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Statement of Principles

concerning

MALIGNANT NEOPLASM OF UNKNOWN PRIMARY SITE

No. 80 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 malignant neoplasm of unknown primary site No. 80 of 2014.

Determination

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

(a) revokes Instrument No. 44 of 2004, as amended by Instrument No. 69 of 2011, concerning malignant neoplasm of unknown primary site; and

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

Kind of injury, disease or death

3. (a) This Statement of Principles is about malignant neoplasm of unknown primary site and death from malignant neoplasm of unknown primary site.

(b) For the purposes of this Statement of Principles, "malignant neoplasm of unknown primary site" means a metastatic malignant neoplasm for which the site of origin cannot be determined after a complete history, physical examination and appropriate investigations have been carried out. This definition excludes soft tissue sarcoma, non-Hodgkin's lymphoma, Hodgkin's lymphoma and malignant melanoma.

(d) In the application of this Statement of Principles, the definition of "malignant neoplasm of unknown primary site" is that given at paragraph 3(b) above.

Basis for determining the factors

4. The Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that malignant neoplasm of unknown primary site and death from malignant neoplasm of unknown primary site 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 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 as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting malignant neoplasm of unknown primary site or death from malignant neoplasm of unknown primary site with the circumstances of a person’s relevant service is:

(a) smoking at least ten pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical onset of malignant neoplasm of unknown primary site, and

(i) smoking commenced at least five years before the clinical onset of malignant neoplasm of unknown primary site; and

(ii) where smoking has ceased, the clinical onset of malignant neoplasm of unknown primary site has occurred within 20 years of cessation; or

(b) drinking at least 250 kilograms of alcohol before the clinical onset of malignant neoplasm of unknown primary site, where drinking alcohol commenced at least five years before the clinical onset of malignant neoplasm of unknown primary site; or

(c) having received a cumulative equivalent dose of at least 0.1 sievert of ionising radiation to at least one location in the body, at least five years before the clinical onset of malignant neoplasm of unknown primary site; or

(d) for head and neck squamous cell carcinoma of unknown primary site, acquiring persistent infection of the oropharyngeal epithelium or of the laryngeal epithelium with human papilloma virus type 16 or 18 before the clinical onset of malignant neoplasm of unknown primary site; or

(e) inability to obtain appropriate clinical management for malignant neoplasm of unknown primary site.

Factors that apply only to material contribution or aggravation

7. Paragraph 6(e) applies only to material contribution to, or aggravation of, malignant neoplasm of unknown primary site where the person’s malignant neoplasm of unknown primary site 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:

"alcohol" is measured by the alcohol consumption calculations utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink;

"cumulative equivalent dose" means the total dose of ionising radiation received by the particular location in the body. 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 malignant neoplasm of unknown primary site" in relation to a person includes death from a terminal event or condition that was contributed to by the person’s malignant neoplasm of unknown primary site;

"head and neck squamous cell carcinoma of unknown primary site" means the presence of squamous cell carcinoma in one or more lymph nodes within the head and neck region that were not solely in the supra-clavicular fossa, without identification of a primary tumour after a complete history, physical examination and appropriate investigations have been carried out;

"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) operational service under the VEA;

(b) peacekeeping 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;

"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 120A of the VEA or section 338 of the MRCA applies.

Date of effect

11. This Instrument takes effect from 22 September 2014.

Dated this twenty-second day of August 2014

The Common Seal of the )

Repatriation Medical Authority )

was affixed at the direction of: )

PROFESSOR NICHOLAS SAUNDERS AO

CHAIRPERSON