National Health (Immunisation Program - Designated Vaccines) Variation Determination 2015 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01713 Not in force Legislative Instrument

Legislation content

 

EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (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 2015 (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 hexavalent vaccine, Hexaxim, for infants aged 2, 4 and 6 months to protect against six diseases (diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenza type B);
  • add a new diphtheria, tetanus and pertussis vaccine, Tripacel, for children aged approximately 18 months, for the prevention of pertussis (whooping cough);
  • add two new quadrivalent influenza vaccines – Fluarix Tetra for persons aged 3 years and above, and FluQuadri Junior for children aged less than 3 years – for the prevention of influenza; and
  • add a clause to allow for children under the age of 10 years to ‘catch up’ on any scheduled vaccinations that the child did not receive at the specified age/s under the National Immunisation Schedule, as clinically required based on the current age of the child.

 

Background

Designated Vaccines

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

In March 2015, the PBAC recommended that:

  • Hexaxim be listed on the National Immunisation Program (NIP) as part of the primary series of vaccinations for infants aged 2, 4 and 6 months; and
  • Fluarix Tetra be listed on the NIP for persons aged 3 years and above who are currently eligible for trivalent influenza vaccine (TIV) under the NIP.

In July 2015, the PBAC recommended that:

  • Tripacel be listed on the NIP as a pertussis booster dose for infants aged approximately 18 months; and
  • FluQuadri Junior be listed on the NIP for persons aged less than 3 years who are currently eligible for TIV under the NIP.

On 29 September 2015, the Minister for Health, Minister for Aged Care and Minister for Sport, the Hon Sussan Ley MP, approved for Hexaxim and Tripacel to be designated vaccines for the purposes of subsection 9B(2) of the Act, from 31 October 2015.

On 2 October 2015, Minister Ley approved for Fluarix Tetra to be a designated vaccine for the purposes of subsection 9B(2) of the Act, from 1 November 2015.

On 8 October 2015, Minister Ley approved for FluQuadri Junior to be a designated vaccine for the purposes of subsection 9B(2) of the Act, from 1 November 2015.

Catch‑up Program for Children under 10 years

On 1 September 2015, the Australian Government agreed to implement a nationally consistent catch‑up program for children less than 10 years of age, using the vaccines already listed on the NIP.

The catch‑up program will secure ongoing clinically appropriate vaccines for children aged less than 10 years who did not receive a vaccination at the specified age/s under the National Immunisation Schedule, using existing mechanisms under the NIP for vaccine funding, delivery and administrations.

Consultation

The Department of Human Services and the Department of Social Services have been consulted on the policy that underpins Schedule 1, Item 3 of the Variation Determination.

In relation to Schedule 1, Items 1, 2, 4, 5, 6 and 7 of the Variation Determination, 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 in accordance with section 18(2)(a) of the Legislative Instruments Act 2003 it has been determined that further consultation is unnecessary.

 

Commencement dates for each Item of the Variation Determination are as follows:

  • Schedule 1, Items 4 and 7 commence on 31 October 2015.
  • Schedule 1, Items 1, 2, 5 and 6 commence on 1 November 2015; and
  • Schedule 1, Item 3 commences on 1 January 2016.

 

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

 

 

 

 

 

 


NOTES ON SECTIONS

 

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 2015 (No.2).

 

Section 2 – Commencement

 

This section provides for Schedule 1, Items 4 and 7 of the Variation Determination to commence on 31 October 2015; Schedule 1, Items 1, 2, 5 and 6 of the Variation Determination to commence on 1 November 2015; and Schedule 1, Item 3 of the Variation Determination to commence on 1 January 2016.

 

Section 3 – Variation

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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 2015 (No.2)

 

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (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 hexavalent vaccine, Hexaxim, for infants aged 2, 4 and 6 months to protect against six diseases (diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenza type B);
  • a new diphtheria, tetanus and pertussis vaccine, Tripacel, for children aged approximately 18 months, for the prevention of pertussis (whooping cough);
  • two new quadrivalent influenza vaccines – Fluarix Tetra for persons aged 3 years and above, and FluQuadri Junior for children aged less than 3 years – for the prevention of influenza; and
  • a clause to allow for children under the age of 10 years to ‘catch up’ on any scheduled vaccinations that the child did not receive at the specified age/s under the National Immunisation Schedule, as clinically required based on the current age of the child.

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.

