National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) - conditions (No. PB 46 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L01601 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 46 OF 2012

NATIONAL HEALTH ACT 1953

AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b) OF THE NATIONAL HEALTH ACT 1953

 

Summary

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under section 98C(1)(b) made by legislative instrument number PB 119 of 2008 which came into effect on
1 December 2008. The amendments provide for changes to the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The amendments are set out in the items of Schedule 1 to the instrument.

 

Purpose and operation

Part VII of the National Health Act 1953 (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.

Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.

Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1). 

The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)).  These determinations govern what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.  Under section 84AF, the Minister may determine a responsible person for a brand of a pharmaceutical item.

Paragraph 98C(1)(b) of the Act provides that the Minister may, from time to time, determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.

The determination under paragraph 98C(1)(b) of the Act sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.

 

 

Changes to PB 119 of 2008 made by this instrument

This instrument amends Schedules 1 and 4 of PB 119 of 2008 by the addition of the listed drug Cefuroxime and also amends Schedule 4 of PB 119 of 2008 by deleting Oestradiol in the form transdermal patches 2 mg, 8.

 

Consultations

The Department consulted with the Pharmaceutical Benefits Advisory Committee (PBAC) during the regular process of its meetings to consider applications in order to recommend to the Minister which medicines should be subsidised through the Pharmaceutical Benefits Scheme.  The Committee is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists.  The Committee has received submissions and representations from interested pharmaceutical companies and has recommended the changes to the Minister who has determined the changes to the conditions under paragraph 98C(1)(b) which appear in this Determination. 

 

General

The instrument commences on 1 August 2012.

This instrument is a legislative instrument for the purposes 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 paragraph 98C(1)(b) of the National Health Act 1953

 

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

The determination under paragraph 98C(1)(b) of the National Health Act 1953 sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.

This legislative instrument amends the Determination under paragraph 98C(1)(b) of the National Health Act 1953 which came into effect on 1 December 2008. The amendments provide for changes to the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.

This instrument adds one pharmaceutical item to Schedule 1 of the Determination, adds one pharmaceutical item to Schedule 4 of the Determination and also removes one other pharmaceutical item from Schedule 4 of the Determination.

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.

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

Overview

The National Health Act 1953, enacted by the Australian Parliament, provides the legislative framework for the Pharmaceutical Benefits Scheme (PBS). The Act aims to ensure that all Australians have reliable, timely, and affordable access to a wide range of medicines. One of the key mechanisms through which this is achieved is the Pharmaceutical Benefits Advisory Committee (PBAC), which advises the Minister on which medicines should be subsidised. The National Health Act 1953 Amendment Determination under paragraph 98C(1)(b) made in 2012 updates the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This determination is based on recommendations from the PBAC and aims to ensure that the PBS remains effective and evidence-based in providing access to essential medicines. The amendments introduced in this determination include adding certain pharmaceutical items to the list of approved benefits and removing others, thereby refining the scope of the scheme to better meet the health needs of the population.

Scope and Application

The National Health Act 1953, as amended by the legislative instrument PB 46 of 2012, pertains to the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth provides subsidised access to a range of medicines for all Australians. This Act applies to pharmaceutical benefits, which are declared by the Minister and listed in the schedules of the Act. The Act governs the conditions under which payments are made by the Commonwealth for the supply of these benefits by approved pharmacists and medical practitioners. The instrument specifically amends the determination under paragraph 98C(1)(b) of the Act, which outlines these conditions. The changes include the addition of the drug Cefuroxime to Schedule 1 and Schedule 4, and the removal of Oestradiol in the form of transdermal patches 2 mg from Schedule 4. These amendments commenced on 1 August 2012. The Act applies nationally across Australia, with the Minister having the authority to determine the conditions for pharmaceutical benefits, including their form, manner of administration, and responsible persons. The instrument is compatible with human rights, particularly engaging Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by enhancing access to affordable medicines and ensuring evidence-based decision-making through the Pharmaceutical Benefits Advisory Committee.

Key Provisions

The primary operative sections of this legislative instrument (F2012L01601) concern amendments to the determination under paragraph 98C(1)(b) of the National Health Act 1953, which governs the conditions for Commonwealth payments regarding the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Specifically, section 98C(1)(b) allows the Minister to determine these conditions. The amendments, detailed in Schedule 1 of the instrument, include adding the listed drug Cefuroxime to Schedules 1 and 4, and removing Oestradiol in the form of transdermal patches 2 mg from Schedule 4. This legislative instrument ensures the Pharmaceutical Benefits Scheme (PBS) can adapt to include new medications and remove outdated ones, ensuring that the scheme remains effective and relevant. The Act imposes several obligations and requirements on the parties it governs. The Minister is required to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) and consider recommendations before making any determinations under section 98C(1)(b). This ensures that decisions regarding the PBS are evidence-based and informed by expert opinions from various fields, including consumers, health economists, and medical professionals. Approved pharmacists and approved medical practitioners must adhere to the conditions set out in the determination when supplying pharmaceutical benefits to ensure they receive the appropriate Commonwealth payments. These conditions may include specific criteria related to the form, strength, and manner of administration of listed drugs. There are no explicit offences, penalties, or civil/criminal consequences mentioned in this legislative instrument for breaches of the conditions under section 98C(1)(b). However, any non-compliance with the conditions by approved pharmacists or approved medical practitioners could potentially lead to the cessation of Commonwealth payments, which would have financial implications for these entities. While the instrument does not specify penalties, the National Health Act 1953 and related regulations may provide further guidance on consequences for non-compliance in other areas. The overarching objective of the Act is to ensure that the PBS remains a reliable, timely, and affordable means of providing access to essential medicines for all Australians.

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