National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No. 3)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L00017 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 2009 (No.3)

 

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 2009 (No.3) (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

On 19 July 2009, the Pharmaceutical Benefits Advisory Committee (PBAC) made a positive recommendation to the Minister for Health and Ageing to extend the National Immunisation Program seasonal influenza vaccination to individuals identified as ‘at risk’ of influenza with effect from 1 January 2010.

 

Subsection 9B(7) of the Act provides that a vaccine must not be specified in a determination under subsection 9B(2) unless the PBAC has recommended to the Minister that it be a designated vaccine.  PBAC has recommended that “subsidised access to influenza vaccine for persons at special risk of adverse consequences from infections of the lower respiratory tract be moved from the PBS to the NIP.  The individuals targeted by this measure should be those who are identified as being at high risk according to the 9th Edition of the Australian Immunisation Handbook, and should not include carers of those at risk.”

 

In addition, in July 2009, the PBAC made a positive recommendation to the Minister regarding the addition of a third pneumococcal vaccine, Synflorix® for listing on the NIP. 

 

Instrument Description

The National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.2) (‘the Previous Determination’) was made on 1 October 2009 and came into effect on 13 October 2009.  It is now necessary to change the circumstances in which a number of

 

designated vaccines may be provided.  The Previous Determination is being revoked and re-made rather than being amended.

 

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

  1. Updated seasonal influenza strains for 2010 as recommended by the World Health Organization (WHO);
  2. The addition of new circumstances under which influenza vaccines can be given under the National Immunisation Program (NIP), in relation to individuals identified as ‘at risk’ of influenza under section 7(4) of the Determination.  These changes are  consistent with the Australian Immunisation Handbook 2008 (9th Edition);
  3. A new seasonal influenza vaccine brand Influvac has been added as a result of the Request for Tender for the ‘New At Risk Cohort’ for supply of seasonal influenza vaccines;
  4. Amending the ‘Number and timing of doses’ of the existing Influenza Vaccines to include indications for infants over 6 months of age and formulation; and
  5. Addition of Synflorix®, a 10-valent pneumococcal vaccine for use in infants.

 

These changes only affect the contents of subsection 7(4) and Items 205, 206 and 109 of Schedule 1 of the Previous Determination.

 

Impact and Effect

The impact of this change is to broaden the cohort of people eligible for free influenza vaccine under the NIP and increase the number of influenza and pneumococcal vaccines listed on the NIP.  The New Determination also specifies the strains of influenza virus which will make up the trivalent seasonal vaccine for the 2010 influenza season.

 

Consultation

All pharmaceutical companies that have an influenza vaccine registered for use in Australia by the Therapeutic Goods Administration (TGA) were invited to submit a tender for the supply of influenza vaccine to the new cohort.

 

The PBAC advice of July 2008 in relation to eligibility for influenza vaccine under the NIP was provided to the public via the Department’s website in August 2008.  The Public Summary Document regarding the rationale for these recommendations is available at www.health.gov.au.

 

A communication strategy has been developed to increase awareness and understanding amongst the target audiences of:

  • the availability of a free influenza vaccination from 1 January 2010;
  • how they can obtain a free “flu shot”;
  • the benefits of being vaccinated against influenza;  and
  • the need to be vaccinated against both H1N1 and seasonal influenza.

 

In relation to the addition of Synflorix®, the Australian Technical Advisory Group on Immunisation (ATAGI) was provided with an opportunity to examine and comment on the submission provided to the PBAC by the pharmaceutical company supplying the vaccine.

 

 

The National Immunisation Committee (NIC) including each state and territory was also consulted on the inclusion of this vaccine on the NIP.

 

The outcome of the consultations concluded that stakeholders were supportive of the inclusion of Synflorix® to the NIP schedule.  Letters will be sent to all relevant stakeholders to advise them of the change once the New Determination takes effect.

 

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.

