National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 4) (PB 40 of 2018)

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 2018 (No. 4)

PB 40 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. 4) (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 June 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. 4)

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. 4).  It can also be cited as PB 40 of 2018.

Section 2 Commencement

This section provides that this Instrument commences on 1 June 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

Nusinersen

Listed Drugs Deleted

Didanosine

Interferon Alfa-2b

Stavudine

Forms Deleted

Lamivudine

Oral solution 5 mg per mL, 240 mL

Alteration of Responsible Person

Listed Drug

Form

Brand Name

Responsible Person

Interferon Gamma-1b

Injection 2,000,000 I.U. in 0.5 mL

Imukin

From: BY

To: EU

Valganciclovir

Tablet 450 mg (as hydrochloride)

Valganciclovir AN

From: EA

To: JO

Addition of Responsible Person Code

Emerge Health Pty Ltd (EU)

Juno Pharmaceuticals Pty Ltd (JO)

Alteration of circumstances

Infliximab

 

Ivacaftor

 

Omalizumab

 

Riociguat

 

Vedolizumab

 


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. 4)

(PB 40 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

Private Health Insurance and Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 4) (PB 40 of 2018) is a legislative instrument made under subsection 100(2) of the National Health Act 1953. Its purpose is to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, reflecting changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment involves additions, deletions, and changes to drugs, forms, responsible person codes, and prescribing circumstances, including authority requirements. The amendments are in line with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which ensures that decisions about subsidised access to medicines on the Pharmaceutical Benefits Scheme (PBS) are evidence-based. The Instrument ensures that patients with chronic conditions requiring specialised treatment have access to necessary pharmaceutical benefits, thereby advancing the right to the highest attainable standard of physical and mental health as recognised in international human rights instruments. This Instrument is compatible with human rights as it supports the progressive realisation of the right to health by facilitating access to highly specialised drugs. The involvement of PBAC in the decision-making process ensures that the amendments are based on sound clinical evidence, thereby promoting both the effectiveness and cost-efficiency of the PBS. The amendments do not undermine any human rights and, in fact, contribute to the protection and advancement of the right to health by providing necessary treatments to patients in need. The Instrument commences on 1 June 2018, aligning with the changes to the PBS listings.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 4) applies to the amendments of the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, which concerns the Highly Specialised Drugs program under the National Health Act 1953. This Act applies at the Commonwealth level and is intended to make changes to the listing of pharmaceutical benefits, including the addition, deletion, and modification of drugs, forms, responsible person codes, and the circumstances for prescribing pharmaceutical benefits. The amendments are designed to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The Instrument extends its reach by amending the Special Arrangement to include new drugs like Nusinersen, while removing others such as Didanosine, and adjusting the responsible persons and prescribing conditions for certain medications. The changes are to ensure that the Pharmaceutical Benefits Scheme provides for the highest attainable standard of physical and mental health, as per international human rights obligations. The Instrument is compatible with the human rights and freedoms recognised in international instruments, such as the International Covenant on Economic, Social and Cultural Rights, by facilitating the progressive realisation of the right to the highest attainable standard of health. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in ensuring that decisions regarding the inclusion of medicines on the PBS are evidence-based and aligned with these human rights obligations. The amendments made by this Instrument are consistent with recommendations from PBAC, which involves extensive consultation with various stakeholders, including pharmaceutical companies. This ensures that the changes are well-considered and reflect the best interests of patient health and access to necessary medications.

Key Provisions

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 4) (sections 1 to 3) amends the National Health (Highly specialised drugs program) Special Arrangement 2010. This Instrument modifies the Highly Specialised Drugs program to update the list of drugs, their forms, and the conditions under which they can be prescribed. Specifically, the amendments include adding new drugs like Nusinersen, removing drugs such as Didanosine, Interferon Alfa-2b, and Stavudine, and altering the forms of certain drugs and their responsible persons (sections 1 to 3). This change ensures that the list of drugs and their prescribing conditions align with the latest recommendations and clinical evidence. The amendments require pharmaceutical companies and healthcare providers to update their records and practices to reflect these changes. For example, healthcare providers must be aware of the new drugs that can be prescribed under the Highly Specialised Drugs program and the conditions associated with their use (section 3). Pharmaceutical companies need to ensure that their products comply with the new specifications and that they update their marketing and distribution practices accordingly. There are no explicit offences or penalties outlined in the Instrument for non-compliance with these amendments. However, failure to comply with the changes may result in non-eligibility for reimbursement under the Pharmaceutical Benefits Scheme (PBS) for the affected drugs. This means that healthcare providers and patients may have to bear the full cost of the drugs, which can be significant. Additionally, pharmaceutical companies may face reputational risks and loss of market share if their products do not comply with the new requirements. The Instrument is designed to ensure that the Highly Specialised Drugs program remains effective and aligned with current medical practices. By updating the list of drugs and their prescribing conditions, the amendments aim to improve patient outcomes and ensure that the program remains financially sustainable. The involvement of the Pharmaceutical Benefits Advisory Committee (PBAC) in the consultation process ensures that the changes are evidence-based and reflect the latest clinical evidence and expert recommendations.

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