Statement of Principles concerning Guillain-Barre syndrome (Balance of Probabilities) (No. 24 of 2018)

Guillain-Barre syndrome: Defined in subsection 7(2) as an acute or subacute immune-mediated disorder of the peripheral nervous system producing symptoms of impaired motor, sensory or autonomic functioning. It includes acute inflammatory demyelinating polyneuropathy, acute motor axonal neuropathy, acute motor sensory axonal neuropathy, Miller Fisher syndrome, and other variant forms. It expressly excludes chronic inflammatory demyelinating polyneuropathy. The definition is not limited to the ICD-10-AM code G61.0, though that code is noted for administrative reference. The clinical diagnosis is normally confirmed by electrodiagnostic testing or elevated protein in cerebrospinal fluid without elevated white cell count (cytoalbuminologic dissociation). Death from GBS includes death from a terminal event contributed to by GBS; terminal event is defined in the Dictionary to include pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

Relevant service: Defined in the Dictionary to mean: eligible war service (other than operational service) under the VEA; defence service (other than hazardous service and British nuclear test defence service) under the VEA; or peacetime service under the MRCA. This is critical: it excludes operational service and hazardous service, which fall under a different SoP using the reasonable hypothesis standard. The definition thus determines which claimants can rely on this instrument.

Balance of probabilities: The standard of proof mandated by the RMA’s view in section 8: the RMA is satisfied that, on the sound medical-scientific evidence available, it is more probable than not that GBS and death from GBS can be related to relevant service. This is a lower threshold than “reasonable hypothesis” (which does not require probability) but higher than simply “possible.” The factors in section 9 are each individually sufficient, but at least one must exist.

Factors: Section 9 lists nine factors. Each factor is an epidemiological or clinical association that the RMA considers sufficient to connect GBS to service on the balance of probabilities. The factors include: specified infections (e.g. Campylobacter jejuni, SARS-CoV-2, influenza virus) within two months before clinical onset; HIV infection at onset; herpes zoster within two months; symptomatic gastrointestinal or respiratory tract infection within two months; receiving a specified vaccine (adenovirus vector COVID-19, influenza, or nerve tissue derived rabies vaccine) within two months; having a malignant neoplasm (excluding non-melanotic skin cancer) at onset; solid organ or stem cell transplant before onset; treatment with a tumour necrosis factor-α inhibitor within two months; or inability to obtain appropriate clinical management for GBS.

Specified list of infections and vaccines: Defined in the Dictionary. The infection list includes 14 pathogens (13 original plus SARS-CoV-2 added in 2021). The vaccine list was substituted in 2022 to include only three types: adenovirus vector COVID-19 vaccine, influenza vaccine, and nerve tissue derived rabies vaccine. Notably, mRNA COVID-19 vaccines (e.g. Pfizer, Moderna) are not included. The Dictionary provides examples of adenovirus vector COVID-19 vaccines (Johnson & Johnson, AstraZeneca, Sputnik V, Convidecia). This is a deliberate narrowing based on the RMA’s assessment of available evidence.

Relationship to service: Section 10 requires that the factor must be related to the relevant service. The factor must have occurred during or be attributable to service - not merely temporally coincident. For factor 9(9) (inability to obtain appropriate clinical management), it applies only to material contribution to or aggravation of GBS where the GBS was suffered or contracted before or during (but did not arise out of) relevant service. This prevents claimants from using post-service failure of clinical management as a basis for initial liability.

Cross-references to other SoPs: Section 11 provides that if a factor refers to an injury or disease for which another SoP has been determined, the factors in that other SoP apply. For example, factor 9(6) refers to a malignant neoplasm - that is a separate condition governed by its own SoP, so the claimant must also satisfy the malignant neoplasm SoP to establish that the malignant neoplasm is service-related.

The primary affected persons are veterans and members of the Australian Defence Force who claim compensation for GBS under the VEA or MRCA. Specifically, those with eligible war service (non-operational), defence service (non-hazardous, non-British nuclear test), or peacetime service. This excludes veterans with operational service (e.g. combat service) - they would use a separate instrument under s 196B(2) using the reasonable hypothesis standard, though the factors are usually identical. The instrument also affects dependants claiming death benefits where GBS contributed to death.

Decision-makers directly affected include the Repatriation Commission (VEA) and the Military Rehabilitation and Compensation Commission (MRCA). They must apply this instrument as binding authority when assessing claims. They cannot substitute their own medical opinion on causation if the factors are not met, nor can they accept a claim on other grounds not listed - unless the claimant brings a successful challenge to the instrument itself.

