EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 11)
PB 104 of 2016
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 first new brand 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 (or delegate) 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 three new drugs – evolocumab, lenvatinib and ocriplasmin to F1and removes the drug homatropine from F1 as this drug is no longer PBS listed. It also moves five currently listed drugs – aripiprazole, bivalirudin, entecavir, itraconazole and rivastigmine from F1 to F2. In addition, it also moves two currently listed drugs – olmesartan with amlodipine and olmesartan with hydrochlorothiazide from the single brand Combination Drug List (CDL) to F2.
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. Further consultation on the Amending Determination was deemed unnecessary due to the consultations with affected pharmaceutical companies on allocation of the drugs to formularies having already taken place.
The Amending Determination Instrument commences on 1 December 2016.
This Instrument constitutes a legislative instrument for the purpose of the
Legislation Act 2003.
Overview
The National Health Act 1953, enacted by the Australian Parliament, serves to regulate the allocation of drugs to specific formularies within the Pharmaceutical Benefits Scheme (PBS). This Act addresses the need for a structured system to categorise drugs based on their brand and therapeutic grouping to ensure effective and equitable access to medication. The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 11) amends the National Health (Listed drugs on F1 or F2) Determination 2010 to adjust the allocation of certain drugs to either F1 or F2 formularies. F1 is designated for drugs with a single brand, while F2 accommodates drugs with multiple brands or those in therapeutic groups with multiple brands. This amendment aims to refine the drug allocation process, ensuring it aligns with the policy objectives of the Act, which include the efficient and equitable provision of pharmaceutical benefits to the Australian public.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 11) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which is a legislative instrument made under the National Health Act 1953. The Act governs the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS), where F1 is for single brand drugs and F2 is for drugs with multiple brands or in therapeutic groups with other drugs with multiple brands. The Amendment Determination applies to listed drugs that are included on the PBS, affecting pharmaceutical companies with medicines listed on the PBS. The amendment adds three new drugs to F1, removes one drug from F1, and shifts five drugs from F1 to F2, and two combination drugs from the single brand Combination Drug List to F2. The determination does not specify exclusions or exemptions but operates within the criteria for inclusion in F1 and F2 as outlined in the Act. The Amending Determination is a legislative instrument that constitutes a variation to the Principal Determination and comes into effect on 1 December 2016.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 11) (the Amending Determination) are found in sections 2 and 3, where it amends the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination). Section 2 of the Amending Determination adds three drugs—evolocumab, lenvatinib and ocriplasmin—to F1 and removes homatropine from F1 because it is no longer listed on the Pharmaceutical Benefits Scheme (PBS). Section 3 moves five drugs—aripiprazole, bivalirudin, entecavir, itraconazole and rivastigmine—from F1 to F2, and two combination drugs—olmesartan with amlodipine and olmesartan with hydrochlorothiazide—from the single brand Combination Drug List to F2.
The Amending Determination imposes obligations on parties such as pharmaceutical companies, the Pharmaceutical Benefits Advisory Committee (PBAC), and the Minister for Health. Pharmaceutical companies must engage in detailed consultations regarding the allocation of drugs to formularies on the PBS. The PBAC, which advises the Minister, must recommend drug allocations based on submissions from affected pharmaceutical companies. The Minister, or a delegate, must then make a determination under section 85AB(1) of the National Health Act 1953, which is the basis for the Amending Determination. The determination process includes criteria for assigning drugs to F1 or F2 based on bioequivalence, biosimilarity, and therapeutic grouping.
Failure to comply with the provisions of the Amending Determination could result in civil or criminal penalties. However, the explanatory statement does not explicitly outline specific offences, penalties, or consequences for breach. Under the general legislative framework of the National Health Act 1953, breaches of the Act or its subsidiary instruments could potentially lead to civil or criminal sanctions, including fines and imprisonment, depending on the nature and severity of the breach. The maximum penalties would be determined according to the specific provisions of the Act that are contravened.