Life Sciences Ontario applauds the federal government’s recent decision to delay the implementation of the Patented Medicines Regulations to January 1, 2021 as part of the response to the COVID-19 crisis.
This measure will help the Canadian life sciences sector remain unwaveringly focused on developing vaccines, treatments, and other tools to fight the COVID-19 pandemic. The delay will also allow more time for dialogue on the Patented Medicine Prices Review Board’s (PMPRB) draft implementation plan and perhaps even a reconsideration of the regulation changes themselves.
In fact, Health Canada’s notice to stakeholders stated that the “delay will minimize the imposition of new administrative burden on industry […]” which is focused on bolstering supplies of medicines and solving for COVID-19. Notably, this is the first time that Health Canada has recognized that the new PMPRB regime would impose a measurable administrative challenge for industry (the Regulatory Impact Analysis Statement for the August 2019 changes forecast a negligible administrative burden on industry).
In sum, while the postponement represents a positive development, it is important to note that the delay does not change the flawed regulations – the same regulatory barriers will still be in place six months from now and are expected to continue to impact new drug launches and R&D investments in Canada. These issues still need to be addressed.
Life Sciences Ontario looks forward to more details about the PMPRB’s draft guidelines and further opportunities for dialogue on the changes to the regulations.
Jason Field, PhD
President & CEO
Life Sciences Ontario