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 2007 (No.2)
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 National Health (Immunisation Program - Designated Vaccines) Determination 2007(No. 1) (‘the Original Determination’) was made on 18 June 2007 and came into effect upon registration on 21 June 2007. It is now necessary for a change to the circumstances under which a specified vaccine can be provided under subsection 9B(2), and circumstances specified under subsection 9B(5). It has been decided to provide for these additional matters by revoking and remaking the Original Determination rather than amending it.
Instrument Description
The Original Determination came into effect on 1 January 2006, designating vaccines that were available under the repealed section 9B of the National Health Act 1953 at any time during the period of 60 days immediately before the commencement of paragraph 9B(7)(b) as a 'designated vaccine' under the new section 9B of the Act.
The new determination is called the National Health (Immunisation Program - Designated Vaccines) Determination 2007 (No.2) (‘the New Determination’) and the only changes from the provisions of the Original Determination are in respect of the circumstances under which the Q Fever vaccine (Q-Vax) can be provided.
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
The likely impact and effect of this change is minimal. As mentioned above, the New Determination is substantively identical to the Original Determination except for a change to the circumstances under which Q-Vax can be provided in a specified area in Waikerie SA. After this amendment has been made, a vaccination program to target people living in the area and now eligible for Q-Vax will be initiated.
Consultation
The Office of Best Practice Regulation has been consulted regarding the need for a Regulation Impact Statement (RIS). The advice received was that a RIS is not necessary as the amendment is a minor or machinery matter.
Reference Documents
- The Instrument of Delegation is at Attachment A.
Overview
The National Health (Immunisation Program - Designated Vaccines) Determination 2007 (No.2) was introduced to amend the existing immunisation program under the National Health Act 1953. This determination was enacted to address the need for a minor adjustment in the circumstances under which the Q Fever vaccine, Q-Vax, can be provided. The National Health Act 1953 provides the legislative framework for the provision of designated vaccines and related services, and the 2007 Determination was made by the Minister for Health and Ageing, who delegated authority to the Assistant Secretary of the Targeted Prevention Programs Branch, Population Health Division in the Department of Health and Ageing. The policy objective of this amendment is to ensure that the immunisation program remains effective and responsive to public health needs, with the expectation that minimal impact and effect will result from this change. The Office of Best Practice Regulation confirmed that a Regulation Impact Statement was not necessary due to the minor nature of this amendment.
Scope and Application
The National Health (Immunisation Program – Designated Vaccines) Determination 2007 (No. 2) applies to the provision of designated vaccines under the National Health Act 1953, which governs the public health system in Australia. This legislation allows the Minister for Health and Ageing to designate specific vaccines and outline the circumstances for their provision. The Minister has delegated this authority to Ms Jenny Bourne, the Assistant Secretary of the Targeted Prevention Programs Branch, Population Health Division in the Department of Health and Ageing. This Determination specifically modifies the conditions under which the Q Fever vaccine, Q-Vax, can be administered, differing from the previous National Health (Immunisation Program – Designated Vaccines) Determination 2007 (No. 1) by addressing eligibility in a specified area in Waikerie, South Australia. The amendment is intended to have minimal impact but will enable the initiation of a vaccination program targeting individuals in the designated area. Consultation with the Office of Best Practice Regulation determined that a Regulation Impact Statement was unnecessary due to the minor nature of the changes.
Key Provisions
The National Health (Immunisation Program – Designated Vaccines) Determination 2007 (No. 2) primarily revises the conditions under which a specified vaccine, the Q Fever vaccine (Q-Vax), can be provided under subsection 9B(2) of the National Health Act 1953 (the Act). The determination specifies Q-Vax as a designated vaccine and outlines the specific circumstances under which it can be administered, as provided under subsection 9B(5) of the Act. The key change in this determination is the alteration of the circumstances for the provision of Q-Vax in a specified area in Waikerie, South Australia.
The Act imposes specific obligations on the parties involved, including the Minister for Health and Ageing and the entities administering the vaccination programs. The Minister has the authority to determine which vaccines are designated under subsection 9B(2) of the Act and can specify the circumstances under which these vaccines can be provided under subsection 9B(5). This responsibility was delegated to the Assistant Secretary of the Targeted Prevention Programs Branch, Population Health Division in the Department of Health and Ageing, currently Ms Jenny Bourne. Entities administering the vaccination programs must comply with the conditions specified in the determination to ensure the vaccines are provided appropriately and effectively.
Breaches of the provisions in the National Health (Immunisation Program – Designated Vaccines) Determination 2007 (No. 2) can lead to civil or criminal consequences, depending on the nature and severity of the breach. While the determination does not explicitly state maximum penalties, violations of provisions under the National Health Act 1953 can result in substantial fines or other legal repercussions. Compliance with the specified conditions is crucial to avoid any legal ramifications.
Overall, the determination aims to ensure that Q-Vax is provided under the correct circumstances, facilitating an effective vaccination program in the designated area. The changes are relatively minor but essential for the targeted public health initiative. The Office of Best Practice Regulation has advised that a Regulation Impact Statement is unnecessary for this amendment, given its minor nature.