National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 8) (PB 84 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01087 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. 8)

 

PB 84 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 listed drugs may be assigned to formularies identified as F1 and F2. 

F1 is intended for single brand 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.

 

This Instrument amends the Principal Determination by adding to F1 one new drug, acalabrutinib.

 

 

 

 

 

 

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.  Acalabrutinib meets the criteria for F1 set out in section 85AB(4) of the Act.

 

Before this drug was listed and allocated to the F1 formulary, there were detailed consultations about the drug with the responsible person, and a recommendation was received 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 consultations with experts was undertaken regarding this determination because consultation with the affected responsible person and the PBAC drew on the knowledge of persons with relevant expertise.

 

Commencement

 

This Instrument commences on 1 September 2020.

 

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. 8)
(PB 84 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 one new drug, acalabrutinib. 

 

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 is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. 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 on the PBS clinically important medicines and placing them in formularies that ensure the most cost effective pricing for supply of each medicine to Australians.

 

 

Thea Daniel

  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 2020 (No. 8) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010 under the National Health Act 1953. This amendment was made to add the drug acalabrutinib to the F1 formulary of the Pharmaceutical Benefits Scheme (PBS). The National Health Act 1953 provides for the allocation of drugs to the F1 and F2 formularies of the PBS, with F1 intended for single brand drugs and F2 for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands. The purpose of this amendment was to ensure that acalabrutinib, which meets the criteria for F1, is included in the F1 formulary to provide patients with access to the most cost-effective pricing for the drug. This legislative instrument was made by the Minister for Health under subsection 85AB(1) of the National Health Act 1953, and it engages Article 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.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2020 (No. 8) amends the National Health (Listed Drugs on F1 or F2) Determination 2010, which pertains to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This legislative instrument applies to the Minister for Health or their delegate, pharmaceutical companies, and the Pharmaceutical Benefits Advisory Committee (PBAC). The instrument primarily affects pharmaceutical companies with new medicines seeking listing on the PBS. The amendment involves adding the drug acalabrutinib to the F1 formulary, which is intended for single brand drugs that meet specific criteria, including the absence of bioequivalent or biosimilar brands and not having been on the F2 formulary previously. The amendment extends the application of the National Health Act 1953 across Australia, ensuring uniform regulation and access to the PBS. The instrument does not include any exclusions or exemptions, and its scope is strictly defined by the criteria for inclusion in the F1 or F2 formularies. The commencement date of 1 September 2020 activates the changes, and the legislative instrument complies with human rights standards by facilitating access to essential medications under the PBS, thereby promoting the highest attainable standard of physical and mental health.

Key Provisions

The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 8) (PB 84 of 2020) amend the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010). Specifically, this amendment adds the drug acalabrutinib to the F1 formulary of the Pharmaceutical Benefits Scheme (PBS) (section 2). Section 85AB(1) of the National Health Act 1953 provides the authority for this amendment, enabling the Minister or a delegate to determine by legislative instrument that a listed drug is on F1 or F2. The criteria for F1, as set out in subsection 85AB(4) of the Act, require that there are no listed brands of pharmaceutical items that have the drug that are bioequivalent or biosimilar, and that the drug was not on F2 the day before the determination comes into effect. The obligations imposed by this amendment primarily concern pharmaceutical companies that have new medicines listed on the PBS. The amendment requires these companies to ensure that their drugs meet the criteria for inclusion in the F1 or F2 formulary as specified by the Act. For acalabrutinib, this means satisfying the conditions that there are no bioequivalent or biosimilar brands and that it was not on F2 prior to the determination. The amendment also mandates consultation with the relevant stakeholders, including the Pharmaceutical Benefits Advisory Committee (PBAC), which provides recommendations based on evidence-based considerations. There are no specific offences, penalties, or civil/criminal consequences mentioned for breaches of this amendment. However, the broader legislative framework under the National Health Act 1953 may include provisions for penalties related to non-compliance with the Act’s requirements. Typically, breaches of the Act could lead to fines or other sanctions, though the exact penalties would depend on the specific nature of the breach and other relevant legal provisions. In summary, this amendment introduces acalabrutinib into the F1 formulary of the PBS, ensuring that it meets the specified criteria for cost-effective and accessible pharmaceutical benefits. It imposes obligations on pharmaceutical companies to ensure their drugs comply with the Act’s requirements and mandates consultation with the PBAC to ensure decisions are evidence-based. While the amendment itself does not detail specific penalties for non-compliance, the overarching legislative framework may include provisions for sanctions in case of breaches.

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