EXPLANATORY STATEMENT
Issued by the Authority of the Delegate of the Minister for Health and Ageing
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Determination 2008 (No.2)
Legislation
Subsection 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. Subsection 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. Subsection 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 National Health (Immunisation Program - Designated Vaccines) Determination 2008 (‘the Current Determination’) was made on 25 February 2008 and came into effect on the day after registration, 26 February 2008. It is now necessary for an additional vaccine to be specified as a designated vaccine under subsection 9B(2), and for circumstances to be determined under subsection 9B(5). The Current Determination is being revoked and re-made rather than amended.
Instrument Description
This determination is called the National Health (Immunisation Program - Designated Vaccines) Determination 2008 (No.2) (‘the New Determination’) and the only change from the provision of the Current Determination is in respect of the designation of an additional vaccine against human papillomavirus (HPV). This change only affects the contents of Schedule 1.
The specification of the new HPV vaccine will allow it to be provided under the National Immunisation Program (the NIP). The brand name of the new vaccine against HPV is Cervarix® and it will be provided under the NIP to 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. In July 2007, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended that Cervarix® be listed under the NIP schedule. Subsection 9B(7) of the Act provides that a vaccine must not be specified in a determination under subsection 9B(2) unless PBAC has recommended to the Minister that it be a designated vaccine.
Impact and Effect
The likely impact and effect of this change is minimal. The New Determination is substantively identical to the Current Determination except for the specification of the addition of another/additional HPV vaccine. After this amendment has been made, state and territory governments will be able to choose which HPV vaccine they wish to purchase for distribution.
Consultation
The pharmaceutical company supplying the vaccine was regularly consulted regarding the addition of Cervarix® to the NIP schedule.
A Public Summary Document was provided to the public via the Departments Health and Ageing website in November 2007, containing information pertaining to the PBAC recommendation to list Cervarix® onto the NIP schedule. The document offered stakeholders with the rationale for the PBAC recommendations, and an understanding of the overall PBS listing process.
In addition, the Australian Technical Advisory Committee and National Immunisation Committee (NIC) including each state and territory, were provided with an opportunity to examine and comment on the submission provided by the pharmaceutical company supplying the vaccine.
The outcome of the consultations concluded that stakeholders were supportive of the inclusion of Cervarix® to the NIP schedule.