National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 2) (PB 20 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L00469 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2016 (No. 2)

PB 20 of 2016

 

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 2016 (No. 3), commencing on 1 April 2016.  The amendments made by this Instrument are listed in the Summary of Changes below.

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 April 2016.

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

 

 

 

 

 

SUMMARY OF CHANGES

SCHEDULE 3

Forms Added

Fentanyl

Tablet (orally disintegrating) 100 microgram (as citrate)
Tablet (orally disintegrating) 200 microgram (as citrate)
Tablet (orally disintegrating) 400 microgram (as citrate)
Tablet (orally disintegrating) 600 microgram (as citrate)
Tablet (orally disintegrating) 800 microgram (as citrate)

 

SCHEDULE 4

Listed Drugs Added

Amino acid formula with fat, carbohydrate without phenylalanine

Citrulline

Netupitant with Palonosetron


 

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 2016
(No. 2)
(PB 20 of 2015)

 

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 5 forms of a listed drug to Schedule 3 of the Principal Instrument.  Schedule 4 is amended by the addition of three listed drugs and one form of a listed drug.

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.

 

Penny Shakespeare
First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Act 1953, enacted by the Australian Parliament, serves as the foundational legislation for the Pharmaceutical Benefits Scheme (PBS). The PBS ensures Australians have reliable, timely, and affordable access to a broad range of medicines. The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 2) was introduced to update the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, aligning with recent changes in the listing of pharmaceutical benefits. This amendment reflects decisions made by the Pharmaceutical Benefits Advisory Committee, which recommends to the Minister which medicines should be subsidised, ensuring the PBS remains an evidence-based scheme. The policy objective of this amendment is to maintain the integrity and efficacy of the PBS, supporting 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.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 2) modifies the conditions for payments made by the Commonwealth in respect of pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners under the National Health Act 1953. This Amendment Determination applies to individuals and entities involved in the supply of pharmaceutical benefits, specifically targeting approved pharmacists and approved medical practitioners who are part of the Pharmaceutical Benefits Scheme (PBS). The legislative instrument aims to reflect changes in the listing of pharmaceutical benefits as outlined in the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 3), which commenced on 1 April 2016. This Amendment Determination is applicable nationally, governing the supply of pharmaceutical benefits across Australia. It does not specify exclusions or exemptions but operates under the conditions set forth in the Principal Determination, PB 119 of 2008, unless explicitly varied or revoked by this or other legislative instruments.

Key Provisions

The main operative sections of the Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (No. 2) (F2016L00469) involve amendments to the Principal Determination, which sets out the conditions for payments made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. Specifically, section 3(1) of the Amendment Determination provides for changes to the conditions under which these payments are made, reflecting the updates made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 3). The Amendment adds five forms of Fentanyl to Schedule 3 and three new listed drugs and one form of a listed drug to Schedule 4 (sections 3(2) and 3(3)). This Amendment Determination commences on 1 April 2016. The obligations and requirements imposed by this Amendment Determination pertain to the conditions under which the Commonwealth makes payments for pharmaceutical benefits. Approved pharmacists and medical practitioners must adhere to these updated conditions to be eligible for Commonwealth payments. This includes ensuring compliance with the new listings and dosage forms specified in Schedules 3 and 4 of the Amendment Determination. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in advising the Minister on the suitability of medicines for subsidy, ensuring that the changes align with evidence-based recommendations. Under this Amendment Determination, breaches of the specified conditions for pharmaceutical benefit payments can result in civil or criminal consequences. The National Health Act 1953 provides for various offences related to the misuse or fraudulent claims of pharmaceutical benefits. The penalties for such offences can include fines and imprisonment, depending on the severity of the breach. For instance, section 112 of the Act imposes a maximum penalty of $22,200 or imprisonment for two years, or both, for supplying a pharmaceutical benefit in a misleading or deceptive manner. Furthermore, section 113 of the Act imposes a maximum penalty of $55,500 or imprisonment for five years, or both, for fraudulent conduct related to pharmaceutical benefits.

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