Statement of Principles concerning localised sclerosis (Balance of Probabilities) (No. 62 of 2018)

Administered by Department of Veterans' Affairs

Legislation au F2018L00884 In force Legislative Instrument

Legislation content

Statement of Principles concerning localised sclerosis (Balance of Probabilities) (No. 62 of 2018)

made under subsection 196B(3) of the

Veterans' Entitlements Act 1986

Compilation No. 1  

Compilation date:   23 July 2018

Includes amendments up to: Amendment Statement of Principles concerning localised sclerosis (Balance of Probabilities) (No. 16 of 2019) (F2019L00006)

The day of commencement of this Amendment Statement of Principles concerning localised sclerosis is 23 July 2018.

 

About this compilation

 

This compilation

This is a compilation of the Statement of Principles concerning localised sclerosis (Balance of Probabilities) (No. 62 of 2018) that shows the text of the law as amended and in force on 23 July 2018.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Selfrepealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

 

 

 

Statement of Principles

concerning

LOCALISED SCLEROSIS
(Balance of Probabilities)

(No. 62 of 2018)

The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.

 

Dated 22 June 2018

 

 

 

 

 

 

 

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 localised sclerosis (Balance of Probabilities) (No. 62 of 2018).

2               Commencement

This instrument commences on 23 July 2018.

3               Authority

This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.

4               Repeal

The Statement of Principles concerning localised sclerosis No. 67 of 2009 (Federal Register of Legislation No. F2009L03230) made under subsection 196B(3) of the VEA is repealed.

5               Application

This instrument applies to a claim to which section 120B of the VEA or section 339 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 localised sclerosis and death from localised sclerosis.

Meaning of localised sclerosis

(2)          For the purposes of this Statement of Principles, localised sclerosis (also known as localised scleroderma or morphea):

(a)          means an autoimmune, fibrosing connective tissue disorder characterised by localised skin thickening with increased quantities of collagen; and

(b)          excludes systemic sclerosis, graft versus host disease with dermal fibrosis, and scleroderma-like conditions (for example, lipodermatosclerosis, scleromyxoedema, eosinophilic fasciitis and chronic radiation dermatitis).

Note 1: Localised sclerosis is limited to the skin, subcutaneous tissue and underlying bone.

Note 2: Localised sclerosis typically presents with an absence of sclerodactyly, Raynaud phenomenon and nailfold capillary changes, and is not associated with major vascular symptoms or with visceral disease.

Note 3: The diagnosis of localised sclerosis is based on clinical findings, although histopathologic confirmation is sometimes needed to rule out other diseases.  Serological markers for localised sclerosis include elevated levels of antinuclear antibody, anti-ssDNA antibody, anti-topoisomerase II alpha antibody and rheumatoid factor.

(3)          While localised sclerosis attracts ICD10AM code L94.0 or L94.1, in applying this Statement of Principles the meaning of localised sclerosis 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 localised sclerosis

(5)          For the purposes of this Statement of Principles, localised sclerosis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's localised sclerosis.

Note: terminal event is defined in the Schedule 1 – Dictionary.

8               Basis for determining the factors

On the sound medicalscientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that localised sclerosis and death from localised sclerosis can be related to relevant service rendered by veterans 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 exist before it can be said that, on the balance of probabilities, localised sclerosis or death from localised sclerosis is connected with the circumstances of a person's relevant service:

(1)          being treated with a drug or a drug from a class of drugs from the specified list of drugs at the time of the clinical onset of localised sclerosis;

Note: specified list of drugs is defined in the Schedule 1 - Dictionary.

(2)          undergoing a course of therapeutic radiation for cancer, where the affected site was in the field of radiation, before the clinical onset of localised sclerosis;

(3)          being treated with a drug or a drug from a class of drugs from the specified list of drugs at the time of the clinical worsening of localised sclerosis;

Note: specified list of drugs is defined in the Schedule 1 - Dictionary.

(4)          undergoing a course of therapeutic radiation for cancer, where the affected site was in the field of radiation, before the clinical worsening of localised sclerosis;

(5)          inability to obtain appropriate clinical management for localised sclerosis.

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 factors set out in subsections 9(3) to 9(5) apply only to material contribution to, or aggravation of, localised sclerosis where the person's localised sclerosis 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(3) 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:

                             localised sclerosis—see subsection 7(2).

                             MRCA means the Military Rehabilitation and Compensation Act 2004.

                             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

(c)          peacetime service under the MRCA.

Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary.

                               specified list of drugs means:

(a)          balicatib;

(b)          bleomycin;

(c)          enfuvirtide;

(d)          pemetrexed;

(e)          taxanes; or

(f)           tumour necrosis factor-α inhibitors.

                             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.

 

 

 

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history. 

