National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 1) (PB 3 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L00077 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. 1)

PB 3 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. 1), commencing on 1 February 2016.  Schedule 3 to the Principal Determination is amended by the addition of fentanyl in the forms: tablet (sublingual) 100 micrograms (as citrate); tablet (sublingual) 200 micrograms (as citrate); tablet (sublingual) 300 micrograms (as citrate); tablet (sublingual) 400 micrograms (as citrate); tablet (sublingual) 600 micrograms (as citrate); and tablet (sublingual) 800 micrograms (as citrate).

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 February 2016.

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 2016
(No. 1)
(PB 3 of 2016)

 

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 six forms of a listed drug to Schedule 3 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.

 

Julianne Quaine
First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 1) (PB 3 of 2016) amends the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953, which sets out the conditions for payments made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Enacted by the Australian Government, this legislative instrument aims to align the determination with the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 1), which commenced on 1 February 2016. The primary objective is to ensure that the conditions for Commonwealth payments accurately reflect the latest amendments to the Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee, which comprises representatives from various health-related fields, has been consulted during the amendment process to ensure evidence-based decision-making. This legislative instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by providing subsidised access to medicines through the PBS.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 1) modifies the conditions under which the Commonwealth makes payments for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. This amendment, made under the National Health Act 1953, responds to the changes implemented by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2008 (No. 1) and is effective from 1 February 2016. Specifically, this Amendment Determination introduces six new forms of fentanyl to Schedule 3 of the Principal Determination, thereby expanding the range of pharmaceutical benefits available under the Pharmaceutical Benefits Scheme (PBS). This legislative instrument applies to all approved pharmacists and approved medical practitioners who provide pharmaceutical benefits within the scope of the PBS, which is overseen by the Commonwealth and is designed to ensure affordable access to a wide range of medicines for all Australians. The changes made by this determination are made pursuant to subsection 33(3) of the Acts Interpretation Act 1901, unless there is an express power to revoke or vary the Principal Determination. The amendments are compatible with human rights as they facilitate the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised under the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The main operative sections of the National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 1) (PB 3 of 2016) focus on 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 Amendment Determination specifically modifies the Principal Determination (PB 119 of 2008) to incorporate changes mandated by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 1), which took effect on 1 February 2016. It adds six forms of fentanyl, in sublingual tablet forms ranging from 100 to 800 micrograms, to Schedule 3 of the Principal Determination (sections 1(1) and (2)). The changes are made to reflect the latest recommendations for inclusion of certain pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). The obligations imposed by this Amendment Determination require approved pharmacists and approved medical practitioners to adhere to the updated conditions specified in the Principal Determination. These conditions include compliance with the new listing of fentanyl formulations in Schedule 3, which means they are now eligible for PBS subsidies. Practitioners must ensure that their prescriptions and supply of these pharmaceutical benefits comply with the updated conditions to be eligible for Commonwealth payments. The Amendment Determination also reiterates the role of the Pharmaceutical Benefits Advisory Committee (PBAC) in recommending changes to the Minister, ensuring that decisions regarding pharmaceutical benefits are evidence-based and consider various stakeholder inputs. Failure to comply with the conditions specified in the Amendment Determination may lead to legal consequences. While the specific penalties for non-compliance are not detailed in the text, breaches of the National Health Act 1953 can generally result in civil or criminal penalties. For example, supplying pharmaceutical benefits without meeting the stipulated conditions could be considered a breach of the Act, potentially leading to fines or other legal actions. The exact penalties would depend on the nature and severity of the breach, as well as any additional relevant legislation. The overarching intent of these provisions is to ensure that the PBS remains a reliable and efficient system for providing affordable access to necessary medicines.

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