Statement of Principles concerning immune thrombocytopaenia (Balance of Probabilities) (No. 64 of 2017)

Mechanically, this instrument is a Statement of Principles (SoP) made under subsection 196B(3) of the Veterans' Entitlements Act 1986 and compiled as No. 64 of 2017 (with amendment No. 58 of 2022). It sets the medical criteria that decision makers must use when determining, on the balance of probabilities, whether immune thrombocytopaenia (ITP) or death from ITP is connected with a person's relevant service for the purposes of claims that fall under section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 (MRCA) (see s 3, s 5). In short, it is not a statute creating rights or liabilities on its own; it operates as the Repatriation Medical Authority's formal, evidence‑based statement of the factors that, if present and related to relevant service, will support a finding of service connection for ITP or death from ITP (see s 8 and s 9).

The SoP performs three discrete functions, as expressed in its text. First, it defines the medical entity in issue , "immune thrombocytopaenia" , with a specific clinical threshold (an isolated thrombocytopaenia with a peripheral platelet count of less than 100 000 per microlitre accompanied by bleeding symptoms or the need for treatment), and it lists explicit exclusions (see s 7(2)). Second, it enumerates the factors that "must exist" before it can be said, on the balance of probabilities, that ITP or death from ITP is connected with relevant service; at least one listed factor must be present and related to relevant service (s 9; s 10(1)). Third, it specifies nuances about onset versus worsening: factors 1-13 relate to clinical onset, while factors 14-26 are limited to material contribution to, or aggravation of, an existing ITP where the condition was suffered or contracted before or during (but did not arise out of) the person's relevant service (see s 9; s 10(2)).

The instrument explicitly states the Repatriation Medical Authority's posture about the evidence base: "On the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that immune thrombocytopaenia and death from immune thrombocytopaenia can be related to relevant service" (s 8). That expresses the RMA's view that a causal link can be made on a balance of probabilities where the SoP's criteria are met. The SoP therefore modifies the evidentiary landscape for claims under the VEA/MRCA by providing legally cognisable, enumerated clinical and exposure factors (including specified lists of infections, drugs, vaccines, foods, cancers and lymphoproliferative disorders) which, if proven and related to relevant service, satisfy the statutory causal test used in claims governed by the referenced sections of the VEA/MRCA (s 5).

The SoP is a compilation current to 30 May 2022 and includes the Schedule 1 dictionary that lists particular drugs, infections, vaccines and other items that are treated as qualifying factors (Schedule 1). The instrument itself contains no penalty provisions. Its legal effect is to be applied by the decision makers who process claims under the VEA and the MRCA; it does not by itself create compensation or administrative processes, although its application will influence entitlements determined under those Acts (s 5).

At core, the document operationalises three main legal concepts: the medical definition of the condition, a closed list of causative or aggravating factors, and the service‑connection test. Each is anchored to specific text in the instrument.

Definition of the disease. The SoP provides a precise, gatekeeping medical definition of immune thrombocytopaenia (ITP). For the SoP's purposes ITP is "an autoimmune disorder characterised by an isolated thrombocytopaenia, and a peripheral platelet count of less than 100 000 per microlitre, together with either: (i) the presence of bleeding symptoms; or (ii) the need for treatment to increase the platelet count" (s 7(2)(a)). The instrument also sets out explicit exclusions: pseudothrombocytopaenia, thrombocytopaenia caused by non‑immunological mechanisms, allergic and other non‑thrombocytopaenic purpura, qualitative platelet defects, thrombotic thrombocytopaenic purpura, Evan's syndrome, pancytopaenia, and thrombocytopaenia occurring with abnormal red or white blood cells (s 7(2)(b)). This definition establishes an objective clinical gate that claimants must meet to call their condition "immune thrombocytopaenia" under this SoP.

