Statement of Principles concerning erectile dysfunction (Reasonable Hypothesis) (No. 72 of 2022)

Several core legal and medical concepts structure the instrument. First, the condition covered is defined in operational clinical terms. Subsection 7(2) gives the meaning of “erectile dysfunction” as persistent or recurrent inability to develop or maintain an erection adequate for sexual intercourse, expressly including psychogenic and organic impotence and excluding transient failures due to fatigue, situational anxiety, alcohol or drugs. The instrument notes that while ED attracts ICD‑10‑AM codes F52.2 or N48.4, the working definition for the instrument is the subsection 7(2) text, and it references the specific edition of ICD‑10‑AM for code definitions (s 7(3)-(4)).

Second, the instrument operates to raise a “reasonable hypothesis” connecting the medical condition to relevant service. The statutory phrase “reasonable hypothesis” is not redefined in the instrument, but the instrument specifies that at least one of the enumerated factors in section 9 must exist as a minimum before it can be said that a reasonable hypothesis has been raised (s 9). The structure thus converts medical and factual circumstances into a checklist of qualifying factors, with precise qualifiers about timing and severity.

Third, the instrument separates factors relevant to clinical onset from factors relevant to clinical worsening. Items 9(1)-9(25) concern the person at the time of clinical onset of ED; items 9(26)-9(50) parallel that list but relate to clinical worsening. Subsection 10(2) qualifies the application of the worsening factors: they apply only to material contribution to, or aggravation of, pre‑existing ED where the ED was suffered or contracted before or during, but did not arise out of, the person’s relevant service. The separation of onset and worsening is therefore a structured way to treat new onset ED and aggravation of pre‑existing ED differently within the causation analysis.

Fourth, the instrument relies heavily on precise, operational definitions in Schedule 1. Definitions convert clinical and exposure concepts into objective thresholds. Examples include being obese defined by BMI thresholds or waist circumference (Schedule 1); chronic renal failure defined by GFR less than 15 mL/min/1.73 m2 for at least 3 months, or need for renal replacement therapy, or undergoing chronic dialysis (Schedule 1); and one pack‑year defined and explained with equivalences for pipe tobacco and cigars (Schedule 1). The instrument also defines technical terms such as ischaemic priapism, blunt trauma, MET, and terminal event.

Fifth, the instrument adopts a relatively broad range of causal factors spanning psychiatric disorder, cardiovascular disease, endocrine disease, neurological disease, urological conditions, infection, trauma including burns and nerve injuries, smoking exposure, radiation, obesity, specified drugs, occupational chemical exposure (carbon disulphide), prolonged physical inactivity measured by the MET threshold, childhood sexual abuse, and inability to obtain appropriate clinical management. Each factor has explicit temporal or exposure criteria in the main text and sometimes further precision in the dictionary.

Sixth, Schedule 2 provides a closed list of specified drugs that, if being taken at the time of clinical onset or worsening, count as a causal factor (ss 9(22), 9(47), Schedule 2). The list is broad, including psychotropic medications, hormonal therapies, antiandrogens, cardiovascular medicines such as beta‑blockers, certain anti‑epileptics, and testosterone among others.

Lastly, the instrument contains an explicit cross‑reference rule in section 11. Where a factor in section 9 refers to an injury or disease that is the subject of another RMA Statement of Principles determined under subsection 196B(2) of the VEA, the factors in that other Statement apply according to that Statement’s terms. This mechanism delegates detailed causation analyses for comorbid conditions to their respective Statements of Principles.

Those concepts collectively convert clinical and exposure evidence into a structured causation framework for decision‑makers adjudicating entitlements under the VEA and MRCA. Each concept is anchored to text in the instrument; examples include the clinical definition at s 7(2), the requirement that at least one factor in s 9 must exist, and the dictionary thresholds in Schedule 1.

The primary persons affected by this Statement of Principles are claimants who make, or intend to make, claims under the parts of the VEA or MRCA identified in section 5. Section 5 states the instrument applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies. Those references signal the instrument’s audience is people whose claims for veterans’ entitlements or compensation raise issues of causal connection between erectile dysfunction (or death from erectile dysfunction) and relevant service.

Relevant service is defined in Schedule 1 and includes operational service, peacekeeping service, hazardous service, British nuclear test defence service under the VEA, and warlike or non‑warlike service under the MRCA. Therefore the instrument affects veterans and current or former members of the Australian Defence Force who have rendered those categories of service, insofar as they claim that ED or death from ED is connected to that service (Schedule 1 definition of relevant service).

