National Health (Listed drugs on F1 or F2) Amendment Determination 2021 (No. 2) (PB 19 of 2021)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00148 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 2021 (No. 2)

 

PB 19 of 2021

 

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

 

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 two new drugs dupilumab and ozanimod.  

 

Variation and revocation

 

Unless there is an express power to revoke or vary PB 93 of 2010 cited in this Instrument, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 93 of 2010.

 

Consultation

 

This instrument affects pharmaceutical companies with new medicines listing on the PBS. Dupilumab and ozanimod 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 2021.

 

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 2021 (No. 2)
(PB 19 of 2021)

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 2010 (PB 93 of 2010) (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 two new drugs dupilumab and ozanimod. 

 

Human rights implications

This Legislative Instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) 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 advancement of this human right by providing for subsidised access of medicines to patients. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

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.

 

 

Thea Connolly

  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 2021 (No. 2) amends the National Health (Listed drugs on F1 or F2) Determination 2010 to allocate two new drugs, dupilumab and ozanimod, to the F1 formulary of the Pharmaceutical Benefits Scheme (PBS). The National Health Act 1953 governs the PBS, which provides subsidised access to medicines for Australians. The F1 formulary is designated for drugs with a single brand, while F2 is for drugs with multiple brands or in therapeutic groups with multiple brands. This amendment was made to ensure these new drugs meet the criteria for F1 placement, which requires that there are no bioequivalent or biosimilar drugs in the same therapeutic group. The determination was enacted by the Minister for Health under the authority of the National Health Act 1953, aiming to align the PBS with the latest therapeutic needs and ensure cost-effective pricing for patients. The policy objective is to maintain high standards of healthcare by providing access to necessary medicines through a structured and evidence-based formulary system.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2021 (No. 2) 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). This amendment applies to pharmaceutical companies and entities involved in the PBS, specifically affecting new drugs listed on the PBS. The amendment adds two new drugs, dupilumab and ozanimod, to the F1 formulary, which is designated for single-branded drugs. This determination is applicable across Australia, as it is a legislative instrument made under the authority of the Commonwealth and impacts the nationwide PBS. The Act ensures that the placement of drugs into the F1 or F2 formularies is based on specific criteria, such as the absence of bioequivalent or biosimilar listed brands and prior placement on F2. The instrument does not specify exclusions but relies on the criteria outlined in the Act and the Principal Determination. The commencement of this amendment is set for 1 March 2021, and it constitutes a legislative instrument under the Legislation Act 2003. This amendment is compatible with human rights, as it supports the right to the highest attainable standard of physical and mental health by ensuring accessible and cost-effective access to essential medicines through the PBS.

Key Provisions

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 2) amends the National Health (Listed Drugs on F1 or F2) Determination 2010 (referred to as the Principal Determination) by adding two new drugs, dupilumab and ozanimod, to the F1 formulary of the Pharmaceutical Benefits Scheme (PBS) (subsection 85AB(1) of the National Health Act 1953). The F1 formulary is for single branded drugs, while the F2 formulary is for drugs with multiple brands or those in a therapeutic group with multiple brands (subsection 85AB(3) and (4) of the Act). The amendment ensures that these drugs are subject to the provisions of the Act relating to price disclosure and guarantee of supply. The obligations under this Amendment Determination include ensuring that pharmaceutical companies consult with the responsible person and obtain recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) before a drug is listed on the PBS and allocated to a formulary (subsection 85AB(5) of the Act). The PBAC comprises experts from various fields such as consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. This ensures that decisions about the subsidy of medicines on the PBS are evidence-based. The National Health Act 1953 does not explicitly outline specific offences, penalties, or civil/criminal consequences for breach in relation to this Amendment Determination. However, general provisions within the Act and associated regulations may apply to breaches involving the listing and allocation of drugs to the PBS formularies. Penalties for breaches of the Act and its regulations can include fines and imprisonment, depending on the severity of the offence. The maximum penalties for specific breaches are outlined in relevant sections of the Act and associated regulations. The amendment aligns with the human rights framework by facilitating access to essential medicines, thereby supporting the right to the highest attainable standard of physical and mental health as recognised in the International Covenant on Economic, Social and Cultural Rights. By ensuring that these drugs are available through the PBS, the Act promotes equitable access to healthcare for all Australians.

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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.