» Drug, Devices, and Supplements

» Physician Accountability

» Consumer Product Safety

» Worker Safety

» Health Care Delivery

» Auto and Truck Safety

» Global Access to Medicines

» Infant Formula Marketing


Leaked Cables Show U.S. Tried, Failed to Organize Against Ecuador Compulsory Licensing

May 10, 2011

View document as pdf.

In October 2009, Ecuador's President Rafael Correa issued Decree 118 to improve access to medicines and support public health programs through a protocol that would reduce drug costs.

The protocol established procedures for the compulsory licensing of pharmaceutical patents. Compulsory licensing authorizes generic competition with patented, monopoly protected drugs. Generic competition reduces costs and enables public agencies to scale-up treatment and other services.

Ecuador's protocol limits compulsory licensing to medical conditions that are priorities for public health, requiring interagency cooperation to grant licenses on a case-by-case basis and pay royalties to patent holders.

Nevertheless, cables from U.S. Embassy personnel in Ecuador to the U.S. Department of State, released by Wikileaks, show the United States, multinational pharmaceutical companies, and three Ministers within the government shared information and worked to undermine Ecuador's emerging policy.

According to the cables, shortly before President Correa issued Decree 118, the U.S. mission in Quito explored organizing wealthy countries with patent-based pharmaceutical industries against Ecuador’s policy. This effort apparently met with relatively little interest.

The U.S. Ambassador warned officials in Ecuador's Ministry of Foreign Affairs of the "IPR eligibility requirements" of trade benefit programs including the Andean Trade Promotion and Drug Eradication Act, implying that compulsory licensing could jeopardize Ecuador's eligibility But Ecuador's compulsory licensing protocol complies fully with the World Trade Organization’s TRIPS Agreement on intellectual property. And even the Office of the United States Trade Representative has bound itself to “respect[] its trading partners’ rights to grant compulsory licenses, in a manner consistent with the provisions of the TRIPS Agreement."

U.S. Embassy officials met repeatedly with multinational pharmaceutical companies, and separately met some of the companies’ “well-placed contacts” in “potentially sympathetic ministries.”  The companies, their government contacts, and Embassy officials shared strategies to prevent or limit Ecuador’s use of compulsory licensing.  

One of these well-placed contacts, Ecuador's former Minister of Health – who has since been replaced – reportedly assured multinational pharmaceutical companies that her office was investigating the business dealings of local medicine suppliers, with the explicit objective of "gain[ing] some leverage."  

The Ministry also reportedly raised a criticism that generics sold under compulsory license might not contain active ingredients. But this confuses patent licensing with the separate and independent drug regulatory approval process.  Compulsory licensing of patents does not, on its own, authorize the sale of any medicine – only the use of the patents.  Typically, and in Ecuador, a separate agency regulates medicines and determines which are safe for consumers.   A product benefiting from a compulsory license must, like other medicines, still obtain the approval of INH, Ecuador’s regulatory agency.

The cables betray a strong U.S. Embassy bias against compulsory licensing, and damage the credibility of assurances offered elsewhere that the United States supports the use of TRIPS flexibilities to promote public health.

In spite of efforts to undermine Ecuador’s access protocol, Ecuador issued its first compulsory license in April 2010, enabling generic imports of the HIV/AIDS drug ritonavir.  IFI, the association of multinational pharmaceutical companies operating in Ecuador, issued a statement “democratically accepting” President Correa’s decision.  The United States has refrained from public criticism. 

Ecuador's access to medicines and compulsory licensing protocol remains in place.  

The complete leaked cables follow.  The cables are dated October 13 and 21 of 2009 and February 10 of 2010, and were recently published in Ecuador’s El Universo newspaper.  (I have also included a relevant excerpt from a cable sent October 29, 2009.) 

The cables include some misinterpretations of law, precedent, and Ecuador’s licensing protocol, and should not be considered source documents for technical analysis of these subjects.   Source documents are available on the website of Ecuador’s intellectual property office, IEPI, or by following the links at:

Public Citizen’s Global Access to Medicines Program (formerly with Essential Action) has provided technical assistance to the government of Ecuador since 2007.  

Links to cables:

Back to Compulsory Licensing Page

Copyright © 2016 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.


To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.