Colombia's Battle With a Cancer Drug Company Could Set a Global Precedent for Generic Meds

Colombia has told pharmaceutical giant Novartis that unless it lowers the price of one of its cancer medications by the end of the month, it will lose the monopoly of the market in the country that it currently enjoys.

The government's tough stance on the cancer medication imatinib — which is commercially sold as Gilvec or Gleevec — has been applauded by activists who say it could set a precedent that could start to improve access to expensive drugs throughout the world.

James Love, the director of Knowledge Ecology International, an US-based NGO that campaigns for a more equal distribution of knowledge resources, told VICE News that the Colombian effort to bring down the prices of the drug would have an impact way beyond its borders.

"It is going to be consequential in terms of price, especially in other South American nations, where the goal is to build a universal healthcare system," Love said. "It would mean imatinib would be more accessible than ever in other parts of the world."

The ultimatum culminates four years of tension over the government's plan to widen access to the medicine. In 2012 the authorities refused to give Novartis the patent to imatinib in Colombia but, later that year, a judge overturned that decision and granted the company exclusive rights over the drug in the country.

After the ruling, the government sought to persuade Novartis to reduce the price of the drug by 50 percent but, so far, the Swiss pharmaceutical giant has ruled this out.

Imatinib, which is used to treat leukemia, costs $0.10 per mg in Colombia. With dosage varying between 100mg and 800mg per day, the drug costs an average of $15,000 per year per patient — nearly double the country's per capital income. According to a study published in BMJ, a popular medical journal, generic imatinib could cost as little as $128 per patient per year.

"For us, it's a question of survival," Colombia's health minister Alejandro Gaviria told the Associated Press this week.

Gaviria has said that it is still possible that a deal could be reached with Novartis before the industry regulator gives the green light to forcing the end of the patent, and allowing him to issue "compulsory licenses" that would permit other pharmaceutical companies to put generic versions of imatinib on the market at a fraction of the cost. If not deal is forthcoming, this is expected to happen by the end of the month.

Leaked diplomatic papers dated in late April and obtained by Knowledge Ecology International show that high officials in Colombia's Embassy in Washington warned the government back home that they were receiving pressure from the US Congress and the Office of the Unites States Trade Representative to pull back from its conflict with Novartis.

According to a copy of one of the documents posted on the NGO's website, the embassy's second in command, Andrés Flórez, suggests that "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." He goes on to suggest it could impact funding of the ongoing peace process, as well as free trade treaties.

In another cable, Flórez, says that Everett Eissenstat, Chief of the International Trade Counsel for the US Senate Committee on Finance, "could jeopardize" peace funding.

"Mr Elissenstat mentioned that although Novartis is not an American company, the US pharmaceutical industry is very worried by the fact that such a case might become a precedent that could be applied for any patent in any industry," the letter said.

On Monday, 122 health, trade, and intellectual property international experts defended the Colombian government's right to issue a compulsory license on imatinib in a letter to Colombian President Juan Manuel Santos.

"We affirm that international law and policy support Colombia's right to issue compulsory licenses on patents in order to promote public interests including access to affordable medicines," the experts wrote. "When a pharmaceutical company uses a patent to exclude competition, it can charge much higher prices."

In a letter sent by the Colombian branch of Novartis, the company said the conditions in the market have actually reduced the price of imatinib making the government's decision unjustified. They insisted that they have the right to exclusively sell the medicine in Colombia until 2018.

"The imposition or the threat to impose a public interest declaration that would lead to a compulsory license shouldn't be used as a mechanism to enforce a price negotiation," the company said. "None of the factors that would justify this are present."

Meanwhile, health minister Gaviria said Novartis had the chance to negotiate and now the government has the right to enforce its decision.

"It is a complex step, we have checked all the international treaties, we have the autonomy to use these administrative tools," he said. "We have the authority to do it, we are willing to do so."

Follow Alan Hernández on Twitter: @alanpasten