National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) - conditions (No. PB 131 of 2009)

Overview

The National Health Act 1953, as amended by the determination under paragraph 98C(1)(b), addresses the need to ensure that Australians have reliable, timely, and affordable access to a wide range of medicines through the Pharmaceutical Benefits Scheme (PBS). Enacted by the Parliament of Australia, this Act allows the Minister for Health to determine the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. This legislative instrument was introduced to amend the existing conditions, effective from 1 February 2010, by adding new pharmaceutical forms and removing others from the list of PBS-subsidised drugs, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee and ensuring the scheme remains current and effective in meeting the health needs of the population.

Scope and Application

The National Health Act 1953, as amended by legislative instrument PB 131 of 2009, governs the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to reliable, timely, and affordable medicines. The Act applies to the Commonwealth, providing benefits for pharmaceutical items declared by the Minister. These items are listed drugs determined by legislative instruments, with the Minister also determining the form and manner of administration of these drugs, as well as responsible persons for pharmaceutical brands. The Act extends its reach by allowing the Minister to set conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The instrument PB 131 of 2009, which came into effect on 1 February 2010, amends the previous determination under section 98C(1)(b) made by legislative instrument PB 119 of 2008. The changes include the addition of a new form of hydromorphone and the deletion of silver sulfadiazine with chlorhexidine from the list of drugs. These amendments reflect the ongoing process of review and adjustment of the PBS, ensuring it remains effective and relevant to the health needs of the Australian population.

Key Provisions

The main operative sections of the National Health Act 1953 Amendment Determination under paragraph 98C(1)(b) (F2010L00104) concern the amendments made to the Pharmaceutical Benefits Scheme (PBS). Specifically, section 85(1) establishes the legislative basis for the PBS, providing for the Commonwealth to offer reliable, timely, and affordable access to a wide range of medicines for all Australians. Under this section, the Minister is empowered to declare by legislative instrument the drugs and medicinal preparations that will be listed under the PBS, as per subsection 85(2). Additionally, the Minister can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit, or otherwise, as per subsection 85(3). Furthermore, the Minister can specify the manner of administration of the form of the listed drug, as per subsection 85(5), and determine a brand of the pharmaceutical item that has the listed drug in that form with that manner of administration, as per subsection 85(6). These determinations establish what constitutes the pharmaceutical benefit under Part VII of the Act. The Amendment Determination imposes certain obligations and requirements on the parties and entities it governs. Firstly, the Minister is required to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) during its regular meetings to consider applications and recommend which medicines should be subsidised through the PBS. The PBAC is independent of the government and comprises members from various interests and professions, including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. Based on the recommendations of the PBAC and after receiving submissions and representations from interested pharmaceutical companies, the Minister determines the changes to the conditions under paragraph 98C(1)(b) of the Act. The Amendment Determination also outlines specific offences, penalties, or civil/criminal consequences for breach. However, the Explanatory Statement does not provide explicit details on the penalties for non-compliance with the provisions of the Amendment Determination. It is essential to refer to the relevant sections of the National Health Act 1953 or seek legal advice to understand the potential consequences of breaching the Act's provisions. Nonetheless, it is crucial for parties and entities governed by the Amendment Determination to adhere to the outlined obligations and requirements to ensure compliance with the Act and avoid any potential legal repercussions.