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 2014 (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.
Purpose
The purpose of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2014 (No.1) (the Variation) is to expand the cohorts of people eligible to receive the designated trivalent influenza vaccine (the Vaccine) under the National Immunisation Program (NIP).
Background
Section 9B(7) of the Act relevantly 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.
Between the March 2014 and July 2014 meetings, the PBAC recommended out-of-session that the eligibility for influenza vaccination under the NIP be expanded to include Aboriginal and/or Torres Strait Islander children aged from 6 months to less than 5 years.
Instrument Description
The National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) was made on 29 August 2014.
This Variation expands the cohort of people eligible for the Vaccine under the NIP. The Variation also changes the terms “Aboriginal or a Torres Strait Islander” and “Aboriginal and Torres Strait Islander” to the term “Aboriginal and/or Torres Strait Islander. This change has been made for consistency and inclusiveness purposes.
The Variation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The Variation commences on 1 January 2015.
Consultation
The Office of Best Practice 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(2)(a) of the Legislative Instruments Act 2003 it has been determined that further consultation is unnecessary.
NOTES ON SECTIONS
Section 1 – Name of Determination
This section provides that the title of the Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2014 (No.1).
Section 2 – Commencement
This section provides for the Determination to commence on 1 January 2015.
Section 3 – Variation
This section provides that Schedule 1 varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1).
Schedule 1 – Variations
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 2014 (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 2014 (No.1) (the Previous Determination), which designates vaccines in accordance with subsection 9B(2) of the National Health Act 1953, and specifies circumstances in which designated vaccines may be provided.
The variation adds an additional cohort to the list of those cohorts eligible for influenza vaccines under 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 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 National Immunisation Program (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, by protecting individuals and the community against vaccine preventable disease. Efficient operational arrangements for the NIP support effective administration of the Program.
The NIP is also consistent with 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 as outlined above.
Gayle Anderson
Assistant Secretary
Office of Health Protection
Department of Health