EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No.2)
Authority
Section 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. Section 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. Section 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 2017 (No.2) (the Variation Determination) is to make amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination), including:
- adding item 218A of Schedule 1 of the Determination to the list of items set out in subsection 7(11) of the Determination that provide additional circumstances in which relevant items of Schedule 1 of the Determination may be provided; and
- adding a 9-valent human papillomavirus vaccine (Gardasil 9) as item 218A to Schedule 1 of the Determination for individuals aged at least 12 but less than 14 years who are eligible to receive human papillomavirus 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 July 2017, the PBAC recommended that:
- 9-valent human papillomavirus (9vHPV) vaccine (Gardasil 9) be made available as a designated vaccine for the purpose of funding through the NIP as a 2-dose schedule for 12-13 year olds as part of a school based immunisation program for the prevention of HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.
Government approval
On 12 September 2017, the Minister for Health, approved Gardasil 9 to be a designated vaccine for the purposes of subsection 9B(2) of the Act. It will take effect from 18 September 2017.
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 vaccine 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 18 September 2017.
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 2017 (NO. 2)
1. Name of the Determination
Section 1 provides that the title of the Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No 2).
2. Commencement
Section 2 provides that the Determination commence on 18 September 2017.
3. Authority
Section 3 provides that the 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)
Section 4 provides that the Determination varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1).
Schedule 1 Amendments
National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1)
Item 1- subsection 7(11)
Item 1 repeals subsection 7(11) in the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) and substitutes it with a new subsection 7(11). The new subsection 7(11) provides additional circumstances in which Item 218A of Schedule 1 of the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) can be provided under the National Immunisation Program.
Item 2 – Item added to Schedule
Item 2 adds item 218A to Schedule 1 of the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1). Item 218A of Schedule 1 provides the details of the Gardasil 9 immunisation and the circumstances in which this item can be provided under the National Immunisation Program.
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 2017 (No.2)
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 2017 (No. 2) (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 adds a new 9-valent human papillomavirus vaccine (Gardasil 9) for individuals aged at least 12 but less than 14 years who are eligible to receive human papillomavirus vaccine through the National Immunisation Program (NIP). In addition, the Variation Determination adds Gardasil 9 to subsection 7(11), allowing individuals up to the age of 19 years to catch-up on 2 doses of missed Gardasil 9 vaccinations.
Human Rights Implications
This Variation Determination engages the right to health as set out in Article 12 of the International Covenant on Economic, Social and Cultural Right 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