To Colorado officials charged with developing one of the nation’s first state programs to import cheaper prescription drugs from Canada, the announcement last month by U.S. Health and Human Services Secretary Alex Azar seemed like great news.
Not only was the Trump administration changing course after initially being skeptical of such importation schemes, but it appeared poised to give its blessing to programs under development in Colorado and other states.
“President Trump has been clear: for too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices,” Azar said in a statement announcing that his department will create rules for how states should go about setting up drug-importation programs.
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But then officials in Canada quickly said they hadn’t been consulted on the administration’s announcement and were skeptical of American efforts to divert Canadian drugs. And now Colorado’s plan — which is really just getting started — is already facing some pretty big questions about whether it can deliver on its promise.
As part of a historic session for ambitious health care reforms, lawmakers at the state Capitol this year passed a bill to set up a program to import certain prescription drugs from Canada. In a statement earlier this month, Gov. Jared Polis called the plan one of the key parts of his health care roadmap.
“We are done being ripped off,” he said.
Officials at the Colorado Department of Health Care Policy and Financing, which is working on the state’s plan, declined to speculate on whether the rumblings from Canada represent serious storm clouds hovering over their work.
“We’re not far enough along yet to know whether that’s a factor or not,” HCPF spokesman Marc Williams said. “… We are still in the very, very, very first early stages.”
That means Colorado has not yet established protocols to ensure the drugs it imports are safe, nor has it sought out suppliers to actually get the drugs into the state. It hasn’t yet put together a list of which drugs the program will try to import, and it can’t yet say how much money — if any — the drug-importation program would save Colorado patients.
The state is still about a year away from a self-imposed deadline to submit its plan to the federal government for approval. And, even if Colorado were ready to go with a plan today, the federal Health and Human Services Department now needs time to develop draft rules on how state drug-importation programs should work, to seek public comment on those rules and then to finalize them, said Rachel Sachs, a law professor at Washington University in St. Louis who specializes in health and pharmaceutical policy.
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“One problem that states have is that it’s going to be quite some time before they’re going to be able to engage in this process,” she said.
That’s not the only problem — as indicated by Canada’s increasingly vocal concerns.
Last week, the nation’s health minister convened a large meeting of doctors, pharmacists, drug companies and patients to “discuss recent decisions in the U.S., share knowledge and examine options to ensure all Canadians have consistent access to the medications they rely on.” The Globe and Mail, one of Canada’s largest newspapers, headlined an editorial: “Donald Trump, keep your hands off our drugs.”
Patient advocates and government officials have warned that the American plans could cause drug shortages in Canada.
“The government needs to pull up its socks and figure out how to protect Canadians from having our supply hoovered by Florida,” John Adams, the chair of the advocacy group Best Medicines Coalition, told The Toronto Star.
Canada has two ways it could do that, Sachs said. It could pass a new law blocking prescription drug exports, or it could add the drugs to its export control list, requiring government approval anytime someone wants to ship pharmaceuticals outside the country.
And even if Canada changes its mind on allowing drug exports to the U.S., states like Colorado may still find it difficult to find an industry partner that wants to undercut the prices it gets for drugs in America by routing its Canadian supply south. The pharmaceutical manufacturer trade group PhRMA and the Healthcare Distribution Alliance, a pharmaceutical distributor trade group, have come out against the idea.
“The administration’s importation scheme is far too dangerous for American patients,” PhRMA wrote in its statement.
Both groups cite concerns about patient safety — how are American consumers to know that the drugs coming from Canada are what they say they are? Colorado’s law requires the state’s program to have specific checks for safety. But, nonetheless, Sachs said states are facing multiple challenges as they move ahead with their plans.
“It’s very possible that, between the actions of the pharmaceutical industry and the Canadian government, that states interested in engaging in the importation of pharmaceutical drugs may not find a willing partner,” she said.
And that would finish Colorado’s program before it even started.