National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 5) (No. PB 47 of 2014)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 5), enacted in 2014, amends the National Health (Listed drugs on F1 or F2) Determination 2010, which governs the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This legislation was introduced to address the need for a dynamic and responsive framework for the allocation of drugs within the PBS, ensuring that drugs are appropriately categorised to meet the diverse therapeutic needs of the population. The National Health Act 1953, administered by the Parliament of Australia, aims to provide a comprehensive and efficient health system for the Australian population. The policy objective behind the Amending Determination is to ensure that drugs are correctly placed in the appropriate formulary, taking into account bioequivalence and biosimilarity, as well as the therapeutic grouping of drugs. The Amending Determination involves extensive consultation with stakeholders, including pharmaceutical companies, and recommendations from the Pharmaceutical Benefits Advisory Committee, reflecting a commitment to evidence-based decision-making.

Scope and Application

The National Health Act 1953, specifically through the National Health (Listed drugs on F1 or F2) Amendment Determination 2014, applies to the classification of listed drugs within the Pharmaceutical Benefits Scheme (PBS), affecting pharmaceutical companies with drugs listed on the PBS. The Act pertains to the allocation of drugs to the F1 and F2 formularies of the PBS, with F1 intended for single brand drugs and F2 for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands. The Act allows the Minister to determine by legislative instrument whether a listed drug is on F1 or F2, based on specific criteria such as the presence of bioequivalent or biosimilar drugs. The Amendment Determination modifies the Principal Determination by removing a specific drug from F1 and adding another to F2, reflecting changes in drug formulations and therapeutic groupings. The instrument also includes provisions for the revocation or variation of the Principal Determination where necessary, relying on the Acts Interpretation Act 1901 unless otherwise specified. The process involves extensive consultation with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, ensuring a balanced consideration of consumer, economic, and clinical perspectives.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 5) primarily amends the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS) by moving certain drugs between formularies F1, F2, and the administrative combination drug list (subsection 85AB(5)). Specifically, the determination removes the drug carbomer with triglyceride lipids from F1 and places it on the administrative combination drug list, and adds the drug telmisartan with amlodipine to F2, removing it from the administrative combination drug list (subsection 85AB(1)). These changes are grounded in the criteria outlined in the National Health Act 1953 (the Act), which require that certain conditions are met for a drug to be classified under F1 or F2. The Act imposes obligations on parties and entities involved with the PBS to ensure compliance with the determinations regarding drug allocations. Pharmaceutical companies, for instance, must adhere to the criteria set forth in the Act for drug classification, and ensure their products are correctly listed in the appropriate formulary. The Minister for Health has the authority to make these determinations, relying on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which comprises members from various healthcare-related professions and consumer representatives. This committee plays a crucial role in advising on the suitability of drug classifications based on therapeutic needs and market conditions. Failure to comply with the provisions of the National Health Act 1953 and the accompanying determinations may result in legal consequences. While the explanatory statement does not detail specific offences or penalties within the Amendment Determination itself, the Act generally outlines potential civil or criminal penalties for non-compliance with PBS regulations. For example, under section 112 of the Act, a person who contravenes the Act may be liable for penalties, which could include fines or imprisonment, depending on the severity of the breach. The maximum penalties are not specified within the explanatory statement but would typically be detailed in the relevant sections of the Act. Consultation is a critical part of the process outlined in the Act and the Amendment Determination. Pharmaceutical companies must engage in detailed consultations with the relevant authorities before drugs are allocated to the PBS formularies. This ensures that all stakeholders are informed and have an opportunity to provide input, aligning with the transparent and inclusive approach mandated by the Act. The determination also relies on subsection 33(3) of the Acts Interpretation Act 1901 for its revocation or variation, ensuring that changes to drug allocations are legally sound and properly authorised.