Statement of Principles concerning dermatomyositis (Reasonable Hypothesis) (No. 70 of 2022)

The core legal-conceptual mechanism in this instrument is the "reasonable hypothesis" threshold used in veterans’ entitlements claims. The instrument specifies what factual/medical factors, if present, satisfy the minimum evidentiary showing required to say that a reasonable hypothesis has been raised that dermatomyositis or death from dermatomyositis is related to relevant service (title, s 9). The following concepts are central and defined or operationalised in the instrument.

Dermatomyositis, as defined for this Statement of Principles, is a chronic inflammatory disease characterised by inflammatory skin changes, usually accompanied by progressive and symmetric skeletal muscle weakness, and includes amyopathic dermatomyositis (s 7(2)). The instrument includes clinical aids to diagnosis in notes: typical skin changes (heliotrope rash, Gottron papules), typical muscle weakness distribution, and possible confirming tests such as elevated muscle-associated enzymes, biopsy, imaging or presence of myositis-associated antibodies (s 7 notes). Amyopathic dermatomyositis is explicitly included as a variant with skin signs but absent muscle abnormalities on clinical testing (s 7(2) notes).

Relevant service is defined in the Schedule and includes operational, peacekeeping, hazardous and British nuclear test defence service under the VEA, plus warlike and non-warlike service under the MRCA (Schedule 1 definitions). The instrument applies to claims falling under specific statutory claim provisions (s 5).

Factors: s 9 enumerates discrete factors that may connect dermatomyositis to service. These include specified drug exposures (with a "specified list of drugs" defined in Schedule 1), hydroxyurea exposure, exposure to immune checkpoint inhibitors or interferon alfa, temporal association with drug therapy including improvement on drug cessation or redevelopment on rechallenge, presence of a malignant neoplasm (excluding non-melanotic skin cancers) within 5 years of clinical onset or clinical worsening, and inability to obtain appropriate clinical management. The instrument distinguishes between factors relevant to clinical onset and factors relevant to clinical worsening; for example, taking a listed drug for at least 4 weeks before clinical onset is a factor for onset (s 9(1)), and taking such a drug for at least 4 weeks before clinical worsening is a factor for worsening (s 9(6)). Temporal thresholds vary by factor: 4 weeks for the specified list of drugs, 6 months for hydroxyurea, 1 year for immune checkpoint inhibitors or interferon alfa, and 7 days minimum exposure where the factor is a drug-associated onset/worsening during drug therapy coupled with improvement after discontinuation or redevelopment on rechallenge (s 9(1)-(4), (6)-(9)).

Death: The instrument treats death from dermatomyositis as including death from a terminal event or condition that was contributed to by the person’s dermatomyositis, and defines "terminal event" in the Schedule (s 7(3); Schedule 1).

Relationship to service: Section 10 requires that any factor relied upon must be related to the person's relevant service. Subsection 10(2) limits the application of factors 9(6)-9(11) so that those factors only operate as evidence of material contribution or aggravation where the person's dermatomyositis was suffered or contracted before or during, but did not arise out of, the person's relevant service.

Cross-references: If a factor in s 9 refers to an injury or disease covered by another Statement of Principles, the other Statement's factors apply in accordance with its terms as in force from time to time (s 11). This ensures that overlapping disease relationships defer to the relevant instrument for that other disease.

Authority and applicability: The instrument is made under the statutory power in s 196B(2) of the VEA (s 3) and applies specifically to claims under specified sections of the VEA and the MRCA (s 5). The Repatriation Medical Authority records its view that there is sound medical-scientific evidence for the service relationship (s 8), which is the justificatory statement that underpins the Statement of Principles as an administrative evidentiary standard.

This Statement of Principles affects three linked groups of people and administrative actors, as defined within the instrument.

Affected persons:

• Veterans and former members of the Forces, being persons who may lodge claims under the Veterans' Entitlements Act 1986 or the Military Rehabilitation and Compensation Act 2004. The instrument applies to claims to which section 120A of the VEA or section 338 of the MRCA applies (s 5). The Schedule defines "relevant service" expansively to include operational service, peacekeeping service, hazardous service, British nuclear test defence service under the VEA, and warlike and non-warlike service under the MRCA. Any person who rendered such service and who claims that dermatomyositis or death from dermatomyositis is connected to that service will be affected by the criteria in this Statement (Schedule 1, definitions; s 5).
• Persons claiming death benefits where dermatomyositis contributed to a terminal event. The instrument treats death from dermatomyositis as including death from a terminal event or condition that was contributed to by dermatomyositis (s 7(3); Schedule 1 definition of "terminal event").

