National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 3) 2018

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01267 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Health

 

National Health Act 1953

 

National Health (Immunisation Program – Designated Vaccines) Variation Determination (No 3) 2018

 

Authority

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 the Act.  Subsection 9B(5) provides that in addition to specifying a vaccine, a determination may specify the circumstances in which the vaccine may be provided.

 

Purpose

The purpose of the National Health (Immunisation Program – Designated Vaccines) Variation Determination (No.3) 2018 (the Variation Determination) is to make amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination), including:

  • adding item 202A of Schedule 1 of the Determination to the list of items set out in subsection 7(11) of the Determination that provide additional circumstances in which relevant items of Schedule 1 of the Determination may be provided;
  • adding item 202A of Schedule 1 of the Determination to the list of items set out in subsection 7(12) of the Determination that provide additional circumstances in which relevant items of Schedule 1 of the Determination may be provided; and
  • adding item 202A to Schedule 1 of the Determination which provides for the vaccine Hepatitis B viral infection - Engerix B (adult formulation) and the circumstances in which the vaccine may be provided under the National Immunisation Program (the NIP).

 

Background

Pharmaceutical Benefits Advisory Committee (PBAC) recommendations

Subsection 9B(7) of the Act relevantly provides that a vaccine must not be specified in a determination under subsection 9B(2) unless the PBAC has recommended to the Minister that the vaccine be a designated vaccine.

In July 2018, the PBAC recommended that Engerix-B (adult formulation) be a designated vaccine for the purposes of section 9B of the Act on a temporary basis for use in adolescents and adults until either the current shortage of H-B-Vax II (adult formulation, Seqirus Australia Pty Ltd) has been resolved, or 31 December 2019 (when shortage is predicted to end), whichever were to occur first. 

 

Government approval

On 22 August 2018, the Minister for Health agreed to list Engerix B (adult formulation) as a designated vaccine for the purposes of subsection 9B(2) of the Act. It will take effect from the day after registration.

Details

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

 

Consultation

The Office of Best Practice Regulation has advised 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.

 

Details of the Determination are set out in the Attachment.

 

The Determination commences on the day after registration.

 

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

Authority:     Subsection 9B(2) of the

 National Health Act 1973

 

ATTACHMENTS

 

DETAILS ON THE NATIONAL HEALTH (IMMUNISATION PROGRAM – DESIGNATED VACCINES) VARIATION DETERMINATION (NO. 3) 2018

 

1. Name of Determination

Section 1 provides that the title of the Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination (No 3) 2018 (the Variation Determination).

 

2. Commencement

Section 2 provides that the Variation Determination commences on the day after registration.

 

3. Authority

Section 3 provides that the Variation Determination is made under subsection 9B(2) of the National Health Act 1953.

 

4. Variation of National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1)

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

 

Schedule  Amendments

 

Item 1 – Subsection 7(11)

Item 1 repeals subsection 7(11) in the Determination and substitutes it with a new subsection 7(11). The new subsection 7(11) provides additional circumstances in which item 202A may be provided under the NIP. The purpose of this subsection is to provide for catch-up immunisations, where an individual has not received the vaccine in the circumstances mentioned for it in Schedule 1 of the Determination.

 

Item 2 – Subsection 7(12)

Item 2 repeals subsection 7(12) in the Determination and substitutes it with a new subsection 7(12). The new subsection 7(12) provides additional circumstances in which item 202A may be provided under the NIP. The purpose of this subsection is to provide for catch-up immunisations, where an individual has not received the vaccine in the circumstances mentioned for it in Schedule 1 of the Determination.

 

Item 3 – After item 202 in Schedule 1, Part 1

Item 3 adds item 202A to Schedule 1 in the Determination. Item 202A of Schedule 1 provides details of the Hepatitis B viral infection vaccine - Engerix-B (adult formulation) and the circumstances in which the vaccine may 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 (No.3) 2018

 

This Legislative Instrument 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 National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 3) 2018 (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).

The Variation Determination adds a new Hepatitis B viral infection vaccine - Engerix B (adult formulation) and specifies the circumstances in which the vaccine may be provided under the NIP.

