National Health Act 1953

A brand of a pharmaceutical item is a guaranteed brand of a guaranteed item for the purposes of this Division (other than section 99AEC) if subsection (2) applies to the brand of the pharmaceutical item.

This subsection applies to a brand (the guaranteed brand) of a pharmaceutical item (the guaranteed item) if:

the drug in the guaranteed item is on F2; and

the guaranteed brand is a listed brand of the guaranteed item; and

the Minister and the responsible person for the guaranteed brand of the guaranteed item agree, in a price agreement, an agreed price (the new price) of the guaranteed brand of the guaranteed item; and

on the day (the new price day) the new price comes into force, the new price is less than what the approved ex‑manufacturer price of the guaranteed brand of the guaranteed item would have been on that day if the new price had not come into force; and

the responsible person was the first responsible person for a brand of the guaranteed item to offer the Minister the new price.

The guaranteed period for the guaranteed brand of the guaranteed item is the period that commences on the new price day and ends on the earliest of the following days:

the last day of the 24 month period beginning on the new price day;

if, after the new price day:

a determination under subsection 85(6) comes into force on a day (the later determination day) in relation to a brand (the later brand) of a pharmaceutical item (the later item); and

the later brand of the later item is bioequivalent or biosimilar to the guaranteed brand of the guaranteed item; and

on the day before the later determination day, the later brand was not a listed brand of the later item;

if, after the new price day, subsection (2) applies, in another application of that subsection, to:

a brand of the guaranteed item; or

a brand of a pharmaceutical item that is bioequivalent or biosimilar to the guaranteed brand of the guaranteed item;

the day that is the first whole day on which the guaranteed brand is not a listed brand of the guaranteed item.

For the purposes of paragraph (b), the later brand and the guaranteed brand may be the same brand, or the later item and the guaranteed item may be the same item.

For the purposes of paragraph (c), the brand mentioned in that paragraph and the guaranteed brand may be the same brand, or the pharmaceutical item mentioned in that paragraph and the guaranteed item may be the same pharmaceutical item.