Statement of Principles concerning adrenal insufficiency (Reasonable Hypothesis) (No. 71 of 2018)

The instrument turns clinical and pharmaceutical particulars into legal rules. The central doctrinal concept is that the Repatriation Medical Authority (RMA) has determined a list of factors which, if present and related to relevant service, are sufficient to raise a reasonable hypothesis linking adrenal insufficiency or death from adrenal insufficiency to service (s 8-9). The SoP does not set out the standard of proof used in the final determination of entitlement under the VEA or MRCA. It sets the minimum factual predicates that will, as a legal matter, satisfy the "reasonable hypothesis" threshold for causation in the context of claims covered by s 120A VEA and s 338 MRCA (s 5, s 9).

Important definitional and operational concepts in the Schedule (Schedule 1) feed into the factors:

• Adrenal insufficiency is defined as an endocrine disease that is biochemically demonstrated and sufficient to produce clinical symptoms and signs and to necessitate replacement therapy (s 7(2)(a)). The SoP therefore requires biochemical evidence plus clinical consequence and treatment, not merely a laboratory abnormality.

• Glucocorticoid therapy as specified is articulated with multiple pathways to meet the threshold: topical high or very high potency application over 10 per cent of body surface daily for three months; inhaled doses at or above 1 600 micrograms budesonide (or equivalent) daily for three months; systemic therapy with cumulative and average dose thresholds (for example cumulative hydrocortisone 600 mg and average 20 mg/day), or equivalent glucocorticoid therapy as listed in the "equivalent glucocorticoid therapy" table in the Schedule; concurrent use with drugs that inhibit CYP3A4 (moderate to strong) daily for four weeks; concurrent use with a drug from Specified List 2 daily for four weeks; ocular, intranasal, or enema glucocorticoid regimes above specified durations or doses; or any glucocorticoid regimen that produced Cushing syndrome (Schedule 1,definitions under "glucocorticoid therapy as specified").

• Equivalent dosing conversions are supplied in a small conversion table for common glucocorticoids (for example prednisolone 150 mg cumulative and 5 mg/day average as equivalent thresholds) (Schedule 1).

• Time windows are precise and vary by factor. Examples: exposure to a drug in Specified List 1 within three months before clinical onset or worsening (s 9(7), 9(19)); surgery to both or a single adrenal gland within one year before clinical onset or worsening (s 9(4), 9(16)); haemorrhage or infarction within one year (s 9(5), 9(17)); medroxyprogesterone or megestrol used continuously for at least four weeks with last dose within three months before onset or worsening (s 9(9), 9(21)). For glucocorticoid therapy, cessation or decrease with last dose within one year before clinical onset or worsening is required where therapy has ceased or decreased (s 9(8), 9(20)).

• The instrument distinguishes "clinical onset of adrenal insufficiency" from "clinical worsening" of adrenal insufficiency with different factors applying to each circumstance and an explicit limitation that factors in ss 9(13)-(25) apply only where the adrenal insufficiency pre‑existed or was suffered during but did not arise out of relevant service, and are limited to material contribution or aggravation (s 10(2)).

• Adrenal crisis is defined in the Schedule as severe adrenal insufficiency of rapid onset causing haemodynamic decompensation and listing characteristic symptoms; it is singled out for a shorter exposure window to acute severe stressors, namely within seven days before clinical onset or worsening in the case of adrenal crisis (s 9(12), 9(24); Schedule 1 definitions).

• "Relevant service" is defined in the Schedule to include various VEA and MRCA service categories such as operational service, peacekeeping, hazardous service, British nuclear test defence service, warlike service, and non‑warlike service (Schedule 1).

• The instrument contains lists with concrete items: Specified List 1 of drugs (e.g. etomidate, mitotane, rifampicin, immune checkpoint inhibitors), Specified List 2 (a number of CYP3A4 inhibitors and antivirals, macrolides, azoles, verapamil, diltiazem), specified infectious organisms (a list of fungi, mycobacteria, viruses and parasites), and a specified list of infiltrative disorders (primary or metastatic neoplasm, amyloidosis, iron overload, sarcoidosis) (Schedule 1).

