EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 9)
PB 81 of 2019
Authority
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 first new brand 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 (or delegate) 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 (the Amending Determination) amends the Principal Determination by adding to F1 two drugs, aprepitant, a recently delisted drug which is relisted on the PBS and teduglutide, a new drug. It also moves two currently listed drugs, insulin glargine and rituximab, from F1 to F2 in addition. It changes the drug description for two drugs on F2 from fluticasone and fluticasone with salmeterol to fluticasone propionate and fluticasone propionate with salmeterol. It also removes one drug from F1, biperiden, as this drug is no longer PBS listed.
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. Biperiden is being removed from the PBS at the request of the pharmaceutical company. 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. The PBAC was also consulted about the removal of biperiden from the PBS. Further consultation on the Amending Determination was deemed unnecessary due to the consultation on allocation of the drugs to formularies with affected pharmaceutical companies that had already taken place.
The Amending Determination Instrument commences on 1 October 2019.
This Instrument constitutes a legislative instrument for the purpose of the
Legislation Act 2003.
Overview
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019, enacted by the Australian Government under the authority of the National Health Act 1953, aims to amend the National Health (Listed drugs on F1 or F2) Determination 2010. This amendment responds to the need to update the allocation of drugs to the Pharmaceutical Benefits Scheme's (PBS) formularies, specifically F1 and F2, ensuring the scheme remains effective and relevant. F1 is designated for single brand drugs while F2 accommodates drugs with multiple brands or those within therapeutic groups with other multi-brand drugs. This legislative instrument is intended to streamline the management of drug listings on the PBS, ensuring that drugs are appropriately categorised to facilitate equitable access and cost-efficiency within the healthcare system. The Minister for Health, or their delegate, has the authority to make such determinations under section 85AB of the National Health Act 1953, ensuring that the amendments align with the overarching policy objectives of the PBS.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 pertains to the National Health Act 1953 and serves to modify the National Health (Listed drugs on F1 or F2) Determination 2010 by altering the allocation of drugs to the F1 and F2 formularies within the Pharmaceutical Benefits Scheme (PBS). The Act applies to the Minister for Health or their delegate, who are empowered to make determinations regarding the placement of drugs into these formularies under subsection 85AB(1) of the Act. The determinations affect pharmaceutical companies with medicines listed on the PBS and consequently influence the availability and pricing of these drugs to the public. The amendment impacts the geographic scope of the Commonwealth of Australia, applying to all states and territories under the overarching framework of the National Health Act 1953. Exclusions and exemptions are not explicitly stated in the determination, although the criteria for inclusion in F1 or F2 are clearly outlined, with certain drugs being ineligible for F1 placement if they meet specific biosimilar or therapeutic group criteria. The application of the Act can be further refined through subordinate instruments, which may provide additional detail or modify the scope of the determination as needed.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 9) amends the National Health (Listed drugs on F1 or F2) Determination 2010. This amendment alters the allocation of certain drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) (subsection 85AB(1)). Specifically, the Amendment Determination adds two drugs to F1: aprepitant and teduglutide (paragraph 1(1)). It also moves insulin glargine and rituximab from F1 to F2 (paragraph 1(2)). Furthermore, it modifies the drug descriptions for fluticasone and fluticasone with salmeterol on F2 to fluticasone propionate and fluticasone propionate with salmeterol (paragraph 1(3)). Additionally, it removes biperiden from F1 as it is no longer listed on the PBS (paragraph 1(4)). These changes are effective from 1 October 2019.
The obligations imposed by this Amendment Determination primarily concern the classification and management of listed drugs on the PBS. Pharmaceutical companies with medicines listed on the PBS must ensure compliance with the updated formulary allocations. The Minister or delegate has the authority to determine the placement of listed drugs on F1 or F2 based on specific criteria (subsection 85AB(4)-(5)). Drugs must meet certain conditions to be placed on F1, such as the absence of bioequivalent or biosimilar brands in their therapeutic group (subsection 85AB(4)). Conversely, drugs may only be placed on F2 if they do not meet the criteria for F1 (subsection 85AB(3)). The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending drug allocations, ensuring that decisions are informed by comprehensive consultations with various stakeholders.
The Amendment Determination does not explicitly outline offences or penalties for non-compliance with its provisions. However, any failure to adhere to the updated formulary allocations may result in broader implications under the National Health Act 1953. Non-compliance could potentially lead to legal actions for breach of the Act's provisions, including civil or criminal penalties as stipulated in other sections of the Act. For example, the Act includes provisions for offences related to the supply of pharmaceutical benefits without authority, which could attract penalties such as fines or imprisonment (sections 108A and 109). The Pharmaceutical Benefits Scheme Regulations 1990 also contain detailed rules and penalties for non-compliance with the PBS, including fines and other administrative actions.