Document ID: chunk:federal_register_of_legislation:C2005A00140:clause:1_4
Version: federal_register_of_legislation:C2005A00140
Segment Type: clause
Provision Reference: sch 1 cl 4
Character Range: 5942–7936

4  After subsection 101(4A)
Insert:

Functions relating to vaccines

 (4B) The Pharmaceutical Benefits Advisory Committee must:
 (a) make recommendations to the Minister from time to time about the vaccines it considers should be designated vaccines (see section 9B); and
 (b) advise the Minister about any other matter concerning the operation of section 9B referred to it by the Minister.

 (4C) For the purpose of deciding whether to recommend to the Minister that a vaccine be a designated vaccine, the Committee must give consideration to the effectiveness and cost of immunisation involving the use of the vaccine, including by comparing the effectiveness and cost of immunisation involving the use of the vaccine with the effectiveness and cost of alternative options, whether or not involving the use of other vaccines.

 (4D) If immunisation involving the use of a particular vaccine (the first vaccine) is substantially more costly than an alternative vaccine:
 (a) the Committee must not recommend to the Minister that the first vaccine be a designated vaccine unless the Committee is satisfied that the first vaccine, for some individuals, provides a significant improvement in efficacy or reduction of toxicity over the alternative vaccine; and
 (b) if the Committee recommends to the Minister that the first vaccine be a designated vaccine—the Committee must include in its recommendation a statement that the Committee is satisfied as mentioned in paragraph (a).

 (4E) Subsection (4D) does not limit subsection (4C).

 (4F) If the Committee is of the opinion that a vaccine should be a designated vaccine, but should only be provided under subsection 9B(1) in certain circumstances, the Committee must, in its recommendation under subsection (4B), specify those circumstances.

Note 1: The following heading to subsection 101(3) is inserted "Functions relating to drugs and medicinal preparations".

Note 2: The following heading to subsection 101(5) is inserted "Procedure".