Statement of Principles concerning IgA nephropathy (Reasonable Hypothesis) (No. 63 of 2021) (Cth)

Statement of Principles concerning IgA NEPHROPATHY (Reasonable Hypothesis) (No. 63 of 2021) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated 21 May 2021

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 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 IgA nephropathy (Reasonable Hypothesis) (No. 63 of 2021). 2 Commencement This instrument commences on 21 June 2021. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning mesangial IgA glomerulonephritis No. 52 of 2012 (Federal Register of Legislation No. F2012L01792) made under subsection 196B(2) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004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 IgA nephropathy and death from IgA nephropathy. Meaning of IgA nephropathy (2) For the purposes of this Statement of Principles, IgA nephropathy means: (a) a disease of the kidneys characterised by deposition of immunoglobulin A in the renal mesangium demonstrated by renal biopsy and which results in haematuria or proteinuria or renal dysfunction; and (b) excludes IgA vasculitis (Henoch-Schönlein purpura). Note: IgA nephropathy is also known as mesangial IgA glomerulonephritis or IgA glomerulonephritis. (3) While IgA nephropathy attracts ICD‑10‑AM code N02.1, N02.2, N02.2.1, N02.3, N02.5 or N02.8, in applying this Statement of Principles the meaning of IgA nephropathy 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 IgA nephropathy (5) For the purposes of this Statement of Principles, IgA nephropathy, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's IgA nephropathy. Note: terminal event is defined in the Schedule 1 - Dictionary. 8 Basis for determining the factors The Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that IgA nephropathy and death from IgA nephropathy can be related to relevant service rendered by veterans, members of Peacekeeping Forces, 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 as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting IgA nephropathy or death from IgA nephropathy with the circumstances of a person's relevant service: (1) having cirrhosis of the liver or chronic liver disease at the time of the clinical onset of IgA nephropathy; Note: chronic liver disease is defined in the Schedule 1 - Dictionary. (2) having an autoimmune disease from the specified list of autoimmune diseases at the time of the clinical onset of IgA nephropathy; Note: specified list of autoimmune diseases is defined in the Schedule 1 - Dictionary. (3) having a malignant neoplasm at the time of the clinical onset of IgA nephropathy; (4) having an infection from the specified list of infections within the 30 days before the clinical onset of IgA nephropathy; Note: specified list of infections is defined in the Schedule 1 - Dictionary. (5) taking a drug which is associated in the individual with the clinical onset of IgA nephropathy during drug therapy and either: (a) the improvement of IgA nephropathy within 3 months of discontinuing or tapering drug therapy; or (b) the redevelopment of IgA nephropathy on rechallenge with the same drug; where taking the drug continued for at least the 7 days before the clinical onset of IgA nephropathy; (6) taking a biologic agent for the treatment of cancer or autoimmune disease for at least the 7 days before the clinical onset of IgA nephropathy; Note: biologic agent is defined in the Schedule 1 - Dictionary. (7) undergoing kidney transplantation before the clinical onset of IgA nephropathy; (8) having cirrhosis of the liver or chronic liver disease at the time of the clinical worsening of IgA nephropathy; Note: chronic liver disease is defined in the Schedule 1 - Dictionary. (9) having an autoimmune disease from the specified list of autoimmune diseases at the time of the clinical worsening of IgA nephropathy; Note: specified list of autoimmune diseases is defined in the Schedule 1 - Dictionary. (10) having a malignant neoplasm at the time of the clinical worsening of IgA nephropathy; (11) having an infection from the specified list of infections within the 30 days before the clinical worsening of IgA nephropathy; Note: specified list of infections is defined in the Schedule 1 - Dictionary. (12) taking a drug which is associated in the individual with the clinical worsening of IgA nephropathy during drug therapy and either: (a) the improvement of IgA nephropathy within 3 months of discontinuing or tapering drug therapy; or (b) the clinical worsening of IgA nephropathy on rechallenge with the same drug; and where taking the drug continued for at least the 7 days before the clinical worsening of IgA nephropathy; (13) taking a biologic agent for the treatment of cancer or autoimmune disease for at least the 7 days before the clinical worsening of IgA nephropathy; Note: biologic agent is defined in the Schedule 1 - Dictionary. (14) undergoing kidney transplantation before the clinical worsening of IgA nephropathy; (15) being overweight or obese for at least the 5 years before the clinical worsening of IgA nephropathy; Note: being overweight or obese is defined in the Schedule 1 - Dictionary. (16) having smoked at least 5 pack-years of tobacco products in the 10 years before the clinical worsening of IgA nephropathy; Note: one pack-year is defined in the Schedule 1 - Dictionary. (17) inhaling, ingesting or having cutaneous contact with an organic solvent in an unventilated and confined space: (a) for an average of at least 2 hours per week; and (b) for at least 1 year within the 5 years before the clinical worsening of IgA nephropathy; Note: organic solvent is defined in the Schedule 1 - Dictionary. (18) inability to obtain appropriate clinical management for IgA nephropathy. 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(8) to 9(18) apply only to material contribution to, or aggravation of, IgA nephropathy where the person's IgA nephropathy 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(2) 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.