National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2024

Administered by Department of Health, Disability and Ageing

Legislation au F2024N01003 In force Notifiable Instrument

Legislation content

 

PB 84 of 2024

 

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2024

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

Dated 23 October 2024    

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

Schedule 2—Amendments— Additional designated brands effective from 1 February 2025

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

Schedule 3—Amendments— Additional designated brands effective from 1 April 2025

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

 

 

1  Name

 (1) This instrument is the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2024.

 (2) This instrument may also be cited as PB 84 of 2024.

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 February 2025.

1 February 2025

4.  Schedule 3

1 April 2025.

1 April 2025

Note: This table relates only to the provisions of this instrument as originally made.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 (table)

Omit:

Diltiazem AN

Diltiazem

Tablet containing diltiazem hydrochloride 60 mg

Oral

Schedule 2—Amendments— Additional designated brands effective from 1 February 2025

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

1  Section 5 (after table item dealing with the brand Isoleucine 50 of the drug Isoleucine with carbohydrate in the form Sachets of oral powder 4 g containing 50 mg isoleucine, 30 (Isoleucine 50))

Insert:

APO-Levetiracetam

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Keppra

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Kerron

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Levetiracetam GH

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Levetiracetam-AFT

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

APO-Levetiracetam

Levetiracetam

Tablet 1 g

Oral

Keppra

Levetiracetam

Tablet 1 g

Oral

Kevtam 1000

Levetiracetam

Tablet 1 g

Oral

Levactam

Levetiracetam

Tablet 1 g

Oral

Levetiracetam GH

Levetiracetam

Tablet 1 g

Oral

Levetiracetam Mylan

Levetiracetam

Tablet 1 g

Oral

Levetiracetam SZ

Levetiracetam

Tablet 1 g

Oral

Levetiracetam Viatris

Levetiracetam

Tablet 1 g

Oral

Levi 1000

Levetiracetam

Tablet 1 g

Oral

NOUMED LEVETIRACETAM

Levetiracetam

Tablet 1 g

Oral

 


Schedule 3—Amendments— Additional designated brands effective from 1 April 2025

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

1  Section 5 (before table item dealing with the brand GA gel of the drug Amino acid formula with vitamins and minerals without lysine and low in tryptophan in the form Sachets containing oral powder 24 g, 30 (GA gel))

Insert:

Fosamax Plus 70 mg/140 mcg

Alendronic acid with colecalciferol

Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

Oral

Fosamax Plus

Alendronic acid with colecalciferol

Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

Oral

2  Section 5 (after table item dealing with the brand Kineret of the drug Anakinra in the form Injection 100 mg in 0.67 mL single use pre-filled syringe)

Insert:

Atropine Injection (Pfizer)

Atropine

Injection containing atropine sulfate monohydrate 600 micrograms in 1 mL

Injection

Colazide

Balsalazide

Capsule containing balsalazide sodium 750 mg

Oral

3  Section 5 (after table item dealing with the brand Bicillin L-A of the drug Benzathine benzylpenicillin in the form Injection containing 600,000 units benzathine benzylpenicillin tetrahydrate in 1.17 mL single use pre-filled syringe)

Insert:

Lax-Tab

Bisacodyl

Tablet 5 mg

Oral

4  Section 5 (after table item dealing with the brand Pulmicort Turbuhaler of the drug Budesonide in the form Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses)

Insert:

Calci-Tab 600

Calcium

Tablet 600 mg (as carbonate)

Oral

5  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:

Mayne Pharma Erythromycin

Erythromycin

capsule 250 mg (containing enteric coated pellets)

Oral

6  Section 5 (after table item dealing with the brand Estraderm MX 25 of the drug Estradiol in the form Transdermal patches 750 micrograms (as hemihydrate), 8)

Insert:

Ferro-Liquid

Ferrous Sulfate

Oral liquid containing 30 mg ferrous sulfate heptahydrate per mL, 250 mL

Oral

7  Section 5 (after table item dealing with the brand Flucil of the drug Flucloxacillin in the form Powder for oral liquid 250 mg (as sodium monohydrate) per 5 mL, 100 mL)

Insert:

Lasix

Furosemide

Oral solution 10 mg per ml, 30 ml

Oral

8  Section 5 (after table item dealing with the brand Fucidin of the drug Fusidic acid in the form Tablet containing sodium fusidate 250 mg)

