National Health (Listed drugs on F1 or F2) Amendment Determination 2021 (No. 1) (PB 6 of 2021)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00078 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. 1)

 

PB 6 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 one new drug selexipag.  In addition, it also moves one currently listed F1 drug methenamine to F2.

 

 

 

 

 

 

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. Selexipag meets the criteria for F1 under subsection 85AB(4). Methenamine 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 February 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. 1)
(PB 6 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 one new drug selexipag.  In addition, it also moves one currently listed F1 drug methenamine to F2.

 

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. 1) was enacted under subsection 85AB(1) of the National Health Act 1953 to amend the National Health (Listed drugs on F1 or F2) Determination 2010. This amendment serves to update the allocation of drugs within the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS), which are designed for single-branded drugs and those with multiple brands or in therapeutic groups with other multiple-branded drugs, respectively. The National Health Act 1953 allows for the assignment of PBS-listed drugs to these formularies, with F2 drugs also subject to specific provisions regarding price disclosure and guaranteed supply. The purpose of this amendment is to address the need for updates in the allocation of certain drugs to ensure cost-effective pricing and access to essential medicines. The instrument commenced on 1 February 2021 and was made by the Minister for Health under the authority of the relevant legislation. The amendments involve adding the new drug selexipag to F1 and moving methenamine from F1 to F2, reflecting changes in their therapeutic and market status.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 1) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This legislation applies to pharmaceutical companies with new medicines listed on the PBS, specifically targeting those entities responsible for placing new drugs within the specified formularies. The amendment adds the drug selexipag to F1 and moves the drug methenamine from F1 to F2, thus affecting the availability and pricing of these drugs within the PBS framework. The changes are geographically and jurisdictionally applicable throughout Australia as the PBS is a national scheme. The determination does not introduce any new exclusions, exemptions, or thresholds; however, it does rely on existing criteria set out in the National Health Act 1953 for the classification of drugs into F1 or F2. The Act empowers the Minister (or delegate) to determine by legislative instrument the placement of listed drugs on F1 or F2, thereby extending or restricting application through subordinate instruments.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2021 (No. 1) (PB 6 of 2021) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) by adjusting the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS) formularies. Specifically, the amendment adds the drug selexipag to the F1 formulary, which is reserved for drugs that have a single brand and meet specific criteria, and moves the drug methenamine from F1 to F2, which is for drugs with multiple brands or in therapeutic groups with other drugs with multiple brands (subsection 85AB(3) and (4) of the National Health Act 1953). These changes are effective from 1 February 2021. Under the National Health Act 1953, entities such as pharmaceutical companies must ensure their drugs comply with the criteria for placement in either F1 or F2. For instance, a drug must meet certain conditions, such as having no bioequivalent or biosimilar listed brands and not having been on F2 the day before the determination comes into effect, to be placed on F1. Conversely, a drug may only be placed on F2 if it does not satisfy the criteria for F1. The Act also mandates that before a drug can be listed on the PBS and assigned to a formulary, there must be consultations with the responsible person and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, composed of members from various relevant fields, plays a critical role in advising on the suitability of drugs for the PBS. The National Health Act 1953 imposes penalties for non-compliance with the provisions governing the PBS. While specific penalties for breaches related to the formulary placement are not detailed in the Explanatory Statement, general penalties under the Act can include fines and other civil or criminal consequences depending on the nature and severity of the breach. The Act also allows for the revocation or variation of the Principal Determination, ensuring that the PBS can adapt to changes in medical evidence and market conditions. The amendment to the Principal Determination by adding selexipag to F1 and moving methenamine to F2 reflects an ongoing effort to manage the cost and availability of pharmaceutical products within the PBS. This adjustment ensures that the PBS continues to provide access to essential medicines in a manner that is both clinically effective and financially sustainable for the Australian healthcare system. The process of determining drug placements involves detailed consultation with stakeholders, including pharmaceutical companies and the PBAC, ensuring that decisions are evidence-based and aligned with public health objectives.

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