PB 21 of 2024
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2025
I, Rebecca Richrdson, as delegate of the Minister for Health and Aged Care, make the following Determination.
Dated 20 February 2025
Rebecca Richardson
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— Additional designated brands effective from 1 August 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. 1) 2025.
(2) This instrument may also be cited as PB 21 of 2025.
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. | |
3. Schedule 1 | 1 August 2025. | 1 August 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Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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— Additional designated brands effective from 1 August 2025
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023
1 Section 5 (after table item dealing with the brand Largactil of the drug Chlorpromazine in the form Tablet containing chlorpromazine hydrochloride 25 mg)
Insert:
Ciloxan | Ciprofloxacin | Ear drops 3 mg (as hydrochloride) per mL, 5 mL | Application to the Ear |
2 Section 5 (after table item dealing with the brand Depo-Nisolone of the drug Methylprednisolone in the form Injection containing methylprednisolone acetate 40 mg in 1 mL)
Insert:
Metoclopramide HCl Medsurge | Metoclopramide | Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL | Injection |
Overview
The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2025, made under subsection 99ADHC(2) of the National Health Act 1953, was introduced to address the need for a floor price on certain pharmaceutical items. This amendment, enacted by Rebecca Richardson, acting as the delegate of the Minister for Health and Aged Care, aims to ensure that the pricing of certain pharmaceutical brands is not set below a specified level, thereby maintaining affordability and accessibility for consumers. The determination will come into effect on 1 August 2025, amending the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 to include additional designated brands. The policy objective behind this amendment is to provide stability and predictability in the pricing of essential pharmaceutical items, which is crucial for the sustainability of the healthcare system and to protect public health.
Scope and Application
The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2025 applies to designated brands of pharmaceutical items listed in the Schedule, specifically Ciloxan, Ciprofloxacin Ear drops, and Metoclopramide HCl Medsurge, which are set to have a floor price effective from 1 August 2025. This determination is applicable to pharmaceutical manufacturers, wholesalers, and retailers involved in the supply of these specified pharmaceutical brands within Australia. The scope of the Act is to ensure a minimum price for certain pharmaceutical items to maintain affordability and accessibility for consumers. Geographically, the Act applies nationally across all states and territories of Australia, as it is made under the authority of the Commonwealth through the National Health Act 1953. The Act does not explicitly state any exclusions or exemptions, implying its broad application to the designated brands within the healthcare sector. Any further clarifications or extensions regarding the application of the Act may be provided through subordinate instruments made under the authority of the Minister for Health and Aged Care.
Key Provisions
The main operative sections of the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2025 (sections 1 to 4) establish the instrument's name, commencement, authority, and the schedule of amendments. This determination amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023, introducing additional designated pharmaceutical brands subject to a floor price from 1 August 2025. Specifically, the amendments are detailed in Schedule 1, which adds two new brands: Ciloxan, a ciprofloxacin ear drop, and Metoclopramide HCl Medsurge, a metoclopramide injection.
The Act imposes several obligations on parties and entities it governs. Firstly, it mandates the setting of a floor price for certain brands of pharmaceutical items listed in the amended determination. This requirement ensures that the cost of these items is not set below a specified minimum level, which aims to maintain affordability and access for consumers while providing reasonable remuneration to manufacturers. Secondly, pharmaceutical companies and suppliers must adhere to the new pricing rules for the specified brands, ensuring compliance with the mandated floor prices. This obligation is critical for maintaining the integrity of the pharmaceutical pricing framework established under the National Health Act 1953.
Breaches of the provisions outlined in this determination can lead to significant consequences. While specific penalties are not detailed in the text, breaches of similar provisions under the National Health Act 1953 can result in substantial fines and other legal repercussions. The maximum penalties for contravening health-related regulations can be significant, reflecting the importance of compliance with these pricing frameworks. Civil and criminal penalties may apply depending on the severity and intent behind the breach, with potential fines and imprisonment for serious or repeated violations. Ensuring strict adherence to the mandated floor prices is therefore crucial to avoid these severe consequences.