National Health (August 2025 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2025

Overview

The National Health (August 2025 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2025 (PB 83 of 2025) was enacted to address the statutory price reduction for certain brands of pharmaceutical items as part of the broader objectives of the National Health Act 1953. This determination, made under subsection 99ACD(7A) of the National Health Act, aims to ensure that the agreed price of specified pharmaceutical brands is aligned with the approved ex-manufacturer price on the day before the determination day. This measure is intended to provide cost-effective access to essential medications while maintaining the integrity of pricing mechanisms within the health sector. Enacted by the Department of Health, Disability and Ageing, the policy objective of this determination is to regulate and manage the pricing of certain pharmaceutical items to benefit consumers and the health system without compromising on the quality or availability of medications.

Scope and Application

The National Health (August 2025 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2025 applies to specific brands of pharmaceutical items listed in the Schedule of the instrument, with the aim of setting their agreed prices to the approved ex-manufacturer price as of the day before the determination date. This determination is made under the authority of the National Health Act 1953 and is applicable nationwide across Australia. It specifically targets the prices of certain pharmaceutical brands of drospirenone with ethinylestradiol, categorising them based on their drug form and manner of administration. The instrument does not cover any other pharmaceutical items or brands not listed in the Schedule, thereby excluding them from the price reduction provisions. The scope of this determination is limited to the brands specified and does not extend to any other pharmaceutical items or brands unless explicitly included through future amendments or subordinate instruments.

Key Provisions

The main operative sections of the National Health (August 2025 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2025 (section 1) establish that the agreed price of certain specified pharmaceutical brands will be set at the approved ex-manufacturer price of the existing brand on the day before the determination day. This is outlined in section 5, which identifies the specific brands of drospirenone with ethinylestradiol that will not undergo a price reduction. These brands include Bella, Rosie, YANA, Isabelle, Rosalee, and Yelena, all of which are administered orally. The instrument is titled PB 83 of 2025 and comes into effect on 1 August 2025, as stated in sections 1 and 2. The authority for this determination is provided under subsection 99ACD(7A) of the National Health Act 1953, as noted in section 3. The obligations imposed by this Determination include setting the prices of specific pharmaceutical brands to align with the approved ex-manufacturer price of the existing brands. This applies to the brands Bella, Rosie, YANA, Isabelle, Rosalee, and Yelena, ensuring that the prices do not undergo a statutory reduction as specified in section 5. The Department of Health, Disability and Ageing, through Rebecca Richardson, Assistant Secretary, Pricing and PBS Policy Branch, is responsible for implementing this Determination. The provisions ensure that these particular pharmaceutical brands will not see a price reduction from the specified date. Failure to comply with the provisions of this Determination could lead to various consequences. Under the National Health Act 1953, breaches of the provisions could result in civil or criminal penalties. However, the specific penalties are not detailed within this Determination. The National Health Act 1953, from which this Determination derives its authority, typically outlines a range of penalties for non-compliance, which may include fines or imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as any additional legislative provisions that may apply.