{"id":"F2021L00619","name":"Statement of Principles concerning hypogonadism (Reasonable Hypothesis) (No. 73 of 2021)","slug":"statement-of-principles-concerning-hypogonadism-reasonable-hypothesis-no-73-of-2021","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":101801,"registerId":"commonwealth-F2021L00619-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning hypogonadism (Reasonable Hypothesis) (No. 73 of 2021)","content":"![Commonwealth Coat of Arms](image.001.png)\n\nStatement of Principles concerning hypogonadism (Reasonable Hypothesis) (No. 73 of 2021)\n\nmade under subsection 196B(2) of the\n\nVeterans' Entitlements Act 1986\n\nCompilation No. 1\n\nCompilation date: 30 May 2022\n\nIncludes amendments up to: Amendment Statement of Principles concerning hypogonadism (Reasonable Hypothesis) (No. 51 of 2022) (F2022L00667)\n\nThe day of commencement of this Amendment Statement of Principles concerning hypogonadism is 30 May 2022.\n\nAbout this compilation\n\nThis compilation\n\nThis is a compilation of the Statement of Principles concerning hypogonadism (Reasonable Hypothesis) (No. 73 of 2021) that shows the text of the law as amended and in force on 30 May 2022.\n\nThe notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.\n\nUncommenced amendments\n\nThe 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.\n\nApplication, saving and transitional provisions for provisions and amendments\n\nIf 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.\n\nModifications\n\nIf 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.\n\nSelf‑repealing provisions\n\nIf a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.\n\nContents\n\n1 Name\n\n3 Authority\n\n4 Application\n\n5 Definitions\n\n6 Kind of injury, disease or death to which this Statement of Principles relates\n\n7 Basis for determining the factors\n\n8 Factors that must exist\n\n9 Relationship to service\n\n10 Factors referring to an injury or disease covered by another Statement of Principles\n\nSchedule 1 - Dictionary\n\n1 Definitions\n\nEndnotes\n\nEndnote 1—About the endnotes\n\nEndnote 2—Abbreviation key\n\nEndnote 3—Legislation history\n\nEndnote 4—Amendment history\n\n  \n\n1 Name\n\nThis is the Statement of Principles concerning hypogonadism (Reasonable Hypothesis) (No. 73 of 2021).\n\n3 Authority\n\nThis instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.\n\n4 Application\n\nThis instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies.\n\n5 Definitions\n\nThe terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.\n\n6 Kind of injury, disease or death to which this Statement of Principles relates\n\n(1) This Statement of Principles is about hypogonadism and death from hypogonadism.\n\nMeaning of hypogonadism\n\n(2) For the purposes of this Statement of Principles, hypogonadism:\n\n(a) means deficient production of testosterone from the testis or estrogen from the ovary, or deficient production of ova (eggs) or sperm, where any such deficiency is associated with clinical symptoms and signs or a requirement for treatment; and\n\n(b) includes:\n\n(i) primary hypogonadism;\n\n(ii) secondary hypogonadism (also known as central hypogonadism and hypogonadotropic hypogonadism); and\n\n(iii) infertility due to endocrine or gonadal pathology; and\n\n(c) excludes heritable and congenital forms of hypogonadism, compensated hypogonadism, diminished ovarian reserve, naturally occurring menopause and abnormal semen analysis.\n\n> Note 1: Associated clinical symptoms and signs of hypogonadism may include loss of secondary sexual characteristics, loss of sexual function and loss of reproductive function (endocrine or gonadal infertility).\n\n> Note 2: infertility is defined in the Schedule 1 - Dictionary.\n\nDeath from hypogonadism\n\n(3) For the purposes of this Statement of Principles, hypogonadism, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's hypogonadism.\n\n> Note: terminal event is defined in the Schedule 1 - Dictionary.\n\n7 Basis for determining the factors\n\nThe Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that hypogonadism and death from hypogonadism 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.\n\n> Note: MRCA, relevant service and VEA are defined in the Schedule 1 - Dictionary.\n\n8 Factors that must exist\n\nAt least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting hypogonadism or death from hypogonadism with the circumstances of a person's relevant service:\n\n(1) having hypopituitarism involving deficiency of follicle stimulating hormone or luteinising hormone at the time of the clinical onset of hypogonadism;\n\n(2) having hyperprolactinaemia at the time of the clinical onset of hypogonadism;\n\n(3) for males only, having a spinal cord injury resulting in paraplegia or tetraplegia before the clinical onset of hypogonadism;\n\n(4) having blunt or penetrating trauma to:\n\n(a) both ovaries or testes; or\n\n(b) a single functional ovary or testis, where there is only one functional ovary or testis;\n\nsufficient to cause gonadal atrophy before the clinical onset of hypogonadism;\n\n(5) having surgical excision of:\n\n(a) both ovaries or testes; or\n\n(b) a single functional ovary or testis, where there is only one functional ovary or testis;\n\nbefore the clinical onset of hypogonadism;\n\n(6) undergoing a course of therapeutic radiation for cancer, where:\n\n(a) both ovaries or testes; or\n\n(b) a single functional ovary or testis, where there is only one functional ovary or testis;\n\nwere in the field of radiation before the clinical onset of hypogonadism;\n\n(7) having infection with human immunodeficiency virus before the clinical onset of hypogonadism;\n\n(8) having infection with Mycobacterium leprae before the clinical onset of hypogonadism;\n\n> Note: Mycobacterium leprae is the organism that causes leprosy.