Health professionals providing evidence (treating doctors, neurologists, infectious disease specialists) are indirectly affected because their reports must address the specified factors, particularly the timing of infections or vaccinations relative to GBS onset. The two-month window is critical, and evidence of acquisition of an infection during service is required.

Vaccine manufacturers are indirectly affected: the inclusion of adenovirus vector COVID-19 vaccines means that a service member who receives such a vaccine (e.g. AstraZeneca) and develops GBS within two months may have a compensable claim if the vaccination occurred during service (e.g. mandatory military vaccination programs). This creates a contingent liability for the Commonwealth (which self-insures) and may influence procurement decisions. The exclusion of mRNA vaccines from the list may reflect a judgment about weaker evidence, but it also means those vaccinated with Pfizer or Moderna cannot rely on this factor - they would need another factor.

The RMA is the body that determines these instruments. It relies on “sound medical-scientific evidence available” - but the instrument becomes law and binds decision-makers. The RMA’s selection of factors determines which scientific associations become legally operative.

Taxpayers bear the ultimate cost: successful claims result in compensation paid from consolidated revenue. The more inclusive the factor list, the higher the potential claim volume. The 2021 addition of SARS-CoV-2 and the 2022 amendment to vaccines reflect evolving pandemic evidence and policy judgment.

Claimants’ rights: The primary right is to have a claim for GBS assessed in accordance with this instrument. If a claimant satisfies at least one factor in section 9 and establishes under section 10 that the factor is related to relevant service, then the decision-maker must accept that the GBS is connected with service on the balance of probabilities. This right is procedural but dispositive: the instrument removes any discretion on causation. Claimants have the right to seek review of adverse decisions through the Veterans’ Review Board, the Administrative Appeals Tribunal, and ultimately the Federal Court.

Decision-makers’ duties: The Repatriation Commission and the Military Rehabilitation and Compensation Commission must apply this instrument. They are bound by section 120B of the VEA and section 339 of the MRCA, which require them to determine claims in accordance with the relevant SoP. They must not adopt a different causation standard. Their duty is to determine whether the claimed factor is made out on the evidence and whether it is related to service. Where the claimant relies on a malignant neoplasm (factor 9(6)), the decision-maker must also apply the SoP for that neoplasm (section 11 cross-reference).

No duty to investigate: The instrument imposes no duty on decision-makers to seek out evidence of factors not raised by the claimant. However, practical administration often involves obtaining medical records to check for infections or vaccinations. The burden of proof lies on the claimant to show the factor exists, though the standard is balance of probabilities.

Interaction with medical evidence: The definition of GBS in section 7(2) includes diagnostic criteria; a claimant must first establish that they have GBS as defined, not merely symptoms. The notes indicate that electrodiagnostic testing or elevated CSF protein without pleocytosis is typical. A doctor who misdiagnoses chronic inflammatory demyelinating polyneuropathy (CIDP) as GBS may be excluded by the definition.

Rights of vaccine recipients: A veteran who received an adenovirus vector COVID-19 vaccine and developed GBS within two months has a presumptive path to compensation if the vaccination was performed in connection with service (e.g. a mandatory Defence vaccination). The instrument does not require proof that the vaccine caused GBS - only that the vaccination occurred within two months before onset. This is a generous causation standard, but it is balanced by the narrow list of vaccines.

No individual rights against the RMA: The instrument is a legislative instrument; there is no right to challenge the RMA’s factor determination in a claim process except by judicial review of the instrument itself, which is difficult.

This instrument does not contain any penalty provisions. It is an evidentiary and administrative instrument, not a penal law. There are no criminal offences, fines, or imprisonment for non-compliance. Enforcement mechanisms operate through the administrative law framework: if a decision-maker fails to apply the instrument correctly, the claimant can seek merits review at the Veterans’ Review Board under Part XI of the VEA, or the AAT under the MRCA. If the instrument itself is flawed (e.g. made without proper evidence), a person aggrieved may seek judicial review under the Administrative Decisions (Judicial Review) Act 1977 or the Constitution, arguing jurisdictional error or unreasonableness.

The real penalty for misapplication falls on the claimant: an incorrect denial of benefits means loss of compensation, medical treatment, and rehabilitation. Conversely, an incorrect grant of benefits imposes a cost on the public purse and distorts resource allocation. The instrument is designed to minimise arbitrary decision-making but it does so at the cost of rigidity: even if a medical expert believes a factor not listed caused GBS, the claim must fail unless the claimant can fit within the listed factors. This is a legislative choice that prioritises certainty over individualised justice.

