EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 6)
PB 61 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 new drug, semaglutide. In addition, it also removes one drug from F1, prasugrel as this drug is no longer PBS listed.
Variation and revocation
Unless there is an express power to revoke or vary PB 93 of 2010 cited in this Instrument, 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 a pharmaceutical company with a new medicine listing on the PBS and a pharmaceutical company removing a products from the PBS. Prasugrel is being removed from the PBS at the request of the pharmaceutical company. Semaglutide meets the criteria for F1 set out in section 85AB(4) of the Act. Before the drug semaglutide was listed and allocated to a formulary, there were detailed consultations about the drug with the responsible person, and a recommendation was received from the Pharmaceutical Benefits Advisory Committee (PBAC). Any PBAC recommendation is made following receipt of a submission made by the affected pharmaceutical company. 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 July 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, introduced under the National Health Act 1953, addresses the need to update the formularies of the Pharmaceutical Benefits Scheme (PBS) by amending the National Health (Listed drugs on F1 or F2) Determination 2010. This amendment, enacted by the Parliament of Australia, aims to ensure that the allocation of drugs to the F1 and F2 formularies aligns with current therapeutic needs and market conditions. The F1 formulary is designated for single brand drugs, while the F2 formulary is intended for drugs with multiple brands or those in therapeutic groups with multiple brands. The determination process follows rigorous criteria, including bioequivalence and biosimilarity assessments, to ensure appropriate drug placement. The Amending Determination introduces semaglutide to F1, meeting the specified criteria, and removes prasugrel from F1 due to its removal from the PBS. This legislative amendment reflects the ongoing evaluation and adjustment of the PBS to meet public health needs effectively.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 6) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which governs the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This legislation applies to pharmaceutical companies, specifically those with drugs listed on the PBS, as it affects their drugs being placed on or removed from the F1 and F2 formularies. The Act has a Commonwealth reach, as it is an instrument made under the National Health Act 1953. The Amendment Determination adds the drug semaglutide to F1 and removes prasugrel from F1 as it is no longer listed on the PBS. The criteria for F1 placement are outlined in section 85AB(4) of the Act, which requires that the drug must have no listed bioequivalent or biosimilar brands and must not have been on F2 previously. There are no stated exclusions or thresholds in this Amendment Determination. The application of the Act may be extended or restricted through subordinate instruments, as per subsection 33(3) of the Acts Interpretation Act 1901.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 6) amend the National Health (Listed drugs on F1 or F2) Determination 2010, which governs the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Under section 85AB(1) of the National Health Act 1953, the Minister (or delegate) can determine by legislative instrument that a listed drug is on F1 or F2. This amendment adds semaglutide to F1 and removes prasugrel from F1 (subsection 85AB(5)). F1 is intended for single brand drugs that meet specific criteria, including the absence of bioequivalent or biosimilar brands in the same therapeutic group, and F2 is for drugs with multiple brands. Drugs on F2 are subject to certain provisions of the Act, such as first new brand statutory price reductions, price disclosure, and guarantee of supply.
The obligations and requirements imposed by the Act on the parties or entities it governs include ensuring that drugs are appropriately allocated to the correct formulary based on the criteria outlined in the Act. Pharmaceutical companies must comply with these criteria when seeking to have their drugs listed on the PBS and assigned to the appropriate formulary. The Minister (or delegate) must consult with relevant stakeholders, including the Pharmaceutical Benefits Advisory Committee (PBAC), before making any determinations. The PBAC, composed of members from various healthcare interests and professions, provides recommendations to the Minister (or delegate) following submissions from pharmaceutical companies. Additionally, the Act mandates that any amendments to the Principal Determination, such as those made by the Amending Determination, be made under the authority of the Acts Interpretation Act 1901, unless otherwise specified.
Offences, penalties, or civil/criminal consequences for breach of the Act are not explicitly stated in the Explanatory Statement. However, the Act provides that listed drugs must be assigned to the correct formulary based on the criteria set out in the Act. Failure to comply with these criteria or the provisions of the Act may result in legal consequences. For example, pharmaceutical companies that do not comply with the requirements for drug listing and formulary allocation may face challenges in having their drugs included on the PBS. Additionally, any misuse of the determination process or non-compliance with the obligations and requirements of the Act may lead to legal action or penalties as prescribed by other relevant legislation. The specifics of such penalties would be governed by the broader legislative framework rather than this particular amendment.