EXPLANATORY STATEMENT
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No.2)
Authority
Section 9B(1) of the National Health Act 1953 (the Act) states 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 this Act. Section 9B(5) provides that in addition to specifying a vaccine, a determination under subsection (2) may specify the circumstances in which the vaccine may be provided.
Purpose
The purpose of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No.2) (the Variation Determination) is to make the following amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination):
- add a new hexavalent vaccine, Hexaxim, for infants aged 2, 4 and 6 months to protect against six diseases (diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenza type B);
- add a new diphtheria, tetanus and pertussis vaccine, Tripacel, for children aged approximately 18 months, for the prevention of pertussis (whooping cough);
- add two new quadrivalent influenza vaccines – Fluarix Tetra for persons aged 3 years and above, and FluQuadri Junior for children aged less than 3 years – for the prevention of influenza; and
- add a clause to allow for children under the age of 10 years to ‘catch up’ on any scheduled vaccinations that the child did not receive at the specified age/s under the National Immunisation Schedule, as clinically required based on the current age of the child.
Background
Designated Vaccines
Section 9B(7) of the Act relevantly provides that a vaccine must not be specified in a determination under section 9B(2) unless the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Minister that the vaccine be a designated vaccine.
In March 2015, the PBAC recommended that:
- Hexaxim be listed on the National Immunisation Program (NIP) as part of the primary series of vaccinations for infants aged 2, 4 and 6 months; and
- Fluarix Tetra be listed on the NIP for persons aged 3 years and above who are currently eligible for trivalent influenza vaccine (TIV) under the NIP.
In July 2015, the PBAC recommended that:
- Tripacel be listed on the NIP as a pertussis booster dose for infants aged approximately 18 months; and
- FluQuadri Junior be listed on the NIP for persons aged less than 3 years who are currently eligible for TIV under the NIP.
On 29 September 2015, the Minister for Health, Minister for Aged Care and Minister for Sport, the Hon Sussan Ley MP, approved for Hexaxim and Tripacel to be designated vaccines for the purposes of subsection 9B(2) of the Act, from 31 October 2015.
On 2 October 2015, Minister Ley approved for Fluarix Tetra to be a designated vaccine for the purposes of subsection 9B(2) of the Act, from 1 November 2015.
On 8 October 2015, Minister Ley approved for FluQuadri Junior to be a designated vaccine for the purposes of subsection 9B(2) of the Act, from 1 November 2015.
Catch‑up Program for Children under 10 years
On 1 September 2015, the Australian Government agreed to implement a nationally consistent catch‑up program for children less than 10 years of age, using the vaccines already listed on the NIP.
The catch‑up program will secure ongoing clinically appropriate vaccines for children aged less than 10 years who did not receive a vaccination at the specified age/s under the National Immunisation Schedule, using existing mechanisms under the NIP for vaccine funding, delivery and administrations.
Consultation
The Department of Human Services and the Department of Social Services have been consulted on the policy that underpins Schedule 1, Item 3 of the Variation Determination.
In relation to Schedule 1, Items 1, 2, 4, 5, 6 and 7 of the Variation Determination, the Office of Best Practice Regulation considers that regulatory amendments that update the listing of vaccines on the NIP and their associated price to be machinery in nature. Therefore in accordance with section 18(2)(a) of the Legislative Instruments Act 2003 it has been determined that further consultation is unnecessary.
Commencement dates for each Item of the Variation Determination are as follows:
- Schedule 1, Items 4 and 7 commence on 31 October 2015.
- Schedule 1, Items 1, 2, 5 and 6 commence on 1 November 2015; and
- Schedule 1, Item 3 commences on 1 January 2016.
The Variation Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
NOTES ON SECTIONS
Section 1 – Name of the Variation Determination
This section provides that the title of the Variation Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No.2).
Section 2 – Commencement
This section provides for Schedule 1, Items 4 and 7 of the Variation Determination to commence on 31 October 2015; Schedule 1, Items 1, 2, 5 and 6 of the Variation Determination to commence on 1 November 2015; and Schedule 1, Item 3 of the Variation Determination to commence on 1 January 2016.
Section 3 – Variation
This section provides that Schedule 1 varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1).
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 2015 (No.2)
The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No. 2) (the Variation Determination) 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 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), and also specifies circumstances in which designated vaccines may be provided for the purposes of subsection 9B(3) of the Act.
The Variation Determination adds:
- a new hexavalent vaccine, Hexaxim, for infants aged 2, 4 and 6 months to protect against six diseases (diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenza type B);
- a new diphtheria, tetanus and pertussis vaccine, Tripacel, for children aged approximately 18 months, for the prevention of pertussis (whooping cough);
- two new quadrivalent influenza vaccines – Fluarix Tetra for persons aged 3 years and above, and FluQuadri Junior for children aged less than 3 years – for the prevention of influenza; and
- a clause to allow for children under the age of 10 years to ‘catch up’ on any scheduled vaccinations that the child did not receive at the specified age/s under the National Immunisation Schedule, as clinically required based on the current age of the child.
Human Rights Implications
The Variation Determination engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) 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.
The Variation Determination is also consistent with the advancement of Article 1 of the ICESCR. Since vaccination is not mandatory in Australia this enables the right to self-determination.
Conclusion
The Variation Determination is compatible with human rights because it advances the protection of human rights as outlined above.
Kirsty Faichney
Assistant Secretary Immunisation Branch
Office of Health Protection
Department of Health