National Health (Immunisation Program - Designated Vaccines) Variation Determination 2012 (No. 2)

Overview

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2012 (No.2) was enacted to amend the existing National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No.1) under the National Health Act 1953. The primary purpose of this variation is to incorporate the recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC) from July 2008, which advised the inclusion of the Priorix-Tetra® vaccine in the National Immunisation Program (NIP). This amendment ensures that Priorix-Tetra® is designated as a vaccine under the Act, facilitating its provision under the NIP to eligible individuals free of charge. The determination was enacted by the Minister for Health and is designed to align with the policy objective of enhancing public health through the immunisation program by incorporating recommended vaccines. The instrument is compatible with human rights as it supports the progressive realisation of the right to health and self-determination by providing access to designated vaccines through the NIP.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2012 (No.2) amends the National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No.1) to designate Priorix-Tetra as a designated vaccine for the purposes of the National Health Act 1953. This instrument applies nationally across Australia, and it targets the Minister for Health who is responsible for the provision or arrangement of designated vaccines and associated goods or services. The Determination specifies that Priorix-Tetra may be provided free of charge to eligible individuals under the National Immunisation Program, as recommended by the Pharmaceutical Benefits Advisory Committee in July 2008. The amendment includes the replacement of the existing MMR vaccine dose for 4-year-olds and the varicella vaccine dose for 18-month-olds with Priorix-Tetra, aligning with the recommendations to enhance immunisation coverage and public health outcomes. This legislative instrument is compatible with human rights, particularly by advancing the right to the highest attainable standard of health, as recognised in the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2012 (No.2) (the Determination) modifies the National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No.1) (Principal Determination) to incorporate Priorix-Tetra as a designated vaccine under section 9B(2) of the National Health Act 1953 (the Act). This change aligns with the Pharmaceutical Benefits Advisory Committee's (PBAC) recommendation from July 2008, which proposed that Priorix-Tetra be added to the National Immunisation Program (NIP) for the active immunisation of Australian children at about 18 months of age. Additionally, this new designation will replace the existing MMR vaccine dose scheduled for 4-year-olds and the varicella vaccine dose scheduled for 18-month-olds. This means that MMR will be provided at about 12 months of age and MMRV at about 18 months of age. The Determination imposes certain obligations on the parties involved. Under section 9B(1) of the Act, the Minister is authorised to provide or arrange for the provision of designated vaccines and related goods or services. Furthermore, section 9B(5) of the Act allows for the specification of circumstances under which the vaccine may be provided. The Determination specifies the conditions under which Priorix-Tetra can be provided free of charge to eligible people under the NIP. This includes ensuring that the vaccine is provided in accordance with the recommendations of the PBAC and the specific circumstances outlined in the Principal Determination. Breach of the provisions outlined in the Determination can lead to various consequences. However, the Determination itself does not explicitly state any specific offences, penalties, or civil/criminal consequences for non-compliance. Typically, breaches of provisions under the National Health Act 1953 may result in administrative or civil penalties, depending on the nature of the breach and the relevant state or territory laws. For example, unauthorised administration of vaccines could lead to disciplinary actions against healthcare providers or administrative penalties imposed by health authorities. It is important to note that the exact penalties would depend on the specific laws governing health and safety in the respective jurisdiction. The Determination also aligns with the human rights framework, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). By incorporating Priorix-Tetra into the NIP, the Determination supports the progressive realisation of the right to the highest attainable standard of physical and mental health. The NIP provides free access to designated vaccines, thereby advancing this human right and facilitating the highest standard of health for all Australians. Additionally, the non-mandatory nature of vaccination in Australia respects the right to self-determination, as outlined in Article 1 of the ICESCR.