National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 12) (PB 131 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01700 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 2020 (No. 12)

 

PB 131 of 2020

 

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; apremilast and daratumumab.  In addition, it also moves two currently listed single brand combination list drugs ledipasvir with sofosbuvir and sofosbuvir with velpatasvir to F1 with the delisting and removal from F1 of the supply only drug sofosbuvir.

 

 

 

 

 

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. Apremilast and daratumumab meet the criteria for F1 under subsection 85AB(4).
Ledipasvir with sofosbuvir and sofosbuvir with velpatasvir no longer meet the criteria for CDL under subsection 85AB(5), so are required to be moved to F1. Sofosbuvir is being delisted from Supply Only as requested by the sponsor company Gilead Sciences Pty Limited.

 

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 January 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 2020 (No. 12)
(PB 131 of 2020)

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; apremilast and daratumumab.  In addition, it also moves two currently listed single brand combination list drugs ledipasvir with sofosbuvir and sofosbuvir with velpatasvir to F1 with the delisting and removal from F1 of the supply only drug sofosbuvir.

 

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.

 

 

Caroline Turnour

  Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health Act 1953, enacted by the Australian Parliament, governs the provision of health services and the Pharmaceutical Benefits Scheme (PBS). The National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 12) was introduced to address the allocation of drugs to the F1 and F2 formularies of the PBS. This legislative instrument amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding two new drugs, apremilast and daratumumab, to the F1 formulary and moving two single brand combination list drugs, ledipasvir with sofosbuvir and sofosbuvir with velpatasvir, to the F1 formulary as well. The policy objective of this determination is to ensure the most cost-effective pricing for the supply of each medicine to Australians by assigning drugs to the appropriate formularies based on their therapeutic characteristics and market competition. This amendment aligns with the human rights recognised or declared in the International Covenant on Economic, Social and Cultural Rights by providing subsidised access to medicines on the PBS, thereby assisting with the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 12) is an instrument made under the National Health Act 1953 and it amends the National Health (Listed drugs on F1 or F2) Determination 2010, which concerns the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The Act applies to the Minister for Health, the Pharmaceutical Benefits Advisory Committee (PBAC), pharmaceutical companies, and ultimately to all Australians who require access to PBS-listed medicines. The geographic reach of the Act is national, affecting all states and territories within Australia. The Act does not provide explicit exclusions or exemptions, but it does establish thresholds and criteria for drugs to be placed in either the F1 or F2 formularies. Subordinate instruments can extend or restrict the application of the Act, although the primary focus of this amendment is on the specific reallocation of certain drugs within the PBS formularies. This amendment particularly affects pharmaceutical companies involved with the newly added drugs and those whose products have been reallocated or removed from specific formularies.

Key Provisions

The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 12) (PB 131 of 2020) pertain to amendments made to the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) under subsection 85AB(1) of the National Health Act 1953 (the Act). This determination primarily involves the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) (section 85AB). The amendment adds two new drugs, apremilast and daratumumab, to the F1 formulary and moves two combination drugs, ledipasvir with sofosbuvir and sofosbuvir with velpatasvir, to F1 while removing sofosbuvir from the supply-only list (section 1). The Act imposes several obligations on parties involved. Pharmaceutical companies must ensure that any new drugs they wish to have listed on the PBS meet the criteria set out in subsection 85AB(4) for allocation to F1 or F2. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role by providing recommendations based on detailed consultations with responsible persons and reviewing submissions from pharmaceutical companies (subsection 85AB(5)). Additionally, the Minister or their delegate is empowered to determine by legislative instrument that a listed drug is on F1 or F2, provided it meets the criteria specified in the Act (subsection 85AB(1)). Breaches of the Act or the determinations made under it can lead to various consequences. The Act does not explicitly outline specific offences or penalties for non-compliance with the determinations. However, failure to comply with the conditions for PBS listing or formulary allocation can result in civil or administrative consequences, including the potential for a drug to be removed from the PBS. Moreover, non-compliance with the human rights compatibility statement may raise concerns about the legitimacy and ethical standing of the legislative instrument, potentially impacting the public's trust in the PBS and the health care system. The legislative instrument explicitly states that it is compatible with human rights as recognised in international instruments (section 4).

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