National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 8) (PB 80 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01350 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. 8)

PB 80 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. 8), commencing on 1 September 2015.  Schedule 3 of the Principal Determination is amended by the addition of the listed drug lisdexamfetamine.  Schedule 4 of the Principal Determination is amended by the deletion of glucose indicator—blood in the form test strips, 100 (EasyMate II) and also by the removal of the listed drugs lactulose and rivastigmine.  

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 September 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. 8)
(PB 80 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 one listed drug to Schedule 3 of the Principal Instrument and removes two drugs and one form 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.

 

Kylie Jonasson

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 8) is an amendment to the National Health Act 1953, which was enacted to address the need for a flexible framework to manage the Pharmaceutical Benefits Scheme (PBS). This Act was introduced by the Commonwealth of Australia and provides a legislative basis for the PBS, ensuring reliable, timely, and affordable access to a wide range of medicines for all Australians. The primary objective of this determination is to align the Principal Determination with the recent changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 8), which came into effect on 1 September 2015. The determination process involves amendments to Schedule 3 and Schedule 4 of the Principal Determination, including the addition of lisdexamfetamine to Schedule 3 and the removal of glucose indicator—blood in the form test strips, 100 (EasyMate II), lactulose, and rivastigmine from Schedule 4. The changes are intended to reflect the recommendations of the Pharmaceutical Benefits Advisory Committee, ensuring that decisions regarding pharmaceutical benefits are evidence-based and contribute to the progressive realisation of the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 8) pertains to the conditions under which payments are made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners, as outlined in the National Health Act 1953. This amendment applies to the entities and individuals involved in the supply of pharmaceutical benefits, specifically focusing on the pharmaceutical drugs listed in Schedules 3 and 4 of the Principal Determination. The amendment adds lisdexamfetamine to Schedule 3, thereby including it in the list of drugs eligible for Commonwealth payments, and removes glucose indicator—blood in the form test strips, 100 (EasyMate II), lactulose, and rivastigmine from Schedule 4, excluding these from the list of drugs that can be paid for under the scheme. The amendment is applicable nationally across Australia as it is a Commonwealth legislative instrument. There are no explicit exclusions or exemptions mentioned in the text, but it is implied that only approved pharmacists and approved medical practitioners who supply the listed drugs can avail of the payments. The Act extends its application through subordinate instruments such as the Principal Determination, which is amended by this legislative instrument.

Key Provisions

The key provisions of the National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 8) (PB 80 of 2015) amend the Principal Determination, which outlines the conditions under which payments are made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners (section 98C(1)(b) of the National Health Act 1953). These amendments reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 8), which came into effect on 1 September 2015. Specifically, the Amendment Determination adds lisdexamfetamine to Schedule 3 of the Principal Determination and removes glucose indicator—blood in the form test strips, 100 (EasyMate II), lactulose, and rivastigmine from Schedule 4. The obligations and requirements imposed by this Amendment Determination are primarily concerned with ensuring that the conditions under which pharmaceutical benefits are paid are updated to reflect the current availability and eligibility of certain medications under the Pharmaceutical Benefits Scheme (PBS). Approved pharmacists and approved medical practitioners must adhere to the revised schedules within the Principal Determination, which now include or exclude certain medications. This means that suppliers and prescribers must be aware of the changes to comply with the conditions governing the supply and payment of pharmaceutical benefits. Additionally, the process involves regular consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that decisions are evidence-based and consider a wide range of interests. In terms of consequences for breach, the National Health Act 1953 does not explicitly outline specific offences, penalties, or consequences for non-compliance with the amended conditions in this Amendment Determination. However, failure to comply with the conditions could potentially lead to financial penalties or legal action under the broader provisions of the National Health Act 1953 or other relevant legislation. The Act generally empowers the Minister to enforce compliance and may involve actions such as fines or other administrative measures to ensure adherence to the conditions set forth. The precise penalties would depend on the context of the non-compliance and the specific provisions of the Act that are being breached.

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