National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 1) (PB 5 of 2017)

Overview

The National Health Act 1953, as amended by the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 1), was enacted to address the need for changes in the Highly Specialised Drugs (HSD) program. This legislative instrument, made under the authority of the Minister for Health, was introduced to align the HSD program with recent amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The primary objective of the Amending Instrument is to reflect these changes in the Special Arrangement by modifying various aspects such as quantity and repeat exceptions, adding and amending restrictions, removing certain pharmaceutical items, and incorporating new pharmaceutical items, all of which are summarised in the attachment. The amendments were made in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that recommends which drugs should be available as pharmaceutical benefits, ensuring the changes are in line with expert advice and stakeholder interests. The instrument commenced on 1 February 2017, serving to update the regulatory framework governing the Highly Specialised Drugs program within the National Health Act.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 1) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, introducing changes to the Highly Specialised Drugs (HSD) program. This instrument applies to the entities and persons involved in the supply of pharmaceutical benefits as outlined under the National Health Act 1953, specifically those entities and persons engaged in the provision of highly specialised drugs under the HSD program. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which include adjustments to quantity and repeat exceptions, modifications to restrictions, removal and addition of pharmaceutical items, and amendments to the General statement for drugs used in the treatment of hepatitis C. The changes are applicable across Australia as the National Health Act operates on a Commonwealth level. Subordinate instruments may extend or restrict the application of this Act, subject to the provisions set out within the Act and this amending instrument.

Key Provisions

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 1) (the Amending Instrument) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (the Special Arrangement) to update the Highly Specialised Drugs (HSD) program. This involves modifying the pharmaceutical items covered under the program, as well as the restrictions and exceptions associated with their supply (Schedule, Items 1-37). These changes are designed to reflect the most recent amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The Amending Instrument imposes specific obligations on the entities involved in the supply and administration of highly specialised drugs. For example, it mandates the addition of quantity and repeat exceptions for certain drugs like Riociguat (Schedule, Items 1-2), while also adding and amending restrictions for other drugs such as Ambrisentan, Bosentan, and Eltrombopag (Schedule, Items 3-36). Additionally, it requires the removal of certain pharmaceutical items, such as Ribavirin and peginterferon alfa-2a, from the treatment regimen (Schedule, Item 37). These changes are necessary to ensure the HSD program aligns with the latest pharmaceutical benefits listings. Failure to comply with the provisions of the Amending Instrument may result in legal consequences. Although the Act does not explicitly state penalties for non-compliance, breaches of similar provisions in the National Health Act 1953 can lead to criminal charges and fines. For instance, unauthorised supply of pharmaceutical benefits can result in a fine of up to $22,000 for an individual and $110,000 for a body corporate (National Health Act 1953, Section 109). Furthermore, the Act allows for the revocation of special arrangements in cases of non-compliance or if the arrangement is no longer in the public interest (National Health Act 1953, Section 100(2)). The Amending Instrument also emphasises the importance of consultation and expert input in the development of the HSD program. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending changes to the program, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness. This ensures that the HSD program remains up-to-date and aligned with the latest medical evidence and best practices. Pharmaceutical companies are also consulted throughout the process, further ensuring that the program reflects the needs of both patients and healthcare providers.