Document ID: chunk:federal_register_of_legislation:C2010A00126:clause:2_99acea:p1
Version: federal_register_of_legislation:C2010A00126
Segment Type: clause
Provision Reference: sch 2 cl 99ACEA (pt 1/2)
Character Range: 12636–15175

99ACEA  Price reduction for new brand of pharmaceutical item having drug with outstanding staged reductions—new brand bioequivalent or biosimilar to existing listed brand

When this section applies
 (1) Subject to subsection (2), this section applies to a brand (the new brand) of a pharmaceutical item (the trigger item) on a day (the reduction day) if:
 (a) on the reduction day, a determination under subsection 85(6) comes into force in relation to the new brand of the trigger item; and
 (b) on the day before the reduction day:
 (i) the new brand of the trigger item was not a listed brand of the trigger item; and
 (ii) a brand (the existing brand) of a pharmaceutical item (the existing item) was a listed brand of the existing item; and
 (c) the new brand of the trigger item is bioequivalent or biosimilar to the existing brand of the existing item; and
 (d) the trigger item and existing item have the same drug and manner of administration; and
 (e) on the reduction day, either or both of the following are subject to an outstanding staged reduction:
 (i) the existing brand of the existing item;
 (ii) a brand (the related brand) of a pharmaceutical item (the related item) that has the same drug as the existing item and the trigger item.
Note 1: For the purposes of this subsection, 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.
Note 2: For the purposes of this subsection, the new brand and the related brand may be the same brand, or the trigger item and the related item may be the same pharmaceutical item.
Note 3: For the purposes of this subsection, the existing brand and related brand may be the same brand, or the existing item and related item may be the same pharmaceutical item.

When this section does not apply
 (2) This section does not apply if, before the reduction day, this section applied to:
 (a) the new brand, or another listed brand, of the trigger item; or
 (b) a listed brand of another pharmaceutical item that has the same drug as the new brand of the trigger item.
Note: Subsection (1) is taken not to have applied in relation to a brand of a pharmaceutical item in some cases: see section 99AEI.

Price reduction
 (3) The Minister:
 (a) may, under section 85AD, make a price agreement for the new brand of the trigger item; and
 (b) must not make a determination under section 85B in relation to the new brand of the trigger item.
 (4) Subject to subsection (5), the agreed price for the new brand of