National Health (Listed drugs on F1 or F2) Amendment Determination 2022 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2022L00199 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. 2)

 

PB 18 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, gemtuzumab ozogamicin, molnupiravir, ravulizumab and zanubrutinib. 

 

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.  Gemtuzumab ozogamicin, molnupiravir, ravulizumab and zanubrutinib 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 March 2022.

 

This Instrument constitutes a legislative instrument for the purpose 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. 2)
(PB 18 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, gemtuzumab ozogamicin, molnupiravir, ravulizumab and zanubrutinib.

 

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.

 

 

Nikolai Tsyganov

  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. 2) amends 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). Enacted by the Parliament of Australia under subsection 85AB(1) of the National Health Act 1953, this determination responds to the need for a structured approach to the allocation of PBS listed drugs, ensuring that they are assigned to appropriate formularies to manage costs and ensure access to essential medicines. This amendment adds four new drugs—gemtuzumab ozogamicin, molnupiravir, ravulizumab, and zanubrutinib—to the F1 formulary, which is designated for single-branded drugs, ensuring they meet the criteria set out in the Act for inclusion in F1. The policy objective is to enhance the efficiency and effectiveness of the PBS by appropriately categorising drugs, thereby facilitating better access to necessary medications for the Australian population. This legislative instrument was developed following consultations with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, which ensures that decisions are evidence-based and consider the needs of various stakeholders. The determination is compatible with human rights as it supports the right to the highest attainable standard of physical and mental health by providing subsidised access to medicines through the PBS. The involvement of the Pharmaceutical Benefits Advisory Committee, which includes experts from diverse fields, further ensures that the decisions are well-informed and aligned with the broader objectives of social security and health equity.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2022 (No. 2) amends the National Health (Listed Drugs on F1 or F2) Determination 2021, which deals with the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This amendment applies to pharmaceutical companies with new medicines listed on the PBS and adds four new drugs—gemtuzumab ozogamicin, molnupiravir, ravulizumab, and zanubrutinib—to the F1 formulary. These drugs meet the criteria for F1, which requires the absence of bioequivalent or biosimilar listed brands and that the drug was not on F2 the day before the determination comes into effect. The amendment is in line with the human rights recognised in international instruments, particularly by supporting access to essential health care through the PBS and ensuring decisions about drug subsidies are evidence-based. The determination commenced on 1 March 2022 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 2022 (No. 2) (PB 18 of 2022) include the amendment of the National Health (Listed Drugs on F1 or F2) Determination 2021 (PB 33 of 2021) (the Principal Determination). This amendment adds four new drugs—gemtuzumab ozogamicin, molnupiravir, ravulizumab, and zanubrutinib—to the F1 formulary of the Pharmaceutical Benefits Scheme (PBS). This is done under subsection 85AB(1) of the National Health Act 1953 (the Act), which allows the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2. The criteria for F1 require 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. The drug must also not have been on F2 the day before the determination comes into effect. The obligations imposed by this Act on the parties it governs are primarily related to the allocation and pricing of drugs within the PBS. Pharmaceutical companies must engage in detailed consultations about their drugs with the responsible person and follow the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, which comprises experts from various relevant fields, ensures that decisions about the inclusion of drugs on the PBS are evidence-based. Additionally, the Act ensures that drugs on F2 are subject to provisions relating to price disclosure and guarantee of supply. This ensures that patients have access to these drugs at a reasonable cost and with assured supply. There are no explicit offences, penalties, or civil/criminal consequences mentioned for breaches of this determination. However, the Act provides a framework within which the PBS operates, ensuring that drugs are allocated to the most appropriate formularies based on their therapeutic and economic characteristics. The determination ensures that the PBS continues to provide cost-effective access to clinically important medicines, thereby supporting the broader objectives of the National Health Act 1953. The legislative instrument is compatible with human rights, as it assists in the progressive realisation of the right to the highest attainable standard of physical and mental health, and ensures access to essential health care through the PBS.

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