Statement of Principles concerning malignant neoplasm of the thyroid gland (Reasonable Hypothesis) (No. 39 of 2022)

The central concept is the "reasonable hypothesis". Under the VEA and MRCA, a claim for a service-related injury or disease will succeed if the decision-maker is satisfied that the material raises a reasonable hypothesis connecting the condition with the circumstances of the person's service. This SoP supplies the minimum factors that must exist to support such a hypothesis. The factors are not themselves the hypothesis; they are factual preconditions.

"Relevant service" is defined in the Schedule 1 dictionary and includes operational service, peacekeeping service, hazardous service, and British nuclear test defence service under the VEA, as well as warlike and non-warlike service under the MRCA. This definition restricts the scope of the SoP to those who served in specific capacities that attract the statutory standard of proof.

"Cumulative equivalent dose" is a key technical concept for factors 1 and 2. It means the total dose of ionising radiation received by the thyroid gland from external exposure, internal exposure or both, excluding normal background radiation in Australia. The dose must be calculated according to the methodology in the ARPANSA guide in force on 2 August 2017. The threshold is 0.1 sievert for any age, or 0.05 sievert if received by age 20. The longer time to onset for younger recipients reflects higher sensitivity. The note provides examples such as nuclear weapons testing, medical procedures involving ionising radiation, and aircrew cosmic radiation exposure.

"Being overweight or obese" is defined as a Body Mass Index (BMI) of 25 or greater, with BMI calculated as weight in kilograms divided by height in metres squared. This factor requires the condition to have existed for at least five years before clinical onset.

The "specified list of thyroid conditions" includes goitre, Graves disease, Hashimoto thyroiditis, hyperthyroidism, and thyrotoxicosis. The "specified list of autoimmune diseases" includes Behcet disease, inflammatory bowel disease, polymyositis, Sjögren syndrome, and systemic lupus erythematosus. These lists are exhaustive; conditions not listed do not count.

"Acromegaly" is defined as a chronic disease from excess growth hormone after epiphyseal closure. "Organ or tissue transplantation" includes transplantation of all or part of an organ or tissue, or a substance obtained from an organ or tissue, but excludes corneal transplant. "Parous women only" restricts factor 10 to women who have given birth; the cumulative period of inability to breastfeed must total at least six months, and the period can be aggregated over multiple pregnancies.

"Clomiphene" is a fertility medication; the factor requires taking it at least five years before clinical onset. Factor 12, "inability to obtain appropriate clinical management", is a catch-all but is limited in its operation: it applies only where the person already suffered or contracted the malignant neoplasm before or during, but not arising out of, their relevant service, and it relates to material contribution to or aggravation.

The dictionary defines "terminal event" narrowly as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. This limits the scope of death attribution.

The SoP also incorporates by reference other Statements of Principles if a factor refers to an injury or disease covered by another SoP. For example, if the factor of having diabetes mellitus requires proof of diabetes, and a separate SoP specifies factors for diabetes, that SoP must be applied as in force from time to time. This ensures consistency across conditions.

This SoP directly affects any person who has rendered relevant service as defined in the Schedule 1 dictionary and who is claiming that malignant neoplasm of the thyroid gland is connected to that service. That includes veterans with operational service under the VEA, members of the Peacekeeping Forces with peacekeeping or hazardous service, persons who rendered British nuclear test defence service, and members under the MRCA with warlike or non-warlike service. Their dependants and legal personal representatives are indirectly affected when a death claim is made.

Decision-makers within the Department of Veterans' Affairs, the Veterans' Review Board and the Administrative Appeals Tribunal are required to apply this SoP when assessing claims under section 120A of the VEA or section 338 of the MRCA. The instrument binds these bodies; they cannot accept a reasonable hypothesis that relies on a factor not listed, unless the hypothesis is based on sound medical-scientific evidence not covered by the SoP (which is rare given the RMA's finding that there is sound evidence for the listed factors).

Medical professionals providing evidence for claims are affected: they must understand the precise definitions, such as cumulative equivalent dose calculation methodology, the specified lists of conditions, and the requirement for a five-year latency period for most factors. Claimants' legal representatives must ensure that evidence addresses the specific factor and its service connection.

