National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 8) (PB 85 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01361 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2018 (No. 8)

PB 85 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. 8) (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).

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 October 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. 8)

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. 8).  It can also be cited as PB 85 of 2018.

Section 2 Commencement

This section provides that this Instrument commences on 1 October 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

Lumacaftor with ivacaftor

Listed Drugs Deleted

Emtricitabine

Indinavir

Brands Added

Bosentan

Tablet 62.5 mg (as monohydrate) (BOSENTAN DR. REDDY'S)

Bosentan

Tablet 125 mg (as monohydrate) (BOSENTAN DR. REDDY'S)

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg (Tenofovir/Emtricitabine 300/200 APOTEX)

Alteration of circumstances

Ganciclovir (GANCICLOVIR SXP brand only)

Infliximab

Lipegfilgrastim

Pomalidomide

Alteration of Responsible Person Code

Listed Drug

Form

Brand Name

Responsible Person

Pegfilgrastim

Injection 6 mg in 0.6 mL single use pre-filled syringe

Neulasta

From: AN

To: JU

Pegfilgrastim

Injection 6 mg in 0.6 mL single use pre-filled syringe

Ristempa

From: GV

To: JO

Deletion of Responsible Person

Amgen Australia Pty Limited (GV)

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. 8)

(PB 85 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.

 

 

 

Natasha Ploenges

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 8) was enacted to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, addressing the need for adjustments to the Special Arrangement concerning the Highly Specialised Drugs program. This Instrument was introduced by the Minister under the authority granted by subsection 100(2) of the National Health Act 1953. The policy objective of this amendment is to align the Special Arrangement with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the Highly Specialised Drugs program remains up-to-date with the latest recommendations and requirements. The amendments involve additions, deletions, and modifications to the drugs listed, their forms, responsible person codes, and prescribing conditions, reflecting the advice from the Pharmaceutical Benefits Advisory Committee (PBAC). The amendments aim to enhance the effectiveness and efficiency of the Highly Specialised Drugs program by ensuring it accommodates the most current medical evidence and clinical practices. This Instrument underscores the commitment of the Australian government to providing equitable access to highly specialised pharmaceutical benefits, thereby improving the health outcomes for patients with chronic conditions requiring specialised treatment. The amendments, which have undergone thorough consultation with relevant stakeholders including PBAC and pharmaceutical companies, are designed to ensure that the Scheme remains responsive to medical advancements and patient needs. The commencement date of 1 October 2018 marks the implementation of these changes, ensuring that the Highly Specialised Drugs program continues to deliver necessary treatments effectively and efficiently.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 8) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, which governs the supply of highly specialised drugs under the National Health Act 1953. This Instrument applies to the pharmaceutical benefits available under the Highly Specialised Drugs program, including additions, deletions, and changes to drugs, forms, responsible person codes, and prescribing circumstances, all of which are designed to align with amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments reflect recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the drugs listed are evidence-based and cost-effective. This legislative instrument operates nationally, as it is made under the authority of the Commonwealth of Australia. The amendments made by this Instrument are effective from 1 October 2018 and are subject to the broader provisions of the National Health Act 1953, including the ability to vary or revoke special arrangements through subordinate instruments. The human rights implications of this Instrument have been considered, and it has been determined that it is compatible with human rights, particularly advancing the right to the highest attainable standard of physical and mental health.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 8) (sections 1-3) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (section 3). This special arrangement pertains to the provision of highly specialised drugs, which are pharmaceutical benefits intended for the treatment of chronic conditions that require specialised treatment. The amendment involves changes to the drugs listed, forms, responsible person codes, and the circumstances for prescribing these pharmaceutical benefits, including authority requirements (Schedule). These changes are aligned with the amendments made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, reflecting the latest recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The entities governed by this Act, primarily pharmaceutical companies and healthcare providers, must comply with the changes specified in the Instrument. This includes updating their records to reflect the new listings, deletions, and changes to drugs, forms, and responsible person codes. Healthcare providers must also ensure that their prescribing practices align with the new circumstances and authority requirements for the drugs listed under the Special Arrangement. Breach of the provisions set out in this Instrument may result in legal consequences. The Pharmaceutical Benefits Scheme (PBS) is a critical component of Australia's healthcare system, and any non-compliance with the amendments could affect the availability and accessibility of highly specialised drugs to patients who need them. While the explanatory statement does not explicitly outline specific penalties for breach, general provisions under the National Health Act 1953 may apply, including fines and other civil or criminal penalties as deemed appropriate by the relevant authorities. This Instrument ensures that the Special Arrangement remains current and effective, facilitating the provision of essential pharmaceutical benefits to patients requiring specialised treatment. By aligning with the recommendations of the PBAC and the amendments to the PBS, the Instrument upholds the integrity and efficacy of the healthcare system in Australia.

Legal classification tags

Area of Law
Health Law
Instrument
Statutory Instrument
Concepts
Definitions & Interpretation
Licensing & Registration
Reporting & Disclosure Obligations
Regulatory Standards

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.