E-DRUG: Ecuador President on Access to Medicines & Compulsory Licensing
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[Note: President Correa's decree is available online, in Spanish, at:
http://www.sigob.gov.ec/decretos/\]
Ecuador’s Presidential Declaration on
Access to Medicines and Compulsory Licensing
– Backgrounder –
Quito, Ecuador, October 26, 2009 – Today, Ecuador’s President Rafael
Correa declared access to priority medicines affecting the health of
the Ecuadorean population to be a matter of public interest. Under
Andean Community law, the declaration opens the door to competition
of generic medicines with patented brand-name drugs, through use of
an internationally recognized legal mechanism called compulsory
licensing. The declaration could lead to government policies that
expand access to medicines.
Globally, competition has consistently proven the most effective
method to reduce medicine prices, and ensure prices continue to fall
over time. Over the last ten years, generic competition has produced
a revolution in HIV/AIDS treatment, reducing prices for first-line
antiretrovirals from around $10,000 to around $100 per year, and
enabling over four million people worldwide to access treatment.
By issuing a compulsory license, a government can authorize
competition with patented products, including the importation,
domestic production, distribution and/or sale of generic medicines.
In exchange, licensees pay reasonable royalties to the patent holder,
set by the government according to the circumstances of each case.
Compulsory licenses do not “eliminate” or “override” patents.
Instead, they authorize the use of patented technology under
enumerated conditions.
Countries’ right to issue compulsory licenses “on grounds of their
choosing” is enshrined in the World Trade Organization’s TRIPS
Agreement (1995) and unanimous Doha Declaration (2001) on
intellectual property and public health. The WTO’s Doha Declaration
also states, “the [TRIPS] Agreement can and should be interpreted and
implemented in a manner supportive of WTO Members' right to protect
public health and, in particular, to promote access to medicines for
all.”
Ecuador’s Presidential declaration does not on its own issue a
compulsory license. Rather, it authorizes procedures by which the
government can subsequently decide, case-by-case, to issue compulsory
licenses for priority medicines (as determined by the Ministry of
Public Health), based in public interests such as reducing treatment
costs and enabling greater access to treatment. The declaration
follows public pronouncements by President Correa articulating a
vision of intellectual property as “a mechanism for development for
the people,” and is an important step toward access to medicines for
all.
Many countries have used compulsory licenses to promote public
interests and remedy anti-competitive practices in a variety of
sectors. Today, the United States is perhaps the most frequent user
of compulsory licensing; including the government use of defense
technologies, and judicially-issued licenses to remedy anti-
competitive practices in information technology and biotechnology,
among others. Canada routinely issued compulsory licenses during the
1960s and 70s to develop its national pharmaceutical industry. In
recent years, a number of countries have issued compulsory licenses
to improve access to medicines, including Thailand, Malaysia,
Eritrea, Mozambique and Indonesia, among others.
In 2007, Brazil issued a compulsory license for the HIV/AIDS medicine
efavirenz. Brazil has provided treatment to hundreds of thousands of
people living with HIV/AIDS and saved well over US$1 billion through
its combined medicines strategy of domestic production, importation,
negotiation and compulsory licensing.
President Correa signed the declaration Friday, but his office
released it today. The declaration enables Ecuador’s government
officials to consider introducing generic competition with some of
the country’s expensive patented drugs, including second-line HIV/
AIDS treatments that cost more than double the current competitive
price, and lifesaving cancer treatments that exceed $35,000 per
person, per year, and which some hospitals cannot afford. The UNAIDS
2008 report estimated 42% of Ecuadoreans needing antiretroviral
therapy received it. Resource constraints in Ecuador limit
availability of treatment.
Ecuador’s declaration cites Constitutional principles as well as
provisions of the National Development Plan and international
agreements, including the WTO TRIPS Agreement and the World Health
Assembly Global Strategy and Plan of Action on Public Health,
Innovation and Intellectual Property. The declaration charges the
Intellectual Property Institute of Ecuador (IEPI) with establishing
royalties and the terms of licenses, in compliance with all
applicable national legislation and international rules. The
Presidential declaration incorporates requirements of the WTO’s TRIPS
Agreement and Andean Community legislation, including excerpting some
passages word-for-word. IEPI has published an administrative guide to
compulsory licensing for the use of Ecuador’s government agencies.
For more information, contact:
Peter Maybarduk
Attorney
Essential Action
Access to Medicines Project
In Quito:
Hotel Reína Isabel: +593-2-254-5156; 255-5156; 254-4454
Skype: petesystem
IEPI (Ecuador’s patent office): +593-2-250-8000; 8001; 8002; 8003
(Oficina de Andrés Ycaza)
peter.maybarduk@essentialinformation.org