National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) - conditions (No. PB 38 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L01202 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 38 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 July 2012.

Changes to PB 119 of 2008 made by this instrument

This instrument amends Schedule 3 of PB 119 of 2008 by changing the form description of Fentanyl lozenges in all strengths.

This instrument also amends Schedule 4 of PB 119 of 2008 by adding Glucose Indicator—Blood in the form test strips, 100 (BGStar).  Schedule 4 is further amended by the deletion of the listed drugs Dabigatran etexilate and Rivaroxaban as a result of pack size changes.

 

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 July 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 changes the description of the form of several items in Schedule 3, adds 1 pharmaceutical item to Schedule 4 of the Determination and also removes 2 listed drugs from Schedule 4 as a result of changes in pack size.

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 Commonwealth of Australia, provides the legislative basis for the Pharmaceutical Benefits Scheme (PBS), ensuring Australians have reliable, timely, and affordable access to a wide range of medicines. The Act was amended in 2012 to incorporate changes recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). This amendment, made under paragraph 98C(1)(b) of the Act, alters the conditions subject to which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The objective is to align the PBS with contemporary medical needs and evidence-based recommendations, ensuring the scheme remains effective in supporting public health.

Scope and Application

The National Health Act 1953, through its Part VII, forms the legislative basis for the Pharmaceutical Benefits Scheme (PBS), whereby the Commonwealth ensures Australians have reliable, timely, and affordable access to a wide range of medicines. The Act applies to the pharmaceutical benefits provided by the Commonwealth and the terms under which these benefits are supplied by approved pharmacists and medical practitioners. The legislation encompasses declared drugs and medicinal preparations, excluding certain additives, and these are detailed by legislative instrument under subsection 85(2). The Minister, guided by recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), determines the conditions under which payments for these pharmaceutical benefits will be made, as outlined in the determination under paragraph 98C(1)(b) of the Act. This legislative instrument amends the previous determination, effective from 1 July 2012, to include modifications to the form descriptions of certain pharmaceutical items and the addition or removal of specific drugs from the list based on changes such as pack sizes. The Act applies nationally, ensuring consistent standards and access across Australia.

Key Provisions

The key provisions of the legislative instrument (F2012L01202) amend the determination under paragraph 98C(1)(b) of the National Health Act 1953, which governs the conditions under which payments will be made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners (paragraph 98C(1)(b)). This amendment, which came into effect on 1 July 2012, modifies the conditions set out in Schedule 3 and Schedule 4 of the original determination made in 2008. Specifically, the amendments adjust the form description for Fentanyl lozenges in Schedule 3, add Glucose Indicator—Blood in the form of test strips, 100 (BGStar) to Schedule 4, and remove Dabigatran etexilate and Rivaroxaban from Schedule 4 due to pack size changes. Under the National Health Act 1953, the Minister has the authority to determine the conditions for Commonwealth payments regarding pharmaceutical benefits. These conditions are essential to ensure that the Pharmaceutical Benefits Scheme (PBS) provides timely and affordable access to a wide range of medicines. The Act mandates that the Minister can determine the form, manner of administration, and brand of pharmaceutical items that are eligible for benefits, and these determinations guide the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The obligations imposed by the Act on parties and entities include ensuring that the supply of pharmaceutical benefits adheres to the conditions specified in the amended determination. Approved pharmacists and approved medical practitioners must comply with these conditions to receive payments from the Commonwealth. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in advising the Minister on which medicines should be subsidised through the PBS, ensuring that decisions are evidence-based and reflect the highest attainable standard of health. Failure to comply with the conditions set forth in the amended determination may lead to civil or criminal consequences. While specific penalties are not detailed in the instrument, breaches of the National Health Act 1953 can result in significant fines and other legal repercussions. The exact penalties for non-compliance would depend on the nature and severity of the breach, as well as any additional provisions outlined in related legislation. The amendments aim to ensure that the PBS continues to provide reliable and affordable access to essential medicines, thus maintaining the integrity of the health care system.

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