National Health (April 2019 Anniversary statutory price reduction) (Exercise of Ministerial discretion) Determination 2019

Overview

The National Health (April 2019 Anniversary statutory price reduction) (Exercise of Ministerial discretion) Determination 2019 was enacted in 2019 under the National Health Act 1953. This legislation was introduced to address the issue of statutory price reductions for certain pharmaceutical items on the Pharmaceutical Benefits Scheme (PBS). The determination was made by Thea Daniel, the Assistant Secretary of the Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, as a delegate of the Minister for Health. The policy objective of this determination is to exercise ministerial discretion in relation to the price reductions for specific pharmaceutical items on the PBS, ensuring that particular brands are not subjected to these reductions. This determination came into effect on the day it was made, 27 March 2019. The purpose of this determination is to specify certain brands of pharmaceutical items that will not be subject to a statutory price reduction as outlined in the National Health Act 1953. The Schedule 1 of this determination lists the pharmaceutical items and their respective brands that will not be affected by the price reductions. This legislation provides clarity and direction for the implementation of the statutory price reduction policy while ensuring that specific pharmaceutical items remain exempt from these reductions.

Scope and Application

The National Health (April 2019 Anniversary statutory price reduction) (Exercise of Ministerial discretion) Determination 2019 applies to the approved ex-manufacturer prices of specific pharmaceutical items, which are outlined in the Schedule 1 of the Determination. This instrument was made under the National Health Act 1953 and specifies certain pharmaceutical brands whose prices are not subject to reduction in accordance with particular provisions of the Act. The Determination operates at the Commonwealth level and affects the pharmaceutical industry, particularly those manufacturers and suppliers of the listed pharmaceutical items. By specifying which pharmaceutical brands are exempt from the price reduction, the Determination directly influences pricing strategies and market dynamics within the pharmaceutical sector. The Determination does not explicitly state any exclusions or thresholds other than those specified in the Schedule 1. However, the application of the Determination can be extended or further defined through subordinate instruments made under the authority of the National Health Act 1953.

Key Provisions

The main operative sections of the National Health (April 2019 Anniversary statutory price reduction) (Exercise of Ministerial discretion) Determination 2019 specify that certain pharmaceutical items will not be subject to a price reduction on the price reduction day. Under section 5 of the Determination, the approved ex-manufacturer price of each brand of pharmaceutical item listed in Schedule 1 is not reduced under the relevant provisions of the National Health Act 1953. This decision is made by the Assistant Secretary under the authority provided by subsection 99ACF(3) of the Act. The listed pharmaceutical items include various forms of Deferiprone, Glycomacropeptide, and other related products. These items are identified by their brand names, drug forms, and manners of administration. The obligations and requirements imposed by this Determination on the parties or entities it governs primarily relate to the pricing of specified pharmaceutical items. Manufacturers and suppliers of the listed pharmaceutical items must adhere to the decision that the approved ex-manufacturer price of these items will not be reduced as per the National Health Act 1953 provisions. This means that these items will retain their existing prices on the price reduction day, despite any statutory requirements for price reductions that might apply to other pharmaceutical items. Compliance with this Determination ensures that the pricing of these specific items remains unchanged, aligning with the Ministerial discretion exercised under the Act. Breach of the provisions set out in the Determination could lead to civil or criminal consequences, although specific offences, penalties, or consequences are not detailed in the Determination itself. Generally, under the National Health Act 1953, non-compliance with statutory requirements can result in penalties, which can vary depending on the nature and severity of the breach. For civil penalties, the Act may impose fines, while criminal penalties could include imprisonment, reflecting the seriousness of the non-compliance. The exact penalties would be determined by the courts based on the specific circumstances of any breach.