National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 4) (PB 38 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00690 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH DETERMINATION UNDER PARAGRAPH 98C(1)(b) AMENDMENT 2018 (No. 4)

PB 38 of 2018

 

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.  The 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

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  This Instrument amends the Principal Determination by adding a pharmaceutical benefit to Schedule 4.  This change is summarised, by subject matter, in the Attachment.

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 June 2018.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH DETERMINATION UNDER PARAGRAPH 98C(1)(b) AMENDMENT 2018 (No. 4)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 4) and may also be cited as PB 38 of 2018.

Section 2 Commencement

This section provides that the Instrument commences on 1 June 2018.

Section 3 Amendment of Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008)

This section provides that Schedule 1 amends the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008).

Schedule 1 Amendments

The amendment in Schedule 1 involves the addition of a drug to the list in Schedules 4 of the Principal Determination.  This change is summarised below.

 

SUMMARY OF CHANGES

Drugs Added to Schedule 4 (Complete pack must be supplied)

Fluticasone furoate with umeclidinium and vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses


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 2018 (No. 4)

(PB 38 of 2018)

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 (PB 119 of 2008) (the Principal Determination) 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 Principal Determination to provide for changes to those conditions.  Schedule 1 to this Legislative Instrument provides for the addition of a drug to the list in Schedule 4 of the Principal 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.

 

 

 

Lisa La Rance

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 4), also known as PB 38 of 2018, amends the National Health Act 1953 to update the conditions for payments made by the Commonwealth in respect of the supply of pharmaceutical benefits. This amendment was introduced to address the need to align the Pharmaceutical Benefits Scheme (PBS) with changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The determination was enacted by the Minister for Health under the authority of paragraph 98C(1)(b) of the National Health Act 1953, with the policy objective of ensuring the PBS remains current and effective in providing access to necessary medications. The changes include the addition of a new drug to Schedule 4, ensuring that the conditions for pharmaceutical benefit payments are kept up-to-date with advancements in medical treatments and therapies. The determination was made following consultation with the Pharmaceutical Benefits Advisory Committee, an independent body that considers applications and recommends which medicines should be subsidised. This process ensures that decisions regarding the PBS are evidence-based and aligned with the highest attainable standard of physical and mental health as recognised by the International Covenant on Economic, Social and Cultural Rights. The changes are intended to facilitate better access to essential medications for Australians, reflecting the ongoing commitment to reliable, timely, and affordable healthcare services.

Scope and Application

The National Health Determination under Paragraph 98C(1)(b) Amendment 2018 (No. 4) amends the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as stipulated under the National Health Act 1953. This legislative instrument applies to the entities involved in the supply of pharmaceutical benefits, including approved pharmacists and approved medical practitioners, and to the pharmaceutical products listed under the Pharmaceutical Benefits Scheme (PBS). The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, and are effective from 1 June 2018. The amendments include the addition of a specific pharmaceutical product to Schedule 4 of the Principal Determination, which lists drugs for which a complete pack must be supplied. This Instrument has national jurisdiction, applying across Australia, and it extends the application of the Principal Determination by modifying the conditions for pharmaceutical benefit payments. There are no specific exclusions or thresholds mentioned in the text, and the changes are implemented through the subordinate instrument in accordance with the National Health Act 1953.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 4) (PB 38 of 2018) amends the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. This amendment is in response to changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which also commenced on 1 June 2018. The primary change involves the addition of a specific drug, Fluticasone furoate with umeclidinium and vilanterol, to Schedule 4 of the Principal Determination (section 3). This addition necessitates the complete pack of the drug to be supplied (Schedule 1). The obligations and requirements imposed by this Amendment are primarily administrative and procedural, ensuring that the newly listed drug is supplied under the correct conditions as per the PBS framework. Approved pharmacists and medical practitioners must comply with the updated conditions, which include the appropriate documentation and supply protocols for the new drug. The Pharmaceutical Benefits Advisory Committee (PBAC) played a crucial role in recommending these changes, ensuring that the decision-making process was evidence-based and considered various stakeholders' interests. Breaching the conditions set out in this Determination could result in serious consequences. The National Health Act 1953 outlines various offences related to the PBS, including fraudulent claims and improper supply of pharmaceutical benefits. Penalties for such breaches can be substantial. Under section 114 of the Act, individuals and entities found guilty of offences related to fraudulent claims can face fines up to $210,000 or imprisonment for up to five years, or both. Additionally, corporations may be subject to even higher fines, potentially reaching up to $1,050,000 for serious offences. These penalties underscore the importance of compliance with the conditions stipulated in the Determination and the broader requirements of the PBS.

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