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Increase Access to Safe, Low Cost Prescription Drugs

Millions of Americans struggle to pay for their prescriptions — one in ten don’t take prescribed medications because they can’t afford them. It doesn’t have to be this way. Many of the most expensive prescription drugs are available at significantly lower prices outside the United States. The Safe and Low Cost Prescriptions Act gives customers in U.S. states access to safe, regulated prescription drugs at lower costs by importing them. It’s a safe, effective way to bring drug prices down so Americans get the treatment they need at a price they can afford.

The National Landscape

Passed in:

Vermont

Introduced in:

Colorado, Connecticut (12), Florida, Illinois, Maine, Massachusetts, Minnesota (12), New Mexico, Oklahoma, Oregon, Utah, West Virginia

In The News

“The drug industry is global; 40 percent of America’s drugs are manufactured abroad. ...States have responded by developing a wholesale importation model that uses existing distributor and pharmacy networks, which the federal government can allow as long as consumer safety and savings are assured.”
“There are thousands of us across Utah that face the same choices: whether [to] buy prescriptions or ... have a roof over my head,’ said Magna resident Moira Jackson-Drage [...] ‘If I was able to buy them from Canada, I would be able to take the prescriptions.’”

Partners

  • Consumers and families
  • Patient advocates
  • Patients who rely on prescription medications
  • Employers

Opposition

  • Pharmaceutical companies averse to lowering drug prices
Call us for real-time support using this library, problem-solving tips, and follow-up from our team of national experts:
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FAQ

Who does this help?
This bill helps all Americans facing high prescription drug costs, since the exact drugs they need are available at lower cost outside the United States: For example, prescription drug prices are 30% lower on average in Canada. Taking advantage of these price differences help state residents afford the safe prescription drugs they need to stay healthy.
How does this save consumers money?
This program targets drugs that are currently high cost in the United States, and makes them available at the lower costs at which these same drugs are currently sold outside the United States. A report from the Vermont Agency of Human Services estimated healthcare cost savings of between $1 and $5 million per year in that state from this program.
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Model Policy

SECTION 1 (TITLE):
This act shall be known as the Safe, Low-Cost Prescription Drugs Program Act.

SECTION 2 (PURPOSE):
To make prescription drugs that are available at lower costs outside the United States available to consumers in STATE at those lower costs.

SECTION 3 (PROVISIONS):

(a) DEPARTMENT in consultation with interested stakeholders and appropriate federal officials, shall design a wholesale prescription drug importation program that complies with the applicable requirements of 21 U.S.C. § 384, including the requirements regarding safety and cost savings. The program design shall:
  • (i) designate a State Agency that shall either become a licensed drug wholesaler or contract with a licensed drug wholesaler in order to seek federal certification and approval to import safe prescription drugs and provide significant prescription drug cost savings to consumers;
  • (ii) use Canadian prescription drug suppliers regulated under the laws of Canada or of one or more Canadian provinces, or both;
  • (iii) ensure that only prescription drugs meeting the U.S. Food and Drug Administration’s safety, effectiveness, and other standards shall be imported by or on behalf of the State;
  • (iv) import only those prescription drugs expected to generate substantial savings for consumers;
  • (v) ensure that the program complies with the tracking and tracing requirements of 21 U.S.C. §§ 360eee and 360eee-1 to the extent feasible and practical prior to imported drugs coming into the possession of the State wholesaler and that it complies fully after imported drugs are in the possession of the State wholesaler;
  • (vi) prohibit the distribution, dispensing, or sale of imported products outside the state’s borders;
  • (vii) recommend a charge per prescription or another method of support to ensure that the program is funded adequately in a manner that does not jeopardize significant consumer savings; and
  • (viii) include a robust audit function.

(b) DEPARTMENT shall recommend a funding design for the program, and submit the proposed program design to the Governor, Legislature, and appropriate DEPARTMENTS.

(c) DEPARTMENT shall consult with the Office of the Attorney General to identify the potential, and to monitor, for anticompetitive behavior in industries that would be affected by a wholesale prescription drug importation program.

(d) DEPARTMENT shall submit a formal request to the Secretary of the U.S. Department of Health and Human Services for certification of the State’s wholesale prescription drug importation program.

(e) DEPARTMENT shall seek the appropriate federal approvals, waivers, exemptions, or agreements, or a combination thereof, as needed to enable all covered entities enrolled in or eligible for the federal 340B Drug Pricing Program to participate in the State’s wholesale prescription drug importation program to the fullest extent possible without jeopardizing their eligibility for the 340B Program.

(f) DEPARTMENT shall not implement the wholesale prescription drug importation program until the Legislature enacts legislation establishing a charge per prescription or another method of financial support for the program; or another source of program funding is in place.

(g) Upon the last to occur of the Legislature enacting a method of financial support pursuant to Section 3 and receipt of certification and approval by the Secretary of the U.S. Department of Health and Human Services, DEPARTMENT shall begin implementation of the wholesale prescription drug importation program and shall begin operating the program within six months. As part of the implementation process, DEPARTMENT shall, in accordance with State procurement and contract laws, rules, and procedures as appropriate:
  • (i) become licensed as a wholesaler or enter into a contract with a state-licensed wholesaler;
  • (ii) contract with one or more state-licensed distributors;
  • (iii) contract with one or more licensed and regulated Canadian suppliers;
  • (iv) engage with health insurance plans, employers, pharmacies, health care providers, and consumers;
  • (v) develop a registration process for health insurance plans, pharmacies, and prescription drug-administering health care providers who are willing to participate in the program;
  • (vi) create a publicly available source for listing the prices of imported prescription drug products that shall be made available to all participating entities and consumers;
  • (vii) create an outreach and marketing plan to generate program awareness;
  • (viii) starting in the weeks before the program becomes operational, create and staff a hotline to answer questions and address the needs of consumers, employers, health insurance plans, pharma;
  • (ix) establish the audit function and a two-year audit work-plan cycle; and
  • (x) conduct any other activities that the Agency determines to be important for successful implementation of the program.

(h) Annually, DEPARTMENT shall report to the Legislature, Governor and appropriate DEPARTMENTS regarding the operation of the wholesale prescription drug importation program during the previous calendar year, including:
  • (i) which prescription drugs were included in the wholesale importation Program;
  • (ii) the number of participating pharmacies, health care providers, and health insurance plans;
  • (iii) the number of prescriptions dispensed through the program;
  • (iv) the estimated savings to consumers, health plans, employers, and the State during the previous calendar year and to date;
  • (v) information regarding implementation of the audit plan and audit findings; and
  • (vi) any other information The Department deems relevant.