National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 1) (No. PB 12 of 2013)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 1) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010. This instrument, made under the authority of the National Health Act 1953, updates the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS) formularies. The determination addresses the need to assign specific drugs to the appropriate formulary based on their therapeutic category and brand availability, ensuring that they comply with statutory requirements for price reductions, price disclosure and guaranteed supply. This legislative amendment by the Minister for Health seeks to maintain the integrity of the PBS by ensuring drugs are correctly categorised within the F1 and F2 formularies, thereby facilitating appropriate reimbursement and access for consumers. The Amending Determination introduces pregabalin to F1, reflecting a careful consideration of its therapeutic profile and brand status.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 1) amends the National Health (Listed drugs on F1 or F2) Determination 2010 to adjust the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS). This legislation applies to pharmaceutical companies with medicines listed on the PBS, as well as the therapeutic goods and drugs themselves. The amendment specifically adds the drug pregabalin to the F1 formulary, which is intended for drugs with a single brand, by virtue of its compliance with the criteria outlined in the National Health Act 1953. The amendment comes into effect on 1 March 2013 and adheres to the legislative framework established by the Legislative Instruments Act 2003. The geographic and jurisdictional reach of this Act is national, as it pertains to the PBS which is a Commonwealth initiative. There are no specific exclusions, exemptions, or thresholds mentioned in the text, although the process for determining drug allocation involves extensive consultation with various stakeholders, including the Pharmaceutical Benefits Advisory Committee (PBAC).

Key Provisions

The main operative sections of this instrument are subsections 85AB(1) and 85AB(5) of the National Health Act 1953 (the Act), which empower the Minister to determine by legislative instrument that a listed drug is on F1 or F2. This determination is made under subsection 85AB(1) of the Act. The Amending Determination specifically adds one drug, pregabalin, to F1, aligning with the criteria outlined in subsection 85AB(4) of the Act. This means that pregabalin must meet the requirements of having no listed brands of pharmaceutical items that are bioequivalent or biosimilar, and it must not have been on F2 the day before the determination came into effect. The Act also specifies that if a drug does not meet the criteria for F1, it can be placed on F2, as detailed in subsection 85AB(3). However, when subsection 85AB(5) applies, drugs with a single brand combination item on the PBS are placed on the administrative combination drug list instead of F1 or F2. The obligations and requirements imposed by the Act on the parties it governs include ensuring that drugs are appropriately allocated to the F1 or F2 formularies based on their bioequivalence, biosimilarity, and therapeutic grouping. Pharmaceutical companies must engage in detailed consultations with the responsible person and provide necessary information for the Pharmaceutical Benefits Advisory Committee (PBAC) to make recommendations. The PBAC, consisting of members from various health-related professions, reviews submissions from affected pharmaceutical companies before making recommendations to the Minister. The Minister then uses this information to determine the appropriate formulary allocation for the drug. The Act also mandates that the determination must be made by legislative instrument and that any changes to the formulary allocations must be communicated effectively to all relevant parties. The National Health Act 1953 imposes specific offences, penalties, or civil and criminal consequences for breaches of its provisions. While the Act itself does not detail specific penalties for non-compliance with the formulary allocations, breaches of other sections related to the PBS could result in penalties. For example, subsection 109C(1) of the Act outlines that a person who contravenes a provision of the Act is liable to a penalty not exceeding $22,200 for a corporation and $4,440 for an individual. Additionally, subsection 109C(2) stipulates that in the case of a continuing failure to comply, a further penalty may be imposed for each day the failure continues. These penalties underscore the importance of adhering to the Act's requirements for the proper management and allocation of drugs on the PBS. The Amending Determination, as a legislative instrument, is subject to the requirements and processes outlined in the Legislative Instruments Act 2003. This includes ensuring that the instrument is made in accordance with the legislative authority granted by the Act, and that it is registered and published as required. The determination also requires that any changes to the formulary allocations are clearly communicated to the relevant pharmaceutical companies and stakeholders to ensure compliance with the Act’s provisions. Failure to comply with these legislative requirements could result in the instrument being deemed invalid or unenforceable, thereby affecting the legal status and efficacy of the drug allocations specified within it.