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n a dramatic move, the Colombian health minister plans to unilaterally force Novartis to lower the price for its Gleevec cancer medicine after more than two weeks of talks over a price cut went nowhere, according to reports and sources in Colombia.

In public comments today, Health Minister Alejandro Gaviria said he will declare a lower price for the widely used cancer medicine as being in the public interest because it would save the country needed health dollars. Under this scenario, Novartis would be obligated to sell Gleevec at the new price, although he did not specify what that might be.

However, Gaviria stopped short of pursuing a compulsory license, which would have allowed the government to sidestep the Novartis patent for the drug so that generic companies could make lower-cost versions. Such a move is permitted under World Trade Organization rules. The current patent for the Novartis drug expires in 2018.

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The battle over Gleevec has been closely watched as the latest manifestation of a global skirmish over the cost of medicines. Patient groups see it as a test case for using legal rights to ensure needed medicines are accessible, while companies see it as a potentially precedent-setting case in which a middle-income country use trade rules to lower its drug costs.

For the past four years, Novartis and the Colombian government have been sparring over the cost of the medicine. But even as price controls worked to lower the price, the drug remained about 172 percent higher than comparable medicines. With prodding from patient advocates, Gaviria eventually threatened to pursue a compulsory license.

Patient advocates note that the annual cost of Gleevec is roughly $15,000, which patient advocacy groups say is excessive in a country where the nation’s per capita gross national income is about $8,000. And they note that some efforts by drug makers to enforce intellectual property rights may come at the expense of patients who cannot afford medicines.

As the squabble intensified in recent weeks, staffers from both the US Senate Finance Committee and the US Trade Representative’s office met with Colombian embassy officials in Washington DC, and suggested that Washington might withdraw support for a free trade agreement and $450 million in backing for a peace initiative between the Colombian government and Marxist rebels. The threat prompted a rebuke from Democratic lawmakers.

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A Novartis spokesman sent us this: “Throughout this dialogue we have remained fully committed to finding a resolution that benefits patients, innovators and the Colombian health care system. We have received no official confirmation from the Colombian authorities regarding the conclusion of these talks. Until we do, it is not appropriate to make further comment.

“We have consistently said that Declarations of Public Interest can be important and legitimate tools to be used only in exceptional circumstances. This is simply not the case in Colombia. There are no shortages of Gleevec or other access issues. Colombia’s universal healthcare system means all patients who need Gleevec receive it. Novartis does not have a monopoly. There are already noninfringing generic versions on the market, which the government could purchase instead of Gleevec in order to reduce its costs.”

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  • I believe the government is proceeding on a compulsory license, but will abandon the compulsory licensing effort if and only if Novartis cuts the price of Gleevec. There are generic versions of the drug registered in Colombia, but Novartis as threatened to sue the generic companies for infringing their patents, which is why the compulsory license has been an issue.

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