EXPLANATORY STATEMENT
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No.2)
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 2016 (No.2) (the Variation Determination) is to make the following amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination):
- Add a new quadrivalent influenza vaccine (Afluria Quad) for individuals aged 18 years and older who are eligible to receive influenza vaccine through the National Immunisation Program (NIP).
Background
Pharmaceutical Benefits Advisory Committee (PBAC) recommendations
Section 9B(7) of the Act relevantly provides that a vaccine must not be specified in a determination under section 9B(2) unless the PBAC has recommended to the Minister that the vaccine be a designated vaccine.
In September 2016, the PBAC recommended that:
- Afluria Quad be listed on the NIP for persons aged 18 years and over who are currently eligible to receive NIP-funded influenza vaccine.
Government approval
On 16 September 2016, the Minister for Health, Minister for Aged Care and Minister for Sport, the Hon Sussan Ley MP, approved Afluria Quad to be a designated vaccine for the purposes of subsection 9B(2) of the Act, from 21 September 2016.
Details
The Determination commenced on 23 September 2014. Once a vaccine is listed on the Determination, the supplier of that vaccine is eligible to participate in any tenders run by the Department of Health for supply of vaccine on the NIP.
Consultation
The Office of Best Practice Regulation considers that regulatory amendments that update the listing of vaccines on the NIP and their associated price to be machinery in nature. Therefore it has been determined that further consultation is unnecessary.
The commencement date for Item 1 and Item 2 of the Variation Determination is the day following registration.
The Variation Determination is a legislative instrument for the purposes of the Legislation Act 2003.
NOTES ON ATTACHMENTS
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 2016 (No2).
Section 2 – Commencement
This section provides that Item 1 and Item 2 of the Variation Determination commence on the day after registration.
Section 3 – Authority
These Rules are made under subsections 9B (2) and (5) of the National Health Act 1953.
Section 4 – Variation
This section provides that the Variation Determination varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1).
Schedule 1 Amendments
Item 1 of Variation Determination
Adds a new clause under Subsection 7(8) of the Determination as ‘7(8A)’. This clause outlines the circumstances by which Item 207C (below) can be provided under the NIP.
Item 2 of Variation Determination
Adds a new item under Schedule 1 Part 2 of the Determination as ‘Item 207C’. This item provides the details of a new quadrivalent influenza vaccine, Afluria Quad, which can be provided on the NIP under the circumstances outlined in Subsection 7(8A) (above).
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 2016 (No.2)
The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2016 (No. 2) (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 determines that a specified vaccine is a designated vaccine for the purposes of subsection 9B(2) of the National Health Act 1953 (the Act), and also specifies circumstances in which designated vaccines may be provided for the purposes of subsection 9B(3) of the Act.
The Variation Determination:
- adds a new quadrivalent influenza vaccine (Afluria Quad) for individuals aged 18 years and older who are eligible to receive influenza vaccine through the National Immunisation Program (NIP).
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 Variation 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 Variation 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.
Masha Somi
Assistant Secretary Immunisation Branch
Office of Health Protection
Department of Health