National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 1) (PB 3 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00059 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2018 (No. 1)

PB 3 of 2018

 

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 2018 (No. 1), commencing on 1 February 2018.  Schedule 4 to the Principal Determination is amended by the deletion of the pharmaceutical benefit coal tar–prepared.

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 February 2018.

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 2018
(No. 1)
(PB 3 of 2018)

 

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 4 is amended by the deletion of the pharmaceutical benefit coal tar–prepared.

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.

 

Lisa La Rance
Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health Act 1953, enacted by the Australian Parliament, serves as the legislative foundation for the Pharmaceutical Benefits Scheme (PBS). This Act addresses the need for a structured and accessible system to provide Australians with affordable access to essential medicines. The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 1), introduced by the Minister for Health, aims to update the conditions governing payments for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. This amendment ensures that the PBS remains responsive to changes in medical needs and technological advancements, thereby maintaining its effectiveness in delivering timely and reliable access to a wide range of medicines. The policy objective is to facilitate evidence-based decision-making through consultations with the Pharmaceutical Benefits Advisory Committee, ensuring that the PBS continues to meet the health needs of the Australian population.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 1) amends the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953, which governs 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 amendment, effective from 1 February 2018, modifies the conditions to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 1). Specifically, it removes the pharmaceutical benefit for coal tar–prepared from Schedule 4. The amendment applies nationally, ensuring consistency across all states and territories in the administration of the Pharmaceutical Benefits Scheme (PBS). The determination does not specify any exclusions or thresholds, but the conditions under which payments are made are subject to the overarching provisions of the National Health Act 1953. The Minister's determination power under paragraph 98C(1)(b) of the Act allows for further adjustments to these conditions through subordinate instruments, ensuring the scheme can adapt to new medical and pharmaceutical developments.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 1) (PB 3 of 2018) amends the existing National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 (the Act). This amendment, effective from 1 February 2018, modifies the conditions governing payments made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. Specifically, Schedule 4 is updated by removing the pharmaceutical benefit coal tar–prepared, reflecting the changes introduced by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 1). The Act imposes certain obligations on parties involved in the Pharmaceutical Benefits Scheme (PBS). Approved pharmacists and approved medical practitioners must adhere to the conditions set out in the amended determination to be eligible for Commonwealth payments. These conditions include requirements related to the prescription, supply, and record-keeping of pharmaceutical benefits. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in advising the Minister on which medicines should be subsidised under the PBS. The PBAC's recommendations ensure that decisions about pharmaceutical benefits are evidence-based, considering submissions and representations from various stakeholders, including pharmaceutical companies and healthcare professionals. Breaches of the conditions stipulated in the amended determination can lead to various consequences. While the explanatory statement does not detail specific offences or penalties, it is reasonable to infer that non-compliance could result in financial penalties, administrative sanctions, or other enforcement actions as provided under the National Health Act 1953. The precise nature and extent of penalties would be determined by the relevant authorities in accordance with the provisions of the Act and associated regulations. 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, as recognised in the International Covenant on Economic, Social and Cultural Rights (ICESCR). By ensuring subsidised access to necessary medicines through the PBS, the amended determination contributes to the advancement of this human right. The involvement of the PBAC in decision-making processes further ensures that these decisions are grounded in evidence and serve the public interest effectively.

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