Thus the main concepts are the legalised mapping from particular exposures, events, infections, surgeries and treatments, measured against specified doses and windows, to a statutory floor for raising a reasonable hypothesis of service connection. The Schedule supplies the granular thresholds and lists required to operationalise the factors set out in section 9.

Primarily, the instrument affects claimants seeking entitlement under the Veterans' Entitlements Act 1986 provisions that invoke an RMA Statement of Principles and claims under corresponding MRCA provisions. The instrument expressly "applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies" (s 5). The text identifies the classes of persons whose service is "relevant service",these include veterans who rendered operational, peacekeeping, hazardous or British nuclear test defence service under the VEA, and members whose service is warlike or non‑warlike under the MRCA (Schedule 1 definition of "relevant service").

Stakeholders directly affected include:

• Claimants who assert that their adrenal insufficiency, or death from adrenal insufficiency, is connected to relevant service. The SoP both narrows and clarifies the kinds of evidence and exposures that will be regarded as sufficient to raise a reasonable hypothesis linking the disease to service (s 9, s 7).

• Medical practitioners and expert witnesses who prepare opinions used in claims. They will need to address the precise predicates in the SoP: biochemical demonstration, requirement for replacement therapy, specific drug exposure names and timing, doses and cumulative/average systemic glucocorticoid dosing across the Schedule 1 conversions, evidence of surgeries or haemorrhage, infections with specific organisms, and the timing of any clinical worsening versus clinical onset (s 7, s 9, Schedule 1).

• Administrators and decision‑makers under the VEA and MRCA who assess entitlement. The instrument is made by the RMA and applies to specified claims; those decision‑makers will need to apply its definitions and factor lists when assessing whether a reasonable hypothesis has been raised, and whether a condition pre‑existed or was aggravated (ss 3, 5, 10).

• Legal advisers and advocates for claimants or the Department, who must frame legal submissions and assemble evidence consistent with the SoP’s thresholds and temporal limits.

• Next of kin and estates where death from adrenal insufficiency is alleged. The instrument explicitly includes death from adrenal insufficiency where death was contributed to by the person’s adrenal insufficiency, and defines "terminal event" by reference to listed proximate or ultimate causes such as pneumonia, respiratory failure or cardiac arrest (s 7(5) and Schedule 1).

The instrument also indirectly affects clinical record custodians and treating institutions. To meet the thresholds, records must show biochemical proof, treatment regimens, dates and doses of medications, surgical details, culture or pathology reports for infections, and documentation of inability to obtain appropriate clinical management where that factor is relied upon (s 7, s 9; Schedule 1). The repeal clause (s 4) means that from the commencement date (24 September 2018) the prior SoP No. 74 of 2009 no longer applies, so claims assessed from that date must be considered against this SoP rather than the repealed version.

The instrument does not create direct liabilities or private civil rights in its own text. Its immediate legal effect is evidentiary and procedural within the statutory framework for veterans’ entitlements, by setting the RMA’s considered position on medical causation links between adrenal insufficiency and relevant service (s 8).

The instrument is predominantly prescriptive of factual predicates for the purposes of raising a "reasonable hypothesis" of service connection. It does not itself create criminal or civil penalties. Key duties and rights are therefore primarily evidentiary and procedural within the VEA/MRCA claims process.

Duties implied by the instrument and its structure

• Duty to show a factor listed in section 9 if a claimant wishes to satisfy the minimum requirement for raising a reasonable hypothesis that adrenal insufficiency or death from adrenal insufficiency is related to relevant service. The SoP requires at least one of the factors in s 9 to exist before the reasonable hypothesis can be said to be raised (s 9).

• Duty to demonstrate that any such factor is related to the person's relevant service. Section 10(1) states that the existence of any factor in section 9 "must be related to the relevant service rendered by the person."

