National Health (Listed Drugs on F1 or F2) Amendment Determination (No. 4) 2026

Administered by Department of Health, Disability and Ageing

Legislation au F2026L00490 In force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health (Listed Drugs on F1 or F2) Amendment Determination (No. 4) 2026

 

PB 52 of 2026

 

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 one new drug, fruquintinib from 1 May 2026. In addition, one drug, fluvastatin is being removed from F2 as this drug will no longer be PBS listed from 1 May 2026.

 

 

 

 

 

 

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.  One new drug, fruquintinib meets the criteria for F1 under subsection 85AB(4). The drug, fluvastatin is being removed from F2 as this drug will no longer be listed on the PBS.

 

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 2026.

 

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 (No. 4) 2026
(PB 52 of 2026)

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 one new drug, fruquintinib from 1 May 2026. In addition, one drug, fluvastatin is being removed from F2 as this drug will no longer be PBS listed from 1 May 2026.

 

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 PBAC 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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Rebecca Richardson

 Assistant Secretary

PBS Listing, Pricing and Policy Branch

Technology Assessment and Access Division

Department of Health, Disability and Ageing

Overview

The National Health (Listed Drugs on F1 or F2) Amendment Determination (No. 4) 2026, made under the National Health Act 1953, addresses the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS) by amending the National Health (Listed Drugs on F1 or F2) Determination 2021. This instrument, enacted by the Commonwealth of Australia, aims to update the PBS formularies to ensure that drugs are assigned to the appropriate formulary based on their therapeutic category and brand status. Specifically, the amendment adds fruquintinib to the F1 formulary, which is designated for single-branded drugs, and removes fluvastatin from the F2 formulary as it will no longer be listed on the PBS. The legislative process involved consultations with pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee, ensuring that the determination aligns with evidence-based recommendations for drug allocation. This amendment seeks to maintain the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination (No. 4) 2026 is a legislative instrument made under the National Health Act 1953, which applies to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The Act applies to pharmaceutical companies, patients, and the broader community, particularly in relation to the PBS listed drugs and their pricing and availability. The determination affects the drugs fruquintinib and fluvastatin, with fruquintinib being added to F1 and fluvastatin being removed from F2 effective from 1 May 2026. The instrument amends the National Health (Listed Drugs on F1 or F2) Determination 2021, which originally provided for the allocation of drugs to the F1 and F2 formularies of the PBS. The amendments are made to reflect changes in the availability of certain drugs and to ensure that the PBS continues to provide affordable access to essential medications for Australians. The instrument does not contain any stated exclusions, exemptions, or thresholds. The National Health Act 1953 has a Commonwealth jurisdiction, and its application is not restricted by state or territory boundaries. This legislative instrument is compatible with human rights, as it aims to progressively realise the right to the highest attainable standard of physical and mental health by ensuring affordable access to essential medications through the PBS.

Key Provisions

The National Health (Listed Drugs on F1 or F2) Amendment Determination (No. 4) 2026 (PB 52 of 2026) amends the National Health (Listed Drugs on F1 or F2) Determination 2021 (PB 33 of 2021). This amendment adds fruquintinib to F1 and removes fluvastatin from F2, both effective from 1 May 2026. Section 85AB(1) of the National Health Act 1953 empowers the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2, with specific criteria for each formulary as outlined in the Act. F1 is intended for single-branded drugs that meet certain conditions, while F2 is for drugs with multiple brands or in therapeutic groups with multiple brands. The obligations imposed by this Act primarily concern pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC). Pharmaceutical companies must ensure their drugs meet the criteria for F1 or F2 placement based on the Act's requirements. The PBAC has a recommendatory role, providing evidence-based recommendations that influence the allocation of drugs to the PBS formularies. These recommendations are based on consultations with affected pharmaceutical companies and other relevant experts. The Act also requires that any changes to drug placements are made through legislative instruments, ensuring transparency and adherence to the statutory framework. Breaches of the provisions in the National Health Act 1953 could lead to various consequences. Although specific offences, penalties, or civil/criminal consequences are not detailed in the explanatory statement, violations of the Act generally could result in regulatory actions, fines, or other penalties as prescribed by law. The Pharmaceutical Benefits Scheme (PBS) itself ensures compliance through its regulatory framework, which includes measures for monitoring and enforcing adherence to the Act's provisions. The penalties for non-compliance typically depend on the nature and severity of the breach but can include financial penalties or other administrative actions. This legislative instrument is compatible with human rights, particularly the right to the highest attainable standard of physical and mental health as recognised in Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights. By providing access to affordable medicines through the PBS, the Act supports the progressive realisation of this human right. The role of the PBAC ensures that decisions about drug subsidies are evidence-based, which further supports the right to health. The UN Committee on Economic, Social and Cultural Rights also supports the notion that legitimate re-direction of resources to meet the general health needs of society is permissible, provided it does not reduce existing levels of social security benefits or deny benefits to those previously entitled to them.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.