\n\n(9) having infection with Trypanosoma brucei before the clinical onset of hypogonadism;\n\n> Note: Trypanosoma brucei is the organism that causes African sleeping sickness (trypanosomiasis).\n\n(10) having mumps orchitis as an adult affecting:\n\n(a) both testes; or\n\n(b) a single functional testis, where there is only one functional testis;\n\nbefore the clinical onset of hypogonadism;\n\n(11) for males only, having rheumatoid arthritis or granulomatosis with polyangiitis before the clinical onset of hypogonadism;\n\n(12) having Addison disease before the clinical onset of hypogonadism;\n\n(13) having an infiltrative disease from the specified list of infiltrative diseases of:\n\n(a) both ovaries or testes; or\n\n(b) a single functional ovary or testis, where there is only one functional ovary or testis;\n\nbefore the clinical onset of hypogonadism;\n\n> Note: specified list of infiltrative diseases is defined in the Schedule 1 - Dictionary.\n\n(14) for males only, having a testicular varicocoele before the clinical onset of hypogonadism;\n\n(15) having infarction of:\n\n(a) both ovaries or testes; or\n\n(b) a single functional ovary or testis, where there is only one functional ovary or testis;\n\nwithin the 1 year before the clinical onset of hypogonadism;\n\n(16) having sickle-cell disorder before the clinical onset of hypogonadism;\n\n(17) having a bone marrow or stem cell transplant before the clinical onset of hypogonadism;\n\n(18) having cirrhosis of the liver at time of the clinical onset of hypogonadism;\n\n(19) having chronic kidney disease at time of the clinical onset of hypogonadism;\n\n> Note: chronic kidney disease is defined in the Schedule 1 - Dictionary.\n\n(20) having anorexia nervosa at the time of the clinical onset of hypogonadism;\n\n(21) taking a course of systemic cytotoxic drugs for treatment of a malignant neoplasm before the clinical onset of hypogonadism;\n\n(22) taking gonadotrophin releasing hormone agonists or antagonists as androgen or estrogen deprivation therapy for at least 1 year within the 2 years before the clinical onset of hypogonadism;\n\n(23) having active epilepsy before the clinical onset of hypogonadism;\n\n> Note: active epilepsy is defined in the Schedule 1 - Dictionary.\n\n(24) taking a drug from the Specified List 1 of drugs before the clinical onset of hypogonadism;\n\n> Note: Specified List 1 of drugs is defined in the Schedule 1 - Dictionary.\n\n(25) taking an immune checkpoint inhibitor within the 1 year before the clinical onset of hypogonadism;\n\n> Note: immune checkpoint inhibitor is defined in the Schedule 1 - Dictionary.\n\n(26) taking a drug from the Specified List 2 of drugs, which cannot be ceased or substituted, at the time of the clinical onset of hypogonadism;\n\n> Note: Specified List 2 of drugs is defined in the Schedule 1 - Dictionary.\n\n(27) taking a drug which cannot be ceased or substituted and which is associated in the individual with the clinical onset of hypogonadism during drug therapy and either:\n\n(a) the improvement of hypogonadism within 2 months of discontinuing or tapering drug therapy; or\n\n(b) the redevelopment of hypogonadism on rechallenge with the same drug; and\n\nwhere taking the drug continued for at least the 30 days before the clinical onset of hypogonadism;\n\n(28) inhaling fumes from a metal from the specified list of metals or a compound containing a metal from the specified list of metals:\n\n(a) for a cumulative period of at least 2,000 hours before the clinical onset of hypogonadism; and\n\n(b) if that exposure has ceased before the clinical onset of hypogonadism, then that onset occurred within 2 years of cessation;\n\n> Note: fumes and specified list of metals are defined in the Schedule 1 - Dictionary.\n\n(29) inhaling, ingesting or having cutaneous contact with a chemical agent from the specified list of chemical agents:\n\n(a) for a cumulative period of at least 2,000 hours before the clinical onset of hypogonadism; and\n\n(b) if that exposure has ceased before the clinical onset of hypogonadism, then that onset occurred within 2 years of cessation;\n\n> Note: specified list of chemical agents is defined in the Schedule 1 - Dictionary.\n\n(30) for females only, inhaling, ingesting or having cutaneous contact with a chemical agent contaminated by 2,3,7,8-tetrachlorodibenzo-para-dioxin (TCDD):\n\n(a) for a cumulative period of at least 1,000 hours, within a consecutive period of 10 years before the clinical onset of hypogonadism; and\n\n(b) if that exposure has ceased before the clinical onset of hypogonadism, then that onset occurred within 25 years of cessation;\n\n> Note: inhaling, ingesting or having cutaneous contact with a chemical agent contaminated by 2,3,7,8-tetrachlorodibenzo-para-dioxin (TCDD) is defined in the Schedule 1 - Dictionary.