National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 2) (PB 18 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00448 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH DETERMINATION UNDER PARAGRAPH 98C(1)(b) AMENDMENT 2019 (No. 2)

PB 18 of 2019

 

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.  The 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

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

The amendments made by this Instrument include additions, deletions and changes to drugs and forms in Schedules 1 to 5 of the Principle Determination.

A provision by provision description of this Instrument is contained in the Attachment.

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, medical specialists and a pharmaceutical industry nominee.  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 April 2019.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH DETERMINATION UNDER PARAGRAPH 98C(1)(b) AMENDMENT 2019 (No. 2)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 2) and may also be cited as PB 18 of 2019.

Section 2 Commencement

This section provides that the Instrument commences on 1 April 2019.

Section 3 Amendment of Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008)

This section provides that Schedule 1 amends the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008).

Schedule 1 Amendments

The amendments in Schedule 1 include additions, deletions and changes to drugs and forms in Schedules 4 of the Principle Determination.  These changes are summarised below.

 

SUMMARY OF CHANGES

Forms added to Schedule 4 (complete pack must be supplied)

Aciclovir

Eye ointment 30 mg per g, 4.5 g (Acivision)


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 2019 (No. 2)

(PB 18 of 2019)

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 (PB 119 of 2008) (the Principal Determination) 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 Principal Determination to provide for changes to those conditions.  Schedule 1 to this Legislative Instrument provides for additions, deletions and changes to drugs and forms in Schedules 1 to 5 of the Principle 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.

 

 

 

 

 

Thea Daniel

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health Act 1953 provides the legislative basis for the Pharmaceutical Benefits Scheme (PBS) through which the Commonwealth offers affordable access to a wide range of medicines for all Australians. Pursuant to paragraph 98C(1)(b) of the Act, the Minister has the authority to determine the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 2) (PB 18 of 2019) amends the Principal Determination (PB 119 of 2008) to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights 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 assists with advancement of this human right by providing for subsidised access by patients to medicines. The amendments made by this Instrument include additions, deletions and changes to drugs and forms in Schedules 1 to 5 of the Principal Determination. These changes were recommended by the Pharmaceutical Benefits Advisory Committee, an independent body comprising members from various interests and professions, including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, medical specialists, and a pharmaceutical industry nominee. The Committee has received submissions and representations from interested pharmaceutical companies and recommended the changes to the Minister who has determined the changes to the conditions under paragraph 98C(1)(b). This Legislative Instrument is compatible with human rights because it advances the protection of human rights.

Scope and Application

The National Health Act 1953 provides the legislative basis for the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth offers access to affordable medicines for all Australians. The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 2) (PB 18 of 2019) amends the Principal Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008) to adjust the conditions for Commonwealth payments in respect of pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. The amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) and involves additions, deletions, and changes to drugs and forms in Schedules 1 to 5 of the Principal Determination. This legislative instrument is compatible with human rights, as it advances the right to the highest attainable standard of physical and mental health by facilitating access to necessary medications through the PBS. The amendments take effect from 1 April 2019.

Key Provisions

The main operative sections of this legislation (National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 2)) focus on amending the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners under the National Health Act 1953 (section 3). This is achieved by amending the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008) through Schedule 1. The changes outlined in Schedule 1 include additions, deletions and changes to drugs and forms in Schedules 1 to 5 of the Principal Determination. The obligations and requirements imposed by this Act on parties or entities it governs primarily revolve around the updated conditions for pharmaceutical benefits payments. Approved pharmacists and approved medical practitioners must now adhere to the amended conditions as outlined in Schedule 1 of the Legislative Instrument. These changes dictate which drugs and forms will be included or excluded from the Pharmaceutical Benefits Scheme (PBS) and the specific quantities or forms required for supply. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on which medicines should be subsidised, ensuring that decisions are evidence-based and consider various interests and professions. In terms of offences, penalties, or civil/criminal consequences for breach, the legislation itself does not explicitly state any specific penalties for non-compliance with the updated conditions. However, non-compliance with the conditions set out in the Principal Determination could potentially lead to legal consequences under the National Health Act 1953 or other relevant legislation. For instance, failure to adhere to the conditions for pharmaceutical benefits payments could result in the revocation of approval as an approved pharmacist or approved medical practitioner, thereby preventing the individual or entity from participating in the PBS. Additionally, there could be implications under other legislation, such as the Acts Interpretation Act 1901, which provides for the revocation or variation of legislative instruments.

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Legislative Instrument
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Definitions & Interpretation
Amendments & Changes
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