National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L00144 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2014 (No. 2)

PB 10 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. 2), commencing on 1 March 2014.  Schedule 4 of the Principal Determination is amended by the addition of bimatoprost in the form eye drops 300 micrograms per mL, single dose units 0.4 mL, 30.  Schedule 4 is further amended by removing terbutaline in the form powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses.

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 2014.

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. 2)
(PB 10 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 form of a listed drug to Schedule 4 of the Determination and also removes one form of a listed drug 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 Determination under paragraph 98C(1)(b) Amendment 2014 (No. 2) (PB 10 of 2014) was introduced to update the conditions under which payments are made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as outlined in the National Health Act 1953. This amendment was enacted to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 2), which commenced on 1 March 2014. The amendments involved adding bimatoprost in a specific form to Schedule 4 and removing a form of terbutaline from Schedule 4 of the Principal Determination. The determination was made by the Minister under the authority provided by paragraph 98C(1)(b) of the National Health Act 1953, with the objective of ensuring the Pharmaceutical Benefits Scheme (PBS) remains current and effective in providing reliable, timely, and affordable access to a wide range of medicines for all Australians. The Pharmaceutical Benefits Advisory Committee (PBAC) played a crucial role in advising on these changes, ensuring the recommendations were evidence-based and aligned with the objective of advancing public health.

Scope and Application

The National Health Act 1953, through the National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 2), governs the conditions under which the Commonwealth makes payments for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. This Act applies specifically to the Pharmaceutical Benefits Scheme (PBS), which ensures affordable access to a range of medicines for Australians. The determination amends the Principal Determination to incorporate changes such as the addition of bimatoprost in the form of eye drops and the removal of terbutaline in the form of powder for oral inhalation from Schedule 4, reflecting adjustments made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 2). The changes are effective from 1 March 2014 and are designed to ensure the PBS remains aligned with the latest health needs and evidence-based recommendations from the Pharmaceutical Benefits Advisory Committee. This legislative instrument not only updates the list of subsidised pharmaceuticals but also remains compatible with human rights, particularly by advancing access to affordable health care, which is a fundamental aspect of the right to health.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 2) (PB 10 of 2014) amends the National Health Determination under paragraph 98C(1)(b) (PB 119 of 2008). These amendments are designed to reflect changes to the Pharmaceutical Benefits Scheme (PBS) as stipulated by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 2). Specifically, the amendment adds bimatoprost in the form of eye drops 300 micrograms per mL, single dose units 0.4 mL, 30, to Schedule 4 of the Principal Determination. Simultaneously, it removes terbutaline in the form of powder for oral inhalation in a breath-actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses, from Schedule 4. These changes commenced on 1 March 2014. The determination sets forth the conditions under which the Commonwealth will make payments for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. These conditions are established under paragraph 98C(1)(b) of the National Health Act 1953. The changes outlined in the Amendment aim to align the Principal Determination with the most recent updates to the PBS, ensuring that the scheme remains responsive to the evolving healthcare needs of Australians. The Act imposes specific obligations on approved pharmacists and approved medical practitioners to adhere to the conditions set out in the Determination. These professionals must ensure that the supply of pharmaceutical benefits aligns with the updated listing in Schedule 4, reflecting the addition and removal of certain medications. Additionally, they must comply with the procedural requirements for claiming payments under the PBS, ensuring that the services provided are eligible for Commonwealth subsidies as per the conditions outlined. Failure to comply with the conditions set by the Amendment may result in significant consequences. The Act provides for both civil and criminal penalties for breaches. For instance, providing pharmaceutical benefits not in accordance with the conditions may lead to financial penalties, including fines. The maximum penalties for such breaches can vary, but they are designed to enforce compliance and maintain the integrity of the PBS. Moreover, persistent or egregious non-compliance could result in legal action against the offending parties, further underscoring the seriousness of adhering to the stipulated conditions. In conclusion, the Amendment to the National Health Determination under paragraph 98C(1)(b) serves to update the conditions for Commonwealth payments regarding the supply of pharmaceutical benefits. It requires approved pharmacists and approved medical practitioners to align their practices with these updated conditions, under penalty of financial and legal consequences. These changes ensure that the PBS continues to provide timely, reliable, and affordable access to essential medicines for all Australians.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Offence Provisions
Reporting & Disclosure Obligations

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.