Commonwealth Consolidated Acts

NATIONAL HEALTH ACT 1953 - SECT 99AEKE

  (1)   This section applies if:

  (a)   a brand of a pharmaceutical item is subject to the minimum stockholding requirement; and

  (b)   the responsible person for the brand of the pharmaceutical item has breached section   99AEKB in relation to the brand of the pharmaceutical 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 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 the following:

  (a)   both:

  (i)   the responsible person's reasons for the breach; and

  (ii)   whether those reasons are, in the Minister's opinion, reasonable;

  (b)   whether, in the Minister's opinion, the responsible person will consistently maintain adequate stock levels of the brand of the pharmaceutical item in the future;

  (c)   whether the responsible person for the brand of the pharmaceutical item has offered discounts or incentives in relation to sales of the brand of the pharmaceutical item;

  (d)   whether the responsible person for the brand of the pharmaceutical item has previously breached section   99AEKB and, if so:

  (i)   the person's reasons for the breach; and

  (ii)   whether those reasons are, in the Minister's opinion, reasonable;

  (e)   whether the responsible persons for other brands of the pharmaceutical item have breached section   99AEKB in relation to those other brands of the pharmaceutical item;

  (f)   any other matter the Minister thinks is relevant.

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

  (5)   For the purposes of this section, discount or incentive has the same meaning as in section   99AEL.