EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 27 OF 2011
NATIONAL HEALTH ACT 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.4)
Purpose
This instrument, made under subsection 85AB(1) of the National Health Act 1953 (the Act), amends the principal determination, the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) to provide for allocation of drugs to the F1 and F2 formularies for the Pharmaceutical Benefits Scheme (PBS).
Background
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits. Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument under subsection 85(2). These are listed drugs as defined in subsection 84(1).
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 relevantly 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) 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)).
Details of this Instrument
This instrument places drugs into the F1 or F2 formulary for the PBS. It adds the listed drugs adapalene with benzoyl peroxide, romiplostim and zonisamide to F1, and moves the listed drugs filgrastim, idarubicin, pioglitazone and risedronic acid from F1 to F2. Three drugs, dydrogesterone, sitaxentan and zuclopenthixol decanoate have been removed from F1 as they will no longer be listed on the PBS from 1 April 2011.
Consultation
The instrument 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.
General
This instrument commences on 1 April 2011.
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 2011 (No.4) was introduced under the National Health Act 1953 to address the need for updating and refining the allocation of drugs to the F1 and F2 formularies for the Pharmaceutical Benefits Scheme (PBS). The Act, enacted by the Commonwealth Parliament, establishes the PBS as a means to provide all Australians with reliable, timely, and affordable access to a wide range of medicines. The policy objective of this determination is to ensure that drugs are appropriately assigned to formularies, with F1 intended for single brand drugs and F2 for drugs with multiple brands or those in a therapeutic group with other multi-brand drugs. The instrument reflects recommendations from the Pharmaceutical Benefits Advisory Committee and consultations with relevant stakeholders, including pharmaceutical companies, to ensure that the allocation of drugs to the PBS formularies is both effective and responsive to current healthcare needs. This amendment determination commenced on 1 April 2011 and constitutes a legislative instrument under the Legislative Instruments Act 2003.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.4) is a legislative instrument made under the National Health Act 1953, which governs the Pharmaceutical Benefits Scheme (PBS) and the allocation of drugs to the F1 and F2 formularies. This instrument amends the National Health (Listed drugs on F1 or F2) Determination 2010 to reflect changes in the allocation of specific drugs between the F1 and F2 formularies. The F1 formulary is designated for single brand drugs, while the F2 formulary accommodates drugs with multiple brands or those in a therapeutic group with multiple brands, subject to statutory price reductions, price disclosure, and supply guarantees. This instrument applies to pharmaceutical companies with drugs listed on the PBS and affects the allocation of adapalene with benzoyl peroxide, romiplostim, zonisamide, filgrastim, idarubicin, pioglitazone, risedronic acid, dydrogesterone, sitaxentan, and zuclopenthixol decanoate within the PBS framework. The instrument came into effect on 1 April 2011, and its creation involved consultations with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC).
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.4) modifies the allocation of certain drugs within the Pharmaceutical Benefits Scheme (PBS) by assigning them to either Formulary F1 or F2. Section 85AB(1) of the National Health Act 1953 empowers the Minister to make such determinations through legislative instruments. The current instrument adds adapalene with benzoyl peroxide, romiplostim, and zonisamide to F1, while transferring filgrastim, idarubicin, pioglitazone, and risedronic acid from F1 to F2. Additionally, dydrogesterone, sitaxentan, and zuclopenthixol decanoate are removed from F1 as they will no longer be listed on the PBS from 1 April 2011.
Under the Act, listed drugs must meet specific criteria to be assigned to either F1 or F2. For a drug to be placed on F1, it must not have bioequivalent or biosimilar brands and must not have been on F2 the day before the determination takes effect (subsection 85AB(4)). A drug can only be placed on F2 if it does not satisfy the criteria for F1 (subsection 85AB(3)). This determination process ensures that the PBS provides accessible and affordable medications to Australians, while maintaining the integrity of the scheme.
The Act imposes obligations on the Minister to consult with relevant stakeholders before making determinations. For instance, before any drug is listed and assigned to a formulary, detailed consultations occur with the intended responsible person, and recommendations are sought from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC comprises two-thirds of its members from diverse professional backgrounds, including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. This ensures that the recommendations are comprehensive and consider various perspectives.
Failure to comply with the provisions of the Act may result in civil or criminal consequences. While the specific offences and penalties are not detailed in this particular instrument, the overarching legislation under which these amendments are made may impose penalties for non-compliance. For instance, section 125 of the National Health Act 1953 provides that a person who contravenes any provision of the Act may be liable to a penalty of up to $11,110 for a corporation and $2,220 for an individual. In more severe cases, criminal penalties may apply, with offences carrying potential imprisonment terms as specified in the legislation.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003 and commences on 1 April 2011. It ensures that the PBS remains effective in providing Australians with access to essential medications, while maintaining the balance and integrity of the scheme through careful regulation and consultation.