EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 30 OF 2010
NATIONAL HEALTH ACT 1953
DETERMINATIONS UNDER SECTIONS 85, 85A and 88
Summary
This instrument amends the principal legislative instrument, PB 15 of 2010, which gives effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and provides for additions, deletions and changes to the names, forms, manners of administration, and brands of listed drugs on the PBS and the conditions for prescribing pharmaceutical benefits. Due to an administrative oversight, the “type of unit” for all forms of the listed drug dabigatran etexilate has been incorrectly described as “tablet” or “tablets” in instrument PB 15 of 2010 when the “type of unit” should be described as “capsule” or “capsules” wherever occurring.
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).
Subsection 85(3) authorises the Minister by legislative instrument to determine by reference to strength, type of unit, size of unit, or otherwise, the form or forms of a listed drug.
Subsection 85(5) authorises the Minister by legislative instrument to determine the manner of administration of a form of a listed drug where the form has been determined under subsection 85(3).
Subsection 85(6) authorises the Minister by legislative instrument to determine a brand of a pharmaceutical item. A “brand” is defined in subsection 84(1) to mean the trade name which the person who is or will be the “responsible person” supplies the pharmaceutical item, or if there is no trade name, the name of the responsible person. The responsible person for a brand of a pharmaceutical item is determined by the Minister by legislative instrument under section 84AF.
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(1A) authorises the Minister to determine the pharmaceutical benefits for the supply of which a dental practitioner is authorised to write a prescription.
This amending instrument amends the principal instrument before it commences by removing the reference to “tablet” or “tablets” by substituting with “capsule” or “capsules”. The correct forms for the listed drug dabigatran etexilate are capsules 75 mg (as mesilate), 60; capsules 110 mg (as mesilate), 60; capsule 75 mg (as mesilate) and capsule 110 mg (as mesilate). The amendment is set out in Schedule 1 to the instrument.
This instrument, expressed to commence on the day after registration on the Federal Register of Legislative Instruments, was made on 26 March 2010, and is intended to have effect before commencement of PB 15 of 2010, which commences on 1 April 2010.
Consultations
This amendment is required to be made as a result of an administrative oversight. The responsible person that supplies the listed drug dabigatran etexilate in the forms capsules 75 mg (as mesilate), 60; capsules 110 mg (as mesilate), 60; capsule 75 mg (as mesilate) and capsule 110 mg (as mesilate) has been advised of this correction. Medicare Australia has been advised of this correction for the purposes of administering payments for the supply of these pharmaceutical benefits.