National Health (Weighted average disclosed price – April 2018 reduction day) Amendment Determination 2018 (No.1) (PB 18 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00213 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 18 OF 2018

 

NATIONAL HEALTH ACT 1953

 

National Health (Weighted average disclosed price – April 2018 reduction day)
Amendment Determination 2018 (No.1)

Authority

This legislative instrument is made pursuant to subsection 99ADB(4) of the National Health Act 1953 (the Act), which provides that the Minister may, by legislative instrument, determine the weighted average disclosed price (WADP) of a brand of a pharmaceutical item (listed brand) in accordance with the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations).

 

Subsection 99ADB(7) of the Act further provides that a subsection 99ADB(4) determination for a listed brand may include the adjusted approved ex-manufacturer price (AAEMP) for the listed brand.

Purpose

This legislative instrument amends the National Health (Weighted average disclosed price – April 2018 reduction day) Determination 2018 (PB 9 of 2018) (the Principal Instrument) by re-allocating brands of pharmaceutical items and their corresponding WADPs that no longer meet the criteria for a price reduction under subsection 99ADH(1)(c) of the Act.

All brands of all pharmaceutical items containing the following drugs and manners of administration are affected (except where a particular pharmaceutical item is specified; only brands of that pharmaceutical item are affected):

  • alendronic acid for oral administration;
  • amoxycillin with clavulanic acid for oral administration;
  • ampicillin for administration by injection;
  • anastrozole for oral administration;
  • azathioprine for oral administration;
  • azithromycin, tablet 500 mg (as dihydrate), oral;
  • bleomycin for administration by injection;
  • candesartan for oral administration;
  • candesartan with hydrochlorothiazide for oral administration;
  • carvedilol for oral administration;
  • ceftriaxone for administration by injection;
  • cephazolin for administration by injection;
  • ciprofloxacin for oral administration;
  • clindamycin for oral administration;
  • dexamethasone, intravitreal injection 700 micrograms, injection;
  • escitalopram for oral administration;
  • fentanyl for transdermal administration;
  • filgrastim for administration by injection;
  • frusemide for administration by injection;
  • lamivudine, tablet 100 mg, oral;
  • lamivudine, tablet 150 mg, oral;
  • lamivudine, tablet 300 mg, oral;
  • meloxicam for oral administration;
  • methylprednisolone, powder for injection 40 mg (as sodium succinate) with diluent, injection;
  • montelukast for oral administration;
  • naltrexone for oral administration;
  • olanzapine for oral administration;
  • oxaliplatin for administration by injection;
  • pramipexole for oral administration;
  • risedronic acid for oral administration;
  • risperidone, tablet 0.5 mg, oral;
  • rosuvastatin for oral administration;
  • tacrolimus for oral administration;
  • telmisartan with hydrochlorothiazide for oral administration;
  • terbinafine for oral administration;
  • valproic acid for oral administration; and
  • vinorelbine for administration by injection.

 

The Principal Instrument was made pursuant to subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the Act for brands of pharmaceutical items with a data collection period ending 30 September 2017 (2018 April cycle).

Amendments

Amendments are being made following commencement of changes to the Act by the National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2017.  Amendments included changes to the price disclosure requirements under Division 3B of the Act.

This amending instrument re-allocates brands of pharmaceutical items from Schedule 1 to Schedule 2 of the Principal Instrument because they no longer meet the criteria for a price reduction on the reduction day.

Basis for amendments

Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to vary or revoke the determination made under subsection 99ADB(4) for the medicines affected by this amending instrument.

Consultation

This instrument affects companies that are Responsible Persons for all brands of all pharmaceutical items containing the following drugs and manners of administration (except where a particular pharmaceutical item is specified; only Responsible Persons for brands of that pharmaceutical item are affected):

