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.
Overview
The National Health (Ceasing of Co-marketed Brands) Determination 2013 (No. 1) was enacted in 2013 under the authority of subsection 84AE(3B) of the National Health Act 1953. This legislation was introduced to address a specific gap identified in the co-marketing of pharmaceutical brands under the Pharmaceutical Benefits Scheme (PBS). The 2007 PBS reforms, which introduced the concept of co-marketed brands, aimed to treat these brands as a single brand for the purpose of allocating drugs to formularies. However, the emergence of additional brands necessitated adjustments to ensure the continued appropriateness of co-marketing status.
The policy objective of this Determination is to cease the co-marketing status of certain pharmaceutical brands when another brand of the same pharmaceutical item becomes listed on the PBS. Specifically, the Determination mandates that Avapro and Karvea cease to be co-marketed brands of irbesartan tablet 75mg, 150mg, and 300mg effective from 1 April 2013. This change aligns with the criteria set out in section 85AB of the National Health Act, ensuring that the PBS formularies accurately reflect the market dynamics and availability of pharmaceutical brands.
Scope and Application
The National Health (Ceasing of Co-marketed Brands) Determination 2013 (No. 1) applies to the pharmaceutical industry, specifically pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS). It relates to the cessation of co-marketed brands of pharmaceutical items, affecting how drugs are treated and allocated to formularies under the National Health Act 1953. This determination specifically targets the co-marketed brands of irbesartan tablets 75mg, 150mg, and 300mg, ceasing their status as co-marketed brands effective from 1 April 2013. The jurisdictional reach of this Act is national, as it is made under the authority of the Commonwealth of Australia. There are no specific exclusions or exemptions mentioned in the explanatory statement; however, the cessation of co-marketed brands is contingent on other brands being listed brands of the co-marketed item. The application and enforcement of this Act may be further detailed or extended through subordinate instruments, as allowed under the legislative framework.
Key Provisions
The main operative sections of the National Health (Ceasing of Co-marketed Brands) Determination 2013 (No. 1) (the Determination) concern the cessation of certain pharmaceutical brands from being co-marketed brands under section 84AE of the National Health Act 1953 (the Act). Specifically, section 3 of the Determination (section 3) mandates that from 1 April 2013, the brands Avapro and Karvea will cease to be co-marketed brands for the pharmaceutical items irbesartan tablet 75mg, 150mg, and 300mg. This decision aligns with the criteria for listing drugs on the Pharmaceutical Benefits Scheme (PBS) and the provisions outlined in the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations).
Under the Act, co-marketed brands are treated as a single brand for the purposes of allocating drugs to formularies, as specified in section 85AB. However, the presence of an additional brand listed for the same pharmaceutical item results in the cessation of the co-marketed status for the specified brands. This is pursuant to section 84AE(3B) of the Act, which allows the Minister to determine such cessation via a legislative instrument. Consequently, the parties governed by this Act, primarily pharmaceutical companies, must adjust their marketing and listing strategies accordingly to comply with the new regulations.
The Determination imposes specific obligations on the entities it governs, such as pharmaceutical companies. These entities must ensure that their marketing and listing practices for the affected brands comply with the cessation provisions. They must update their internal records and marketing materials to reflect the new status of Avapro and Karvea as non-co-marketed brands from 1 April 2013. Failure to comply with these obligations could result in legal consequences, including the potential for regulatory action against the companies involved.
In terms of consequences for non-compliance, the Determination itself does not explicitly outline specific offences or penalties. However, breaches of the National Health Act or the Regulations, which govern the PBS, could lead to civil or criminal penalties as stipulated elsewhere in the Act. For instance, section 115 of the Act allows for the imposition of fines for non-compliance with certain provisions, and more severe penalties may apply in cases of fraudulent conduct or deliberate breaches. The exact penalties would depend on the nature and severity of the breach, as interpreted by the relevant authorities.