National Health (Originator Brand) Amendment Determination 2020 (No. 3) (PB 49 of 2020)

Overview

The National Health (Originator Brand) Amendment Determination 2020 (No. 3) was enacted to address the issue of originator brand data in price disclosure calculations for pharmaceutical items on the Pharmaceutical Benefits Scheme (PBS) F2 formulary. This legislative instrument amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a specific drug, dutasteride with tamsulosin, which was moving from the Combination Drug List to F2 on 1 June 2020. The determination is necessary to implement the originator removal provision under the National Health (Pharmaceutical Benefits) Regulations 2017, which aims to increase price disclosure-related price reductions by excluding originator brand data, potentially leading to lower prices for consumers. The instrument was made under subsection 99ADB(6B) of the National Health Act 1953 and was prepared in accordance with the Acts Interpretation Act 1901. The policy objective is to improve the value for money in the PBS by reducing the prices of certain medications, thereby enhancing access to affordable and cost-effective medicines for Australians.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2020 (No. 3) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a pharmaceutical item for one drug that is new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 June 2020. This amendment is made to implement the removal of originator brand data from price disclosure calculations under the National Health (Pharmaceutical Benefits) Regulations 2017. The determination applies to the originator brand of a specific drug, dutasteride with tamsulosin, moving from the Combination Drug List to the F2 formulary on the specified date. This amendment aims to potentially increase price disclosure related price reductions for PBS medicines, as originator brands often maintain higher prices than other brands, thereby enhancing the cost-effectiveness of the PBS for consumers. The amendment is made under the authority of subsection 99ADB(6B) of the National Health Act 1953 and is necessary to align with the criteria set out in the National Health (Pharmaceutical Benefits) Regulations 2017. The originator brand determination for dutasteride with tamsulosin is based on the brand being listed when the drug was first determined under subsection 85(6) of the Act. The instrument is a legislative instrument for the purposes of the Legislation Act 2003 and is compatible with human rights as it advances the protection of human rights by providing better value for money for PBS medicines and reducing out-of-pocket costs for consumers. This legislative instrument commences on 1 June 2020.

Key Provisions

The National Health (Originator Brand) Amendment Determination 2020 (No. 3) (PB 49 of 2020) amends the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) to determine the originator brand of a pharmaceutical item for one drug newly listed on the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 June 2020. This amendment is necessary to implement the removal of originator brand data from price disclosure calculations, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. The originator brand for the drug dutasteride with tamsulosin, moving from the Combination Drug List (CDL) to F2, is determined in Schedule 1 of this amending instrument. The decision to determine originator brands is made pursuant to subsection 99ADB(6B) of the National Health Act 1953 (the Act), with consideration given to whether the brand was on F1 or CDL when it was first determined as a brand of pharmaceutical item under subsection 85(6) of the Act. The Act imposes specific obligations on the parties involved, ensuring that the determination of originator brands aligns with the criteria set forth in the Act and Regulations. These criteria primarily involve whether the brand was listed on F1 or CDL when it was first determined as a brand of pharmaceutical item. The Act also mandates that the Minister or their delegate must consider these criteria when making an originator brand determination. Furthermore, the affected company with a PBS listed brand of the drug in question was consulted on the potential originator brand determination, although no comments were received. The Regulations further specify the details and requirements for price disclosure calculations and the removal of originator brand data. Breach of the provisions in the National Health (Originator Brand) Amendment Determination 2020 (No. 3) could lead to civil or criminal consequences, although specific penalties are not outlined in the explanatory statement. The determination of originator brands is crucial for ensuring accurate price disclosure calculations, which directly impacts the affordability and accessibility of PBS medicines. By potentially increasing price reductions, the removal of originator brand data aligns with the goal of providing better value for money for PBS medicines, ultimately reducing out-of-pocket costs for consumers. Therefore, compliance with these provisions is essential to uphold the integrity and effectiveness of the PBS.