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.
Overview
The National Health Act 1953, enacted by the Australian Parliament, serves to regulate the provision of health services and the administration of the Pharmaceutical Benefits Scheme (PBS). The Act was introduced to ensure reliable, timely, and affordable access to a wide range of medicines for Australians. The Act allows the Minister for Health to declare drugs and medicinal preparations listed on the PBS through legislative instruments, and these drugs are assigned to formularies F1 or F2 based on their brand status. Specifically, section 84AE of the Act introduces the concept of co-marketed brands, treating them as a single brand for the purposes of formulary allocation, thereby allowing multiple brand drugs to remain eligible for the F1 formulary. The explanatory statement for instrument number PB 117 of 2009, made pursuant to subsection 84AE(3) of the Act, specifies that certain brands are co-marketed brands of a pharmaceutical item. This legislative instrument determines that “DuoCover” and “CoPlavix” are co-marketed brands of the pharmaceutical item containing clopidogrel with aspirin in a tablet blister pack (ratio 75mg/100mg) with an oral manner of administration, thereby ensuring they are treated as a single brand under the PBS.
Scope and Application
The legislative instrument, numbered PB 117 of 2009, is made under the National Health Act 1953 and pertains to the classification of pharmaceutical items under the Pharmaceutical Benefits Scheme (PBS). It applies to pharmaceutical companies and entities that manufacture and market drugs listed on the PBS, focusing on the specific brands of pharmaceutical items that are deemed co-marketed brands. The geographic reach of this legislation is national, as it governs the operation of the PBS across Australia. The instrument identifies particular brands of pharmaceutical items, in this case "DuoCover" and "CoPlavix," as co-marketed brands of the pharmaceutical item containing clopidogrel with aspirin in a specified form and manner of administration, thus ensuring these brands are treated as a single brand for the purposes of allocating drugs to the PBS formularies. The instrument does not exclude any specific entities or brands from its application but rather sets out criteria for determining co-marketed brands, which must be met for the brands to receive a specific classification under the Act. The instrument commenced on 1 December 2009, subsequent to the relevant determinations under subsection 85(6) of the Act for each brand.
Key Provisions
The legislative instrument, numbered PB 117 of 2009, made under subsection 84AE(3) of the National Health Act 1953, clarifies that certain brands of pharmaceutical items are co-marketed brands, specifying "DuoCover" and "CoPlavix" as co-marketed brands of the pharmaceutical item containing clopidogrel with aspirin in the form of a tablet blister pack (75mg/100mg) with an oral manner of administration. This determination ensures that these brands are treated as a single brand for the purposes of allocating drugs to the Pharmaceutical Benefits Scheme (PBS) formularies, specifically impacting their eligibility for the F1 formulary. This is crucial as F1 is reserved for single brand drugs, and by treating co-marketed brands as a single brand, they are not disqualified from being considered for F1.
The obligations under this Act primarily fall on the Minister, who is tasked with determining which brands are co-marketed brands and declaring these by legislative instrument. The Minister must ensure that these determinations are made in accordance with the criteria set out in the Act, particularly in subsection 84AE(3). Pharmaceutical companies must comply with these determinations by marketing their products in accordance with the declared forms and manners of administration. Additionally, the Minister is responsible for ensuring that the declarations and determinations are consistent with the objectives of the PBS, which include providing reliable, timely, and affordable access to a wide range of medicines for Australians.
Failure to comply with the provisions of the Act and the legislative instrument can result in various consequences. While the Act does not explicitly detail specific offences, penalties, or consequences for breaches, non-compliance with ministerial determinations could potentially lead to administrative actions, such as fines or other penalties prescribed under the Act or related legislation. The National Health Act 1953 does not specify maximum penalties for breaches in this context, but other relevant legislation, such as the Administrative Penalties Act 1998, may apply. Additionally, companies failing to adhere to the declared forms and manners of administration might face civil consequences, such as disputes with the Commonwealth over benefits paid under the PBS, or even criminal charges if the breach is deemed to be of a serious nature, under other applicable criminal laws.