EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No.4)
PB 41 of 2012
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 listed drug, polygeline from F1.
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 July 2012.
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 2012 (No. 4) was enacted to 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). The National Health Act 1953 empowers the Minister to determine by legislative instrument the placement of listed drugs into F1 or F2 categories, based on criteria such as the presence of bioequivalent or biosimilar drugs. The 2012 Amendment Determination specifically removes the drug polygeline from F1, reflecting a policy decision based on the criteria set forth in the Act. This determination is the result of a consultative process involving the Pharmaceutical Benefits Advisory Committee and affected pharmaceutical companies, ensuring that recommendations align with the interests of consumers, health economists, and medical professionals. The determination was made under the authority of the Minister for Health and commenced on 1 July 2012.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 applies to pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS) and affects the allocation of drugs to the F1 and F2 formularies. This instrument, made under subsection 85AB(1) of the National Health Act 1953, amends the National Health (Listed drugs on F1 or F2) Determination 2010, which outlines the criteria for assigning drugs to the F1 and F2 formularies. F1 is designated for single brand drugs, while F2 is for drugs with multiple brands or in therapeutic groups with other multiple brand drugs. The purpose of this legislation is to ensure the appropriate allocation of listed drugs in the PBS, taking into consideration statutory price reductions, price disclosure, and guarantee of supply for drugs on F2. The Amending Determination removes polygeline from F1 and it is effective from 1 July 2012. The instrument constitutes a legislative instrument for the purpose of the Legislative Instruments Act 2003.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No.4) amends the National Health (Listed drugs on F1 or F2) Determination 2010. This instrument is made under subsection 85AB(1) of the National Health Act 1953 and it changes the allocation of drugs in the Pharmaceutical Benefits Scheme (PBS) formularies. Specifically, it removes polygeline from F1. The Act provides that listed drugs can be assigned to F1 or F2 formularies, with F1 being for single brand drugs and F2 for drugs that have multiple brands or are in a therapeutic group with multiple brand drugs. Drugs on F2 are subject to provisions relating to statutory price reductions, price disclosure and guarantee of supply. The criteria for a drug to be on F1 include no bioequivalent or biosimilar listed brands and it not being on F2 the day before the determination comes into effect. A drug may only be on F2 if it does not satisfy the criteria for F1.
The obligations imposed by the Act include ensuring that pharmaceutical companies with medicines listed on the PBS consult with the relevant parties before drugs are listed and allocated to formularies. This includes a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC), which has a majority of its members from key interest groups such as consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The Act requires that any PBAC recommendation is made following receipt of submissions by affected pharmaceutical companies. The Amending Determination affects pharmaceutical companies with medicines listed on the PBS and it commences on 1 July 2012.
Failure to comply with the provisions of the Act and the Amending Determination may result in civil or criminal consequences. The specific offences and penalties are not detailed in the Explanatory Statement but could include fines and imprisonment for serious breaches. The Act also includes provisions for the enforcement of its provisions by the Minister for Health. It is important to note that the Amending Determination constitutes a legislative instrument for the purpose of the Legislative Instruments Act 2003.