Increasing Drug Importation To Lower Prices for American Patients

Executive Order 13938 of July 24, 2020

Increasing Drug Importation To Lower Prices for
American Patients

By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:

Section 1. Purpose. Americans spend more per capita on
pharmaceutical drugs than residents of any other
developed country. Americans often pay more for the
exact same drugs, even when they are produced and
shipped from the exact same facilities.

One way to minimize international disparities in price
is to increase the trade of prescription drugs between
nations with lower prices and those with persistently
higher ones. Over time, reducing trade barriers and
increasing the exchange of drugs will likely result in
lower prices for the country that is paying more for
drugs. For example, in the European Union, a market
characterized by price controls and significant
barriers to entry, the parallel trade of drugs has
existed for decades and has been estimated to reduce
the price of certain drugs by up to 20 percent.
Accordingly, my Administration supports the goal of
safe importation of prescription drugs.

Sec. 2. Permitting the Importation of Safe Prescription
Drugs from Other Countries. The Secretary of Health and
Human Services shall, as appropriate and consistent
with applicable law, take action to expand safe access
to lower-cost imported prescription drugs by:

    (a) facilitating grants to individuals of waivers
of the prohibition of importation of prescription
drugs, provided such importation poses no additional
risk to public safety and results in lower costs to
American patients, pursuant to section 804(j)(2) of the
Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C.
384(j)(2);
    (b) authorizing the re-importation of insulin
products upon a finding by the Secretary that it is
required for emergency medical care pursuant to section
801(d) of the FDCA, 21 U.S.C. 381(d); and
    (c) completing the rulemaking process regarding the
proposed rule to implement section 804(b) through (h)
of the FDCA, 21 U.S.C. 384(b) through (h), to allow
importation of certain prescription drugs from Canada.

Sec. 3. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or
the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.

    (b) This order shall be implemented consistent with
applicable law and subject to the availability of
appropriations.

    (c) This order is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any
other person.

    (Presidential Sig.)

THE WHITE HOUSE,

    July 24, 2020.