EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 27 OF 2010
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SUBSECTION 84AE(3B)
This legislative instrument is made pursuant to subsection 84AE(3B) of the National Health Act 1953 (“the Act”) and determines that certain brands of pharmaceutical item cease to be co-marketed brands of a pharmaceutical item.
Part VII of the Act provides for the supply of drugs and medicinal preparations under Commonwealth subsidy (commonly known as the Pharmaceutical Benefits Scheme - “PBS”), by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument under 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 purpose 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 Regulations”).
Paragraph 84AE(3B)(b) provides that the Minister may, by legislative instrument, determine that all brands (“the co-marketed brands”) that are prescribed by the Regulations as being co-marketed brands of a pharmaceutical item (“the co-marketed item”) cease to be co-marketed brands of the co-marketed item if another brand is a listed brand of the co-marketed item.
This legislative instrument provides that brands of a pharmaceutical item specified in columns 2 and 3 of an item specified in column 1 of the Schedule cease to be co-marketed brands of the pharmaceutical item.
The instrument is expressed to commence on 1 April 2010 after PB 16 of 2010 commences.
Consultations
This instrument affects pharmaceutical companies with medicines listed on the PBS. Consultation has occurred through a company submission to the Therapeutic Goods Administration and the Pharmaceutical Benefits Advisory Committee (“PBAC”) for a drug to be listed on the PBS. When drugs are listed on the PBS each drug is allocated into a formulary (F1 or F2) from the recommendation of the PBAC.
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.