National Health (Pharmaceutical Benefits - Therapeutic Groups) Amendment Determination 2015 (No. 1) (PB 99 of 2015)

Overview

The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2015 (No. 1) was enacted in 2015 by the Australian Government under the authority of the National Health Act 1953. This legislative instrument was introduced to address the need to update the therapeutic groups and the drugs listed within them, particularly in response to new price disclosure requirements set out in section 99ADH, which became effective on 1 October 2015. This amendment was necessitated to ensure that the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 remains accurate and up-to-date. The policy objective of this amendment is to enhance the efficiency and transparency of the Pharmaceutical Benefits Scheme by appropriately categorising drugs and ensuring that the scheme continues to provide the highest attainable standard of physical and mental health in accordance with international human rights obligations. This determination is a consequential amendment and does not require additional consultation as it is minor and machinery in nature.

Scope and Application

The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2015 (No. 1) is an instrument made under the National Health Act 1953, which primarily focuses on the classification and management of therapeutic groups for pharmaceutical benefits. This determination specifically amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010, adjusting the composition of therapeutic groups by removing certain drugs from their existing groups. This amendment is consequential to the implementation of price disclosure and price reduction measures under section 99ADH of the Act, effective from 1 October 2015. The amendment affects the Angiotensin II receptor antagonist group, removing the drug 'Telmisartan' from its therapeutic classification. The application of this determination is nationwide, impacting entities and individuals involved in the pharmaceutical industry and those who rely on the Pharmaceutical Benefits Scheme (PBS). No specific exclusions or thresholds are detailed in the explanatory statement, although the variation and revocation of the principal determination rely on the provisions of the Acts Interpretation Act 1901. The instrument is minor and machinery in nature, not necessitating further consultation.

Key Provisions

The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2015 (No. 1) (the Determination) is an amendment to the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 (PB 1 of 2010), and it is made under the authority of subsection 84AG(1) of the National Health Act 1953 (the Act). The primary purpose of this Determination is to adjust the classification of therapeutic groups, specifically by removing certain listed drugs from their existing groups (subsection 84AG(4)). This amendment takes effect from 1 October 2015, and it affects the ATRA group (the Angiotensin II receptor antagonist group) by removing the listed drug ‘Telmisartan’ from this group. The Determination imposes specific obligations on the parties it governs, particularly regarding the classification and management of therapeutic groups under the National Health Act. It requires that any listed drug with at least one listed brand to which section 99ADH applies be removed from its therapeutic group. This classification change is intended to align with the provisions of section 99ADH, which deals with price disclosure and price reductions. The amendment ensures that the therapeutic groups are accurately and appropriately defined in accordance with the evolving requirements of the pharmaceutical benefits scheme. Any breach of the obligations set forth in the Determination may lead to legal consequences. The Act provides for a variety of penalties and consequences for non-compliance. The specific penalties are not detailed in the Determination but generally, under the Act, non-compliance can result in civil or criminal penalties. Civil penalties can include fines, while criminal penalties can include imprisonment, depending on the severity of the breach. The maximum penalties are not explicitly stated in this Determination but are typically outlined in the relevant sections of the National Health Act. It is important for entities governed by the Act to ensure that they are compliant with the requirements of the Determination to avoid any potential legal repercussions. The Determination’s impact is limited to the reclassification of therapeutic groups, but adherence to these changes is crucial for maintaining compliance with the National Health Act. This legislative instrument is considered minor and machinery in nature, and it does not necessitate additional consultation as it is consequential to the price disclosure and price reduction measures under section 99ADH.