Leaked letters show trade tensions over Colombian CL for Novartis’ Gleevec

By Eric Sagonowsky, FiercePharma | May 17, 2016

Two leaked letters written by a representative of the Embassy of Colombia in Washington, DC, and sent to officials in that country showcase deep tensions over a plan by the government there to issue a compulsory license and allow generic knockoffs of Novartis’ ($NVS) cancer med Gleevec, sold as Glivec in some other countries.

The documents, which note that pharma companies are “concerned” and have contacted the embassy, tie in a perceived threat that hundreds of millions of dollars in seemingly unrelated funding could be at risk over the compulsory license plan.

Written by the embassy’s deputy chief of mission Andrés Flórez and posted online by the nonprofit Knowledge Ecology International, the letters outline Flórez’s concerns–and others’ concerns as well–about the Colombian government’s plan to grant the Gleevec compulsory license. In the documents, Flórez noted the move could violate an existing free trade pact between the U.S. and Colombia, interfere with Colombia’s potential place in the new Trans-Pacific Partnership trade deal, and threaten a Peace Colombia initiative previously announced by U.S. President Barack Obama.

“Given the direct link that exists between a significant group of members of Congress and the pharmaceutical industry in the United States, the case of Glivec is susceptible to escalate to the point that it could impair the approval of the financing of the new initiative ‘Paz Colombia’ as well as become an issue in the framework of the free-trade treaty,” Flórez wrote according to a KEI translation of the first letter written on April 27.

In the second letter, penned on April 28, Flórez said he and others met with Everett Eissenstat, chief international trade counsel of the Senate Finance Committee, who conveyed that the U.S. pharmaceutical industry is “very worried” that the move “might become a precedent that could be applied for any patent in any industry,” according to Flórez’s take on the meeting.

Flórez in a memo said Eissenstat emphasized, “the pharmaceutical industry in the United States and related interest groups could become very vocal and interfere with other interests that Colombia could have in the United States.”

A $450 million project announced in February, Peace Colombia will seek to end turmoil between the government and rebels in the Latin American country.

In a response to FiercePharma, Colombian embassy spokesperson Olga Acosta said: “It is not true that there was some form of threat pertaining to this issue; we simply transmit concerns given to the Embassy to our authorities in Bogota. We keep a constructive dialogue with all stakeholders in Washington.

“In such dialogue, we always convey the concerns of the Colombian government and people,” Acosta continued. “Also we explain the policies that our authorities execute for the best national interest.”

Senate Finance Committee spokesperson Julia Lawless confirmed to FiercePharma that discussions with Colombian officials took place, but said that the Peace Colombia initiative was not part of the talks.

“The Senate Finance Committee has jurisdiction over international trade policy and staff routinely, like the Office of the U.S. Trade Representative, meets with foreign governments to discuss actions related to trade obligations,” she wrote. “Staff met with Colombian officials and discussed a variety of trade issues, including adequate intellectual property protections as outlined in numerous trade agreements. The Committee has no jurisdiction over the Paz Colombia initiative and it was not discussed.”

The letters followed an April 26 announcement by Colombian officials that they’ll move forward with a Gleevec compulsory license and allow for a generic version. Flórez stated in his first letter the “whole situation might have a negative impact on the commercial interests of our country in the United States,” according to the KEI translation.

The episode represents the latest flare-up in tensions between pharmaceutical companies and countries with tight healthcare budgets. India, for one, has served as a headliner on the topic over its issuance of compulsory licenses in efforts to curb healthcare costs.

According to The Intercept, which reported the leaks along with other media outlets, Gleevec costs twice the average Colombian’s income at $15,000 per year. A generic could cost 30% less. In the U.S., Gleevec’s list price is $90,000, and Sun Pharma’s forthcoming version could cost around $60,000.

The Senate Finance Committee is chaired by Sen. Orrin Hatch, who stood to gain from a $750,000 PhRMA expenditure on a pro-Hatch organization during his re-election campaign in 2011.

This entry was posted in Compulsory Licensing, Patent, Uncategorized. Bookmark the permalink.

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