EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 1)
PB 6 of 2015
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 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 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 removing one drug cidofivir from F1 and also removes one drug ticlopidine from F2. In addition, administrative amendments are being applied to two PBS listed drugs in F2. Doxorubicin – peglyated liposomal and electrolyte replacement (oral) are changing their descriptions to doxorubicin – pegylated liposomal and electrolyte replacement, oral to match, for consistency, the description in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
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.
The Amending Determination Instrument commences on 1 February 2015.
This Instrument constitutes a legislative instrument for the purpose of the
Legislative Instruments Act 2003.
Overview
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 1), made under the National Health Act 1953, amends the National Health (Listed drugs on F1 or F2) Determination 2010. This legislation, enacted by the Australian Parliament, aims to address the need for an updated and accurate allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). F1 is designated for single brand drugs, while F2 is for drugs with multiple brands or those in a therapeutic group with other drugs that have multiple brands. The amendment removes cidofivir from F1 and ticlopidine from F2, and makes administrative changes to the descriptions of doxorubicin – pegylated liposomal and electrolyte replacement, oral to ensure consistency with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The policy objective of the Act is to ensure that listed drugs are appropriately allocated to the relevant formularies, promoting efficient and effective management of the PBS.
Scope and Application
The National Health Act 1953, as amended by the National Health (Listed drugs on F1 or F2) Amendment Determination 2015, pertains to the regulation of listed drugs within the Pharmaceutical Benefits Scheme (PBS) in Australia. The Act applies to pharmaceutical companies and entities responsible for the provision of listed drugs, ensuring they adhere to the criteria and guidelines set out for allocation to the F1 and F2 formularies. These formularies serve specific purposes: F1 is designated for single brand drugs, while F2 accommodates drugs that have multiple brands or fall within a therapeutic group with other drugs having multiple brands. The Act also includes provisions for statutory price reductions, price disclosure, and the guarantee of supply for drugs on F2. The Amending Determination, which came into effect on 1 February 2015, modifies the Principal Determination by removing certain drugs from their respective formularies and making administrative changes to others, ensuring consistency and accuracy in drug descriptions across PBS listings. The determination process involves consultation with stakeholders, including pharmaceutical companies, and recommendations from the Pharmaceutical Benefits Advisory Committee, which comprises experts from various relevant fields.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 1) (the Amending Determination) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination) under section 85AB(1) of the National Health Act 1953 (the Act). The primary purpose of the Amending Determination is to adjust the allocation of certain drugs within the Pharmaceutical Benefits Scheme (PBS) formularies. Specifically, it removes cidofivir from the F1 formulary and ticlopidine from the F2 formulary, and modifies the descriptions of doxorubicin – pegylated liposomal and electrolyte replacement, oral to align with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The F1 formulary is designated for single brand drugs, while the F2 formulary is for drugs that have multiple brands or belong to a therapeutic group with multiple brands. These formularies are subject to specific provisions under the Act, including statutory price reductions, price disclosure, and a guarantee of supply.
Entities governed by the Act, particularly pharmaceutical companies with drugs listed on the PBS, must adhere to the requirements set forth in the Principal Determination and the Amending Determination. These entities must ensure that their drugs are correctly allocated to the appropriate formularies based on the criteria specified in section 85AB of the Act. For a drug to be placed on the F1 formulary, it must meet strict criteria such as the absence of bioequivalent or biosimilar brands and must not have been on the F2 formulary the day before the determination takes effect. Conversely, drugs that do not meet the F1 criteria may be placed on the F2 formulary. The changes effected by the Amending Determination necessitate adjustments by pharmaceutical companies to comply with the updated formulary allocations.
Breaches of the requirements under the Act and the Amending Determination may result in various consequences, though specific offences, penalties, or civil/criminal consequences are not explicitly detailed in the explanatory statement. However, the Act provides a framework within which non-compliance could lead to actions under relevant sections of the legislation, potentially including fines, administrative penalties, or other legal actions as deemed appropriate by the relevant authorities. The determination of exact penalties would depend on the nature and severity of the breach, as well as any additional legislative provisions that may apply.