Health Canada on Monday emphasized its commitment to taking swift action to “safeguard” the country’s prescription drug supply after a U.S. ruling that could see certain drugs imported south of the border from Canada.
The warning comes days after the U.S. Food and Drug Administration (FDA) agreed to allow Florida to import bulk pharmaceuticals, including medication for asthma, diabetes, and HIV, from Canadian wholesalers as a way to avoid the high cost of drugs in that country.
However, Friday’s ruling has raised concerns about potential impacts on the Canadian drug supply.
“The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.,” Health Canada said in Monday’s statement.
The federal Liberal government passed an interim order in November 2020 to restrict exports of drugs that are at risk of shortage in Canada. Health Canada reiterated that it plans to make sure that order is enforced.
The health department said it is actively monitoring the Canadian drug supply and is prepared to enforce corrective measures, issue advisories or take other actions if non-compliance is detected.
“Regulations have been implemented under the Food and Drugs Act to prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada. This includes all drugs that are eligible for bulk importation to the U.S., including those identified in Florida’s bulk importation plan, or any other US state’s future importation programs,” the statement said.
“Health Canada stands ready to take immediate additional action, if needed, to help safeguard the Canadian drug supply.”
Canadian Pharmacists Association vice-president of public affairs Joelle Walker said hearing that the Canadian government will take necessary steps, “sends a signal to the U.S.”
“Canada’s not in support of this and that they’ll take whatever measures necessary for Canadians,” she said.
Why does Florida want Canadian drugs?
The U.S. pays some of the highest prices for patented medicines among members of the Organisation for Economic Co-operation and Development (OECD), with essentially no government limits on what companies can charge.
Drugs in the U.S. are on average 218 per cent more expensive than Canadian prices, according to 2021 data from International Prescription Drug Price Comparison.
Americans have long been able to fill prescriptions from Canadian pharmacies, but the newly announced policy change affects mass imports.
The FDA’s decision follows years of successful lobbying against the idea by the pharmaceutical industry, which said imports would expose U.S. patients to risks of counterfeit or adulterated drugs.
“It’s been in the works for a while, Congress wanted to do this for decades,” explained Mark Warner, a Toronto-based trade lawyer. “And then it was picked up the Republican governor in Florida, DeSantis. And Biden is more or less signed on to this as well. It is a sign of the times.”
Florida, which filed its proposal with the FDA in 2020, expects to save up to US$180 million in the first year and around US$183 million annually once the program is fully implemented, the state said.
Other states, like Colorado, Maine and Texas, have passed laws that would allow them to create state drug importation programs.
'No immediate threat for Canadians'
As other U.S. states contemplate similar initiatives, the pressure on Canada’s pharmaceutical resources raises concerns, as many drugs in the country are already in short supply.
Walker said although the FDA ruling is not good news for Canadians, however, she stressed her confidence in the existing regulations within Canada to effectively safeguard the country’s drug supply.
“There’s no immediate threat for Canadians as part of this,” she said. “Florida has to do a lot more, a lot of steps have to be taken to permit this and we don’t think it’s going to be happening tomorrow.”
For example, Walker said Florida still has to show what drugs are needed, establish cost savings, and undertake the inspection and re-labeling of medications—an inherently expensive process. Because of this believe there aren’t any realistic timelines in the future.
She added that from a mass importation perspective, Florida will also need to find a willing partner in Canada.
“And we don’t think that there’s a lot of people who are going to be wanting to do that because there’s just not enough supply here in Canada,” she said.
Potential loopholes
Although Canada has export rules designed to prevent drug shortages experts believe potential loopholes exist.
“We shouldn’t suffer so much as long as people respect the rules,” Warner said. “But the one hole in the regulations is that they do apply to the wholesalers and the producers. They don’t apply at the level of the individual pharmacy. That seems to be a hole that you could probably drive a truck through.”
Walker agreed, cautioning that on an individual level, there may be opportunities for people to circumvent these laws.
In early 2023, for example, a significant number of U.S. patients were purchasing the diabetes and weight loss drug Ozempic from pharmacies in British Columbia, leading to shortages in the province.
“The people who are importing drugs like Ozempic individually, that doesn’t get captured by some of the regulations that the federal government has put in place,” Walker cautioned. “It’s hard to anticipate all the schemes that may emerge from that in the future.”
She also worries that widespread news coverage on the subject may unintentionally trigger a shortage, as Canadians, anxious about their prescriptions, may rush to pharmacies simultaneously.
“There’s no huge there. We want to assure Canadians,” she added.
In an email to Global News on Friday, Health Minister Mark Holland said, “Canadians will continue to have access to medications they need when they need them. Canadians can be confident that our government will continue to take all necessary measures to protect the drug supply in Canada.”
What's next?
Warner believes that we will need to “wait and see” how the Florida ruling unfolds and whether Health Canada decides to enforce the drug export rules.
“It’s one thing to put out the press release and issue the regulation. It’s another thing to make sure that it’s actually being enforced,” he said.
But he believes if the 2020 ruling is enforced Canadians should not experience a significant impact from the FDA decision.
In the meantime, Warner said the FDA ruling will continue unfolding in the U.S. courts.
“So it’s not as if tomorrow Florida is going to start loading up the wagons and, shipping lots of drugs from Canada. There’s lots of steps between that and now,” he said.
— With files from Global News’ Mackenzie Gray and the Canadian Press
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