Six states have undertaken efforts to pass legislation and design State Importation Programs in order to offer citizens access to drastically lower Canadian drug prices. Federal rules governing importation are still under litigation and under review by the Biden administration. Whether or not Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont are able to proceed with State Importation Programs, questions remain as to whether patients would actually recoup savings under their wholesale importation plans.
In 2020, the Department of Health and Human Services (HHS) approved federal rulemaking for state importation programs, which the Food and Drug Administration (FDA) would use to approve state-based wholesale Canadian drug importation programs.
Millions of Americans have found price savings from Canadian for personal importation of drugs since the Medicare Modernization Act (MMA) of 2003—but the law requires that imported medicines come from Canada’s drug supply, that they introduce no additional risk, and that they deliver substantial savings. While federal legislation to fully open the border to prescription drugs from Canada has been debated for decades and has broad support from Democrats and Republicans, it has never won a majority vote in the Senate. The PHARMA trade group representing big manufacturers, filed suit in federal court in Washington, D.C., to stop the drug-purchasing initiatives in November, and the Biden Administration has yet to announce their intentions regarding the regulatory effort.
Since 2017, state legislatures across the country have taken over 120 legislative actions to try to reign in high drug costs. Efforts aimed at importation programs have taken hold in six states. There is opposition to the wholesale importation pathway these states are pursuing because it would not deliver the full savings to patients, instead, programs would layer in new middlemen.
None of the State Importation Programs have been enacted as of yet. U.S. and Canadian regulatory restrictions, as well as legal challenges, remain obstacles for these state pursuits.
Colorado’s SB19-005, signed into law in May 2019, created a “Canadian Prescription Drug Importation Program” in the Department of Health Care Policy and Financing (CHCPF). In January, 2021, Colorado Department of Health Care Policy and Financing issued a request for companies to bid on its plan to import drugs from Canada.
Florida enacted its importation bill, SB19, in June 2019 and submitted the Florida State Import Proposal to HHS in July. Under the Florida plan, the state will purchase drugs for state agencies (including for the Medicaid program and the corrections and health departments) and it is projected to save the state between $80 and $150 million in the first year alone. Florida Governor Ron DeSantis included $15 million in his proposed 2021-2022 budget for an importation program and has contracted with LifeScience to lead proposed implementation.
Maine signed LD1272 into law in June 2019 and submitted an application to HHS in April 2020. Maine’s bill allows the state to consider whether the program may be developed on a multistate basis through collaboration with other states.
New Hampshire’s drug importation law, which was enacted in July 2020, stated that the state would submit a plan to HHS by February 1, 2021.
New Mexico’s governor signed SB1, in March 2020. New Mexico’s plan would authorize the state to create a wholesale prescription drug importation program administered by New Mexico’s Department of Health. PHARMA has contested New Mexico’s new law in court.
Vermont’s governor signed S 175, in May 2018, which directed the Agency of Human Services (VAHS) to design a program for wholesale Canadian prescription drug importation. In October 2019, the governor submitted a concept plan to HHS.