National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 12) (PB 106 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01688 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. 12)

PB 106 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.12) (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.

Schedule 1 to this Instrument provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs Tezacaftor with ivacaftor and ivacaftor, and Vedolizumab (including authority requirements).  It also provides for the addition of one new brand and deletion of two existing brands of existing pharmaceutical benefits. These changes are summarised, by subject matter, in the Attachment.

These changes are summarised, by subject matter, 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 January 2020.

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. 12)

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. 12). It can also be cited as PB 106 of 2019.

Section 2 Commencement

This section provides that this Instrument commences on 1 January 2020.

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 1 Amendments

The amendments in Schedule 1 provide for additions and deletions of brands of existing pharmaceutical items and alterations to the circumstances for prescribing various pharmaceutical benefits (including authority requirements).  These changes are summarised below.

 

 

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT 2010 MADE BY THIS INSTRUMENT

Brands Added

Listed Drug

Form and Brand

Azacitidine

Powder for injection 100 mg (Azacitidine-Teva)

Brands Deleted

Listed Drug

Form and Brand

Abacavir with Lamivudine

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

Nevirapine

Tablet 200 mg (Viramune)

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

Tezacaftor with ivacaftor and ivacaftor

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 2019 (No. 12)

(PB 106 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. 12) is an instrument made under the authority of subsection 100(2) of the National Health Act 1953 to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. Its purpose is to modify the Special Arrangement in relation to the Highly Specialised Drugs Program to reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes include alterations to prescription circumstances for certain listed drugs, as well as the addition and deletion of specific pharmaceutical brands. These amendments are consistent with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) and have undergone consultation with relevant stakeholders, including pharmaceutical companies. The instrument is designed to ensure that the Highly Specialised Drugs Program remains effective and aligned with the latest clinical and cost-effectiveness data. This legislative instrument is compatible with human rights, particularly under Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), by enhancing access to subsidised medications that contribute to the highest attainable standard of physical and mental health. The role of PBAC in recommending which drugs should be listed on the Pharmaceutical Benefits Scheme (PBS) ensures that decisions are evidence-based and aimed at progressively realising the right to health for all Australians.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2019 (No. 12) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, which governs the supply of pharmaceutical benefits under the Highly Specialised Drugs program. This program is concerned with the supply of drugs for chronic conditions requiring specialised treatment. The instrument applies to the Minister for Health under subsection 100(1) of the National Health Act 1953, and its amendments take effect from 1 January 2020. These changes include modifications to prescription requirements and the addition or deletion of specific drug brands, as detailed in Schedule 1. The alterations are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established under the Act that advises on which drugs should be listed as pharmaceutical benefits. The PBAC comprises experts from various fields, including healthcare professionals and industry representatives, ensuring a comprehensive review process. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on the same day. The instrument is compatible with human rights, particularly the right to the highest attainable standard of physical and mental health, as it facilitates access to essential medicines through the Pharmaceutical Benefits Scheme.

Key Provisions

The main sections of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 12) (the Instrument) pertain to the alterations made to the National Health (Highly specialised drugs program) Special Arrangement 2010 (the Special Arrangement) (sections 1 and 3). Schedule 1 to the Instrument details the amendments, including the addition and deletion of brands of pharmaceutical benefits and changes to the circumstances under which prescriptions may be written (section 3). This Instrument is designed to update the Special Arrangement to reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (section 1). The Instrument imposes several obligations on the parties it governs. It mandates that the amendments detailed in Schedule 1 be implemented to reflect changes to the Pharmaceutical Benefits Scheme (PBS) (section 3). It also requires that the new provisions come into effect on 1 January 2020 (section 2). The Instrument further imposes an obligation on the Minister to consult with relevant stakeholders, such as the Pharmaceutical Benefits Advisory Committee (PBAC), during the amendment process (Attachment). The Instrument outlines specific offences, penalties, and consequences for non-compliance. However, the text does not specify any particular penalties or consequences for breaches of the Instrument. Instead, it relies on the broader legislative framework of the National Health Act 1953 (the Act) and related instruments for enforcement (section 100(3)). The penalties for non-compliance would typically be in accordance with the general provisions of the Act and other relevant legislation. The Instrument also ensures compatibility with human rights, as it advances the protection of human rights by providing for subsidised access to medicines through the PBS, thereby assisting in the realisation of the right to the highest attainable standard of physical and mental health (Statement of Compatibility with Human Rights). The involvement of the PBAC ensures that decisions about subsidised access to medicines are evidence-based, further supporting the protection of human rights. In conclusion, the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 12) makes amendments to the Special Arrangement to update the Highly Specialised Drugs program. It imposes obligations on the parties it governs, including the implementation of the detailed amendments and consultation with relevant stakeholders. While the Instrument does not specify particular penalties for non-compliance, it relies on the broader legislative framework for enforcement. The Instrument is also compatible with human rights, as it assists in the realisation of the right to the highest attainable standard of physical and mental health.

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