EXPLANATORY STATEMENT
Issued by the Authority of the delegate of the Minister for Health
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Variation Determination 2012 (No.2)
Legislation
Section 9B(1) of the National Health Act 1953 (the Act) states 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. Section 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. Section 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. The National Health (Immunisation Program – Designated Vaccine) Determination 2012 (No.1) (the Principal Determination) designates vaccines in accordance with subsection 9B(2) of the Act and specifies circumstances in which designated vaccines may be provided.
Purpose
The purpose of this Determination is to vary the Principal Determination to designate Priorix –Tetra® as a vaccine in accordance with subsection 9B(2) of the Act.
A designated vaccine may be provided free of charge to eligible people under the National Immunisation Program (NIP), in the circumstances set out in the Principal Determination.
Background
Section 9B(7) of the Act provides that a vaccine must not be specified in a determination under section 9B(2) unless the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Minister for Health that it be a designated vaccine.
In July 2008, the PBAC recommended that Priorix-Tetra should be added to the NIP for the active immunisation of all Australian children at about 18 months of age. This recommendation also indicated that Priorix-Tetra should replace the existing MMR vaccine dose scheduled for 4 year olds and the varicella vaccine dose scheduled for 18 month olds. Following the implementation of this recommendation, MMR will be provided at about 12 months of age and MMRV at about 18 months of age.
Instrument Description
The Principal Determination was made on 24 September 2012 and came into effect on 28 September 2012. It is now necessary to vary the Principal Determination to give effect to the PBAC recommendations of July 2008 regarding the listing of Priorix-Tetra on the NIP for the cohort comprising children of 18 months of age.
Item 209 in Schedule 1, Part 1 of the Previous Determination is revised to include the circumstances and use for Priorix-Tetra.
As a result of the amendments, other minor formatting amendments have been made.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The instrument will commence on the day after it is registered on the Federal Register of Legislative Instruments.
Consultation
The Office of Best Practice and Regulation considers that regulatory amendments that update the listing of vaccines on the National Immunisation Program and their associated price to be machinery in nature. Therefore in accordance with section 18(a) of the Legislative Instruments Act it has been determined that further consultation is unnecessary.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Immunisation Program – Designated Vaccines) Variation
Determination 2012 (No.2)
This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the legislative instrument
The legislative instrument varies the National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No.1) (the Principal Determination) which designates vaccines in accordance with subsection 9B(2) of the Act, and specifies circumstances in which designated vaccines may be provided.
This instrument varies the Principal Determination by designating a new vaccine, Priorix‑Tetra.
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The NIP assists the advancement of this human right by providing free access for eligible people to designated vaccines. This is a positive step towards attaining the highest standard of health for all Australians. Efficient operational arrangements for the NIP support effective administration of the Program.
The NIP also assists the advancement of Article 1 of the ICESCR. Since vaccination is not mandatory in Australia this enables the right to self-determination.
Conclusion
This legislative instrument is compatible with human rights because it advances the protection of human rights.
Karen Hall
Acting Assistant Secretary
Office of Health Protection
Department of Health and Ageing