Background FAQ on Glivec (imatinib) compulsory license in Colombia

(More on Colombia here: http://keionline.org/colombia)

For more information, contact:
(U.S.) Andrew Goldman, KEI: andrew.goldman@keionline.org or +1 (202) 332-2670
(Colombia) Andrea Carolina Reyes Rojas, Misión Salud: subdireccion@mision-salud.org
(Colombia) Dr. Francisco Rossi, IFARMA: francisco_rossi@hotmail.com

Frequently Asked Questions

What is happening in Colombia with regard to imatinib?
Public health civil society groups in Colombia have asked the government to grant a compulsory license on imatinib, a leukemia drug marketed by Novartis, to allow generic manufacturers to supply the drug at a cost that accounts for the government’s budget constraints in providing the drug to leukemia patients.

What is imatinib (a.k.a. Glivec/Gleevec)?
Imatinib is a small molecule cancer drug that is used to treat leukemia. Novartis, a giant Swiss pharmaceutical company, markets imatinib as Gleevec in the United States and Glivec in Colombia and other countries. Gleevec recently lost patent protection in the United States, opening the door to generic competition, while Glivec will remain patented until 2018 in Colombia.

How much does imatinib cost in Colombia?
Imatinib costs 368 Colombian pesos ($0.12 USD) per mg. At the recommended dosage for the average patient (400 mg), imatinib costs $15,161 USD per year — nearly double the gross national income per capita (Atlas method, World Bank, for 2014) of $7,970 in Colombia. Gleevec dosage can vary from between 100 mg to 800 mg per day.

How much does generic imatinib cost in other countries?
The generic price for imatinib ranges from $803 per year in India to $13,453 per year in South Africa, according to a study published in BMJ. That same study indicated that generic imatinib could be sold for as low a price as $128 per patient per year, accounting for the cost of the active pharmaceutical ingredient (API), and “costs of excipients, formulation, packaging, shipping and a 50% profit margin.”

How much did Novartis spend on the R&D for Glivec?
According to an academic article written by 100 experts in chronic myeloid leukemia seeking to highlight the problem of high cancer drug prices, Novartis once claimed imatinib was developed as a “goodwill gesture.” Approximately 90 percent of the early research on Imatinib was funded by grants from the National Institutes of Health (NIH) and charities. An analysis by KEI estimated that Novartis spent between $38-96 million, on a risk adjusted basis, for the phase II clinical trials used to support the FDA registration of the drug in 2001.

What is a compulsory license?
A compulsory license is a legal procedure that allows a government or a judge to authorize the non-voluntary use of a patented invention. A compulsory license does not result in the invalidation of a patent, and in most cases, the patent holder is entitled to receive a royalty or other compensation or remuneration for use of the invention.

For examples of compulsory licenses, see:

Who requested this compulsory license?
Colombian civil society groups, including IFARMA, Misión Salud, and CIMUN filed a request with the Colombian Ministry of Health on 24 November 2014, asking that the Minister use his authority to issue a compulsory license on imatinib. (See the timeline below for more information.)

What is the process for granting a compulsory license in Colombia?
When a compulsory license is sought on public interest grounds under Article 65 of Decision 486 of the Andean Community Commission, Colombia’s Decree 4302 of 2008 requires that several interim steps be taken prior to the actual grant of the license. An appointed technical committee is tasked with exploring submitted documents and soliciting further information that culminates in a recommendation to the Minister of Health as to whether or not a compulsory license would be in the public interest. If such reasons exist, the Minister must formally make a declaration on the matter, after which the SIC (Superintendencia de Industria y Commercio) may proceed with granting the actual license.

How are Senator Orrin Hatch, the Senate Finance Committee, and the United States Trade Representative involved in this compulsory licensing case?
In separate letters sent on 27 and 28 April 2016, the Colombian Embassy in Washington, DC, warned the Minister of External Affairs and the Minister of Health that the grant of a compulsory license on imatinib would anger the pharmaceutical industry and could jeopardize Colombian interests in the United States. In particular, the Embassy explained that it feared that the compulsory license could jeopardize funding for the Paz Colombia program, a new initiative in the Colombian peace process through which President Obama promised $450 million in support.

The 27 April letter notes that both the United States Trade Representative and the Senate Finance Committee requested meetings with the Embassy on the issue of the grant of a compulsory license on imatinib.

On 28 April, the Embassy reported to the Minister of Health that Everett Eisenstatt, a top aide for Senate Finance Committee Chairman Orrin Hatch, R-Utah, asserted that the pharmaceutical industry could become “vocal” with its allies in Congress if the Ministry of Health decides to grant the compulsory license on imatinib. Eissenstat also reportedly argued that the grant of a compulsory license would violate Novartis’ intellectual property rights and the U.S.-Colombia Free Trade Agreement.

Timeline

April 2012: Following a court order, the Colombian government grants Novartis a patent on imatinib for the beta polymorph. Until then, the drug had been sold as a generic.

24 November 2014: IFARMA, Misión Salud, and CIMUN request that the government issue a compulsory license on imatinib (marketed as Glivec by Novartis), citing the weakness of the patent (and noting that this same patent had been rejected by India), the high price of the drug, the budget constraints of the Colombian government, and the possibility of price reductions through generic competition.

24 February 2016: In accordance with the procedures of Colombian law, a government Technical Committee recommends to Alejandro Gaviria, the Colombian Minister of Health, that he declare that a compulsory license on imatinib is in the public interest. The recommendation was grounded in large part in the burden that the lack of competition for Glivec places on the budget, and the realities of budget constraints in a finite budget.

11 April 2016: Health Minister Gaviria, following the recommendation of the Technical Committee, opens negotiations with Novartis on a new price for imatinib, offering 140 Colombian pesos ($0.05 USD) per mg, reflective of a price simulation exercise showing what the price should be with market competition.

20 April 2016: Novartis refuses to negotiate with the Colombian Ministry of Health on the price of imatinib.

26 April 2016: El Espectador reports that Health Minister Gaviria will issue a declaration that the grant of a compulsory license on imatinib would be in the public interest, the next step in the official compulsory licensing process in Colombia.

27 April 2016: Deputy Chief of Mission Andrés Flórez of the Colombian Embassy in Washington, DC, communicates to the Minister of External Affairs, Maria Angela Holguin, that the Senate Finance Committee and USTR have both requested meetings on the imatinib compulsory license; Flórez explains that Ambassador Juan Carlos Pinzón fears that the license will jeopardize funding for Paz Colombia, an initiative that President Obama promised $450 million of funding for.

28 April 2016: Deputy Chief Flórez of the Colombian Embassy sends a letter to Health Minister Gaviria after meeting with Everett Eissenstat, a top aide to Senator Orrin Hatch, R-Utah, on the Senate Finance Committee. Flórez reiterates his fears about Paz Colombia, and also summarizes Eissenstat’s concerns that the compulsory license would anger the pharmaceutical industry, violate the intellectual property rights of Novartis, and jeopardize Colombian interests in the US.

14 June 2016: Colombia Issues Public Interest Declaration To Lower Price of Glivec.

21 December 2016: Colombia finalizes 44% price reduction of leukemia drug Glivec.