National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) (No. PB 33 of 2013)

Overview

The Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 33 of 2013) was enacted to update the conditions under which payments are made by the Commonwealth in respect of pharmaceutical benefits provided by approved pharmacists and approved medical practitioners. This amendment reflects changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 6) commencing on 1 June 2013. Specifically, it adds three forms of the drug Glucose Indicator―Blood to Schedule 4 of the Principal Determination. The policy objective of this amendment is to ensure that the Pharmaceutical Benefits Scheme (PBS) provides reliable, timely, and affordable access to a wide range of medicines for all Australians, which aligns with the broader goal of advancing the right to the highest attainable standard of physical and mental health. The determination was made by the Minister, informed by recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body representing various interests including consumers, health economists, and medical professionals. This legislative instrument is compatible with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), as it supports the progressive realisation of the right to health by ensuring access to necessary medications through the PBS.

Scope and Application

This legislative instrument, the Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 33 of 2013), amends the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The changes reflect modifications to the Pharmaceutical Benefits Schedule that were enacted by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 6), effective from 1 June 2013. Specifically, the Amendment Determination updates Schedule 4 of the Principal Determination to include three new forms of the drug Glucose Indicator―Blood: test strips, 100 (TRUEbalance); test strips, 100 (TRUEresult); and test strips, 100 (TRUEtrack). These amendments ensure that the conditions for Commonwealth payments are aligned with the most current listings on the Pharmaceutical Benefits Schedule. The instrument applies nationally and is part of the broader legislative framework under the National Health Act 1953, which governs the Pharmaceutical Benefits Scheme (PBS). The legislative instrument also confirms compatibility with human rights, particularly through advancing access to affordable medicines as part of the right to the highest attainable standard of physical and mental health.

Key Provisions

The main operative sections of this legislative instrument are found in the Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 33 of 2013). This Amendment Determination amends Schedule 4 of the Principal Determination (PB 119 of 2008) to incorporate the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 6), which commenced on 1 June 2013. Specifically, this Amendment Determination adds three forms of the drug Glucose Indicator―Blood, namely test strips, 100 (TRUEbalance), test strips, 100 (TRUEresult), and test strips, 100 (TRUEtrack), to the list of pharmaceutical benefits eligible for Commonwealth payments. The obligations and requirements imposed by the Act on the parties it governs include adherence to the conditions set out in the Amendment Determination. Approved pharmacists and approved medical practitioners must comply with these conditions to be eligible for payments under the Pharmaceutical Benefits Scheme (PBS). The conditions pertain to the supply of pharmaceutical benefits and ensure that the PBS operates effectively, providing reliable and affordable access to medicines for Australians. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in recommending changes to the Minister, who then determines the conditions for payments. The PBS is designed to ensure that decisions about which medicines are subsidised are evidence-based and reflect the highest attainable standard of physical and mental health. The legislative instrument also outlines potential consequences for breaches. While specific offences and penalties are not detailed in the provided text, breaches of conditions under the National Health Act 1953 could lead to civil or criminal consequences. The severity of these consequences would depend on the nature and extent of the breach, as well as any applicable penalties prescribed by the Act. The compatibility statement indicates that this legislative instrument aligns with human rights, particularly by advancing the right to the highest attainable standard of health through the PBS. In summary, the Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 33 of 2013) modifies the conditions for Commonwealth payments regarding pharmaceutical benefits, specifically adding three forms of Glucose Indicator―Blood to the list of eligible drugs. The Act imposes clear obligations on approved pharmacists and approved medical practitioners to comply with these conditions to receive payments. While the specific penalties for non-compliance are not detailed, adherence to the conditions is crucial for the proper functioning of the PBS and the protection of human rights related to health.