National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 3) (PB 31 of 2018)

Overview

The National Health Act 1953 is the foundational legislation for the Pharmaceutical Benefits Scheme (PBS) in Australia, providing reliable, timely, and affordable access to a broad range of medicines for all Australians. This Act allows the Minister to determine the conditions under which payments are made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 3) (PB 31 of 2018) amends the original determination to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 5), which took effect on 1 May 2018. This amendment was made to ensure that the PBS conditions remain aligned with current therapeutic needs and evidence-based recommendations. The changes involved the deletion of risedronic acid and calcium with colecalciferol from Schedule 4 of the Principal Determination, reflecting decisions made through consultations with the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent committee comprising members from various relevant interests and professions, recommends which medicines should be subsidised, ensuring the PBS remains effective and responsive to public health needs.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 3) (PB 31 of 2018) amends the conditions governing payments made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners under the National Health Act 1953. The Act applies to approved pharmacists and medical practitioners, and to pharmaceutical benefits that they supply. The Amendment 2018 specifically targets the conditions under which Commonwealth payments are made for these benefits, modifying the Principal Determination (PB 119 of 2008) to reflect the changes enacted by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 5), effective from 1 May 2018. This Amendment removes one pharmaceutical item from Schedule 4 of the Principal Determination. The changes apply nationally, as the Pharmaceutical Benefits Scheme (PBS) is a Commonwealth initiative designed to ensure affordable access to a range of medicines for all Australians. The instrument does not specify exclusions, exemptions, or thresholds, but it does rely on the Acts Interpretation Act 1901 for the power to revoke or vary the Principal Determination unless expressly stated otherwise. This legislative instrument aligns with human rights by facilitating access to the highest attainable standard of health, as recognised in the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 3) (PB 31 of 2018) amends the existing National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 (the Act) (PB 119 of 2008) (Principal Determination). Specifically, it modifies the conditions for payments made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This change is prompted by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 5) which came into effect on 1 May 2018. Under these amendments, Schedule 4 of the Principal Determination is updated to remove certain pharmaceutical items, namely risedronic acid and calcium with colecalciferol (sections 3 and 4). The determination imposes specific obligations on approved pharmacists and approved medical practitioners. These professionals must comply with the updated conditions set forth in the Amendment Determination to be eligible for Commonwealth payments for the supply of pharmaceutical benefits. The changes in the legislation require these practitioners to adhere to the new list of approved pharmaceutical items for which they can claim payments. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on which medicines should be subsidised, ensuring that decisions are evidence-based and consider various stakeholder interests (section 4). Breaches of the conditions specified in the Amendment Determination can lead to various consequences. For instance, if approved pharmacists or approved medical practitioners do not comply with the new conditions, they may not be eligible to receive payments for the supply of certain pharmaceutical benefits. The Act does not explicitly outline specific penalties for non-compliance, but it can be inferred that failure to adhere to the conditions might result in the denial of payments for the pharmaceutical items that are no longer listed or approved under the updated conditions (section 3). The overarching aim is to ensure that the Pharmaceutical Benefits Scheme remains effective in providing affordable access to essential medications for all Australians. The Amendment Determination is designed to engage with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), by facilitating the progressive realisation of the right to the highest attainable standard of physical and mental health. By providing subsidised access to medicines through the PBS, the Amendment Determination supports the broader objective of ensuring equitable health outcomes for all Australians (section 7). The involvement of the PBAC in recommending changes to the Minister further ensures that the decisions are well-grounded in evidence and stakeholder input, thereby upholding human rights standards. In summary, the National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 3) updates the conditions for Commonwealth payments related to the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. It imposes obligations on these professionals to comply with the new conditions to remain eligible for payments. While the Act does not specify explicit penalties for non-compliance, the primary consequence would be the denial of payments for the pharmaceutical items no longer listed under the updated conditions. The Amendment Determination is compatible with human rights as it supports the progressive realisation of the right to health by providing affordable access to essential medications.