EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 117 OF 2009
NATIONAL HEALTH ACT 1953
DETERMINATION MADE PURSUANT TO SUBSECTION 84AE(3)
This legislative instrument is made pursuant to subsection 84AE(3) of the National Health Act 1953 (“the Act”) and determines that certain brands of pharmaceutical item are co-marketed brands of that pharmaceutical item.
Part VII of the Act regulates when benefits will be paid by the Commonwealth in respect of drugs and medicinal preparations that are listed on the Pharmaceutical Benefits Scheme (PBS). As such, it is the legislative basis by which the Commonwealth provides reliable, timely and affordable access to a wide range of medicines to Australians.
Drugs and medicinal preparation to which Part VII applies are declared by the Minister by legislative instrument pursuant to subsection 85(2) of the Act. A drug or medicinal preparation for which there is a declaration under subsection 85(2) is a listed drug for the purposes of the PBS. The Act provides for listed drugs to be assigned to formularies, identified as F1 and F2. F1 is intended to be for single brand drugs and F2 is intended to be for drugs that have multiple brands, or are interchangeable at the patient level with other drugs.
The Minister may also determine by legislative instrument the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)) and the manner of administration of the form of the listed drug so determined (subsection 85(5)). If a drug has a declaration under subsection 85(2) in force in respect of it and determinations under subsections 85(3) and 85(5) in force in respect of it, then that declared drug in that determined form with that determined manner of administration is a pharmaceutical item. The Minister may also determine, by legislative instrument, brands of pharmaceutical items (subsection 85(6)).
Section 84AE provides for the concept of co-marketed brands. Co-marketed brands of a pharmaceutical item are treated as a single brand of the item for the purposes of the criteria for allocating drugs to formularies in section 85AB. Multiple brand drugs are not eligible for F1 under the criteria set out in section 85AB. However, as co-marketed brands are treated as a single brand, listed drugs in co-marketed brands of a pharmaceutical item are not disqualified from being on F1.
Co-marketed brands that were included on F1 at the commencement of section 84AE (1 August 2007) are prescribed in the National Health (Pharmaceutical Benefits) Regulations 1960. The effect of section 84AE is that subsequent additions will be made by Ministerial determination, by legislative instrument, pursuant to subsection 84AE(3).
This legislative instrument provides that brands of pharmaceutical item specified in columns 2 and 3 of an item specified in column 1 of the Schedule are co-marketed brands of the pharmaceutical item.
This legislative instrument determines that “DuoCover” and “CoPlavix” are co-marketed brands of the pharmaceutical item that has the listed drug clopidogrel with aspirin, in the form of a tablet blister pack (ratio 75mg/100mg) with an oral manner of administration. Both brands of the pharmaceutical item satisfy the criteria in subsection 84AE(3).
This pharmaceutical item also meets the definition of combination item in subsection 84(1) of the Act and it will not appear in the F1 or F2 formulary.
This instrument is expressed to commence on 1 December 2009, after the determination made under subsection 85(6) in respect of each of the brands which are the subject of the determination comes into force.
Consultation
This instrument affects pharmaceutical companies with medicines listed on the PBS.
Co-marketed brands and the criteria used to determine the placement of listed drugs on formularies were introduced into the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 (“the 2007 PBS Reforms”). The pharmaceutical industry was consulted during both the policy development and implementation phases of the 2007 PBS Reforms. This instrument arises out of the 2007 PBS Reforms and is machinery in nature.