National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 1) (PB 3 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L00071 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. 1)

PB 3 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. 1), commencing on 1 February 2017.  Schedule 3 to the Principal Determination is amended by the deletion of alprazolam in the form tablet 2 mg.  Schedule 4 to the Principal Determination is amended by the addition of glyceryl trinitrate in the form tablets 300 micrograms, 100.

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 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. 1)
(PB 3 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 to the Principal Determination is amended by the deletion of one form of a pharmaceutical item.  Schedule 4 to the Principal Determination is amended by the addition 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.

 

Louise Clarke
First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 1) was enacted to amend the National Health Act 1953. This amendment was necessary to adjust the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The amendment responds to changes introduced by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 1), effective from 1 February 2017. The Minister, authorised by paragraph 98C(1)(b) of the Act, made these changes based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent committee comprising representatives from various healthcare sectors. The policy objective of this amendment is to ensure that the Pharmaceutical Benefits Scheme (PBS) remains aligned with the latest evidence-based recommendations for the listing and de-listing of pharmaceutical items, thereby maintaining the scheme’s effectiveness in providing affordable and accessible medicines to all Australians.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 1) is an amendment to the National Health Act 1953, specifically addressing the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits through approved pharmacists and approved medical practitioners. This amendment applies to the entire Commonwealth of Australia and targets the Pharmaceutical Benefits Scheme (PBS) as the legislative basis for providing subsidised access to a wide range of medicines. The amendment removes alprazolam 2 mg tablets from Schedule 3, while adding glyceryl trinitrate 300 micrograms tablets to Schedule 4, reflecting the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 1). This legislative instrument is compatible with human rights, particularly engaging Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights, by facilitating the progressive realisation of the highest attainable standard of physical and mental health through the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending evidence-based changes, ensuring the scheme remains aligned with public health needs.

Key Provisions

The main operative sections of this Amendment Determination under the National Health Act 1953 (section 98C(1)(b)) pertain to the conditions governing payments made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners (paragraph 98C(1)(b)). Specifically, this determination modifies the Principal Determination (PB 119 of 2008) to reflect the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 1). These changes include the removal of alprazolam in the form of a 2 mg tablet from Schedule 3 and the addition of glyceryl trinitrate in the form of 300 micrograms and 100 tablets to Schedule 4. These modifications ensure that the conditions governing payments for the supply of pharmaceutical benefits remain current and aligned with recent amendments to the Pharmaceutical Benefits Scheme (PBS). The obligations and requirements imposed by this Amendment Determination on the parties and entities it governs include adherence to the updated conditions specified in Schedules 3 and 4 of the Principal Determination. Approved pharmacists and approved medical practitioners must ensure that their claims for pharmaceutical benefits are consistent with these updated conditions. The Pharmaceutical Benefits Advisory Committee (PBAC), which is independent and includes members from various relevant professions, plays a crucial role in recommending which medicines should be subsidised. The Minister, based on the PBAC's recommendations, determines the changes to the conditions, which are then reflected in this Amendment Determination. In terms of potential breaches and consequences, the determination does not explicitly outline specific offences or penalties within the text provided. However, any non-compliance with the conditions set out in this Amendment Determination could lead to financial repercussions for approved pharmacists and approved medical practitioners. Typically, under the National Health Act 1953, penalties for non-compliance with conditions governing the supply of pharmaceutical benefits could include fines, reimbursement of payments, or other civil or administrative penalties as deemed appropriate by the relevant authorities. The exact penalties would depend on the nature and severity of the breach, as well as any applicable laws or regulations in force at the time of the infringement.

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