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
Legislation
Subsection 9B(1) of the National Health Act 1953 (‘the Act’) provides 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 Determination will replace the National Health (Immunisation Program – Designated Vaccines) Determination 2007 (No.2) (‘the Original Determination’) which was made on 11 September 2007 and came into effect upon registration on that date.
The only change from the Original Determination is that this Determination addresses the interruption to worldwide supply of Comvax and Pedvax Hib vaccines. The Commonwealth was advised of this interruption by CSL in December 2007. Comvax and Pedvax Hib vaccines are used in several jurisdictions in Australia. In late December 2007, the Australian Technical Advisory Group on Immunisation (ATAGI) provided advice regarding the safety and efficacy of replacement options for these vaccines. In the short term, all affected jurisdictions can shift to a universal State/Territory wide PRP-T vaccine schedule. The affected jurisdictions have indicated that they will commence the alternate schedule from March 2008.
Instrument Description
The only change from the Original Determination is the removal of references to circumstance (b) for Items 103, 304 and 305 of Schedule 1 of the Original Determination.
Authority
On 5 June 2006 the Minister for Health and Ageing delegated his powers under subsection 9B(2) of the National Health Act 1953 (‘the Act’) to the person occupying the position of Assistant Secretary of the Targeted Prevention Programs Branch, Population Health Division in the Department of Health and Ageing. This person is currently Ms Jenny Bourne.
Impact and Effect
Jurisdictions impacted by this supply issue have indicated that they will commence the alternate schedule from March 2008; therefore, there will be no impact on the National Immunisation Program (NIP). Each affected jurisdiction has developed its own strategy for managing the schedule change, particularly with regard to children who have already commenced the existing schedule.
The replacement vaccines are existing vaccines on the NIP. Subject to monitoring and surveillance outcomes, jurisdictions may need to revert to PRP-OMP vaccines once the supply issue is resolved. ATAGI will provide further advice on long term issues around this vaccine.
Consultation
Each state and territory government was consulted regarding these changes through their representation on the National Immunisation Committee. No jurisdiction was opposed to the proposed amendments. A Regulation Impact Statement is not necessary as the amendment is a minor matter. A “Best Practice Regulation - Preliminary Assessment” (Office of Best Practice Regulations reference number 9485) has been completed.
Reference Documents
- The Instrument of Delegation is at Attachment A.