National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 10) (PB 114 of 2018)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2018, enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010, was introduced by the Australian Parliament under subsection 85AB(1) of the National Health Act 1953. This legislation addresses the need to update the formularies of the Pharmaceutical Benefits Scheme (PBS), specifically assigning drugs to the F1 and F2 formularies. The F1 formulary is designated for single brand drugs, while F2 is for drugs with multiple brands or those in a therapeutic group with other drugs having multiple brands. The policy objective is to ensure effective and efficient management of drugs within the PBS, facilitating equitable access to necessary medications while considering therapeutic alternatives and cost implications. This amendment involves the addition of a new drug, tolvaptan, to F1 and a modification in the description of an existing drug on F2. The legislative process involved extensive consultation with pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that recommendations align with public health interests and stakeholder concerns.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 10) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This determination applies to pharmaceutical companies that have medicines listed on the PBS, specifically those involved in the manufacture, supply, and provision of drugs to patients in Australia. The amendment involves the addition of tolvaptan to F1 and a modification to the description of an existing drug on F2. This change reflects updates in drug formulations or therapeutic classifications. The Act applies nationally across Australia, and its amendments extend through legislative instruments under the authority of the National Health Act 1953. There are no exclusions or exemptions stated in this particular amendment, though broader provisions of the Act may apply thresholds or conditions based on the nature of the drugs and their therapeutic groups. The Amending Determination, which commenced on 1 January 2019, operates under the authority conferred by the Acts Interpretation Act 1901, allowing for the revocation or variation of the Principal Determination where expressly permitted by this or other legislation.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 10) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding a new drug, tolvaptan, to the F1 formulary and modifying the description of an existing form of a drug already on the F2 formulary. This Amendment Determination is made under section 85AB(1) of the National Health Act 1953, which empowers the Minister or a delegate to determine by legislative instrument that a listed drug is on F1 or F2. The National Health Act 1953 provides that listed drugs may be assigned to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS), with F1 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 first new brand statutory price reductions, price disclosure, and guarantee of supply. The Amendment Determination imposes specific requirements on pharmaceutical companies that have drugs listed on the PBS. These companies must comply with the criteria for allocation to the F1 and F2 formularies as set out in the National Health Act 1953. For a drug to be allocated to F1, it must satisfy the criteria in subsection 85AB(4) of the Act, which includes having no bioequivalent or biosimilar listed brands of pharmaceutical items that are bioequivalent or biosimilar to another drug in the same therapeutic group. Additionally, the drug must not have been on F2 the day before the determination comes into effect. A drug may only be allocated to F2 if it does not meet one or more of the criteria for F1, as specified in subsection 85AB(3) of the Act. Pharmaceutical companies must also be aware of the provisions in subsection 85AB(5), which applies to listed drugs with a single brand combination item on the PBS, placing them on the administrative combination drug list rather than on F1 or F2. Breach of the requirements set out in the National Health Act 1953 and the Amendment Determination may lead to various civil or criminal consequences, depending on the nature and severity of the breach. The Act does not explicitly state the maximum penalties for breaches, but breaches of legislative instruments made under the Act may be subject to penalties as prescribed by the legislation itself or other relevant laws. Pharmaceutical companies must ensure compliance with the criteria for drug allocation to avoid any potential legal repercussions. Failure to comply with the requirements may result in enforcement actions by the relevant authorities, including fines, sanctions, or other civil or criminal penalties as deemed appropriate under the law.