Statement of Principles concerning malignant neoplasm of the bile duct (Reasonable Hypothesis) (No. 53 of 2024)

Administered by Department of Veterans' Affairs

Legislation au F2024L00755 In force Legislative Instrument

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EXPLANATORY STATEMENT

 

STATEMENT OF PRINCIPLES CONCERNING

MALIGNANT NEOPLASM OF THE BILE DUCT

(REASONABLE HYPOTHESIS) (NO. 53 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 bile duct (Reasonable Hypothesis) (No. 53 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. 69 of 2015 (Federal Register of Legislation No. F2015L00654) determined under subsections 196B(2) and (8) of the VEA concerning malignant neoplasm of the bile duct.

3.             The Authority is of the view that there is sound medical-scientific evidence that indicates that malignant neoplasm of the bile duct and death from malignant neoplasm of the bile duct can be related to particular kinds of service.  The Authority has therefore determined pursuant to subsection 196B(2) of the VEA a Statement of Principles concerning malignant neoplasm of the bile duct (Reasonable Hypothesis) (No. 53 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  This Instrument will in effect replace the repealed Statement of Principles.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 as a minimum exist, and which of those factors must be related to the following kinds of service rendered by a person:

 operational service under the VEA;

 peacekeeping service under the VEA;

 hazardous service under the VEA;

 British nuclear test defence service under the VEA;

 warlike service under the MRCA;

 non-warlike service under the MRCA,

before it can be said that a reasonable hypothesis has been raised connecting malignant neoplasm of the bile duct or death from malignant neoplasm of the bile duct, 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 bile duct 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 bile duct' in subsection 7(2);
  • revising ICD-10-AM codes for 'malignant neoplasm of the bile duct' in subsection 7(3);
  • revising the reference to 'ICD-10-AM code' in subsection 7(4);
  • revising the factor in subsection 9(1) concerning having an infestation of the hepatobiliary tract;
  • revising the factor in subsection 9(4) concerning having cholelithiasis, choledocholithiasis or hepatolithiasis;
  • new factor in subsection 9(5) concerning having had an injection of Thorotrast (thorium dioxide);
  • revising the factor in subsection 9(11) concerning inhaling respirable asbestos fibres in an enclosed space;
  • revising the factor in subsection 9(12) concerning inhaling respirable asbestos fibres in an open environment;
  • revising the factor in subsection 9(13) concerning undergoing solid organ transplantation;
  • revising the factor in subsection 9(14) concerning smoking;
  • new factor in subsection 9(15) concerning having non-alcoholic fatty liver disease;
  • new factor in subsection 9(16) concerning consuming alcohol;
  • new factor in subsection 9(17) concerning inhaling, ingesting or having cutaneous contact with 1,2-dichoropropane;
  • new factor in subsection 9(18) concerning having an infection with Helicobacter pylori, Helicobacter bilis or Helicobacter hepaticus;
  • new factor in subsection 9(19) concerning having IgG4 sclerosing cholangitis;
  • new factor in subsection 9(20) concerning having evidence of infection with Epstein-Barr virus;
  • deleting factor concerning having received a cumulative equivalent dose of ionising radiation'
  • new definitions of 'BMI', 'MRCA', 'one pack-year', 'ppm-years' and 'VEA' in Schedule 1 - Dictionary;
  • revising the definitions of 'being obese' , 'chronic infection with the hepatitis B virus' and 'chronic infection with the hepatitis C virus' in Schedule 1 - Dictionary; and
  • deleting the definitions of 'cumulative equivalent dose', 'pack-years of cigarettes, or the equivalent thereof in other tobacco products' and 'primary sclerosing cholangitis'.

Consultation

8.             Prior to determining this Instrument, the Authority advertised its intention to undertake an investigation in relation to malignant neoplasm of the bile duct 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 16 April 2024, 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 the factor relating to 'ionising radiation'.  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 bile duct 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. 53 of 2024

Kind of Injury, Disease or Death: Malignant neoplasm of the bile duct

 

