National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 4) 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L01444 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 143 OF 2025

 

NATIONAL HEALTH ACT 1953

National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 4) 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 = Ondansetron, form = Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL, manner of administration = Oral) is no longer determined to be an exempt item as it does not meet criteria a and d (iii) above, that is, there is an alternative pharmaceutical item that has the same listed drug, form and manner of administration, and  it is also suitable for the same patient subgroup.

 

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 ondansetron.  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 December 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. 4) 2025 (PB 143 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 ondansetron from the exempt list as it does not meet the criteria in section 84AH of the Act.

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. 4) 2025, made under section 84AH of the National Health Act 1953, aims to revise the list of pharmaceutical items deemed exempt from certain statutory price reductions and disclosure requirements. This determination is designed to ensure that the Pharmaceutical Benefits Scheme (PBS) provides reliable and affordable access to medications while allowing for the availability of certain formulations that are particularly suited to specific patient demographics, such as children or geriatric patients. Enacted by the Australian Government, the policy objective is to maintain a balance between cost-effective healthcare and the availability of suitable therapeutic options. This legislative instrument, which comes into effect on 1 December 2025, removes a particular form of ondansetron from the exempt list, reflecting a reassessment of its eligibility under the criteria set forth in the Act.

Scope and Application

The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 4) 2025 amends the National Health (Pharmaceutical Benefits Scheme-Exempt items – Section 84 AH) Determination 2017 to modify the pharmaceutical items determined to be exempt items under the National Health Act 1953. This legislation applies to pharmaceutical items, specifically focusing on the Pharmaceutical Benefits Scheme (PBS) and its exemptions under section 84AH of the Act. The purpose of this amendment is to ensure that pharmaceutical items meeting the criteria outlined in the Act are correctly identified as exempt, thereby excluding them from certain statutory price reductions and price disclosure requirements. This amendment impacts the pharmaceutical industry, particularly companies manufacturing or supplying the affected pharmaceutical items, and it has a national jurisdictional reach as it pertains to the Commonwealth's PBS. The instrument does not introduce any new exclusions or exemptions but rather modifies the criteria for determining exempt items based on the therapeutic suitability for specific patient populations, such as children or geriatric patients. The changes made by this instrument commence on 1 December 2025.

Key Provisions

This legislative instrument, National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 4) 2025, amends the National Health (Pharmaceutical Benefits Scheme-Exempt items – Section 84 AH) Determination 2017 (PB 81 of 2017) to alter the list of pharmaceutical items that are exempt from certain statutory price reductions and price disclosure requirements under the National Health Act 1953 (the Act). Specifically, the instrument removes one pharmaceutical item from the exempt list, as it no longer meets the criteria outlined in section 84AH of the Act. The key change involves the removal of ondansetron in syrup form from the exempt items list because there is now an alternative pharmaceutical item that meets the same criteria and is suitable for the same patient subgroup. Under the Act, the Minister for Health has the authority to determine which pharmaceutical items are exempt from certain provisions if they meet specific criteria, such as being the only listed brand of a drug with no bioequivalent or biosimilar alternatives, and if there is suitable therapy available for a particular patient population. These criteria are designed to ensure that certain pharmaceutical items, particularly those with particular formulations suitable for specific demographic subgroups, remain accessible and affordable. The obligations imposed by this Act primarily concern the Minister’s duty to assess and determine whether pharmaceutical items meet the criteria for exemption. This involves consulting with relevant stakeholders, including the Pharmaceutical Benefits Advisory Committee, to make informed decisions that support public health needs. Failure to comply with the provisions of this Act may result in civil or criminal penalties, although the specific penalties are not detailed in the instrument. Generally, breaches of the National Health Act can lead to fines, imprisonment, or both, depending on the nature and severity of the offence. For instance, under section 18 of the Act, a person who contravenes any provision of the Act or any regulation made under the Act may be liable to a penalty of up to $22,200 for an individual offence and up to $111,000 for a corporate offence. Additionally, the Act provides for the recovery of costs incurred by the Commonwealth in taking legal action to enforce the provisions of the Act. In summary, this legislative instrument aims to ensure that the Pharmaceutical Benefits Scheme remains effective in providing subsidised access to essential medicines while maintaining appropriate exemptions where necessary to meet specific patient needs. The changes reflect a careful assessment of the criteria for exempt items and the ongoing commitment to ensuring the highest attainable standard of health for all Australians.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.