Statement of Principles concerning primary myelofibrosis (Reasonable Hypothesis) (No. 89 of 2021)

The text centrally uses the following legal-medical concepts and ties them to administrative decision-making under the VEA and MRCA.

• Primary myelofibrosis: defined as a chronic, Philadelphia‑chromosome negative myeloproliferative neoplasm, with a non‑exhaustive list of clinical features (bone marrow megakaryocytic proliferation, marrow fibrosis, extramedullary haematopoiesis, splenomegaly and leukoerythroblastosis) and explicit exclusions (secondary myelofibrosis, myelofibrosis secondary to other myeloid neoplasms, and bone marrow fibrosis due to infections, autoimmune disorders, metastatic malignancies, toxic myelopathies, hairy cell leukaemia and lymphoid neoplasms) (s 7(2)(a)-(b)). The Schedule cross‑references this definition (Schedule 1: primary myelofibrosis,see subsection 7(2)).

• Death from primary myelofibrosis: the instrument treats a death that was “contributed to” by primary myelofibrosis as included (s 7(3)). The Schedule clarifies terminal event as the proximate or ultimate cause of death and lists examples (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function) (Schedule 1).

• Reasonable hypothesis threshold: the instrument is titled and framed around the reasonable hypothesis standard; it states that “at least one” of the specified factors in s 9 must exist before it can be said that a reasonable hypothesis has been raised connecting primary myelofibrosis or death from it with relevant service (s 9). The instrument is made under subsection 196B(2) of the VEA (s 3), which is the statutory mechanism for Statements of Principles.

• Specified factors: the instrument lists two alternative factors sufficient to raise the reasonable hypothesis if they are present and related to service (s 9):

  • a quantifiable smoking history: at least 10 pack‑years before clinical onset, commencing at least 5 years prior to clinical onset, and where smoking ceased prior to onset, the onset must have been within 15 years of cessation (s 9(1); Schedule 1 defines pack‑year and gives calculation method and equivalences);
  • inability to obtain appropriate clinical management for primary myelofibrosis (s 9(2)).

• Relationship to service: any factor asserted must be related to the person’s relevant service, and s 10(2) limits the application of the clinical‑management factor where the primary myelofibrosis pre‑existed or was contracted before or during service but did not arise out of service (s 10).

• Interaction with other Statements: s 11 provides that where a factor in this Statement refers to an injury or disease covered by another Statement of Principles, that other Statement applies in accordance with its own terms.

• Relevant service categories: Schedule 1 lists the types of service that count as relevant service for the purposes of the instrument: operational, peacekeeping, hazardous, British nuclear test defence service under the VEA, and warlike and non‑warlike service under the MRCA (Schedule 1 definitions).

These concepts form the binding, operative structure that decision‑makers will apply when assessing claims under the cited provisions of the VEA and MRCA.

Primary direct stakeholders under this instrument are claimants to whom s 120A of the VEA or s 338 of the MRCA applies (s 5). These will include veterans and members whose service falls within the categories of relevant service defined in Schedule 1: operational, peacekeeping, hazardous, British nuclear test defence service under the VEA, and warlike or non‑warlike service under the MRCA (Schedule 1). The Repatriation Medical Authority (RMA) is the decision‑making body that determined the Statement under s 196B(2) of the VEA (s 3), and the instrument is to be applied by persons and bodies administering entitlements under the VEA and MRCA.

Third parties affected in practice will include treating clinicians and medical record holders who supply medical onset dates, smoking histories and evidence about attempts to obtain appropriate clinical management. The Schedule defines one pack‑year and gives a calculation method and conversion example; claimants’ smoking histories will need to be translated into pack‑years (Schedule 1). For deaths, the instrument’s definition of death from primary myelofibrosis includes terminal events contributed to by the disease and lists common terminal events (Schedule 1); coronial or death certification processes will therefore be relevant to establishing causation in death cases.

Administrators and decision‑makers applying the VEA and MRCA will use this Statement as the medical framework to determine whether a reasonable hypothesis has been raised linking the condition and relevant service (s 9). The Statement also affects other Statement of Principles instruments by cross‑reference: if a factor in s 9 refers to an injury or disease covered by another Statement, that other Statement’s factors apply as in force from time to time (s 11). Finally, the repeal of the 2013 Statement (s 4) means that determinations made after the commencement date must use this instrument rather than the earlier version; thus advisers must check which Statement is current for the claim‑relevant period (s 2, s 4).