\n\n(31) for females only, having smoked tobacco products:\n\n(a) in an amount of at least 5 pack-years before the clinical onset of hypogonadism; and\n\n(b) if smoking has ceased before the clinical onset of hypogonadism, then that onset occurred within 10 years of cessation;\n\n> Note: one pack-year is defined in the Schedule 1 - Dictionary.\n\n(32) having alcohol use disorder before the clinical onset of hypogonadism;\n\n(33) being obese for at least the 5 years before the clinical onset of hypogonadism;\n\n> Note: being obese is defined in the Schedule 1 - Dictionary.\n\n(34) for females only, being underweight for at least the 5 years before the clinical onset of hypogonadism;\n\n> Note: being underweight is defined in the Schedule 1 - Dictionary.\n\n(35) for females only, being nulliparous at the time of the clinical onset of hypogonadism;\n\n> Note: being nulliparous is defined in the Schedule 1 - Dictionary.\n\n(36) for parous women only, an inability to breast feed for a cumulative period of at least 6 months before the clinical onset of hypogonadism;\n\n> Note: The period of breastfeeding could be cumulative over a number of pregnancies.\n\n(37) having diabetes mellitus before the clinical onset of hypogonadism;\n\n(38) for males only, having obstructive sleep apnoea at the time of the clinical onset of hypogonadism;\n\n(39) having hypopituitarism involving deficiency of follicle stimulating hormone or luteinising hormone at the time of the clinical worsening of hypogonadism;\n\n(40) having hyperprolactinaemia at the time of the clinical worsening of hypogonadism;\n\n(41) for males only, having a spinal cord injury resulting in paraplegia or tetraplegia before the clinical worsening of hypogonadism;\n\n(42) having blunt or penetrating trauma to:\n\n(a) both ovaries or testes; or\n\n(b) a single functional ovary or testis, where there is only one functional ovary or testis;\n\nsufficient to cause gonadal atrophy before the clinical worsening of hypogonadism;\n\n(43) having surgical excision of:\n\n(a) both ovaries or testes; or\n\n(b) a single functional ovary or testis, where there is only one functional ovary or testis;\n\nbefore the clinical worsening of hypogonadism;\n\n(44) undergoing a course of therapeutic radiation for cancer, where:\n\n(a) both ovaries or testes; or\n\n(b) a single functional ovary or testis, where there is only one functional ovary or testis;\n\nwere in the field of radiation before the clinical worsening of hypogonadism;\n\n(45) having infection with human immunodeficiency virus before the clinical worsening of hypogonadism;\n\n(46) having infection with Mycobacterium leprae before the clinical worsening of hypogonadism;\n\n> Note: Mycobacterium leprae is the organism that causes leprosy.\n\n(47) having infection with Trypanosoma brucei before the clinical worsening of hypogonadism;\n\n> Note: Trypanosoma brucei is the organism that causes African sleeping sickness (trypanosomiasis).\n\n(48) having mumps orchitis as an adult affecting:\n\n(a) both testes; or\n\n(b) a single functional testis, where there is only one functional testis;\n\nbefore the clinical worsening of hypogonadism;\n\n(49) for males only, having rheumatoid arthritis or granulomatosis with polyangiitis before the clinical worsening of hypogonadism;\n\n(50) having Addison disease before the clinical worsening of hypogonadism;\n\n(51) having an infiltrative disease from the specified list of infiltrative diseases of:\n\n(a) both ovaries or testes; or\n\n(b) a single functional ovary or testis, where there is only one functional ovary or testis;\n\nbefore the clinical worsening of hypogonadism;\n\n> Note: specified list of infiltrative diseases is defined in the Schedule 1 - Dictionary.\n\n(52) for males only, having a testicular varicocoele before the clinical worsening of hypogonadism;\n\n(53) having infarction of:\n\n(a) both ovaries or testes; or\n\n(b) a single functional ovary or testis, where there is only one functional ovary or testis;\n\nwithin the 1 year before the clinical worsening of hypogonadism;\n\n(54) having sickle-cell disorder before the clinical worsening of hypogonadism;\n\n(55) having a bone marrow or stem cell transplant before the clinical worsening of hypogonadism;\n\n(56) having cirrhosis of the liver at time of the clinical worsening of hypogonadism;\n\n(57) having chronic kidney disease at time of the clinical worsening of hypogonadism;\n\n> Note: chronic kidney disease is defined in the Schedule 1 - Dictionary.\n\n(58) having anorexia nervosa at the time of the clinical worsening of hypogonadism;\n\n(59) taking a course of systemic cytotoxic drugs for treatment of a malignant neoplasm before the clinical worsening of hypogonadism;\n\n(60) taking gonadotrophin releasing hormone agonists or antagonists as androgen or estrogen deprivation therapy for at least 1 year within the 2 years before the clinical worsening of hypogonadism;\n\n(61) having active epilepsy before the clinical worsening of hypogonadism;\n\n> Note: active epilepsy is defined in the Schedule 1 - Dictionary.\n\n(62) taking a drug from the Specified List 1 of drugs before the clinical worsening of hypogonadism;\n\n> Note: Specified List 1 of drugs is defined in the Schedule 1 - Dictionary.\n\n(63) taking an immune checkpoint inhibitor within the 1 year before the clinical worsening of hypogonadism;\n\n> Note: immune checkpoint inhibitor is defined in the Schedule 1 - Dictionary.