EXPLANATORY STATEMENT
National Health (Ceasing of Co-marketed Brands)
Determination 2013 (No. 1)
PB 20 of 2013
Authority
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.
Purpose
Section 84AE of the Act 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) of the Act 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.
On 1 April 2013 there will be at least one more brand of each of the three co-marketed items irbesartan tablet 75mg, 150mg and 300mg (Avapro and Karvea). It is therefore appropriate that Avapro and Karvea cease to be co-marketed brands of these three co-marketed items on 1 April 2013.
The instrument is expressed to commence on 1 April 2013.
Consultations
The Determination affects pharmaceutical companies with medicines listed on the PBS. Before drugs are listed and allocated to formularies, there are detailed consultations about the drug with the intended responsible person, and a recommendation is received from the Pharmaceutical Benefits Advisory Committee (PBAC). Any PBAC recommendation is made following receipt of submissions by affected pharmaceutical companies. Two-thirds of the PBAC membership is from the following interests or professions: consumers, health economists, practising community pharmacist, general practitioners, clinical pharmacologists and medical specialists.
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 Amendments (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 Determination arises out of the 2007 PBS reforms and is machinery in nature.
This Determination constitutes a legislative instrument for the purpose of the Legislative Instruments Act 2003.