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.
Overview
The National Health (Weighted average disclosed price – April 2019 reduction day) Amendment Determination 2019 was enacted to address the need for adjusting the weighted average disclosed price (WADP) for certain new brands of pharmaceutical items, specifically those containing hypromellose for administration by application to the eye, that were listed between 30 September 2018 and 31 March 2019. This amendment was made under the authority of the National Health Act 1953 by the Minister for Health, in line with the National Health (Pharmaceutical Benefits) Regulations 2017. The policy objective is to ensure that the pricing of new pharmaceutical items aligns with the data collection period, thereby maintaining consistency and fairness within the pharmaceutical benefits scheme. The amendment was made after consultation with the relevant companies, which did not raise any concerns, and it commenced on the day following its registration on the Federal Register of Legislation.
Scope and Application
The National Health (Weighted average disclosed price – April 2019 reduction day) Amendment Determination 2019 applies to the determination of the weighted average disclosed price (WADP) for new brands of new pharmaceutical items containing hypromellose for administration by application to the eye. This legislative instrument is made under the authority of the National Health Act 1953 and specifically amends the National Health (Weighted average disclosed price – April 2019 reduction day) Determination 2018 to include WADP determinations for the Genteal® and In a Wink Moisturising® brands of hypromellose eye drops. The amendment applies to companies that are Responsible Persons for these brands and affects the pharmaceutical industry by setting the WADP for these specific brands. This instrument is applicable nationally and commences on the day after it is registered on the Federal Register of Legislation. The amendment does not specify any exclusions, exemptions, or thresholds beyond those already outlined in the principal determination and the underlying Act. The application of the Act extends through subordinate instruments as necessary to maintain compliance with the National Health (Pharmaceutical Benefits) Regulations 2017.
Key Provisions
The main operative sections of the National Health (Weighted average disclosed price – April 2019 reduction day) Amendment Determination 2019 (F2019L00156) involve the determination of the weighted average disclosed price (WADP) for two new brands of hypromellose eye drops, Genteal® and In a Wink Moisturising®, which have been listed between 30 September 2018 and 31 March 2019. Section 99ADB(4) of the National Health Act 1953 allows the Minister to make this determination, and this legislative instrument provides the updated WADP figures for these specific brands. This amendment is essential because it ensures that the prices of these new pharmaceutical items are appropriately assessed and regulated under the Act. The Act also mandates that the adjusted approved ex-manufacturer price (AAEMP) for these brands is included in the determination, as specified in section 99ADB(7).
The obligations imposed by this Act on the parties it governs primarily concern the accurate reporting and assessment of prices for new pharmaceutical brands. Companies that are Responsible Persons for these brands must ensure that the disclosed prices are in line with the determinations made under the Act. This includes submitting necessary data and information to the relevant authorities for the calculation of the WADP and AAEMP. Additionally, these companies must comply with the data collection period stipulated in the National Health (Pharmaceutical Benefits) Regulations 2017. Failure to comply with these obligations could result in regulatory scrutiny and potential penalties.
Breach of the provisions under the National Health Act 1953 can lead to various civil or criminal consequences. For example, inaccurate reporting or failure to comply with the mandated price assessments can result in financial penalties. The exact penalties are not specified in the amending instrument but typically would align with the broader regulatory framework governing pharmaceutical pricing and data accuracy. Under the general legislative context, significant non-compliance could also lead to legal action against the companies involved, which could further escalate to criminal charges in severe cases. It is important for companies to adhere strictly to the requirements set forth to avoid these potential repercussions.