Document ID: chunk:federal_register_of_legislation:C2025C00090:section:101:p4
Version: federal_register_of_legislation:C2025C00090
Segment Type: section
Provision Reference: s 101 (pt 4/5)
Character Range: 519793–522690

of therapeutic groups
 (4AA) If the Committee is of the opinion that the Minister should, or should not, determine a therapeutic group, the Committee must advise the Minister accordingly.

Function relating to Minister's determination about exempt items
 (4AB) If the Committee is of the opinion that the following circumstances exist in relation to a pharmaceutical item:
 (a) the listed drug in the pharmaceutical item represents suitable therapy for a particular patient population;
 (b) the pharmaceutical item is suitable for use by a particular subgroup of that population because of either or both of the form and manner of administration of the drug in the item;
 (c) no other pharmaceutical item that has that drug is suitable for use by that subgroup because of either or both of the form and manner of administration of the drug in that other item;
the Committee must advise the Minister that those circumstances exist in relation to the pharmaceutical item.

Function relating to Minister's decisions about prices of combination items
 (4AC) If the Committee is satisfied that therapy involving a combination item provides, for some patients:
 (a) a significant improvement in patient compliance with the therapy; or
 (b) a significant improvement in efficacy or reduction in toxicity;
over alternative therapies, then the Committee must advise the Minister accordingly.

Functions relating to determinations that brands are not new brands
 (4AD) The Pharmaceutical Benefits Advisory Committee may give advice to the Minister in relation to whether the Minister should determine that a brand of a pharmaceutical item is not a new brand for the purposes of section 99ACB or 99ACD.

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