Statement of Principles concerning malignant neoplasm of the gallbladder (Balance of Probabilities) (No. 37 of 2024)

Administered by Department of Veterans' Affairs

Legislation au F2024L00488 In force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

STATEMENT OF PRINCIPLES CONCERNING

MALIGNANT NEOPLASM OF THE GALLBLADDER

(BALANCE OF PROBABILITIES) (NO. 37 OF 2024)

 

VETERANS' ENTITLEMENTS ACT 1986

MILITARY REHABILITATION AND COMPENSATION ACT 2004

 

  1. This is the Explanatory Statement to the Statement of Principles concerning malignant neoplasm of the gallbladder (Balance of Probabilities) (No. 37 of 2024).

Background

2.             The Repatriation Medical Authority (the Authority), under subsection 196B(8) of the Veterans' Entitlements Act 1986 (the VEA), repeals Instrument No. 90 of 2015 (Federal Register of Legislation No. F2015L00922) determined under subsections 196B(3) and (8) of the VEA concerning malignant neoplasm of the gallbladder.

3.             The Authority is of the view that on the sound medical-scientific evidence available it is more probable than not that malignant neoplasm of the gallbladder and death from malignant neoplasm of the gallbladder can be related to particular kinds of service.  The Authority has therefore determined pursuant to subsection 196B(3) of the VEA a Statement of Principles concerning malignant neoplasm of the gallbladder (Balance of Probabilities) (No. 37 of 2024).  This Instrument will in effect replace the repealed Statement of Principles.

Purpose and Operation

4.             The Statement of Principles will be applied in determining claims under the VEA and the Military Rehabilitation and Compensation Act 2004 (the MRCA).

5.             The Statement of Principles sets out the factors that must exist, and which of those factors must be related to the following kinds of service rendered by a person:

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

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

 peacetime service under the MRCA,

before it can be said that, on the balance of probabilities, malignant neoplasm of the gallbladder or death from malignant neoplasm of the gallbladder is connected with the circumstances of that service.  The Statement of Principles has been determined for the purposes of both the VEA and the MRCA.

6.             This Instrument results from an investigation notified by the Authority in the Government Notices Gazette of 1 November 2022 concerning malignant neoplasm of the gallbladder in accordance with section 196G of the VEA.  The investigation involved an examination of the sound medical-scientific evidence now available to the Authority, including the sound medical-scientific evidence it has previously considered.

7.             The contents of this Instrument are in similar terms as the repealed Instrument.  Comparing this Instrument and the repealed Instrument, the differences include:

  • adopting the latest revised Instrument format, which commenced in 2015;
  • specifying a day of commencement for the Instrument in section 2;
  • revising the definition of 'malignant neoplasm of the gallbladder' in subsection 7(2);
  • revising ICD-10-AM codes for 'malignant neoplasm of the gallbladder' in subsection 7(3);
  • revising the reference to 'ICD-10-AM code' in subsection 7(4);
  • revising the factors in Section 9 that must as a minimum exist before it can be said that on the balance of probabilities malignant neoplasm of the gallbladder or death from malignant neoplasm of the gallbladder are connected with the circumstances of a veteran's relevant service. The revision is required to reflect advances in sound medical scientific evidence that have occurred since the repealed Statement of Principles was made;
  • deleting factor concerning ionising radiation;
  • new factor in subsection 9(4) concerning having had an intravascular injection of Thorotrast (thorium dioxide);
  • new factor in subsection 9(8) concerning having chronic infection with hepatitis B or C virus;
  • new definitions of 'BMI' and 'chronic infection with hepatitis B or C' in Schedule 1 - Dictionary; and
  • deleting the definition of 'cumulative equivalent dose'.

Consultation

8.             Prior to determining this Instrument, the Authority advertised its intention to undertake an investigation in relation to malignant neoplasm of the gallbladder in the Government Notices Gazette of 1 November 2022, and circulated a copy of the notice of intention to investigate to a wide range of organisations representing veterans, service personnel and their dependants.  The Authority invited submissions from the Repatriation Commission, the Military Rehabilitation and Compensation Commission, organisations and persons referred to in section 196E of the VEA, and any person having expertise in the field.  No submissions were received for consideration by the Authority in relation to the investigation.

9.             On 22 December 2023, the Authority wrote to organisations representing veterans, service personnel and their dependants regarding the proposed Instrument and the medical-scientific material considered by the Authority.  This letter emphasised the deletion of factors relating to 'having received a cumulative equivalent dose of at least 0.5 sievert of ionising radiation to the gallbladder at least ten years before the clinical onset of malignant neoplasm of the gallbladder'.  The Authority provided an opportunity to the organisations to make representations in relation to the proposed Instrument prior to its determination.  No submissions were received for consideration by the Authority.  No changes were made to the proposed Instrument following this consultation process.