Kirsty Faichney

Assistant Secretary Immunisation Branch

Office of Health Protection

Department of Health

Overview

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No.2) was enacted to amend the National Health (Immunisation Program - Designated Vaccines) Determination 2014 under the authority of Section 9B(1) of the National Health Act 1953. The determination was introduced by the Minister for Health, Minister for Aged Care and Minister for Sport, the Hon Sussan Ley MP, and aims to improve the immunisation program by adding new vaccines and allowing children under the age of 10 years to catch up on missed vaccinations. This determination includes the addition of Hexaxim, a hexavalent vaccine for infants, Tripacel for children aged around 18 months, and two new quadrivalent influenza vaccines, Fluarix Tetra and FluQuadri Junior, for different age groups. Furthermore, it allows for a catch-up program for children under 10 years of age who did not receive scheduled vaccinations at the specified ages. The National Health Act 1953 was enacted by the Australian Parliament to provide for national health and medical research. The purpose of this variation determination is to improve the immunisation program by providing free access to designated vaccines, as recommended by the Pharmaceutical Benefits Advisory Committee, and to protect individuals and the community against vaccine-preventable diseases. The Variation Determination is consistent with the advancement of human rights as outlined in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No.2) amends the National Health (Immunisation Program - Designated Vaccines) Determination 2014 by adding four new vaccines to the National Immunisation Program (NIP) and introducing a catch-up program for children under 10 years who missed their scheduled vaccinations. The Variation Determination applies to all Australian residents, and the vaccines can be provided through authorised medical practitioners or public health programs across the Commonwealth, states, and territories. The catch-up program allows for the administration of missed vaccines as clinically required, based on the current age of the child. The Determination is made under the authority of the National Health Act 1953, which empowers the Minister to specify vaccines for the purposes of providing or arranging for the provision of designated vaccines and associated goods or services. The Variation Determination is compatible with human rights, as it enhances the right to the highest attainable standard of physical and mental health by ensuring access to designated vaccines. The commencement dates for each item of the Variation Determination vary, with items 4 and 7 commencing on 31 October 2015, items 1, 2, 5, and 6 commencing on 1 November 2015, and item 3 commencing on 1 January 2016.

Key Provisions

The key provisions of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No.2) amend the existing National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) by adding new vaccines to the National Immunisation Program (NIP). This includes a hexavalent vaccine called Hexaxim for infants aged 2, 4, and 6 months to protect against six diseases: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenza type B (Section 3). Another new addition is the Tripacel vaccine, a diphtheria, tetanus, and pertussis vaccine for children aged approximately 18 months to prevent pertussis or whooping cough (Section 3). Furthermore, the Determination introduces two new quadrivalent influenza vaccines: Fluarix Tetra for persons aged 3 years and above and FluQuadri Junior for children aged less than 3 years, both intended for the prevention of influenza (Section 3). Additionally, it includes a clause that allows children under 10 years of age to receive catch-up vaccinations for any scheduled vaccines they missed at the specified ages, based on their current age and clinical requirements (Section 3). The obligations imposed by this Variation Determination primarily fall on the Minister for Health, who is tasked with ensuring that the specified vaccines are provided under the NIP. This includes the responsibility of arranging for the provision of these vaccines and associated goods or services (Section 9B(1) of the National Health Act 1953). The Minister is also responsible for determining the circumstances under which these vaccines can be provided (Section 9B(5) of the Act). Furthermore, the Pharmaceutical Benefits Advisory Committee (PBAC) has the obligation to recommend vaccines to be included in the NIP, ensuring that these recommendations are based on clinical evidence and public health needs (Section 9B(7) of the Act). Failure to comply with the provisions of the Variation Determination may result in civil or criminal penalties, although the specific penalties are not detailed in the Determination itself. Generally, breaches of provisions under the National Health Act 1953 can lead to fines and, in severe cases, imprisonment. The precise penalties would depend on the nature and severity of the breach, as well as any additional regulations or guidelines that apply. For instance, any person who knowingly makes a false statement or provides misleading information in relation to the provision of a designated vaccine could face fines of up to $22,200 or imprisonment for up to two years, or both, under the National Health Act 1953. It is essential for all parties involved to adhere to the provisions of the Determination to avoid any legal repercussions.

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Public Health Law
Instrument
Statutory Instrument
Concepts
Commencement Provisions
Reporting & Disclosure Obligations
Prohibited Conduct
Regulatory Standards
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Designated Vaccines
Immunisation Program

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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.