By Donald Zuhn --
Last month, we reported on a letter sent by three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), in which the organizations informed the CEWG of resistance to efforts to secure a compulsory license in Colombia for Imatinib, marketed by Novartis as Gleevec® or Glivec. According to the Colombian organizations, "enormous pressure" was being applied by developed countries and pharmaceutical companies to block Colombia from issuing a compulsory license for Imatinib, and that resistance to such a compulsory license had combined "inaccuracies, distortions of international trade rules and even threats of trade claims under the dispute settlement mechanism."
When word of the resistance to Colombia's issuance of a compulsory license for Imatinib reached Capitol Hill, two Senators and fifteen Representatives sent separate letters in May to Michael Froman, the U.S. Trade Representative ("USTR"), seeking clarification regarding the Administration's position on compulsory licenses. Representatives Sander Levin (D-MI), James McGovern (D-MA), Jim McDermott (D-WA), Jan Schakowsky (D-IL), Eddie Bernice Johnson (D-TX), Peter Welch (D-VT), Rosa L. DeLauro (C-CT), John Lewis (D-GA), Barbara Lee (D-CA), Chris Van Hollen (D-MD), Peter DeFazio (D-OR), Lloyd Doggett (D-TX), David Price (D-NC), Carolyn Maloney (D-NY), and Sam Farr (D-CA) signed the first letter, and Senators Sherrod Brown (D-OH) and Bernard Sanders (I-VT) signed the second letter.
In the letter from Senators Brown and Sanders, the legislators began by expressing their concern that "representatives of the U.S. government may have pressured the Colombian government not to issue compulsory licenses for pharmaceutical products," and urging the USTR "to publicly clarify that issuing a compulsory license for a pharmaceutical product and promoting access to medicines are consistent with Colombia's international trade obligations." The Senators referred to reports of "leaked diplomatic letters" indicating that congressional staffers conveyed opposition to the issuance of a compulsory license to Colombian Embassy officials, and that embassy officials were under the impression that issuance of the compulsory license for Imatinib could threaten U.S. funding to Columbia as well as Colombia's future membership in the Trans-Pacific Partnership. The leaked letters also refer to the USTR's concerns regarding the compulsory license, and the USTR's attempts to meet with the Colombian Ambassador to discuss the compulsory license.
The Senators state that they "object to any efforts to intimidate and discourage Colombia's government from taking measures to protect the public health of Colombians in a way that is appropriate, effective, and consistent with the country's trade and public health obligations," and "find it unconscionable that any representatives of the U.S. government would threaten to rescind funding for Colombia's peace initiative if a compulsory license for Glivec were issued." They note that compulsory licenses have been permitted under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement since 1995, that the ability to issue compulsory licenses was confirmed in 2001 with the Doha Declaration on the TRIPS agreement, and that this authority was reiterated in the U.S.-Colombia Free Trade Agreement in 2012. Senators Brown and Sanders contend that:
Attempts to dissuade Colombia from using these authorities -- especially by threatening unrelated streams of financial support -- would be inconsistent with the goals of these agreements and would signal that the United States is not committed to living up to the standards of our free trade agreements when it does not suit corporate interests. Moreover, they would give the appearance that the United States is elevating corporate profits over public health priorities.
They conclude their letter by urging the USTR "to immediately and publicly clarify that compulsory licenses are not only permitted under international trade agreements, including the Colombia FTA and the TRIPS Agreement, but also a legitimate means of promoting access to medicines."
The Representatives similarly express their "serious concern" that recent press reports indicated that U.S. officials may have discouraged Colombian government officials from issuing a compulsory license for Imatinib, and that a "Senate Finance Committee spokeswoman also recently suggested that the issuance of a compulsory license 'may be inconsistent with international trade obligations.'" According to the Representatives, the Colombian officials were "left with the deeply troubling impression that $450 million in U.S. funding to aid peace efforts could be in jeopardy if Colombia failed to change course."
After discussing the trade agreements that conferred the authority to issue compulsory licenses, the Representatives stated that they "find it deeply troubling that U.S. officials may not be respecting the Doha Declaration." They added that they were unaware of "any actions that Colombia has taken or is considering taking that are inconsistent with [requirements under the trade agreements]." Noting that "the annual price of [Imatinib] in Colombia is almost twice as much as the average annual income per person in Colombia," the Representatives argue that the U.S. "should not seek to limit the existing, agreed upon flexibilities public health authorities have to address these concerns."
Like the Senators, the Representatives conclude by asking the USTR to "clarify the position the Administration has taken in meetings with Colombian officials on this important issue as soon as possible."