_

Statement of Principles

concerning

CHRONIC MYELOID LEUKAEMIA

No. 48 of 2014

for the purposes of the

Veterans’ Entitlements Act 1986

and

Military Rehabilitation and Compensation Act 2004

Title

1. This Instrument may be cited as Statement of Principles concerning chronic myeloid leukaemia No. 48 of 2014.

Determination

2. The Repatriation Medical Authority under subsection 196B(3) and (8) of the Veterans’ Entitlements Act 1986 (the VEA):

(a) revokes Instrument No. 16 of 2003, as amended by Instrument No. 48 of 2011, concerning chronic myeloid leukaemia; and

(b) determines in their place this Statement of Principles.

Kind of injury, disease or death

3. (a) This Statement of Principles is about chronic myeloid leukaemia and death from chronic myeloid leukaemia.

(b) For the purposes of this Statement of Principles, "chronic myeloid leukaemia" means a malignant myeloproliferative disorder characterised by the clonal proliferation of myeloid cells in the bone marrow and their accumulation in the peripheral blood, and which is associated with the presence of the Philadelphia chromosome on cytogenetic analysis, or the presence of the BCR-ABL1 fusion gene or its product, BCR-ABL1 fusion mRNA, on molecular analysis. Chronic myeloid leukaemia is also known as chronic myelogenous leukaemia, chronic myelocytic leukaemia, chronic granulocytic leukaemia and chronic myeloblastic leukaemia. This definition excludes chronic myelomonocytic leukaemia.

(d) In the application of this Statement of Principles, the definition of "chronic myeloid leukaemia" is that given at paragraph 3(b) above.

Basis for determining the factors

4. On the sound medical-scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that chronic myeloid leukaemia and death from chronic myeloid leukaemia can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the Military Rehabilitation and Compensation Act 2004 (the MRCA).

Factors that must be related to service

5. Subject to clause 7, at least one of the factors set out in clause 6 must be related to the relevant service rendered by the person.

Factors

6. The factor that must exist before it can be said that, on the balance of probabilities, chronic myeloid leukaemia or death from chronic myeloid leukaemia is connected with the circumstances of a person’s relevant service is:

(a) smoking at least 30 pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical onset of chronic myeloid leukaemia, and where smoking has ceased, the clinical onset of chronic myeloid leukaemia has occurred within ten years of cessation; or

(b) having received a cumulative equivalent dose of at least 0.05 sievert of ionising radiation to the bone marrow at least two years before the clinical onset of chronic myeloid leukaemia; or

(c) undergoing treatment with radioactive iodine for cancer before the clinical onset of chronic myeloid leukaemia, where the first exposure occurred at least two years before the clinical onset of chronic myeloid leukaemia; or

(d) inability to obtain appropriate clinical management for chronic myeloid leukaemia.

Factors that apply only to material contribution or aggravation

7. Paragraph 6(d) applies only to material contribution to, or aggravation of, chronic myeloid leukaemia where the person’s chronic myeloid leukaemia was suffered or contracted before or during (but not arising out of) the person’s relevant service.

Inclusion of Statements of Principles

8. In this Statement of Principles if a relevant factor applies and that factor includes an injury or disease in respect of which there is a Statement of Principles then the factors in that last mentioned Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.

Other definitions

9. For the purposes of this Statement of Principles:

"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;

"death from chronic myeloid leukaemia" in relation to a person includes death from a terminal event or condition that was contributed to by the person’s chronic myeloid leukaemia;

"ICD-10-AM code" means a number assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Australian Modification (ICD-10-AM), Eighth Edition, effective date of 1 July 2013, copyrighted by the Independent Hospital Pricing Authority, and having ISBN 978-1-74128-213-9;

"pack-years of cigarettes, or the equivalent thereof in other tobacco products" means a calculation of consumption where one pack-year of cigarettes equals twenty tailor-made cigarettes per day for a period of one calendar year, or 7 300 cigarettes. One tailor-made cigarette approximates one gram of tobacco or one gram of cigar or pipe tobacco by weight. One pack-year of tailor-made cigarettes equates to 7.3 kilograms of smoking tobacco by weight. Tobacco products mean cigarettes, pipe tobacco or cigars, smoked alone or in any combination;

"relevant service" means:

(a) eligible war service (other than operational service) under the VEA;

(b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or

"terminal event" means the proximate or ultimate cause of death and includes:

(a) pneumonia;

(b) respiratory failure;

(d) circulatory failure; or

(e) cessation of brain function.

Application

10. This Instrument applies to all matters to which section 120B of the VEA or section 339 of the MRCA applies.

Date of effect

11. This Instrument takes effect from 7 May 2014.

Dated this twenty-fourth day of April 2014

The Common Seal of the )

Repatriation Medical Authority )

was affixed to this instrument )

in the presence of: )

PROFESSOR NICHOLAS SAUNDERS AO

CHAIRPERSON