National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) (No. PB 80 of 2013)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953

PB 80 of 2013

 

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 Schedule 4 to the Principal Determination to reflect the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 13), commencing on 1 December 2013, by adding the listed drugs atorvastatin and ezetimibe, and fluticasone with eformoterol.

Schedule 4 is also amended by adding to the listed drug budesonide with eformoterol the forms: pressurised inhalation containing budesonide 50 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2; pressurised inhalation containing budesonide 100 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2; and pressurised inhalation containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses, 2.

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 December 2013.

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

 

Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 80 of 2013)

 

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 two listed drugs and three forms of a listed drug to Schedule 4 of the Determination.

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 Act 1953 was enacted by the Parliament of Australia to establish the framework for the Pharmaceutical Benefits Scheme (PBS), ensuring affordable access to a broad range of medicines for all Australians. The Act allows the Minister for Health to determine the conditions under which payments are made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. This is achieved through a determination under paragraph 98C(1)(b) of the Act, which is amended periodically to reflect changes in the availability and listing of pharmaceutical benefits. The Amendment Determination PB 80 of 2013 amends the Principal Determination PB 119 of 2008 to include additional pharmaceutical benefits in Schedule 4, specifically atorvastatin and ezetimibe, fluticasone with eformoterol, and three forms of budesonide with eformoterol. This legislative instrument was introduced to update the PBS in alignment with the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 13), which took effect on 1 December 2013. The policy objective is to progressively enhance the highest attainable standard of physical and mental health for all Australians by facilitating timely and evidence-based access to essential medications.

Scope and Application

The Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 applies to the conditions governing payments made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. It amends the existing conditions set out in the Principal Determination, which were initially established to regulate how payments are made for pharmaceutical benefits. This Amendment Determination specifically adds new pharmaceutical products to the list of those covered under the Pharmaceutical Benefits Scheme (PBS), thereby expanding the range of medications eligible for Commonwealth-funded subsidies. The changes are intended to enhance access to essential medicines for Australians by including additional drugs and specific formulations of existing drugs. The geographic reach of this legislation is national, as it pertains to the PBS which operates throughout Australia under the Commonwealth's authority. The Act does not explicitly mention any exclusions or exemptions but relies on the existing framework established under the National Health Act 1953, including the provisions for subordinate instruments that may further specify or modify the application of these amendments.

Key Provisions

The main operative sections of the Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 80 of 2013) include the addition of new pharmaceutical benefits to the Pharmaceutical Benefits Scheme (PBS) by amending Schedule 4 of the Principal Determination (PB 119 of 2008). This amendment adds the drugs atorvastatin and ezetimibe, fluticasone with eformoterol, and three specific forms of budesonide with eformoterol to the PBS. This amendment aims to ensure that these pharmaceutical benefits are subject to the conditions for Commonwealth payments, as outlined in the Principal Determination. The obligations and requirements imposed by this Act on the parties involved include the adherence to the new conditions for the payment of pharmaceutical benefits for the listed drugs. Approved pharmacists and approved medical practitioners must comply with these conditions when supplying these benefits. The Pharmaceutical Benefits Advisory Committee (PBAC) has a key role in recommending the inclusion of new drugs based on evidence and expert advice. The Department of Health is responsible for implementing the recommendations and ensuring that the conditions under which payments are made are properly enforced. There are no explicit offences, penalties, or civil/criminal consequences mentioned for breach of the conditions outlined in this Amendment Determination. However, failure to comply with the conditions for the payment of pharmaceutical benefits could result in the non-payment of benefits by the Commonwealth. This could potentially lead to financial losses for approved pharmacists and approved medical practitioners who supply these benefits. Additionally, non-compliance could undermine the integrity of the PBS and the health outcomes for patients who rely on these subsidised medicines.

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