Canadian officials, responding to a move by President Trump allowing Americans to import some prescription drugs, blocked bulk importation of drugs in cases in which a domestic shortage would be created.
The order took effect Friday ahead of the U.S. rule, which drug suppliers have warned could lead to shortages within Canada, Reuters reported.
“Certain drugs intended for the Canadian market are prohibited from being distributed for consumption outside of Canada if that sale would cause or worsen a drug shortage,” Health Minister Patty Hajdu said in a statement, according to the news service. “Companies will now also be required to provide information to assess existing or potential shortages when requested, and within 24 hours if there is a serious or imminent health risk.”
Prime Minister Justin Trudeau said earlier this year that while he was willing to aid other nations, he would prioritize Canadians’ access to drug supplies.
“Canada is a small market, representing 2 percent of global drug sales, that sources 68 percent of its drugs internationally. The need for vigilance in maintaining the national drug supply continues,” Hadju said.
A major U.S. pharmaceutical lobbying group is also suing to end the rule, claiming it violates the Federal Food, Drug, and Cosmetic Act, according to Endpoints News.
“It is particularly disturbing that the administration is punting the responsibility for demonstrating safety and cost savings to state governments despite the clear requirement under federal law that the Secretary of HHS must certify that imported drugs both pose no additional risk to public safety and will lead to significant savings for the American consumer,” said James Stansel, general counsel for the Pharmaceutical Research and Manufacturers of America.
The lobbying group’s lawsuit specifically alleges that Health and Human Services Secretary Alex Azar violated Section 804 of the law by leaving importation gatekeeping in the hands of state governments.
