National Health (Pharmaceutical Benefits - Therapeutic Groups) Amendment Determination 2013 (No. 2) (No. PB 7 of 2013)

Overview

The National Health Act 1953 was enacted to provide a framework for the administration of health services and benefits in Australia. The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 2) was introduced to address the gap in the Pharmaceutical Benefits Scheme (PBS) concerning the classification and pricing of therapeutic drugs. This amendment, made under subsection 84AG(1) of the National Health Act, was created to align with changes in pricing mechanisms, particularly the application of section 99ADH which mandates price disclosure and price reductions for certain listed drugs. The amendment removes specific drugs, such as 'Cimetidine' and 'Ranitidine', from their designated therapeutic groups, reflecting their updated market status and ensuring consistency with the legislative requirements for the PBS. This legislative instrument aims to maintain the integrity of the PBS by ensuring that therapeutic classifications remain accurate and reflective of current market conditions.

Scope and Application

The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 2) operates within the framework of the National Health Act 1953, focusing on the classification and management of therapeutic groups for pharmaceutical benefits. This legislation applies to the Minister for Health who has the authority to determine therapeutic groups and the listed drugs within those groups. The amendment specifically targets the removal of certain drugs from their respective therapeutic groups, effective from 1 April 2013, based on the applicability of price disclosure price reductions under section 99ADH. The determination modifies the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 by removing 'Cimetidine' and 'Ranitidine' from the H2 receptor antagonist group. The scope of this legislation is national, applying across Australia as it pertains to the Pharmaceutical Benefits Scheme (PBS), which is a Commonwealth initiative. No exclusions or exemptions are noted within the text of this specific instrument, though broader exclusions and exemptions may apply under the overarching National Health Act 1953. The instrument is effective from its commencement date of 1 April 2013 and operates as a legislative instrument under the Legislative Instruments Act 2003.

Key Provisions

The main sections of the National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 2) pertain to the amendment of the therapeutic groups under the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 (subsection 84AG(1)). This amendment is specifically concerned with removing certain listed drugs from their designated therapeutic groups effective 1 April 2013. This is done to align with the provisions of section 99ADH, which addresses price disclosure and price reductions. More specifically, the determination removes 'Cimetidine' and 'Ranitidine' from the H2 receptor antagonist group (Part 4 of Schedule 1 to the Principal Determination). This change is effective from the date the legislative instrument commences, which is 1 April 2013. The Act imposes several obligations and requirements on the parties involved. Firstly, it mandates that the Minister make determinations regarding therapeutic groups and the classification of listed drugs within those groups (subsection 84AG(1)). Secondly, it requires the alignment of these determinations with the requirements set out in section 99ADH, which necessitates the removal of certain drugs from their therapeutic groups. Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) has a recommendatory role, ensuring that decisions about subsidised access to medicines on the Pharmaceutical Benefits Scheme (PBS) are evidence-based and in line with the progressive realisation of the right to health (Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights). The determination does not explicitly outline specific offences or penalties for non-compliance with its provisions. However, the broader framework of the National Health Act 1953 does include provisions for penalties in the event of non-compliance with its requirements. For example, breaches of the Act could result in fines or other civil and criminal penalties as prescribed by the legislation. The determination itself, being a minor and machinery-based instrument, does not introduce new offences but rather modifies existing provisions in accordance with the legislative authority provided under the Act. This legislative instrument is compatible with the human rights and freedoms recognised or declared in international instruments such as the International Covenant on Economic, Social and Cultural Rights. By ensuring that the PBS provides subsidised access to medicines, the Act assists with the progressive realisation of the right to the highest attainable standard of physical and mental health. The involvement of the PBAC in decision-making processes ensures that these decisions are evidence-based, thereby upholding the principles of human rights in the context of healthcare provision.