Statement of Principles concerning neoplasm of the pituitary gland (Reasonable Hypothesis) (No. 70 of 2024)

Reasonable hypothesis is the evidentiary standard applied to claims for operational service, peacekeeping service, hazardous service, British nuclear test defence service, warlike service, and non‑warlike service under the VEA and MRCA. Under section 120A of the VEA and section 338 of the MRCA, a claim cannot succeed unless the decision‑maker is satisfied that the material raises a reasonable hypothesis connecting the injury or disease with the service. An SoP, once determined, must be applied. If the SoP does not cover the claimed condition, or if the claimant cannot satisfy any factor, the claim must fail on the reasonable hypothesis test. The standard is lower than the balance of probabilities but higher than mere possibility; the hypothesis must be plausible and consistent with the medical‑scientific evidence as reflected in the SoP.

Statement of Principles is the instrument issued by the Repatriation Medical Authority under subsection 196B(2) of the VEA. The Authority is an independent statutory body comprised of medical experts. An SoP sets out the factors that justify a causal connection between a particular kind of injury, disease, or death and service. The Authority determines these factors based on "sound medical‑scientific evidence". The SoP is a legislative instrument and is binding on the Repatriation Commission, the Veterans' Review Board, and the Administrative Appeals Tribunal. The instrument notes that the Authority is of the view that there is sound medical‑scientific evidence that neoplasm of the pituitary gland can be related to relevant service. This statement is a claim by the Authority; it is not a legal conclusion but a precondition for making the SoP.

Neoplasm of the pituitary gland is defined in subsection 7(2). It must be a primary neoplasm (not metastatic) and can be benign or malignant. It includes tumours of the anterior pituitary (adenohypophysis), posterior pituitary (neurohypophysis), and the pituitary stalk (infundibulum). The definition excludes several tumour types: soft tissue sarcoma, carcinoid tumour, non‑Hodgkin lymphoma, Hodgkin lymphoma, tumours of the hypothalamus, tumours of the sella turcica of the sphenoid bone, and tumours of the diaphragma sellae. The exclusion of hypothalamic tumours is notable because the hypothalamus is anatomically adjacent to the pituitary and symptoms may overlap; claimants with such tumours cannot use this SoP. The exclusion of sella turcica tumours and diaphragma sellae tumours also narrows coverage because those structures surround the pituitary gland. The instrument attaches ICD‑10‑AM codes C75.1 (malignant neoplasm of pituitary), D35.2 (benign neoplasm of pituitary), and D44.3 (neoplasm of uncertain behaviour of pituitary) as references, but the meaning of the condition is from the instrument text, not the codes.

Factors are listed in section 9. They are the minimum requirements for a reasonable hypothesis. The factors are specific and medical. Factor 1 requires bilateral adrenalectomy (excision of both adrenal glands) as treatment for Cushing syndrome due to a corticotroph pituitary adenoma, occurring before the clinical worsening of that adenoma. The notes explain that Cushing disease is Cushing syndrome from a corticotroph pituitary adenoma, and an example of clinical worsening is Nelson syndrome. Factor 2 involves four named GnRH agonists taken at the time of pituitary apoplexy of a pre‑existing pituitary adenoma. Factor 3 involves four named hormones administered as part of a dynamic endocrine test within four days before pituitary apoplexy. Factor 4 requires obesity (BMI ≥30) for at least five years, at least five years before the clinical onset of pituitary adenoma. Factor 5 covers inability to obtain appropriate clinical management before clinical worsening.

Pituitary apoplexy is defined in the notes to factors 2 and 3 as the sudden loss of blood supply to the pituitary gland, leading to tissue necrosis and loss of function. It is a clinical worsening of a pre‑existing pituitary adenoma. The instrument ties the factor to the timing of this event relative to drug administration.

