National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 2) 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L01017 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 100 OF 2025

 

NATIONAL HEALTH ACT 1953

National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 2) 2025

Purpose

 

The purpose of this legislative instrument, made under section 84AH of the National Health Act 1953 (the Act), is to amend the legislative instrument titled National Health (Pharmaceutical Benefits Scheme-Exempt items – Section 84 AH) Determination 2017 (PB 81 of 2017) to make changes to the pharmaceutical items that are determined to be exempt items.

 

Background

 

Part VII of the Act is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely and affordable access to a wide range of medicines for all Australians.

 

Drugs and medicinal preparations to which Part VII applies are declared as such by the Minister, by legislative instrument under subsection 85(2) of the Act. These are listed drugs (as defined in subsection 84(1)). The Minister may also determine by legislative instrument the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)) and the manner of administration of the form of the listed drug so determined (subsection 85(5)). If a drug has a declaration under subsection 85(2) in force in respect of it and determinations under subsections 85(3) and 85(5) in force in respect of it, then that declared drug in that determined form with that determined manner of administration is a pharmaceutical item. The Minister may also determine, by legislative instrument, brands of pharmaceutical items (subsection 85(6)).

 

Section 84AH empowers the Minister to determine, by legislative instrument, that a pharmaceutical item is an ‘exempt item’ if the pharmaceutical item satisfies the criteria in section 84AH. The criteria in section 84AH are as follows:

  1.    that there is only one listed brand of the relevant pharmaceutical item; and
  2.    there are no listed brands of other pharmaceutical items that are bioequivalent or biosimilar to the one listed brand of the relevant pharmaceutical item; and
  3.    there is at least one other pharmaceutical item that has the same listed drug as the relevant pharmaceutical item; and
  4.    the Minister is satisfied (having regard to advice, if any, from the Pharmaceutical Benefits Advisory Committee that:
    1.       the listed drug in the relevant pharmaceutical item represents suitable therapy for a particular patient population; and
    2.       the relevant pharmaceutical item is suitable for use by a particular subgroup of that population because of either or both of the form and manner of administration; and
    3.       no other pharmaceutical item that has that drug is suitable for use by that subgroup because of either or both of the form and manner of administration of the drug in that other item.

 

The effect of a pharmaceutical item being determined to be an exempt item is that the listed brand of that pharmaceutical item is excluded from certain statutory price reductions and price disclosure requirements under Divisions 3A and 3B of Part VII of the Act. The intention is to encourage the availability of certain pharmaceutical items with particular formulations of drugs that are used by a demographic subgroup (e.g. children or geriatric patients) for whom other formulations of the drug are not suitable.

 

Changes to PB 81 of 2017 made by this instrument

 

This instrument makes the following changes to PB 81 of 2017:

 

One pharmaceutical item (listed drug = Artemether with lumefantrine, form = Tablet (dispersible) 20 mg‑120 mg, manner of administration = Oral) is no longer determined to be an exempt item because it is delisting from the PBS as requested by the responsible person.  

 

Variation and revocation

Unless there is an express power to revoke or vary PB 81 of 2017 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 81 of 2017.

 

Consultation

Consultation on the Amending Determination has taken place with the relevant pharmaceutical company regarding the removal of exempt status on the specified form of artemether with lumefantrine.  Advice from the Pharmaceutical Benefits Advisory Committee (PBAC) was requested regarding the delisting of the specified form of artemether with lumefantrine. 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. The PBAC considered that the deletion of artemether with lumefantrine dispersible tablet would not result in an unmet clinical need.  No additional consultations with experts was undertaken regarding this determination because consultation with the affected company drew on the knowledge of persons with relevant expertise.

General

This instrument commences on 1 September 2025.

This instrument is a legislative instrument for the purposes 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 (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 2) 2025 (PB 100 of 2025)

 

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 National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Determination 2017 (the Principal Determination) determines exempt pharmaceutical items. This instrument (the Amending Determination) amends the principal determination which provides for the allocation of drugs to the exempt list if the pharmaceutical item satisfies the criteria in section 84AH of the National Health Act 1953 (the Act).

This instrument amends the principal determination by removing the specified form of the drug artemether with lumefantrine from the exempt list because it is delisting from the Pharmaceutical Benefits Scheme (PBS) as requested by the responsible person. 

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 is a benefit scheme which assists with providing subsidised access to medicines for people. This is a positive and supportive step towards attaining the highest standard of health for all Australians. Determining exempt items under section 84AH of the Act encourages the availability of certain pharmaceutical items with particular formulations of drugs that are used by a demographic subgroup (e.g. children or geriatric patients) for whom other formulations of the drug are not suitable. 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 on the PBS clinically important medicines and maintaining exemptions from pricing reductions only where appropriate under the legislation.

