National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 2) (PB 18 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L00355 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. 2)

PB 18 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. 2), commencing on 1 April 2017.  Schedule 4 to the Principal Determination is amended by the addition of the listed drug epoprostenol.  Schedule 4 is also amended by the addition of: calcipotriol with betamethasone in the form foam containing calcipotriol
50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g; and salbutamol in the form nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 20.

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 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. 2)
(PB 18 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 to the Principal Determination is amended by the addition of one pharmaceutical item and one form to each of two 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.

 

Louise Clarke
First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Act 1953, enacted by the Commonwealth Parliament, establishes the framework for the Pharmaceutical Benefits Scheme (PBS) to ensure that all Australians have reliable, timely, and affordable access to a wide range of medicines. Under paragraph 98C(1)(b) of the Act, the Minister has the authority to determine the conditions subject to which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 2) (PB 18 of 2017) was introduced to align the conditions of these payments with the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 2), effective from 1 April 2017. The determination specifically amends Schedule 4 by adding epoprostenol, calcipotriol with betamethasone in foam form, and salbutamol in nebuliser solution, ensuring that the PBS continues to provide access to necessary medications in line with contemporary health needs and evidence-based recommendations from the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 2) (PB 18 of 2017) amends the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, aligning with changes introduced by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 2). This amendment applies to the Pharmaceutical Benefits Scheme (PBS) as established under Part VII of the National Health Act 1953, ensuring that the Commonwealth provides timely access to a range of medicines for Australians. The amendment adds specific pharmaceutical items, including epoprostenol, calcipotriol with betamethasone in the form of foam, and salbutamol in the form of nebuliser solution, to the schedule of pharmaceutical benefits. The amendments are effective from 1 April 2017, and are implemented pursuant to the authority provided under paragraph 98C(1)(b) of the National Health Act 1953, with the Pharmaceutical Benefits Advisory Committee providing recommendations to the Minister based on their expert evaluation of pharmaceutical applications.

Key Provisions

The main operative sections of this legislation, the National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 2) (PB 18 of 2017), are those which amend the Principal Determination (PB 119 of 2008) under the National Health Act 1953. Specifically, section 3 of this Amendment Determination revises the Principal Determination to include new pharmaceutical benefits that will be eligible for Commonwealth payments. These changes are outlined in Schedule 4, which now lists epoprostenol, calcipotriol with betamethasone in the form of a foam, and salbutamol in the form of a nebuliser solution. These additions represent the conditions under which payments will be made by the Commonwealth for the supply of these pharmaceutical benefits by approved pharmacists and approved medical practitioners. The obligations and requirements imposed by this Amendment Determination primarily concern the eligibility criteria for pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). Approved pharmacists and approved medical practitioners must ensure that they comply with the conditions set out in the amended Principal Determination. This includes understanding which new pharmaceutical items are now eligible for Commonwealth payments and adhering to the specific requirements for the supply of these items. The inclusion of epoprostenol, calcipotriol with betamethasone foam, and salbutamol nebuliser solution in Schedule 4 means that practitioners must be aware of and comply with the relevant conditions governing the supply of these drugs to be eligible for payments. The legislation does not explicitly state offences, penalties, or civil/criminal consequences for breaches of the conditions set out in the amended Principal Determination. However, failure to comply with the requirements of the PBS could result in non-payment for services rendered, which could have financial implications for approved pharmacists and approved medical practitioners. Furthermore, any fraudulent or deliberate non-compliance could potentially lead to investigations and penalties under other relevant legislation, such as the Commonwealth's criminal code or specific health-related regulations. It is important for practitioners to stay informed about the conditions and ensure compliance to avoid any potential repercussions.

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