National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 10) (No. PB 85 of 2014)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 10), enacted under the National Health Act 1953, was introduced to address the allocation of listed drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This legislation is an amendment to the National Health (Listed drugs on F1 or F2) Determination 2010, which originally outlined the criteria for assigning drugs to these formularies. The purpose of the Act is to provide a framework for determining which drugs are placed on F1 (for single brand drugs) and F2 (for drugs with multiple brands or in therapeutic groups with other multi-brand drugs). The policy objective of the Amendment Determination is to ensure that drugs are appropriately allocated to the relevant formularies in accordance with the criteria specified in the Act, thereby facilitating the statutory price reductions, price disclosure, and guarantee of supply provisions for drugs on F2. The Amendment Determination adds two new drugs to F1 and is made by the Minister under the authority of the National Health Act, subject to consultation with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2014 (No. 10) amends the National Health (Listed Drugs on F1 or F2) Determination 2010, which allocates drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). F1 is designated for single brand drugs, whereas F2 accommodates drugs with multiple brands or those in a therapeutic group with other multi-brand drugs. This determination applies to pharmaceutical companies whose drugs are listed on the PBS, impacting their allocation to specific formularies. The amendment adds two new drugs to F1: amino acid formula without valine, leucine, and isoleucine, and perampanel. The determination operates under the authority of the National Health Act 1953, which mandates that a drug can only be placed on F1 if it meets specific criteria, including the absence of bioequivalent or biosimilar listed brands. Conversely, a drug can only be placed on F2 if it does not satisfy the criteria for F1. The Amending Determination commences on 1 November 2014 and constitutes a legislative instrument under the Legislative Instruments Act 2003.

Key Provisions

The primary operative sections of this legislation, specifically the National Health (Listed drugs on F1 or F2) Amendment Determination 2014, are sections 85AB(1), 85AB(3), 85AB(4), and 85AB(5) of the National Health Act 1953. These sections empower the Minister to determine by legislative instrument whether a listed drug is assigned to the F1 or F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Section 85AB(1) specifically provides the authority for such determinations, while subsections 85AB(3) and 85AB(4) detail the criteria for allocation to F1 and F2, respectively. Subsection 85AB(5) stipulates that a drug with a single brand combination item on the PBS is not placed on F1 or F2 but on the administrative combination drug list. The Act imposes several obligations and requirements on the parties and entities it governs. Pharmaceutical companies must engage in detailed consultations with the responsible person and the Pharmaceutical Benefits Advisory Committee (PBAC) before drugs are listed and allocated to formularies. PBAC, which comprises representatives from various interests including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists, provides recommendations based on submissions received from affected pharmaceutical companies. The Minister, in exercising the power to make determinations under section 85AB, must consider these recommendations and the broader public health implications of drug allocation. Offences, penalties, or civil/criminal consequences for breach of the provisions in this legislation are not explicitly stated in the provided text. However, the Act generally provides for the regulation of listed drugs and their allocation to the PBS formularies, and breaches of these provisions could potentially lead to legal actions under the National Health Act 1953 or other relevant legislation. Penalties for breaches may vary depending on the specific nature of the offence, but could include fines or other sanctions as prescribed by law. The Amending Determination itself does not specify maximum penalties for non-compliance but refers to the overarching legislative framework within which these penalties are determined. The Pharmaceutical Benefits Scheme operates under a comprehensive regulatory environment where compliance is critical to ensuring the equitable and effective distribution of pharmaceutical benefits to the Australian public. Failure to adhere to the requirements set out in the National Health Act 1953 and its subordinate legislation could result in legal consequences for the entities involved.