Relevant service is defined in the Schedule 1 dictionary as: operational service under the VEA; peacekeeping service under the VEA; hazardous service under the VEA; British nuclear test defence service under the VEA; warlike service under the MRCA; or non‑warlike service under the MRCA. This is important because the SoP only applies to these service types. Other service (e.g., peacetime service under the VEA for claims after 1994) would be assessed under the balance of probabilities standard, where the SoP is not necessarily binding but may be considered.

Clinical worsening is a concept used in factors 1, 2, 3, and 5, and in section 10(2). It refers to material contribution to, or aggravation of, neoplasm of the pituitary gland where the neoplasm was suffered or contracted before or during (but did not arise out of) the person's relevant service. This means that for those factors, the claimant must show that the factor led to a worsening of a pre‑existing condition, not that it caused the initial onset.

Terminal event is defined in the Schedule 1 dictionary and includes pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. For the purpose of death from neoplasm of the pituitary gland, the instrument includes death contributed to by the neoplasm even if the immediate cause is one of these terminal events. This broadens the compensable death to include indirect causation.

The primary group affected is current and former members of the Australian Defence Force who have rendered relevant service as defined in the SoP: operational service, peacekeeping service, hazardous service, British nuclear test defence service, warlike service, or non‑warlike service. This covers veterans under the VEA and members under the MRCA. Their dependents are also affected because the SoP applies to death claims. For a widow or dependent child to succeed in a claim for death from neoplasm of the pituitary gland, the claimant must show that the death was contributed to by the neoplasm (including via a terminal event) and that one of the factors existed and was related to the veteran's service.

The instrument directly binds the Repatriation Commission (the primary decision‑maker), the Veterans' Review Board, and the Administrative Appeals Tribunal. They must apply the factors as the minimum threshold for a reasonable hypothesis. Their discretion is constrained: they cannot accept a hypothesis that relies on a factor not listed, unless the claimant argues that the hypothesis is reasonable without any SoP factor (which is almost impossible given the Authority's view that the SoP contains the factors that satisfy the standard). The instrument also affects medical practitioners who provide evidence for claims. For example, if an endocrinologist or forensic pathologist certifies that a veteran had a pituitary tumour, they must address the specific factors: the timing of obesity, the use of GnRH agonists, or the administration of dynamic endocrine tests. The instrument may also affect the ADF health system: service personnel who develop pituitary adenomas during service may be subject to record‑keeping requirements to document obesity or medications that could later be relevant to a claim.

The exclustions narrow the affected group. Individuals with tumours of the hypothalamus, sella turcica, or diaphragma sellae fall outside the SoP. They may need to rely on a different SoP (if one exists for those specific conditions) or face a more difficult evidentiary path. Claimants with soft tissue sarcoma, carcinoid tumour, or lymphoma of the pituitary region are also excluded. The instrument therefore may shift the burden onto those claimants to prove causation without the benefit of a favourable SoP.

Professionally, the instrument affects lawyers and advocates in the veterans' jurisdiction. They must know the factors intimately to advise clients on the viability of a claim. For instance, if a veteran has a pituitary adenoma but was never obese, never took GnRH agonists, never had dynamic endocrine tests, never had bilateral adrenalectomy, and had adequate clinical management, the claim cannot succeed on the reasonable hypothesis test. The advocate must then consider whether the claim can be brought under the balance of probabilities standard (if service is not operational, etc.) or whether there is any other SoP that might cover the condition (e.g., if the neoplasm is a soft tissue sarcoma, another SoP for sarcoma might apply). The instrument also affects the Repatriation Medical Authority itself, which must monitor medical‑scientific evidence and potentially revise the SoP in future.

The instrument does not itself create new duties beyond those already in the VEA and MRCA. However, it operationalises the duty of the Repatriation Commission to determine claims in accordance with the applicable SoP. Under section 120A of the VEA, the Commission must be satisfied that the material before it raises a reasonable hypothesis connecting the injury, disease, or death with the service. For that purpose, it must have regard to any SoP determined by the Authority. The SoP imposes an implicit duty on the Commission to assess whether at least one factor in section 9 exists and is related to relevant service. If the Commission fails to apply the factor correctly, the claimant may have grounds for review.

