National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 2) (PB 16 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00162 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 2018 (No.2)

 

PB 16 of 2018

 

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 2018 (No. 2) (this Instrument). The purpose of this Instrument 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 (HSD) program.

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.

The amendments in PB 16 of 2018 include additions, deletions and changes to forms, brands, 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), the 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 2018.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.


ATTACHMENT

Provision by provision description of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 2)

PART 1 PRELIMINARY

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 2018 (No. 2). It can also be cited as PB 16 of 2018.

 

Section 2 Commencement

This section provides that this Instrument commences on 1 March 2018.

 

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

 

Items 1 to 14 Schedules 1, 2 and 3

Items 1 to 14 provide for additions, deletions and changes to forms, brands, responsible person codes, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements). These changes are summarised below.

 

 

SUMMARY OF CHANGES

Brand Added

Abacavir with Lamivudine

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

Brands Deleted

Zoledronic acid

Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL (Zometa)

Addition of Responsible Person Code

BGP Products Pty Ltd (GO)

Alteration of circumstances

Deferasirox

Ustekinumab

Infliximab

Vedolizumab

Mepolizumab

 


 

 

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 2018 (No. 2)

(PB 16 of 2018)

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 Legislative Instrument

The purpose of this legislative 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 legislative 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 Regulation amendments and this instrument are a positive step towards attaining the highest standard of health for all Australians. 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 legislative instrument is compatible with human rights because it advances the protection of human rights.

Natasha Ploenges

Assistant Secretary (Acting)

Private Health Insurance and Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 2) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, addressing issues related to the Highly Specialised Drugs (HSD) program. Enacted under the authority of the National Health Act 1953, the instrument allows the Minister to make special arrangements for the supply of pharmaceutical benefits, including amendments to the forms, brands, responsible person codes, and prescribing circumstances of various pharmaceutical benefits. The policy objective of this amendment is to align the HSD program with the changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the program reflects the latest recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, provides recommendations to the Minister about which drugs should be available as pharmaceutical benefits, taking into account clinical effectiveness, safety, and cost-effectiveness. The amendments in PB 16 of 2018 include additions, deletions, and changes to the pharmaceutical benefits covered under the HSD program, commencing on 1 March 2018.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No.2) is a legislative instrument that amends the National Health (Highly specialised drugs program) Special Arrangement 2010, made under the authority of the National Health Act 1953. This Act applies to the provision of pharmaceutical benefits and allows the Minister for Health to make special arrangements for their supply. The amendments made by this Instrument specifically address changes to the Highly Specialised Drugs (HSD) program, which is part of the Pharmaceutical Benefits Scheme (PBS). These amendments include adjustments to forms, brands, responsible person codes, and the prescribing circumstances of various pharmaceutical benefits, including authority requirements. This Instrument applies to entities and individuals involved in the supply and prescribing of pharmaceutical benefits under the HSD program, and it has a national reach as it is enacted under Commonwealth legislation. The amendments are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which ensures that decisions about the listing of medicines on the PBS are evidence-based and take into account medical conditions, clinical effectiveness, safety, and cost-effectiveness. The Instrument commenced on 1 March 2018 and reflects amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The legislative instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 2) (PB 16 of 2018) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (PB 116 of 2010), focusing on modifications to the Highly Specialised Drugs (HSD) program. This amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which are effective from the same date. The changes involve additions, deletions, and alterations to forms, brands, responsible person codes, and prescribing circumstances for various pharmaceutical benefits, including modifications to authority requirements. These amendments are detailed in the Schedules and are designed to ensure that the HSD program remains current with the latest therapeutic developments and clinical practices. The Act imposes several obligations on the parties involved, particularly those administering the Highly Specialised Drugs Program. The Minister for Health is responsible for making special arrangements for the supply of pharmaceutical benefits under the National Health Act 1953, and this Instrument specifies the changes to these arrangements. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established under the Act, plays a crucial role in recommending which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC's recommendations are based on clinical effectiveness, safety, and cost-effectiveness, ensuring that the decisions align with the highest standards of medical practice and patient care. The Minister must also ensure that the amendments comply with the recommendations made by PBAC and that the changes reflect the latest therapeutic advancements. Breaches of the requirements set forth in this Instrument may lead to various civil and criminal consequences. Although the specific penalties for non-compliance are not detailed in the explanatory statement, penalties for breaches of the National Health Act 1953 can include substantial fines and potential imprisonment, depending on the severity of the breach and the specific provisions contravened. The Pharmaceutical Benefits Scheme (PBS) regulations also outline penalties for non-compliance, which can include financial penalties and other administrative actions. These measures ensure that the integrity of the HSD program is maintained and that the program continues to provide necessary treatments to patients in a safe and effective manner. The amendments made by this Instrument are designed to ensure the continued effectiveness and relevance of the Highly Specialised Drugs Program. By aligning the program with the latest therapeutic developments and clinical practices, the amendments aim to improve patient outcomes and ensure that Australians have access to the best possible treatments for chronic conditions. The involvement of the Pharmaceutical Benefits Advisory Committee ensures that the changes are evidence-based and aligned with the highest standards of medical practice. This comprehensive approach to managing the HSD program demonstrates the commitment to providing high-quality healthcare services and ensuring the availability of necessary pharmaceutical benefits.

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