The SoP also affects the Repatriation Medical Authority itself, which is the body that determines these instruments. The RMA must review the SoP periodically and update it as medical-scientific evidence changes. The repeal of the 2014 version and replacement with this instrument reflects such a review.

From an economic perspective, the SoP imposes compliance costs on claimants and the government. Claimants must gather evidence of factors like radiation dose reconstruction, BMI over five years, or prescription records for clomiphene. The government bears the cost of assessing claims and possibly paying out entitlements if the factors are satisfied. The specificity of the factors may reduce the number of successful claims compared to a broader approach, but it also reduces uncertainty for decision-makers.

The instrument itself does not create duties in the traditional sense, but it imposes obligations on administrative decision-makers when applying the standard of proof. Under the VEA and MRCA, if the material before the decision-maker raises a reasonable hypothesis that a condition is connected to service, the decision-maker must accept liability unless there is evidence to the contrary that is up to date and reliable and that points away from the hypothesis. This SoP effectively sets the floor: if none of the factors in section 9 exist, then no reasonable hypothesis can be raised, and the claim must fail.

Claimants have the right to have their claim assessed by reference to this SoP. If they can demonstrate that at least one factor existed and that the factor is related to their relevant service, they are entitled to have the hypothesis accepted. The claimant also has the right to rely on factor 12 (inability to obtain appropriate clinical management) only in cases of aggravation, not initial onset.

A key right is the ability to use the cross-reference in section 11: if a factor refers to an injury or disease covered by another SoP (for example, diabetes mellitus), the factors in that other SoP apply. This means that a veteran who has diabetes from service can use that as a stepping stone to satisfy the thyroid cancer factor, provided the other SoP's factors are met.

Decision-makers have a duty to apply the definitions strictly. The dictionary definitions are exhaustive. For example, "being overweight or obese" means a BMI of 25 or greater, not a clinical diagnosis of obesity. "Cumulative equivalent dose" must be calculated according to the ARPANSA guide, not some other methodology. "Specified list of thyroid conditions" and "specified list of autoimmune diseases" are closed lists.

The instrument also creates a duty for the decision-maker to consider the relationship to service under section 10. Even if a factor exists, it must be related to the person's relevant service. So a factor like acromegaly, which is not ordinarily service-related, would need to be connected through evidence, such as head trauma from service causing pituitary dysfunction. This limits the scope of the factor: it is not enough to show the factor exists; the claimant must also show a connection between the factor and service.

No private rights of action arise from this SoP. It is a legislative instrument used in administrative decision-making. The only remedy if it is misapplied is review by the Veterans' Review Board, the Administrative Appeals Tribunal, or the Federal Court on questions of law.

This instrument does not contain any penalty provisions. It is not a regulatory offence-creating instrument. It is a standard-setting SoP used for determining entitlements to compensation and benefits under the VEA and MRCA. The consequences of non-compliance are administrative, not penal.

If a claimant fails to satisfy the factors, the claim will be rejected. That is not a penalty in the legal sense, but it means the claimant does not receive the benefit (such as disability pension, medical treatment, or dependant's pension). If a claimant deliberately provides false evidence to meet a factor, the relevant fraud provisions under the VEA or the Criminal Code would apply, but those are not in this instrument.

Decision-makers who fail to apply the SoP correctly may have their decisions overturned on review. There is no personal penalty for the decision-maker, but the Veteran's Entitlements Act provides for merits review and judicial review.

The enforcement mechanism is thus the review system. Claimants can seek review by the Veterans' Review Board, which is independent of the original decision-maker. Further appeal lies to the Administrative Appeals Tribunal, and then to the Federal Court on a question of law. The SoP is binding on all these review bodies; they must apply it as the instrument stands, not substitute their own views on medical causation.

Because this is a legislative instrument made under the VEA, it is subject to disallowance by either House of the Commonwealth Parliament, but that is a political enforcement mechanism, not a legal one for individual cases.

In practical terms, the most significant enforcement risk for a claimant is that the factor is not made out. For example, if a veteran claims exposure to ionising radiation but cannot produce a dose reconstruction consistent with the ARPANSA methodology, the factor is not met and the claim fails. The claimant bears the evidentiary burden of raising the factor. The Department then has the onus of disproving the hypothesis if it is raised.

