EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 6)
PB 53 of 2019
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 removing three drugs – abciximab, cystine with carbohydrate and pyrimethamine from F1 as these drugs are 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 delisting from the PBS. These medicines are being removed from the PBS at the request of the pharmaceutical companies. 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 PBAC was also consulted about the removal of these drugs from the PBS. 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 July 2019.
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 2019 (No. 6) was enacted to address the need for updating the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS) formularies. This Amendment Determination, made under the National Health Act 1953, amends the National Health (Listed drugs on F1 or F2) Determination 2010 by removing certain drugs from the F1 formulary, specifically abciximab, cystine with carbohydrate, and pyrimethamine, as these drugs have been delisted from the PBS at the request of the pharmaceutical companies. The purpose of the Amendment Determination is to ensure that the formulary reflects the current PBS listings and that the criteria for drug allocation are accurately maintained. The Minister for Health, or a delegate, has the authority to make such determinations under the Act, with the policy objective being to efficiently manage the PBS by ensuring only relevant drugs are included in the formularies.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 applies to pharmaceutical companies that have medicines listed on the Pharmaceutical Benefits Scheme (PBS) and affects their allocation to the F1 and F2 formularies. This legislative instrument amends the National Health (Listed drugs on F1 or F2) Determination 2010 by removing three drugs from F1 as they have been delisted from the PBS at the request of the pharmaceutical companies. The determination is made under subsection 85AB(1) of the National Health Act 1953, and its scope is national, applying across Australia as a Commonwealth legislation. The exclusions and exemptions from this determination are limited to the specific drugs mentioned, abciximab, cystine with carbohydrate, and pyrimethamine, which are no longer PBS listed. The Amending Determination does not extend or restrict its application through subordinate instruments but relies on the Acts Interpretation Act 1901 for its variation or revocation. Consultation with stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee, was undertaken prior to the amendment, and no further consultation was deemed necessary.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 6) are found in subsection 85AB(1) of the National Health Act 1953. This provision empowers the Minister (or a delegate) to determine by legislative instrument that a listed drug is on either the F1 or F2 formulary of the Pharmaceutical Benefits Scheme (PBS). Section 84AC specifies that a drug is on F1 or F2 if there is a determination in force under section 85AB. The Amending Determination (subsection 85AB(5)) removes three drugs – abciximab, cystine with carbohydrate and pyrimethamine – from F1 as these drugs are no longer listed on the PBS. The criteria for F1 (subsection 85AB(4)) require 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. Additionally, the drug must not have been 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)).
The Amending Determination imposes certain obligations and requirements on the parties or entities it governs. Pharmaceutical companies with medicines delisted from the PBS must comply with the determination, which removes abciximab, cystine with carbohydrate and pyrimethamine from F1. The Pharmaceutical Benefits Advisory Committee (PBAC) is consulted during the process of determining the allocation of drugs to formularies, and any recommendations from the PBAC are considered. The PBAC is comprised of two-thirds members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The determination also relies on subsection 33(3) of the Acts Interpretation Act 1901 for revoking or varying the Principal Determination, unless there is an express power cited in the Instrument.
There are no explicit offences, penalties, or civil/criminal consequences for breach of the Amending Determination stated in the explanatory statement. However, non-compliance with the determination could potentially lead to legal or administrative consequences, such as the removal of a drug from the PBS or the failure to meet the requirements for drug allocation to formularies. The Pharmaceutical Benefits Scheme is a critical part of Australia’s health care system, and adherence to the requirements of the National Health Act 1953 and its subsidiary legislation is essential for ensuring the continued availability and affordability of necessary medications to the Australian public.