National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01468 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No.2)

 

Authority

Section 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.  Section 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.  Section 9B(5) provides that in addition to specifying a vaccine, a determination under subsection (2) may specify the circumstances in which the vaccine may be provided.

 

Purpose

The purpose of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No.2) (the Variation Determination) is to make the following amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination):

  • Add a new quadrivalent influenza vaccine (Afluria Quad) for individuals aged 18 years and older who are eligible to receive influenza vaccine through the National Immunisation Program (NIP).

 

Background

Pharmaceutical Benefits Advisory Committee (PBAC) recommendations

Section 9B(7) of the Act relevantly provides that a vaccine must not be specified in a determination under section 9B(2) unless the PBAC has recommended to the Minister that the vaccine be a designated vaccine.

In September 2016, the PBAC recommended that:

  • Afluria Quad be listed on the NIP for persons aged 18 years and over who are currently eligible to receive NIP-funded influenza vaccine.

 

Government approval

On 16 September 2016, the Minister for Health, Minister for Aged Care and Minister for Sport, the Hon Sussan Ley MP, approved Afluria Quad to be a designated vaccine for the purposes of subsection 9B(2) of the Act, from 21 September 2016.

Details

The Determination commenced on 23 September 2014.  Once a vaccine is listed on the Determination, the supplier of that vaccine is eligible to participate in any tenders run by the Department of Health for supply of vaccine on the NIP.

 

Consultation

The Office of Best Practice Regulation considers that regulatory amendments that update the listing of vaccines on the NIP and their associated price to be machinery in nature.  Therefore it has been determined that further consultation is unnecessary.

 

The commencement date for Item 1 and Item 2 of the Variation Determination is the day following registration.

 

The Variation Determination is a legislative instrument for the purposes of the Legislation Act 2003.

 

NOTES ON ATTACHMENTS

 

Section 1 – Name of the Variation Determination

 

This section provides that the title of the Variation Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No2).

 

Section 2 – Commencement

 

This section provides that Item 1 and Item 2 of the Variation Determination commence on the day after registration.

 

Section 3 – Authority

These Rules are made under subsections 9B (2) and (5) of the National Health Act 1953.

 

Section 4 – Variation

This section provides that the Variation Determination varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1).

 

Schedule 1 Amendments

 

Item 1 of Variation Determination

Adds a new clause under Subsection 7(8) of the Determination as ‘7(8A)’. This clause outlines the circumstances by which Item 207C (below) can be provided under the NIP.

 

Item 2 of Variation Determination

Adds a new item under Schedule 1 Part 2 of the Determination as ‘Item 207C’. This item provides the details of a new quadrivalent influenza vaccine, Afluria Quad, which can be provided on the NIP under the circumstances outlined in Subsection 7(8A) (above).

 

 

 

 

 

 

 


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 2016 (No.2)

 

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No. 2) (the Variation Determination) 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

The Variation Determination varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination), which determines that a specified vaccine is a designated vaccine for the purposes of subsection 9B(2) of the National Health Act 1953 (the Act), and also specifies circumstances in which designated vaccines may be provided for the purposes of subsection 9B(3) of the Act.

The Variation Determination:

  • adds a new quadrivalent influenza vaccine (Afluria Quad) for individuals aged 18 years and older who are eligible to receive influenza vaccine through the National Immunisation Program (NIP).

 

Human Rights Implications

The Variation Determination engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. 

The Variation Determination assists the advancement of this human right by providing free access for eligible people to designated vaccines.  This is a positive step towards attaining the highest standard of health for all Australians, by protecting individuals and the community against vaccine preventable disease. 

The Variation Determination is also consistent with the advancement of Article 1 of the ICESCR. Since vaccination is not mandatory in Australia this enables the right to self-determination.

Conclusion

The Variation Determination is compatible with human rights because it advances the protection of human rights as outlined above.

 

Masha Somi

Assistant Secretary Immunisation Branch

Office of Health Protection

Department of Health

Overview

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No.2) was enacted to amend the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) under section 9B of the National Health Act 1953. This legislation was introduced to address the need to update the list of vaccines eligible for provision through the National Immunisation Program (NIP). The National Health Act 1953, enacted by the Australian Parliament, establishes a framework for providing health services, including immunisation programs. The policy objective of the 2016 Variation Determination is to ensure that individuals aged 18 years and older who are eligible for the NIP can receive the newly recommended quadrivalent influenza vaccine, Afluria Quad, thereby enhancing public health protection against vaccine-preventable diseases. The determination was approved by the Minister for Health and commenced on 23 September 2014, with the 2016 Variation coming into effect on 21 September 2016 following the Pharmaceutical Benefits Advisory Committee's recommendation.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No.2) applies to the Minister for Health, who is empowered under Section 9B of the National Health Act 1953 to determine designated vaccines and associated goods or services for the National Immunisation Program (NIP). The Variation Determination specifies a new quadrivalent influenza vaccine, Afluria Quad, for individuals aged 18 years and older who are eligible to receive influenza vaccine through the NIP. The determination specifies the circumstances under which the vaccine may be provided, ensuring it aligns with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The Determination operates within the Commonwealth jurisdiction and extends to entities and suppliers that participate in the NIP. The Determination does not specify any exclusions, exemptions, or thresholds beyond those outlined in the PBAC recommendations and ministerial approval. Any further clarification or detailed specifications regarding the provision of the vaccine may be addressed through subordinate instruments, which would be issued as necessary to support the implementation of the Determination.

Key Provisions

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No.2) (the Variation Determination) amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination) by adding a new quadrivalent influenza vaccine, Afluria Quad, for individuals aged 18 years and older who are eligible to receive influenza vaccine through the National Immunisation Program (NIP) (Items 1 and 2). This amendment is made under the authority of sections 9B(2) and 9B(5) of the National Health Act 1953 (the Act) (Item 3). The Variation Determination commenced on the day after its registration, as specified in Item 2 of the Variation Determination. The Variation Determination specifies the circumstances under which Afluria Quad may be provided under the NIP, as outlined in Item 1 of the Variation Determination. The Variation Determination imposes specific obligations on the parties or entities it governs. It mandates that Afluria Quad be listed on the NIP for individuals aged 18 years and older who are eligible to receive influenza vaccine through the NIP (Item 1 of the Variation Determination). The Determination also specifies the circumstances in which Afluria Quad can be provided under the NIP (Item 1 of the Variation Determination). Additionally, the Determination requires that the supplier of Afluria Quad be eligible to participate in any tenders run by the Department of Health for the supply of vaccine on the NIP once the vaccine is listed on the Determination (Item 1 of the Determination). The Variation Determination does not explicitly outline any offences, penalties, or civil/criminal consequences for breach. However, it is implicit that any failure to comply with the provisions of the Determination could lead to legal consequences, as it is a legislative instrument made under the authority of the National Health Act 1953. The penalties for non-compliance would be determined by the relevant provisions of the Act, which could include fines, imprisonment, or other civil or criminal sanctions as prescribed by law. The maximum penalties would depend on the specific nature and severity of the breach, as well as any applicable statutory provisions.

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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.