EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 5)
PB 59 of 2018
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 new drug – ribociclib, in addition to changes to the drug name for 37 drugs on both the F1 and F2 formulary due to International Harmonisation of Ingredient Names (IHIN) reform.
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 in addition to the administrative nature of the changes due to the IHIN reform. All changes in this instrument except one are amendments to the naming of drugs in Schedule 1 and are consistent with the naming conventions adopted by the IHIN reform.
The Amending Determination Instrument commences on 1 July 2018.
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 2018 (No. 5) is an amendment made under subsection 85AB(1) of the National Health Act 1953. This Act, enacted to ensure that listed drugs are allocated appropriately within the Pharmaceutical Benefits Scheme (PBS), was amended to refine the allocation of drugs to the F1 and F2 formularies. The determination addresses the administrative changes necessary due to the International Harmonisation of Ingredient Names (IHIN) reform, which necessitated changes in drug names, and adds one new drug, ribociclib, to the F1 formulary. The policy objective is to ensure that drugs are correctly categorised and managed within the PBS framework, promoting consistency and accessibility in drug supply and pricing. The changes made by this amendment are consistent with the conventions adopted by the IHIN reform, and further consultation was deemed unnecessary due to the prior consultation process and the administrative nature of these amendments.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 5) amends the National Health (Listed drugs on F1 or F2) Determination 2010 to update the allocation of listed drugs within the Pharmaceutical Benefits Scheme (PBS). This legislation applies to pharmaceutical companies that have drugs listed on the PBS, and specifically affects drugs assigned to the F1 and F2 formularies, which cater to single brand and multiple brand drugs, respectively. The amendments include the addition of ribociclib to the F1 formulary and modifications to the names of 37 drugs on both the F1 and F2 formularies, reflecting the International Harmonisation of Ingredient Names reform. The changes are made under the authority of the National Health Act 1953, and the amendment instrument operates across the Commonwealth of Australia, impacting the national pharmaceutical market. The Amending Determination does not introduce new exclusions or exemptions but updates existing provisions and drug names in alignment with international naming conventions. The instrument revokes and varies the Principal Determination where necessary, and it commenced on 1 July 2018, constituting 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 2018 (No. 5) (the Amending Determination) pertain to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This determination, under section 85AB(1) of the National Health Act 1953, amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding ribociclib to the F1 formulary and updating the drug names for 37 drugs on both the F1 and F2 formularies due to International Harmonisation of Ingredient Names (IHIN) reform. Section 85AB(4) stipulates the criteria for a drug to be placed on F1, while section 85AB(3) outlines the criteria for a drug to be placed on F2. Additionally, subsection 85AB(5) specifies that listed drugs with a single brand combination item on the PBS are placed on the administrative combination drug list instead of F1 or F2.
The Act imposes obligations on pharmaceutical companies with medicines listed on the PBS. These obligations include participation in consultations about drug allocation to the formularies and adherence to the criteria set forth in the Act for drugs to be placed on F1 or F2. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a significant role in these consultations, providing recommendations following submissions from affected pharmaceutical companies. The PBAC, which comprises representatives from various interests and professions, including consumers, health economists, community pharmacists, general practitioners, clinical pharmacologists, and medical specialists, ensures a comprehensive review of the drug's suitability for the F1 or F2 formulary.
Breach of the obligations and requirements set forth in the National Health Act 1953 can result in various consequences. Although the specific offences and penalties are not detailed in the explanatory statement, breaches of legislative instruments generally can lead to civil or criminal penalties under the Legislation Act 2003. Civil penalties can include fines, while criminal penalties can include imprisonment, depending on the severity of the breach. The maximum penalties are not specified in the explanatory statement but would be determined by the relevant legislation governing the PBS and the National Health Act 1953. Compliance with the Act is essential to avoid these potential legal repercussions and to ensure the proper administration of the Pharmaceutical Benefits Scheme.