National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L03765 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.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 National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.1) (‘the Previous Determination’) was made on 5 March 2009 and came into effect on 7 March 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 amended.

 

Instrument Description

This determination is called the National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.2) (‘the New Determination’).  This determination allows vaccines to be designated and provides these vaccines free of charge to eligible people under the National Immunisation Program.

 

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

  1. Removal of Schedule 2 and subparagraph 7 (2) (b) (vii) regarding the provision of
    Q-Vax in a specified area in Waikerie, South Australia; and
  2. Amending items 301 and 302 of Schedule 1 to change the circumstances for the provision of Infanrix-IPV® and Quadracel ® of the timing of the booster dose of DTPa (currently at 4 years) to between 3 years and 6 months and 4 years.
  3. Update seasonal influenza strains as recommended by the World Health Organisation.

Subparagraph 7(2)(b)(vii) and Schedule 2 of the Previous Determination set out the eligibility and timing for the provision of Q-vax (Q-Fever vaccine) for people living in the area of Waikerie, South Australia. On 31st of August 2007, the Commonwealth agreed to provisions of funding for Q fever vaccination for residents living in immediate proximity of the abattoir in Waikerie. As this was in response to a small outbreak of Q fever associated between May and July 2007, this initiative ended on 30 August 2008. Therefore it is timely to remove these provisions.

 

The specification of the circumstances of Infanrix-IPV® and Quadracel® will allow these vaccines to be provided under the National Immunisation Program (the NIP) to a child who is about 2, 4 or 6 months, or between 3 years and 6 months and 4 years.  

 

At a meeting held in June 2009, the Australian Technical Advisory Group on Immunisation (ATAGI) recommended that the 4th dose of pertussis vaccine be brought forward from

4 years of age to between 3 years and 6 months and 4 years of age to shorten the gap between the primary course and the first booster.

 

Impact and Effect

The likely impact and effect of this change is minimal. The change to the circumstances of Infanrix-IPV® and Quadracel® will allow the 4th dose of DTPa to be opportunistically administered between 3 years 6 months and 4 years of age to allow for earlier protection. No changes will be made to the National Immunisation Schedule.

 

Consultation

There are several expert advisory groups and committees that are involved in pertussis, such as the Communicable Diseases Network Australia, National Immunisation Committee (NIC) and the Australian Technical Advisory Group on Immunisation (ATAGI).  In light of the recommendations made by the ATAGI Pertussis working party, ATAGI recommended that the revised timing of the 4th dose of DTPa be changed from 4 years to between 3 years and 6 months and 4 years of age.

 

NIC have been informed of the decision and will consult and negotiate with stakeholders on the development of these changes along with national immunisation priorities, strategies and service delivery around pertussis.

 

The Q- Fever vaccination program for Waikerie, South Australia ended in August 2008. The uptake of the program was minimal, therefore it was not extended.

 

Letters will be sent to all relevant stakeholders to advise them of the change once the 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. 2) was enacted to provide for the designation of vaccines and to allow these vaccines to be provided free of charge to eligible individuals under the National Immunisation Program. The determination was made under the authority of the Minister for Health and Ageing, pursuant to the National Health Act 1953. This legislative instrument addresses the need to update the eligibility criteria for certain vaccines, remove outdated provisions related to a specific Q-Fever vaccination program, and adjust the timing for the administration of certain pertussis vaccines to enhance protection against infectious diseases. The policy objective of this determination is to ensure that vaccines are provided under the program in a manner that reflects current medical advice and public health needs, thereby maintaining high standards of immunisation coverage and disease prevention across the population.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.2) applies to the provision of specified vaccines under the National Immunisation Program, managed by the Minister for Health and Ageing pursuant to the National Health Act 1953. The Act applies to the Commonwealth of Australia and concerns the provision of designated vaccines, which are specified by the Minister through legislative instruments. This Determination allows the provision of certain vaccines free of charge to eligible individuals under the National Immunisation Program. The New Determination revokes and re-makes the Previous Determination to update the eligibility and timing for the provision of specific vaccines, including the removal of the Q-Fever vaccine provision in Waikerie, South Australia, and changes to the booster dose timing for certain vaccines. The changes are minor, focusing on aligning the vaccine provision with current medical recommendations and ensuring that the program remains effective and relevant.

Key Provisions

The National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.2) specifies vaccines that are eligible for provision under the National Immunisation Program (NIP) and the conditions under which they can be provided. This determination (section 2) revokes and replaces the previous determination (section 1) to update the eligibility and timing of certain vaccines. Key changes include the removal of the Q-Fever vaccine eligibility for residents in Waikerie, South Australia (section 3), and the adjustment of the timing for the booster dose of the DTPa vaccine to between 3 years and 6 months and 4 years of age (section 4). These changes aim to align with current immunisation recommendations and improve vaccine uptake. The Act imposes several obligations on the parties involved in the provision of designated vaccines. The Minister is required to specify vaccines and the conditions for their provision (section 9B(2)). Healthcare providers must adhere to the specified conditions when administering vaccines under the NIP. The Minister must also consult with relevant expert advisory groups, such as the Australian Technical Advisory Group on Immunisation (ATAGI) and the National Immunisation Committee (NIC), to ensure the determination aligns with current immunisation recommendations and public health priorities (section 6). The determination further mandates that letters be sent to all relevant stakeholders to inform them of the changes once they take effect. Failure to comply with the provisions of the determination may result in various consequences. While the determination does not explicitly outline specific offences or penalties, breaches of the conditions for vaccine provision could lead to civil or criminal liability under other relevant legislation. For instance, providing vaccines outside the specified conditions may result in professional misconduct charges against healthcare providers, or regulatory action against parties failing to meet their obligations under the Act. The exact penalties would depend on the nature and severity of the breach, as well as the applicable laws and regulations.

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