Affected administrative bodies and decision processes:

• The Repatriation Medical Authority exercises the statutory power to determine Statements of Principles under s 196B(2) of the VEA and is the author of this instrument (s 3). The instrument is intended for use within the claims-assessment processes governed by the VEA and MRCA. Decision-makers applying the VEA or MRCA when assessing whether a reasonable hypothesis has been raised will directly use the factors here. The instrument does not in itself adjudicate claims; rather, it supplies the medical-factual triggers that are treated as raising the reasonable hypothesis threshold for the purposes of the applicable statutory provisions (s 5, s 9).

Third parties and clinicians:

• Treating clinicians, pathologists and other medical practitioners will be implicated because the instrument depends on evidence such as clinical onset dates, clinical worsening, diagnostic tests cited in notes to s 7 (serum muscle-associated enzymes, biopsy, imaging, myositis-associated antibodies), drug exposure records, and oncology histories (s 7 notes; s 9). The Schedule also lists specific drug classes and agents that are relevant, including statins and tumour necrosis factor-alpha inhibitors among others, and gives examples of immune checkpoint inhibitors in notes to s 9.

Who bears evidential effort:

• The instrument establishes minimum factual triggers. It does not set out which party bears legal burden in the claim process; however, mechanically it changes what factual matters must be shown to satisfy the “reasonable hypothesis” threshold. That practical effect means claimants and their medical advisers must present evidence of the presence and timing of at least one of the enumerated factors, and decision-makers will determine whether the threshold is met using these listed factors (s 9, s 10).

Disallowed populations or exclusions:

• The Schedule excludes non-melanotic malignant neoplasm of the skin from the malignant neoplasm factor: a malignant neoplasm factor applies only where the person had a malignant neoplasm other than non-melanotic malignant neoplasm of the skin within 5 years of clinical onset or clinical worsening (s 9(5), s 9(10), Schedule 1).

Temporal and clinical distinctions:

• The instrument distinguishes onset from worsening and treats some factors as applicable to onset and others to worsening, and imposes different temporal exposure windows and minimum exposure durations for drug-related factors (s 9). Subsection 10(2) further restricts certain aggravation-related factors to cases where dermatomyositis pre-existed. This segmentation affects which claimants can rely on which factors depending on whether their dermatomyositis began prior to service, during service, or after service.

In short, persons with potential entitlement claims under the VEA or MRCA alleging dermatomyositis-related injury or death, the medical professionals documenting the condition, and the administrative decision-makers within the statutory compensation frameworks are the primary audiences affected by this Statement of Principles.

The Statement of Principles is not a statute that imposes traditional civil or criminal duties; rather, its legal effect is procedural and evidentiary within the statutory claims framework. It defines the factors that must exist for a decision-maker to conclude that a reasonable hypothesis has been raised that dermatomyositis or death from dermatomyositis is related to a person’s relevant service. This transforms specific medical and exposure facts into the administrative threshold for progressing a claim under the VEA or MRCA (s 9, s 5).

Rights created or clarified by the instrument

• Right to have a claim for dermatomyositis or death from dermatomyositis considered under the reasonable hypothesis standard using the enumerated factors. If at least one factor in s 9 exists and is related to the person’s relevant service, the instrument provides the basis to say a reasonable hypothesis has been raised (s 9; s 10(1)).
• Right to rely on particular medical evidence types identified in the instrument. The note to s 7 lists confirmatory diagnostic modalities (serum muscle-associated enzymes, biopsy, imaging, myositis-associated antibodies) that are relevant to establishing the diagnosis of dermatomyositis, which is a predicate for applying the Statement’s factors.

Duties and obligations of decision-makers

• Administrative decision-makers applying the VEA or MRCA must take the Statement into account when assessing whether a reasonable hypothesis has been raised. The instrument is made under the statutory power in subsection 196B(2) and is intended to be applied in claims processing (s 3; s 5). Where a factor in s 9 refers to an injury or disease covered by another Statement of Principles, decision-makers must apply the factors of that other Statement as it stands from time to time (s 11).
• Decision-makers have to assess relationship to service. Section 10(1) requires that the existence of any factor referred to in s 9 must be related to the relevant service rendered by the person before treating it as raising a reasonable hypothesis.

