EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 11)
PB 123 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 removing three PBS listed drugs, aluminium hydroxide with magnesium trisilicate and magnesium hydroxide, chloramphenicol, and ferrous fumarate from F1 and moves one PBS listed drug from the combination drug list to F1. It also moves one already PBS listed drug, pemetrexed, from F1 to F2. In addition, several administrative amendments are being applied to PBS listed drugs to match, for consistency, the description in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
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 January 2016.
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 2015 (No. 11) is an amendment to the National Health (Listed drugs on F1 or F2) Determination 2010, made under subsection 85AB(1) of the National Health Act 1953. This legislation aims to adjust the allocation of certain drugs within the Pharmaceutical Benefits Scheme (PBS) formularies, specifically moving them between F1 and F2 categories or the combination drug list, thereby addressing any inconsistencies or changes in market conditions since the original determination. The amendment process involves detailed consultations with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, ensuring a balanced consideration of consumer, economic, and clinical perspectives. The determination is set to commence on 1 January 2016, providing a structured framework for the ongoing management and evaluation of drugs listed on the PBS.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 11) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which allocates drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. The Act applies to listed drugs and their manufacturers, with F1 intended for single brand drugs and F2 for drugs with multiple brands or in a therapeutic group with other multiple-brand drugs. This Amendment Determination specifically removes three PBS listed drugs from F1 and moves one drug from the combination drug list to F1, while also moving pemetrexed from F1 to F2, and making several administrative amendments to match descriptions in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The Amending Determination impacts pharmaceutical companies with medicines listed on the PBS and requires consultation with the Pharmaceutical Benefits Advisory Committee, which includes members from various health-related professions. The changes outlined in the Amending Determination commence on 1 January 2016.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 11) (the Amending Determination) are those that provide for the amendment of the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination) in relation to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Section 3 of the Amending Determination removes three drugs—aluminium hydroxide with magnesium trisilicate and magnesium hydroxide, chloramphenicol, and ferrous fumarate—from F1. It also moves one drug, pemetrexed, from F1 to F2. Furthermore, it moves one drug from the combination drug list to F1 and makes several administrative amendments to the descriptions of PBS listed drugs to ensure consistency with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). These changes are significant as they directly affect the availability and pricing of these drugs under the PBS.
The Amending Determination imposes obligations on pharmaceutical companies and other stakeholders to comply with the new allocations of drugs to F1 and F2. Pharmaceutical companies must ensure that the drugs are correctly listed and marketed according to their new formulary status. Additionally, healthcare providers must be aware of and comply with the new provisions when prescribing and dispensing these drugs. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in the process, providing recommendations based on detailed consultations with stakeholders and expert analysis. These obligations ensure that the changes are implemented smoothly and that the PBS continues to function effectively in providing affordable access to necessary medications.
There are no specific offences, penalties, or consequences outlined in the Amending Determination itself. However, non-compliance with the National Health Act 1953 (the Act) and its associated regulations could lead to enforcement actions under the Act. The Act provides for the imposition of fines and other penalties for breaches, including misleading or deceptive conduct, failure to comply with statutory requirements, and other regulatory infractions. The maximum penalties can vary depending on the nature and severity of the breach but could include substantial fines for both individuals and corporations. Therefore, it is essential for all parties involved to adhere to the provisions of the Act and the Amending Determination to avoid any potential legal repercussions.