The instrument also affects decision‑makers under the VEA and MRCA who determine entitlement disputes. The RMA made the instrument under subsection 196B(2) of the VEA (s 3), and it supplies an evidentiary rule set that will be applied when determining whether a reasonable hypothesis has been raised. Practitioners advising claimants, medical experts preparing opinions, and medical records custodians are affected because the instrument prescribes specific evidence types and time windows necessary to meet the RMA’s factor thresholds. For example, if relying on radiation exposure, the claimant will need records showing a course of therapeutic radiation where the penis, pelvis or perineal region was in the radiation field within the 10 year look‑back period (9(20), 9(45)).

Schedule 2’s drug list affects prescribing clinicians and claimants because taking a specified drug at the time of clinical onset or worsening is itself a listed factor (9(22), 9(47); Schedule 2). The list includes medicines commonly prescribed in primary and specialist care. Claimants who have taken those drugs will need to document timing and dosage to link the drug exposure to the clinical onset or worsening.

The instrument affects parties responsible for occupational exposure records where carbon disulphide exposure is alleged. The carbon disulphide factor (9(23), 9(48)) requires exposure in an unventilated and confined space on more days than not for a consecutive period of at least five years before clinical onset or worsening, and if exposure has ceased the onset or worsening must have occurred within one year. That creates a requirement for workplace records and exposure assessments.

Finally, the instrument affects legal advisers, advocates and specialists who design claims and assemble evidence, because it prescribes objective thresholds and cross‑references to other Statements of Principles in section 11. Where a factor in section 9 names an injury or disease subject to another Statement of Principles, that other Statement’s factors apply in accordance with its terms. This means coordinated application of multiple Statements of Principles may be required in claims involving comorbid conditions.

In sum, the instrument affects claimants with ED or death from ED, medical witnesses and record‑keepers, decision‑makers under specified VEA and MRCA sections, and parties producing occupational, surgical, psychiatric or pharmaceutical evidence. The instrument delineates which factual and temporal circumstances a claimant must establish to raise the statutory reasonable hypothesis that ED is related to relevant service.

The instrument itself does not create new statutory entitlements or administrative rights outside the VEA or MRCA framework, but it creates binding criteria that decision‑makers will use in assessing causation for claims to which section 120A of the VEA or section 338 of the MRCA applies (s 5). The principal “duty” embedded in the instrument is a rule for proof: a claimant must establish that at least one of the factors listed in section 9 existed at the relevant time in order to raise a reasonable hypothesis that ED or death from ED is related to relevant service (s 9). The duty to link any such factor to relevant service is explicit in section 10(1), which requires the existence of the factor to be related to the person’s relevant service.

Rights recognised by the instrument are procedural rather than substantive. A claimant whose medical and factual evidence satisfies one or more of the enumerated factors has the right to have a decision‑maker treat a reasonable hypothesis as raised, subject to the decision‑maker’s application of the VEA/MRCA provisions that govern entitlement determination. Section 11 preserves the right to have the factors in other Statements of Principles applied where a factor in section 9 refers to an injury or disease that is covered by another RMA Statement; the instrument therefore recognises interlocking procedural rights to be assessed under the specialised Statements that cover comorbid diseases.

The instrument imposes no express administrative obligations on private practitioners or employers, but it creates practical obligations for claim preparation. For example, many factors hinge on objective measurements and documented timings. The dictionary defines BMI and waist circumference thresholds for obesity, GFR/dialysis thresholds for chronic renal failure, pack‑year calculation methods for smoking exposure, and MET as a unit of metabolic exertion (Schedule 1). A claimant seeking to rely on those factors will need to produce medical records, laboratory reports, specialist statements and occupational records aligned to those definitions. Those evidentiary obligations flow from the instrument’s factors.

The instrument also creates a temporal duty in the form of look‑back windows and duration thresholds to be satisfied. Several factors require that the condition or exposure was present “at the time of the clinical onset” or “at the time of the clinical worsening” (s 9). Certain triggers have explicit durations or windows, for example ischaemic priapism for a continuous period of at least 4 hours before clinical onset or worsening (9(14), 9(39)), or radiation within 10 years prior to onset or worsening (9(20), 9(45)). The duty therefore is to adduce records that align onset or worsening dates with the factor’s timing.