What the instrument does not impose

• It does not impose duties on claimants to pursue particular medical interventions beyond the evidentiary need to show the presence and timing of listed factors. It also does not itself create entitlement or award compensation; those outcomes remain for the decision processes under VEA and MRCA. The instrument does not specify who carries the legal burden of proof in claims; it specifies the minimum factual triggers that, if established, amount to raising a reasonable hypothesis.

Evidential specificity and rights to challenge

• Because the instrument specifies discrete factual triggers (for example, duration of drug exposure, timing of malignancy relative to clinical onset), it creates a predictable evidentiary yardstick. Claimants can therefore focus evidence procurement on the listed items: records of drug prescriptions and administration with dates to meet specific minimum durations, oncological diagnoses and dates, clinical onset and worsening dates, and records of inability to obtain appropriate clinical management (s 9; s 7 note). Decision-makers retain the duty to relate the factor to relevant service per s 10(1), and to distinguish between onset and aggravation contexts via s 10(2).

Cross-referenced duties

• Where a factor in s 9 implicates another condition already covered by a different Statement, the duty to apply that other Statement’s factors falls to decision-makers and claimants indirectly through s 11. This creates an interlocking evidentiary duty across Statements of Principles.

Procedural consequence

• The practical legal effect of satisfying a listed factor is to move the claim across the "reasonable hypothesis" threshold. The instrument’s design therefore gives claimants a clearer map of what evidence to pursue to obtain that procedural entitlement within the VEA/MRCA claims route.

The instrument itself contains no criminal penalties, pecuniary fines, licensing sanctions, or enforcement mechanisms. It is an administrative instrument that operates as a medical-evidentiary standard within the veterans’ claims framework. The instrument is made under the Repatriation Medical Authority's statutory power (s 3) and is applied in the adjudication of claims under the relevant statutory provisions of the VEA and MRCA (s 5). Enforcement and remedies therefore follow the claim and review regimes established in those Acts, not from this Statement itself.

How it is enforced in practice

• The enforcement mechanism is administrative rather than punitive. Decision-makers responsible for determining entitlement under the VEA or MRCA are to use the factors in this Statement when deciding whether a reasonable hypothesis has been raised that links dermatomyositis or death from dermatomyositis to relevant service (s 9; s 5). If decision-makers find that the factors are established in a way related to service (s 10), that finding affects the course of adjudication under the VEA or MRCA: it can qualify a claim to progress to further consideration on causation and compensation under those Acts.

Review and judicial oversight

• The instrument does not itself set out review rights or judicial remedies. Any review or appeal rights that arise from a decision by a statutory decision-maker will be those provided within the VEA and MRCA frameworks. The Statement functions as an evidentiary tool in those procedures; judicial review or merits review of decisions that apply this Statement would be conducted under the appeal and review provisions of the parent statutes, though the instrument itself does not describe those processes.

Practical compliance and evidentiary consequences

• Non-compliance in the sense of failing to supply the evidence that the Statement requires will have an evidentiary consequence: the decision-maker may conclude the claimant has not raised a reasonable hypothesis. The Statement does not prescribe penalties for failing to show a factor; the consequence is denial at the reasonable hypothesis stage and continuation of the normal claims process as provided in the VEA/MRCA. Claimants who fail to present or prove the required evidence will not reach the stage where the claims statutes can be found to link the condition to service under the standard used in those statutes.

Limits on penal or enforcement actions

• Because the Statement makes no finding of fault or misconduct and contains no sanctioning powers, there is no direct enforcement action triggered by a failure to comply with it. Its enforcement is limited to the discretionary, fact-based decisions of officers applying the VEA and MRCA processes. The instrument does not create novel regulatory offences or enforcement roles.

This Statement of Principles is expressly made under subsection 196B(2) of the Veterans' Entitlements Act 1986 and is designed to be used within the claims frameworks of the VEA and the Military Rehabilitation and Compensation Act 2004 (MRCA). Section 5 states that the instrument applies to claims to which section 120A of the VEA or section 338 of the MRCA applies. Therefore the instrument’s legal effect is as an evidentiary standard applied by decision-makers operating under those statutes. The Statement does not amend or repeal substantive entitlements in the VEA or MRCA; it operates as the Repatriation Medical Authority’s medical statement on causation relevant to those entitlements.

Cross-Statement relationships

• Section 11 sets out a specific cross-instrument rule: where a factor in this Statement refers to an injury or disease that is covered by another Statement made under subsection 196B(2) of the VEA, the factors in that other Statement apply according to its terms as in force from time to time (s 11). That means where an exposure or disease overlaps multiple Statements of Principles, the relevant cross-referenced Statement supplies the applicable evidence factors and those shall be applied by decision-makers. This is a mechanism for resolving overlaps between disease-specific Statements without duplicative or contradictory factor lists.

Reference to test and standard in parent Acts

• The instrument operates pursuant to the statutory framework in the VEA and MRCA. It uses the phrase "reasonable hypothesis" which is the statutory standard used in the parent legislation to establish a link between service and injury or disease. The instrument itself does not change the statutory standard; it furnishes the medical facts that are treated by decision-makers as sufficient to meet that standard if the facts exist and are related to service (title, s 9, s 10). How the reasonable hypothesis standard is applied procedurally, including burdens of proof and review rights, is governed by the VEA and MRCA and not redefined here.

Operational intersections with healthcare and pharmacological law

• The Statement identifies particular drugs and drug classes as specified factors (Schedule 1 definition of "specified list of drugs", and notes giving examples of immune checkpoint inhibitors). This creates an evidentiary intersection with medical records, pharmaceutical prescribing and administration records, hospital records, and oncology records. Those records are typically created and maintained under health information regulatory frameworks, privacy law, and clinical governance regimes; the Statement therefore implies a need for access to and use of such records in claims, but it does not alter health privacy obligations or create new powers to compel records. The instrument presumes that evidential records of drug-taking and diagnosis will be provided in the claims process.

No conflict with other federal statutory entitlements spelled out in the instrument

• The Statement does not purport to displace any other federal statutory entitlement regimes outside the VEA/MRCA claims context. Where overlap or reference occurs to an injury or disease covered by another Statement, s 11 ensures the other Statement governs the factors. The instrument is silent on interactions with state workers compensation systems, private insurance, or other federal benefits, so any nexus with those schemes must be resolved within those schemes’ laws and by evidence adduced under their own procedures.

Temporal operation and repeal

• The instrument repeals an earlier Statement (No. 9 of 2014) (s 4). For claims relying on events occurring before the commencement date, decision-makers will need to apply the Statement that is in force at the time of the claim process. The instrument itself does not specify transitional provisions; the repeal in s 4 is direct. Any transitional application would be determined by the parent Acts or administrative guidance, though this instrument contains no extra-textual transitional rules.

The instrument’s own internal amendment history, as expressed in the text provided, is limited and concise. The Statement is dated 24 June 2022 and commences on 25 July 2022 (s 2 and the signature block). Section 4 expressly repeals the earlier Statement of Principles concerning dermatomyositis No. 9 of 2014 (Federal Register of Legislation No. F2014L00008) that had been made under subsection 196B(2) of the VEA. No other amendments, variations or schedule edits are recorded within the instrument itself.

Key chronological milestones recorded in the document:

• Prior instrument: Statement No. 9 of 2014 existed and is now repealed (s 4).
• This instrument: Determined and sealed by the Repatriation Medical Authority, dated 24 June 2022, and coming into force on 25 July 2022 (s 2; signature and seal page).

Absence of other amendment records

• The instrument contains no record of earlier amendments to this particular instrument because it is the instrument, and it replaces the 2014 statement in full. It does not list past amendments to the 2014 instrument nor provide an amendment log beyond the repeal. Any later amendments to this instrument after commencement would be recorded in the Federal Register of Legislation and in later statutory instruments; none are present in this text.

Implication for claimants and decision-makers

• The repeal of the 2014 Statement and replacement by this 2022 Statement means that, from the commencement date, the Repatriation Medical Authority’s current expression of the medical-factual triggers for dermatomyositis claims is the 2022 Statement. Administrative decision-makers and claimants should therefore consult this instrument when assessing claims lodged on or after the commencement date. The instrument contains no transitional rules, so any questions about which Statement applies to claims lodged or decided around the cut-off date must be resolved with reference to the parent Acts and any administrative guidance or practice notes, none of which are contained in this instrument.

