National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2023

Administered by Department of Health, Disability and Ageing

Legislation au F2023N00372 Not in force Notifiable Instrument

Legislation content

 

PB 104 of 2023

 

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2023

I, Nikolai Tsyganov, as delegate of the Minister for Health and Aged Care, make the following Determination.

Dated 3 October 2023

Nikolai Tsyganov

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

Contents

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments—General

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023

5  Floor price of certain brands of pharmaceutical items

Schedule 2—Amendments—Additional designated brands effective from 1 April 2024

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023

Schedule 3—Repeals

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2022

 

1  Name

 (1) This instrument is the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2023.

 (2) This instrument may also be cited as PB 104 of 2023.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

The day after this instrument is registered.

 

2.  Schedule 1

The day after this instrument is registered.

 

3.  Schedule 2

1 April 2024.

1 April 2024

4.  Schedule 3

The day after this instrument is registered.

 

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under subsection 99ADHC(2) of the National Health Act 1953.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

Schedule 1—Amendments—General

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023

1  Section 5

Repeal the section, substitute:

5  Floor price of certain brands of pharmaceutical items

  For the purposes of subsection 99ADHC(2) of the Act, paragraph 99ADHC(1)(c) of the Act applies to a brand mentioned in column 1 of an item in the following table of a pharmaceutical item that is the drug mentioned in column 2 of that table item, in the form mentioned in column 3 of that table item and with the manner of administration mentioned in column 4 of that table item.

 

Floor price of certain brands of pharmaceutical items

Column 1
Brand

Column 2
Drug

Column 3
Form

Column 4
Manner of administration

PKU squeezie

Amino acid formula with vitamins and minerals without phenylalanine

Oral gel 85 g, 30 (PKU squeezie)

Oral

Cal-500

Calcium

Tablet, chewable, 500 mg (as carbonate)

Oral

Dantrium

Dantrolene

Capsule containing dantrolene sodium hemiheptahydrate 25 mg

Oral

DBL Desferrioxamine Mesilate

Desferrioxamine

Powder for injection containing desferrioxamine mesilate 2 g

Injection

Cardizem

Diltiazem

Tablet containing diltiazem hydrochloride 60 mg

Oral

Diltiazem AN

Diltiazem

Tablet containing diltiazem hydrochloride 60 mg

Oral

Vasocardol

Diltiazem

Tablet containing diltiazem hydrochloride 60 mg

Oral

Triumeq

Dolutegravir with abacavir and lamivudine

Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg

Oral

Flucil

Flucloxacillin

Powder for injection 1 g (as sodium monohydrate)

Injection

Flucil

Flucloxacillin

Powder for oral liquid 125 mg (as sodium monohydrate) per 5 mL, 100 mL

Oral

Flucil

Flucloxacillin

Powder for oral liquid 250 mg (as sodium monohydrate) per 5 mL, 100 mL

Oral

DBL Heparin Sodium

Heparin

Injection 5,000 units (as sodium) in 0.2 ml

Injection

Moduretic

Hydrochlorothiazide with amiloride

Tablet containing hydrochlorothiazide 50 mg with amiloride hydrochloride 5 mg

Oral

Hymenoptera Honey Bee Venom

Insect allergen extract-honey bee venom

Injection set containing 550 micrograms with diluent

Injection

Hymenoptera Paper Wasp Venom

Insect allergen extract-paper wasp venom

Injection set containing 550 micrograms with diluent

Injection

Hymenoptera Yellow Jacket Venom

Insect allergen extract-yellow jacket venom

Injection set containing 550 micrograms with diluent

Injection

Toujeo Solostar

Insulin glargine

Injections (human analogue), cartridge, 300 units per mL, 1.5 mL, 3

Injection

Toujeo Solostar

Insulin glargine

Injections (human analogue), cartridges, 300 units per mL, 1.5 mL, 5

Injection

Lithicarb

Lithium

Tablet containing lithium carbonate 250 mg

Oral

Quilonum SR

Lithium

Tablet containing lithium carbonate 450 mg (slow release)

