EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 3)
PB 46 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 five new listed drugs abiraterone, glycomacropeptide and essential amino acids, glycomacropeptide and essential amino acids with vitamins and minerals, ipilimumab, and mifepristone to F1. It also moves two drugs misoprostol and montelukast from F1 to F2. In addition three drugs, candesartan with hydrochlorothiazide, lamivudine with zidovudine, and telmisartan with hydrochlorothiazide move from the combination drug list to F2. Two listed drugs are changing their legal instrument description in the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 9) (PB 40 of 2013) to Bacillus Calmette and Guerin Connaught strain and Bacillus Calmette and Guerin, Tice strain and for consistency need to match this description in this determination.
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 August 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. 3) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010 under the National Health Act 1953. This Act was introduced to address the need for a structured approach to the allocation of drugs to specific formularies within the Pharmaceutical Benefits Scheme (PBS). The determination allows for drugs to be assigned to either F1 or F2 formularies, where F1 is intended for drugs with a single brand and F2 for drugs with multiple brands or those in a therapeutic group with other multi-brand drugs. The purpose of this legislative instrument, authorised by the Minister for Health, is to adjust the allocation of certain drugs within these formularies to ensure better management and accessibility of pharmaceutical benefits. The determination involves detailed consultation with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, ensuring a comprehensive and informed approach to drug allocation.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 3) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by allocating specific drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The National Health Act 1953 governs this allocation, allowing drugs to be assigned to F1 or F2 formularies to facilitate single brand or multiple brand drug arrangements, respectively. The F2 formulary is subject to statutory price reductions, price disclosure, and supply guarantees. The Amending Determination adds abiraterone, glycomacropeptide and essential amino acids, glycomacropeptide and essential amino acids with vitamins and minerals, ipilimumab, and mifepristone to F1, and moves misoprostol and montelukast from F1 to F2, as well as three combination drugs from the combination drug list to F2. Additionally, two drugs' legal descriptions are updated to match recent changes. The Amending Determination affects pharmaceutical companies and commences on 1 August 2013.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 3) (Amending Determination) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (Principal Determination). The Act, specifically section 85AB(1), empowers the Minister to determine that a listed drug is on F1 or F2. The Amending Determination adds five new drugs to F1 and moves two drugs from F1 to F2, as well as three drugs from the combination drug list to F2. The purpose of this Amendment is to allocate drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS), where F1 is for single brand drugs and F2 for drugs with multiple brands or in a therapeutic group with other drugs with multiple brands.
The Act imposes obligations on the Minister to determine the allocation of drugs to F1 or F2, ensuring that the criteria in subsection 85AB(4) for F1 and subsection 85AB(3) for F2 are met. Drugs on F2 are subject to statutory price reductions, price disclosure, and guarantee of supply. Additionally, the Amending Determination requires consultation with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, composed of experts in various relevant fields, reviews submissions from affected pharmaceutical companies before making recommendations to the Minister.
There are no specific offences, penalties, or civil/criminal consequences outlined in the Amending Determination. However, the overarching National Health Act 1953 does provide for penalties in cases of non-compliance with the provisions of the Act. The Minister may face administrative and financial penalties for failure to comply with the Act's requirements, including fines of up to $22,200 per contravention for individuals and $111,000 for corporations. Additionally, the Act may provide for civil and criminal liability for breaches of the Act and its regulations.