Document ID: chunk:federal_register_of_legislation:F2018N00171:front:0:p1
Version: federal_register_of_legislation:F2018N00171
Segment Type: other
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National Health (December 2018 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2018
National Health Act 1953

I, SEAN LANE, Acting Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this determination under subsections 99ACF(3AA) and 99ACB(6A) of the National Health Act 1953.

Dated          28 November 2018

SEAN LANE

Acting Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health

1 Name of Instrument
  This instrument is the National Health (December 2018 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2018.

2 Commencement
  This instrument commences on the day after it is registered.
3 Definitions

          Note: A number of expressions used in this instrument are defined in Part VII the Act.

      In this instrument:

      Act means the National Health Act 1953.
4 Authority

      This instrument is made under subsections 99ACF(3AA) and 99ACB(6A) of the Act.
5 Brand of pharmaceutical item not subject to a price reduction

  I determine under subsection 99ACF(3AA) of the Act that, for the purposes of subsection 99ACF(2AB), the approved ex-manufacturer price that comes into force on 1 December 2018 of each brand of pharmaceutical item specified in an item in the table in Part 1 of the Schedule is to be worked out using a reduction of zero %.

      Note: Subsection 99ACF(3AA) enables the Minister to determine that the reduction to the approved ex-manufacturer price or claimed price of a brand of pharmaceutical item subject to subsection 99ACF(2AB) is to be worked out using a lower percentage, including zero %, than would otherwise be the case.
6 Brand of pharmaceutical item subject to a lower price reduction than would otherwise apply

 (1) I determine under subsection 99ACF(3AA) of the Act that, for the purposes of subsection 99ACF(2AB), the approved ex-manufacturer price that comes into force on 1 December 2018 of the brand of pharmaceutical item specified in item 1 in the table in Part 2 of the Schedule is to be worked out using a reduction of 20%.
  Note: Subsection 99ACF(3AA) enables the Minister to determine that limit on the maximum agreed price of a new brand of an existing pharmaceutical item subject to subsection 99ACF(2AB) is to be calculated using a lower percentage, including zero %, than would otherwise be the case.

 (2) I determine under subsection 99ACB(6A) of the Act that, for the purposes of subsection 99ACB(5), the maximum agreed price of the brand of pharmaceutical item specified in item 2 in the table in Part 2 of the Schedule that comes into force on 1 December 2018 is to be worked out using a reduction of 20%.
  Note: Subsection