National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 5) (PB 64 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01109 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2017 (No. 5)

PB 64 of 2017

 

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 2017 (No. 7), commencing on 1 September 2017.  Schedule 3 to the Principal Determination is amended by the omission of hydromorphone in the form injection containing hydromorphone hydrochloride 50 mg in 5 mL. 

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 September 2017.

This Instrument is a legislative instrument for the purposes of the Legislation 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 2017
(No. 5)
(PB 64 of 2017)

 

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.  Schedule 3 is amended by the omission of one form of a pharmaceutical item.

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

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 5) (PB 64 of 2017) amends the National Health Act 1953, specifically the conditions under which payments will be made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. Enacted by the Australian Parliament, this legislation is intended to update the Pharmaceutical Benefits Scheme (PBS) to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 7), which commenced on 1 September 2017. The amendment primarily addresses the omission of a specific pharmaceutical item from the PBS, ensuring that the conditions for Commonwealth payments remain current and aligned with the latest health care provisions. The policy objective is to maintain a reliable, timely, and affordable access to a wide range of medicines for all Australians, as stipulated in Part VII of the Act.

Scope and Application

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 7) amends the conditions under which the Commonwealth makes payments in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, pursuant to the National Health Act 1953. This Amendment Determination, effective from 1 September 2017, modifies the Principal Determination under section 98C(1)(b) to reflect the changes introduced by the Amendment Instrument. The determination outlines the specific conditions and criteria for Commonwealth payments for pharmaceutical benefits, which are part of the Pharmaceutical Benefits Scheme (PBS). The PBS is a Commonwealth scheme that provides affordable access to a range of medicines for Australians. The determination applies to approved pharmacists and approved medical practitioners involved in the supply of pharmaceutical benefits. The amendment involves the removal of hydromorphone in the form of an injection containing hydromorphone hydrochloride 50 mg in 5 mL from Schedule 3 of the Principal Determination. This legislative instrument is compatible with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights, by ensuring access to subsidised medicines and promoting the highest attainable standard of physical and mental health. The Pharmaceutical Benefits Advisory Committee, an independent body that advises the Minister, was consulted in the process of making these amendments.

Key Provisions

The main sections of this Amendment Determination (F2017L01109) concern the conditions under which payments are made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Under paragraph 98C(1)(b) of the National Health Act 1953, the Minister may determine these conditions, and this Amendment Determination amends the original Principal Determination (PB 119 of 2008) to reflect changes in the Pharmaceutical Benefits listed in the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 7), which commenced on 1 September 2017. Specifically, this Amendment Determination removes hydromorphone in the form of an injection containing hydromorphone hydrochloride 50 mg in 5 mL from Schedule 3 of the Principal Determination. This Act imposes obligations on approved pharmacists and approved medical practitioners to ensure they comply with the conditions outlined in the Amendment Determination when supplying pharmaceutical benefits. These conditions are critical in determining the circumstances under which the Commonwealth will make payments for the supply of pharmaceutical benefits. Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on which medicines should be subsidised through the Pharmaceutical Benefits Scheme (PBS). The PBAC's recommendations are based on submissions and representations from interested parties, including pharmaceutical companies. Failure to comply with the conditions set out in the Amendment Determination may lead to various consequences. Although the specific offences, penalties, or civil/criminal consequences are not detailed in the text, it is clear that non-compliance with the conditions for payments could result in the Commonwealth withholding payment for the supplied pharmaceutical benefits. Furthermore, as this legislative instrument is compatible with human rights, any failure to adhere to these conditions might impact 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 (ICESCR).

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