The SoP is also relevant for internal quality assurance within the Department: decision-makers must document their reasoning against each factor. Failure to do so may lead to a review body remitting the matter.

The instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. That section confers power on the Repatriation Medical Authority to determine Statements of Principles about injuries or diseases within the scope of the VEA and MRCA. The SoP itself is not part of the VEA; it is a legislative instrument made under that Act, which means it must be consistent with the parent Act.

Section 5 of the instrument provides that it applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies. Section 120A of the VEA deals with the standard of proof for claims involving operational service: a claim will succeed if the material raises a reasonable hypothesis connecting the injury or disease with the circumstances of the service, provided the hypothesis is not contrary to proven facts or the SoP that covers that injury or disease. So this SoP is the authoritative statement of what factors can constitute a reasonable hypothesis for thyroid cancer. Section 338 of the MRCA contains a similar provision for warlike and non-warlike service.

The SoP interacts with other Statements of Principles via section 11. If a factor in this SoP refers to an injury or disease covered by another SoP (for example, "diabetes mellitus" or "autoimmune disease" as defined), the factors in that other SoP apply. This creates a chain of causation: a veteran may need to satisfy a factor for diabetes under the diabetes SoP to then satisfy factor 7 of this SoP. This integration ensures consistency and prevents the need to re-litigate foundational conditions.

The definition of "cumulative equivalent dose" refers to a specific ARPANSA guide in force on 2 August 2017. This incorporates external technical standards into the SoP. Changes to that guide would not automatically affect this SoP; the instrument locks in the 2017 edition. Claimants must use that specific methodology.

The SoP also interacts with the Safety, Rehabilitation and Compensation (Defence-related Claims) Act 1988 for some defence service matters, but the instrument's definitions of relevant service limit its scope to VEA and MRCA, so it does not directly apply to DRCA claims unless the SoP is made under another Act.

In terms of state workers' compensation laws, this SoP has no direct effect. It is specific to the Commonwealth veterans' and military compensation systems.

The ICD-10-AM coding is referenced in subsection 7(4) for classification purposes, but the meaning of malignant neoplasm of the thyroid gland for the SoP is independent of the code; the code is merely assigned to the condition.

This instrument repeals and replaces the Statement of Principles concerning malignant neoplasm of the thyroid gland No. 39 of 2014 (Federal Register of Legislation No. F2014L00476). The 2014 instrument was made under subsections 196B(2) and (8) of the VEA. The 2022 version is made under subsection 196B(2) only, reflecting a statutory change or the RMA's decision to use only that subsection.

The instrument was determined on 29 April 2022 and commences on 30 May 2022. It is numbered No. 39 of 2022, indicating it is the 39th SoP determined in that year. No transitional provisions are included beyond the general application clause in section 5, which states it applies to claims to which section 120A of the VEA or section 338 of the MRCA applies. This means it applies to claims made before commencement that are not yet finally determined, as well as new claims.

The instrument does not include details of what amendments were made compared to the 2014 version. However, from a plain reading, the 2022 version contains twelve factors, while the 2014 version likely had a similar structure but with different thresholds or definitions. For example, the cumulative equivalent dose thresholds in (1) and (2) - 0.1 sievert and 0.05 sievert by age 20 - may have been adjusted. The inclusion of factor 10 for parous women (inability to breastfeed) and factor 11 (clomiphene) may be new or revised. The specified lists of autoimmune diseases and thyroid conditions may have changed.

The repeal of the 2014 version means that any claim determined after 30 May 2022 must be assessed under the 2022 version. The 2014 version no longer has effect.

The instrument notes on its face that the RMA is of the view that there is sound medical-scientific evidence indicating the connection. This is a standard recital justifying the determination of factors.

No other amendments are mentioned. The SoP will remain in force until it is itself repealed and replaced by a later version, which typically occurs when the RMA reviews the condition based on new evidence. The instrument does not contain a sunset clause.

