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.
Overview
The National Health (Immunisation Program – Designated Vaccines) Determination 2008 is a legislative instrument enacted by the Australian Government to address an unexpected supply disruption of the Comvax and Pedvax Hib vaccines, which are part of the National Immunisation Program (NIP). The determination was introduced to ensure the continuity of immunisation services across various jurisdictions in Australia, as advised by the Australian Technical Advisory Group on Immunisation (ATAGI). The Act was enacted 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 primary objective of this legislation is to allow for the specification of replacement vaccines and the modification of immunisation schedules to accommodate the temporary unavailability of the affected vaccines. Jurisdictions were consulted through the National Immunisation Committee, and no opposition to the amendments was recorded. This determination represents a minor amendment to the existing immunisation program, aiming to maintain the efficacy and safety of the immunisation services provided to the public.
Scope and Application
The National Health (Immunisation Program – Designated Vaccines) Determination 2008 applies to the provision of designated vaccines and related goods or services within the framework of the National Health Act 1953. Specifically, it governs the arrangement for the provision of these vaccines by the Commonwealth, ensuring that the immunisation programs are delivered effectively across Australia. This Determination affects all jurisdictions within Australia, including states and territories, as it pertains to the national immunisation program. The changes outlined in this Determination address the temporary supply interruption of specific vaccines, namely Comvax and Pedvax Hib, by replacing references to certain circumstances in the 2007 Determination with an alternate schedule that utilises the PRP-T vaccine. This Determination excludes any other vaccines not specified within its scope. Subordinate instruments may extend or restrict the application of this Determination, but for the current purposes, the focus is on the immediate replacement of the affected vaccines to ensure continuity in immunisation services.
Key Provisions
The main operative sections of this Determination (F2008L00641) pertain to the provision of designated vaccines under the National Health Act 1953 (section 9B(2)). This legislative instrument specifies that certain vaccines, in this instance Comvax and Pedvax Hib, are designated vaccines for the purposes of the Act. The Determination also allows the Minister to specify the circumstances under which these vaccines may be provided (section 9B(5)). The current Determination replaces the earlier National Health (Immunisation Program – Designated Vaccines) Determination 2007, and it addresses an interruption in the worldwide supply of Comvax and Pedvax Hib vaccines. It outlines the shift to a universal State/Territory-wide PRP-T vaccine schedule as a temporary measure until the supply issue is resolved.
The Act imposes obligations on the parties involved to ensure the smooth transition to the alternate vaccine schedule. The relevant authorities are required to monitor the implementation of the alternate vaccine schedule and the outcomes of the vaccination program. They must also ensure that the affected jurisdictions develop strategies for managing the schedule change, particularly for children who have already commenced the existing vaccine schedule. Additionally, the authorities must keep track of the supply situation and revert to PRP-OMP vaccines once the supply issue is resolved, subject to the advice of the Australian Technical Advisory Group on Immunisation (ATAGI).
There are no specific offences, penalties, or civil/criminal consequences outlined in the Determination for breach of its provisions. However, failure to comply with the requirements and obligations imposed by the Act could result in legal consequences under the broader National Health Act 1953. The penalties for breaches of the Act may vary depending on the nature and severity of the offence, and may include fines, imprisonment, or both. The maximum penalties are not specified in the Determination but can be found in the relevant sections of the National Health Act 1953.