National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 4) (PB 37 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00708 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. 4)

PB 37 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 June 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. 4)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 4) and may also be cited as PB 37 of 2019.

Section 2 Commencement

This section provides that the Instrument commences on 1 June 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 deleted from Schedule 3 (Dangerous Drug Fee applies)

Hydromorphone

Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 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. 4)

(PB 37 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. 4) (PB 37 of 2019) is an amendment to the National Health Act 1953, designed to adjust the conditions for payments under the Pharmaceutical Benefits Scheme (PBS). Enacted by the Australian Parliament, the National Health Act 1953 serves as the legislative foundation for the PBS, ensuring Australians have access to affordable medications. The 2019 amendment addresses updates to the listing of pharmaceutical benefits by modifying the conditions in the Principal Determination (PB 119 of 2008) that govern payments for pharmaceutical supplies. This adjustment responds to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), aligning the Principal Determination with the latest pharmaceutical inclusions and exclusions. The policy objective of this amendment is to maintain the integrity and effectiveness of the PBS by ensuring that the benefits provided are current and based on the most recent evaluations by the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent committee, advises the Minister on which medicines should be subsidised, ensuring decisions are evidence-based. This amendment reflects the PBAC’s recommendations, thus facilitating timely and reliable access to essential medications for all Australians.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 4) amends the conditions for Commonwealth payments made to approved pharmacists and medical practitioners for the supply of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS), as set out in the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 (the Principal Determination). This legislative instrument, effective from 1 June 2019, reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which include additions, deletions, and modifications to drugs and forms in Schedules 1 to 5 of the Principal Determination. The amendments are made to ensure that the PBS remains current with medical advancements and aligns with recommendations from the Pharmaceutical Benefits Advisory Committee. This committee, which comprises members from various relevant sectors including consumer representatives and the pharmaceutical industry, advises on which medicines should be subsidised. The Act applies to approved pharmacists and medical practitioners supplying pharmaceutical benefits, and its jurisdiction extends nationally across Australia as it is a Commonwealth instrument. There are no stated exclusions, exemptions, or specific thresholds in this legislative instrument, but it may be subject to further refinement through subordinate instruments as needed.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 4) amends the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (the Principal Determination) (sections 3 and 11). This Determination outlines the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Schedule 1 of the Amendment introduces changes to drugs and forms in Schedules 1 to 5 of the Principal Determination, including additions, deletions, and modifications. These changes reflect the amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commenced on 1 June 2019. Under this Determination, approved pharmacists and approved medical practitioners must comply with the specified conditions to receive payments from the Commonwealth for the supply of pharmaceutical benefits. The amendments to the Principal Determination involve updates to the lists of drugs and forms covered by the Pharmaceutical Benefits Scheme (PBS), ensuring that the scheme reflects the most current therapeutic and safety information. Approved practitioners must ensure that the drugs they supply, and the forms in which they supply them, are included in the updated schedules of the Principal Determination to be eligible for Commonwealth payments. Breach of the conditions set out in the Determination may result in the Commonwealth withholding payments for pharmaceutical benefits supplied. The Act does not explicitly state specific criminal or civil penalties for non-compliance with the conditions; however, failure to adhere to the conditions could lead to administrative consequences such as fines or other enforcement actions under the relevant provisions of the National Health Act 1953. The maximum penalties for breaches of the Act are detailed in the respective sections of the Act and may include fines up to a significant amount, reflecting the seriousness of non-compliance with national health provisions. This legislative amendment ensures the PBS remains a robust and effective mechanism for providing Australians with access to essential medicines. By aligning the Principal Determination with the latest therapeutic guidelines and safety standards, the Amendment supports the ongoing goal of making medicines affordable and accessible to all Australians while maintaining high standards of patient safety and efficacy. The involvement of the Pharmaceutical Benefits Advisory Committee (PBAC) in recommending these changes underscores the evidence-based approach to decision-making in the PBS, thereby safeguarding the public’s health and well-being.

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