EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 3) 2019
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.
In addition to the power to make this instrument under section 9B of the Act, subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.
Purpose
The National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No.3) 2019 (the Amendment Determination) amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) (the Determination) to:
- add Fluad Quad® to the list of designated vaccines for the prevention of influenza and the circumstances, including the specified population of patients to which they may be provided; and
- expand the circumstances in which FluQuadri® (a designated vaccine under existing item 207B of Part 2 of Schedule 1 of the Determination) may be provided.
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 August 2019, the PBAC recommended changes to the existing subsection 9B(2) determination to add Fluad Quad® to the current National Immunisation Program (NIP) for the prevention of influenza for individuals aged 65 years and over.
In November 2019, the PBAC recommended changes to the existing subsection 9B(2) determination for FluQuadri® to expand the circumstances in which that vaccine may be provided for the National Immunisation Program (NIP). The recommended changes will lower the age of persons to whom FluQuadri® can be provided under the NIP from 3 years to 6 months (the person must also meet other eligibility criteria, which are not changed by the recommendations); and add a new circumstance for healthy children aged 6 months to less than 5 years.
Government approval
On 18 December 2019, the Minister for Health, the Hon Greg Hunt, announced the Government has approved the PBAC recommendation to list Fluad Quad on the NIP for adults aged 65 years and older.
On 4 December 2019, the Minister for Health, the Hon Greg Hunt MP, approved the PBAC recommendations to extend the listing for FluQuadri to at risk individuals aged 6 months to less than 3 years and healthy children aged 6 months to less than 5 years.
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 involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation. The PBAC is an independent expert body established by section 100A of the Act, which makes recommendations to, and advises the Minister about, the determination of specified vaccines as designated vaccines under section 9B, for the NIP. The PBAC members are appointed from nominations by organisations and associations representing industry, consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications or experience in a field relevant to the functions of the PBAC that would enable them to contribute meaningfully to the deliberations of the PBAC.
When recommending the listing of a vaccine on the NIP and the circumstances in which a designated vaccine should be provided, PBAC takes into account the target population for which the vaccine has been approved for use in Australia and its clinical effectiveness, safety and cost-effectiveness. PBAC also receives advice from the Australian Technical Advisory Group on Immunisation regarding the clinical aspects of the disease and the vaccine.
Pharmaceutical companies are consulted throughout the process of the listing of their vaccine on the NIP and in relation to changes to those listings. This includes the company submission to the PBAC and involvement throughout the PBAC process.
As part of the PBAC process, patients, carers, members of the public, health professionals or members of consumer interest groups may provide comments and feedback on vaccines being considered by the PBAC via a web interface or in writing over a period of six weeks prior to PBAC meetings. These are provided to the PBAC in a de-identified form for consideration alongside the company submission.
It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that had already taken place.
Details of the Amendment Determination are set out in the Attachment.
The Amendment Determination commences on the day after registration.
The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENTS
DETAILS ON THE NATIONAL HEALTH (IMMUNISATION PROGRAM – DESIGNATED VACCINES) AMENDMENT DETERMINATION (NO. 3) 2019
Section 1 – Name
Section 1 provides that the name of the instrument is the National Health (Immunisation Program – Designated Vaccines) Amendment Determination (No. 3) 2019 (the Amendment Determination).
Section 2 - Commencement
Section 2 provides that the Amendment Determination commences on the day after its registration.
Section 3- Authority
Section 3 provides that the Amendment Determination is made under section 9B of the National Health Act 1953.
Section 4- Schedules
Section 4 provides that the Amendment Determination amends the instrument specified in a schedule to the Amendment Determination, and any other item in a Schedule to the instrument has effect according to its terms.
Schedule 1- Amendments
Schedule 1 varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) (the Principal Determination).
Item 1
Item 1 repeals subsection 7(8) in the Determination and substitutes it with a new subsection 7(8). The new subsection 7(8) provides revised circumstances in which the vaccine mentioned in the subsection can be provided under the National Immunisation Program (NIP).
Item 2
Item 2 amends Part 2 of Schedule 1 (table item 207B, column headed “Number and timing of doses”) so that the number and timing of doses that applied to “children 3 years and older but less than 9 years”, prior to the amendment, now applies to “children 6 months and older but less than 9 years”.
Item 3
Item 1 inserts a new item 207G in Part 2 of Schedule 1 (after table item 207F). Item 207G in Part 2 of Schedule 1 provides the details of the vaccine Fluad Quad® and the circumstances in which this vaccine can be provided under the NIP including individuals aged 65 years and over.
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) Amendment
Determination (No.3) 2019
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) Amendment Determination (No. 3) 2019 (the Amendment Determination) varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination), which determines, under subsection 9B(2) of the National Health Act 1953 (the Act), that a specified vaccine in the instrument is a designated vaccine for the purposes of the Act.
The Amendment Determination adds the quadrivalent influenza vaccine, Fluad Quad®, to the National Immunisation Program (NIP) for adults aged 65 years and over.
The Amendment Determination also expands the circumstances in which FluQuadri® (a designated vaccine under existing item 207B of Part 2 of Schedule 1 of the Determination) may be provided to include persons aged 6 months and over who meet the existing specified circumstances and a new circumstance for all healthy children aged 6 months to <5 years. Prior to the amendment, FluQuadri® could only be provided to persons aged 3 years and over who met the existing specified circumstances.
Human Rights Implications
This Amendment Determination engages the right to health as set out in Article 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 Amendment Determination maintains compliance with the right to health by continuing to provide free access for eligible people to designated vaccines. The Amendment Determination continues to support the attainment of the highest standard of health for all Australians, by protecting individuals and the community against vaccine preventable disease.
Conclusion
The Amendment Determination is compatible with human rights as it continues to promote the right to health.
Hope Peisley
Acting Assistant Secretary
Office of Health Protection
Department of Health