Enumerated causal and aggravating factors. Section 9 lists the factors that "must exist" before a connection to service can be made on the balance of probabilities. The factors are structured around timing (mostly a six week exposure window before clinical onset or clinical worsening), specific categories of exposures (viral, bacterial/fungal infections, drugs, vaccines, foods and beverages), clinical events (pregnancy, solid organ transplant, solid organ cancer), and particular therapeutic agents (for example alemtuzumab; s 9(13)). Some items are further qualified: for example, factors numbered 5, 10, 18 and 23 require individual‑level evidence of temporal association together with absence of prior disease, recovery on cessation, exclusion of other aetiologies and, in the food re‑exposure case, recurrence or identification of specific platelet reactive antibodies (s 9(5), 9(10), 9(18), 9(23)). The Schedule 1 dictionary provides "specified lists" for drugs, vaccines, infections, foods, lymphoproliferative and autoimmune disorders, so the SoP is list‑based rather than open‑ended (Schedule 1).

Service connection and burden. The instrument is expressly applied to claims subject to section 120B of the VEA or section 339 of the MRCA (s 5). Its legal test is framed in probabilistic terms: the instrument signals that, based on the RMA's review of medical‑scientific evidence, it is "more probable than not" that ITP and death from ITP can be related to relevant service (s 8). Operationally the SoP requires: (a) proof that at least one enumerated factor exists (s 9); and (b) that the factor is related to the person's relevant service (s 10(1)). The SoP also contains a procedural cross‑reference where a factor points to an injury or disease already the subject of another SoP: in that case the other SoP's terms apply (s 11).

Direct statutory audience. The SoP applies directly to claimants who lodge claims "to which section 120B of the VEA or section 339 of the MRCA applies" (s 5). That identifies a defined group: veterans, members of the Forces, and members under the MRCA whose claims invoke those specific sections. The instrument itself does not define the administrative or judicial decision makers who will apply it, but its legal effect is to inform determinations under the VEA and MRCA claims processes.

Veterans and members with potential ITP. Any person asserting that they have immune thrombocytopaenia, or that ITP contributed to their death, and who seeks a finding that the condition is connected with relevant service for the purposes listed above will be affected. To be considered under this SoP, the person's clinical presentation must match the definition in s 7(2), including the platelet count threshold and either bleeding symptoms or need for treatment. Cases that involve excluded forms of thrombocytopaenia (for example thrombotic thrombocytopaenic purpura, pseudothrombocytopaenia, pancytopaenia) are excluded from the SoP's coverage (s 7(2)(b)), and so claimants with those conditions will not obtain a favourable finding on the basis of this SoP.

Medical practitioners and claims handlers. Clinicians preparing medical records for claims will need to document the precise clinical features the SoP requires: platelet counts, presence of bleeding symptoms or treatment indications, exposure histories (vaccines, drugs, infections, foods, pregnancy, transplants, cancers), and any temporal relationships, recovery on cessation, or recurrence on re‑exposure where the relevant factor requires that evidence (see s 9(5), s 9(10), s 9(18), s 9(23)). Claims officers and decision makers in the Department or agencies administering the VEA and MRCA will use this SoP as an evidentiary rubric to decide whether the threshold for service connection is met.

Dependants and estates. Because the SoP includes death from ITP (s 7(3)), dependants and estates seeking entitlements that arise from a finding that death was contributed to by ITP will be affected, provided the claim is within the scope of s 120B VEA or s 339 MRCA.

Third parties and private actors. Pharmaceutical companies, vaccine suppliers, hospitals and employers are not directly regulated by the SoP, but the instrument can affect private commercial interests indirectly. For example, a claimant establishing a causal link between a listed drug or vaccine and ITP could influence liability or reputation outcomes in parallel civil or regulatory processes, though those processes are outside the SoP and not referenced in it. The SoP’s specified lists explicitly include particular drugs, vaccines (including ChAdOx1 nCoV‑19 as amended in 2022), and SARS‑CoV‑2 among viral infections (Schedule 1), which concentrates attention on those products in the claims context.

