National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 8) (PB 85 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01388 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH DETERMINATION UNDER PARAGRAPH 98C(1)(b) AMENDMENT 2019 (No. 8)

PB 85 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 November 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. 8)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 8) and may also be cited as PB 85 of 2019.

Section 2 Commencement

This section provides that the Instrument commences on 1 November 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 1 to 5 of the Principle Determination.  These changes are summarised below.

 

SUMMARY OF CHANGES

Listed drugs added to Schedule 4 (complete pack must be supplied)

Naloxone

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

Mupirocin

Nasal ointment 20 mg (as calcium) per g, 5 g

Forms deleted from Schedule 4 (complete pack must be supplied)

Timolol

Eye drops (gellan gum solution) 2.5 mg (as maleate) per mL, 2.5 mL

 


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. 8)

(PB 85 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 Determination under paragraph 98C(1)(b) Amendment 2019 (No. 8) (PB 85 of 2019) was enacted to amend the existing conditions under which payments are made for pharmaceutical benefits under the National Health Act 1953. This amendment was introduced to align the Pharmaceutical Benefits Scheme (PBS) with recent changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The PBS, established under Part VII of the National Health Act, aims to provide Australians with reliable, timely, and affordable access to a wide range of medicines. The changes made by this amendment include the addition, deletion, and modification of drugs and their forms across Schedules 1 to 5 of the Principal Determination. These amendments were determined by the Minister after consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that decisions regarding the PBS are evidence-based and consider various healthcare interests. This legislative instrument is compatible with human rights, specifically engaging Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), by assisting in the progressive realisation of the right to the highest attainable standard of physical and mental health. The PBS, as part of the National Health Act, contributes to this human right by providing subsidised access to medicines. The role of the PBAC ensures that decisions about which medicines are subsidised on the PBS are based on sound evidence and recommendations.

Scope and Application

The National Health Determination under Paragraph 98C(1)(b) Amendment 2019 (No. 8) amends the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This Determination is made under paragraph 98C(1)(b) of the National Health Act 1953, which empowers the Minister to set the conditions for such payments. The changes outlined in the Determination align with amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which include additions, deletions, and modifications to the drugs and forms listed in Schedules 1 to 5 of the Principal Determination. This amendment ensures that the Pharmaceutical Benefits Scheme (PBS) remains current and reflects the most recent evidence-based recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The changes in this Determination will take effect from 1 November 2019, and unless explicitly stated, any variations or revocations to the Principal Determination are made under the authority of subsection 33(3) of the Acts Interpretation Act 1901. This legislative instrument is compatible with human rights as it contributes to the progressive realisation of the right to the highest attainable standard of physical and mental health, as outlined in the International Covenant on Economic, Social and Cultural Rights (ICESCR).

Key Provisions

The main operative sections of the National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 8) (F2019L01388) include Section 1, which names the Instrument as the National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 8) and cites it as PB 85 of 2019, and Section 2, which sets the commencement date of the Instrument as 1 November 2019. Section 3 details the amendment of the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008), and Schedule 1 outlines the specific amendments to drugs and forms in Schedules 1 to 5 of the Principal Determination. These changes include additions, deletions, and modifications to the listed drugs and forms. The Act imposes specific obligations on parties and entities involved in the Pharmaceutical Benefits Scheme (PBS), particularly approved pharmacists and approved medical practitioners. They must comply with the conditions set out in the Principal Determination and its amendments, ensuring that they supply pharmaceutical benefits in accordance with the terms specified. This includes adherence to the requirements for complete pack supplies, as well as the necessity to provide certain drugs and forms as listed in Schedules 1 to 5 of the Determination. Breaches of the conditions set out in the Determination could lead to civil or criminal consequences. Although the specific penalties for non-compliance are not detailed in the text, the legislation generally allows for significant penalties under the National Health Act 1953 for non-compliance with the conditions governing pharmaceutical benefits. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in ensuring that decisions about subsidised access to medicines on the PBS are evidence-based, thereby safeguarding the integrity and effectiveness of the scheme. Failure to comply with the regulations could result in financial penalties or other legal repercussions, as determined by the relevant authorities.

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