National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 7) (PB 70 of 2015)

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 7) (PB 70 of 2015) is an amendment to the National Health Act 1953, enacted to align the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners with recent changes made to the listing of pharmaceutical benefits. The amendment, which came into effect on 1 August 2015, was introduced by the Commonwealth Minister for Health, with the intention of ensuring the Pharmaceutical Benefits Scheme (PBS) continues to provide reliable, timely, and affordable access to a range of essential medicines. This legislative instrument adds specific forms of glucose indicator test strips, and testosterone in the forms of transdermal cream and gel to Schedule 4 of the Principal Determination. The amendments were developed in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body that advises the Minister on which medicines should be subsidised under the PBS. The policy objective of this legislative instrument is to progressively realise the right of everyone to the highest attainable standard of physical and mental health, as recognised under Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The PBS plays a crucial role in advancing this objective by providing subsidised access to necessary medicines. The decision-making process, overseen by the PBAC, ensures that the inclusion of new pharmaceutical benefits on the PBS is evidence-based and aligns with the overarching goal of improving public health outcomes.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 7) pertains to 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. This legislative instrument amends the Principal Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008) to incorporate changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 7), which commenced on 1 August 2015. The amendment adds three new pharmaceutical products to Schedule 4 of the Principal Instrument, namely glucose indicator—blood in the form test strips, 100 (Betachek C50), testosterone in the form of transdermal cream 50 mg per mL, 50 mL, and testosterone in the form of transdermal gel (pump pack) 12.5 mg per 1.25 g dose, 60 doses. The instrument also revokes or varies PB 119 of 2008 unless there is an express power to do so. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended these changes to the Minister who has determined the changes to the conditions under paragraph 98C(1)(b) as per this Determination. This legislative instrument is compatible with human rights as it engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

Key Provisions

The primary sections of the National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 7) (PB 70 of 2015) amend the existing determination under the National Health Act 1953 to reflect the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 7). Specifically, section 3 of the Amendment introduces new pharmaceutical products to the list of those covered by the Pharmaceutical Benefits Scheme (PBS). These additions include glucose indicator—blood in the form test strips, 100 (Betachek C50), testosterone in the form of transdermal cream 50 mg per mL, 50 mL, and testosterone in the form of transdermal gel (pump pack) 12.5 mg per 1.25 g dose, 60 doses. These changes will be incorporated into Schedule 4 of the Principal Determination, thus altering the conditions under which payments will be made by the Commonwealth for these pharmaceutical benefits. The Amendment imposes specific obligations on approved pharmacists and approved medical practitioners by expanding the list of pharmaceutical benefits that are eligible for Commonwealth payments under the PBS. These healthcare providers must now ensure they are aware of the new additions to Schedule 4 and comply with the updated conditions for making claims for payments. The changes require them to be knowledgeable about the new forms of pharmaceutical benefits and adhere to the updated criteria set forth by the Minister. Additionally, the Amendment ensures that the Pharmaceutical Benefits Advisory Committee (PBAC) continues to play a key role in recommending changes to the Minister, thus maintaining the integrity and evidence-based approach of the PBS. In terms of consequences for non-compliance, the Amendment itself does not explicitly outline specific offences, penalties, or civil/criminal consequences for breach. However, under the broader legislative framework of the National Health Act 1953, there are general provisions that apply. For instance, if approved pharmacists or approved medical practitioners do not comply with the updated conditions, they may face administrative actions such as fines or other sanctions as determined by the Minister. Additionally, there could be implications for the funding and reimbursement processes, potentially leading to financial losses or penalties for non-compliance with the new conditions. The precise penalties would depend on the specific nature and severity of the breach, in accordance with the existing provisions of the National Health Act 1953 and related regulations.