EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 97 OF 2011
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)
Summary
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under section 98C(1)(b) made by legislative instrument number PB 119 of 2008 which came into effect on
1 December 2008. The amendments provide for changes to the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The amendments are set out in the items of Schedule 1 to the instrument.
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
The Minister by legislative instrument can determine 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 of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act. Under section 84AF, the Minister may determine a responsible person for a brand of a pharmaceutical item.
Paragraph 98C(1)(b) of the Act provides that the Minister may, from time to time, determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
The determination under paragraph 98C(1)(b) of the Act sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument constitutes a legislative instrument for the purposes of the Legislative Instruments Act 2003.
This instrument commences on 1 January 2012.
Consultations
The Department consulted with the Pharmaceutical Benefits Advisory Committee (PBAC) during the regular process of its meetings to consider applications in order to recommend to the Minister which medicines should be subsidised through the Pharmaceutical Benefits Scheme. The Committee is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The Committee has received submissions and representations from interested pharmaceutical companies and has recommended the changes to the Minister who has determined the changes to the conditions under paragraph 98C(1)(b) which appear in this Determination.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 January 2012.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendment:
SCHEDULE 4
Alteration of Form
Glucose Indicator—Blood | From: Test strips, 100 (Optium glucose) To: Test strips, 100 (FreeStyle Optium) |
Overview
The National Health Act 1953, amended by legislative instrument F2011L02736, addresses the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This amendment was introduced to implement the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the Pharmaceutical Benefits Scheme (PBS) remains responsive to evolving healthcare needs. The instrument, which commenced on 1 January 2012, makes specific changes to the conditions for pharmaceutical supply as outlined in Schedule 1. The enacting body in this process is the Minister for Health, who exercises the powers granted under paragraph 98C(1)(b) of the Act. The policy objective is to ensure that the PBS continues to provide reliable, timely, and affordable access to a wide range of medicines for all Australians.
Scope and Application
The F2011L02736 legislative instrument amends the National Health Act 1953, specifically under section 98C(1)(b), to update the conditions governing payments by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. This Act applies to entities and individuals involved in the supply of pharmaceutical benefits, such as approved pharmacists and medical practitioners, and pertains to transactions involving the supply of drugs listed under the Pharmaceutical Benefits Scheme (PBS). The geographical reach of this Act is national, as it governs the PBS across Australia, which is administered by the Commonwealth under the National Health Act. The amendments in this instrument are targeted and do not broadly alter the scope of the PBS but rather refine the specific conditions for certain pharmaceutical items. The instrument excludes any changes not outlined in the Schedule 1 of the instrument, maintaining the existing framework outside of these specific amendments. This legislative instrument extends the application of the Act by detailing specific conditions for payments concerning certain drugs, thus ensuring precise regulation and implementation of the PBS.
Key Provisions
The main operative sections of this instrument (paragraphs 1 and 2) set out the commencement date and the amendment to the previous legislative instrument PB 119 of 2008, which came into effect on 1 December 2008 (paragraph 2). Schedule 1 of the instrument provides specific amendments to the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The amendments reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and are designed to update and refine the existing conditions.
The Act imposes several obligations and requirements on the parties it governs. Firstly, the Minister is tasked with determining the conditions under which payments will be made for pharmaceutical benefits, as per section 98C(1)(b). This includes setting out the criteria and processes for approved pharmacists and approved medical practitioners to follow when supplying pharmaceutical benefits (Schedule 1). Secondly, approved pharmacists and approved medical practitioners must adhere to the conditions specified by the Minister to be eligible for Commonwealth payments (Schedule 1). These conditions could include requirements related to the form, brand, and manner of administration of pharmaceutical items.
There are potential civil or criminal consequences for breaches of the conditions set out in this instrument. While the explanatory statement does not explicitly detail these consequences, breaches of the Pharmaceutical Benefits Scheme regulations generally can result in penalties under the National Health Act 1953. For example, a person who knowingly provides false or misleading information in order to obtain a pharmaceutical benefit may be liable to a penalty of up to 50 penalty units (section 126). In addition, failure to comply with the conditions specified by the Minister for the supply of pharmaceutical benefits could result in the Commonwealth withholding payments or taking other corrective actions as deemed necessary.
In summary, the instrument amends the conditions for Commonwealth payments for pharmaceutical benefits by approved pharmacists and approved medical practitioners. It imposes obligations on the Minister to determine these conditions and on approved practitioners to comply with them. Breaches of these conditions could lead to civil penalties or other corrective measures.