Enforcement of the instrument’s application is through supervised self-regulation by the Department of Veterans’ Affairs and the Military Rehabilitation and Compensation Commission. There is no independent inspectorate. However, decisions are subject to internal review, external merits review by the VRB/AAT, and judicial review. The instrument itself is subject to oversight by the Senate Standing Committee for the Scrutiny of Delegated Legislation, which can disallow it (though disallowance is rare for SoPs). The RMA must also review and revoke or remake SoPs periodically under the VEA, ensuring they remain current.

Potential compliance burden for claimants is high: they must gather medical records to prove the absence of specified infections within exactly two months before onset. If the exact date of onset is uncertain, the two-month window may be impossible to establish, leading to denial even if a factor existed. The instrument imposes no penalty for late claims, but the evidentiary difficulty is a practical barrier.

The instrument is made under the VEA, which establishes the overarching compensation scheme. It is given binding force by section 120B of the VEA (for claims where balance of probabilities applies) and section 339 of the MRCA. It does not replace the VEA’s substantive provisions on rates of pension, medical treatment, or other benefits; it only addresses the preliminary issue of causal connection. A claimant must still satisfy the usual requirements for incapacity, death, or medical treatment under the VEA or MRCA.

Interaction with other Statements of Principles: Section 11 of the instrument provides that if a factor refers to an injury or disease for which another SoP exists (e.g. malignant neoplasm), the factors in that other SoP apply. This means a claim relying on factor 9(6) (malignant neoplasm at time of GBS onset) also requires the claimant to prove that the malignant neoplasm is related to service under its own SoP. This cross-reference avoids duplication but adds complexity: the claim now involves two SoPs.

Interaction with the Military Rehabilitation and Compensation Act 2004: For peacetime service, the MRCA’s section 339 requires the Military Rehabilitation and Compensation Commission to apply the SoP. However, the MRCA has its own definition of “peacetime service” and “disease”; this definition is incorporated by the Dictionary’s definition of “relevant service.” The instrument does not override any provisions of the MRCA itself; it merely informs the causation decision.

Interaction with the Safety, Rehabilitation and Compensation Act 1988 (the Comcare scheme) is limited. The instrument applies only to veterans and defence members, not to Commonwealth employees generally. However, if a defence member also has coverage under the SRC Act for non-service conditions, the instrument has no application to those claims.

Interaction with tort law: The instrument does not affect any right to sue a third party (e.g. a vaccine manufacturer) for negligence or breach of duty. Compensation paid under the VEA is not a bar to a common law claim, though the Commonwealth may have a right of recovery in some circumstances. The instrument’s list of vaccines may be used as evidence in a tort case, but it is not binding on civil courts.

Interaction with state workers’ compensation: Not directly relevant; this instrument is exclusively federal.

Effect on private contract and choice: The instrument creates a compliance burden on the Defence Force’s vaccination programs. If a particular vaccine (e.g. adenovirus vector COVID-19) is included in the factor list, that may affect the vaccine’s cost-benefit calculus for Defence, potentially increasing demand for alternative vaccines not on the list (such as mRNA vaccines). This is a form of regulatory influence on private choices within the military system.

The instrument was originally made as the Statement of Principles concerning Guillain-Barre syndrome (Balance of Probabilities) (No. 24 of 2018) on 5 March 2018 and commenced on 2 April 2018.

First amendment: Amendment Statement of Principles concerning Guillain-Barre syndrome (Balance of Probabilities) (No. 58 of 2021) registered 23 April 2021, commenced 24 May 2021. This amended subsection 9(1) and the definition of “specified list of infections” in the Dictionary to add severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a factor. The RMA’s stated basis was the emerging evidence linking COVID-19 infection to GBS. This is a significant expansion: it opened the door to compensation claims for pandemic-related GBS.

Second amendment: Amendment Statement of Principles concerning Guillain-Barre syndrome (Balance of Probabilities) (No. 75 of 2022) registered 30 June 2022, commenced 25 July 2022. This substituted subsection 9(5) (the vaccine factor) and replaced the definition of “specified list of vaccines” with a new list. The original 2018 vaccine list had included “any vaccine available in Australia” - a broad catch-all. The 2022 amendment narrowed it to three specific vaccine types: adenovirus vector COVID-19 vaccine, influenza vaccine, and nerve tissue derived rabies vaccine. This reflects the RMA’s reassessment of evidence, likely concluding that only these vaccines have sufficient epidemiological evidence of an association with GBS on balance of probabilities. Notably, the amendment removed other vaccines (including hepatitis B, HPV, meningococcal, etc.) that were previously covered. The practical effect is that claims based on most routine military vaccinations (beyond influenza and COVID-19 vector vaccines) will now fail under this factor.

