Health Canada reminded the pharmaceutical industry of export rules intended to prevent possible drug shortages, after a major change in U.S. policy on purchasing prescription drugs north of the border raised fears a shortage in the country.
The U.S. Food and Drug Administration (FDA) announced plans Friday to allow Florida to import millions of dollars’ worth of pharmaceutical products from Canadian wholesalers to help curb high costs. drugs in the United States.
The move is not good news for Canada, which has faced acute drug shortages more frequently in recent years, said Joelle Walker, vice-president of public affairs at the Canadian Pharmacists Association. .
Florida’s population is more than half that of all of Canada. And in addition to Florida, other US states are considering similar requests to the FDA to reduce drug costs.
“Canada cannot become America’s pharmacy, it’s simply not practical. We can’t do it, it’s not possible,” Ms Walker said.
In recent years, Canada has experienced shortages of certain medications, including those for fever in children and certain cancer medications. More recently, the popular weight loss and diabetes management drug Ozempic has been difficult to find in pharmacies.
Florida’s proposal includes a number of drug classes, including those for asthma, chronic obstructive pulmonary disease, diabetes, HIV-AIDS and mental illness.
Walker stresses, however, that Canadians should not rush to the corner pharmacy to refill their prescriptions, because the threat is not imminent.
The state of Florida still has work to do to prove that imports would actually save Americans money without impacting public safety. Florida authorities will also have to test the drugs to ensure their authenticity and relabel them so that they comply with American standards.
“All of this could actually be very costly and we hope it will deter Florida from moving forward,” Ms. Walker said.
Health Canada promises to ensure
If a manufacturer wants to export drugs to the United States, it will need approval from Health Canada, something the federal regulator would likely refuse if it feared a shortage at home.
Health Canada sent a bulletin Friday suggesting its intention to maintain this position. The message reminds manufacturers and distributors of pharmaceutical products, as well as pharmacists and other players in this sector, of the existing guarantees against shortages.
Canadian regulations prohibit the distribution outside the country of certain locally produced pharmaceutical products if there are “reasonable grounds to believe that doing so would cause or worsen a shortage,” the bulletin said.
Drugs intended for the Canadian market may continue to be sold for consumption outside Canada “if there are no reasonable grounds to believe that the distribution could cause a drug shortage or worsen a drug shortage.” existing” in Canada.
The department will not hesitate to address cases of non-compliance, a Health Canada spokesperson said Friday.
Failure to comply with the rules could be subject to public notice or more serious sanctions, including revocation or suspension of licenses, according to the statement.
In a statement, Health Minister Mark Holland assured Canadians that they will continue to have access to the medications they need.
The federal government will take “all necessary measures to protect the drug supply in Canada,” he said.
Among all member countries of the Organization for Economic Co-operation and Development, the United States, by far, pays the highest price for patented medicines, with no government limits on what companies can charge. Although Canada pays much less in comparison, its prices still ranked third in 2021.
Americans have long been able to fill their prescriptions at Canadian pharmacies, but the recently announced policy change affects mass imports.
These imported drugs would be intended for certain people, notably children placed in foster families, prisoners, certain elderly patients and, possibly, beneficiaries of the “Medicaid” plan.
The FDA’s decision follows decades of lobbying by the pharmaceutical industry, which claimed such imports would put American patients at risk from counterfeit or adulterated drugs. The FDA also warned that it could be difficult to ensure the safety of drugs coming from outside the United States.
But the political mood around the issue has changed in recent years in the United States, with both Democrats and Republicans doubling down on their pro-import efforts.