EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 7)
PB 64 of 2012
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 the Act, is to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the special arrangement relating to the highly specialised drugs program for hospitals.
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 treatment at or from a public or private hospital having access to appropriate specialised facilities.
This instrument makes changes to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010, which commence on the same day.
This instrument:
- adds 6 pharmaceutical benefits; and
- removes 3 pharmaceutical benefits.
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), 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.
This Instrument commences on 1 September 2012.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 7)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No.7) and that it may also be cited as PB 64 of 2012.
Section 2 Commencement
This section provides that this Instrument commences on 1 September 2012.
Section 3 Amendments to PB 116 of 2010
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement).
Schedule 1
SUMMARY OF CHANGES
Brands deleted from this Special Arrangement
Listed Drug | Form | Brand |
Cyclosporin | Capsule 25 mg | Cicloral |
Cyclosporin | Capsule 50 mg | Cicloral |
Cyclosporin | Capsule 100 mg | Cicloral |
Brands added to this Special Arrangement
Listed Drug | Form | Brand |
Cyclosporin | Capsule 25 mg | Cyclosporin Sandoz |
Cyclosporin | Capsule 50 mg | Cyclosporin Sandoz |
Cyclosporin | Capsule 100 mg | Cyclosporin Sandoz |
Lamivudine | Tablet 100 mg | Zetlam |
Lamivudine | Tablet 150 mg | Alphapharm Lamivudine |
Lamivudine | Tablet 300 mg | Alphapharm Lamivudine |
Overview
The National Health Act 1953 was enacted to provide a framework for the administration of public health services in Australia. The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2012 (No. 7) was introduced to address the need for updating the special arrangement for the supply of highly specialised drugs to hospitals. This amendment instrument was made under the authority of subsections 100(1) and 100(2) of the Act, enabling the Minister to adjust the special arrangement in response to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2010. The primary objective of this amendment is to align the highly specialised drugs program for hospitals with the updated pharmaceutical benefits list, ensuring that hospitals have access to the necessary medications for treating chronic conditions. This legislative instrument reflects recommendations from the Pharmaceutical Benefits Advisory Committee, which advises the Minister on which drugs should be available as pharmaceutical benefits. The changes involve adding six new pharmaceutical benefits and removing three existing ones, all of which are crucial for the treatment of specific medical conditions in hospital settings.
Scope and Application
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2012 (No. 7) amends the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010, which pertains to the supply of pharmaceutical benefits under the National Health Act 1953. This instrument applies to public and private hospitals with access to appropriate specialised facilities, ensuring the availability of highly specialised drugs for the treatment of chronic conditions. The amendment involves the addition of six pharmaceutical benefits and the removal of three, reflecting changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010. The changes are effective from 1 September 2012 and were made in accordance with recommendations by the Pharmaceutical Benefits Advisory Committee, which involves extensive consultation with stakeholders, including pharmaceutical companies. The amendment is part of a legislative instrument under the Legislative Instruments Act 2003, ensuring that the changes are formally implemented and monitored within the Commonwealth jurisdiction.
Key Provisions
The main operative sections of the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2012 (No. 7) (referred to as the Instrument) are found in Section 3, which amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (the Special Arrangement). This Instrument introduces six new pharmaceutical benefits and removes three existing ones, thereby updating the Special Arrangement to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010. These changes ensure that the Special Arrangement aligns with the current listings of pharmaceutical benefits.
The Instrument imposes specific obligations on the parties involved, primarily centred around the administration and compliance with the updated Special Arrangement. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a pivotal role in these obligations, providing recommendations for the listing of pharmaceutical benefits based on clinical effectiveness, safety, and cost-effectiveness. Additionally, pharmaceutical companies are required to consult with PBAC and agree on the final listing details to ensure alignment with the Special Arrangement. These obligations ensure that the highly specialised drugs program for hospitals remains effective and up-to-date with the latest medical advancements and recommendations.
Under the Instrument, breaches of the updated Special Arrangement may lead to various civil or criminal consequences, although the specific penalties are not detailed within the text provided. However, it is important to note that the Instrument is subject to the broader legislative framework of the National Health Act 1953, which includes provisions for penalties and enforcement actions for non-compliance with the Act's requirements. These penalties could include fines or other sanctions, depending on the nature and severity of the breach. The Minister also has the authority to vary or revoke special arrangements made under the Act, further underscoring the importance of compliance with the updated Special Arrangement.
In summary, the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2012 (No. 7) updates the Special Arrangement to reflect changes in the pharmaceutical benefits listings. This Instrument imposes obligations on PBAC, pharmaceutical companies, and other relevant parties to ensure compliance with the updated Special Arrangement. While the specific penalties for non-compliance are not detailed in the provided text, the Instrument is subject to the broader enforcement mechanisms outlined in the National Health Act 1953, which could include fines or other sanctions for breaches of the Act's provisions.