Amendment Determination under section 84AH of the National Health Act 1953 (2014) (No. 2) (No. PB 33 of 2014)

Overview

The Amendment Determination under section 84AH of the National Health Act 1953 (2014) (No. 2) (PB 33 of 2014) was enacted to update the list of pharmaceutical items exempt from certain provisions of the National Health Act 1953, specifically to remove a particular drug from the list of exempt items due to its delisting from the Pharmaceutical Benefits Scheme (PBS). The determination was made by the Minister for Health under the authority provided by section 84AH of the Act, which allows for the exclusion of certain pharmaceutical items from statutory price reductions and price disclosure requirements if they meet specified criteria. The purpose of these criteria is to encourage the availability of pharmaceutical items with particular formulations that are suitable for specific patient subgroups for whom other formulations may not be suitable. The instrument reflects changes to the PBS and ensures the list of exempt items remains accurate and relevant. It was developed in consultation with pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises on the suitability of pharmaceutical items for particular patient subgroups. This legislative instrument aligns with human rights by promoting access to affordable medicines, which is essential for the enjoyment of the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights. The PBS, supported by the expert advice of PBAC, ensures that decisions about which medicines are subsidised are evidence-based, furthering the protection and realisation of human rights in Australia.

Scope and Application

The Amendment Determination under Section 84AH of the National Health Act 1953 (2014) (No. 2) pertains to modifications of the legislative instrument that establishes exemptions for certain pharmaceutical items under the Pharmaceutical Benefits Scheme (PBS). This instrument operates within the jurisdiction of the Commonwealth of Australia and applies to pharmaceutical items listed on the PBS, specifically those meeting the criteria for being designated as 'exempt items'. These criteria include the pharmaceutical item having a single listed brand, no bioequivalent or biosimilar alternatives, and specific suitability for a particular patient subgroup based on form and manner of administration. The amendment primarily affects pharmaceutical companies and stakeholders involved in the PBS by altering the list of exempt items, in this case by removing verapamil injection from the exempt list due to its delisting from the PBS effective 1 October 2012. The instrument commenced on 1 May 2014 and can be revoked or varied under the provisions of the Acts Interpretation Act 1901. The Pharmaceutical Benefits Advisory Committee (PBAC) was consulted during the development of this instrument, ensuring that decisions are evidence-based and align with human rights obligations as recognised under the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The primary sections of this legislative instrument are those that amend the existing Determination under section 84AH of the National Health Act 1953 (PB 58 of 2007) to update the list of pharmaceutical items deemed exempt under the Pharmaceutical Benefits Scheme (PBS). Section 84AH of the National Health Act 1953 stipulates the criteria for a pharmaceutical item to be considered an exempt item. The main change introduced by this instrument is the removal of one specific pharmaceutical item from the list of exempt items because it has been delisted from the PBS effective from 1 October 2012. The obligations imposed by the Act on the parties and entities it governs include the determination of pharmaceutical items that qualify for exempt status under the PBS, as outlined in section 84AH. This process involves assessing whether the pharmaceutical item meets specific criteria, such as having a single listed brand, no bioequivalent or biosimilar listed brands, and the availability of other pharmaceutical items with the same listed drug. Pharmaceutical companies with medicines listed on the PBS are required to comply with these determinations and ensure their products meet the criteria if they wish to be included on the PBS or exempt lists. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on the suitability of pharmaceutical items for specific patient populations, which is a critical part of the determination process. Breaches of the provisions outlined in this legislative instrument could result in significant consequences. While the instrument itself does not explicitly detail specific offences, penalties, or consequences for non-compliance, it is implied that any failure to adhere to the criteria for exempt items or to comply with the determinations made by the Minister could lead to exclusion from the PBS. This exclusion could have substantial implications for pharmaceutical companies, including loss of access to a significant market and potential financial losses. Furthermore, non-compliance with the Act's requirements could potentially lead to legal actions or penalties as stipulated in the broader legislative framework of the National Health Act 1953.