This item is part of Watch Washingtona regular dispatch of CBC News correspondents reporting on American politics and developments affecting Canadians.
Colorado is the latest state to apply for a license to import drugs from Canada, the latest development in a politically sensitive cross-border issue.
This week state announce thats it Requested The US Food and Drug Administration (FDA) for permission to import 112 drugs from Canada including EpiPens, drugs for cancer, asthma, multiple sclerosis, diabetes and other diseases.
Because these drugs are cheaper in Canada, projects in the country that imports them will save Coloradans an average of 65 percent per drug.
“This exciting move means we’re one step closer to savings for Coloradons,” Colorado Gov. Jared Polis said in a statement.
What is the context?
This is partly due to national regulations: other countries have stricter rules for setting maximum prices and negotiating with drug companies.
The United States has taken limited steps to address this. Years ago I made my choice Coverage plan for seniors that allowed for price negotiations, and the just-passed Inflation Reduction Act includes many cost saving measures.
The pharmaceutical industry lobbied aggressively against price controls. health sector each spends Another US industry in the squeeze last year, with pharmaceutical companies Especially funding legislators who voted against such reforms.
Some US states have adopted another idea: free trade in medicine. Why don’t we only import medicines from abroad?
Six US states enacted laws Allowing the import of drugs from abroad, particularly from Canada, and now Colorado is the second, after Florida, to have requested official authorization from the Food and Drug Administration.
It is applied under a to treat Created by the Food and Drug Administration in 2020. But no country has received approval yet, because the process is complex. To help explain the rules, the Food and Drug Administration has released a dossier Compliance guide this year.
Why this matters to Canadians can be summed up in nine letters: imperfection.
Ottawa has sporadically expressed concerns for years about the potential for the giant US market to swallow up Canadian supplies and clear pharmacy shelves.
Provided by the government of Paul Martin Bill in Parliament 2005 to enhance the ability of the Minister of Health to freeze exports in the event of a shortage. That government fell shortly thereafter, the bill was never passed, and the issue mostly lay dormant for years.
But talk of importing has re-emerged in the US states recently. And Ottawa resumed its talk of export bans: Trudeau’s government was drafted in 2020 systems To better monitor potential shortages and Restrict foreign sales of affected products.
The issue now rests with the Food and Drug Administration. You must agree to import requests. This is in addition to the complex requirements that import and export companies must meet.
There are complex rules for the industry in both countries.
On the export side – the Canadian government says Canada’s laws require companies to keep records proving that cross-border drug sales will not cause shortages.
Federal regulations, as well Canadian Food and Drug ActAnd allow the government to then intervene to prevent shortages.
On the import side: The current US import process, introduced in 2020, has several hoops that US buyers must jump through.
To be eligible for import, the product requires the necessary Canadian labeling; The seller must be licensed to wholesale medicines by Health Canada; The seller must also be registered with the Food and Drug Administration as a foreign seller; The US importer must be a licensed wholesale distributor or pharmacist in the United States
Then there are the many testing and security requirements for shipments.
The Canadian government says it is still working with the United States to understand the FDA’s plans to implement drug imports.
So far, says the Canadian Embassy in Washington, no government plans have been approved by the Food and Drug Administration.