National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 4) (PB 36 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L00620 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. 4)

PB 36 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. 4), commencing on 1 June 2017.  Schedule 4 to the Principal Determination is amended by the addition of fluticasone furoate with vilanterol and salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20.  Schedule 4 is further amended by the omission of the pharmaceutical items colestipol; epoprostenol; fluticasone with vilanterol; and leuprorelin.

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 June 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. 4)
(PB 36 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 4 is amended by the addition of a pharmaceutical item, the addition of a new form of an existing pharmaceutical item and the omission of four pharmaceutical items.

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 was enacted by the Parliament of Australia to provide a legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable, timely, and affordable access to a broad range of medicines. The Act empowers the Minister for Health to determine the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and medical practitioners, which is elaborated in the National Health Determination under paragraph 98C(1)(b). This Determination was amended in 2017 to reflect changes to the listing of pharmaceutical benefits, ensuring the PBS remains current with medical advancements and public health needs. The 2017 Amendment Determination specifically introduced a new nebuliser solution to the PBS while removing several other pharmaceutical items to streamline the scheme. The policy objective of these amendments is to enhance the effectiveness and efficiency of the PBS, ensuring it continues to support the right to the highest attainable standard of physical and mental health as recognised in international human rights instruments.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 4) pertains to the conditions governing Commonwealth payments for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as stipulated in the National Health Act 1953. This Amendment Determination specifically modifies the existing Principal Determination (PB 119 of 2008) to incorporate changes enacted by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 4), effective from 1 June 2017. The amendment involves the addition of fluticasone furoate with vilanterol and salbutamol in the form of Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units to Schedule 4, while simultaneously removing colestipol, epoprostenol, fluticasone with vilanterol, and leuprorelin from the same Schedule. This legislative instrument applies nationally and is subject to the overarching provisions of the National Health Act 1953, which forms the basis of the Pharmaceutical Benefits Scheme (PBS), ensuring that Australians have access to affordable and reliable medicines.

Key Provisions

The primary operative sections of the National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 4) (PB 36 of 2017) pertain to the conditions governing Commonwealth payments for pharmaceutical benefits supplied by approved pharmacists and medical practitioners (section 1). This determination is grounded in the National Health Act 1953, which provides the legislative framework for the Pharmaceutical Benefits Scheme (PBS). The amendments made in this determination primarily affect Schedule 4, which lists pharmaceutical items eligible for Commonwealth subsidy under the PBS. Specifically, this amendment adds fluticasone furoate with vilanterol and salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20, and removes colestipol, epoprostenol, fluticasone with vilanterol, and leuprorelin from the list of subsidised pharmaceutical items (section 3). These changes reflect the latest recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and are intended to align the PBS with current therapeutic needs and evidence-based practices. The determination imposes specific obligations on parties and entities governed by it. Approved pharmacists and medical practitioners must adhere to the conditions set out in the determination when supplying pharmaceutical benefits to ensure they are eligible for Commonwealth payments. This includes compliance with the updated list of pharmaceutical items in Schedule 4 and any other conditions specified in the determination. Additionally, pharmaceutical companies and suppliers must ensure their products meet the criteria for inclusion in the PBS as outlined in the amended schedule. The Department of Health, through its Pharmaceutical Benefits Division, is responsible for administering the PBS and ensuring that the determination is implemented effectively and efficiently. Breaches of the conditions specified in the determination may lead to various civil and criminal consequences. For example, supplying pharmaceutical items that are not listed in Schedule 4, or that are listed with incorrect conditions, may result in the Commonwealth not making payments for those items. In cases of deliberate non-compliance, there could be further penalties under other relevant laws, such as the Crimes Act 1914. The determination does not explicitly state maximum penalties for breaches but indicates that existing laws and regulations apply. The penalties could range from fines to more severe criminal sanctions, depending on the nature and extent of the breach. It is essential for all parties involved to understand and comply with the conditions to avoid any legal repercussions.

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