- A Colombian Embassy official last month sent a memo to his country's foreign minister warning government efforts to override a patent on a cancer drug made by Novartis could harm U.S. support for peace initiative in Colombia.
- According to the leaked memo, posted by the non-profit Knowledge Ecology International, the U.S. Trade Representative and staffers from the Senate Finance Committee requested to meet with Embassy officials to discuss U.S. concerns with Colombia's plans.
- The Colombian Health Ministry reportedly has been planning to issue a so-called compulsory license for the leukemia treatment Gleevec (also marketed as Glivec), which would allow generic drugmakers to manufacture a lower cost copy of the drug. Novartis has strongly opposed the move.
In the April 27 letter, Andres Florez, the deputy chief of mission at the Colombian Embassy in Washington, D.C., said U.S. concerns over the planned compulsory license could jeopardize U.S. funding for Paz Colombia, an initiative aimed at assisting peace efforts between the Colombian government and FARC rebels.
In a February news conference, President Barack Obama proposed $450 million in funding to help the country transition away from its long and bloody civil conflict. "The United States will work with you, hand-in-hand," Obama said at the time, speaking next to Colombian President Juan Manuel Santos.
But U.S. government pressure over the compulsory licensing issue has Florez worried the new support could be weakened.
"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," Florez wrote.
The Colombian Embassy would not comment on internal correspondence, while the Senate Finance Committee did not respond to a request by publication time.
Compulsory licenses have become a flash point between the global pharma industry and developing country governments. Although countries have the right to issue compulsory licenses under an international agreement through the World Trade Organization, pharma companies have argued such measures should be reserved only for use in public health emergencies.
The U.S. Trade Representative has kept both Colombia and India, a major supplier of generic drugs, on its priority watch list flagging weak protection of intellectual property rights.
In this case, Colombia's Health Ministry is concerned over the high cost of Novartis' Gleevec in the country, despite the presence of cheaper generic versions elsewhere.
The apparent pressure from Congress and the administration was not well received by the advocacy group Knowledge Ecology International (KEI).
"Novartis has profited enough from Colombia, and Senator Hatch and USTR have no business defending the patent interests of a Swiss pharmaceutical company over the lives of cancer patients in Colombia," said Andrew Goldman, counsel for policy and legal affairs at KEI.
But Novartis has strongly pushed back on a compulsory license previously, arguing there is no evidence of access issues and noting its price is already subject to government controls, according to Stat.
When reached for comment, a company spokesperson said, "Novartis is actively seeking a resolution to discussions around our Glivec patent in Colombia that benefits patients, innovation and the healthcare system."