Claimants have the right to have their claim assessed under this SoP from its commencement date (24 September 2024). For claims lodged before commencement but not yet determined, the transitional provisions are not addressed in this instrument, but ordinarily, the new SoP applies to claims not yet decided unless the old SoP is preserved. The instrument says it applies to a claim to which s120A or s338 applies, but does not specify a date limitation. Practitioners should check the VEA section 120A(1) which requires the Commission to apply the SoP in force at the time of the decision. Therefore, from 24 September 2024, the new SoP must be used for all new and pending claims.

Claimants also have the right to argue that the factor exists even if the medical evidence is not strong, because the reasonable hypothesis standard is lower than balance of probabilities. However, the factor must be "related to" service under section 10(1). This does not require that the service caused the factor; it requires that the factor itself is connected to service. For example, if the factor is obesity, the claimant must show that the obesity was related to service (e.g., due to service‑related inactivity or medication side effects). The instrument does not define what "related to" means; this is left to case law under the VEA.

The clinical worsening aspects in factors 1, 2, 3, and 5 impose a duty on the claimant to show that the neoplasm existed before the relevant service or arose during service but not out of service, and that the factor materially contributed to its aggravation. The instrument is silent on what qualifies as "material contribution", but the term is likely to be informed by the common law. This creates uncertainty: how much worsening is enough? The example of Nelson syndrome in factor 1 gives some guidance for that specific scenario.

The instrument also creates a right to rely on other SoPs through section 11. If a factor refers to an injury or disease that is itself the subject of another SoP (for example, if the factor of "inability to obtain appropriate clinical management" refers to inadequate treatment of a condition that is separately covered by an SoP, such as depression), then the factors from that other SoP must also exist. This layered compliance duty can complicate claims. Essentially, the claimant must satisfy two SoPs: one for the pituitary neoplasm and one for the underlying condition referenced in the factor.

No duties are imposed on private citizens who are not claimants. The instrument does not regulate medical practice or impose obligations on doctors to report or treat in a particular way. However, indirectly, to support a claim, a doctor may need to document weight, hormone use, or test timing, which could affect clinical record‑keeping.

This instrument contains no penalties. It is not a penal or regulatory instrument. Enforcement of any breach of the VEA (such as making a false statement in a claim) is dealt with under the VEA itself, not this SoP. The SoP is purely evidential. If a claimant fraudulently misrepresents that a factor exists, the penalties would be those under section 60 of the VEA (false statements to obtain a pension) which include imprisonment and fines. However, the SoP does not reference those provisions.

The enforcement mechanism for applying the SoP correctly is administrative and judicial review. If the Repatriation Commission misapplies a factor (e.g., it finds that obesity did not exist for five years when the medical records suggest otherwise), the claimant can appeal to the Veterans' Review Board, then to the Administrative Appeals Tribunal, and then to the Federal Court on a question of law. The SoP is a legislative instrument, so its interpretation is a matter of law. The Tribunal and courts can set aside a decision if the factor was incorrectly applied or if the Commission gave no reasons.

The instrument also indirectly affects enforcement of the VEA's reasonable hypothesis standard. Because the SoP sets out the factors, a decision‑maker cannot simply accept any hypothesis; they must check against the listed factors. If the Commission accepts a hypothesis that does not match any factor, that might be an error of law, and the decision could be set aside. Conversely, if the Commission rejects a claim because none of the five factors exists, the claimant's only recourse is to challenge whether the factor should be interpreted differently or whether the facts actually meet a factor (e.g., whether "being obese" for five years can be met by intermittent obesity). The SoP's definition of "being obese" requires a BMI of 30 or greater at a given time, but the factor requires that the person was obese "for at least five years". The dictionary does not define "for at least five years" , it does not say whether the obesity must be continuous or can be cumulative. This ambiguity could lead to litigation. However, the instrument itself has not been litigated yet (it is new). Practitioners should be alert to potential interpretive disputes that may reach tribunals.

