2/18/2023 0 Comments Federal register 2017 mip rates![]() ![]() If a patented medicine appears to be priced excessively based on these Guidelines and an acceptable Voluntary Compliance Undertaking (“VCU”) has not been submitted by the patentee, the Chairperson may receive a recommendation from Staff that a hearing be held on the matter. ![]() The Guidelines also provide an overview of the processes that patentees should be aware of regarding their filing obligations under the Patented Medicines Regulations (“Regulations”).ģ. These Guidelines, which are issued pursuant to subsection 96(4) of the Act, are intended to provide transparency and predictability to patentees regarding the triage and review process typically engaged in by public servant employees of the PMPRB (“Staff”) in assessing whether a patented medicine appears to be priced excessively in any market in Canada. As a member of the Health Portfolio, the PMPRB contributes to a modern and sustainable health system by ensuring that Canadians continue to have access to patented medicines at non-excessive prices.Ģ. Its creation arose out of concern that stronger patent protection for medicines might cause their prices to rise unacceptably and become unaffordable to consumers. The PMPRB is a quasi-judicial body with a regulatory mandate to prevent pharmaceutical patentees from charging consumers excessive prices during the statutory monopoly period. The Patented Medicine Prices Review Board (PMPRB) was created in 1987 as the consumer protection “pillar” of a major set of reforms to the Patent Act (“Act”). ![]()
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