The Patented Medicine Prices Review Board published its new guidelines on Friday.
The guidelines, which will take effect on Jan. 1, 2021, aim to modernize Canada’s pricing framework for patented medicines. They explain the steps that will typically be taken by the PMPRB’s staff in assessing whether a patented medicine appears to be priced excessively in Canada. The guidelines also explain what information patent-holding pharmaceutical companies must provide to the PMPRB to enable that assessment.
The publication is the result of a lengthy process, including a series of consultations and the work of a multi-stakeholder steering committee on modernizing the guidelines. This summer, the PMPRB published its draft guidelines and announced the six-month postponement of the new guidelines.
“The PMPRB would like to acknowledge and thank the thousands of Canadians who shared their thoughts and perspectives on the modernization of its regulatory framework over the entirety of this five-year period and, in particular, those who took the time to submit their views in writing,” said the PMPRB. “As noted, a number of important changes were made to the guidelines as a result of stakeholder feedback, the most recent of which differentiate the June 2020 draft from the final guidelines.”
Canada’s life and health insurers continue to support the amendments and guidelines and are ready to do our part, said Stephen Frank, president and chief executive officer of the Canadian Life and Health Insurance Association, in a press release.
“Through workplace benefits plans, insurers provide employers and their employees with access to over 11,000 patented medicines, which include an increasing number of high-cost drugs. Lower drug costs will help to keep these plans sustainable.”
In an online statement, Innovative Medicines Canada noted it has raised concerns about the negative impact of the PMPRB’s amendments for the last five years. “The final guidelines released today do nothing to relieve those concerns.
“If implemented, they will have a negative impact on Canadian patients. Specifically, innovative new medicines will not launch in Canada, depriving patients of potentially life-changing new treatments; we will see further reductions in the number of clinical trials in this country; and our life sciences sector will lose out on critical investments.
“We will continue to ask that Health Canada delay the Jan. 1, 2021 implementation of the final PMPRB guidelines until after the COVID-19 crisis is passed. At this time, our collective focus should only be on the discovery, development and delivery of COVID-19 medicines to treat those infected by the virus and vaccines to halt its spread.”