EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 19 OF 2011
NATIONAL HEALTH ACT 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2011(No.2)
Purpose
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) Amendment Determination 2010 (PB 9 of 2011) to correct a typographical error in the title of that instrument.
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.
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).
Subsection 85AB(1) of the Act empowers the Minister to determine by legislative instrument that a listed drug is on either the F1 or F2 formulary. 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.
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.
From 11 October 2010 all formulary allocations were consolidated in legislative instruments made under subsections 85AB(1) and 85AC(1), and the provisions in the Regulations prescribing formulary allocations have been repealed as they were redundant.
Details of this Instrument
PB 9 of 2011 amended the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) (“the principal instrument”) to place drugs into the F1 or F2 formularies as of 1 February 2011. However, PB 9 of 2011 contained a typographical error in the title of the instrument – the title of PB 9 of 2011 should have been National Health (Listed drugs on F1 or F2) Amendment Determination 2011 instead of National Health (Listed drugs on F1 or F2) Amendment Determination 2010. This instrument amends subsection 1(1) of PB 9 of 2011 to correct this error in the title.
As PB 9 of 2011 is not being remade, and no items in the Schedule to PB 9 of 2011 (which was what actually amended the principal instrument) are being amended, section 46 of the Legislative Instrument Act 2003 does not prevent this instrument from having effect.
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. Each drug may be allocated into F1 or F2 based on the recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC). The 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 February 2011, immediately after the commencement of PB 9 of 2011.
This instrument constitutes a legislative instrument for the purpose of the
Legislative Instruments Act 2003.