• Duty to apply the definitions and thresholds in the Schedule. Where a factor depends on an identified exposure, dose, duration or organism, the practical duty is to prove the exposure meets the Schedule’s definitions of the relevant terms, such as the glucocorticoid therapy thresholds, the equivalent glucocorticoid table, the Specified Lists, and the definitions of critical illness, acute severe stressor and adrenal crisis (Schedule 1 and s 9).

• Duty to apply cross‑references where factors involve injuries or diseases covered by other Statements. Section 11 provides that if a factor refers to an injury or disease for which another SoP exists, then the factors in that other SoP apply "in accordance with the terms of that Statement of Principles as in force from time to time." This imposes a duty to consult and apply other SoPs when relevant.

Rights or entitlements for claimants implicit in the instrument

• Right to rely on drug‑induced adrenal insufficiency. The definition in s 7(2)(b) explicitly includes drug‑induced causes.

• Right to have death from adrenal insufficiency considered as including deaths where the adrenal insufficiency contributed to a terminal event or condition, with "terminal event" defined in the Schedule (s 7(5), Schedule 1).

• Right to have particular exposures and events treated as sufficient to support a reasonable hypothesis if the claimant can demonstrate the exposure met the specified thresholds and was related to relevant service (s 9, s 10).

Other practical duties and procedural implications

• Proof burdens in practice fall on claimants to assemble medical records showing the biochemical evidence of deficiency, symptomatic clinical presentation, and treatment with replacement therapy, because the statutory definition of adrenal insufficiency requires these elements (s 7(2)(a), notes to s 7). For factors that involve time windows and dosing, proof requires medication histories with dates and doses, operative reports, imaging or histopathology for haemorrhage or infiltration, laboratory or culture evidence for infections, HIV status, and documentation of inability to obtain appropriate management where factor 25 is relied upon (s 9; Schedule 1).

• Claimants relying on aggravation material contribution provisions must prove that the pre‑existing adrenal insufficiency was present before or during relevant service and that a listed factor materially contributed to or aggravated the condition; subsections 9(13)-9(25) are limited to that circumstance (s 10(2)).

Limitations of duties and rights in the instrument

• The instrument does not set the final legal standard of causation for acceptance of a claim under the VEA or MRCA. It lists factors that, if present, are sufficient to raise the reasonable hypothesis that service connection exists. It does not itself determine entitlement or the precise standard of proof applied by the decision maker at later stages of adjudication. The text confines itself to the SoP task under subsection 196B(2) of the VEA (s 3, s 8).

In sum, the primary procedural duty imposed by this instrument is evidentiary: parties must adduce proof that at least one of the specified factors existed and was related to relevant service, applying the Schedule’s precise thresholds and cross‑references where relevant (ss 9-11; Schedule 1).

This instrument contains no penalties in the sense of criminal or civil fines. It is an administrative, statutory instrument made by the Repatriation Medical Authority under subsection 196B(2) of the Veterans' Entitlements Act 1986 and functions as a determinative medical promulgation used by the statutory decision‑making machinery under the VEA and MRCA (ss 3, 5, 8). Enforcement of the SoP’s provisions therefore operates through the claims assessment and entitlement processes under the VEA and MRCA rather than by direct sanctioning clauses within the instrument itself.

Key enforcement and operational mechanisms include:

• Use by decision‑makers. The instrument "applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies" (s 5). Within those statutory schemes, RMA Statements are used to determine whether a "reasonable hypothesis" exists connecting a condition with service; the practical enforcement mechanism is the administrative outcome,entitlement accepted or refused by the relevant decision‑maker according to the statute’s decision rules, which incorporate RMA SoPs.

• Repeal and replacement. The 2018 SoP repeals the earlier SoP (No. 74 of 2009) (s 4). That repeal is an enforcement mechanism in the sense that from commencement the old list of factors no longer governs claims; decision‑makers must apply the current instrument’s factors.

