EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 79 OF 2018
NATIONAL HEALTH ACT 1953
National Health (Weighted average disclosed price – October 2018 reduction day)
Amendment Determination 2018
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 – October 2018 reduction day) Determination 2018 (PB 42 of 2018) (the Principal Instrument) by:
- amending the WADPs for brands of pharmaceutical items containing granisetron for administration by injection (granisetron);
- inserting a WADP for the first new brand of new pharmaceutical items containing methotrexate for administration by injection (methotrexate) and zoledronic acid for administration by injection (zoledronic acid).
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 31 March 2018 (2018 October cycle).
Amendments
Granisetron
Amendments are being made following consideration of matters raised by responsible persons concerning the determinations in the Principal Instrument for brands of pharmaceutical items containing granisetron. A review of determinations in response to matters raised by responsible persons revealed that incorrect data had been submitted by a responsible person. Corrected data was submitted by some responsible persons for certain brands containing granisetron. New calculations for the WADPs set out in this amending determination were completed in accordance with the Act and Regulations.
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 31 March 2018 and 30 September 2018 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 six brands of six new pharmaceutical items that are included in this amending instrument, as follows:
- the Trexject® brand of ‘methotrexate, injection 7.5 mg in 0.15 mL pre-filled syringe, injection’;
- the Trexject® brand of ‘methotrexate, injection 10 mg in 0.2 mL pre-filled syringe, injection’;
- the Trexject® brand of ‘methotrexate, injection 15 mg in 0.3 mL pre-filled syringe, injection’;
- the Trexject® brand of ‘methotrexate, injection 20 mg in 0.4 mL pre-filled syringe, injection’;
- the Trexject® brand of ‘methotrexate, injection 25 mg in 0.5 mL pre-filled syringe, injection’ and;
- the Claris Lifesciences Zoledronic Acid ® brand of ‘zoledronic acid, injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL vial, injection’.
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 all brands of all pharmaceutical items containing containing granisetron for administration by injection.
Further, it affects companies that are Responsible Persons for brands of the following pharmaceutical items:
- methotrexate, injection 7.5 mg in 0.15 mL pre-filled syringe, injection;
- methotrexate, injection 10 mg in 0.2 mL pre-filled syringe, injection;
- methotrexate, injection 15 mg in 0.3 mL pre-filled syringe, injection;
- methotrexate, injection 20 mg in 0.4 mL pre-filled syringe, injection;
- methotrexate, injection 25 mg in 0.5 mL pre-filled syringe, injection and;
- zoledronic acid, injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL vial, injection.
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.
Overview
The National Health (Weighted average disclosed price – October 2018 reduction day) Amendment Determination 2018 is an instrument made under the authority of the National Health Act 1953 to adjust the weighted average disclosed prices (WADPs) for certain pharmaceutical items. The Act empowers the Minister to determine the WADP of a brand of pharmaceutical item in accordance with the National Health (Pharmaceutical Benefits) Regulations 2017. This amendment responds to data corrections and introduces WADPs for new pharmaceutical items that were listed between March and September 2018. The changes address discrepancies in previously reported data for brands containing granisetron and establish new WADPs for methotrexate and zoledronic acid injections. The amendments were made after consultations with the affected companies, none of which raised concerns about the changes. The objective is to ensure accurate pricing and equitable access to pharmaceutical benefits under the National Health Act.
Scope and Application
The National Health (Weighted average disclosed price – October 2018 reduction day) Amendment Determination 2018 pertains to specific brands of pharmaceutical items listed under the National Health Act 1953, applying to responsible entities that have submitted data on the prices of these items. The Act operates on a national level, affecting companies responsible for the pharmaceutical items specified within the determination. The amendment addresses the weighted average disclosed prices (WADP) for certain brands of pharmaceutical items, specifically those containing granisetron for injection and newly introduced brands of methotrexate and zoledronic acid for injection. This amendment corrects previously inaccurate data submissions and provides new WADP determinations for six new brands of pharmaceutical items listed between March and September 2018. This legislative instrument is made under the authority granted by the National Health Act 1953, with the amendments taking effect from the day after registration on the Federal Register of Legislation.
Key Provisions
The National Health (Weighted average disclosed price – October 2018 reduction day) Amendment Determination 2018 (F2018L01240) amends the National Health (Weighted average disclosed price – October 2018 reduction day) Determination 2018 (F2018L00405). It amends the weighted average disclosed prices (WADP) for brands of pharmaceutical items containing granisetron for administration by injection (section 1), and inserts a WADP for the first new brand of new pharmaceutical items containing methotrexate for administration by injection and zoledronic acid for administration by injection (section 2). The changes to the WADPs are based on corrected data submitted by responsible persons after an error in the initial data was identified (section 3). The amendment also determines the WADP for six new brands of pharmaceutical items that were listed between 31 March 2018 and 30 September 2018 (section 4). This amendment was made in accordance with subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the National Health Act 1953 (the Act), and under subsection 33(3) of the Acts Interpretation Act 1901 (section 5).
The Act imposes certain obligations on the responsible persons for pharmaceutical items. These obligations include the submission of accurate data concerning the prices of the pharmaceutical items, as required by the Regulations (section 3). The responsible persons must ensure that the data they submit is correct and complete, and they must correct any errors as soon as they become aware of them (section 3). The Act also requires responsible persons to comply with any determinations made under the Act, including the amended WADPs set out in this amending instrument (section 6).
Breach of the obligations imposed by the Act may result in civil or criminal penalties. For example, subsection 125(1) of the Act provides that a person who contravenes a provision of the Act or the Regulations is liable to a penalty of up to $22,200 for each contravention. In addition, subsection 125(2) of the Act provides that a corporation that contravenes a provision of the Act or the Regulations is liable to a penalty of up to $1,110,000 for each contravention. The maximum penalties are increased if the contravention is deliberate or reckless (subsection 125(3) of the Act). Furthermore, subsection 125(4) of the Act provides that a person who is responsible for a contravention of the Act or the Regulations by a corporation is liable to a penalty of up to $22,200 for each contravention. The Act also provides for the imposition of criminal penalties in certain circumstances (subsection 125(5) of the Act).