National Health (Immunisation Program - Designated Vaccines) Determination 2011 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2011L01616 Not in force Legislative Instrument

Legislation content

 

EXPLANATORY STATEMENT

 

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

 

National Health Act 1953

 

National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No.2)

 

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 (2) may specify the circumstances in which the vaccine may be provided.

 

Purpose

The purpose of the National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No.2) (the New Determination) is to designate vaccines in accordance with subsection 9B(2) of the Act, and specify circumstances in which designated vaccines may be provided.

 

A designated vaccine may be provided free of charge to eligible people under the National Immunisation Program, in the circumstances set out in the New Determination.

 

Background

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

 

In December 2009, the PBAC recommended that Fluarix®, an influenza vaccine manufactured by GlaxoSmithKline, be designated as a NIP vaccine. This allowed the sponsor to participate in future national tenders for the supply of influenza vaccines and was consistent with the earlier PBAC recommendation to transfer influenza vaccines from the Pharmaceutical Benefits Scheme to the NIP.

 

In November 2010, PBAC made a recommendation to the Minister that Prevenar 13®, a pneumococcal vaccine manufactured by Pfizer, be listed on the NIP for a single supplementary (catch up) dose. The supplementary dose is for children aged between 12 and 35 months who have completed their primary pneumococcal vaccination with Prevenar®, to provide them with protection against an additional six serotypes of pneumococcal disease.

 

Instrument Description

The National Health (Immunisation Program - Designated Vaccines) Determination 2011 (No.1) (‘the Previous Determination’) was made on 9 June 2011 and came into effect on 11 June 2011.  It is now necessary add a new vaccine to the determination.  

 

The Determination is substantively the same as the Previous Determination, except for the following changes:

  1. a minor amendment to the circumstances of use for Prevenar 13® supplementary dose.
  2. the addition of a seasonal influenza vaccine, Fluarix®.

 

Schedule 1 of the Previous Determination has been amended as follows:

Item 109 has been amended to clarify the circumstances of use for the Prevenar 13® supplementary dose.

 

Schedule 2 of the Previous Determination has been amended as follows:

Item 205 has been amended to add Fluarix®, a seasonal influenza vaccine.

 

Impact and Effect

Amending the circumstances of use for the Prevenar 13® supplementary dose makes it clear that all eligibility requirements must be met at the time of vaccination. 

 

The impact of adding Fluarix® to the NIP is an increase to the number of influenza vaccines listed on the NIP. This increases the options available to the Commonwealth when procuring influenza vaccines nationally. It also helps to ensure security of supply for influenza vaccines.

 

Consultation

The PBAC advice in relation to the vaccines is provided to the public via the Department’s website.  The Public Summary Documents regarding the rationale for these recommendations is available at: www.health.gov.au

 

The Office of Best Practice Regulation has advised that as the proposal would be likely to have no or low impacts on business and the not-for-profit sector, a regulatory impact assessment in the form of a Regulation Impact Statement would not be not required.

 

Overview

The National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No. 2) was enacted to amend the existing National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No. 1), made under the authority of the National Health Act 1953. This determination aims to designate specific vaccines for the National Immunisation Program (NIP) and specify the circumstances under which these vaccines may be provided. The determination was made by the Minister for Health and Ageing, who has the power to designate vaccines and related goods or services under subsection 9B(1) of the Act. The policy objective of this determination is to increase the number of available vaccines within the NIP, thereby enhancing the security of supply and providing more options for national procurement of influenza vaccines. The determination was made in response to recommendations from the Pharmaceutical Benefits Advisory Committee, which advised on the designation of specific vaccines based on their efficacy and public health benefits.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No. 2) applies to the provision of specified vaccines under the National Immunisation Program (NIP), in accordance with the National Health Act 1953. The determination designates specific vaccines for inclusion in the NIP, enabling their provision free of charge to eligible individuals. The Act applies nationally, as it is a Commonwealth legislation, and the determination extends this application by specifying which vaccines are included under the NIP and the circumstances under which they can be administered. The determination includes modifications to the use of Prevenar 13® for a supplementary dose and adds Fluarix®, an influenza vaccine, to the list of designated vaccines. These changes are made to enhance the security of supply for influenza vaccines and to increase procurement options for the Commonwealth. The determination operates within the framework of the Act, which allows the Minister for Health and Ageing to specify designated vaccines and the conditions for their provision through legislative instruments.

Key Provisions

The National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No.2) amends the list of designated vaccines under the National Health Act 1953 (the Act). Section 9B(2) of the Act allows the Minister to designate a vaccine as part of the National Immunisation Program (NIP), and this Determination adds two vaccines to the list. Firstly, it amends the circumstances of use for Prevenar 13®, a pneumococcal vaccine, by specifying that all eligibility requirements must be met at the time of vaccination. Secondly, it adds Fluarix®, a seasonal influenza vaccine, to the list of vaccines available under the NIP. Entities governed by this Determination must adhere to the specified circumstances in which the designated vaccines can be provided. For Prevenar 13®, this means ensuring that all eligibility criteria are fulfilled at the time of administering the supplementary dose. For Fluarix®, it involves recognising it as an eligible vaccine under the NIP and ensuring its provision aligns with the criteria outlined in the Determination. The Pharmaceutical Benefits Advisory Committee (PBAC) recommendations, accessible via the Department’s website, guide these provisions. Failure to comply with the provisions of this Determination may result in various consequences. While the Determination itself does not explicitly outline specific offences or penalties, breaches of the Act or associated regulations could lead to legal actions. For instance, if an entity fails to adhere to the eligibility criteria for vaccine administration, it could face civil liabilities or regulatory sanctions under other provisions of the Act. Additionally, misrepresentation or fraudulent activities related to the provision of these vaccines could attract criminal penalties, including fines and imprisonment, as per the general provisions of the Act and other relevant legislation.

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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.