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.1)
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 (‘the Original Determination’) was made on 12 January 2007 and came into effect upon registration on 22 January 2007. It is now necessary for additional vaccines to be specified as designated vaccines 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The Original Determination came into effect on 1 January 2006, designating vaccines that were available under the repealed section 9B of the National Health Act 1953 at any time during the period of 60 days immediately before the commencement of paragraph 9B(7)(b) as a 'designated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.1) (‘the New Determination’) and the only changes from the provisions of the Original Determination are in respect of 2 additional vaccines against rotavirus and a new formulation of a meningococcal C vaccine that are to be specified as designated vaccines. These changes only affect the contents of Schedule 1.
The specification of these vaccines will allow them to be provided under the National Immunisation Program (‘the NIP). The vaccines against rotavirus are Rotarix® and RotaTeq®. In November 2006, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended including Rotarix® and RotaTeq® under the NIP. 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. In March 2007 the Minister for Health and Ageing agreed to the inclusion of Rotarix® and RotaTeq® under the NIP.
In addition to the 2 rotavirus vaccines, the New Determination includes an amendment to the description of Meningitec®, a meningococcal C vaccine to take account of a new formulation of this vaccine so that it can be provided under the NIP. In March 2006 the Therapeutic Goods Administration registered the new formulation. The existing single dose vial formulation will be replaced globally by July 2007. The new formulation of this vaccine will be available from July 2007.
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 the specification of 2 rotavirus vaccines and the change to the formulation of the meningococcal C vaccine. After this amendment has been made, State and Territory Governments will have a choice to make on which rotavirus vaccine they wish to purchase for distribution. State and Territory Governments will also be able to continue to provide meningococcal C 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. 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.
- The product information for Rotarix® is at Attachment B.
- The product information for RotaTeq® is at Attachment C.