National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 6) (PB 84 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01348 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH DETERMINATION UNDER PARAGRAPH 98C(1)(b) AMENDMENT 2018 (No. 6)

PB 84 of 2018

 

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 October 2018.

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 2018 (No. 6)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 6) and may also be cited as PB 84 of 2018.

Section 2 Commencement

This section provides that the Instrument commences on 1 October 2018.

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

Forms Deleted from Schedule 4 (Complete pack must be supplied)

Calcipotriol with betamethasone

Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g

Timolol

Eye gel 1 mg (as maleate) per g, 5 g

 


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 2018 (No. 6)

(PB 84 of 2018)

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.

 

 

 

Lisa La Rance

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 2018 (No. 6) (PB 84 of 2018) amends the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as set out in the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008). Enacted by the Australian Parliament, this legislation responds to the need for regular updates to the Pharmaceutical Benefits Scheme (PBS), ensuring that the scheme reflects the latest medical and pharmaceutical developments. The policy objective of the amendment is to provide affordable access to a wide range of medicines for all Australians, achieved by making necessary adjustments to the listings of drugs and forms in Schedules 1 to 5 of the Principal Determination. These amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and include additions, deletions, and modifications to the drugs and forms covered by the PBS.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 6) amends the conditions for Commonwealth payments regarding the supply of pharmaceutical benefits by approved pharmacists and medical practitioners as outlined in the National Health Act 1953. This Amendment applies to all entities involved in the supply of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS), including approved pharmacists, approved medical practitioners, and pharmaceutical companies. The Amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which include additions, deletions, and modifications to drugs and forms in Schedules 1 to 5 of the Principal Determination. The changes are effective from 1 October 2018, with the amendment coming into force on the same date. The Amendment ensures that the conditions governing the supply of pharmaceutical benefits are updated to reflect the most recent recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent committee comprising members from various relevant fields, advises the Minister on which medicines should be subsidised through the PBS. The changes are made to maintain the scheme's alignment with the highest attainable standard of physical and mental health as recognised by the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 6) (PB 84 of 2018) amends the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This is achieved by modifying Schedules 1 to 5 of the Principal Determination, which originally set out these conditions (PB 119 of 2008). The changes include additions, deletions, and modifications to the drugs and forms listed in these schedules. These changes are intended to reflect updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). The obligations imposed by this Amendment primarily involve ensuring that approved pharmacists and approved medical practitioners comply with the updated conditions outlined in the amended schedules. Specifically, these professionals must adhere to the new listings, delistings, and changes to the pharmaceutical benefits that are detailed in the schedules. This includes ensuring that the supply of pharmaceutical benefits aligns with the updated criteria and that any changes in the availability or conditions of those benefits are communicated and implemented correctly. The determination includes provisions that carry potential penalties and consequences for non-compliance. While specific penalties are not detailed in the text, the National Health Act 1953 generally provides for penalties that may include fines, imprisonment, or both, depending on the severity and nature of the breach. Non-compliance with the conditions set out in the amended schedules could lead to legal action against the offending parties, resulting in these penalties being imposed. This underscores the importance of adhering to the updated conditions to avoid any legal repercussions.

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