Country Disputes and Other ...

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).

Earlier this year, Colombian HIV/AIDS groups won major price reductions for the antiretroviral drug lopinavir + ritonavir (Abbott Laboratories' Kaletra) through a compulsory license campaign. While the Colombian health ministry eventually turned down the license request "for now", the campaign moved the government to fix a price ceiling for Kaletra, some 54-68% lower than Abbott's previous prices. The price ceiling should reduce the average annual treatment cost per person by about $2,000 per year.

Nevertheless, reports are surfacing that Chicago-based Abbott may be defying the price order in its sales to some buyers. The National Medicines Pricing Commission (Cnpm), which imposed the ceiling, is investigating. An article this week in El Tiempo , Colombia's largest newspaper, quoted an anonymous knowledgeable source in Colombia's largest healthcare providers association, saying Abbott's prices have not changed. (Officially, the association reported it could not disclose the prices it pays Abbott, due to a confidentiality agreement.) And receipts from a separate source show at least one consumer recently paid prices considerably higher than the ceiling.

Although Abbott has not commented on the reports, it has petitioned the government to revoke the price order.

Health Minister Diego Palacio sent healthcare providers a letter last week concerning lopinavir+ritonavir's new price, saying the state "will prevent any person or company from abusing their dominant position in the market." If the Pricing Commission's investigation reveals Abbott has failed to comply with the price order, it will refer the case to the Agency for Industry and Competition (SIC) to levy sanctions.

Notably, Abbott's refusal to comply with the price order would provide Colombia new and persuasive legal grounds to issue a compulsory license: precisely the anti-competitive conduct cited by Minister Palacio in his letter. In order to maintain credibility and preserve its authority, the Colombian government needs to take swift and stern action. Colombian HIV/AIDS groups will make the case.

The El Tiempo article is available in Spanish in the continuation of this post.
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Today, Essential Action along with eight other civil society organizations, sent a letter to the World Health Organization Expert Working Group on R&D financing (EWG) to express concerns and make suggestions regarding issues of transparency and balance, conflict of interest and substantive outcomes. The expert working group, which is meeting today in Geneva, was created as the third stage of a longer process to address important flaws in the current system of financing medical R&D. The EWG follows the work of the WHO Commission on Intellectual Property Rights, Innovation, and Public Health (CIPIH) and the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The overall objective of these initiatives has been to reform and change the current system of R&D financing.

Download a .pdf version of the letter here: ngos2ewg_30jun2009.pdf

You can read a text version of the letter below the jump.
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In June 2009, a paper by Sarah Rimmington and Peter Maybarduk of Essential Action, titled "Compulsory Licenses: A Tool to Improve Global Access to the HPV Vaccine?," was published in the American Journal of Law and Medicine.

Cervical cancer disproportionately affects women in lower- and middle-income countries. But the new vaccines developed to prevent infection with some strains of the human papillomavirus (HPV) that cause cervical cancer are priced beyond the reach of most women and health agencies in these regions, due in part to the monopoly pricing power of brand-name companies that hold the patents on the vaccines.

Maybarduk and Rimmington conclude that compulsory licenses, which authorize generic competition with patented products, could expand access to HPV vaccines under certain circumstances. If high-quality biogeneric HPV vaccines can be produced at low cost and be broadly and efficiently registered, and if Merck and GSK are unwilling to grant licenses on a voluntary basis, compulsory licensing could play a pivotal role in ensuring vaccinations against HPV are available to all, around the world, regardless of ability to pay.

The authors also note that some of the barriers they identify could pose formidable – and perhaps insurmountable – hurdles to the successful use of compulsory licensing of this one particular product (Merck and GSK's HPV vaccines) in the near term. Of particular concern are the possible scientific and regulatory challenges to manufacturing and registering generic HPV vaccines (which are biologic products), and the likelihood manufacturing would in any event be concentrated in very few countries. They point out this last challenge could be eased if more manufacturing countries adopt TRIPS Paragraph 6 legislation, enabling them to export vaccines under compulsory license.

However, though barriers to making and using compulsory licenses to ensure the distribution of low-cost generic HPV vaccines may prove insurmountable in the near term, the analysis provided in their paper can still assist governments, humanitarian organizations and others to evaluate the appropriateness of compulsory licensing as a tool to promote access to other life-saving products. For many products, the hurdles will not be so great. Important examples include the prohibitively expensive newer, second-generation drugs for HIV-AIDS, as well as other traditional, chemical-based drugs aimed at additional diseases, which will not face the manufacturing and registration hurdles unique to biologic products like the HPV vaccine.

The context for every product will necessarily be different. But as brand-name companies intensify global patenting, compulsory licensing as a tool to promote access to affordable medical technology becomes ever more important.


Download a copy of the paper here: Rimmington_Maybardukpaper.pdf