EXPLANATORY STATEMENT
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No.1)
Authority
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 2015 (No.1) (the Variation Determination) is to add a new eligible cohort of children aged approximately 18 months, for the diphtheria-tetanus-acellular-pertussis (DTPa) vaccine under the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination).
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.
In the November 2014 PBAC meeting, the PBAC recommended that DTPa be listed as a vaccine on the NIP for infants aged approximately 18 months.
The Determination commenced on 23 September 2014.
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.
The Variation commences on 1 June 2015.
The Variation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
NOTES ON SECTIONS
Section 1 – Name of the Variation Determination
This section provides that the title of the Variation Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No.1).
Section 2 – Commencement
This section provides for the Variation Determination to commence on 1 June 2015.
Section 3 – Variation
This section provides that Schedule 1 varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1).
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 2015 (No.1)
The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No. 1) (the Variation Determination) 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 Variation Determination varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the 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 Determination adds an additional cohort of children aged approximately 18 months to the list of those cohorts eligible for the diphtheria-tetanus-acellular-pertussis (DTPa) vaccine under the Determination.
Human rights implications
The Variation Determination 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 Determination 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.
The Determination 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
The Variation Determination 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