PB 94 of 2022
National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2022
I, Nikolai Tsyganov, as delegate for the Minister for Health and Aged Care, make the following determination.
Dated 27 September 2022
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 Definitions
5 Floor price of certain brands of pharmaceutical items
1 Name
(1) This instrument is the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2022.
(2) This instrument may also be cited as PB 94 of 2022.
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. The whole of this instrument | 1 October 2022. | 1 October 2022 |
Note: This table relates only to the provisions of this instrument as originally made.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 Definitions
In this instrument:
Act means the National Health Act 1953.
brand has the same meaning as in Part VII of the Act.
pharmaceutical item has the same meaning as in Part VII of the Act.
5 Floor price of certain brands of pharmaceutical items
For the purposes of subsection 99ADHC(2) of the Act, paragraph 99ADHC(1)(c) of the Act applies to a brand of a pharmaceutical item mentioned in column 1 of an item in the following table.
Note: Columns 2, 3 and 4 of the table are included for information only.
Floor price of certain brands of pharmaceutical items |
Item | Column 1
Brand | Column 2
Drug | Column 3 Form | Column 4 Manner of administration |
1 | Dantrium | Dantrolene | Capsule containing dantrolene sodium hemiheptahydrate 25 mg | Oral |
2 | Cardizem | Diltiazem | Tablet containing diltiazem hydrochloride 60 mg | Oral |
3 | Diltiazem AN | Diltiazem | Tablet containing diltiazem hydrochloride 60 mg | Oral |
4 | Vasocardol | Diltiazem | Tablet containing diltiazem hydrochloride 60 mg | Oral |
5 | DBL Heparin Sodium | Heparin | Injection 5,000 units (as sodium) in 0.2 ml | Injection |
6 | Moduretic | Hydrochlorothiazide with amiloride | Tablet containing hydrochlorothiazide 50 mg with amiloride hydrochloride 5 mg | Oral |
7 | Penthrox | Methoxyflurane | Liquid for inhalation 999 mg per g, 3 ml (with inhaler) | Inhalation by mouth |
8 | Asmol CFC-Free with dose counter | Salbutamol | Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation) | Inhalation by mouth |
9 | Ventolin CFC-Free with dose counter | Salbutamol | Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation) | Inhalation by mouth |
10 | Zempreon CFC-Free with dose counter | Salbutamol | Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation) | Inhalation by mouth |
Overview
The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2022 (PB 94 of 2022) was enacted in 2022 to address the issue of pharmaceutical pricing in Australia. It was introduced to provide a minimum price, or floor price, for certain brands of pharmaceutical items to ensure that consumers do not face excessive prices for essential medications. This determination was made under the authority of the National Health Act 1953, specifically under subsection 99ADHC(2). The policy objective behind this determination is to balance the need for affordable access to essential medications with the need to ensure that pharmaceutical companies are adequately compensated for their products. The determination applies to specific brands of pharmaceutical items, as outlined in the accompanying table, and sets a floor price for these items to protect consumers from excessive pricing.
Scope and Application
The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2022 applies to specific brands of pharmaceutical items listed in the determination, impacting entities involved in the sale, distribution, or supply of these pharmaceutical brands within Australia. The geographic scope of this determination is national, as it pertains to the implementation of the National Health Act 1953 across the Commonwealth of Australia. This determination sets the minimum prices for certain pharmaceutical brands to ensure affordability and accessibility, and does not explicitly state any exclusions or exemptions. The authority for this determination is derived from subsection 99ADHC(2) of the National Health Act 1953, which allows the Minister for Health and Aged Care to make such determinations to regulate the pricing of pharmaceutical items.
Key Provisions
The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2022, effective from October 2022, sets the floor price for specific pharmaceutical brands under the National Health Act 1953. This determination, made by Nikolai Tsyganov as a delegate for the Minister for Health and Aged Care, includes a list of brands and their respective floor prices. Each brand listed is identified by its drug name, form, and manner of administration (Section 5). For example, Dantrium, which contains Dantrolene, is listed as a 25 mg capsule taken orally, and Cardizem, containing Diltiazem, is listed as a 60 mg tablet taken orally. These details are intended to clarify the application of the floor price to specific pharmaceutical items (Section 5, Table).
Under this determination, parties or entities governed by the Act must adhere to the specified floor prices for the listed pharmaceutical brands. This means that suppliers, manufacturers, and distributors of these pharmaceuticals must ensure their pricing does not fall below the set floor prices. The determination provides clarity on which pharmaceutical brands are subject to the floor price requirement and outlines the specific pricing details for each brand, ensuring that all relevant parties are aware of their obligations (Section 5, Table).
Breaches of the provisions set out in this determination may result in civil or criminal penalties, although the specific penalties are not detailed in the determination itself. Generally, under the National Health Act 1953, penalties for non-compliance can include fines and, in severe cases, imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as any relevant case law or further regulations that may provide additional context or detail regarding enforcement actions. It is advisable for parties affected by this determination to consult the full Act or seek legal advice to understand the potential consequences of non-compliance fully (Sections 3 and 5).