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Analysis: Importation Policies Cost-Prohibitive to U.S. Healthcare System, Pose Risks to Patients

July 15, 2019

ARLINGTON, Va. — A new report published by the HDA Research Foundation concludes that federal proposals to permit the importation of prescription drugs into the U.S. fail to provide comprehensive guidance and funding to meet current federal safety and quality standards. As highlighted in the report, “The Risks and Realities of Commercial Drug Importation,” implementation of these policies would result in at least $1.1 billion in costs due to patient risks, required federal regulatory oversight and the operational challenges placed on the supply chain.

“While the overall goal of achieving affordability is commendable, it is clear that the risks and costs of prescription drug importation may outweigh any perceived benefits,” said Perry Fri, Executive Vice President and COO of the HDA Research Foundation. “As federal and state legislators continue to consider — and enact — these policies, the Foundation’s research is a valuable resource to understand how supply chain stakeholders, as well as patients, may be affected.”

Through a literature review, expert interviews and quantitative modeling, the report explores current federal drug importation policies for their commercial feasibility, operational costs to the pharmaceutical supply chain and any effects on patient safety. Commercial drug importation is defined within the report as an activity in which a manufacturer, distributor, pharmacy or third-party entity introduces into the American supply chain, drugs that were produced outside of the U.S., without the necessary approvals by the U.S. Food and Drug Administration as well as the regulatory oversight to ensure the product’s safety and quality. State and personal reimportation policies were outside the scope of the analysis.

Among the other topline findings of this report:

  • Significant barriers to importation exist outside of current U.S. policy proposals, including a limited supply based on the small amount of countries with compatible approval and safety regulations, limits on products feasible to import and the various legal and exclusivity provisions covering many medicines.

  • Many of the products viable for importation do not align with the products that are most needed by American patients, due to specific handling requirements, available supply and legal issues.

  • Enacting moderate drug importation policies will likely lead to a 5 percent increase in drug-related adverse events, representing $200 million to $1.4 billion in costs to patients.

“The Risks and Realities of Commercial Drug Importation” was made possible through the support of platinum sponsors Anda, Inc. and Novartis Pharmaceuticals Corporation; gold sponsors Astellas Pharma US, Inc. and Pfizer Inc.; and silver sponsor, Genentech, A Member of the Roche Group. The report is available as a complimentary download through the HDA website.

ABOUT THE HDA RESEARCH FOUNDATION

The HDA Research Foundation is the 501(c)(3) non-profit charitable organization of the Healthcare Distribution Alliance (HDA). The Foundation serves the healthcare industry by providing research and education focused on healthcare supply chain issues. The Foundation’s mission is to conduct research and disseminate information that will enhance the knowledge base, efficiency and effectiveness of the total healthcare supply chain; and to provide thought leadership to further enhance the safety and security of the healthcare supply chain through future-focused study and programming.

ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and  pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

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