Document ID: chunk:federal_register_of_legislation:C2007A00111:clause:1_99acb:p1
Version: federal_register_of_legislation:C2007A00111
Segment Type: clause
Provision Reference: sch 1 cl 99ACB (pt 1/2)
Character Range: 33492–36026

99ACB  12.5% price reduction for new brands of pharmaceutical items that are not combination items

When section applies to new brands

 (1) Subject to subsections (2) and (3), this section applies to a brand (the new brand) of a pharmaceutical item (the trigger item) that is not a combination item if:
 (a) a determination under subsection 85(6) comes into force in relation to the new brand of the trigger item on a day (the determination day); and
 (b) on the day before the determination day, the new brand of the trigger item was not a listed brand of the trigger item; and
 (c) on the day before the determination day:
 (i) a brand (the existing brand) of a pharmaceutical item (the existing item) was a listed brand of the existing item; and
 (ii) the new brand of the trigger item is bioequivalent or biosimilar to the existing brand of the existing item; and
 (iii) the trigger item and existing item have the same drug and manner of administration.

Note: For the purposes of paragraph (c), the new brand and the existing brand may be the same brand, or the trigger item and the existing item may be the same pharmaceutical item.

Circumstances in which section does not apply

 (2) This section does not apply in relation to the new brand of the trigger item if:
 (a) the trigger item is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied; or
 (b) another pharmaceutical item that has the same drug and manner of administration as the new brand of the trigger item is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied; or
 (c) if the drug that is in the trigger item is in a therapeutic group—a pharmaceutical item that:
 (i) has another drug that is in that group; and
 (ii) has the same manner of administration as the new brand of the trigger item;
  is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied.

 (3) This section does not apply in relation to the new brand of the trigger item if:
 (a) any of the following has applied:
 (i) subsection (1);
 (ii) subsection 99ACF(1) or (2) because of item 1 of the table in that section;
in relation to:
 (b) the new brand, or another listed brand, of the trigger item; or
 (c) a listed brand of another pharmaceutical item that has the same drug and manner of administration as the new brand of the trigger item; or
 (d) if the drug that is in the trigger item is in a therapeutic group—a listed brand of a pharmaceutical item that:
 (i)