National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 9) (PB 95 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01251 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. 9)

 

PB 95 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.

 

This Instrument amends the Principal Determination by moving four currently listed F1 drugs gefitinib, hydroxycarbamide, icatibant and tadalafil to F2. In addition, it also removes three drugs daclatasvir, danazol and dipyridamole from F1 as these three drugs will no longer be PBS listed.

 

 

 

 

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

 

Gefitinib, hydroxycarbamide, icatibant and tadalafil no longer meet the criteria for F1 under subsection 85AB(3), so are required to be moved to F2. Daclatasvir, danazol and dipyridamole are being removed from the PBS at the request of the responsible persons.

 

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 consultations with experts were 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 October 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. 9)
(PB 95 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 moving four currently listed F1 drugs gefitinib, hydroxycarbamide, icatibant and tadalafil to F2. In addition, it also removes three drugs daclatasvir, danazol and dipyridamole from F1, as these three drugs will no longer be PBS listed.

 

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 2020 (No. 9) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010, which allocates drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This amendment was made under the authority of the National Health Act 1953, enacted by the Parliament of Australia, to address the need for a dynamic and responsive allocation of drugs within the PBS. The policy objective is to ensure that the PBS continues to provide access to essential medicines in a cost-effective manner, while also ensuring that decisions about the inclusion and allocation of drugs are evidence-based and consider the highest attainable standard of health for all Australians. This amendment specifically moves four drugs from F1 to F2 and removes three drugs from F1, reflecting changes in their market status and availability.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2020 (No. 9) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which governs the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This amendment pertains to specific drugs that are either moved from F1 to F2 or removed from F1 due to changes in their listing status on the PBS. The determination applies to pharmaceutical entities and their products, particularly those involved in the manufacture, supply, or listing of drugs within the PBS framework. Geographically, the application of this amendment is national, as it pertains to the PBS, a Commonwealth-administered scheme. The amendment moves gefitinib, hydroxycarbamide, icatibant, and tadalafil from F1 to F2, while removing daclatasvir, danazol, and dipyridamole from F1 as they are no longer listed on the PBS. The instrument operates under the authority granted by the National Health Act 1953 and is subject to the criteria outlined therein for the classification of drugs into F1 or F2 formularies.

Key Provisions

This amendment determination, made under the National Health Act 1953, modifies the National Health (Listed drugs on F1 or F2) Determination 2010 (section 85AB(1)) by reallocating certain drugs to different formularies within the Pharmaceutical Benefits Scheme (PBS). Specifically, it moves four drugs—gefitinib, hydroxycarbamide, icatibant, and tadalafil—from F1 to F2, while also removing three drugs—daclatasvir, danazol, and dipyridamole—from F1 because they will no longer be listed on the PBS (subsection 85AB(3)). The F1 formulary is designated for single-branded drugs, whereas F2 is intended for drugs with multiple brands or those in therapeutic groups with multiple-branded drugs, subject to certain price disclosure and supply guarantees (subsection 85AB(4) and (5)). The Act imposes several obligations on parties involved in the PBS. The Minister (or their delegate) must determine the allocation of listed drugs to the F1 or F2 formularies based on specific criteria, including the absence of bioequivalent or biosimilar brands and the drug's previous listing status (subsection 85AB(4)). Pharmaceutical companies must ensure that any drug they wish to list complies with these criteria and engage in consultations with the Pharmaceutical Benefits Advisory Committee (PBAC) to support their submissions. The PBAC, composed of experts from various health-related fields, provides recommendations that guide the Minister’s determinations. Failure to comply with the requirements set forth in the Act can lead to civil or criminal consequences, although specific penalties are not detailed in the text. The determinations made under the Act, including this amendment, are intended to ensure that the PBS operates efficiently and effectively, maintaining access to essential medicines at affordable prices for Australians. This amendment determination also engages with human rights principles, particularly the right to the highest attainable standard of physical and mental health as outlined in the International Covenant on Economic, Social and Cultural Rights. By ensuring that important medicines remain accessible and affordable, the PBS supports the progressive realisation of these human rights. The role of the PBAC in making evidence-based recommendations further ensures that the PBS remains aligned with these human rights obligations.

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