Oral

Penthrox

Methoxyflurane

Liquid for inhalation 999 mg per g, 3 ml (with inhaler)

Inhalation by mouth

Lyclear

Permethrin

Cream 50 mg per g, 30 g

Application

Pro-Cid

Probenecid

Tablet 500 mg

Oral

Asmol CFC-Free with dose counter

Salbutamol

Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

Inhalation by mouth

Ventolin CFC-Free with dose counter

Salbutamol

Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

Inhalation by mouth

Zempreon CFC-Free with dose counter

Salbutamol

Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

Inhalation by mouth

PHOSPHATE PHEBRA

Sodium acid phosphate

Tablet, compound effervescent, equivalent to 500 mg phosphorus

Oral

Lipistart

Triglycerides - medium chain, formula

Oral powder 400 g (Lipistart)

Oral

K.Quik

Triglycerides, medium chain

Oral liquid 225 mL, 15 (K.Quik)

Oral

 

Schedule 2—Amendments—Additional designated brands effective from 1 April 2024

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023

1  Section 5 (after table item dealing with the brand PKU squeezie of the drug Amino acid formula with vitamins and minerals without phenylalanine in the form Oral gel 85 g, 30 (PKU squeezie))

Insert:

Kineret

Anakinra

Injection 100 mg in 0.67 mL single use pre-filled syringe

Injection

Bicillin L-A

Benzathine benzylpenicillin

Injection containing 1,200,000 units benzathine benzylpenicillin tetrahydrate in 2.3 mL single use pre-filled syringe

Injection

Bicillin L-A

Benzathine benzylpenicillin

Injection containing 600,000 units benzathine benzylpenicillin tetrahydrate in 1.17 mL single use pre-filled syringe

Injection

2  Section 5 (after table item dealing with the brand Vasocardol of the drug Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg)

Insert:

ADT Booster

Diphtheria and tetanus vaccine, adsorbed, diluted for adult use

Injection 0.5 mL in pre-filled syringe

Injection

3  Section 5 (after table item dealing with the brand Triumeq of the drug Dolutegravir with abacavir and lamivudine in the form Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg)

Insert:

Estraderm MX 50

Estradiol

Transdermal patches 1.5 mg (as hemihydrate), 8

Transdermal

Estraderm MX 100

Estradiol

Transdermal patches 3 mg (as hemihydrate), 8

Transdermal

Estraderm MX 25

Estradiol

Transdermal patches 750 micrograms (as hemihydrate), 8

Transdermal

4  Section 5 (after table item dealing with the brand Quilonum SR of the drug Lithium in the form Tablet containing lithium carbonate 450 mg (slow release))

Insert:

OsmoLax

Macrogol 3350

Powder for oral solution 510 g

Oral

5  Section 5 (after table item dealing with the brand Penthrox of the drug Methoxyflurane in the form Liquid for inhalation 999 mg per g, 3 ml (with inhaler))

Insert:

Flagyl

Metronidazole

Suppositories 500 mg, 10

Rectal

Carbohydrate Free Mixture

Milk protein and fat formula with vitamins and minerals -- carbohydrate free

Oral powder 225 g (Carbohydrate Free Mixture)

Oral

MORPHINE SULFATE 15 mg/1 mL MEDSURGE

Morphine

Injection containing morphine sulfate pentahydrate 15 mg in 1 mL

Injection

MORPHINE SULFATE 30 mg/1 mL MEDSURGE

Morphine

Injection containing morphine sulfate pentahydrate 30 mg in 1 mL

Injection

Ditropan

Oxybutynin

Tablet containing oxybutynin hydrochloride 5 mg

Oral

Oxytrol

Oxybutynin

Transdermal patches 36 mg, 8

Transdermal

6  Section 5 (after table item dealing with the brand Lyclear of the drug Permethrin in the form Cream 50 mg per g, 30 g)

Insert:

Elidel

Pimecrolimus

Cream 10 mg per g, 15 g

Application

7  Section 5 (after table item dealing with the brand Pro-Cid of the drug Probenecid in the form Tablet 500 mg)

Insert:

