Amendment Determination under section 84AH of the National Health Act 1953 (2017) (No. 1) (PB 10 of 2017)

Overview

The National Health Act 1953 was enacted to establish the framework for the provision of healthcare services in Australia. This legislation addresses the need to ensure the availability of reliable, timely, and affordable access to a wide range of medicines for all Australians through the Pharmaceutical Benefits Scheme (PBS). The PBS is the legislative basis for providing these medicines and is administered by the Minister for Health, who has the authority to declare drugs and medicinal preparations as pharmaceutical items and to determine their form and manner of administration. Additionally, the Minister can determine certain pharmaceutical items as exempt, ensuring that specific formulations are available for particular patient populations where other formulations are not suitable. The Amendment Determination under section 84AH of the National Health Act 1953 (2017) (No. 1) was introduced by the Parliament of Australia to make changes to the pharmaceutical items that are exempt from statutory price reductions and price disclosure requirements, thus ensuring that suitable therapeutic options remain accessible to specific subgroups within the population. This legislative instrument engages with Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by supporting the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The PBS, as part of the National Health Act, facilitates this by providing subsidised access to medicines. The role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions regarding access to medicines on the PBS are evidence-based, thereby protecting and promoting human rights through the availability of clinically important medicines.

Scope and Application

The National Health Act 1953 Amendment Determination under Section 84AH (2017) (No. 1) serves to modify the pharmaceutical items that are designated as exempt items under the Act. This legislative instrument applies to pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS), which is overseen by the Commonwealth and provides subsidised access to a variety of medicines for Australians. The amendment specifically determines the form of the drug voriconazole (Powder for oral suspension 40 mg per mL, 70 mL, administered orally) as an exempt item, thereby excluding it from statutory price reductions and price disclosure requirements under Division 3A and 3B of Part VII of the Act. This exemption is intended to facilitate the availability of certain pharmaceutical items with specific formulations suitable for particular patient subgroups, such as children or geriatric patients, for whom other formulations may not be appropriate. The instrument commenced on 1 February 2017 and constitutes a legislative instrument under the Legislation Act 2003. The changes made by this instrument affect only those pharmaceutical items meeting the specific criteria outlined in section 84AH of the Act.

Key Provisions

The National Health Act 1953 (the Act) is the foundation for the Pharmaceutical Benefits Scheme (PBS), through which the Commonwealth ensures Australians have reliable, timely, and affordable access to a wide range of medicines. Section 84AH of the Act empowers the Minister to determine, by legislative instrument, that a pharmaceutical item is an 'exempt item' if it meets specific criteria. The Amendment Determination under section 84AH of the National Health Act 1953 (2017) (No. 1) (PB 10 of 2017) amends the principal determination to include the specified form of the drug voriconazole as an exempt item. The criteria for an exempt item include having only one listed brand, no bioequivalent or biosimilar listed brands, and at least one other pharmaceutical item with the same listed drug. Additionally, the Minister must be satisfied that the listed drug represents suitable therapy for a particular patient population, the relevant pharmaceutical item is suitable for use by a particular subgroup of that population because of the form and manner of administration, and no other pharmaceutical item with that drug is suitable for use by that subgroup for the same reasons. The obligations and requirements imposed by this Act on the parties it governs include the declaration of drugs and medicinal preparations by the Minister, determination of the form and manner of administration of pharmaceutical items, and the inclusion of pharmaceutical items on the exempt list if they meet the specified criteria. Pharmaceutical companies with medicines listed on the PBS are directly affected by this instrument, as it governs the availability and pricing of their products. The Pharmaceutical Benefits Advisory Committee (PBAC) provides advice to the Minister regarding the suitability of pharmaceutical items for particular sub-groups, ensuring evidence-based decision-making. The Minister must also consult with relevant parties, such as pharmaceutical companies, during the policy development and implementation phases. Breaches of the Act may lead to civil or criminal consequences, depending on the nature and severity of the violation. While specific penalties are not outlined in the text, general penalties for breaches of Commonwealth legislation can include fines, imprisonment, or both. The exact penalties depend on the specific provision breached and the circumstances of the offence. The Act ensures that human rights are protected by maintaining exemptions from pricing reductions only where appropriate under the legislation, thereby safeguarding access to essential medicines.