National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2021 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00663 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (BOTULINUM TOXIN PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2021 (No. 1)

PB 53 of 2021

 

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 (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2021 (No. 1) (this Instrument).  The purpose of this Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Botulinum Toxin Program) Special Arrangement 2015 (PB 87 of 2015) (the Special Arrangement), to make changes to the Special Arrangement relating to the Botulinum Toxin program.

The amendments made by this Instrument reflect changes made during the remaking of the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations). The amendments for sections 4 and 6 of the Special Arrangement, reflect the repeal and remaking of the Regulations which commenced on 1 April 2017. Further amendments in this Instrument omit sections 23, 24, 25, 26 and 27 of the Special Arrangement to reflect that the previous Arrangements are no longer in place and that the program is now underpinned by the provisions under this Special Arrangement.

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 2021.

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


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (BOTULINUM TOXIN PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2021 (No. 1)

Section 1 Name of Instrument

This section provides the name of this Instrument as the National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2021 (No. 1) and may also be cited as PB 53 of 2021.

Section 2 Commencement

This section provides that this Instrument commences on 1 June 2021.

Section 3 Amendment of National Health (Botulinum Toxin Program) Special Arrangement 2015 (PB 87 of 2015)

This section provides that Schedule 1 amends the National Health (Botulinum Toxin Program) Special Arrangement 2015 (PB 87 of 2015).

Schedule Amendments

Item 1 omits and replaces the definition of ‘Regulations’ in section 4 of the Special Arrangement to account for the remaking of the National Health (Pharmaceutical Benefits) Regulations 1960 which commenced on 1 April 2017.

Item 2 omits and replaces references from the National Health (Pharmaceutical Benefits) Regulations 1960 to National Health (Pharmaceutical Benefits) Regulations 2017.

Item 3 omits and replaces references from the National Health (Pharmaceutical Benefits) Regulations 1960 to National Health (Pharmaceutical Benefits) Regulations 2017.

Items 4 omits the Transitional arrangements as the old Arrangement is no longer in place and the program is now underpinned by the provisions under this Special Arrangement.

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2021 (No. 1)

(PB 53 of 2021)

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 (Botulinum Toxin Program) Special Arrangement 2015 (PB 87 of 2015) (the Special Arrangement), to make changes to the Special Arrangement relating to the Botulinum Toxin Program.

The purpose of the Special Arrangement is to ensure that an adequate supply of pharmaceutical benefits is available for patients who require treatment with botulinum toxin.  Restrictions on the provision of this treatment mean that these pharmaceutical benefits can be more conveniently or efficiently supplied under a special arrangement.

The amendments made by this Instrument reflect changes made during the repeal and remaking of the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations). The amendments for sections 4 and 6 of the Special Arrangement, reflect the repeal and remaking of the Regulations which commenced on 1 April 2017. Further amendments in this Instrument omit sections 23, 24, 25, 26 and 27 of the Special Arrangement to reflect that the previous Arrangements are no longer in place and the program is now underpinned by the provisions under this 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.

This Instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

Mariana Crank

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2021 (No. 1) amends the National Health (Botulinum Toxin Program) Special Arrangement 2015, made under the National Health Act 1953. This Instrument was introduced to reflect the changes made during the repeal and remaking of the National Health (Pharmaceutical Benefits) Regulations 1960, as well as to account for the cessation of certain arrangements and the establishment of new provisions for the Botulinum Toxin Program. Enacted by the Australian Parliament, the purpose of this amendment is to ensure the progressive realisation of the highest attainable standard of physical and mental health through the provision of pharmaceutical benefits, particularly in relation to the Botulinum Toxin Program. The amendments made by this Instrument have been aligned with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the Act. The PBAC, comprising members from various healthcare fields, provides recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. The amendments made through this Instrument are consistent with the human rights recognised or declared in international instruments, particularly the International Covenant on Economic, Social and Cultural Rights. By ensuring evidence-based decisions regarding the inclusion of medicines on the Pharmaceutical Benefits Scheme, this amendment furthers the protection of human rights by facilitating access to essential treatments.

Scope and Application

The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2021 (No. 1) amends the National Health (Botulinum Toxin Program) Special Arrangement 2015, primarily to reflect changes resulting from the repeal and remaking of the National Health (Pharmaceutical Benefits) Regulations 1960 which commenced on 1 April 2017. This Instrument applies to the supply of botulinum toxin treatments, ensuring these pharmaceutical benefits are available to patients who require such treatments. It specifically addresses the provisions of the Special Arrangement that facilitate the efficient and convenient supply of these treatments under a special arrangement, as permitted by subsection 100(1) of the National Health Act 1953. The Instrument also removes outdated sections of the Special Arrangement that were previously in place, thereby streamlining and updating the regulatory framework to align with current legislative requirements. This legislative amendment is a response to the recommendations of the Pharmaceutical Benefits Advisory Committee, ensuring that the changes are evidence-based and consider the clinical effectiveness, safety, and cost-effectiveness of the treatments. This Instrument operates within the Commonwealth jurisdiction, governed by the National Health Act 1953. It is designed to ensure the Special Arrangement remains effective and compliant with contemporary legislative standards. There are no specific exclusions or thresholds outlined in the Instrument itself, but the scope of its application is inherently limited to the provisions of the Special Arrangement it amends. The Instrument does not introduce new exclusions or exemptions beyond those already established in the Special Arrangement or the broader regulatory framework. The amendments made by this Instrument are effective from 1 June 2021, and it is a legislative instrument under the Legislation Act 2003.

Key Provisions

The main operative sections of the National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2021 (No. 1) include amendments to the National Health (Botulinum Toxin Program) Special Arrangement 2015 (section 3). This amendment ensures the Special Arrangement reflects the changes made during the repeal and remaking of the National Health (Pharmaceutical Benefits) Regulations 1960, which commenced on 1 April 2017. Furthermore, it omits sections 23, 24, 25, 26, and 27 of the Special Arrangement to indicate that the previous arrangements are no longer in place and the program is now underpinned by the provisions under this Special Arrangement. This Instrument commences on 1 June 2021. The obligations and requirements imposed by the Act on parties or entities governed by this Act include the necessity for pharmaceutical companies to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) throughout the process of changes to the listings on the Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee (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. Additionally, the amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). The Instrument outlines specific offences, penalties, or civil/criminal consequences for breach. However, it does not specify the maximum penalties for breaches. The Instrument is compatible with human rights as it advances the protection of human rights 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. It engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by ensuring that decisions about subsidised access to medicines on the PBS are evidence-based.

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