Note on scope: the instrument is specific to primary myelofibrosis and explicitly excludes secondary myelofibrosis from other myeloid neoplasms or other causes of marrow fibrosis (s 7(2)(b)). Consequently, persons whose marrow fibrosis is secondary to excluded conditions will not fit within this Statement’s definition of primary myelofibrosis for the purpose of raising the reasonable hypothesis under this instrument (s 7).

This instrument itself does not create administrative duties or statutory rights in the manner of an Act. It is a Statement of Principles made under s 196B(2) of the VEA to be used by decision‑makers when determining whether a reasonable hypothesis connects primary myelofibrosis or death from it with relevant service (s 3, s 9). That said, it sets out the operative factual requirements decision‑makers must look for and must relate to service.

Obligations that follow from the instrument for decision‑makers and claimants can be described as follows:

• Decision‑makers must assess whether “at least one” of the factors in s 9 exists and whether that factor is related to the person’s relevant service (s 9, s 10(1)). The instrument therefore functions as a mandatory analytical step in claims captured by s 5.

• Decision‑makers must apply the temporal and quantitative requirements for the smoking factor in s 9(1): at least 10 pack‑years prior to clinical onset, smoking commencing at least 5 years before clinical onset, and, if smoking ceased before clinical onset, the onset must have occurred within 15 years of cessation (s 9(1)). The Schedule supplies the precise method for calculating pack‑years and equivalences (Schedule 1).

• For the clinical management factor in s 9(2), decision‑makers will need to assess whether an inability to obtain appropriate clinical management existed and whether that inability is related to relevant service. Section 10(2) constrains the use of this factor to cases where primary myelofibrosis was suffered or contracted before or during service (but did not arise out of service) and the factor is being relied on to show material contribution to, or aggravation of, the condition.

• Where a factor refers to another injury or disease covered by another Statement of Principles, decision‑makers must apply the factors in that other Statement “in accordance with the terms of that Statement of Principles as in force from time to time” (s 11). That creates a duty to consult and apply other Statements where relevant.

For claimants and advisers the instrument defines what evidence will be determinative for the reasonable hypothesis step. In practice, claimants must be prepared to establish: smoking quantity and timing, date of clinical onset, cessation dates (if applicable), evidence that they were unable to obtain appropriate clinical management, and the link between the asserted factor and the relevant service as defined in the Schedule. The instrument’s definitions and numerical thresholds (pack‑years, commencement before clinical onset, 15‑year cessation window) convert clinical facts into administrative triggers that determine whether the reasonable hypothesis has been raised (s 9; Schedule 1).

The instrument does not itself create new monetary entitlements, nor does it set out appeal rights, application forms or procedures. Those duties and rights lie in the VEA and MRCA provisions referenced in s 5; this instrument supplies the medical criteria to be applied under those statutory schemes.

The Statement of Principles instrument is a medical‑factual instrument and contains no express penalties, offences or enforcement mechanisms within its text (the instrument sets out definitions and factors; see s 7-s 11 and the Schedule). It is made under subsection 196B(2) of the VEA (s 3). Enforcement in the sense of giving the instrument effect will occur through the decision‑making processes and adjudicative mechanisms that implement the VEA and MRCA provisions to which the instrument applies (s 5). Those enforcement and review mechanisms are not set out in this instrument.

Consequently, the practical effect of the instrument is to bind or guide the RMA and administrators when they evaluate whether a reasonable hypothesis exists linking primary myelofibrosis or death from it to relevant service. If a decision‑maker accepts a factor in s 9 as established and related to relevant service, that finding will support the view that a reasonable hypothesis has been raised; the downstream enforcement or entitlement determination will then be carried out under the VEA or MRCA processes to which this Statement is tied (s 5). The instrument itself does not prescribe sanctions, criminal penalties or civil liabilities for non‑compliance with its provisions.

The text requires factual assessments that create scope for administrative discretion: for example, the clinical concept “inability to obtain appropriate clinical management” in s 9(2) is not further defined in the instrument. Where an instrument leaves terms undefined, decision‑makers must interpret and apply the term within the statutory decision framework of the VEA and MRCA. The lack of a statutory definition for that term means that enforcement will depend on how decision‑makers and adjudicators interpret “inability to obtain appropriate clinical management” in individual cases, including what evidence is sufficient to establish it.

The instrument’s Schedule provides quantitative and definitional certainty for other terms that reduce enforcement uncertainty. The definition of pack‑year, including kilogram/grain equivalences and calculation method (Schedule 1), creates a clear numerical standard for the smoking factor (s 9(1)). The Schedule’s list of terminal events clarifies what deaths fall within the instrument’s scope (Schedule 1). The instrument’s repeal clause (s 4) and commencement date (s 2) enforce which Statement of Principles is current for claims.

