EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 8)
PB 72 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 removing one drug from F1 – ofatumumab 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 delisting from the PBS. Ofatumumab 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 ofatumumab from the PBS.
The Amending Determination Instrument commences on 1 September 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. 8) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010 under the National Health Act 1953. This legislation, created by the Commonwealth Parliament, addresses the need to update the allocation of drugs on the Pharmaceutical Benefits Scheme (PBS) formularies. Specifically, it removes ofatumumab from F1 as it is no longer listed on the PBS. The policy objective is to ensure that the PBS formularies accurately reflect the current status of drugs available for subsidy, thus maintaining the integrity and efficiency of the PBS.
The amendment to the Principal Determination follows a structured process of consultation, including with the Pharmaceutical Benefits Advisory Committee, which comprises representatives from various healthcare sectors. This ensures that decisions about the PBS listings and formulary allocations are well-informed and balanced, reflecting the interests of both consumers and the healthcare industry. The Amending Determination is effective from 1 September 2019 and constitutes a legislative instrument under the Legislation Act 2003.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which governs the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The F1 formulary is designated for single brand drugs, while the F2 formulary is intended for drugs that have multiple brands or are part of a therapeutic group with other drugs that have multiple brands. This amendment specifically removes ofatumumab from the F1 formulary as it is no longer listed on the PBS. The Act applies to entities involved in the pharmaceutical industry, particularly pharmaceutical companies with medicines listed on the PBS. The amendment affects these companies by adjusting the formulary allocation of their drugs, which has financial and regulatory implications. The amendment applies nationally across Australia, as it is made under the Commonwealth's National Health Act 1953. The determination process involves consultations with the Pharmaceutical Benefits Advisory Committee and affected pharmaceutical companies, ensuring a comprehensive review of the drug's status and suitability for the PBS.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010, specifically concerning the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The F1 formulary is designated for single-brand drugs, while the F2 formulary is intended for drugs that have multiple brands or are in a therapeutic group with other drugs having multiple brands (subsection 85AB(1)). This amendment removes ofatumumab from the F1 formulary as it is no longer listed on the PBS (subsection 85AB(3)).
The Act imposes specific criteria for a drug to be placed on the F1 formulary (subsection 85AB(4)), which includes the absence of bioequivalent or biosimilar listed brands for the drug or any drug in the same therapeutic group. Additionally, the drug must not have been on the F2 formulary the day before the determination takes effect. Conversely, a drug can only be placed on the F2 formulary if it does not satisfy the criteria for F1 (subsection 85AB(3)). This regulatory framework ensures a structured approach to managing the pharmaceutical landscape within the PBS.
The obligations imposed by the Act require that the Minister (or delegate) determines the placement of listed drugs on F1 or F2 through legislative instruments. Pharmaceutical companies must comply with these determinations, ensuring that their drugs are correctly placed within the appropriate formulary. This compliance extends to the removal of ofatumumab from the PBS, as stipulated in the Amending Determination, which mandates that pharmaceutical companies must align with the Minister's determination regarding the PBS listing status of their drugs.
Any breaches of the requirements set forth in the National Health Act 1953 may result in civil or criminal penalties, as stipulated in relevant sections of the Act. For example, contravening the provisions of the Act may lead to fines and, in severe cases, imprisonment. The specific penalties are determined based on the nature and severity of the breach, with maximum penalties outlined in the Act. Ensuring adherence to these provisions is crucial for maintaining the integrity of the PBS and its regulatory framework.