This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. It is a legislative instrument subordinate to the VEA. It interacts primarily with the VEA and the MRCA. Section 120A of the VEA and section 338 of the MRCA require that claims be determined in accordance with the applicable SoP if one exists. If no SoP exists for a particular injury or disease, the claim falls back to the general standard of proof (reasonable hypothesis for operational service, balance of probabilities for others). This SoP fills that gap for neoplasm of the pituitary gland.

The instrument incorporates other SoPs by reference under section 11. If a factor in this SoP refers to an injury or disease that is covered by another SoP (for example, if the factor refers to "inability to obtain appropriate clinical management" and that clinical management was for a condition like depression, which has its own SoP), then that other SoP must be satisfied. This creates a chain of dependencies. The instrument does not list which other SoPs might be relevant; it is a general incorporation. This could lead to complexity where a claimant has multiple conditions and needs to satisfy multiple SoPs.

The SoP references the ICD‑10‑AM coding system, tenth edition, effective 1 July 2017. While the coding is not determinative of the condition's meaning, it provides a cross‑reference for medical terminology. The ICD‑10‑AM is a classification system used for morbidity and mortality data. The instrument does not incorporate future editions; only the 2017 edition is specified. If the ICD is updated, the codes may change, but the instrument will retain the same codes unless amended. This could lead to a discrepancy between current coding and the instrument if the classification system is revised.

The SoP also interacts with the Military Rehabilitation and Compensation Act 2004 (MRCA). The MRCA has its own claim provisions and standard of proof. Section 338 of the MRCA mirrors section 120A of the VEA. The definition of relevant service includes warlike and non‑warlike service under the MRCA. However, the MRCA also has its own definition of "member" and "service". Practitioners must ensure that the service type matches the applicable Act. A veteran who served after 1 July 2004 may be covered by the MRCA for warlike service, while earlier service may be under the VEA. The SoP applies to both regimes equally.

The instrument does not interact with state workers' compensation schemes, nor with the Safety, Rehabilitation and Compensation Act 1988 (which covers civilian Commonwealth employees). It is specific to military compensation. It does not affect tort claims (common law claims by veterans against the Commonwealth are barred or limited by the VEA and MRCA). The instrument may be considered in common law proceedings as evidence of medical causation, but it is not binding in that context.

The Human Rights (Parliamentary Scrutiny) Act 2011 and the Legislation Act 2003 govern the making and tabling of legislative instruments. This SoP was tabled and may be subject to disallowance. It has been registered on the Federal Register of Legislation. Its operation is subject to review by the Senate Standing Committee on Regulations and Ordinances, though such review rarely touches on medical content.

The instrument does not create any interaction with privacy laws directly, but medical records used to prove factors (e.g., BMI, medication history) are subject to the Privacy Act 1988 and the Defence (Personnel) Data Protection Act. Claimants must consent to disclosure. The instrument does not waive those requirements.

This is a new instrument. It repeals and replaces the Statement of Principles concerning neoplasm of the pituitary gland No. 53 of 2015 (F2015L00259). The 2015 SoP was also made under subsection 196B(2) of the VEA. This instrument is No. 70 of 2024, indicating it is the 70th SoP determined in 2024. No other amendment history is given in the source. The instrument itself is a standalone determination; it does not contain transitional or saving provisions, so any claim decided before 24 September 2024 would have been determined under the 2015 SoP. Claims still pending on that date would be determined under this new SoP, unless the Commission exercises a discretion to delay decision until the new SoP is in operation (which it likely will, given the instrument's application clause). The 2015 SoP likely had a different set of factors; this is the first revision in nine years. Without the text of the old SoP, we cannot compare. The new SoP may have refined the factors based on evolving medical‑scientific evidence. The Authority's view that sound medical‑scientific evidence indicates the condition can be related to service is unchanged from the basis of the old SoP, but the specific factors and definitions have been updated.

