National Health (Pharmaceutical Benefits - Therapeutic Groups) Amendment Determination 2014 (No. 2) (PB 80 of 2014)

Overview

The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2014 (No. 2) was enacted in 2014 under the authority of the National Health Act 1953. This amendment was introduced to align the therapeutic groups of listed drugs under the Pharmaceutical Benefits Scheme (PBS) with changes in pricing and disclosure regulations, specifically those pertaining to price reductions effective from 1 October 2014. This instrument was made by the Minister for Health in accordance with the provisions of the National Health Act 1953, specifically subsection 84AG(1) which allows for the determination of therapeutic groups and the classification of drugs within those groups. The policy objective is to ensure that the PBS continues to provide affordable access to necessary medications while adapting to new regulatory requirements. This amendment removes certain drugs from their respective therapeutic groups due to the application of section 99ADH, which deals with price disclosure and price reductions, from 1 October 2014. Specifically, 'Candesartan' and 'Irbesartan' were removed from the ATRA group, and 'Rosuvastatin' was removed from the Statins-HP group. Consequently, the Statins-HP group was also dissolved as it no longer contained any listed drugs. This amendment is effective from 1 October 2014, and it ensures that the PBS remains compliant with updated pricing regulations while maintaining access to essential medications.

Scope and Application

The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2014 (No. 2) applies to entities and individuals involved in the pharmaceutical benefits scheme under the National Health Act 1953, specifically targeting the therapeutic groups and listed drugs that are part of the Pharmaceutical Benefits Scheme (PBS). This legislative instrument pertains to the removal of certain drugs from their respective therapeutic groups based on the application of section 99ADH, which concerns price disclosure and price reductions. This amendment affects the classification of drugs such as Candesartan, Irbesartan, and Rosuvastatin, altering their therapeutic groupings and impacting their eligibility for certain benefits under the PBS. The amendment is effective from 1 October 2014 and revokes the Statins-HP group due to the absence of any remaining listed drugs in that category. The application of this determination is national in scope, extending across all jurisdictions in Australia as it modifies the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010. This legislative instrument does not specify any exclusions or thresholds but operates under the broader authority provided by the National Health Act 1953.

Key Provisions

The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2014 (No. 2) (F2014L01310) amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 (PB 1 of 2010) by removing certain drugs from their respective therapeutic groups. Specifically, under section 84AG(1) of the National Health Act 1953, the Minister has the authority to determine therapeutic groups and classify drugs within these groups. This amending instrument, effective from 1 October 2014, removes 'Candesartan' and 'Irbesartan' from the ATRA group (the Angiotensin II receptor antagonist group), and 'Rosuvastatin' from the Statins-HP group (the HMG Co-A reductase inhibitor higher potency group) (sections 2 and 7 of Schedule 1). Furthermore, it removes the entire Statins-HP group as it no longer contains any listed drugs (section 84AG(5) of the Act). Entities governed by this Act, including pharmaceutical companies, healthcare providers, and patients, must comply with the changes by recognising the updated classification of the drugs. Pharmaceutical companies must adjust their pricing strategies as per the new classification, while healthcare providers must ensure they are prescribing the correct drugs according to the updated therapeutic groups. Patients should be informed about any changes in their medication classifications and potential impacts on their treatment. Failure to comply with the amendments may result in civil or criminal penalties, although the specific consequences are not detailed in the Act. Generally, penalties for non-compliance with health regulations can include fines and legal action. The exact penalties would depend on the nature and severity of the breach, as well as any applicable regulations or statutes. The instrument also ensures compatibility with human rights by engaging with Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). It assists in the progressive realisation of the right to the highest attainable standard of physical and mental health by providing for subsidised access to medicines through the Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines are evidence-based, thereby upholding human rights by facilitating access to necessary healthcare.