Statement of Principles concerning steatohepatitis (Balance of Probabilities) (No. 87 of 2022) (Cth)

Statement of Principles concerning STEATOHEPATITIS (Balance of Probabilities) (No. 87 of 2022) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.

Dated 23 August 2022.

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 Schedules 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 Schedule 2 - Drugs 1 Specified drugs

1 Name This is the Statement of Principles concerning steatohepatitis (Balance of Probabilities) (No. 87 of 2022). 2 Commencement This instrument commences on 19 September 2022. 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning steatohepatitis No. 80 of 2013 (Federal Register of Legislation No. F2013L01900) made under subsection 196B(3) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004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 Schedules Any item in a Schedule to this Instrument has effect according to its terms. 7 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about steatohepatitis and death from steatohepatitis. Meaning of steatohepatitis (2) For the purposes of this Statement of Principles, steatohepatitis: (a) means the presence of fatty change and inflammation of the liver with hepatocyte injury, with or without fibrosis; and (b) includes alcoholic steatohepatitis and non-alcoholic steatohepatitis; and (c) excludes: (i) alpha-1 antitrypsin deficiency; (ii) biliary obstruction; (iii) haemochromatosis; and (iv) Wilson's disease. Death from steatohepatitis (3) For the purposes of this Statement of Principles, steatohepatitis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's steatohepatitis. 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 steatohepatitis and death from steatohepatitis 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, steatohepatitis or death from steatohepatitis is connected with the circumstances of a person's relevant service: (1) having diabetes mellitus at the time of the clinical onset of steatohepatitis; (2) being obese at the time of the clinical onset of steatohepatitis; Note: being obese is defined in the Schedule 1 – Dictionary. (3) having rapid weight loss causing protein-calorie malnutrition within the 18 months before the clinical onset of steatohepatitis; Note: rapid weight loss is defined in the Schedule 1 – Dictionary. (4) undergoing jejunoileal bypass surgery before the clinical onset of steatohepatitis; (5) receiving total parenteral nutrition for at least 6 months within the 1 year before the clinical onset of steatohepatitis; Note: total parenteral nutrition is defined in the Schedule 1 – Dictionary. (6) having dyslipidaemia at the time of the clinical onset of steatohepatitis; Note: dyslipidaemia is defined in the Schedule 1 – Dictionary. (7) for males, consuming at least 75 kilograms of alcohol within any 5 year period before the clinical onset of steatohepatitis; Note: Alcohol consumption is calculated utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink. (8) for females, consuming at least 40 kilograms of alcohol within any 5 year period before the clinical onset of steatohepatitis; Note: Alcohol consumption is calculated utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink. (9) taking irinotecan for at least the 30 days before the clinical onset of steatohepatitis; (10) taking a drug specified in the Schedule 2 - Drugs of this Instrument, that cannot be ceased or substituted, for at least the 30 days before the clinical onset of steatohepatitis; (11) taking a drug that cannot be ceased or substituted and which is associated in the individual with: (a) the development of steatohepatitis within 30 days of first taking the drug; and (b) the redevelopment of steatohepatitis on rechallenge with the same drug; (12) inability to obtain appropriate clinical management for steatohepatitis. 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(12) applies only to material contribution to, or aggravation of, steatohepatitis where the person's steatohepatitis 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.