Despite alleged pressure from the US protecting pharmaceutical interests, international experts are vehemently defending Colombia’s right to produce a cheaper version of a life-saving drug for cancer.
Some 122 lawyers, academics, and experts in other related fields wrote a letter to Colombian President Juan Manuel Santos on Monday, supporting his country’s right to create a generic version of Imatinib, a leukemia treatment currently being sold by Swiss drug company Novartis under the names of Glivec and Gleevec.
In the letter, the experts also explicitly condemned the United States for pressure they reportedly levied against Colombia in attempting to protect private interests, which became public after Colombian cables from Washington to Bogota leaked warning that challenging the drug price could result in reduced congressional support for aid for ongoing peace talks.
In April, Colombia’s health minister announced plans to begin the process of obtaining a compulsory license that would allow the country to produce a cheap, generic version of the drug that would make it available for less wealthy cancer patients.
A few days later, Colombian diplomat Andres Florez sent a memo to the Colombian Foreign Minister warning her that the US might withhold its promised $450 million promised in the new plan “Peace Colombia” if they sidestepped Novartis’ patent.
Those funds are planned to be used mostly for land-mine removal and reconciliation initiatives in the country that’s suffered an internal conflict since 1964.
The Minister, Maria Angela Holguin, is a member of the negotiation team working to finalize a peace deal with the leftist FARC rebels which would end the hemisphere’s longest ongoing armed conflict.
Nevertheless, according to the experts hailing from universities such as Harvard, international law and policy support Colombia´s right to issue compulsory licenses on patents, which essentially gives them the right to reproduce a drug at a lower cost without the permission of the patent holder, in this case Novartis.
“Article 31 of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property (WTO’s TRIPS) permits all WTO members, including Colombia, to issue compulsory licenses at any time on grounds of their choosing. The only compensation due to patent-holders in instances of compulsory licensing is a reasonable royalty, which governments may determine at their discretion.”
Novartis charges nearly double a Colombian’s median annual income for a year’s supply of Glivec to treat a single patient, according to the Huffington Post.
A generic version of the drug could cost 30% less, reported news website The Intercept, and would save Colombia $12 million annually.
After the Swiss company rejected Colombia’s petition to lower the price on the treatment, Colombia’s government declared access to the drug a matter of public interest, which allows for the granting of a compulsory license.
In the leaked memo, Florez also said he felt pressure from the Office of the US Trade Representative and from members of US Congress who had links to the pharmaceutical industry.
“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 “Peace Colombia.”
Senate Finance Committee Chairman Orrin Hatch, for example, has received millions in campaign contributions from pharmaceuticals, and they comprise his second-largest pool of donors, as reported by newspaper The Intecept. Hatch’s son has also lobbied on behalf of the top lobbying group for the prescription drug industry, which also indirectly supported his father’s campaign.
Though the terms of Colombia’s trade agreement with the US under the May 10th Agreement of 2007 expressly preserved “certain public health safeguards” as well as Colombia’s right to issue licenses for patented inventions, this same Finance Committee has jurisdiction over US trade policy.
In the letter, the experts stated that if the allegations are true and the US Senate Finance Committee staff and other US representatives communicated incorrect beliefs about compulsory licensing, then they acted inappropriately and contravened US government policy.
Florez also warned that the compulsory license could also potentially hinder Colombia’s ability to participate in the new Trans-Pacific Partnership trade pact between the US and several Asian and South American countries.
According to the memo, Colombia’s ambassador Juan Carlos Pinzon has already been called in for a meeting with the US Trade Representative (USTR) Michael Froman over the latter’s “major concerns” concerning over the compulsory license.
Senate Finance Committee spokesperson Julia Lawless acknowledged that their committee also had discussions with Colombian officials, but said that the Paz Colombia initiative was not discussed, as reported by newspaper FiercePharma.
“The Senate Finance Committee has jurisdiction over international trade policy and staff routinely, like the Office of the U.S. Trade Representative, meets with foreign governments to discuss actions related to trade obligations,” she said. “Staff met with Colombian officials and discussed a variety of trade issues, including adequate intellectual property protections as outlined in numerous trade agreements. The Committee has no jurisdiction over the Paz Colombia initiative and it was not discussed.”