EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Variation Determination (No.5) 2018
Authority
Subsection 9B(1) of the National Health Act 1953 (the Act) provides 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 the Act. Subsection 9B(5) provides that in addition to specifying a vaccine, a determination may specify the circumstances in which the vaccine may be provided.
Purpose
The purpose of the National Health (Immunisation Program – Designated Vaccines) Variation Determination (No.5) 2018 (the Variation Determination) is to make amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination), including:
- omit paragraph 7(8)(b) of the Determination and substitute with a new paragraph 7(8)(b) that provides revised circumstances in which the vaccines mentioned in subsection 7(8) of the Determination (Fluarix Tetra®, GSK and FluQuadri®, Sanofi) can be provided under the National Immunisation Program (NIP);
- omit paragraphs 7(8A)(b) and 7(8A)(c) of the Determination and substitute with new paragraphs 7(8A)(b) and 7(8A)(c), respectively, that provides revised circumstances in which the vaccine mentioned in subsection 7(8A) of the Determination (Afluria Quad®, Seqirus) can be provided under the NIP; and
- insert after paragraph 7(8A)(c) a new paragraph 7(8A)(d) that provides a revised circumstance in which the vaccine mentioned in subsection 7(8A) of the Determination (Afluria Quad®, Seqirus) can be provided under the NIP.
Background
Pharmaceutical Benefits Advisory Committee (PBAC) recommendations
Subsection 9B(7) of the Act relevantly provides that a vaccine must not be specified in a determination under subsection 9B(2) unless the PBAC has recommended to the Minister that the vaccine be a designated vaccine.
In November 2018, the PBAC recommended changes to the current NIP listing of Afluria Quad® to include individuals aged 5 to 17 years who are currently eligible for free quadrivalent influenza vaccines through the NIP. The PBAC also recommended expanding the eligibility for free seasonal influenza vaccine (Fluarix Tetra®, FluQuadri® and Afluria Quad®) on the NIP to Aboriginal and Torres Strait Islander people aged 5 to 14 years.
Government approval
On 14 December 2018, the Minister for Health, the Hon Greg Hunt MP, approved amendments to the current NIP listing for Afluria Quad®, Fluarix Tetra® and FluQuadri® under the Act. This will take effect from the day after registration.
Details
The Determination commenced on 23 September 2014. Once a vaccine is listed in the Determination, the supplier of that vaccine is eligible to participate in any procurement processes undertaken by the Department of Health for the supply of vaccines on the NIP.
Consultation
The Office of Best Practice Regulation has advised 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.
Details of the Determination are set out in the Attachment.
The Determination commences on the day after registration.
The Determination is a legislative instrument for the purposes of the Legislation Act 2003.
Authority: Subsection 9B(2) of the
National Health Act 1973
ATTACHMENTS
DETAILS ON THE NATIONAL HEALTH (IMMUNISATION PROGRAM – DESIGNATED VACCINES) VARIATION DETERMINATION (NO. 5) 2018
1. Name of Determination
Section 1 provides that the title of the Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination (No 5) 2018 (the Variation Determination).
2. Commencement
Section 2 provides that the Variation Determination commences on the day after registration.
3. Authority
Section 3 provides that the Variation Determination is made under subsection 9B(2) of the National Health Act 1953.
4. Variation of National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1)
Schedule 1 varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) (the Determination)
Schedule Amendments
Item 1 – Paragraph 7(8)(b)
Item 1 omits paragraph 7(8)(b) of the Determination and substitutes with a new paragraph 7(8)(b). The new paragraph 7(8)(b) provides revised circumstances in which item 207A and 207B of Schedule 1 (Fluarix Tetra® and FluQuadri®, respectively) may be provided under the NIP.
Item 2 – Paragraph 7(8A)(b)
Item 2 omits paragraph 7(8A)(b) of the Determination and substitutes with a new paragraph 7(8A)(b). The new paragraph 7(8A)(b) provides revised circumstances in which the item 207C (Afluria Quad®) of Schedule 1 may be provided under the NIP.
Item 3 – Paragraph 7(8A)(c)
Item 3 omits paragraph 7(8A)(c) of the Determination and substitutes with a new paragraph 7(8A)(c). The new paragraph 7(8A)(c) provides revised circumstances in which the item 207C (Afluria Quad®) of Schedule 1 may be provided under the NIP.
Item 4 - After paragraph 7(8A)(c)
Item 4 inserts a new paragraph 7(8A)(d) after paragraph 7(8A)(c) of the Determination. The new paragraph 7(8A)(d) provides revised circumstances in which the item 207C (Afluria Quad®) of Schedule 1 may be provided under the NIP.
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 (No.5) 2018
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 National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 5) 2018 (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).
The Variation Determination extends the age eligibility for Afluria Quad® to persons aged 5 to 17 years listed in Item 207C of Schedule 1 of the Determination
The Variation Determination also adds an additional cohort of Aboriginal and Torres Strait Islander persons aged 5 years to 14 years to the list of cohorts eligible for Fluarix Tetra®, FluQuadri® and Afluria Quad® listed in items 207A, 207B and 207C of Schedule 1 of the Determination.
Human Rights Implications
This Variation Determination engages the right to health as set out in Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights 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.
Conclusion
The Variation Determination is compatible with human rights as it promotes the right to health.
Masha Somi
Assistant Secretary Immunisation Branch
Office of Health Protection
Department of Health