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. 1)
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 Vaccines) 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 Menitorix® as a vaccine in accordance with subsection 9B(2) of the Act, and to vary the specified circumstances in which Gardasil®, and Prevenar 13® may be provided.
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 November 2010, PBAC recommended inclusion of Menitorix®, a haemophilus influenzae type b (Hib) and group C meningococcal polysaccharide conjugate (Men C) vaccine, in the NIP listing for the 12 month cohort. This is intended to serve as an alternative to the current administration of monovalent Hib and Men C vaccines.
In November 2011, PBAC recommended extension of the NIP listing of Gardasil®, a 4-valent vaccine for the prevention of human papillomavirus, to include ongoing administration to boys approximately 12 to 13 years of age in a school-based program. The PBAC also recommended a catch-up over two years for boys in Year 9. As the age of year 9 students differs according to jurisdiction, an age bracket of 14 to 16 years has been included in the determination. The measure complements the existing school-based vaccination program for females, which was introduced under the NIP in April 2007.
In November 2010, PBAC made a further recommendation to the Minister that the Prevenar 13® listing be extended to include a single supplementary (catch up) dose for children aged between 12 and 35 months who have completed their primary pneumococcal vaccination with Prevenar 7®, to provide them with protection against an additional six serotypes.
On 10 May 2011, in the 2011-12 Budget, the Australian Government announced that a supplementary dose of Prevenar 13® would be available on the NIP for a period of one year, from 1 October 2011 to 30 September 2012
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 November 2010 and November 2011 respectively, regarding the listing of Menitorix® in the NIP for the cohort comprising children of 12 months of age and the variation to the circumstances for use of Gardasil® to include both males and females.
Item 105 in Schedule 1, Part 1 of the Previous Determination is revised to include the circumstances and use for Menitorix.
Item 110 in Schedule 1, Part 1 of the Previous Determination has been revised to remove the circumstances under which a catch up dose of Prevanar 13 can be provided, as this program finished on 30 September 2012.
Item 212 in Schedule 1, Part 2 of the Previous Determination is amended to alter the circumstances of use of Gardasil.
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. 1)
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, Menitorix and varying the circumstances for use of Gardasil, and alters the circumstances for the provision of Prevanar 13, as the catch up program ceased on 30 September 2012.
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.
Julianne Quaine
Assistant Secretary
Office of Health Protection
Department of Health and Ageing