Duties placed on decision makers and the evidentiary consequence for claimants. The SoP creates an evidentiary framework that decision makers are expected to apply when determining, on the balance of probabilities, whether immune thrombocytopaenia or death from it is connected with relevant service in claims under s 120B VEA and s 339 MRCA (s 5). The instrument requires that at least one of the enumerated factors in s 9 "must exist" before a finding of connection can be made on that standard. It follows that decision makers have a duty to assess whether any of the listed factors is present in the applicant's medical history and whether that factor is related to the person's relevant service (s 9; s 10(1)).

Duty to apply temporal and clinical thresholds. Several duties flow from the SoP’s structure. Decision makers must check that the clinical definition of ITP is met (peripheral platelet count <100 000/uL plus bleeding symptoms or need for treatment , s 7(2)(a)) and must ensure that any excluded conditions are properly considered and excluded in the claimant’s case (s 7(2)(b)). Where the SoP requires a temporal relationship , typically exposure within six weeks before clinical onset or clinical worsening , decision makers must verify timing through medical records or other admissible evidence (s 9 clauses). For certain factors that require individual association evidence (for example drug or vaccine associated in the individual with development within six weeks, absence of ITP prior, sustained recovery on cessation, exclusion of other aetiologies , s 9(5)), decision makers must assess the presence of those specific elements rather than rely on generic epidemiological association.

Right to a finding where criteria are met. The SoP is expressed in terms that create a pathway to a service connection finding: if at least one listed factor exists and that factor is related to relevant service, then, on the balance of probabilities, ITP or death from ITP can be regarded as connected with the circumstances of the person’s relevant service (s 9; s 10(1)). The instrument communicates the RMA's view that, on the available medical‑scientific evidence, such a causal link is more probable than not (s 8). Practically, this means claimants who produce evidence satisfying the SoP’s criteria have the right to have their claim treated according to those criteria in decisions under the VEA/MRCA.

Duty to cross‑refer other Statements of Principles. Section 11 creates a duty to check for overlap with other SoPs. If a factor in this SoP refers to an injury or disease covered by a different SoP, then that other SoP applies "in accordance with the terms of that Statement of Principles as in force from time to time" (s 11). Decision makers must therefore ensure coherent application of SoPs where factors or injuries overlap.

No express offences or fines. The Statement of Principles itself does not create criminal offences, civil penalties or regulatory sanctions. It operates as a medical‑evidentiary instrument to be applied by decision makers under the VEA and MRCA (s 5). There are no provisions imposing penalties on claimants, medical practitioners or administrators for failing to comply with any of the SoP’s content. The instrument is silent on enforcement in the sense of sanctions.

Administrative enforcement by application in entitlement decisions. The practical enforcement mechanism for the SoP is administrative rather than penal. Its content is enforced by being taken as the medical criteria that must be met to establish a link between ITP (or death from ITP) and relevant service when deciding claims that fall under s 120B VEA or s 339 MRCA (s 5). Decision makers are therefore the primary enforcers in practice: they must assess submitted evidence against the SoP’s listed factors, clinical thresholds and timing windows. If evidence satisfies the SoP’s criteria and is related to relevant service, the consequence is an entitlement determination under the VEA/MRCA framework. If evidence does not satisfy the SoP, the decision maker will not be able to find service connection on that basis.

No internal compliance regime within the SoP. The instrument does not create a compliance reporting regime, audit powers, monitoring obligations or a sanctions regime directed at clinical or administrative behaviour. Any compliance oversight will come from the agencies and statutory review mechanisms that administer the VEA and MRCA, not from the SoP itself.

Appeals and review processes are implied but not specified. The SoP does not set out appeal or review mechanisms. Practitioners and claimants should therefore look to the VEA, MRCA and the relevant administrative law frameworks for review rights when a decision maker applies the SoP in a way a party disputes. The SoP is silent on whether or how administrative reviewers must treat the RMA’s stated view; it simply expresses the RMA’s view that, on the sound medical‑scientific evidence available, it is more probable than not that ITP and death from ITP can be related to relevant service (s 8). Any review, appeal or judicial scrutiny would assess whether the decision maker correctly applied the SoP and the governing statutory test, but those procedures are external to the text.

