National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) - conditions (No. PB 63 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L01732 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 63 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.

Changes to PB 119 of 2008 made by this instrument

This instrument amends Schedule 4 of PB 119 of 2008 by deleting Calcipotriol in the form Scalp solution 50 micrograms (as monohydrate) per mL, 30 mL and the listed drug Etidronic Acid and Calcium.

 

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 September 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 removes two pharmaceutical items 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 Commonwealth Parliament, serves as the legislative basis for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable, timely, and affordable access to a range of medicines. The Act allows the Minister to determine various aspects of the PBS, including the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. Pursuant to this authority, legislative instrument PB 63 of 2012 amends the conditions set out in PB 119 of 2008, which took effect on 1 December 2008. The changes, effective from 1 September 2012, remove two pharmaceutical items from the list of those eligible for Commonwealth payments. These amendments follow recommendations from the Pharmaceutical Benefits Advisory Committee, an independent body that advises on the inclusion of medicines in the PBS. The purpose of these legislative changes is to align the PBS with current medical practices and ensure the scheme remains effective and efficient in delivering pharmaceutical benefits to the Australian public.

Scope and Application

The National Health Act 1953 (the Act) forms the legislative basis of the Pharmaceutical Benefits Scheme (PBS), under which the Commonwealth provides access to a wide range of medicines for all Australians. The Act applies to pharmaceutical benefits that are declared by the Minister by legislative instrument, which are listed drugs, and it governs the form, manner of administration, and brands of these drugs. Payments for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners are subject to conditions determined by the Minister under paragraph 98C(1)(b) of the Act. This legislative instrument amends the determination under this provision, removing two pharmaceutical items from Schedule 4 of the Determination, which governs the conditions for Commonwealth payments for the supply of pharmaceutical benefits. The instrument applies nationally and is compatible with human rights, as it advances the protection of the right to the highest attainable standard of physical and mental health. The instrument commences on 1 September 2012 and is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Key Provisions

The National Health Act 1953 (the Act) governs the Pharmaceutical Benefits Scheme (PBS) through which the Commonwealth provides access to a range of medicines for Australians. The scheme operates under Part VII of the Act, which provides the legal framework for the supply of pharmaceutical benefits. The Act allows the Minister to declare drugs and medicinal preparations that will be included in the PBS, determine the form and manner of administration of these drugs, and designate brands of pharmaceutical items (sections 85(2), 85(3), 85(5), and 85(6)). Section 84AF allows the Minister to determine a responsible person for a brand of a pharmaceutical item. Paragraph 98C(1)(b) of the Act empowers the Minister to determine conditions for payments made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The main operative sections of this legislative instrument, which is an amendment to a previous determination, involve changes to the conditions under which payments are made for certain pharmaceutical benefits. Specifically, the instrument amends Schedule 4 of the previous determination by removing two pharmaceutical items: Calcipotriol in the form Scalp solution 50 micrograms (as monohydrate) per mL, 30 mL, and the listed drug Etidronic Acid and Calcium. These changes are detailed in the items of Schedule 1 to the instrument. The legislative instrument seeks to refine the criteria and conditions under which the Commonwealth makes payments to approved pharmacists and approved medical practitioners for the supply of pharmaceutical benefits. The obligations and requirements imposed by the Act on parties and entities involved in the PBS are extensive. The Minister must determine the conditions under which payments will be made for pharmaceutical benefits, ensuring that these conditions are in line with the objectives of the PBS. Approved pharmacists and approved medical practitioners must comply with these conditions to be eligible for payments from the Commonwealth. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on which medicines should be included in the PBS, ensuring that decisions are evidence-based. Pharmaceutical companies must also adhere to the determinations and conditions set by the Minister, particularly regarding the form and manner of administration of their pharmaceutical products. Breaches of the conditions set out in the Act can lead to various civil and criminal consequences. While specific offences and penalties are not detailed in the instrument, violations of the conditions for payments under the PBS can result in financial penalties, legal action, or other administrative consequences. The severity of penalties may depend on the nature and extent of the breach, with potential for significant fines and other sanctions for non-compliance. The instrument ensures that the integrity and objectives of the PBS are upheld by imposing these obligations and consequences on the parties involved.

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