National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 9) (PB 88 of 2017)

Overview

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 9) was enacted to amend the National Health (Highly specialised drugs program) Special Arrangement 2010, specifically to update the Highly Specialised Drugs (HSD) program. This amendment instrument was introduced to address changes in drug listings on the Pharmaceutical Benefits Scheme (PBS), as reflected in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument was made under the authority of the National Health Act 1953 by the Minister for Health, with the policy objective of ensuring that the Special Arrangement remains aligned with the most recent amendments to the PBS. The changes include the addition of new forms of listed drugs and modifications to the prescribing conditions for several drugs, as recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, played a crucial role in consulting with various stakeholders, including pharmaceutical companies, to ensure the recommendations were well-informed and comprehensive. This amendment instrument commenced on 1 November 2017.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 9) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 to adjust the supply of highly specialised drugs in Australia under the Pharmaceutical Benefits Scheme (PBS). This amendment applies to individuals and entities involved in the prescribing, dispensing, and administration of these drugs, particularly within the healthcare sector. The amendments are aligned with changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and are effective from 1 November 2017. The amendments include modifications to the maximum quantities and repeats for certain drugs like Infliximab and Vedolizumab, and the addition of a new form of Baclofen. These changes ensure that the Highly Specialised Drugs (HSD) program remains current with the latest pharmaceutical listings and clinical recommendations. The Instrument operates nationally across Australia, reflecting the Commonwealth's role in regulating pharmaceutical benefits.

Key Provisions

The primary sections of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 9) include the introduction of new forms of listed drugs and alterations to the prescribing conditions for certain drugs under the Highly Specialised Drugs (HSD) program. Specifically, Section 24(2) of Part 2, Division 4 now details the maximum quantities applicable to Infliximab and Vedolizumab, while Section 25(2) of the same division specifies the maximum number of repeats for these drugs (Section 3). Items 3 to 23 in the Schedule detail the addition of a new form of Baclofen, an intrathecal injection of 40 mg in 20 mL, alongside modifications to the prescribing conditions for Infliximab, Vedolizumab, and other listed drugs. These changes are aligned with updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (Sections 3, Items 3 to 23). The Act imposes several obligations and requirements on the entities it governs. Firstly, it mandates that pharmaceutical benefits, including those under the HSD program, be supplied in accordance with the special arrangements outlined in the Act. The Minister, under Section 100(1), has the authority to make these special arrangements, which must be adhered to by all parties involved in the supply of these benefits. Additionally, Section 100(3) ensures that the provisions of Part VII of the Act and any instruments made for its purposes are subject to these special arrangements, thereby integrating them into the broader regulatory framework of the Act. Furthermore, the Pharmaceutical Benefits Advisory Committee (PBAC), established under Section 100A, plays a crucial role in recommending which drugs should be available as pharmaceutical benefits, taking into account clinical effectiveness, safety, and cost-effectiveness (Section 100A). There are potential civil and criminal consequences for non-compliance with the provisions of this Instrument. Offences under the National Health Act 1953 can lead to penalties, although the exact penalties are not detailed within this specific Instrument. The general penalty provisions under the Act may apply, where penalties can include fines and imprisonment, depending on the severity and nature of the offence. The maximum penalties would be in accordance with the broader legislative framework established by the National Health Act 1953 and any other relevant laws. Non-compliance with the special arrangements and the prescribing conditions specified in the Instrument can result in legal action being taken against the offending parties, potentially leading to significant financial and reputational consequences. The amendments made by this Instrument are designed to align with the recommendations of the PBAC and reflect the latest updates in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The PBAC, through its rigorous consultation process and expert recommendations, ensures that the changes are evidence-based and consider the latest medical and economic data. Given the extensive consultation with pharmaceutical companies and the alignment with PBAC recommendations, further consultation for this Instrument was deemed unnecessary. The Instrument is set to commence on 1 November 2017, bringing these important amendments into effect and ensuring that the Highly Specialised Drugs program remains up-to-date with current medical practices and regulatory standards.