EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 11)
PB 98 of 2019
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 two drugs, risankizumab and sodium phenylbutyrate. It also moves one currently listed drug, sevelamer from F1 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 December 2019.
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 2019 (No. 11) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010. This legislation, introduced by the Parliament of Australia under the National Health Act 1953, aims to adjust the allocation of listed drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Formulary F1 is designated 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. This amendment specifically adds two drugs, risankizumab and sodium phenylbutyrate, to F1 and moves sevelamer from F1 to F2. The policy objective is to ensure the appropriate distribution of drugs within the PBS to manage costs and ensure equitable access to pharmaceutical treatments.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 11) amends the National Health (Listed drugs on F1 or F2) Determination 2010 under the National Health Act 1953, which governs the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The Act applies to pharmaceutical companies with medicines listed on the PBS, and the amendment specifically affects the drugs risankizumab, sodium phenylbutyrate, and sevelamer by altering their placement within the F1 and F2 formularies. The amendment adds risankizumab and sodium phenylbutyrate to F1 and moves sevelamer from F1 to F2, thereby altering the regulatory and pricing frameworks for these drugs. The geographic and jurisdictional reach of this Act is national, as it pertains to the PBS, a Commonwealth-administered scheme. The Act does not explicitly state any exclusions, but its application is subject to the criteria outlined in the Act for drug allocation to F1 and F2. The application and interpretation of this Act may be further extended or restricted through subordinate instruments as necessary.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 11) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (F2011L01103) by adding two new drugs to the F1 formulary and moving one drug from F1 to F2 (section 3(1)). Specifically, the drugs risankizumab and sodium phenylbutyrate are added to F1 (section 3(1)(a)), and sevelamer is moved from F1 to F2 (section 3(1)(b)). This amendment affects the Pharmaceutical Benefits Scheme (PBS) and how drugs are allocated and reimbursed.
The obligations imposed by the Act on the parties it governs include the requirement for thorough consultations before any changes to drug allocations. This process involves consultations with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which is composed of members from various health-related fields such as consumers, health economists, pharmacists, general practitioners, clinical pharmacologists, and medical specialists (section 3(1)). The PBAC’s recommendations are based on submissions from affected pharmaceutical companies, ensuring a comprehensive review of each drug's therapeutic value, cost-effectiveness, and other relevant factors.
Failure to comply with the provisions of the Act and the Amending Determination may lead to civil or criminal consequences. While the explanatory statement does not explicitly mention specific offences or penalties, breaches of the Act or its regulations can generally result in fines and, in severe cases, imprisonment. The precise penalties would depend on the specific provisions of the Act that are breached. The Amending Determination is a legislative instrument under the Legislation Act 2003, which further underscores its legal enforceability and the potential for enforcement actions in case of non-compliance.
The Amending Determination revokes the Principal Determination to the extent necessary to implement the changes specified in this amendment (subsection 33(3) of the Acts Interpretation Act 1901). This means that any parts of the Principal Determination that conflict with the changes made by this Instrument are effectively revoked. The Amending Determination takes effect from 1 December 2019, marking the date from which the new allocations of drugs to the F1 and F2 formularies will be legally applicable.