EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 12)
PB 105 of 2014
Authority
The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 12) (this Instrument), made under subsection 85AB(1) of the National Health Act 1953 (the Act), amends the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) (the Principal Determination).
The Principal Determination provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS).
Purpose
The Act provides that listed drugs may be assigned to formularies identified as F1 and F2.
F1 is 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. Drugs on F2 are subject to the provisions of the Act relating to statutory price reductions, price disclosure and guarantee of supply.
Section 84AC of the Act provides that a drug is on F1 or F2 if there is a determination in force under section 85AB that the drug is on F1 or F2.
Subsection 85AB(1) of the Act empowers the Minister to determine by legislative instrument that a listed drug is on F1 or F2. For a drug to be on F1, it must satisfy the criteria in subsection 85AB(4). This requires that 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. It also requires that the drug was not on F2 the day before the determination comes into effect. 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)).
When subsection 85AB(5) of the Act applies, which relates to listed drugs with a single brand combination item on the PBS, the listed drug is not placed on F1 or F2, but on the administrative combination drug list.
This Instrument amends the Principal Determination by adding one new listed drug empagliflozin to F1. It also removes one drug sodium chloride compound from F1.
Variation and revocation
Unless there is an express power to revoke or vary PB 93 of 2010 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 93 of 2010.
Consultation
The Amending Determination affects pharmaceutical companies with medicines listed on the PBS. Before drugs are listed and allocated to formularies, there are detailed consultations about the drug with the intended responsible person, and a recommendation is received from the Pharmaceutical Benefits Advisory Committee (PBAC). Any PBAC recommendation is made following receipt of submissions by affected pharmaceutical companies. 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.
This Instrument commences on 1 January 2015.
This Instrument constitutes a legislative instrument for the purpose of the
Legislative Instruments Act 2003.
Overview
The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 12) was enacted by the Australian government to amend the National Health (Listed drugs on F1 or F2) Determination 2010. The purpose of this amendment is to update the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This Act addresses the need for updated and precise allocation of drugs within the PBS formularies to ensure efficient and effective pharmaceutical management. The National Health Act 1953 provides the legislative framework for the PBS, allowing the Minister to determine by legislative instrument which listed drugs are assigned to F1 or F2. This Instrument was made under the authority of subsection 85AB(1) of the Act and is intended to bring the Principal Determination up to date by adding empagliflozin to F1 and removing sodium chloride compound from F1. The policy objective is to maintain the integrity and efficacy of the PBS by ensuring drugs are appropriately categorised within the formularies.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 12) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which sets out the criteria for allocating drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This Act applies to the Minister for Health, pharmaceutical companies with listed drugs, and the Pharmaceutical Benefits Advisory Committee (PBAC), which makes recommendations based on submissions from relevant stakeholders. The Amendment Determination is a legislative instrument that comes into effect on 1 January 2015 and is applicable nationally, as it is made under the authority of the Commonwealth of Australia. The determination adds empagliflozin to the F1 formulary and removes sodium chloride compound from F1, with specific criteria for inclusion in each formulary detailed in the Act and the Principal Determination. The Minister has the power to revoke or vary the Principal Determination under subsection 33(3) of the Acts Interpretation Act 1901, unless otherwise specified.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 12) amends the National Health (Listed drugs on F1 or F2) Determination 2010. This legislative instrument, made under subsection 85AB(1) of the National Health Act 1953, pertains to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). According to section 84AC, a drug is considered to be on F1 or F2 if there is a determination in force under section 85AB that it is on F1 or F2. Subsection 85AB(1) empowers the Minister to determine by legislative instrument that a listed drug is on F1 or F2. For a drug to be on F1, it must satisfy the criteria in subsection 85AB(4), which includes the absence of bioequivalent or biosimilar listed brands of pharmaceutical items that have the drug or another drug in the same therapeutic group. 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)). The Amending Determination adds empagliflozin to F1 and removes sodium chloride compound from F1.
Under the Act, the obligations imposed on parties include ensuring that drugs are appropriately classified into the F1 or F2 formularies based on the criteria outlined in the Act and its subsidiary legislation. Pharmaceutical companies must comply with the criteria set out in the determination for drugs to be listed and allocated to the appropriate formularies. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in the process, providing recommendations after receiving submissions from affected pharmaceutical companies. Two-thirds of the PBAC membership comprises representatives from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists, ensuring a broad spectrum of interests and expertise in the decision-making process.
Breaching the provisions of the National Health Act 1953 or the National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 12) can lead to civil or criminal consequences. While the specific offences and penalties are not detailed in the text, violations of the Act could result in penalties as prescribed by the legislation. The determination and the underlying Act are designed to ensure that drugs are appropriately managed and that the Pharmaceutical Benefits Scheme operates effectively and fairly. Non-compliance could, therefore, lead to significant legal repercussions for the parties involved, including pharmaceutical companies and the Minister responsible for the determination.