National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2023 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2023L00070 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 8 OF 2023

 

NATIONAL HEALTH ACT 1953

National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2023 (No. 1)

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:

(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 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 change to PB 81 of 2017:

 

This instrument changes the form description for one listed drug – oxycodone.  The form description is changing from oral solution containing oxycodone hydrochloride 1 mg per mL, 250 mL to oral solution containing oxycodone hydrochloride 1 mg per mL, 1 mL.  This change is to facilitate the dispensing of lower quantities (as required) and resolve serious safety issues.

 

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 administrative change to the form description and the reasons for doing so. No additional consultations with experts were 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 February 2023.

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 2023 (No. 1) (PB 8 of 2023)

 

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 changing the form description for one listed drug – oxycodone. This change is to facilitate the dispensing of lower quantities (as required) and resolve serious safety issues.

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.

 

 

Nikolai Tsyganov

Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division
Department of Health and Aged Care

 

Overview

The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2023 (No. 1) was enacted to amend the National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84 AH) Determination 2017, addressing the need to refine the pharmaceutical items that are exempt from certain statutory price reductions and price disclosure requirements under the Pharmaceutical Benefits Scheme (PBS). This legislative instrument, made under section 84AH of the National Health Act 1953, ensures the availability of specific pharmaceutical formulations that are particularly suited to certain demographic subgroups, such as children or geriatric patients, where other formulations are not suitable. The objective of the policy is to support the progressive realisation of the right to the highest attainable standard of physical and mental health, as outlined in the International Covenant on Economic, Social and Cultural Rights. The determination was made by the Minister for Health under the authority of the National Health Act 1953 and engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights. This amendment facilitates the dispensing of lower quantities of oxycodone in a more practical form, thereby addressing serious safety issues. It ensures that the PBS continues to provide access to clinically important medicines while maintaining exemptions from pricing reductions only where appropriate, thus protecting human rights within the legislative framework.

Scope and Application

This legislative instrument, made under section 84AH of the National Health Act 1953, amends the Pharmaceutical Benefits Scheme-Exempt items Determination 2017 to modify the pharmaceutical items that are determined to be exempt items. The Act applies to pharmaceutical items listed under the Pharmaceutical Benefits Scheme, which provides affordable access to a wide range of medicines for Australians. The Pharmaceutical Benefits Advisory Committee advises the Minister on these matters. The Minister can determine, by legislative instrument, that a pharmaceutical item is an 'exempt item' if it satisfies specific criteria related to its suitability for particular patient populations, such as children or geriatric patients. This amendment changes the form description for the listed drug oxycodone to facilitate dispensing of lower quantities and address safety concerns. The instrument revokes or varies the principal determination unless there is an express power to do so, as per subsection 33(3) of the Acts Interpretation Act 1901. The changes made by this instrument are consistent with the human rights and freedoms recognised in international instruments, particularly in relation to the right to the highest attainable standard of physical and mental health.

Key Provisions

The main operative sections of the National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2023 (No. 1) (PB 8 of 2023) amend the National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Determination 2017 (PB 81 of 2017). Specifically, this amending determination alters the form description of one listed drug, oxycodone, from an oral solution containing oxycodone hydrochloride 1 mg per mL, 250 mL to an oral solution containing oxycodone hydrochloride 1 mg per mL, 1 mL. This change is intended to facilitate the dispensing of lower quantities and to address serious safety concerns. The purpose of these changes is to ensure that certain pharmaceutical items with specific drug formulations, suitable for particular patient populations, remain available and accessible. The obligations and requirements imposed by this Act on the parties or entities it governs primarily involve ensuring that the criteria for determining exempt pharmaceutical items are met. The Minister, under section 84AH of the National Health Act 1953, must determine whether a pharmaceutical item qualifies as an exempt item based on the criteria outlined in the Act. These criteria include the uniqueness of the listed brand, the absence of bioequivalent or biosimilar listed brands, the existence of other pharmaceutical items with the same listed drug, and the suitability of the drug for specific patient populations based on form and manner of administration. The Minister must also consult with relevant entities, such as pharmaceutical companies, to ensure that the changes address safety issues and facilitate appropriate dispensing practices. There are no specific offences, penalties, or civil/criminal consequences mentioned in the text for breaches of this amending determination. However, under the general legislative framework, non-compliance with regulations and determinations made under the National Health Act 1953 could potentially lead to enforcement actions, including fines and other penalties as prescribed by the Act or related legislation. The exact penalties would depend on the nature and severity of the breach, and would be determined in accordance with the relevant provisions of the Act and other applicable laws.

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