\n\n(64) taking a drug from the Specified List 2 of drugs, which cannot be ceased or substituted, at the time of the clinical worsening of hypogonadism;\n\n> Note: Specified List 2 of drugs is defined in the Schedule 1 - Dictionary.\n\n(65) taking a drug which cannot be ceased or substituted and which is associated in the individual with the clinical worsening of hypogonadism during drug therapy and either:\n\n(a) the improvement of hypogonadism within 2 months of discontinuing or tapering drug therapy; or\n\n(b) the clinical worsening of hypogonadism on rechallenge with the same drug; and\n\nwhere taking the drug continued for at least the 30 days before the clinical worsening of hypogonadism;\n\n(66) inhaling fumes from a metal from the specified list of metals or a compound containing a metal from the specified list of metals:\n\n(a) for a cumulative period of at least 2,000 hours before the clinical worsening of hypogonadism; and\n\n(b) if that exposure has ceased before the clinical worsening of hypogonadism, then that worsening occurred within 2 years of cessation;\n\n> Note: fumes and specified list of metals are defined in the Schedule 1 - Dictionary.\n\n(67) inhaling, ingesting or having cutaneous contact with a chemical agent from the specified list of chemical agents:\n\n(a) for a cumulative period of at least 2,000 hours before the clinical worsening of hypogonadism; and\n\n(b) if that exposure has ceased before the clinical worsening of hypogonadism, then that worsening occurred within 2 years of cessation;\n\n> Note: specified list of chemical agents is defined in the Schedule 1 - Dictionary.\n\n(68) for females only, inhaling, ingesting or having cutaneous contact with a chemical agent contaminated by 2,3,7,8-tetrachlorodibenzo-para-dioxin (TCDD):\n\n(a) for a cumulative period of at least 1,000 hours, within a consecutive period of 10 years before the clinical worsening of hypogonadism; and\n\n(b) if that exposure has ceased before the clinical worsening of hypogonadism, then that worsening occurred within 25 years of cessation;\n\n> Note: inhaling, ingesting or having cutaneous contact with a chemical agent contaminated by 2,3,7,8-tetrachlorodibenzo-para-dioxin (TCDD) is defined in the Schedule 1 - Dictionary.\n\n(69) for females only, having smoked tobacco products:\n\n(a) in an amount of at least 5 pack-years before the clinical worsening of hypogonadism; and\n\n(b) if smoking has ceased before the clinical worsening of hypogonadism, then that worsening occurred within 10 years of cessation;\n\n> Note: one pack-year is defined in the Schedule 1 - Dictionary.\n\n(70) having alcohol use disorder before the clinical worsening of hypogonadism;\n\n(71) being obese for at least the 5 years before the clinical worsening of hypogonadism;\n\n> Note: being obese is defined in the Schedule 1 - Dictionary.\n\n(72) for females only, being underweight for at least the 5 years before the clinical worsening of hypogonadism;\n\n> Note: being underweight is defined in the Schedule 1 - Dictionary.\n\n(73) for females only, being nulliparous at the time of the clinical worsening of hypogonadism;\n\n> Note: being nulliparous is defined in the Schedule 1 - Dictionary.\n\n(74) for parous women only, an inability to breast feed for a cumulative period of at least 6 months before the clinical worsening of hypogonadism;\n\n> Note: The period of breastfeeding could be cumulative over a number of pregnancies.\n\n(75) having diabetes mellitus before the clinical worsening of hypogonadism;\n\n(76) for males only, having obstructive sleep apnoea at the time of the clinical worsening of hypogonadism;\n\n(77) inability to obtain appropriate clinical management for hypogonadism.\n\n9 Relationship to service\n\n(1) The existence in a person of any factor referred to in section 8, must be related to the relevant service rendered by the person.\n\n(2) The factors set out in subsections 8(39) to 8(77) apply only to material contribution to, or aggravation of, hypogonadism where the person's hypogonadism was suffered or contracted before or during (but did not arise out of) the person's relevant service.\n\n10 Factors referring to an injury or disease covered by another Statement of Principles\n\nIn this Statement of Principles:\n\n(1) if a factor referred to in section 8 applies in relation to a person; and\n\n(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;\n\nthen 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.\n\nSchedule 1 \\- Dictionary\n\nNote: See Section 5\n\n1 Definitions\n\nIn this instrument:\n\nabnormality of kidney structure or function means:\n\n(a) having a glomerular filtration rate of less than 60 mL/min/1.73 m2; or\n\n(b) having kidney damage, as evidenced by renal biopsy, imaging studies, albuminuria, urinary sediment abnormalities or other markers of abnormal renal function; or\n\n(c) having had a kidney transplant.\n\nactive epilepsy means having at least one epileptic seizure per year.\n\nbeing nulliparous means never having experienced a gestation period of at least 20 weeks.\n\nbeing obese means having a Body Mass Index (BMI) of 30 or greater.\n\n> Note: BMI is also defined in the Schedule 1 - Dictionary.\n\nbeing underweight means having a Body Mass Index (BMI) of 18.5 or less.