Amendment Determination under section 84AH of the National Health Act 1953 (2016) (No. 1) (PB 25 of 2016)

Overview

The National Health Act 1953, enacted by the Australian Parliament, provides the legislative basis for the Pharmaceutical Benefits Scheme (PBS) which ensures Australians have reliable, timely, and affordable access to a wide range of medicines. This Act empowers the Minister for Health to determine which pharmaceutical items are exempt from statutory price reductions and price disclosure requirements, if certain criteria are met. The 2016 Amendment Determination under section 84AH of the National Health Act 1953 (No. 1) modifies the criteria for pharmaceutical items to be exempt, specifically addressing the suitability of certain drugs for particular patient populations due to their form and manner of administration. The policy objective of this amendment is to encourage the availability of specific pharmaceutical formulations that are better suited to certain demographic subgroups, such as children or geriatric patients, for whom other formulations may not be suitable. The determination affects pharmaceutical companies with medicines listed on the PBS and involves consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises on the suitability of pharmaceutical items for particular subgroups. The 2016 Amendment Determination removes Baclofen (in the form of an intrathecal injection) from the list of exempt items and adds Hydromorphone (in the form of an oral liquid) to the exempt list. This legislative instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring access to suitable pharmaceutical formulations for specific patient populations, in line with the International Covenant on Economic, Social and Cultural Rights. The PBS, through its recommended decisions by PBAC, ensures that access to these medicines is evidence-based, thereby advancing human rights by facilitating better health outcomes for Australians.

Scope and Application

The National Health Act 1953 Amendment Determination under section 84AH of the National Health Act 1953 (2016) (No. 1) amends the determination of pharmaceutical items that are exempt from certain statutory price reductions and price disclosure requirements under the Pharmaceutical Benefits Scheme (PBS). This legislative instrument applies to pharmaceutical items listed under the Act, specifically targeting the forms and manners of administration of listed drugs. It applies across the Commonwealth of Australia, impacting pharmaceutical companies with medicines listed on the PBS. The Minister for Health has the authority to determine which pharmaceutical items meet the criteria for exemption, based on advice from the Pharmaceutical Benefits Advisory Committee (PBAC). The criteria for exemption include the uniqueness of the listed brand, the absence of bioequivalent or biosimilar brands, and the suitability of the pharmaceutical item for a specific patient population due to its form and manner of administration. This instrument removes the specified form of the drug baclofen from the exempt list and determines the specified form of the drug hydromorphone to be an exempt item, effective from 1 April 2016. This change is intended to refine the availability and accessibility of certain pharmaceutical items that are particularly suited for specific demographic subgroups.

Key Provisions

The main operative sections of this legislative instrument are section 84AH of the National Health Act 1953 (the Act), which outlines the criteria for determining whether a pharmaceutical item is an 'exempt item'. This instrument also references subsections 85(2), (3), (5), and (6) of the Act, which deal with the declaration and determination of listed drugs, their forms, and the manner of administration, as well as the determination of brands of pharmaceutical items. The primary purpose of this instrument is to amend the determination under section 84AH of the Act by changing the pharmaceutical items that are determined to be exempt items (paragraphs 4 and 5). The Act imposes several obligations on the parties it governs, primarily the Minister for Health and pharmaceutical companies. The Minister must ensure that pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) meet the criteria outlined in section 84AH of the Act for being deemed an exempt item. Pharmaceutical companies must comply with the determinations made by the Minister regarding the listing, form, and manner of administration of pharmaceutical items on the PBS. These companies must also adhere to any changes made to the exempt list as per this legislative instrument. In terms of breaches and penalties, the Act does not explicitly detail offences, penalties, or consequences for non-compliance with the determinations under section 84AH. However, the overarching legal framework of the National Health Act 1953 would apply, potentially involving civil or administrative penalties for non-compliance with health regulations. The specific penalties would depend on the nature and severity of the breach, as well as any additional provisions under the Act or related legislation. The instrument provides a detailed process for consultation with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC). This ensures that determinations regarding exempt items are evidence-based and consider the suitability of pharmaceutical items for particular patient populations. The legislative instrument also complies with human rights obligations by facilitating access to necessary medications, thereby supporting the right to the highest attainable standard of physical and mental health as per international covenants.