Document ID: chunk:federal_register_of_legislation:C2010A00126:clause:2_99aceb
Version: federal_register_of_legislation:C2010A00126
Segment Type: clause
Provision Reference: sch 2 cl 99ACEB
Character Range: 16514–19022

99ACEB  New brands of pharmaceutical items having drug with outstanding staged reductions——new brands not bioequivalent or biosimilar to existing listed brand

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

This section does not limit Minister's powers
 (4) This section does not limit the Minister's powers, after the reduction day, to make:
 (a) further price agreements; or
 (b) determinations under section 85B;
for the new brands of the trigger items.