Almost everything you need to know about importing drugs from Canada

President Trump’s new plan to import cheaper drugs from Canada seems like a no-brainer. But like most things in health care, it’s complicated.

The logic is simple enough: Canadians buy the same drugs, made by the same manufacturers, but they get them at a much cheaper cost. So, says Trump, let’s take their drugs.

It’s also wildly popular: 80% of Americans said in a recent survey they support importing prescription drugs, making the idea one of the most well-liked drug pricing proposals currently being considered in Washington.

But the questions abound: Can Trump do this under existing law? Can Canada keep up with American demand? And can Trump get such an ambitious plan across the finish line before the 2020 election?

And then there’s the biggest concern of all: Is the Trump administration opening Americans up to dangerous, even deadly, counterfeit drugs?

Below STAT walks through everything you need to know about President Trump’s drug pricing plan, and how it’s likely to impact your budget.

What drugs will be imported?

Not the most expensive ones, quite frankly. Existing law prevents the importation of biologic drugs, which are new, high-tech drugs made from living organisms and which often carry seven- or eight-figure price tags. Insulin, too, which costs roughly 10 times more in the U.S. than it does in Canada, couldn’t be imported under the main part of the new plan.

Under a separate part of the plan, drug makers could bring in cheaper, foreign versions of their own drugs — including biologics and insulin — but they’d have to do that voluntarily — meaning, it wouldn’t be up to the state or a pharmacy. And it isn’t clear that there’s much of an incentive for drug makers to use this pathway.

So will this plan actually save me money?

Assuming you’re in a state that participates, yes. Most drugs are cheaper in Canada than in the U.S. For example, the high cholesterol medicine Crestor costs roughly $40 for a month’s supply in Canada, versus nearly $300 in the U.S.

The Congressional Budget Office estimated a similar proposal from Sen. Bernie Sanders (I-Vt.) would save the government roughly $7 billion over 10 years.

Who can import drugs under Trump’s plan?

Pharmacies, wholesalers, and states could all import drugs under the plan, so long as they meet the Trump administration’s requirements, such as having the ability to track drugs throughout the supply chain, and reporting any patient adverse events. Drug makers, too, could bring in versions of their drugs made in international factories.

The new proposal says nothing about patients importing drugs themselves, either by crossing the border, buying drugs online, or using one of the many storefront shops around the country that help customers import drugs. Personal importation, as it’s often called, is technically illegal, but there are exceptions. For example, consumers can import a drug that treats a serious condition but isn’t sold in the U.S.

When will the drugs from Canada start rolling in?

A long time from now. Trump is proposing a regulatory proposal to start a pilot program. In plain English, that means the administration needs to issue a proposed regulation, give the public at least a month or more to comment formally on it, and then finalize the regulation. Only after all that will it start reviewing proposals for states that want to try importing — as long as states and others have started to submit them by then.

Health and Human Services declined to provide a specific timeline for implementation. “The FDA remains committed to advancing these policies as quickly as possible,” an HHS spokesperson wrote in a statement. “We expect to have additional announcements in the coming months.”

And the states, too, have to take the time to write their proposals. The first state to express interest in importing drugs, Vermont, has been working on its proposal for more than a year, and has blown through its previous pledge to submit a plan to the federal government by July 1, 2019. Florida, which recently passed a law directing the state government to come up with an importation plan, is planning to submit its own by July 2020.

This all means that it’s unlikely any importation plans will be ready before the 2020 election. If Trump loses, that’ll throw an even bigger wrench in the project.

Are there actually enough drugs in Canada for U.S. patients?

No. The Canadian drug market is much smaller than the U.S. market, and if Americans start buying Canadian drugs, it’ll cause serious supply issues for both countries. A 2018 study found that if 20% of U.S. prescriptions were filled in Canada, our neighbor to the north would see its drug supply depleted in roughly 200 days. Even proponents of drug importation have said the U.S. shouldn’t depend on Canada alone, and have called for importation from a number of European Union countries, as well as Japan.

Supply issues are such a concern that Canadian officials, reportedly, have already begun readying their talking points against the proposal. In a written statement, the Canadian ministry of health said it looks forward to discussing the proposal with the Trump administration, although it emphasized its concerns with supply issues.

“Ensuring that Canadians have access to the medicines they need is one of our top priorities: we constantly monitor Canada’s drug supply, will be working closely with health experts to better understand the implications for Canadians and will ensure there are no adverse effects to the supply or cost of prescription drugs in Canada,” the ministry wrote.

Health secretary Alex Azar has yet to acknowledge that fact, however. When asked about Canada’s concerns, he told reporters it was up to the states and pharmacies to make their plans work.

Is this safe?

This is the most contentious question you can ask. Drug makers, and nearly every FDA commissioner in recent history, have insisted that drug importation simply can’t be done safely. Even Azar once opposed the idea.

Skeptics point out that drug counterfeiting is a huge criminal enterprise, and that counterfeiters can trick even the most sophisticated expert. They also point to a few high-profile examples of imported drugs causing serious harm — chief among them, a string of deaths in 2008 from counterfeit versions of the blood clot drug Heparin.

Proponents, however, insist that these sorts of issues are remedied when drugs are imported carefully.

Azar is now insisting that new technology has made safe to import drugs. On a call with reporters, he defended his about-face on the issue. He cited the increasing globalization of drug distributors and pharmacies and the implementation of a 2013 law requiring the FDA to stand up a tracking system for drugs. He said those are  examples of “a real maturation and development of the supply chain,” which, he argues, now makes importation safe.

Who supports the idea? Who opposes it?

Pharmaceutical companies are the most vocal skeptics of the idea. Both of the top trade associations representing drug companies, PhRMA and BIO, almost immediately fired off statements opposing the new plan. (BIO CEO Jim Greenwood even called the plan “a misguided attempt to keep an ill-informed campaign promise.”)

The loudest proponents of importation include seniors groups like AARP. Drug pricing advocacy groups like Patients for Affordable Drugs and Families USA also support the idea of importing drugs.

The American Medical Association, the nation’s top doctors group, has said it supports in-person importation, but has opposed importation over the internet. (The AMA has not yet weighed in specifically on Trump’s proposal.)

On Capitol Hill, the idea has most loudly been championed by Democrats. Sanders has introduced a number of bills on the topic over the decades and has made it a pillar of his presidential campaign. He also recently led a pilgrimage to Canada to buy cheaper insulin. Some Republicans too, support the idea: The Senate’s most senior Republican, Sen. Chuck Grassley (R-Iowa) has backed it, as did the late Sen. John McCain of Arizona.

Everything (or almost everything) you need to know about importing drugs from Canada