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09 November 2020
On 23 October 2020 the Patented Medicine Prices Review Board (PMPRB) released the final guidelines operationalising the amended Patented Medicines Regulations. The guidelines describe the price review methodology that will apply to medicines from 1 January 2021, when the amended regulations come into force (for further details please see "Amended Patented Medicines Regulations will come into force on 1 January 2021").
The PMPRB has also released its October 2020 Newsletter, which includes an overview of final changes as well as next steps, outreach and engagement opportunities.
Notably, since the publication of the revised draft guidelines in June 2020, the Federal Court has invalidated the amended regulations' price calculation provision (for further details please see "Federal Court strikes price calculation provision of amendments to Patented Medicines Regulations"). The decision has been appealed. A separate challenge to the constitutionality of the PMPRB provisions of the Patent Act and the Patented Medicines Regulations is ongoing.
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