Practical enforcement implications. Because the SoP prescribes precise medical thresholds and enumerated qualifying factors, the "enforcement" lens for practitioners is evidentiary: the document increases predictability for decision makers and claimants by identifying what constitutes acceptable proof of service connection in ITP cases. However, it also places a burden on claimants to produce the specific types of evidence the SoP requires (timing within six weeks for many factors, platelet counts less than 100 000 per microlitre, documentation of recovery on cessation of drugs or vaccines in certain clauses, etc.), and the absence of such evidence will be decisive in administrative determinations. Those consequences are administrative and remedial in nature, not penal.

Operative within the VEA/MRCA scheme. The SoP is expressly made under subsection 196B(3) of the Veterans' Entitlements Act 1986 (s 3) and applies to claims to which s 120B of the VEA or s 339 of the MRCA applies (s 5). Consequently the SoP is an interpretive and evidentiary tool that decision makers must use when determining service connection under those statutory provisions. The SoP does not itself create a compensation entitlement; entitlement, procedural steps, payment mechanisms, review rights and ancillary obligations remain governed by the VEA, MRCA and associated regulations. The SoP supplies the medical criteria necessary to satisfy the causal aspect of those Acts’ entitlement tests.

Interaction with other Statements of Principles. Section 11 creates a specific cross‑reference mechanism between SoPs. If a factor in this SoP refers to an injury or disease that is the subject of another SoP, then the factors in that other SoP apply "in accordance with the terms of that Statement of Principles as in force from time to time" (s 11). Practically, that means decision makers must reconcile overlapping SoPs: where a listed factor points to a disease already covered by another SoP, the substantive tests in the other SoP take precedence for that factor. This cross‑referencing prevents inconsistent or duplicated medical criteria across SoPs, but it requires claim handlers to consult multiple instruments when factors overlap.

Administrative law overlay. The instrument does not specify review, appeal or judicial remedies; those are provided by the VEA and MRCA and the general administrative law framework. Any challenge to a decision that applies this SoP would proceed under the statutory review mechanisms available under the governing Acts and administrative law, rather than through the instrument itself. The SoP’s statement that its conclusions are based on "sound medical‑scientific evidence" (s 8) is descriptive of the RMA’s view; it does not by itself insulate administrative decisions from review. Questioning whether the SoP was correctly applied or whether a decision maker failed to consider relevant evidence would fall to the usual administrative and judicial review processes under the broader legal framework.

No conflict‑resolution provisions included. The SoP does not include express rules for resolving conflicts between its list and other statutory instruments, nor does it provide a hierarchy beyond the cross‑reference in s 11. Therefore, conflict resolution is a practical task for decision makers applying the SoP alongside other statutory provisions and SoPs.

Compilation and amendments recorded. The compilation is current to 30 May 2022 and includes amendments up to Amendment Statement of Principles concerning immune thrombocytopaenia (Balance of Probabilities) (No. 58 of 2022) (the day of commencement of that amendment is 30 May 2022). The instrument's endnotes include a detailed amendment history and legislation history (Endnote 3 and Endnote 4).

Key amendment entries. Endnote 3 records the original instrument as registered on 6 November 2017 with commencement on 4 December 2017, and the amendment No. 58 of 2022 as registered on 2 May 2022, commencing 30 May 2022. Endnote 4 shows that Schedule 1 , the Dictionary , was amended by No. 58 of 2022 specifically with respect to the specified list of vaccines and the specified list of viral infections. The amendment history table in Endnote 4 indicates that those are the provisions of the instrument that changed in that amendment.

Effects of the 2022 amendment. The amendment to Schedule 1 changed the specified lists for vaccines and viral infections. The current Schedule 1 in this compilation now explicitly includes the ChAdOx1 nCoV‑19 vaccine (Vaxevria, Oxford/Astra‑Zeneca) and lists "severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2)" among specified viral infections (Schedule 1 entries). Those insertions are reflected in the compiled text; the endnotes record that the vaccine and viral infection lists were amended by No. 58 of 2022 (Endnote 4).

