Canada’s health minister signed an ordinance last week designed to restrict Americans’ ability to import prescription drugs from our northern neighbors.
Health Minister Patty Hajdu’s order to restrict bulk exports of prescription drugs came just days before the Ministry of Health and Human Services’ new regime came into effect, allowing pharmacists or wholesalers to import certain prescription drugs in bulk.
“Our health system is a symbol of our national identity and we are determined to defend it,” Hajdu said in a statement, according to the NPR. “The actions we are taking today will help protect Canadians’ access to the medicines they depend on.” . ”
Under the ordinance, the Canadian government will not sell prescription drugs if the sale would cause or worsen a drug shortage in Canada, NPR reported. According to the NPR, 10 to 15% of drugs in Canada are in short supply at any point in time. With the Covid-19 pandemic, the demand for certain drugs is growing. There were 42 major drug shortages in the country in October, compared with 10 in 2019.
No group or class of pharmaceuticals that would be excluded from export was specifically mentioned in the Ministry of Health ordinance. According to the NPR, the regulation only applies to drugs for which a deficiency is reported. This group would include prescription drugs and controlled substances.
“It doesn’t apply to over-the-counter drugs or drugs that are manufactured in Canada or imported for export purposes only,” Health Canada spokeswoman Anna Maddison told NPR.
When announcing the new rule in September, President Donald J. Trump called it “a pioneer for American seniors,” according to Kaiser Family News. “We’re doing it very, very quickly.” In early November, the president said the new rule would cut prescription drug costs in half by excluding middlemen who raise prices, according to the NPR.
However, since the new rule was announced in September, Canadian politicians have made it clear that the country will not adhere to the program because it does not have the prescription drugs. Many Canadian pharmacists and distributors have pledged not to participate in the Trump administration’s plan.
Prescription drugs are cheaper in Canada because the government limits drug manufacturers’ fees. And for years, Americans have crossed the border to buy drugs from Canada-regulated pharmacies when it was illegal to do so. The U.S. government generally looked different when it came to purchases for personal use.
According to the president’s plan, a Canadian licensed wholesaler would buy drugs approved for sale in Canada from a pharmaceutical company and then export the drugs to a US importer. The importer would then sign a contract with a state that would then hand over the drugs to pharmacies.
One state that has submitted an import plan to the federal government is Florida. The plan, which was approved by state lawmakers in 2019, is administered by Florida’s Agency for Health Care Administration.
“Floridians have been paying exorbitant prices for prescription drugs for far too long,” said Governor Ron DeSantis in a Tampa Bay Times press release on Monday. “Today we’re taking another step towards lowering these prices.”
However, a pharmaceutical lobby group has filed a lawsuit in federal court to prevent Florida and other states from importing prescription drugs from Canada. Pharmaceutical Research and Manufacturers of America (PhRMA), one of the groups suing the administration, said the program has not proven it will be safe and effective, two requirements of the new rule.
“Every secretary who’s looked at it for the past 20 years, Republican or Democrat, has said I can’t certify it either,” PhRMA executive vice president and general counsel James C. Stansel told Tampa Bay Mal.
The American Pharmaceutical Association (APhA) told Medical Daily in an interview last month that it was against the president’s order for a number of reasons, with safety a top priority.
“Nothing in the final regulation and other supporting documents released by the FDA (Food and Drug Administration) shows that this can be done safely and results in savings for patients,” said Illisa Bernstein, senior vice president of pharmacy practice and Government affairs at APhA. said.
Ms. Bernstein said the main concern was that drugs would switch hands multiple times between the Canadian wholesaler and the local American pharmacy counter. This could make it possible to re-label medicines and include them in the importer’s supply chain, which also includes medicines from other countries. It is possible, she said, that when someone picks up a prescription, the contents are not the FDA-cleared version, but rather a counterfeit drug.
“There is very little information HHS has given about it, and that carries even greater risks,” she said. “You don’t know what you’re getting from the global supply chain.”
When it released Florida’s plan, the DeSantis office said it would take steps to “ensure counterfeit drugs don’t get into the supply chain,” according to the Tampa Bay Times.
Robert Calandra is an award-winning journalist and author who has written extensively on health and medicine. His work has been published in national and regional magazines and newspapers.