National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 3)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00524 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. 3)

 

PB 45 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 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, cannabidiol.  

 

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 a pharmaceutical company with a new medicine listing on the PBS. Cannabidiol meets 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 person and the PBAC drew on the knowledge of persons with relevant expertise.

 

Commencement

 

This Instrument commences on 1 May 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. 3)
(PB 45 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 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 cannabidiol. 

 

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. 3) (PB 45 of 2021) 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) under the National Health Act 1953. This amendment introduces cannabidiol into the F1 formulary, which is intended for single branded drugs. The determination is made by the Minister or their delegate under subsection 85AB(1) of the Act, and it follows consultations with the relevant pharmaceutical company and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The instrument aims to ensure that the PBS provides subsidised access to medicines, thereby contributing to the progressive realisation of the right to the highest attainable standard of physical and mental health as recognised under the International Covenant on Economic, Social and Cultural Rights. The determination is compatible with human rights, ensuring that the most cost-effective pricing is maintained for the supply of medicines to Australians.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 3) 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). The National Health Act 1953, under which this instrument is made, applies to the Commonwealth of Australia. The Act provides for the regulation of the supply and pricing of PBS listed drugs, and this amendment specifically pertains to the allocation of cannabidiol to the F1 formulary, which is intended for drugs with a single brand. The determination ensures that cannabidiol meets the criteria for F1, which includes having no bioequivalent or biosimilar brands and not having been on F2 previously. The amendment is made under the authority of the Minister for Health or a delegate, as specified in the Act. This instrument commences on 1 May 2021 and constitutes a legislative instrument under the Legislation Act 2003. It is compatible with human rights, particularly engaging with the International Covenant on Economic, Social and Cultural Rights by facilitating access to affordable medicines.

Key Provisions

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 3) (PB 45 of 2021) amends the National Health (Listed Drugs on F1 or F2) Determination 2021 (PB 33 of 2021) (the Principal Determination) under subsection 85AB(1) of the National Health Act 1953 (the Act). This amendment pertains specifically to the allocation of drugs within the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The F1 formulary is designated for single-branded drugs, while the F2 formulary is for drugs that have multiple brands or are part of a therapeutic group with other multi-branded drugs. Drugs on F2 are subject to the Act's provisions related to price disclosure and the guarantee of supply. This Amendment Determination introduces cannabidiol to the F1 formulary, ensuring it meets the criteria outlined in subsection 85AB(4) of the Act. The obligations and requirements imposed by the Amendment Determination are primarily directed at pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC). Pharmaceutical companies must ensure their drugs meet the criteria for placement in either the F1 or F2 formulary, as specified in the Act. The PBAC, composed of experts from various healthcare-related fields, plays a critical role in recommending the suitability of drugs for the PBS and their placement in the appropriate formulary. Before a drug can be listed on the PBS and allocated to a formulary, extensive consultations with the responsible person and recommendations from the PBAC are necessary. These consultations ensure that the drug's listing and formulary placement are evidence-based and in the best interest of public health. In terms of legal consequences, the Act does not explicitly outline offences, penalties, or civil/criminal consequences for breaches of the formulary placement criteria or the recommendations of the PBAC. However, the overarching National Health Act 1953 and associated regulations provide a framework for enforcement, including potential administrative actions and financial penalties for non-compliance with PBS requirements. Additionally, the legislation ensures that the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised in international human rights instruments, is upheld through the subsidised access to medicines facilitated by the PBS. This legislative framework protects human rights by maintaining clinically important medicines on the PBS and ensuring cost-effective pricing for 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.