National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 2) (PB 17 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00185 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 2020 (No. 2)

PB 17 of 2020

 

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 2020 (No.2) (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 deletion of the drugs tenofovir with emtricitabine, elvitegravir and cobicistat and tenofovir with emtricitabine and rilpivirine and the addition of one new form of the listed drug tacrolimus to the Special Arrangement.  It also provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs dolutegravir with abacavir and lamivudine, levodopa with carbidopa, and nusinersen.  Additionally, this instrument provides for the addition of one new brand and the deletion of three brands of existing pharmaceutical benefits. 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 March 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 2020 (No. 2)

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 2020 (No. 2) and may be cited as PB 17 of 2020.

Section 2 Commencement

This section provides that this Instrument commences on 1 March 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 involve the deletion of drugs, addition of a form, addition and deletion of brands, and the alteration to circumstances for prescribing various pharmaceutical benefits available under the Special Arrangement.  These changes are summarised below.

 

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

Listed Drugs Deleted

Listed Drug

Tenofovir with emtricitabine, elvitegravir and cobicistat

Tenofovir with Emtricitabine and Rilpivirine

Forms Added

Listed Drug

Form

Tacrolimus

Capsule 3 mg (once daily prolonged release)

Brands Added

Listed Drug

Form and Brand

Pegfilgrastim

Injection 6 mg in 0.6 mL single use pre-filled syringe (Ziextenzo)

Brands Deleted

Listed Drug

Form and Brand

Octreotide

Injection 50 micrograms (as acetate) in 1 mL (Hospira Pty Limited)

 

Injection 100 micrograms (as acetate) in 1 mL (Hospira Pty Limited)

 

Injection 500 micrograms (as acetate) in 1 mL (Hospira Pty Limited)

 

 

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

Dolutegravir with abacavir and lamivudine

Levodopa with Carbidopa

Nusinersen

 


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 2020 (No. 2)

(PB 17 of 2020)

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.

The amendments in Schedule 1 involve the deletion of drugs, addition of a form, addition and deletion of brands, and the alteration to circumstances for prescribing various pharmaceutical benefits 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 Instrument 2020 (No. 2) was enacted to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, addressing the need for updates to the Highly Specialised Drugs program. This legislative instrument, created under subsection 100(2) of the National Health Act 1953, modifies the special arrangement concerning the supply of pharmaceutical benefits. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and are aligned with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This committee, composed of experts from various health-related fields, ensures that decisions about the listing of medicines on the Pharmaceutical Benefits Scheme (PBS) are evidence-based. The policy objective is to maintain the integrity and effectiveness of the Highly Specialised Drugs program by ensuring that the drugs listed are aligned with current medical standards and patient needs. The amendments involve the deletion of certain drugs, addition of new drug forms and brands, and changes to the prescribing conditions for specific drugs within the Special Arrangement. These changes are intended to reflect advancements in medical treatment and ensure the continued availability of essential medications for patients with chronic conditions requiring specialised treatment. The Instrument commenced on 1 March 2020, and it is compatible with human rights, supporting 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.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 2) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, which pertains to the Highly Specialised Drugs program under the National Health Act 1953. This instrument applies to the Minister of Health who has the authority to make special arrangements for the supply of pharmaceutical benefits. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and involve the deletion of certain drugs, addition of new forms and brands, and alterations in the circumstances for prescribing various pharmaceutical benefits. The changes are designed to ensure that the medications listed in the Special Arrangement align with the latest recommendations and evidence regarding their clinical effectiveness, safety, and cost-effectiveness. The amendments commence on 1 March 2020 and are part of the broader legislative framework that governs the supply and listing of pharmaceutical benefits in Australia.

Key Provisions

This legislation, the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 2), amends the National Health (Highly specialised drugs program) Special Arrangement 2010, which pertains to the Highly Specialised Drugs program. This program supplies pharmaceutical benefits for the treatment of chronic conditions that may only be supplied to patients receiving specialised treatment. The amendments are made under subsection 100(2) of the National Health Act 1953 (the Act), which allows the Minister to make special arrangements for the supply of pharmaceutical benefits and to vary or revoke those arrangements. The amendments made by this Instrument include deleting two drugs from the list of pharmaceutical benefits, adding a new form of tacrolimus, and altering the circumstances under which certain drugs may be prescribed. Additionally, this Instrument adds one new brand of a listed drug and deletes three brands of existing pharmaceutical benefits. These changes are outlined in detail in the Attachment. The obligations and requirements imposed by this Act on the parties governed by it include ensuring that the pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions that may only be supplied to patients receiving specialised treatment. The Act also mandates that any changes to the Special Arrangement, such as the deletion or addition of drugs, forms, or brands, are made in accordance with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). There are no direct offences, penalties, or civil/criminal consequences specified for breach of this Instrument. However, the amendments made by this Instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which are made under sections 84AF, 84AK, 85, 85A, 88, and 101 of the Act. These sections outline the processes and criteria for listing pharmaceutical benefits on the Pharmaceutical Benefits Scheme (PBS), including the role of the PBAC in making recommendations to the Minister. The PBAC is an independent expert body that considers factors such as the medical conditions for which a medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness compared with other treatments. Consultation with pharmaceutical companies and other interested parties has been conducted throughout the process of changes to the listings on the PBS, including through the PBAC process. Further consultation for this Instrument was deemed unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication. The changes made by this Instrument are intended to ensure that the Highly Specialised Drugs program continues to provide appropriate and effective treatments for patients with chronic conditions requiring specialised care.

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