The Statement is made under subsection 196B(2) of the VEA (s 3). It applies to claims to which section 120A of the VEA or section 338 of the MRCA applies (s 5). Therefore, the Statement does not operate in isolation; it functions as a medical criteria instrument incorporated into the claim assessment processes established by those provisions. The instrument cross‑references the VEA and MRCA terminology by defining MRCA and VEA in the Schedule (Schedule 1), and by listing relevant service types that align with the service categories used in those Acts (Schedule 1).

Section 11 creates explicit interaction with other Statements of Principles: if a factor in s 9 refers to an injury or disease covered by another Statement determined under subsection 196B(2) of the VEA, then the factors in that other Statement apply in accordance with its terms as in force from time to time (s 11). This formal cross‑reference means decision‑makers must consult the relevant other Statements and apply their terms where the factual factor overlaps with another Statement’s subject matter. The instrument therefore forms part of an integrated body of Statements that collectively determine the medical links between particular conditions and relevant service for the statutory claim processes.

The Schedule’s definition list explicitly ties the instrument to the VEA and MRCA frameworks by enumerating the types of relevant service that count under those Acts (Schedule 1). The instrument’s repeal of the prior 2013 Statement (s 4) implements a change in the corpus of Statements of Principles; decision‑makers and advisers must apply the current Statement (this instrument) to claims falling within its commencement date (s 2, s 4).

The instrument does not amend the VEA or MRCA themselves; it neither creates nor extinguishes statutory benefits by its terms. Rather, it supplies medical facts for the application of entitlement provisions under those Acts. The instrument is silent on appeals, review procedures or evidentiary rules; these procedural and remedial rules remain in the VEA and MRCA frameworks to which the instrument attaches. The instrument’s definitions and numerical standards (for example, pack‑year calculation in the Schedule) can constrain how the VEA and MRCA decision‑makers evaluate medical evidence, thereby affecting the application of those Acts’ entitlement provisions.

Because the Statement is framed to establish a “reasonable hypothesis” when factors in s 9 exist and relate to relevant service (s 9), its primary legal interaction is with adjudicative standards in the VEA and MRCA: claims will turn on whether, in the administrative application of those Acts, the Statement’s prescribed factual triggers are satisfied and linked to relevant service.

The instrument contains a direct statement that it repeals the Statement of Principles concerning primary myelofibrosis No. 17 of 2013 (Federal Register of Legislation No. F2013L00416) made under subsection 196B(2) of the VEA (s 4). The current instrument is dated 20 August 2021 and commences on 20 September 2021 (s 2 and the front matter). No other amendments or prior versions are recorded within the text of this instrument.

What the instrument records, therefore, is a single discrete replacement: the 2013 Statement is explicitly repealed and replaced by this 2021 Statement. The text does not list any incremental amendments to this 2021 instrument itself; it is presented as a stand‑alone instrument “No. 89 of 2021” and includes the date of determination and the RMA Chairperson’s certification (front matter). The Schedule cross‑references relevant Acts and provides definitions for terms used; there are no textual amendments to those Acts in this instrument.

Because the instrument provides that where a factor refers to an injury or disease covered by another Statement then that other Statement applies “as in force from time to time” (s 11), the effective legal framework for claims can change over time as other Statements are amended or replaced. The instrument does not record those other Statements’ histories; it only sets the mechanism for their application.

Practitioners should therefore treat this instrument as the operative Statement for primary myelofibrosis from 20 September 2021 forward, and be aware that any subsequent repeal or amendment would appear as a separate instrument (following the practice reflected in s 4). The instrument itself contains no retrospective amendment language, transitional provisions or savings clauses beyond the simple repeal of the 2013 Statement.

The Statement text contains no references to cases, judicial decisions or litigation applying or construing this instrument. It does not name any proceedings, reviews or judicial determinations that have considered its provisions. The instrument is silent on any litigation history; there are no case names, citations or summaries in the document provided.

Because the instrument is a Statement of Principles intended to be applied in claims processes under the VEA and MRCA (s 5), it is possible in practice that decisions applying it may be the subject of administrative review or litigation under the appeal mechanisms of those Acts. However, the instrument itself does not record or describe any such litigation nor does it specify the procedural paths for review or appeal. Those procedural details would be located in the VEA and MRCA, not in this Statement.

For the purposes of research and citation, this instrument stands on its own as an RMA determination dated 20 August 2021 and commencing 20 September 2021 (s 2; front matter). Any reported litigation that interprets the meaning of terms used in this Statement , for example the phrase “inability to obtain appropriate clinical management” or the temporal thresholds for the smoking factor , would need to be located in judicial or administrative decisions outside the text of this Statement. The instrument provided does not supply such materials.

The instrument contains a number of features and definitional choices that are likely to produce practical points of contention or evidentiary complexity in claims.

1. Limited set of factors: only two alternative factors are listed in s 9. If a claimant cannot establish either the quantified smoking history in s 9(1) or the clinical‑management failure in s 9(2), the instrument states that it cannot be said that a reasonable hypothesis has been raised under this Statement (s 9). That creates a binary gate at the reasonable hypothesis step.

2. Strict numerical and temporal thresholds for smoking: the smoking factor at s 9(1) requires at least 10 pack‑years prior to clinical onset and that smoking commenced at least 5 years before clinical onset. The Schedule defines one pack‑year and gives conversion and calculation guidance; these numerical requirements will convert what might otherwise be descriptive histories into discrete pass/fail criteria (s 9(1); Schedule 1). Claimants must therefore produce evidence of cigarettes per day and duration to calculate pack‑years precisely.

3. Fixed cessation window: for former smokers, the instrument requires that clinical onset occurred within 15 years of cessation (s 9(1)). This creates a clear temporal limitation that can exclude long‑ago smokers even if they had historically heavy use.

4. Undefined key term , “inability to obtain appropriate clinical management”: s 9(2) relies on this phrase without a definition in the instrument. Practically, this is likely to be a focal point for administrative interpretation and evidentiary dispute. The absence of definition means decision‑makers will need to form a view about what constitutes “appropriate clinical management” and what evidence demonstrates an “inability” to obtain it. That invites variability in outcomes and potential for challenge on grounds of administrative error if inconsistent standards are applied.

5. Limited scope for clinical‑management factor: s 10(2) restricts the operation of s 9(2) to cases where primary myelofibrosis was suffered or contracted before or during service (but did not arise out of service), and only for material contribution to or aggravation of the condition. That restricts the clinical‑management factor’s applicability to a narrower subset of claims where the condition pre‑existed or was acquired during service but was not caused by service. The wording requires careful chronological analysis of onset and service dates (s 10(2)).

6. Exclusions from definition of primary myelofibrosis: s 7(2)(b) excludes myelofibrosis secondary to essential thrombocythaemia, polycythaemia vera or another myeloid neoplasm and excludes secondary myelofibrosis from a list of other causes. If the claimant’s marrow fibrosis is secondary to those conditions, this Statement will not apply. That places importance on accurate diagnostic classification in medical records.

7. Cross‑reference complexity: s 11 requires importing factors from other Statements “as in force from time to time” when a factor refers to another injury or disease. That means the legal test may change over time as other Statements are amended, requiring practitioners to track multiple instruments to know which framework applies to a given factor.

8. Death causation: the instrument treats death from primary myelofibrosis as included where the disease contributed to death, and Schedule 1 lists typical terminal events (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function). Determining whether primary myelofibrosis contributed to a listed terminal event will often require careful review of death certification, clinical records and proximate cause analyses (s 7(3); Schedule 1).

9. Repeal timing and transitional effect: s 4 repeals the 2013 Statement. The instrument’s commencement date is 20 September 2021 (s 2). Practitioners should not assume the prior Statement applies to claims after the commencement date. The instrument contains no express transitional provisions; the repeal appears to be effective on commencement.

10. Evidence burden implicit but not specified: the instrument sets factual gates (s 9 and Schedule 1) but does not specify the nature or standard of evidence. The instrument requires that a factor “must as a minimum exist” to raise a reasonable hypothesis (s 9), but the Rule does not state how evidence is marshalled or weighed; those procedural rules are left to the VEA/MRCA claim processes. This leaves potential uncertainty about what documentary or testimonial proof will be accepted to establish pack‑years, dates of clinical onset, cessation dates, or inability to obtain care.

Each of these points is grounded in the instrument’s language. Practitioners should plan evidence collection and legal argumentation around these defined thresholds and the areas where the instrument is silent or leaves interpretative space.

For advisers and claimants preparing a claim under the VEA or MRCA where primary myelofibrosis is alleged, the instrument translates into a focused evidentiary and chronological checklist. The Statement requires that at least one of the s 9 factors be established and related to relevant service (s 9; s 10(1)). The following steps align with the instrument’s operative text.

1. Establish the condition is primary myelofibrosis as defined:

   • Obtain diagnostic records that demonstrate the disease fits the s 7(2)(a) description: chronic, Philadelphia‑chromosome negative myeloproliferative neoplasm with marrow megakaryocytic proliferation, marrow fibrosis, extramedullary haematopoiesis, splenomegaly and leukoerythroblastosis where present (s 7(2)(a)).
   • Exclude secondary causes listed in s 7(2)(b) by securing pathology, haematology and oncology records showing no evidence of essential thrombocythaemia, polycythaemia vera, other myeloid neoplasms, infections, autoimmune disorders, metastatic malignancy, lymphoid neoplasms, toxic myelopathies or hairy cell leukaemia.

