EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2015 (No. 13)
PB 121 of 2015
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.
These changes are summarised 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 18 December 2015.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
Details of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015
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 2015 (No. 13). It can also be citied as PB 121 of 2015.
Section 2 Commencement
This section provides that this instrument commences on 18 December 2015.
Section 3 Amendment
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Items 1 - 2
Provide for changes to the circumstances for prescribing pharmaceutical benefits Eculizumab.
Overview
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 13) was enacted to address the need for amending the highly specialised drugs program as part of the National Health Act 1953. The instrument was introduced to implement changes recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) and to ensure the continued availability and accessibility of highly specialised drugs for patients. The amendments were made under the authority of the Minister for Health, pursuant to subsections 100(1) and 100(2) of the Act, to facilitate the supply of pharmaceutical benefits. The policy objective behind these amendments was to align the highly specialised drugs program with the most current recommendations regarding the clinical effectiveness, safety, and cost-effectiveness of drugs, ensuring that Australians have access to the best possible treatments. The instrument, which commenced on 18 December 2015, is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Scope and Application
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 applies to the Minister for Health under the National Health Act 1953, who is empowered to make special arrangements for the supply of pharmaceutical benefits. This instrument amends the National Health (Highly specialised drugs program) Special Arrangement 2010, specifically altering the conditions for prescribing the highly specialised drug Eculizumab. The changes are in line with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which includes members from various healthcare sectors and is involved in an ongoing consultation process. The amendments are designed to align with the clinical effectiveness, safety, and cost-effectiveness criteria considered by the PBAC. This legislative instrument is applicable nationally across Australia and comes into effect on 18 December 2015.
Key Provisions
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 13) (referred to as the Instrument) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. This amendment focuses on modifying the conditions for prescribing the highly specialised drug Eculizumab (section 3, Schedule 1). These changes are aimed at refining the eligibility criteria and conditions under which Eculizumab can be prescribed as part of the Pharmaceutical Benefits Scheme (PBS).
Under the amended Special Arrangement, certain obligations and requirements are imposed on healthcare providers and entities involved in the prescription and supply of Eculizumab. These include adherence to the updated eligibility criteria for prescribing the drug, ensuring that patients meet the specified medical conditions and treatment requirements, and complying with the administrative procedures outlined in the Special Arrangement. Pharmaceutical companies and healthcare providers are expected to ensure that their practices align with the revised provisions to maintain the integrity and effectiveness of the highly specialised drugs program.
Breaches of the provisions outlined in the amended Special Arrangement can lead to various consequences. The National Health Act 1953 provides for both civil and criminal penalties for non-compliance. Civil penalties may include fines and other administrative penalties as stipulated in the Act. Criminal penalties could apply in more severe cases, with maximum fines and potential imprisonment as outlined in the legislation. It is crucial for all parties involved to understand and comply with the amended requirements to avoid these penalties.
In summary, the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 13) introduces amendments to the prescription criteria for Eculizumab, imposes specific obligations on healthcare providers and pharmaceutical companies, and outlines potential civil and criminal penalties for non-compliance with the new provisions. The amendments are intended to ensure that the highly specialised drugs program remains effective and accessible to those who need it most.