Document ID: chunk:federal_register_of_legislation:C2007A00111:clause:1_99acc:p1
Version: federal_register_of_legislation:C2007A00111
Segment Type: clause
Provision Reference: sch 1 cl 99ACC (pt 1/2)
Character Range: 37867–40489

99ACC  Price reductions for single brands of combination items

When section applies

 (1) This section applies if:
 (a) subsection 85AB(5) applies to the drug in a combination item; and
 (b) there is only one listed brand (the single brand) of the combination item; and
 (c) an agreed price (the existing agreed price) is in force for the single brand of the combination item; and
 (d) after the day on which the existing agreed price came into force for the single brand of the combination item:
 (i) if the drug in the combination item contains only one listed component drug—that listed component drug becomes subject to a statutory price reduction on a day (the reduction day); or
 (ii) if the drug in the combination item contains 2 or more listed component drugs—one of the listed component drugs becomes subject to a statutory price reduction on a day (the reduction day); or
 (iii) if the drug in the combination item contains 2 or more listed component drugs—2 or more of the listed component drugs become subject to a statutory price reduction on the same day (the reduction day); and
 (e) on the reduction day, or on the day before that day, no listed brand of another combination item that has a drug that contains the same component drugs as the combination item:
 (i) is bioequivalent or biosimilar to the single brand of the combination item; and
 (ii) has the same manner of administration as the single brand of the combination item.

Price reduction

 (2) The existing agreed price ceases to have effect at the end of the day before the reduction day.

 (3) The Minister may, under a price agreement, agree on a new price for the single brand of the combination item that comes into force on the reduction day.

Note: The new price for the single brand of the combination item may be the same as the existing agreed price.

 (4) If the Pharmaceutical Benefits Advisory Committee gives advice to the Minister under subsection 101(4AC) in relation to the combination item, then, in working out the new price of the single brand of the combination item, the Minister may have regard to that advice in considering the extent (if any) to which to reduce the existing agreed price.

 (4A) If:
 (a) subsection (4) applies; and
 (b) the Minister decides to reduce the existing agreed price;
then, in agreeing the new price of the single brand of the combination item, the Minister:
 (c) may have regard to the advice referred to in subsection (4) in relation to the combination item; and
 (d) must take into account, in relation to the listed component drug, or each listed component drug, that became subject