The instrument confers no criminal penalties, licensing conditions or procedural sanctions in its text. It is an evidentiary instrument used by the RMA and decision‑makers interacting with the VEA and MRCA. The rights it creates concern how factual medical and exposure evidence are to be assessed for the reasonable hypothesis causation threshold. Subsection 10(2) also creates a substantive limitation that affects rights to rely on worsening factors: those items apply only where ED was suffered or contracted before or during, but did not arise out of, relevant service. That limits the class of claim where worsening factors can contribute as material contribution or aggravation.

Finally, the RMA’s view expressed in section 8 is not itself a procedural right, but an evidentiary positioning: the RMA is of the view that sound medical‑scientific evidence exists linking ED and death from ED to relevant service. That view provides the statutory and administrative basis for using the factors in the instrument as a route to establishing the reasonable hypothesis in decisions under the VEA and MRCA.

The instrument contains no penal provisions and does not create offences, fines, or criminal liability in its text. It is a Statement of Principles made under subsection 196B(2) of the VEA (s 3) that prescribes medical and factual criteria for establishing a reasonable hypothesis of causation in claims to which specified sections of the VEA and MRCA apply (s 5). Its operative function is evidentiary: to identify the factors that decision‑makers will consider as sufficient to raise a reasonable hypothesis that erectile dysfunction or death from erectile dysfunction is related to relevant service.

Enforcement in the typical sense of criminal or civil sanction is therefore absent from the instrument. Instead, the instrument’s practical effect is to influence administrative determinations under the VEA and MRCA. A claimant who cannot satisfy the factors in section 9 will not, on the basis of this Statement alone, have raised a reasonable hypothesis; the decision‑maker will proceed to decide entitlement under the relevant statutory scheme. Conversely, a claimant who demonstrates at least one factor related to relevant service will have satisfied the instrument’s minimal evidentiary criteria to raise a reasonable hypothesis.

The instrument does not itself set a review or appeal process; any review or appeal remedies are those provided by the VEA or MRCA and the administrative law mechanisms that apply to decisions under those Acts. The instrument’s repeal of the 2013 Statement of Principles (s 4) changes the evidentiary landscape for claims decided after commencement, but it does not, in its text, prescribe sanctions for non‑compliance by any particular actor.

Operationally, the “enforcement” mechanism is the decision‑making process: decision‑makers under the VEA and MRCA will apply the instrument when assessing whether a reasonable hypothesis exists. That application will determine whether a claimant proceeds to entitlement consideration. Because the instrument supplies discrete thresholds, decision‑makers have clear criteria to apply, and failure to meet those criteria will be a basis for adverse administrative decisions. Any legal challenges to decisions that apply or fail to apply the Statement of Principles would be pursued under the remedies and processes in the VEA/MRCA and general administrative law, but the instrument itself does not create or regulate those remedies.

Finally, section 11 establishes that where a factor in section 9 refers to a disease covered by another Statement of Principles, the factors of that other Statement apply. This is not an enforcement tool in the punitive sense, rather a procedural coordination mechanism that requires decision‑makers to consult other RMA Statements where appropriate.

This Statement of Principles is created under the statutory power in subsection 196B(2) of the Veterans’ Entitlements Act 1986 (s 3). Section 5 makes plain that the instrument applies to claims to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 apply. The instrument therefore functions within the adjudicative architecture of the VEA and the MRCA, serving as medical evidence guidance for causation under those Acts.

Section 11 is the principal text dealing with interaction with other RMA instruments. It provides that if a factor in section 9 refers to an injury or disease that is itself the subject of another Statement of Principles determined under subsection 196B(2) of the VEA, then the factors in that other Statement apply in accordance with its terms as in force. That creates an internal system of interactions between distinct Statements of Principles. For example, a factor in this instrument that refers to diabetes mellitus, cirrhosis or multiple sclerosis would engage the relevant Statement of Principles for those conditions; decision‑makers must apply the other instrument’s factors to determine whether the referenced injury or disease exists for causation purposes.

The instrument mentions ICD‑10‑AM codes and the International Classification of Diseases as a background reference in subsection 7(3)-(4). It references the Tenth Edition, effective date 1 July 2017, and supplies the ISBN and copyright owner for the code set. That link means the instrument uses internationally recognised disease classification codes as an interpretive aid where relevant.

