Commonwealth Consolidated Acts Commonwealth Consolidated ActsWhen this section applies
(1) This section applies if:
(a) a brand of a pharmaceutical item has an approved ex - manufacturer price of $4 or less; and
(b) the responsible person offers a discount or incentive, in relation to sales of the brand of the pharmaceutical item, on one or more occasions; and
(c) section 99ADHC applies to the brand of the pharmaceutical item.
Minister's powers
(2) Without limiting any power the Minister may otherwise have under this Part, the Minister may do any or all of the following:
(a) by legislative instrument, revoke or vary a determination under subsection 85(6) in relation to the brand of the pharmaceutical item;
(b) by legislative instrument, revoke or vary a determination under subsection 85(6) in relation to any brand of any pharmaceutical item of the responsible person;
(c) refuse to make a determination under subsection 85(6) in relation to any brand of any pharmaceutical item of the responsible person;
(d) if the only listed brand of a pharmaceutical item would be a brand of the pharmaceutical item of the responsible person--refuse to make:
(i) a declaration under subsection 85(2) in relation to the drug in the pharmaceutical item; or
(ii) a determination under subsection 85(3) in relation to the form of the pharmaceutical item; or
(iii) a determination under subsection 85(5) in relation to the manner of administration of the pharmaceutical item.
Note: For the purposes of paragraphs (b), (c) and (d), a brand mentioned in those paragraphs may be the brand referred to in subsection (1), or a pharmaceutical item mentioned in those paragraphs may be the item referred to in subsection (1).
(3) In exercising a power under subsection (2), the Minister must have regard to any relevant information that:
(a) relates to discounts or incentives; and
(b) was disclosed in compliance with the price disclosure requirements referred to in Division 3B.
(4) In exercising a power under subsection (2), the Minister may have regard to the following:
(a) the extent to which the discount or incentive will compromise the responsible person's capacity to continue to supply the brand of the pharmaceutical item;
(b) whether the responsible person will consistently maintain adequate stock levels of the brand of the pharmaceutical item in the future;
(ba) whether the responsible person has breached section 99AEKB;
(c) the extent to which the discount or incentive will compromise another person's capacity to continue to supply another brand of the pharmaceutical item;
(d) any other matter the Minister thinks is relevant.
(5) The refusals referred to in paragraphs (2)(c) and (d) are not legislative instruments.
Meaning of discount or incentive
(6) For the purposes of this section, discount or incentive , in relation to sales of a brand of a pharmaceutical item, means:
(a) anything that results in the net revenue for the brand of the pharmaceutical item for a data collection period for the brand of the pharmaceutical item falling below the amount that would have been the net revenue for the brand of the pharmaceutical item for the data collection period if the price charged for the brand of the pharmaceutical item had been equal to the approved ex - manufacturer price of the brand of the pharmaceutical item; or
(b) an incentive given in relation to sales of the brand of the pharmaceutical item.
(7) For the purposes of subsection (6), incentive and net revenue have the same respective meanings as they have when used in regulations made for the purposes of subsection 99ADB(6).
(8) For the purposes of subsection (6), data collection period has the same meaning as in Division 3B.