Practitioners should note that the current instrument's dictionary and section 9 are the only operative provisions. The repeal of the 2015 SoP means that any claim relying on the old factors (e.g., a factor that existed in 2015 but was removed) cannot succeed unless saved by transitional provisions, of which there are none. This may affect claimants who had a reasonable hypothesis under the old SoP but not under the new one. However, the VEA requires the decision‑maker to apply the SoP in force at the time of decision, so a claim pending during the transition will be assessed under the new SoP, even if the evidence relates to an older factor. This underscores the need to check the date of the decision.

The source does not cite any litigation history. The instrument is new (dated 20 August 2024, commencing 24 September 2024). As at the date of this writing, it has not been the subject of any reported tribunal or court decisions. The predecessor SoP (No. 53 of 2015) may have been considered in cases, but this instrument does not mention them. It would be improper to invent cases. However, it is well established in the veterans' jurisdiction that SoPs are frequently litigated on issues such as construction of causal language, the meaning of "reasonable hypothesis", and whether the Authority acted within power. The Repatriation Medical Authority has been subject to judicial review in the Federal Court under the Administrative Decisions (Judicial Review) Act. For example, the case of Repatriation Commission v Bey (1997) 79 FCR 364 held that the standard of reasonable hypothesis requires more than a mere possibility but less than probability. That principle will still apply to this SoP. Also, the meaning of "sound medical‑scientific evidence" was considered in Repatriation Commission v Deledio (1998) 83 FCR 82. Those cases are not cited in the source, but they form the background against which the SoP operates. Practitioners should assume that this SoP will be interpreted in light of those authorities. Because the instrument is new, it may be some time before specific challenges to its factors arise. One likely area of dispute is the interpretation of "for at least five years" in factor 4. Does it require continuous obesity for the entire five years, or can it be a cumulative total? The dictionary defines "being obese" by BMI at a point in time, but the factor requires a duration. This ambiguity may prompt litigation.

Another potential ground for challenge is the exclusion of certain tumours. A claimant with a tumour of the hypothalamus may argue that the condition is functionally the same as a pituitary neoplasm. The SoP explicitly excludes that; the Authority has determined that such tumours are not covered. A court might review whether the Authority took into account relevant considerations or made an error of law, but given the Authority's expertise, such a challenge would be difficult. The notes to factors (e.g., Nelson syndrome as an example of clinical worsening) are not binding definitions but may be used in interpretation. Disputes over whether a particular case of pituitary apoplexy was "sudden" or whether a dynamic endocrine test was "within the 4 days" may also arise.

In summary, the litigation history of this specific instrument is nil, but it will be litigated in time. Practitioners should stay alert to emerging case law in the Administrative Appeals Tribunal and the Federal Court.

Several traps exist for the unwary practitioner or claimant. First, the definition of neoplasm of the pituitary gland in subsection 7(2) excludes tumours of the hypothalamus, sella turcica, and diaphragma sellae. These are adjacent anatomical structures. A radiologist's report might describe a "pituitary region tumour" but further specify it as a hypothalamic glioma. Such a claimant cannot rely on this SoP. The claimant would need to find another SoP (e.g., for brain cancer), or proceed without SoP guidance, which is a harder path. The ICD‑10‑AM codes include D44.3 (neoplasm of uncertain behaviour of pituitary), but the instrument says the meaning is from the instrument, not the code. A claimant with a tumour coded as D44.3 but which is actually a tumour of the sella turcica is not covered.

Second, the obesity factor (factor 4) requires that the person was obese for at least five years, and that at least five years elapsed between the start of that obesity and the clinical onset of pituitary adenoma. This is effectively a ten‑year window from the start of obesity to onset. A claimant who was obese for only four years, or who became obese less than five years before onset, fails. The definition of "being obese" uses a simple BMI threshold. But BMI is not always recorded in service medical records. A claimant may have been overweight (BMI 29) but not obese (BMI 30) for years, then became obese shortly before onset. That fails. The instrument does not allow for "morbid obesity" or other measures.

