National Health (Listed Drugs on F1 or F2) Amendment Determination 2022 (No. 4)

Administered by Department of Health, Disability and Ageing

Legislation au F2022L00649 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health (Listed Drugs on F1 or F2) Amendment Determination 2022 (No. 4)

 

PB 40 of 2022

 

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 2021 (PB 33 of 2021) (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

 

This instrument makes amendments to the Principal Determination.

 

The Act provides that PBS listed drugs may be assigned to formularies identified as F1 and F2. F1 is intended for single branded 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 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 (CDL).

 

This instrument amends the Principal Determination by adding to F1 four new drugs, apalutamide, elotuzumab, onasemnogene abeparvovec and sacituzumab govitecan.

 

Variation and revocation

 

Unless there is an express power to revoke or vary PB 33 of 2021 cited in this instrument, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 33 of 2021.

 

Consultation

 

This instrument affects pharmaceutical companies with new medicines listing on the PBS.  Apalutamide, elotuzumab, onasemnogene abeparvovec and sacituzumab govitecan meet the criteria for F1 under subsection 85AB(4).

 

Before a drug is PBS listed and allocated to a formulary, there are detailed consultations about the drug with the responsible person and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). Any PBAC recommendation is made following receipt of a submission made by the affected pharmaceutical company. 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.

 

No additional consultation with experts was undertaken regarding this determination because consultation with the affected responsible persons and the PBAC drew on the knowledge of persons with relevant expertise.

 

Commencement

 

This instrument commences on 1 May 2022.

 

This instrument is a legislative instrument for the purposes of the Legislation Act 2003.

 

 

 

 

 

 

 

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Listed Drugs on F1 or F2) Amendment Determination 2022 (No. 4)
(PB 40 of 2022)

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

This legislative instrument is made pursuant to subsection 85AB(1) of the National Health Act 1953 (the Act), which relates to listed drugs on F1 or F2.  This instrument amends the National Health (Listed Drugs on F1 or F2) Determination 2021 (PB 33 of 2021) (the Principal Determination) which provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS).

 

This instrument amends the Principal Determination by adding to F1 four new drugs, apalutamide, elotuzumab, onasemnogene abeparvovec and sacituzumab govitecan.

 

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS assists with the advancement of this human right by providing for subsidised access of medicines to patients. The recommendatory role of the Pharmaceutical Benefits Advisory Committee ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

The right to social security is contained in Article 9 of the International Covenant on Economic Social and Cultural Rights (ICESCR). It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.

The UN Committee on Economic Social and Cultural Rights reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a Government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.

 

Conclusion

This legislative instrument is compatible with human rights. Human rights continue to be protected by retaining clinically important medicines on the PBS and placing them in formularies that ensure the most cost-effective pricing for supply of each medicine to Australians.

 

 

Caroline Turnour

  Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2022 (No. 4) was enacted to amend the National Health (Listed Drugs on F1 or F2) Determination 2021, which allocates drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The National Health Act 1953 provides that PBS listed drugs may be assigned to these formularies, with F1 intended for single-branded drugs and F2 for drugs with multiple brands or in therapeutic groups with multiple brands. This amendment was made under the authority of the Minister for Health, or their delegate, as provided in section 85AB(1) of the Act. The purpose of this amendment is to include four new drugs—apalutamide, elotuzumab, onasemnogene abeparvovec, and sacituzumab govitecan—into the F1 formulary, ensuring that they meet the criteria for F1 as specified in subsection 85AB(4). This process involves detailed consultation with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, ensuring evidence-based decision-making. The amendment is compatible with human rights, particularly the right to the highest attainable standard of physical and mental health, by facilitating subsidised access to essential medicines through the PBS.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2022 (No. 4) amends the National Health (Listed Drugs on F1 or F2) Determination 2021, which governs the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This instrument applies to pharmaceutical companies with new medicines listed on the PBS, particularly those concerning the drugs apalutamide, elotuzumab, onasemnogene abeparvovec, and sacituzumab govitecan, which have been added to the F1 formulary. The amendment is intended to ensure that these drugs meet the criteria for F1, which applies to single-branded drugs that have no bioequivalent or biosimilar listed brands and were not previously on F2. The instrument has a national jurisdictional reach, affecting the entire Commonwealth of Australia. No specific exclusions or exemptions are noted, but the determination can be varied or revoked under the authority provided by the Acts Interpretation Act 1901. This legislative instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring evidence-based, cost-effective access to essential medicines through the PBS.

Key Provisions

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2022 (No. 4) (PB 40 of 2022) amends the National Health (Listed Drugs on F1 or F2) Determination 2021 (PB 33 of 2021), which provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under section 85AB of the National Health Act 1953 (the Act). This amendment adds four new drugs, apalutamide, elotuzumab, onasemnogene abeparvovec, and sacituzumab govitecan, to the F1 formulary. The F1 formulary is intended for drugs with a single brand, while F2 is for drugs with multiple brands or in a therapeutic group with other drugs having multiple brands. Drugs on F2 are subject to the provisions of the Act relating to price disclosure and guarantee of supply. The Act, particularly section 84AC, mandates that PBS listed drugs are assigned to the F1 or F2 formularies if there is a determination in force under section 85AB. 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 meet specific criteria in subsection 85AB(4), which includes having no bioequivalent or biosimilar listed brands and not being on F2 the day before the determination comes into effect. A drug may only be on F2 if it does not satisfy the criteria for F1 (subsection 85AB(3)). If a drug has a single brand combination item on the PBS, it is placed on the administrative combination drug list (CDL) rather than F1 or F2 under subsection 85AB(5). The obligations imposed on the parties governed by this Act include ensuring that drugs are allocated to the appropriate formulary based on their brand and therapeutic group characteristics. Pharmaceutical companies must consult with the responsible person and the Pharmaceutical Benefits Advisory Committee (PBAC) before a drug is PBS listed and allocated to a formulary. The PBAC, composed of members from various relevant interests and professions, provides recommendations following submissions by affected pharmaceutical companies. The determination of drugs for F1 or F2 placement ensures that decisions about subsidised access to medicines on the PBS are evidence-based and cost-effective. Offences and penalties under this Act are not explicitly detailed in the explanatory statement, but the Act generally imposes strict regulatory measures to ensure compliance. The consequences for non-compliance could include legal actions or financial penalties, depending on the specific breaches and the provisions of the Act. The legislative instrument is compatible with human rights, particularly the right to the highest attainable standard of physical and mental health, as it ensures access to clinically important medicines through the PBS. This compatibility is maintained by the evidence-based decisions of the PBAC and the cost-effective pricing strategies for drug supply to Australians.

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