EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health and Ageing
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.1)
Legislation
Subsection 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. Subsection 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. Subsection 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 National Health (Immunisation Program - Designated Vaccines) Determination 2008 (No.2) (‘the Current Determination’) was made on 22 July 2008 and came into effect on 31 July 2008. It is now necessary for an additional vaccine to be specified as a designated vaccine under subsection 9B(2) in substitution for another vaccine that was designated previously, and for circumstances to be determined under subsection 9B(5) for the vaccine. The Current Determination is being revoked and re-made rather than amended.
Instrument Description
This determination is called the National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.1) (‘the New Determination’) and the only change from the provision of the Current Determination is in respect of:
This determination is called the National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.1) (‘the New Determination’) and the only change from the provision of the Current Determination is in respect of the designation of a new formulation of an existing vaccine against Human Rotavirus (Rotarix®). This change only affects the contents of Schedule 1.
The specification of the new liquid formulation of Rotarix® will allow it to be provided under the National Immunisation Program (the NIP). The new Human rotarvirus (live attenuated oral vaccine), oral suspension, 1.5ml in an oral applicator (Rotarix®) will be provided under the NIP in the same circumstances as the existing Rotarix® powder formulation:
2 doses:
(a) first dose given at 6 to 14 weeks of age;
(b) second dose given at 14 to 24 weeks of age
Subsection 9B(7) of the Act provides that a vaccine must not be specified in a determination under subsection 9B(2) unless Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Minister that it be a designated vaccine.
At an out of session meeting held in June 2008, the PBAC recommended listing of a new liquid formulation of Rotarix®, replacing the lyophilised formulation at the same price. This new formulation was registered by the Therapeutic Goods Administration (TGA) on 8 August 2008.
Impact and Effect
The likely impact and effect of this change is minimal. The change to a new liquid formulation of Rotarix® will allow for a direct oral administration of the 1.5ml dose in an oral applicator with a plunger stopper onto the inside of the infant’s cheek.
Currently, Rotarix® is presented as a white powder for reconstitution with a separately supplied diluent, and a transfer adapter. The syringe/oral plunger containing the diluent is attached to the vial of lyophilised powder via the transfer adapter, and following reconstitution the 1ml dose of the vaccine is administered orally via the syringe/oral plunger onto the inside of the infant’s cheek.
The new liquid formulation of Rotarix® will not require reconstitution or dilution, therefore administering Rotarix® will be safer and more efficient.
The New Determination is substantively identical to the Current Determination except for the specification of the change in formulation of Rotarix®.
Consultation
Positive recommendations made by PBAC in July 2008 were provided to the public via the Department of Health and Ageing website in August 2008, containing information pertaining to the PBAC recommendation to the listing of a new liquid formulation of human rotavirus under the NIP schedule. Letters will be sent to all relevant stakeholders to advise them of the change once the determination takes effect.
In addition, the new formulation and product information of Rotarix® was registered and approved by TGA in August 2008.
Overview
The National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.1), enacted by the Parliament of Australia under the National Health Act 1953, addresses the need to update the list of designated vaccines provided under the National Immunisation Program (NIP). This determination, issued by the Minister for Health and Ageing, replaces the 2008 version to incorporate a new liquid formulation of the Rotarix® vaccine against Human Rotavirus, as recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). The policy objective is to enhance the efficiency and safety of vaccine administration within the NIP, by specifying a new liquid formulation of Rotarix® that eliminates the need for reconstitution and dilution, thereby streamlining the process and reducing potential errors. The change is intended to have minimal impact, with the new formulation facilitating direct oral administration and thereby improving the overall delivery of the immunisation program.
Scope and Application
The National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.1) specifies the provision of designated vaccines under the National Immunisation Program (NIP) as stipulated by the National Health Act 1953. This legislative instrument applies to the Minister for Health and Ageing, who is responsible for determining which vaccines are designated for inclusion in the NIP. The determination primarily affects the medical and pharmaceutical sectors involved in the administration and supply of vaccines. It also impacts parents and caregivers of infants who are eligible for vaccination under the NIP. Geographically, the Act has a national reach across Australia, as it is a Commonwealth Act. The legislation specifies a new liquid formulation of the Rotarix® vaccine, which is a human rotavirus (live attenuated oral vaccine), replacing the existing powder formulation. The only alteration in the New Determination is the specification of the new formulation of Rotarix®, which allows for direct oral administration without the need for reconstitution or dilution. The change is expected to enhance the safety and efficiency of vaccine administration. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended this change, and the Therapeutic Goods Administration (TGA) registered and approved the new formulation. The determination revokes and re-makes the previous National Health (Immunisation Program - Designated Vaccines) Determination 2008 (No.2) to incorporate this update.
Key Provisions
The National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.1) outlines the provision of designated vaccines under the National Health Act 1953. Specifically, Section 9B(2) of the Act enables the Minister to designate a specified vaccine as a designated vaccine through legislative instrument. This Determination specifies the new liquid formulation of Rotarix® as a designated vaccine, replacing the previous powder formulation, and determines the circumstances under which this vaccine may be provided (Section 9B(5)). The new formulation allows for direct oral administration of a 1.5ml dose using an oral applicator, simplifying the administration process compared to the previous method requiring reconstitution with a diluent.
The Act imposes several obligations on parties involved in the provision of designated vaccines. Firstly, a vaccine cannot be designated unless the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended it to the Minister (Section 9B(7)). In this case, the PBAC recommended the new liquid formulation of Rotarix® in June 2008. Additionally, the Therapeutic Goods Administration (TGA) must register and approve the vaccine, as it did for the new Rotarix® formulation in August 2008. Parties must adhere to the specified administration guidelines, ensuring vaccines are provided under the same conditions as outlined in the Determination, including the age-specific dosing schedule.
The Determination does not explicitly detail specific offences, penalties, or consequences for non-compliance within its text. However, under the overarching National Health Act 1953, unauthorised provision of goods or services associated with designated vaccines could lead to civil or criminal penalties. The Act may also provide for the revocation of registration or approval for non-compliance with the regulations governing the provision of designated vaccines. The exact penalties would depend on the nature and severity of the breach, as outlined in other sections of the Act.