National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 7) (PB 61 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01023 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. 7)

PB 61 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. 7) (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 August 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. 7)

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. 7). It can also be cited as PB 61 of 2019.

Section 2 Commencement

This section provides that this Instrument commences on 1 August 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 added

Deferiprone

Tablet 1000 mg

Tenofovir with emtricitabine and efavirenz

Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg

Brands added

Mycophenolic Acid

Tablet containing mycophenolate mofetil 500 mg (MycoCept)

Alteration of Maximum Quantity

Listed Drug

Form

Brand

Max Qty

Deferiprone

Tablet 500 mg

Ferriprox

From: 600

To: 300

Alteration of circumstances

Infliximab

Ivacaftor

Lanreotide

Pasireotide

Addition of Responsible Person Code

Arrow Pharma Pty Ltd (RF)

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. 7)

(PB 61 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.

 

 

 

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 2019 (No. 7) was enacted to amend the National Health (Highly specialised drugs program) Special Arrangement 2010. This amendment responds to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, reflecting updates in the listing of pharmaceutical benefits on the Pharmaceutical Benefits Scheme (PBS). The Instrument was made under the authority of the National Health Act 1953, with the policy objective of ensuring that the Highly Specialised Drugs program aligns with the most recent recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). PBAC, an independent expert body established under the Act, advises the Minister on which drugs should be available as pharmaceutical benefits based on their clinical effectiveness, safety, and cost-effectiveness. The amendments include additions, deletions, and modifications to the drugs, forms, responsible person codes, and prescribing conditions within the program. This legislative amendment ensures that the Highly Specialised Drugs program continues to meet the therapeutic needs of patients requiring specialised treatment, supported by evidence-based recommendations. The Instrument, which commenced on 1 August 2019, incorporates a formal consultation process with relevant stakeholders, including pharmaceutical companies, through the PBAC process. This ensures that the amendments reflect current clinical standards and patient needs. The amendments made by this Instrument are compatible with human rights, particularly advancing the right to the highest attainable standard of physical and mental health as recognised in the International Covenant on Economic, Social and Cultural Rights (ICESCR). The role of PBAC in recommending drug listings ensures that decisions about access to medicines are evidence-based, thereby protecting and promoting human rights within the Highly Specialised Drugs program.

Scope and Application

This legislative instrument, the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 7), amends the National Health (Highly specialised drugs program) Special Arrangement 2010 to make changes to the Highly Specialised Drugs program. It applies to the Minister for Health, entities involved in the supply of pharmaceutical benefits, and patients receiving specialised treatment for chronic conditions. The amendments relate to drugs, forms, responsible person codes, and prescribing circumstances, reflecting updates in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes are in line with recommendations from the Pharmaceutical Benefits Advisory Committee and involve consultation with pharmaceutical companies. The amendments take effect from 1 August 2019, and the Instrument is compatible with human rights, advancing the right to the highest attainable standard of physical and mental health.

Key Provisions

The main operative sections of this Instrument (National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2019 (No. 7)) are Section 3 and the amendments listed in Schedule 1, which collectively modify the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (the Special Arrangement) (sections 1 and 2). Section 3 outlines the amendments to the Special Arrangement, including additions, deletions, and changes to drugs, forms, responsible person codes, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements). Schedule 1 details the specific changes being made, such as the addition of Deferiprone and Mycophenolic Acid, alterations in the maximum quantity listed for Deferiprone, and the addition of a responsible person code for Arrow Pharma Pty Ltd. This Instrument imposes obligations on the parties involved, particularly those concerning the supply of pharmaceutical benefits under the Highly Specialised Drugs Program. The changes necessitate adjustments in the prescribing and supply processes for the listed drugs, ensuring they align with the updated Special Arrangement. Pharmaceutical companies, prescribers, and patients must adhere to the new specifications, such as the authority requirements for certain drugs and the changes in maximum quantities. Additionally, the Instrument mandates that the Pharmaceutical Benefits Advisory Committee (PBAC) continues its role in recommending the listing of medicines on the Pharmaceutical Benefits Scheme (PBS) based on clinical effectiveness, safety, and cost-effectiveness. The Instrument does not explicitly outline specific offences, penalties, or consequences for breach; however, non-compliance with the amended Special Arrangement could lead to various civil or administrative consequences. For instance, supplying drugs in violation of the new maximum quantities or authority requirements could result in the pharmaceutical benefits not being covered under the Scheme, leading to higher costs for patients or healthcare providers. Additionally, prescribers or pharmaceutical companies failing to adhere to the new provisions might face scrutiny or penalties from relevant health authorities. The overarching compliance framework under the National Health Act 1953 ensures that any breaches are addressed according to the relevant legislative provisions.

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