National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) - conditions (No. PB 81 of 2009)

Overview

The National Health Act 1953 was enacted to provide the legislative basis for the Pharmaceutical Benefits Scheme (PBS), ensuring that all Australians have reliable, timely, and affordable access to a wide range of medicines. The Act empowers the Minister to declare listed drugs and determine their form, manner of administration, and brand, governing what constitutes a pharmaceutical benefit under the scheme. The Act also allows for the establishment of conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The legislative instrument F2009L03153 amends the conditions under which these payments are made, coming into effect on 1 September 2009. The amendments were determined following consultations with the Pharmaceutical Benefits Advisory Committee, an independent body that recommends which medicines should be subsidised through the PBS. This committee comprises members from various interests and professions, including consumers, health economists, and medical specialists.

Scope and Application

The National Health Act 1953 governs the Pharmaceutical Benefits Scheme (PBS), which is the legislative foundation for the Commonwealth's provision of affordable and timely access to a broad range of medicines for all Australians. Specifically, Part VII of the Act, which is the cornerstone of the PBS, ensures that pharmaceutical benefits are supplied in accordance with the Act. The Act applies to pharmaceutical benefits, including drugs and medicinal preparations declared by the Minister through legislative instruments, which are listed drugs as defined in the Act. The Minister can also determine the form and manner of administration of these listed drugs, as well as the brands of pharmaceutical items that include these drugs. The Act further allows for the Minister to determine a responsible person for a brand of a pharmaceutical item. The Act's scope extends nationally and applies to all approved pharmacists and approved medical practitioners who supply pharmaceutical benefits. The instrument amends the previous determination made by legislative instrument number PB 119 of 2008, which came into effect on 1 December 2008. The amendments are detailed in the items of Schedule 1 to the instrument, which came into effect on 1 September 2009. This instrument was made on 31 July 2009, and the Department consulted with the Pharmaceutical Benefits Advisory Committee during the regular process of its meetings to consider applications to recommend to the Minister which medicines should be subsidised through the PBS. The Committee, which is independent of the government and includes members from various interests or professions, received submissions and representations from interested pharmaceutical companies and recommended the changes to the Minister, who then determined the changes to the conditions under paragraph 98C(1)(b) which appear in this Determination.

Key Provisions

The main sections of this legislation (F2009L03153) amend 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, as determined by the Minister under the National Health Act 1953 (subsection 98C(1)(b)). This amendment updates the conditions set out in the previous legislative instrument (PB 119 of 2008) which came into effect on 1 December 2008. The changes are detailed in the Schedule 1 to this instrument, which commenced on 1 September 2009. Specifically, Schedule 1 amends PB 119 of 2008 by adding a listed drug, Silver sulfadiazine, to the Pharmaceutical Benefits Scheme (PBS). This addition is part of the ongoing process of determining which drugs and medicinal preparations will be covered by the PBS, which is administered by the Commonwealth to provide affordable access to a wide range of medicines for Australians. The obligations imposed by this legislation include the responsibility of the Minister to determine the conditions for payments related to the supply of pharmaceutical benefits. This involves consulting with the Pharmaceutical Benefits Advisory Committee (PBAC), which includes representatives from various sectors such as consumers, health economists, community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. The Minister must consider recommendations from the PBAC and other submissions from interested parties, such as pharmaceutical companies, before making determinations about which drugs will be listed and the conditions under which payments will be made. The Minister must ensure these determinations align with the objectives of the National Health Act 1953, particularly ensuring reliable, timely, and affordable access to necessary medicines. Failure to comply with the conditions set out in this legislation could result in legal consequences. While the specific offences and penalties are not detailed in the explanatory statement, breaches of the National Health Act 1953 could lead to civil or criminal penalties. For instance, supplying pharmaceutical benefits without adhering to the stipulated conditions might result in fines or other penalties as prescribed by the Act. Additionally, the Minister's determinations and the processes involved in listing drugs and setting conditions are subject to review, and any improper actions could be challenged in court, leading to further legal ramifications. It is crucial for approved pharmacists and approved medical practitioners to adhere strictly to the conditions outlined in this legislation to avoid any legal repercussions.