EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Variation Determination (No.4) 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.4) 2018 (the Variation Determination) is to make amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination), including:
- repealing subsection 7(1) of the Determination and substituting with a new subsection 7(1) that provides revised circumstances in which the vaccine mentioned in subsection 7(1) of the Determination (13vPCV, Prevenar 13®) can be provided under the National Immunisation Program (NIP); and
- repealing item 108A in Schedule 1 of the Determination and substituting with a new item 108A that provides revised circumstances in which the vaccine listed in the item (MenACWY-TT, Nimenrix®) 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 March 2018, the PBAC recommended changes to the current NIP listing of 13vPCV (Prevenar 13®) under the Act for the prevention of pneumococcal disease. However, one of the recommendations was inadvertently omitted from the earlier legislative amendments, that is:
- For Aboriginal and Torres Strait Islander children in at risk areas, the additional dose of 13vPCV (Prevenar 13®) be provided at 6 months of age to adjust for the booster dose now to be given in the second year of life.
In March 2018, the PBAC recommended that MenACWY-TT (Nimenrix®) be a designated vaccine for the purposes of the Act for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W135, and Y, respectively in adolescents as part of a school based immunisation program for year 10 students (aged 14-16 years of age) and via a catch-up program for adolescents aged up to and including 19 years of age.
Government approval
On 21 May 2018, the Minister for Health, the Hon Greg Hunt MP, approved amendments to the current NIP listing for 13vPCV (Prevenar 13®) under the Act, including the provision of an additional dose of 13vPCV to Aboriginal and Torres Strait Islander children in at risk areas at 6 months of age. This will take effect from the day after registration.
On 24 September 2018, the Minister for Health, the Hon Greg Hunt MP, agreed to list Nimenrix® as a designated vaccine for the purposes of subsection 9B(2) of the Act for use in adolescents. 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. 4) 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 4) 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(1)
Item 1 repeals subsection 7(1) in the Determination and substitutes it with a new subsection 7(1). The new subsection 7(1) provides additional circumstances in which item 101 of Schedule 1 (13vPCV, Prevenar 13®) may be provided under the NIP.
Item 2 – Item 108A in Schedule 1, Part 1
Item 2 repeals item 108A in Schedule 1 of the Determination and substitutes it with a new item 108A. The new item 108A provides revised circumstances in which the vaccine
(MenACWY-TT, Nimenrix®) can 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.4) 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. 4) 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 rectifies an inadvertent error by amending the dosing schedule of 13-valent pneumococcal vaccine (13vPCV, Prevenar 13®), to allow an additional dose to be provided to Aboriginal and Torres Strait Islander children in at risk areas at 6 months of age to adjust for the booster dose which is now provided to children in the second year of their life.
In addition, the Variation Determination adds an additional cohort of persons aged at least 14 years of age and less than 20 years of age to the list of cohorts eligible for meningococcal polysaccharide serogroups A, C, W135 and Y conjugate vaccine (MenACWY-TT, Nimenrix®) listed in item 108A 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