National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 2) (No. PB 22 of 2014)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 2) amends the National Health (Listed drugs on F1 or F2) Determination 2010, and was introduced to address the need to update the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS) formularies. This instrument, enacted under the National Health Act 1953, specifies which listed drugs are assigned to either the F1 or F2 formulary, which are intended for single brand and multiple brand drugs, respectively. The amendment adds four new drugs to F1 and moves three drugs from F1 to F2, reflecting changes in therapeutic considerations and availability. The determination was made by the Minister for Health, with a view to ensuring the PBS remains effective and efficient in providing accessible medications to Australians. The determination follows consultations with stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee, which advises on the clinical and economic merits of listing drugs on the PBS.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 2) applies to pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS). The amendment determines that certain drugs are to be assigned to either Formulary 1 (F1) or Formulary 2 (F2) based on specific criteria set out in the National Health Act 1953. F1 is designated for drugs that have a single brand, while F2 is for drugs with multiple brands or that are part of a therapeutic group with other drugs that have multiple brands. This amendment adds four new drugs, namely clobetasol, dolutegravir, glycopyrronium, and panitumumab, to F1, and reassigns three existing drugs, acitretin, doxorubicin – peglyated liposomal, and metoclopramide, from F1 to F2. The geographic reach of this legislation is national, as it pertains to the PBS which is administered across Australia. The determination does not specify any exclusions or exemptions, but the allocation process involves consultation with the Pharmaceutical Benefits Advisory Committee, ensuring a balanced consideration of various interests and professions. The determination itself is a legislative instrument under the Legislative Instruments Act 2003 and came into effect on 1 April 2014.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 2) (the Amending Determination) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination) by adding four new drugs to the F1 formulary and moving three drugs from the F1 to the F2 formulary (subsection 85AB(5) of the National Health Act 1953). The F1 formulary is for single brand drugs, while the F2 formulary is for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands. The F2 formulary is subject to statutory price reductions, price disclosure and guarantee of supply provisions. The four new drugs added to the F1 formulary are clobetasol, dolutegravir, glycopyrronium and panitumumab. The three drugs moved from the F1 to the F2 formulary are acitretin, doxorubicin – peglyated liposomal and metoclopramide. The Act imposes several obligations on parties and entities it governs. Pharmaceutical companies must consult with the intended responsible person and provide a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) before drugs are listed and allocated to formularies. The PBAC recommendation is made following receipt of submissions by affected pharmaceutical companies, and two-thirds of the PBAC membership is from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. Additionally, the Minister is empowered to determine by legislative instrument that a listed drug is on F1 or F2, and for a drug to be on F1, it must satisfy the criteria in subsection 85AB(4) of the Act. A drug may only be determined to be on F2 if it does not satisfy one or more of the criteria for F1 (subsection 85AB(3)). Breaching the provisions of the Amending Determination may result in civil and criminal consequences. The maximum penalty for contravening a provision of the Act is 120 penalty units (approximately AUD 13,000 at the time of writing) for an individual and 600 penalty units (approximately AUD 65,000 at the time of writing) for a body corporate. In addition, subsection 85AB(5) of the Act provides that a drug is not placed on F1 or F2 if it has a single brand combination item on the Pharmaceutical Benefits Scheme (PBS). Any contravention of this provision may result in the drug being placed on the administrative combination drug list instead of the intended formulary.