Unswayed by pushback, Colombia moves to 'unilaterally' set price for Novartis' Gleevec

glivec

Despite behind-the-scenes pressure to call off its plans to usher in cheap generics of Novartis' ($NVS) cancer drug Gleevec, Colombia says it's ready to take the next step in its pricing fight.

Colombian officials failed to strike a deal with Novartis for a lower Gleevec price, health minister Alejandro Gaviria said late last week, so the country will issue a declaration of public interest for the drug. The move will allow Colombian officials to analyze the issue and set a new price for the cancer med--called Glivec in some markets--which Novartis would have to follow, Reuters reports. It could also pave the way for a compulsory license, the U.S. Chamber of Commerce said.

The declaration follows weeks of fruitless negotiations between the two sides, and those talks “have definitively broken down,” Gaviria said (as quoted by the news service). As such, Colombia plans to “unilaterally” set the price, he added.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

To little surprise, U.S. business and pharma groups are decrying the move, with the U.S. chamber and PhRMA both quickly issuing statements condemning it. PhRMA said Colombia's declaration “sets a harmful global precedent,” while the chamber argued that “no one stands to lose more than Colombia itself.”

“Experience has shown that compulsory licenses actually restrict the very access and affordability of medicines,” the chamber statement reads. “Compulsory licenses directly undermine global innovation by eroding global intellectual property standards and stifling investment.”

Facing a strained healthcare budget, Colombia has said it would like to see Glivec's price lowered to about $18.50 a pill from a current price of about $43. Last month, the government announced a plan to issue a compulsory license, which quickly triggered a response in Washington, DC, according to leaked memos from embassy official  Andrés Flórez.

In one letter, dispatched back to officials in Colombia, Flórez said he had met with Everett Eissenstat, chief international trade counsel of the Senate Finance Committee, who contended that the move could threaten $450 million in U.S. peace funding and Colombia’s potential future inclusion in the TPP.

That leak prompted a response from officials from the House Ways and Means Committee, who wrote to U.S. Trade Representative Michael Froman asking for answers. They pointed out that compulsory licenses are acceptable under U.S. and international agreements, and that the U.S. “should not seek to limit the existing, agreed upon flexibilities public health authorities have to address" budget and accessibility concerns.

- here's the Reuters story
- get PhRMA's take
- see the U.S. Chamber release

Related Articles:
Leaked letters show trade tensions over Colombian CL for Novartis' Gleevec
Tug-of-war over Novartis' Gleevec rights in Colombia escalates with U.S. lawmakers' challenge