Statement of Principles concerning primary myelofibrosis (Reasonable Hypothesis) (No. 89 of 2021) (Cth)

Statement of Principles concerning PRIMARY MYELOFIBROSIS (Reasonable Hypothesis) (No. 89 of 2021) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated 20 August 2021

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 primary myelofibrosis (Reasonable Hypothesis) (No. 89 of 2021). 2 Commencement This instrument commences on 20 September 2021. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning primary myelofibrosis No. 17 of 2013 (Federal Register of Legislation No. F2013L00416) made under subsection 196B(2) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004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 primary myelofibrosis and death from primary myelofibrosis. Meaning of primary myelofibrosis (2) For the purposes of this Statement of Principles, primary myelofibrosis: (a) means a chronic, Philadelphia-chromosome negative myeloproliferative neoplasm characterised by bone marrow megakaryocytic proliferation, resulting in the replacement of bone marrow with fibrous tissue, extramedullary haematopoiesis, splenomegaly and leukoerythroblastosis in the blood; and (b) excludes: (i) myelofibrosis secondary to essential thrombocythaemia, polycythaemia vera or another myeloid neoplasm; and (ii) secondary myelofibrosis resulting from other causes of bone marrow fibrosis including infections, autoimmune disorders or other chronic inflammatory conditions, hairy cell leukaemia or other lymphoid neoplasms, metastatic malignancies and toxic (chronic) myelopathies. Note: Typical clinical manifestations of primary myelofibrosis include fatigue, anaemia, bone pain and night sweats. Patients can be asymptomatic. Death from primary myelofibrosis (3) For the purposes of this Statement of Principles, primary myelofibrosis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's primary myelofibrosis. 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 primary myelofibrosis and death from primary myelofibrosis 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 primary myelofibrosis or death from primary myelofibrosis with the circumstances of a person's relevant service: (1) having smoked tobacco products: (a) in an amount of at least 10 pack-years before the clinical onset of primary myelofibrosis; and (b) commencing at least 5 years before the clinical onset of primary myelofibrosis; and if smoking has ceased before the clinical onset of primary myelofibrosis, then that onset occurred within 15 years of cessation; Note: one pack-year is defined in the Schedule 1 - Dictionary. (2) inability to obtain appropriate clinical management for primary myelofibrosis. 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(2) applies only to material contribution to, or aggravation of, primary myelofibrosis where the person's primary myelofibrosis 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.