The instrument also references DSM‑5‑TR in the dictionary when defining severe alcohol use disorder and when the DSM‑5‑TR term is used (Schedule 1). That cross‑reference to an internationally used psychiatric diagnostic manual supplies a diagnostic standard for certain psychiatric definitions in the instrument.

The instrument repeals the prior 2013 Statement of Principles concerning erectile dysfunction made under subsections 196B(2) and (8) of the VEA (s 4). That repeal is an explicit interaction with an earlier RMA instrument; it replaces the prior list of factors and definitions with the current list.

Beyond these internal administrative and diagnostic cross‑references, the instrument does not itself displace other statutes or grant regulatory authority over third parties. It does not amend substantive entitlements in the VEA or MRCA, nor does it enumerate procedures for benefits payment, compensation quantum, or review rights. Those matters remain subject to the governing provisions of the VEA and MRCA. The Statement of Principles is therefore an instrument that interfaces with those Acts by providing the medical causation criteria decision‑makers must apply when assessing entitlement under the statutory schemes.

Practically, the instrument will intersect with clinical practice standards, occupational health and safety records, and administrative record‑keeping obligations because those sources supply evidence for the instrument’s factors. For example, surgical operation records, radiation treatment fields, pharmacy dispensing records for drugs in Schedule 2, and occupational exposure records for carbon disulphide will be used in decisions under the VEA and MRCA. The instrument’s dictionary definitions determine what clinical tests and records are necessary to meet thresholds such as GFR for chronic renal failure or MET measures for physical capacity.

Finally, the instrument’s internal cross‑reference mechanism in section 11 means a multi‑instrument application is likely where comorbid disease is alleged. Decision‑makers should therefore consult and apply relevant Statements of Principles together, in accordance with section 11, when a section 9 factor refers to a disease that has its own Statement.

This instrument is expressed as No. 72 of 2022 and records key dates in its text. It is dated 24 June 2022 and commences on 25 July 2022 (ss 1, 2). Section 4 expressly repeals the Statement of Principles concerning erectile dysfunction No. 43 of 2013 (Federal Register of Legislation No. F2013L01136) which was made under subsections 196B(2) and (8) of the VEA. The repeal therefore replaces the 2013 instrument with the 2022 instrument as the operative Statement of Principles for erectile dysfunction.

The instrument does not record prior amendments to itself, because it is the replacement instrument. The text indicates the RMA made the current Statement under subsection 196B(2) of the VEA (s 3) and that any item in a Schedule has effect according to its terms (s 6). Schedule 1 contains a considerable dictionary of definitions, many of which are precise operational thresholds that may represent updates or refinements compared to the 2013 instrument, though the instrument does not provide a comparative history within the text.

Where changes from the prior instrument exist, the legislative mechanism is repeal and replacement rather than amendment of the older instrument. The instrument’s schedule structure means that future changes could be effected by subsequent RMA instruments that either replace or amend the Statement of Principles under the enabling provision in subsection 196B(2). The instrument itself does not set out processes for amendment, but the enabling statutory provision (subsection 196B(2)) is cited as the authority for making Statements of Principles.

The schedule lists, and dictionary definitions, appear comprehensive; any amendment history beyond this replacement is not recorded in the instrument. The instrument does not provide a chronology of drafting changes, consultations, or revisions in the text that it publishes. Users who require an historical comparison between the 2013 Statement and this 2022 Statement will need to obtain the 2013 text (repealed) and compare the two instruments, because the 2022 text does not summarise the exact differences.

In short, the amendment history recorded within the instrument consists of its own commencement date (25 July 2022) and the express repeal of the 2013 Statement of Principles concerning erectile dysfunction (s 4). Any further amendment or replacement will require a subsequent RMA determination under subsection 196B(2) of the VEA.

The Statement of Principles text supplied does not record any litigation history. It contains no references to court decisions, administrative appeals, or judicial consideration of this instrument. The instrument states the RMA’s view that there is sound medical‑scientific evidence that indicates erectile dysfunction and death from erectile dysfunction can be related to relevant service (s 8), but it does not cite cases or indicate a litigation record.

Because the instrument functions as an evidentiary framework for causation under the VEA and MRCA, it is conceptually possible that decisions applying the instrument may be the subject of administrative review or judicial review under the statutory schemes, but the instrument does not record any such proceedings. The instrument also provides a mechanism in section 11 for cross‑application of other Statements of Principles where a factor refers to another disease; again no litigation history is provided about disputes arising from those interactions.

