EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 3)
PB 34 of 2018
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 to F1 three new drugs – afatinib; amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids; and brivaracetam. In addition, it also removes one drug from F2 – risedronic acid and calcium with colecalciferol as this drug is no longer PBS listed.
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 consultation on allocation of the drugs to formularies with affected pharmaceutical companies that had already taken place.
The Amending Determination Instrument commences on 1 May 2018.
This Instrument constitutes a legislative instrument for the purpose of the
Legislation Act 2003.
Overview
The National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 3) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010. This amendment responds to the need to update the formulary list under the National Health Act 1953, ensuring that the Pharmaceutical Benefits Scheme (PBS) remains current and effective in providing access to necessary medications. The National Health Act 1953, enacted by the Australian Parliament, governs the provision of health services and the administration of the PBS. The policy objective of this determination is to ensure that drugs are appropriately allocated to the F1 and F2 formularies based on their therapeutic characteristics and market status, thereby maintaining the efficiency and effectiveness of the PBS. The Amending Determination adds three new drugs to the F1 formulary and removes one drug from the F2 formulary, reflecting changes in the PBS listings and therapeutic group considerations.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 3) amends the National Health (Listed drugs on F1 or F2) Determination 2010 under the National Health Act 1953. The Act applies to listed drugs that are allocated to formularies identified as F1 and F2 within the Pharmaceutical Benefits Scheme (PBS). F1 is designated for single brand drugs, while F2 is for drugs with multiple brands or those in a therapeutic group with other drugs that have multiple brands. Drugs on F2 are subject to specific provisions of the Act relating to first new brand statutory price reductions, price disclosure, and guarantee of supply. The Amendment Determination adds three new drugs to F1 and removes one drug from F2. The changes reflect adjustments based on therapeutic considerations and the current listing status of the drugs on the PBS. The Act's application extends nationally, with the Minister (or delegate) empowered to determine by legislative instrument the placement of drugs on F1 or F2, subject to specific criteria. The Amending Determination was made after consultations with relevant pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 3) (the Amending Determination) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination) by adding three new drugs to F1: afatinib, amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids, and brivaracetam. It also removes risedronic acid and calcium with colecalciferol from F2, as this drug is no longer listed on the Pharmaceutical Benefits Scheme (PBS). These changes were made under the authority of the National Health Act 1953 (the Act), which provides that listed drugs may be assigned to formularies identified as F1 or 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.
The Amending Determination imposes specific obligations on the parties and entities it governs. Pharmaceutical companies with medicines listed on the PBS are directly affected by these changes. Before drugs are listed and allocated to formularies, there are detailed consultations with the intended responsible person and a recommendation is received from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC comprises two-thirds members from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. For this Amending Determination, further consultation was deemed unnecessary due to the prior consultation on allocation of the drugs to formularies with affected pharmaceutical companies.
The Amending Determination includes provisions for potential breaches and consequences. If any party or entity fails to comply with the requirements set out in the Determination, they may be subject to civil or criminal penalties. The maximum penalties for breaches of the Act are not explicitly stated in the Explanatory Statement but could be found in the Act itself or related legislation. The consequences of non-compliance could include fines, legal action, or other regulatory measures imposed by the relevant authorities. The determination stresses that unless there is an express power to revoke or vary the Principal Determination cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary the Principal Determination.