EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 4)
PB 43 of 2018
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 three new drugs – cabozantinib; dulaglutide; and nusinersen, in addition to moving eight currently listed drugs – acamprosate; adrenaline; buprenorphine; enoxaparin; everolimus; ezetimibe; lincomycin; and moxonidine from F1 to F2. It also removes four drugs from F1 – daclizumab; didanosine; interferon alfa-2b; and stavudine as these drugs are no longer PBS listed and changes the drug name of one drug on F2 - dothiepin to dosulepin due to the International Harmonisation of Ingredient Names reform. In addition, it also moves two currently listed drugs – ezetimibe and rosuvastatin; and ezetimibe with simvastatin from the single brand Combination Drug List (CDL) to F2.
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. 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 June 2018.
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 2018 (No. 4) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which allocates drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Enacted by the Australian Parliament under section 85AB(1) of the National Health Act 1953, this legislation aims to ensure the effective allocation of drugs to appropriate formularies within the PBS, thereby addressing issues related to the availability and pricing of pharmaceutical items. The primary objective is to maintain a well-structured PBS by ensuring that drugs are appropriately categorised based on their therapeutic groups and brand availability. This legislative instrument introduces changes such as adding new drugs to F1, moving certain drugs between F1 and F2, and adjusting the drug names in accordance with international standards. The Amending Determination also removes drugs from F1 that are no longer listed on the PBS, reflecting the current market and therapeutic landscape.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 4) 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 instrument applies to pharmaceutical companies with drugs listed on the PBS, ensuring that these companies adhere to the specified formulary allocations. The determination specifies which drugs are to be placed on either the F1 or F2 formularies, 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. This instrument is enacted under the National Health Act 1953, which has a Commonwealth reach, and it constitutes a legislative instrument under the Legislation Act 2003. The Amending Determination, which commenced on 1 June 2018, includes the addition of three new drugs to F1 and the reclassification of several drugs between F1 and F2, as well as adjustments to the single brand Combination Drug List (CDL). The instrument does not specify exclusions, exemptions, or thresholds, but it does note that certain drugs are removed from F1 if they are no longer listed on the PBS.
Key Provisions
The National Health (Listed Drugs on F1 or F2) Amendment Determination 2018 (No. 4) amends the National Health (Listed Drugs on F1 or F2) Determination 2010 by introducing changes to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953 (section 85AB(1)). The F1 formulary is intended for drugs with a single brand, while the F2 formulary is for drugs with multiple brands or those in a therapeutic group with other drugs that also have multiple brands. The determination affects the pricing, disclosure, and supply of drugs on the F2 formulary (section 85AB(4) and (5)). Specifically, it adds three new drugs to F1 (cabozantinib, dulaglutide, and nusinersen) and moves eight drugs from F1 to F2 (acamprosate, adrenaline, buprenorphine, enoxaparin, everolimus, ezetimibe, lincomycin, and moxonidine) (section 85AB(3)). It also removes four drugs from F1 (daclizumab, didanosine, interferon alfa-2b, and stavudine) as these are no longer PBS listed (section 85AB(5)). Furthermore, the name of dothiepin on F2 is changed to dosulepin due to the International Harmonisation of Ingredient Names reform, and two drugs (ezetimibe and rosuvastatin) and one combination drug (ezetimibe with simvastatin) are moved from the Combination Drug List to F2 (section 85AB(4)).
The Act imposes obligations on pharmaceutical companies to comply with the drug allocations to the F1 and F2 formularies, ensuring that the drugs are appropriately priced, disclosed, and supplied as required by the PBS. Pharmaceutical companies must ensure that their drugs are correctly listed and allocated to the appropriate formulary, adhering to the criteria specified in the Act. The determination also requires pharmaceutical companies to update their records and systems to reflect the changes in drug allocations. Additionally, the Minister or delegate has the authority to determine by legislative instrument that a listed drug is on F1 or F2, ensuring that the formularies are correctly managed and updated in accordance with the Act.
Breach of the provisions of the Act or the determination may result in offences, penalties, or civil/criminal consequences. However, the Explanatory Statement does not specify the exact offences, penalties, or consequences for breach. It is likely that penalties would be outlined in the National Health Act 1953 or in other related legislation. The Act may impose fines, imprisonment, or other penalties for non-compliance, and the determination may provide for specific consequences for failing to comply with the drug allocations to the F1 and F2 formularies. Pharmaceutical companies must ensure that they comply with the requirements of the Act and the determination to avoid any potential penalties or consequences.