The instrument itself does not reference any litigation. As a legislative instrument, it has not been the subject of judicial review in the instrument itself. However, SoPs generally are frequently litigated in the Federal Court and the High Court. The leading authority on SoPs is the High Court decision in Repatriation Commission v Deledio (1998) 83 FCR 82 (though that case predates the SoP system), but more specifically, Repatriation Commission v Gorton (2001) 110 FCR 321 and McMullan v Repatriation Commission (2005) 144 FCR 155 are relevant for the operation of SoPs.

The 2014 predecessor to this instrument may have been litigated in specific cases, but no such cases are mentioned. The Repatriation Medical Authority is required to ensure that SoPs are based on sound medical-scientific evidence, and the RMA is not a party in claim litigation. Instead, the litigation concerns how the SoP is applied.

Claimants have challenged decisions where the Department found that a factor was not made out, for example regarding the calculation of cumulative equivalent dose or the interpretation of "inability to breastfeed". The Federal Court has held that the SoP factors are exhaustive: if a factor is not met, no reasonable hypothesis can be raised, even if the claimant has other evidence of causation. The court also requires that the factor be related to service, not just exist.

Given the specific nature of this SoP, litigation would likely focus on technical definitions, such as whether a particular autoimmune disease falls within the specified list, or whether a claimant's radiation dose calculation was properly done. The closure of the lists means that any disease not listed cannot be used to satisfy factor 5 or 8. That has been a source of litigation in other SoPs.

No notable judgments specific to this 2022 SoP are available as the instrument is relatively new. The previous 2014 SoP was replaced, which may indicate that the RMA considered that the medical evidence had changed, possibly in response to litigation or new studies.

Several features of this SoP can trap unwary claimants or decision-makers.

First, the definition of malignant neoplasm of the thyroid gland in subsection 7(2) is narrow. It excludes haematolymphoid tumours, mesenchymal tumours and neuroendocrine tumours, including medullary thyroid carcinoma. Medullary thyroid carcinoma is a distinct form of thyroid cancer that arises from parafollicular C cells, not follicular epithelial cells. If a veteran has medullary thyroid cancer, this SoP cannot be used; they would need to rely on the condition not being covered or seek a separate SoP. Similarly, lymphoma of the thyroid is excluded.

Second, the cumulative equivalent dose calculation must follow the ARPANSA guide as in force on 2 August 2017. Claimants cannot use newer methodologies or simplified assumptions. The guide prescribes a specific method for averaging dose over the mass of the thyroid. If the dose reconstruction is not performed according to that guide, the factor is not met. The note says dose is calculated as an average over the mass of a specific tissue or organ, which may be complex for internal exposures.

Third, the latency period for most factors is "at least 5 years before the clinical onset". For factor 2, the radiation must be received by age 20, which creates a complication for older veterans who were exposed after age 20; they cannot use the lower threshold. The 0.1 sievert threshold still applies, but the latency period must still be five years.

Fourth, "being overweight or obese" requires a BMI of 25 or greater for at least five years before onset. BMI is calculated as weight/(height squared). A person who is overweight but whose BMI fluctuates may not satisfy the five-year continuous requirement. The factor does not require a clinical diagnosis of obesity, only the BMI standard.

Fifth, the list of thyroid conditions and autoimmune diseases is closed. For example, Hashimoto thyroiditis is listed, but other autoimmune thyroid diseases like postpartum thyroiditis are not. Similarly, the autoimmune disease list does not include rheumatoid arthritis or type 1 diabetes, though these are autoimmune. Claimants cannot use unlisted conditions.

Sixth, factor 10 applies only to parous women. This means a woman who has never given birth cannot use this factor. Also, the "inability to breastfeed" must be for a cumulative period of at least six months. It is unclear whether this includes periods of partial inability or only complete inability. The note says the period can be cumulative over a number of pregnancies.

Seventh, factor 11 (clomiphene) requires taking the drug at least five years before onset. Clomiphene is used for female infertility. Male veterans would not be affected. The factor does not apply to other fertility drugs.

Eighth, factor 12 (inability to obtain appropriate clinical management) is limited by subsection 10(2). It applies only where the malignant neoplasm was suffered or contracted before or during (but did not arise out of) the person's relevant service. So it does not apply to initial onset claims. It must relate to material contribution or aggravation. This factor is often pleaded but rarely successful because it requires proof that clinical management was unavailable and that this contributed to the condition.

