National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No.6) (PB 59 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01008 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH DETERMINATION UNDER PARAGRAPH 98C(1)(b) AMENDMENT 2019 (No. 6)

PB 59 of 2019

 

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.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

The amendments made by this Instrument include additions, deletions and changes to drugs and forms in Schedules 1 to 5 of the Principle Determination.

A provision by provision description of this Instrument is contained 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 August 2019.

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 2019 (No. 6)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 6) and may also be cited as PB 59 of 2019.

Section 2 Commencement

This section provides that the Instrument commences on 1 August 2019.

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 amendments in Schedule 1 include additions, deletions and changes to drugs and forms in Schedules 1 to 5 of the Principle Determination.  These changes are summarised below.

 

SUMMARY OF CHANGES

Listed drugs added to Schedule 4 (complete pack must be supplied)

Fluticasone furoate

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms per dose, 30 doses

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms per dose, 30 doses

Forms added to Schedule 4 (complete pack must be supplied)

Testosterone

Transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses

Forms deleted from Schedule 4 (complete pack must be supplied)

Hypromellose

Eye drops 3 mg per mL, 15 mL

 


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 2019 (No. 6)

(PB 59 of 2019)

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 additions, deletions and changes to drugs and forms in Schedules 1 to 5 of the Principle 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.

 

 

 

 

 

Thea Daniel

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health Act 1953 was enacted to establish and maintain a framework for the provision of healthcare services in Australia, including the Pharmaceutical Benefits Scheme (PBS) which ensures affordable access to a wide range of medicines for all Australians. The problem or gap this Act was introduced to address was the need for a reliable and efficient system to subsidise essential medications, making them accessible and affordable to the public. The National Health Determination under Paragraph 98C(1)(b) Amendment 2019 (No. 6) was introduced by the Australian Government to further refine the conditions under which payments are made for pharmaceutical benefits under the PBS. This amendment, which commenced on 1 August 2019, was enacted by the Minister for Health and reflects changes to the listing of pharmaceutical benefits, incorporating recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The policy objective of this amendment is to ensure that the PBS remains current with medical advancements and patient needs by adjusting the list of subsidised medications accordingly.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 6) pertains to the conditions governing payments made by the Commonwealth under the Pharmaceutical Benefits Scheme (PBS) for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This legislation, effective from 1 August 2019, is an amendment to the existing National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953, specifically altering the Principal Determination (PB 119 of 2008). It applies to all entities and individuals involved in the supply of pharmaceutical benefits, including pharmacists, medical practitioners, and pharmaceutical companies, and encompasses the geographical scope of Australia as a whole, governed under Commonwealth jurisdiction. The amendment involves modifications to the listing of pharmaceutical benefits, including additions, deletions, and changes to drugs and forms in Schedules 1 to 5 of the Principal Determination, reflecting updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This 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 through the PBS.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 6) (PB 59 of 2019) amends the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008) by making changes to drugs and forms listed in Schedules 1 to 5 of the Principal Determination (section 3). These changes include the addition of new drugs and forms to be supplied as pharmaceutical benefits and the removal of certain drugs and forms from the list (Schedule 1). This determination sets 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 (section 1). The parties or entities governed by this Act include approved pharmacists, approved medical practitioners, the Pharmaceutical Benefits Advisory Committee (PBAC), and pharmaceutical companies. Approved pharmacists and approved medical practitioners must ensure they are supplying the correct pharmaceutical benefits as per the updated schedules and comply with the conditions set out in the Determination (section 3). The PBAC is responsible for recommending changes to the Minister, and pharmaceutical companies must be aware of the changes in the listing of pharmaceutical benefits to ensure compliance with the updated conditions (section 3). The Minister then determines the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners (section 3). Any breach of the conditions set out in this Determination may result in civil or criminal consequences, depending on the nature and severity of the breach. For example, supplying a drug not listed in the updated schedules may result in a financial penalty or prosecution under the relevant legislation. The maximum penalties for breaches of the National Health Act 1953 are set out in section 28 of the Act, which may include fines of up to $22,200 for individuals and $111,000 for corporations, as well as imprisonment for up to two years for serious offences. Additionally, pharmaceutical companies may face reputational damage and loss of market share if they are found to be non-compliant with the updated conditions (section 3).

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