EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 19 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER
SUBSECTIONS 85A(1) AND (2) AND 88(1C)
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 declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
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 (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.
Subsection 85A(1) authorises the Minister to determine the form or forms of pharmaceutical benefits or pharmaceutical item that may be prescribed under Part VII of the Act by specified classes of persons.
Subsection 85A(2) authorises the Minister to determine various matters with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit. Paragraph 85A(2)(a) authorises the determination of the maximum quantity or number of units that may in one prescription be directed to be supplied for all purposes or for a particular purpose. Paragraph 85A(2)(b) authorises the determination of the maximum number of occasions in which the supply may in one prescription be directed to be repeated for all purposes or a particular purpose. Paragraph 85A(2)(c) authorises the determination of the manner of administration that may, in a prescription, be directed to be used.
Section 88 provides for various matters relating to the prescribing of pharmaceutical benefits. Subsection 88(1C) authorises the Minister to determine the pharmaceutical benefits for the supply of which an optometrist is authorised to write a prescription on or after 1 January 2008.
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends determination under subsections 85A(1) and (2), and 88(1C) made by legislative instrument number PB 11 of 2009 which came into effect on 1 March 2009. The amendments are set out in the items of Schedule 1 to the instrument.
A provision-by-provision description of the instrument is contained in the attachment.
This instrument, expressed to commence on 1 April 2010, was made on 3 March 2010.
Consultations
The involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (PBAC) constitutes a formal and ongoing process of consultation. The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. When making recommendations relevant to a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
The medicine determined under subsection 88(1C) reflects the recommendations of the PBAC and the outcome of the consultation process.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 April 2010.
Paragraph 2: provides that Schedule 1 amends PB 11 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Deletion of Form
Pilocarpine | Eye drops containing pilocarpine hydrochloride 60 mg per mL, 15 mL |
Deletion of Brands
Pilocarpine | Eye drops containing pilocarpine hydrochloride 10 mg per mL, 15 mL
(P.V. Carpine, Pilopt) Eye drops containing pilocarpine hydrochloride 20 mg per mL, 15 mL
(P.V. Carpine, Pilopt) Eye drops containing pilocarpine hydrochloride 40 mg per mL, 15 mL
(P.V. Carpine, Pilopt) |
Overview
The F2010L00677 Amendment Determination under subsections 85A(1) and (2), and 88(1C) of the National Health Act 1953 was enacted in 2010 by the Commonwealth Parliament to amend the Pharmaceutical Benefits Scheme (PBS). The primary objective of this amendment was to address specific gaps and issues identified in the previous legislative instrument, PB 11 of 2009, by refining the forms and brands of certain pharmaceutical items covered under the PBS. This amendment was made in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on which drugs and medicinal preparations should be included in the PBS. The PBAC's recommendations considered factors such as the medical conditions for which the medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. The amendments resulted in the deletion of specific forms and brands of pilocarpine eye drops from the PBS, reflecting the outcome of the consultation process and the PBAC's recommendations.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument F2010L00677, governs the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth provides affordable access to a wide range of medicines for Australians. This legislation applies to the Minister for Health, who determines the forms and brands of listed drugs, the manner of administration, and the maximum quantities or repetitions allowed in prescriptions for pharmaceutical benefits. These determinations extend to specified classes of persons, such as medical practitioners and optometrists, who can prescribe pharmaceutical benefits. The geographic reach of this Act is national, applying throughout Australia, and it extends to subordinate instruments that may further detail the operation of the PBS. The amendments made by the instrument primarily involve changes to the forms and brands of pharmaceutical items that can be prescribed, reflecting the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, which comprises members from various relevant fields, consults extensively before making recommendations to the Minister regarding the availability of drugs on the PBS, ensuring a balanced and expert-informed approach to the management of the scheme.
Key Provisions
The main operative sections of this legislation, specifically sections 85A(1), 85A(2), and 88(1C), provide the framework for the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. Subsection 85(1) ensures that the Commonwealth offers pharmaceutical benefits to Australians, while subsection 85(2) mandates that the Minister declare the drugs and medicinal preparations included in the scheme by legislative instrument. Subsection 85A(1) allows the Minister to specify the form or forms of pharmaceutical benefits that may be prescribed by certain classes of persons. Subsection 85A(2) further empowers the Minister to determine the maximum quantity, number of units, and the manner of administration in prescriptions for these pharmaceutical benefits. Subsection 88(1C) grants the Minister authority to determine which pharmaceutical benefits optometrists can prescribe.
The Act imposes several obligations on the parties and entities it governs. Firstly, the Minister must declare which drugs and medicinal preparations are included in the PBS, ensuring that these are accessible and affordable for all Australians. The Minister also determines the specific forms and brands of these pharmaceutical items, governing what constitutes a pharmaceutical benefit under the scheme. Furthermore, the Act requires the Minister to set parameters for prescriptions, including the maximum quantity or number of units, the frequency of supply, and the manner of administration, thereby regulating the use and distribution of these pharmaceutical items.
Breaches of the provisions outlined in this legislation can lead to various consequences. While specific offences and penalties are not detailed in the provided text, it is reasonable to infer that any non-compliance with the Minister’s determinations regarding pharmaceutical benefits could result in legal repercussions. Typically, such breaches might be subject to administrative actions, fines, or other penalties as prescribed by the Act or relevant regulations. Additionally, failure to adhere to the determined forms and conditions for prescriptions could lead to civil or criminal liability, depending on the severity and intent of the breach.
The amendments set forth in the Schedule of this instrument are designed to reflect the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and the outcomes of the consultation process. These changes include the deletion of specific forms and brands of eye drops containing pilocarpine hydrochloride, which were previously included in the PBS. By removing these items, the Act ensures that the scheme remains focused on providing reliable and cost-effective pharmaceutical benefits to the public.