EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 1)
PB 8 of 2020
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 to F1 one drug cinacalcet, a previously delisted drug which is relisting on the PBS. It also moves one currently listed drug, tiotropium from F1 to F2 in addition to moving one currently listed drug, ezetimibe with atorvastatin from the single brand Combination Drug List (CDL) to 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 February 2020.
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 2020 (No. 1) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010 under subsection 85AB(1) of the National Health Act 1953. This Act was introduced to address the need for the ongoing management and allocation of listed drugs to the Pharmaceutical Benefits Scheme (PBS) formularies, specifically F1 and F2. The F1 formulary is designated for single brand drugs, while F2 is for drugs with multiple brands or those in a therapeutic group with multiple brands. This amendment was made by the Minister under the authority of the National Health Act, and it aims to ensure that drugs are appropriately categorised to facilitate effective healthcare delivery and cost management. The determination follows detailed consultations with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, which includes experts from various healthcare-related fields. The legislative instrument became effective on 1 February 2020.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 1) is an instrument made under the National Health Act 1953, specifically amending the National Health (Listed drugs on F1 or F2) Determination 2010. This determination pertains to the allocation of listed drugs within the Pharmaceutical Benefits Scheme (PBS), categorising them into F1 and F2 formularies. F1 is designated for single brand drugs, whereas F2 is for drugs with multiple brands or those in a therapeutic group with other multi-brand drugs. The amendment affects pharmaceutical companies with medicines listed on the PBS, and it includes the reallocation of specific drugs such as cinacalcet to F1, tiotropium from F1 to F2, and ezetimibe with atorvastatin from the Combination Drug List (CDL) to F2. The changes are effective from 1 February 2020 and are subject to the provisions of the Act relating to statutory price reductions, price disclosure, and supply guarantees for drugs on F2. The amendment is made through legislative instrument and constitutes a legislative instrument under the Legislation Act 2003.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 1) (the Amending Determination) include section 2, which amends the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination) by adding cinacalcet to F1, moving tiotropium from F1 to F2, and moving ezetimibe with atorvastatin from the single brand Combination Drug List (CDL) to F2. Section 3 of the Amending Determination provides the commencement date of 1 February 2020, which is when these changes take effect. Additionally, section 4 refers to the authority of the Minister or delegate to determine by legislative instrument that a listed drug is on F1 or F2 under section 85AB of the National Health Act 1953 (the Act).
The Amending Determination imposes specific obligations and requirements on the parties it governs. Pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS) must comply with the allocation of drugs to the F1 and F2 formularies as specified in the Amending Determination. This includes ensuring that drugs are placed in the appropriate formulary based on the criteria outlined in the Principal Determination and the Amending Determination. Additionally, pharmaceutical companies must adhere to the provisions of the Act relating to first new brand statutory price reductions, price disclosure, and guarantee of supply for drugs on F2.
Breaches of the provisions of the Amending Determination or the Principal Determination may result in offences, penalties, or civil and criminal consequences. While the explanatory statement does not specify the exact penalties, breaches of the Act or the determinations may lead to enforcement actions, fines, or other legal consequences as prescribed by the relevant legislation. It is essential for pharmaceutical companies and other relevant parties to ensure compliance with the requirements to avoid potential penalties and consequences.