EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Variation Determination (No.1) 2018
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 (No.1) 2018 (the Variation Determination) is to make amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination), including:
- repealing Item 101 in Schedule 1 of the Determination and replacing with a new item that provides additional circumstances in which the vaccine mentioned in Item 101 of Schedule 1 of the Determination can be provided under the National Immunisation Program (NIP);
- repealing Item 102 in Schedule 1 of the Determination and replacing with a new item that provides additional circumstances in which the vaccine mentioned in Item 102 of Schedule 1 of the Determination can be provided under the NIP;
- repealing Item 103 in Schedule 1 of the Determination and replacing with a new item that provides revised circumstances in which the vaccine mentioned in Item 103 of Schedule 1 of the Determination can be provided under the NIP;
- the addition of Item 108A to Schedule 1 of the Determination which provides for the vaccine meningococcal polysaccharide conjugate serogroups A, C, W-135 and Y (MenACWY, Nimenrix) to be made available for individuals about 12 months of age who are eligible to receive Nimenrix through the NIP;
- the addition of Item 207D to the Determination, which provides for the vaccine inactivated trivalent influenza vaccine (Split Virion) Fluzone High Dose (Fluzone HD) to be made available for a person who is a least 65 years of age through the NIP;
- the addition of Item 207E to the Determination, which provides for the inactivated influenza vaccine (surface adjuvant) adjuvanted, Fluad (Fluad) to be made available for a person who is a least 65 years of age through the 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 December 2017, the PBAC concluded the review of the pertussis vaccination schedule. This announcement was made public in February 2018, and relates to two earlier recommendations from July 2016 and March 2017, respectively, for the following:
- Diphtheria, tetanus and pertussis vaccine (adult/adolescent) (pertussis, Boostrix) be made available as a designated vaccine for the purpose of funding through the NIP as a single dose for a person who is pregnant for the prevention of whooping cough; and
- Diphtheria, tetanus and pertussis vaccine (adult/adolescent) (pertussis, Adacel) be made available as a designated vaccine for the purpose of funding through the NIP as a single dose for a person who is pregnant for the prevention of whooping cough.
In January 2018, the PBAC recommended that:
- meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and Y (MenACWY, Nimenrix) be made available as a designated vaccine for the purpose of funding through the NIP as a single dose for infants at 12 months of age vaccine for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W135, and Y (Men A, MenC, MenW135 and MenY, respectively) in infants.
- Haemophilus influenza type b vaccine (Hib, ActHib and Hiberix) (monovalent PRP‑T) be displaced to 18 months of age;
- inactivated trivalent influenza vaccine (Split Virion) Fluzone High Dose (Fluzone HD), be made available as a designated vaccine for the purpose of funding through the NIP as a single dose for prevention of influenza disease caused by influenza virus subtypes A and type B in persons 65 years and older.
- inactivated influenza vaccine (surface adjuvant) adjuvanted, Fluad (Fluad) be made available as a designated vaccine for the purpose of funding through the NIP as a single dose for prevention of influenza disease caused by influenza virus subtypes A and type B in persons 65 years and older.
Government approval
On 15 February 2018, the Minister for Health agreed to amend the current listings for Adacel, Boostrix and Hib; and add listings for Nimenrix, Fluzone HD and Fluad as designated vaccines 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 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 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. 1) 2018
1. Name of the Determination
Section 1 provides that the title of the Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination (No 1)2018 (the Variation Determination).
2. Commencement
Section 2 provides that the Determination commence on the day after registration.
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) (the Determination)
Item 1- Schedule 1, item 101
Item 1 repeals Item 101 in Schedule 1 in the Determination and substitutes it with a new Item 101. The new Item 101 provides additional circumstances in which the vaccine mentioned in the item can be provided under the National Immunisation Program (NIP).
Item 2- Schedule 1, item 102
Item 1 repeals Item 102 in Schedule 1 in the Determination and substitutes it with a new Item 102. The new Item 102 provides additional circumstances in which the vaccine mentioned in the item can be provided under the NIP.
Item 3- Schedule 1, item 103
Item 1 repeals Item 103 in Schedule 1 in the Determination and substitutes it with a new Item 103. The new Item 103 provides additional circumstances in which the vaccine mentioned in the item can be provided under the NIP.
Item 4 – Schedule 1, item 108A
Item 2 adds item 108A to Schedule 1 of the Determination. Item 108A of Schedule 1 provides the details of the Nimenrix vaccine and the circumstances in which this vaccine can be provided under the NIP.
Item 5 – Item added to Schedule
Item 2 adds item 207D to Schedule 1 of the Determination. Item 207D of Schedule 1 provides the details of the Fluzone High Dose vaccine and the circumstances in which this vaccine can be provided under the NIP.
Item 6 – Item added to Schedule
Item 2 adds item 207E to Schedule 1 of the Determination. Item 207E of Schedule 1 provides the details of the Fluad vaccine and the circumstances in which this vaccine 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.1) 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. 1) 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).
Pertussis containing vaccines for pregnancy – Boostrix and Adacel
Boostrix (GSK) and Adacel (Sanofi) provide protection against diphtheria, tetanus and pertussis (dTpa) for individuals aged 10 years and older. Both vaccines are supplied to individuals aged 10 years and older on the NIP through school based vaccination programs and as catch up vaccines for those aged 10 to 19 and refugee and humanitarian entrants, and for a person who is pregnant.
Hib – ActHib and Hiberix
ActHib and Hiberix are monovalent vaccines that provide protection against Hib for child who is about 18 months old.
MenACWY - Nimenrix
Nimenrix provides protection against meningococcal serogroups A, C, W-135 and Y and is registered for use in Australia for children and adults aged 12 months through to 55 years.
Seasonal influenza - Fluad and Fluzone HD
Fluad is an adjuvanted seasonal trivalent influenza vaccine manufactured by Seqirus – the adjuvant stimulates an enhanced immune response to the vaccine. Fluzone HD is a high dose seasonal trivalent vaccine manufactured by Sanofi – it contains four times the usual antigen levels, triggering a higher immune response to vaccination. These vaccines are specifically for use in those aged 65 years and older as this cohort has a lowered immune response and receive less protection from standard vaccines than other cohorts.
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