No other amendments have been made to date (up to the compilation date of 25 July 2022). The instrument has been formally reviewed and re-made periodically; the compilation shows only these two amendments. Endnote 3 lists the three instruments as the only amendments. No application, saving or transitional provisions were included for either amendment, meaning the amended instrument applies to claims made on or after the commencement date, but possibly also to pending claims under transitional rules not shown.

The amendment history illustrates the RMA’s reactive approach to emerging medical evidence, particularly the COVID-19 pandemic. The rapid inclusion of SARS-CoV-2 infection (2021) and the later narrowing of vaccine factors (2022) suggest a process of scientific calibration. However, the cost of amendment is uncertainty: claimants and decision-makers must ensure they apply the correct version of the instrument as at the claim date.

The source instrument itself contains no reference to any litigation. There are no cases cited in the text, endnotes, or schedule. However, as a matter of public record, Statements of Principles have been the subject of judicial review in the Federal Court and the Administrative Appeals Tribunal, though the GBS-specific instrument appears not to have generated significant case law yet.

Potential grounds for challenge include: whether the RCA made the instrument based on “sound medical-scientific evidence” (required by s 196B); whether the instrument fails to take into account relevant considerations; or whether it is irrational in its omission of certain factors. For example, a claimant denied compensation because they received an mRNA COVID-19 vaccine (not on the list) might argue that the evidence linking mRNA vaccines to GBS is as strong as for adenovirus vector vaccines, and that the distinction is arbitrary. Such a challenge would require expert evidence and a review of the RMA’s decision-making process. The courts have generally afforded the RMA a wide margin of appreciation because it is a specialist body. In Repatriation Commission v Smith (2006) and other cases, the Federal Court has held that the RMA’s “sound medical-scientific evidence” standard is not amenable to stringent judicial review; the instrument stands unless it is manifestly unreasonable.

Another potential challenge is the temporal restriction: the two-month window for infections and vaccines. A claimant with a longer latency period might argue the RMA should have adopted a three-month window. However, courts are unlikely to second-guess the medical judgment of the RMA on such matters. The more plausible litigation arises from incorrect application of the instrument by decision-makers, rather than the instrument itself. For example, whether a particular gastrointestinal infection was truly “symptomatic” or whether an infection was “acquired” during service.

The absence of listed litigation in the instrument is not surprising: it is a legislative instrument, not a court judgment. Practitioners should search the Australasian Legal Information Institute (AustLII) for cases citing the GBS SoP. Given the instrument’s limited scope (only balance-of-probabilities claims) and the relatively low incidence of GBS, the volume of litigation is likely small. The addition of SARS-CoV-2 in 2021 may generate more claims and potential disputes over whether the infection was service-related (e.g. through overseas deployment or close quarters).

1. Narrow definition of “relevant service” : The instrument applies only to eligible war service (non-operational), defence service (non-hazardous), and peacetime service. If a veteran has operational service (e.g. service in a warlike operation), they cannot use this instrument; they must use the reasonable hypothesis SoP, even if the factors are identical. A misapplication could see a claim denied under the wrong instrument.

2. Two-month window is strict: All infection and vaccine factors require occurrence within two months before clinical onset. If the onset date is vague (e.g. “some time in March”), the claimant may fail to prove the factor fell within the window. The instrument does not allow a flexible interpretation. Decision-makers should obtain precise dating of onset symptoms.

3. Specified vaccine list is very limited: As amended in 2022, only three vaccine types are covered. Most routine vaccines (e.g. hepatitis B, typhoid, yellow fever, HPV) are not included. A service member who receives a routine military vaccination and develops GBS may have no claim under this factor unless another factor applies. The previous catch-all was removed, so many pre-2022 claims may have succeeded, but post-2022 claims cannot rely on other vaccines.

4. Malignant neoplasm excludes non-melanotic skin cancer: Factor 9(6) only includes malignant neoplasms other than non-melanotic malignant neoplasm of the skin. So a keratinocyte carcinoma (basal cell carcinoma, squamous cell carcinoma) does not qualify. Only melanoma or internal malignancies count.

5. HIV factor requires infection at time of clinical onset: Factor 9(2) does not require a recent acquisition; the person must be infected with HIV at the onset. But establishing HIV status at that exact time may be difficult. Note that HIV is not in the specified list of infections; it is a separate standalone factor.

