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

Overview

The National Health (June 2025 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2025, or PB 65 of 2025, was introduced to address the need for statutory price reductions for specific pharmaceutical brands in alignment with the National Health Act 1953. This determination was enacted by Rebecca Richardson, an Assistant Secretary from the Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, Disability and Ageing, on behalf of the Minister for Health and Ageing. The primary policy objective of this determination is to ensure that the agreed price of newly introduced pharmaceutical brands is aligned with the approved ex-manufacturer price of existing brands on the day before the determination took effect. This legislative instrument commenced on 1 June 2025 and is intended to provide clarity and consistency in the pricing of pharmaceutical items covered under the Act.

Scope and Application

The National Health (June 2025 First New Brand Statutory Price Reduction) (Exercise of Ministerial Discretion) Determination 2025 applies to the agreed prices of specified pharmaceutical brands. This determination is applicable under the National Health Act 1953 and is specifically targeted at the agreed prices of particular pharmaceutical items listed in Schedule 1 of the determination. This determination applies to the Commonwealth of Australia and is intended to regulate and adjust the prices of certain pharmaceutical brands effective from 1 June 2025. The Act mandates that the agreed price of certain new pharmaceutical brands be set equal to the approved ex-manufacturer price of existing brands as of the day before the determination day. The legislation does not explicitly state any exclusions or exemptions, but the specific brands outlined in Schedule 1 are the focus of this regulatory intervention. The scope of this determination is limited to the brands and items listed in the schedule and is intended to ensure pricing consistency and fairness within the pharmaceutical market.

Key Provisions

The National Health (June 2025 First New Brand Statutory Price Reduction) (Exercise of Ministerial Discretion) Determination 2025, under sections 1 to 5, establishes that certain brands of pharmaceutical items will not undergo a statutory price reduction. Specifically, Section 5 outlines that the agreed price of the specified brands of pharmaceutical items will be set to the approved ex-manufacturer price, as it stood the day before the determination day. The brands listed include Dienogest, a 2 mg oral tablet known as Dinasane, and various formulations of Oxycodone with naloxone, available in controlled release tablets with different dosages. This legislation imposes clear obligations on the entities involved. The primary obligation is the setting of the agreed prices of specified pharmaceutical brands as per the determination, ensuring that these prices are aligned with the approved ex-manufacturer prices from the previous day. This requirement is explicitly stated under sections 4 and 5, which mandate that no statutory price reduction will apply to these brands. In terms of consequences for breach, the Determination itself does not explicitly detail offences, penalties, or consequences for non-compliance. However, given the nature of the National Health Act 1953 and the authority under which this Determination is made, any failure to adhere to the stipulated price settings could potentially lead to regulatory scrutiny or enforcement actions under the broader provisions of the Act. The penalties for non-compliance with the National Health Act 1953 could include fines, legal action, or other administrative measures as deemed appropriate by the relevant authorities.