National Health (August 2021 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2021

Overview

The National Health (August 2021 First New Brand Statutory Price Reduction) (Exercise of Ministerial Discretion) Determination 2021, enacted under the National Health Act 1953, addresses the issue of setting the approved ex-manufacturer price for certain pharmaceutical brands starting from August 2021. This legislation was introduced to provide the Minister for Health and Aged Care with the authority to exercise discretion over the price reduction of specific pharmaceutical items, ensuring that prices are set in a manner that aligns with broader health policy objectives. The determination was made by Nikolai Tsyganov, Acting Assistant Secretary of the Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, on behalf of the Minister. The policy objective is to manage pharmaceutical pricing effectively, ensuring that the cost of these items is appropriate and sustainable within the national health framework.

Scope and Application

The National Health (August 2021 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2021 applies to specific brands of pharmaceutical items as outlined in the Act and is in effect from 1 August 2021. This determination pertains to the approved ex-manufacturer prices of certain pharmaceutical items, specifically those that are not subject to a price reduction as determined by the Acting Assistant Secretary under the authority vested in them by the Minister for Health and Aged Care. The legislation is made under subsections 99ACB(6A) and 99ACF(3AA) of the National Health Act 1953, which grants the Minister the discretion to exercise certain pricing controls over pharmaceutical items listed on the Pharmaceutical Benefits Scheme. This determination applies nationally, affecting all entities involved in the supply and administration of these pharmaceutical items within Australia. There are no exclusions or exemptions specified within the determination itself, although broader exclusions and exemptions may be found within the overarching Act. Any further application or interpretation of the Act may be detailed in subordinate instruments, which would provide additional clarity on the operation and scope of this determination.

Key Provisions

The main operative sections of this Determination establish that the approved ex-manufacturer price for certain pharmaceutical items will not be reduced on 1 August 2021 (subsections 99ACB(6A) and 99ACF(3AA)). Specifically, these provisions apply to the brands of pharmaceutical items specified in Schedule 1, where the reduction is set at zero percent for the brands listed in column 2 of items 1 and 2 (subsection 99ACB(5) and subsection 99ACF(2AB)). The instrument commences on 1 August 2021 (item 2) and is made under the authority of the National Health Act 1953 (item 4). The obligations and requirements imposed by this Determination are primarily concerned with the calculation and enforcement of the approved ex-manufacturer price for the specified pharmaceutical brands. Under the provisions outlined, the approved ex-manufacturer price for the listed brands will not undergo any reduction as of 1 August 2021. This means that the prices for Aciclovir Eye ointment 30 mg per g, 4.5 g, administered via application to the eye, will remain unchanged as determined by the Minister for Health and Aged Care. The determination also specifies the relevant brands and their forms and manners of administration, as detailed in Schedule 1. Any breach of this Determination could potentially lead to civil or criminal consequences, though specific penalties are not stated within the text. Under the National Health Act 1953, penalties for non-compliance with determinations regarding pharmaceutical pricing could include fines or other sanctions as prescribed by law. Given that this Determination exercises ministerial discretion, failure to adhere to its provisions could result in legal action against the entities involved, depending on the specific circumstances and the broader legislative framework governing pharmaceutical pricing and regulation in Australia.