EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 4)
PB 58 of 2013
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 adding one new listed drug tafluprost to F1.
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 September 2013.
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 2013 (No. 4) 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 amendment was introduced to address the need for updating the formularies of the Pharmaceutical Benefits Scheme (PBS) by adding the drug tafluprost to F1, which is intended for single brand drugs. The National Health Act 1953 provides for the allocation of drugs to the F1 and F2 formularies, with F2 drugs subject to statutory price reductions, price disclosure and guaranteed supply. The determination process involves detailed consultation with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which comprises members from various relevant interests and professions. The Amending Determination instrument commenced on 1 September 2013 and constitutes a legislative instrument under the Legislative Instruments Act 2003.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 4) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which is concerned with the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This legislative instrument applies to pharmaceutical companies with medicines listed on the PBS, as well as to the Minister for Health who has the authority to determine by legislative instrument that a listed drug is on F1 or F2. The geographic reach of this Act is national, as it is a Commonwealth instrument. The instrument commences on 1 September 2013, and there are no stated exclusions or exemptions. The criteria for F1 and F2 drug allocations are set out in subsections 85AB(3) and 85AB(4) of the National Health Act 1953, and any changes to the Principal Determination are made through subordinate instruments such as this Amending Determination.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 4) primarily concerns the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS), specifically adding the drug tafluprost to the F1 formulary (subsection 85AB(1) and (4)). The F1 formulary is designated for drugs with a single brand, while F2 is for drugs with multiple brands or those within a therapeutic group with other multi-brand drugs (subsection 85AB(3) and (4)). The F2 formulary is subject to statutory price reductions, price disclosure, and guaranteed supply provisions (subsection 85AB(5)). The criteria for F1 drugs include the absence of bioequivalent or biosimilar listed brands of the same drug or similar therapeutic group drugs, and the drug must not have been on F2 the day before the determination comes into effect (subsection 85AB(4)).
The obligations imposed by this Amendment Determination include the requirement for pharmaceutical companies to ensure that their listed drugs comply with the criteria for allocation to F1 or F2 formularies. This involves providing detailed information and undergoing consultations with the Pharmaceutical Benefits Advisory Committee (PBAC) and the intended responsible person. The PBAC, consisting of two-thirds members from relevant interests or professions such as consumers, health economists, and medical specialists, plays a critical role in recommending the allocation of drugs to the appropriate formularies (subsection 85AB(5)). The Minister, empowered by subsection 85AB(1) of the Act, must make the determination based on these recommendations and criteria.
Failure to comply with the provisions outlined in this Amendment Determination may lead to administrative or legal consequences. Although the Explanatory Statement does not explicitly state penalties, breaches of the National Health Act 1953 can result in civil or criminal penalties depending on the nature and severity of the breach. For instance, non-compliance with price disclosure requirements could lead to civil penalties, while more severe breaches might result in criminal charges. The maximum penalties are not specified in the Explanatory Statement, but they can be found in the relevant sections of the Act and other related legislation.