EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 35 OF 2008
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 10 of 2008 which came into effect on 1 January 2008. 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 2008, was made on 3 March 2008.
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
Section 1: provides that this instrument commences on 1 April 2008.
Section 2: provides that Schedule 1 amends PB 10 of 2008.
Schedule 1: provides for the deletion of the brand ‘Isopto Tears’ from Hypromellose, in the form eye drops
5 mg per mL, 15 mL.