National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 6) (PB 73 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01277 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2017 (No. 6)

PB 73 of 2017

 

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 2017 (No. 8), commencing on 1 October 2017.  Schedule 3 to the Principal Determination is amended by the alteration of the description of oxycodone in the form oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL.  This form is now described as ‘oral solution containing oxycodone hydrochloride 1 mg per mL, 250 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, medical specialists and a pharmaceutical industry nominee.  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 October 2017.

This Instrument is a legislative instrument for the purposes of the Legislation 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 2017
(No. 6)
(PB 73 of 2017)

 

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.  Schedule 3 is amended by the omission of one form of a pharmaceutical item.

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.

 

Julianne Quaine
First Assistant Secretary (Acting)

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health Act 1953 forms the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to affordable and reliable medicines. This Act allows the Minister to determine conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 6) (PB 73 of 2017) amends the principal determination to reflect updates made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 8). Specifically, the determination modifies the description of oxycodone in the form of an oral solution, adjusting its concentration from 5 mg per 5 mL to 1 mg per mL. The changes are designed to align with the evolving standards of medical practice and patient safety. The policy objective is to ensure the PBS remains a progressive system that supports the highest attainable standard of health for all Australians, as recognised by the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 6) pertains to the conditions governing Commonwealth payments for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as outlined in the National Health Act 1953. This legislative instrument amends the existing Principal Determination, specifically modifying the description of a pharmaceutical item, oxycodone in the form of an oral solution, to reflect recent changes to its composition. The amendment to the Principal Determination is effective from 1 October 2017 and applies nationally across Australia. This determination ensures that the conditions under which payments are made by the Commonwealth for pharmaceutical benefits are updated to align with the changes in the pharmaceutical products listed under the Pharmaceutical Benefits Scheme (PBS). The PBS, established under Part VII of the National Health Act 1953, facilitates reliable, timely, and affordable access to a wide range of medicines for Australians. The decision-making process for determining these conditions involved consultation with the Pharmaceutical Benefits Advisory Committee, an independent body comprising representatives from various healthcare interests and professions. The legislative instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring access to affordable medications.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 6) (PB 73 of 2017) amends the Principal Determination (PB 119 of 2008) concerning the conditions for payments made by the Commonwealth in respect of pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners (section 1). The main change involves the description of oxycodone in the form of an oral solution containing oxycodone hydrochloride, altering the concentration from 5 mg per 5 mL to 1 mg per mL in a 250 mL bottle (Schedule 3). This determination aligns with the changes introduced by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 8), which took effect on 1 October 2017. The Act imposes specific obligations on approved pharmacists and approved medical practitioners to adhere to the conditions set out in the determination. These conditions govern how pharmaceutical benefits are supplied and reimbursed under the Pharmaceutical Benefits Scheme (PBS). The obligations include ensuring that the prescribed pharmaceutical items meet the criteria as detailed in the amended determination, particularly in relation to the altered description of oxycodone in the oral solution form. Additionally, healthcare providers must comply with the requirements for claiming payments under the PBS as stipulated in the determination. Breaches of the conditions outlined in the determination may result in various consequences. While specific offences and penalties are not detailed in the explanatory statement, non-compliance with PBS regulations generally can lead to penalties under the National Health Act 1953. For instance, fraudulent claims or misrepresentation of facts to obtain payments could be considered offences under the Act, potentially resulting in fines or other civil or criminal penalties. The Act also provides for the revocation or variation of the determination if there is a need to correct or update the conditions, ensuring the PBS remains effective and aligned with public health needs.

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