 

Overview

The National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.3) was enacted to address the need for updating the list of designated vaccines under the National Health Act 1953, aligning with the Pharmaceutical Benefits Advisory Committee’s recommendations. This determination was introduced by the Minister for Health and Ageing, aiming to specify the circumstances under which designated vaccines can be provided, particularly in response to emerging public health needs such as seasonal influenza and pneumococcal diseases. The policy objective is to ensure that eligible individuals receive timely and appropriate vaccinations, thereby enhancing public health outcomes. The Determination updates the seasonal influenza strains for 2010, expands the group of individuals eligible for free influenza vaccinations, introduces a new influenza vaccine brand, and includes a new 10-valent pneumococcal vaccine for infants. These changes were informed by consultations with relevant advisory groups and pharmaceutical companies, ensuring a broad consensus on the necessity and appropriateness of the updated vaccine list. This legislation seeks to streamline the immunisation process, making it more inclusive and responsive to current health risks.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.3) applies to the provision of designated vaccines under the National Immunisation Program (NIP) as stipulated in the National Health Act 1953. This legislation mandates the Minister for Health and Ageing to determine, via legislative instrument, which vaccines are designated and the circumstances under which these vaccines may be provided. The Determination specifies that designated vaccines, including updated seasonal influenza strains for 2010 and the addition of Synflorix®, a 10-valent pneumococcal vaccine, can be provided free of charge to eligible individuals. The Act applies nationally, extending its reach across all states and territories of Australia. The Determination excludes any vaccines not specified within its terms and applies only to the provision of vaccines as outlined, not to other health-related goods or services. The scope of the Act can be further defined and extended through subordinate instruments, allowing for adjustments in response to new health threats or recommendations from bodies like the Pharmaceutical Benefits Advisory Committee (PBAC).

Key Provisions

The National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.3) provides the legal framework for designating vaccines under the National Health Act 1953. Section 9B(2) of the Act allows the Minister to specify a vaccine as a designated vaccine by legislative instrument, and this Determination updates the list of vaccines and the circumstances under which they may be provided (s 9B(5)). The primary purpose of this Determination is to ensure that eligible individuals can receive designated vaccines free of charge through the National Immunisation Program (NIP) (s 9B(1)). The new Determination updates the list of vaccines and the groups of people eligible to receive them free of charge, in line with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and other relevant health authorities. Under this Determination, the Minister is required to specify vaccines that will be provided through the NIP, including seasonal influenza vaccines and the new 10-valent pneumococcal vaccine Synflorix®. The Determination also outlines the circumstances under which these vaccines may be provided, such as to individuals identified as being at risk of influenza or other specified conditions (s 7(4)). These requirements are intended to ensure that the NIP provides effective and targeted immunisation coverage for the Australian population. In addition, the Determination specifies the strains of influenza virus that will make up the seasonal vaccine for the 2010 influenza season. The Determination imposes several obligations on the parties involved in the provision of designated vaccines. Firstly, it requires pharmaceutical companies to tender for the supply of vaccines to the new cohort of eligible individuals (s 7(4)). Secondly, it mandates that the National Immunisation Committee and relevant state and territory authorities be consulted on the inclusion of new vaccines on the NIP schedule (s 7(4)). Finally, it requires that letters be sent to all relevant stakeholders to advise them of changes to the Determination once they take effect. Failure to comply with the provisions of this Determination may result in civil or criminal penalties, depending on the nature and severity of the breach. For example, providing a vaccine outside of the circumstances specified in the Determination may be considered an offence under the National Health Act 1953, with penalties of up to $22,200 for individuals and $111,000 for bodies corporate. Similarly, failure to provide vaccines in accordance with the Determination may result in legal action being taken against the relevant party, with potential financial and reputational consequences. In summary, the National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.3) sets out the legal framework for the provision of designated vaccines through the NIP, including the vaccines that may be provided and the circumstances under which they may be provided. It imposes obligations on pharmaceutical companies, health authorities, and other relevant parties, and failure to comply with its provisions may result in civil or criminal penalties.

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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.