National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 7) (PB 57 of 2014)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01052 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2014 (No. 7)

PB 57 of 2014

 

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 2014 (No. 7), commencing on 1 August 2014.  Schedule 4 of the Principal Determination is amended by the addition of two new listed drugs, aclidinium and betaine.

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 August 2014.

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 2014
(No. 7)
(PB 57 of 2014)

 

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 two 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.

 

Paul Creech

First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 7) (PB 57 of 2014) amends the Principal Determination to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 7), which commenced on 1 August 2014. This Amendment Determination, introduced by the Australian Government, aims to address the need for updating the Pharmaceutical Benefits Scheme (PBS) to include new pharmaceutical benefits, thereby ensuring that the PBS remains current and effective in providing reliable, timely, and affordable access to medicines for all Australians. The determination under paragraph 98C(1)(b) of the National Health Act 1953 sets out the conditions for payments by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This amendment specifically adds two new listed drugs, aclidinium and betaine, to Schedule 4 of the Principal Determination. The changes are consistent with the human rights recognised in the International Covenant on Economic, Social and Cultural Rights by enhancing access to affordable medicines and thus contributing to the highest attainable standard of physical and mental health.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 7) is an amendment to the principal determination that governs the conditions under which the Commonwealth makes payments for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This determination applies to all entities and individuals involved in the supply of pharmaceutical benefits, ensuring that the changes outlined in the amendment are uniformly implemented. It has a national reach across Australia, as it pertains to the Pharmaceutical Benefits Scheme (PBS), a Commonwealth initiative. This Amendment Determination adds two new drugs, aclidinium and betaine, to Schedule 4 of the Principal Instrument, thereby expanding the list of pharmaceutical benefits available under the PBS. The instrument revokes and varies the earlier Principal Determination, PB 119 of 2008, unless there is an express power to do so, in which case it relies on subsection 33(3) of the Acts Interpretation Act 1901. The instrument is compatible with human rights, particularly advancing the right to the highest attainable standard of physical and mental health as outlined in the International Covenant on Economic, Social and Cultural Rights (ICESCR).

Key Provisions

The primary operative sections of the National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 7) (PB 57 of 2014) (the Amendment) pertain to the addition of two new listed drugs, aclidinium and betaine, to Schedule 4 of the Principal Determination. This schedule outlines the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Specifically, the Amendment introduces these two new drugs to the list of those eligible for Commonwealth payments under the Pharmaceutical Benefits Scheme (PBS), thus expanding the range of medicines available to patients under the PBS. The Amendment imposes specific obligations and requirements on parties involved in the supply of pharmaceutical benefits. Approved pharmacists and approved medical practitioners must now adhere to the updated conditions outlined in Schedule 4, ensuring that the new drugs, aclidinium and betaine, are supplied under the correct terms and conditions as stipulated by the PBS. This includes compliance with all relevant regulations and guidelines set forth by the Commonwealth to facilitate the appropriate and efficient distribution of these drugs. Any breach of the conditions specified in the Amendment could lead to civil or criminal consequences. While the specific penalties for non-compliance are not detailed in the text, it is clear that adherence to the PBS regulations is crucial. Historically, penalties for non-compliance with PBS conditions can include fines, suspension of benefits, or legal action. These measures are intended to ensure that the scheme operates effectively and that all parties involved maintain the highest standards of conduct and compliance. The legislative instrument is designed to ensure that the human rights implications are considered, particularly in relation to Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). By facilitating access to a broader range of subsidised medicines, the Amendment supports the right of everyone to the highest attainable standard of physical and mental health. The involvement of the Pharmaceutical Benefits Advisory Committee (PBAC) in the decision-making process ensures that the changes are evidence-based and aligned with the overarching goal of advancing public health.

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Human Rights (ICESCR)

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