National Health (Listed drugs on F1 or F2) Amendment Determination 2023 (No. 9)

Administered by Department of Health, Disability and Ageing

Legislation au F2023L01450 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health (Listed Drugs on F1 or F2) Amendment Determination 2023 (No. 9)

 

PB 109 of 2023

 

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, trastuzumab deruxtecan from 1 November 2023.

 

 

 

 

 

 

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.

Trastuzumab deruxtecan 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 persons and the PBAC drew on the knowledge of persons with relevant expertise.

 

Commencement

 

This instrument commences on 1 November 2023.

 

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 2023 (No. 9)
(PB 109 of 2023)

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, trastuzumab deruxtecan from 1 November 2023.

 

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.

 

 

 

 

Eden Simon

 Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care

Overview

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2023 (No. 9) 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 amendment addresses the need to ensure the appropriate allocation of listed drugs to formularies that facilitate cost-effective pricing and guarantee of supply. This legislative instrument was introduced to streamline the allocation process of new drugs to the PBS, thereby ensuring Australians have timely access to essential medications while maintaining the economic sustainability of the PBS. The amendment specifically adds trastuzumab deruxtecan to the F1 formulary from 1 November 2023, reflecting its suitability under the criteria for F1 as outlined in the Act. This process involves detailed consultations with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, which ensures that decisions are evidence-based and aligned with public health objectives.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2023 (No. 9) is an instrument made under the National Health Act 1953, and it amends the National Health (Listed Drugs on F1 or F2) Determination 2021. This legislation pertains specifically to the allocation of drugs to the F1 and F2 formularies within the Pharmaceutical Benefits Scheme (PBS). The Act applies to pharmaceutical companies and the drugs they list for consideration under the PBS, particularly focusing on the criteria for F1 and F2 formularies. These formularies are designed to ensure the efficient and cost-effective supply of single-branded and multi-branded drugs, respectively. The amendment adds the drug trastuzumab deruxtecan to the F1 formulary from 1 November 2023. The geographic scope of this Act is national, applying across Australia and overseen by the Commonwealth. The determination is made following consultations with the relevant pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, which includes experts from various healthcare fields. No specific exclusions or thresholds are detailed in this amendment; however, it is contingent upon the drug meeting the criteria specified under the Act for allocation to either F1 or F2.

Key Provisions

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2023 (No. 9) amends the National Health (Listed Drugs on F1 or F2) Determination 2021 (Principal Determination), as stated in subsection 85AB(1) of the National Health Act 1953 (the Act). This amendment adds one new drug, trastuzumab deruxtecan, to the F1 formulary effective from 1 November 2023. The F1 formulary is designated for single-branded drugs, while F2 is intended for drugs with multiple brands or those in a therapeutic group with other multiple-brand drugs. Drugs on F2 must comply with price disclosure and supply guarantee provisions under the Act. The determination imposes specific obligations on the parties involved, particularly pharmaceutical companies. Before a drug can be listed on the Pharmaceutical Benefits Scheme (PBS) and allocated to a formulary, extensive consultations must occur with the responsible person and recommendations must be sought from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC comprises members from various relevant interests, including consumers, health economists, and medical professionals, ensuring decisions are evidence-based. The Act requires that any drug placed on F1 must meet the criteria specified in subsection 85AB(4), such as having no bioequivalent or biosimilar listed brands and not having been on F2 the day before the determination comes into effect. Trastuzumab deruxtecan meets these criteria, hence its inclusion on F1. Failure to comply with the provisions of the Act can result in various civil and criminal consequences. Although specific penalties are not detailed in this amendment, the overarching Act and associated regulations may impose fines or other penalties for non-compliance. It is essential for pharmaceutical companies and other affected parties to adhere to the legislative requirements to avoid these potential consequences. The amendments aim to ensure that the PBS remains effective in providing affordable access to essential medications, thereby protecting public health. The legislative instrument aligns with human rights obligations, particularly under 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 facilitate cost-effective pricing, the amendments support the right to the highest attainable standard of physical and mental health, as well as the right to social security. The involvement of the PBAC in the decision-making process further ensures that access to these medications is evidence-based, thereby reinforcing the protection of human rights within the legislative framework.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Regulatory Standards
Licensing & Registration
Compliance Obligations

Interactions

Authorises

All Versions

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.