National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) - conditions (No. PB 34 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L01004 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 34 OF 2012

NATIONAL HEALTH ACT 1953

AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)

 

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.

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

This instrument commences on 1 June 2012.

Changes to PB 119 of 2008 made by this instrument

This instrument amends Schedule 4 of PB 119 of 2008 by adding Glucose Indicator-Blood in the form Test strips, 100 (Contour).

 

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 June 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)

 

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 1 pharmaceutical item to 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 Amendment (Pharmaceutical Benefits Scheme) Determination 2012 is an instrument that amends the National Health Act 1953, specifically addressing the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits. Enacted by the Australian Parliament, this instrument responds to recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) to enhance the Pharmaceutical Benefits Scheme (PBS). The objective is to ensure the PBS provides reliable, timely, and affordable access to a wide range of medicines for Australians. By amending the determination under section 98C(1)(b), this instrument updates the conditions governing payments for pharmaceutical benefits supplied by approved pharmacists and medical practitioners, ensuring the scheme remains responsive to current healthcare needs. The amendments are designed to facilitate the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health Act 1953, as amended by the legislative instrument PB 34 of 2012, pertains to the Pharmaceutical Benefits Scheme (PBS) which facilitates reliable, timely, and affordable access to a broad range of medicines for all Australians. This Act applies to pharmaceutical benefits declared by the Minister, which are generally medicines listed by the Minister under subsection 85(2). The Act sets out the conditions under which payments will be made by the Commonwealth for the supply of these pharmaceutical benefits by approved pharmacists and approved medical practitioners, as stipulated in section 98C(1)(b). The amendments to the PBS, implemented through this legislative instrument, adjust the conditions for payments related to certain pharmaceutical benefits. This Act has a nationwide jurisdictional reach, applying to all individuals and entities involved in the supply of pharmaceutical benefits within Australia, including approved pharmacists and medical practitioners. The legislative instrument is designed to align with human rights, particularly the right to the highest attainable standard of physical and mental health, as it ensures subsidised access to medicines through evidence-based decisions facilitated by the Pharmaceutical Benefits Advisory Committee (PBAC).

Key Provisions

The National Health Act 1953 (the Act) Amendment Determination under paragraph 98C(1)(b) introduces amendments to the conditions under which payments will be made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. These amendments were made in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The primary change involves the addition of a pharmaceutical item, specifically Glucose Indicator-Blood in the form of Test strips, 100 (Contour), to Schedule 4 of the Determination. This addition ensures that patients have access to necessary medical supplies and treatments that were previously not covered under the existing provisions. The Act imposes several obligations on the parties involved, including approved pharmacists and approved medical practitioners, to ensure compliance with the conditions set forth in the amended Determination. These professionals must adhere to the specified requirements for the supply of pharmaceutical benefits, ensuring that the treatments provided meet the standards and criteria established by the Commonwealth. Additionally, the Minister has the authority to determine the form, administration, and brand of pharmaceutical items, which helps maintain the integrity and effectiveness of the Pharmaceutical Benefits Scheme (PBS). Failure to comply with the conditions set out in the Determination may result in legal consequences. Although the specific penalties are not detailed in the Explanatory Statement, it is reasonable to infer that breaches of the Act could lead to enforcement actions, fines, or other legal repercussions. These measures are designed to uphold the standards of the PBS and ensure that all parties involved contribute to the reliable and timely provision of affordable pharmaceutical benefits to Australians. The overarching aim is to protect public health and maintain the integrity of the scheme.

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