PB 11 of 2024
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2024
I, Nikolai Tsyganov, as delegate of the Minister for Health and Aged Care, make the following Determination.
Dated 30/01/2024
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—Additional designated brands effective from 1 June 2024
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) 2024.
(2) This instrument may also be cited as PB 11 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 June 2024. | 1 June 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Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 June 2024
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023
1 Section 5 (after table item dealing with the brand Cal-500 of the drug Calcium in the form Tablet, chewable, 500 mg (as carbonate)
Insert:
Largactil | Chlorpromazine | Injection containing chlorpromazine hydrochloride 50 mg in 2 mL | Injection |
Largactil | Chlorpromazine | Oral solution containing chlorpromazine hydrochloride 25 mg per 5 mL, 100 mL | Oral |
Largactil | Chlorpromazine | Tablet containing chlorpromazine hydrochloride 100 mg | Oral |
Largactil | Chlorpromazine | Tablet containing chlorpromazine hydrochloride 25 mg | Oral |
2 Section 5 (after table item dealing with the brand Oxytrol of the drug Oxybutynin in the form Transdermal patches 36 mg, 8
Insert:
Neulactil | Periciazine | Tablet 10 mg | Oral |
Neulactil | Periciazine | Tablet 2.5 mg | Oral |
Overview
The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2024 (PB 11 of 2024) was enacted to amend the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. This amendment introduces additional designated brands for the purpose of establishing a floor price for certain pharmaceutical items under the National Health Act 1953. The determination is made by Nikolai Tsyganov, as delegate of the Minister for Health and Aged Care, and it aims to ensure that the floor prices for specific pharmaceutical brands are established and maintained to provide affordability and accessibility to essential medicines. The instrument commenced on the day after its registration, with specific provisions related to the designated brands effective from 1 June 2024.
Scope and Application
This National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2024 applies to certain pharmaceutical brands, specifically additional designated brands of Chlorpromazine and Periciazine, effective from 1 June 2024. It amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 to include these additional brands under the scope of the legislation. The amendment impacts entities involved in the manufacturing, distribution, and sale of these pharmaceutical products within Australia, ensuring compliance with the floor price provisions set out under the National Health Act 1953. The determination is made under the authority vested in Nikolai Tsyganov as a delegate of the Minister for Health and Aged Care, and it operates across the Commonwealth of Australia. No specific exclusions or exemptions are noted in the text, and the provisions of this determination apply to all relevant brands specified in the amended schedule. The application of this Act can be further extended or restricted through any future subordinate instruments issued under the authority of the National Health Act 1953.
Key Provisions
The main operative sections of the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2024 (referenced as PB 11 of 2024) concern the amendment of the original 2023 determination to include additional pharmaceutical brands under the designated floor price scheme. Specifically, Section 1 provides the name and citation of the instrument, while Section 2 outlines the commencement dates for various provisions. The key amendments are detailed in Schedule 1, which specifies additional brands that will be subject to the floor price from 1 June 2024. This includes brands such as Largactil Chlorpromazine and Neulactil Periciazine, which are now included under the floor price regulations for certain pharmaceutical items.
The obligations and requirements imposed by this Amendment Determination primarily revolve around ensuring that the additional designated brands comply with the floor price provisions set forth in the original 2023 Determination. Manufacturers, suppliers, and other entities involved in the distribution and sale of these pharmaceutical items must adhere to the specified floor prices. This means they cannot sell the designated brands below the set minimum price, which is intended to regulate pricing and ensure affordability and accessibility for consumers. Additionally, entities must update their pricing and marketing strategies to reflect these new requirements, ensuring compliance with the legislative amendments.
Failure to comply with the floor price regulations can result in various civil and criminal consequences. Under the National Health Act 1953, non-compliance may lead to fines or other penalties. The exact penalties are not specified in the Amendment Determination but typically align with the penalties outlined in the principal Act, which can include significant financial penalties. In severe cases, non-compliance may also result in criminal charges, leading to prosecution and potential imprisonment. It is imperative for all parties governed by this legislation to understand and adhere to the stipulated requirements to avoid these consequences.