EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 58 OF 2010
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, expressed to commence on 1 July 2010, was made on 3 June 2010.
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 July 2010.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Deletion of Listed Drugs
Addition of Form
Glucose Indicator—Blood | Test strips, 100 (Accu-Chek Active) |
Deletion of Forms
Glucose Indicator—Blood | Test strips, 100 (SofTact) |
Oestradiol | Transdermal patches 4 mg, 8 |
Oestradiol and Oestradiol with Norethisterone | Pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg |
Overview
The F2010L01622 National Health Act 1953 Amendment Determination, enacted in 2010, serves to modify the conditions under which the Commonwealth will make payments in respect of pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners, as stipulated by paragraph 98C(1)(b) of the Act. This legislative instrument responds to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and amends the previous determination made in 2008. The amendments outlined in Schedule 1 of the instrument include the addition and deletion of certain listed drugs and their forms, ensuring that the Pharmaceutical Benefits Scheme (PBS) remains aligned with current medical needs and practices. The enactment of this determination by the relevant authority aims to maintain the PBS's objective of providing reliable, timely, and affordable access to a wide range of medicines for all Australians.
Scope and Application
This legislative instrument amends the conditions under which payments are 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 paragraph 98C(1)(b) of the National Health Act 1953. The changes are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and reflect updates to the Pharmaceutical Benefits Scheme (PBS). The Act applies to all parties involved in the supply of pharmaceutical benefits, including approved pharmacists, approved medical practitioners, and relevant pharmaceutical entities. The changes are national in scope, impacting all jurisdictions within Australia. The instrument specifies additions and deletions to the list of drugs eligible for subsidy, including certain forms of glucose indicators and oestradiol transdermal patches, among others. The instrument also makes technical amendments to the conditions for payments but does not introduce any new exclusions, exemptions, or thresholds. The changes take effect from 1 July 2010.
Key Provisions
The main operative sections of this legislative instrument involve amendments to the National Health Act 1953 (the Act) as set out in Schedule 1. Specifically, these amendments modify the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This change was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) and subsequently determined by the Minister under paragraph 98C(1)(b) of the Act. These amendments, effective from 1 July 2010, include the deletion of certain listed drugs and the addition of new forms of pharmaceutical items, such as glucose indicator test strips.
The Act imposes certain obligations and requirements on the parties involved, including approved pharmacists and approved medical practitioners. These professionals must adhere to the conditions outlined in the determination for the supply of pharmaceutical benefits. The changes in the legislation mean that they must comply with the new listing of drugs and forms, ensuring that they provide pharmaceutical benefits in accordance with the updated criteria. This includes maintaining accurate records and ensuring that the pharmaceutical items supplied meet the specified conditions to be eligible for Commonwealth payments.
There are no explicit offences, penalties, or civil/criminal consequences detailed in the explanatory statement for breaches of the conditions set out in this determination. However, non-compliance with the Act's requirements could potentially lead to financial penalties or legal consequences. For example, approved pharmacists and approved medical practitioners who fail to adhere to the conditions for the supply of pharmaceutical benefits may be subject to fines or other sanctions under the relevant sections of the National Health Act 1953. While the maximum penalties are not specified in the explanatory statement, they would typically be outlined in the main body of the Act or in associated regulations. The overarching principle is that adherence to the Act is mandatory, and any breaches could result in enforcement actions by the relevant authorities.