Endnote 2—Abbreviation key

 

o = order(s)

ad = added or inserted

Ord = Ordinance

am = amended

orig = original

amdt = amendment

par = paragraph(s)/subparagraph(s)

c = clause(s)

    /subsubparagraph(s)

C[x] = Compilation No. x

pres = present

Ch = Chapter(s)

prev = previous

def = definition(s)

(prev…) = previously

Dict = Dictionary

Pt = Part(s)

disallowed = disallowed by Parliament

r = regulation(s)/rule(s)

Div = Division(s)

 

exp = expires/expired or ceases/ceased to have

reloc = relocated

    effect

renum = renumbered

F = Federal Register of Legislation

rep = repealed

gaz = gazette

rs = repealed and substituted

LA = Legislation Act 2003

s = section(s)/subsection(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

(md) = misdescribed amendment can be given

Sdiv = Subdivision(s)

    effect

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

    cannot be given effect

SubCh = SubChapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

 

    commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Statement of Principles concerning localised sclerosis (Balance of Probabilities) (No. 62 of 2018)

 

26 June 2018

 

F2018L00884

23 July 2018

 

 

Amendment Statement of Principles concerning localised sclerosis (Balance of Probabilities) (No. 16 of 2019)

 

2 January 2019

 

F2019L00006

 

23 July 2018

 

 

 

Endnote 4—Amendment history

 

Provision affected

How affected

Subsection 9(1)……..

am. No. 16 of 2019

Subsection 9(3)……..

am. No. 16 of 2019

 

 

Overview

The Statement of Principles concerning localised sclerosis (Balance of Probabilities) (No. 62 of 2018) was enacted to address the need for a comprehensive understanding and recognition of the relationship between localised sclerosis and the service rendered by veterans, members of the Australian Defence Force, and other eligible persons. This legislative instrument was made under subsection 196B(3) of the Veterans' Entitlements Act 1986 and is administered by the Repatriation Medical Authority. The policy objective is to ensure that claims related to localised sclerosis are evaluated based on sound medical-scientific evidence, thereby facilitating appropriate recognition and compensation for veterans and other eligible persons suffering from this condition or its consequences. This legislation came into effect on 23 July 2018 and repealed the previous Statement of Principles concerning localised sclerosis No. 67 of 2009. It applies to claims made under the Veterans' Entitlements Act 1986 or the Military Rehabilitation and Compensation Act 2004, providing a structured framework for determining the connection between localised sclerosis and relevant service.

Scope and Application

The Statement of Principles concerning localised sclerosis (Balance of Probabilities) (No. 62 of 2018), made under subsection 196B(3) of the Veterans' Entitlements Act 1986, applies to claims under section 120B of the Veterans' Entitlements Act 1986 or section 339 of the Military Rehabilitation and Compensation Act 2004. This Statement of Principles pertains to veterans and members of the Australian Defence Force who have been diagnosed with localised sclerosis, a condition also known as localised scleroderma or morphea, which is an autoimmune, fibrosing connective tissue disorder. This particular legislation excludes systemic sclerosis, graft versus host disease with dermal fibrosis, and scleroderma-like conditions such as lipodermatosclerosis, scleromyxoedema, eosinophilic fasciitis, and chronic radiation dermatitis. The Statement of Principles sets out the factors that must be present to establish a connection between the localised sclerosis and the relevant service rendered by the veterans or members of the Defence Force, such as treatment with specified drugs or therapeutic radiation for cancer at the time of clinical onset or worsening of the condition. The factors are designed to ascertain whether the localised sclerosis was materially contributed to or aggravated by the relevant service. The application of this Statement of Principles is subject to amendment through subordinate instruments, and the legislation also repealed the previous Statement of Principles concerning localised sclerosis No. 67 of 2009.

Key Provisions

The main operative sections of the Statement of Principles concerning localised sclerosis (Balance of Probabilities) (No. 62 of 2018) establish the criteria for determining whether a veteran's localised sclerosis or death from localised sclerosis is connected to their relevant service. Specifically, section 7 identifies the kind of injury, disease, or death this Statement of Principles pertains to, namely localised sclerosis and death from localised sclerosis. Section 8 outlines the basis for determining these connections, which is on the sound medical-scientific evidence available. Section 9 lists the factors that must exist for a connection to be made, such as treatment with specific drugs or undergoing therapeutic radiation for cancer in the affected site before the onset or worsening of localised sclerosis. Finally, section 10 clarifies the relationship to service, stating that the existence of any of the factors in section 9 must be related to the relevant service rendered by the person. The obligations and requirements imposed by this legislation primarily concern the Repatriation Medical Authority, which must determine whether the specified factors exist in a veteran's case. The Authority must assess whether at least one of the factors listed in section 9 is present and related to the veteran's relevant service. If such factors are present, it is more probable than not that the localised sclerosis or death from localised sclerosis is connected to the veteran's service, as per section 8. The Authority must rely on the sound medical-scientific evidence available to make these determinations. The Statement of Principles concerning localised sclerosis does not explicitly state any offences, penalties, or civil/criminal consequences for breach. However, the legislation falls under the purview of the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004, which include provisions for enforcement and penalties related to the administration of veterans' entitlements and compensation. Breaches of these acts could lead to penalties as prescribed within those respective acts, but such consequences are not detailed in this specific Statement of Principles.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.