National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 6) (PB 67 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01069 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2018 (No. 6)

PB 67 of 2018

 

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 2018 (No. 6) (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.

The amendments made by this Instrument include additions, deletions and changes to drugs, forms, responsible person codes and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).

The Instrument also makes changes required to implement the International Harmonisation of Ingredient Names (IHIN).  Under the IHIN, the names used for active ingredients and pharmaceutical formulations in Australia are being updated to conform with nomenclature used internationally.  The changes in the Instrument are consistent with changes already made to the Australian Register of Therapeutic Goods. These changes are detailed in the attached Summary of Changes.

A provision by provision description of this Instrument is contained 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 August 2018.

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 2018 (No. 6)

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 2018 (No. 6).  It can also be cited as PB 67 of 2018.

Section 2 Commencement

This section provides that this Instrument commences on 1 August 2018.

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 Amendments

The amendments in Schedule 1 provide for additions, deletions and changes to drugs, forms, responsible person codes and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).  These changes are summarised below.

 

SUMMARY OF CHANGES

Listed Drugs Added

Glecaprevir with pibrentasvir

Brands Added

Clozapine

Oral liquid 50 mg per mL, 100 mL (Versacloz)

Alteration of circumstances

Infliximab

Lenalidomide

Nusinersen

Pegfilgrastim

Pomalidomide

International Harmonisation of Ingredient Names – form changes

The following forms of listed drugs have been updated to align with the International Harmonisation of Ingredient Names (IHIN) reform being administered by Therapeutic Goods Administration (TGA).

Listed drug

From

To

Apomorphine

Injection containing apomorphine hydrochloride 20 mg in 2 mL

Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL

 

Injection containing apomorphine hydrochloride 50 mg in 5 mL

Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

 

Injection containing apomorphine hydrochloride 100 mg in 20 mL

Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL

 

Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre filled syringe

Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre filled syringe

Levodopa with Carbidopa

Intestinal gel 20 mg-5 mg per mL ,100 mL

Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL

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 2018 (No. 6)

(PB 67 of 2018)

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.

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.

 

 

 

Julianne Quaine

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 6) is an amendment to the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, enacted under subsection 100(2) of the National Health Act 1953. The purpose of this Instrument is to revise the Highly Specialised Drugs Program, which provides pharmaceutical benefits for chronic conditions requiring specialised treatment. These changes are aligned with modifications to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and aim to implement the International Harmonisation of Ingredient Names (IHIN) by updating drug names to align with international nomenclature. This Instrument also includes changes to drugs, forms, responsible person codes, and prescribing circumstances, including authority requirements. The amendments have been recommended by the Pharmaceutical Benefits Advisory Committee (PBAC), which ensures decisions about pharmaceutical benefits are evidence-based. This legislative instrument commenced on 1 August 2018 and is compatible with human rights, specifically advancing the right to the highest attainable standard of physical and mental health as outlined in the International Covenant on Economic, Social and Cultural Rights. This Instrument reflects the commitment of the Australian Government to provide access to high-quality, evidence-based pharmaceutical treatments, ensuring that patients receive the best possible care. The legislative changes are consistent with international standards and are designed to maintain the integrity and effectiveness of the Highly Specialised Drugs Program within the Pharmaceutical Benefits Scheme (PBS).

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 6) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. This legislative instrument applies to the Highly Specialised Drugs Program under the National Health Act 1953, focusing on the supply of pharmaceutical benefits for the treatment of chronic conditions requiring specialised treatment. The amendments are intended to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and the implementation of the International Harmonisation of Ingredient Names (IHIN) to align with international nomenclature. The changes include additions, deletions, and modifications to drugs, forms, responsible person codes, and prescribing circumstances for various pharmaceutical benefits, as well as authority requirements. The amendments have been made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which involves consultation with stakeholders, including industry representatives. The Instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health through the provision of subsidised access to medicines under the Pharmaceutical Benefits Scheme (PBS). The Instrument applies nationally as it falls under the Commonwealth jurisdiction, impacting the Highly Specialised Drugs Program and the PBS across Australia. The amendments commence on 1 August 2018 and are consistent with the changes made to the Australian Register of Therapeutic Goods. Subordinate instruments may extend or further specify the application of this Amendment Instrument, but no exclusions, exemptions, or thresholds are explicitly stated in the provided text.

Key Provisions

The main sections of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 6) (the Instrument) are Section 1, which names the Instrument, and Section 3, which amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (the Special Arrangement). Section 2 sets the commencement date of the Instrument as 1 August 2018. The amendments in Schedule 1 provide for additions, deletions, and changes to drugs, forms, responsible person codes, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements). The changes are consistent with those made to the Australian Register of Therapeutic Goods and include updates to align with the International Harmonisation of Ingredient Names (IHIN). The Instrument imposes obligations on the parties involved in the Highly Specialised Drugs program, including the requirement for pharmaceutical companies to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) during the process of changes to the listings on the Pharmaceutical Benefits Scheme (PBS). The amendments in the Instrument reflect recommendations made by the PBAC. The PBAC is an independent expert body established under section 100A of the National Health Act 1953 (the Act) that makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and specialists. The Instrument does not explicitly outline specific offences, penalties, or consequences for breach. However, the amendments made by the Instrument are consistent with changes already made to the Australian Register of Therapeutic Goods, and the changes are detailed in the attached Summary of Changes. It can be inferred that any non-compliance with these amendments could result in regulatory action by the Therapeutic Goods Administration (TGA) or other relevant authorities, although the exact penalties or consequences are not specified within the text of the Instrument itself. The 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. It 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 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 PBAC ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

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