Document ID: chunk:federal_register_of_legislation:C2007A00111:clause:1_99acd:p1
Version: federal_register_of_legislation:C2007A00111
Segment Type: clause
Provision Reference: sch 1 cl 99ACD (pt 1/3)
Character Range: 41912–44543

99ACD  12.5% price reduction for new brands of 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 combination item) that is a combination item if:
 (a) a determination under subsection 85(6) comes into force in relation to the new brand of the trigger combination item on a day (the determination day); and
 (b) on the day before the determination day, the new brand of the trigger combination item was not a listed brand of the trigger combination 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 combination item is bioequivalent or biosimilar to the existing brand of the existing item; and
 (iii) the drug in the trigger combination item and existing item contain the same component drugs; and
 (iv) the trigger combination item and the existing item have the same 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 combination item and the existing item may be the same pharmaceutical item.

Circumstances in which section does not apply to new brands

 (1A) This section does not apply in relation to the new brand of the trigger combination item if:
 (a) the trigger combination item is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied; or
 (b) another combination item that has the same drug and manner of administration as the new brand of the trigger combination item is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied; or
 (c) if the drug in the trigger combination item is in a therapeutic group—a combination 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 combination item;
  is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied.

 (2) This section does not apply in relation to the new brand of the trigger combination item if subsection (1) or section 99ACE has applied in relation to:
 (a) the new brand, or another listed brand, of the trigger combination item; or
 (b) a brand of another combination item that:
 (i) has a drug that contains the same component drugs as the new brand of the trigger combination item; and
 (ii) has the same manner of administration as the new brand of the trigger