National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 10) (PB 109 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01894 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2015 (No. 10)

PB 109 of 2015

 

Authority

Paragraph 98C(1)(b) of the National Health Act 1953 (the Act) provides that the Minister may 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.  Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008) (the Principal Determination) sets out the conditions subject to which these payments will be made.

Purpose

This Amendment Determination amends the Principal Determination to reflect the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 11), commencing on 1 December 2015.  Schedule 4 of the Principal Determination is amended by the addition of aclidinium with eformoterol; brinzolamide with brimonidine; and tiotropium with olodaterol.  

Variation and revocation

Unless there is an express power to revoke or vary PB 119 of 2008 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 119 of 2008.

Background

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.

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.


 

 

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. 

 

This Instrument commences on 1 December 2015.

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

 

National Health Determination under paragraph 98C(1)(b) Amendment 2015
(No. 10)
(PB 109 of 2015)

 

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 (PB 119 of 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 three listed drugs to Schedule 4 of the Principal Instrument.  

Human rights implications

This legislative instrument engages Articles 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.

 

Penny Shakespeare

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Act 1953, as amended by the National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 10), governs the conditions under which the Commonwealth makes payments for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. This legislation was enacted by the Australian Parliament to establish and regulate the Pharmaceutical Benefits Scheme (PBS), ensuring affordable access to a broad range of medicines for all Australians. The 2015 amendment was introduced to align the Principal Determination with the changes specified in the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 11), which added three new pharmaceutical combinations to Schedule 4 of the Principal Determination. The amendment aims to ensure that the conditions for Commonwealth payments accurately reflect the current list of subsidised medicines, thereby maintaining the integrity and effectiveness of the PBS.

Scope and Application

The National Health Act 1953, under the authority of paragraph 98C(1)(b), authorises the Minister to determine the conditions subject to which payments will be made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. This authority is exercised through the National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 10) (PB 109 of 2015), which amends the Principal Determination to incorporate changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 11), effective from 1 December 2015. The amendment involves the addition of aclidinium with eformoterol, brinzolamide with brimonidine, and tiotropium with olodaterol to Schedule 4 of the Principal Determination. The changes are based on recommendations from the Pharmaceutical Benefits Advisory Committee, an independent body comprising members from various health-related professions and interests, ensuring that decisions about the Pharmaceutical Benefits Scheme are evidence-based. The Act 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 by facilitating access to subsidised medicines.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 10) (PB 109 of 2015) amends the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners (s 1). This Amendment Determination updates the Principal Determination (PB 119 of 2008) to include changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 11) which became effective on 1 December 2015. Specifically, the Amendment Determination adds aclidinium with eformoterol, brinzolamide with brimonidine, and tiotropium with olodaterol to Schedule 4 of the Principal Determination (s 2). The Amendment Determination imposes obligations on approved pharmacists and medical practitioners by specifying the conditions that must be met to receive payments for the supply of pharmaceutical benefits (s 2). These conditions ensure that the medications supplied are aligned with the provisions set out in the National Health Act 1953 and the Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in recommending changes to the Minister, who then determines these changes. This ensures that the decisions about which medicines are subsidised are evidence-based and consider the interests of consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. There are no explicit offences or penalties detailed in the Amendment Determination itself. However, failure to comply with the conditions set out in the Determination could potentially lead to legal consequences under the National Health Act 1953. Non-compliance with the PBS conditions may result in the Commonwealth withholding payments from approved pharmacists and medical practitioners. Additionally, there could be implications under other relevant legislative provisions if the non-compliance is deemed significant or deliberate. The specific penalties or consequences for non-compliance would be governed by the provisions of the National Health Act 1953 and related regulations.

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