Stemetil

Prochlorperazine

Injection containing prochlorperazine mesilate 12.5 mg in 1 mL

Injection

Aptamil Gold+ Pepti-Junior

Protein hydrolysate formula with medium chain triglycerides

Oral powder 450 g (Aptamil Gold+ Pepti-Junior)

Oral

8  Section 5 (after table item dealing with the brand Zempreon CFC-Free with dose counter of the drug Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation))

Insert:

Eldepryl

Selegiline

Tablet containing selegiline hydrochloride 5 mg

Oral

9  Section 5 (after table item dealing with the brand PHOSPHATE PHEBRA of the drug Sodium acid phosphate in the form Tablet, compound effervescent, equivalent to 500 mg phosphorus)

Insert:

Micolette

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Enemas 3.125 g-450 mg-45 mg in 5 mL, 12

Rectal

10  Section 5 (after table item dealing with the brand K.Quik of the drug Triglycerides, medium chain in the form Oral liquid 225 mL, 15 (K.Quik))

Insert:

Epilim Liquid

Valproic acid

Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL

Oral

Epilim Syrup

Valproic acid

Oral solution containing sodium valproate 200 mg per 5 mL, 300 mL

Oral

Schedule 3—Repeals

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2022

1  The whole of the instrument

Repeal the instrument.

 

Overview

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2023, enacted by Nikolai Tsyganov, as delegate of the Minister for Health and Aged Care, amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 to address gaps in the pricing of certain pharmaceutical items under the National Health Act 1953. This Determination introduces amendments effective from 3 October 2023, with additional designated brands becoming effective from 1 April 2024. The amendments aim to ensure a floor price is set for specific brands of pharmaceutical items to maintain affordability and access to essential medications within the Australian healthcare system. The policy objective is to provide a consistent and equitable pricing structure for these items, ensuring they are available to those who need them without excessive cost disparities.

Scope and Application

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2023, made by Nikolai Tsyganov, as delegate of the Minister for Health and Aged Care, amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. This instrument applies to the Commonwealth and sets out the floor prices for certain brands of pharmaceutical items listed under Schedule 1, with additional designated brands to be effective from 1 April 2024 as specified in Schedule 2. It repeals the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2022, as outlined in Schedule 3. The determination applies to pharmaceutical brands listed in the Schedules, which include drugs, forms, and manners of administration, with specific prices set to ensure accessibility and affordability under the National Health Act 1953. The application of this instrument is not limited by geographic boundaries within Australia and extends to all entities and individuals involved in the sale or supply of these pharmaceutical items. There are no stated exclusions, exemptions, or thresholds in this Determination; however, the application may be further refined or extended through subordinate instruments issued under the authority of the National Health Act 1953.

Key Provisions

The main operative sections of this Determination (sections 1 to 4) require the specified brands of pharmaceutical items to be subject to a floor price, as per the amendments detailed in Schedules 1 and 2. Section 5 of the Determination lists the pharmaceutical items that are subject to the floor price, including details such as brand name, drug, form, and manner of administration. Schedule 1 outlines general amendments to the existing determination, while Schedule 2 provides additional designated brands that will be subject to the floor price from 1 April 2024. Schedule 3 repeals the previous determination, the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2022, in its entirety. The obligations imposed by this Determination primarily affect pharmaceutical manufacturers and suppliers, requiring them to adhere to the specified floor prices for the listed pharmaceutical items. These obligations ensure that the prices of these items remain at a certain minimum level, which is intended to provide cost predictability and affordability for consumers and the healthcare system. There are no explicit offences, penalties, or consequences for breach outlined in this Determination. However, the enforcement of the floor price provisions would likely be managed under the National Health Act 1953 and associated regulations, where penalties for non-compliance could be applicable. The maximum penalties for breaches of the National Health Act 1953 can vary depending on the specific provisions and the nature of the breach but may include fines and/or imprisonment for serious offences. It is important to note that the specific penalties for breaches of the floor price provisions would need to be referred to the relevant sections of the National Health Act 1953 and any associated 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.