National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 2) (No. PB 17 of 2012)

Overview

The National Health Act 1953, as amended by the National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No.2), addresses the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This Act was enacted by the Parliament of Australia to provide a structured approach to the categorisation of drugs on the PBS, aiming to ensure efficient and equitable access to medications. The F1 formulary is designated for single brand drugs, while the F2 formulary is for drugs that have multiple brands or are in a therapeutic group with other multi-brand drugs. The policy objective is to streamline the provision of pharmaceuticals by ensuring appropriate pricing, disclosure, and supply guarantees. This legislative amendment, made under subsection 85AB(1) of the National Health Act, updates the National Health (Listed drugs on F1 or F2) Determination 2010 by adding rilpivirine and tadalafil to the F1 formulary and reassigning eight drugs to the F2 formulary, thus enhancing the management and accessibility of these medications under the PBS.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No.2) 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). Under the National Health Act 1953, the Minister has the authority to determine by legislative instrument the allocation of listed drugs to these formularies, which are intended for single brand drugs and drugs with multiple brands, respectively. The Amending Determination specifically adds two drugs, rilpivirine and tadalafil, to F1 and moves eight drugs from F1 to F2. This amendment applies to pharmaceutical companies with medicines listed on the PBS, and the decision-making process involves consultations with these companies and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which comprises experts from various relevant fields. The instrument commences on 1 April 2012 and constitutes a legislative instrument under the Legislative Instruments Act 2003.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No.2) (the Amending Determination) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding two drugs to F1 and moving eight drugs from F1 to F2. The amendment is made under subsection 85AB(1) of the National Health Act 1953 (the Act) and affects the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). F1 is designated for single brand drugs, while F2 is for drugs with multiple brands or those in a therapeutic group with other drugs with multiple brands. The Act imposes specific obligations on the Minister, who is responsible for determining the allocation of drugs to the F1 and F2 formularies. The criteria for a drug to be placed on F1 or F2 are detailed in subsections 85AB(4) and 85AB(3) of the Act. For F1, there must be no listed brands of pharmaceutical items that have the drug that are bioequivalent or biosimilar, and no listed brands of pharmaceutical items that have another drug in the same therapeutic group as the first drug that are bioequivalent or biosimilar. Additionally, the drug must not have been on F2 the day before the determination comes into effect. If a drug does not satisfy the criteria for F1, it may be placed on F2. The Amending Determination adds rilpivirine and tadalafil to F1 and moves anastrozole, atorvastatin, letrozole, mycophenolic acid, olanzapine, quetiapine, rosuvastatin and venlafaxine from F1 to F2. The Amending Determination also includes provisions for consultation with pharmaceutical companies, as drugs must be listed and allocated to formularies following detailed consultations. The Pharmaceutical Benefits Advisory Committee (PBAC) makes recommendations after receiving submissions from affected pharmaceutical companies. Two-thirds of the PBAC membership represents interests or professions such as consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. The instrument commences on 1 April 2012 and constitutes a legislative instrument for the purposes of the Legislative Instruments Act 2003. In terms of consequences, there are no explicit offences, penalties, or civil/criminal consequences stated in the Amending Determination itself. However, breaches of the provisions in the National Health Act 1953 could lead to enforcement actions by the relevant authorities, such as fines or other penalties as prescribed by the Act. The Pharmaceutical Benefits Scheme (PBS) is governed by the broader provisions of the National Health Act 1953, which include measures to ensure compliance and the protection of public health.