Practitioners seeking reported litigation concerning the application, interpretation, or validity of this Statement of Principles will need to consult case law and administrative tribunal decisions external to this instrument, because none are referred to or summarised in the text. The instrument itself is silent on whether and how courts or tribunals have applied it since commencement.

Therefore, within the bounds of the material provided, there is no litigation history described. Any litigation arising from the instrument’s application will be recorded in administrative and judicial decisions outside the instrument’s text.

The instrument contains numerous precise thresholds and cross‑references that can trip up claimants and advisers if they are not addressed carefully in claim preparation. Below are concrete, text‑grounded pitfalls to watch for.

1. Onset versus worsening distinction and the s 10(2) limitation. The instrument separates onset factors (9(1)-9(25)) from worsening factors (9(26)-9(50)), but subsection 10(2) imposes an important limitation: the worsening factors apply only where the person’s ED was suffered or contracted before or during, but did not arise out of, the person’s relevant service. That means if a person’s ED first arose out of service, the worsening list cannot be used to show material contribution or aggravation; use of the worsening factors is limited to aggravation of pre‑existing ED that did not arise out of service (s 10(2)).

2. Temporal windows and duration thresholds. Many factors require evidence tied to specific time frames. Examples include surgical operations within 3 months before onset or worsening (9(15), 9(40)), ischaemic priapism for at least 4 continuous hours before onset or worsening (9(14), 9(39)), therapeutic radiation within 10 years if the penis, pelvis or perineal region was in the field (9(20), 9(45)), and carbon disulphide exposure on more days than not for at least five consecutive years with a one year cessation window (9(23), 9(48)). Failure to align clinical onset or worsening dates with these windows will mean the factor is not established under the instrument.

3. Objective measurement thresholds in the dictionary. Several factors require precise measurement. “Being obese” is BMI 30 or greater or waist circumference thresholds (Schedule 1). Chronic renal failure requires GFR <15 mL/min/1.73 m2 for at least 3 months, or need for renal replacement therapy, or chronic dialysis (Schedule 1). Smoking requires at least 10 pack‑years with a 20 year cessation limit (9(19), 9(44) and Schedule 1 pack‑year definition). MET incapacity requires inability to undertake activity greater than 3 METs for at least 5 years (9(24), 9(49) and Schedule 1 MET). Claimants will need contemporaneous objective data or credible retrospective medical assessment that maps to these thresholds.

4. Drugs listed in Schedule 2. Taking any of the specified drugs at the time of clinical onset or worsening is a factor (9(22), 9(47)). The Schedule 2 list is broad and includes agents that may be prescribed for other indications or used intermittently, such as antidepressants, antipsychotics, beta‑blockers, certain antiepileptics, and testosterone. Medication timing and continuity evidence is therefore critical.

5. “Inability to obtain appropriate clinical management” as a factor. Item 9(50) permits inability to obtain appropriate clinical management for ED to be treated as a factor for clinical worsening. This is conceptually open ended but practically challenging. The instrument does not define “appropriate clinical management”; claimants will need to document attempts to obtain care, refusals, barriers, geographic or systemic limitations, and how those limitations materially contributed to worsening ED.

6. Cross‑references to other Statements of Principles. If a factor in section 9 refers to a disease that has its own Statement of Principles, section 11 requires application of that other Statement’s factors. Missing that cross‑application could lead to a mismatch between the evidence tendered and the governing causation factors. For example, if reference to diabetes mellitus occurs, the diabetes Statement of Principles should be consulted where one exists.

7. Definitions that allow clinical diagnosis without prior treatment. The definition “clinically significant disorder of mental health as specified” recognises conditions of sufficient severity to warrant ongoing management and includes a Note that ongoing management does not require that any actual management was received (Schedule 1, clinically significant disorder definition, Note 2). That means absence of treatment does not automatically negate the factor, but proving the severity criteria may require psychiatric assessment or documentation of impairment.

8. Smoking calculation technicalities. The pack‑year calculation includes equivalences for pipe tobacco and cigars and sets out a grams‑to‑cigarette equivalence for smoking tobacco by weight (Schedule 1), which may not be intuitive. Claimants with mixed tobacco use need careful calculation to meet the 10 pack‑year threshold.

