EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 7)
PB 63 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 one new drug – fluticasone furoate in addition to removing the drug – fluticasone furoate with vilanterol from F1 and allocating it to the single brand Combination Drug List (CDL). It also moves two currently listed drugs – hydromorphone and trastuzumab from F1 to F2, in addition to moving one currently listed drug – tenofovir with emtricitabine and efavirenz from CDL to F2. In addition, it also removes one drug from F1 – aprepitant 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. Aprepitant 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 aprepitant 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 August 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 (No. 7) amends 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). The National Health Act 1953 enables the Minister for Health, or a delegate, to assign listed drugs to F1 or F2 formularies, with F1 intended for single brand drugs and F2 for drugs with multiple brands or those in a therapeutic group with other multi-brand drugs. The 2019 amendment to the determination adds fluticasone furoate to F1, removes fluticasone furoate with vilanterol from F1 and places it on the single brand Combination Drug List, moves hydromorphone and trastuzumab from F1 to F2, moves tenofovir with emtricitabine and efavirenz from the Combination Drug List to F2, and removes aprepitant from F1 as it is no longer listed on the PBS. The determination was enacted by the Parliament of Australia and aims to provide an updated allocation of drugs to the PBS formularies.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 7) 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). The Act applies to the Minister for Health or a delegate, who is empowered to determine by legislative instrument which listed drugs are assigned to F1 or F2. F1 is intended for single brand drugs, while F2 is for drugs that have multiple brands or are in a therapeutic group with other drugs that have multiple brands. The amendment includes adding fluticasone furoate to F1, moving hydromorphone and trastuzumab from F1 to F2, and moving tenofovir with emtricitabine and efavirenz from the Combination Drug List (CDL) to F2. Additionally, aprepitant is removed from F1 as it is no longer PBS listed. This amendment affects pharmaceutical companies with medicines listed on the PBS and is based on consultations with relevant stakeholders, including the Pharmaceutical Benefits Advisory Committee. The determination commences on 1 August 2019.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 7) (the Amending Determination) involve adjustments to the allocation of drugs in the Pharmaceutical Benefits Scheme (PBS) formularies. Specifically, section 2 of the Amending Determination adds fluticasone furoate to F1, removes fluticasone furoate with vilanterol from F1 and places it on the Combination Drug List (CDL), moves hydromorphone and trastuzumab from F1 to F2, moves tenofovir with emtricitabine and efavirenz from CDL to F2, and removes aprepitant from F1 as it is no longer listed on the PBS. These changes are made under the authority of the National Health Act 1953 (the Act) and are intended to reflect the current status and therapeutic groupings of these drugs.
The obligations imposed by the Act on the parties or entities it governs include ensuring that drugs are correctly allocated to the appropriate formulary, which in this case involves F1 for single brand drugs and F2 for drugs with multiple brands or those in therapeutic groups with multiple brands. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process by providing recommendations based on detailed consultations with pharmaceutical companies and other stakeholders. Pharmaceutical companies must comply with the criteria outlined in section 85AB of the Act to have their drugs listed and allocated to the appropriate formulary. The Minister, or a delegate, has the authority to make determinations regarding the allocation of drugs to F1 or F2 under section 85AB(1) of the Act.
The Amending Determination does not explicitly outline specific offences, penalties, or consequences for breaches within the text provided. However, under the broader framework of the National Health Act 1953, there are likely to be provisions for enforcement and penalties for non-compliance with the Act’s requirements. Typically, breaches of the Act could result in civil or criminal penalties, including fines and potential imprisonment, depending on the nature and severity of the breach. The exact penalties would be determined by the relevant sections of the Act and any associated regulations or subsidiary legislation.