Amendment Determination under section 84AH of the National Health Act 1953 (2014) (No. 4) (No. PB 77 of 2014)

Overview

The National Health Act 1953, amended by the Amendment Determination under section 84AH of the National Health Act 1953 (2014) (No. 4), addresses the need to regulate pharmaceutical items listed under the Pharmaceutical Benefits Scheme (PBS), particularly by determining which items qualify as exempt items. Enacted by the Parliament of Australia, this legislative instrument aims to enhance access to suitable medications for specific patient populations, ensuring that certain formulations of drugs are available to those for whom other forms are unsuitable. The Minister for Health, empowered under section 84AH of the Act, makes determinations based on criteria such as the uniqueness of the listed brand and suitability for specific patient subgroups, ensuring that these items are excluded from statutory price reductions and price disclosure requirements. This approach aims to balance the need for affordable access to medicines with the necessity of providing appropriate formulations for diverse patient needs. The Amendment Determination under section 84AH of the National Health Act 1953 (2014) (No. 4) specifically adjusts the list of exempt items by including a particular form of the drug oxycodone, thus refining the scheme to better cater to the health needs of certain patient demographics. This legislative change was informed by consultations with pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the amendments are evidence-based and aligned with the broader objective of the PBS to provide reliable, timely, and affordable access to medicines. This instrument, which commenced on 1 October 2014, represents a legislative effort to progressively realise the human right to the highest attainable standard of physical and mental health, as recognised under international human rights instruments.

Scope and Application

The Amendment Determination under section 84AH of the National Health Act 1953 (2014) (No. 4) pertains to the Pharmaceutical Benefits Scheme (PBS) and is concerned with the regulation of pharmaceutical items listed under the scheme. The Act applies to pharmaceutical companies whose products are listed on the PBS, and it involves the Minister for Health determining certain pharmaceutical items to be exempt from statutory price reductions and price disclosure requirements. This is achieved by amending the principal instrument which allocates drugs to the exempt list based on specific criteria. The determination ensures that certain pharmaceutical items, particularly those with unique formulations suitable for particular patient populations, remain available at prices that are appropriate for their intended use. The instrument has a national reach, as it is enacted under Commonwealth legislation. There are no specific exclusions mentioned, but the criteria for exemption are stringent, ensuring that only those pharmaceutical items meeting the specified conditions are exempt. The instrument also extends its application through subordinate instruments, allowing for further amendments to the list of exempt items as needed. The instrument commenced on 1 October 2014 and is considered a legislative instrument under the Legislative Instruments Act 2003.

Key Provisions

The main operative sections of this legislative instrument (PB 77 of 2014) pertain to the amendments made under section 84AH of the National Health Act 1953 (the Act). This section empowers the Minister to determine, by legislative instrument, that a pharmaceutical item is an ‘exempt item’ if it meets specific criteria outlined in section 84AH. The primary change introduced by this instrument is the determination of a specific form of the drug oxycodone as an exempt item (subsection 84AH(a)-(d)). This decision is based on advice from the Pharmaceutical Benefits Advisory Committee (PBAC) and ensures that the drug is suitable for a particular patient population and subgroup due to its form and manner of administration. The effect of this determination is that the listed brand of the pharmaceutical item is exempt from statutory price reductions and price disclosure requirements under Division 3A and 3B of Part VII of the Act. The Act imposes several obligations and requirements on the parties it governs. Pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS) must comply with the criteria set out in section 84AH for determining exempt items. They must also provide the necessary information and advice to the Minister and the PBAC to facilitate the determination of exempt items. The Minister, in turn, must consider the advice from the PBAC and make the determination in accordance with the criteria specified in section 84AH. Additionally, the Minister must ensure that the determination is made in a manner that is compatible with human rights, as required by the Human Rights (Parliamentary Scrutiny) Act 2011. Breach of the obligations and requirements imposed by the Act may result in civil or criminal consequences. However, the specific offences, penalties, or consequences for breach are not explicitly stated in the instrument. The maximum penalties for contraventions of the Act would be determined by the relevant legislation governing the enforcement of the Act. It is important for parties subject to the Act to comply with its requirements to avoid any potential penalties or consequences. In summary, this legislative instrument amends the principal instrument under section 84AH of the National Health Act 1953 by determining a specific form of the drug oxycodone as an exempt item. The instrument imposes obligations and requirements on pharmaceutical companies and the Minister to ensure the determination of exempt items is made in accordance with the criteria specified in section 84AH. Compliance with the Act is essential to avoid potential penalties or consequences for breach.