Human Rights

10.         This instrument is compatible with the Human Rights and Freedoms recognised or declared in the International Instruments listed in Section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.  A Statement of Compatibility with Human Rights follows.

Finalisation of Investigation

11.         The determining of this Instrument finalises the investigation in relation to malignant neoplasm of the gallbladder as advertised in the Government Notices Gazette of 1 November 2022.

References

12.         A list of references relating to the above condition is available on the Authority's website at: www.rma.gov.au. Any other document referred to in this Statement of Principles is available on request to the Repatriation Medical Authority at the following address:

              

Email:    info@rma.gov.au

Post:      The Registrar

Repatriation Medical Authority

GPO Box 1014

BRISBANE    QLD    4001


Statement of Compatibility with Human Rights

(Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011)

 

Instrument No.:   Statement of Principles No. 37 of 2024

Kind of Injury, Disease or Death: Malignant neoplasm of the gallbladder

 

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

1. This Legislative Instrument is determined pursuant to subsection 196B(3) of the Veterans' Entitlements Act 1986 (the VEA) for the purposes of the VEA and the Military Rehabilitation and Compensation Act 2004 (the MRCA).  Part XIA of the VEA requires the determination of these instruments outlining the factors connecting particular kinds of injury, disease or death with service such being determined solely on the available sound medical-scientific evidence.

2. This Legislative Instrument:-

  • facilitates claimants in making, and the Repatriation Commission and the Military Rehabilitation and Compensation Commission in assessing, claims under the VEA and the MRCA respectively, by specifying the circumstances in which medical treatment and compensation can be extended to eligible persons who have malignant neoplasm of the gallbladder;
  • facilitates the review of such decisions by the Veterans' Review Board and the Administrative Appeals Tribunal;
  • outlines the factors which the current sound medical-scientific evidence indicates must exist before it can be said that, on the balance of probabilities, malignant neoplasm of the gallbladder is connected with the circumstances of eligible service rendered by a person, as set out in clause 5 of the Explanatory Statement;
  • replaces Instrument No. 90 of 2015; and
  • reflects developments in the available sound medical-scientific evidence concerning malignant neoplasm of the gallbladder which have occurred since that earlier instrument was determined. 

3. The Instrument is assessed as being a technical instrument which improves the medico-scientific quality of outcomes under the VEA and the MRCA. 

Human Rights Implications

4. This Legislative Instrument does not derogate from any human rights. It promotes the human rights of veterans, current and former Defence Force members as well as other persons such as their dependents, including:

  • the right to social security (Art 9, International Covenant on Economic, Social and Cultural Rights; Art 26, Convention on the Rights of the Child and Art 28, Convention on the Rights of Persons with Disabilities) by helping to ensure that the qualifying conditions for the benefit are 'reasonable, proportionate and transparent'[1];
  • the right to an adequate standard of living (Art 11, ICESCR; Art 27, CRC and Art 28, CRPD) by facilitating the assessment and determination of social security benefits;
  • the right to the enjoyment of the highest attainable standard of physical and mental health (Art 12, ICESCR and Art 25, CRPD), by facilitating the assessment and determination of compensation and benefits in relation to the treatment and rehabilitation of veterans and Defence Force members;
  • the rights of persons with disabilities by facilitating the determination of claims relating to treatment and rehabilitation (Art 26, CRPD); and
  • ensuring that those rights "will be exercised without discrimination of any kind as to race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status" (Art 2, ICESCR).

Conclusion

This Legislative Instrument is compatible with human rights as it does not derogate from and promotes a number of human rights.

 

Repatriation Medical Authority

 

 

 

 

 

 

[1] In General Comment No. 19 (The right to social security), the Committee on Economic, Social and Cultural Rights said (at paragraph 24) this to be one of the elements of ensuring accessibility to social security.

Overview

The Statement of Principles concerning malignant neoplasm of the gallbladder (Balance of Probabilities) (No. 37 of 2024), enacted by the Repatriation Medical Authority under the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004, aims to address the gap in connecting malignant neoplasm of the gallbladder and its resulting fatalities to specific kinds of service rendered by veterans and service personnel. This legislative instrument replaces the previous Instrument No. 90 of 2015, incorporating updated medical-scientific evidence and a revised format to better reflect current understandings of the condition. It identifies the necessary factors for a claim to be substantiated, including new considerations such as chronic infection with hepatitis B or C virus, and the deletion of certain previous factors, such as those relating to ionising radiation. The Authority sought and considered no submissions during the process of determining this instrument, which concludes the investigation into malignant neoplasm of the gallbladder initiated in 2022. This instrument facilitates claims and reviews under the VEA and MRCA, ensuring that veterans and their dependents can access appropriate benefits and compensation based on the latest evidence. The instrument is designed to be compatible with human rights, promoting the rights of veterans and their families without discrimination.

