National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 12) (No. PB 108 of 2014)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01772 Not in force Legislative Instrument

Legislation content

 

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2014 (No. 12)

PB 108 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. 13), commencing on 1 January 2015.  Schedule 4 of the Principal Determination is amended by the addition of the listed drug ezetimibe and rosuvastatin.

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 January 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 2014
(No. 12)
(PB 108 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 one listed drug 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.

 

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 12) is an amendment to the National Health Act 1953. This legislative instrument, enacted to align with the changes introduced by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 13), updates the conditions under which payments are made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. Specifically, it adds the drugs ezetimibe and rosuvastatin to Schedule 4 of the Principal Determination, thereby expanding the range of pharmaceutical benefits covered under the Pharmaceutical Benefits Scheme (PBS). The amendment ensures that the PBS continues to provide affordable access to a broad spectrum of essential medicines for Australians, as outlined in the Act. The policy objective is to maintain and enhance the provision of timely, reliable, and cost-effective access to necessary medications through the PBS, as mandated by the National Health Act.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 12) applies to the conditions governing payments made by the Commonwealth for the supply of pharmaceutical benefits through approved pharmacists and approved medical practitioners. This amendment to the National Health Act 1953 ensures that the conditions for these payments reflect the changes introduced by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 13), which took effect from 1 January 2015. The amendment specifically involves the addition of the listed drug ezetimibe and rosuvastatin to Schedule 4 of the Principal Determination. The scope of the Act extends to the whole of Australia, given that it is a Commonwealth instrument, and it applies to the Pharmaceutical Benefits Scheme (PBS) which is a national initiative. There are no specific exclusions or exemptions mentioned in this amendment, though it is understood that the conditions and thresholds for subsidy are determined through the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body that ensures decisions are evidence-based. This legislative instrument is compatible with human rights as it promotes access to affordable medicines, thereby supporting the highest attainable standard of physical and mental health as recognised under the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The main operative sections of the National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 12) (PB 108 of 2014) are found in the amendments to the Principal Determination (PB 119 of 2008). Section 3 of the Act, specifically paragraph 98C(1)(b), provides the authority for the Minister to determine the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This Amendment Determination modifies the Principal Determination to include changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 13), effective from 1 January 2015. Notably, Schedule 4 of the Principal Determination has been updated to include the listed drug ezetimibe and rosuvastatin. The obligations imposed by this Amendment Determination on the parties and entities it governs are primarily concerned with ensuring that payments for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners are made under the revised conditions. The determination seeks to streamline the process of pharmaceutical benefits payments to align with the latest changes in the Pharmaceutical Benefits Scheme (PBS). Specifically, pharmacists and medical practitioners must ensure that their practices comply with the updated conditions outlined in the amended Principal Determination. This includes adherence to the new inclusions in Schedule 4, such as the listed drug ezetimibe and rosuvastatin. Any breach of the conditions outlined in this Amendment Determination may result in civil or criminal consequences. Although the specific penalties are not detailed within the Amendment Determination itself, the National Health Act 1953 and related instruments typically impose fines or other penalties for non-compliance. The exact penalties would depend on the nature and severity of the breach, and could include administrative penalties, financial penalties, or in more severe cases, criminal charges. It is important for parties governed by this Determination to ensure full compliance to avoid any potential repercussions.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Commencement Provisions
Reporting & Disclosure Obligations
Regulatory Standards

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.