• Cross‑reliance with other SoPs. Section 11 enforces consistency where factors refer to other injuries or diseases that have their own SoPs. The instrument mandates that the factors in those other SoPs apply according to their terms as they stand from time to time. The practical effect is that enforcement of causation for certain related conditions requires applying the current terms of other SoPs.

Practical enforcement risks and sources of administrative dispute

• Disputes about whether a specified factor exists will be factual and medical in nature. The instrument sets precise dose and timing thresholds for some factors (for example, drug exposure windows and glucocorticoid thresholds) but leaves factual determinations about whether a particular medical record meets those thresholds to decision‑makers and their medical panels. This creates potential for contested findings and appeals.

• Ambiguity and interpretative risk arise from terms that may be clinically fluid, such as "clinical onset", "clinical worsening", and "inability to obtain appropriate clinical management". The SoP does not further define how those will be delineated in a contested record. Section 10 clarifies that subsections concerning clinical worsening only apply to earlier‑existing conditions, but precise application to individual factual matrices will be a matter for adjudicators.

• The instrument relies on external classifications when convenient. It references ICD‑10‑AM codes as an identifier but states that the legal meaning of "adrenal insufficiency" is the s 7(2) definition. Claimants and decision‑makers must avoid conflating coding entries with the statutory definition (s 7(3)-(4)).

Sanctions or remedies outside the instrument

• The instrument does not create private causes of action or civil remedies; the consequences of failing to meet the required factors are administrative,namely, a claim may not reach the threshold of a reasonable hypothesis and therefore may be refused under the VEA or MRCA claims process. Any further remedies or appeals would proceed under the statutory appeals framework of the VEA and MRCA, which are not set out in this instrument.

In short, enforcement is administrative and evidentiary. The instrument supplies the RMA’s medical predicates; administrative decision‑makers apply those predicates and produce entitlement outcomes; disputes about application lead to internal review or appeals under the parent statutes rather than to penalties within this instrument.

The instrument sits within the VEA/MRCA statutory framework and expressly engages with other Statements of Principles and medical classification systems. Interaction with other laws and instruments in the text occurs principally in three ways.

Statutory basis and application

• Authority: the SoP is made under subsection 196B(2) of the VEA (s 3). That is the statutory power assigned to the Repatriation Medical Authority to determine Statements of Principles; the instrument therefore operates as a statutory medical determination under the VEA regime.

• Application: it "applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies" (s 5). Those cross‑references place the SoP into the statutory decision process under the VEA and MRCA; in practice, decision‑makers under those Acts will use the SoP to test whether a reasonable hypothesis of a service nexus has been raised. The SoP is thus embedded as an evidentiary instrument within the statutory adjudication regime.

Interaction with other Statements of Principles

• Section 11 addresses cross‑SoP interaction. If a factor in s 9 refers to an injury or disease for which another SoP exists, then the factors in that other SoP "apply in accordance with the terms of that Statement of Principles as in force from time to time." This produces two implications:

  • The evidentiary assessment for a factor that involves a separate condition must import the contemporaneous requirements of the other SoP. For example, if a factor refers to hypopituitarism and that condition has an SoP, the terms of that SoP govern how hypopituitarism is treated in the causation chain.

  • Since the clause applies to other SoPs "as in force from time to time", there is temporal dynamism. Changes to other SoPs may alter how a factor in this instrument is applied, unless and until this instrument itself is amended or repealed. This creates an interaction where multiple instruments are co‑operative and dynamic.

Interaction with medical classification systems and external authorities

• Section 7(3)-(4) references ICD‑10‑AM codes and specifies that while adrenal insufficiency attracts particular codes, "in applying this Statement of Principles the meaning of adrenal insufficiency is that given in subsection (2)". The instrument thus uses the external classification for identification but insists its legal meaning is statutory. The ICD‑10‑AM is cited with edition and effective date details, indicating that epidemiological or coding practices may be consulted but are subordinated to the instrument’s definitional criterion (s 7(3)-(4)).

