EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 31 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER SECTION 84AF
Summary
This instrument amends the principal legislative instrument, PB 16 of 2010, which determines the responsible persons for the brands of pharmaceutical items. 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 16 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).
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.
Section 84AF empowers the Minister to determine that a person is the responsible person for a brand of a pharmaceutical item. The Minister can do this if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to wholesalers or, if not, to approved pharmacists directly. The brand must be a listed brand (defined in subsection 84(1) as a brand in relation to which a determination under subsection 85(6) is in force), and there can be no determination in force that any other person is the responsible person for the brand of the pharmaceutical item or of any other pharmaceutical item.
A responsible person for a brand of pharmaceutical item has various responsibilities or functions under the Act. These include those in relation to entering into price agreements under section 85AD, compliance with price disclosure requirements under Division 3B, and the requirement to supply certain brands of pharmaceutical item for a specified period under Division 3C.
This amending instrument amends the principal legislative instrument before it commences by removing the reference to “tablet” or “tablets” and 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 16 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.