9. Diagnosis standards referenced. The dictionary references DSM‑5‑TR for psychiatric diagnostic criteria where relevant, for example severe alcohol use disorder (Schedule 1). Medical experts should align their diagnostic statements to the DSM‑5‑TR criteria where those definitions are the basis of a factor.

10. Death from ED defined by terminal event contribution. Subsection 7(5) expands ED to include death from a terminal event or condition that was contributed to by the person’s ED, and the dictionary defines “terminal event” by proximate causes like pneumonia, respiratory failure, cardiac arrest, circulatory failure or cessation of brain function (s 7(5) and Schedule 1). Establishing that ED contributed to such a terminal event will require forensic medical assessment showing causal contribution.

11. Occupational exposure specificity. Carbon disulphide exposure requires inhalation in an unventilated and confined space on more days than not for at least five consecutive years, with cessation timing constraints (9(23), 9(48)). Generic assertions of exposure will not satisfy the precise workplace exposure conditions listed.

12. The instrument is an evidentiary gatekeeper. The RMA’s view in section 8 that sound medical science exists linking ED to relevant service gives weight to the factors, but proof remains fact specific. Decision‑makers will require clear evidence that a listed factor existed at the relevant time and was related to relevant service (s 10(1)). Failure to map evidence precisely to the instrument’s text is a common practical pitfall.

Practitioners and claimants should therefore map medical and non‑medical records to the instrument’s specific textual thresholds, and avoid relying on general statements about causation that do not establish the particular factor and its temporal relationship to clinical onset or worsening and to relevant service.

Complying with the instrument’s evidentiary requirements means presenting medical and factual material that maps directly to the textual factors in section 9, the timing rules in section 10, and the definitions in Schedule 1. Below are practical steps and the specific textual hooks to use when preparing a claim or advising a claimant.

1. Establish the date of clinical onset and, if relevant, the date(s) of clinical worsening. The instrument’s factors are typically tied to being present “at the time of the clinical onset” or “at the time of the clinical worsening” (s 9). Accurate clinical chronology is therefore the first compliance step. Use contemporaneous GP notes, specialist letters, hospital records, emergency department presentations, and patient history notes to anchor onset and worsening dates.

2. Map each alleged causal factor to the instrument’s language and time windows. For example:

   • For surgical operations listed in the specified list, provide operation reports showing the date and type of surgery within 3 months before onset or worsening (9(15), 9(40) and Schedule 1 specified list of surgical operations).
   • For ischaemic priapism, provide emergency department records documenting continuous duration of at least 4 hours (9(14), 9(39) and Schedule 1 ischaemic priapism).
   • For therapeutic radiation, provide radiation oncology records showing that the penis, pelvis or perineal region was in the radiation field within 10 years prior to onset or worsening (9(20), 9(45)).
   • For burns, provide burn clinic records documenting surface area and timing aligned to the “substantial external burns” definition (9(18), 9(43) and Schedule 1).

3. Use dictionary thresholds for objective conditions. Provide laboratory or diagnostic evidence where the Schedule 1 definition sets a numerical threshold:

   • Chronic renal failure: provide GFR values, dialysis records or transplant records to satisfy the chronic renal failure definition (Schedule 1).
   • Obesity: document weight and height to calculate BMI and waist circumference per Schedule 1 thresholds (Schedule 1).
   • Smoking: calculate pack‑years using the Schedule 1 method and provide smoking history dates to show cessation was within 20 years if relevant (9(19), 9(44) and Schedule 1).
   • MET incapacity: obtain functional capacity assessments that quantify METs or specialty reports explaining inability to undertake activities greater than 3 METs for the required 5 year period (9(24), 9(49), Schedule 1 MET).

4. Document drug exposures against Schedule 2. If a claim relies on a drug factor (9(22), 9(47)), obtain pharmacy dispensing records, prescriptions, hospital medication charts, and specialist notes to prove the drug named in Schedule 2 was taken at the time of clinical onset or worsening. Because Schedule 2 lists agents across multiple therapeutic classes, detail dose and timing, and explain any changes proximal to onset or worsening.

5. For psychiatric factors, align diagnoses to the instrument’s “clinically significant disorder of mental health as specified” definition. That definition lists conditions such as severe alcohol use disorder, anxiety disorder, depressive disorder, PTSD, schizophrenia and others, and notes that ongoing management need not have been received (Schedule 1, clinically significant disorder definition and Notes). Provide psychiatric assessments, DSM‑5‑TR based diagnostic statements where relevant, and evidence of functional impairment that supports the “sufficient severity to warrant ongoing management” criterion.

