National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 6) (PB 56 of 2015)

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 6) (PB 56 of 2015) was enacted to align the conditions for Commonwealth payments concerning the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners with the changes introduced by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 6). This amendment was made under the authority of paragraph 98C(1)(b) of the National Health Act 1953, which empowers the Minister to determine such conditions. The policy objective behind these amendments is to ensure that the Pharmaceutical Benefits Scheme (PBS) remains effective and aligned with current medical needs and evidence-based practices, facilitated by recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent committee comprising members from various healthcare sectors, provides recommendations to the Minister, who then determines the necessary changes. This legislative instrument is compatible with human rights as it contributes to 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.

Scope and Application

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 6) amends the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953, which governs the conditions for Commonwealth payments regarding the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This Amendment Determination reflects changes made to the Principal Determination, which sets out the conditions for such payments. Specifically, the Amendment Determination removes glucose indicator—blood in the form test strips, 100 (Accu-Chek Advantage/Sensor Comfort) from Schedule 4 of the Principal Determination. The changes take effect from 1 July 2015 and are aligned with the objectives of the Pharmaceutical Benefits Scheme (PBS) to provide affordable access to a wide range of medicines for Australians. The determination applies nationally across Australia, impacting approved pharmacists and medical practitioners who supply pharmaceutical benefits. This legislative instrument is compatible with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights, by facilitating access to subsidised medicines, thereby supporting the highest attainable standard of physical and mental health.

Key Provisions

The main operative sections of this legislative instrument (paragraph 98C(1)(b) of the National Health Act 1953) pertain to the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This amendment determination (F2015L01065) modifies the Principal Determination (PB 119 of 2008) to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 6), which commenced on 1 July 2015. Specifically, the amendment involves the removal of glucose indicator—blood in the form test strips, 100 (Accu-Chek Advantage/Sensor Comfort) from Schedule 4 of the Principal Determination. The Act imposes several obligations and requirements on the parties and entities it governs. Firstly, it mandates that payments for pharmaceutical benefits will only be made under the conditions specified in the determination. Approved pharmacists and medical practitioners must comply with these conditions to receive Commonwealth payments. This includes adhering to the criteria for the supply of pharmaceutical benefits, which are outlined in Schedule 4 of the Principal Determination. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending changes to these conditions based on evidence and expert opinions, ensuring that decisions about which medicines are subsidised are grounded in thorough analysis and stakeholder input. Failure to comply with the conditions specified in the Act can result in various consequences. There are no explicit offences or penalties mentioned in the text, but non-compliance with the stipulated conditions for receiving payments could lead to the withholding of payments by the Commonwealth. This financial disincentive underscores the importance of adhering to the requirements set forth in the Act. Additionally, entities involved in the supply of pharmaceutical benefits are expected to maintain records and documentation that attest to their compliance with the conditions, which could be subject to review or audit by the relevant authorities. 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, as recognised in Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). By providing subsidised access to medicines through the Pharmaceutical Benefits Scheme (PBS), the Act contributes to the advancement of this human right. The involvement of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about which medicines are subsidised are evidence-based, further protecting and promoting the right to health.