National Health (Highly specialised drugs program) Special Arrangement Amendment (June Update) Instrument 2021

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00667 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM)
SPECIAL ARRANGEMENT AMENDMENT (JUNE UPDATE) INSTRUMENT 2021

PB 50 of 2021

 

Authority

Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).

Purpose

This is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (June Update) Instrument 2021 (PB 50 of 2021) (this Instrument).  The purpose of this Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs Program.

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.

Schedule 1 to this Instrument provides for the addition of a form of the listed drug tenofovir with emtricitabine to the Special Arrangement.  It also provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs abatacept, infliximab, midostaurin, rituximab, and tocilizumab under the Special Arrangement.  These changes are summarised, by subject matter, in the Attachment.

Consultation

The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).

An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.

PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits.  PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.  In addition, an industry nominee has been appointed to the PBAC membership.  When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS.  This includes consultation through the PBAC process.

Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication.

Details of this Instrument are set out in the Attachment.

This Instrument commences on 1 June 2021.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT (JUNE UPDATE) INSTRUMENT 2021

Section 1 Name of Instrument

This section provides the name of this Instrument as the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (June Update) Instrument 2021 and may also be cited as
PB 50 of 2021.

Section 2 Commencement

This section provides that this Instrument commences on 1 June 2021.

Section 3 Amendment of National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

This section provides that Schedule 1 amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021).

Schedule 1 Amendments

The amendments in Schedule 1 involve the addition of a form to a listed drug, and the alteration of circumstances for prescribing for various listed drugs available under the Special Arrangement. These changes are summarised below.

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT 2021 MADE BY THIS INSTRUMENT

Form Added

Listed Drug

Form

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

Abatacept

Infliximab

Midostaurin

Rituximab

Tocilizumab

 


Documents incorporated by reference

Listed Drug

Document incorporated

Document access

Abatacept

Infliximab

Rituximab

Tocilizumab

Therapeutic Goods Administration (TGA)-approved Product Information. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

This document provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine.

TGA-approved Product Information is available for download for free from the TGA website: https://www.tga.gov.au/product-information-0

 

 

 


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Highly Specialised Drugs Program)
Special Arrangement Amendment (June Update) Instrument 2021

(PB 50 of 2021)

This 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 Instrument

The purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs Program.

The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving specialised treatment.

The amendments in Schedule 1 involve the addition of a form to a listed drug, and the alteration of circumstances for prescribing for various listed drugs available under the Special Arrangement.

Human Rights Implications

This Instrument engages Article 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 Pharmaceutical Benefits Scheme (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 Instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

Mariana Crank

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (June Update) Instrument 2021 (PB 50 of 2021) is a legislative instrument made under subsection 100(2) of the National Health Act 1953, designed to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021). This Instrument aims to update the Special Arrangement to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). The purpose of these amendments is to incorporate new forms of listed drugs into the Highly Specialised Drugs Program and alter the circumstances under which certain drugs can be prescribed. This Instrument addresses the need for the continuous review and updating of pharmaceutical benefits to ensure they remain aligned with current medical practices and recommendations. The amendments are based on recommendations from the Pharmaceutical Benefits Advisory Committee, which ensures that the changes are evidence-based and consider clinical effectiveness, safety, and cost-effectiveness. This legislative update ensures the Special Arrangement remains relevant and effective in providing necessary pharmaceutical benefits for highly specialised medical treatments.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (June Update) Instrument 2021 amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 to update the Highly Specialised Drugs Program, which provides pharmaceutical benefits for the treatment of chronic conditions that require specialised treatment. The amendments involve the addition of a form of the listed drug tenofovir with emtricitabine to the Special Arrangement, and alterations to the circumstances in which a prescription may be written for the supply of the listed drugs abatacept, infliximab, midostaurin, rituximab, and tocilizumab. This Instrument applies to persons who require specialised treatment for the chronic conditions listed in the Special Arrangement, as well as pharmaceutical companies that supply the drugs listed in the Special Arrangement. The Instrument applies nationally, as it is made under the National Health Act 1953, a Commonwealth Act. There are no stated exclusions, exemptions, or thresholds in this Instrument. The application of this Instrument may be extended or restricted through subordinate instruments made under the National Health Act 1953.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (June Update) Instrument 2021 (sections 1 to 3) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021. The changes made by this Instrument include the addition of a form of the drug tenofovir with emtricitabine to the Special Arrangement, as well as alterations to the prescribing conditions for abatacept, infliximab, midostaurin, rituximab, and tocilizumab. These amendments reflect updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring consistency and alignment with changes in the Pharmaceutical Benefits Scheme (PBS). The Instrument's purpose is to facilitate access to highly specialised drugs for patients with chronic conditions requiring specialised treatment. The obligations imposed by this Instrument on parties governed by the National Health Act 1953 include compliance with the updated Special Arrangement, which now includes the specified form of tenofovir with emtricitabine and altered prescribing conditions for the other drugs mentioned. Pharmaceutical companies, prescribers, and other relevant entities must adhere to these updated conditions to ensure proper supply and prescription of these drugs under the Highly Specialised Drugs Program. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending changes to the PBS, ensuring that decisions about drug subsidies are evidence-based and aligned with public health needs. Breaching the provisions of this Instrument could lead to civil or administrative penalties, as the amendments are designed to ensure that the Highly Specialised Drugs Program operates within the legislative framework set by the National Health Act 1953. While specific penalties are not detailed in the Instrument itself, violations of the Act or associated regulations could result in fines or other legal consequences. The Minister retains the authority to vary or revoke any special arrangements under subsection 100(2) of the Act, ensuring flexibility and responsiveness to changing healthcare needs. Compliance with these provisions is essential for maintaining the integrity of the Highly Specialised Drugs Program and ensuring that patients receive appropriate and timely access to necessary treatments.

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