National Health (Immunisation Program - Designated Vaccines) Variation Determination 2013 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00996 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Issued by the Authority of the delegate of the Minister for Health

 

National Health Act 1953

 

National Health (Immunisation Program – Designated Vaccines) Variation Determination 2013 (No.1)

 

Legislation

 

Subsection 9B(1) of the National Health Act 1953 (the Act) states that the Minister may provide, or arrange for the provision of, designated vaccines and goods or services that are associated with, or incidental to, the provision or administration of designated vaccines.  Subsection 9B(2) provides that the Minister may, by legislative instrument, determine that a specified vaccine is a designated vaccine for the purposes of this Act.  Subsection 9B(5) provides that in addition to specifying a vaccine, a determination under subsection 9B(2) may specify the circumstances in which the vaccine may be provided. The National Health (Immunisation Program – Designated Vaccine) Determination 2012 (No.1) (the Principal Determination) specifies vaccines that are designated in accordance with subsection 9B(2) of the Act and specifies the circumstances in which designated vaccines may be provided.

 

Purpose

The purpose of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2013 (No.1) is to add the influenza vaccine Intanza® and the combination measles, mumps, rubella and varicella vaccine ProQuad® to the Principal Determination. This has the effect of adding these vaccines to the National Immunisation Program (NIP). The Australian Government provides funding for vaccines that are included in the NIP.

 

Background

 

A vaccine that is specified as a designated vaccine by legislative instrument under subsection 9B(2) of the Act may be provided free of charge to eligible people under the NIP in the circumstances set out in the Principal Determination.

 

Subsection 9B(7) of the Act provides that a vaccine must not be specified in a determination made under subsection 9B(2) unless the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Minister that it be a designated vaccine. 

In July 2009, PBAC recommended that Intanza® 15mcg be added to the NIP as a vaccination against influenza to be administered to persons aged 65 years and older.

In November 2012, PBAC recommended that ProQuad® be added to the NIP as a vaccination against measles, mumps, rubella and varicella to be administered when children are approximately 18 months of age.


Instrument Description

 

The Principal Determination was made on 24 September 2012 and came into effect on 28 September 2012. To give effect to the PBAC recommendations of July 2009 and November 2012 regarding the inclusion of Intanza® and ProQuad® on the NIP it is necessary to vary the Principal Determination.

 

Item 206 has been varied to specify Intanza®  as a designated vaccine to prevent influenza and may be administered to persons aged 65 years and over.

 

Item 212 has been inserted to specify ProQuad® as a designated vaccine for the prevention of measles, mumps, rubella and varicella and may be administered to children aged approximately 18 months of age.

 

This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA).

 

The instrument will commence on the day after it is registered on the Federal Register of Legislative Instruments.

 

Consultation

 

The Office of Best Practice and Regulation considers that amendments that have the effect of updating the listing of vaccines on the NIP are regulatory amendments that are minor or machinery in nature.  Therefore, in accordance with subparagraph 18(2)(a) of the LIA it has been determined that further consultation is unnecessary.

 


Statement of Compatibility with Human Rights

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

 

National Health (Immunisation Program – Designated Vaccines) Variation
Determination 2013 (No.1)

 

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in the definition of ‘human rights’ contained in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the legislative instrument

This legislative instrument varies the National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No.1) (the Principal Determination) which specifies designated vaccines in accordance with subsection 9B(2) of the Act and may specify the circumstances in which designated vaccines can be provided. The Principal Determination is the legislative instrument that gives effect to the National Immunisation Program (the NIP). The Australian Government provides funding for vaccines that are included in the NIP.

 

This legislative instrument adds the influenza vaccine Intanza® and the combination measles, mumps, rubella and varicella vaccine ProQuad® to the Principal Determination. This has the effect of adding these vaccines to the NIP.

 

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by providing a legislative basis to assist with the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. This legislative instrument assists in the advancement of this human right by providing free access for eligible people to designated vaccines. 

 

This legislative instrument also engages Article 1 of the ICESCR which recognises the right of all peoples to self-determination. The right to self-determination is positively engaged as vaccination is not mandatory in Australia.

 

Conclusion

This legislative instrument is compatible with human rights because it advances the progressive realisation and protection of the human rights mentioned above.

 

 

 

 

 

Julianne Quaine

Assistant Secretary

Immunisation Branch

Department of Health and Ageing

 

 

 

Overview

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2013 (No.1) was enacted to address the need for updating the list of designated vaccines under the National Health Act 1953. This legislative instrument, made by the Minister for Health under the authority granted by the Act, aims to add the influenza vaccine Intanza® and the combination measles, mumps, rubella and varicella vaccine ProQuad® to the National Immunisation Program (NIP). These additions are in response to recommendations by the Pharmaceutical Benefits Advisory Committee (PBAC) that these vaccines should be included in the NIP to improve public health outcomes. By specifying these vaccines, the legislation ensures that they can be provided free of charge to eligible individuals, thereby supporting the Australian Government's commitment to funding vaccines that contribute to the highest attainable standard of health.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2013 (No.1) applies to the addition of the influenza vaccine Intanza® and the combination measles, mumps, rubella and varicella vaccine ProQuad® to the National Immunisation Program (NIP) as specified vaccines. This variation to the Principal Determination, made in accordance with the National Health Act 1953, is a legislative instrument designed to provide free access to these vaccines for eligible individuals. The addition of these vaccines to the NIP is based on recommendations by the Pharmaceutical Benefits Advisory Committee (PBAC) and aims to enhance public health by ensuring broader immunisation coverage. The legislation is applicable nationwide as it operates under the Commonwealth jurisdiction, ensuring uniformity in vaccine availability across Australia. The determination itself does not include specific exclusions or exemptions beyond those outlined in the Principal Determination, which specifies the conditions for the provision of designated vaccines. Further refinement of the application may occur through subordinate instruments, which may specify additional details or criteria for vaccine administration.

Key Provisions

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2013 (No.1) (the Variation Determination) amends the National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No.1) (the Principal Determination) by adding the influenza vaccine Intanza® and the combination measles, mumps, rubella and varicella vaccine ProQuad® to the list of designated vaccines. These additions are made to reflect the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) in July 2009 for Intanza® and in November 2012 for ProQuad®. By making these vaccines designated, they are now part of the National Immunisation Program (NIP) and are eligible for Australian Government funding (subsection 9B(2) and (5)). The Variation Determination imposes obligations on the Minister for Health to provide, or arrange for the provision of, the specified vaccines to eligible individuals under the NIP, in accordance with the circumstances set out in the Principal Determination (subsection 9B(1)). It also requires that a vaccine can only be specified as a designated vaccine if the PBAC has recommended it for inclusion in the NIP (subsection 9B(7)). The Australian Government, through the Minister, is thus responsible for ensuring that these vaccines are available to the eligible population as per the conditions specified in the NIP. There are no explicit provisions in the Variation Determination regarding offences, penalties, or civil/criminal consequences for breach. However, the determination itself is a legislative instrument subject to the requirements of the Legislative Instruments Act 2003. Any non-compliance with the provisions of the National Health Act 1953 or the LIA could potentially lead to legal consequences, although these are not detailed within the text of the Variation Determination. The focus of the legislation is on the administrative and procedural aspects of adding these vaccines to the NIP rather than on punitive measures for non-compliance.

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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.