National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 3) (PB 32 of 2017)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 3) is an amendment to the National Health (Listed drugs on F1 or F2) Determination 2010, enacted under subsection 85AB(1) of the National Health Act 1953. This Act was introduced to address the need for a structured allocation of drugs to specific formularies within the Pharmaceutical Benefits Scheme (PBS) to ensure efficient and effective management of pharmaceutical benefits. The amendment was necessitated by the need to update the list of drugs on F1 and F2, and the Amending Determination serves to incorporate four new drugs into the F1 formulary, while removing three drugs from F1 and moving one drug from F1 to F2. The enacting body is the Minister for Health, who has the authority to make such determinations under the Act. The policy objective is to ensure that the allocation of drugs to formularies within the PBS is kept current and reflective of the latest therapeutic developments and market conditions.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2017 applies to drugs listed under the Pharmaceutical Benefits Scheme (PBS) and affects pharmaceutical companies involved with these drugs. The Amendment Determination amends the National Health (Listed drugs on F1 or F2) Determination 2010, assigning four new drugs—blinatumomab, chloramphenicol, daclizumab, and nintedanib, as well as a protein formula with carbohydrate, fat, vitamins, and minerals—to the F1 formulary. It also removes three drugs—bacillus calmette and guerin, connaught strain; boceprevir; and gestrinone—from F1 as they are no longer listed on the PBS. Additionally, the determination moves tranexamic acid from F1 to F2. This legislation operates under the National Health Act 1953, which is a Commonwealth Act and thus has a national jurisdictional reach in Australia. The Act allows for the assignment of listed drugs to F1 and F2 formularies, with F1 designated for single brand drugs and F2 for drugs that have multiple brands or are in a therapeutic group with other multi-brand drugs. The criteria for inclusion in F1 and F2 are outlined in the Act, and the Minister or delegate can make determinations by legislative instrument. The amendment determination does not introduce any new exclusions, exemptions, or thresholds beyond what is already stipulated in the principal determination or the Act itself.

Key Provisions

The main sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 3) (the Amending Determination) amend the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination). These amendments are detailed in section 2 of the Amending Determination and involve changes to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Specifically, four new drugs – blinatumomab, chloramphenicol, daclizumab, nintedanib, and protein formula with carbohydrate, fat, vitamins and minerals – are added to F1. Concurrently, three drugs – bacillus calmette and guerin, connaught strain; boceprevir; and gestrinone – are removed from F1 because they are no longer listed on the PBS. Moreover, tranexamic acid is moved from F1 to F2. These changes are made under the authority of the National Health Act 1953 (the Act), which allows the Minister or a delegate to determine by legislative instrument that a listed drug is on F1 or F2. The obligations and requirements imposed by the Act on the parties or entities it governs include ensuring that the criteria for drug allocation to F1 and F2 are met. Section 85AB(4) of the Act specifies that for a drug to be placed on F1, there must be no bioequivalent or biosimilar listed brands of pharmaceutical items that contain the drug or another drug in the same therapeutic group. Additionally, the drug must not have been on F2 the day before the determination takes effect. Conversely, a drug may only be placed on F2 if it does not meet one or more of the criteria for F1. Section 85AB(5) of the Act also notes that certain drugs with a single brand combination item on the PBS are placed on the administrative combination drug list instead of F1 or F2. Pharmaceutical companies must adhere to these criteria and ensure that their drugs comply with the requirements set out in the Act and the Principal Determination. The Amending Determination does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches. However, the National Health Act 1953 provides a framework for enforcement. Breaches of the Act may result in civil or criminal penalties, depending on the nature and severity of the violation. For example, section 114 of the Act allows for civil penalties for non-compliance with certain provisions, while section 121 allows for criminal penalties for breaches involving fraud or other serious misconduct. The maximum penalties for these offences are detailed in the relevant sections of the Act. Compliance with the Act and its determinations is therefore crucial to avoid potential legal repercussions.