2. For the smoking factor (s 9(1)):

   • Calculate pack‑years using the Schedule’s method: divide cigarettes per day by 20 and multiply by years smoked; use the Schedule’s equivalences if other tobacco products were used (Schedule 1 describes one pack‑year, gives 7,300 grams equivalence and provides examples). For mixed tobacco types, apply the Schedule’s conversions (Schedule 1 note).
   • Document the date of clinical onset of primary myelofibrosis; that date is the reference point for the temporal requirements in s 9(1).
   • Show that smoking commenced at least 5 years prior to clinical onset and that cumulative consumption reached at least 10 pack‑years before clinical onset.
   • If smoking ceased prior to clinical onset, produce cessation evidence and show clinical onset occurred within 15 years of cessation (s 9(1)).

3. For the clinical management factor (s 9(2)):

   • Collect contemporaneous clinical correspondence, appointment records, letters, referrals or other documentary evidence showing attempted access to treatment and the reasons treatment was unavailable or delayed.
   • Assemble statements from treating clinicians about the standard of clinical management for primary myelofibrosis and why the claimant did not obtain it (bearing in mind the instrument does not define “appropriate clinical management”; practitioners should aim to demonstrate why available care was inadequate or inaccessible).
   • If relying on s 9(2) to show material contribution or aggravation where the condition pre‑existed or was contracted during service, ensure the chronology supports s 10(2): that the condition was suffered or contracted before or during service and did not arise out of service, and that lack of access materially contributed or aggravated the condition (s 10(2)).

4. Link the relevant factor to relevant service (s 10(1)):

   • Document service type and dates, and align these with the Schedule’s definition of relevant service (operational, peacekeeping, hazardous, British nuclear test defence service under the VEA; warlike and non‑warlike under the MRCA) (Schedule 1).
   • Prepare a causal narrative with supporting records to show how the asserted factor is related to the service circumstances. For example, if asserting inability to obtain appropriate clinical management due to service location or medical infrastructure while posted, gather service records, postings, medical board minutes and contemporaneous evidence.

5. Death cases:

   • For claims concerning death from primary myelofibrosis, secure death certification and clinical documentation that shows primary myelofibrosis contributed to the terminal event listed in the Schedule (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function) (s 7(3); Schedule 1).
   • Provide the same factual evidence for the antecedent disease factors (smoking history, clinical management access) as in paragraphs 2 and 3 above.

6. Cross‑reference other Statements (s 11):

   • If any asserted factor refers to another injury or disease covered by a different Statement of Principles, identify and obtain the current version of that other Statement and apply its factors “as in force from time to time” (s 11). Make sure evidence meets the other Statement’s thresholds where applicable.

7. Anticipate definitional disputes and prepare expert evidence:

   • Because the instrument leaves “inability to obtain appropriate clinical management” undefined, consider obtaining an expert opinion from haematologists or health‑service experts to explain what constitutes appropriate clinical management for primary myelofibrosis and whether the claimant’s circumstances met the instrument’s requirement of inability to obtain it.
   • For smoking histories, obtain corroborating records where possible (medical records noting tobacco use, employment records, statements from family, military medical records).

8. Be mindful of timing and current Statement:

   • Use this Statement for claims with relevant events or decision dates after the instrument’s commencement (s 2). The 2013 Statement was repealed by s 4; ensure the correct Statement is cited and applied.

9. Documentation checklist (minimum):

   • Diagnostic pathology and haematology reports confirming primary myelofibrosis (s 7(2)(a), s 7(2)(b));
   • Smoking history with pack‑year calculation and dates (s 9(1); Schedule 1);
   • Clinical onset date(s);
   • Evidence of smoking cessation, where applicable (s 9(1));
   • Records showing attempts to obtain clinical management or correspondence showing inability to access treatment, with expert explanation where useful (s 9(2); s 10(2));
   • Service records showing relevant service type and dates (Schedule 1);
   • Death documentation where applicable showing contribution of primary myelofibrosis to terminal event (s 7(3); Schedule 1).

Following these steps aligns the claim preparation with the concrete, enumerated thresholds and terms in the instrument. Because the Statement does not prescribe evidentiary standards or procedural steps, practitioners must ensure the factual record clearly satisfies the instrument’s numerical and temporal tests and addresses the instrument’s definitional gaps with contemporaneous records and expert evidence where necessary.