Statement of Principles concerning malignant neoplasm of the breast (Reasonable Hypothesis) (No. 84 of 2023) (Cth)

Statement of Principles concerning MALIGNANT NEOPLASM OF THE BREAST (Reasonable Hypothesis) (No. 84 of 2023) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated 25 August 2023.

The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of:

Professor Terence Campbell AM 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 malignant neoplasm of the breast (Reasonable Hypothesis) (No. 84 of 2023). 2 Commencement This instrument commences on 26 September 2023. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning malignant neoplasm of the breast No. 96 of 2014 (Federal Register of Legislation No. F2014L01383) made under subsections 196B(2) and (8) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004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 malignant neoplasm of the breast and death from malignant neoplasm of the breast. Meaning of malignant neoplasm of the breast (2) For the purposes of this Statement of Principles, malignant neoplasm of the breast: (a) means a primary malignant neoplasm arising from the epithelial cells of the breast of males and females; and (b) includes: (i) carcinoma in situ; and (ii) Paget disease of the breast; and (c) excludes: (i) haematolymphoid tumours including non-Hodgkin lymphoma and Hodgkin lymphoma; (ii) malignant melanoma; and (iii) mesenchymal tumours including soft tissue sarcoma. (3) While malignant neoplasm of the breast attracts ICD‑10‑AM code C50 or D05, in applying this Statement of Principles the meaning of malignant neoplasm of the breast 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 malignant neoplasm of the breast (5) For the purposes of this Statement of Principles, malignant neoplasm of the breast, 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 breast. 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 malignant neoplasm of the breast and death from malignant neoplasm of the breast 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 malignant neoplasm of the breast or death from malignant neoplasm of the breast with the circumstances of a person's relevant service: (1) having received a cumulative equivalent dose of at least 0.1 sievert of ionising radiation to the breast at least 5 years before the clinical onset of malignant neoplasm of the breast; Note: cumulative equivalent dose is defined in the Schedule 1 - Dictionary. (2) taking menopausal hormone therapy for at least 1 year before the clinical onset of malignant neoplasm of the breast, and if the use of menopausal hormone therapy has ceased before the clinical onset of malignant neoplasm of the breast, then that onset occurred within 5 years of cessation; Note: menopausal hormone therapy is defined in the Schedule 1 - Dictionary. (3) using a combined oral contraceptive pill containing both estrogen and a progestogen: (a) for a continuous period of between 2 and 5 years where: (i) usage commenced at least 5 years before the clinical onset of malignant neoplasm of the breast; and (ii) if usage has ceased before the clinical onset of malignant neoplasm of the breast, then that onset occurred within 10 years of cessation; or (b) for a continuous period of at least 5 years where: (i) usage commenced at least 5 years before the clinical onset of malignant neoplasm of the breast; and (ii) if usage has ceased before the clinical onset of malignant neoplasm of the breast, then that onset occurred within 15 years of cessation; (4) taking diethylstilbestrol while pregnant before the clinical onset of malignant neoplasm of the breast; (5) receiving estrogen therapy for prostate cancer for at least 15 months before the clinical onset of malignant neoplasm of the breast; (6) for male to female transgender persons only, receiving transgender cross-sex hormone therapy containing estrogen for at least the 2 years before the clinical onset of malignant neoplasm of the breast; (7) for parous females only, inability to breast feed for a cumulative period of at least 3 months before the clinical onset of malignant neoplasm of the breast; Note 1: The period of breastfeeding could be cumulative over a number of pregnancies. Note 2: parous is defined in the Schedule 1 – Dictionary. (8) for females aged over 35 years only, being nulliparous at the time of the clinical onset of malignant neoplasm of the breast; Note: nulliparous is defined in the Schedule 1 – Dictionary. (9) being pregnant within the 25 years before the clinical onset of malignant neoplasm of the breast; (10) having a first live birth after the age of 