National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 2) (PB 16 of 2016)

Overview

The National Health Act 1953, enacted by the Australian Parliament, governs the provision of health services, including the Pharmaceutical Benefits Scheme (PBS). The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 2) was introduced to address the need to update the list of drugs assigned to the F1 and F2 formularies of the PBS, which are intended for single brand drugs and drugs with multiple brands, respectively. This amendment ensures that the formularies are up-to-date with current therapeutic needs and pharmaceutical advancements. The policy objective of the Act is to provide a structured system for the allocation of drugs to formularies, ensuring that the PBS remains effective and responsive to the health needs of Australians. The Amending Determination was made under the authority of the Act and follows extensive consultations with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee, to ensure the accuracy and appropriateness of the drug allocations.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 2) amends the National Health (Listed drugs on F1 or F2) Determination 2010 to allocate specific drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This determination applies to pharmaceutical entities and companies that have drugs listed on the PBS, impacting their compliance with statutory price reductions, price disclosure, and supply guarantee provisions. The amendment affects drugs such as amino acid and protein formulas, daclatasvir, ribavirin, and sofosbuvir, by assigning them to F1 or F2, or in the case of ribavirin and peginterferon alfa-2b, to the single brand combination drugs list. The Amending Determination has a national reach as it is made under the National Health Act 1953, which is a Commonwealth Act. The determination can be varied or revoked through subordinate legislation, with specific powers cited in the Act or by relying on the Acts Interpretation Act 1901. The process for these amendments involves extensive consultation with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, ensuring a comprehensive review of the drugs' therapeutic value and market conditions.

Key Provisions

The key operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 2) are those that amend the National Health (Listed drugs on F1 or F2) Determination 2010. Specifically, section 85AB(1) of the National Health Act 1953 allows the Minister to determine by legislative instrument that a listed drug is on F1 or F2, and this Amendment Determination adds five new drugs to F1 and reassigns one drug from F1 to the single brand combination drugs list (subsection 85AB(5)). The criteria for F1 placement require 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 (subsection 85AB(4)). The criteria for F2 placement are that the drug does not satisfy one or more of the criteria for F1 (subsection 85AB(3)). The obligations and requirements imposed by the Act and this Amendment Determination include the need for detailed consultations with pharmaceutical companies before drugs are listed and allocated to formularies. A recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) is also required, which is made following receipt of submissions by affected pharmaceutical companies. Two-thirds of the PBAC membership must be from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The drugs that are added or reassigned under this Amendment Determination must satisfy the criteria for F1 or F2 placement, as set out in the Act and the Principal Determination. The Amendment Determination provides for civil and criminal consequences for breach of the provisions of the Act and this Determination. Offences may include the unauthorised use of a drug that is not listed on the Pharmaceutical Benefits Scheme (PBS), or the provision of a drug that does not comply with the statutory price reductions, price disclosure and guarantee of supply provisions. The maximum penalties for these offences vary depending on the nature and severity of the breach, but may include fines of up to $22,200 for individuals and $111,000 for corporations. In addition, the Minister may revoke or vary this Determination under subsection 33(3) of the Acts Interpretation Act 1901, which may result in further civil or criminal consequences for non-compliance.