National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 8) (PB 70 of 2014)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 8) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010, which sets out the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This amendment was made under the authority of the National Health Act 1953 and was introduced to address the need to update the list of drugs assigned to the F1 and F2 formularies. The Act provides for listed drugs to be assigned to F1, which is intended for single brand drugs, and F2, which is for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands. The policy objective behind this amendment is to ensure that the formularies accurately reflect the current therapeutic landscape and to facilitate appropriate access to medications for patients. The determination was made by the Minister for Health under subsection 85AB(1) of the National Health Act 1953, with the aim of ensuring that the formularies of the PBS are updated to reflect changes in the pharmaceutical market and therapeutic practices. This involves adding new drugs to the appropriate formularies and removing outdated drugs to ensure that the scheme remains effective and responsive to current healthcare needs. The amendment adds the drug macitentan to F1 and removes the drugs omeprazole, clarithromycin, and amoxycillin from F2. The determination was subject to consultation with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee, to ensure that the changes are evidence-based and in the best interest of public health.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010, altering the allocation of certain drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The Act applies to pharmaceutical companies and suppliers of listed drugs, particularly those involved in the manufacturing, supply, and distribution of medicines covered under the PBS. Geographically, this determination operates under the Commonwealth of Australia, impacting the national allocation of pharmaceutical benefits across states and territories. The amendment specifically adds the drug macitentan to the F1 formulary, which is designated for single-brand drugs, and removes the drugs omeprazole and clarithromycin and amoxycillin from the F2 formulary, which accommodates drugs with multiple brands or those in therapeutic groups with multiple brands. This determination ensures that the drugs are subject to the statutory price reductions, price disclosure, and guarantee of supply provisions stipulated by the National Health Act 1953. The changes will come into effect on 1 September 2014.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding a new drug, macitentan, to the F1 formulary, and removing omeprazole, clarithromycin, and amoxycillin from the F2 formulary (sections 2 and 3). The F1 formulary is for single brand drugs, and F2 is for drugs with multiple brands or those in a therapeutic group with other multiple brand drugs. These changes are made under the authority of subsection 85AB(1) of the National Health Act 1953, which allows the Minister to determine by legislative instrument that a listed drug is on F1 or F2. The obligations imposed by the Act on pharmaceutical companies and other entities governed by the Act include ensuring that listed drugs are allocated to the appropriate formulary as determined by the Minister. Pharmaceutical companies must comply with the criteria set out in the Act for drugs to be placed on F1 or F2. For example, a drug can only be placed 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)). Drugs that do not satisfy the criteria for F1 can only be placed on F2 (subsection 85AB(3)). Pharmaceutical companies must also ensure that any drugs they list on the Pharmaceutical Benefits Scheme (PBS) comply with the statutory price reductions, price disclosure, and guarantee of supply provisions of the Act. Failure to comply with the requirements of the Act or the determinations made under it may result in civil or criminal penalties. Subsection 12(1) of the National Health Act 1953 provides that a person who contravenes any provision of the Act or any regulation made under it is liable to a penalty not exceeding the greater of three times the benefit obtained or $50,000. In addition, subsection 12(2) of the Act provides that a person who contravenes any provision of the Act or any regulation made under it that is punishable by a fine is also liable to imprisonment for a term not exceeding two years. However, the Explanatory Statement does not specify the maximum penalties for breach of the determinations made under the Act. In summary, the National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding macitentan to the F1 formulary and removing omeprazole, clarithromycin, and amoxycillin from the F2 formulary. Pharmaceutical companies and other entities governed by the Act must comply with the criteria set out in the Act for drugs to be placed on F1 or F2, and failure to do so may result in civil or criminal penalties.