Ecuador licenses a second life-saving HIV/AIDS treatment to local pharmaceutical firm

En Español

On November 12, 2012, Ecuador authorized cost-cutting generic competition for yet another lifesaving but patented HIV/AIDS treatment. The compulsory license (in official Spanish) and an English summary of the text can be found under "Technical Documents".

This decision comes on the heels of both Indonesia’s licenses for seven HIV/AIDS and hepatitis B treatments, as well as India’s license for sorafenib, a cancer drug, earlier this year in addition to important successful patent oppositions in Brazil and India.

Ecuador has become a leader in the fight for access to affordable medicines. In 2009, President Correa declared access to priority medicines affecting the health of the Ecuadorean population to be a matter of public interest, effectively clearing the way for generic competition. The President declared: “compulsory licenses may be granted for patents on any human use medicine that may be necessary for treatment,” inaugurating a licensing protocol. President Correa spoke on live television for several minutes on the specific subject of compulsory licensing. In 2010, the country issued its first license for ritonavir, a component of the HIV/AIDS treatment Kaletra, cutting bid prices by about 27%. Read more about the development of Ecuador’s compulsory licensing protocol.

It is estimated that about 37,000 individuals in Ecuador are affected by HIV/AIDS with approximately 2,000 new infections every year. According to a 2011 report conducted by the Ministry of Public Health, 6,765 people were registered as being on ARV treatment in 2010. The report states that the government seeks to expand access to ARV treatment by 20% annually and has budgeted 3,431,094.00 USD between 2011-2013 for the purchase of second and third-line treatments.

The government’s move to issue a compulsory license (CL) to Acromax, a firm based in Ecuador, will allow Acromax to import and locally produce Glaxo’s patented abacavir+lamivudine combination (ABC+3TC), a second-line treatment in Ecuador. The license should enable the government to expand access to affordable treatments. It could also facilitate development of industrial capacity, as this is the first Ecuadorean license intended to enable local production of the product.

Ecuador expanded its compulsory licensing protocol despite counter-CL efforts by the U.S. government and pharmaceutical companies. In April 2011, an Ecuadorean newspaper published Wikileaks cables from U.S. Embassy personnel to the U.S. Department of State, showing the United States, multinational pharmaceutical companies, and three Ministers within the government shared information and worked to undermine Ecuador's emerging policy. According to the cables, shortly before President Correa issued Decree 118, the U.S. mission in Quito explored organizing wealthy countries with patent-based pharmaceutical industries against Ecuador’s policy. This effort apparently met with relatively little interest. The leaks can be found here.

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