National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 7)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01371 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. 7)

 

PB 103 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 two new drugs, brolucizumab and ofatumumab and also removes three currently listed drugs, nadroparin, nedocromil and nilutamide, from F1 as these drugs will no longer be PBS listed. In addition, it also moves three currently listed F1 drugs: darunavir, sunitinib and teriparatide to F2.  It also removes two supply only drugs, cefalotin and cimetidine from F2 as these drugs 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.  Brolucizumab and ofatumumab meet the criteria for F1 under subsection 85AB(4). Nadroparin, nedocromil, nilutamide, cefalotin and cimetidine are being removed from the PBS at the request of the responsible persons. Darunavir, sunitinib and teriparatide no longer meet the criteria for F1 under subsection 85AB(3), so are 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 October 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. 7)
(PB 103 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 two new drugs, brolucizumab and ofatumumab and also removes three currently listed drugs, nadroparin, nedocromil and nilutamide, from F1 as these drugs will no longer be PBS listed. In addition, it also moves three currently listed F1 drugs: darunavir, sunitinib and teriparatide to F2.  It also removes two supply only drugs, cefalotin and cimetidine from F2 as these drugs 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 (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 7) was enacted by the Australian government to amend the National Health (Listed Drugs on F1 or F2) Determination 2021. This amendment aims to address the need for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The determination is made under the authority of subsection 85AB(1) of the National Health Act 1953, and the policy objective is to ensure the most cost-effective pricing for the supply of each medicine to Australians. This legislative instrument adds two new drugs to F1, removes three drugs from F1, and moves three drugs from F1 to F2, while also removing two supply only drugs from F2. The Pharmaceutical Benefits Advisory Committee plays a crucial role in providing recommendations for the allocation of drugs on the PBS, ensuring that decisions about subsidised access to medicines are evidence-based. This amendment aligns with the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation of the right to the highest attainable standard of physical and mental health. By retaining clinically important medicines on the PBS and placing them in formularies that ensure the most cost-effective pricing, human rights continue to be protected. The Pharmaceutical Benefits Advisory Committee's recommendatory role ensures that decisions about subsidised access to medicines on the PBS are evidence-based, and the human rights implications of this legislative instrument are compatible with the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 7) amends the National Health (Listed Drugs on F1 or F2) Determination 2021, which governs the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. The amendment affects pharmaceutical companies with new medicines listed on the PBS by adding brolucizumab and ofatumumab to F1, while removing nadroparin, nedocromil, and nilutamide from F1 as these drugs are no longer PBS listed. Additionally, it moves darunavir, sunitinib, and teriparatide from F1 to F2, and removes cefalotin and cimetidine from F2, as these drugs are also no longer PBS listed. The amendments are made under the authority of the National Health Act 1953 and are effective from 1 October 2021. The Act applies nationally across Australia, and the amendments are made through subordinate instruments, thereby extending the application of the Act to the newly allocated drugs. There are no stated exclusions, exemptions, or thresholds in this amendment, and it is compatible with human rights as it ensures continued access to clinically important medicines on the PBS.

Key Provisions

The main operative sections of the National Health (Listed Drugs on F1 or F2) Amendment Determination 2021 (No. 7) (PB 103 of 2021) are sections 2 and 3. Section 2 amends the National Health (Listed Drugs on F1 or F2) Determination 2021 by adding two new drugs, brolucizumab and ofatumumab, to F1, while removing three drugs, nadroparin, nedocromil, and nilutamide, from F1. Additionally, it moves three drugs, darunavir, sunitinib, and teriparatide, from F1 to F2. Section 3 removes two supply-only drugs, cefalotin and cimetidine, from F2 as these drugs are no longer listed on the PBS. The determination imposes specific obligations on pharmaceutical companies and entities involved in the listing and allocation of drugs to the PBS formularies. Pharmaceutical companies must ensure that their drugs meet the criteria for either F1 or F2 formularies, as specified under subsection 85AB(4) and (3) of the National Health Act 1953. The responsible persons for the drugs must comply with the provisions of the Act and the determination to ensure appropriate classification and listing on the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) is also involved in the process, providing recommendations based on evidence and expert advice to support the appropriate allocation of drugs to the formularies. There are no specific offences, penalties, or civil/criminal consequences outlined in this determination for breach of its provisions. However, non-compliance with the requirements of the National Health Act 1953 or the determination could potentially lead to regulatory action by the relevant authorities, such as the Therapeutic Goods Administration (TGA) or the Department of Health. These actions may include the revocation of PBS listing or other administrative penalties, as appropriate. The determination itself does not specify maximum penalties for breach, but such penalties would be determined under the relevant legislation and regulatory frameworks governing the PBS and the TGA.

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