Statement of Principles concerning MELIOIDOSIS (Balance of Probabilities) (No. 56 of 2023) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986. Dated 24 April 2023. The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of: Professor Terence Campbell AM Chairperson Contents 1 Name 2 Commencement 3 Authority 4 Repeal 5 Application 6 Definitions 7 Kind of injury, disease or death to which this Statement of Principles relates 8 Basis for determining the factors 9 Factors that must exist 10 Relationship to service 11 Factors referring to an injury or disease covered by another Statement of Principles Schedule 1 - Dictionary 1 Definitions 1 Name This is the Statement of Principles concerning melioidosis (Balance of Probabilities) (No. 56 of 2023). 2 Commencement This instrument commences on 23 May 2023. 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning melioidosis No. 61 of 2014 (Federal Register of Legislation No. F2014L00934) made under subsection 196B(3) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 applies. 6 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 7 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about melioidosis and death from melioidosis. Meaning of melioidosis (2) For the purposes of this Statement of Principles, melioidosis means an illness caused by infection with the bacterium Burkholderia pseudomallei. Note: Melioidosis may present as an acute, chronic or latent infection. Clinical manifestations may be local or systemic, and include pulmonary infection, septicaemia, meningoencephalitis and chronic suppurative infection. (3) While melioidosis attracts ICD‑10‑AM codes A24.1, A24.2, A24.3 or A24.4, in applying this Statement of Principles the meaning of melioidosis is that given in subsection (2). (4) For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4. Death from melioidosis (5) For the purposes of this Statement of Principles, melioidosis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's melioidosis. Note: terminal event is defined in the Schedule 1 – Dictionary. 8 Basis for determining the factors On the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that melioidosis and death from melioidosis can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA. Note: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary. 9 Factors that must exist At least one of the following factors must exist before it can be said that, on the balance of probabilities, melioidosis or death from melioidosis is connected with the circumstances of a person's relevant service: (1) being exposed to Burkholderia pseudomallei before the clinical onset of melioidosis; Note: being exposed to Burkholderia pseudomallei is defined in the Schedule 1 – Dictionary. (2) being in an immunocompromised state as specified at the time of the clinical onset of melioidosis; Note: immunocompromised state as specified is defined in the Schedule 1 - Dictionary. (3) having a medical condition from the specified list of medical conditions at the time of the clinical onset of melioidosis; Note: specified list of medical conditions is defined in the Schedule 1 – Dictionary. (4) for males, having consumed at least 65 kilograms of alcohol within the 3 years before the clinical onset of melioidosis; Note: Alcohol is measured by the alcohol consumption calculations utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink. (5) for females, having consumed at least 44 kilograms of alcohol within the 3 years before the clinical onset of melioidosis; Note: Alcohol is measured by the alcohol consumption calculations utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink. (6) having alcohol use disorder at the time of the clinical onset of melioidosis; (7) inability to obtain appropriate clinical management for melioidosis. 10 Relationship to service (1) The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person. (2) The factor set out in subsection 9(7) applies only to material contribution to, or aggravation of, melioidosis where the person's melioidosis was suffered or contracted before or during (but did not arise out of) the person's relevant service. 11 Factors referring to an injury or disease covered by another Statement of Principles In this Statement of Principles: (1) if a factor referred to in section 9 applies in relation to a person; and (2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA; then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time. Schedule 1 - Dictionary Note: See Section 6 1 Definitions In this instrument: albuminuria means an albumin to creatinine ratio of at least 3 mg/mmol. being exposed to Burkholderia pseudomallei means: (a) consuming water or food contaminated with Burkholderia pseudomallei; (b) having direct contact of the skin or mucous membranes with: (i) a fluid contaminated with Burkholderia pseudomallei; (ii) blood, body fluid or tissue from an animal or person infected with Burkholderia pseudomallei; or (iii) water or soil contaminated with Burkholderia pseudomallei; (c) inhaling dust, water or an aerosol contaminated with Burkholderia pseudomallei; or (d) undergoing a medical procedure involving an object contaminated with Burkholderia pseudomallei. Note: direct contact is defined in Schedule 1 – Dictionary. chronic kidney disease means: (a) having a glomerular filtration rate of less than 60 ml/min/1.73 m2 for at least 3 months; (b) having albuminuria for at least 3 months; (c) having kidney damage, as evidenced by renal biopsy, imaging studies, urinary sediment abnormalities or other markers of abnormal renal function; or (d) having had a kidney transplant. Note: albuminuria is defined in the Schedule 1 - Dictionary. chronic renal failure means: (a) having a glomerular filtration rate of less than 15 ml/min/1.73 m2 for a period of at least 3 months; (b) a need for renal replacement therapy (dialysis or transplantation) for treatment of complications of decreased glomerular filtration rate which would otherwise increase the risk of morbidity and mortality; or (c) undergoing chronic dialysis. direct contact means physical contact where no protective or impermeable barrier is used. immunocompromised state as specified means a condition of substantially lowered immune function, such as would occur in the following conditions or circumstances: (a) having a haematological or solid organ malignancy; (b) having chronic renal failure; (c) having severe malnutrition; (d) taking an immunosuppressive drug; or (e) undergoing solid organ, stem cell or bone marrow transplantation. Note: chronic renal failure and immunosuppressive drug are defined in the Schedule 1 - Dictionary. immunosuppressive drug means a drug or an agent which results in substantial suppression of immune responses. Note: Examples of an immunosuppressive drug include: (a) chemotherapeutic agents used for the treatment of cancer; (b) corticosteroids, other than inhaled or topical corticosteroids; (c) drugs used to prevent transplant rejection; and (d) tumour necrosis factor-α inhibitors. melioidosis—see subsection 7(2). MRCA means the Military Rehabilitation and Compensation Act 2004. relevant service means: (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA. Note: MRCA and VEA are defined in the Schedule 1 - Dictionary. specified list of medical conditions means: (a) chronic kidney disease; (b) chronic lung disease including bronchiectasis and chronic obstructive pulmonary disease; (c) cirrhosis of the liver; (d) diabetes mellitus; (e) heart failure; or (f) rheumatic heart disease. Note: chronic kidney disease is defined in the Schedule 1 – Dictionary. terminal event means the proximate or ultimate cause of death and includes the following: (a) pneumonia; (b) respiratory failure; (c) cardiac arrest; (d) circulatory failure; or (e) cessation of brain function. VEA means the Veterans' Entitlements Act 1986.