EXPLANATORY STATEMENT
Issued by the Authority of the delegate of the Minister for Health and Ageing
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.2)
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 2009 (No.1) (‘the Previous Determination’) was made on 5 March 2009 and came into effect on 7 March 2009. It is now necessary to change the circumstances in which a number of designated vaccines may be provided. The Previous 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.2) (‘the New Determination’). This determination allows vaccines to be designated and provides these vaccines free of charge to eligible people under the National Immunisation Program.
The New Determination is substantively the same as the Previous Determination, except for the following changes:
- Removal of Schedule 2 and subparagraph 7 (2) (b) (vii) regarding the provision of
Q-Vax in a specified area in Waikerie, South Australia; and - Amending items 301 and 302 of Schedule 1 to change the circumstances for the provision of Infanrix-IPV® and Quadracel ® of the timing of the booster dose of DTPa (currently at 4 years) to between 3 years and 6 months and 4 years.
- Update seasonal influenza strains as recommended by the World Health Organisation.
Subparagraph 7(2)(b)(vii) and Schedule 2 of the Previous Determination set out the eligibility and timing for the provision of Q-vax (Q-Fever vaccine) for people living in the area of Waikerie, South Australia. On 31st of August 2007, the Commonwealth agreed to provisions of funding for Q fever vaccination for residents living in immediate proximity of the abattoir in Waikerie. As this was in response to a small outbreak of Q fever associated between May and July 2007, this initiative ended on 30 August 2008. Therefore it is timely to remove these provisions.
The specification of the circumstances of Infanrix-IPV® and Quadracel® will allow these vaccines to be provided under the National Immunisation Program (the NIP) to a child who is about 2, 4 or 6 months, or between 3 years and 6 months and 4 years.
At a meeting held in June 2009, the Australian Technical Advisory Group on Immunisation (ATAGI) recommended that the 4th dose of pertussis vaccine be brought forward from
4 years of age to between 3 years and 6 months and 4 years of age to shorten the gap between the primary course and the first booster.
Impact and Effect
The likely impact and effect of this change is minimal. The change to the circumstances of Infanrix-IPV® and Quadracel® will allow the 4th dose of DTPa to be opportunistically administered between 3 years 6 months and 4 years of age to allow for earlier protection. No changes will be made to the National Immunisation Schedule.
Consultation
There are several expert advisory groups and committees that are involved in pertussis, such as the Communicable Diseases Network Australia, National Immunisation Committee (NIC) and the Australian Technical Advisory Group on Immunisation (ATAGI). In light of the recommendations made by the ATAGI Pertussis working party, ATAGI recommended that the revised timing of the 4th dose of DTPa be changed from 4 years to between 3 years and 6 months and 4 years of age.
NIC have been informed of the decision and will consult and negotiate with stakeholders on the development of these changes along with national immunisation priorities, strategies and service delivery around pertussis.
The Q- Fever vaccination program for Waikerie, South Australia ended in August 2008. The uptake of the program was minimal, therefore it was not extended.
Letters will be sent to all relevant stakeholders to advise them of the change once the determination takes effect.
The Office of Best Practice Regulation has been consulted regarding the need for a Regulation Impact Statement (RIS). The advice received was that a RIS is not necessary as the amendment is a minor or machinery matter