99ADBDefinitions etc.

#### 99ADB Definitions etc. (1) In this Division: > adjusted approved ex‑manufacturer price of a brand of a pharmaceutical item is the amount equal to the amount of the weighted average disclosed price of the brand of the pharmaceutical item. > applicable approved ex‑manufacturer price: see subsection (3A). > data collection period, for a brand of a pharmaceutical item, has the meaning given by section 99ADBA. > originator brand has the meaning given by subsection (6B). > price disclosure requirements has the meaning given by section 99ADC. > related brand, of a brand of a pharmaceutical item, means a brand of a pharmaceutical item that has the same drug and manner of administration as the first‑mentioned pharmaceutical item (including another brand of the same pharmaceutical item), but does not include a brand of an exempt item. > relevant day means the day after the end of the period in respect of which the weighted average disclosed price of the brand of the pharmaceutical item is determined. > start day, for a brand of a pharmaceutical item, means the day that the brand was first required to comply with the price disclosure requirements under section 99ADD. > unadjusted price reduction for a brand of a pharmaceutical item is the difference between: (a) the applicable approved ex‑manufacturer price of the brand of the pharmaceutical item; and (b) the weighted average disclosed price of the brand of the pharmaceutical item; expressed as a percentage of that applicable approved ex‑manufacturer price. > weighted average disclosed price of a brand of a pharmaceutical item is the weighted average disclosed price of the brand of the pharmaceutical item determined by the Minister under subsection (4). Applicable approved ex‑manufacturer price (3A) The applicable approved ex‑manufacturer price of a brand of a pharmaceutical item is the approved ex‑manufacturer price of the brand on the relevant day. (3B) For the purposes of subsection (3A), if: (a) apart from this subsection, the brand of the pharmaceutical item would not have an approved ex‑manufacturer price on the relevant day; and (b) the brand of the pharmaceutical item has an approved ex‑manufacturer price before the first reduction day that: (i) is determined under paragraph 99ADH(1)(aa) in relation to the brand of the pharmaceutical item; and (ii) occurs after the relevant day; then: (c) the regulations may prescribe the approved ex‑manufacturer price, or a method or formula for working out the approved ex‑manufacturer price, of the brand of the pharmaceutical item on the relevant day; and (d) if the regulations do so, the amount so worked out is taken to be the approved ex‑manufacturer price of the brand of the pharmaceutical item on the relevant day. Weighted average disclosed price (4) The Minister may, by legislative instrument, determine the weighted average disclosed price of a brand of a pharmaceutical item in accordance with the regulations. (6) Without limiting subsection (4), the regulations may prescribe a method or formula for determining the weighted average disclosed price of a brand of a pharmaceutical item. The method or formula prescribed may take into account information (if any) that has been provided in compliance with the price disclosure requirements, and any other information, about: (a) the brand of the pharmaceutical item; and (b) other brands of the pharmaceutical item; and (c) all brands (including the brand) of all pharmaceutical items that have the same drug and manner of administration as the pharmaceutical item. (6A) The regulations may prescribe information that the method or formula must not take into account (including information that has been provided in compliance with the price disclosure requirements). Information prescribed for the purposes of this section may include information relating to originator brands. (6B) The Minister may, by legislative instrument, determine that a brand of a pharmaceutical item that has a drug on F2 is an originator brand. (6C) In deciding whether to determine that a brand of a pharmaceutical item is an originator brand, the Minister must have regard to whether, when the brand of the pharmaceutical item was first determined under subsection 85(6): (a) the drug in the pharmaceutical item was on F1; or (b) subsection 85AB(5) applied to the drug. (6D) Subsection (6C) does not apply if the drug is on F2 on 31 March 2016. (7) A determination made under subsection (4) in relation to a brand of a pharmaceutical item may include the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item.