EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 18 of 2013
NATIONAL HEALTH ACT 1953
National Health (Weighted average disclosure price – main disclosure cycle) Amendment Determination 2013 (No. 1)
Authority
This legislative instrument is made pursuant to subsection 99ADB(4) of the National Health Act 1953 (the Act), which provides that the Minister may, by legislative instrument, determine the weighted average disclosed price (WADP) of a brand of a pharmaceutical item (listed brand) in accordance with the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations).
Subsection 99ADB(7) of the Act further provides that a subsection 99ADB(4) determination for a listed brand may include the adjusted approved ex-manufacturer price (AAEMP) for the listed brand.
Purpose
This legislative instrument amends the National Health (Weighted average disclosure price – main disclosure cycle) Determination 2012 (PB 107 of 2012) (the Principal Instrument), which is made pursuant to subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the Act and makes certain determinations relating to price disclosure for listed brands in the main disclosure cycle with a data collection period ending 30 September 2012.
The purpose of this amending instrument is to add listed brands of new pharmaceutical items that were listed on the Pharmaceutical Benefits Scheme (PBS) after the Principal Instrument was made, but prior to the reduction day of 1 April 2013, and which have been allocated to the main disclosure cycle by regulation 37F of the Regulations (new listed brands of new pharmaceutical items).
New listed brands of existing pharmaceutical items that listed on the PBS after the Principal Instrument was made but prior to the reduction day are not included in this amending instrument as they will receive a flow-on reduction under section 99ADHA of the Act on 1 April 2013 if at least one existing brand of the same pharmaceutical item is in Schedule 1.
This amending instrument also amends the entry for two brands of pharmaceutical items included in the Principal Instrument where the WADP (and consequently for one brand the AAEMP) were unintentionally omitted.
A responsible person for a listed brand appearing in Schedule 1 of the Principal Instrument will receive a price disclosure reduction on and from 1 April 2013, provided that, on that date, the ‘approved ex-manufacturer price’ for the listed brand is more than the determined ‘AAEMP’ for that brand.
New listed brands
The new listed brands of new pharmaceutical items containing the drugs and manners of administration (MoA) morphine injection and macrogol 3350 oral that are added to PB 107 of 2012 by this instrument were listed on the PBS on 22 January 2013 and 1 March 2013 respectively.
Each new entry for the brands containing the drugs morphine and macrogol 3350 is inserted into Schedule 2 of the Principal Instrument because these listed brands do not have an unadjusted price reduction that has been calculated to be at least 10%.
Listed brands with no WADP amount in the Principal Instrument
Two brands of pharmaceutical items mentioned in the Principal Instrument had no WADP determined in that instrument.
The entry in the Principal Instrument for the Vita-B12 brand containing the drug and MoA hydroxocobalamin injection is in Schedule 1 of the Principal Instrument. This amending instrument inserts the WADP for this brand of pharmaceutical item in the appropriate column, and the same amount is also determined as the AAEMP for the brand. This listed brand has an unadjusted price reduction that has been calculated to be at least 10%.
The entry in the Principal Instrument for the VitA-POS brand containing the drug and MoA paraffin application to the eye is in Schedule 2 of the Principal Instrument. This amending instrument inserts the WADP for this brand of pharmaceutical item in the appropriate column. This listed brand does not have an unadjusted price reduction that has been calculated to be at least 10%.
Consultation
This instrument affects pharmaceutical companies with medicines listed on the PBS. Pharmaceutical companies have been consulted in relation to the introduction of price disclosure requirements during both the policy development and implementation of the further PBS reforms of 2010. This has occurred through meetings with both peak body organisations and individual companies. Information on the price disclosure measure has been disseminated through peak industry bodies, during regular meetings with the Price Disclosure Working Group and direct to responsible persons through information sessions and educational workshops.
This instrument commences on the day after it is registered on the Federal Register of Legislative Instruments.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.