99ADGOther consequences for failing to comply with the price disclosure requirements

99ADG Other consequences for failing to comply with the price disclosure requirements

(1) This section applies if: (a) a responsible person is required to comply with the price disclosure requirements for a supply of a brand (the disclosure brand) of a pharmaceutical item (the disclosure item); and (b) the responsible person does not comply with those requirements for the supply of the disclosure brand of the disclosure item. (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 disclosure brand of the disclosure 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 disclosure brand, or a pharmaceutical item mentioned in those paragraphs may be the disclosure item.

(3) Without limiting the powers of the Minister under subsection (2), in exercising a power under that subsection, the Minister may have regard to: (a) the number of times the responsible person did not comply with the price disclosure requirements for: (i) the disclosure brand of the disclosure item; and (ii) if, in addition to the disclosure brand of the disclosure item, the person was also required to comply with the price disclosure requirements for a brand of a pharmaceutical item—the brand of the pharmaceutical item; and (b) the period in which the non‑compliances occurred; and (c) the duration of each non‑compliance; and (d) the reasons for the non‑compliances; and (e) whether those reasons are, in the Minister’s opinion, reasonable; and (f) any other matter the Minister thinks is relevant.

Note: For the purposes of subparagraph (a)(ii), a brand mentioned in that subparagraph may be the disclosure brand, or a pharmaceutical item mentioned in that subparagraph may be the disclosure item.

(4) The refusals referred to in paragraphs (2)(c) and (d) are not legislative instruments.