National Health Act 1953 - Amendment determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 21 of 2009)

Overview

The National Health Act 1953 was enacted to establish and maintain the Pharmaceutical Benefits Scheme (PBS), ensuring that all Australians have reliable, timely, and affordable access to a wide range of medicines. This Act addresses the need for a structured system to provide financial assistance for pharmaceuticals, thereby improving public health outcomes and reducing the burden of healthcare costs on individuals and the broader community. The Parliament of Australia enacted this legislation to provide a legislative basis for the PBS, overseen by the Minister for Health, with the policy objective of ensuring equitable access to essential medicines. The legislative instrument F2009L01072, expressed to commence on 1 April 2009, amends determinations under sections 85, 85A, and 88 of the National Health Act 1953, implementing recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). These amendments adjust the forms and brands of listed drugs, the maximum quantities and repeats for certain prescriptions, and include new drugs and forms on the PBS, reflecting changes in medical needs, advancements in pharmaceutical formulations, and considerations of cost-effectiveness and safety.

Scope and Application

The National Health Act 1953, through its Part VII, provides the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures all Australians have reliable, timely, and affordable access to a wide range of medicines. The Act applies to drugs and medicinal preparations declared by the Minister to be pharmaceutical benefits under the Act. The listed drugs and certain extemporaneously-prepared medicinal preparations are specified by the Minister through legislative instruments. The Minister is also authorised to determine the form or forms of a listed drug, its administration, and specific brands by legislative instrument. Additionally, the Act allows the Minister to determine prescription-related matters, such as the maximum quantity or number of units that may be supplied, the maximum number of repeats, and the manner of administration. The Act's application extends nationally, as it is a Commonwealth Act. However, the instrument in question, PB 21 of 2009, amends previous determinations and is effective from 1 April 2009. The instrument includes detailed changes to the listed drugs, forms, brands, and prescription-related matters, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee.

Key Provisions

The main operative sections of this legislation, F2009L01072, pertain to the Pharmaceutical Benefits Scheme (PBS) under Part VII of the National Health Act 1953. Under subsection 85(1), the Commonwealth is mandated to provide benefits in accordance with Part VII with respect to pharmaceutical benefits. The Minister declares by legislative instrument which drugs and medicinal preparations are to be included in the PBS under subsection 85(2). This includes listed drugs as defined in subsection 84(1) and certain extemporaneously-prepared medicinal preparations. The Minister can also determine the form or forms of a listed drug by reference to strength, type of unit, size of unit, or otherwise under subsection 85(3), as well as the manner of administration of a form of a listed drug under subsection 85(5). Additionally, the Minister can determine a brand of a pharmaceutical item under subsection 85(6). Subsection 85A(2) allows the Minister to determine various matters with respect to the writing of prescriptions by specified classes of persons for the supply of a pharmaceutical benefit, such as the maximum quantity or number of units that may be directed to be supplied in one prescription, the maximum number of occasions in which the supply may be directed to be repeated, and the manner of administration that may be directed to be used. Finally, subsection 88(1A) authorises the Minister to determine the pharmaceutical benefits for the supply of which a dental practitioner is authorised to write a prescription. This legislation imposes obligations on the Minister to ensure that the PBS operates effectively and efficiently. The Minister must make determinations under subsections 85(3), 85(5), 85(6), 85A(2), and 88(1A) in accordance with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC is an independent expert body that makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. The Minister must also ensure that the determinations made under this legislation are in line with the purpose of the PBS, which is to provide reliable, timely, and affordable access to a wide range of medicines for all Australians. Breach of this legislation may result in civil or criminal consequences, depending on the nature and severity of the offence. For example, a person who contravenes a determination made under this legislation may be liable to a penalty of up to $22,200 for a single offence, or up to $444,000 for a continuing offence. In addition, a person who makes a false or misleading statement in relation to a pharmaceutical benefit may be liable to a penalty of up to $11,100 for a single offence, or up to $222,000 for a continuing offence. Criminal penalties may also apply in certain circumstances, such as where a person knowingly or recklessly makes a false or misleading statement in relation to a pharmaceutical benefit. In summary, this legislation provides the framework for the PBS under the National Health Act 1953. It imposes obligations on the Minister to ensure that the PBS operates effectively and efficiently, and it sets out the penalties for breach of the legislation. The determinations made under this legislation are based on the recommendations of the PBAC, which ensures that the PBS is informed by expert advice and takes into account a range of factors, including clinical effectiveness, safety, and cost-effectiveness.