EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 7)
PB 82 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 five new drugs febuxostat, lisdexamfetamine, lutropin alfa, pembrolizumab and secukinumab to F1 and also removes two listed drugs flurbiprofen and telaprevir from F1and one listed drug lactulose from F2. One previously listed drug mexiletine is also removed from F1. 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 September 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 facilitate the provision of health services and administer the Pharmaceutical Benefits Scheme (PBS) among other things. The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 7) was introduced to address gaps in the allocation of listed drugs to the F1 and F2 formularies of the PBS. The determination, made by the Minister for Health under subsection 85AB(1) of the Act, amends the National Health (Listed drugs on F1 or F2) Determination 2010 to add and remove certain drugs from the F1 and F2 formularies. The policy objective of the determination is to ensure that drugs are appropriately allocated to the relevant formularies based on their characteristics and therapeutic groups, thereby facilitating better management and access to these medications within the PBS.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 7) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which pertains to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. The Act allows for the assignment of listed drugs to these formularies, with F1 designated for single brand drugs and F2 for drugs with multiple brands or those in therapeutic groups with multiple brands. The Amendment Determination adds five drugs to F1 and removes three drugs from F1 and F2, while also making administrative amendments to align drug descriptions with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes are applicable to pharmaceutical companies with medicines listed on the PBS and were developed following consultations with relevant parties, including the Pharmaceutical Benefits Advisory Committee. This legislative instrument comes into effect on 1 September 2015.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 7) 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). F1 is designated for drugs with a single brand, while F2 includes drugs with multiple brands or those in therapeutic groups with multiple brands. This amendment specifically affects the classification of certain drugs by adding or removing them from these formularies. For instance, it adds febuxostat, lisdexamfetamine, lutropin alfa, pembrolizumab, and secukinumab to F1, and removes flurbiprofen, telaprevir, lactulose, and mexiletine from their respective formularies.
The Act imposes several obligations on the entities it governs. It requires that drugs be classified accurately according to the criteria set out in the Act. Pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC) must engage in thorough consultations to ensure that drugs are listed and allocated to the appropriate formularies. PBAC, which comprises experts from various healthcare sectors, plays a pivotal role in recommending drug allocations based on detailed submissions and evaluations. These recommendations must be considered before any drug is listed and placed in either F1 or F2.
Breaches of the requirements set out in the Act can lead to various consequences. While the Act does not explicitly state the penalties for non-compliance, general provisions under the National Health Act 1953 may apply. Offences involving the misrepresentation of drug classifications or failure to comply with the Act’s requirements can result in both civil and criminal penalties. Civil penalties may include fines, while criminal penalties can include imprisonment, depending on the severity of the breach. The exact penalties would be determined in the context of the broader legal framework and specific circumstances of the breach.