National Health Act 1953 - Amendment determination under subsections 85A(1) and (2) and 88(1C) - Prescription of pharmaceutical benefits by authorised optometrists (No. PB 67 of 2009)

Overview

The National Health Act 1953, as amended by F2009L02716, addresses the need to regulate and provide access to pharmaceutical benefits through the Pharmaceutical Benefits Scheme (PBS). This legislative instrument, enacted by the Australian Government, amends previous determinations under subsections 85A(1) and (2), and 88(1C) of the Act, to implement recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body appointed by the Minister, ensures that the drugs and medicinal preparations included in the PBS are based on clinical effectiveness, safety, and cost-effectiveness. The amendments, effective from 1 August 2009, incorporate additional listed drugs such as Bimatoprost with timolol and Soy lecithin, thereby enhancing the scope of pharmaceutical benefits available to Australians under the PBS. This legislative change is part of an ongoing process to consult with relevant stakeholders and ensure the PBS remains a reliable, timely, and affordable means of accessing essential medicines.

Scope and Application

The National Health Act 1953 Amendment Determination under subsections 85A(1) and (2), and 88(1C) applies to the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable, timely, and affordable access to a wide range of medicines. The Act applies to drugs and medicinal preparations that are declared by the Minister to be listed drugs under subsection 85(2). This encompasses specific forms of these drugs by strength, type of unit, size of unit, and brand, as well as certain extemporaneously-prepared medicinal preparations. The amendments, effective from 1 August 2009, are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and reflect the outcomes of consultations with relevant stakeholders. The PBAC, comprising experts from various health-related fields, advises the Minister on which drugs should be available under the PBS. The amendments set out in Schedule 1 include the addition of Bimatoprost with timolol and Soy lecithin to the list of drugs under subsection 85(2). This legislative instrument, PB 67 of 2009, modifies previous determinations under PB 11 of 2009, which came into effect on 1 March 2009.

Key Provisions

The Pharmaceutical Benefits Scheme (PBS) is governed under Part VII of the National Health Act 1953, as amended by the legislative instrument F2009L02716. This instrument amends previous determinations made by legislative instrument number PB 11 of 2009, which came into effect on 1 March 2009. The amendments, detailed in Schedule 1, are designed to implement recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and to update the list of pharmaceutical benefits available under the PBS. The changes are effective from 1 August 2009. The Minister is authorised under subsections 85A(1) and (2), and 88(1C) to make various determinations concerning the form and prescription of pharmaceutical benefits. These include determining the form or forms of a listed drug by reference to strength, type of unit, size of unit, or otherwise (subsection 85(3)); the manner of administration (subsection 85(5)); and a brand that has the listed drug in that form with that manner of administration (subsection 85(6)). Additionally, the Minister can specify the maximum quantity or number of units that may be supplied in one prescription (subsection 85A(2)(a)), the maximum number of occasions a prescription may be repeated (subsection 85A(2)(b)), and the manner of administration that may be directed in a prescription (subsection 85A(2)(c)). Subsection 88(1C) allows the Minister to determine which pharmaceutical benefits an optometrist is authorised to prescribe from 1 January 2008 onwards. The obligations imposed by the Act require the Minister to make determinations about the pharmaceutical benefits listed under the PBS. This includes ensuring that the benefits are provided in accordance with the provisions of Part VII, and that the drugs and medicinal preparations listed are those declared by the Minister. Furthermore, the Minister must ensure that the forms and conditions of pharmaceutical benefits, including the maximum quantities and repetitions allowed in prescriptions, are clearly defined and adhered to by the relevant parties. The Act also mandates that the Minister consult with the PBAC, an independent expert body, to make recommendations on the inclusion of drugs and medicinal preparations in the PBS. Failure to comply with the provisions of the Act can result in various penalties. For example, if an entity or individual does not adhere to the determined forms, quantities, or methods of administration for pharmaceutical benefits, they may face legal consequences. While the exact penalties are not specified in the Act, breaches of such provisions could lead to civil or criminal charges, depending on the severity of the non-compliance. The Minister also has the authority to impose fines or other penalties for violations of the PBS regulations, although the specifics of these penalties are typically detailed in other legislative instruments or regulations.