\n\n> Note: BMI is also defined in the Schedule 1 - Dictionary.\n\nBMI means W/H2 where:\n\n(a) W is the person's weight in kilograms; and\n\n(b) H is the person's height in metres.\n\nchronic kidney disease means an abnormality of kidney structure or function that has been present for at least 3 months.\n\n> Note: abnormality of kidney structure or function is also defined in the Schedule 1 - Dictionary.\n\nfumes means combustion products, aerosols, vapours or dust arising through industrial processes or from workplace practices that involve the refining, manufacture or use of the stated material.\n\nhypogonadism—see subsection 6(2).\n\nimmune checkpoint inhibitor means a form of cancer immunotherapy that uses monoclonal antibodies targeting the immune checkpoint proteins. Examples include ipilimumab, tremelimumab, nivolumab and pembrolizumab.\n\ninfertility means inability to conceive a pregnancy after 12 months of unprotected sexual intercourse, use of assisted reproductive technology or azoospermia in males.\n\ninhaling, ingesting or having cutaneous contact with a chemical agent contaminated by 2,3,7,8-tetrachlorodibenzo-para-dioxin (TCDD) means:\n\n(a) decanting or spraying;\n\n(b) cleaning or maintaining equipment used to apply;\n\n(c) being sprayed with;\n\n(d) handling or sawing timber treated with;\n\n(e) being in an environment shrouded in dust from timber treated with; or\n\n(f) using cutting oils contaminated with;\n\none of the following chemicals:\n\n(i) 2,4,5-trichlorophenoxyacetic acid;\n\n(ii) 2,4,5-trichlorophenoxypropionic acid;\n\n(iii) 2,4,5-trichlorophenol;\n\n(iv) 2-(2,4,5-trichlorophenoxy)-ethyl 2,2-dichloropropionionate;\n\n(v) o,o-dimethyl-o-(2,4,5-trichlorophenyl)-phosphorothioate;\n\n(vi) pentachlorophenol;\n\n(vii) 2,3,4,6-tetrachlorophenol;\n\n(viii) 2,4,6-trichlorophenol;\n\n(ix) 1,3,5-trichloro-2-(4-nitrophenoxy)benzene;\n\n(x) 2,4-dichloro-1-(4-nitrophenoxy)benzene; or\n\n(xi) 2,4-dichloro-1-(3-methoxy-4-nitrophenoxy)-benzene.\n\nMRCA means the Military Rehabilitation and Compensation Act 2004.\n\none pack-year means the amount of tobacco consumed in smoking 20 cigarettes per day for a period of 1 year, or an equivalent amount of tobacco products.\n\n> Note 1: An equivalent amount of tobacco products is 7,300 grams of smoking tobacco by weight, either in cigarettes, pipe tobacco or cigars, or a combination of same. For pipe tobacco, cigars or combinations of multiple tobacco types, 1 gram of tobacco is considered to be equal to one cigarette.\n\n> Note 2: Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 and multiplying this number by the number of years the person has smoked. For example, smoking 10 cigarettes per day for 10 years is equal to 5 pack-years, and smoking 40 cigarettes per day for 10 years is equal to 20 pack-years.\n\nrelevant service means:\n\n(a) operational service under the VEA;\n\n(b) peacekeeping service under the VEA;\n\n(c) hazardous service under the VEA;\n\n(d) British nuclear test defence service under the VEA;\n\n(e) warlike service under the MRCA; or\n\n(f) non-warlike service under the MRCA.\n\n> Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary.\n\nSpecified List 1 of drugs means:\n\n(a) alkylating agents including busulphan, carmustine, chlorambucil, cyclophosphamide, dacarbazine, lomustine, melphalan (phenylalanine mustard), nitrogen mustard (mechlorethamine), procarbazine and ifosfamide (isophosphamide);\n\n(b) anthracycline antibiotics including daunorubicin, doxorubicin, epirubicin and idarubicin;\n\n(c) etoposide;\n\n(d) ibiraterone;\n\n(e) platinum compounds including cisplatin and carboplatin.\n\nSpecified List 2 of drugs means:\n\n(a) androgens;\n\n(b) antipsychotics;\n\n(c) bevacizumab for females only;\n\n(d) dutasteride for males only;\n\n(e) estrogens for males only;\n\n(f) finasteride for males only;\n\n(g) flutamide for males only;\n\n(h) glucocorticoids;\n\n(i) ketoconazole for males only;\n\n(j) opioids;\n\n(k) progestins for males only;\n\n(l) sirolimus for males only;\n\n(m) spironolactone for males only;\n\n(n) steroidal antiandrogens (including cyproterone acetate) for males only;\n\n(o) sulfasalazine for males only; or\n\n(p) vismodegib for females only.\n\nspecified list of chemical agents means:\n\n(a) 2-bromopropane;\n\n(b) carbon disulphide for females only; or\n\n(c) dibromochloropropane for males only.\n\nspecified list of infiltrative diseases means:\n\n(a) amyloidosis;\n\n(b) endometriosis;\n\n(c) haemochromatosis;\n\n(d) a primary or secondary malignant neoplasm; or\n\n(e) sarcoidosis.\n\nspecified list of metals means:\n\n(a) cadmium;\n\n(b) lead; or\n\n(c) mercury.\n\nterminal event means the proximate or ultimate cause of death and includes the following:\n\n(a) pneumonia;\n\n(b) respiratory failure;\n\n(c) cardiac arrest;\n\n(d) circulatory failure; or\n\n(e) cessation of brain function.\n\nVEA means the Veterans' Entitlements Act 1986.\n\n> Note: Endnotes\n\n> Note: Endnote 1—About the endnotes\n\nThe endnotes provide information about this compilation and the compiled law.\n\nThe following endnotes are included in every compilation:\n\nEndnote 1—About the endnotes\n\nEndnote 2—Abbreviation key\n\nEndnote 3—Legislation history\n\nEndnote 4—Amendment history\n\nAbbreviation key—Endnote 2\n\nThe abbreviation key sets out abbreviations that may be used in the endnotes.