EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 3)
PB 22 of 2016
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
The purpose of this legislative instrument, made under subsections 100(1) and 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 amendment made by this Instrument reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.
The amendments in PB 22 of 2016 include adding, removing and changing the circumstances for prescribing various pharmaceutical benefits, and amendments to responsible person codes.
These changes are summarised, by drug name, in the Attachment.
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. 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 and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
Details of the instrument are set out in the Attachment.
This Instrument commences on 1 April 2016.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
Details of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 3)
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 2016 (No. 3). It can also be citied as PB 22 of 2016.
Section 2 Commencement
This section provides that this instrument commences on 1 April 2016.
Section 3 Amendment
This section amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Items 1 to 13 Sections 1, 2 and 3
Items 1 to 13 provide for additions of and changes to pharmaceutical items, responsible persons and circumstances for prescribing. These changes are summarised below:
Listed Drug | Type of Change |
Apomorphine | Deletion of pharmaceutical items |
Atazanavir with cobicistat; Baclofen; Tenofovir with emtricitabline, elvitegravir and cobicistat | Addition of new pharmaceutical items |
Baclofen | Addition of new responsible person |
Baclofen;Natalizumab; Rituximab;Tocilizumab | Remodelled restrictions |
Overview
The National Health Act 1953 was enacted to provide a framework for the administration of health services in Australia, and it includes provisions for the supply of pharmaceutical benefits. The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 3) was introduced to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, reflecting changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment instrument was made under the authority of subsections 100(1) and 100(2) of the Act, enabling the Minister to make special arrangements for the supply of pharmaceutical benefits. The policy objective of these amendments is to update the highly specialised drugs program in alignment with the changes in the Pharmaceutical Benefits Scheme (PBS), ensuring that the program remains effective and responsive to the current healthcare needs. The changes include adding, removing, and modifying the circumstances for prescribing various pharmaceutical benefits and updating responsible person codes. These amendments are in accordance with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), which ensures that the changes are based on expert advice and comprehensive consultation with relevant stakeholders.
Scope and Application
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 3) applies to the supply of pharmaceutical benefits under the National Health Act 1953, specifically amending the National Health (Highly specialised drugs program) Special Arrangement 2010. This legislative instrument affects pharmaceutical companies, prescribing medical practitioners, and patients accessing highly specialised drugs covered under the program. It pertains to the modifications of pharmaceutical benefits, responsible person codes, and prescribing circumstances for certain drugs, thereby impacting the conduct and transactions related to the supply of these highly specialised drugs within Australia. The amendments are effective from 1 April 2016 and are subject to changes outlined in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments are implemented in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee, ensuring that the changes reflect clinical effectiveness, safety, and cost-effectiveness. The instrument does not explicitly state exclusions, but its application is contingent upon the specific details provided in the attachment, which summarises the changes by drug name.
Key Provisions
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 3) (section 2) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (section 3, items 1 to 13) to modify the provision of highly specialised drugs under the National Health Act 1953. These changes include the addition of new pharmaceutical items such as Atazanavir with cobicistat, Baclofen, and Tenofovir with emtricitabline, elvitegravir and cobicistat (section 3, item 2). Additionally, new responsible persons for certain drugs, such as Baclofen, Natalizumab, Rituximab, and Tocilizumab, have been added (section 3, item 3). The document also specifies changes to the circumstances for prescribing these drugs, including the remodelling of restrictions for Baclofen, Natalizumab, Rituximab, and Tocilizumab (section 3, item 4).
The obligations imposed by this instrument on the parties involved include adherence to the newly specified conditions for the prescription and supply of the amended pharmaceutical items. Pharmaceutical companies and healthcare providers must ensure that they comply with the new listing details and any changes in responsible persons. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on these changes, and stakeholders, including pharmaceutical companies, must consult with the PBAC as part of the formal consultation process (section 100A). The Minister has the authority to make special arrangements for the supply of pharmaceutical benefits under subsection 100(1) of the Act, and these arrangements are subject to any special arrangements made under subsection 100(1) (section 100(3)).
The Act does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches of the amended Special Arrangement. However, failure to comply with the provisions of the National Health Act 1953 and the amended Special Arrangement could potentially lead to enforcement actions by the Minister, including the variation or revocation of special arrangements (subsection 100(2)). This could have significant implications for pharmaceutical companies and healthcare providers, potentially affecting their ability to supply or prescribe certain drugs under the program. Compliance with the amended Special Arrangement is therefore critical to avoid any adverse regulatory consequences.