National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No.7) (PB 67 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01130 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. 7)

PB 67 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 September 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. 7)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 7) and may also be cited as PB 67 of 2019.

Section 2 Commencement

This section provides that the Instrument commences on 1 September 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

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

Buprenorphine

Injection (modified release) 16 mg in 0.32 mL pre-filled syringe

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

Macrogol 3350

Sachets containing powder for oral solution 17 g, 30

 


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. 7)

(PB 67 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, enacted by the Commonwealth Parliament, establishes the Pharmaceutical Benefits Scheme (PBS), a vital program that ensures Australians have reliable, timely, and affordable access to a wide range of medicines. The 2019 Amendment (No. 7) to the National Health Determination under paragraph 98C(1)(b) reflects updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, adjusting the conditions for payments made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This legislative instrument, which commenced on 1 September 2019, makes specific changes to the drugs and forms listed in Schedules 1 to 5 of the Principal Determination, including additions, deletions, and modifications. The amendments are designed to align with the evolving healthcare needs of the Australian population, ensuring that the PBS continues to provide effective and efficient pharmaceutical benefits.

Scope and Application

The National Health Determination under Paragraph 98C(1)(b) Amendment 2019 (No. 7) pertains to the conditions governing payments made by the Commonwealth for the supply of pharmaceutical benefits through approved pharmacists and approved medical practitioners under the National Health Act 1953. The Act applies to all individuals and entities involved in the supply of pharmaceutical benefits, including pharmacists, medical practitioners, and pharmaceutical companies. The amendments to the Principal Determination, originally made under PB 119 of 2008, affect the listing of pharmaceutical benefits by introducing changes such as additions, deletions, and modifications to drugs and their forms in Schedules 1 to 5 of the Principal Determination. These amendments are effective from 1 September 2019 and are aligned with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The scope of the Act is national, as it concerns the Pharmaceutical Benefits Scheme (PBS) which is administered at the Commonwealth level. The changes are determined by the Minister based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body that assesses the suitability of pharmaceutical benefits to be included in the PBS. This Legislative Instrument is compatible with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights, as it facilitates access to medicines, thereby contributing to the highest attainable standard of health.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 7) (PB 67 of 2019) amends the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and medical practitioners under the National Health Act 1953 (the Act) (sections 1, 3). These amendments are reflected in changes to Schedules 1 to 5 of the Principal Determination (PB 119 of 2008). The changes primarily involve additions, deletions, and modifications to drugs and their forms available under the Pharmaceutical Benefits Scheme (PBS). The amended Determination imposes obligations on approved pharmacists and medical practitioners to supply drugs and forms as updated in Schedules 1 to 5 of the Principal Determination. These changes ensure that the supply of pharmaceutical benefits aligns with the current listing of pharmaceutical benefits, reflecting the latest recommendations and evidence-based decisions by the Pharmaceutical Benefits Advisory Committee (PBAC). Approved pharmacists and medical practitioners must comply with these updated conditions to be eligible for Commonwealth payments for the supplied pharmaceutical benefits. Failure to comply with the conditions set out in the amended Determination may result in legal consequences. While the specific penalties for non-compliance are not detailed in the provided text, it is generally understood that breaches of the conditions under the National Health Act 1953 can lead to civil or criminal penalties. Civil penalties may include fines, and in severe cases, criminal penalties could be imposed, including imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as other relevant laws and regulations. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commenced on the same day as the amended Determination. The determination ensures that the PBS continues to provide timely and affordable access to a range of medicines for all Australians, in line with the objectives of the Act. The legislative instrument is compatible with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), by facilitating the progressive realisation of the right to the highest attainable standard of physical and mental health through the PBS.

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