EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Variation Determination (No 3) 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.3) 2018 (the Variation Determination) is to make amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination), including:
- adding item 202A 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;
- adding item 202A of Schedule 1 of the Determination to the list of items set out in subsection 7(12) of the Determination that provide additional circumstances in which relevant items of Schedule 1 of the Determination may be provided; and
- adding item 202A to Schedule 1 of the Determination which provides for the vaccine Hepatitis B viral infection - Engerix B (adult formulation) and the circumstances in which the vaccine may be provided under the National Immunisation Program (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 July 2018, the PBAC recommended that Engerix-B (adult formulation) be a designated vaccine for the purposes of section 9B of the Act on a temporary basis for use in adolescents and adults until either the current shortage of H-B-Vax II (adult formulation, Seqirus Australia Pty Ltd) has been resolved, or 31 December 2019 (when shortage is predicted to end), whichever were to occur first.
Government approval
On 22 August 2018, the Minister for Health agreed to list Engerix B (adult formulation) as a designated vaccine for the purposes of subsection 9B(2) of the Act. It 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. 3) 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 3) 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 – Subsection 7(11)
Item 1 repeals subsection 7(11) in the Determination and substitutes it with a new subsection 7(11). The new subsection 7(11) provides additional circumstances in which item 202A may be provided under the NIP. The purpose of this subsection is to provide for catch-up immunisations, where an individual has not received the vaccine in the circumstances mentioned for it in Schedule 1 of the Determination.
Item 2 – Subsection 7(12)
Item 2 repeals subsection 7(12) in the Determination and substitutes it with a new subsection 7(12). The new subsection 7(12) provides additional circumstances in which item 202A may be provided under the NIP. The purpose of this subsection is to provide for catch-up immunisations, where an individual has not received the vaccine in the circumstances mentioned for it in Schedule 1 of the Determination.
Item 3 – After item 202 in Schedule 1, Part 1
Item 3 adds item 202A to Schedule 1 in the Determination. Item 202A of Schedule 1 provides details of the Hepatitis B viral infection vaccine - Engerix-B (adult formulation) and the circumstances in which the vaccine 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.3) 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. 3) 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 adds a new Hepatitis B viral infection vaccine - Engerix B (adult formulation) and specifies the circumstances in which the vaccine may be provided under the NIP.
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