EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 2)
PB 19 of 2013
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 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 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 three new listed drugs boceprevir, rotigotine and telaprevir to F1. It also moves twelve drugs candesartan, desvenlafaxine, donepezil, duloxetine, eprosartan, interferon-beta-1b, irbesartan, losartan, olmesartan, telmisartan, tropisetron and valsartan from F1 to F2. In addition one drug, irbesartan with hydrochlorothiazide moves from the combination drug list to F2.
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.
The Amending Determination instrument commences on 1 April 2013.
This instrument constitutes a legislative instrument for the purpose of the Legislative Instruments Act 2003.
Overview
The National Health (Listed Drugs on F1 or F2) Amendment Determination 2013 (No. 2) was enacted to amend the National Health (Listed Drugs on F1 or F2) Determination 2010, which governs the allocation of drugs to the F1 and F2 formularies within the Pharmaceutical Benefits Scheme (PBS). This determination was made under the National Health Act 1953 and is intended to address gaps in the allocation of certain drugs to the appropriate formulary, ensuring that they are appropriately categorised to benefit patients and the healthcare system. The determination was enacted by the Australian Government to provide clarity and ensure effective allocation of pharmaceutical resources. The policy objective is to facilitate efficient and equitable access to medications by ensuring drugs are placed in the correct formulary based on their therapeutic characteristics and market presence.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 2) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which governs the allocation of drugs to the F1 and F2 formularies under the Pharmaceutical Benefits Scheme (PBS) as specified in the National Health Act 1953. This legislation applies to pharmaceutical companies and entities that have drugs listed on the PBS, affecting their classification and the pricing and supply mechanisms that govern those drugs. The determination is applicable across the Commonwealth of Australia and is instrumental in regulating the availability and pricing of certain medications. The amendment specifically adds three new drugs to the F1 list and reclassifies twelve existing drugs from F1 to F2, alongside adjusting the classification of a combination drug. The legislative instrument extends to allow further amendments through subordinate instruments, thereby ensuring flexibility in responding to new pharmaceutical developments and market changes.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 2) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by introducing changes to the allocation of certain drugs within the Pharmaceutical Benefits Scheme (PBS). Specifically, three new drugs, boceprevir, rotigotine and telaprevir, are added to the F1 formulary (s. 3(1)), while twelve drugs, candesartan, desvenlafaxine, donepezil, duloxetine, eprosartan, interferon-beta-1b, irbesartan, losartan, olmesartan, telmisartan, tropisetron and valsartan, are moved from F1 to F2 (s. 3(2)). Additionally, irbesartan with hydrochlorothiazide is moved from the combination drug list to F2 (s. 3(3)). These changes are effective from 1 April 2013 (s. 4).
Under the National Health Act 1953, the Minister is responsible for determining the allocation of listed drugs to either F1 or F2 formularies. F1 is designated for drugs that have only one brand, whereas F2 is for drugs that have multiple brands or belong to a therapeutic group with other drugs that have multiple brands (s. 85AB(4)-(5)). For a drug to be placed on F1, it must meet specific criteria, including the absence of bioequivalent or biosimilar listed brands within the same therapeutic group (s. 85AB(4)). Conversely, a drug can only be placed on F2 if it does not meet the criteria for F1 (s. 85AB(3)). Drugs on F2 are subject to statutory price reductions, price disclosure and a guarantee of supply (s. 85AB(1)).
The Amending Determination imposes obligations on pharmaceutical companies with medicines listed on the PBS. These companies must ensure that their drugs are appropriately allocated to the correct formulary, F1 or F2, as determined by the Minister. This includes adhering to the criteria for F1 or F2 placement and complying with any requirements related to statutory price reductions, price disclosure and supply guarantees for drugs on F2. Pharmaceutical companies must also engage in consultations with the Pharmaceutical Benefits Advisory Committee (PBAC), which provides recommendations on drug allocation based on submissions from affected companies and other stakeholders (s. 85AB(1)).
Breach of the provisions under the National Health Act 1953 can result in civil and criminal consequences. For instance, if a pharmaceutical company fails to comply with the statutory price reductions or supply guarantees for drugs on F2, it may be subject to penalties under the Act. The specific penalties are not detailed in the determination, but they can include fines and other sanctions as prescribed by the Act. Additionally, if a company knowingly provides misleading information during consultations with the PBAC, it may face criminal charges, including imprisonment and fines, as per the general provisions of the Act. The exact penalties for such offences would be determined in accordance with the relevant sections of the Act.