\n\nLegislation history and amendment history—Endnotes 3 and 4\n\nAmending laws are annotated in the legislation history and amendment history.\n\nThe 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.\n\nThe 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.\n\nMisdescribed amendments\n\nA 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.\n\nIf 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.\n\n> Note: Endnote 2—Abbreviation key\n\n|                                                | o = order(s)                        |\n| ---------------------------------------------- | ----------------------------------- |\n| ad = added or inserted                         | Ord = Ordinance                     |\n| am = amended                                   | orig = original                     |\n| amdt = amendment                               | par = paragraph(s)/subparagraph(s)  |\n| c = clause(s)                                  | /sub‑subparagraph(s)                |\n| C[x] = Compilation No. x                       | pres = present                      |\n| Ch = Chapter(s)                                | prev = previous                     |\n| def = definition(s)                            | (prev…) = previously                |\n| Dict = Dictionary                              | Pt = Part(s)                        |\n| disallowed = disallowed by Parliament          | r = regulation(s)/rule(s)           |\n| Div = Division(s)                              |                                     |\n| exp = expires/expired or ceases/ceased to have | reloc = relocated                   |\n| effect                                         | renum = renumbered                  |\n| F = Federal Register of Legislation            | rep = repealed                      |\n| gaz = gazette                                  | rs = repealed and substituted       |\n| LA = Legislation Act 2003                      | s = section(s)/subsection(s)        |\n| LIA = Legislative Instruments Act 2003         | Sch = Schedule(s)                   |\n| (md) = misdescribed amendment can be given     | Sdiv = Subdivision(s)               |\n| effect                                         | SLI = Select Legislative Instrument |\n| (md not incorp) = misdescribed amendment       | SR = Statutory Rules                |\n| cannot be given effect                         | Sub‑Ch = Sub‑Chapter(s)             |\n| mod = modified/modification                    | SubPt = Subpart(s)                  |\n| No. = Number(s)                                | underlining = whole or part not     |\n|                                                | commenced or to be commenced        |\n\n> Note: Endnote 3—Legislation history\n\n| Name                                                                                               | Registration           | Commencement | Application, saving and transitional provisions |\n| -------------------------------------------------------------------------------------------------- | ---------------------- | ------------ | ----------------------------------------------- |\n| Statement of Principles concerning hypogonadism (Reasonable Hypothesis) (No. 73 of 2021)           | 24 May 2021F2021L00619 | 21 June 2021 |                                                 |\n| Amendment Statement of Principles concerning hypogonadism (Reasonable Hypothesis) (No. 51 of 2022) | 2 May 2022F2022L00667  | 30 May 2022  |                                                 |\n\n> Note: Endnote 4—Amendment history\n\n| Provision affected                                              | How affected      |\n| --------------------------------------------------------------- | ----------------- |\n| Section 2……………….                                                | rep LA s 48D      |\n| Schedule 1 – Dictionary – immune checkpoint inhibitor……………...…. | rs No. 51 of 2022 |","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"This instrument appears consistent with the standard format and scope of Repatriation Medical Authority Statements of Principles. It follows the typical structure of listing specific factors for clinical onset and worsening based on medical-scientific evidence. The scope remains focused on establishing service connection for hypogonadism claims under veterans' compensation legislation, which is the original purpose of such instruments under section 196B(2) of the Veterans' Entitlements Act 1986."},"complexity_factors":["77 distinct factors with specific temporal requirements (e.g., 'within 1 year before', 'for at least 5 years before', 'at the time of')","Multiple gender-specific provisions (18 factors apply to 'males only' or 'females only')","Extensive cross-referencing to defined terms in Schedule 1 Dictionary (approximately 20 defined terms)","Nested conditional logic in exposure factors (cumulative hours requirements plus cessation timing windows)","Complex drug-related factors requiring assessment of cessation/substitution possibilities and rechallenge protocols","Reference to external 'Specified Lists' (metals, chemical agents, infiltrative diseases, drugs) that are defined within the instrument but require lookup","Dual structure covering both clinical onset (factors 1-38) and clinical worsening (factors 39-76) with nearly parallel provisions","Specific anatomical distinctions (both organs vs single functional organ scenarios)"],"plain_english_summary":"This Statement of Principles sets the medical-scientific rules the Repatriation Medical Authority uses to decide whether hypogonadism (new or worsened) can be reasonably linked to Australian defence service. It identifies 77 factors that establish a \"reasonable hypothesis\" of service connection.