History of Compulsory Licensing in Ecuador
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.”
decision established a protocol for authorizing generic competition with
patented medicines, in order to reduce prices and promote access to medicines.
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.
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
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.
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 +
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
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.
Back to Ecuador's action page