Third, the GnRH agonist factor (factor 2) requires that the agonist was taken at the time of pituitary apoplexy. The note defines pituitary apoplexy as "sudden loss of blood supply". If the apoplexy occurs weeks after the last dose, the factor is not satisfied. The instrument lists only four specific drugs: goserelin, leuprorelin/leuprolide, nafarelin, and triptorelin. Other GnRH agonists (e.g., buserelin, histrelin) are not covered. Similarly, the dynamic endocrine test factor (factor 3) lists only four specific hormones. Any other test (e.g., insulin tolerance test, CRH plus desmopressin) is not covered.

Fourth, the "inability to obtain appropriate clinical management" factor (factor 5) is vague. It does not define "appropriate". It does not require that the inability was due to service; it simply says inability to obtain before clinical worsening. But section 10 requires the factor to be related to service. So the claimant must show that the inability was caused by service (e.g., due to remoteness of posting, or lack of specialist care in a combat zone). This is an underexplored factor and may lead to contradictory decisions.

Fifth, the clinical worsening provisions in section 10(2) apply only if the neoplasm was suffered or contracted before or during (but did not arise out of) the relevant service. This means that if the neoplasm arose out of service (i.e., was caused by service), then the clinical worsening factors are not needed; the claimant would rely on initial onset. But if the neoplasm was pre‑existing, only worsening is compensable. This creates a threshold question: at what point did the neoplasm arise? Given that pituitary adenomas are often slow‑growing and asymptomatic, it may be difficult to determine when it "arose". The instrument does not offer a presumption.

Sixth, the SoP incorporates other SoPs by reference (section 11). This means a claim may require satisfaction of multiple SoPs, increasing compliance burdens. For example, if the factor is bilateral adrenalectomy for Cushing syndrome, the adrenalectomy itself is a surgical procedure. If the Cushing syndrome was caused by a condition that has its own SoP (e.g., adrenal tumour), that SoP must also be met. The chain can be long.

Seventh, the instrument does not provide a definition of "pituitary adenoma" separately from "neoplasm of the pituitary gland". The factors use "pituitary adenoma" and "corticotroph pituitary adenoma". A pituitary adenoma is a benign neoplasm of the pituitary. The instrument does not clarify whether non‑adenomatous neoplasms (e.g., craniopharyngioma, pituicytoma) are covered. They are likely not, because the definition in s7(2) says "primary neoplasm ... arising from the cells of the pituitary gland". Craniopharyngioma arises from Rathke's pouch, not pituitary cells. So such tumours are excluded.

Eighth, the terminal event definition for death claims is broad but not open‑ended; it includes only five listed events. A death from a pulmonary embolism that was contributed to by the pituitary neoplasm would not qualify unless it is classified as respiratory failure or circulatory failure. The list is exhaustive.

Ninth, the instrument does not address the standard of proof for the factors themselves. The existence of the factor must be determined on the balance of probabilities (as per the usual rule for factual findings in claims). But the overall claim is on the reasonable hypothesis standard. This means the facts underlying the factor must be proved on the balance of probabilities, while the causal link to service is assessed at the lower standard. This can be confusing.

Tenth, the instrument is silent on what happens if the claimant has never had a pituitary neoplasm but had a pituitary apoplexy without an underlying adenoma (e.g., a ruptured pituitary hemorrhage). The definition requires a neoplasm; apoplexy alone is not compensable under this SoP.

For legal practitioners advising a veteran or member with a possible claim for neoplasm of the pituitary gland, compliance begins with confirming the diagnosis. Obtain a histological or definitive radiological report that states the tumour arises from the cells of the pituitary gland. Ensure the report does not describe a tumour of the hypothalamus, sella turcica, or diaphragma sellae. If the report uses an ICD‑10‑AM code, cross‑check it against C75.1, D35.2, or D44.3, but remember the instrument's meaning controls. Also exclude soft tissue sarcoma, carcinoid, lymphomas, etc.

