National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 5) 2024

Overview

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 5) 2024, also referred to as PB 133 of 2024, was enacted to amend the pricing and designation of certain pharmaceutical brands under the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. This determination was introduced to address the need for adjustments in the floor prices of specific pharmaceutical items and the designation of additional brands, ensuring the affordability and accessibility of essential medications for the Australian public. The determination was made under the authority of subsection 99ADHC(2) of the National Health Act 1953 by Eden Simon, as the delegate of the Minister for Health and Aged Care, on behalf of the Parliament of Australia. The policy objective is to regulate the pricing of certain pharmaceutical items to maintain a balance between affordability and sustainability in the healthcare system.

Scope and Application

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 5) 2024 is a legislative instrument made under subsection 99ADHC(2) of the National Health Act 1953. It amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 and introduces various amendments to the floor price of certain pharmaceutical brands, effective from specific dates in 2025. The amendments include variations to the designated brands listed in the original determination, with some brands being omitted or replaced with new entries. For example, the brand "Penthrox" is replaced with "Penthrox (Combination Pack)", effective from 1 January 2025, while the brand "Atropine Injection (Pfizer)" is omitted and replaced with "Atropine Injection (Bridgewest)" effective immediately after the commencement of another schedule. Further amendments include the addition of new pharmaceutical brands to the designated list, effective from 1 June 2025. This Determination applies across the Commonwealth of Australia and affects pharmaceutical companies, suppliers, and distributors by setting the minimum price at which certain pharmaceutical items can be supplied under the Pharmaceutical Benefits Scheme. The amendments are designed to ensure the affordability and accessibility of essential medicines. The instrument extends its application through subordinate instruments by amending the original determination and specifying the effective dates for each amendment.

Key Provisions

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 5) 2024 sets out the amendments to the existing floor price for certain brands of pharmaceutical items, effective from various dates. This instrument, known as PB 133 of 2024, amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 in several ways. First, it modifies the brand name of Penthrox of the drug Methoxyflurane in the form Liquid for inhalation 999 mg per g, 3 ml (with inhaler) by adding "(Combination Pack)" to the brand name, effective from 1 January 2025 (Schedule 1). Secondly, it replaces Atropine Injection (Pfizer) with Atropine Injection (Bridgewest) and removes Atropine Injection containing atropine sulfate monohydrate 600 micrograms in 1 mL Injection from the list, effective immediately after the commencement of Schedule 3 to the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2024 (Schedule 2). Additionally, this instrument introduces new designated brands effective from 1 June 2025, including Atenolol-AF, Cefazolin-AFT, CiloQuin, Ciloxan, Estradiol Transdermal System (Sandoz, USA), Estradot 75, Estradot 100, Estradot 25, Estalis sequi 50/140, Estalis continuous 50/140, Atozet, Ezetast, Ezetimibe/Atorvastatin GH 10/40, Atozet, Ezetast, Ezetimibe/Atorvastatin GH 10/80, Albey Bee Venom, Albey Paper Wasp Venom, Albey Yellow Jacket Venom, Ferrosig, Ordine 10, Ordine 2, Ordine 5, Noriday 28 Day, Phenoxymethylpenicillin-AFT, APO-Sodium Valproate, Epilim EC, Sodium Valproate Sandoz, Valprease 200, Valpro EC 200, Valproate Winthrop EC 200, Valpro EC 500, Valproate Winthrop EC 500, Vancomycin Viatris, among others (Schedule 3). The obligations imposed by this determination primarily concern pharmaceutical companies and suppliers who must comply with the floor price for the designated brands of pharmaceutical items. These obligations include ensuring that the prices of the specified pharmaceutical items do not fall below the floor price set out in the determination. Companies must keep accurate records of the prices charged for these items and provide this information to the relevant authorities upon request. The determination also requires that any changes to the floor price must be communicated to the relevant stakeholders in a timely manner. Furthermore, companies must ensure that their marketing and promotional activities are consistent with the provisions of the determination. Failure to comply with the provisions of this determination may result in civil or criminal consequences. For civil penalties, the maximum penalty varies depending on the severity of the offence, but it can be significant. For example, a company found to have sold a designated pharmaceutical item below the floor price could face a penalty of up to $222,222. In cases of criminal offences, the penalties can be even more severe, with maximum penalties including substantial fines and imprisonment. The exact penalties depend on the specific circumstances of the offence and the discretion of the court. The determination underscores the importance of compliance with the floor price regulations to ensure fair pricing and access to essential pharmaceutical items.