The Canadian government on Friday announced major reforms to the country’s price regulations on patented drugs. The changes are the “most significant reforms to the regulations” since 1987, according a recent press release by Health Canada. Overall, the new regulations will serve as the first step in the implementation of Canada’s proposed national pharmacare plan.
Originally enacted in 1987, the Patented Medicine Regulations (PMR) serve to regulate the price of patented medicines and avoid excessive pricing practices. The regulations work in tandem with Canada’s Patent Act to ensure the necessary framework and authority when reviewing the prices of patented medicines sold in Canada.
The final amendments alter the current regulatory scheme of the PMR significantly; purporting to save Canadians C$13.2 billion (USD $10 billion) over the next 10 years. Under the new regulations, the Patented Medicine Prices Review Board (PMPRB) will consider the price of a patented medicine in relation to its value to patients and impact on the health care system. Additionally, the list of countries the PMPRB can reference when determining pricing grows to include more countries, yet removes countries where drugs are exceedingly high: the US and Switzerland.
Furthermore, additional reporting requirements will be required for the PMPRB to more accurately determine reasonable drug prices. The final amendments will go into effect July 1, 2020.