Next, identify which of the five factors in section 9 might be present. Gather medical records for the period of relevant service and before/after. For factor 4 (obesity), collect records showing weight and height over at least five years before clinical onset. Calculate BMI. The records should establish that BMI was ≥30 for a continuous period of at least five years, and that the onset of the pituitary adenoma occurred at least five years after the start of that period. Note: the instrument does not specify that the five years of obesity must be continuous; but the safer approach is to ensure continuity. If the veteran had fluctuating weight, it may be contested. Also, the clinical onset date must be established (often the date of first symptoms or diagnosis). Link the obesity to service: show that service contributed to the obesity (e.g., poor diet in barracks, physical limitations due to service‑related injuries, medication‑induced weight gain from service‑prescribed drugs).

For factor 2 (GnRH agonists), obtain records of prescriptions for goserelin, leuprorelin/leuprolide, nafarelin, or triptorelin. Show that the drug was administered at the time of pituitary apoplexy. The records must document the date of apoplexy (sudden headache, visual disturbance, imaging showing haemorrhage). Link the drug to service: was it prescribed for a service‑connected condition? For factor 3 (dynamic endocrine test), show that the test was performed within four days before apoplexy, using only GnRH, GHRH, TRH, or CRH. Again, connect the test to service (e.g., part of investigation for service‑related endocrine dysfunction).

For factor 1 (bilateral adrenalectomy), obtain records of the adrenalectomy and evidence of Cushing syndrome due to a corticotroph pituitary adenoma. Show that the adrenalectomy was performed before clinical worsening of the adenoma (e.g., development of Nelson syndrome). Link the adrenalectomy to service: was the Cushing syndrome caused by a service‑related condition? If the adrenalectomy itself was due to service (e.g., combat injury causing adrenal tumour), that factor is satisfied. For factor 5 (inability to obtain appropriate clinical management), gather evidence that the veteran was unable to access appropriate medical care (e.g., due to remote posting, lack of specialists, or misdiagnosis) and that this inability occurred before clinical worsening. The clinical worsening must be documented.

If the factor refers to an injury or disease covered by another SoP (e.g., obesity is not itself a disease under an SoP, but inability to obtain clinical management might refer to a condition with its own SoP), then that SoP must also be satisfied. Check the current SoP for that condition and ensure its factors are met.

The factor must be related to relevant service under section 10. This means the claimant must show a connection between the factor and the service. For example, if the factor is GnRH agonist use, the use must be for a service‑related condition. If the factor is obesity, the obesity must have been caused or contributed to by service (e.g., service‑related medication, physical inactivity due to service injuries, or psychological conditions from service leading to overeating). This nexus is often the most difficult part. Obtain service medical records, personnel records, and statements from the veteran and comrades.

For claims involving clinical worsening, confirm that the neoplasm existed before or during (but not arising out of) the relevant service. The clinical onset date is critical. The worsening factors (1,2,3,5) only apply to material contribution to aggravation. Document the baseline condition prior to the factor and the deterioration after.

Keep in mind the SoP's application date: 24 September 2024. For claims made before that date, the old SoP (No. 53 of 2015) applies if the decision was made before 24 September. For decisions after that date, apply the new SoP. If a claim is still pending, ensure the decision‑maker applies the correct SoP , request a decision under the current instrument.

If the claim is for death from neoplasm of the pituitary gland, establish that the neoplasm contributed to a terminal event from the list (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function). Obtain the death certificate and medical opinions linking the neoplasm to the terminal event.

Finally, ensure all evidence is submitted in a form that addresses each legal element. Legal representatives should prepare a statement of facts and contentions specifying which factor under section 9 is relied upon and how it is related to relevant service. If multiple factors are available, plead all that apply. The reasonable hypothesis standard means the claimant does not need to prove causation on balance, but the existence of the factor itself must be proved on the balance of probabilities. So gather sufficient medical records to establish the fact (e.g., BMI records, prescription records, test dates). If records are incomplete, the claim may fail. In summary, compliance is a matter of meticulous record linkage and legal argument; the SoP's narrow factors reward early collection of evidence.