EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 32 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)
Summary
This instrument amends the legislative instrument, PB 20 of 2010, which amends
PB 119 of 2008, which came into effect on 1 December 2008 and 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. Due to an administrative oversight, the “type of unit” for all forms of the listed drug dabigatran etexilate has been incorrectly described as “tablets” in amending instrument PB 20 of 2010 when the “type of unit” should be described as “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 (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.
This amending instrument amends instrument PB 20 of 2010 before it commences, by removing the reference to “tablets” and substituting with “capsules”. The correct forms for the listed drug dabigatran etexilate are capsules 75 mg (as mesilate), 60 and capsules 110 mg (as mesilate), 60. The amendment is set out in the item of 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 20 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 and capsules 110 mg (as mesilate), 60 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.