Tug-of-war over Novartis' Gleevec rights in Colombia escalates with U.S. lawmakers' challenge

glivec

Some top lawmakers are up in arms that U.S. officials allegedly pressured the Colombian government to nix a compulsory license on Novartis’ ($NVS) cancer med Gleevec. Now, they’re demanding answers from U.S. trade representatives.

“We are writing to express our serious concern that, according to recent press reports, officials may have discouraged Colombian government officials from issuing a compulsory license” on Gleevec, a bipartisan group of Congressmen including Rep. Sander Levin (D-MI), a ranking member of the House Ways and Means Committee, wrote in a letter to U.S. Trade Representative Michael Froman.

A compulsory license would allow generic versions of Gleevec to be sold in Colombia, despite its current intellectual property protections.

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Earlier this month, two leaked letters written by Andrés Flórez, a representative of the Embassy of Colombia in Washington, D.C., showed trade tensions tied to the issue. Flórez said that he had met with Everett Eissenstat, chief international trade counsel of the Senate Finance Committee, and that Eissenstat pressured Colombia not to move ahead with its plans.

Eissenstat said that the U.S. pharma industry is worried that Colombia’s decision to grant a compulsory license “might become a precedent that could be applied for any patent in any industry,” Flórez wrote in a letter. The Finance committee representative also allegedly threatened Colombian diplomats that the move could result in less funding for President Obama’s $450 million "Paz Colombia" peace initiative.

But issuing a compulsory license is acceptable under U.S. and international trade agreements, lawmakers pointed out in their recent letter. “U.S. officials should respect the flexibilities” granted to countries as part of those pacts, the group wrote.

Even though issuing compulsory licenses can create problems between companies and governments, lawmakers “are not aware of any actions that Colombia has taken or is considering taking” that run afoul of trade rules, the group said in its letter.

Colombia has not issued a compulsory license for any other product. And the government is only considering granting one for Gleevec, or Glivec as it’s known in some countries, “based on its individual merits and not as part of a blanket policy,” the group wrote.

“There are growing concerns about the very high and increasing costs of pharmaceuticals in the United States and in other nations,” the Ways and Means members wrote. “As policymakers struggle to address this issue, we should not seek to limit the existing, agreed upon flexibilities public health authorities have to address these concerns.”

Colombian health officials have said that they would try to work with Novartis to lower the price for Gleevec. A 400 mg tablet of Gleevec costs 129,000 Colombian pesos, about $43. The Colombian government wants that price lowered to $18.50, but Novartis has reportedly dragged its heels on pricing.

But the Colombian officials said their patience is limited. “We have not shut the door to negotiations. We’re keeping it open, but not for much longer,” Colombian Health Minister Alejandro Gaviria told Reuters last week.

Novartis said that it is "actively seeking a resolution to discussions around our Glivec patent in Colombia that will benefit patients, innovation and the healthcare system," the company told FiercePharma in an email. "Discussions with stakeholders, including the Colombian ministries of Health and Trade, have covered a range of topics--none of which have been agreed or finalized."

- read the letter (PDF)

Related Articles:
Clock is ticking on CL deal for Novartis' Gleevec, Colombia says
Leaked letters show trade tensions over Colombian CL for Novartis' Gleevec
In a victory for U.S. pharma, India pledges to abandon compulsory licensing, trade group says
India awards Gilead patent for Sovaldi, disappointing civic groups
Novartis hit on Gleevec in U.S. tells the tale for India's Sun Pharma

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