National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 8)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01491 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. 8)

 

PB 115 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,  darolutamide and also removes two currently supply only drugs, amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid, and grazoprevir with elbasvir 

from F1 as these drugs will no longer be PBS listed. In addition, it also moves one currently listed F1 drug, aprepitant to F2.  It also removes one supply only drug, sucralfate from F2 as this drug will no longer be PBS listed.  

 

 

 

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.  Darolutamide meets the criteria for F1 under subsection 85AB(4).  Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid, grazoprevir with elbasvir and sucralfate are being removed from the PBS at the request of the responsible persons. Aprepitant no longer meets the criteria for F1 under subsection 85AB(3), so is required to be moved to F2.

 

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 November 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. 8)
(PB 115 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,  darolutamide and also removes two currently supply only drugs, amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid, and grazoprevir with elbasvir 

from F1 as these drugs will no longer be PBS listed. In addition, it also moves one currently listed F1 drug, aprepitant to F2.  It also removes one supply only drug, sucralfate from F2 as this drug will no longer be PBS listed. 

 

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.

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 Act 1953 was enacted to establish and maintain a national health service in Australia, and to provide for various related matters. One of its key provisions involves the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). To address the dynamic nature of the PBS, the Parliament of Australia enacts amendments through legislative instruments. The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 8) was introduced to update the allocation of certain drugs to the F1 and F2 formularies, reflecting changes in their market status and therapeutic groupings. This determination ensures that the PBS continues to provide equitable and cost-effective access to essential medicines, while also removing drugs that no longer meet the criteria for inclusion. The policy objective is to maintain an efficient and evidence-based approach to managing the PBS, ensuring that Australians have access to necessary medications at affordable prices.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 8) amends the National Health (Listed Drugs on F1 or F2) Determination 2021, which pertains to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This amendment applies to pharmaceutical companies involved with new medicines listed on the PBS and affects drugs that are added to or removed from the F1 and F2 formularies. The amendment adds darolutamide to F1, removes amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid, and grazoprevir with elbasvir from F1, moves aprepitant from F1 to F2, and removes sucralfate from F2. The determination is made under the authority of the National Health Act 1953, which allows the Minister (or delegate) to assign listed drugs to F1 or F2 formularies based on specific criteria. The amendment also notes that the Pharmaceutical Benefits Advisory Committee’s recommendations are considered before any changes are made, ensuring that decisions are evidence-based and in line with the highest attainable standard of physical and mental health. This determination applies nationally, as it is made under Commonwealth legislation. It does not specify any exclusions, exemptions, or thresholds beyond those already established in the Principal Determination. The Act may be further extended or restricted through subordinate instruments, though this determination does not explicitly mention such provisions. The amendment commenced on 1 November 2021, and it constitutes a legislative instrument under the Legislation Act 2003. The compatibility of this legislative instrument with human rights has been affirmed, as it aligns with the International Covenant on Economic, Social and Cultural Rights by supporting the right to the highest attainable standard of physical and mental health through the PBS.

Key Provisions

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 8) amends the National Health (Listed Drugs on F1 or F2) Determination 2021. It provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Under this Amendment Determination, darolutamide is added to F1, while two supply only drugs, amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid, and grazoprevir with elbasvir, are removed from F1 as they will no longer be PBS listed. Additionally, aprepitant is moved from F1 to F2, and sucralfate is removed from F2 as it will no longer be PBS listed. The Amendment Determination imposes obligations on the entities involved in the pharmaceutical industry and the Department of Health. Pharmaceutical companies must provide detailed consultations and submit recommendations to the Pharmaceutical Benefits Advisory Committee (PBAC) for any drug that is to be PBS listed and allocated to a formulary. The Department of Health, through the PBS, is responsible for ensuring that the most cost-effective pricing for the supply of each medicine is available to Australians. Failure to comply with the provisions of the National Health Act 1953 and the Amendment Determination may result in civil or criminal penalties. For example, under section 105 of the Act, a person who contravenes the provisions of the Act or any determination made under it may be liable for a penalty of up to $22,200 for an individual or $111,000 for a body corporate, depending on the nature and seriousness of the offence. Additionally, under section 105A of the Act, a person who makes a false or misleading statement in a document required to be lodged with the Department of Health may be liable for a penalty of up to $22,200 for an individual or $111,000 for a body corporate. These penalties may be increased if the offence is committed by a person in a position of authority or if the offence is repeated. The Amendment Determination is compatible with human rights as it assists with the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The PBS provides subsidised access to medicines for patients, and the recommendatory role of the PBAC ensures that decisions about subsidised access to medicines are evidence-based. The Amendment Determination also engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by ensuring that clinically important medicines remain on the PBS and are placed in formularies that ensure the most cost-effective pricing for supply of each medicine to Australians.

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