National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 1) (PB 11 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00212 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. 1)

PB 11 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 March 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. 1)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 1) and may also be cited as PB 11 of 2019.

Section 2 Commencement

This section provides that the Instrument commences on 1 March 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 4 of the Principle Determination.  These changes are summarised below.

 

SUMMARY OF CHANGES

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

Hypromellose

Eye drops 3 mg per mL, 10 mL

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

Venetoclax

 


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. 1)

(PB 11 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 forms the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), enabling the Commonwealth to provide affordable access to a broad range of medicines for Australians. Pursuant to this Act, the Minister is empowered to determine the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 1) (PB 11 of 2019) amends the Principal Determination to reflect changes in the listing of pharmaceutical benefits. These amendments, which come into effect on 1 March 2019, include additions, deletions, and modifications to drugs and forms across Schedules 1 to 5 of the Principal Determination. The policy objective of these amendments is to ensure that the PBS remains responsive to evolving health needs and evidence-based recommendations, thereby continuing to advance the right to the highest attainable standard of physical and mental health as outlined in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 1) amends 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, as set out in the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008). This legislation applies nationally across Australia, impacting the pharmaceutical industry, healthcare providers, and patients who rely on the Pharmaceutical Benefits Scheme (PBS) for affordable access to medicines. The amendments include additions, deletions, and changes to drugs and forms listed in Schedules 1 to 5 of the Principal Determination, reflecting updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes are aimed at ensuring that the PBS remains current with medical advancements and patient needs. The Act does not specify any exclusions or thresholds but operates through subordinate instruments that can further detail specific conditions or exceptions as necessary.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 1) makes amendments to the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Specifically, it modifies the conditions set out in the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008) to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). These changes include additions, deletions, and modifications to drugs and forms listed in Schedules 1 to 5 of the Principal Determination (sections 3, 4). The obligations imposed by this Act primarily concern approved pharmacists and approved medical practitioners who supply pharmaceutical benefits. These professionals must ensure compliance with the updated conditions specified in the Determination, which now include new additions and deletions to the list of drugs and forms eligible for Commonwealth payments under the Pharmaceutical Benefits Scheme (PBS). This ensures that all supplied medications and forms meet the current criteria set forth by the Minister, as recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). In terms of penalties and consequences for non-compliance, the Act does not explicitly state penalties for breaching these conditions. However, non-compliance with the conditions for pharmaceutical benefits payments could potentially lead to financial penalties or legal actions, as outlined in the broader provisions of the National Health Act 1953. Such penalties typically depend on the severity and frequency of the non-compliance and could include fines or other administrative actions. Overall, the Act ensures that the PBS remains a reliable and effective scheme by regularly updating the list of eligible pharmaceutical benefits, thereby maintaining the highest attainable standard of physical and mental health for Australians. This is achieved through the evidence-based recommendations of the PBAC, ensuring that decisions about which medicines are subsidised are grounded in sound medical and economic evidence.

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