Insert:

Nitrolingual Pumpspray

Glyceryl trinitrate

Sublingual spray (pump pack) 400 micrograms per dose, 200 doses

Sublingual

9  Section 5 (after table item dealing with the brand Isoleucine 50 of the drug Isoleucine with carbohydrate in the form Sachets of oral powder 4 g containing 50 mg isoleucine, 30 (Isoleucine 50)

Insert:

Presolol 100

Labetalol

Tablet containing labetalol hydrochloride 100 mg

Oral

10  Section 5 (after table item dealing with the brand MORPHINE SULFATE 30 mg/1 mL MEDSURGE of the drug Morphine in the form Injection containing morphine sulfate pentahydrate 30 mg in 1 mL)

Insert:

Norimin-1 28 Day

Norethisterone with ethinylestradiol

Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets

Oral

Norimin 28 Day

Norethisterone with ethinylestradiol

Pack containing 21 tablets 500 micrograms-35 micrograms and 7 inert tablets

Oral

11  Section 5 (after table item dealing with the brand Lipistart of the drug Triglycerides - medium chain, formula in the form Oral powder 400 g (Lipistart))

Insert:

MCT Oil

Triglycerides, medium chain

Oil 500 ml (MCT Oil)

Oral

 

Overview

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2024, PB 84 of 2024, was enacted to amend the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. This amendment was made by Nikolai Tsyganov, as delegate of the Minister for Health and Aged Care, under the authority granted by subsection 99ADHC(2) of the National Health Act 1953. The determination introduces new pharmaceutical brands to the list of items subject to a floor price, aiming to regulate the pricing of certain medications and ensure affordable access to essential medicines for the public. The policy objective behind this amendment is to maintain a balanced pricing structure for pharmaceutical items, ensuring that both manufacturers and consumers are fairly treated within the national healthcare framework. The determination is set to have various commencement dates, with sections 1 to 4 and the general amendments taking effect the day after registration, while specific brands and their amendments will come into effect on 1 February 2025 and 1 April 2025 as outlined in the schedules.

Scope and Application

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2024, made under the National Health Act 1953, amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. This legislation applies to pharmaceutical brands listed in the schedules of the determination, governing their pricing within the Australian healthcare system. The amendment adds specific brands of pharmaceutical items to the list of designated brands effective from 1 February 2025 and 1 April 2025, establishing a minimum price, or "floor price", that must be paid by the Commonwealth for these items under the Pharmaceutical Benefits Scheme (PBS). The Act applies nationally across Australia, impacting pharmaceutical companies, suppliers, and entities involved in the distribution and sale of these designated pharmaceutical items. Notably, the determination does not specify exclusions, exemptions, or thresholds other than those related to the designated brands and effective dates outlined in the schedules. The application of this Act extends through subordinate instruments which may further specify the implementation details or additional amendments.

Key Provisions

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2024 amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. This amendment introduces a floor price for certain pharmaceutical brands, setting a minimum price that must be charged for specified pharmaceutical items. The amendment includes updates to the list of designated brands and their effective dates, with some changes taking effect on 1 February 2025 and others on 1 April 2025. The amendment aims to regulate the pricing of certain pharmaceutical brands to ensure affordability and accessibility of essential medications. The Act imposes specific obligations on entities such as pharmaceutical manufacturers, wholesalers, and retailers involved in the supply chain of the designated pharmaceutical brands. These entities must comply with the floor price set for the specified pharmaceutical items, ensuring that the minimum price is not undercut. Additionally, the Act requires these entities to maintain records and documentation that demonstrate compliance with the pricing provisions. The obligations extend to providing accurate and timely information to the relevant authorities to facilitate monitoring and enforcement of the floor price regulations. Violations of the pricing provisions set out in the Act may result in civil and criminal penalties. Entities found to be in breach of the floor price regulations may face fines and other financial penalties. In more serious cases, criminal charges may be pursued, potentially leading to imprisonment for individuals responsible for non-compliance. The maximum penalties for such offences are prescribed under the relevant sections of the National Health Act 1953, with the specific fines and imprisonment terms varying based on the nature and severity of the breach.

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Area of Law
Health Law
Instrument
Statutory Instrument
Concepts
Definitions & Interpretation
Commencement Provisions
Regulatory Standards
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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.