30 years or having a first full-term pregnancy after the age of 30 years, before the clinical onset of malignant neoplasm of the breast; (11) having smoked tobacco products: (a) in an amount of at least 10 pack-years before the clinical onset of malignant neoplasm of the breast; and (b) commencing at least 5 years before the clinical onset of malignant neoplasm of the breast; and if smoking has ceased before the clinical onset of malignant neoplasm of the breast then that onset occurred within 30 years of cessation; Note: one pack-year is defined in the Schedule 1 - Dictionary. (12) having been exposed to second-hand smoke: (a) for at least 10,000 hours before the clinical onset of malignant neoplasm of the breast; and (b) commencing at least 5 years before the clinical onset of malignant neoplasm of the breast; and if exposure to second-hand smoke has ceased before the clinical onset of malignant neoplasm of the breast, then that onset occurred within 30 years of cessation; Note: having been exposed to second-hand smoke is defined in the Schedule 1 – Dictionary. (13) for females only, consuming alcohol: (a) in an amount of at least 40 kilograms before the clinical onset of malignant neoplasm of the breast; and (b) at least 5 years before the clinical onset of malignant neoplasm of the breast; and if consumption of alcohol has ceased before the clinical onset of malignant neoplasm of the breast, then that onset occurred within 40 years of cessation; Note: Alcohol consumption is calculated utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink. (14) inability to undertake any physical activity greater than 3 METs for at least 5 consecutive years within the 30 years before the clinical onset of malignant neoplasm of the breast; Note: MET is defined in the Schedule 1 – Dictionary. (15) for males and postmenopausal females only, being obese for a period of at least 5 years within the 20 years before the clinical onset of malignant neoplasm of the breast; Note: being obese is defined in the Schedule 1 - Dictionary. (16) for males and postmenopausal females only, having diabetes mellitus before the clinical onset of malignant neoplasm of the breast; (17) for death from malignant neoplasm of the breast only, for females aged 50 to 69 years, being prevented from accessing mammographic screening for malignant neoplasm of the breast in accordance with contemporary medical standards at the time, within the 10 years before the clinical onset of malignant neoplasm of the breast, and where: (a) if mammographic screening has been resumed in the interim, there has been no normal test result; and (b) the opportunity for subsequent appropriate mammographic screening has not been declined; (18) taking digoxin, digitalis or digitoxin for a continuous period of at least 1 year before the clinical onset of malignant neoplasm of the breast, and if taking digoxin, digitalis or digitoxin has ceased before the clinical onset of malignant neoplasm of the breast, then that onset occurred within 5 years of cessation; (19) inhaling ethylene oxide vapour: (a) at an ambient 8-hour time-weighted average concentration of at least 1.5 parts per million for a cumulative total of at least 2,500 hours within a continuous period of 10 years before the clinical onset of malignant neoplasm of the breast; or (b) in an amount greater than 10 ppm-years of cumulative exposure before the clinical onset of malignant neoplasm of the breast; and where the first exposure occurred at least 5 years before the clinical onset of malignant neoplasm of the breast; Note 1: Inhalation of ethylene oxide vapour can occur during the sterilisation of surgical instruments or protective clothing in hospitals. Note 2: 8-hour time-weighted average and ppm-years are defined in the Schedule 1 - Dictionary. (20) undertaking night shift work: (a) on at least 3 nights per week for a minimum of 10 hours per shift; and (b) for a continuous period of at least 5 years before the clinical onset of malignant neoplasm of the breast; and if night shift work has ceased before the clinical onset of malignant neoplasm of the breast, then that onset occurred within 3 years of cessation; (21) inability to obtain appropriate clinical management for malignant neoplasm of the breast before the clinical worsening of malignant neoplasm of the breast. 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 factor set out in subsection 9(21) applies only to material contribution to, or aggravation of, malignant neoplasm of the breast where the person's malignant neoplasm of the breast 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.