National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 3) (PB 22 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00428 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. 3)

 

PB 22 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. 3) (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 (HSD) 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 and changes to brands, responsible persons, 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 April 2018.

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


ATTACHMENT

Provision by provision description of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 3)

PART 1 PRELIMINARY

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. 3).  It can also be cited as PB 22 of 2018.

 

Section 2 Commencement

This section provides that this Instrument commences on 1 April 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

 

Items 1 to 7 Schedules 1, 2 and 3

Items 1 to 7 provide for additions and changes to brands, responsible persons, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).  These changes are summarised below.

 

SUMMARY OF CHANGES

Brand Added

Abacavir with Lamivudine

Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg (Abacavir/Lamivudine Mylan)

Ganciclovir

Powder for I.V. infusion 500 mg (as sodium) (GANCICLOVIR SXP)

Alteration of Responsible Person

Listed Drug

Form

Brand Name

Responsible Person

Ibandronic acid

Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate) in 6 mL

Bondronat

From: RO

To: IX

Addition of Responsible Person Code

Mylan Health Pty Ltd (GO)

Horizon Hospital Healthcare Pty Ltd (HN)

Deletion of Responsible Person Code

BGP Products Pty Ltd (GO)

Alteration of circumstances

Lanreotide

 


 

 

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. 3)

(PB 22 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 Legislative Instrument

The purpose of this legislative 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 legislative 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 Regulation amendments and this instrument are a positive step towards attaining the highest standard of health for all Australians.  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 legislative instrument is compatible with human rights because it advances the protection of human rights.

 

Karen Hall

Assistant Secretary (Acting)

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. 3) is an amendment made under the authority of the National Health Act 1953 to adjust the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. This Instrument aims to update the Highly Specialised Drugs (HSD) program by reflecting changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The policy objective is to ensure that the HSD program remains aligned with the latest recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which advises the Minister on which drugs should be available as pharmaceutical benefits. The amendments include changes to brands, responsible persons, and prescribing conditions for various pharmaceutical benefits. This legislative update ensures that the HSD program continues to provide necessary treatments for chronic conditions under the supervision of specialised treatment, in line with the highest attainable standard of health as recognised by international human rights instruments. This legislative 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, as outlined in Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights. The amendments enhance the Pharmaceutical Benefits Scheme (PBS) by ensuring evidence-based decisions regarding the listing of medicines, thereby advancing the protection of human rights. The involvement of the PBAC in the decision-making process ensures that the amendments are aligned with the latest medical evidence and best practices. The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 3) thus plays a crucial role in maintaining the effectiveness and relevance of the HSD program in the Australian healthcare system.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 3) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 to modify the Highly Specialised Drugs (HSD) program. This legislation applies to the pharmaceutical benefits supplied under the Special Arrangement, which are specifically intended for the treatment of chronic conditions requiring specialised treatment. The changes introduced by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and include additions and modifications to brands, responsible persons, and the prescribing conditions for various pharmaceutical benefits, including authority requirements. The amendments are made in accordance with recommendations by the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the changes are evidence-based and align with the highest standards of clinical effectiveness, safety, and cost-effectiveness. This legislative instrument is applicable across Australia, extending its reach to all entities involved in the supply and prescription of these highly specialised drugs within the Pharmaceutical Benefits Scheme (PBS). The Instrument commences on 1 April 2018 and 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. 3) (referred to as the Instrument) is primarily concerned with amending the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010). This amendment is made to adjust the Special Arrangement concerning the Highly Specialised Drugs (HSD) program. The key provisions of this Instrument include amendments to the brands, responsible persons, and prescribing conditions for various pharmaceutical benefits (section 3). These changes reflect updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) and are intended to align with current therapeutic practices and evidence-based recommendations. The Instrument imposes specific obligations on parties involved in the HSD program. It requires the responsible persons, who are tasked with supplying the drugs, to adhere to the updated terms and conditions as outlined in the amended Special Arrangement. This includes ensuring that the prescribed drugs are supplied in accordance with the updated authority requirements and other stipulations. The responsible persons must also ensure that the drugs listed under the HSD program are administered correctly and that any changes in the supply or prescribing conditions are communicated effectively to all relevant stakeholders. Failure to comply with the provisions of the Instrument may result in various consequences. The National Health Act 1953 provides for penalties for non-compliance with its requirements. Such penalties may include fines or other sanctions as prescribed by the Act. Additionally, there may be civil or criminal liabilities for any breaches that result in harm to patients or non-adherence to regulatory standards. The exact penalties are determined by the severity of the breach and the specific provisions of the Act that have been contravened. The amendments introduced by the Instrument are designed to improve the efficiency and effectiveness of the HSD program. By aligning the Special Arrangement with the most recent therapeutic updates and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), the Instrument aims to ensure that patients have access to the most appropriate and effective treatments available. The ongoing consultation process with industry stakeholders and expert bodies like the PBAC ensures that the changes reflect the latest in medical evidence and clinical practice, thereby supporting the progressive realisation of the right to the highest attainable standard of health for all Australians.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Commencement Provisions
Reporting & Disclosure Obligations
Licensing & Registration

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.