By Suzanne Elvidge, BioPharma Dive| Sept 15, 2016
- Major trade organization PhRMA sharply criticized a decision by the Colombian government to reduce the price of Novartis’ cancer drug Gleevec (imatinib) in the country, calling the move a “harmful global precedent” in a statement issued Wednesday.
- Colombia decided to enforce a so-called declaration of public interest, which sets a path for price cuts to be imposed on Gleevec (marketed as Glivec in Colombia). Novartis and the Colombia government have been locked in a battle over pricing of the drug, which PhRMA argues is accessible to patients in the country.
- PhRMA is concerned Colombia’s decision could provide a high-profile precedent for unilateral government action to reduce drug prices and infringe on international patent rights. This issue is of particular relevance given the release this week of a major UN report on access to medicines, which points to the Colombia controversy.
Colombia had already issued the declaration of public interest, and now appears ready to move ahead with a potentially sharp price cut for Gleevec. The government could also take the additional step of issuing a compulsory license for the drug.
Under the terms of a compulsory license, a provision of the World Trade Organization’s TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement, a government can grant a license to generic manufacturers allowing production and supply of a branded drug still under patent protection.
These rights are generally reserved for cases of national public health emergencies, but can be used in other circumstances as well.
PhRMA slammed Colombia’s decision to move forward with this process, arguing Gleevec is available to “all Colombian patients who need it” and claiming nearly half of patients in the country take a generic version of the drug.
According to the non-profit group Knowledge Ecology International, which focuses on IP rights, a year’s supply of Gleevec at a 400 mg dose costs $15,161. PhRMA, however, says this price was “negotiated and agreed to” by Colombia’s government, decrying the decision as therefore without merit.
“The enforcement of a declaration of public interest as a mechanism to impose superfluous price controls sets a harmful global precedent, undermining the incentives that enable high-risk research and development investments in life-saving medical innovation and a host of other cutting-edge industries,” the trade organization said.
Civil society groups in Colombia appealed to the Colombia government in 2014 for a compulsory license to be issued for Gleevec, setting off a lengthy and convoluted process to evaluate such a step.
It’s possible that the spat could have other ramifications as well. In April 2016, Andres Flórez, the deputy chief of mission at the Colombian Embassy in Washington, D.C.,warned Colombian efforts to reduce the price could damage relations with the U.S. after hearing from the U.S. Trade Representative and a key Senate committee.
And just this week, the U.N. pointed to the pressure exerted by government and corporate interests against Colombia, warning against “explicit or implicit” threats to dissuade countries from infringing on patent rights in the interests of public health.