Statement of Principles concerning immune thrombocytopaenia (Reasonable Hypothesis) (No. 63 of 2017) made under subsection 196B(2) of the Veterans' Entitlements Act 1986 Compilation No. 1 Compilation date: 30 May 2022 Includes amendments up to: Amendment Statement of Principles concerning immune thrombocytopaenia (Reasonable Hypothesis) (No. 57 of 2022) (F2022L00656) The day of commencement of this Amendment Statement of Principles concerning immune thrombocytopaenia is 30 May 2022. About this compilation This compilation This is a compilation of the Statement of Principles concerning immune thrombocytopaenia (Reasonable Hypothesis) (No. 63 of 2017) that shows the text of the law as amended and in force on 30 May 2022. The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents 1 Name 3 Authority 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 Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history 1 Name This is the Statement of Principles concerning immune thrombocytopaenia (Reasonable Hypothesis) (No. 63 of 2017). 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 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 immune thrombocytopaenia and death from immune thrombocytopaenia. Meaning of immune thrombocytopaenia (2) For the purposes of this Statement of Principles, immune thrombocytopaenia means: (a) an autoimmune disorder characterised by an isolated thrombocytopaenia, and a peripheral platelet count of less than 100 000 per microlitre, together with either: (i) the presence of bleeding symptoms; or (ii) the need for treatment to increase the platelet count; and Note: Bleeding symptoms can include bruising (purpura), mucocutaneous bleeding (petechiae), retinal haemorrhage, intracranial haemorrhage, nose bleeds (epistaxis), bleeding from the bowels (melaena) and vaginal bleeding (menorrhagia). (b) excludes pseudothrombocytopaenia, thrombocytopaenia that is caused by non-immunological mechanisms, allergic and other non-thrombocytopaenic purpura, purpura caused by qualitative platelet defects, thrombotic thrombocytopaenic purpura, Evan's syndrome, pancytopaenia, and thrombocytopaenia occurring in the presence of abnormal red or white blood cells. Death from immune thrombocytopaenia (3) For the purposes of this Statement of Principles, immune thrombocytopaenia, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's immune thrombocytopaenia. 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 immune thrombocytopaenia and death from immune thrombocytopaenia 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: relevant service is 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 immune thrombocytopaenia or death from immune thrombocytopaenia with the circumstances of a person's relevant service: (1) having a viral infection from the specified list of viral infections within the six weeks before the clinical onset of immune thrombocytopaenia; Note: specified list of viral infections is defined in the Schedule 1 - Dictionary. (2) having a bacterial or fungal infection from the specified list of bacterial and fungal infections, within the six weeks before the clinical onset of immune thrombocytopaenia; Note: specified list of bacterial and fungal infections is defined in the Schedule 1 - Dictionary. (3) being treated with a drug or a drug from a class of drugs from the specified list of drugs, within the six weeks before the clinical onset of immune thrombocytopaenia; Note: specified list of drugs is defined in the Schedule 1 - Dictionary. (4) receiving a vaccine from the specified list of vaccines within the six weeks before the clinical onset of immune thrombocytopaenia; Note: specified list of vaccines is defined in the Schedule 1 - Dictionary. (5) being treated with a drug or receiving a dose of vaccine which is associated in the individual with the following: (a) the development of immune thrombocytopaenia within six weeks of commencing drug therapy or receiving the dose of vaccine; and (b) an absence of immune thrombocytopaenia prior to commencing drug therapy or vaccination; and (c) sustained recovery from immune thrombocytopaenia on ceasing drug therapy or vaccination; and (d) exclusion of other aetiologies for thrombocytopaenia (including other drugs or vaccines); (6) being pregnant within the six weeks before the clinical onset of immune thrombocytopaenia; (7) having a lymphoproliferative disorder from the specified list of lymphoproliferative disorders, at the time of the clinical onset of immune thrombocytopaenia; Note: specified list of lymphoproliferative disorders is defined in the Schedule 1 - Dictionary. (8) having an autoimmune or inflammatory disorder from the specified list of autoimmune and inflammatory disorders, at the time of the clinical onset of immune thrombocytopaenia; Note: specified list of autoimmune and inflammatory disorders is defined in the Schedule 1 - Dictionary. (9) consuming a food or beverage from the specified list of food and beverages, within the six weeks before the clinical onset of immune thrombocytopaenia; Note: specified list of food and beverages is defined in the Schedule 1 - Dictionary. (10) consuming a food or beverage which is associated in the individual with the following: (a) the development of immune thrombocytopaenia within six weeks of consuming the food or beverage; and (b) an