\n\nIt applies to veterans and current/former defence members claiming under the VEA or MRCA and matters because establishing service connection affects eligibility for pensions, treatment and other entitlements by using a lower threshold than direct causation."},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":false,"description":"This compilation and its listed amendment(s) update and clarify definitional and evidentiary detail (for example, updates to the definition of immune checkpoint inhibitor noted in the amendment history) but do not materially broaden the instrument's core purpose. The Statement remains focused on identifying medical and exposure factors that raise a reasonable hypothesis linking hypogonadism (or its worsening or contribution to death) to relevant service; amendments are limited to definitions and clarifying entries rather than extending the substantive scope of conditions covered."},"complexity_factors":["Large number of discrete factors listed (77 items covering onset and a largely parallel set for worsening)","Multiple defined terms in Schedule 1 (drugs, exposures, diseases, BMI, pack‑years, terminal event, relevant service, etc.) — roughly 20+ defined items of operational importance","Sex‑specific provisions and many conditional clauses (\"for males only\", \"for females only\") increasing branching logic","Different temporal tests (\"clinical onset\" vs \"clinical worsening\") requiring separate evidentiary showings","Quantitative exposure thresholds (e.g. 2,000 hours, 1,000 hours, 5 pack‑years, 5 years of obesity) that require retrospective measurement","Cross‑reference to other Statements of Principles where a listed factor is itself a covered disease (s10), adding inter‑instrument dependency","Lists of specified items (Specified List 1 and 2 of drugs, specified list of metals, chemicals, infiltrative diseases) that require lookups and sex‑specific application","Timing windows after exposure cessation (e.g. onset must occur within 2 years of cessation, or 25 years for TCDD‑contaminated agents for females) that create layered conditionality","Administrative burden for verification (surgical records, radiation fields, drug duration, occupational exposure records) increases practical complexity"],"plain_english_summary":"**What this instrument does (mechanics first)\n\n- This is a Statement of Principles made under the Veterans' Entitlements Act. It does not create new benefits itself but tells decision-makers which medical facts are sufficient to raise a \"reasonable hypothesis\" that a particular medical condition (hypogonadism) is related to a person's military or related service (see sections 3–4, 6–8).\n- It defines hypogonadism (low sex-hormone production or deficient sperm/ova associated with clinical signs or need for treatment) and lists which forms are excluded (for example, congenital/heritable forms and natural menopause) (s6).\n- It sets out a long list of discrete factors (77 numbered items) — medical diagnoses, injuries, surgeries, infections, drug treatments, occupational exposures, lifestyle thresholds and timing windows — any one of which, if linked to the person's relevant service, is sufficient to raise the required \"reasonable hypothesis\" for a service connection (s8, Schedule 1 for defined terms).\n- The instrument distinguishes between factors that establish a link with the initial clinical onset of hypogonadism and factors that can establish a link to a clinical worsening of pre-existing hypogonadism (see the duplicate sets of items for \"onset\" and for \"worsening\", s8(1)–(38) and s8(39)–(77)).\n- It requires that the listed factor(s) be related to the person's \"relevant service\" (that is, operational, peacekeeping, hazardous, nuclear test, warlike or non‑warlike service as defined) (s9, Schedule 1).\n- If a listed factor refers to another injury or disease covered by a different Statement of Principles, that other Statement of Principles applies as drafted (s10).\n\nWho this affects\n\n- Veterans, former members of the Australian Defence Force, members of peacekeeping forces and other persons with \"relevant service\" who claim under the Veterans' Entitlements Act 1986 (VEA) or the Military Rehabilitation and Compensation Act 2004 (MRCA) for hypogonadism (s4, Schedule 1 definition of \"relevant service\").\n- The Repatriation Medical Authority (RMA) and decision-makers in the Department of Veterans' Affairs (DVA), who use this Statement of Principles to assess medical causation in claims (authority in s3 and the RMA's stated basis in s7).\n- Treating clinicians and medico-legal advisers, because the Statement identifies what kinds of clinical findings, exposure histories and testable thresholds (for example, hours of exposure, pack-years, BMI cut-offs, timing windows after cessation) will be treated as sufficient to raise a reasonable hypothesis (s8, Schedule 1).