National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 7) (PB 77 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01211 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. 7)

PB 77 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. 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 September 2018.

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 2018 (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 2018 (No. 7).  It can also be cited as PB 77 of 2018.

Section 2 Commencement

This section provides that this Instrument commences on 1 September 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

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

Tacrolimus

Capsule 0.5 mg (Tacrograf)

 

Capsule 1 mg (Tacrograf)

 

Capsule 5 mg (Tacrograf)

Alteration of circumstances

Infliximab

 


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. 7)

(PB 77 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 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.

 

 

 

Natasha Ploenges

Acting Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 7) (PB 77 of 2018) is an amendment to the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (PB 116 of 2010). This Instrument was enacted to amend the Special Arrangement relating to the Highly Specialised Drugs program under subsection 100(2) of the National Health Act 1953. The changes made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) and involve additions, deletions, and modifications to drugs, forms, responsible person codes, and prescribing circumstances, including authority requirements. The Pharmaceutical Benefits Advisory Committee (PBAC) played a significant role in the consultation process, ensuring that the recommendations for these changes are evidence-based and aligned with the objectives of providing accessible and affordable pharmaceutical benefits. This Instrument, which commenced on 1 September 2018, is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by facilitating subsidised access to medicines through the Pharmaceutical Benefits Scheme (PBS). The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 7) was enacted by the Australian Government under the authority of the National Health Act 1953. The Instrument amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to reflect changes made to the Pharmaceutical Benefits listings. The policy objective of the Instrument is to ensure that the Highly Specialised Drugs program continues to provide access to necessary pharmaceutical benefits for patients with chronic conditions, while maintaining the integrity and cost-effectiveness of the Pharmaceutical Benefits Scheme (PBS). The amendments were made in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that recommends drugs for inclusion on the PBS based on clinical effectiveness, safety, and cost-effectiveness. This amendment process ensures that the Highly Specialised Drugs program remains aligned with the broader objectives of the National Health Act 1953 and the PBS.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 7) applies to the National Health Act 1953, specifically amending the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. This legislation concerns the special arrangement for the supply of highly specialised drugs, which are typically used for the treatment of chronic conditions requiring specialised medical attention. The amendments include additions, deletions, and changes to the drugs, forms, responsible person codes, and prescribing circumstances within the Highly Specialised Drugs Program, aligning with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This legislative instrument is applicable nationwide, operating under the authority of the Commonwealth of Australia and affecting the pharmaceutical industry and medical practitioners involved in prescribing and supplying these drugs. The amendments come into effect on 1 September 2018 and are subject to the authority and oversight of the Minister for Health, who has the power to vary or revoke these arrangements. The Instrument is consistent with the human rights framework, particularly engaging with the International Covenant on Economic, Social and Cultural Rights by promoting access to health services and ensuring evidence-based decision-making through the Pharmaceutical Benefits Advisory Committee.

Key Provisions

The main operative sections of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 7) are found in the amendments to the National Health (Highly specialised drugs program) Special Arrangement 2010. These amendments include additions, deletions, and changes to drugs, forms, responsible person codes, and prescribing circumstances (Section 3). These changes are detailed in Schedule 1 and involve modifications to the Highly Specialised Drugs program, such as adding new drugs like Tacrolimus and altering the prescribing circumstances for other drugs such as Infliximab. The obligations and requirements imposed by this Act on the parties or entities it governs primarily revolve around the management and administration of the Highly Specialised Drugs program. The Minister, as the authority to make special arrangements, has the obligation to ensure that the amendments align with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. Pharmaceutical companies and healthcare providers must adhere to the updated specifications regarding drug listings, forms, and prescribing requirements. The responsible persons, as defined by the Act, must ensure that the drugs are supplied according to the new guidelines set forth in this Instrument. There are no specific offences, penalties, or civil/criminal consequences outlined for breaches of the provisions in this Instrument. However, non-compliance with the amendments to the Highly Specialised Drugs program could result in administrative actions or other regulatory measures by the Department of Health. The Pharmaceutical Benefits Scheme (PBS) ensures that the supply of pharmaceutical benefits is managed within the framework of the National Health Act 1953, and any deviations from the prescribed guidelines may lead to scrutiny and corrective actions to maintain the integrity of the program. The amendments to the Highly Specialised Drugs program are consistent with the recommendations made by the PBAC, ensuring that the changes are evidence-based and align with the objectives of the National Health Act. The PBAC, being an independent expert body, plays a critical role in advising the Minister on the listing of pharmaceutical benefits, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness. This process ensures that the amendments reflect the latest medical and pharmaceutical standards, thereby maintaining the quality and efficacy of the drugs supplied under the program.

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