet the requirement. Also, the 20-year or 15,000-hour requirement is high; a veteran who worked in a sawmill for only 10 years will not meet this factor unless they also had additional exposure.

Fourth, factor 5 (formaldehyde) requires a cumulative total of at least 1,500 hours at a level of at least one part per million (ppm) or resulting in sensory irritation. This is a difficult evidentiary hurdle. The exposure must be measured or reliably estimated; it is not enough to say the claimant "smelled formaldehyde". The 15-year latency before onset is also strict.

Fifth, factor 6 (Chinese-style salted fish) requires consumption of at least ten grams per week for at least five consecutive years within the 20 years before clinical onset. The definition in the Schedule notes that this fish is a traditional food in certain Asian regions. A claimant who is not of Chinese or South-East Asian background may still have consumed it, but the definition is specific to a method of salting and fermentation. Factor 7 (preserved vegetables) uses the same pattern: at least 75 grams per week for five consecutive years within the 20-year window.

For a claimant seeking to establish a connection between nasopharyngeal cancer and relevant service, the first step is to obtain a definitive diagnosis confirming a primary malignancy of the nasopharynx mucosa that is not one of the excluded types. A pathology report or specialist opinion using the ICD-10-AM C11 code will help, but the decision-maker will apply the clinical definition in subsection 7(2). The claimant should also provide evidence of the date of clinical onset, which is when symptoms or signs first became manifest such that a diagnosis could reasonably be made.

The next step is to review each factor in section 9 and gather evidence to support at least one. The easiest factor to prove may be factor 1 (Epstein-Barr virus infection). The claimant should obtain a blood test showing serological evidence of past or current infection (e.g., VCA IgG, EA IgG, EBNA). If the infection occurred before clinical onset, the factor is met regardless of when or how the infection was acquired. However, the claimant must still show that the infection is related to their service under section 10(1). A seroconversion during service would be ideal; if the infection occurred before service, it may be harder to relate to service unless the service contributed to reactivation, which is not explicitly covered.

For factor 2 (smoking), the claimant must provide a detailed smoking history: age at start, average number of cigarettes per day, duration, and any periods of cessation. This must be converted to pack-years using the calculation that one pack-year equals 20 tailor-made cigarettes per day for one year (7,300 cigarettes) or 7.3 kg of smoking tobacco. The smoking must have commenced at least 20 years before clinical onset, and if the claimant stopped, the onset must be within 10 years of cessation. The claimant should also explain how the smoking is related to service (e.g., started or continued due to service stressors, or smoked on base). Even if smoking was purely civilian, it may still be considered related to service if the service itself did not cause the smoking but the smoking occurred during service. The decision-maker will apply the relationship test under section 10(1) flexibly, but causation is not required; only existence of the factor in connection with service.

For factor 3 (mustard gas), the claimant must prove exposure to mustard gas at least five years before onset. This will often require historical records of chemical exposure during military service, such as being present at tests or during conflict. This factor is likely to apply only to veterans of certain conflicts or training exercises.