National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (May Update) Instrument 2021

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00523 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM)
SPECIAL ARRANGEMENT AMENDMENT (MAY UPDATE) INSTRUMENT 2021

PB 42 of 2021

 

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 (May Update) Instrument 2021 (PB 42 of 2021) (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 2021 (PB 27 of 2021) (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 addition of a brand of the listed drug tenofovir with emtricitabine to the Special Arrangement.  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 May 2021.

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 (MAY UPDATE) INSTRUMENT 2021

Section 1 Name of Instrument

This section provides the name of this Instrument as the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (May Update) Instrument 2021 and may also be cited as
PB 42 of 2021.

Section 2 Commencement

This section provides that this Instrument commences on 1 May 2021.

Section 3 Amendment of National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

This section provides that Schedule 1 amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021).

Schedule 1 Amendments

The amendment in Schedule 1 involves the addition of a brand for a drug available under the Special Arrangement.  This change is summarised below.

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT 2021 MADE BY THIS INSTRUMENT

Brands Added

Listed Drug

Form and Brand

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

(CIPLA TENOFOVIR + EMTRICITABINE 300/200)

 

 

 

 

 

 

 

 

 


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 (May Update) Instrument 2021

(PB 42 of 2021)

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 2021 (PB 27 of 2021) (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.

The amendment in Schedule 1 involves the addition of a brand for a drug available under the Special Arrangement.

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.

 

 

 

Ben Sladic

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (May Update) Instrument 2021 (PB 42 of 2021) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021, made under the National Health Act 1953. Enacted by the Minister for Health, this legislative instrument aims to update the Highly Specialised Drugs Program by modifying the arrangement related to the supply of pharmaceutical benefits. This change specifically addresses the need to add a brand of the listed drug tenofovir with emtricitabine to the Special Arrangement, aligning with the amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments reflect recommendations from the Pharmaceutical Benefits Advisory Committee and ensure the progressive realisation of the right to the highest attainable standard of physical and mental health as outlined in the International Covenant on Economic, Social and Cultural Rights. The Instrument is compatible with human rights and advances the protection of these rights through the provision of subsidised access to medicines. The purpose of this Instrument is to refine the Highly Specialised Drugs Program by incorporating a new brand of the drug tenofovir with emtricitabine into the Special Arrangement. This amendment aligns with changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and follows recommendations from the Pharmaceutical Benefits Advisory Committee. The Instrument facilitates the provision of pharmaceutical benefits for chronic conditions requiring specialised treatment, thereby supporting the overarching goal of improving patient access to necessary medications under the National Health Act 1953. By amending the existing Special Arrangement, the Instrument ensures that the Highly Specialised Drugs Program remains current and effective in meeting the health needs of patients.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (May Update) Instrument 2021 applies to the National Health (Highly Specialised Drugs Program) Special Arrangement 2021, modifying it to include the addition of a specific drug brand to the list of drugs available under the Highly Specialised Drugs Program. This Instrument, made under the authority of the National Health Act 1953, is designed to ensure that pharmaceutical benefits are supplied for the treatment of chronic conditions that require specialised treatment, thereby catering to specific medical needs that are not covered under the general Pharmaceutical Benefits Scheme. The geographic reach of this Instrument is national, as it pertains to the operation and administration of the Australian healthcare system. There are no explicit exclusions mentioned in this Instrument, although its applicability is inherently limited to the Highly Specialised Drugs Program and does not extend to other pharmaceutical benefits or healthcare services. The amendments made by this Instrument are subject to further regulation through subordinate instruments, which may specify additional details or conditions related to the supply of the newly added drug brand.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (May Update) Instrument 2021 (PB 42 of 2021) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021). The primary operative sections of this Instrument involve amending the Special Arrangement to include a new brand of the drug tenofovir with emtricitabine in the Highly Specialised Drugs Program (sections 3 and Schedule 1). This amendment reflects changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commenced on the same day. The Act imposes several obligations on the parties involved in the Highly Specialised Drugs Program. Firstly, the Minister, under subsection 100(1), is empowered to make special arrangements for the supply of pharmaceutical benefits. Secondly, the Minister can vary or revoke these special arrangements under subsection 100(2). Thirdly, the Pharmaceutical Benefits Advisory Committee (PBAC) is tasked with providing recommendations to the Minister regarding which drugs should be included in the Pharmaceutical Benefits Scheme (PBS). PBAC's recommendations are based on the clinical effectiveness, safety, and cost-effectiveness of the drugs compared to other treatments. Breach of the provisions under this Instrument can lead to civil or criminal consequences. While specific penalties are not outlined in the explanatory statement, breaches of provisions in the National Health Act 1953 can result in fines and imprisonment. The Pharmaceutical Benefits Advisory Committee's role in ensuring evidence-based recommendations underscores the importance of compliance with these provisions. Failure to adhere to the recommendations or the special arrangements can lead to legal ramifications, impacting the availability and accessibility of highly specialised drugs to patients in need.

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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.