National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L00589 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No.1)

 

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 2017 (No.1) (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 clause which allows for the on-going provision of vaccines to individuals aged from 10 years to 19 years to receive vaccines that were not received at the specified age under the National Immunisation Program Schedule, as clinically appropriate.
  • Add a new clause which allows for the provision of vaccines to refugee and other humanitarian visa entrants who have not received the full schedule of vaccinations under the National Immunisation Program Schedule, as clinically appropriate.

 

Background

Government approval

On 9 May 2017 as part of the 2017 Budget, the Government announced access to catch-up vaccines for all Australians aged 10-19 years as well as refugees and humanitarian entrants.

Details

The Determination commenced on 23 September 2014.  Once a vaccine is listed on the Determination, the supplier of that vaccine is eligible to participate in any tenders run by the Department of Health for supply of vaccine on the NIP.

 

Consultation

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 it has been determined that further consultation is unnecessary.

 

The commencement date for the Variation Determination is the day following registration.

 

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

 


NOTES ON ATTACHMENTS

 

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 2017 (No.1).

 

Section 2 – Commencement

 

This section provides the Variation Determination commences on the day after registration.

 

Section 3 – Authority

These Rules are made under subsections 9B (2) of the National Health Act 1953.

 

Section 4 – Variation

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

 

Schedule  Amendments

 

Item 1 of Variation Determination

Adds a new clause under Subsection 7 of the Determination as ‘7(11)’. This clause outlines additional circumstances by which Items 101, 102, 106, 107, 108, 202, 211, 212, 213, 214, 215, 216, 217, 218 and 219 can be provided under the NIP.

 

Adds a new clause under Subsection 7 of the Determination as ‘7(12)’. This clause outlines additional circumstances by which Items 101, 102, 202, 211, 212, 215, 216 and 217 can be provided under the NIP.

 

 

 

 

 

 

 


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 2017 (No.1)

 

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No. 1) (the Variation Determination) is compatible with the human rights and freedoms recognised or declared in the international instruments listed in Part 1, 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 clause which allows for the on-going provision of vaccines to individuals aged from 10 years to 19 years to receive vaccines that were not received at the specified age under the National Immunisation Program Schedule, as clinically appropriate.
  • Adds a new clause which allows for the provision of vaccines to refugee and other humanitarian visa entrants who have not received the full schedule of vaccinations under the National Immunisation Program Schedule, as clinically appropriate.

 

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.

 

Hope Peisley

Assistant Secretary (a/g) Immunisation Branch

Office of Health Protection

Department of Health

Overview

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No.1) was enacted to address the need for a more inclusive immunisation program in Australia, ensuring that all Australians, including those aged between 10 and 19 years, and refugee and humanitarian visa entrants, have access to vaccines that they may have missed under the National Immunisation Program (NIP) schedule. This variation determination was made under the authority of Section 9B(2) of the National Health Act 1953, which allows the Minister to specify vaccines as designated for the purposes of the Act and to determine the circumstances in which these vaccines may be provided. The policy objective of this determination is to enhance public health by providing free access to catch-up vaccines for eligible individuals, thus protecting them and the broader community from vaccine-preventable diseases. The variation determination is a legislative instrument for the purposes of the Legislation Act 2003, and it varies the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) by adding clauses that facilitate the provision of vaccines under specific circumstances.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No.1) is a legislative instrument made under section 9B of the National Health Act 1953. This Determination varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) by allowing the ongoing provision of specified vaccines to individuals aged from 10 years to 19 years, and to refugee and other humanitarian visa entrants, who have not received the full schedule of vaccinations under the National Immunisation Program Schedule, as clinically appropriate. This Determination is applicable across Australia, extending the reach of the National Immunisation Program to include these additional groups. The Determination does not specify any exclusions or thresholds but instead identifies the vaccines and the circumstances under which they may be provided. Subordinate instruments may further extend or restrict the application of this Determination, providing flexibility in the administration of the program.

Key Provisions

The main sections of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No.1) are Sections 9B(2) and 9B(5) of the National Health Act 1953, which empower the Minister to determine via legislative instrument that a specified vaccine is a designated vaccine and to specify the circumstances under which it can be provided. The Variation Determination updates the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) by allowing the ongoing provision of vaccines to individuals aged 10-19 years and refugee and humanitarian visa entrants who have not received the full schedule of vaccinations, as clinically appropriate. The Variation Determination imposes several obligations on the parties it governs. It requires the provision of specified vaccines to eligible individuals, including those aged 10-19 years and refugee and humanitarian visa entrants, who have not received the full schedule of vaccinations under the National Immunisation Program Schedule, as determined by a healthcare professional to be clinically appropriate. The determination also stipulates that once a vaccine is listed, the supplier of that vaccine becomes eligible to participate in tenders run by the Department of Health for the supply of vaccines under the National Immunisation Program. There are no specific offences, penalties, or civil/criminal consequences outlined in the Variation Determination for breaches of its provisions. However, any breaches of the overarching National Health Act 1953 may incur penalties under that Act. The Determination operates within the framework of the Act, and any non-compliance with the Act's provisions would be subject to the penalties prescribed therein. The Variation Determination itself focuses on clarifying and updating the eligibility criteria for vaccine provision under the National Immunisation Program, ensuring that more Australians have access to necessary vaccinations.

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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.