  • alendronic acid for oral administration;
  • amoxycillin with clavulanic acid for oral administration;
  • ampicillin for administration by injection;
  • anastrozole for oral administration;
  • azathioprine for oral administration;
  • azithromycin, tablet 500 mg (as dihydrate), oral;
  • bleomycin for administration by injection;
  • candesartan for oral administration;
  • candesartan with hydrochlorothiazide for oral administration;
  • carvedilol for oral administration;
  • ceftriaxone for administration by injection;
  • cephazolin for administration by injection;
  • ciprofloxacin for oral administration;
  • clindamycin for oral administration;
  • dexamethasone, intravitreal injection 700 micrograms, injection;
  • escitalopram for oral administration;
  • fentanyl for transdermal administration;
  • filgrastim for administration by injection;
  • frusemide for administration by injection;
  • lamivudine, tablet 100 mg, oral;
  • lamivudine, tablet 150 mg, oral;
  • lamivudine, tablet 300 mg, oral;
  • meloxicam for oral administration;
  • methylprednisolone, powder for injection 40 mg (as sodium succinate) with diluent, injection;
  • montelukast for oral administration;
  • naltrexone for oral administration;
  • olanzapine for oral administration;
  • oxaliplatin for administration by injection;
  • pramipexole for oral administration;
  • risedronic acid for oral administration;
  • risperidone, tablet 0.5 mg, oral;
  • rosuvastatin for oral administration;
  • tacrolimus for oral administration;
  • telmisartan with hydrochlorothiazide for oral administration;
  • terbinafine for oral administration;
  • valproic acid for oral administration; and
  • vinorelbine for administration by injection.

 

All of the affected companies were notified that amendments would occur upon commencement of the National Health Amendment (Pharmaceutical Benefits – Budget and Other Measures) Act 2018. No concerns were expressed.

 

This instrument commences on the day after it is registered on the Federal Register of Legislation. This instrument is a legislative instrument for the purposes of the Legislation Act 2003.


 

Overview

The National Health (Weighted average disclosed price – April 2018 reduction day) Amendment Determination 2018 (No.1) is a legislative instrument made under the authority of the National Health Act 1953. It was enacted to address the need for adjustments in the weighted average disclosed prices (WADPs) of certain pharmaceutical brands, specifically those that no longer met the criteria for a price reduction under the Act. This amendment was necessitated by changes introduced by the National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2017, which altered the price disclosure requirements. The instrument re-allocates certain pharmaceutical brands from Schedule 1 to Schedule 2 of the Principal Instrument, reflecting the updated criteria for price reductions. This amendment aims to ensure that the pricing of pharmaceutical items aligns with the legislative changes, maintaining the integrity and effectiveness of the National Health Act's provisions.

Scope and Application

The National Health (Weighted average disclosed price – April 2018 reduction day) Amendment Determination 2018 (No.1) amends the National Health (Weighted average disclosed price – April 2018 reduction day) Determination 2018, which was made under the National Health Act 1953. This legislation applies to companies that are Responsible Persons for brands of pharmaceutical items containing specific drugs and manners of administration, such as alendronic acid for oral administration, amoxycillin with clavulanic acid for oral administration, and ampicillin for administration by injection, among others. The amendment affects these companies by re-allocating brands of pharmaceutical items and their corresponding weighted average disclosed prices that no longer meet the criteria for a price reduction on the reduction day. The instrument applies nationally across Australia, and it comes into effect on the day after it is registered on the Federal Register of Legislation. While the Act does not specify exclusions or thresholds in this context, the determination process is subject to changes in the Act and the Regulations.

Key Provisions

The primary operative sections of the National Health (Weighted Average Disclosed Price – April 2018 Reduction Day) Amendment Determination 2018 (No. 1) (F2018L00213) are sections that amend the Principal Instrument, specifically the National Health (Weighted Average Disclosed Price – April 2018 Reduction Day) Determination 2018 (PB 9 of 2018). This amendment instrument reclassifies certain brands of pharmaceutical items from Schedule 1 to Schedule 2, due to these brands no longer meeting the criteria for a price reduction under subsection 99ADH(1)(c) of the National Health Act 1953 (the Act). This reclassification is based on changes to the price disclosure requirements introduced by the National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2017. The obligations and requirements imposed by this legislation primarily concern the entities responsible for the pharmaceutical brands affected by the amendments. These Responsible Persons must ensure that the brands of pharmaceutical items they manage are accurately classified under either Schedule 1 or Schedule 2 of the amended determination. Responsible Persons for the specified brands must also ensure that they comply with any new requirements imposed by the amendments, particularly regarding price disclosures and reporting obligations as outlined in the updated National Health (Pharmaceutical Benefits) Regulations 2017. The Act and the accompanying regulations do not explicitly outline specific offences, penalties, or civil/criminal consequences for non-compliance with the amended determination. However, under the broader framework of the National Health Act 1953, non-compliance with the Act or its regulations may result in administrative actions, fines, or other penalties as deemed appropriate by the Minister or other authorised officers. The specific penalties for breaches are not detailed in the amendment instrument itself but are governed by the general provisions of the Act and related regulations.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.