Ninth, the terminal event definition for death claims is limited to five specific causes: pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. Other causes of death that might be contributed to by thyroid cancer, such as sepsis from a thyroid cancer complication, are not included unless they fall within those five.

Finally, section 10 requires that the factor be related to relevant service. Even if a factor exists, the veteran must show that the factor itself is connected to service. For example, if a veteran became obese after service due to civilian lifestyle, the obesity factor is not related to service and the factor fails.

For a claimant seeking to establish a reasonable hypothesis that malignant neoplasm of the thyroid gland is connected to their relevant service, compliance means demonstrating that at least one factor in section 9 existed and that the factor is related to service.

Start by determining which factor might apply. If the veteran was exposed to ionising radiation, obtain a dose reconstruction from a qualified health physicist using the ARPANSA guide dated 2 August 2017. The dose must be at least 0.1 sievert to the thyroid, or 0.05 sievert if received by age 20, and the exposure must have occurred at least five years before clinical onset. Keep records of the timing and source of exposure, such as nuclear testing participation, medical radiation treatments, or aircrew cosmic exposure. The dose reconstruction report should explicitly state the cumulative equivalent dose to the thyroid.

If the veteran has a history of radioactive iodine therapy (iodine-131), obtain medical records showing the administration and date. Ensure at least five years elapsed before the thyroid cancer diagnosis.

If using factor 4 (overweight/obese), obtain medical records or weight measurements showing BMI of 25 or greater for at least five consecutive years before onset. Body weight records from service medical files or GP records can establish this. If the veteran's weight fluctuated, it may be necessary to show that the BMI was 25 or more at the start of the five-year period and throughout.

For factor 5 (specified thyroid condition) or factor 8 (specified autoimmune disease), obtain a diagnosis from a specialist confirming the condition and that it was present at the time of clinical onset of the thyroid cancer. For factor 5, ensure the condition is one of goitre, Graves disease, Hashimoto thyroiditis, hyperthyroidism, or thyrotoxicosis. For factor 8, ensure it is Behcet disease, inflammatory bowel disease, polymyositis, Sjögren syndrome, or systemic lupus erythematosus. No other conditions count.

Factor 6 (acromegaly) requires a diagnosis of that rare condition before onset, with medical evidence.

Factor 7 (diabetes mellitus) requires a diagnosis of diabetes for at least five years before onset. The type of diabetes is not specified, but it must be diabetes mellitus, not pre-diabetes.

Factor 9 (organ or tissue transplantation) requires evidence of transplantation other than corneal transplant. The date of transplant must be before the clinical onset.

Factor 10 (inability to breastfeed for parous women) requires evidence of having given birth and a medical opinion that the veteran was unable to breastfeed for a cumulative period of at least six months. This could be from multiple pregnancies. The inability must be documented; mere failure to breastfeed is not enough.

Factor 11 (clomiphene) requires prescription records showing the veteran took clomiphene at least five years before onset. The indication for clomiphene is not relevant.

Factor 12 (inability to obtain appropriate clinical management) is complex. It applies only to aggravation of a pre-existing thyroid cancer. The veteran must show that during their service, they could not obtain appropriate management, and that this materially contributed to the condition. This requires evidence of what management was appropriate and why it was unavailable. It is unlikely to succeed without strong evidence.

For all factors, the veteran must also establish a connection between the factor and their service. For example, ionising radiation from service activities, or diabetes caused by service, or organ failure from service injury. If the factor itself is unrelated to service, the claim fails.

Decision-makers should verify each factor strictly, check the definitions, and ensure that the latency periods are met. The application of the ARPANSA guide for radiation dose is critical. Any reliance on a factor not listed, or on an unlisted autoimmune disease, is impermissible.

Claimants should also be aware that if a factor refers to another condition covered by a separate SoP (e.g., diabetes), the requirements of that SoP must be satisfied. This may require obtaining a diagnosis and showing the diabetes factor is met under its own SoP.

Finally, for death claims, ensure that the cause of death is one of the terminal events listed, and that the malignant neoplasm contributed to that event. Autopsy reports or death certificates should specify the terminal event.