Scope and Application

The Statement of Principles concerning malignant neoplasm of the gallbladder (Balance of Probabilities) (No. 37 of 2024), determined by the Repatriation Medical Authority under the Veterans' Entitlements Act 1986, applies to veterans and current or former Defence Force members who have malignant neoplasm of the gallbladder or who have died from this condition, and are seeking benefits or compensation under the VEA or the Military Rehabilitation and Compensation Act 2004. This legislation sets out the criteria that must be met for a veteran's or service member's gallbladder cancer to be considered connected with their service, thereby qualifying them for related benefits and compensation. The factors outlined include specific conditions relating to exposure to certain substances or infections, and exclude others that were considered in previous legislation, such as exposure to ionising radiation. The determination of these principles is based on the latest sound medical-scientific evidence available, replacing the previously repealed Statement of Principles No. 90 of 2015. This new instrument ensures that the assessment of claims remains current and reflects advances in medical understanding. The Authority consulted with relevant organisations and stakeholders during the investigation and drafting of the principles but did not receive any submissions for consideration. The principles are designed to facilitate the claims process and are compatible with human rights, ensuring that benefits are accessible and non-discriminatory.

Key Provisions

The Statement of Principles concerning malignant neoplasm of the gallbladder (Balance of Probabilities) (No. 37 of 2024) (the Instrument), determined under subsection 196B(3) of the Veterans' Entitlements Act 1986 (VEA), outlines the circumstances under which malignant neoplasm of the gallbladder or death from malignant neoplasm of the gallbladder can be considered connected to service (sections 4 and 5). This determination applies to eligible war service (other than operational service), defence service (other than hazardous service and British nuclear test defence service), and peacetime service (section 5). The Instrument outlines the factors that must exist for a connection to be established, including new factors such as having had an intravascular injection of Thorotrast (thorium dioxide) or chronic infection with hepatitis B or C virus (subsection 9). It also revises certain definitions and ICD-10-AM codes related to malignant neoplasm of the gallbladder (subsections 7 and 9). The Instrument is intended to facilitate the assessment of claims under the VEA and the Military Rehabilitation and Compensation Act 2004 (MRCA) and replaces the repealed Instrument No. 90 of 2015 (section 7). The Authority is required to determine such Statements of Principles solely on the available sound medical-scientific evidence (subsection 196B(3) of the VEA). The Instrument must be applied when assessing claims under the VEA and MRCA (section 4). The Authority must also ensure that claimants and the relevant Commissions (Repatriation and Military Rehabilitation and Compensation) are aware of the requirements and factors outlined in the Instrument (section 6). Failure to apply the Instrument correctly could lead to improper assessment of claims, potentially resulting in claimants not receiving benefits to which they are entitled, or conversely, claimants receiving benefits to which they are not entitled. This could have significant legal and financial repercussions for both the claimants and the government. The Statement of Principles imposes obligations on claimants, the Repatriation Commission, the Military Rehabilitation and Compensation Commission, and the Veterans' Review Board and the Administrative Appeals Tribunal to ensure that claims are assessed correctly in accordance with the Instrument. Claimants must provide sufficient evidence to demonstrate that the factors outlined in the Instrument exist and are related to their service. The Repatriation Commission and the Military Rehabilitation and Compensation Commission are responsible for assessing claims and determining whether the conditions of the Instrument are met. The Veterans' Review Board and the Administrative Appeals Tribunal are responsible for reviewing decisions made by the Commissions. The Authority must also ensure that the Instrument is applied consistently and that all relevant parties are aware of its provisions. Failure to comply with these obligations could result in legal challenges and the potential for claimants to be unfairly denied benefits. The Statement of Principles does not create specific offences or penalties for breach. However, any failure to apply the Instrument correctly in the assessment of claims could lead to legal consequences. Claimants who are unfairly denied benefits may seek review and appeal through the Veterans' Review Board and the Administrative Appeals Tribunal. If the Authority fails to apply the Instrument correctly, it could face legal challenges and potential reputational damage. Additionally, claimants who are found to have provided false information in their claims could face penalties under the VEA and MRCA, including fines and imprisonment. The maximum penalties for fraud under the VEA are a fine of up to 120 penalty units ($22,200) or imprisonment for up to five years, or both (section 205). Under the MRCA, the maximum penalty for fraud is a fine of up to 120 penalty units ($22,200) or imprisonment for up to two years, or both (section 313). The Authority must ensure that the Instrument is applied correctly to avoid these potential legal and financial consequences.

Legal classification tags

Area of Law
Veterans' Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Reporting & Disclosure Obligations
Prohibited Conduct

Interactions

Authorises

All Versions

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.