Overlap with other regulatory or clinical standards

• The Schedule’s drug lists and dosing equivalence tables intersect with pharmaceutical regulation and clinical practice. For example, the inclusion of "immune checkpoint inhibitors" and named antifungals and antivirals means that contemporary prescribing practice and drug scheduling will inform causation assessments under the SoP. However, the instrument does not displace or amend therapeutic practice; it simply incorporates certain medicines and dose thresholds into its causation logic.

• The definition of "critical illness or injury" references intensive care and organ failure states; that connects to hospital admission and clinical coding standards. The SoP will require a match between clinical records and the Schedule’s definitions to establish factors like critical illness.

Limitations in the instrument about interaction

• The instrument does not purport to amend other statutes nor create rights or obligations outside the VEA and MRCA claims processes. It operates within the RMA’s delegated function under the VEA. Any cross‑statute impacts are therefore mediated by the claims processes of the VEA and MRCA rather than by direct legal effect across other regulatory regimes.

In summary, the SoP interacts with other laws by: being authorised by the VEA and applied under the VEA/MRCA claims processes (ss 3, 5); by importing and deferring to other SoPs where factors refer to other conditions (s 11); and by referencing external clinical classification systems and drug naming, while making clear that its own statutory definitions prevail where applied (s 7).

The instrument contains a minimal amendment history within its own text. It is identified as "No. 71 of 2018" and dated 24 August 2018, with commencement on 24 September 2018 (ss 1-2). The only express amendment action contained in the instrument is the repeal of the previous Statement of Principles concerning adrenal insufficiency No. 74 of 2009 (Federal Register of Legislation No. F2009L04045), which was made under subsection 196B(2) of the VEA (s 4). That repeal means that from the commencement date the 2009 instrument no longer has legal effect; this 2018 instrument replaces it.

No other amendments to this instrument are recorded in the text provided. The instrument does not list any earlier amendments, transitional provisions or savings clauses beyond the repeal. It does however include in section 11 a mechanism that effectively ties its operation to other SoPs "as in force from time to time", which means that changes to other SoPs made later will affect how certain factors in this instrument are applied. That creates a contingent amendment effect: while this instrument itself contains no further amendment history, its interaction with other documents can produce practical changes in application as other SoPs are amended.

Key points for practitioners about amendment‑history consequences

• Replacement effect: because the 2009 SoP is repealed, any claim assessments that would otherwise have referred to the 2009 instrument must now apply the 2018 instrument from its commencement date (s 4). Practitioners should therefore confirm which SoP was in force at the date of assessment or decision.

• Dynamic cross‑references: section 11’s reference to other SoPs "as in force from time to time" means that the practical application of this 2018 SoP will change alongside amendments to other SoPs, even if the 2018 instrument itself remains unamended.

• No transitional text provided: the instrument contains no express transitional provisions preserving particular decisions or grandfathering previous findings. The text of the instrument is silent on transitional application beyond the explicit repeal. That suggests administrative practice will determine whether decisions begun under the 2009 SoP but finalised after 24 September 2018 are to be assessed under the 2009 or the 2018 SoP. The instrument itself does not direct transitional handling.

Beyond these points, the instrument’s text supplies no further amendment chronology. Any subsequent amendments to the 2018 instrument, or to other SoPs that it imports by reference, would need to be located in later instruments or the Federal Register of Legislation records; such documents are not part of the text supplied here.

The instrument contains no litigation history. There are no cases, appeals, or judicial interpretations referenced in its text. The Statement of Principles is a statutory instrument: it sets medical predicates used in administrative decision‑making under the VEA and MRCA. Any litigation that touches this SoP, such as judicial review of administrative decisions that applied it, judicial interpretation of its terms, or appeals regarding whether a reasonable hypothesis was raised, is not recited in the instrument itself.

For practitioners this absence of recorded litigation in the instrument means:

• There is no binding judicial gloss contained in the instrument to guide interpretation of key terms used in this SoP, such as "clinical onset", "clinical worsening", "inability to obtain appropriate clinical management", or the temporal limits attached to particular factors.

