National Health (Immunisation Program - Designated Vaccines) Determination 2007 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L01804 Not in force Legislative Instrument

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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 2007 (No.1)

 

Legislation

Subsection 9B(1) of the National Health Act 1953 (‘the Act’) provides 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 National Health (Immunisation Program - Designated Vaccines) Determination 2007 (‘the Original Determination’) was made on 12 January 2007 and came into effect upon registration on 22 January 2007.  It is now necessary for additional vaccines to be specified as designated vaccines under subsection 9B(2), and circumstances specified under subsection 9B(5).  It has been decided to provide for these additional matters by revoking and remaking the Original Determination rather than amending it. 

 

Instrument Description

The Original Determination came into effect on 1 January 2006, designating vaccines that were available under the repealed section 9B of the National Health Act 1953 at any time during the period of 60 days immediately before the commencement of paragraph 9B(7)(b) as a 'designated vaccine' under the new section 9B of the Act.

 

The new determination is called the National Health (Immunisation Program - Designated Vaccines) Determination 2007  (No.1) (‘the New Determination’) and the only changes from the provisions of the Original Determination are in respect of 2 additional vaccines against rotavirus and a new formulation of a meningococcal C vaccine that are to be specified as designated vaccines.  These changes only affect the contents of Schedule 1.

 

The specification of these vaccines will allow them to be provided under the National Immunisation Program (‘the NIP).  The vaccines against rotavirus are Rotarix® and RotaTeq®.  In November 2006, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended including Rotarix® and RotaTeq® under the NIP.  Subsection 9B(7) of the Act provides that a vaccine must not be specified in a determination under subsection 9B(2) unless PBAC has recommended to the Minister that it be a designated vaccine.  In March 2007 the Minister for Health and Ageing agreed to the inclusion of Rotarix® and RotaTeq® under the NIP. 

 

In addition to the 2 rotavirus vaccines, the New Determination includes an amendment to the description of Meningitec®, a meningococcal C vaccine to take account of a new formulation of this vaccine so that it can be provided under the NIP.  In March 2006 the Therapeutic Goods Administration registered the new formulation.  The existing single dose vial formulation will be replaced globally by July 2007.  The new formulation of this vaccine will be available from July 2007. 

 

Authority

On 5 June 2006 the Minister for Health and Ageing delegated his powers under subsection 9B(2) of the National Health Act 1953 (‘the Act’) to the person occupying the position of Assistant Secretary of the Targeted Prevention Programs Branch, Population Health Division in the Department of Health and Ageing.  This person is currently Ms Jenny Bourne.

 

Impact and Effect

The likely impact and effect of this change is minimal. As mentioned above, the New Determination is substantively identical to the Original Determination except for the specification of 2 rotavirus vaccines and the change to the formulation of the meningococcal C vaccine.  After this amendment has been made, State and Territory Governments will have a choice to make on which rotavirus vaccine they wish to purchase for distribution.  State and Territory Governments will also be able to continue to provide meningococcal C vaccine.

 

Consultation

Each State and Territory Government was consulted regarding these changes through their representation on the National Immunisation Committee.  No jurisdiction was opposed to the proposed amendments.  The Office of Best Practice Regulation has been consulted regarding the need for a Regulation Impact Statement (RIS).  The advice received was that a RIS is not necessary as the amendment is a minor or machinery matter.

 

Reference Documents

-          The Instrument of Delegation is at Attachment A.

-          The product information for Rotarix® is at Attachment B.

-          The product information for RotaTeq® is at Attachment C.

 

Overview

The National Health (Immunisation Program – Designated Vaccines) Determination 2007 (No.1) was enacted to address the need for updating the list of designated vaccines under the National Health Act 1953. This legislative instrument, issued by the Minister for Health and Ageing, specifies additional vaccines to be included in the National Immunisation Program (NIP). The determination revokes and replaces the previous National Health (Immunisation Program – Designated Vaccines) Determination 2007, primarily to incorporate two new rotavirus vaccines, Rotarix® and RotaTeq®, as well as a new formulation of the meningococcal C vaccine, Meningitec®. This update responds to recommendations from the Pharmaceutical Benefits Advisory Committee and ensures that the NIP remains current with the latest therapeutic advancements. The enactment of this determination by the Parliament aims to safeguard public health by ensuring access to the most effective vaccines available.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Determination 2007 (No.1) applies to the provision of specified vaccines under the National Immunisation Program (NIP) as designated vaccines under the National Health Act 1953. This Act allows the Minister for Health and Ageing to specify vaccines and associated goods or services for provision under the NIP. The Determination, which revokes and replaces the earlier 2007 version, now specifies two additional vaccines against rotavirus (Rotarix® and RotaTeq®) and a new formulation of a meningococcal C vaccine (Meningitec®). These specifications are based on recommendations by the Pharmaceutical Benefits Advisory Committee (PBAC) and the Therapeutic Goods Administration's registration of the new vaccine formulation. The Determination applies nationally across Australia and allows State and Territory Governments the choice of which rotavirus vaccine to purchase for distribution, while continuing to provide the meningococcal C vaccine. The impact of these changes is minimal, as the Determination is largely identical to its predecessor except for these specified vaccines.

Key Provisions

The National Health (Immunisation Program - Designated Vaccines) Determination 2007 (No.1) specifies vaccines to be included under the National Immunisation Program (NIP) as designated vaccines. This is pursuant to subsection 9B(2) of the National Health Act 1953, which empowers the Minister to determine, through legislative instrument, that a specified vaccine is a designated vaccine. The Determination identifies two vaccines against rotavirus, Rotarix® and RotaTeq®, and a new formulation of the meningococcal C vaccine, Meningitec®, as designated vaccines. These additions are made to Schedule 1 of the Determination. The obligations under this Determination require State and Territory governments to consider the specified vaccines for inclusion in their immunisation programs. The Determination allows these governments to make choices regarding which rotavirus vaccines to purchase and continue providing meningococcal C vaccines. Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) must recommend these vaccines to the Minister for them to be included in the NIP, as per subsection 9B(7) of the Act. The Therapeutic Goods Administration’s registration of the new meningococcal C vaccine formulation also plays a role in these obligations. The Determination does not explicitly outline specific offences, penalties, or consequences for breaches. However, under the National Health Act 1953, any failure to comply with the provisions of the Determination could potentially lead to legal actions under the general provisions of the Act, including fines or other penalties as deemed appropriate by the courts. The focus remains on ensuring the proper administration of vaccines under the NIP and maintaining public health standards. Consultation with State and Territory governments was conducted through their representation on the National Immunisation Committee, ensuring that all jurisdictions were informed and no opposition to the amendments was recorded. This process underscores the collaborative approach in managing immunisation programs across Australia.

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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.