Statement of Principles concerning toxic retinopathy (Reasonable Hypothesis) (No. 19 of 2018)

Administered by Department of Veterans' Affairs

Legislation au F2018L00192 In force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

STATEMENT OF PRINCIPLES CONCERNING

TOXIC RETINOPATHY

(REASONABLE HYPOTHESIS) (NO. 19 OF 2018)

 

VETERANS' ENTITLEMENTS ACT 1986

MILITARY REHABILITATION AND COMPENSATION ACT 2004

 

  1. This is the Explanatory Statement to the Statement of Principles concerning toxic retinopathy (Reasonable Hypothesis) (No. 19 of 2018).

Background

2.             The Repatriation Medical Authority (the Authority), under subsection 196B(8) of the Veterans' Entitlements Act 1986 (the VEA), revokes Instrument No. 39 of 2009, determined under subsection 196B(2) of the VEA concerning toxic maculopathy.

3.             The Authority is of the view that there is sound medical-scientific evidence that indicates that toxic retinopathy and death from toxic retinopathy 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 toxic retinopathy (Reasonable Hypothesis) (No. 19 of 2018).  This Instrument will in effect replace the revoked 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 toxic retinopathy or death from toxic retinopathy, 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 19 October 2016 concerning toxic maculopathy 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 revoked Instrument.  Comparing this Instrument and the revoked 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;
  • changing the title of the Instrument to 'toxic retinopathy';
  • revising the definition of 'toxic retinopathy' in subsection 7(2);
  • new factor in subsection 9(1) concerning 'being treated with a quinoline-based drug';
  • revising the factor in subsection 9(2) concerning 'being treated with tamoxifen';
  • new factor in subsection 9(3) concerning 'being treated with an intravitreal or subconjunctival aminoglycoside';
  • new factor in subsection 9(4) concerning 'being treated with intravitreal fomivirsen or ganciclovir';
  • new factor in subsection 9(5) concerning 'being treated with intravenous deferoxamine';
  • revising the factor in subsection 9(6) concerning 'being treated with a phenothiazine';
  • revising the factor in subsection 9(7) concerning 'being treated with daily clofazimine';
  • new factor in subsection 9(8) concerning 'being treated with ritonavir';
  • new factor in subsection 9(9) concerning 'being treated with interferon';
  • new factor in subsection 9(10) concerning 'being treated with daily topiramate';
  • revising the factor in subsection 9(11) concerning 'having iron chelating therapy';
  • new factor in subsection 9(12) concerning 'haematological or biochemical evidence of poisoning with cobalt';
  • new factor in subsection 9(13) concerning 'taking oral canthaxanthin supplements or tablets';
  • new factor in subsection 9(14) concerning 'inhaling isopropyl nitrite';
  • new factor in subsection 9(15) concerning 'using an intravenous drug containing talc';
  • new factor in subsection 9(16)(a) concerning 'being treated with daily niacin', for cystoid macular oedema only;
  • new factor in subsection 9(16)(b) concerning 'being treated with intravenous paclitaxel or docetaxel', for cystoid macular oedema only;
  • new factor in subsection 9(16)(c) concerning 'being treated with the thiazolidinedione drugs rosiglitazone or pioglitazone', for cystoid macular oedema only;
  • new factor in subsection 9(17)(a) concerning 'being treated with topical adrenaline eye drops', for cystoid macular oedema only, in an aphakic or pseudophakic eye only;
  • new factor in subsection 9(17)(b) concerning 'being treated with latanoprost', for cystoid macular oedema only, in an aphakic or pseudophakic eye only;
  • deleting the factor concerning 'being treated with chloroquine, hydroxychloroquine or mepacrine' as it is now subsumed by the factor in subsection 9(1) concerning 'being treated with a quinoline-based drug';
  • deleting the factor concerning 'intravitreal gentamicin, amikacin or fomivirsen' as it is now subsumed by the factors in subsections 9(3) & 9(4) concerning 'being treated with an intravitreal or subconjunctival aminoglycoside' and 'being treated with intravitreal fomivirsen or ganciclovir', respectively;
  • new definitions of 'aphakic or pseudophakic eye', 'being treated with a quinoline-based drug as specified', 'being treated with tamoxifen as specified', 'cystoid macular oedema', 'MRCA', 'specified list of aminoglycosides', 'specified list of phenothiazines', 'taking oral canthaxanthin supplements or tablets as specified' and 'VEA' in Schedule 1 - Dictionary;
  • revising the definitions of 'iron chelating therapy as specified' and 'relevant service' in Schedule 1 - Dictionary; and
  • deleting the definitions of 'a phenothiazine as specified' and 'being treated with chloroquine, hydroxychloroquine or mepacrine as specified'.

Consultation

8.             Prior to determining this Instrument, the Authority advertised its intention to undertake an investigation in relation to toxic maculopathy in the Government Notices Gazette of 19 October 2016, 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, 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 during the investigation.

Human Rights

9.             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

10.         The determining of this Instrument finalises the investigation in relation to toxic maculopathy as advertised in the Government Notices Gazette of 19 October 2016.