6. Inability to obtain appropriate clinical management factor is limited to aggravation: Factor 9(9) applies only to material contribution to or aggravation of GBS where the GBS was suffered or contracted before or during (but did not arise out of) relevant service. This is essentially a worsening factor for pre-existing GBS, not a way to establish initial liability. Claimants cannot use it to say “my GBS was caused by service because I couldn’t get treatment.” The wording is restrictive.

7. Definition of GBS excludes CIDP: Chronic inflammatory demyelinating polyneuropathy is expressly excluded. A misdiagnosis of CIDP as GBS can lead to a flawed claim. Decision-makers should require diagnostic confirmation per the definition (electrodiagnostic testing or CSF analysis). A clinical diagnosis without such testing might still be accepted if consistent, but the instrument notes the normal confirmatory methods.

8. Terminal event definition: For death claims, the GBS must have contributed to a terminal event (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function). If the death is from another cause (e.g. suicide) not related to GBS, the claim fails even if GBS was present.

9. Factor must be related to service: The instrument lists factors that, if present, allow connection, but section 10 requires that the factor itself be related to service. For example, a Campylobacter infection acquired from a meal at the local pub while on leave is not service-related, even if it precedes GBS. The infection must be contracted during or as a result of service (e.g. from eating in a military mess overseas). This is often overlooked.

10. Cross-reference to other SoPs: Claimants using factor 9(6) (malignant neoplasm) must also satisfy the SoP for that neoplasm. If the neoplasm is not itself accepted as service-related, the GBS claim fails. This creates a cascade of requirements.

For claimants and their representatives: The first step is to confirm that the claimant’s service falls under “relevant service” as defined - that is, eligible war service (non-operational), defence service (non-hazardous), or peacetime service. If the service is operational, seek the reasonable hypothesis SoP instead. Ensure that the diagnosis of GBS meets the definition in section 7(2), including exclusion of CIDP. Obtain medical records confirming the diagnosis with electrodiagnostic or CSF findings if possible.

Identify which of the nine factors in section 9 applies. Gather evidence for the chosen factor(s) with particular attention to timing. For infections (factor 9(1)), the infection must be from the specified list and acquired within two months before clinical onset. Acquire laboratory confirmation (e.g. positive serology, PCR) and link it to service (e.g. infection during deployment). For symptomatic gastrointestinal or respiratory infection (factor 9(4)), the claimant need not prove the specific pathogen but must show a symptomatic infection (fever, diarrhoea, cough) within two months. For vaccination (factor 9(5)), verify that the vaccine is from the specified list (adenovirus vector COVID-19, influenza, nerve tissue derived rabies). Obtain vaccination dates and records. For malignant neoplasm (factor 9(6)), ensure it is not non-melanotic skin cancer and obtain biopsy evidence. For transplant (factor 9(7)) or TNF-α inhibitor (factor 9(8)), obtain relevant medical records.

Establish that the factor is related to service. Show that the infection was contracted during service (e.g. during a posted location), or that the vaccine was administered as part of a military program, or that the malignant neoplasm is recognised as service-related under its own SoP. For HIV (factor 9(2)), the infection must be present at onset but need not be acquired during service? Section 10 requires the factor to be related to service, so HIV itself must be linked to service (e.g. via blood transfusion during service). That is often difficult.

If no factor applies, consider whether there is evidence for aggravation under factor 9(9) - but only if GBS existed before service and service-related lack of clinical management worsened it. This is a narrow path.

For decision-makers: Verify the instrument version effective at the date of claim. The compilation date is 25 July 2022; later amendments may exist. Confirm that the claimant’s service type matches the definition of relevant service. Accept the diagnosis if it fits section 7(2); if there is doubt, request neurological evidence. Apply each factor strictly; do not accept arguments based on factors omitted from the list. For the vaccine factor, the onus is on the claimant to prove the specific vaccine type; the examples in the note are illustrative, but the vaccine must fall within the defined category. For infection factors, require objective evidence of infection (not mere suspicion). Enforce the two-month window; if onset is unclear, the claim may fail.

For health professionals: When assessing a veteran with GBS, document the date of first symptoms precisely. Consider the list of infections and vaccines relevant to service. If the patient has had a recent vaccine, record the brand and type. If the patient has had a recent infection, attempt to identify the pathogen (especially Campylobacter, SARS-CoV-2, influenza). This documentation will be crucial for any compensation claim.

Compliance burden: The instrument does not impose reporting or auditing requirements. It is a claimant-driven process. The main cost is in gathering evidence that may be several years old. The two-month window can be impossible to prove if records are missing. Claimants may need to rely on other factors if one is unprovable. Practitioners should list all potentially applicable factors in the claim to maximise chance. The instrument itself is straightforward; the difficulty lies in the factual proof.