EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 4)
PB 52 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 adding one new drug anakinra to F1 and also removes one drug calcipotriol from 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 June 2015.
This Instrument constitutes a legislative instrument for the purpose of the
Legislative Instruments Act 2003.
Overview
The National Health Act 1953 was enacted to establish and maintain a health care system that provides accessible and affordable health services to Australians. One of the mechanisms through which the Act achieves this is by allocating drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 4) was introduced to amend the National Health (Listed drugs on F1 or F2) Determination 2010. This amendment was made under subsection 85AB(1) of the National Health Act 1953 by the Minister for Health. The purpose of this amendment is to adjust the allocation of certain drugs within the PBS formularies to ensure appropriate access and affordability for consumers. The policy objective is to manage the therapeutic groups and brand availability of drugs on the PBS, thereby ensuring that the scheme remains effective and efficient.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 4) applies to the Pharmaceutical Benefits Scheme (PBS) and governs the allocation of drugs to the F1 and F2 formularies within this scheme. This legislation amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding anakinra to the F1 formulary and removing calcipotriol from the F1 formulary. The Act applies to pharmaceutical companies with medicines listed on the PBS, and the amendments are made following detailed consultations and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The determination is applicable nationally and is subject to the provisions of the National Health Act 1953. The amendment does not include any specific exclusions, exemptions, or thresholds, and the application of the Act may be extended or restricted through subordinate instruments as necessary.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 4) are concerned with the amendment of the National Health (Listed drugs on F1 or F2) Determination 2010. Specifically, the Amending Determination adds the drug anakinra to the F1 formulary and removes the drug calcipotriol from the F1 formulary (subsection 85AB(1) of the Act). The F1 formulary is intended 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. The F1 and F2 formularies are part of the Pharmaceutical Benefits Scheme (PBS), and drugs on F2 are subject to the provisions of the Act relating to statutory price reductions, price disclosure, and guarantee of supply.
The obligations and requirements imposed by the Act on the parties and entities it governs are primarily related to the classification and allocation of drugs to the F1 and F2 formularies. The Act requires that drugs must satisfy specific criteria to be placed on either F1 or F2 (subsection 85AB(4) and (3) of the Act). For a drug to be placed on F1, it must have no bioequivalent or biosimilar listed brands and must not have been on F2 the day before the determination comes into effect. A drug can only be placed on F2 if it does not satisfy the criteria for F1. The Act also requires that drugs with a single brand combination item on the PBS are placed on the administrative combination drug list rather than on F1 or F2 (subsection 85AB(5) of the Act).
The Amending Determination contains no explicit provisions regarding offences, penalties, or civil/criminal consequences for breach. However, it is reasonable to assume that any breach of the Act or its regulations would result in the standard consequences under Australian law. This could include fines, imprisonment, or other civil or criminal penalties, depending on the nature and severity of the breach. The maximum penalties for breaches of the National Health Act 1953 or its regulations would be determined by the relevant legislation and could vary widely depending on the specific offence and circumstances.