References

11.         A list of references relating to the above condition is available to any person or organisation referred to in subsection 196E(1)(a) to (c) of the VEA.  Any such request must be made in writing to the Repatriation Medical Authority at the following address:

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. 19 of 2018

Kind of Injury, Disease or Death: Toxic retinopathy

 

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(8) 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 linking 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 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 toxic retinopathy;
  • 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 toxic retinopathy with the circumstances of eligible service rendered by a person, as set out in clause 5 of the Explanatory Statement;
  • replaces Instrument No. 39 of 2009; and
  • reflects developments in the available sound medical-scientific evidence concerning toxic retinopathy 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, ICSECR; 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, ICSECR 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 toxic retinopathy (Reasonable Hypothesis) (No. 19 of 2018) is an instrument enacted under the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004, aimed at addressing the problem of determining eligibility for compensation and medical treatment for veterans and Defence personnel who have developed toxic retinopathy as a result of their service. This legislation was introduced by the Repatriation Medical Authority, in response to sound medical-scientific evidence linking toxic retinopathy to specific types of military service. The primary policy objective of this Statement of Principles is to facilitate the assessment of claims by specifying the minimum circumstances that must exist to establish a reasonable hypothesis connecting toxic retinopathy to the claimant's service, thereby ensuring that eligible individuals receive appropriate compensation and medical care. This instrument replaces the previous Statement of Principles concerning toxic maculopathy, reflecting advancements in medical-scientific evidence since the previous instrument was determined. The Statement of Principles is designed to operate in conjunction with the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004 by outlining the necessary factors that must be related to specific types of service in order to raise a reasonable hypothesis connecting toxic retinopathy or death from toxic retinopathy with the service rendered. This legislative instrument not only aids claimants and the Repatriation Commission in processing claims but also supports the review of such decisions by the Veterans' Review Board and the Administrative Appeals Tribunal. The Statement of Principles promotes human rights by facilitating access to social security, adequate living standards, and health benefits, while ensuring that these rights are exercised without discrimination.

Scope and Application

The Statement of Principles concerning toxic retinopathy (Reasonable Hypothesis) (No. 19 of 2018) applies to individuals who are veterans or members of the Australian Defence Force, including current and former service personnel, and their dependants. The Act facilitates the process of making and assessing claims for compensation and medical treatment under the Veterans' Entitlements Act 1986 (VEA) and the Military Rehabilitation and Compensation Act 2004 (MRCA) for those who have developed toxic retinopathy as a result of their service. It outlines the minimum factors that must exist for a reasonable hypothesis to be raised linking toxic retinopathy to particular kinds of service. The Act's geographic reach is national, as it applies across Australia, and it replaces the previously revoked Instrument No. 39 of 2009 concerning toxic maculopathy. The Act does not specify any exclusions or exemptions, but the determination of claims is contingent on the sound medical-scientific evidence presented. Subordinate instruments may extend or further detail the application of the Act, although no such instruments are mentioned in the provided text.

Key Provisions

The main operative sections of this Statement of Principles (No. 19 of 2018) (Sections 2, 4, 5, 7, and 9) detail the factors that must exist for a reasonable hypothesis to connect toxic retinopathy with specific kinds of service rendered by a person. These factors include exposure to certain drugs or substances, as listed in subsection 9(1) to 9(17), and must be related to operational service, peacekeeping service, hazardous service, British nuclear test defence service, warlike service, or non-warlike service (Section 5). The Statement of Principles is intended to replace the previously revoked Instrument No. 39 of 2009 and is designed to be applied in determining claims under the Veterans' Entitlements Act 1986 (VEA) and the Military Rehabilitation and Compensation Act 2004 (MRCA) (Sections 2 and 4). The Statement of Principles also includes updated definitions and factors reflecting the latest medical-scientific evidence concerning toxic retinopathy (Section 7). The obligations and requirements imposed by this Statement of Principles include the necessity for claimants to provide evidence that the specified factors linking toxic retinopathy to their service exist. The Repatriation Medical Authority (the Authority) is required to consider this evidence when assessing claims under the VEA and MRCA. The Statement of Principles also requires that the Authority ensure the determination of these instruments is based on the available sound medical-scientific evidence (Section 8). Furthermore, the Authority must ensure the compatibility of this instrument with human rights, as outlined in the Statement of Compatibility with Human Rights (Section 9). The Statement of Principles does not explicitly state offences, penalties, or consequences for breach. However, the determination of this instrument under subsection 196B(2) of the VEA implies that failure to comply with the requirements set out in the Statement of Principles could result in the denial of claims for compensation and benefits under the VEA and MRCA. The Authority is tasked with ensuring that claimants and the Repatriation Commission adhere to the provisions of this instrument when assessing and determining claims (Section 5). Additionally, the Authority must review and revise the Statement of Principles as new medical-scientific evidence becomes available to ensure the ongoing accuracy and relevance of the criteria for linking toxic retinopathy to service (Section 6). In conclusion, the Statement of Principles concerning toxic retinopathy (Reasonable Hypothesis) (No. 19 of 2018) establishes the necessary factors for claimants to link their condition with specific kinds of service, thereby facilitating the assessment and determination of claims under the VEA and MRCA. The Authority is required to ensure these provisions are based on sound medical-scientific evidence and are compatible with human rights. Failure to comply with the Statement of Principles may result in the denial of claims for compensation and benefits.

Legal classification tags

Area of Law
Veterans' Law
Health Law
Military Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Reporting & Disclosure Obligations
Human Rights Law
Regulatory Standards
Offence Provisions
Compliance Obligations

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.