Signature and execution

• The instrument bears the common seal of the Repatriation Medical Authority and shows execution by the Chairperson, Professor Terence Campbell AM, which is the formal act of making the instrument under the Authority’s statutory power (cover pages and signature block).

The text of this Statement of Principles contains no record of litigation. It does not cite any judicial decisions nor does it include any summary of cases. The instrument is an administrative medical statement prepared under statutory authority and presented as a determinative list of factors for the "reasonable hypothesis" standard; it neither references nor summarises prior judicial authority, nor records any litigation concerning the 2014 Statement that it repeals.

What this absence means for practitioners

• Practitioners seeking judicial interpretation of how these factors are to be applied in contested claims will need to look to the VEA and MRCA decision and appeal pathways, and to any subsequent case law that discusses the application or adequacy of Statements of Principles in claims. This particular instrument does not supply such litigation history or examples of application. Where judicial or tribunal decisions later engage with these factors, those decisions will be additional sources of interpretive law external to this instrument.

How to proceed in the absence of litigation guidance in the instrument

• Because no litigation history is recorded in the instrument, administrative decision-makers and advising practitioners should:
  • Apply the instrument’s factors as written when assessing the reasonable hypothesis threshold in claims under the VEA or MRCA (s 9).
  • Document the evidential basis for any finding or denial, noting that the Statement provides discrete factual triggers and temporal thresholds that guide assessments.
  • Monitor tribunal or judicial decisions that may subsequently interpret the instrument. Any such decisions will be found in tribunal or court records rather than in this Statement.

Records and registers

• If litigation arises, the particulars of any judicial review, merits review or appellate decision involving the application of this Statement of Principles will not appear within the instrument itself. Interested parties should search relevant tribunal and court databases and the Federal Register of Legislation for amended or replacement Statements or for published decisions that reference them.

This section highlights particular features, interpretive pitfalls and practical sticking points that arise from the instrument’s text. Each item is tied to the instrument’s provisions.

1. One-factor minimum, but that factor must be related to relevant service (s 9; s 10(1))

• The instrument requires at least one of the listed factors to exist before it can be said that a reasonable hypothesis has been raised (s 9). However, s 10(1) requires that the existence of any factor referred to in s 9 must be related to the person's relevant service. Practically, that means evidence that a factor existed is not, by itself, determinative. Decision-makers must also be satisfied that the factor is service-related, creating a two-step evidential inquiry: existence of factor, then relationship to relevant service.

2. Different temporal windows and minimum exposures require precise documentary proof (s 9)

• The conditions impose differing minimum exposure durations and look-back windows: at least 4 weeks for drugs on the specified list prior to clinical onset or worsening (s 9(1), (6)); at least 6 months for hydroxyurea (s 9(2), (7)); within 1 year for immune checkpoint inhibitors or interferon alfa (s 9(3), (8)); and at least 7 days of drug exposure where the factor depends on association and improvement on cessation or redevelopment on rechallenge (s 9(4), (9)). Practitioners must match clinical onset/worsening dates to records of drug exposure with sufficient precision. Poorly dated or vague prescribing records can prevent meeting these temporal thresholds.

3. The "specified list of drugs" is finite and includes commonly used agents (Schedule 1)

• The Schedule defines the specified list narrowly as 5‑fluorouracil, capecitabine, D‑penicillamine, statins, trastuzumab, and tumour necrosis factor-alpha inhibitors. Many drug classes or agents that cause myopathies are not listed. Where a claimant alleges association with an unlisted drug, s 9(4) and s 9(9) may apply if the case is one of individual association during drug therapy with improvement after cessation or redevelopment on rechallenge, but in those subclauses the minimum 7-day exposure and evidence of temporal association or rechallenge are required. Claimants relying on drugs not in the specified list face a narrower route.

4. "Inability to obtain appropriate clinical management" is a factor but undefined (s 9(11))

• Section 9(11) lists "inability to obtain appropriate clinical management for dermatomyositis" as a factor. The instrument provides no definition or objective criteria for what constitutes "appropriate clinical management", nor the causal chain from lack of management to onset or worsening. Decision-makers will need to interpret that phrase operationally in claims, which creates implementation risk and potential disputes over the sufficiency and standard of evidence needed to prove inability to obtain care.