6. Where the factor refers to another disease that has its own Statement of Principles, invoke that Statement. Section 11 directs application of other Statements of Principles where section 9 refers to another disease. Identify the relevant Statement of Principles and assemble the evidence that that Statement requires. For instance, if diabetes mellitus is relied upon (specified list of medical conditions), consult the diabetes Statement of Principles for its factors and evidentiary thresholds and include relevant glycaemic control data.

7. For occupational chemical exposure such as carbon disulphide, collect employer records, occupational hygiene reports, rosters, witness statements and environmental testing evidence showing exposure in an unventilated confined space on more days than not for at least five consecutive years, and date cessation if applicable (9(23), 9(48)). Demonstrate that exposure was related to the claimant’s relevant service per s 10(1).

8. For “inability to obtain appropriate clinical management” (9(50)), document attempts to obtain care, referrals, wait times, denials, geographical or service access limitations, and contemporaneous deterioration in clinical state. Because “appropriate clinical management” is not defined in the instrument, show what accepted treatments were available and why they were inaccessible or not delivered.

9. For traumatic events and nerve injuries, provide surgical notes, imaging, neurological assessments and neurophysiology where the instrument requires trauma or surgery involving the brain, spinal cord, nerve roots, cauda equina or nerve supply to the penis resulting in permanent neurological impairment within the relevant 3 month window (9(16), 9(41)). Use objective neurological testing to support claims of permanent impairment.

10. For death from ED, obtain forensic or coronial records that demonstrate ED contributed to a terminal event as defined in Schedule 1 (pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function) and align the contribution argument to the medical evidence required by coronial or clinical investigators (s 7(5), Schedule 1 terminal event).

11. Prepare expert medical opinions that explicitly tie the factor to the clinical onset or worsening and to relevant service. The instrument requires not only that a factor existed, but that the factor was related to the person’s relevant service (s 10(1)). Experts should articulate how service exposures, injuries, treatments, or deployments produced or materially contributed to the factor being present at the relevant time.

12. Account for the s 10(2) material contribution standard for pre‑existing ED. If the claim is for aggravation of pre‑existing ED, use the worsening factors in 9(26)-9(50) and ensure the expert opinion addresses material contribution or aggravation caused by service, remembering the statutory limitation that the ED must have been suffered or contracted before or during, but not arise out of, relevant service (s 10(2)).

13. Ensure consistency with coding references when disease codes are used. If relying on ICD‑10‑AM coding or psychiatric coding, ensure the edition referenced by the instrument (ICD‑10‑AM Tenth Edition effective 1 July 2017) is used as the coding reference (s 7(3)-(4)). Use DSM‑5‑TR where psychiatric criteria are invoked per Schedule 1.

14. Where a factor requires ongoing management or severity demonstration, provide records showing management needs even if actual treatment was not received. The instrument notes that to warrant ongoing management does not require actual management was received (Schedule 1, clinically significant disorder definition, Note 2), but evidence of impairment consistent with the definition remains necessary.

15. Cross‑check for competing factors and double counting. A single clinical state may satisfy more than one factor, but the claimant should identify which factor(s) are relied upon and ensure the evidence supports the specific textual requirement for each. For example, a patient with diabetes and peripheral autonomic neuropathy may be able to rely on both, but evidence needs to be tailored to each factor and any relevant other Statement as required by s 11.

As a practical checklist, assemble the following documents to match the instrument’s demands: chronological clinical notes, hospital and ED records, operation and radiation reports, pharmacy dispensing and medication histories, specialist letters (urology, endocrinology, psychiatry, neurology), laboratory data (GFR, hormone levels), imaging reports, occupational exposure records, functional capacity evaluations quantifying METs, smoking history with pack‑year calculation, psychiatric diagnostic statements linked to DSM‑5‑TR where applicable, and expert medico‑legal reports connecting the factor(s) to relevant service per s 10(1).

Finally, remember the instrument itself does not adjudicate entitlement. It supplies the RMA’s factors that raise a reasonable hypothesis. Compliance is established by aligning the documentary and expert evidence with the precise thresholds and temporal windows in the instrument so that decision‑makers can lawfully find a reasonable hypothesis exists under the VEA or MRCA provisions to which the instrument applies.