• Interpretative questions and disputes about how the SoP should be applied in particular factual matrices will be resolved in administrative decision processes and, if contested, in the courts or merits review bodies. Any such authorities would have to be located outside this instrument.

• Section 11’s cross‑references to other SoPs "as in force from time to time" could be the subject of litigation if competing SoPs provide divergent or changing requirements; again, any such litigation would be external to the instrument.

In short, the instrument records no litigation, and any case law applicable to its interpretation must be sourced from decisions under the VEA and MRCA which are not supplied within this instrument.

The instrument contains numerous technical features and precise thresholds that create practical issues claimants and advisers must watch for. The following are concrete risks, traps and interpretative points grounded in the instrument’s text.

1. Definition requires biochemical demonstration and replacement therapy (s 7(2)(a)). A mere clinical suspicion, a single abnormal test without corroboration or absence of replacement therapy will not satisfy the statutory definition of adrenal insufficiency. Practitioners must establish biochemical evidence and that the disease necessitated replacement therapy.

2. Inclusion and exclusion in the definition (s 7(2)(b)-(c)). Drug‑induced adrenal insufficiency is expressly included, but heritable and congenital forms are excluded. Claims based on congenital adrenal hypoplasia or genetic causes will not fall within this SoP and will need different approaches.

3. ICD‑10‑AM codes are not dispositive (ss 7(3)-(4)). Even though the instrument lists ICD codes that commonly apply to adrenal insufficiency, it insists that “in applying this Statement of Principles the meaning of adrenal insufficiency is that given in subsection (2).” Lawyers and medical advisers must not equate administrative coding with meeting the statutory definition.

4. Distinction between clinical onset and clinical worsening and timing consequences (s 10, s 9). Factors in ss 9(1)-(12) relate to clinical onset, while ss 9(13)-(25) relate to clinical worsening. Section 10(2) limits subsections 9(13)-(25) to material contribution to, or aggravation of, adrenal insufficiency where the person's adrenal insufficiency was suffered or contracted before or during but did not arise out of the relevant service. That means that for aggravation claims the condition must have been present earlier and the claimant must prove material contribution or aggravation. Distinguishing onset from worsening chronologically and medically will be critical and often contentious.

5. Precise dose/duration thresholds for glucocorticoid therapy (Schedule 1). "Glucocorticoid therapy as specified" contains many specific pathways to meet the threshold. For systemic therapy the Schedule uses cumulative and average dose minima (for hydrocortisone, cumulative 600 mg and average 20 mg/day) or an equivalent glucocorticoid defined by a table. For inhaled and topical preparations the thresholds differ. Failing to match these exact thresholds will risk losing the factor. Converting between glucocorticoids requires use of the table supplied; incomplete medication records will be a problem.

6. Temporal windows vary and are short in some instances (s 9). Examples: Specified List 1 drugs must have been used within three months before clinical onset or worsening (s 9(7), 9(19)); certain surgeries or haemorrhage must occur within one year of onset or worsening (s 9(4)-(5), 9(16)-(17)); for adrenal crisis only, acute severe stressors within seven days count (s 9(12), 9(24)). Missing dates in clinical records may make it difficult to show the exposure sits in the required window.

7. Broad categories and vagueness in some definitions. Terms such as "inability to obtain appropriate clinical management" (s 9(25)) or "critical illness or injury" have practical ambiguity. The Schedule defines "critical illness or injury" by listing ICU admission or specific organ failures, but "inability to obtain appropriate clinical management" is not defined beyond its inclusion in s 9. That could be litigated or become a site of contestation.

8. Cross‑SoP references may import changing requirements (s 11). If a factor refers to a disease covered by another SoP, the terms of that other SoP "as in force from time to time" apply. This creates potential for shifting ground if other SoPs are amended, and the instrument contains no transitional provisions dealing with such changes.

