The Trump administration unveiled plans July 31 to allow the U.S. to import drugs from Canada. Here are six things to know about the pricing plan:
1. The drugs that can't be imported. Under current law, biologic drugs can't be imported. This means the U.S. would not be able to import some of the most expensive drugs that often come with seven- or eight-figure price tags, according to STAT. Insulin, which costs about 10 times more in the U.S. than Canada, would not be able to be imported under current law. Drugmakers could bring in cheaper, foreign versions of their own drugs, but they would need to do so voluntarily. This would leave it in the drugmakers hands, instead of the state or pharmacy.
2. The players who can import drugs. Under President Trump's plan, pharmacies, wholesalers and states can import drugs if they meet certain requirements. For example, they would need to track drugs throughout the supply chain and report any adverse events. Drugmakers could also bring into the U.S. versions of their drugs made at international factories. It is unclear if patients will be able to import drugs themselves.
3. The timeline of drug importation. HHS didn't provide a timeline for implementation, but the reality is that the U.S. won't be seeing drugs from Canada for a while, according to STAT. Under President Trump's plan, HHS will issue a regulatory proposal to allow states and pharmacies to submit drug importation pilot programs for approval. This means that the administration would first need to issue a proposed regulation, give about a month for public comment and then finalize the regulation. After that process, the administration would begin reviewing proposals from states. And states have to take time to flesh out their proposals.
4. The supply issue. The Canadian drug market is much smaller than the U.S. market. If U.S. patients start buying Canadian drugs, it could lead to serious supply issues in Canada, according to STAT.
5. The savings opportunity. Most drugs are cheaper in Canada than they are in the U.S., so the importation plan could save patients money, according to STAT. The Congressional Budget Office estimated a similar importation proposal from Sen. Bernie Sanders, I-Vt., would save about $7 billion over 10 years.
6. The players who support or oppose importation. Pharmaceutical companies fiercely oppose drug importation. Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization, two of the industry's top lobbying groups, immediately sent statements in opposition to the new proposal. Some of the main supporters are such advocacy groups as Patients for Affordable Drugs and Families USA. Senior citizens' advocate AARP supports importation. The American Medical Association has expressed support of in-person, personal importation, but opposed importation via the internet. It has not commented on President Trump's proposal.
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