Amendment mechanics and uncommenced amendments. The compilation includes notices that uncommenced amendments, modifications and saving or transitional provisions that affect the operation of the compiled law may not be shown in the text. That means future or parallel amendments could alter which factors are specified in the lists or change the SoP's scope without being visible in this compilation unless and until they commence (see the "Uncommenced amendments" and "Modifications" notes in the compilation preface).

Implications for claim timing and retrospective application. The SoP does not itself state retrospective application rules or transitional provisions for its amendments. Changes to the SoP typically affect decisions from their commencement date forward unless the administering statutory framework provides otherwise. Practitioners must therefore check the relevant amendment commencement dates and any transitional provisions in the VEA, MRCA or the amending instrument to determine which version applies to a given claim. The endnotes provide commencement dates for this compilation and its amendments which are the authoritative guide in this compilation (Endnote 3).

No litigation recorded in the instrument. The compiled SoP contains no recital of case law and names no judicial decisions that have interpreted or applied it. The text itself does not refer to any litigation, and the endnotes list only legislative amendment history. Therefore, within the confines of this instrument there is no internal record of litigation or appellate treatment.

Implications of absent litigation references. The absence of litigation references in the SoP text and endnotes does not mean the SoP has not been the subject of dispute in external administrative or judicial proceedings; it simply means that this instrument and its compilation do not document any such cases. Practitioners must therefore check the administrative tribunal and court records for any decisions that have considered this SoP when preparing or litigating claims. The SoP's legal effect will be realised in how decision makers apply it; challenges to such decisions would be found outside the SoP text.

How litigation would typically engage the SoP. Where disputes arise about entitlement under the VEA or MRCA and the SoP is applied, litigation or administrative review would likely examine whether the decision maker correctly: (a) identified the relevant SoP in force; (b) applied the SoP's clinical definition of ITP (s 7(2)); (c) determined whether at least one of the s 9 factors existed and was related to relevant service (s 9; s 10(1)); (d) applied the timing windows and specific evidentiary requirements in the subsets of s 9 that require individual association or exclusion of other aetiologies (for example s 9(5), s 9(10)); and (e) reconciled any overlap with other SoPs under s 11. Administrative or judicial review would focus on errors of law, failure to take into account relevant evidence, or unreasonable factual findings, but those avenues and standards are provided by VEA/MRCA administrative and judicial review mechanisms, not by the SoP itself.

No named cases in the SoP. Because the SoP names no cases and provides no litigation summary, the instrument offers no internal precedent or adjudicative gloss. Legal practitioners must therefore rely on external sources , administrative decisions, tribunal reports and court judgments , to see how the SoP has been interpreted in practice.

Advice for litigators and reviewers. Given the SoP’s precise medical thresholds and enumerated factors, any litigation that challenges a decision applying this SoP should be prepared to confront detailed medical evidence. Issues likely to arise include whether the claimant’s records meet the platelet count and bleeding/treatment criteria (s 7(2)), whether the timing requirements are met (six week windows in many clauses of s 9), whether the requisite individual evidence exists in clauses that demand sustained recovery on cessation or recurrence on re‑exposure (s 9(5), s 9(10), s 9(18), s 9(23)), and whether the factor is properly related to the person’s relevant service (s 10(1)). The SoP’s text provides a framework for those factual disputes, but not a litigation roadmap within its own pages.

Narrow clinical gate. The SoP’s definition of immune thrombocytopaenia is strictly clinical: an isolated thrombocytopaenia with a platelet count of less than 100 000 per microlitre plus either bleeding symptoms or a need for treatment (s 7(2)(a)). If a claimant's platelet counts never fell below that threshold, or if thrombocytopaenia occurred in the context of abnormal red or white blood cells or one of the excluded conditions, the SoP does not apply to support service connection for ITP (s 7(2)(b)). Practitioners should not assume any thrombocytopaenia qualifies.