9. Drug lists combine classes and specific agents (Schedule 1). Specified List 1 includes categories such as "imidazole antifungals" alongside specific drugs such as rifampicin and mitotane. Claimants must show that the actual agent used falls within the listed class or named item; generic labels in records may not suffice.

10. Death claims require demonstration that adrenal insufficiency contributed to a terminal event (s 7(5)). For death claims, medical records and cause‑of‑death documentation must show that adrenal insufficiency contributed to the terminal event as defined in the Schedule (for example pneumonia, respiratory failure, cardiac arrest). The term "contributed to" has practical evidentiary implications; decision‑makers will require linkage in the clinical record.

11. Modern therapies included. The presence of entries like "immune checkpoint inhibitors" in Specified List 1 brings contemporary oncology treatments into the SoP’s scope. For cases involving newer agents, records of timing relative to onset/worsening are necessary.

12. Administrative record completeness matters. The SoP is precise. Missing hospital discharge summaries, operative reports, medication charts, or pathology reports can mean inability to prove a listed factor, even where clinically plausible. The conversion tables and thresholds require numerical proof.

13. No transitional or saving clauses. The instrument repeals the 2009 SoP and provides no transitional rules. Practitioners should confirm which SoP applies to each claim on the basis of decision date and administrative practice.

These "gotchas" are concrete, documentable risks because they arise from the instrument’s own text, definitions and timing rules. They create evidentiary and procedural burdens for claimants and advise points for advisers.

Compliance for claimants, advisers, treating clinicians and decision‑makers is practical and documentary: meet the SoP’s defined predicates by producing records that match the Schedule’s precise definitions, dosing thresholds and temporal windows. Below is a checklist and procedural roadmap drawn from the instrument’s provisions.

1. Confirm which SoP is operative

• Check dates. The 2018 SoP (No. 71 of 2018) commenced 24 September 2018 and repealed the 2009 SoP (s 2-4). Ensure the claim is assessed under the correct SoP based on the operative date for the decision under the relevant statutes (s 5).

2. Establish the statutory definition of adrenal insufficiency

• Biochemical evidence. Obtain and assemble laboratory tests demonstrating deficient production of adrenal cortical hormones. The statutory definition requires biochemical demonstration plus clinical symptoms and necessity for replacement therapy (s 7(2)(a)). Record test names, dates and reference ranges.

• Clinical symptomatology and treatment. Document clinical signs and symptoms and that replacement therapy with glucocorticoid, mineralocorticoid or adrenal androgen replacement was necessitated. Retain prescriptions, medication charts, endocrinology notes, and treatment plans.

3. Map the claim to a factor in section 9

• Identify at least one factor in s 9 that can be supported on the facts. The SoP requires that "at least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised" (s 9). Factors cover autoimmune adrenal disease, infiltrative disorders, infections, surgery, haemorrhage, drugs from specified lists, glucocorticoid therapy as specified, medroxyprogesterone/megestrol for stated indications, hypopituitarism, critical illness, acute severe stressors for adrenal crisis, and inability to obtain appropriate management.

• For aggravation claims: ensure the adrenal insufficiency pre‑existed or was suffered during relevant service but did not arise out of it. Subsections 9(13)-9(25) apply only to aggravation material contribution and are limited by s 10(2).

4. Gather documentary proof tailored to the factor’s requirements

• Drug exposure and dosing: For Specified List 1 exposures, assemble pharmacy records, prescriptions and administration charts showing the specific drug, dates of administration and that the exposure falls within three months before onset or worsening where that timeframe applies (s 9(7), 9(19); Schedule 1).

• Glucocorticoid therapy thresholds: Use the "equivalent glucocorticoid therapy" table in the Schedule to convert records into the instrument’s equivalence framework. Document cumulative doses and average daily rates for systemic steroids, or dosing and duration for inhaled, topical, ocular, intranasal or enema glucocorticoids as specified (Schedule 1 definitions under "glucocorticoid therapy as specified" and "equivalent glucocorticoid therapy").

