National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 8) (PB 70 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01123 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 2019 (No. 8)

PB 70 of 2019

 

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 2019 (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 September 2019.

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 2019 (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 2019 (No. 8). It can also be cited as PB 70 of 2019.

Section 2 Commencement

This section provides that this Instrument commences on 1 September 2019.

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

Forms deleted

Ribavirin

Tablet 200 mg

Brands added

Azacitidine

Powder for injection 100 mg (Azacitidine Juno)

Brands deleted

Zoledronic acid

Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL (Zoledronic Acid 4 mg/100 mL APOTEX)

Alteration of circumstances

Deferasirox

Deferiprone

Doxorubicin - Pegylated Liposomal

Ibandronic acid

Infliximab

Interferon Alfa-2a

Lanreotide

Lenograstim

Lipegfilgrastim

Octreotide

Pamidronic Acid

Pegfilgrastim

Plerixafor

Thalidomide

Valaciclovir

Valganciclovir

Zoledronic acid

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 2019 (No. 8)

(PB 70 of 2019)

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 2019 (No. 8) is an amendment made under the authority of the National Health Act 1953 to update the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. This Instrument was enacted to make adjustments to the Highly Specialised Drugs program, which provides access to certain pharmaceutical benefits for the treatment of chronic conditions requiring specialised treatment. The changes made by this Instrument reflect updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and include additions, deletions, and alterations to drugs, forms, responsible person codes, and prescribing circumstances, including authority requirements. These amendments align with recommendations from the Pharmaceutical Benefits Advisory Committee, an independent expert body involved in consulting interested parties. The Instrument aims to ensure the provision of appropriate pharmaceutical benefits remains current and effective, enhancing the accessibility and management of highly specialised drugs within the National Health framework. This legislative instrument was made by the Minister for Health under the authority vested in them by the National Health Act 1953 and is designed to facilitate the progressive realisation of the right to the highest attainable standard of physical and mental health as recognised in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2019 (No. 8) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, which was established under the National Health Act 1953. This Instrument applies to the Highly Specialised Drugs Program, which provides for the supply of pharmaceutical benefits for the treatment of chronic conditions requiring specialised treatment. The amendments include changes to the list of drugs, their forms, responsible person codes, and prescribing circumstances, including any authority requirements. The changes are aligned with the recommendations of the Pharmaceutical Benefits Advisory Committee, an independent expert body that advises the Minister on which drugs should be available as pharmaceutical benefits. The Instrument is designed to ensure that the supply of highly specialised drugs meets the necessary medical, clinical, and cost-effectiveness standards. The amendments commence on 1 September 2019 and are subject to further variation or revocation by the Minister under the provisions of the National Health Act 1953. The Instrument is applicable nationally within Australia, with the purpose of ensuring that highly specialised drugs are available to patients in need, while also ensuring the sustainability and integrity of the Pharmaceutical Benefits Scheme. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring consistency across related legislative instruments. This legislative amendment process is supported by extensive consultation with pharmaceutical companies and other stakeholders, primarily through the Pharmaceutical Benefits Advisory Committee. The amendments do not specify any exclusions or exemptions but rather focus on updating the list of drugs, their forms, and prescribing requirements to reflect the latest clinical evidence and cost-effectiveness data.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2019 (No. 8) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (Section 3). This Instrument is designed to make changes to the Highly Specialised Drugs program, reflecting amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) that also commence on 1 September 2019. The amendments include additions, deletions, and changes to drugs, forms, responsible person codes, and the circumstances for prescribing various pharmaceutical benefits, including authority requirements. The obligations imposed by the Act on parties and entities governed by this Instrument involve ensuring that any changes to the Special Arrangement are aligned with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). PBAC is an independent expert body that advises the Minister on which drugs should be available as pharmaceutical benefits. The composition of PBAC ensures a broad representation of relevant interests and professions, including consumers, health economists, and medical practitioners, with the aim of making evidence-based recommendations. Pharmaceutical companies are also required to be consulted throughout the process of changes to the listings on the Pharmaceutical Benefits Scheme (PBS). The Instrument stipulates that the amendments to the Special Arrangement must be made in accordance with the recommendations of PBAC and must take into account factors such as clinical effectiveness, safety, and cost-effectiveness of the drugs. In terms of consequences for non-compliance, breaches of the provisions of this Instrument could result in civil or criminal penalties, depending on the nature and severity of the breach. However, the specific penalties are not detailed within the explanatory statement. The Instrument is designed to operate in a manner that 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 recognised under the International Covenant on Economic, Social and Cultural Rights (ICESCR). The involvement of PBAC in the decision-making process ensures that the decisions about which drugs are subsidised are evidence-based and aligned with human rights principles.

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