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(2) 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 bile duct;
  • 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 as a minimum exist, before it can be said that a reasonable hypothesis has been raised, connecting malignant neoplasm of the bile duct with the circumstances of eligible service rendered by a person, as set out in clause 5 of the Explanatory Statement;
  • replaces Instrument No. 69 of 2015; and
  • reflects developments in the available sound medical-scientific evidence concerning malignant neoplasm of the bile duct 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 bile duct (Reasonable Hypothesis) (No. 53 of 2024), enacted in 2024, addresses the need for updated medical-scientific evidence concerning the connection between malignant neoplasm of the bile duct and specific military services. This Statement of Principles, determined by the Repatriation Medical Authority under the Veterans' Entitlements Act 1986 (VEA) and the Military Rehabilitation and Compensation Act 2004 (MRCA), aims to facilitate the assessment and compensation claims for veterans and service personnel suffering from this condition. The Authority was prompted to revise the existing principles due to new medical-scientific evidence, ensuring that the criteria for linking the disease with service are based on the most current research. This legislation replaces the previous Statement of Principles No. 69 of 2015 and incorporates the latest research findings, improving the medico-scientific quality of outcomes under the VEA and MRCA. The policy objective is to provide a transparent and proportionate framework for assessing claims, ensuring that veterans and service personnel receive the necessary medical treatment and compensation. This instrument ensures compatibility with human rights, promoting the rights to social security, an adequate standard of living, and the highest attainable standard of physical and mental health, without discrimination. It facilitates the assessment and determination of benefits for veterans and service personnel, ensuring that their rights are upheld under international human rights standards.

Scope and Application

The Statement of Principles concerning malignant neoplasm of the bile duct (Reasonable Hypothesis) (No. 53 of 2024) applies to individuals making claims under the Veterans' Entitlements Act 1986 (VEA) and the Military Rehabilitation and Compensation Act 2004 (MRCA). This legislation specifies the circumstances under which service-related malignant neoplasm of the bile duct and death from malignant neoplasm of the bile duct can be connected to particular kinds of service, including operational, peacekeeping, hazardous, British nuclear test defence service, warlike, and non-warlike service. The Instrument is determined by the Repatriation Medical Authority under the VEA and is applicable nationally across Australia. It replaces the previous Instrument No. 69 of 2015 and incorporates updated medical-scientific evidence. The application of the Instrument may be extended or restricted through subordinate instruments as necessary to reflect further developments in medical-scientific evidence. The Instrument does not contain any specific exclusions, exemptions, or thresholds beyond those outlined in the detailed factors that must be present for a reasonable hypothesis to be raised.

Key Provisions

The Statement of Principles concerning Malignant Neoplasm of the Bile Duct (Reasonable Hypothesis) (No. 53 of 2024) (the Instrument) outlines the circumstances under which claims for medical treatment and compensation related to malignant neoplasm of the bile duct can be assessed and approved for veterans and service members under the Veterans' Entitlements Act 1986 (VEA) and the Military Rehabilitation and Compensation Act 2004 (MRCA). This Instrument is determined under subsection 196B(2) of the VEA and replaces the previous Instrument No. 69 of 2015. The primary focus is on the sound medical-scientific evidence that links specific types of service with the onset of malignant neoplasm of the bile duct or death from such a condition. This includes various types of military service such as operational, peacekeeping, hazardous, and British nuclear test defence service under the VEA, and warlike and non-warlike service under the MRCA. The obligations imposed by the Instrument require claimants to provide evidence that the factors specified in the Statement of Principles are present and related to their service. The factors include specific medical conditions and exposures that must be related to the service to establish a reasonable hypothesis of connection between the service and the malignant neoplasm of the bile duct. These factors range from infestations of the hepatobiliary tract to exposure to various substances like asbestos fibres, Thorotrast, and 1,2-dichloropropane. Additionally, the Instrument requires claimants to demonstrate their service was of the kind specified in the Instrument. The Repatriation Commission and the Military Rehabilitation and Compensation Commission are tasked with assessing these claims based on the evidence provided and the criteria outlined in the Instrument. Failure to comply with the requirements of the Instrument, or providing false or misleading information, can lead to serious consequences. Under both the VEA and MRCA, there are provisions for penalties and legal actions against individuals who knowingly provide false information. Such actions may include fines, imprisonment, or both, depending on the severity of the offence. The maximum penalties for providing false information can vary, but typically include substantial fines and potential imprisonment terms. These legal repercussions are intended to ensure the integrity of the claims process and to protect the rights of legitimate claimants. In conclusion, the Statement of Principles concerning Malignant Neoplasm of the Bile Duct (Reasonable Hypothesis) (No. 53 of 2024) serves to guide both claimants and the authorities in the assessment and approval of claims related to malignant neoplasm of the bile duct. It sets forth the necessary factors and conditions that must be met for a claim to be considered valid, ensuring that the process is both thorough and fair. By doing so, it upholds the rights of veterans and service members to receive appropriate medical treatment and compensation while maintaining the integrity of the claims process.

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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.