National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 10) (No. PB 83 of 2014)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01393 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2014 (No. 10)

PB 83 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. 11), commencing on 1 November 2014.  Schedule 4 of the Principal Determination is amended by the addition of glucose indicator―blood in the form test strips, 100 (Contour next).

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 November 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. 10)
(PB 83 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 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 Act 1953, enacted by the Australian Parliament, serves as the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which aims to provide all Australians with reliable, timely, and affordable access to a broad range of medicines. This Act allows the Minister to determine the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and medical practitioners, as outlined in paragraph 98C(1)(b). The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 10) (PB 83 of 2014) modifies the Principal Determination to align with changes introduced by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 11), which became effective on 1 November 2014. This amendment specifically adds glucose indicator-blood test strips, 100 (Contour next), to Schedule 4 of the Principal Determination. The policy objective of these amendments is to ensure that the PBS remains effective and up-to-date in meeting the healthcare needs of the population, with decisions supported by the Pharmaceutical Benefits Advisory Committee, ensuring evidence-based and comprehensive access to necessary medications.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 10) amends the Principal Determination made under the National Health Act 1953, focusing on the conditions for payments made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This determination applies to entities and individuals involved in the supply of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS), ensuring that the payments align with the legislative changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 11). The amendment specifically adds glucose indicator―blood in the form test strips, 100 (Contour next) to Schedule 4 of the Principal Determination, thereby extending the range of subsidised medicines available under the PBS. This legislative instrument is applicable across the Commonwealth of Australia and does not include any specific exclusions beyond the conditions outlined within the Principal Determination and its amendments. The changes implemented by this Amendment Determination reflect decisions made by the Pharmaceutical Benefits Advisory Committee (PBAC) and are designed to enhance access to essential medications for all Australians.

Key Provisions

The main operative sections of this legislation are those that amend the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 (the Act). Specifically, section 1 of the Amendment Determination (PB 83 of 2014) amends the Principal Determination (PB 119 of 2008) to include a new pharmaceutical benefit, namely glucose indicator-blood in the form test strips, 100 (Contour next), in Schedule 4 of the Principal Instrument. This addition reflects the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 11), which came into effect on 1 November 2014. The amendments aim to provide approved pharmacists and approved medical practitioners with the conditions under which payments will be made by the Commonwealth for the supply of this new pharmaceutical benefit. The Act imposes specific obligations and requirements on the parties and entities it governs. Approved pharmacists and approved medical practitioners must adhere to the conditions outlined in the Determination for the supply of pharmaceutical benefits, including the newly added glucose indicator-blood in the form test strips, 100 (Contour next). These conditions are established to ensure that the supply of pharmaceutical benefits is managed in a manner that aligns with the objectives of the Pharmaceutical Benefits Scheme (PBS). Furthermore, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending changes to the Minister, ensuring that decisions about subsidised access to medicines on the PBS are evidence-based and aligned with public health needs. In terms of offences, penalties, or consequences for breach, the Act does not explicitly outline specific penalties within the Amendment Determination itself. However, breaches of the conditions set out in the Determination could potentially lead to legal consequences under the National Health Act 1953 and other relevant legislation. Penalties for non-compliance may include fines, suspension, or revocation of approval as an approved pharmacist or approved medical practitioner. Additionally, individuals or entities found to be in breach of the Act’s provisions could face civil or criminal proceedings, depending on the nature and severity of the breach. The Amendment Determination, by adding the glucose indicator-blood in the form test strips, 100 (Contour next), to the list of pharmaceutical benefits, ensures that the PBS continues to provide reliable, timely, and affordable access to a wider range of medicines for Australians. This legislative change aligns with the broader objectives of the National Health Act 1953, particularly those outlined in Part VII, which governs the PBS. The role of the PBAC in advising the Minister further ensures that the scheme remains evidence-based and responsive to public health needs, thereby enhancing the protection of human rights as recognised in international instruments.

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