Remaking of the National Health (Immunisation – Designated Vaccines) Determination 2005
EXPLANATORY STATEMENT
Purpose
It is necessary to make revoke and remake the National Health (Immunisation – Designated Vaccines) Determination 2005 (‘the Determination’) to enable additional vaccines, known as Adacel® and Gardasil®, to be provided under the National Immunisation Program (NIP). Adacel® is a vaccine against diphtheria, tetanus and pertussis (adult booster) that can be used in place of a similar vaccine known as Boostrix. In March 2006, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended including Adacel® under the NIP and in July 2006 the Minister for Health and Ageing approved the inclusion of Adacel® under the NIP. Gardasil® is a vaccine against human papillomavirus (HPV). In November 2006, the PBAC recommended including Gardasil® under the NIP, and the Minister for Health and Ageing approved the inclusion of Gardasil® under the NIP. This approval has prompted the need for a new determination.
The new determination also enables meningococcal C vaccine to be provided under the NIP until 30 June 2007 for people who, on 1 January 2003, were as at least 1 year but less than 20 years; and who had not received a vaccine mentioned items 104, 105 and 106 in Schedule 1 of the Determination. In July 2006 the Department of Health and Ageing agreed to extend the catch-up component of the National Meningococcal C Vaccination Program to 30 June 2007 in some jurisdictions. This approval means that an amendment to the circumstances in which meningococcal C vaccine may be provided under the NIP is required.
Authority
On 5 June 2006 the Minister for Health and Ageing delegated his powers under subsection 9B(2) of the National Health Act 1953 (‘the Act’) to the person occupying the position of Assistant Secretary of the Targeted Prevention Programs Branch, Population Health Division in the Department of Health and Ageing. This person is currently Ms Andriana Koukari.
Impact and Effect
The likely impact and effect of this change is minimal. After this amendment has been made, State and Territory Governments will have a choice to make on which diphtheria-tetanus-pertussis (adult booster) vaccine they wish to purchase for distribution. State and Territory Governments will also be able to continue to provide meningococcal C vaccine through already established programs until 30 June 2007. The HPV vaccine will also be available for program implementation commencing in March 2007.
Consultation
The Office of Regulation Review has been consulted regarding the need for a Regulatory Impact Statement (RIS). The advice received was that a RIS is not necessary as the amendment is a minor or machinery matter.
Each State and Territory Government was consulted regarding these changes through their representation on the National Immunisation Committee. No jurisdiction was opposed to the proposed amendments.
Reference Documents
- The Instrument of delegation is at Attachment A.
- RIS exception from the Office of Regulation is at Attachment B.
- The product information for Adacel® is at Attachment C.
- The product information for Gardasil® is at Attachment D.
Instrument Description
The Principal Determination came into effect on 1 January 2006, designating vaccines that were available under the repealed section 9B of the National Health Act 1953 at any time during the period of 60 days immediately before the commencement of paragraph 9B(7)(b) as a 'designated vaccine' under the new section 9B of the Act.