National Health (Pharmaceutical Benefits Scheme- class of pharmaceutical items – Subsection 99ACA(3) Determination 2017

Overview

The National Health (Pharmaceutical Benefits Scheme - Class of Pharmaceutical Items - Subsection 99ACA(3) Determination) 2017 was enacted to address the need for a clear definition of pharmaceutical items that had already undergone a 12.5% administrative price reduction prior to the implementation of the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007. This legislative instrument was made under section 99ACA(3) of the National Health Act 1953 by the relevant authority, in this case, presumably the Federal Government, to ensure that pharmaceutical items which had already experienced the specified price reduction are not subjected to additional reductions. The policy objective behind this determination is to maintain consistency and fairness in the pricing of pharmaceutical items listed under the Pharmaceutical Benefits Scheme, preventing double reductions and ensuring that the administrative price reductions made before 1 August 2007 are accurately reflected in the statutory framework. This determination revokes and replaces the previous determination under subsection 99ACA(3) of the National Health Act 1953 (PB 59 of 2007).

Scope and Application

The National Health (Pharmaceutical Benefits Scheme - class of pharmaceutical items - Subsection 99ACA(3) Determination 2017 applies to pharmaceutical items listed under the Pharmaceutical Benefits Scheme (PBS) administered under the National Health Act 1953. This legislation specifically targets pharmaceutical items that were subject to a 12.5% administrative price reduction prior to the commencement of the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 on 1 August 2007. The purpose of this determination is to ensure that these items, which have already undergone a specified price reduction, do not incur further reductions as stipulated under section 99ACB of the Act. This legislative instrument is applicable nationwide, reflecting its status as a Commonwealth regulation. The scope of the Act is defined through its Schedule, which lists the specific classes of pharmaceutical items affected by the 12.5% reduction. This instrument revokes and replaces the previous determination (PB 59 of 2007) and comes into operation on the day of its registration on the Federal Register of Legislation.

Key Provisions

Section 99ACA(3) of the National Health Act 1953 mandates the determination of classes of pharmaceutical items that have been subject to a 12.5% administrative price reduction. This requirement ensures that these specific pharmaceutical items do not undergo additional price reductions as stipulated in section 99ACB. Section 99ACB(2) explicitly states that no further reductions are applicable to drugs that have already been part of the class identified as having experienced the 12.5% reduction. The current legislative instrument replaces the previous determination (PB 59 of 2007) and sets out the specific classes of pharmaceutical items that qualify for this reduction, detailing the drug and method of administration in Schedule 1. The Act imposes clear obligations on the parties involved, particularly those administering or involved in the pricing of pharmaceutical items under the Pharmaceutical Benefits Scheme. It mandates that any pharmaceutical item that falls within the determined classes must not be subject to an additional 12.5% price reduction. This requirement ensures consistency and fairness in the application of price reductions across the scheme. Pharmaceutical companies and suppliers must ensure that their pricing structures comply with these determinations, particularly in documenting and reporting the price reductions applied to their products. Failure to comply with the provisions of this legislation may result in legal consequences. While specific offences and penalties are not detailed in this instrument, breaches of the National Health Act can lead to civil or criminal penalties, depending on the nature and severity of the non-compliance. Penalties can include fines and other sanctions as determined by the relevant authorities. The maximum penalties would typically be in accordance with the broader provisions of the National Health Act, which could include significant fines for corporate entities and potential criminal charges for individuals responsible for the non-compliance.