Country Disputes and Other ...

During this week's Meeting of the South American Union of Nations (UNASUR) in Guayaquil and Quito Ecudaor, UNASUR Health Ministers announced their strong support for Ecuador's new policy of licensing patents to improve access to medicines.

Speaking for the delegates, Peruvian Health Minister Oscar Ugarte Ubillús said Ecuador's decision is an "exercise of sovereignty, a positive act, in accordance with international rules, for which the UNASUR ministers and officers of Health offer our support." Ministers from Argentina, Paraguay, Bolivia, Brazil, Venezuela and Chile each spoke in turn in support of Ecuador's policy.

The ministers also discussed the advantages of block negotiating for better AH1N1 vaccine access.

So far the news stories on this subject are all in Spanish. Stories from Voice of America and El Nuevo Empresario (Guayaquil) are available below.
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IP-Watch
By Catherine Saez

Since Ecuadorean President Rafael Correa signed a decree on 23 October allowing compulsory licences, the national intellectual property office has been working on a mechanism for issuing those licences, which should be studied case by case, according to the national decree.

Referring to Article 31 of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, the Ecuadorean constitution, and the WTO Doha Declaration on TRIPS and Public Health, Correa declared access to essential medicines of public interest to the Ecuadorean population.

Ecuador’s intellectual property office is currently working on legislation for issuing compulsory licences that will be TRIPS-consistent and will respect all of Ecuador’s obligations as a member of the WTO, an Ecuadorean official in Geneva told Intellectual Property Watch.

Patently-O Patent Law Blog
by Dennis Crouch

Under the TRIPS agreement member Nations can force compulsory patent licenses at their discretion. The 2001 Doha declaration clarifies this point: "Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted."pic-76.jpg

In October 2009, Ecuador's president issued a decree that allows its Ministry of Public Health to issue compulsory licenses based on public interests such as access and costs. According to IP Watch, the government is now "working on a mechanism for issuing those licenses" on a case-by-case basis. [Link]

Spinning this decision, Access-to-Medicines advocate Peter Maybarduk indicated that the US is the world leader in compulsory licensing:

"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."

Major pharmaceutical companies have reportedly agreed to work with the government in collecting royalty payments. The same report indicates that Ecuador plans to obtain drugs both through local manufacture and imports. Prior to TRIPS, more than four-dozen countries categorically refused to grant patent rights on pharmaceuticals.

On October 26, Ecuadorean President Rafael Correa announced a bold new national access to medicines policy through decree no. 118, declaring access to priority medicines a matter of public interest, and establishing procedures for issuing compulsory licenses. Such licenses would authorize price-lowering competition with expensive patented drugs.

Many news articles, in Spanish, English and French, reported on the decree, as well as on subsequent comments and analyses by the patent office, national and international pharmaceutical companies, and observers. Unfortunately, several inaccuracies circled the globe through some of these reports. Essential Action has produced a fact sheet to correct a few of the most commonly repeated inaccuracies.

Download a .pdf version of the Ecuador fact sheet here: EcuadorCLPolicyClarifications.pdf

The fact sheet is also available in the continuation of this post.

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On October 26, 2009 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.

Download a .pdf version of the Essential Action backgrounder on Ecuador's Presidential Declaration on compulsory licensing here: EcuadorPresidentialdeclarationbackgrounder.pdf

Download a .doc version of the backgrounder here: EcuadorPresidentialdeclarationbackgrounder.doc

You can read a text version of the backgrounder in the continuation of this post.
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On October 26, 2009 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.

You can download a .doc version of an unofficial English translation of the declaration here: Decree_CorreaEnglishunofficialtranslation.doc

Dear Colleagues,

On Monday October 5 I wrote you about Ecuador's plans to expand access to medicines by issuing compulsory licenses, and about President Correa's vision for intellectual property "as a mechanism for development for the people" (see my post at the bottom of this email for a reminder and an excerpt of President Correa's comments). Compulsory licenses authorize generic competition with patented medicines, reducing costs and enabling more people to access treatment. Discussions on a compulsory licensing administrative framework are advancing in Quito. This is a critical moment in the discussion, and we would like to show President Correa he has the support of the access to medicines movement.

