EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health and Ageing
NATIONAL HEALTH ACT 1953
National Health (Immunisation Program – Designated Vaccines) Determination 2005
The purpose of Australia’s National Immunisation Program is to reduce the incidence of vaccine-preventable diseases in the Australian community through the provision of free vaccine at the point of delivery.
Vaccines for the National Immunisation Program are funded under section 9B of the National Health Act 1953(‘the Act’). The Act will be amended by the National Health Amendment (Immunisation Program) Act 2005 which has recently been passed by both Houses of Parliament and will commence by proclamation on 1 January 2006.
The amendments to the Act include the repeal and replacement of section 9B of the Act and the insertion of the following definitions in subsection 4(1) of the Act.
“Vaccine” will be defined under subsection 4(1) of the Act as “a vaccine for the purpose of immunising persons”.
“Designated vaccine” will be defined under subsection 4(1) of the Act as “has the meaning given by subsection 9B(2)” of the Act.
Subsection 9B(2) will say that the Minister may, by legislative instrument, determine that a specified vaccine is a designated vaccine for the purposes of this Act.
Subsection 9B(3) will define the manner in which a designated vaccine will be specified by reference to any or all of the following:
(a) brand;
(b) formulation;
(c) active ingredient;
(d) strength;
(e) number and timing of doses in a course of immunisation.
Subsection 9B(5) will state that in addition to specifying a vaccine, a determination under subsection 9B(2) may specify the circumstances in which the vaccine may be provided.
This Determination will have the effect, from 1 January 2006, of designating vaccines that were available under the repealed section 9B of the Act at any time during the period of 60 days immediately before the commencement of subsection 9B(7)(b) as a “designated vaccine” under the new section 9B of the Act.
Consultations
Vaccines have been funded through the National Immunisation Program and its predecessors since 1953. Since 1975 the National Health and Medical Research Council (NHMRC) provided recommendations to the Government on which vaccines should be funded; from 1997 this role has been undertaken by the Australian Technical Advisory Group on Immunisation (ATAGI). However, from 1 January 2006, the Pharmaceutical Benefits Advisory Committee (PBAC) will assume this responsibility. Extensive consultations on the Australian Immunisation Handbook (in which ATAGI’s recommendations are contained) are conducted prior to NHMRC endorsement of the Handbook. The ATAGI membership has also been constructed to ensure a broad variety of views are incorporated in the decision-making process.
The Office of Regulation Review has assessed this Determination and has confirmed that there is no requirement to conduct a Regulation Impact Statement.
This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Details of the Determination are set out in the Attachment.
The Determination will commence on 1 January 2006 when Part 1 of Schedule 1 to the National Health Amendment (Immunisation Program) Act 2005 will be proclaimed.
ATTACHMENT
Section 1 provides the name of the Determination as being the National Health (Immunisation Program – Designated Vaccines) Determination 2005.
Section 2 provides that this Determination commences on the commencement of Part 1 of Schedule 1 to the National Health Amendment (Immunisation Program) Act 2005. This will occur on 1 January 2006.
Section 3 defines the terms used for the purposes of the Determination.
Section 4 provides that each vaccine mentioned in column 2 of Schedule 1 of the Determination is a designated vaccine as defined under subsection 9B(2).
Section 5 provides that a designated vaccine mentioned in an item of Schedule 1 may be provided in the circumstances mentioned in that item in accordance with subsection 9B(5).
Section 6 provides the circumstances in which particular designated vaccines may be provided in accordance with subsection 9B(5).
Schedule 1 to the Determination lists those vaccines that are “designated vaccines” and the circumstances in which the vaccine may be provided.