• Surgery and haemorrhage/infarction: Obtain operative notes, discharge summaries, imaging and pathology confirming surgery to adrenal gland(s) or haemorrhage/infarction, and show the timing within one year before onset or worsening if required (s 9(4)-(5), 9(16)-(17)).

• Infectious organisms: If relying on infection with a specified organism, obtain microbiology, pathology, or specialist notes identifying the organism from the specified list and indicate the infection was present at the time of onset or worsening (s 9(6), 9(18); Schedule 1).

• HIV infection: For HIV as a factor, document testing and positive results predating clinical onset or worsening as required (s 9(3), 9(15)).

• Critical illness or injury: Produce ICU records, ventilation notes, or documentation of sepsis, adult respiratory distress syndrome, acute renal tubular necrosis, disseminated intravascular coagulation or multiple organ failure to meet the Schedule's definition of "critical illness or injury" and show the timing within one year (s 9(11), 9(23); Schedule 1).

• Acute severe stressor and adrenal crisis: For adrenal crisis claims, document the stressor (examples in Schedule 1 include abrupt cessation of glucocorticoids, surgery, dehydration, etc.) and show it occurred within seven days of onset or worsening (s 9(12), 9(24); Schedule 1).

• Medroxyprogesterone and megestrol exposure: If relying on these, confirm treatment was for malignant disease or HIV, that it was used continuously for at least four weeks, and that the last dose was within three months of onset or worsening (s 9(9), 9(21)).

• Inability to obtain appropriate clinical management: If relying on s 9(25), collect contemporaneous records showing the nature of the inability, attempts to obtain management, referrals, access barriers, or administrative refusals. The instrument does not define this term; concrete documentary evidence will be essential.

5. Establish relationship to relevant service

• Tie the factor to the period and nature of relevant service as defined in the Schedule. Section 10(1) requires factors be related to the relevant service rendered by the person. Assemble service records, deployment dates and medical encounters proximate to service where exposures or events occurred.

• For aggravation claims under s 10(2), show that adrenal insufficiency pre‑existed or was suffered during relevant service and that a factor materially contributed to or aggravated the condition while taking place in relation to relevant service.

6. Prepare robust medical opinion

• Expert reports should do three things: (a) certify that the person meets the instrument’s definition of adrenal insufficiency (biochemical, symptomatic and needing replacement therapy), (b) map clinical facts and records to one or more of the s 9 factors and the Schedule definitions, including dose conversions and time windows, and (c) explain causation in terms acceptable to the SoP standard of a "reasonable hypothesis" in relation to relevant service.

• Address the difference between "clinical onset" and recorded diagnosis date. Experts should link symptoms and objective findings to onset dates where possible.

7. For death claims

• Provide death certificate, post‑mortem reports if any, terminal event description and narrative clinical notes tying adrenal insufficiency as a contributory factor to the terminal event. The Schedule defines "terminal event" and lists proximate causes; evidence should explain the chain of contribution (s 7(5); Schedule 1).

8. For decision‑makers and administrators

• Apply the statutory definition in s 7(2) rather than relying solely on diagnostic codes (s 7(3)-(4)). Use the Schedule’s dose conversions, drug lists and time windows. Where a factor references another SoP, consult that SoP "as in force from time to time" and apply it per s 11.

9. Recordkeeping and conversions

• Keep a conversion worksheet using the equivalent glucocorticoid table provided in the Schedule so systemic steroid regimens can be expressed in terms the instrument recognises. Document assumptions and any gaps transparently.

10. Anticipate disputes and prepare appeals strategy

• Expect contention over timing, dose conversion and proof of inability to obtain management. Preserve hospital charts, GP notes, medication charts, pharmacy dispensing records and any correspondence that evidences attempts to obtain management or that documents doses and dates.

Following these steps aligns documentary and expert evidence to the instrument’s legal predicates and reduces the risk that a claim fails at the threshold stage for lack of a listed s 9 factor or a demonstrable relation to relevant service.