PB 65 of 2024
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 3) 2024
I, Nikolai Tsyganov, as delegate of the Minister for Health and Aged Care, make the following Determination.
Dated 4 June 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 December 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. 3) 2024.
(2) This instrument may also be cited as PB 65 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. | 18 July 2024 |
2. Schedule 1 | The day after this instrument is registered. | 18 July 2024 |
3. Schedule 2 | 1 December 2024. | 1 December 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Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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—General
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023
1 Section 5 (table)
Omit:
K.Quik | Triglycerides, medium chain | Oral liquid 225 mL, 15 (K.Quik) | Oral |
Schedule 2—Amendments—Additional designated brands effective from 1 December 2024
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023
1 Section 5 (after table item dealing with the brand Flagyl of the drug Metronidazole in the form Suppositories 500 mg, 10)
Insert:
MS-2 Step | Mifepristone and misoprostol | Pack containing 1 tablet mifepristone 200 mg and 4 tablets misoprostol 200 micrograms | Oral |
2 Section 5 (after table item dealing with the brand Teglutik of the drug Riluzole in the form Oral suspension 50 mg per 10 mL, 300 mL)
Insert:
Salbutamol Cipla | Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 ml single dose units, 30 | Inhalation |
Salbutamol Cipla | Salbutamol | Nebuliser solution 5 mg (as sulfate) in 2.5 ml single dose units, 30 | Inhalation |
3 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:
Valine 1000 | Valine with carbohydrate | Sachets of oral powder 4 g containing 1 g valine, 30 (Valine 1000) | Oral |
Valine 50 | Valine with carbohydrate | Sachets of oral powder 4 g containing 50 mg valine, 30 (Valine 50) | Oral |
Overview
The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 3) 2024 (PB 65 of 2024) was enacted to amend the pricing of certain pharmaceutical items listed under the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. This determination was made under subsection 99ADHC(2) of the National Health Act 1953 by Nikolai Tsyganov, as delegate of the Minister for Health and Aged Care. The primary objective of this determination is to adjust the floor price for specific pharmaceutical brands, ensuring more accurate and competitive pricing within the Pharmaceutical Benefits Scheme (PBS). Certain amendments to the list of designated brands will come into effect on 18 July 2024, with additional brands being added effective from 1 December 2024. This legislative amendment aims to address issues related to the affordability and accessibility of essential medications by ensuring that the prices of certain pharmaceutical items are regulated in a manner that benefits both consumers and the broader healthcare system.
Scope and Application
This determination, referred to as the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 3) 2024, is made under the authority of the National Health Act 1953. The Act applies to the setting of a minimum price for certain pharmaceutical items in Australia, with the amendments taking effect on specified dates. The primary objective is to regulate the pricing of particular pharmaceutical brands, ensuring affordability and access to essential medications. The amendments outlined in Schedule 1, which come into effect on 18 July 2024, involve the removal of certain brands from the list of designated pharmaceutical items subject to the floor price. Conversely, Schedule 2 introduces additional brands to the list, effective from 1 December 2024. These changes are integral to maintaining the balance between pharmaceutical pricing and accessibility in the Australian healthcare system. The amendments do not extend beyond the specified brands and dates, and no broader exclusions or exemptions are outlined in the determination.
Key Provisions
The main operative sections of the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 3) 2024 (F2024N00644) are primarily found in the Schedules, where amendments to the 2023 Determination are detailed. Specifically, Schedule 1 includes general amendments to the original determination, while Schedule 2 lists additional designated brands effective from 1 December 2024. Section 1 provides the name and citation of the instrument, and Section 2 outlines the commencement dates for the various provisions. The instrument commences on 18 July 2024, except for the amendments in Schedule 2, which take effect on 1 December 2024. The instrument is made under subsection 99ADHC(2) of the National Health Act 1953, empowering the Minister for Health and Aged Care to set a floor price for certain brands of pharmaceutical items.
This Act imposes obligations on pharmaceutical companies and suppliers to adhere to the floor prices set forth in the amended determinations. The amendments specify certain pharmaceutical brands subject to these floor prices and outline the applicable dates for these price regulations. Companies must ensure compliance with these newly designated floor prices for the listed pharmaceutical brands, failing which they may face legal repercussions. The Act also requires that all relevant stakeholders are notified of these changes, ensuring transparency and compliance across the industry.
Breaches of the obligations imposed by this Act can result in significant penalties. While the exact penalties are not detailed in the provided text, breaches of the National Health Act 1953 typically attract substantial fines. The penalties for non-compliance can be both civil and criminal, depending on the severity and intent of the breach. Companies found in violation of the floor price regulations may face fines that can amount to thousands of dollars, in addition to potential legal action. It is crucial for pharmaceutical entities to adhere strictly to the requirements set forth to avoid these consequences.