EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 10)
PB 89 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, triglycerides, long chain, 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. Triglycerides, long chain is being removed from the PBS at the request of the pharmaceutical company. The Pharmaceutical Benefits Advisory Committee (PBAC) was also consulted about the removal of triglycerides, long chain from the PBS. 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 November 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. 10) amends the National Health (Listed drugs on F1 or F2) Determination 2010, made under the National Health Act 1953. The primary purpose of this determination is to adjust the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS) formularies, specifically F1 and F2, which are used to categorise single brand and multiple brand drugs respectively. This legislative instrument was introduced to address the need to update the list of drugs on F1 and F2, ensuring that it reflects the current status of drugs listed on the PBS. The Act empowers the Minister for Health or a delegate to make such determinations, and this particular amendment removes triglycerides, long chain from F1 due to it no longer being listed on the PBS. The determination was developed in consultation with relevant stakeholders, including the Pharmaceutical Benefits Advisory Committee, and commenced on 1 November 2019.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 amends the National Health (Listed drugs on F1 or F2) Determination 2010, providing for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This Act applies to pharmaceutical companies with medicines listed on the PBS, and the changes are made in accordance with the criteria specified in the National Health Act 1953. The Act applies to a Commonwealth jurisdiction, with its reach extending across Australia as it pertains to the PBS, which is a national scheme. The Amending Determination removes triglycerides, long chain from the F1 formulary, as this drug is no longer PBS listed, at the request of the pharmaceutical company, and after consultation with the Pharmaceutical Benefits Advisory Committee. The changes made by this Determination are effective from 1 November 2019 and constitute a legislative instrument under the Legislation Act 2003.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 10) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination), which sets out the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The main operative sections of this legislation, specifically subsection 85AB(1) of the National Health Act 1953 (the Act), empower the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2. Subsection 85AB(4) of the Act specifies the criteria for a drug to be on F1, which includes having no bioequivalent or biosimilar listed brands and not being on F2 the day before the determination comes into effect. Conversely, a drug may only be on F2 if it does not satisfy one or more of the criteria for F1 (subsection 85AB(3)).
The Act imposes several obligations on the parties involved. Pharmaceutical companies with medicines listed on the PBS must comply with the requirements of the Principal Determination and its amendments. The Minister (or delegate) has the responsibility to ensure that drugs are correctly allocated to the appropriate formularies based on the criteria set out in the Act. This includes the requirement to remove drugs from F1 or F2 when they no longer meet the criteria, as illustrated by the removal of triglycerides, long chain from F1 due to it being delisted from the PBS.
Breach of the provisions set out in this legislation can lead to various consequences. While the explanatory statement does not detail specific offences or penalties, non-compliance with the Act's requirements could potentially lead to administrative or legal action under the relevant legislative framework. The maximum penalties for breaches of the National Health Act 1953 could include fines and other civil or criminal penalties, depending on the nature and severity of the breach.
In summary, the National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 10) serves to update the Principal Determination by removing triglycerides, long chain from F1 as it is no longer listed on the PBS. This amendment ensures that the allocation of drugs to the F1 and F2 formularies remains accurate and compliant with the criteria set out in the Act. The Minister (or delegate) and pharmaceutical companies must adhere to the requirements of the Act, with potential consequences for non-compliance.