National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 5) (PB 39 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00697 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. 5)

PB 39 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. 5) (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 June 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. 5)

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. 5). It can also be cited as PB 39 of 2019.

Section 2 Commencement

This section provides that this Instrument commences on 1 June 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

Brands added

Entecavir

Tablet 0.5 mg (as monohydrate) (ENTECAVIR APO)

 

Tablet 1 mg (as monohydrate) (ENTECAVIR APO)

Deletion form

Filgrastim

Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim)

 

Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim)


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. 5)

(PB 39 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. 5) was enacted to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, which pertains to the Highly Specialised Drugs program. This legislative instrument was introduced to reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument was made under the authority of subsection 100(2) of the National Health Act 1953, which allows the Minister to vary or revoke special arrangements made under subsection 100(1). The policy objective of this amendment is to ensure that the pharmaceutical benefits supplied under the Special Arrangement are available for the treatment of chronic conditions requiring specialised treatment, thus supporting the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights. The amendments made by this instrument include additions, deletions, and changes to drugs, forms, responsible person codes, and prescribing circumstances, aligning with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This ongoing consultation process includes the involvement of various stakeholders such as consumers, health economists, and medical professionals, ensuring that the decisions regarding the listing of medicines on the Pharmaceutical Benefits Scheme (PBS) are evidence-based. The amendments aim to provide subsidised access to medicines, thereby advancing the protection of human rights by ensuring that patients have access to necessary treatments.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2019 (No. 5) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to update the Highly Specialised Drugs program, which facilitates access to drugs for patients with chronic conditions that require specialised treatment. The changes reflect updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and include modifications to drug listings, forms, responsible person codes, and prescribing conditions, including authority requirements. This legislative instrument is made under the authority provided by subsection 100(2) of the National Health Act 1953 and applies to entities and individuals involved in the provision of pharmaceutical benefits under the Special Arrangement. The amendments, which are consistent with recommendations from the Pharmaceutical Benefits Advisory Committee, commenced on 1 June 2019. The scope of the amendments is detailed in the attached schedule, which outlines specific additions, deletions, and changes to drugs and prescribing requirements. The Instrument is a legislative instrument under the Legislation Act 2003.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2019 (No. 5) (sections 2 and 3) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. The purpose of this amendment is to update the Special Arrangement to reflect recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. These updates include modifications to drugs, forms, responsible person codes, and the circumstances for prescribing various pharmaceutical benefits (section 3). The amendment adds certain brands of Entecavir tablets and removes specific forms of Filgrastim injection from the Highly Specialised Drugs program (Schedule). The National Health Act 1953 (the Act) empowers the Minister to make special arrangements for the supply of pharmaceutical benefits, and this Instrument falls under that authority (subsection 100(1)). The Instrument amends the Special Arrangement by incorporating the changes reflected in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the Highly Specialised Drugs program aligns with the latest updates in pharmaceutical listings (section 3). Parties governed by the Act, including pharmaceutical companies, healthcare providers, and patients, are affected by the obligations and requirements set forth in this Instrument. Pharmaceutical companies must adhere to the new listings and changes to drugs, forms, and responsible person codes. Healthcare providers must update their prescribing practices to align with the changes, ensuring they are aware of the new authority requirements for certain drugs. Patients, particularly those receiving specialised treatment for chronic conditions, may experience changes in the availability and prescribing of specific drugs. Breaches of the requirements set out in this Instrument may lead to civil or criminal consequences, although the specific penalties are not detailed in the provided text. However, the Act generally allows for enforcement actions such as fines or other penalties for non-compliance with pharmaceutical benefit regulations. It is essential for all parties to adhere to the updated provisions to avoid any potential legal repercussions.

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