Statement of Principles concerning vaccine-induced thrombotic thrombocytopaenia (Balance of Probabilities) (No. 34 of 2022)

Administered by Department of Veterans' Affairs

Legislation au F2022L00269 In force Legislative Instrument

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EXPLANATORY STATEMENT

 

Statement of Principles concerning

VACCINE-INDUCED THROMBOTIC THROMBOCYTOPAENIA

(Balance of PROBABILITIES) (NO. 34 OF 2022)

 

VETERANS' ENTITLEMENTS ACT 1986

MILITARY REHABILITATION AND COMPENSATION ACT 2004

 

  1. This is the Explanatory Statement to the Statement of Principles concerning vaccine-induced thrombotic thrombocytopaenia (Balance of Probabilities) (No. 34 of 2022).

Background

2.             The Repatriation Medical Authority (the Authority) has determined, under subsection 196B(3) of the Veterans' Entitlements Act 1986 (the VEA), Statement of Principles concerning vaccine-induced thrombotic thrombocytopaenia (Balance of Probabilities) (No. 34 of 2022).

3.             The Authority is of the view that on the sound medical-scientific evidence available it is more probable than not that vaccine-induced thrombotic thrombocytopaenia and death from vaccine-induced thrombotic thrombocytopaenia can be related to particular kinds of service.  The Authority has therefore determined this Statement of Principles concerning vaccine-induced thrombotic thrombocytopaenia pursuant to subsection 196B(3) of the VEA.

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, vaccine-induced thrombotic thrombocytopaenia or death from vaccine-induced thrombotic thrombocytopaenia 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.             The Repatriation Commission, Military Rehabilitation and Compensation Commission, Veterans' Review Board or Administrative Appeals Tribunal cannot accept any claim for pension; or a claim for liability or compensation relating to vaccine-induced thrombotic thrombocytopaenia or death from vaccine-induced thrombotic thrombocytopaenia that was lodged on or after 1 June 1994 in the case of the VEA, or 1 July 2004 in the case of the MRCA respectively, unless this Statement of Principles upholds that claim (subsection 120B(3) of the VEA or subsection 339(3) of the MRCA).

7.             This new Instrument results from an investigation notified by the Authority in the Government Notices Gazette of 31 August 2021 concerning thrombosis with thrombocytopenia syndrome in accordance with section 196G of the VEA.  The investigation involved an examination of the sound medical-scientific evidence available to the Authority.

Consultation

8.             Prior to determining this Instrument, the Authority advertised its intention to undertake an investigation in relation to thrombosis with thrombocytopenia syndrome in the Government Notices Gazette of 31 August 2021, 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.

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 new Instrument finalises the investigation in relation to thrombosis with thrombocytopenia syndrome as advertised in the Government Notices Gazette of 31 August 2021.

References

11.         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. 34 of 2022

Kind of Injury, Disease or Death: Vaccine-induced thrombotic thrombocytopaenia

 

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 vaccine-induced thrombotic thrombocytopaenia;
  • facilitates the review of such decisions by the Veterans' Review Board and the Administrative Appeals Tribunal; and
  • outlines the factors which the current sound medical-scientific evidence indicates must exist before it can be said that, on the balance of probabilities, vaccine-induced thrombotic thrombocytopaenia is connected with the circumstances of eligible service rendered by a person, as set out in clause 5 of the Explanatory Statement.

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 vaccine-induced thrombotic thrombocytopaenia (Balance of Probabilities) (No. 34 of 2022) was determined by the Repatriation Medical Authority under subsection 196B(3) of the Veterans' Entitlements Act 1986 (VEA). This legislative instrument addresses the need to establish a clear framework for assessing claims related to vaccine-induced thrombotic thrombocytopaenia (VITT) by veterans and service personnel. The primary objective of this Statement of Principles is to outline the medical and scientific factors that must be present to establish a connection between VITT and particular kinds of service rendered, thereby facilitating the assessment and determination of claims under both the VEA and the Military Rehabilitation and Compensation Act 2004 (MRCA). By setting out these factors, the instrument aims to ensure that claims are evaluated based on sound evidence, thereby promoting fairness and transparency in the claims process. Additionally, the instrument has been crafted to be compatible with human rights, ensuring that the rights of veterans, service personnel, and their dependents are upheld.

Scope and Application

The Statement of Principles concerning vaccine-induced thrombotic thrombocytopaenia (Balance of Probabilities) (No. 34 of 2022) applies to claims made under the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004, relating to individuals who have served in eligible war service, defence service, or peacetime service, and who have developed vaccine-induced thrombotic thrombocytopaenia or died from it. The principles aim to establish a connection between such medical conditions and the service rendered by the claimant, provided the claim is lodged after the specified dates of 1 June 1994 for the Veterans' Entitlements Act and 1 July 2004 for the Military Rehabilitation and Compensation Act. The Statement of Principles will be used by the Repatriation Commission, Military Rehabilitation and Compensation Commission, Veterans' Review Board, and Administrative Appeals Tribunal in their respective functions of assessing and reviewing claims. The instrument is a result of an investigation into thrombosis with thrombocytopenia syndrome, mandated by section 196G of the Veterans' Entitlements Act, and finalises the investigation as advertised in the Government Notices Gazette. The instrument is compatible with human rights as it does not derogate from, and promotes, several human rights including the right to social security, adequate standard of living, and the highest attainable standard of physical and mental health.

Key Provisions

The Statement of Principles concerning vaccine-induced thrombotic thrombocytopaenia (Balance of Probabilities) (No. 34 of 2022) sets forth the criteria that must be met to determine a connection between vaccine-induced thrombotic thrombocytopaenia or death from it, and particular kinds of service under the Veterans' Entitlements Act 1986 (VEA) and the Military Rehabilitation and Compensation Act 2004 (MRCA). According to section 5 of the Explanatory Statement, these criteria are based on the sound medical-scientific evidence available, and they must be related to eligible war service, defence service, or peacetime service. For any claim relating to vaccine-induced thrombotic thrombocytopaenia or death from it to be considered, it must be lodged on or after 1 June 1994 under the VEA or 1 July 2004 under the MRCA, and it must be upheld by this Statement of Principles (subsection 120B(3) of the VEA or subsection 339(3) of the MRCA). The obligations under this legislation are primarily for the Repatriation Medical Authority (the Authority), which is responsible for determining the Statement of Principles based on available sound medical-scientific evidence. The Authority must ensure that any claim for pension or compensation related to vaccine-induced thrombotic thrombocytopaenia is assessed in accordance with the criteria outlined in the Statement of Principles. Additionally, the Repatriation Commission, Military Rehabilitation and Compensation Commission, Veterans' Review Board, and Administrative Appeals Tribunal must apply these principles in their respective assessments and reviews of claims. The legislation does not explicitly detail specific offences, penalties, or consequences for breach. However, the implications of not adhering to the Statement of Principles could involve the rejection of claims that do not meet the specified criteria. This could potentially lead to legal challenges and reviews by the Administrative Appeals Tribunal or the Federal Court, where the validity and application of the Statement of Principles might be contested. The maximum penalties or specific legal consequences for non-compliance are not explicitly stated in the document, but they would likely follow the general provisions of the VEA and MRCA concerning the mishandling of claims or the misapplication of legislative instruments.

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