National Health (Immunisation Program - Designated Vaccines) Determination 2008 (No. 2)

Overview

The National Health (Immunisation Program – Designated Vaccines) Determination 2008 (No.2) was enacted by the Minister for Health and Ageing under the authority delegated by the Parliament of Australia to address a gap in the National Health Act 1953 concerning the provision of specified vaccines under the National Immunisation Program (NIP). This legislation was introduced to specify an additional vaccine against human papillomavirus (HPV) to be provided under the NIP, complementing the existing provisions that allow for the designation and provision of vaccines through the program. The policy objective is to expand the immunisation offerings under the NIP, thereby enhancing public health outcomes by providing a broader range of vaccine options to the population. This determination replaces the previous National Health (Immunisation Program – Designated Vaccines) Determination 2008, specifying the new HPV vaccine, Cervarix®, for inclusion in the NIP schedule. The Pharmaceutical Benefits Advisory Committee (PBAC) had recommended the addition of Cervarix® in July 2007, a recommendation that aligns with the legislative framework requiring PBAC endorsement before a vaccine can be specified under the Act. The change will enable state and territory governments to select and purchase the HPV vaccine of their choice for distribution, ensuring flexibility and responsiveness to public health needs.

Scope and Application

The National Health (Immunisation Program - Designated Vaccines) Determination 2008 (No.2) is a legislative instrument under the National Health Act 1953, which allows the Minister for Health and Ageing to specify vaccines that are to be provided as part of the National Immunisation Program (NIP). This particular determination amends the previous 2008 determination by specifying an additional vaccine against human papillomavirus (HPV), known by the brand name Cervarix®, for inclusion in the NIP. This change allows for the provision of the new HPV vaccine to females who are at least 12 years but less than 14 years of age, or who are between 13 and 26 years of age as of certain dates, facilitating state and territory governments to choose which HPV vaccine to procure for distribution. The addition of this vaccine is contingent upon the recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) and consultation with relevant stakeholders, including the pharmaceutical company, the Australian Technical Advisory Committee, and the National Immunisation Committee, with input from each state and territory.

Key Provisions

The main sections of the National Health (Immunisation Program – Designated Vaccines) Determination 2008 (No.2) provide for the specification of vaccines under the National Immunisation Program (NIP) (subsection 9B(2)) and the circumstances in which these vaccines can be provided (subsection 9B(5)). Specifically, the Determination specifies the HPV vaccine Cervarix® as a designated vaccine under the NIP (Schedule 1). The Determination also outlines the eligibility criteria for the provision of Cervarix®, which includes females who are at least 12 years but less than 14 years, or who between 1 March 2007 and 30 June 2009 are at least 13 years but less than 27 years (Schedule 1). The Determination imposes obligations on various parties involved in the provision of vaccines under the NIP. The Minister for Health and Ageing is responsible for making the Determination under subsection 9B(2) of the National Health Act 1953, and for specifying the circumstances in which the vaccine can be provided (subsection 9B(5)). State and territory governments are responsible for purchasing and distributing the vaccines to eligible individuals, in accordance with the provisions of the Determination (subsection 9B(1)). The Pharmaceutical Benefits Advisory Committee (PBAC) is responsible for providing recommendations to the Minister regarding the inclusion of vaccines in the NIP schedule (subsection 9B(7)). The Determination does not explicitly outline any offences, penalties, or consequences for breach. However, the National Health Act 1953 does provide for a range of civil and criminal penalties for breaches of the Act or regulations made under the Act. These include fines of up to $22,200 for individuals and $111,000 for bodies corporate, imprisonment for up to two years for individuals and five years for bodies corporate, or both. In addition, the Minister for Health and Ageing may take administrative action to revoke or suspend the registration of a medical practitioner or health service provider who is found to have contravened the Act or regulations. In summary, the National Health (Immunisation Program – Designated Vaccines) Determination 2008 (No.2) specifies the HPV vaccine Cervarix® as a designated vaccine under the NIP and outlines the circumstances in which it can be provided. The Determination imposes obligations on the Minister for Health and Ageing, state and territory governments, and the PBAC, and does not explicitly outline any offences, penalties, or consequences for breach. However, the National Health Act 1953 does provide for a range of civil and criminal penalties for breaches of the Act or regulations made under the Act.