National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 11) (PB 129 of 2020)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2020 (No. 11)

PB 129 of 2020

 

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 Instrument 2020 (No.11) (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 2010 (PB 116 of 2010) (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 brands of the listed drug ambrisentan to the Special Arrangement, the alteration of the responsible person for a brand of the listed drug zoledronic acid, the addition of two responsible person codes to the list of responsible persons and the alteration of circumstances in which a prescription may be written for the supply of the listed drugs ambrisentan, and infliximab.  It also provides for the listed drug sofosbuvir to be removed from supply only.  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 January 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 INSTRUMENT 2020 (No. 11)

Section 1 Name of Instrument

This section provides the name of this Instrument as the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 11) and may also be cited as
PB 129 of 2020.

Section 2 Commencement

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

Section 3 Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule 1 Amendments

The amendments in Schedule 1 involve the addition of brands, the alteration of the responsible person for a brand of a drug, the addition of responsible person codes to the list of responsible persons and the alteration of circumstances for prescribing various pharmaceutical benefits available under the Special Arrangement.  The amendments also involve one listed drug to be removed from supply only. These changes are summarised below.

 

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT 2010 MADE BY THIS INSTRUMENT

 

Listed Drug Deleted

Listed Drug

 

Sofosbuvir

 

Brands Added

Listed Drug

Form and Brand

Ambrisentan

Tablet 5 mg (PULMORIS)

Tablet 10 mg (PULMORIS)

Alteration of Responsible Person

Listed Drug

Form

Brand Name

Responsible Person Code

Zoledronic acid

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

Zometa

From: NV
To: SA

 

Addition of Responsible Person Code

Responsible Person and Code

SciGen (Australia) Pty Limited (SA)

Cipla Australia Pty Ltd (YC)

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

 

Ambrisentan

 

Infliximab

 

Document/s incorporated by reference

Listed Drug

Document incorporated

Document access

Infliximab

Psoriasis Area Severity Index (PASI). 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.

The PASI is a widely used tool that enables measurement of the severity and extent of baseline and response of therapy in psoriasis.

The PASI calculation form is available for download for free from the Services Australia website: https://www.servicesaustralia.gov.au/ and forms part of the SA authority application process.

Infliximab

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 Instrument 2020 (No. 11)

(PB 129 of 2020)

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 2010 (PB 116 of 2010) (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 brands, the alteration of the responsible person for a brand of a drug, the addition of responsible person codes to the list of responsible persons and the alteration of circumstances for prescribing various pharmaceutical benefits available under the Special Arrangement.  The amendments also involve one listed drug to be removed from supply only.

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.

 

 

 

Natasha Ploenges

Acting Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2020 (No. 11) was enacted to make changes to the Highly Specialised Drugs program under the National Health Act 1953. The Instrument, authorised by subsection 100(2) of the Act, aims to update the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 by adding brands of certain drugs, altering the responsible persons for specific brands, adding new responsible person codes, and modifying the circumstances under which certain drugs can be prescribed. These amendments reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring consistency across related instruments. The changes were recommended by the Pharmaceutical Benefits Advisory Committee and align with their consultation processes, which involve stakeholders from various healthcare sectors. The Instrument is set to commence on 1 January 2021, and it is compatible with human rights as it supports the provision of accessible and effective healthcare services through the Pharmaceutical Benefits Scheme.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 11) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, impacting the supply of highly specialised drugs in Australia. This legislation applies to the entities and individuals involved in the supply and prescription of pharmaceutical benefits under the Highly Specialised Drugs program, which is part of the broader National Health Act 1953. The amendments pertain to specific drugs, their brands, and the entities responsible for their supply, as well as the conditions under which these drugs can be prescribed. The amendments include adding certain brands of drugs, altering the responsible persons for specific drug brands, adding new responsible person codes, and modifying the prescribing conditions for specific drugs. This Instrument ensures that the provisions of the Act are adapted to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also came into effect on 1 January 2021. The amendments have a national reach, affecting the entire pharmaceutical supply chain across Australia. The changes are in response to recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on which drugs should be available as pharmaceutical benefits. This committee involves consultation with a wide range of stakeholders, including industry representatives, to ensure that the amendments are evidence-based and in the best interest of public health. This Instrument is a legislative tool that allows for the flexibility needed to adapt to changes in medical treatments and practices, ensuring that patients have access to the most effective and safe pharmaceutical options available. The amendments are designed to enhance the efficiency and effectiveness of the Highly Specialised Drugs program by ensuring that the list of available drugs and the conditions for their use are kept up-to-date with the latest medical evidence and practices.

Key Provisions

The primary sections of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2020 (No. 11) amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, introducing changes to the Highly Specialised Drugs program. Specifically, the amendments involve adding brands of certain drugs, altering the responsible person for specific drug brands, adding new responsible person codes, and modifying the circumstances under which prescriptions may be written for certain drugs (sections 3 and Schedule 1). Furthermore, the listed drug sofosbuvir is removed from supply only. These changes are intended to align with amendments made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commenced on 1 January 2021. The amendments reflect recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), which plays a crucial role in advising the Minister on which drugs should be available as pharmaceutical benefits. The amendments include adding brands of ambrisentan, altering the responsible person for a brand of zoledronic acid, adding responsible person codes for SciGen (Australia) Pty Limited and Cipla Australia Pty Ltd, and modifying prescribing circumstances for ambrisentan and infliximab. The obligations imposed on parties by this Instrument primarily revolve around the updated requirements for supplying, prescribing, and administering the drugs affected by the amendments. Healthcare providers and pharmaceutical companies must comply with the new specifications for the drugs listed, including ensuring that the correct brands are supplied, the responsible persons are appropriately identified, and the new prescribing conditions are adhered to. For instance, the new responsible person for zoledronic acid must be identified as SA, and the new brands of ambrisentan must be supplied as specified. Additionally, the updated prescribing criteria for ambrisentan and infliximab must be followed, including the incorporation of the Psoriasis Area Severity Index (PASI) for infliximab prescriptions. Failure to comply with the new provisions outlined in this Instrument may result in various consequences. While the Instrument does not explicitly detail penalties for non-compliance, breaches of similar legislative requirements typically result in administrative actions, fines, or other legal repercussions under the National Health Act 1953. The precise penalties would depend on the nature and severity of the breach, but they could include financial penalties or other corrective measures to ensure compliance with the amended provisions.

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