EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 85 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 December 2011.
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 December 2011.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendment:
SCHEDULE 3
Addition of Listed Drug
Oxycodone with naloxone | Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg Tablet (controlled release) containing oxycodone hydrochloride
10 mg with naloxone hydrochloride 5 mg Tablet (controlled release) containing oxycodone hydrochloride
20 mg with naloxone hydrochloride 10 mg Tablet (controlled release) containing oxycodone hydrochloride
40 mg with naloxone hydrochloride 20 mg |
Overview
The National Health Act 1953, enacted by the Parliament of Australia, provides the legal foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to affordable and reliable medicines. This Act was introduced to address the need for a structured system that provides equitable access to essential pharmaceuticals. The Act allows the Minister for Health to declare drugs and medicinal preparations that are eligible for benefits and to determine the conditions under which payments will be made for the supply of these pharmaceutical benefits by approved pharmacists and medical practitioners. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on which medicines should be subsidised, considering inputs from various stakeholders including consumers, health economists, and medical professionals. The 2011 amendment to the Act, as reflected in the legislative instrument F2011L02475, was made to incorporate PBAC recommendations and adjust the conditions for Commonwealth payments concerning the supply of pharmaceutical benefits. This amendment aims to refine the criteria for subsidy and ensure the PBS remains effective and responsive to public health needs.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument PB 85 of 2011, pertains to the Pharmaceutical Benefits Scheme (PBS), which is the framework through which the Commonwealth ensures Australians have access to reliable, timely, and affordable medicines. This Act applies to the Minister of Health, approved pharmacists, and approved medical practitioners who are involved in the supply of pharmaceutical benefits. The Act's provisions extend across the Commonwealth of Australia, and its amendments are determined by legislative instruments, such as the one referenced here, which provide specific details on the conditions for payments related to the supply of pharmaceutical benefits. The Act also includes mechanisms for the Minister to declare listed drugs and determine their forms and manners of administration, thereby governing the scope of pharmaceutical benefits under the Scheme. Notably, the instrument in question provides for the addition of a listed drug, specifically Oxycodone with naloxone, and sets out new conditions for payments in respect of this pharmaceutical benefit. The instrument commences on 1 December 2011 and is a legislative instrument under the Legislative Instruments Act 2003.
Key Provisions
The main operative sections of this instrument are primarily concerned with the amendment of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. The key section, 98C(1)(b), allows the Minister to determine the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners (subsection 85(1)). The amendments, as detailed in Schedule 1, modify the list of drugs that are eligible for these benefits by adding Oxycodone with naloxone, a controlled-release tablet, in various dosages. This addition to the list of drugs means that these specific forms of Oxycodone with naloxone will now be subject to the PBS, ensuring their availability and affordability to Australians under the scheme.
The obligations imposed by this Act on the parties involved include the requirement for approved pharmacists and approved medical practitioners to adhere to the new conditions set out in the amendments. These conditions likely encompass various aspects such as the documentation, prescription protocols, and other administrative requirements necessary to ensure compliance with the PBS. Additionally, pharmaceutical companies that manufacture and supply Oxycodone with naloxone must ensure their products meet the newly listed specifications and comply with all regulatory requirements to be eligible for payments under the scheme.
Failure to comply with the conditions stipulated by the Minister under section 98C(1)(b) can result in significant legal and financial consequences. While the specific penalties for breaches are not detailed in the explanatory statement, violations of the PBS regulations can generally lead to fines, suspension of benefits, or other administrative penalties under the National Health Act 1953. In severe cases, criminal charges may be pursued, resulting in substantial fines and imprisonment, depending on the nature and severity of the breach. The exact penalties would be determined based on the specific provisions of the Act and the regulatory guidelines set by the Department of Health.