Document ID: chunk:federal_register_of_legislation:C2007A00111:clause:1_83
Version: federal_register_of_legislation:C2007A00111
Segment Type: clause
Provision Reference: sch 1 cl 83
Character Range: 97043–98517

83  After subsection 101(4A)
Insert:

Function relating to Minister's determination 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.