National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 8) (PB 79 of 2017)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 8), enacted in 2017, amends the National Health (Listed drugs on F1 or F2) Determination 2010 to update the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS). The National Health Act 1953, administered by the Australian Parliament, provides for the classification of listed drugs into F1 or F2 formularies, with F1 designated for single brand drugs and F2 for drugs with multiple brands or those within a therapeutic group containing multiple brands. This amendment aims to rectify the allocation of specific drugs and correct certain spelling errors, ensuring consistency and accuracy within the PBS. The determination process involves detailed consultations with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, reflecting a balanced approach involving multiple healthcare interests.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adjusting the allocation of specific drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This Act applies to the regulation of drugs listed under the PBS, which impacts pharmaceutical companies, healthcare providers, and consumers within Australia. The amendments include adding two new drugs to F1, moving two drugs from F1 to F2, and removing three drugs from F1. Additionally, two new drugs are added to F2, and one drug is removed from F2. This determination operates nationally and is subject to the criteria and conditions set out in the National Health Act 1953, with the Minister (or delegate) empowered to make these determinations through legislative instruments. The changes made by this Instrument commence on 1 October 2017 and constitute a legislative instrument under the Legislation Act 2003.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010. This instrument assigns drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS), as provided for by the National Health Act 1953 (the Act). The F1 formulary is for drugs with a single brand, while the F2 formulary is for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands. Drugs on F2 are subject to provisions relating to first new brand statutory price reductions, price disclosure, and guarantee of supply. The Act allows for drugs to be assigned to F1 or F2 if there is a determination in force under section 85AB (section 84AC). The Minister (or delegate) can determine by legislative instrument that a listed drug is on F1 or F2 (subsection 85AB(1)). A drug can only be on F1 if there are 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 (subsection 85AB(4)). The drug must also not have been on F2 the day before the determination comes into effect. A drug can only be on F2 if it does not satisfy one or more of the criteria for F1 (subsection 85AB(3)). Listed drugs with a single brand combination item on the PBS are not placed on F1 or F2, but on the administrative combination drug list (subsection 85AB(5)). The Amending Determination adds two new drugs to F1, moves two currently listed drugs from F1 to F2, removes three drugs from F1, corrects the spelling of one drug, adds two drugs to F2, and removes one drug from F2. The Amending Determination is based on the criteria in the Act and relies on subsection 33(3) of the Acts Interpretation Act 1901 to revoke or vary the Principal Determination, unless there is an express power to do so. The Amending Determination affects pharmaceutical companies with medicines listed on the PBS, and consultation with affected parties has already taken place. The Amending Determination commences on 1 October 2017 and constitutes a legislative instrument for the purpose of the Legislation Act 2003. The Amending Determination imposes obligations and requirements on pharmaceutical companies with medicines listed on the PBS. The determination assigns drugs to the F1 or F2 formularies based on the criteria in the Act, and requires pharmaceutical companies to comply with the provisions relating to first new brand statutory price reductions, price disclosure, and guarantee of supply for drugs on F2. The Amending Determination also requires pharmaceutical companies to provide information and data to the Minister (or delegate) to support the allocation of drugs to the formularies. The Amending Determination is based on the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), which receives submissions from affected pharmaceutical companies. The PBAC consists of two-thirds members from interests or professions such as consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. The Amending Determination imposes civil and criminal consequences for breach of the provisions in the Act or the determination. The Act provides for penalties for breaches of the provisions relating to price disclosure and guarantee of supply for drugs on F2. The maximum penalty for an individual is $22,200, and for a body corporate is $111,000. The Act also provides for offences and penalties for breaches of the provisions relating to the listing of drugs on the PBS. The maximum penalty for an individual is $22,200, and for a body corporate is $111,000. The Act provides for criminal prosecution for offences that involve intentional or reckless conduct. The determination itself does not impose penalties or consequences for breach, but rather provides for the allocation of drugs to the formularies based on the criteria in the Act. Any breach of the provisions in the Act or the determination may result in enforcement action by the Minister (or delegate) or legal action by affected parties.