National Health (Immunisation Program - Designated Vaccines) Determination 2007

Overview

The National Health (Immunisation – Designated Vaccines) Determination 2007, which revoked and remade the 2005 Determination, was introduced to address the need to include additional vaccines, specifically Adacel® and Gardasil®, under the National Immunisation Program (NIP). This change was necessary following recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and subsequent approvals by the Minister for Health and Ageing. The 2007 Determination also extended the provision of meningococcal C vaccine until 30 June 2007 for specific age groups who had not previously received certain vaccines. Enacted by the Australian Parliament, the objective of this amendment was to enhance the immunisation coverage under the NIP, providing flexibility to State and Territory Governments in their vaccine procurement and distribution choices, while ensuring the continued availability of critical vaccines such as meningococcal C and the newly introduced HPV vaccine. The impact of these changes was expected to be minimal, primarily affecting the procurement decisions of State and Territory Governments.

Scope and Application

The National Health (Immunisation – Designated Vaccines) Determination 2005 applies to the provision of vaccines under the National Immunisation Program (NIP) across Australia, involving State and Territory Governments in the procurement and distribution of designated vaccines. The Act applies to persons, entities, and programs involved in the administration of the NIP, particularly those responsible for the purchase and distribution of vaccines to eligible individuals. This includes health departments within each state and territory, as well as medical practitioners and other healthcare providers who administer the vaccines. The geographic reach of the Act is national, impacting all jurisdictions within Australia. The Act includes provisions for the inclusion of additional vaccines, Adacel® and Gardasil®, under the NIP, and an extension for the provision of meningococcal C vaccine until 30 June 2007 for specific age groups. The Act operates under the authority delegated by the Minister for Health and Ageing to the Assistant Secretary of the Targeted Prevention Programs Branch, Population Health Division in the Department of Health and Ageing. The impact of the Act is minimal, primarily affecting the choices available to State and Territory Governments in the procurement of vaccines and the extension of the meningococcal C vaccination program. The Act does not specify exclusions or exemptions beyond the outlined provisions. Subordinate instruments may be used to further define the application and administration of the Act.

Key Provisions

The National Health (Immunisation – Designated Vaccines) Determination 2005 (the Determination) has been revoked and remade to include additional vaccines in the National Immunisation Program (NIP). Specifically, Adacel®, a diphtheria, tetanus, and pertussis (adult booster) vaccine, and Gardasil®, a human papillomavirus (HPV) vaccine, are now designated vaccines under the NIP (sections 2 and 3). This amendment responds to recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) and subsequent approvals by the Minister for Health and Ageing. The new Determination also allows for the continued provision of meningococcal C vaccine until 30 June 2007 for eligible individuals who have not received certain vaccines mentioned in the previous Determination (section 3). The entities governed by this Determination, primarily State and Territory Governments, now have the option to purchase either Adacel® or Boostrix as the diphtheria-tetanus-pertussis (adult booster) vaccine for distribution under the NIP (section 2). Additionally, they can continue to provide meningococcal C vaccine through established programs until the specified date (section 3). The Determination also facilitates the implementation of the HPV vaccination program starting in March 2007 (section 3). All jurisdictions were consulted through their representation on the National Immunisation Committee, and none opposed the proposed amendments. The Act does not specify particular offences or penalties for breaches of the Determination. However, it is implied that any non-compliance with the provisions could lead to administrative or legal consequences under the National Health Act 1953 or relevant State and Territory laws. The minor nature of the amendment, as advised by the Office of Regulation Review, suggests that any enforcement would likely be aimed at ensuring compliance with the program requirements rather than imposing significant penalties (Attachment B). The determination is a regulatory measure designed to streamline the vaccination process under the NIP, and adherence to its provisions is essential for the effective implementation of the immunisation programs.