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Canada mulls strategy to fight Trump's proposals for foreign drug importation

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Canada mulls strategy to fight Trump's proposals for foreign drug importation

Canadian health officials and various stakeholders launched an effort this week to devise a strategy to protect the nation's drug supply from being depleted by Americans seeking cheaper prescription medicines if two importation pathways conceived by the Trump administration are ever implemented.

Health Minister Ginette Petitpas Taylor said she convened a roundtable discussion in Ottawa on Aug. 12 with a broad coalition of players, including pharmacists, patients, physicians, industry representatives and policy experts, to mull over ideas for addressing President Donald Trump's plans to import drugs.

"Participants expressed their appreciation to the minister for swiftly convening the group and shared their perspectives on the importance of consistent patient access to prescription drugs, as well as their concerns about anything that could lead to or worsen drug shortages in Canada," Alexander Cohen, press secretary for Petitpas Taylor, told S&P Global Market Intelligence in an emailed statement.

Among those who met with Petitpas Taylor was Pamela Fralick, the president of Innovative Medicines Canada, which represents brand-name drugmakers — Canada's counterpart to the Pharmaceutical Research and Manufacturers of America, the U.S. lobbying group.

Both the Canadian and the U.S. drug organizations have expressed opposition to Trump's importation plans.

In an Aug. 13 tweet, Jody Ciufo, CEO of the Canadian Society of Hospital Pharmacists, said her group talked about the importance of a direct and timely response from the Canadian government to the U.S.

"The longer we have uncertainty around this issue, the greater the impact on patient health," Ciufo tweeted.

"Patients are concerned about Canada's growing drug shortages and the impact on patient safety," the Canadian Patient Safety Institute said in an Aug. 12 tweet. "U.S. drug importation proposals threaten to cause greater shortages, which would place Canadian patients at risk."

Implementation uncertain

Right now, Trump's plan to import drugs is only an idea, with no official proposals on the table.

On July 31, the administration outlined two potential pathways that could be taken, but putting them in place could take years.

The first path involves launching a series of pilot projects that would be run by states, wholesalers and pharmacists for importing medicines from Canada. The second scheme involves a complicated process that would let drug manufacturers sell products intended for foreign markets in the U.S.

A 2003 law that reformed the U.S. federal Medicare program for seniors and disabled Americans included a clause that legalized drug importation under certain circumstances if the secretary of the U.S. Department of Health and Human Services deems it safe.

So far, no HHS secretary has been willing to sign off on allowing drugs to be imported.

Currently, it is illegal for individual Americans to import drugs or devices into the U.S. for personal use.

A medicine approved for use in another country but not cleared by the U.S. Food and Drug Administration would be considered an unapproved drug in the U.S. and therefore illegal to import, according to the agency.

"The FDA cannot ensure the safety and effectiveness of medicine purchased over the Internet from foreign sources, storefront businesses that offer to buy foreign medicine for you or during trips outside the U.S.," the agency stated on its website.

But those warnings have not stopped some Americans from ordering prescription drugs online from foreign pharmacies, according to the nonprofit Consumer Reports.

A 2017 nationally representative Consumer Reports survey found that an estimated 3.4 million people had ordered at least one prescription drug online from outside the U.S.

It noted that a review by the National Association of Boards of Pharmacy of 11,000 pharmacy websites found that 95% did not comply with U.S. federal and state laws and were likely selling drugs not approved by the FDA.

Aside from any safety concerns, the 2003 law also requires the HHS secretary to certify that any importation plan must result in a significant reduction in the cost of drugs, said Rachel Sachs, an associate professor of law at Washington University in St. Louis.

"It is unclear how such a certification would be made," Sachs wrote in the policy journal Health Affairs. She noted that issue is among a number of roadblocks the Trump importation proposals face.