EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 4)
PB 41 of 2017
Authority
This Instrument, made under subsection 85AB(1) of the National Health Act 1953 (the Act), amends the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) (the Principal Determination).
The Principal Determination provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS).
Purpose
The Act provides that listed drugs may be assigned to formularies identified as F1 and F2.
F1 is intended for single brand drugs and F2 for drugs that have multiple brands, or are in a therapeutic group with other drugs with multiple brands. Drugs on F2 are subject to the provisions of the Act relating to first new brand statutory price reductions, price disclosure and guarantee of supply.
Section 84AC of the Act provides that a drug is on F1 or F2 if there is a determination in force under section 85AB that the drug is on F1 or F2.
Subsection 85AB(1) of the Act empowers the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2. For a drug to be on F1, it must satisfy the criteria in subsection 85AB(4). This requires that there are no listed brands of pharmaceutical items that have the drug that are bioequivalent or biosimilar, and no listed brands of pharmaceutical items that have another drug in the same therapeutic group as the first drug that are bioequivalent or biosimilar. It also requires that the drug was not on F2 the day before the determination comes into effect. A drug may only be determined to be on F2 if it does not satisfy one or more of the criteria for F1 (subsection 85AB(3)).
When subsection 85AB(5) of the Act applies, which relates to listed drugs with a single brand combination item on the PBS, the listed drug is not placed on F1 or F2, but on the administrative combination drug list.
This Instrument (the Amending Determination) amends the Principal Determination by adding one new drug – fluticasone furoate with vilanterol to F1 and removes three drugs from F1 – colestipol, fluphenazine decanoate and rosiglitazone as these drugs are no longer PBS listed. It also moves two currently listed drugs – fluticasone and zonisamide from F1 to F2 and moves another currently listed drug – fluticasone with salmeterol from the single brand Combination Drug List (CDL) to F2. In addition, it also removes one drug from F1 – etanercept as it is currently sitting in both F1 and F2.
Variation and revocation
Unless there is an express power to revoke or vary PB 93 of 2010 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 93 of 2010.
Consultation
The Amending 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 pharmacists, general practitioners, clinical pharmacologists and medical specialists. Further consultation on the Amending Determination was deemed unnecessary due to the consultation on allocation of the drugs to formularies with affected pharmaceutical companies that had already taken place.
The Amending Determination Instrument commences on 1 June 2017.
This Instrument constitutes a legislative instrument for the purpose of the
Legislation Act 2003.
Overview
The National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 4) is an amendment to the National Health (Listed drugs on F1 or F2) Determination 2010, which allocates drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. The purpose of this amendment is to update the list of drugs allocated to the F1 and F2 formularies by adding, removing, and transferring certain drugs in accordance with their current status as PBS-listed drugs. This legislative instrument was enacted by the Minister for Health or their delegate under subsection 85AB(1) of the National Health Act 1953 and constitutes a legislative instrument under the Legislation Act 2003. The amendment aims to reflect changes in the pharmaceutical landscape, ensuring that the allocation of drugs to formularies aligns with their current market status and therapeutic relevance.
Scope and Application
The National Health (Listed Drugs on F1 or F2) Amendment Determination 2017 applies to pharmaceutical companies with drugs listed on the Pharmaceutical Benefits Scheme (PBS) and directly affects the allocation of drugs to the F1 and F2 formularies within the PBS. Formulary F1 is designated for single-brand drugs, whereas F2 is for drugs that have multiple brands or are in a therapeutic group with other drugs having multiple brands. This Amendment Determination, made under the National Health Act 1953, amends the National Health (Listed Drugs on F1 or F2) Determination 2010 by adding fluticasone furoate with vilanterol to F1, and removing colestipol, fluphenazine decanoate and rosiglitazone from F1 due to their removal from the PBS list. It also involves shifting certain drugs between F1 and F2, and the Combination Drug List, based on their therapeutic classifications and brand status. The determination is applicable nationally, affecting the entire Commonwealth of Australia. The Amending Determination comes into effect on 1 June 2017 and constitutes a legislative instrument under the Legislation Act 2003.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 4) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The amendment adds fluticasone furoate with vilanterol to F1, and removes colestipol, fluphenazine decanoate, and rosiglitazone from F1 because these drugs are no longer listed on the PBS. Additionally, it moves fluticasone and zonisamide from F1 to F2, fluticasone with salmeterol from the single brand Combination Drug List (CDL) to F2, and removes etanercept from F1 because it is currently listed in both F1 and F2. The F1 formulary is for single brand drugs, while F2 is for drugs that have multiple brands, or are in a therapeutic group with other drugs with multiple brands. Drugs on F2 are subject to the provisions of the Act relating to first new brand statutory price reductions, price disclosure, and guarantee of supply.
The Amending Determination imposes obligations on pharmaceutical companies with medicines listed on the PBS. These companies must comply with the criteria for the allocation of drugs to the F1 and F2 formularies, as specified in the National Health Act 1953. For a drug to be placed on F1, it must satisfy the criteria outlined in subsection 85AB(4) of the Act, which includes the absence of bioequivalent or biosimilar listed brands of pharmaceutical items for the drug or any drug in the same therapeutic group. A drug may only be placed on F2 if it does not meet one or more of the criteria for F1. Additionally, the Act requires detailed consultations with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) before drugs are listed and allocated to formularies. The PBAC, composed of members from various health-related interests and professions, reviews submissions from affected pharmaceutical companies and makes recommendations based on their assessments.
The Act also outlines various offences, penalties, and consequences for breaches. Section 84AC of the National Health Act 1953 provides that a drug is on F1 or F2 if there is a determination in force under section 85AB that the drug is on F1 or F2. Subsection 85AB(1) empowers the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2. If a pharmaceutical company fails to comply with the criteria for the allocation of drugs to the F1 and F2 formularies, they may face penalties or consequences as specified in the Act. However, the maximum penalties for breaches are not explicitly stated in the provided text. It is essential for pharmaceutical companies to adhere to the requirements outlined in the Act to avoid potential penalties and ensure the proper allocation of drugs to the appropriate formularies.