National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 2) (PB 12 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L00207 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. 2)

PB 12 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. 2), commencing on 1 March 2015.  Schedule 4 of the Principal Determination is amended by the addition of the listed drugs coal tar, mercaptopurine and peginterferon
beta-1a; and the addition of glucose indicator—blood in the form test strips, 100 (Dario).  Schedule 4 of the Principal Determination is further amended by the deletion of escitalopram in the form oral solution 10 mg (as oxalate) per mL, 28 mL.  

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 March 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. 2)
(PB 12 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 and one form of a listed drug to
Schedule 4 of the Principal Instrument.  One form of a listed drug is removed from
Schedule 4. 

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.

 

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Act 1953, enacted by the Parliament of Australia, serves as the legislative basis for the Pharmaceutical Benefits Scheme (PBS), which aims to provide all Australians with reliable, timely, and affordable access to a broad range of medicines. This Act empowers the Minister to determine the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 2) further refines these conditions by adding and removing specific pharmaceutical products from the list eligible for subsidy under the PBS. This amendment addresses the ongoing need to update the list of subsidised medications in line with evolving medical needs and new pharmaceutical developments, ensuring the PBS remains effective and responsive to public health requirements. The policy objective is to maintain the PBS as a vital mechanism for ensuring equitable access to essential medications.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 2) modifies the conditions for Commonwealth payments concerning the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This Amendment Determination is an alteration to the Principal Determination established under the National Health Act 1953, which outlines the specific terms and conditions for these payments. The amendments reflect the changes introduced by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 2), which came into effect on 1 March 2015. This includes adding three new drugs and a form of a listed drug to Schedule 4, while removing a specific form of escitalopram from the schedule. The changes are designed to align with the Pharmaceutical Benefits Scheme (PBS) and are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body that advises the Minister on which medicines should be subsidised. The amendment ensures that the PBS continues to provide affordable access to a wide range of medicines for Australians.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 2) (PB 12 of 2015) amends the existing National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 (the Act). This Amendment Determination, which commences on 1 March 2015, updates the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The changes are primarily reflected in the addition and removal of specific drugs and drug forms from Schedule 4 of the Principal Determination. The main sections of this Amendment Determination (sections 3 and 4) outline the additions and deletions to Schedule 4. Specifically, the listed drugs coal tar, mercaptopurine, and peginterferon beta-1a, as well as the glucose indicator—blood in the form test strips, 100 (Dario), are added. Conversely, the form escitalopram in the form oral solution 10 mg (as oxalate) per mL, 28 mL, is removed from Schedule 4. These changes ensure that the conditions for Commonwealth payments are current and reflective of the latest recommendations regarding pharmaceutical benefits. The obligations imposed by this Amendment Determination primarily concern approved pharmacists and approved medical practitioners who are eligible to receive payments under the Pharmaceutical Benefits Scheme (PBS). These professionals must ensure that their practices comply with the updated conditions specified in Schedule 4 of the Principal Determination. Additionally, they must adhere to any new requirements or guidelines issued by the Department of Health in relation to the newly listed or removed drugs. Failure to comply with the conditions set out in this Amendment Determination may result in civil or criminal consequences, depending on the nature and severity of the breach. While the specific penalties for non-compliance are not detailed in the text, breaches of conditions under the National Health Act 1953 may typically result in fines, sanctions, or other administrative penalties. For more severe cases, criminal penalties could apply, especially if the breach is deemed wilful or involves fraudulent activities. The exact penalties would be determined in accordance with the relevant sections of the Act and any applicable regulations or guidelines.

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