Statement of Principles concerning MALIGNANT NEOPLASM OF THE URETHRA (Reasonable Hypothesis) (No. 19 of 2025) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986. Dated 18 February 2025. Professor Terence Campbell AM Chairperson by and on behalf of The Repatriation Medical Authority 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 malignant neoplasm of the urethra (Reasonable Hypothesis) (No. 19 of 2025). 1. Commencement This instrument commences on 25 March 2025. 1. Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 1. Repeal The Statement of Principles concerning malignant neoplasm of the urethra (Reasonable Hypothesis) (No. 49 of 2016) (Federal Register of Legislation No. F2016L00580) made under subsections 196B(2) of the VEA is repealed. 1. 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. 1. Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 1. Kind of injury, disease or death to which this Statement of Principles relates 1. This Statement of Principles is about malignant neoplasm of the urethra and death from malignant neoplasm of the urethra. Meaning of malignant neoplasm of the urethra 1. For the purposes of this Statement of Principles, malignant neoplasm of the urethra: 1. means a primary malignant neoplasm arising from the epithelial cells lining the urethra; and 2. includes: 1. adenocarcinoma of the urethra; 2. carcinoma in situ of the urethra; 3. clear cell adenocarcinoma of the urethra; 4. malignant neoplasms of the urethral accessory glands; 5. squamous cell carcinoma of the urethra; 6. urothelial cell carcinoma of the urethra; 7. urethral diverticular carcinoma; 8. primary melanoma of the urethra; and 3. excludes: 1. carcinoid tumours; 2. haematolymphoid tumours including non-Hodgkin lymphoma and Hodgkin lymphoma; 3. malignant neoplasm of the urethral orifice of the bladder; 4. metastatic cancer from other primary sites including bladder, ureter and renal pelvis; 5. soft tissue sarcoma. 2. While malignant neoplasm of the urethra attracts ICD‑10‑AM codes C68.0 and C68.1, in applying this Statement of Principles the meaning of malignant neoplasm of the urethra is that given in subsection (2). 3. 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 malignant neoplasm of the urethra 1. For the purposes of this Statement of Principles, malignant neoplasm of the urethra, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's malignant neoplasm of the urethra. Note: terminal event is defined in the Schedule 1 – Dictionary. 1. Basis for determining the factors The Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that malignant neoplasm of the urethra and death from malignant neoplasm of the urethra 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. 1. 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 malignant neoplasm of the urethra or death from malignant neoplasm of the urethra with the circumstances of a person's relevant service: 1. for squamous cell or mixed squamous and urothelial cell carcinomas only, having infection of the urethra with human papilloma virus (HPV) types 16 or 18 before clinical onset; 2. being exposed to arsenic in any of the following circumstances before clinical onset; 1. consuming drinking water with an average arsenic concentration of at least 50 micrograms per litre for a cumulative period of at least 10 years; 2. consuming drinking water resulting in a cumulative total arsenic exposure equivalent to having consumed drinking water containing at least 50 micrograms per litre for at least 10 years; 3. exposure resulting in clinical evidence of chronic arsenic toxicity; 3. having received a cumulative equivalent dose of at least 0.1 sieverts of ionising radiation to the affected site at least 5 years before clinical onset; Note: cumulative equivalent dose is defined in the Schedule 1 – Dictionary. 1. having a urethral diverticulum at the time of clinical onset; Note: Urethral diverticulum can be acquired and has been associated with infection of the periurethral glands, urethral trauma (e.g. during vaginal delivery), urethral dilatation or catheterisation, and a history of vaginal or urethral surgery (often for stress incontinence). 1. having smoked at least 5 pack-years before clinical onset, and smoking commenced at least 5 years before clinical onset; Note: one pack-year is defined in the Schedule 1 – Dictionary. 1. inability to obtain appropriate clinical management for malignant neoplasm of the urethra before clinical worsening. 1. 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(6) applies only to material contribution to, or aggravation of, malignant neoplasm of the urethra where the person's malignant neoplasm of the urethra was suffered or contracted before or during (but did not arise out of) the person's relevant service. 2. 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: cumulative equivalent dose means the total dose of ionising radiation received by the particular organ or tissue. The formula used to calculate the cumulative equivalent dose allows doses from multiple types of ionising radiation to be combined, by accounting for their differing biological effect. The unit of equivalent dose is the sievert. For the purposes of this Statement of Principles, the calculation of cumulative equivalent dose excludes doses received from normal background radiation, but includes therapeutic radiation, diagnostic radiation, cosmic radiation at high altitude, radiation from occupation-related sources and radiation from nuclear explosions or accidents. malignant neoplasm of the urethra—see subsection 7(2). MRCA means the Military Rehabilitation and Compensation Act 2004. one 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. 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. 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. 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 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.