Human Rights Implications

This Variation Determination engages the right to health as set out in Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights 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. 

Conclusion

The Variation Determination is compatible with human rights as it promotes the right to health.

 

Masha Somi

Assistant Secretary Immunisation Branch

Office of Health Protection

Department of Health

 

 

 

Overview

The National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 3) 2018 is a legislative instrument enacted to amend the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) under subsection 9B(2) of the National Health Act 1953. The Variation Determination, issued by the Minister for Health, aims to address the temporary shortage of H-B-Vax II (adult formulation) by specifying the Hepatitis B viral infection vaccine - Engerix B (adult formulation) as a designated vaccine for the purposes of the Act. This amendment allows for its inclusion in the National Immunisation Program (NIP), ensuring continuity in the provision of essential vaccines. The addition of Engerix B (adult formulation) is based on recommendations from the Pharmaceutical Benefits Advisory Committee and responds to the need for alternative vaccines until the shortage is resolved. The Variation Determination also updates the circumstances in which the vaccine can be provided under the NIP, facilitating catch-up immunisations for those who have not received the vaccine under previous conditions. This legislative variation aligns with the overarching policy objective of the National Health Act 1953, which is to progressively realise the highest attainable standard of physical and mental health for all Australians by ensuring the availability of essential vaccines through the NIP. The compatibility with human rights, particularly the right to health as outlined in the International Covenant on Economic, Social and Cultural Rights, is upheld by providing free access to designated vaccines and thereby protecting individuals and the community from vaccine-preventable diseases.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 3) 2018 amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014, which specifies vaccines designated under the National Health Act 1953 for provision under the National Immunisation Program (NIP). The Variation Determination adds the Hepatitis B viral infection vaccine - Engerix B (adult formulation) to the list of designated vaccines, effective from the day after its registration. This addition allows the vaccine to be provided under the NIP, particularly addressing the temporary shortage of another Hepatitis B vaccine, H-B-Vax II, until either the shortage is resolved or 31 December 2019. The new provisions also include specific circumstances for the provision of the Engerix B vaccine, including catch-up immunisations for individuals who have not previously received it. The Variation Determination applies across Australia, and its provisions can be extended or modified through subordinate instruments as necessary. This legislative action ensures continued immunisation coverage during supply constraints, thereby supporting public health objectives.

Key Provisions

The main operative sections of the National Health (Immunisation Program – Designated Vaccines) Variation Determination (No 3) 2018 (the Variation Determination) are sections 1 to 3. Section 1 provides the title of the Determination, section 2 provides the commencement date, and section 3 provides the authority under which the Determination is made. The Determination varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) by adding item 202A to Schedule 1, which specifies the Hepatitis B viral infection vaccine - Engerix B (adult formulation) and the circumstances in which the vaccine may be provided under the National Immunisation Program (NIP) (subsection 7(11) and 7(12)). This addition allows for catch-up immunisations where an individual has not received the vaccine in the circumstances mentioned for it in Schedule 1 of the Determination. The Variation Determination imposes obligations on the parties involved in the procurement and provision of vaccines under the NIP. Suppliers of the Hepatitis B viral infection vaccine - Engerix B (adult formulation) are eligible to participate in any procurement processes undertaken by the Department of Health for the supply of vaccines on the NIP once the vaccine is listed in the Determination. The Determination also specifies the circumstances in which the vaccine may be provided under the NIP, which aids in ensuring that eligible individuals receive the vaccine in a timely and appropriate manner. There are no specific offences, penalties, or civil/criminal consequences outlined for breaches of the Variation Determination. However, the Determination is a legislative instrument for the purposes of the Legislation Act 2003, which means that breaches of the Determination may be subject to the general penalties and enforcement provisions applicable to legislative instruments under the Legislation Act 2003. These may include fines, imprisonment, or other penalties as prescribed by the relevant legislation. Additionally, any failure to comply with the requirements of the Determination may result in the supplier being ineligible to participate in procurement processes for the supply of vaccines on the NIP.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Regulatory Standards
Reporting & Disclosure Obligations

Interactions

Authorises

All Versions

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.