National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 2) (PB 15 of 2015)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 2) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010 under subsection 85AB(1) of the National Health Act 1953. This amendment was introduced to address the need to update the formulary allocation of certain listed drugs on the Pharmaceutical Benefits Scheme (PBS). The Act aims to provide a clear framework for the allocation of drugs to F1 and F2 formularies, with F1 intended for single brand drugs and F2 for drugs with multiple brands or those in therapeutic groups with multiple brands. The policy objective of this determination is to ensure that drugs are appropriately categorised to facilitate statutory price reductions, price disclosure, and guarantee of supply. This legislative instrument was developed following extensive consultation with pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring a balanced approach that considers the interests of consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. The Amending Determination adds three new listed drugs—coal tar, peginterferon beta-1a, and phytomenadione—to F1 and is effective from 1 March 2015.

Scope and Application

The National Health Act 1953 provides the framework for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 2) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding three new listed drugs: coal tar, peginterferon beta-1a, and phytomenadione to F1. This Amendment Determination applies to pharmaceutical companies with medicines listed on the PBS and affects the allocation of drugs to the F1 formulary. The criteria for F1 placement require that there are no listed brands of pharmaceutical items that are bioequivalent or biosimilar to the drug, and the drug was not on F2 the day before the determination comes into effect. The Amending Determination commences on 1 March 2015 and is subject to consultation with pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, which comprises representatives from various interests and professions, provides recommendations on the allocation of drugs to the PBS formularies.

Key Provisions

The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 2) are primarily concerned with amending the existing National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination). Section 2 of the Amending Determination amends the Principal Determination by adding three new drugs: coal tar, peginterferon beta-1a, and phytomenadione to the F1 formulary. This means that these drugs will now be available under the Pharmaceutical Benefits Scheme (PBS) as single brand drugs, subject to the criteria and provisions outlined in the National Health Act 1953. The obligations and requirements imposed by this Act on the parties or entities it governs are primarily focused on the Pharmaceutical Benefits Advisory Committee (PBAC) and pharmaceutical companies. The PBAC must consider submissions from affected pharmaceutical companies and make recommendations on the listing and allocation of drugs to the appropriate formularies. Pharmaceutical companies, in turn, are required to provide detailed information and data about the drugs they wish to have listed on the PBS. The Act ensures that the allocation of drugs to the F1 and F2 formularies is based on objective criteria, such as the number of bioequivalent or biosimilar brands and the therapeutic group of the drug. The National Health Act 1953 imposes several potential penalties and consequences for non-compliance with its provisions. Section 85AB of the Act outlines the criteria for determining whether a drug should be placed on the F1 or F2 formulary, and failure to comply with these criteria could result in the drug not being eligible for listing on the PBS. Furthermore, section 85AB(5) states that listed drugs with a single brand combination item on the PBS are not placed on F1 or F2, but on the administrative combination drug list. This means that pharmaceutical companies may face difficulties in having their drugs listed on the PBS if they do not meet the required criteria. Additionally, the Act may also provide for civil or criminal penalties for more serious breaches, such as providing false or misleading information during the consultation process or engaging in fraudulent activities related to the listing of drugs on the PBS. However, the specific penalties for these breaches are not mentioned in the provided text.