National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2018 (No. 2) (PB 61 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00958 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 61 OF 2018

 

NATIONAL HEALTH ACT 1953

National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2018 (No. 2)

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 (as amended) (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:

(a)   that there is only one listed brand of the relevant pharmaceutical item; and

(b)   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

(c)   there is at least one other pharmaceutical item that has the same listed drug as the relevant pharmaceutical item; and

(d)   the Minister is satisfied (having regard to advice, if any, from the Pharmaceutical Benefits Advisory Committee (PBAC)) 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 statutory price reductions and price disclosure requirements under Division 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 (eg. 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:

 

It changes the drug name for four drugs on the exempt item list – amoxycillin to amoxicillin, cyclosporin to ciclosporin, frusemide to furosemide and indomethacin to indometacin in addition to one form description change - injection containing prochlorperazine mesylate 12.5 mg in 1 mL to injection containing prochlorperazine mesilate 12.5 mg in 1 mL. These changes are due to the International Harmonisation of Ingredient Names reform.

 

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

The Amending Determination affects pharmaceutical companies with medicines listed on the PBS.  Before drugs are determined to be exempt, there are detailed consultations about the drug with the responsible person, and a recommendation is received from the Pharmaceutical Benefits Advisory Committee (PBAC).  Any PBAC recommendation is made following receipt of submissions by affected pharmaceutical companies.  For all pharmaceutical items that are determined to be exempt, affected pharmaceutical companies have previously sought exempt item status and the Pharmaceutical Benefits Advisory Committee (PBAC) has previously provided advice (where appropriate) to the Minister or the Minister’s Delegate under subsection 101(4AB) of the Act.  Further consultation on the Amending Determination was deemed unnecessary due to the administrative nature of the changes due to the International Harmonisation of Ingredient Names (IHIN) reform.  All changes in this instrument are amendments to the naming of drugs or forms in columns one and two consistent with the naming conventions adopted by the IHIN reform.

General

The instrument commences on 1 July 2018.

This instrument is a legislative instrument for the purposes of the Legislation Act 2003.

 

 


Overview

The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2018 (No. 2) amends the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This legislative instrument, enacted by the Minister of Health, aims to adjust the names of certain pharmaceutical items on the PBS exempt list, aligning with the International Harmonisation of Ingredient Names reform. The purpose of this change is to standardise drug names and ensure consistency across international pharmaceutical naming conventions, thereby reducing confusion and errors related to drug administration. The policy objective is to maintain the integrity and accessibility of the PBS by ensuring that the pharmaceutical items listed are accurately identified and administered. The changes made by this instrument are primarily administrative, correcting the names of four drugs and a form description to reflect the new naming conventions. The Pharmaceutical Benefits Advisory Committee (PBAC) and affected pharmaceutical companies were previously consulted on the exemption status of these items, and further consultation was deemed unnecessary due to the nature of these changes. The instrument is effective from 1 July 2018 and is considered a legislative instrument under the Legislation Act 2003.

Scope and Application

The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2018 (No. 2) amends the National Health (Pharmaceutical Benefits Scheme-Exempt items – Section 84 AH) Determination, made under section 84AH of the National Health Act 1953. This instrument is applicable to pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS), which is administered by the Commonwealth of Australia to ensure the availability of affordable and reliable medicines to all Australians. The amendment pertains specifically to the nomenclature of drugs and forms of pharmaceutical items listed as exempt items under the PBS, reflecting the International Harmonisation of Ingredient Names reform. The instrument changes the drug names and form descriptions for certain pharmaceutical items to align with new naming conventions. The exemption from statutory price reductions and price disclosure requirements for these items remains unchanged, as does the criteria for determining an exempt item under section 84AH of the Act. The instrument comes into effect on 1 July 2018 and is subject to the provisions of the Legislation Act 2003.

Key Provisions

The main operative sections of this legislation, the National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2018 (No. 2), are found in section 84AH of the National Health Act 1953, which empowers the Minister to determine by legislative instrument that a pharmaceutical item is an ‘exempt item’ under certain conditions. This Amendment Determination updates the names of some drugs and forms to align with the International Harmonisation of Ingredient Names reform, and it makes changes to the National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84 AH) Determination (PB 81 of 2017). Specifically, it modifies the names of four drugs and the form description of one drug, reflecting the standardised naming conventions. The Act imposes obligations on parties involved in the Pharmaceutical Benefits Scheme (PBS), such as pharmaceutical companies and the Minister. Pharmaceutical companies must seek exempt item status for their products and provide necessary information for consideration by the Pharmaceutical Benefits Advisory Committee (PBAC). The Minister must consult with the PBAC and consider their recommendations before determining whether a pharmaceutical item qualifies as an exempt item under section 84AH. This process ensures that only suitable pharmaceutical items with unique formulations and administration methods that are necessary for specific patient populations are exempt from statutory price reductions and price disclosure requirements. In terms of breaches and penalties, the Act does not explicitly state offences or penalties related to the determination of exempt items. However, general legal obligations and penalties under the National Health Act 1953 or other relevant legislation may apply if there is non-compliance with the requirements of the PBS or other statutory obligations. For example, non-compliance with the Act or regulations may result in civil or criminal penalties, including fines or imprisonment, depending on the nature and severity of the breach. The National Health Act 1953, along with any relevant regulations and subsidiary legislation, will provide the legal framework for enforcing compliance and imposing penalties for breaches of the requirements set out in the Act. The Minister’s role in determining exempt items and the involvement of the PBAC in providing advice to the Minister ensure that the process for determining exempt items is thorough and evidence-based. The changes made by this Amendment Determination are primarily administrative, aimed at aligning drug names with international standards, and do not introduce new obligations or penalties beyond those already established in the Act and associated regulations.

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Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Regulatory Standards
Reporting & Disclosure Obligations
Prohibited Conduct
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