National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 7) (PB 66 of 2017)

Overview

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 7) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 to update the Highly Specialised Drugs (HSD) program. This instrument, enacted by the Minister under the authority of the National Health Act 1953, aims to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. It introduces new drugs and brands into the HSD program, removes certain brands, and modifies prescribing conditions for several listed drugs, including maximum quantities and the number of repeats. These amendments align with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and involve extensive consultation with pharmaceutical companies. The policy objective is to ensure the HSD program remains current with the latest medical and pharmaceutical advancements, providing Australians with access to the most effective and cost-efficient treatments available. The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 7) commenced on 1 September 2017 and is a legislative instrument under the Legislation Act 2003. The amendments include the addition of two new drugs to the HSD program, the addition of several new brands of already listed drugs, the removal of specific drug brands, and changes to the prescribing circumstances for a number of drugs, reflecting the most recent PBAC recommendations. This amendment process ensures the HSD program stays responsive to evolving healthcare needs and maintains the balance between providing access to innovative treatments and ensuring fiscal responsibility within the national health framework.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 7) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to update the Highly Specialised Drugs (HSD) program. This Amendment Instrument applies to the Minister for Health under the National Health Act 1953, and its purpose is to reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments include the addition of two new listed drugs, new brands of already listed drugs, deletion of certain brands, and changes to prescribing circumstances for listed drugs, such as maximum quantities and numbers of repeats. The changes are aligned with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on which drugs should be available as pharmaceutical benefits. This Instrument commences on 1 September 2017 and is a legislative instrument for the purposes of the Legislation Act 2003.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 7) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (No. 116 of 2010). The Amendment Instrument introduces changes to the Highly Specialised Drugs (HSD) program, which includes the addition of two new listed drugs, the addition of several new brands of already listed drugs, the deletion of certain brands of listed drugs and modifications to the prescribing circumstances for a number of listed drugs (including maximum quantities and numbers of repeats). The changes are reflected in Schedules 1 and 3 of the Amendment Instrument. The Amendment Instrument imposes specific obligations on the entities it governs, primarily concerning the administration and compliance with the HSD program. Pharmaceutical companies and healthcare providers must adhere to the updated listing of drugs and brands, as well as the new prescribing guidelines. For instance, when prescribing drugs under the HSD program, healthcare providers must now follow the new maximum quantities and numbers of repeats specified in the Amendment Instrument. This ensures that the drugs are prescribed in accordance with the most current medical guidelines and regulatory requirements. The Amendment Instrument also delineates the offences and potential penalties for non-compliance with the HSD program. Although the specific penalties are not detailed within the Amendment Instrument itself, breaches of the National Health Act 1953 can generally result in civil or criminal consequences. Civil penalties may include fines, while criminal penalties can include imprisonment, reflecting the severity of non-compliance with national health regulations. The precise penalties would be determined by the courts and could vary based on the nature and extent of the breach. Entities that fail to comply with the requirements of the HSD program risk facing both civil and criminal consequences. Civil penalties can include fines, which serve as a deterrent and a means of recovering costs associated with non-compliance. Criminal penalties can include imprisonment, which underscores the seriousness of violating national health regulations. The courts have the discretion to determine the exact penalties based on the specifics of the breach, including its severity and the intent behind the non-compliance. Overall, the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 7) provides a comprehensive update to the HSD program, ensuring that the program remains current with the latest medical and regulatory standards. By amending the Special Arrangement, the Amendment Instrument imposes specific obligations on entities involved in the provision and prescription of highly specialised drugs, and establishes clear consequences for non-compliance.