National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No 2) (PB 22 OF 2017) [F2017L00361]-Response required [2017] AUSStaCSDLM 150 (5 October 2017)

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Instrument	National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 2) (PB 22 OF 2017) [F2017L00361]
Purpose	Amends the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010)
Authorising legislation	National Health Act 1953
Department	Health
Disallowance	15 sitting days after tabling (tabled Senate 9 May 2017) Notice of motion to disallow must be given by 16 August 2017
Scrutiny principle	Standing Order 23(3)(a)

Drafting

The National Health Act 1953 (the Act) provides that drugs listed on the pharmaceutical benefits scheme 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 identified as F2 are subject to the provisions of the Act relating to first new brand statutory price reductions, price disclosure and guarantee of supply.

The ES for National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 2) (PB 22 OF 2017) [F2017L00361] (the determination) states that,

in addition to adding 5 new drugs to the F1 list, the determination is also moving

5 currently listed drugs from the F1 list to the F2 list.

However, the committee notes that one of the drugs listed as being moved from the F1 list to the F2 list (etanercept) has been inserted into Schedule 2 of the determination (relating to the F2 list) but not omitted from Schedule 1 (relating to the F1 list). This drug is therefore now included in both lists. It is unclear to the committee whether this was the intention of the determination, or whether the listing of the drug etanercept on both the F1 list and F2 list is the result of a drafting error in the determination.

The committee requests the advice of the minister in relation to this matter.