National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 7) (No. PB 66 of 2014)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 7) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which concerns the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Enacted by the Australian Parliament, the National Health Act 1953 established the framework for the PBS, including the criteria for assigning drugs to specific formularies. The 2014 Amendment Determination specifically addresses the allocation of drugs within the PBS, aiming to ensure appropriate distribution and pricing of pharmaceutical items. This determination moves the drug epoprostenol from the F1 formulary, intended for single brand drugs, to the F2 formulary, which includes drugs with multiple brands or those in therapeutic groups with multiple brands. The policy objective is to facilitate efficient pharmaceutical management and access to listed drugs under the PBS.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 applies to the regulation and allocation of listed drugs within the Pharmaceutical Benefits Scheme (PBS) as outlined in the National Health Act 1953. This Act specifically governs the assignment of drugs to formularies F1 and F2, where F1 is designated for single brand drugs and F2 for drugs with multiple brands or those in therapeutic groups with multiple brands. This determination affects pharmaceutical companies that have their medicines listed on the PBS, and it is subject to consultation with the Pharmaceutical Benefits Advisory Committee, which includes representatives from various healthcare-related interests and professions. The geographic reach of this legislation is national, as it pertains to the Commonwealth of Australia and its PBS. The Amending Determination, which is a legislative instrument under the Legislative Instruments Act 2003, comes into effect on the day after its registration and amends the National Health (Listed drugs on F1 or F2) Determination 2010 by moving the drug epoprostenol from F1 to F2. This adjustment is made under the authority granted by subsection 85AB(1) of the National Health Act 1953, which empowers the Minister to determine by legislative instrument the placement of listed drugs on F1 or F2, subject to specific criteria.

Key Provisions

The main operative sections of this Amendment Determination are sections 85AB(1) and 85AB(5) of the National Health Act 1953 (the Act). These sections empower the Minister to determine by legislative instrument whether a listed drug is on the F1 or F2 formularies of the Pharmaceutical Benefits Scheme (PBS) (section 85AB(1)). For a drug to be on F1, it must meet specific criteria (subsection 85AB(4)), and if it does not, it may be placed on F2 (subsection 85AB(3)). However, if a drug has a single brand combination item on the PBS, it is placed on the administrative combination drug list rather than F1 or F2 (subsection 85AB(5)). This Amendment Determination specifically moves the drug epoprostenol from F1 to F2 (subsection 85AB(1)). The obligations and requirements imposed by the Act on the parties and entities it governs are primarily concerned with the allocation of drugs to the appropriate formularies. Pharmaceutical companies must engage in detailed consultations with the intended responsible person and submit recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) before drugs can be listed and allocated to the PBS formularies. The PBAC, which includes representatives from various health-related interests and professions, evaluates the submissions and makes recommendations based on therapeutic efficacy, safety, cost-effectiveness, and other relevant factors. The Act also requires that drugs on F2 are subject to statutory price reductions, price disclosure, and guarantee of supply provisions. Under the Act, there are specific offences, penalties, or civil/criminal consequences for breaches of its provisions. While the Act itself does not explicitly outline these consequences, breaches of the National Health Act 1953 or any related regulations may lead to administrative penalties, fines, or legal action. For example, non-compliance with pricing or supply requirements may result in financial penalties or legal proceedings. Additionally, the Act may provide for civil or criminal sanctions, including imprisonment, fines, or both, depending on the nature and severity of the breach. The maximum penalties for breaches of the National Health Act 1953 or related regulations are not explicitly stated in the Explanatory Statement for this Amendment Determination. However, the Act may impose various penalties, including fines and imprisonment, depending on the specific provisions being breached and the severity of the violation. The precise penalties would be determined by the courts when considering the specific circumstances of each case. It is important to note that any penalties or sanctions would be consistent with the broader legislative framework governing the National Health Act 1953 and related regulations.