National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 1) (PB 3 of 2014)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L00050 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2014 (No. 1)

PB 3 of 2014

 

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 Schedule 3 to the Principal Determination to reflect the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 1), commencing on 1 February 2014, by adding the listed drug alprazolam in the forms: tablet 250 micrograms; tablet 500 micrograms; tablet 1 mg; and tablet 2 mg.  Alprazolam is added to Schedule 3 as consequence of a dangerous drug fee now being applied to this drug.

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 2014.

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 2014
(No. 1)
(PB 3 of 2014)

 

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 one listed drug to Schedule 3 of the Determination.

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.

 

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 1) was enacted to update the conditions governing payments made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners under the National Health Act 1953. This legislative instrument was introduced to address the need to add alprazolam to the list of drugs covered under the Pharmaceutical Benefits Scheme (PBS), specifically to reflect a new dangerous drug fee applied to this medication. The determination was made by the Minister for Health in accordance with the provisions of the Act and aims to ensure the continued provision of affordable access to essential medicines for Australians. The Amendment Determination was made under the authority of the National Health Act 1953, which establishes the legislative framework for the PBS, ensuring that the Commonwealth provides timely and reliable access to a broad range of medicines. The policy objective of the amendment is to align the conditions for pharmaceutical benefits with recent changes in the scheduling of medications, ensuring that the PBS remains effective in meeting the healthcare needs of the population. This was achieved through consultation with the Pharmaceutical Benefits Advisory Committee, which recommended the inclusion of alprazolam to the Minister, who then determined the changes to the conditions under the Act.

Scope and Application

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 1) amends the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 to adjust the conditions for Commonwealth payments concerning the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Specifically, it adds the drug alprazolam in various dosage forms to Schedule 3 of the Principal Determination, reflecting the application of a dangerous drug fee to this medication. This legislative instrument applies to approved pharmacists and approved medical practitioners involved in the supply of pharmaceutical benefits within the Pharmaceutical Benefits Scheme (PBS). The PBS is a Commonwealth initiative aimed at ensuring reliable, timely, and affordable access to a wide range of medicines for all Australians. The changes in the Amendment Determination are effective from 1 February 2014 and are subject to revocation or variation under the Acts Interpretation Act 1901, unless explicitly stated otherwise. The amendment aligns with human rights by promoting access to essential medicines, thereby supporting the right to the highest attainable standard of physical and mental health as recognised in the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 1) (PB 3 of 2014) amends Schedule 3 of the Principal Determination under paragraph 98C(1)(b) of the National Health Act 1953 (the Act). The amendment involves the addition of the drug alprazolam in various forms—tablet 250 micrograms, tablet 500 micrograms, tablet 1 mg, and tablet 2 mg—to Schedule 3 of the Determination (section 2). This change reflects the application of a dangerous drug fee to alprazolam, thereby altering the conditions under which payments will be made by the Commonwealth in respect of its supply (section 3). The Act imposes specific obligations on approved pharmacists and approved medical practitioners to comply with the conditions set out in the Determination when supplying pharmaceutical benefits (section 85(1)). These conditions now include the addition of alprazolam to Schedule 3, which means that any payment made by the Commonwealth for the supply of this drug must adhere to the newly stipulated conditions. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in ensuring these decisions are evidence-based and align with the overarching objectives of the Pharmaceutical Benefits Scheme (PBS). Failure to comply with the conditions set forth in the Determination can lead to civil or criminal consequences, although the specific penalties are not detailed in the provided text. The Act generally provides for penalties for non-compliance with its provisions, which may include fines or other sanctions, although the exact penalties would depend on the nature and severity of the breach. The 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, ensuring that decisions about the PBS are evidence-based and aligned with international human rights standards.

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