EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 9 OF 2019
NATIONAL HEALTH ACT 1953
National Health (Weighted average disclosed price – April 2019 reduction day)
Amendment Determination 2019
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 2017 (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 disclosed price – April 2019 reduction day) Determination 2018 (PB 109 of 2018) (the Principal Instrument) by:
- inserting a WADP for the first new brands of new pharmaceutical items containing hypromellose for administration by application to the eye (hypromellose).
The Principal Instrument was made pursuant to subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the Act for brands of pharmaceutical items with a data collection period ending 30 September 2018 (2019 April cycle).
Amendments
Insertion of WADP determinations for New Brands of New Pharmaceutical Items
A WADP is required to be determined for new brands of pharmaceutical items listing between 30 September 2018 and 31 March 2019 that have no other existing brand of the same pharmaceutical item (including a single brand pharmaceutical item where the brand or pharmaceutical item changes, or where all existing brands change).
There are two brands of one new pharmaceutical item that are included in this amending instrument, as follows:
- the Genteal® brand of ‘hypromellose, eye drops 3 mg per mL, 10 mL, application to the eye’ and;
- the In a Wink Moisturising® brand of ‘hypromellose, eye drops 3 mg per mL, 10 mL, application to the eye’.
Basis for amendments
Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to vary or revoke the determination made under subsection 99ADB(4) for the medicines affected by this amending instrument.
Consultation
This instrument affects companies that are Responsible Persons for brands of the following pharmaceutical item:
- hypromellose, eye drops 3 mg per mL, 10 mL, application to the eye;
All of the affected companies were consulted about the amendments. No concerns were expressed.
This instrument commences on the day after it is registered on the Federal Register of Legislation. This instrument is a legislative instrument for the purposes of the Legislation Act 2003.