National Health (Originator Brand) Amendment Determination 2019 (No. 3) (PB 34 of 2019)

Overview

The National Health (Originator Brand) Amendment Determination 2019 (No. 3) amends the National Health (Originator Brand) Determination 2015 to address a specific issue related to the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This legislative instrument was introduced to determine the originator brand of a new pharmaceutical item of an existing PBS listed drug on the F2 formulary as of 1 May 2019. The amendment was made in response to the need to implement the removal of originator brand data from price disclosure calculations, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. The primary objective of this amendment is to potentially increase price disclosure-related price reductions, given that originator brands typically maintain higher prices compared to other brands. This change is expected to improve the operation of the PBS by delivering better value for money for PBS medicines, thereby reducing out-of-pocket costs for some PBS medicines and contributing to the progressive realisation of the right to the highest attainable standard of physical and mental health.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2019 (No. 3) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a new pharmaceutical item of an existing PBS listed drug on the F2 formulary, effective from 1 May 2019. This amendment is made pursuant to the National Health Act 1953 and is necessary to implement the removal of originator brand data from price disclosure calculations under the National Health (Pharmaceutical Benefits) Regulations 2017. The primary purpose of this change is to potentially increase price disclosure related price reductions, as originator brands typically maintain higher prices than other brands, thereby offering better value for money to consumers and enhancing the affordability of PBS medicines. This legislative instrument applies to pharmaceutical items listed under the Pharmaceutical Benefits Scheme (PBS) on the F2 formulary, which includes drugs that have moved from the F1 formulary or the single brand Combination Drug List (CDL). The amendment specifically addresses the originator brand determination for a new pharmaceutical item of a PBS listed drug (apomorphine), Apomine Intermittent, effective from 1 May 2019. The determination is based on the criteria that the brand was listed on F1 or CDL when it was first determined as a brand of pharmaceutical item. This instrument is a legislative instrument for the purposes of the Legislation Act 2003 and is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Key Provisions

The National Health (Originator Brand) Amendment Determination 2019 (No. 3) (F2019L00657) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a new pharmaceutical item of an existing PBS listed drug on the F2 formulary as of 1 May 2019. This amendment is necessary to implement the removal of originator brand data from price disclosure calculations under certain circumstances outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. Originator removal is expected to increase price disclosure-related price reductions because originator brands typically maintain higher prices than other brands. The amendment was made under the authority of subsection 99ADB(6B) of the National Health Act 1953, and the main criteria used to determine these brands as originators were that they were the listed brands of the drug when it was on F1 or CDL. This legislation imposes certain obligations and requirements on the parties involved. The determination of originator brands is based on whether the brand was on F1 or the Combination Drug List (CDL) when it was first determined as a brand of pharmaceutical item under the National Health Act. The Minister, or a delegate, must have regard to this criterion when deciding whether to determine originator brands. The amendment ensures that the Government price more closely reflects the prices at which generic brands of the medicine are being sold in the market, rather than the prices of all brands. This amendment is intended to improve the operation of the Pharmaceutical Benefits Scheme (PBS) by delivering better value for money for PBS medicines through price reductions. Breaching the provisions of this amendment can result in civil or criminal consequences, although the specific penalties are not stated in the text. The amendment is a legislative instrument for the purposes of the Legislation Act 2003, and it is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. The PBS provides Australians with timely, reliable, and affordable access to necessary and cost-effective medicines. By removing originator brand data from price disclosure calculations, the amendment assists with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, as recognised in Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights.