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