Essential Action is collecting signatures in support of President Correa's vision, and reiterating the benefits of TRIPS-compliant compulsory licenses. See our letter below. If you would like to sign on, please send your organization's name (or your name and organizational affiliation, if any, if you would like to sign on as an individual), your mailing address and email address to . For organizations and individuals able to arrive at a decision quickly, we would appreciate your signature right away – by this Sunday October 11th if possible. The outside deadline for sign-ons is Wednesday, October 21. Please feel free to send me any questions you may have.

Thank you,
Peter Maybarduk
Essential Action

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In July of this year, Ecuador’s President Rafael Correa articulated a vision of intellectual property as “a mechanism for development for the people.” His speech before a live audience on the nationally televised program "Enlace Ciudadano" ("Citizen Connection") announced a new state policy of using compulsory licenses to improve access to medicines.

I’ve translated an excerpt below. The clip is available (in Spanish and sign language) on YouTube here, as well as the homepage of the Ecuadorean Intellectual Property Institute (IEPI, Ecuador’s patent office), here.

Last week, President Correa announced plans to use compulsory licenses to facilitate the domestic production of medicines. Here is the story in El Universo, courtesy of Judit Rius Sanjuan.

Correa, an economist recently elected to a second term (with a simple majority and a twenty-three point lead over his closest competitor), has charged high-ranking officials in his administration to implement the policy.

Nevertheless, we have heard reports of multinational pharmaceutical companies organizing behind the scenes to disrupt the licensing policy before it can take effect. To realize President Correa’s vision, Ecuador needs the support of the global access to medicines movement.

To show your support and find out how you can help, write:

Essential Action, peter.maybarduk@essentialinformation.org and

Health Action International Ecuador, teranj_aisec@cablemodem.com.ec

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Comunicación Positiva, a Colombian NGO that develops communication strategies for civic engagement and human rights, has produced a series of documentary audio programs and a video short covering the evolution of the HIV/AIDS compulsory license & access to medicines campaign in Colombia, 2008-2009. The Spanish-language series is entitled "For the right to health – no to patents!" ("Por el derecho a la salud – no a las patentes!"), and features interviews with about thirty activists, analysts and people living with HIV/AIDS.

Check out the video introduction (in spanish) on Youtube here.

To download a zip file (higher-resolution version also in spanish), click here.

To listen to the audio series (in spanish), visit this site.

The audio series (in spanish) is also available on CD from Comunicación Positiva. Contact: David Morales; david.morales.alba@gmail.com

Bogotá, Colombia – Wednesday, September 16, 2009 –

Today, NGOs, attorneys and activists filed suit in Colombian court to compel the government to authorize price-lowering generic competition with Abbott Laboratories' costly HIV/AIDS treatment Kaletra (lopinavir+ritonavir, LPV/r).

The "acción popular" demands an open compulsory license allowing any producer that can demonstrate drug safety and efficacy and good manufacturing practices to use patented technology to bring generic LPV/r to market.

Chicago-based Abbott enjoys a LPV/r monopoly in Colombia, where Kaletra, a key second-line HIV/AIDS medicine, ranks consistently among the health system's most expensive annual medicine purchases and routinely sells for well over $3,000 per person per year. Global competitive prices have dropped under $500. Earlier this year, in response to Colombian NGOS administrative request for a compulsory license, the Colombian government imposed price ceilings on the drug – approximately $1,000 for public sector sales and $1,600 for the private sector. But recent reports suggest Abbott has violated the price order in its transactions with at least some purchasers. The National Commission on Medicine Prices is investigating.

The eighty-page acción popular cites state failures to provide for Constitutional and collective rights to health. It names the health ministry, patent office, drug regulatory authority and Abbott Laboratories as defendants. Plaintiffs include Fundación IFARMA, Fundación Misión Salud, RECOLVIH (Colombian network of people living with HIV/AIDS), and attorneys Luz Marina Umbasía (in her personal capacity), Giomar Angélica Aguilar and Germán Rincón Perfetti.

We will occasionaly issue updates on the suit's progress and also hope provide more information soon. With questions, English speakers can contact Peter Maybarduk at Essential Action (peter.maybarduk@essentialinformation.org) or Francisco Rossi of the Colombian Foundation IFARMA, a plaintiff in the suit (francisco_rossi@hotmail.com).