National Health Act 1953 - Amendment Determination under section 84AH (2013) (No. 1) (No. PB 65 of 2013)

Administered by Department of Health, Disability and Ageing

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 EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 65 OF 2013

 

NATIONAL HEALTH ACT 1953

 

AMENDMENT DETERMINATION UNDER SECTION 84AH OF THE NATIONAL HEALTH ACT 1953 (2013) (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 Determination under section 84AH of the National Health Act 1953 (as amended) (PB 58 of 2007) 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 the 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 58 of 2007 made by this instrument

 

This instrument makes the following changes to PB 58 of 2007:

 

  •   Two pharmaceutical items (listed drug = Diazepam, form = Oral liquid 1 mg in 1 mL, 100 mL, manner of administration = Oral and listed drug = Efavirenz, form = Oral solution 30 mg per mL, 180 mL, manner of administration = Oral) are determined to be exempt items.

 

Variation and revocation

 

Unless there is an express power to revoke or vary PB 58 of 2007 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 58 of 2007.

 

Consultation

This instrument affects pharmaceutical companies with medicines listed on the PBS.  In relation to the introduction of the exempt items measure, which commenced on                      1 August 2007, pharmaceutical companies have been consulted during both the policy development and implementation phases.

The Pharmaceutical Benefits Advisory Committee (PBAC) was also consulted in relation to issues relevant to this determination.  The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Medical Research about which drugs and medicinal preparations should be available as pharmaceutical benefits and about other matters as required under the Act.  Under subsection 101(4AB) of the Act PBAC provides advice to the Minister if it is satisfied of certain matters concerning suitability of pharmaceutical items for use by particular sub-groups.  Consideration given by PBAC, under section 101(4AB), to the pharmaceutical items affected by the instrument, was considered by the delegate of the Minister who made the instrument.

General

The instrument commences on 1 October 2013. 

This instrument constitutes a legislative instrument for the purpose of the                Legislative Instruments Act 2003.

 

 

 

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Amendment Determination under section 84AH of the National Health Act 1953 (2013) (No. 1) (PB 65 of 2013)

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 section 84AH of the National Health Act 1953 (the Act), which determines when a pharmaceutical is exempt.  This instrument amends the principle instrument which provides for the allocation of drugs to the exempt list if the pharmaceutical item satisfies the criteria in section 84AH of the Act. 

This instrument (the Amending Determination) amends the Principal Determination by determining the drugs diazepam and efavirenz to be exempt items.

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 is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. 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 because it advances the protection of human rights.

 

Adriana Platona

Assistant Secretary, Pharmaceutical Evaluation Branch

Pharmaceutical Benefits Division, Department of Health and Ageing

 

 

 

Overview

The Amendment Determination under section 84AH of the National Health Act 1953 (2013) (No. 1) (PB 65 of 2013) serves to modify the principal determination made under section 84AH of the National Health Act 1953, which governs the pharmaceutical items that are exempt from certain statutory price reductions and price disclosure requirements. Enacted by the Minister for Health and Medical Research, this amendment responds to the need for ensuring that certain pharmaceutical formulations, deemed suitable for specific patient sub-groups due to their form and manner of administration, are accessible and affordable. The principal aim of the legislation is to maintain the availability of these specific pharmaceutical items within the Pharmaceutical Benefits Scheme (PBS) by excluding them from the standard pricing regulations, thereby encouraging their continued provision to those who need them most. The instrument engages with the International Covenant on Economic, Social and Cultural Rights by supporting the right to the highest attainable standard of physical and mental health. This is achieved by ensuring that certain medications, specifically tailored for particular patient demographics, remain accessible through the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising on the suitability of these pharmaceutical items for specific patient groups, ensuring that the decisions are evidence-based and aligned with the overarching goal of improving public health outcomes. The legislative instrument is considered compatible with human rights, as it facilitates the progressive realisation of the right to health by providing necessary medications to those who need them most.

Scope and Application

The Amendment Determination under section 84AH of the National Health Act 1953 (2013) (No. 1) pertains to the Pharmaceutical Benefits Scheme (PBS) administered under the National Health Act 1953, providing reliable and affordable access to medicines for Australians. This instrument amends the legislative instrument PB 58 of 2007 by determining that specific pharmaceutical items, namely Diazepam in oral liquid form and Efavirenz in oral solution form, qualify as exempt items. These items are exempt from statutory price reductions and price disclosure requirements under Divisions 3A and 3B of Part VII of the Act, due to their unique suitability for particular patient subgroups, such as children or geriatric patients, where other formulations are not suitable. This exemption aims to encourage the availability of these specific pharmaceutical items. The instrument applies to pharmaceutical companies with medicines listed on the PBS and is in effect from 1 October 2013. The Minister's decision to amend the exempt list was informed by advice from the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the determination aligns with the need for evidence-based, suitable therapies for specific patient populations.

Key Provisions

This legislative instrument, made under section 84AH of the National Health Act 1953 (the Act), amends the Determination under section 84AH of the National Health Act 1953 (as amended) (PB 58 of 2007) to include two new pharmaceutical items in the list of exempt items. These are Diazepam in the form of an oral liquid 1 mg in 1 mL, 100 mL, administered orally, and Efavirenz in the form of an oral solution 30 mg per mL, 180 mL, also administered orally. The determination of these pharmaceutical items as exempt items means they are excluded from statutory price reductions and price disclosure requirements under Division 3A and 3B of Part VII of the Act, aiming to encourage the availability of specific drug formulations suitable for particular patient populations. The Act imposes obligations on the Minister for Health and Medical Research to determine which pharmaceutical items should be exempt under section 84AH, based on the criteria outlined in the Act. This includes ensuring that there is only one listed brand of the pharmaceutical item, no bioequivalent or biosimilar listed brands, and that there is at least one other pharmaceutical item with the same listed drug. The Minister must also be satisfied, with advice from the Pharmaceutical Benefits Advisory Committee (PBAC), that the drug is suitable for a particular patient population and that no other item with the same drug is suitable for use by that subgroup due to the form and manner of administration. Breaches of the provisions under the Act may lead to civil or criminal penalties depending on the nature of the violation. While the specific penalties are not detailed in this instrument, under the general provisions of the National Health Act 1953, penalties for non-compliance could include fines and, in severe cases, imprisonment. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on the suitability of pharmaceutical items for the exempt list, ensuring that decisions are evidence-based and aligned with public health objectives. The determination of these items as exempt aids in the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised under international human rights instruments.

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Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Reporting & Disclosure Obligations
Exemptions & Exclusions
Catchwords
exempt items
Pharmaceutical Benefits Scheme

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