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 2011 (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 purpose of the National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No.2) (the New Determination) is to designate vaccines in accordance with subsection 9B(2) of the Act, and specify circumstances in which designated vaccines may be provided.
A designated vaccine may be provided free of charge to eligible people under the National Immunisation Program, in the circumstances set out in the New Determination.
Background
Subsection 9B(7) of the Act provides that a vaccine must not be specified in a determination under subsection 9B(2) unless the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Minister for Health and Ageing that it be a designated vaccine.
In December 2009, the PBAC recommended that Fluarix®, an influenza vaccine manufactured by GlaxoSmithKline, be designated as a NIP vaccine. This allowed the sponsor to participate in future national tenders for the supply of influenza vaccines and was consistent with the earlier PBAC recommendation to transfer influenza vaccines from the Pharmaceutical Benefits Scheme to the NIP.
In November 2010, PBAC made a recommendation to the Minister that Prevenar 13®, a pneumococcal vaccine manufactured by Pfizer, be listed on the NIP for a single supplementary (catch up) dose. The supplementary dose is for children aged between 12 and 35 months who have completed their primary pneumococcal vaccination with Prevenar®, to provide them with protection against an additional six serotypes of pneumococcal disease.
Instrument Description
The National Health (Immunisation Program - Designated Vaccines) Determination 2011 (No.1) (‘the Previous Determination’) was made on 9 June 2011 and came into effect on 11 June 2011. It is now necessary add a new vaccine to the determination.
The Determination is substantively the same as the Previous Determination, except for the following changes:
- a minor amendment to the circumstances of use for Prevenar 13® supplementary dose.
- the addition of a seasonal influenza vaccine, Fluarix®.
Schedule 1 of the Previous Determination has been amended as follows:
Item 109 has been amended to clarify the circumstances of use for the Prevenar 13® supplementary dose.
Schedule 2 of the Previous Determination has been amended as follows:
Item 205 has been amended to add Fluarix®, a seasonal influenza vaccine.
Impact and Effect
Amending the circumstances of use for the Prevenar 13® supplementary dose makes it clear that all eligibility requirements must be met at the time of vaccination.
The impact of adding Fluarix® to the NIP is an increase to the number of influenza vaccines listed on the NIP. This increases the options available to the Commonwealth when procuring influenza vaccines nationally. It also helps to ensure security of supply for influenza vaccines.
Consultation
The PBAC advice in relation to the vaccines is provided to the public via the Department’s website. The Public Summary Documents regarding the rationale for these recommendations is available at: www.health.gov.au
The Office of Best Practice Regulation has advised that as the proposal would be likely to have no or low impacts on business and the not-for-profit sector, a regulatory impact assessment in the form of a Regulation Impact Statement would not be not required.