absence of immune thrombocytopaenia prior to consuming the food or beverage; and (c) sustained recovery from immune thrombocytopaenia on ceasing consumption of the food or beverage; and (d) exclusion of other aetiologies for thrombocytopaenia; and (e) recurrence of immune thrombocytopaenia on re-exposure to the food or beverage; or (f) identification of platelet reactive antibodies specific to the food or beverage; (11) having a solid organ or stem cell transplant before the clinical onset of immune thrombocytopaenia; (12) having a solid organ cancer at the time of the clinical onset of immune thrombocytopaenia; (13) being treated with alemtuzumab in the two years before the clinical onset of immune thrombocytopaenia; (14) having a viral infection from the specified list of viral infections within the six weeks before the clinical worsening of immune thrombocytopaenia; Note: specified list of viral infections is defined in the Schedule 1 - Dictionary. (15) having a bacterial or fungal infection from the specified list of bacterial and fungal infections, within the six weeks before the clinical worsening of immune thrombocytopaenia; Note: specified list of bacterial and fungal infections is defined in the Schedule 1 - Dictionary. (16) being treated with a drug or a drug from a class of drugs from the specified list of drugs, within the six weeks before the clinical worsening of immune thrombocytopaenia; Note: specified list of drugs is defined in the Schedule 1 - Dictionary. (17) receiving a vaccine from the specified list of vaccines within the six weeks before the clinical worsening of immune thrombocytopaenia; Note: specified list of vaccines is defined in the Schedule 1 - Dictionary. (18) being treated with a drug or receiving a dose of vaccine which is associated in the individual with the following: (a) the worsening of immune thrombocytopaenia within six weeks of drug therapy or receiving the dose of vaccine; and (b) recovery to the individual's baseline platelet level on ceasing drug therapy or vaccination; and (c) exclusion of other aetiologies for thrombocytopaenia (including other drugs or vaccines); (19) being pregnant within the six weeks before the clinical worsening of immune thrombocytopaenia; (20) having a lymphoproliferative disorder from the specified list of lymphoproliferative disorders, at the time of the clinical worsening of immune thrombocytopaenia; Note: specified list of lymphoproliferative disorders is defined in the Schedule 1 - Dictionary. (21) having an autoimmune or inflammatory disorder from the specified list of autoimmune and inflammatory disorders, at the time of the clinical worsening of immune thrombocytopaenia; Note: specified list of autoimmune and inflammatory disorders is defined in the Schedule 1 - Dictionary. (22) consuming a food or beverage from the specified list of food and beverages, within the six weeks before the clinical worsening of immune thrombocytopaenia; Note: specified list of food and beverages is defined in the Schedule 1 - Dictionary. (23) consuming a food or beverage which is associated in the individual with the following: (a) the worsening of immune thrombocytopaenia within six weeks of consuming the food or beverage; and (b) recovery to the individual's baseline platelet level on ceasing consumption of the food or beverage; and (c) exclusion of other aetiologies for thrombocytopaenia; and (d) recurrence of the worsening of immune thrombocytopaenia on re-exposure to the food or beverage; or (e) identification of platelet reactive antibodies specific to the food or beverage; (24) having a solid organ or stem cell transplant before the clinical worsening of immune thrombocytopaenia; (25) having a solid organ cancer at the time of the clinical worsening of immune thrombocytopaenia; (26) inability to obtain appropriate clinical management for immune thrombocytopaenia. 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(14) to 9(26) apply only to material contribution to, or aggravation of, immune thrombocytopaenia where the person's immune thrombocytopaenia 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. Schedule 1 - Dictionary Note: See Section 6 1 Definitions In this instrument: immune thrombocytopaenia—see subsection 7(2). MRCA means the Military Rehabilitation and Compensation Act 2004. relevant service means: (a) operational service under the VEA; (b) peacekeeping service under the VEA; (c) hazardous service under the VEA; (d) British nuclear test defence service under the VEA; (e) warlike service under the MRCA; or (f) non-warlike service under the MRCA. Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary. specified list of autoimmune and inflammatory disorders means: (a) antiphospholipid syndrome; (b) autoimmune hepatitis; (c) coeliac disease; (d) dermatomyositis; (e) Graves' disease; (f) Hashimoto's thyroiditis; (g) inflammatory bowel disease; (h) rheumatoid arthritis; (i) sarcoidosis; (j) Sjögren's syndrome; or (k) systemic lupus erythematosus. specified list of bacterial and fungal infections means: (a) Brucella species; (b) Candida albicans; (c) Helicobacter pylori; or (d) Mycobacterium tuberculosis. specified list of drugs means: (a) abciximab; (b) aminosalicylic acid; (c) amiodarone; (d) amlodipine; (e) carbamazepine; (f) cephalosporins; (g) ciprofloxacin; (h) citalopram; (i) clopidogrel; (j) dactinomycin (actinomycin D); (k) diazoxide; (l) efalizumab; (m) eptifibatide; (n) ethambutol; (o) fludarabine; (p) furosemide (frusemide); (q) gentamicin; (r) glucagon; (s) haloperidol; (t) heparins; (u) hydrochlorothiazide; (v) imipramine; (w) infliximab; (x) interferon-α; (y) interferon-β; (z) irinotecan; (aa) isotretinoin; (bb) lamivudine; (cc) lamotrigine; (dd) levetiracetam; (ee) levofloxacin; (ff) lorazepam; (gg) melperone; (hh) methylphenidate; (ii) mirtazapine; (jj) nifedipine; (kk) nitrofurantoin; (ll) nivolumab; (mm) non-steroidal anti-inflammatory drugs, excluding aspirin; (nn) oxaliplatin; (oo) paracetamol; (pp) pembrolzumab; (qq) penicillin or penicillin derivatives; (rr) phenobarbital (phenobarbitone); (ss) phenytoin; (tt) quetiapine; (uu) quinidine; (vv) quinine; (ww) ranitidine; (xx) rifampicin; (yy) risperidone; (zz) sodium stibogluconate; (aaa) spironolactone; (bbb) sulfamethoxazole/trimethoprim; (ccc) sulfamethoxazole; (ddd) sulfasalazine; (eee) sulfonamides; (fff) suramin; (ggg) tamoxifen; (hhh) terazosin; (iii) tirofiban; (jjj) tolmetin; (kkk) tranilast; (lll) triamterene/hydrochlorothiazide; (mmm) triamterene; (nnn) trimethoprim; or (ooo) vancomycin. specified list of food and beverages means: (a) cranberry juice; (b) Lupinus termis bean; (c) quinine-containing beverages; (d) tahini; or (e) walnuts. specified list of lymphoproliferative disorders means: (a) acute lymphoblastic leukaemia; (b) chronic lymphocytic leukaemia/small lymphocytic lymphoma; (c) Hodgkin's lymphoma; (d) large granular lymphocytic leukaemia; (e) monoclonal gammopathy of unknown significance; (f) myeloma; (g) non-Hodgkin's lymphoma; or (h) Waldenstrom's macroglobulinaemia. specified list of vaccines means: (aa) coronavirus disease 2019 (COVID-19) vaccine; (a) diphtheria-tetanus-acellular pertussis vaccine; (b) hepatitis A vaccine; (c) hepatitis B vaccine; (d) influenza vaccine; (e) measles-mumps-rubella vaccine; (f) pneumococcal conjugate vaccine; (g) rabies vaccine; or (h) varicella vaccine. specified list of viral infections means: (a) cytomegalovirus; (b) dengue virus; (c) Epstein-Barr virus; (d) hepatitis A virus; (e) hepatitis B virus; (f) hepatitis C virus; (g) hepatitis E virus; (h) human immunodeficiency virus; (i) human T-cell lymphotropic virus type-1; (j) influenza virus; (k) measles virus; (l) mumps virus; (m) parvovirus B19; (n) rotavirus; (o) rubella virus; (oa) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); (p) varicella-zoster virus (chickenpox); or (q) Zika virus. Note: SARS-CoV-2 is the virus which causes coronavirus disease 2019 (COVID-19). 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. Endnotes Endnote 1—About the endnotes The endnotes provide information about this compilation and the compiled law. The following endnotes are included in every compilation: Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Abbreviation key—Endnote 2 The abbreviation key sets out abbreviations that may be used in the endnotes. Legislation history and amendment history—Endnotes 3 and 4 Amending laws are annotated in the legislation history and amendment history. The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation. The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law. Misdescribed amendments A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation "(md)" added to the details of the amendment included in the amendment history. If a misdescribed amendment cannot be given effect as intended, the abbreviation "(md not incorp)" is added to the details of the amendment included in the amendment history. Endnote 2—Abbreviation key o = order(s) ad = added or inserted Ord = Ordinance am = amended orig = original amdt = amendment par = paragraph(s)/subparagraph(s) c = clause(s) /sub‑subparagraph(s) C[x] = Compilation No. x pres = present Ch = Chapter(s) prev = previous def = definition(s) (prev…) = previously Dict = Dictionary Pt = Part(s) disallowed = disallowed by Parliament r = regulation(s)/rule(s) Div = Division(s) exp = expires/expired or ceases/ceased to have reloc = relocated effect renum = renumbered F = Federal Register of Legislation rep = repealed gaz = gazette rs = repealed and substituted LA = Legislation Act 2003 s = section(s)/subsection(s) LIA = Legislative Instruments Act 2003 Sch = Schedule(s) (md) = misdescribed amendment can be given Sdiv = Subdivision(s) effect SLI = Select Legislative Instrument (md not incorp) = misdescribed amendment SR = Statutory Rules cannot be given effect Sub‑Ch = Sub‑Chapter(s) mod = modified/modification SubPt = Subpart(s) No. = Number(s) underlining = whole or part not commenced or to be commenced Endnote 3—Legislation history Name Registration Commencement Application, saving and transitional provisions Statement of Principles concerning immune thrombocytopaenia (Reasonable Hypothesis) (No. 63 of 2017) 6 November 2017 4 December 2017 F2017L01448 Amendment Statement of Principles concerning immune thrombocytopaenia (Reasonable Hypothesis) (No. 57 of 2022) 2 May 2022 30 May 2022 F2022L00656 Endnote 4—Amendment history Provision affected How affected Section 2………………. rep LA s 48D Section 4………………. rep LA s 48C Schedule 1 – Dictionary – specified list of vaccines…………...…. am No. 57 of 2022 Schedule 1 – Dictionary – specified list of viral infections…………...…. am No. 57 of 2022