History of Compulsory Licensing in Ecuador

On October 23, 2009, Ecuador’s President, Rafael Correa, declared “access to medicines used for the treatment of diseases that affect the Ecuadorian population and are priorities for public health” a matter of public interest, and declared that “compulsory licenses may be granted for patents on any human use medicine that may be necessary for treatment.”

This decision established a protocol for authorizing generic competition with patented medicines, in order to reduce prices and promote access to medicines.

According to instructions provided in the order, any group wishing to request a compulsory license must submit their request to the Ecuadorian Institute of Intellectual Property (IEPI) through the National Directorate of Industrial Property. If a license is granted, the producer of the generic version would pay a percentage of its profits in royalties to the pharmaceutical patent holder.

License requests are considered on a case-by-case basis, according to their importance to the public interest, including the benefits of reducing costs and increasing access

According to a UNAIDS report, in 2008, only an estimated 42% of Ecuadorians requiring ARVs were actually receiving treatment. In the declaration, Constitutional principles, as well as provisions of the National Development Plan and national agreements such as TRIPS were cited as supporting the decree.

On December 21st, 2009, the president signed a second decree establishing Enfarma, a public pharmaceutical firm, in part to collaborate with IEPI to implement the licensing protocol. In 2010, IEPI granted a compulsory license for ritonavir. This set an important precedent for the global Kaletra campaign, as it permitted generic competition with Abbott’s patented second-line HIV/AIDS drug, a combination of ritonavir and liponavir

The president outlined his vision for the licensing policy on national television, appearing on a program called “Enlace Ciudadano”. The president explained: “Therefore, the subject of intellectual property is tremendously important. What is our vision? When something has been invented or discovered, the more people that use it, the better. For example, a medicine. We're talking about human rights. Do you think it's ethically sustainable that if a cure for cancer is invented, people could continue to die because they don't have the resources to pay?

These proclamations followed actions undertaken by civil society groups to promote such licenses. In January of 2009, organizations met in Ecuador to sign a charter for a new national HIV/AIDS network, termed REDEVIDA. This new network delivered a letter to the Ministry of Public Health on January 26, which was subsequently signed by delegates representing nineteen Ecuadorian organizations, who pledged their support for a compulsory licensing proposal to reduce the costs of lopinavir + ritonavir.

On April 24, 2010, the Ecuadorean Institute of Intellectual Property (IEPI) issued Ecuador’s first compulsory license for ritonavir, an essential component of Abbott’s patented lopinavir+ritonavir, commercially known as Kaletra and Aluvia.

By 2010, close to 9,000 patients were receiving ARV therapy, almost 65% of individuals in need of the medications, an increase of about 5,250 patients since 2008. In 2010 alone, more than 3,439 initiated treatment.

As of 2014, Ecuador has issued nine compulsory licenses covering six drugs. Compulsory licenses issued in 2014 demonstrate that the government’s commitment extends beyond HIV. In addition to licenses for the ARV drugs ritonavir and abacavir + lamivudine, licenses have been granted for indications including arthritis (etoricoxib), kidney transplants (mycofenolate sodium), cancer treatment (sutinib), and rheumatoid arthritis (certolizumab).

Ecuador should encourage robust competition so that the Ecuadorean people can reap the maximum benefit of licensing. The Ministry of Health and other purchasers should invite bids and publish the results online in easily accessible form.

Ecuador’s moves to expand access are reflective of a broader effort across much of Latin America to reexamine pricing, research and development policies for public health. Ecuador’s issuance of nine compulsory licenses represents a significant development in this ongoing process.

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