5. Distinction between onset and worsening; s 10(2) limits aggravation factors

• Subsection 10(2) restricts factors in s 9(6)-(11) to material contribution to or aggravation of dermatomyositis where the person's dermatomyositis pre-existed before or during relevant service but did not arise out of service. That is a fine factual distinction. If a claimant’s dermatomyositis first arose out of service, those aggravation factors are not available. Practitioners must therefore be careful to establish the correct chronology of first manifestation relative to service to determine which parts of s 9 can be invoked.

6. Malignant neoplasm factor excludes non-melanotic skin cancers (s 9(5), (10); Schedule 1)

• The presence of malignant neoplasm within 5 years is a specified factor for onset or worsening, but the Schedule excludes non-melanotic malignant neoplasm of the skin from this consideration. That exclusion can be a decisive and sometimes overlooked detail in oncology histories.

7. Diagnostic confirmation is noted but not prescriptive (s 7 notes)

• The note to s 7 lists methods that may confirm diagnosis: elevated muscle-associated enzymes, biopsy, imaging or myositis-associated antibodies. The instrument does not require a particular test for every case, but the presence or absence of these tests will influence the weight of evidence. Amyopathic dermatomyositis is included and may lack muscle abnormalities on testing, meaning that a claimant can have the condition even where certain objective muscle findings are absent (s 7(2) and notes). This complicates cases where objective muscle signs are minimal.

8. Rechallenge evidence is a high-evidential bar in drug association subclauses (s 9(4), (9))

• Where a drug is implicated by individual association, the Statement requires either improvement within 2 months of discontinuation/tapering or redevelopment on rechallenge, and that the drug be taken for at least 7 days before onset/worsening. Rechallenge is clinically and ethically difficult in many drug classes, making it a demanding evidentiary route. Improvement upon cessation is therefore the more practicable demonstration for many claimants, but it still requires clinical documentation within the 2-month window.

9. Examples in notes are illustrative, not exhaustive (s 9 notes)

• The instrument gives examples, such as immune checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab, tremelimumab) in a note to s 9, but those examples do not limit the meaning of "immune checkpoint inhibitor". Practitioners should treat those examples as illustrative within the instrument’s text rather than exhaustive listings.

10. Repeal of the 2014 Statement may change settled expectations (s 4)

• The 2022 Statement replaces the 2014 Statement. Practitioners and administrators must therefore be attentive to differences between the two instruments when dealing with claims spanning the repeal and commencement dates. The instrument itself contains no transitional provision, so application timing must be determined by reference to the parent statutes and practice guidance.

For claimants, treating clinicians and advisers preparing or assessing claims, compliance with the evidentiary demands of this Statement requires a focused documentary approach because the instrument ties the procedural threshold of the "reasonable hypothesis" to specific factual items and timeframes.

1. Establish the diagnosis and document clinical onset and worsening dates (s 7)

• Record the clinical features for dermatomyositis consistent with the instrument: inflammatory skin changes such as heliotrope rash and Gottron papules, and any objective muscle weakness features. If available, obtain and file objective diagnostic materials noted in the instrument: serum levels of muscle-associated enzymes, biopsy reports, imaging reports, and results for myositis-associated antibodies (s 7 notes). For amyopathic dermatomyositis, document the presence of characteristic skin signs and any testing that indicates subclinical muscle involvement or the absence of muscle disease (s 7(2) notes).

2. Map drug exposure precisely to clinical events (s 9)

• Create a timeline that links dates of drug administration, prescription records, and dispensing records to dates of clinical onset and clinical worsening. For each drug listed in the Schedule or otherwise implicated, identify the applicable threshold:
  • Specified list drugs: at least 4 weeks before clinical onset or clinical worsening (s 9(1), (6); Schedule 1).
  • Hydroxyurea: at least 6 months before onset or worsening (s 9(2), (7)).
  • Immune checkpoint inhibitors or interferon alfa: within 1 year before onset or worsening (s 9(3), (8)).
  • Drug-associated individual cases: drug taken at least 7 days before event, plus improvement within 2 months of cessation or redevelopment on rechallenge (s 9(4), (9)).
• Collect hospital pharmacy administration charts, DVA treatment records, oncology clinic notes, GP prescribing records and community pharmacy dispensing records to establish these durations and timing.

