99ADHBFlow on price reductions for brands of combination items

#### 99ADHB Flow on price reductions for brands of combination items When section applies (1) This section applies if: (a) there is an approved ex‑manufacturer price (the existing price) in force for a brand (the existing brand) of a combination item; and (b) the combination item is not an exempt item; and (c) the combination item has a drug on F2; and (d) a brand of a pharmaceutical item (the non‑combination item) that is not a combination item has a drug (the common drug) that is in the combination item; and (e) the combination item has the same manner of administration as the non‑combination item; and (f) on a day (the reduction day) after the day the existing price came into force for the existing brand of the combination item, section 99ADH applied to the brand of the non‑combination item. > Note: The meaning of the same manner of administration is modified for the purposes of this section by subsection (7). Price reduction (2) Subject to subsections (6) and (6B), on the reduction day, the approved ex‑manufacturer price of the existing brand of the combination item is taken to be reduced in accordance with a method prescribed by the regulations. (3) Different methods may be prescribed by the regulations for different classes of combination items. (4) Subsection (3) does not limit subsection 33(3A) of the Acts Interpretation Act 1901. (5) Subject to subsection (6), if the approved ex‑manufacturer price of the existing brand of the combination item is reduced under subsection (2), then, on the reduction day, the claimed price (if any) of the existing brand of the combination item is taken to be reduced by a percentage equal to the percentage by which the approved ex‑manufacturer price of the existing brand of the combination item is reduced under subsection (2). Ministerial discretion not to apply, or to reduce, statutory price reduction (6) In relation to the existing brand of the combination item, the Minister may, by notifiable instrument, determine that: (a) the approved ex‑manufacturer price, and (if applicable) the claimed price, is not to be reduced under subsection (2) or (5), as the case requires, in relation to a particular reduction day; or (b) the approved ex‑manufacturer price, and (if applicable) the claimed price, is to be reduced by a lower percentage than would otherwise apply under subsection (2) or (5), as the case requires, in relation to a particular reduction day. (6A) In making a determination under subsection (6): (a) the Minister must take into account what the approved ex‑manufacturer price, and (if applicable) the claimed price, of the existing brand of the combination item would otherwise be under this section in relation to the particular reduction day if a determination were not made; and (b) the Minister may take into account: (i) any advice given to the Minister under subsection 101(4AC) in relation to the combination item; and (ii) any other matter the Minister thinks is relevant. (6B) If the Minister makes a determination under subsection (6), the approved ex‑manufacturer price of the existing brand of the combination item is not to be further reduced under this section on any reduction day that occurs after the reduction day specified in the determination made under subsection (6). Section does not limit Minister’s powers (6C) This section does not limit the Minister’s powers, on or after the reduction day, to make: (a) further price agreements; or (b) determinations under section 85B; for the existing brand of the combination item. Modified meaning of the same manner of administration (7) For the purposes of this section, the existing brand of the combination item has the same manner of administration as a pharmaceutical item that is not a combination item (the non‑combination item) if the manner of administration set out in a determination under subsection 85(5) for the combination item, to the extent that the manner of administration relates to the common drug, is the same as the manner of administration set out in a determination under subsection 85(5) for the non‑combination item. Section does not limit Minister’s powers (13) This section does not limit the Minister’s powers, after the reduction day, to make further price agreements or determinations under section 85B in relation to the existing brand of the combination item.