EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 8)
PB 87 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 moving two currently listed drugs – emtricitabine with tenofovir alafenamide; and tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat from the single brand Combination Drug List (CDL) to F1. It also moves one currently listed drug – ivabradine from F1 to F2, in addition to removing four drugs from F1 – emtricitabine, indinavir; milk powder—lactose free formula; and nandrolone decanoate as these drugs are 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. 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 October 2018.
This Instrument constitutes a legislative instrument for the purpose of the
Legislation Act 2003.
Overview
The National Health Act 1953, enacted by the Australian Parliament, governs the administration and funding of health services across the nation. The Act was designed to provide a framework for the provision of health services, including the administration of the Pharmaceutical Benefits Scheme (PBS). The National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 8) was introduced to address the need for updating the allocation of drugs within the PBS formularies. This particular amendment was made under subsection 85AB(1) of the National Health Act 1953, empowering the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2. The policy objective of this amendment is to ensure that drugs are appropriately categorised within the PBS, thereby maintaining effective and efficient health care delivery. This determination moves certain drugs from the single brand Combination Drug List to F1, and from F1 to F2, reflecting changes in therapeutic groupings and brand availability.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010 to adjust the allocation of certain drugs within the Pharmaceutical Benefits Scheme (PBS) formularies. This legislation applies to pharmaceutical companies with drugs listed on the PBS, specifically to the drugs emtricitabine with tenofovir alafenamide, tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat, ivabradine, emtricitabine, indinavir, milk powder—lactose free formula, and nandrolone decanoate. The amendments involve moving some of these drugs from the single brand Combination Drug List (CDL) or from F1 to F2, and removing others from F1 due to their delisting from the PBS. The changes are made under the authority of the National Health Act 1953, with the purpose of adjusting the allocation to better align with the intended therapeutic use and market conditions. The Act applies on a Commonwealth level, affecting the allocation of PBS listed drugs across Australia. The Amending Determination is effective from 1 October 2018 and constitutes a legislative instrument under the Legislation Act 2003.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 8) involve the movement of certain drugs between the formularies of the Pharmaceutical Benefits Scheme (PBS). Specifically, section 85AB(5) of the National Health Act 1953 (the Act) is amended to move two drugs, emtricitabine with tenofovir alafenamide and tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat, from the single brand Combination Drug List (CDL) to F1. This is done to ensure that these drugs are treated appropriately within the PBS framework. Furthermore, section 85AB(3) of the Act is amended to move ivabradine from F1 to F2. Additionally, four drugs are removed from F1 due to their removal from the PBS list altogether: emtricitabine, indinavir, milk powder—lactose free formula, and nandrolone decanoate.
The obligations imposed on parties by this legislation primarily concern pharmaceutical companies with drugs listed on the PBS. These companies must ensure their drugs are allocated correctly within the PBS formularies. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in recommending drug allocations, based on detailed consultations with pharmaceutical companies and other stakeholders. The Minister for Health, or their delegate, has the authority to make determinations regarding which formulary a drug should be placed in, based on the criteria set out in the Act. It is essential for pharmaceutical companies to comply with these determinations to ensure their products are accessible to patients under the PBS.
The determination also includes provisions for the revocation or variation of the Principal Determination, as stated in subsection 33(3) of the Acts Interpretation Act 1901. This means that the original determination can be amended or revoked as necessary, ensuring that the PBS remains current and effective. There are no specific offences or penalties mentioned in the explanatory statement for breaching these provisions. However, non-compliance with the PBS regulations could potentially lead to civil or criminal consequences, depending on the nature and severity of the breach. The maximum penalties for such breaches would be determined by the relevant legislation governing the administration and enforcement of the PBS.