Enumerated lists, not a free‑form test. Many of the qualifying exposures are confined to specified lists in Schedule 1 (for example specified list of drugs, vaccines, viral infections, bacterial/fungal infections, foods and lymphoproliferative/autoimmune disorders). If a claimant points to an exposure not on those lists, the SoP does not treat it as one of the "factors that must exist" (s 9). That does not preclude other evidence from being persuasive under the VEA/MRCA outside this SoP, but relying solely on this SoP for an unlisted exposure is a risky strategy.

Six‑week timing windows. For the majority of exposure factors that relate to clinical onset or clinical worsening, the SoP requires the exposure to have occurred "within the six weeks before" the relevant clinical event (s 9(1)-(4), s 9(14)-(17), s 9(22)). This is an exacting time window. Small discrepancies in medical records about symptom onset dates, vaccination dates, infection onset or drug initiation can be fatal to a claim that seeks to rely on these clauses. Practitioners should ensure timelines in clinical records are precise.

Individual‑level causal tests for some factors. Clauses s 9(5), s 9(10), s 9(18) and s 9(23) are not satisfied by mere population association. They require individual evidence: development within six weeks, absence prior to exposure, sustained recovery on cessation, exclusion of other aetiologies, and in some instances recurrence on re‑exposure or identification of specific platelet reactive antibodies. Those are demanding factual requirements. Absence of documentation showing recovery on cessation or absence of other causes means these clauses will not assist.

Onset versus worsening nuance. Sections 9(14)-9(26) are limited to material contribution to, or aggravation of, ITP where the ITP was "suffered or contracted before or during (but did not arise out of) the person's relevant service" (s 10(2)). That is a critical limitation: if the ITP arose out of relevant service, these clauses for worsening do not apply. Practitioners must carefully frame whether a claimant’s condition is an onset arising out of service or a pre‑existing condition worsened by service exposures.

For claimants and advisers , gather the right medical evidence. Start by confirming that the claimant’s condition meets the SoP’s clinical definition: an isolated thrombocytopaenia with a peripheral platelet count under 100 000 per microlitre plus bleeding symptoms or a documented need for treatment to increase platelets (s 7(2)(a)). Exclude conditions listed in s 7(2)(b) by obtaining laboratory results that rule out pseudothrombocytopaenia, pancytopaenia, qualitative platelet defects, abnormal red or white blood cells, thrombotic thrombocytopaenic purpura, Evan's syndrome, and other specified exclusions.

Document timing meticulously. For exposures that require an association within six weeks of clinical onset or worsening (the majority of s 9 clauses), obtain dated medical records, hospital notes, GP vaccination or drug administration records, laboratory dates, and contemporaneous clinical notes that show the dates of onset, diagnosis and any exposures. Timelines are often determinative.

Match the exposure to the specified lists. If relying on exposure to a drug, vaccine, infection, food/beverage or disorder listed in Schedule 1, specifically identify the item in the claimant’s records and link it to the relevant entry in Schedule 1 (eg align a documented influenza vaccination date with the specified list of vaccines in Schedule 1). For items subject to amendment (for example vaccines and viral infections amended by No. 58 of 2022), confirm which SoP version applies to the relevant date.

Satisfy individual‑level clauses where required. If relying on a clause that imposes individual causal tests (s 9(5), 9(10), 9(18), s 9(23)), collect evidence that shows: absence of ITP prior to the exposure; development of ITP within six weeks of exposure; sustained recovery on cessation of the drug or stopping exposure or treatment; exclusion of other aetiologies for thrombocytopaenia; and, where required, recurrence on re‑exposure or laboratory identification of platelet reactive antibodies. This will typically require pre‑exposure blood counts or clinical notes, serial platelet counts, treatment cessation records, and, where recidivism is alleged, evidence of re‑exposure and subsequent recurrence.

For death claims, connect ITP to a terminal event. If the claim relates to death from ITP, obtain the death certificate, clinical notes surrounding the terminal event, autopsy or coroner reports if available, and medical evidence that ITP contributed to the terminal event listed in Schedule 1 (for example pneumonia, respiratory failure, cardiac arrest) as required by s 7(3) and the Schedule's definition of "terminal event".