3. If alleging malignancy association, obtain oncology records and histopathology (s 9(5), (10))

• For the malignant neoplasm factor, secure oncology diagnoses, histopathology reports, staging information and dates of diagnosis and treatment. Note that the Schedule excludes non-melanotic malignant neoplasm of the skin, so confirm histological subtype and exclude those lesions where relevant.

4. For the "inability to obtain appropriate clinical management" factor, collate health-system access evidence (s 9(11))

• Document attempts to obtain care: referrals, appointment records, evidence of waiting lists, denial letters, geographic or service barriers, correspondence with health services, and clinical notes indicating lack of access to indicated therapy. Because the instrument gives no objective definition of "appropriate clinical management", provide contemporaneous clinical opinions about what management would have been appropriate and evidence that it was not obtained despite attempts.

5. Establish relationship to relevant service (s 10(1); Schedule 1)

• Ensure the factor relied on is shown to be related to the person’s relevant service. That requires mapping the service history (operational, peacekeeping, hazardous, British nuclear test defence service under the VEA, or warlike or non-warlike service under the MRCA) against the timing of the factor (Schedule 1 definitions; s 10(1)). Where the dermatomyositis was suffered or contracted before or during service but did not arise out of service and the claim is one of material contribution or aggravation, use factors in s 9(6)-(11) per s 10(2).

6. Handle overlaps with other Statements of Principles via s 11

• If a factor in s 9 invokes another condition that is the subject of a separate Statement of Principles, gather the evidence required by that other Statement because s 11 directs that the other Statement’s factors apply as in force. Check current Statements of Principles for any referenced conditions and obtain the necessary evidence.

7. Prepare precise timelines and contemporaneous clinical statements

• Decision-makers will typically assess whether the required factor exists and is related to service. Contemporaneous clinical notes that show symptom onset, progression, drug start and stop dates, improvement on cessation, events of rechallenge, and clinical commentary on causation are high-value evidence. Where improvement on drug cessation is relied upon, ensure that clinical documentation shows improvement within 2 months, as required by s 9(4) and s 9(9).

8. Anticipate evidentiary difficulties with rechallenge and with proving service relationship

• Rechallenge evidence may be rare for ethical and clinical reasons. If rechallenge is not available, focus on objective documentation of improvement after cessation, and on causally linking the factor to service by showing exposure during, or in temporal proximity to, the relevant service. For drug exposures that occurred off-service, ensure evidence ties the exposure to service circumstances where relevant.

9. Maintain clear records on death-related claims

• For claims concerning death from dermatomyositis, document the clinical chain showing that dermatomyositis contributed to the terminal event. The instrument treats death from dermatomyositis as including death from a terminal event or condition contributed to by dermatomyositis, with "terminal event" defined to include pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function (s 7(3); Schedule 1). Obtain death certificates, autopsy results, terminal event diagnoses, and clinical opinions regarding contribution.

10. Use the Statement as an evidentiary checklist in claim preparation

• Treat s 9 as a checklist of possible routes to raising the reasonable hypothesis. Exhaustively test which factor or combination of factors a claimant can support, and prepare the documentary evidence accordingly. Where a factor refers back to another Statement of Principles under s 11, obtain and apply that other Statement's requirements.

11. Be mindful of exclusions and definitions

• Confirm the classification of cancers (non-melanotic skin cancers excluded), and identify whether the drug used fits the specified list in the Schedule or falls under the immune checkpoint inhibitor examples in the notes. Remember amyopathic dermatomyositis is explicitly included, which affects how absence of muscle signs is interpreted (s 7(2)).

12. Where in doubt, document clinician opinions on causation and service relationship

• While the Statement specifies discrete factual triggers, decision-makers will still need medical opinion linking the factor to the condition and to service where required. Obtain well-reasoned contemporaneous or retrospective expert opinions that map clinical facts to the Statement’s factors and to the service history.

Following these steps will align claim preparation with the written requirements of the instrument and reduce the risk that a claim fails to meet the reasonable hypothesis stage for technical or documentary reasons.