\n\nWhy it matters (purpose and practical effects)\n\n- The RMA expressly states that \"sound medical‑scientific evidence\" supports a link between hypogonadism and relevant service; the practical effect of the Statement is to lower the evidentiary uncertainty for claimants who meet one or more listed factors so that their condition can be accepted as service-related unless disproof is shown (s7 and s8).\n- Who pays: financial liability for accepted claims (medical treatment, pensions or compensation under the VEA/MRCA) falls to the Commonwealth through DVA — this instrument governs the medical causation test that triggers those payments (s4, s7).\n- Who decides: the RMA issues the Statement; DVA decision-makers apply it when deciding claims. Medical evidence from clinicians is used to establish the presence and timing of listed factors and their relation to service (s3, s8, s9).\n\nPractical implementation features, trade-offs and risks\n\n- Evidence thresholds and verification needs: many items depend on quantifiable thresholds (e.g. cumulative exposure of 2,000 hours to particular fumes or chemicals, 1,000 hours to TCDD‑contaminated agents, 5 pack‑years of smoking, BMI cut-offs, or timing windows such as onset within 2 years of exposure cessation). Those thresholds make determinations more objective but may require detailed occupational, medical or lifestyle records to verify (s8, Schedule 1).\n- Complexity of diagnosis and timing: the Statement separates \"clinical onset\" and \"clinical worsening\" with largely parallel lists. Establishing which applies and the timing relation to service may increase the need for specialist medical reports (s8, s9).\n- Administrative and compliance costs: DVA will need to assess many specific factual elements (surgery, radiation fields, specific infections, drug names and durations, transplant history, exposures measured in hours). Claimants and clinicians carry the compliance burden of documenting these facts; the Commonwealth bears the cost of approved claims and the administrative cost of assessment (s8, Schedule 1).\n- Concentrated benefits vs diffuse costs: benefits (acceptance of service connection and entitlements) are concentrated on claimants who meet a listed factor. Costs of accepted claims and of administering assessments are spread across taxpayers. The instrument narrows the evidentiary hurdle for specified subgroups, which concentrates the gain for those individuals (s8).\n- Incentives and behavioural effects: because any single listed factor can raise a reasonable hypothesis, claimants with borderline causal histories may be more likely to lodge claims; clinicians may be asked to record or search for specific exposures or thresholds. Employers or record-keepers may face increased requests for historical exposure documentation.\n- Implementation risk and verification difficulty: for some factors (e.g. historic exposures to specific contaminated chemicals or cumulative hours of exposure), objective verification may be hard or impossible decades after service; this creates a risk of uncertainty, delays or reliance on secondary evidence such as service records or contemporaneous occupational records (s8, Schedule 1 definitions of exposures).\n- Interaction with other Statements of Principles: where a listed factor is itself an injury/disease covered elsewhere, decision-makers must apply the other Statement of Principles, adding cross‑reference complexity (s10).\n\nLimits, exclusions and diagnostic scope\n\n- The Statement excludes congenital/heritable hypogonadism, compensated hypogonadism, diminished ovarian reserve, natural menopause and abnormal semen analysis (s6(2)(c)).\n- Several factors are sex-specific (many items apply only to males or females), and some drug or chemical entries are sex-limited in the Schedule 1 lists — this requires sex-specific evidence and attention to which items apply to the claimant (s8, Schedule 1).\n\nBottom line in plain terms\n\n- Mechanically, this legal instrument gives decision-makers a defined list of medical and exposure factors that — if shown and connected to a person's relevant service — are enough to create a \"reasonable hypothesis\" that the person's hypogonadism (or death contributed to by it) is service related (s6–9). It therefore shapes which veterans' claims for hypogonadism are likely to be accepted, what evidence is needed, and where verification challenges will fall.\n\n(References: key provisions — application s4; definition of hypogonadism s6; RMA's basis s7; list of factors s8; relationship to service s9; cross-references to other Statements s10; Schedule 1 for defined terms and exposure/drug lists.)"},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-hypogonadism-reasonable-hypothesis-no-73-of-2021","history":"/api/acts/statement-of-principles-concerning-hypogonadism-reasonable-hypothesis-no-73-of-2021/history","analysis":"/api/acts/statement-of-principles-concerning-hypogonadism-reasonable-hypothesis-no-73-of-2021/analysis","conflicts":"/api/acts/statement-of-principles-concerning-hypogonadism-reasonable-hypothesis-no-73-of-2021/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-hypogonadism-reasonable-hypothesis-no-73-of-2021/important-cases","documents":"/api/acts/statement-of-principles-concerning-hypogonadism-reasonable-hypothesis-no-73-of-2021/documents"}}