National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 5) (PB 55 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00904 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. 5)

PB 55 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 July 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. 5)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 5) and may also be cited as PB 55 of 2019.

Section 2 Commencement

This section provides that the Instrument commences on 1 July 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 3 (Dangerous Drug Fee applies)

Methylphenidate

Capsule containing methylphenidate hydrochloride 10 mg (modified release)

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

Amino acid formula with

fat, carbohydrate, without

phenylalanine

Tablet: modified release, 70.8 g protein per 100 g, 110 g (PKU Easy Microtabs)

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

Amoxicillin with

clavulanic acid

Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 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. 5)

(PB 55 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 Determination under Paragraph 98C(1)(b) Amendment 2019 (No. 5) (PB 55 of 2019) amends the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as stipulated in the National Health Act 1953. Enacted by the Australian Parliament, this amendment responds to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The principal objective of this determination is to ensure that the Pharmaceutical Benefits Scheme (PBS) remains responsive to the evolving healthcare needs of Australians by updating the list of pharmaceuticals eligible for subsidy. The amendments reflect decisions made by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body comprising representatives from various health-related fields, ensuring that the recommendations are evidence-based and comprehensive. The changes introduced by this amendment include additions, deletions, and modifications to drugs and forms in Schedules 1 to 5 of the Principal Determination. These updates are crucial for maintaining the efficacy and relevance of the PBS, ensuring that Australians have timely access to necessary medications. The amendments are designed to align with the broader goals of the National Health Act, which seeks to provide reliable, timely, and affordable access to a wide range of medicines for all Australians. This legislative instrument is compatible with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights, by facilitating the progressive realisation of the right to the highest attainable standard of physical and mental health through the PBS.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 5) is an instrument that amends the existing National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953. This Act pertains to the conditions under which the Commonwealth will make payments for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The amendments outlined in the instrument include the addition, deletion, and modification of drugs and forms in Schedules 1 to 5 of the Principal Determination, reflecting changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument aims to align the conditions for pharmaceutical benefits with the latest recommendations and approvals by the Pharmaceutical Benefits Advisory Committee. This legislation applies to the pharmaceutical industry, approved pharmacists, and approved medical practitioners across Australia, and it is effective as of 1 July 2019. The instrument is compatible with human rights, particularly the International Covenant on Economic, Social and Cultural Rights, as it facilitates access to subsidised medicines, thereby promoting the highest attainable standard of physical and mental health.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 5) (the Amendment) modifies the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. This is achieved through changes to Schedules 1 to 5 of the Principal Determination (PB 119 of 2008), which includes additions, deletions, and modifications to the list of drugs and forms eligible for subsidy under the Pharmaceutical Benefits Scheme (PBS) (sections 1, 2, and 3). These changes align with amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) that took effect on the same date. The Amendment imposes specific obligations on approved pharmacists and approved medical practitioners who supply pharmaceutical benefits. These professionals must adhere to the updated conditions set out in the amended Principal Determination. This includes ensuring compliance with the new listings of drugs and forms in Schedules 1 to 5, which dictate the types of pharmaceutical benefits that are eligible for Commonwealth payments. Approved pharmacists and approved medical practitioners must also ensure that any supply of pharmaceutical benefits aligns with the new conditions, including the requirements for complete pack supplies and the application of dangerous drug fees where applicable. Failure to comply with the conditions specified in the amended Principal Determination can result in legal consequences. While the specific offences, penalties, or consequences are not detailed within the text, breaches of the National Health Act 1953 or its associated instruments can typically lead to civil or criminal penalties, depending on the nature and severity of the breach. These penalties could include fines or other sanctions imposed by the relevant authorities. It is crucial for approved pharmacists and approved medical practitioners to stay informed about these conditions to avoid any potential legal ramifications. In summary, the Amendment to the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 introduces modifications to the conditions for pharmaceutical benefit payments. These changes affect approved pharmacists and approved medical practitioners by updating the list of eligible drugs and forms in the PBS. Adhering to these updated conditions is essential to avoid any legal consequences that may arise from non-compliance with the Act and its associated instruments.

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