 

Rebecca Richardson

Assistant Secretary

PBS Listing, Pricing and Policy Branch

Technology Assessment and Access Division
Department of Health, Disability and Ageing

Overview

The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 2) 2025, enacted under the National Health Act 1953, seeks to address the need for certain pharmaceutical items to be exempt from specific statutory price reductions and disclosure requirements. This amendment, introduced by the Australian government, aims to ensure the availability of pharmaceutical items with particular formulations that cater to specific demographic subgroups, such as children or geriatric patients, for whom other formulations may not be suitable. This legislative instrument was made by the Minister for Health and Aged Care under the authority provided by section 84AH of the Act. The policy objective is to facilitate access to medicines that are most beneficial to particular patient populations, ensuring that suitable formulations are maintained within the Pharmaceutical Benefits Scheme (PBS). This determination amends the National Health (Pharmaceutical Benefits Scheme-Exempt items – Section 84AH) Determination 2017 by removing the specified form of artemether with lumefantrine from the exempt list due to its delisting from the PBS. This change was made following consultation with the relevant pharmaceutical company and advice from the Pharmaceutical Benefits Advisory Committee, which confirmed that the removal of this item would not result in an unmet clinical need. This legislative instrument is designed to be compatible with human rights, 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.

Scope and Application

The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 2) 2025 amends the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953, specifically targeting the exemption criteria for certain pharmaceutical items. This determination applies to pharmaceutical items that are listed under the PBS and are subject to the criteria outlined in section 84AH of the Act. The Act applies to all pharmaceutical items listed under the PBS, which are primarily entities and brands of drugs and medicinal preparations determined by the Minister. The geographic reach of this legislation is national, encompassing all states and territories within Australia. The determination removes the specified form of the drug artemether with lumefantrine from the exempt list as it is being delisted from the PBS at the request of the responsible person. This amendment is made to ensure that the PBS continues to provide suitable access to medicines for all Australians, particularly for demographic subgroups such as children or geriatric patients, for whom other formulations of the drug are not suitable. The instrument is compatible with human rights by supporting access to medicines and promoting the highest attainable standard of health. The instrument operates under the authority granted by the National Health Act 1953 and is subject to variation or revocation through subordinate instruments as necessary. Any changes or revocations not expressly stated in this instrument are governed by subsection 33(3) of the Acts Interpretation Act 1901. The determination has undergone consultation with the relevant pharmaceutical company and advice from the Pharmaceutical Benefits Advisory Committee, ensuring that the decisions made are evidence-based and consider the clinical needs of the population. The instrument comes into effect on 1 September 2025 and is considered a legislative instrument under the Legislation Act 2003.

Key Provisions

The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 2) 2025 (PB 100 of 2025) amends the National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Determination 2017 (PB 81 of 2017). The primary changes include removing a specific form of the drug artemether with lumefantrine from the list of exempt items due to its delisting from the Pharmaceutical Benefits Scheme (PBS). The criteria for determining exempt items under section 84AH of the National Health Act 1953 (the Act) remain unchanged, ensuring that certain pharmaceutical items with specific formulations suitable for particular patient subgroups are excluded from certain statutory price reductions and price disclosure requirements. This Act imposes obligations on the Minister to determine, by legislative instrument, whether a pharmaceutical item is an 'exempt item' under section 84AH of the Act. The criteria for this determination include the uniqueness of the listed brand, the absence of bioequivalent or biosimilar brands, and the suitability of the drug for a specific patient subgroup. The Minister must also consider advice from the Pharmaceutical Benefits Advisory Committee (PBAC) to ensure that decisions are evidence-based and meet the needs of the population. In terms of enforcement, the Act does not specify any offences or penalties for non-compliance with the determinations under section 84AH. However, the determinations themselves are legally binding and failure to adhere to them could result in legal consequences under the broader provisions of the National Health Act 1953. The Amending Determination also provides for the revocation or variation of the Principal Determination, relying on subsection 33(3) of the Acts Interpretation Act 1901 where no express power is cited. This legislative instrument ensures that the PBS continues to provide affordable access to medicines, while also allowing for the exemption of certain pharmaceutical items that are critical for specific patient subgroups. The compatibility with human rights is affirmed, as the determinations assist in achieving the highest attainable standard of physical and mental health for all Australians. The Amending Determination takes effect on 1 September 2025, as specified.

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