Statement of Principles concerning HEPATITIS B (Balance of Probabilities) (No. 14 of 2017) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986. Dated 20 December 2016 The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of: Professor Nicholas Saunders AO Chairperson Contents 1 Name 2 Commencement 3 Authority 4 Revocation 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 hepatitis B (Balance of Probabilities) (No. 14 of 2017). 2 Commencement This instrument commences on 23 January 2017. 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 Revocation The Statement of Principles concerning hepatitis B No. 53 of 2008 made under subsection 196B(3) of the VEA is revoked. 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 hepatitis B and death from hepatitis B. Meaning of hepatitis B (2) For the purposes of this Statement of Principles, hepatitis B means infection with the hepatitis B virus resulting in: (a) an acute, symptomatic, clinical illness characterised by inflammation of the liver and commonly accompanied by fever, tiredness, loss of appetite, nausea, vomiting, abdominal discomfort and jaundice; or (b) a chronic infection of at least six months duration and which may involve both inflammation of the liver and the development of fibrosis in the longer term. Both acute and chronic infection must be confirmed by laboratory testing for hepatitis B serological or nucleic acid markers, or both. (3) While hepatitis B attracts ICD‑10‑AM code B16, B18.0 or B18.1, in applying this Statement of Principles the meaning of hepatitis B 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), Ninth Edition, effective date of 1 July 2015, copyrighted by the Independent Hospital Pricing Authority, ISBN 978‑1‑76007‑020‑5. Death from hepatitis B (5) For the purposes of this Statement of Principles, hepatitis B, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's hepatitis B. 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 hepatitis B and death from hepatitis B can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA. Note: relevant service is 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, hepatitis B or death from hepatitis B is connected with the circumstances of a person's relevant service: (1) being exposed to the hepatitis B virus at least 30 days before the clinical onset of hepatitis B; Note: being exposed to the hepatitis B virus is defined in the Schedule 1 - Dictionary. (2) living or working for a continuous period of at least 180 days in an area which, at that time, has a population prevalence of hepatitis B chronic infection of at least 2% before the clinical onset of hepatitis B; (3) for chronic infection only, (a) being treated with an immunosuppressive drug in the five years before the clinical worsening of hepatitis B; Note: being treated with an immunosuppressive drug is defined in the Schedule 1 - Dictionary. (b) being infected with human immunodeficiency virus before the clinical worsening of hepatitis B; (c) undergoing solid organ, stem cell or bone marrow transplantation before the clinical worsening of hepatitis B; (d) undergoing a course of therapeutic radiation for cancer, where the liver was in the field of radiation, before the clinical worsening of hepatitis B; (e) for females only, consuming a total of at least 75 kilograms of alcohol within the ten years before the clinical worsening of hepatitis B; Note: alcohol is defined in the Schedule 1 - Dictionary. (f) for males only, consuming a total of at least 150 kilograms of alcohol within the ten years before the clinical worsening of hepatitis B; Note: alcohol is defined in the Schedule 1 - Dictionary. (g) undergoing surgical resection of hepatocellular carcinoma in the two years before the clinical worsening of hepatitis B; (h) being within the six month postpartum period at the time of the clinical worsening of hepatitis B; (i) having severe hepatic iron overload at the time of the clinical worsening of hepatitis B; or Note: iron overload is defined in the Schedule 1 - Dictionary. (j) having evidence of chronic infection with schistosomiasis involving the liver before the clinical worsening of hepatitis B; (4) being infected with the hepatitis A, hepatitis C, hepatitis D or hepatitis E virus before the clinical worsening of hepatitis B; (5) inability to obtain appropriate clinical management for hepatitis B. 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 factors set out in subsections 9(3)(a) to 9(5) apply only to material contribution to, or aggravation of, hepatitis B where the person's hepatitis B 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: alcohol is measured by the alcohol consumption calculations utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink. being exposed to the hepatitis B virus means having percutaneous (intravenous, intramuscular, subcutaneous or intradermal) or permucosal exposure to a body substance as specified which is derived from a person infected with the hepatitis B virus. Note: body substance as specified is also defined in the Schedule 1 - Dictionary. being treated with an immunosuppressive drug means being treated with a drug or an agent which results in significant suppression of immune responses. This definition includes corticosteroids other than inhaled or topical corticosteroids, drugs used to prevent transplant rejection, tumour necrosis factor-α inhibitors and chemotherapeutic agents used for the treatment of cancer. body substance as specified means: (a) blood, blood products or any body fluid containing blood; or (b) saliva; or (c) semen or vaginal secretions; or (d) serum-derived fluids including serous discharge, or amniotic, cerebrospinal, pericardial, peritoneal, pleural or synovial fluids; or (e) tissues or organs. hepatitis B—see subsection 7(2). iron overload means an accumulation of excess iron in tissues and organs which has been confirmed by elevated ferritin or transferrin saturation levels. Causes include haemochromatosis and blood transfusions. 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 also 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.