The Trump administration said it will create a system to allow for the legal importation of lower-cost prescription drugs from Canada, a first following years of refusals from national health authorities.
The proposal works on a variety of levels: It would allow states, wholesalers, and pharmacists to get approval from the U.S. Food and Drug Administration to import certain medications that are also available in the U.S. and would allow drug makers to seek approval for re-importation of their own drugs. This part of the plan would cover therapies like high-cost biologic drugs, as well as essential medicines like insulin.
Even before the plan was released, Canada’s main pharmaceutical lobbying group, Innovative Medicines Canada ,issued a talking points document for use by its staff and Canadian companies to preempt the U.S.’s plan to import drugs. One of the proposals was to ban the export of all drugs “unless otherwise permitted by regulation.”
Now, other Canadian health officials are voicing their concerns, echoing warnings issued last month that exporting drugs to the U.S. would create drug shortages for Canadian citizens.
“The Canadian medicine supply is not sufficient to support both Canadian and U.S. consumers,” the Canadian Medical Association and 14 other groups representing patients, physicians, and hospital systems wrote last week to Health Minister Ginette Petitpas Taylor. “The supply simply does not, and will not, exist within Canada to meet such demands.”
Other stakeholders are concerned that pharmaceutical companies would not be willing to cooperate, further harming Canada’s access to low-cost prescription drugs.
“If there is widespread export from Canada to the U.S., the companies may limit what they ship to Canada to cover what they estimate the Canadian market is and not send any extras that might be sent back to the U.S.,” said Joel Lexchin, MD, a professor of pharmaceutical policy at the University of Toronto.
The proposed importation plan still needs to clear regulatory approval and could face potential court challenges from drug makers.