National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 2) 2024

Administered by Department of Health, Disability and Ageing

Legislation au F2024N00358 Not in force Notifiable Instrument

Legislation content

 

PB 33 of 2024

 

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 2) 2024

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

Dated 23 April 2024   

Nikolai Tsyganov

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

Contents

1  Name...................................................1

2  Commencement............................................1

3  Authority................................................1

4  Schedules................................................1

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

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 2

Schedule 2—Amendments—Additional designated brands effective from 1 October 2024              3

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 3

 

 

1  Name

 (1) This instrument is the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 2) 2024.

 (2) This instrument may also be cited as PB 33 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

1 August 2024.

1 August 2024

3.  Schedule 2

1 October 2024.

1 October 2024

Note: This table relates only to the provisions of this instrument as originally made.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—Additional designated brands effective from 1 August 2024

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

1  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:

METOCLOPRAMIDE INJECTION BP

Metoclopramide

Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL

Injection

 


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

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

1  Section 5 (before 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:

GA gel

Amino acid formula with vitamins and minerals without lysine and low in tryptophan

Sachets containing oral powder 24 g, 30 (GA gel)

Oral

2  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:

Pulmicort Respules

Budesonide

Nebuliser suspension 500 micrograms in 2 mL single dose units, 30

Inhalation

Pulmicort Turbuhaler

Budesonide

Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses

Inhalation by Mouth

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:

Sandrena

Estradiol

Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28

Transdermal

4  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:

Fucidin

Fusidic acid

Tablet containing sodium fusidate 250 mg

Oral


5  Section 5 (after table item dealing with the brand Toujeo Solostar of the drug Insulin glargine in the form Injections (human analogue), cartridges, 300 units per mL, 1.5 mL, 5)

Insert:

Isoleucine 1000

Isoleucine with carbohydrate

Sachets of oral powder 4 g containing 1 g isoleucine, 30 (Isoleucine 1000)

Oral

Isoleucine 50

Isoleucine with carbohydrate

Sachets of oral powder 4 g containing 50 mg isoleucine, 30 (Isoleucine 50)

Oral

6  Section 5 (after table item dealing with the brand OsmoLax of the drug Macrogol 3350 in the form Powder for oral solution 510 g)

Insert:

Provera

Medroxyprogesterone

Tablet containing medroxyprogesterone acetate 100 mg

Oral

Provera

Medroxyprogesterone

Tablet containing medroxyprogesterone acetate 200 mg

Oral

7  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:

Depo-Nisolone

Methylprednisolone

Injection containing methylprednisolone acetate 40 mg in 1 mL

Injection

8  Section 5 (after table item dealing with the brand Stemetil of the drug Prochlorperazine in the form Injection containing prochlorperazine mesilate 12.5 mg in 1 mL)

Insert:

DBL Promethazine Hydrochloride

Promethazine

Injection containing promethazine hydrochloride 50 mg in 2 mL

Injection

9  Section 5 (after table item dealing with the brand Aptamil Gold+ Pepti-Junior of the drug Protein hydrolysate formula with medium chain triglycerides in the form Oral powder 450 g (Aptamil Gold+ Pepti-Junior))

Insert:

Teglutik

Riluzole

Oral suspension 50 mg per 10 mL, 300 mL

Oral


10  Section 5 (after table item dealing with the brand Micolette of the drug Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate in the form Enemas 3.125 g-450 mg-45 mg in 5 mL, 12)

Insert:

Pfizer Australia Pty Ltd

Tobramycin

Injection 80 mg (as sulfate) in 2 mL (without preservative)

Injection

 

Overview

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 2) 2024 was enacted to address the need for updating the list of designated pharmaceutical brands subject to a floor price under the National Health Act 1953. This instrument, made by Nikolai Tsyganov as delegate of the Minister for Health and Aged Care, introduces amendments to the existing determination to include additional pharmaceutical brands that will be subject to a floor price, effective from specific dates. The policy objective is to ensure that certain pharmaceutical items are priced at a minimum level to maintain affordability and accessibility for consumers under the Pharmaceutical Benefits Scheme. The instrument amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 by adding new brands to the list of designated pharmaceutical items, with some changes taking effect from 1 August 2024 and others from 1 October 2024. This amendment aims to address the evolving needs of the healthcare sector and to maintain fair pricing practices within the pharmaceutical market, ultimately benefiting both consumers and the broader healthcare system.

Scope and Application

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 2) 2024, made under subsection 99ADHC(2) of the National Health Act 1953, amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 to include additional designated brands of pharmaceutical items, effective from 1 August 2024 and 1 October 2024 respectively. This determination applies to specified pharmaceutical brands and their manufacturers, wholesalers, and suppliers, ensuring compliance with the floor pricing requirements for these pharmaceutical items across Australia. The amendments introduce new pharmaceutical brands into the scope of the existing determination, thereby extending the regulatory framework to cover these additional brands and their pricing stipulations. Any exclusions or exemptions from this determination are not specified within the text of the determination itself but would typically be outlined in the parent act or related instruments.

Key Provisions

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 2) 2024 amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 by introducing new designated brands of pharmaceutical items, effective from 1 August 2024 and 1 October 2024. These additional brands are listed in Schedule 1 and Schedule 2, respectively. The main objective of this Amendment Determination is to expand the list of pharmaceutical items subject to the floor price regulation, ensuring that certain pharmaceutical brands meet a minimum pricing threshold to protect public health and maintain affordability. The obligations imposed by this Amendment Determination are primarily on pharmaceutical companies and manufacturers. They must comply with the newly designated floor prices for the listed pharmaceutical brands, ensuring that their pricing adheres to the regulations set forth in the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. Failure to comply with these price regulations can result in significant consequences, including financial penalties and potential legal action. There are no explicit offences, penalties, or civil/criminal consequences outlined in the text of the Amendment Determination itself. However, it is implied that non-compliance with the designated floor prices could lead to enforcement actions under the National Health Act 1953. Penalties for breaches of the National Health Act could include substantial fines and, in severe cases, criminal prosecution. The specific penalties would be determined based on the severity and intent of the breach, as well as any relevant case law or precedents.

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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.