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 2013 (No.1)
Legislation
Subsection 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. 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 9B(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) specifies vaccines that are designated in accordance with subsection 9B(2) of the Act and specifies the circumstances in which designated vaccines may be provided.
Purpose
The purpose of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2013 (No.1) is to add the influenza vaccine Intanza® and the combination measles, mumps, rubella and varicella vaccine ProQuad® to the Principal Determination. This has the effect of adding these vaccines to the National Immunisation Program (NIP). The Australian Government provides funding for vaccines that are included in the NIP.
Background
A vaccine that is specified as a designated vaccine by legislative instrument under subsection 9B(2) of the Act may be provided free of charge to eligible people under the NIP in the circumstances set out in the Principal Determination.
Subsection 9B(7) of the Act provides that a vaccine must not be specified in a determination made under subsection 9B(2) unless the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Minister that it be a designated vaccine.
In July 2009, PBAC recommended that Intanza® 15mcg be added to the NIP as a vaccination against influenza to be administered to persons aged 65 years and older.
In November 2012, PBAC recommended that ProQuad® be added to the NIP as a vaccination against measles, mumps, rubella and varicella to be administered when children are approximately 18 months of age.
Instrument Description
The Principal Determination was made on 24 September 2012 and came into effect on 28 September 2012. To give effect to the PBAC recommendations of July 2009 and November 2012 regarding the inclusion of Intanza® and ProQuad® on the NIP it is necessary to vary the Principal Determination.
Item 206 has been varied to specify Intanza® as a designated vaccine to prevent influenza and may be administered to persons aged 65 years and over.
Item 212 has been inserted to specify ProQuad® as a designated vaccine for the prevention of measles, mumps, rubella and varicella and may be administered to children aged approximately 18 months of age.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA).
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 amendments that have the effect of updating the listing of vaccines on the NIP are regulatory amendments that are minor or machinery in nature. Therefore, in accordance with subparagraph 18(2)(a) of the LIA 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 2013 (No.1)
This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in the definition of ‘human rights’ contained in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the legislative instrument
This legislative instrument varies the National Health (Immunisation Program – Designated Vaccines) Determination 2012 (No.1) (the Principal Determination) which specifies designated vaccines in accordance with subsection 9B(2) of the Act and may specify the circumstances in which designated vaccines can be provided. The Principal Determination is the legislative instrument that gives effect to the National Immunisation Program (the NIP). The Australian Government provides funding for vaccines that are included in the NIP.
This legislative instrument adds the influenza vaccine Intanza® and the combination measles, mumps, rubella and varicella vaccine ProQuad® to the Principal Determination. This has the effect of adding these vaccines to the NIP.
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by providing a legislative basis to assist with the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. This legislative instrument assists in the advancement of this human right by providing free access for eligible people to designated vaccines.
This legislative instrument also engages Article 1 of the ICESCR which recognises the right of all peoples to self-determination. The right to self-determination is positively engaged as vaccination is not mandatory in Australia.
Conclusion
This legislative instrument is compatible with human rights because it advances the progressive realisation and protection of the human rights mentioned above.
Julianne Quaine
Assistant Secretary
Immunisation Branch
Department of Health and Ageing